WO2014056460A1 - Multifunctional ablation catheter system for renal sympathetic denervation - Google Patents

Multifunctional ablation catheter system for renal sympathetic denervation Download PDF

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Publication number
WO2014056460A1
WO2014056460A1 PCT/CN2013/086076 CN2013086076W WO2014056460A1 WO 2014056460 A1 WO2014056460 A1 WO 2014056460A1 CN 2013086076 W CN2013086076 W CN 2013086076W WO 2014056460 A1 WO2014056460 A1 WO 2014056460A1
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WIPO (PCT)
Prior art keywords
ablation
catheter
head
independent
wire
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PCT/CN2013/086076
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French (fr)
Chinese (zh)
Inventor
杨攀
宋治远
钟理
廖新华
王子洪
舒茂琴
仝识非
Original Assignee
第三军医大学第一附属医院
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Publication date
Priority claimed from CN201210313132.0A external-priority patent/CN102908189B/en
Priority claimed from CN201210312999.4A external-priority patent/CN102885649B/en
Priority claimed from CN 201220431913 external-priority patent/CN202726990U/en
Priority claimed from CN 201220434502 external-priority patent/CN202761434U/en
Priority claimed from CN201210312649.8A external-priority patent/CN102885648B/en
Priority claimed from CN201210313087.9A external-priority patent/CN102908188B/en
Application filed by 第三军医大学第一附属医院 filed Critical 第三军医大学第一附属医院
Publication of WO2014056460A1 publication Critical patent/WO2014056460A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1492Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345Vascular system
    • A61B2018/00404Blood vessels other than those in or around the heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00434Neural system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00505Urinary tract
    • A61B2018/00511Kidney
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577Ablation

Definitions

  • the present invention relates to a medical device, and more particularly to a multifunctional ablation catheter system for treating hypertension and intervening into the renal artery to block the renal sympathetic nerve.
  • Hypertension is a common and frequently-occurring disease in the clinic. According to the latest data, the number of hypertensive patients in China has exceeded 200 million, and the number of cases has increased year by year, and the age of onset has gradually advanced. High blood pressure, heart, brain, kidney and other important organs are complicated by high blood pressure and disability, which seriously endangers human health. There are about 30,000 million patients with refractory hypertension in China. In the future, with the aging of the population and the increase in obesity and diabetes, the number of patients with refractory hypertension will further increase, bringing great benefits to society, families and individuals. burden. At present, there is no good treatment for refractory hypertension, and new non-pharmacological treatments are being developed to make up for the shortcomings of current drug therapy, so that it is imperative to control blood pressure safely and effectively.
  • US 2011/0264075 A1 discloses a radiofrequency ablation catheter for renal desympathetic nerves. Although such catheters produced by Ardian have certain applications in foreign countries, there are also significant deficiencies. First, the catheter can only perform single-point ablation. Because the radiofrequency ablation of the renal sympathetic nerve is generally 6-8 points of spiral ablation around the renal artery, Ardian's catheter needs to be ablated 6-8 times. , the operation time is relatively long. For the ablation catheter of Ardian, the problem of multi-point ablation is not possible, US 2012/0116392 Al, US 2012/0029510 Al, CN 201110117776. 8, CN201110327772.
  • CN 102198015A achieves simultaneous multi-point ablation by mounting a plurality of radio frequency electrodes on a spiral electrode rod according to a predetermined position, although the above design achieves a plurality of simultaneous ablation of the renal artery to some extent, Because the radiofrequency ablation electrode is not tightly attached to the vessel wall, the radiofrequency ablation electrode is easy to move during ablation, and the ablation range is too large, causing unnecessary damage to the patient; in order to make the plurality of radiofrequency ablation electrodes closely attached to the vessel wall at the same time , US 2012/0101413A1 uses a solution to provide an expanding balloon in a rotating electrode rod.
  • the radiofrequency ablation electrode By filling the balloon with a liquid, the radiofrequency ablation electrode can be closely attached to the vessel wall, but the renal blood flow is expanded when the balloon is dilated. Will be blocked, if the ablation time is long, it will lead to renal ischemia, causing unnecessary In order to avoid the renal blood flow being blocked US 2012/0029512 Al Replace the ball with a wire tennis ball, although the problem of renal blood flow is blocked, but the operation is far from the convenience of the ball; The arterial variability is large, and the design of these multiple radiofrequency ablation electrodes is difficult to apply when the renal artery is mutated, thus limiting the population of renal sympathetic treatment; and the design of the above multiple radiofrequency ablation electrodes is only For radiofrequency ablation, it is difficult to generalize the same design for laser ablation, microwave ablation, and the like.
  • the object of the present invention is to provide a renal sympathetic multi-functional ablation catheter system capable of achieving simultaneous multi-point ablation, real-time monitoring of ablation blocking effect, and better mechanical stability.
  • the technical solution is such that a renal desympathetic multi-functional ablation catheter system includes:
  • ablation catheter a control handle and an ablation generating device, wherein the ablation catheter comprises a catheter body segment and an ablation segment, wherein the catheter body segment is connected to the control handle;
  • the ablation section includes at least two separate structures with an ablation head mounted on at least one of the separate structures; the ablation head is coupled to an energy exchange connector on the control handle via a wire, conduit, microwave antenna or fiber, the energy exchange connector Connected to the ablation device via a wire, catheter, microwave antenna or fiber;
  • the separate structure allows the ablation head to be fitted or removed from the designated ablation position by pulling or/and pushing one end of the traction structure that is fixed to the separate structure and controlled by the handle at the other end; or the separate structure contains a substance attracted by the magnet, the external structure is deformed by an external magnetic field to cause the ablation head to fit or leave the designated ablation position; or the independent structure (8) contains a smart material deformed by external stimulation to fit the ablation head Or leaving the designated ablation position; the control of the above independent structure also includes the independent structure setting prefabrication deformation;
  • the ablation catheter comprises a catheter body segment and an ablation segment, wherein the catheter body segment is coupled to the control handle;
  • the ablation section includes at least two separate structures with an ablation head mounted on at least one of the separate structures; the ablation head is coupled to an energy exchange connector on the control handle via a wire, conduit, microwave antenna or fiber, the energy exchange connector Connected to the ablation device via a wire, catheter, microwave antenna or fiber;
  • the separate structure allows the ablation head to be fitted or removed from the designated ablation position by pulling or/and pushing one end of the traction structure that is fixed to the separate structure and controlled by the handle at the other end; or the separate structure contains a substance attracted by a magnet, the external structure is deformed by an external magnetic field to cause the ablation head to fit or leave the designated ablation position; or the independent structure contains a smart material deformed by an external stimulus to cause the ablation head to fit or leave the designated Ablation position
  • the control of the above independent structure also includes the independent structure setting prefabrication deformation
  • the guiding catheter is fixed to the guiding catheter head by pulling or pushing one end, and the other end is controlled to be bent by the guiding wire controlled by the handle; or the guiding catheter contains a substance capable of being attracted by the magnet, and the guiding body is guided by the external magnetic field Deformation of the guiding tube; or by controlling the smart material on the guiding catheter that senses external stimuli; or/and compliant bending of the guiding catheter; or/and guiding the prefabrication of the guiding catheter;
  • the guiding catheter is controlled by the guiding catheter handle or control handle and is not controlled by the handle.
  • the distal end of the catheter body segment further includes a controllable curved section coupled to the proximal end of the ablation section, the controllable curved section being secured to the controllable curved section by one end of the pulling or/and pushing and the handle being controlled by the handle at the other end
  • the wire control is deformed; or the controllable bending segment is deformed by pulling or/and pushing one end of the wire to be fixed on the independent structure, and the other end is controlled by the handle; or the controllable curved section contains a magnet An attracting substance that deforms the controllable curved section by an applied magnetic field; or the controllable curved section contains a smart material that is deformed by an external stimulus; or/and a compliance bend is controlled by the control handle to control the controllable curved section; or / Pre-fabrication with the controllable bending section.
  • Sensors are also mounted on the ablation catheter or/and the control handle, the guiding catheter or/and the guiding catheter handle.
  • the independent structures are connected at the proximal end, and the two independent structures comprise four forms: the distal ends of the two independent structures are integrated to form the ablation section head end; or the two independent structures are separated from each other independently of each other. Or the middle portions of the two separate structures are connected together, and the distal ends are separated from each other; or the proximal ends of the two independent structures are connected, and the distal ends are respectively connected to different positions of the traction wires.
  • the ablation head is selected from the group consisting of a radio frequency ablation electrode head, a resistance heating ablation head, a liquid-cold perfusion radio frequency electrode head, a cryoablation head, an ultrasound ablation probe, a focused ultrasound ablation probe, a laser ablation head, a focused laser ablation head, and a photodynamic therapy ablation head.
  • a child wave ablation head wherein the radiofrequency ablation electrode head comprises a radio frequency ablation electrode.
  • the independent structure is provided with detection electrodes for emitting or/and receiving electrical pulses; or / and the ablation heads are also used to dispense or/and receive electrical pulses.
  • a detection electrode for emitting or/and receiving an electrical pulse is disposed on the controllable curved section.
  • the traction wire travels outside the independent structure or/and travels in a separate structure.
  • the tip end attachment point of the traction wire is disposed at the head end of the ablation section, or is disposed on a separate structure of the independent structure head to the connection point, or is disposed on the ablation head.
  • connection point On a separate structure to the connection point, or a separate structure between the ablation section head end and the ablation head, or on a separate structure in the ablation head or adjacent thereto, or a connection joint provided at the connection point of two separate structures
  • the traction wires are merged into one or respectively running on the long axis center line of the controllable bending section and the catheter body section, and finally connected with the control knob or the control panel of the control handle.
  • the head of the guiding catheter is provided with a slanted hole or/and a side channel that communicates with the blood vessel.
  • the leading end of the guiding catheter is provided with a necking structure or a plug, and the side wall of the guiding duct is provided with a side groove; when the independent structures are separated from each other independently
  • the middle portion of the guiding catheter or the side wall of the head is provided with oblique holes; when the middle portions of the independent structure are connected together, and the distal ends are separated from each other, the head end or the head side wall of the guiding catheter is arranged to communicate with the blood vessel
  • the inclined hole after the inclined hole, is provided with a side groove on the side wall of the guiding catheter.
  • the number of guiding wires is set, the tip end attachment point of the guiding wire is arranged at the head of the guiding catheter, and the corresponding centrifugal position is selected according to the direction of bending required, and the guiding wire travels in the guide.
  • the guide wire travels in the controllable curved section or/and outside the controllable curved section, and the number of guiding wires is set according to the number of bending directions required.
  • the controllable curved section is designed with a C-shaped bending, the tip end of the guiding wire is attached. It is arranged at a position where the controllable curved section is close to the ablation section, and the corresponding centrifugal position is selected according to the direction of bending required;
  • a guide wire is attached to the second curved distal end where the S-shaped bending is required to be attached, the guiding The wire is selected according to the direction in which the bending is required, or the number of the guiding wires is not increased.
  • the tail wall of the guiding catheter is further provided with an opening for connecting an injector or a liquid injection device for intravascular injection or injection of an intravascular contrast agent, or by guiding the catheter end opening with a syringe or/and a liquid injection device Connecting intravascularly or/and injecting an intravascular contrast agent; or/and providing a connection connector at the end of the guiding catheter, the connection connector being coupled to the syringe, the infusion device, the ablation catheter or the control handle.
  • the ablation catheter or/and the guiding catheter are manufactured by selecting materials of different hardness, or by selectively reducing or/and increasing the internal structure of the partial catheter segments or/and the structure of the tube wall, or by ablation catheters. Or / and the guiding catheter is implanted with a structure that is susceptible to deformation.
  • the ablation catheter is secured to the upper end of the control handle by a catheter body segment having an energy exchange connector at the lower or lower side of the control handle, and wires, conduits, microwave antennas or fibers from the ablation head are collected through the control handle at the energy exchange connector.
  • the control handle includes an operating handle and an operating handle; the operating handle is provided with a control button for controlling the deformation of the controllable curved section Or a control panel, the control button or the control panel being connected to the guide wire, controlling the controllable curved section by the up and down movement of the control knob, or by controlling the multi-directional rotation of the control disc; or/and including the ring control on the operating handle a button, the ring control button is connected to the pulling wire through a connecting rod, the connecting rod is located in a guiding groove in the control handle, and the independent structure is controlled by moving the ring control button up and down; further comprising preventing excessive pulling Buffer structure.
  • the guiding catheter control handle includes an operating handle and an operating handle 242, and the operating handle 211' is provided with a control button or a control panel for controlling the deformation of the guiding conduit, and the control button or the control panel is connected with the guiding wire, and is controlled by Up and down movement of the button, or control of the guiding catheter by multi-directional rotation of the control panel; further comprising a buffer structure capable of preventing excessive pulling; the guiding catheter control handle and the control handle further comprise a card slot and a hook respectively The latching teeth are separated and combined by the card slot and the hook-shaped latching teeth.
  • the ablation generating device is provided with a connector for energy output and a connector for inputting a sensor signal, and is also provided with a grounding connector connected to an external power source; the ablation generating device includes controlling the parameter and some or all of the information by performing touch screen control.
  • the invention adopts at least two independent structures and each of the independent structures can be provided with an ablation head, so that multiple simultaneous ablation can be realized, the ablation time is shortened, the operation time is reduced, and the patient's pain is reduced. Since the ablation heads on a plurality of independent structures will simultaneously contact the blood vessel wall during ablation, the ablation head can be prevented from sliding, so that the ablation head is more stable during ablation, and the unnecessary tissue damage caused by the instability of the ablation head during ablation is prevented. , reduces complications from ablation and makes the ablation process safer.
  • the independent structure and the controllable curved section have corresponding wire control structure, magnetic control structure or intelligent material to control their deformation, so the catheter has better handling ability, can adapt to different running renal artery, and only ⁇ According to the specific situation, a guiding catheter can be added to the ablation catheter to assist the positioning of the ablation catheter, so that the positioning of the entire ablation catheter system in the blood vessel will be more accurate, preventing unnecessary damage, and the entire ablation system can be applied to more. Crowd.
  • a detection electrode is also mounted on the ablation catheter to facilitate timely detection of the ablation effect and avoid the risk of secondary surgery.
  • the design of the ablation catheter can be adapted to a variety of ablation heads, such as radiofrequency ablation, cryoablation, and ablation, which are easy to generalize.
  • FIG. 1 is a schematic structural view of a specific embodiment of the present invention.
  • Figure 2 is an enlarged schematic view showing four connection modes of two independent structures as ablation sections;
  • FIG. 3 is an enlarged schematic view showing two independent structures as ablation segments deformed in four connection modes;
  • FIG. 4 is a schematic view showing different arrangement modes of the ablation heads on independent structures;
  • Figure 5 is a schematic view of the ablation head as a radiofrequency ablation electrode tip
  • FIG. 6 is a schematic view of the ablation head being a liquid-cooled perfusion radiofrequency ablation electrode tip
  • FIG. 7 is a schematic cross-sectional view of the ablation head when it is a liquid-cooled perfusion radiofrequency ablation electrode tip
  • Figure 8 is a longitudinal cross-sectional view of the ablation head disposed on the head of the independent structure
  • Figure 9 is a view showing the state in which the controllable curved section 5 is in a C-shaped bending design
  • Figure 10-12 is a schematic view of the guiding catheter head in the case where two separate structures are exemplified and the guiding catheter can provide a fulcrum for the deformation of the ablation catheter;
  • Figure 13 is a schematic view showing the working state of the independent structure of the prefabricated deformation and the controllable curved section assisted by the guiding catheter in the case of two independent structures whose distal end is connected to the head end of the ablation section;
  • Fig. 14 and Fig. 15 are schematic diagrams showing the wire control structure of the C-shaped bending design in the case where two independent structures are connected at the distal end of the ablation section as an example.
  • Fig. 16 is a schematic diagram showing the wire-controlled structure of the S-shaped curved design in the case where two independent structures separated from each other are taken as an example.
  • Figure 17, Figure 18, Figure 19 are schematic diagrams showing the hardness distribution of the ablation catheter and the guiding catheter by structural design.
  • Figure 20 is a schematic illustration of the two separate structures of the remote control connected to the tip end of the ablation section and the design of the deformation by adjusting the stiffness distribution of the individual structures.
  • Figure 21 is a schematic diagram showing the design of two separate structures of the remote control separated from each other and the design of the deformation by adjusting the hardness distribution of the individual structures.
  • Figure 22 is a two-wire structure with a separate structure that is connected to the far end and separated from each other in the middle.
  • the hardness distribution of the vertical structure is a schematic diagram of the design deformation.
  • Figure 23 is a schematic diagram of design deformation by adjusting the hardness distribution of the controllable curved section.
  • Figure 24 is a cross-sectional view showing the main structure of the guide catheter tail.
  • Figure 25 is a cross-sectional view showing the wire-controlled structure of the guiding catheter and the design deformation by adjusting the hardness distribution of the guiding catheter.
  • Figure 26 is a cross-sectional view showing the structure of the control handle in the case of taking the wire control structure as an example.
  • Fig. 27 is a cross-sectional view showing the structure of the embodiment of the control handle 2 in the case where the wire guide structure is taken as an example.
  • FIG. 1 shows a specific embodiment of the invention and the main components therein.
  • the renal sympathetic ablation system is mainly composed of an ablation catheter 1, a control handle 2 and an ablation generating device 3, and the guiding catheter 7 is set or not provided according to the situation.
  • the distal end (head end) of the ablation catheter 1 is free, and the proximal end (tail end, end) is connected to the control handle 2, and the ablation catheter 1 is composed of at least the catheter body segment 4 and the ablation segment 6 from the proximal end to the distal end.
  • the proximal end (tail end, end) of the catheter body section 4 is connected to the control handle 1
  • the distal end (head end) of the ablation section 6 is free
  • the front end of the catheter body section may further comprise a controllable curved section 5, depending on the situation. Additional segments are provided between the catheter body segment 4 and the ablation segment 6.
  • the outer rim of each section of the ablation catheter 1 is preferably circular or circular in shape, and the segments into which the ablation catheter 1 enters the blood vessel are preferably of similar or equal diameter.
  • the length of the ablation catheter 1 must be such that the ablation segment 6 can smoothly reach the designated ablation site of the bilateral renal artery, typically 50-120 cm, and the maximum diameter of each segment of the ablation catheter 1 is preferably less than the minimum diameter of the vessel in the vessel path. 5 ⁇
  • the diameter of the ablation catheter is generally 1. 4-2. 5 hidden.
  • the guiding catheter 7 is preferably a hollow tubular structure having openings at both ends, and the guiding catheter 7 is disposed outside the ablation catheter 1 to assist the ablation catheter 1 to reach a designated ablation position.
  • the length of the guiding catheter 7 must be such that the guiding catheter 7 can smoothly guide the ablation catheter 1 to the designated ablation site of the bilateral renal artery, typically 50-120 cm, and the maximum outer diameter of each segment of the guiding catheter 7 is preferably less than 5 ⁇ 5.
  • the hidden diameter of the guiding catheter 7 is generally 1. 4-2. 5 hidden.
  • Figure 1 shows the main features of the ablation section 6 in a particular embodiment of the invention.
  • the ablation section 6 is composed of at least two independent structures 8; the independent structure 8 may be cylindrical, similar cylindrical, semi-cylindrical, pyramidal, pyramidal, curved, etc., each independent structure 8
  • the length and cross-sectional dimensions may be equal or unequal, but preferably, the outer porch of the cross-section of the ablation section 6 surrounded by the outer porch of all the independent structures 8 is preferably adjacent to the outer porch of the cross-section of the controllable curved section 5. .
  • the independent structure 8 may be cylindrical, similar cylindrical, semi-cylindrical, pyramidal, pyramidal, curved, etc., each independent structure 8
  • the length and cross-sectional dimensions may be equal or unequal, but preferably, the outer porch of the cross-section of the ablation section 6 surrounded by the outer porch of all the independent structures 8 is preferably adjacent to the outer porch of the cross-section of the controllable curved section 5. .
  • the distal ends (head ends) of the two independent structures 8 are connected to the ablation section head end 17 (i.e., the ablation catheter tip end); as shown in Fig. 2B, the two independent structures 8 are separated from each other and independent of each other. As shown in FIG. 2C, the middle of the two separate structures 8 are connected together at the distal end and then separated from each other, wherein the connection point 18 is where the two separate structures 8 are connected together.
  • the trailing end of the separate structure 8 is connected to a controllable curved section 5 at the front end of the conduit section 4.
  • the proximal ends of the two separate structures 8 are shown in Fig. 2D, and the distal ends are respectively attached to different positions of the pulling wire 10.
  • Fig. 3 shows the state in which the individual structure 8 of the present invention is deformed in two different connection modes.
  • 3A shows the deformation of the separate structure 8 distally connected to the ablation section head end 17, in which case the intermediate portion of the individual structure 8 will be swelled, generally in the middle or near the middle of the individual structure 8.
  • Figure 3B shows the deformation of the individual structures 8 as they are separated from each other, in which case the individual structures 8 will be remote from each other. Generally, the head ends of the individual structures 8 and their vicinity are most distant from each other.
  • Figure 3C shows the deformation of the independent structure 8 when it is connected to the distal end and then separated from each other. The portion from the connection point 18 to the head end of the independent structure 8 will be away from each other.
  • FIG. 4A is a schematic illustration of the proximal ends of two separate structures 8 connected at different locations of the traction wires 10, respectively.
  • Figure 4 shows the different arrangement of the ablation head 9 on the individual structure 8 in the present invention. As shown in Fig. 4A, at least one of the independent structures 8 is provided with an ablation head 9; as shown in Figs. 4B and 4C, each of the individual structures 8 may be provided with more than one ablation head 9.
  • the ablation head 9 is mainly used for ablation of the renal sympathetic nerve; the ablation head 9 should be the original ablation function, so the ablation head 9 has various types, for example: radiofrequency ablation electrode head, liquid-cooled perfusion radiofrequency ablation electrode head, A cryoablation head, an ultrasound ablation probe, a focused ultrasound ablation probe, a laser ablation head, a focused laser ablation head, a photodynamic therapy ablation head, a microwave ablation head, a resistance heating ablation head, and the like.
  • the types of ablation heads 9 on different individual structures 8 may be the same or different, and the types of a plurality of ablation heads 9 on the same individual structure 8 may be the same or different, for example: the ablation head 9 on a separate structure 8 is a cryoablation head. And the ablation head 9 on the other independent structure 8 is a radio frequency ablation electrode head, or the ablation head 9 at the front end of the same independent structure 8 is a focused laser ablation head, and the latter ablation head 9 is a child ablation head, which makes Different forms of ablation can be accomplished without replacing the ablation catheter 1 in different situations. According to the type of the ablation head 9, the ablation head 9 is different from the connection medium of the energy exchange connector 201 on the control handle 1.
  • the connection medium is generally an optical fiber
  • the ablation head 9 when the electrode tip is ablated for the radio frequency, the connecting medium is generally a wire, and when the ablation head 9 is a cryoablation head, the connecting medium is generally a catheter.
  • Fig. 5 is an example in which the distal ends of two independent structures 8 are connected to the ablation section head end 17, and the main structural features of the ablation head 9 as a radio frequency ablation electrode tip are shown. 5 ⁇ contact with the vessel wall, the radiofrequency ablation electrode 91 is slightly protruded from the surface of the individual structure 8 0. 05-0. 2mm, in order to contact the blood vessel wall, the radiofrequency ablation electrode 91 is provided. . As shown in FIG. 5A, the radio frequency conductor 101 traveling in the independent structure 8 will be connected to the radio frequency ablation electrode 91 to supply energy to the radio frequency ablation electrode 91.
  • the wire connection point 191 is the connection position of the radio frequency conductor 101 and the radio frequency ablation electrode 91. As shown in FIG.
  • the signal line 102 is coupled to a sensor 192 disposed on or adjacent to the radio frequency ablation electrode 91 for transmitting a signal transmitted by the sensor 192 (shown in FIG. 5B); the sensor 192 can be of a different type. For example: temperature sensor, impedance sensor, pressure sensor, etc.; the same type of sensor 192 may be more than one on the independent structure 8 (Fig. 5 is an example of a sensor 192); the sensor 192 is for the radio frequency ablation electrode 91 and the human body. Parameter monitoring helps to understand the real-time situation and adjust the treatment plan in time.
  • Figures 5B and 5C show, in perspective, the main structural features of the RF ablation electrode head 9 and its surrounding independent structure 8. As shown in FIG.
  • the radio frequency ablation electrode 91 (the portion indicated by oblique lines in the figure) may surround only the curved side of the semi-cylindrical body without wrapping the flat side surface 90 of the semi-cylindrical body; as shown in FIG. 5C, the radio frequency ablation electrode 91 (The oblique line indicates the portion) may surround both the curved side of the semi-cylindrical body and the flat side 90 of the semi-cylindrical body; of course, the RF ablation electrode 91 may also adjust the range of its wrapping depending on the situation.
  • the ablation head 9 is designed to be a resistance heating ablation head.
  • FIG. 5 illustrates the design of the ablation head 9 with the distal end of the two independent structures 8 connected to the ablation section head end 17 as an example. Therefore, the design of the ablation head 9 illustrated in FIG. 5 is also applicable to the independent structure 8 .
  • the shape of the individual structure 8 at the position where the ablation electrode 91 is disposed may be changed, and the design may be designed in accordance with the design scheme illustrated in FIG.
  • Figure 6 and Figure 7 show the main structural features of the ablation head 9 when it is a liquid-cooled perfusion radiofrequency ablation electrode head.
  • Figure 7 is a schematic cross-sectional view of the liquid-cooled perfusion radiofrequency ablation electrode tip.
  • the liquid-cooled perfusion radiofrequency ablation electrode head includes a radio frequency ablation electrode 91.
  • the surface of the radio frequency ablation electrode 91 has a plurality of small holes 193 connected to the catheter 103, and the catheter 103 will be connected to the control handle 1.
  • the cooling liquid connected to the liquid filling joint 202 (shown in FIG. 54) is sprayed through the small hole 193 to the surface of the liquid RF ablation electrode 91 for cooling; as shown in FIG.
  • the conduit 103 may be connected to each of the small holes, or Using the design of Figure 6B, the conduit 103 is connected to a cavity 69 below the aperture 193 through which liquid is delivered from each aperture.
  • the cooling can also be performed by using a circulating liquid line around the ablation head 9, preferably by making the catheter 103 spiral, and pouring the coolant from the inlet indicated by the arrow aol, from the arrow ao2. Flow out.
  • the coolant is usually cold brine.
  • the above two types of cooling methods can be used in combination, and can also be used for rewarming, as long as the temperature of the perfusate is adjusted.
  • FIG. 7A shows the main structural features of the cross section of a liquid-cooled perfusion radiofrequency ablation electrode head in the case where the radiofrequency ablation electrode 91 only surrounds the curved side of the semi-cylindrical body without wrapping the flat side 90 of the semi-cylinder;
  • the semicircle shows the case where the radio frequency conductor 101, the signal line 102, and the duct 103 travel in the independent chamber 60, that is, the three structures are moved in separate chambers in the independent structure 8.
  • FIG. 7A shows the case where the radio frequency conductor 101, the signal line 102 and the duct 103 travel in the separate structure 8, at which point the above three structures will be mixed with other structures.
  • Figure 7B shows the main structural features of the cross-section of the liquid-cooled perfusion radiofrequency ablation electrode head with the radiofrequency ablation electrode 91 wrapped around the curved side of the semi-cylindrical and the flat side 90 of the semi-cylinder; the upper semicircle of Figure 7B shows the radio frequency The case where the wire 101, the signal line 102, and the conduit 103 travel in the independent cavity 60; the lower semicircle of FIG.
  • the separate chamber 60 can be divided into a plurality of separate chambers for running different members, and the design of the different members for the different chambers can be used for other types of ablation heads 9, other portions of the ablation catheter 1 and the guiding catheter 7.
  • the design shown in FIG. 6 and FIG. 7 can also be used. The plan is designed.
  • FIG. 8 is an example of a longitudinal section of the longitudinal section of the ablation head 9 as a radio frequency ablation electrode head, showing the ablation head 9 disposed at the distal end of the two independent structures 8; wherein, FIG. 8A shows the ablation The head 9 only surrounds the curved side of the semi-cylindrical body without wrapping the flat side 90 of the semi-cylindrical body, and FIG. 8B shows the ablation head 9 surrounding the curved side of the semi-cylindrical body and the flat side 90 of the semi-cylindrical body.
  • the design of the RF ablation tip illustrated in Figure 8 is similar to the design of the RF ablation tip illustrated in Figure 5. As shown in FIG. 8A and FIG.
  • the distal ends of the independent structures 8 can be separated from each other.
  • the radio frequency wires 101 traveling in the independent structure 8 will be connected to the radio frequency ablation electrodes 91 to provide energy, wires for the radio frequency ablation electrode heads 9.
  • the connection point 191 is a position where the radio frequency wire 101 is connected to the radio frequency ablation electrode 91. As shown in FIGS.
  • the signal line 102 is connected to a sensor 192 disposed on the radio frequency ablation electrode 91 or/and adjacent to the radio frequency ablation electrode 91 for transmitting a signal transmitted by the sensor 192; similarly, the sensor 192 It can be of different types, for example: temperature sensor, impedance sensor, pressure sensor, etc.; the same type of sensor 192 can be more than one on the independent structure 8 (Fig. 8 is an example of one sensor 192); sensor 192 is a pair of radio frequency ablation electrodes
  • the monitoring of the parameters of the head 9 and the human body helps to understand the real-time situation and adjust the treatment plan in time. As shown in FIG.
  • the radio frequency ablation electrode 91 may only surround the curved side of the semi-cylindrical body without wrapping the flat side 90 of the semi-cylindrical body; as shown in FIG. 8B, the radio frequency ablation electrode 91 may surround the semi-cylindrical body.
  • the curved side also surrounds the flat side 90 of the semi-cylinder; of course, the RF ablation electrode 91 can also be adjusted to encompass the extent of the individual structure 8 as appropriate. Since the design shown in FIG. 8 is described by taking the ablation head 9 as a radio frequency ablation electrode head as an example, the design is also applicable to the case where the ablation head 9 is another type of ablation head, and the radiofrequency ablation electrode is required.
  • the head is replaced with other types of ablation heads, such as a liquid-cooled perfusion radiofrequency ablation electrode head, a resistance heating ablation head, etc.; for the case of a plurality of individual structures 8, for a case where the shape of the individual structure 8 is not semi-cylindrical, and for the ablation head 9
  • ablation heads such as a liquid-cooled perfusion radiofrequency ablation electrode head, a resistance heating ablation head, etc.
  • ablation head 9 for the case where the shape of the individual structure 8 at the set position is changed may also be designed in accordance with the design scheme illustrated in FIG.
  • Figure 9 shows the situation in which the controllable curved section 5 is in the C-shaped bending design.
  • the main function of setting the controllable curved section 5 is to facilitate the ablation section 6 to more easily reach the designated ablation position, for example, to ablate Segment 6 is easier to bend through the blood vessel, making it easier for the ablation segment 6 to deflect in a specified direction, and the like.
  • the controllable curved section 5 preferably has a cylindrical or cylindrical design, and the length of the controllable curved section 5 varies according to different designs.
  • the controllable curved section 5 is shown in the working state of the C-shaped bending design. As shown in FIG.
  • the shape of the controllable curved section 5 is C-shaped, and the controllable curved section 5 of the solid line part represents one.
  • the controllable curved section 5 preferably has a length of 60-120 hidden, and the controllable curved section 5 will have two places cl and c2 in contact with the inner wall of the blood vessel, wherein cl and the renal artery
  • the inner side wall of a is in contact, and c2 is in contact with the inner side wall of the abdominal aorta b, which is advantageous for stabilizing the ablation head 9 during ablation
  • the controllable curved section 5 is preferably in the same plane as one of the independent structures 8 at this time,
  • the detecting electrode 19 can be disposed in the cl such that the detecting electrode 19 on the ablation head 9 or the independent structure 8 and the detecting electrode 19 on the controllable curved
  • the controllable curved segment 5 of the broken line portion indicates Another C-shaped bending situation
  • the controllable curved section 5 preferably has a length of 40-100 invisible, the controllable curved section 5 may not be in contact with the inner side wall of the artery, or only one place c2 may be in contact with the inner side wall of the artery, such that the ablation head 9 is Stabilization will primarily rely on the support points formed by the individual structures 8 in contact with the inner sidewalls of the artery.
  • the skilled person can combine, improve and cross-use the design of the above-described ablation section 6 and the controllable bending section 5, and these equivalent variations and modifications also fall within the scope defined by the claims of the present invention.
  • the controllable bending section 5, the independent structure 8 and the guiding duct 7 can take the form of active control deformation or passive control deformation.
  • the active control deformation of the controllable curved section 5, the independent structure 8 and the guiding duct 7 means that the controllable curved section 5, the independent structure 8 and the guiding duct 7 can be controlled by indirect real-time without external force direct action or transmission.
  • the deformation of the curved section 5, the independent structure 8 and the internal force of the guiding catheter for example: the controllable curved section 5, the independent structure 8 and the guiding catheter 7 contain a smart material (such as a shape memory alloy), through ablation
  • a smart material such as a shape memory alloy
  • the control of the temperature of the smart material and the like outside the catheter 1 and the guiding catheter 7 enables real-time transformation of the deformable shape of the controllable curved section 5, the independent structure 8 and the guiding catheter 7 in vivo and in vitro.
  • the passively controlled deformation of the controllable curved section 5, the separate structure 8 and the guiding catheter 7 refers to the controllable bending section 5 by direct or indirect real-time control of external forces acting on the controllable curved section 5, the independent structure 8 and the guiding catheter 7.
  • the deformation of the independent structure 8 and the guiding catheter 7 for example, by pulling the guiding wire 11 fixed on the controllable bending section 5 to deform the controllable bending section 5, by pulling the traction wire fixed on the independent structure 8 10 causes the independent structure 8 to be deformed, and the guiding catheter 7 is deformed by pulling the guiding wire 70 fixed on the guiding catheter 7; for example, during the pushing process, the ablation section head end 17 touches the blood vessel wall to enable Controlling the bending of the bending section 5; for example, the controllable bending section 5, the independent structure 8 and the guiding duct 7 contain substances capable of being attracted by the magnet, and the controllable bending section 5, the independent structure 8 and the guide by the external magnetic field The guide tube 7 is bent.
  • Both the ablation catheter 1 and the guiding catheter 7 can be prefabricated.
  • the controllable curved segment 5 can be preliminarily bent in a certain direction, so that the ablation segment 6 can smoothly enter the renal artery; prefabrication deformation
  • a material having a shape memory function to the ablation catheter 1 and the guiding catheter 7, for example: adding a shape memory alloy to the controllable bending section 5, which can be firstly in vitro
  • the curved shape is pre-formed into a C-shaped bend.
  • the controllable curved section 5 is required to change the curved shape, it can be taken out of the body again to make the controllable curved section 5 into a curved shape of other shapes by temperature change.
  • the smart material is currently preferred, wherein the shape memory alloy with more mature technology is better, and of course, the electroactive polymer and the magnetic activity can be selected according to the technical requirements. Smart materials such as polymers.
  • the shape memory alloy is designed into a spiral shape, a "Z" shape, a "G” shape, etc., and is implanted in the independent structure 8 and the controllable curved section 5 or in their tube walls, and in the wall of the guiding conduit 7, through the current The temperature of the shape memory alloy is adjusted to achieve the purpose of controlling the independent structure 8, the controllable curved section 5 and the guiding catheter 7.
  • the linear control structure design and the magnetic control structure design are preferably used.
  • the wire-controlled structure is designed such that the tension or/and the stress of the guide wire 11 connected to the individual structure 8 or the guide wire 11 connected to the controllable curved section 5 causes a separate structure 8 or a controllable curved section.
  • passive control deformation occurs, but preferably by increasing the tension of the traction wire 10 or/and the guide wire 11, that is, pulling the traction wire 10 and pushing the ablation catheter 1 other than the traction wire 10 or/and the pulling guide wire 11 and Pushing the ablation catheter 1 except for the guide wire 11; similarly, the wire control structure on the guiding catheter 7 is a change in tension or/and stress of the guide wire 70 that travels in the wall of the guiding catheter 7, such that The guide tube 7 undergoes passive control deformation, but it is preferable to increase the tension of the guide wire 70, that is, to pull the guide wire 70 and push the guide catheter 7 except for the guide wire 70.
  • the traction wire 10 is mainly responsible for controlling the deformation of the independent structure 8, and sometimes can also be directed to the ablation catheter 1, and the traction wire 10 can travel in the independent structure 8 in the ablation section 6, or can travel outside the independent structure 8, but in the ablation section. In other portions of the ablation catheter 1 other than 6, the traction wire 10 preferably travels within the ablation catheter 1 and is ultimately coupled to the traction wire retaining disk 205 on the control handle 2.
  • the function of the guide wire 11 is mainly to adjust the direction of travel of the ablation catheter 1 in the blood vessel.
  • the guide wire 11 preferably travels within the controllable curved section 5, and other portions of the ablation catheter 1 other than the controllable curved section 5 are preferably also traversed.
  • the catheter 1 is ablated and ultimately connected to a guide wire retaining disk 204 on the control handle 2.
  • the purpose of the guide wire 70 is primarily to adjust the direction of travel of the guiding catheter 7 within the blood vessel.
  • the guide wire 70 preferably travels in the wall of the guiding catheter 7 and is ultimately coupled to the guiding catheter handle 27 or the control handle 2.
  • the number of the guide wires 11 is mainly determined according to the bending direction to be controlled and the presence or absence of the preset deformation of the controllable curved segments 5.
  • the number of the guide wires 11 is preferably less than or equal to the number of bending directions to be controlled, and Table 1 lists the guide wires. 11 number and control direction and the relationship between preset deformation.
  • the main structure of the magnetron structure is The independent structure 8, the controllable curved section 5 and the guiding catheter 7 are passively activated by the magnetic attraction or repulsion of the independent structure 8, the controllable curved section 5 and the substance capable of being attracted by the magnet in the guiding duct 7 under the action of an external magnetic field. Control deformation, from
  • each of the pulling wires 11 is bent in a direction opposite to the pulling guide wire 11 to realize two directions, and simultaneously
  • Each pulling of a guide wire pulls the guide wire to achieve three directions, and simultaneously pulls two guide wires to achieve three
  • Each pulling of a guide wire pulls the guide wire to achieve a total of four adjacent two into 90 degrees, while pulling the adjacent two guide wires together
  • the angle is in four directions, and the magnitude of the pulling force can be adjusted to the bending direction.
  • the head of the guiding catheter 7 is guided. It is preferable to provide an inclined hole 74 or/and a side groove 76 that communicates with the blood vessel.
  • the inclined hole 74 and the side groove 76 mainly serve as a separate structure 8 to guide the outwardly extending passage of the guide tube 7, and the independent structure 8 is brought into contact with the blood vessel wall.
  • the oblique hole 74 and the side groove 76 can also be used as an injection into the blood vessel or/and The channel into which the contrast agent is injected.
  • FIG. 10A, 10B, and 10C are schematic longitudinal cross-sectional views
  • Figs. 10D and 10E are perspective views.
  • FIG. 10 when the individual structures 8 are separated from each other, a plurality of inclined holes 74 corresponding to the individual structures 8 are formed on the head end (distal end) or the head side wall of the guiding catheter 7; As shown in FIG. 10D, the inclined hole 74 can be opened at the head end of the guiding catheter 7, as shown in FIG. 10B and FIG.
  • the inclined hole 74 can also be opened on the side wall of the guiding catheter 7, each oblique hole.
  • the inner diameter of 74 is greater than the outer diameter of the independent structure 8, generally 1.4 - 2. 4mm, the angle of inclination of each inclined hole 74 is generally 30 - 50 degrees, and the number of inclined holes 74 is preferably equal to the number of independent structures 8, oblique
  • the connecting portion 75 between the holes 74 is preferably tapered, and the connecting portion 75 not only limits the ability of the controllable curved section 5 to be pushed out of the guiding catheter 7 but also helps guide the independent structure 8 to be pushed forward from the inclined hole 74. If the ablation catheter 1 or the retraction guide catheter 7 is pushed, as shown in Fig.
  • the independent structure 8 will be diverged into the blood vessel from the inside of the oblique hole 74, and the ablation head 9 of the head of the independent structure 8 will preferentially The blood vessel wall contact; by controlling the distance between the push ablation catheter 1 or the retraction guide catheter 7 and the inclination of the oblique hole 74, the distance separating the distal ends of the independent structures 8 from each other and the pressure at which the ablation head 9 is in contact with the blood vessel wall can be controlled.
  • 11A, 11B are longitudinal cross-sectional views
  • Fig. 11C is a perspective view. As shown in FIGS.
  • the head end opening of the guiding catheter 7 preferably limits the ablation section head end 17 to be pushed forward by a structural design.
  • Catheter 7, preferably can be set to shrink
  • the structure 73 allows the opening of the tip end of the guiding catheter 7 to be smaller than the outer diameter of the ablation section head end 17 (shown in Fig. 11A), or to close the head end opening of the guiding catheter 7 with the plug 72 (Fig. 11B, Fig. 11C) As shown in FIG.
  • the side wall of the leading end of the guiding catheter 7 is preferably provided with a side groove 76 which is close to the length of the independent structure 8 and communicates with the blood vessel, and the length of the side groove 76 is generally 11-13 mm.
  • the side groove 76 preferably corresponds to the independent structure 8 in parallel.
  • the width of the side groove 76 is slightly larger than the outer diameter of the individual structure 8, generally 1. 4 - 2. 4 hidden, and the number of side grooves 76 is preferably equal to the number of the independent structures 8. If the ablation catheter 1 or the retraction guide catheter 7 is pushed, as shown in FIG.
  • the ablation section head end 17 will cause the individual structures 8 to bulge from the respective side grooves 76 due to the restriction of the plug 72, which will cause the ablation head to be ablated.
  • 9 preferentially in contact with the vessel wall; by controlling the distance between the ablation catheter 1 or the retraction guide catheter 7, the distance between the intermediate portion of the independent structure 8 and the pressure at which the ablation head 9 is in contact with the vessel wall can be controlled.
  • the design of the head of the guiding catheter 7 is combined with the design shown in Figs. As shown in Fig.
  • a plurality of oblique holes 74 communicating with the blood vessel are provided on the side wall of the guiding catheter 7, or a plurality of small oblique holes 74 are provided at the head end of the guiding catheter 7 (similar to Fig. 10A, Fig. 10D).
  • the side groove 76 corresponding to the inclined hole 74 and parallel to the independent structure 8 is disposed on the side wall of the guiding duct 7 at a certain distance after the inclined hole 74, and the spacing between the inclined hole 74 and the side groove 76 is provided.
  • the distance is generally between 2. 5 and 5. 5 mm
  • the inner diameter of each inclined hole is slightly larger than the outer diameter of the independent structure 8, generally 1. 4 - 2.
  • the inclined angle of each inclined hole 74 is generally 30 - 50
  • the connecting portion 75 between the inclined holes is preferably tapered, and the connecting portion 75 can not only restrict the connection point 18 and the controllable curved portion 5 from being pushed out of the guiding duct 7 but also help guide the independent structure 8 from the inclined hole 74.
  • the length of the side groove 76 is preferably slightly larger than the outer diameter of the independent structure 8, generally 1. 4 - 2. 4 hidden, the length of the side groove 76 is similar to the length of the portion of the proximal end of the independent structure 8 to the connection point 18, Typically 10-22 mm, the number of inclined holes 74 and side grooves 76 is preferably equal to the number of individual structures 8.
  • the ablation catheter 1 or the retraction guide catheter 7 If the ablation catheter 1 or the retraction guide catheter 7 is pushed, the portion of the distal end of the independent structure 8 from the connection point 18 will be divergently pushed into the blood vessel from the inside of the oblique hole 74, and the ablation head of the head of the independent structure 8 9 will preferentially contact the vessel wall, and the portion between the proximal end of the independent structure 8 and the junction 18 will bulge from the corresponding side groove 76, and the most prominent place of the ridge will preferentially contact the vessel wall; the ablation catheter is controlled by push 1 or the distance of the retracting guide catheter 7 and the inclination of the oblique hole 74 can control the distance separating the distal ends of the individual structures 8 from each other and the pressure at which the ablation head 9 is in contact with the vessel wall.
  • the oblique holes 74 and the side grooves 76 in the above design also have the effect of injecting a drug into a blood vessel or injecting a contrast agent.
  • the design shape change can be easily realized by adjusting the structural design of the individual structure 8 or by changing the hardness of the manufactured material.
  • FIG. 11, and FIG. 12 illustrate the design of two independent structures 8 as an example, and thus are not limited to the case of two independent structures 8. For more than two independent structures 8, only the map is required. 10.
  • the design concept illustrated in FIG. 11 and FIG. 12 adjusts the number and arrangement positions of the inclined holes 74 and the side grooves 76.
  • the independent structure 8 can also be provided with a pre-formed deformation, the controllable curved section 5 can be prefabricated, and then the ablation catheter 1 can be pressed In the guiding catheter 7, after the head end of the guiding catheter 7 reaches the designated position, the ablation catheter 1 can be pushed out from the opening of the leading end of the guiding catheter 7 to restore the prefabrication deformation.
  • the two separate structures 8 that collect the distal end at the head end 17 of the ablation section are preformed into a spindle-like shape, and the ablation catheter 1 is pressed into the guiding catheter 7, due to the limitation of the guiding catheter 7,
  • the intermediate portions of the two separate structures 8 pre-formed into a spindle shape will be brought closer together; when the guiding catheter 7 reaches the opening of the renal artery a at the aorta b, the ablation section 6 is opened from the opening of the leading end of the guiding catheter 7.
  • the two separate structures 8 will now return to a prefabricated spindle-like shape, with the protruding portion of the attached ablation head 9 preferentially contacting the vessel wall.
  • the guiding catheter 7 can push the ablation section 6 out of the opening of the guiding end of the guiding catheter 7 when approaching the opening of the renal artery a at the aorta b, since By controlling the presence of the C-bend of the curved section 5, the ablation section 6 can also smoothly enter the renal artery a from the aorta b.
  • the two independent structures 8 connected at the distal end to the ablation section head end 17 are taken as an example for design, and thus are not limited to the case of two independent structures 8, and are not limited to the independent structure 8 distal end connected to the ablation section head.
  • connection mode of the two-independent structure 8 of the end 17 is also applicable to the case of more than two independent structures 8 and the other connection modes of the two independent structures 8.
  • the structure 8 is prefabricated in such a manner that the head end and its vicinity are far from each other in the most obvious state, and then pressed into the guiding duct 7, and for example, in the case where the middle of the independent structure 8 is connected to the distal end and then separated from each other, it is necessary to The portion of the individual structure 8 between the distal end and the attachment point 18 is prefabricated in a state in which the head end and its vicinity are far apart from each other, and the portion between the proximal end of the individual structure 8 and the connection point 18 is pre-formed into a spindle shape.
  • the guiding catheter 7 is then pressed into it. Furthermore, it is also possible to provide an oblique hole 74 or/and a side groove 76 corresponding to the individual structure 8 at the head of the guiding catheter 7, so that independence can also be achieved without pushing the guiding catheter 7 before the ablation section 6 is pushed out. Structure 8 restores the prefabricated deformation.
  • FIG. 14 and 15 show the wire-controlled structure when the controllable curved section 5 is a C-shaped curved design.
  • the tip end of the guiding wire 11 is fixed.
  • the point 111 is preferably disposed where the controllable curved section 5 is adjacent to the ablation section 6, and the corresponding centrifugally fixed position should be selected according to the direction in which the bend is desired.
  • the guide wire 11 preferably travels within the controllable curved section 5 and has at least one guide.
  • the wire 11 is coplanar with a pulling wire 10. As shown in Fig.
  • the pulling wire 10 when the controllable curved section 5 is designed with a C-shaped curved portion of a broken line portion, the pulling wire 10 can be used to function as the guiding wire 11, and the head end fixing point 110 of the pulling wire 10 is set at the ablation.
  • the tip end 17 of the segment; of course, the C-shaped curved structure shown in FIG. 15 can also be fixed by the guiding wire 11 shown in FIG. 14, and the arrangement and running of the pulling wire 10 can also be designed according to FIG. Ways to arrange.
  • Figure 16 shows the wire-controlled structure of the controllable curved section 5 in the S-shaped curved design.
  • Fig. 16A when the controllable curved section 5 is designed with an S-shaped curve, the C-shaped curved design shown in Fig. 14A is shown.
  • a guide wire 1 may be attached to the distal end of the second bend which needs to form an S-shaped bend, and the guide wire 1 should be selected according to the direction of bending required to select the corresponding centrifugal attachment.
  • the position is preferably coplanar with at least one of the guide wires 11; as shown in Fig. 16B, the number of the guide wires 11 may not be increased, by adjusting the running path of the guide wire 11, and by adjusting the hardness distribution of the controllable curved segment 5,
  • the "S"-shaped bending can be achieved by one of the guide wires 11.
  • Figures 17, 18 and 19 show the deformation of the ablation catheter 1 and the guiding catheter 7 in a manner designed by the present invention. This manner of structurally facilitating the deformation of the ablation catheter 1 and the guiding catheter 7 does not require the hardness of the material of the respective parts to be different.
  • the chicken rib-like structure shown in Figs. 17A and 17B is disposed inside the ablation catheter 1, i.e., a cross-sectional distance d5 is provided as a structure shown in Fig. 17B, and the structure is indicated by oblique lines.
  • the blank area a1 will form a chamber in the ablation catheter 1, mainly for the running of the traction wire 10 and the poor bending resistance or the easy traction with the wire 10 Or the running of the structure in which the guiding wire 11 is entangled, such as a wire, a conduit, an optical fiber, etc., of course, the blank area a1 is not limited to a circular shape, nor is it limited to only one chamber, and may be set to other shapes according to the situation ( For example, elliptical, rectangular, etc., it is also possible to provide more chambers to travel different components. As shown in Fig. 17A and Fig.
  • the blank region bl will also form a chamber in the ablation catheter 1, mainly for guiding the guide wire 11 or/and the traction wire 10, and of course the blank region a1 is not limited to a semicircle. It is not limited to only one chamber, and may be set to other shapes (for example, elliptical, rectangular, etc.) depending on the situation. It is also possible to provide more chambers to travel different members separately, if it is desired to pull the wire 10 or the guide wire 11 Without affecting each other, the pulling wire 10 and the guiding wire 11 can respectively travel in different chambers. As shown in Fig. 17A, since the area included in d5 lacks the curved structure in the area included in d3 and d4 in Fig.
  • the blank region a1 is located in the blank region.
  • the structure in the region included in d6 in Fig. 17A will be replaced by the structure shown in Fig. 17C.
  • the structure in the region included in d5 of 17A will be an extension of the structure in the region included by dl in Fig. 17C; the blank region a1 will form a chamber in the ablation catheter 1 for pulling the wire 10, which is resistant to bending deformation.
  • the structure or the structure which is easy to be entangled with the pulling wire 10 or the guiding wire 11 is of course not limited to an elliptical shape, nor is it limited to only one chamber; the blank areas bl and b2 are also in the ablation catheter 1 Two chambers will be formed, mainly for guiding the wire 11 or/and the pulling wire 10, of course, the blank areas bl and b2 are not limited to a semicircular shape, nor are they limited to only one chamber, if it is desired to pull the wire 10 and the guide wire 11 do not affect each other, the traction wire 10 and the guide wire 11 can be divided Take different rows chamber; FIG lack in the region of 17C included in d5 d3, d4, d3 ', d4' The arcuate structure in the area contained in the area, so in the direction of the longitudinal axis, the area included in each d5 will easily bend under the action of the pulling wire 10 or the guiding wire 11, and the bending of all the areas included in the d5 will make The
  • FIG. 17A forms an overall curvature, and since the support structure is lacking on both sides of d5, bidirectional bending can occur, and the difficulty of bending in two directions is different by adjusting the sizes of the blank areas bl and b2; Similarly, three bl-like blank regions as illustrated in Fig. 17B can be disposed in three different directions to achieve bending in at least three directions, and such a design structure can be deduced by analogy. As shown in Figs. 17D and 17E, when the cross section of some portions of the ablation catheter 1 is not circular, the chicken rib-like structure can also be realized in the ablation catheter 1 portions, and Figs. 17D and 17E are in a semicircular configuration.
  • the example illustrates the implementation of the chicken rib-like structure in shapes other than a circle, and the positions of the different blank areas a1 and bl are different depending on the direction of the bending.
  • the blank area bl is arranged to the left of the blank area a1, and the structure in the area included in d6 in Fig. 17A will be replaced by the structure shown in Fig. 17D, and the area included in d5 in Fig. 17A
  • the structure will be an extension of the structure in the region covered by dl in Fig.
  • the position can achieve different segments of non-co-directional bending, for example, horizontally rotating the lower half of the structure shown in Fig. 17A by 180 degrees, so that the lower half blank area bl is on the side of the arrow in Fig. 17A, so that the improved structure will help To achieve S-shaped bending.
  • the essence of the chicken rib-like structure is to selectively reduce or/and increase the resistance to bending on one side or sides of certain catheter segments by reducing or/and increasing the internal structure of certain catheter segments so that the catheter It is easier to bend or/and form certain curved forms in certain directions.
  • FIG. 18 shows another design of the present invention which changes the hardness distribution by means of structural design to promote the multi-directional bending of the ablation catheter 1 and the guiding catheter 7.
  • This structural design is preferably used in situations where it is desirable to control the multi-directional bending of the controllable curved section 5.
  • 18A is a schematic perspective view of the structure
  • FIG. 18B is a schematic cross-sectional view of the horizontal center line of the structure included in the structure d6, that is, a cross-sectional view of the cc2 cross section in FIGS. 18C and 18D
  • FIGS. 18C and 18D are the structure.
  • a schematic longitudinal section that is, a cross-sectional view of the ccl cross section in Fig. 18B.
  • the design structure is similar to the chicken rib-like structure, and is also a structure included in a d6 region at a distance d5.
  • the entire three-dimensional structure is a double convex disk overlap.
  • the portion indicated by the oblique line or the horizontal line in the structure is filled with a material having a certain elasticity, and a polymer is preferable.
  • the disc center blank area a1 will form a chamber in the ablation catheter 1, mainly for the traction wire 10, a structure resistant to bending deformation or a structure easily entangled with the guide wire 11.
  • the blank area a1 is not limited to a circle, nor is it limited to only one chamber, and may be set to other shapes (for example, elliptical, rectangular, etc.) depending on the situation, or more chambers may be provided separately.
  • the blank areas bl, b2, b3, b4 around the disc will form four interrupted pipes in the ablation duct 1, mainly for guiding the wire 11, the diameter of the pipe is d3, when the double convex disk
  • the blank areas bl, b2, b3, b4 can also travel the pulling wire 10, etc.; if the pulling wire 10 and the guiding wire 11 are not affected by each other, the pulling wire 10 and the guiding wire 11 can respectively travel in different chambers. In the room. As shown in Fig.
  • some bl-like blank areas may be closer to the blank area a1, so that the tension in the direction of the guide wire 11 or the pulling wire 10 will be greater; the bl-like blank area is in each
  • the position of the double convex disc may also be different, or the same guiding wire 11 or the pulling wire 10 can travel in different bl-like blank areas in the whole structure, so that the bending shape of the entire structure can be adjusted, and distortion can be realized.
  • adjacent two UFO-like disks can be provided with a d5 region, so that the overall structure is more susceptible to bending.
  • each segment can be made different, for example, in Fig. 17A. If a segment is widened by dl, reducing d4 will make this segment not easy to deform. For example, if a segment is widened by d5, this segment will be easier to deform.
  • this structural design is equally applicable to other cross-sectional non-circular structures, such as semi-circles, etc., but in this case, the influence of the asymmetrical structure on the hardness of the guide wire 11, the pulling wire 10, and the structure itself needs to be considered.
  • the essence of the lenticular disc overlap structure is also to selectively reduce or/and increase the resistance to bending on one or both sides of certain duct segments by reducing or/and increasing the internal structure of certain duct segments. To make it easier for the catheter to bend in some directions and/or to form certain curved forms.
  • Fig. 19 shows another design of the present invention which makes the bending easier to achieve by changing the structural design and thereby changing the hardness distribution.
  • the design structure is an implementation of a chicken rib-like structure in a hollow tubular structure, which is preferably used for a hollow tubular structure (e.g., guiding catheter 7, etc.).
  • the structure is achieved by changing the arrangement of the wire mesh in the tube wall of the ablation catheter 1 and the guiding catheter 7 in different catheter segments or by varying the thickness of the ablation catheter 1 and the guiding catheter 7 wall in different catheter segments.
  • the wire mesh described herein should be understood as a design structure for reinforcing the wall hardness of the pipe wall, for example, a polymer material mesh, etc., so the essence of the design is to reduce or/and increase certain conduit segments.
  • the structure of the wall selectively reduces or/and increases the resistance to bending of one or both sides of certain conduit segments to make the catheter more susceptible to bending or forming certain curved configurations in certain directions.
  • Fig. 19 is an illustration of changing the arrangement of the wire mesh in the tube wall of the ablation catheter 1 or the guiding catheter 7 in different catheter segments. As shown in Fig. 19A, the wire in the figure indicates a wire mesh. As can be seen from the lower left view of Fig.
  • the wire mesh in the wall of the catheter tube completely covers the wall of the catheter tube, as can be seen from the upper left diagram of Fig. 19A.
  • it is not limited to the design of the wire mesh in the side wall of the pipe.
  • Fig. 19D there are four S-shaped wires fl, f between the two small sections of the pipe with the complete wire mesh.
  • Fig. 19A can be arranged in a side view as shown in Fig. 19B, so that the bending direction of the entire duct section will be uniform; the structure of Fig. 19A can be arranged in accordance with the side view shown in Fig.
  • the design can still be designed according to the idea, but in this case, the shape of the traction wire 10 and the guide wire 11 need to be considered.
  • the manner in which the ablation catheter 1 and the guiding catheter 7 are hardened by the structural design shown in Figs. 17, 18, and 19 can also be achieved by changing the hardness of the manufactured material.
  • the cross sections of the segments of the catheter can be The design of Figure 17B, but the cross-section d3, d4 of some segments of the region of the manufacturing material is harder than the other segments, then these segments will not easily bend, for example, in the structure shown in Figure 33D, the second The material of the lenticular disc is softer than the first and third, so the bend will be more likely to occur in the second UFO-like disc.
  • Figure 20, Figure 21, and Figure 11 show the ablation of the present invention by taking two independent structures 8 as an example and combining the hardness division adjustment.
  • the blank portion on the individual structure 8 in Figs. 20, 21, and 11 should be understood as a decrease in the hardness of the structure of the independent structure 8 at a certain distance.
  • This hardness reduction can be achieved not only by changing the structural design but also by changing the hardness of the material. Way to achieve. For the case where only the prefabricated deformation is set, only the line control structure in Fig. 20, Fig. 21, Fig. 22 needs to be removed.
  • Figure 20 is a diagram showing the remote control of the ablation section 6 of the present invention with the distal end of the two separate structures 8 attached to the ablation section head end 17 as an example.
  • the head end fixing point 110 of the pulling wire 10 is preferably disposed at the ablation section head end 17 and travels along the long axis center line of the ablation section 6, pulling
  • the filament 10 also travels in the ablation catheter 1 other than the ablation section 6 on the long axis centerline, in which case only one traction wire 10 is preferred.
  • the head end fixing point 110 of the pulling wire 10 is preferably disposed between the ablation section head end 17 and the ablation head 9 independently.
  • the traction wire 10 can travel along the independent structure 8 by the ablation section 6 long axis centerline, as shown in the figure
  • one traction wire 10 is provided in each of the individual structures 8, and for more than two separate structures 8, at least two traction wires 10 may be respectively disposed in the opposite independent structure 8 or in each
  • Each of the individual structures 8 is provided with a pulling wire 10 which is preferably combined into one in the ablation catheter 1 other than the ablation section 6, and preferably travels to the long axis centerline of the ablation catheter 1 section.
  • the pulling wire 10 can also travel along the portion of each of the independent structures 8 away from the center line of the long axis of the ablation section 6, at which time the pulling wire 10 can function as the guiding wire 11; for the two independents shown in Fig. 15.
  • one traction wire 10 is provided in each individual structure 8, and for more than two separate structures 8, at least two traction wires 10 may be respectively in the opposite independent structure 8, or in each
  • Each of the individual structures 8 is provided with a pulling wire 10; as shown in Fig. 15, the pulling wire 10 serving as the guiding wire preferably travels separately in the ablation catheter 1 except for the ablation section 6, does not merge into one, and preferably travels.
  • the traction wire of the traction wire 10 is exerted.
  • the effect of each of the traction wires 10 is increased or the stress of each traction wire 10 is increased to play the role of the guide wire.
  • the two independent structures 8a, 8b are symmetrical with each other, and in order to facilitate the outward bulging of the two independent structures 8a, 8b of the semi-cylindrical shape, FIG. 17 or/and The chicken rib-like structure illustrated in Fig. 19, when the chicken rib-like structure illustrated in Fig.
  • the independent structure 8 can adopt the design shown in Fig. 17D, wherein the shape of the cross section indicated by the broken line cc is preferably Fig. 17D. As shown, at this time, if the pulling wire 10 travels in the independent structure 8, it travels to the blank area bl shown in Fig. 17D; when the chicken rib-like structure shown in Fig. 19 is used, the blank portion in the independent structure 8 should be understood.
  • the structural rigidity of the wall of the independent structure 8 is separated by a certain distance, for example, by removing the wire mesh, changing the density of the wire mesh, and the like. As shown in Fig. 20B, Fig. 20C, and Fig.
  • the bending forms of the two independent structures 8 can also be asymmetric, which is necessary for more than two independent structures 8, which helps to make the ablation points different.
  • the renal artery cross-section similar to the chicken-ribbed structure shown in Fig. 19, the design shown in Fig. 20B, Fig. 20C, and Fig. 20D can also be designed with the chicken rib-like structure shown in Fig. 17 or/and Fig. 19,
  • the hardness of each segment can be different by adjusting the arrangement of the chicken rib-like structure on each individual structure 8. In the place where the curvature is large, the hardness is preferably small, and the bending is more easily realized.
  • the portion of the ablation head 9 to the end of the individual structure 8a in the independent structure 8a and the portion of the ablation head 9 to the ablation section head end 17 in the independent structure 8b have a larger curvature, so that the blank portion is also larger and denser. .
  • Fig. 20B the portion of the ablation head 9 to the end of the individual structure 8a in the independent structure 8a and the portion of the ablation head 9 to the ablation section head end 17 in the independent structure 8b have a larger curvature, so that the blank portion is also larger and denser.
  • the independent structure 8b in order to achieve the equal distance between the two ablation heads 9 and the long axis centerline of the ablation section 6 after the deformation of the independent structure 8, the independent structure 8b is designed to be nearly the same when the lengths of the two independent structures 8 are equal.
  • the end is not easily bent and the distal end and the intermediate portion are susceptible to bending, so that the distal end and the intermediate portion of the separate structure 8b are also denser, making it more flexible.
  • the center line distances of the two ablation heads 9 to the long axis of the ablation section 6 after the deformation of the independent structure 8 are not equal.
  • the most obvious part of the intermediate ridge of the independent structure 8 is The lengths of the two separate structures 8 are different, and the most obvious portion of the intermediate structure 8b is longer, which requires that the other portions of the independent structure 8b have a larger curvature and are more flexible, so the distal end and the proximal end of the independent structure 8b are blank.
  • the parts are also larger and denser.
  • the shape of the blank portion may also be The shape may be as shown in FIG. 20B, or may be the shape shown in FIG. 20A, FIG. 20C, and FIG. 20D. Of course, the skilled person may design other shapes according to specific conditions.
  • Fig. 20 illustrates the design of two independent structures 8 as an example, and therefore is not limited to the case of two independent structures 8, and the same applies to the case of more than two independent structures 8.
  • the blank portion of the independent structure 8 in Fig. 20 can be adjusted accordingly.
  • Fig. 21 shows an example in which the distal ends of the two independent structures 8 are separated from each other, and combined with the hardness division adjustment, the wire-controlled structure of the ablation section 6 of the present invention is shown.
  • the pulling wire 10 when the pulling wire 10 travels outside the separate structure 8, the pulling wire 10 preferably travels along the long axis centerline of the ablation section 6, in which case each individual structure 8 preferably requires a pulling wire 10, a pulling wire
  • the head end fixing point 110 of 10 is preferably disposed on the ablation head 9 or the adjacent independent structure 8, and the head end fixing point 110 is located on the long axis center line of the ablation section 6, generally at 0-8 in the ablation head 9, for no setting
  • the independent structure 8 of the ablation head 9, the head end fixing point 110 of the pulling wire 10 is preferably disposed on the head end of the independent structure 8 or the adjacent independent structure 8 thereof, and the head end fixing point 110 is located on the long axis center line of the ablation section 6, generally The distance between the 8 ends of the independent structure
  • the traction wires 10 are preferably combined into one in the ablation catheter 1 except the ablation segment 6, and preferably travels to the ablation catheter 1 segment.
  • the head end fixing point 110 of the pulling wire 10 is different depending on the traveling path of the pulling wire 10; 21A and 21B, when the pulling wire 10 travels within the independent structure 8 of the long axis centerline of the ablation section 6, the head end fixing point 110 is preferably disposed on the ablation head 9 or the adjacent independent structure 8, the head end.
  • the fixed point 110 is located on the long axis centerline of the ablation section 6, generally at 0-8 in the ablation head 9, and for the independent structure 8 without the energy contacts, the head end fixed point 110 is preferably disposed at the end of the independent structure 8 or On the adjacent independent structure 8, the head end fixing point 110 is located on the long axis center line of the ablation section 6, and generally the head end of the independent structure 8 is hidden at 0-8; as shown in Fig.
  • the head end fixing point 110 is preferably disposed on the ablation head 9 or the adjacent independent structure 8, and the head end fixing point 110 is away from the long axis center line of the ablation section 6, generally ablated Head 9 is hidden at 0-8, for independent structure 8 without energy contacts
  • the head end fixing point 110 is preferably disposed on the independent structure 8 at the head end of the independent structure 8, or the head end fixing point 110 is away from the long axis center line of the ablation section 6, and the distance from the head end of the independent structure 8 is generally 0-8. As shown in Fig.
  • the traction wires 10 are preferably combined into one in the ablation catheter 1 section other than the ablation section 6, and preferably travels to the long axis centerline of the ablation catheter 1 section.
  • 21A, 21B, and 21C will mainly rely on increasing the stress of the traction wire 10 (i.e., pushing the traction wire 10 or the portion of the retraction ablation catheter 1 other than the traction wire 10) to achieve independent structure 8 away from each other and finally ablation head 9 and blood vessel.
  • FIGS. 21A, 21B, and 21C will mainly rely on increasing the tension of the pulling wire 10 to realize that the distal ends of the independent structures 8 are close to each other such that the ablation head 9 and the blood vessel wall Separating; and Fig.
  • 21D will mainly rely on increasing the stress of the pulling wire 10 to achieve the separation of the distal ends of the independent structures 8 so that the ablation head 9 is separated from the blood vessel wall. If the ablation head 9 is brought into closer contact with the blood vessel wall, the pulling wire 10 can also be increased. The tension. As shown in Fig. 21, in order to make the independent structure 8 more susceptible to bending under the action of the pulling wire 10 and to facilitate the contact of the ablation head 9 with the blood vessel wall, it is similar to the aforesaid independent structure 8 connected to the ablation section head end 17, preferably using a chicken rib-like shape. The structure, the chicken rib-like design shown in FIG. 17 or/and FIG.
  • the blank portion is arranged on the independent structure 8 shown in FIGS. 21A, 21B, and 21C in the ablation section of the independent structure 8 6 part of the centerline, and in the portion of the independent structure 8 shown in Fig. 21D where the head end is fixed at a point 110 to the proximal end of the individual structure 8, the blank portion will be arranged in a portion of the separate structure 8 away from the centerline of the ablation section 6;
  • the primary purpose of the blank portion is to protect the vessel wall by making the portion susceptible to bending buffering the pressure of the ablation head 9 in contact with the vessel wall.
  • 21B, 21C, and 21D illustrate two different structures 8 as an example of how to achieve ablation points on different renal artery cross sections.
  • the lengths of the two independent structures 8a, 8b are equal, and the internal structure is substantially mirror-symmetrical, except that the fixing position of the ablation head 9 is different, and the ablation head 9a on the independent structure 8a is closer. In this way, the ablation point can be achieved on different renal artery cross-sections.
  • FIG. 21D two independent structures 8a, 8b of unequal length may also be used, as two The lengths of the individual structures 8 are different and the ablation heads 9 are disposed at the head of each individual structure 8, so that the ablation points can also be realized on different renal artery cross-sections;
  • FIG. 21C differs from FIG. 21D mainly in FIG. 21C.
  • the lengths of the traction wires 10 are shown to be equal, while the lengths of the traction wires 10 shown in Fig. 21D are not equal.
  • Fig. 21 is an illustration of two independent structures 8 as an example. Therefore, it is not limited to the case of two independent structures 8, and the same applies to the case of more than two independent structures 8. Further, for the case where the technician needs the independent structure 8 to form other curved forms or the case where the control of the pulling wire 10 to the independent structure 8 is required, the blank portion of the independent structure 8 in Fig. 21 can be adjusted accordingly.
  • Fig. 22 is an illustration of two independent structures 8 combined with hardness section adjustment, showing the characteristics of the wire control structure in the middle of the independent structure 8 in the present invention when the middle portion is connected to the distal end and then separated from each other.
  • the head end fixing point 110 of the pulling wire 10 is preferably disposed on the head end of each independent structure 8 or its adjacent independent structure 8, the head end fixing point. 110 depends on the long axis centerline of the ablation section 6, generally at a distance of 0-8 from the head end of the independent structure 8.
  • the head end fixed point 110 is preferably located at the ablation head 9 or On the adjacent independent structure 8, the head end fixing point 110 is located on the long axis center line of the ablation section 6, generally 0 to -8 mm from the ablation head 9, and each of the independent structures 8 is preferably provided with a pulling wire 10, and these pulling wires are provided. 10 reversing at the distal end of the head end fixed point 110 into a traction wire that travels along the long axis centerline of the ablation section 6, through the attachment point 18 of the separate structure 8, and ultimately in the controllable curved section. 5 Enters the ablation catheter 1 and thereafter travels along the long axis centerline of the ablation catheter 1.
  • the head end fixing point 110 of the pulling wire 10 is preferably disposed on the independent structure 8 disposed at or adjacent to the head end of each of the independent structures 8, the head The end fixing point 110 is away from the long axis center line of the ablation section 6, and is generally hidden from 0 to 8 at the head end of the independent structure 8. If the ablation head 9 is disposed at the head of the independent structure 8, the head end fixing point 110 is preferably located at the ablation head.
  • the head end fixed point 110 is away from the long axis centerline of the ablation section 6, generally at 0-8 hidden from the ablation head 9; the traction wire 10 is along the individual structures 8 as far as possible before the connection point 18. Moving away from the portion of the long axis centerline of the ablation section 6, the traction wire 10 travels along the portion of the long axis centerline of the ablation section 6 along each of the individual structures 8 as far as possible after the connection point 18, preferably in each individual structure 8 A traction wire 10 is provided which preferably merges into one of the ablation catheters 1 except for the ablation section 6, and preferably travels the longitudinal axis of the ablation catheter 1 section. As shown in Fig.
  • the segment 5 enters the ablation catheter 1 and thereafter preferably travels along the long axis centerline of the ablation catheter 1; as shown in Figure 22C, the tip end fixation point 110 of the traction wire 10 is preferably placed at the tip end of each individual structure 8 or On the adjacent independent structure 8, the head end fixing point 110 is away from the long axis center line of the ablation section 6, and is generally hidden from 0 to 8 at the head end of the independent structure 8. If the ablation head 9 is disposed at the head of the independent structure 8, the head The end fixation point 110 is preferably located on the ablation head 9 or its adjacent independent structure 8, the head end fixation point 110 being remote from the long axis centerline of the ablation section 6, generally at 0-8 from the ablation head 9.
  • Figure 22 will rely primarily on increasing the tension of the traction wire 10 (i.e., pulling the traction wire 10 or the portion of the forward ablation catheter 1 other than the traction wire 10) to achieve that the distal ends of the individual structures 8 are remote from each other and that the middle and the tail are similarly spindle-shaped, and Eventually the ablation head 9 is brought into contact with the vessel wall.
  • a chicken rib-like structure in order to make the independent structure 8 more susceptible to bending in the case where the stress of the pulling wire 10 is increased to facilitate the contact of the ablation head 9 with the blood vessel wall, it is preferable to use a chicken rib-like structure, independent of the foregoing.
  • the structure 8 is similar to the ablation section head end 17 and is similar to the chicken rib-like structure shown in FIG. 17 or/and FIG. 19; wherein the connection point 18 to the head end fixing point 110 shown in FIG. 22A is independent.
  • the blank portion of the structure 8 is arranged in the portion of the independent structure 8 which is centered on the ablation section 6, and on the independent structure 8 of the connection point 18 to the head end fixed point 110 illustrated in Figs. 22B and 22C, the blank portion is arranged independently.
  • the main purpose of the portion of the centerline is to protect the vessel wall by exposing the portion to the pressure of the bending buffer ablation head 9 in contact with the vessel wall.
  • 22D, 22E, and 22F illustrate how the ablation points are on different renal artery cross-sections by taking two separate structures 8 and pulling the wire 10 in the separate structure 8 as an example. As shown in Fig.
  • the lengths of the two independent structures 8a, 8b are equal, the structure is substantially mirror-symmetrical, except that the fixed position of the ablation head 9 is different, and the ablation head 9a on the independent structure 8a is closer to independence.
  • two independent structures 8a, 8b of unequal lengths may also be used, and the portions of the two independent structures 8 at the distal end of the connection point 18 to the independent structure 8 are preferably unequal lengths, and the connection points are The portion of the proximal end of the individual structure 8 is preferably of equal length; since the lengths of the portions of the two separate structures 8 at the distal end of the joint 18 are different and the ablation heads 9 are disposed at the head of each individual structure 8, it is also possible
  • the ablation points are on different renal artery cross-sections; Figure 22E differs from Figure 22F primarily in that the lengths of the two traction wires 10 shown in Figure 22E are equal, while the lengths of the two traction wires 10 shown in Figure 22F are not equal.
  • Figure 11 illustrates the design of two separate structures 8 and is therefore not limited to the case of two separate structures 8, as is the case for more than two independent structures 8.
  • 22D, 22E, and 22F are illustrated by taking two independent structures 8 and the pulling wire 10 running in the independent structure 8 as an example, and thus are not limited to the case of two independent structures 8, for more than two The same applies to the case of the individual structure 8, and is also not limited to the case where the pulling wire 10 travels within the individual structure 8, as is the case with the pulling wire 10 running outside the partial structure 8 or partially running outside the independent structure 8. Further, for the case where the technician needs the separate structure 8 to form other curved forms, the blank portion of the cross-sectional view in Fig. 47 and the blank portion of the independent structure 8 in Fig. 48 can be adjusted accordingly.
  • Fig. 23 is an example of a structure in a C-shaped curved design, showing how the present invention can easily realize the design change by adjusting the hardness distribution of the controllable curved section 5.
  • the blank portion of the controllable curved section 5 in Fig. 23 is understood to mean that the structural hardness of the controllable curved section 5 is reduced by a certain distance. This hardness reduction can be achieved not only by changing the structural design but also by changing the hardness of the material. Therefore, the hardness distribution of the controllable curved section 5 can be changed to make it more flexible by adjusting the size, shape, and partial density of the blank portion on the controllable curved section 5.
  • FIGS. 23A, 23B, and 23C control the direction by the tension wire 11 by increasing the tension.
  • the bending is taken as an example, wherein FIG. 23B and FIG. 23C are enlarged side views of the chicken rib-like structure of the controllable curved section 5.
  • the tip end fixing point 111 of the guide wire 11 is preferably disposed at a position where the controllable curved section 5 is near the ablation section 6 and is located at the centrifugation side on the side of the bending direction, which is independent of the meaning shown in Figs.
  • the design of the structure 8 is similar, and the controllable curved section 5 is also preferably a chicken rib-like structure; when the chicken rib-like structure shown in Fig. 17 is used, the controllable curved section 5 can adopt the design shown in Figs. 17A and 17B.
  • the cross-sectional shape of the cross section indicated by the broken line ccl in FIG. 23B is preferably as shown in FIG. 17B. In this case, if the guide wire 11 travels within the controllable curved section 5, it is preferable to travel as shown in FIGS. 17A and 17B.
  • the blank area bl that is, the part d3 in FIG. 23B and FIG.
  • the guide wire 11 can also travel outside the controllable curved section 5 or partially outside the controllable curved section 5 according to the situation;
  • the blank portion of the controllable curved section 5 in FIGS. 23A, 23B, and 23C should be understood as a decrease in the hardness of the structure of the controllable curved section 5 at a certain distance from the wall, for example, by removing the wire mesh and changing the metal.
  • the density of the screen, etc., the guide wire 11 preferably walks On the curved side of the controllable curved section 5; if the direction of the bend is opposite to the direction indicated by the arrow aol in Fig.
  • the design shown in Fig. 23C can be used, and the guide is used.
  • the wire 11 also travels in the d3 part. If the controllable bending section 5 is bent by pushing the guiding wire 11 or the retracting ablation catheter 1, that is, increasing the stress of the guiding wire 11, the direction in which the bending occurs in the same design will be caused by the increase of the tension of the guiding wire 11.
  • the bending direction of the controllable curved section 5 is opposite. If it is required that the controllable curved section 5 is relatively easy to bend to both sides, the design shown in FIG.
  • the opposite sides of the controllable curved section 5 are preferably disposed respectively as shown in FIG. 17 or/and FIG. Chicken rib-like structure;
  • the design is similar to that shown in Fig. 17C, except that the size of each area is slightly adjusted (as shown in the middle of Fig. 23D), and the two guide wires 11 are preferably Moving the blank areas bl and b2 shown in the middle section of Fig. 23D respectively, since the hardness of both sides of the bendable curved section 5 is relatively small, increasing the tension of the side guide wire 11 will cause the controllable curved section 5 to the side.
  • the blank portion of the controllable curved section 5 in Fig. 23D should be understood as The structural rigidity of the controllable curved section 5 at a certain distance from the wall is reduced, for example, by removing the wire mesh, changing the density of the wire mesh, etc., the guide wire 11 preferably travels on the curved side of the controllable curved section 5.
  • the arrangement of the chicken rib-like structures on both sides is not necessarily completely symmetrical, and may have a certain misalignment.
  • the controllable curved section 5 in the design of the swinging wire 11 can be designed as shown in Fig. 23D. If the chicken rib-like structure shown in Fig. 17 is used, the two pulling wires 10 preferably travel in blank areas respectively. Bl and b2, if the chicken rib-like structure shown in Fig. 19 is used, the two pulling wires 10 preferably travel on the curved side of the controllable curved section 5.
  • the hollow curved section 5 can adopt the design of the double convex disk overlapping structure illustrated in FIG.
  • the hollow curved section 5 can also use the chicken rib-like structure shown in Fig. 19D to help control the multi-directional bending.
  • the controllable curved section 5 is S-shaped curved design, it can be similar to the C-shaped curved design. The technician can adjust the size, shape, and partial density of the blank portion on the controllable curved section 5 according to the actual situation to change the bending shape.
  • Figure 24 shows the main design features of the tail of the guiding catheter 7 of the present invention.
  • the end (tail end, proximal end) of the guiding catheter 7 can be provided with a side hole 77, which is connected with a section of the catheter 20 and connected to a syringe or a liquid injection device, a syringe or a syringe.
  • the fluid device can be intravascularly injected or injected with an intravascular contrast agent through the side hole 77, and the catheter 20 is closed when the side hole 77 is not in use.
  • the tail of the guiding catheter 7 is preferably sealed, such as a sealing jaw or sealing sleeve 79, to prevent blood from leaking through the guiding catheter 7 and to be injected intravascularly through the guiding catheter 7.
  • the drug or the injected contrast agent leaks out, wherein Figs. 24A and 24B show the case where the ablation catheter 1 is not inserted, Fig. 24C shows the case where the ablation catheter 1 is inserted, and Fig. 24B and Fig. 24C show the tail of the guide catheter 7.
  • a reinforcing sleeve 78 around the tail of the guiding catheter 7, so that the tail portion of the guiding catheter 7 is not easily deformed, is easy to operate, and is also convenient to be connected or attached to other structures.
  • the guiding catheter 7 itself can also undergo one-way or multi-directional active control deformation or/and passive control deformation, as well as prefabrication deformation. As shown in FIG. 24A, in the case where the guiding catheter 7 is only prefabricated, it is preferable not to provide the guiding catheter control handle 27 (described later), and only the connecting joint 76 is provided at the end, and the connecting joint 76 can be combined with the syringe and the liquid filling device. , ablation catheter 1 and other connections.
  • the active control deformation of the guiding catheter 7 is preferably achieved by incorporating a smart material (e.g., a shape memory alloy) on the wall of the guiding catheter 7, for example: ⁇ Designing a distribution scheme using a shape memory alloy.
  • a smart material e.g., a shape memory alloy
  • the passive control deformation of the guiding catheter 7 is preferably achieved by a wire-controlled structural design and a magnetron structure design; wherein the wire-controlled structure is designed to penetrate the guiding wire 70 in the wall of the guiding catheter 7 (similar to the ablation catheter 1)
  • the guide wire 11) is realized; in addition, in order to facilitate the formation of the designed deformation shape of the guiding catheter 7, the hardness distribution of the guiding catheter 7 can also be changed.
  • Fig. 25 shows the main structural features of the guiding structure design of the guiding catheter 7 in the present invention and how to optimize the formation of the guiding catheter 7 by adjusting the hardness distribution of the guiding catheter 7.
  • a guide wire 70 is provided in one side wall of the guiding catheter 7, when the tension of the guiding wire 70 is increased (the pulling guide wire 70 or the other portion of the feeding guide catheter 7 except the guiding wire 70) ), the guiding catheter 7 will be bent toward the side where the guiding wire 70 is disposed, that is, the direction indicated by the arrow aol in the figure, and if the multi-directional control bending is required, the guiding can be separately set in several directions of the guiding catheter 7.
  • Silk 70 In order to facilitate the formation of the desired deformation mode of the guiding catheter 7, the hardness distribution of the guiding catheter 7 can be changed. This change in hardness distribution can be achieved not only by changing the structural design but also by changing the hardness of the material.
  • FIG. 26 is a schematic diagram showing the main structural features of the control handle 2 in the case where the control handle 1 can control the bending of the controllable curved section 5 in one direction, wherein FIG. 26B and FIG. 26C are respectively the broken line ccl in FIG. 26A. , cc2 cross section enlarged view.
  • the control handle 2 is preferably designed in a shape, mainly composed of an operating handle 211 and an operating handle 257, wherein the operating handle 211 is generally located at the front of the control handle 1, and is mainly responsible for controlling the controllable curved section 5.
  • the deformation, and the operating handle 257 is generally located at the rear of the control handle 1, and is mainly responsible for controlling the deformation of the independent structure 8.
  • the operating handle 211 and the operating handle 257 are preferably hollow structures.
  • the ablation catheter 1 is connected to the operating handle 211 via a catheter body section 4 (shown in Fig. 1), similar to the reinforcing sleeve 78 of the guiding catheter 7, and a reinforcing sleeve 48 is also provided at the proximal end of the ablation catheter 1, The place where the ablation catheter 1 is connected to the control handle 2 is not easily deformed and is easy to handle.
  • the operating handle 211 is provided with a control button 230 for controlling the deformation of the controllable curved section 5.
  • the control button 230 surrounds a part of the operating handle 211 and can slide on the operating handle 211, since the control button 230 is stuck.
  • the handle 211 is operated so that the control knob 230 does not slide out of the operating handle 211.
  • the guide wire 11 is connected to the guide wire fixing disk 204 on the control knob 230 via the connecting passage 217 on the operating handle 211, and when the control button 230 slides in the direction indicated by the arrow aol, the guide wire can be pulled.
  • the wire fixing disk 205 is located at the intersection of the connecting rods 258 which are radially expanded in cross section, and the connecting rod 258 is connected.
  • a plurality of guiding grooves 258 passing through the operating handle 257 are connected to the ring control button 257.
  • the ring control button 257 surrounds the operating handle 257 to facilitate control of the ring control button 257 while rotating. Since the guiding groove 258 can restrict the rotation of the connecting rod 258, Therefore, the ring control button 257 and the operating handle 21 3 can be rotated together; the number of the connecting rod 258 and the guiding groove 258 is not necessarily four, and can be adjusted according to actual needs. As shown in Fig.
  • the energy exchange joint 201 is preferably disposed at the tail of the control handle 2, and the energy exchange joint 201 is connected to the ablation generating device 3 via a cable 23 (including a wire, a catheter, an optical fiber, etc., as shown in Fig. 1), and is responsible for receiving The energy transmitted by the ablation generating device 3 and transmitted to the ablation head 9 through the wires, catheters, optical fibers ac, etc. in the control handle 2, the other portions of the ablation catheter 1 that require energy supply, and the control handle 1 require energy supply. part. As shown in Fig.
  • a liquid perfusion joint 202 which is connected to a catheter in the ablation catheter 1 for providing cooling fluid, contrast agent or the like to the ablation catheter 1, may also be provided at a position adjacent to the energy exchange joint 201, as the case may be.
  • the operating handle 211 and the operating handle 257 are connected by a slot sliding structure indicated by a broken-line rectangular frame ar in the figure.
  • the slot sliding structure is formed by the annular hook-shaped structure 212 at the rear of the operating handle 211 and the handle 257.
  • the annular hook-like structures 256 are formed to coincide with each other, so that the two can be relatively rotated after the connection.
  • a cushioning structure for example, to replace the middle portion of the guide wire 11 traveling in the connecting passage 217 with a spring or a thin elastic wire.
  • 26 is an example of the spring 208; as shown in FIG. 26A, the connecting passage 217 at the spring 208 is slightly thicker than the spring 208, and the control button 230 slides the pulling guide 11 in the direction indicated by the arrow aol.
  • the spring 208 can be extended, the buffering force can be buffered, and since the diameter of the spring 208 is larger than the diameter of the connecting channel 217, the spring 208 does not extend beyond the bulk of the connecting passage 117.
  • the tension of the guide wire 11 not exceed the tensile force generated by the maximum extension distance of the spring 208, which is equivalent to setting a tensile limit; similarly, such a design idea can also be applied to other wire-controlled structures.
  • the middle section of the pulling wire 10 in the control handle 1 is replaced by a spring or a thin elastic wire.
  • the pulling wire 10 is placed inside the small chamber 207.
  • a section of the front portion of the handle 1 is replaced by a spring 209.
  • the spring 209 can be extended, which can buffer the pulling force, and the like.
  • the spring 208 does not extend beyond the small chamber 207.
  • a tension sensor may be connected to the traction wire 10 and the guide wire 11.
  • the control knob 230 and the operating handle 211 can be rotated together. At this time, it is preferable to provide a groove sliding structure between the control button 230 and the operating handle 211; as shown in Fig.
  • the small dashed rectangular frame rc indicates the slot sliding structure.
  • the position of the slot sliding structure is different from the position of the groove 216 and the groove 284.
  • the slot sliding structure is evenly distributed on the circumference; the large dotted line in FIG. 26B
  • the rectangular frame shows an enlarged view of the groove sliding structure, and the groove sliding structure is composed of a groove 285 and a protruding tooth 286.
  • FIG. 26B is an example in which the groove 285 and the protruding tooth 286 are respectively disposed on the control button 230 and the operating handle 211.
  • the groove 285 and the protruding tooth 286 can be respectively disposed on the operating handle 211 and the control button 230 according to a specific situation; such a slot sliding structure ensures that the control button 230 can freely slide on the operating handle 211.
  • the control button 230 can also drive the operating handle 211 to rotate.
  • the control button 230 can be marked on the operating handle 211 or/and the control button 230 by the moving distance and the moving direction.
  • the operating handle 211 can be marked on the operating handle 211, the operating handle 257 or/and the control button 230.
  • the relative rotation angle and the direction of rotation of the operating handle 257 indicate the movement distance and the moving direction of the ring control button 257 on the operating handle 257 or/and the ring control button 257.
  • the guide wire 11' can be connected to the guide wire fixing disk 204 of the guide wire 11 on the control knob 230,
  • pulling the guide wire 11 will simultaneously pull the guide wire 11', and of course, the degree of tightness of the guide wire 11' and the guide wire 11 can be adjusted, so that the guide wire 11 or the guide wire 11' can be pulled first;
  • the guide wire 11' can also be finally fixed to a separate position on the control button 230 via a separate connecting channel.
  • the corresponding line control structure in the design scheme of the control handle 1 illustrated in FIG. 26 is removed, and the control button 230 is changed for control.
  • the passive control deformation of the magnetron structure design of the controllable curved section 5 changes the ring control knob 257 to a passive control deformation for controlling the design of the magnetron structure of the individual structure 8.
  • the corresponding wire control structure in the design of the control handle 2 illustrated in FIG. 26 is removed, and the control button 230 is changed for control. Controlled bending
  • the active control deformation of segment 5 changes the ring control knob 257 to control the active control deformation of the individual structure 8.
  • FIGS. 27B and 27C are schematic cross-sectional views showing enlarged cross sections of the broken lines ccl and cc2.
  • the guiding catheter control handle 27 is mainly composed of an operating handle 211', an operating handle 242 and a control button 230', wherein the design of the operating handle 211' and the control button 230' and the operating handle 211 and the control button 230 are shown.
  • the design is similar, except that the guide wire 11 is replaced with a guide wire 70.
  • the guide wire fixing plate 279 is disposed on the control button 230', and the guide wire 70 is connected to the guide wire fixing plate 279 on the control button 230' via the connecting passage 217' on the operating handle 211'.
  • a cushioning structure can be provided on the guide wire 70, for example, a section of the guide wire 70 is replaced by a spring 278, or a tension sensor is connected to the guide wire 70; when the control knob 230' slides in the direction indicated by the arrow ao The guide wire 70 will be pulled.
  • a groove sliding structure as illustrated by the broken rectangular frame rc in Fig. 27B. As shown in Fig.
  • the operating handle 211' and the operating handle 242 are connected by a slot sliding structure shown by a dashed rectangular frame arl, which is formed by an annular hook-like structure 212' on the operating handle 211' and The annular hook-like structures 241 on the operating handle 242 are formed to coincide with each other, so that the operating handle 211' and the operating handle 242 are relatively rotatable.
  • the front end of the control handle 2 needs to be improved; as shown in Fig. 27D, the front end of the control handle 2 is provided with two hook-shaped latches 210a of inverted "L" shape.
  • the two hook-shaped latches 210a, 210b are preferably disposed at opposite positions of the circumference; of course, the number and position of the hook-shaped latches 210 can be adjusted according to actual conditions.
  • the end of the operating handle 242 is provided with a card slot 243 for catching the hook-shaped latch 210.
  • the card slot 243 has two slots, preferably disposed at opposite positions of the circumference, of course, if the hook The number and distribution of the shaped teeth 210 are adjusted, and the number and distribution of the slots 243 should be adjusted accordingly so that the hook-shaped latch 210 and the slot 243 can be smoothly engaged; the slot 243 is close to the handle The end of 242 is narrower (shown in Fig. 27C), and can pass through the hook-shaped latch 210; the slot 243 is wider away from the end of the handle 242 (shown in Fig. 27B), so the hook-shaped latch 210 is in the slot.
  • the inner diameter of the operating handle 211' is preferably just enough for the ablation catheter 1 to pass, the inner diameter of the operating handle 242 is slightly larger than the outer diameter of the ablation catheter 1, but slightly smaller than the ablation catheter 1
  • the outer diameter of the sleeve 48 allows the reinforcement sleeve 48 to snap into the handle 242. As shown in Figures 27A, 27B, 27C, and 27D, when the guiding catheter handle 27 and the control handle 2 are required to be engaged, the ablation catheter 1 penetrates into the empty conduit in the guiding catheter control handle 27 and then enters the guide.
  • the hook-shaped latch 210 will be locked in the wider position of the slot 243 away from the end of the operating handle 242, and then the reinforcing sleeve 48 has been snapped into the operating handle 242, thus guiding
  • the guiding tube handle 27 and the control handle 2 can be stably engaged; when the guiding catheter control handle 27 and the control handle 2 are required to be separated, the control handle 2 is reversely rotated to make the hook-shaped engaging teeth 210 align with the narrowing of the card slot 243. Place, roll back the control handle 1.
  • the guiding catheter control handle 27 is replaced with the design of the front part of the control handle 2 illustrated in FIGS.
  • the wire 70 enables control of bidirectional or multi-directional bending of the guiding catheter 7.
  • the movement distance and movement of the control button 230' or the control panel 231' may be marked on the control knob 230' or the control panel 231' of the control guide wire 70, the operating handle 211'.
  • the operating handle 142 indicates the relative rotation angle and rotation direction of the operating handle 211' and the operating handle 242;
  • the catheter handle 27 is engaged with the control handle 2, and the alignment line, the alignment mark, and the like, which are engaged with each other, can be respectively indicated on the guiding catheter control handle 27 and the control handle 2.
  • the guiding guide 7 is deformed by the magnetron structure design, the corresponding wire control structure in the guiding catheter control handle 27 is removed, and the control knob 230' or the control panel 231' is changed to the magnetic force for controlling the guiding catheter 7.
  • the passive control of the structural design is controlled, and an energy exchange joint for guiding the guide tube 7 and the guide catheter handle 27 to provide energy is provided at the guide catheter handle 27.
  • the corresponding wire control structure in the guiding catheter control handle 27 is removed, and the control button 230' or the control panel 231' is changed to control the active control of the guiding catheter 7.
  • Deformation, and an energy exchange joint for guiding the guide tube 7 and the guide catheter handle 27 to provide energy is provided at the guide catheter handle 27.
  • the ablation catheter 1 and the outer surface of the guiding catheter 7 may be marked with a development scale to indicate the depth of the ablation catheter 1 and the guiding catheter 7 into the blood vessel and to facilitate indirect measurement of the length of the human body structure under imaging equipment such as ultrasound and X-ray, Width and so on.
  • Different development marks may be provided on the ablation catheter 1 and the guiding catheter 7 for distinguishing different catheters under imaging devices such as ultrasound and X-ray.
  • Different development marks are preferably provided on each of the individual structures 8 for distinguishing different independent structures 8 under ultrasound, X-ray, etc., for example, a separate structure 8 is marked with a triangle, and the other independent structure is marked with a square, or One independent structure 8 is labeled with three bands, and the other independent structure 8 is labeled with two bands.
  • a development mark may be disposed on the ablation catheter 1 and the guiding catheter 7 for distinguishing different axial rotation states under imaging devices such as ultrasound and X-ray, for example, an ultrasound, X-ray is disposed on the left side of the ablation catheter 1.
  • the two short lines coincide, when the ablation catheter 1 When the axis rotates at a certain angle, the short lines are separated by a certain distance.
  • the ablation catheter 1 and the guiding catheter 7 should be as smooth as possible in contact with the blood vessel wall, and the shape should be as smooth as possible, and the ablation catheter 1
  • the head of the guiding catheter 7 is relatively soft.
  • the parts of the ablation catheter 1 and the guiding catheter 7 that may directly or indirectly contact the body fluid or tissue of the human body must meet the national standards for contacting the human body fluid or tissue, and may directly or indirectly be in contact with the human body fluid for failing to meet the above requirements. Or the portion of the ablation catheter 1 and the guiding catheter 7 that are in contact with the tissue, the outside of which must be wrapped with a material that meets the national standards for materials in contact with human body fluids or tissues.
  • the material from which the ablation catheter 1 and the guiding catheter 7 may be in direct or indirect contact with the human body should be able to withstand at least one medical sterilization method.
  • the ablation catheter 1 and the guiding catheter 7 may be insulatively in direct or indirect contact with the human body, and the insulating material may be overwrapped where insulation requirements are not met.
  • the catheter body section 4 can be used for exercise, and only the design of the controllable curved section 5 is applied to the catheter body section 4 can.
  • the ablation generating device 3 provides a corresponding form of energy for the ablation catheter 1, the guiding catheter 7, the control handle 2, and the portion of the guiding catheter handle 27 that requires energy supply, such as when the guiding catheter 7 is needed.
  • the ablation generating device 3 can provide the energy required to induce the smart material to change shape.
  • the ablation generating device 3 can receive and process the information from the ablation catheter 1, the guiding catheter 7, the control handle 1, and the guiding catheter control handle 27.
  • the processed information can be partially or completely displayed on the display 320 of the ablation generating device 3.
  • the processed information can also feedback adjust the energy output of the ablation generating device 3.
  • the ablation generator comprises a radio frequency ablation generator, a resistance heating generator, a cryoablation generator, an ultrasound ablation generator, a laser ablation generator, and light.
  • the power treatment generator or the microwave ablation generator may be one of the above generators or a combination of the above two or more generators.
  • the control parameters of the ablation generating device 3 can be controlled by the display 320 of the ablation generating device or by the parameter setting button 330; the ablation generating device 3 should be provided with a connector for energy output and a connector 311 for sensor signal input, and A connector 321 is connected to the external power supply for receiving electrical energy transmitted by the power supply circuit.
  • an energy supply is provided without a device having a working switch on the control handle 1 or the guiding catheter handle 27, in the ablation generating device 3
  • a working switch is preferably provided.
  • the ablation generating device 3 or/and the guiding catheter 7 may be provided with a perfusion device for automatic or manual perfusion of the ablation catheter 1
  • the infusion device for connecting the distal end opening 77 of the guiding catheter 7 is provided in the ablation generating device 3, and the ablation generating device 3 should control the infusion device and set a corresponding control panel or control button.
  • the ablation generating device 3 may be a whole machine that integrates the above functions, or may be a separate machine that performs different functions respectively, for example, the part that supplies the ablation head 9 is independently an extension, and the perfusion device is independently another extension. .

Abstract

A multifunctional ablation catheter system for sympathetic denervation of renal arteries. The system comprises an ablation catheter (1), a control handle (2), an ablation generation apparatus (3), and can optionally be provided with a guide cannula (7). The ablation catheter (1), from the near end to the distal end, respectively, consists of a catheter body section (4) and an ablation section (6), the front end of the catheter body section (4) further comprising a controllably bendable section (5) connected to the control handle (2) by means of said catheter body section (4); and the ablation section (6) is provided with at least two independent structures (8), at least one of which is provided with an ablation tip (9). The ablation catheter system is capable of simultaneously ablating multiple points and of real-time monitoring of ablation effects during surgery, and offers improved mechanical stability.

Description

肾脏去交感神经多功能消融导管系统 技术领域  Renal desympathetic multi-functional ablation catheter system
本发明涉及一种医疗器械, 具体是一种用来治疗高血压病、 通过介入的方式进入肾动脉 内阻断肾脏交感神经的多功能消融导管系统。  The present invention relates to a medical device, and more particularly to a multifunctional ablation catheter system for treating hypertension and intervening into the renal artery to block the renal sympathetic nerve.
背景技术 Background technique
高血压是临床常见病、 多发病, 根据最新的数据推算, 中国高血压患者群已超过 2亿, 且呈发病人数逐年增加, 发病年龄逐渐提前趋势。 高血压导致的心、 脑、 肾等重要脏器并发 症, 有很高的致死率与致残率, 严重危害着人类健康。 我国约有 3000 4000万顽固性高血压 患者, 而未来伴随着人口老龄化及肥胖症、 糖尿病人的增加, 顽固性高血压的患者数量将进 一步增加, 给社会、 家庭、 个人带来极大的负担。 目前无很好的顽固性高血压治疗方法, 开 拓新的非药物治疗手段, 弥补当前药物疗法的不足从而筒单、 安全、 有效地控制血压刻不容 緩。  Hypertension is a common and frequently-occurring disease in the clinic. According to the latest data, the number of hypertensive patients in China has exceeded 200 million, and the number of cases has increased year by year, and the age of onset has gradually advanced. High blood pressure, heart, brain, kidney and other important organs are complicated by high blood pressure and disability, which seriously endangers human health. There are about 30,000 million patients with refractory hypertension in China. In the future, with the aging of the population and the increase in obesity and diabetes, the number of patients with refractory hypertension will further increase, bringing great benefits to society, families and individuals. burden. At present, there is no good treatment for refractory hypertension, and new non-pharmacological treatments are being developed to make up for the shortcomings of current drug therapy, so that it is imperative to control blood pressure safely and effectively.
大量研究证实, 过度激活的交感神经系统与高血压的形成与进展密切相关, 其中, 肾脏 交感神经系统特别是最靠近肾动脉壁的肾交感传出和传入神经, 被认为是高血压始动及维持 的重要因素。 针对这一机制, 国外学者提出了通过导管消融肾动脉交感神经治疗顽固性高血 压这一新的高血压治疗策略。  A large number of studies have confirmed that the over-activated sympathetic nervous system is closely related to the formation and progression of hypertension. Among them, the renal sympathetic nervous system, especially the renal sympathetic efferent and afferent nerve closest to the renal artery wall, is considered to be the beginning of hypertension. And important factors for maintenance. In response to this mechanism, foreign scholars have proposed a new hypertension treatment strategy for the treatment of refractory high blood pressure by catheter ablation of renal artery sympathetic nerve.
2009年, Kr画等人在导管消融肾脏交感神经治疗顽固性高血压研究(Symp l ic i ty HTN-1 ) 中首先用 Ardian公司生产 Symp l ic i ty消融导管对 45例顽固性高血压患者实施肾脏去交感神 经射频消融术, 证实这项新技术的筒单、 安全, 压效果出现早, 并能长期保持。 在长达 2 年的追踪观察中, 未发现下降的血压重新增高, 且肾功保持稳定。 国外多个中心正在进行或 已完成经皮导管肾脏去交感神经治疗的临床研究多达十余项, 已完成或正在进行的临床试验 结果令人鼓舞, 该项技术可望成为高血压治疗领域革命性的突破。  In 2009, Kr Hua and others first used Ardian's Symp ic i ty ablation catheter in 45 patients with refractory hypertension in the catheter ablation renal sympathetic treatment of refractory hypertension (Symp ic ty HTN-1 ). The implementation of renal desympathetic radiofrequency ablation confirmed that the new technology has a single, safe, and early pressure effect and can be maintained for a long time. In the 2-year follow-up observation, no decreased blood pressure was found, and renal function remained stable. More than ten clinical studies on percutaneous catheter renal sympathetic therapy have been or have been completed in many foreign centers. The results of completed or ongoing clinical trials are encouraging. This technology is expected to become a revolution in the field of hypertension treatment. Sexual breakthrough.
US 2011 /0264075 A1公开了一种用于肾去交感神经的射频消融导管, Ardian公司生产的 此种导管虽然在国外临床中有一定的应用, 但是也存在明显的不足。 首先该种导管仅能进行 单点消融, 由于肾去交感神经的射频消融治疗一般是绕肾动脉一周进行 6-8个点的螺旋形消 融, 因此 Ardian公司的此种导管需要消融 6-8次, 手术时间比较长。 针对 Ardian公司的消 融导管不能进行多点消融的问题, US 2012/0116392 Al、 US 2012/0029510 Al、 CN 201110117776. 8、 CN201110327772. 2通过在多条电极杆上分别设置射频消融电极从而到达多 点同时消融的目的, CN 102198015A 则通过在一条螺旋形的电极杆上按照预定位置安装多个 射频电极来实现多点同时消融, 虽然上述设计在一定程度上实现了肾动脉内多点同时消融, 但是由于射频消融电极与血管壁贴合不够紧, 使得射频消融电极在消融时容易移动, 而造成 消融范围过大, 给患者造成不必要的损伤; 为了使得多个射频消融电极同时紧密贴附血管壁, US 2012/0101413A1 釆用了在旋形的电极杆内设置扩张球嚢的方案, 通过在球嚢中充入液体 可以使得射频消融电极与血管壁紧密贴附, 但是球嚢扩张时肾血流会被阻断, 如果消融时间 较长容易导致肾缺血, 而引起不必要的并发症; 为了避免肾血流被阻断 US 2012/0029512 Al 将球嚢替换成了金属丝网球, 虽然解决了肾血流被阻断的问题,但是操作上远没有球嚢方便; 此外人的肾动脉走行变异较大, 上述这些多个射频消融电极的设计方案很难在肾动脉走行发 生变异时应用, 因此限制了肾去交感神经治疗的人群; 而且上述多个射频消融电极的设计方 案由于仅针对射频消融,因此很难将同样的设计推广用于激光消融、微波消融等。其次 Ardian 公司的单射频电极导管以及上述多个射频消融电极的导管都需要外加导管的辅助才能够到达 指定的消融部位且导管的导向不够准确, 因此不能很好满足临床要求。 再次, Ardian公司的 单射频电极导管以及上述多个射频消融电极的导管都很难对消融的效果进行实时监测, 因此 很难在术中进行疗效检测, 使得患者二次手术风险增加。 发明内容 US 2011/0264075 A1 discloses a radiofrequency ablation catheter for renal desympathetic nerves. Although such catheters produced by Ardian have certain applications in foreign countries, there are also significant deficiencies. First, the catheter can only perform single-point ablation. Because the radiofrequency ablation of the renal sympathetic nerve is generally 6-8 points of spiral ablation around the renal artery, Ardian's catheter needs to be ablated 6-8 times. , the operation time is relatively long. For the ablation catheter of Ardian, the problem of multi-point ablation is not possible, US 2012/0116392 Al, US 2012/0029510 Al, CN 201110117776. 8, CN201110327772. 2 by setting a radio frequency ablation electrode on multiple electrode rods to reach multiple points For the purpose of simultaneous ablation, CN 102198015A achieves simultaneous multi-point ablation by mounting a plurality of radio frequency electrodes on a spiral electrode rod according to a predetermined position, although the above design achieves a plurality of simultaneous ablation of the renal artery to some extent, Because the radiofrequency ablation electrode is not tightly attached to the vessel wall, the radiofrequency ablation electrode is easy to move during ablation, and the ablation range is too large, causing unnecessary damage to the patient; in order to make the plurality of radiofrequency ablation electrodes closely attached to the vessel wall at the same time , US 2012/0101413A1 uses a solution to provide an expanding balloon in a rotating electrode rod. By filling the balloon with a liquid, the radiofrequency ablation electrode can be closely attached to the vessel wall, but the renal blood flow is expanded when the balloon is dilated. Will be blocked, if the ablation time is long, it will lead to renal ischemia, causing unnecessary In order to avoid the renal blood flow being blocked US 2012/0029512 Al Replace the ball with a wire tennis ball, although the problem of renal blood flow is blocked, but the operation is far from the convenience of the ball; The arterial variability is large, and the design of these multiple radiofrequency ablation electrodes is difficult to apply when the renal artery is mutated, thus limiting the population of renal sympathetic treatment; and the design of the above multiple radiofrequency ablation electrodes is only For radiofrequency ablation, it is difficult to generalize the same design for laser ablation, microwave ablation, and the like. Secondly, Ardian's single RF electrode catheter and the above-mentioned multiple RF ablation electrode catheters require the aid of an external catheter to reach the designated ablation site and the catheter guidance is not accurate enough to meet the clinical requirements. Once again, Ardian's single RF lead and the multiple RF ablation catheters are difficult to monitor the effects of ablation in real time, so It is difficult to perform an efficacy test during surgery, which increases the risk of secondary surgery. Summary of the invention
本发明的目的是提供了一种可实现同时多点消融、 可术中实时监测消融阻断效果、 机械 稳定性更好的肾脏去交感神经多功能消融导管系统.为了实现上述目的而釆用的技术方案是 这样的, 一种肾脏去交感神经多功能消融导管系统, 其包括:  The object of the present invention is to provide a renal sympathetic multi-functional ablation catheter system capable of achieving simultaneous multi-point ablation, real-time monitoring of ablation blocking effect, and better mechanical stability. The technical solution is such that a renal desympathetic multi-functional ablation catheter system includes:
消融导管、 控制手柄及消融发生装置, 其中消融导管包括导管体段和消融段, 其中 所述导管体段与控制手柄相连;  An ablation catheter, a control handle and an ablation generating device, wherein the ablation catheter comprises a catheter body segment and an ablation segment, wherein the catheter body segment is connected to the control handle;
所述消融段包括至少两个独立结构, 在至少一个独立结构上安装有消融头; 所述消融头 通过导线、 导管、 微波天线或光纤与控制手柄上的能量交换接头相连, 所述能量交换接头通 过导线、 导管、 微波天线或光纤与消融发生装置相连;  The ablation section includes at least two separate structures with an ablation head mounted on at least one of the separate structures; the ablation head is coupled to an energy exchange connector on the control handle via a wire, conduit, microwave antenna or fiber, the energy exchange connector Connected to the ablation device via a wire, catheter, microwave antenna or fiber;
所述独立结构通过牵拉或 /和推送一端固定在独立结构上、 另一端由手柄控制的牵引丝 控制发生形变而使消融头贴合或离开指定的消融位置; 或所述独立结构含有可被磁铁吸引的 物质,通过外加磁场使独立结构发生形变而使消融头贴合或离开指定的消融位置;或所述独立 结构(8)含有通过外部刺激而发生形变的智能材料而使消融头贴合或离开指定的消融位置; 以上独立结构的控制还包括独立结构设置预制形变;  The separate structure allows the ablation head to be fitted or removed from the designated ablation position by pulling or/and pushing one end of the traction structure that is fixed to the separate structure and controlled by the handle at the other end; or the separate structure contains a substance attracted by the magnet, the external structure is deformed by an external magnetic field to cause the ablation head to fit or leave the designated ablation position; or the independent structure (8) contains a smart material deformed by external stimulation to fit the ablation head Or leaving the designated ablation position; the control of the above independent structure also includes the independent structure setting prefabrication deformation;
或包括消融导管、 控制手柄及消融发生装置, 其中消融导管包括导管体段和消融段, 其 中所述导管体段与控制手柄相连;  Or comprising an ablation catheter, a control handle and an ablation generating device, wherein the ablation catheter comprises a catheter body segment and an ablation segment, wherein the catheter body segment is coupled to the control handle;
所述消融段包括至少两个独立结构, 在至少一个独立结构上安装有消融头; 所述消融头 通过导线、 导管、 微波天线或光纤与控制手柄上的能量交换接头相连, 所述能量交换接头通 过导线、 导管、 微波天线或光纤与消融发生装置相连;  The ablation section includes at least two separate structures with an ablation head mounted on at least one of the separate structures; the ablation head is coupled to an energy exchange connector on the control handle via a wire, conduit, microwave antenna or fiber, the energy exchange connector Connected to the ablation device via a wire, catheter, microwave antenna or fiber;
所述独立结构通过牵拉或 /和推送一端固定在独立结构上、 另一端由手柄控制的牵引丝 控制发生形变而使消融头贴合或离开指定的消融位置; 或所述独立结构含有可被磁铁吸引的 物质,通过外加磁场使独立结构发生形变而使消融头贴合或离开指定的消融位置;或所述独立 结构含有通过外部刺激而发生形变的智能材料而使消融头贴合或离开指定的消融位置;  The separate structure allows the ablation head to be fitted or removed from the designated ablation position by pulling or/and pushing one end of the traction structure that is fixed to the separate structure and controlled by the handle at the other end; or the separate structure contains a substance attracted by a magnet, the external structure is deformed by an external magnetic field to cause the ablation head to fit or leave the designated ablation position; or the independent structure contains a smart material deformed by an external stimulus to cause the ablation head to fit or leave the designated Ablation position
以上独立结构的控制还包括独立结构设置预制形变;  The control of the above independent structure also includes the independent structure setting prefabrication deformation;
所述导引导管通过牵拉或推送一端固定在导引导管头部,另一端由手柄控制的导引丝控 制弯曲; 或所述导引导管含有能够被磁铁吸引的物质, 通过外加磁场使得导引导管发生形变; 或通过对导引导管上能感知外部刺激的智能材料进行控制; 或 /和导引导管发生顺应性弯曲; 或 /和导引导管设置预制形变;  The guiding catheter is fixed to the guiding catheter head by pulling or pushing one end, and the other end is controlled to be bent by the guiding wire controlled by the handle; or the guiding catheter contains a substance capable of being attracted by the magnet, and the guiding body is guided by the external magnetic field Deformation of the guiding tube; or by controlling the smart material on the guiding catheter that senses external stimuli; or/and compliant bending of the guiding catheter; or/and guiding the prefabrication of the guiding catheter;
所述导引导管由导引导管控制柄或控制手柄控制以及不通过手柄进行控制。  The guiding catheter is controlled by the guiding catheter handle or control handle and is not controlled by the handle.
所述导管体段的远端还包括与消融段近端连接的可控弯曲段,所述可控弯曲段通过牵拉 或 /和推送一端固定在可控弯曲段上、 另一端由手柄控制的导向丝控制发生形变; 或所述可控 弯曲段通过牵拉或 /和推送一端固定在独立结构上、 另一端由手柄控制的牵引丝控制发生形 变; 或所述可控弯曲段含有可被磁铁吸引的物质, 通过外加磁场使得可控弯曲段发生形变; 或所述可控弯曲段含有通过外部刺激而发生形变的智能材料;或 /和通过控制手柄控制可控弯 曲段发生顺应性弯曲; 或 /和可控弯曲段设置预制形变。  The distal end of the catheter body segment further includes a controllable curved section coupled to the proximal end of the ablation section, the controllable curved section being secured to the controllable curved section by one end of the pulling or/and pushing and the handle being controlled by the handle at the other end The wire control is deformed; or the controllable bending segment is deformed by pulling or/and pushing one end of the wire to be fixed on the independent structure, and the other end is controlled by the handle; or the controllable curved section contains a magnet An attracting substance that deforms the controllable curved section by an applied magnetic field; or the controllable curved section contains a smart material that is deformed by an external stimulus; or/and a compliance bend is controlled by the control handle to control the controllable curved section; or / Pre-fabrication with the controllable bending section.
所述消融导管或 /和控制手柄、 导引导管或 /和导引导管控制柄上还安装有传感器。 所述独立结构之间在近端相连, 两个独立结构之间包括四种形式: 两个独立结构的远端 连接为一体而构成消融段头端; 或者两个独立结构远端彼此独立相互分离; 或者两个独立结 构的中间部分连接在一起, 远端再相互分离; 或者两个独立结构的近端相连, 远端分别连在 牵引丝的不同位置上。 所述消融头选自射频消融电极头、 电阻加热消融头、 液冷灌注射频电极头、 冷冻消融头、 超声消融探头、 聚焦超声消融探头、 激光消融头、 聚焦激光消融头、 光动力治疗消融头或孩 波消融头; 其中所述射频消融电极头包括射频消融电极。 Sensors are also mounted on the ablation catheter or/and the control handle, the guiding catheter or/and the guiding catheter handle. The independent structures are connected at the proximal end, and the two independent structures comprise four forms: the distal ends of the two independent structures are integrated to form the ablation section head end; or the two independent structures are separated from each other independently of each other. Or the middle portions of the two separate structures are connected together, and the distal ends are separated from each other; or the proximal ends of the two independent structures are connected, and the distal ends are respectively connected to different positions of the traction wires. The ablation head is selected from the group consisting of a radio frequency ablation electrode head, a resistance heating ablation head, a liquid-cold perfusion radio frequency electrode head, a cryoablation head, an ultrasound ablation probe, a focused ultrasound ablation probe, a laser ablation head, a focused laser ablation head, and a photodynamic therapy ablation head. Or a child wave ablation head; wherein the radiofrequency ablation electrode head comprises a radio frequency ablation electrode.
所述独立结构上设置有用于发放或 /和接收电脉冲的检测电极; 或 /和所述消融头兼用于 发放或 /和接收电脉冲。  The independent structure is provided with detection electrodes for emitting or/and receiving electrical pulses; or / and the ablation heads are also used to dispense or/and receive electrical pulses.
所述可控弯曲段上设置有用于发放或 /和接收电脉冲的检测电极。  A detection electrode for emitting or/and receiving an electrical pulse is disposed on the controllable curved section.
牵引丝走行于独立结构外或 /和走行于独立结构内, 牵引丝的头端附着点设置于消融段 头端, 或设置于独立结构头部到连接点的独立结构上, 或设置于消融头到连接点的独立结构 上, 或消融段头端至消融头之间的独立结构上, 或设置于消融头或其邻近的独立结构上, 或 设置在两条独立结构的连接点设置的连接关节上, 所述牵引丝在可控弯曲段、 导管体段内合 并成一条或分别走行于可控弯曲段、 导管体段的长轴中心线, 最后与控制手柄的控制钮或控 制盘连接。  The traction wire travels outside the independent structure or/and travels in a separate structure. The tip end attachment point of the traction wire is disposed at the head end of the ablation section, or is disposed on a separate structure of the independent structure head to the connection point, or is disposed on the ablation head. On a separate structure to the connection point, or a separate structure between the ablation section head end and the ablation head, or on a separate structure in the ablation head or adjacent thereto, or a connection joint provided at the connection point of two separate structures In the controllable bending section and the catheter body section, the traction wires are merged into one or respectively running on the long axis center line of the controllable bending section and the catheter body section, and finally connected with the control knob or the control panel of the control handle.
当导引导管为消融导管形变提供支点时,导引导管的头部设置与血管相通的斜孔或 /和侧 槽。  When the guiding catheter provides a fulcrum for ablation catheter deformation, the head of the guiding catheter is provided with a slanted hole or/and a side channel that communicates with the blood vessel.
当独立结构的远端连接为一体而构成消融段头端时,导引导管头端设置缩口结构或者堵 头,导引导管的头部侧壁上设置侧槽; 当独立结构彼此独立相互分离时, 导引导管的头端或头 部侧壁上设置斜孔; 当独立结构的中间部分连接在一起, 远端再相互分离时, 导引导管的头 端或头部侧壁设置与血管相通的斜孔, 斜孔之后导引导管的侧壁上再设置侧槽。  When the distal end of the independent structure is integrally connected to form the ablation section head end, the leading end of the guiding catheter is provided with a necking structure or a plug, and the side wall of the guiding duct is provided with a side groove; when the independent structures are separated from each other independently When the middle portion of the guiding catheter or the side wall of the head is provided with oblique holes; when the middle portions of the independent structure are connected together, and the distal ends are separated from each other, the head end or the head side wall of the guiding catheter is arranged to communicate with the blood vessel The inclined hole, after the inclined hole, is provided with a side groove on the side wall of the guiding catheter.
根据需要控制弯曲方向的数量设置导引丝的数量,导引丝的头端附着点设置在导引导管 的头部, 且根据需要弯曲的方向选择相应的离心位置附着, 导引丝走行于导引导管管壁内或 / 和管壁外。  According to the need to control the number of bending directions, the number of guiding wires is set, the tip end attachment point of the guiding wire is arranged at the head of the guiding catheter, and the corresponding centrifugal position is selected according to the direction of bending required, and the guiding wire travels in the guide. Guide the inside of the tube wall or / and outside the tube wall.
导向丝走行于可控弯曲段内或 /和可控弯曲段外, 根据需要控制弯曲方向的数量设置导 向丝数量, 当可控弯曲段釆用 C形弯曲设计时, 导向丝的头端附着点设置在可控弯曲段靠近 消融段的地方, 且根据需要弯曲的方向选择相应的离心位置附着;  The guide wire travels in the controllable curved section or/and outside the controllable curved section, and the number of guiding wires is set according to the number of bending directions required. When the controllable curved section is designed with a C-shaped bending, the tip end of the guiding wire is attached. It is arranged at a position where the controllable curved section is close to the ablation section, and the corresponding centrifugal position is selected according to the direction of bending required;
当可控弯曲段釆用 S形弯曲设计时, 在 C形弯曲设计导向丝的基础上, 在需要形成 S形 弯曲的第二个弯曲的远端另加一根导向丝附着于此, 该导向丝根据需要弯曲的方向选择相应 的离心位置附着; 或不增加导向丝的数量, 通过调整可控弯曲段的内部结构使得一条导向丝 可以实现 S形弯曲。  When the controllable curved section is designed with an S-shaped bending, on the basis of the C-shaped curved designing guide wire, a guide wire is attached to the second curved distal end where the S-shaped bending is required to be attached, the guiding The wire is selected according to the direction in which the bending is required, or the number of the guiding wires is not increased. By adjusting the internal structure of the controllable bending section, a guiding wire can realize S-shaped bending.
所述导引导管的尾部侧壁上还设有用于连接注射器或注液装置进行血管内注药或注射 血管内造影剂的开孔,或通过导引导管末端开口与注射器或 /和注液装置相连进行血管内注药 或 /和注射血管内造影剂; 或 /和所述导引导管末端设置连接接头, 连接接头与注射器、 注液 装置、 消融导管或控制手柄连接。  The tail wall of the guiding catheter is further provided with an opening for connecting an injector or a liquid injection device for intravascular injection or injection of an intravascular contrast agent, or by guiding the catheter end opening with a syringe or/and a liquid injection device Connecting intravascularly or/and injecting an intravascular contrast agent; or/and providing a connection connector at the end of the guiding catheter, the connection connector being coupled to the syringe, the infusion device, the ablation catheter or the control handle.
所述消融导管或 /和导引导管制造时通过选用不同硬度的材料, 或者是通过选择性的减 少或 /和增加部分导管小段的内部结构或 /和管壁的结构,或者是通过在消融导管或 /和导引导 管内植入容易发生形变的结构。  The ablation catheter or/and the guiding catheter are manufactured by selecting materials of different hardness, or by selectively reducing or/and increasing the internal structure of the partial catheter segments or/and the structure of the tube wall, or by ablation catheters. Or / and the guiding catheter is implanted with a structure that is susceptible to deformation.
所述消融导管或 /和导引导管上标记刻度,以指示消融导管或 /和导引导管进入血管的深 度以及在超声或 X射线影像设备下间接测量人体结构的长度、 宽度; 消融导管或 /和导引导管 上设置不同的显影标记用于在超声或 X射线影像设备下区分消融导管或 /和导引导管; 或 /和 各独立结构上设置不同的显影标记用于在超声或 X射线影像设备下区分不同的独立结构; 消 融导管或 /和导引导管上还设置标记用于在超声或 X射线影像设备下区分不同的轴向旋转状 态。  Marking a scale on the ablation catheter or/and the guiding catheter to indicate the depth of the ablation catheter or/and the guiding catheter into the blood vessel and to indirectly measure the length and width of the body structure under ultrasound or X-ray imaging equipment; ablation catheter or / And a different development mark on the guiding catheter for distinguishing the ablation catheter or/and the guiding catheter under the ultrasound or X-ray imaging device; or/and setting different development marks on the individual structures for the ultrasound or X-ray image Different independent structures are distinguished under the device; markers are also provided on the ablation catheter or/and the guiding catheter for distinguishing different axial rotational states under ultrasound or X-ray imaging equipment.
消融导管通过导管体段与控制手柄上端固定,控制手柄的下端或下侧面具有能量交换接 头, 来自消融头的导线、 导管、 微波天线或光纤穿过控制手柄在所述能量交换接头汇集。  The ablation catheter is secured to the upper end of the control handle by a catheter body segment having an energy exchange connector at the lower or lower side of the control handle, and wires, conduits, microwave antennas or fibers from the ablation head are collected through the control handle at the energy exchange connector.
所述控制手柄包括操作柄和操作柄;操作柄上设置有用于控制可控弯曲段形变的控制钮 或控制盘, 所述控制钮或控制盘与导向丝连接, 通过控制钮的上下移动, 或通过控制盘的多 向转动实现对可控弯曲段的控制; 或 /和包括操作柄上的环形控制钮, 所述环形控制钮通过连 接杆与牵引丝连接, 所述连接杆位于控制手柄中的导向槽内, 通过上下移动环形控制钮,实现 对独立结构的控制; 还包括可防止过度牵拉的緩冲结构。 The control handle includes an operating handle and an operating handle; the operating handle is provided with a control button for controlling the deformation of the controllable curved section Or a control panel, the control button or the control panel being connected to the guide wire, controlling the controllable curved section by the up and down movement of the control knob, or by controlling the multi-directional rotation of the control disc; or/and including the ring control on the operating handle a button, the ring control button is connected to the pulling wire through a connecting rod, the connecting rod is located in a guiding groove in the control handle, and the independent structure is controlled by moving the ring control button up and down; further comprising preventing excessive pulling Buffer structure.
所述导引导管控制柄包括操作柄和操作柄 242, 操作柄 211'上设置有用于控制导引导 管形变的控制钮或控制盘, 所述控制钮或控制盘与导引丝连接, 通过控制钮的上下移动, 或 通过控制盘的多向转动实现对导引导管的控制; 还包括可防止过度牵拉的緩冲结构; 所述导 引导管控制柄与控制手柄还分别包括卡槽、 钩状卡齿, 通过卡槽、 钩状卡齿进行分拆与结合。  The guiding catheter control handle includes an operating handle and an operating handle 242, and the operating handle 211' is provided with a control button or a control panel for controlling the deformation of the guiding conduit, and the control button or the control panel is connected with the guiding wire, and is controlled by Up and down movement of the button, or control of the guiding catheter by multi-directional rotation of the control panel; further comprising a buffer structure capable of preventing excessive pulling; the guiding catheter control handle and the control handle further comprise a card slot and a hook respectively The latching teeth are separated and combined by the card slot and the hook-shaped latching teeth.
所述消融发生装置设有能量输出的接头和传感器信号输入的接头, 同时还设有与外接电 源相接地接头; 所述消融发生装置含有通过进行触屏控制来控制参数以及部分或全部信息能 显示在其上的显示器和调节参数的按钮。  The ablation generating device is provided with a connector for energy output and a connector for inputting a sensor signal, and is also provided with a grounding connector connected to an external power source; the ablation generating device includes controlling the parameter and some or all of the information by performing touch screen control. The display and the buttons that adjust the parameters displayed on it.
本发明由于釆用了至少两条独立结构且每条独立结构上均可设置消融头, 因此可以实现 多点同时消融, 缩短了消融时间, 进而减少了手术时间、 减小了患者的痛苦, 此外由于在消 融时多条独立结构上的消融头将同时与血管壁接触, 可以防止消融头滑动, 使得消融时消融 头更加稳定, 防止了消融时因消融头不稳定造成的正常组织不必要的损伤, 减少了消融产生 的并发症, 使消融过程更安全。 另外, 独立结构、 可控弯曲段均有相应的线控结构、 磁控结 构或智能材料对它们的形变进行控制, 因此导管具有较好的操控性, 能适应不同走行的肾动 脉, 而且才艮据具体情况还可以在消融导管外加套导引导管来辅助消融导管定位, 这样整个消 融导管系统在血管内的定位将更准确, 防止不必要的损伤, 同时也可以使整个消融系统应用 于更多的人群。 不仅如此, 为了方便在手术中实时监测消融效果, 在消融导管上还安装有检 测电极以方便及时检测消融效果, 避免二次手术风险。 最后, 该消融导管的设计方案可以适 应多种消融头, 例如射频消融、 冷冻消融、 孩 ί波消融等, 易于推广。  The invention adopts at least two independent structures and each of the independent structures can be provided with an ablation head, so that multiple simultaneous ablation can be realized, the ablation time is shortened, the operation time is reduced, and the patient's pain is reduced. Since the ablation heads on a plurality of independent structures will simultaneously contact the blood vessel wall during ablation, the ablation head can be prevented from sliding, so that the ablation head is more stable during ablation, and the unnecessary tissue damage caused by the instability of the ablation head during ablation is prevented. , reduces complications from ablation and makes the ablation process safer. In addition, the independent structure and the controllable curved section have corresponding wire control structure, magnetic control structure or intelligent material to control their deformation, so the catheter has better handling ability, can adapt to different running renal artery, and only 艮According to the specific situation, a guiding catheter can be added to the ablation catheter to assist the positioning of the ablation catheter, so that the positioning of the entire ablation catheter system in the blood vessel will be more accurate, preventing unnecessary damage, and the entire ablation system can be applied to more. Crowd. Moreover, in order to facilitate real-time monitoring of the ablation effect during surgery, a detection electrode is also mounted on the ablation catheter to facilitate timely detection of the ablation effect and avoid the risk of secondary surgery. Finally, the design of the ablation catheter can be adapted to a variety of ablation heads, such as radiofrequency ablation, cryoablation, and ablation, which are easy to generalize.
附图说明 DRAWINGS
图 1是本发明的一个具体实施方式的结构示意图;  1 is a schematic structural view of a specific embodiment of the present invention;
图 2是作为消融段的两个独立结构的四种连接方式的放大示意图;  Figure 2 is an enlarged schematic view showing four connection modes of two independent structures as ablation sections;
图 3是作为消融段两个独立结构在四种连接方式下发生形变后的放大示意图; 图 4是消融头在独立结构上不同的设置方式的示意图;  FIG. 3 is an enlarged schematic view showing two independent structures as ablation segments deformed in four connection modes; FIG. 4 is a schematic view showing different arrangement modes of the ablation heads on independent structures;
图 5是消融头为射频消融电极头时的示意图;  Figure 5 is a schematic view of the ablation head as a radiofrequency ablation electrode tip;
图 6是消融头为液冷灌注射频消融电极头时的示意图;  6 is a schematic view of the ablation head being a liquid-cooled perfusion radiofrequency ablation electrode tip;
图 7是消融头为液冷灌注射频消融电极头时的横截面示意图;  7 is a schematic cross-sectional view of the ablation head when it is a liquid-cooled perfusion radiofrequency ablation electrode tip;
图 8是消融头设置在独立结构头部时的纵剖面示意图;  Figure 8 is a longitudinal cross-sectional view of the ablation head disposed on the head of the independent structure;
图 9是可控弯曲段 5为 C形弯曲设计时工作状态下的情况;  Figure 9 is a view showing the state in which the controllable curved section 5 is in a C-shaped bending design;
图 10-图 12 是以两条独立结构为例且导引导管能够为消融导管的形变提供支点的情况 下, 导引导管头部的示意图;  Figure 10-12 is a schematic view of the guiding catheter head in the case where two separate structures are exemplified and the guiding catheter can provide a fulcrum for the deformation of the ablation catheter;
图 13是以远端连接于消融段头端的两条独立结构为例的情况下,设置预制形变的独立结 构和可控弯曲段在导引导管辅助下的工作状态示意图;  Figure 13 is a schematic view showing the working state of the independent structure of the prefabricated deformation and the controllable curved section assisted by the guiding catheter in the case of two independent structures whose distal end is connected to the head end of the ablation section;
图 14和图 15是以远端连接于消融段头端的两条独立结构为例的情况下, C形弯曲设计 的线控结构示意图。  Fig. 14 and Fig. 15 are schematic diagrams showing the wire control structure of the C-shaped bending design in the case where two independent structures are connected at the distal end of the ablation section as an example.
图 16是以远端相互分离的两条独立结构为例的情况下, S形弯曲设计的线控结构示意图。 图 17、 图 18、 图 19是通过结构设计的方式改变消融导管和导引导管硬度分布的示意图。 图 20 是远端连接于消融段头端的两个独立结构的线控结构与通过调整独立结构的硬度 分布实现设计形变的示意图。  Fig. 16 is a schematic diagram showing the wire-controlled structure of the S-shaped curved design in the case where two independent structures separated from each other are taken as an example. Figure 17, Figure 18, Figure 19 are schematic diagrams showing the hardness distribution of the ablation catheter and the guiding catheter by structural design. Figure 20 is a schematic illustration of the two separate structures of the remote control connected to the tip end of the ablation section and the design of the deformation by adjusting the stiffness distribution of the individual structures.
图 21 是远端相互分离的两个独立结构的线控结构与通过调整独立结构的硬度分布实现 设计形变的示意图。  Figure 21 is a schematic diagram showing the design of two separate structures of the remote control separated from each other and the design of the deformation by adjusting the hardness distribution of the individual structures.
图 22 是中间某处连接在一起远端再相互分离的两个独立结构的线控结构与通过调整独 立结构的硬度分布实现设计形变的示意图。 Figure 22 is a two-wire structure with a separate structure that is connected to the far end and separated from each other in the middle. The hardness distribution of the vertical structure is a schematic diagram of the design deformation.
图 23是通过调整可控弯曲段的硬度分布实现设计形变的示意图。  Figure 23 is a schematic diagram of design deformation by adjusting the hardness distribution of the controllable curved section.
图 24是导引导管尾部主要结构的剖视图。  Figure 24 is a cross-sectional view showing the main structure of the guide catheter tail.
图 25是导引导管的线控结构与通过调整导引导管的硬度分布实现设计形变的剖视图。 图 26是在以线控结构为例的情况下, 控制手柄实施例的结构剖视图  Figure 25 is a cross-sectional view showing the wire-controlled structure of the guiding catheter and the design deformation by adjusting the hardness distribution of the guiding catheter. Figure 26 is a cross-sectional view showing the structure of the control handle in the case of taking the wire control structure as an example.
图 27是在以线控结构为例的情况下, 存在导引导管控制柄时, 控制手柄 2实施例的结构 剖视图。  Fig. 27 is a cross-sectional view showing the structure of the embodiment of the control handle 2 in the case where the wire guide structure is taken as an example.
具体实施方式 detailed description
下面结合附图和具体实施例, 进一步阐述本发明。 这些实施例应理解为仅用于说明本发 明而不用于限制本发明的保护范围。 在阅读了本发明记载的内容之后, 技术人员可以对本发 明作各种改进或修改, 这些等效变化和修饰同样落入本发明权利要求所限定的范围。  The invention will now be further elucidated with reference to the drawings and specific embodiments. These examples are to be construed as illustrative only and not limiting the scope of the invention. A person skilled in the art can make various modifications and changes to the present invention after reading the contents of the present invention. These equivalent variations and modifications are also within the scope defined by the claims of the present invention.
图 1显示了本发明的具体实施形式和其中主要的部件。 如图 1所示, 该种肾脏去交感神 经消融系统主要由消融导管 1、 控制手柄 2及消融发生装置 3组成, 根据情况设置或不设置 导引导管 7。 参见 1 , 消融导管 1远端(头端)游离, 近端(尾端、 末端)与控制手柄 2相连, 消 融导管 1由近端向远端依次至少由导管体段 4和消融段 6组成,其中导管体段 4的近端(尾端、 末端)与控制手柄 1相连,消融段 6的远端(头端)游离,导管体段前端还可包括可控弯曲段 5 , 根据情况也可以在导管体段 4和消融段 6之间设置其他的段。 优选地, 消融导管 1各段横截 面的外轮廊最好釆用圆形或类圆形, 消融导管 1进入到血管内的各段直径最好相近或相等。 消融导管 1 的长度必须使得消融段 6 能够顺利到达双侧肾动脉指定的消融部位, 一般为 50— 120cm, 且整个消融导管 1 各段的最大直径优选小于所须经过血管路径中血管的最小内 径, 消融导管 1的直径一般为 1. 4—2. 5隱。 如图 1所示, 其中导引导管 7优选为中空管状结 构, 首尾两端均设有开口, 导引导管 7套在消融导管 1外能够辅助消融导管 1到达指定的消 融位置。 导引导管 7的长度必须使得导引导管 7能够顺利地引导消融导管 1到达双侧肾动脉 指定的消融部位, 一般为 50— 120cm, 且整个导引导管 7各段的最大外径优选小于所须经过 血管路径中血管的最小直径, 导引导管 7的直径一般为 1. 4-2. 5隱。  Figure 1 shows a specific embodiment of the invention and the main components therein. As shown in Fig. 1, the renal sympathetic ablation system is mainly composed of an ablation catheter 1, a control handle 2 and an ablation generating device 3, and the guiding catheter 7 is set or not provided according to the situation. Referring to 1, the distal end (head end) of the ablation catheter 1 is free, and the proximal end (tail end, end) is connected to the control handle 2, and the ablation catheter 1 is composed of at least the catheter body segment 4 and the ablation segment 6 from the proximal end to the distal end. Wherein the proximal end (tail end, end) of the catheter body section 4 is connected to the control handle 1, the distal end (head end) of the ablation section 6 is free, and the front end of the catheter body section may further comprise a controllable curved section 5, depending on the situation. Additional segments are provided between the catheter body segment 4 and the ablation segment 6. Preferably, the outer rim of each section of the ablation catheter 1 is preferably circular or circular in shape, and the segments into which the ablation catheter 1 enters the blood vessel are preferably of similar or equal diameter. The length of the ablation catheter 1 must be such that the ablation segment 6 can smoothly reach the designated ablation site of the bilateral renal artery, typically 50-120 cm, and the maximum diameter of each segment of the ablation catheter 1 is preferably less than the minimum diameter of the vessel in the vessel path. 5 隐。 The diameter of the ablation catheter is generally 1. 4-2. 5 hidden. As shown in Fig. 1, the guiding catheter 7 is preferably a hollow tubular structure having openings at both ends, and the guiding catheter 7 is disposed outside the ablation catheter 1 to assist the ablation catheter 1 to reach a designated ablation position. The length of the guiding catheter 7 must be such that the guiding catheter 7 can smoothly guide the ablation catheter 1 to the designated ablation site of the bilateral renal artery, typically 50-120 cm, and the maximum outer diameter of each segment of the guiding catheter 7 is preferably less than 5 隐。 5. The hidden diameter of the guiding catheter 7 is generally 1. 4-2. 5 hidden.
图 1显示了本发明具体实施形式中消融段 6的主要特点。 如图 1所示, 消融段 6由至少 两个独立结构 8组成; 该独立结构 8可以是柱体形、 类似柱体形、 半圆柱形、 锥体形、 类似 锥体形、 弧形等, 各独立结构 8的长度及横截面尺寸可以相等也可以不等, 但优选地, 所有 独立结构 8横截面的外轮廊围成的消融段 6横截面的外轮廊最好接近可控弯曲段 5横截面的 外轮廊。 如图 2A所示, 两个独立结构 8的远端(头端)连接于消融段头端 17 (也即消融导管头 端); 如图 2B所示, 两个独立结构 8相互分离、 彼此独立; 如图 2C所示, 两个独立结构 8的 中间某处连接在一起远端再相互分离,其中连接点 18为所述两个独立结构 8连接在一起的地 方。 独立结构 8的尾端连于导管体段 4前端的可控弯曲段 5。 图 2D所示两个独立结构 8的近 端相连, 远端分别连在牵引丝 10的不同位置上。  Figure 1 shows the main features of the ablation section 6 in a particular embodiment of the invention. As shown in Fig. 1, the ablation section 6 is composed of at least two independent structures 8; the independent structure 8 may be cylindrical, similar cylindrical, semi-cylindrical, pyramidal, pyramidal, curved, etc., each independent structure 8 The length and cross-sectional dimensions may be equal or unequal, but preferably, the outer porch of the cross-section of the ablation section 6 surrounded by the outer porch of all the independent structures 8 is preferably adjacent to the outer porch of the cross-section of the controllable curved section 5. . As shown in Fig. 2A, the distal ends (head ends) of the two independent structures 8 are connected to the ablation section head end 17 (i.e., the ablation catheter tip end); as shown in Fig. 2B, the two independent structures 8 are separated from each other and independent of each other. As shown in FIG. 2C, the middle of the two separate structures 8 are connected together at the distal end and then separated from each other, wherein the connection point 18 is where the two separate structures 8 are connected together. The trailing end of the separate structure 8 is connected to a controllable curved section 5 at the front end of the conduit section 4. The proximal ends of the two separate structures 8 are shown in Fig. 2D, and the distal ends are respectively attached to different positions of the pulling wire 10.
图 3显示了本发明中具体实施形式独立结构 8在不同的两个连接方式下发生形变后的情 况。 其中图 3A显示了远端连接于消融段头端 17的独立结构 8发生形变后的情况, 此时独立 结构 8的中间部分将四散隆起, 一般地, 以独立结构 8的中间或靠近中间处隆起最为明显。 图 3B显示了独立结构 8相互分离时发生形变后的情况,此时独立结构 8将相互远离, 一般地, 以独立结构 8的头端及其附近位置相互远离最为明显。图 3C显示了独立结构 8中间某处连接 在一起远端再相互分离时发生形变后的情况,此时从连接点 18到独立结构 8头端的部分将相 互远离, 一般地, 以独立结构 8头端及其附近位置相互远离最为明显, 从连接点 18到独立结 构 8尾端(末端、 远端)之间的部分将四散隆起, 一般地, 以连接点 18到独立结构 8尾端之间 的部分的中间或靠近中间处隆起最为明显。 图 3D为两个独立结构 8的近端相连, 远端分别连 在牵引丝 10的不同位置上的示意图。 图 4显示了本发明中消融头 9在独立结构 8上不同的设置方式。 如图 4A所示, 至少有一 个独立结构 8上设置有消融头 9 ; 如图 4B、 图 4C所示, 每个独立结构 8可以设置不只一个消 融头 9。 消融头 9主要用于对肾脏交感神经的消融阻断; 消融头 9应是发挥消融作用的原件, 因此消融头 9具有多种类型, 例如: 射频消融电极头、 液冷灌注射频消融电极头、 冷冻消融 头、 超声消融探头、 聚焦超声消融探头、 激光消融头、 聚焦激光消融头、 光动力治疗消融头、 微波消融头、 电阻加热消融头等。 不同独立结构 8上的消融头 9的类型可以相同或不同, 同 一独立结构 8上的多个消融头 9的类型也可以相同或不同, 例如: 一个独立结构 8上的消融 头 9是冷冻消融头, 而另一个独立结构 8上的消融头 9是射频消融电极头, 或者同一个独立 结构 8前端的消融头 9是聚焦激光消融头, 而后一个消融头 9是孩 ί波消融头, 这就使得在不 同情况下不用更换消融导管 1就可完成不同形式的消融。 才艮据消融头 9类型的不同, 消融头 9与控制手柄 1上能量交换接头 201的连接介质有所不同, 例如: 消融头 9为激光消融头时, 连接介质一般为光纤, 而消融头 9为射频消融电极头时, 连接介质一般为导线, 消融头 9为 冷冻消融头时, 连接介质一般为导管。 Fig. 3 shows the state in which the individual structure 8 of the present invention is deformed in two different connection modes. 3A shows the deformation of the separate structure 8 distally connected to the ablation section head end 17, in which case the intermediate portion of the individual structure 8 will be swelled, generally in the middle or near the middle of the individual structure 8. Most obvious. Figure 3B shows the deformation of the individual structures 8 as they are separated from each other, in which case the individual structures 8 will be remote from each other. Generally, the head ends of the individual structures 8 and their vicinity are most distant from each other. Figure 3C shows the deformation of the independent structure 8 when it is connected to the distal end and then separated from each other. The portion from the connection point 18 to the head end of the independent structure 8 will be away from each other. Generally, 8 heads are independent structures. The ends and their vicinity are most distant from each other, and the portion from the connection point 18 to the end (end, end) of the individual structure 8 will be swelled, generally, between the connection point 18 and the end of the individual structure 8. The bulge in the middle or near the middle is most pronounced. Figure 3D is a schematic illustration of the proximal ends of two separate structures 8 connected at different locations of the traction wires 10, respectively. Figure 4 shows the different arrangement of the ablation head 9 on the individual structure 8 in the present invention. As shown in Fig. 4A, at least one of the independent structures 8 is provided with an ablation head 9; as shown in Figs. 4B and 4C, each of the individual structures 8 may be provided with more than one ablation head 9. The ablation head 9 is mainly used for ablation of the renal sympathetic nerve; the ablation head 9 should be the original ablation function, so the ablation head 9 has various types, for example: radiofrequency ablation electrode head, liquid-cooled perfusion radiofrequency ablation electrode head, A cryoablation head, an ultrasound ablation probe, a focused ultrasound ablation probe, a laser ablation head, a focused laser ablation head, a photodynamic therapy ablation head, a microwave ablation head, a resistance heating ablation head, and the like. The types of ablation heads 9 on different individual structures 8 may be the same or different, and the types of a plurality of ablation heads 9 on the same individual structure 8 may be the same or different, for example: the ablation head 9 on a separate structure 8 is a cryoablation head. And the ablation head 9 on the other independent structure 8 is a radio frequency ablation electrode head, or the ablation head 9 at the front end of the same independent structure 8 is a focused laser ablation head, and the latter ablation head 9 is a child ablation head, which makes Different forms of ablation can be accomplished without replacing the ablation catheter 1 in different situations. According to the type of the ablation head 9, the ablation head 9 is different from the connection medium of the energy exchange connector 201 on the control handle 1. For example, when the ablation head 9 is a laser ablation head, the connection medium is generally an optical fiber, and the ablation head 9 When the electrode tip is ablated for the radio frequency, the connecting medium is generally a wire, and when the ablation head 9 is a cryoablation head, the connecting medium is generally a catheter.
图 5是以两个独立结构 8的远端连接于消融段头端 17为例,显示了消融头 9为射频消融 电极头时的主要结构特点。 图 5Α显示了纵剖面下的主要结构特点,射频消融电极头包括射频 消融电极 91 , 优选地, 射频消融电极 91略突出于独立结构 8的表面 0. 05—0. 2mm, 以便与血 管壁接触。 如图 5A所示, 走行于独立结构 8内的射频导线 101将与射频消融电极极 91相连, 为射频消融电极 91提供能量, 导线连接点 191是射频导线 101与射频消融电极 91的连接位 置。 如图 5A所示, 信号线 102与设置在射频消融电极 91上或 /和邻近射频消融电极 91的传 感器 192相连, 用于传输传感器 192 (图 5B示)发送的信号; 传感器 192可以是不同类型的, 例如: 温度传感器、 阻抗传感器、 压力传感器等; 同一类型的传感器 192在独立结构 8上也 可不止一个(图 5是以一个传感器 192作为示例);传感器 192对射频消融电极 91及人体的参 数监控, 有助于了解实时情况, 及时调整治疗方案。 图 5B及图 5C以透视方式显示了射频消 融电极头 9及其周围独立结构 8的主要结构特点。 如图 5B所示, 射频消融电极 91 (图中斜线 表示部分)可以仅包绕半圆柱体的曲侧面而不包绕半圆柱体的平侧面 90; 如图 5C所示, 射频 消融电极 91 (图中斜线表示部分)可以既包绕半圆柱体的曲侧面也包绕半圆柱体的平侧面 90; 当然射频消融电极 91还可根据情况对其包绕的范围进行调整。消融头 9为电阻加热消融头时 可仿此设计。图 5仅是以两个独立结构 8的远端连接于消融段头端 17为例进行消融头 9的设 计方案说明的, 因此图 5所示意的消融头 9的设计方案同样适用于独立结构 8的其他连接方 式以及多个独立结构 8的情况; 此外技术人员还可以根据需要对消融头 9在独立结构 8上的 设置位置进行调整;对于独立结构 8形状不为半圆柱形的情况以及对于射频消融电极 91设置 位置处的独立结构 8的形状有所变化的情况, 也可以仿照图 5所示意的设计方案进行设计。  Fig. 5 is an example in which the distal ends of two independent structures 8 are connected to the ablation section head end 17, and the main structural features of the ablation head 9 as a radio frequency ablation electrode tip are shown. 5毫米的接触为 contact with the vessel wall, the radiofrequency ablation electrode 91 is slightly protruded from the surface of the individual structure 8 0. 05-0. 2mm, in order to contact the blood vessel wall, the radiofrequency ablation electrode 91 is provided. . As shown in FIG. 5A, the radio frequency conductor 101 traveling in the independent structure 8 will be connected to the radio frequency ablation electrode 91 to supply energy to the radio frequency ablation electrode 91. The wire connection point 191 is the connection position of the radio frequency conductor 101 and the radio frequency ablation electrode 91. As shown in FIG. 5A, the signal line 102 is coupled to a sensor 192 disposed on or adjacent to the radio frequency ablation electrode 91 for transmitting a signal transmitted by the sensor 192 (shown in FIG. 5B); the sensor 192 can be of a different type. For example: temperature sensor, impedance sensor, pressure sensor, etc.; the same type of sensor 192 may be more than one on the independent structure 8 (Fig. 5 is an example of a sensor 192); the sensor 192 is for the radio frequency ablation electrode 91 and the human body. Parameter monitoring helps to understand the real-time situation and adjust the treatment plan in time. Figures 5B and 5C show, in perspective, the main structural features of the RF ablation electrode head 9 and its surrounding independent structure 8. As shown in FIG. 5B, the radio frequency ablation electrode 91 (the portion indicated by oblique lines in the figure) may surround only the curved side of the semi-cylindrical body without wrapping the flat side surface 90 of the semi-cylindrical body; as shown in FIG. 5C, the radio frequency ablation electrode 91 (The oblique line indicates the portion) may surround both the curved side of the semi-cylindrical body and the flat side 90 of the semi-cylindrical body; of course, the RF ablation electrode 91 may also adjust the range of its wrapping depending on the situation. The ablation head 9 is designed to be a resistance heating ablation head. FIG. 5 illustrates the design of the ablation head 9 with the distal end of the two independent structures 8 connected to the ablation section head end 17 as an example. Therefore, the design of the ablation head 9 illustrated in FIG. 5 is also applicable to the independent structure 8 . Other connection methods and the case of a plurality of independent structures 8; in addition, the skilled person can also adjust the position of the ablation head 9 on the independent structure 8 as needed; for the case where the independent structure 8 is not semi-cylindrical and for RF The shape of the individual structure 8 at the position where the ablation electrode 91 is disposed may be changed, and the design may be designed in accordance with the design scheme illustrated in FIG.
图 6、 图 7显示了消融头 9为液冷灌注射频消融电极头时的主要结构特点, 其中图 7为 液冷灌注射频消融电极头的横截面示意图。 如图 6A所示, 液冷灌注射频消融电极头包括射频 消融电极 91 , 优选地, 射频消融电极 91的表面有一些小孔 193 , 小孔 193与导管 103相连, 导管 103将从控制手柄 1上的液体灌注接头 202 (图 54示)接入的冷却液体通过小孔 193喷到 液射频消融电极 91的表面进行降温; 如图 6A所示, 导管 103可以与每个小孔分别相连, 也 可以釆用图 6B的设计方案, 导管 103与小孔 193下的空腔 69相连, 通过空腔 69将液体从每 个小孔送出。 如图 6C所示, 冷却的方式还可以釆用消融头 9周围的循环液体管路, 优选地将 导管 103制成螺旋状, 从箭头 aol所示的入口处将冷却液灌入, 从箭头 ao2处流出。 冷却液 一般用冷盐水。 上述两类降温方式可以联合使用, 且还可用于复温, 只要调整灌注液温度即 可。 同时需要降温或复温的其他类型的消融头 9也可以釆用上述设计方案。 图 7A显示了射频 消融电极 91只包绕半圆柱体的曲侧面而不包绕半圆柱体的平侧面 90的情况下, 液冷灌注射 频消融电极头横截面的主要结构特点; 图 7A的上半圆显示了射频导线 101、 信号线 102和导 管 103走行于独立腔 60中的情况, 即在独立结构 8内让上述三个结构在独立的腔室中走行, 以防止其他结构的干扰; 图 7A的下半圆显示了射频导线 101、 信号线 102和导管 103走行于 独立结构 8内的情况, 此时上述三个结构将与其他结构混合走行。 图 7B显示了射频消融电极 91 包绕半圆柱体的曲侧面和半圆柱体的平侧面 90的情况下, 液冷灌注射频消融电极头横截 面的主要结构特点; 图 7B的上半圆显示了射频导线 101、 信号线 102和导管 103走行于独立 腔 60中的情况; 图 7B的下半圆显示的是射频导线 101、 信号线 102和导管 103走行于独立 结构 8内的情况, 此时上述三个结构将与其他结构混合走行。独立腔 60可分成多个独立腔用 于走行不同的构件, 此种用腔室分别走行不同构件的设计思路还可用于其他类型的消融头 9、 消融导管 1的其他部分及导引导管 7。 对于独立结构 8的形状不为半圆柱形的情况以及对于 液冷灌注射频消融电极头 9设置位置处的独立结构 8的形状有所变化的情况, 也可以仿照图 6、 图 7所示意的设计方案进行设计。 Figure 6 and Figure 7 show the main structural features of the ablation head 9 when it is a liquid-cooled perfusion radiofrequency ablation electrode head. Figure 7 is a schematic cross-sectional view of the liquid-cooled perfusion radiofrequency ablation electrode tip. As shown in FIG. 6A, the liquid-cooled perfusion radiofrequency ablation electrode head includes a radio frequency ablation electrode 91. Preferably, the surface of the radio frequency ablation electrode 91 has a plurality of small holes 193 connected to the catheter 103, and the catheter 103 will be connected to the control handle 1. The cooling liquid connected to the liquid filling joint 202 (shown in FIG. 54) is sprayed through the small hole 193 to the surface of the liquid RF ablation electrode 91 for cooling; as shown in FIG. 6A, the conduit 103 may be connected to each of the small holes, or Using the design of Figure 6B, the conduit 103 is connected to a cavity 69 below the aperture 193 through which liquid is delivered from each aperture. As shown in Fig. 6C, the cooling can also be performed by using a circulating liquid line around the ablation head 9, preferably by making the catheter 103 spiral, and pouring the coolant from the inlet indicated by the arrow aol, from the arrow ao2. Flow out. The coolant is usually cold brine. The above two types of cooling methods can be used in combination, and can also be used for rewarming, as long as the temperature of the perfusate is adjusted. Other types of ablation heads 9 that require simultaneous cooling or rewarming may also employ the above design. Figure 7A shows the main structural features of the cross section of a liquid-cooled perfusion radiofrequency ablation electrode head in the case where the radiofrequency ablation electrode 91 only surrounds the curved side of the semi-cylindrical body without wrapping the flat side 90 of the semi-cylinder; The semicircle shows the case where the radio frequency conductor 101, the signal line 102, and the duct 103 travel in the independent chamber 60, that is, the three structures are moved in separate chambers in the independent structure 8. In order to prevent interference from other structures; the lower semicircle of Fig. 7A shows the case where the radio frequency conductor 101, the signal line 102 and the duct 103 travel in the separate structure 8, at which point the above three structures will be mixed with other structures. Figure 7B shows the main structural features of the cross-section of the liquid-cooled perfusion radiofrequency ablation electrode head with the radiofrequency ablation electrode 91 wrapped around the curved side of the semi-cylindrical and the flat side 90 of the semi-cylinder; the upper semicircle of Figure 7B shows the radio frequency The case where the wire 101, the signal line 102, and the conduit 103 travel in the independent cavity 60; the lower semicircle of FIG. 7B shows the case where the radio frequency wire 101, the signal line 102, and the duct 103 travel in the independent structure 8, at which time the above three The structure will be mixed with other structures. The separate chamber 60 can be divided into a plurality of separate chambers for running different members, and the design of the different members for the different chambers can be used for other types of ablation heads 9, other portions of the ablation catheter 1 and the guiding catheter 7. For the case where the shape of the individual structure 8 is not semi-cylindrical and the shape of the independent structure 8 at the position where the liquid-cooled perfusion radiofrequency ablation electrode head 9 is disposed, the design shown in FIG. 6 and FIG. 7 can also be used. The plan is designed.
图 8是以消融头 9为射频消融电极头为例, 显示了消融头 9设置在远端相互分离的两个 独立结构 8头部时纵剖面的主要结构特点; 其中, 图 8A显示的是消融头 9只包绕半圆柱体的 曲侧面而不包绕半圆柱体的平侧面 90的情况, 图 8B显示的是消融头 9包绕半圆柱体的曲侧 面和半圆柱体的平侧面 90的情况。图 8所示意的射频消融电极头的设计方案与图 5所示意的 射频消融电极头的设计方案类似。 如图 8A、 图 8B所示, 独立结构 8的远端能够相互远离, 类似地, 走行于独立结构 8内的射频导线 101将与射频消融电极 91相连, 为射频消融电极头 9提供能量, 导线连接点 191是射频导线 101与射频消融电极 91相连接的位置。 如图 8A、 图 8B所示, 类似地, 信号线 102与设置在射频消融电极 91上或 /和邻近射频消融电极 91的传 感器 192相连, 用于传输传感器 192发送的信号; 类似地, 传感器 192可以是不同类型的, 例如: 温度传感器、 阻抗传感器、 压力传感器等; 同一类型的传感器 192在独立结构 8上也 可不止一个(图 8是以一个传感器 192作为示例); 传感器 192对射频消融电极头 9及人体的 参数监控, 有助于了解实时情况, 及时调整治疗方案。 如图 8A所示, 射频消融电极 91可以 仅包绕半圆柱体的曲侧面而不包绕半圆柱体的平侧面 90; 如图 8B所示, 射频消融电极 91可 以既包绕半圆柱体的曲侧面也包绕半圆柱体的平侧面 90; 当然射频消融电极 91还可根据情 况对其包绕独立结构 8的范围进行调整。 由于图 8所示的设计方案是以消融头 9为射频消融 电极头为例进行说明的, 因此该设计方案同样适用于消融头 9为其他类型的消融头的情况, 此时需将射频消融电极头替换成其他类型的消融头, 例如液冷灌注射频消融电极头、 电阻加 热消融头等; 对于多个独立结构 8的情况、 对于独立结构 8的形状不为半圆柱形的情况以及 对于消融头 9设置位置处的独立结构 8的形状有所变化的情况, 也可以仿照图 8所示意的设 计方案进行设计。  8 is an example of a longitudinal section of the longitudinal section of the ablation head 9 as a radio frequency ablation electrode head, showing the ablation head 9 disposed at the distal end of the two independent structures 8; wherein, FIG. 8A shows the ablation The head 9 only surrounds the curved side of the semi-cylindrical body without wrapping the flat side 90 of the semi-cylindrical body, and FIG. 8B shows the ablation head 9 surrounding the curved side of the semi-cylindrical body and the flat side 90 of the semi-cylindrical body. Happening. The design of the RF ablation tip illustrated in Figure 8 is similar to the design of the RF ablation tip illustrated in Figure 5. As shown in FIG. 8A and FIG. 8B, the distal ends of the independent structures 8 can be separated from each other. Similarly, the radio frequency wires 101 traveling in the independent structure 8 will be connected to the radio frequency ablation electrodes 91 to provide energy, wires for the radio frequency ablation electrode heads 9. The connection point 191 is a position where the radio frequency wire 101 is connected to the radio frequency ablation electrode 91. As shown in FIGS. 8A and 8B, similarly, the signal line 102 is connected to a sensor 192 disposed on the radio frequency ablation electrode 91 or/and adjacent to the radio frequency ablation electrode 91 for transmitting a signal transmitted by the sensor 192; similarly, the sensor 192 It can be of different types, for example: temperature sensor, impedance sensor, pressure sensor, etc.; the same type of sensor 192 can be more than one on the independent structure 8 (Fig. 8 is an example of one sensor 192); sensor 192 is a pair of radio frequency ablation electrodes The monitoring of the parameters of the head 9 and the human body helps to understand the real-time situation and adjust the treatment plan in time. As shown in FIG. 8A, the radio frequency ablation electrode 91 may only surround the curved side of the semi-cylindrical body without wrapping the flat side 90 of the semi-cylindrical body; as shown in FIG. 8B, the radio frequency ablation electrode 91 may surround the semi-cylindrical body. The curved side also surrounds the flat side 90 of the semi-cylinder; of course, the RF ablation electrode 91 can also be adjusted to encompass the extent of the individual structure 8 as appropriate. Since the design shown in FIG. 8 is described by taking the ablation head 9 as a radio frequency ablation electrode head as an example, the design is also applicable to the case where the ablation head 9 is another type of ablation head, and the radiofrequency ablation electrode is required. The head is replaced with other types of ablation heads, such as a liquid-cooled perfusion radiofrequency ablation electrode head, a resistance heating ablation head, etc.; for the case of a plurality of individual structures 8, for a case where the shape of the individual structure 8 is not semi-cylindrical, and for the ablation head 9 The case where the shape of the individual structure 8 at the set position is changed may also be designed in accordance with the design scheme illustrated in FIG.
图 9筒示了可控弯曲段 5为 C形弯曲设计时工作状态下的情况,设置可控弯曲段 5的主 要作用是有助于消融段 6更方便的到达指定的消融位置, 例如使得消融段 6更容易通过血管 的弯曲、 使得消融段 6更容易向指定方向偏转等。 可控弯曲段 5优选釆用圆柱形或类圆柱形 设计, 根据不同的设计方案可控弯曲段 5的长度有所不同。 显示了可控弯曲段 5为 C形弯曲 设计时工作状态下的情况, 如图 9所示, 可控弯曲段 5形变后的形状为 C形, 实线部分的可 控弯曲段 5表示了一种 C形弯曲的情况,在这种形状下,可控弯曲段 5优选长度为 60—120隱, 可控弯曲段 5将有两个地方 cl和 c2与血管内侧壁接触, 其中 cl与肾动脉 a的内侧壁接触, 而 c2与腹主动脉 b的内侧壁接触, 这样有利于在消融时稳定消融头 9 , 可控弯曲段 5此时最 好与其中的一个独立结构 8在同一平面上, 这样对于独立结构 8上仅有消融头 9作为检测电 极的情况, 可在 cl设置检测电极 19 , 这样消融头 9或独立结构 8上的检测电极 19与可控弯 曲段 5上的检测电极 19将形成一个发放电脉冲、 一个接收电脉冲, 当然为适应不同管径的肾 动脉, 可以在 cl附近设置多个环状接收检测电极 19 ; 如图 9所示, 虚线部分的可控弯曲段 5 表示了另一种 C形弯曲的情况, 在这种情况下, 可控弯曲段 5优选长度为 40—100隱, 可控 弯曲段 5可以不与动脉的内侧壁接触, 或者仅有一个地方 c2与动脉的内侧壁接触, 这样消融 头 9的稳定将主要依靠各独立结构 8与动脉的内侧壁接触形成的支撑点。 根据具体情况,技术人员可以对上述这些消融段 6和可控弯曲段 5的设计方案进行融合、 改进及交叉使用, 这些等效变化和修饰同样落入本发明权利要求所限定的范围。 Figure 9 shows the situation in which the controllable curved section 5 is in the C-shaped bending design. The main function of setting the controllable curved section 5 is to facilitate the ablation section 6 to more easily reach the designated ablation position, for example, to ablate Segment 6 is easier to bend through the blood vessel, making it easier for the ablation segment 6 to deflect in a specified direction, and the like. The controllable curved section 5 preferably has a cylindrical or cylindrical design, and the length of the controllable curved section 5 varies according to different designs. The controllable curved section 5 is shown in the working state of the C-shaped bending design. As shown in FIG. 9, the shape of the controllable curved section 5 is C-shaped, and the controllable curved section 5 of the solid line part represents one. In the case of a C-shaped bend, in this shape, the controllable curved section 5 preferably has a length of 60-120 hidden, and the controllable curved section 5 will have two places cl and c2 in contact with the inner wall of the blood vessel, wherein cl and the renal artery The inner side wall of a is in contact, and c2 is in contact with the inner side wall of the abdominal aorta b, which is advantageous for stabilizing the ablation head 9 during ablation, and the controllable curved section 5 is preferably in the same plane as one of the independent structures 8 at this time, Thus, for the case where only the ablation head 9 is used as the detecting electrode on the independent structure 8, the detecting electrode 19 can be disposed in the cl such that the detecting electrode 19 on the ablation head 9 or the independent structure 8 and the detecting electrode 19 on the controllable curved section 5 will Forming a discharge pulse, a receiving electrical pulse, of course, to accommodate renal artery of different diameters, a plurality of annular receiving detection electrodes 19 may be disposed near the cl; as shown in FIG. 9, the controllable curved segment 5 of the broken line portion indicates Another C-shaped bending situation, In this case, the controllable curved section 5 preferably has a length of 40-100 invisible, the controllable curved section 5 may not be in contact with the inner side wall of the artery, or only one place c2 may be in contact with the inner side wall of the artery, such that the ablation head 9 is Stabilization will primarily rely on the support points formed by the individual structures 8 in contact with the inner sidewalls of the artery. Depending on the circumstances, the skilled person can combine, improve and cross-use the design of the above-described ablation section 6 and the controllable bending section 5, and these equivalent variations and modifications also fall within the scope defined by the claims of the present invention.
可控弯曲段 5、 独立结构 8和导引导管 7可发生主动控制形变或和被动控制形变。 其中 可控弯曲段 5、独立结构 8和导引导管 7的主动控制形变是指可控弯曲段 5、独立结构 8和导 引导管 7在无外力直接作用或传动的情况下通过间接实时控制可控弯曲段 5、 独立结构 8和 导引导管 Ί 内力的变化而发生的形变, 例如: 可控弯曲段 5、 独立结构 8和导引导管 7 内含 有智能材料 (如形状记忆合金), 通过消融导管 1和导引导管 7外对智能材料温度等的控制, 实现实时改变可控弯曲段 5、 独立结构 8和导引导管 7在体内和体外的形变形态。 可控弯曲 段 5、 独立结构 8和导引导管 7的被动控制形变则指通过直接或间接实时控制作用于可控弯 曲段 5、独立结构 8和导引导管 7的外力使可控弯曲段 5、独立结构 8和导引导管 7发生的形 变; 例如通过牵拉固定在可控弯曲段 5上的导向丝 11使得可控弯曲段 5发生形变, 通过牵拉 固定在独立结构 8上的牵引丝 10使得独立结构 8发生形变,通过牵拉固定在导引导管 7上的 导引丝 70使得导引导管 7发生形变; 再例如在推送过程中, 消融段头端 17触到血管壁后使 可控弯曲段 5发生的顺应性弯曲; 又例如可控弯曲段 5、 独立结构 8和导引导管 7 内含有能 够被磁铁吸引的物质, 通过外加磁场使得可控弯曲段 5、 独立结构 8和导引导管 7发生弯曲。 消融导管 1和导引导管 7都可以有预制形变, 例如在体外制造时可以事先将可控弯曲段 5预 置成向某个方向弯曲的状态, 使得消融段 6可以顺利进入肾动脉; 预制形变也可以通过在消 融导管 1和导引导管 7中加入具有形状记忆功能的材料来实现在体外对预制形变进行调整, 例如: 在可控弯曲段 5中加入形状记忆合金, 可以先将其在体外的弯曲形态预先制成 C形弯 曲, 当需要可控弯曲段 5改变弯曲形态时, 又可以再次将其拿出体外通过温度变化使可控弯 曲段 5制成其他形状的弯曲样式。  The controllable bending section 5, the independent structure 8 and the guiding duct 7 can take the form of active control deformation or passive control deformation. The active control deformation of the controllable curved section 5, the independent structure 8 and the guiding duct 7 means that the controllable curved section 5, the independent structure 8 and the guiding duct 7 can be controlled by indirect real-time without external force direct action or transmission. The deformation of the curved section 5, the independent structure 8 and the internal force of the guiding catheter ,, for example: the controllable curved section 5, the independent structure 8 and the guiding catheter 7 contain a smart material (such as a shape memory alloy), through ablation The control of the temperature of the smart material and the like outside the catheter 1 and the guiding catheter 7 enables real-time transformation of the deformable shape of the controllable curved section 5, the independent structure 8 and the guiding catheter 7 in vivo and in vitro. The passively controlled deformation of the controllable curved section 5, the separate structure 8 and the guiding catheter 7 refers to the controllable bending section 5 by direct or indirect real-time control of external forces acting on the controllable curved section 5, the independent structure 8 and the guiding catheter 7. The deformation of the independent structure 8 and the guiding catheter 7; for example, by pulling the guiding wire 11 fixed on the controllable bending section 5 to deform the controllable bending section 5, by pulling the traction wire fixed on the independent structure 8 10 causes the independent structure 8 to be deformed, and the guiding catheter 7 is deformed by pulling the guiding wire 70 fixed on the guiding catheter 7; for example, during the pushing process, the ablation section head end 17 touches the blood vessel wall to enable Controlling the bending of the bending section 5; for example, the controllable bending section 5, the independent structure 8 and the guiding duct 7 contain substances capable of being attracted by the magnet, and the controllable bending section 5, the independent structure 8 and the guide by the external magnetic field The guide tube 7 is bent. Both the ablation catheter 1 and the guiding catheter 7 can be prefabricated. For example, in the in vitro manufacturing, the controllable curved segment 5 can be preliminarily bent in a certain direction, so that the ablation segment 6 can smoothly enter the renal artery; prefabrication deformation It is also possible to adjust the prefabrication deformation in vitro by adding a material having a shape memory function to the ablation catheter 1 and the guiding catheter 7, for example: adding a shape memory alloy to the controllable bending section 5, which can be firstly in vitro The curved shape is pre-formed into a C-shaped bend. When the controllable curved section 5 is required to change the curved shape, it can be taken out of the body again to make the controllable curved section 5 into a curved shape of other shapes by temperature change.
对于独立结构 8、 可控弯曲段 5以及导引导管 7的主动控制形变, 目前优选智能材料, 其中以技术较为成熟的形状记忆合金较好, 当然根据技术要求可选择电活性聚合物、 磁活性 聚合物等智能材料。 将形状记忆合金设计成螺旋形、 "Z" 字形、 "G" 字形等结构植入独立结 构 8和可控弯曲段 5内或它们的管壁中, 以及导引导管 7管壁中, 通过电流等调节形状记忆 合金的温度, 达到控制独立结构 8、 可控弯曲段 5和导引导管 7形变的目的。  For the independent structure 8, the controllable curved section 5 and the active control deformation of the guiding catheter 7, the smart material is currently preferred, wherein the shape memory alloy with more mature technology is better, and of course, the electroactive polymer and the magnetic activity can be selected according to the technical requirements. Smart materials such as polymers. The shape memory alloy is designed into a spiral shape, a "Z" shape, a "G" shape, etc., and is implanted in the independent structure 8 and the controllable curved section 5 or in their tube walls, and in the wall of the guiding conduit 7, through the current The temperature of the shape memory alloy is adjusted to achieve the purpose of controlling the independent structure 8, the controllable curved section 5 and the guiding catheter 7.
对于独立结构 8、 可控弯曲段 5以及导引导管 7的被动控制形变, 优选釆用线控结构设 计和磁控结构设计。在消融导管 1上, 线控结构设计是通过连接于独立结构 8的牵引丝 10或 连接于可控弯曲段 5的导向丝 11张力或 /和应力的变化, 使得独立结构 8或可控弯曲段 5发 生被动控制形变, 但优选通过增加牵引丝 10或 /和导向丝 11的张力, 即牵拉牵引丝 10以及 推送消融导管 1除牵引丝 10以外的其他部分或 /和牵拉导向丝 11以及推送消融导管 1除导向 丝 11以外的其他部分; 类似地,在导引导管 7上线控结构是通过走行于导引导管 7管壁中的 导引丝 70张力或 /和应力的变化, 使得导引导管 7发生被动控制形变, 但优选通过增加导引 丝 70的张力, 即牵拉导引丝 70以及推送导引导管 7除导引丝 70以外的其他部分。 牵引丝 10主要负责控制独立结构 8的形变,有时也可导向消融导管 1 , 牵引丝 10在消融段 6时可走 行于独立结构 8内, 也可走行于独立结构 8外, 但在除消融段 6以外的消融导管 1的其他部 分, 牵引丝 10优选走行于消融导管 1内, 并最终与控制手柄 2上的牵引丝固定盘 205相连。 导向丝 11的作用主要是调整消融导管 1在血管内的走行方向, 导向丝 11优选走行于可控弯 曲段 5内, 在除可控弯曲段 5以外的消融导管 1的其他部分也优选走行于消融导管 1内, 并 最终与控制手柄 2上的导向丝固定盘 204相连。导引丝 70的作用主要是调整导引导管 7在血 管内的走行方向, 导引丝 70优选走行于导引导管 7管壁中, 并最终与导引导管控制柄 27或 控制手柄 2连接。导向丝 11的数量主要根据需要控制的弯曲方向及可控弯曲段 5有无预置形 变而定, 导向丝 11的数量优选小于或等于所需要控制的弯曲方向的数量,表 1列举了导向丝 11数量及控制方向和有无预置形变的关系。 在满足牵引丝 10、 导向丝 11、 导引丝 70主要功 能的情况下, 最好尽量减少牵引丝 10、 导向丝 11、 导引丝 70的数量。 磁控结构设计主要是 通过独立结构 8、 可控弯曲段 5以及导引导管 7 内的能够被磁铁吸引的物质在外加磁场作用 下的磁性吸引或排斥使得独立结构 8、 可控弯曲段 5以及导引导管 7发生被动控制形变, 从
Figure imgf000011_0001
For the passive control deformation of the independent structure 8, the controllable curved section 5 and the guiding duct 7, the linear control structure design and the magnetic control structure design are preferably used. On the ablation catheter 1, the wire-controlled structure is designed such that the tension or/and the stress of the guide wire 11 connected to the individual structure 8 or the guide wire 11 connected to the controllable curved section 5 causes a separate structure 8 or a controllable curved section. 5 passive control deformation occurs, but preferably by increasing the tension of the traction wire 10 or/and the guide wire 11, that is, pulling the traction wire 10 and pushing the ablation catheter 1 other than the traction wire 10 or/and the pulling guide wire 11 and Pushing the ablation catheter 1 except for the guide wire 11; similarly, the wire control structure on the guiding catheter 7 is a change in tension or/and stress of the guide wire 70 that travels in the wall of the guiding catheter 7, such that The guide tube 7 undergoes passive control deformation, but it is preferable to increase the tension of the guide wire 70, that is, to pull the guide wire 70 and push the guide catheter 7 except for the guide wire 70. The traction wire 10 is mainly responsible for controlling the deformation of the independent structure 8, and sometimes can also be directed to the ablation catheter 1, and the traction wire 10 can travel in the independent structure 8 in the ablation section 6, or can travel outside the independent structure 8, but in the ablation section. In other portions of the ablation catheter 1 other than 6, the traction wire 10 preferably travels within the ablation catheter 1 and is ultimately coupled to the traction wire retaining disk 205 on the control handle 2. The function of the guide wire 11 is mainly to adjust the direction of travel of the ablation catheter 1 in the blood vessel. The guide wire 11 preferably travels within the controllable curved section 5, and other portions of the ablation catheter 1 other than the controllable curved section 5 are preferably also traversed. The catheter 1 is ablated and ultimately connected to a guide wire retaining disk 204 on the control handle 2. The purpose of the guide wire 70 is primarily to adjust the direction of travel of the guiding catheter 7 within the blood vessel. The guide wire 70 preferably travels in the wall of the guiding catheter 7 and is ultimately coupled to the guiding catheter handle 27 or the control handle 2. The number of the guide wires 11 is mainly determined according to the bending direction to be controlled and the presence or absence of the preset deformation of the controllable curved segments 5. The number of the guide wires 11 is preferably less than or equal to the number of bending directions to be controlled, and Table 1 lists the guide wires. 11 number and control direction and the relationship between preset deformation. In the case where the main functions of the pulling wire 10, the guiding wire 11, and the guiding wire 70 are satisfied, it is preferable to minimize the number of the pulling wire 10, the guiding wire 11, and the guiding wire 70. The main structure of the magnetron structure is The independent structure 8, the controllable curved section 5 and the guiding catheter 7 are passively activated by the magnetic attraction or repulsion of the independent structure 8, the controllable curved section 5 and the substance capable of being attracted by the magnet in the guiding duct 7 under the action of an external magnetic field. Control deformation, from
Figure imgf000011_0001
丝 11 预置 控制方向 点 111优选设置 备注  Wire 11 Preset Control Direction Point 111 Preferred Settings Remarks
数量 弯曲 数量 位置  Quantity bending quantity position
与预置弯曲方向 预置弯曲一个方向,牵拉导向丝 11后转向 With the preset bending direction, preset one direction of bending, pull the guide wire 11 and then turn
1 有 > 2 1 has > 2
相对 预置弯曲的反方向  Relative to the opposite direction of the preset bend
两个分别与预置 预置弯曲一个方向, 每牵拉一根导向丝 11 弯曲方向相对成 牵拉导向丝 11一共实现两个方向,同时牵 The two are respectively bent in one direction with the preset preset, and each of the pulling wires 11 is bent in a direction opposite to the pulling guide wire 11 to realize two directions, and simultaneously
2 有 > 3 2 have > 3
120 度角的不同 拉两根导向丝 11再实现一个方向,变化牵 位置 拉力的大小可以对弯曲方向进行调整  Different angles of 120 degrees. Pulling the two guide wires 11 to achieve one direction, changing the position of the pulling force can adjust the bending direction.
牵拉和推送导向丝 11一共实现两个方向, Pulling and pushing the guide wire 11 achieves two directions in total,
1 无 > 1 1 none > 1
仅有牵拉或推送导向丝 11实现一个方向 相对方向的相同 每牵拉一根导向丝 11一共实现两个方向, Only the pulling or pushing of the guiding wire 11 realizes the same direction in one direction. Each pulling of one guiding wire 11 realizes two directions in total.
2 无 > 2 或不同的横截面 同时牵拉两根导向丝再实现一个方向(头 上 端固定点 111在不同横截面上时) 2 None > 2 or different cross-sections Pulling two guide wires at the same time to achieve one direction (when the upper end fixed point 111 is on a different cross section)
每牵拉一根导向丝牵拉导向丝一共实现三 个方向, 同时牵拉两根导向丝一共实现三 Each pulling of a guide wire pulls the guide wire to achieve three directions, and simultaneously pulls two guide wires to achieve three
3 无 > 3 两个成 120度角 3 no > 3 two into a 120 degree angle
个方向, 变化牵拉力的大小可以对弯曲方 向进行调整  Direction, varying the amount of pulling force can adjust the bending direction
每牵拉一根导向丝牵拉导向丝一共实现四 相邻两个成 90度 个方向, 同时牵拉相邻两根导向丝一共实 Each pulling of a guide wire pulls the guide wire to achieve a total of four adjacent two into 90 degrees, while pulling the adjacent two guide wires together
4 无 > 4 4 no > 4
角 现四个方向, 变化牵拉力的大小可以对弯 曲方向进行调整 参照图 10-12所示, 对于导引导管 7能够为消融导管 1的形变提供支点的情况, 导引导 管 7的头部优选设置与血管相通的斜孔 74或 /和侧槽 76。 斜孔 74和侧槽 76主要作为独立结 构 8向导引导管 7外伸出的通道, 实现独立结构 8与血管壁接触, 当然斜孔 74和侧槽 76也 可以作为向血管内注药或 /和注射造影剂的通道。根据独立结构 8数量和两两独立结构 8相互 连接方式的不同导引导管 7头部的斜孔 74和侧槽 76的设置方式也不同。 图 10A、 图 10B、 图 10C为纵剖面示意图, 图 10D、 图 10E为透视示意图。 如图 10所示, 当独立结构 8相互分离 时, 在导引导管 7的头端(远端)或头部侧壁上开出若干与各独立结构 8相对应的斜孔 74 ; 如 图 10A、 10D所示, 斜孔 74可开于导引导管 7的头端, 如图 10B、 图 10C所示, 斜孔 74也可 开于导引导管 7的头部侧壁上,每个斜孔 74的内径大于独立结构 8的外径,一般 1. 4—2. 4mm, 每个斜孔 74的倾斜角度一般为 30—50度, 同时斜孔 74的数量优选等于独立结构 8的数量, 斜孔 74间的连接部分 75优选呈锥状,连接部分 75不仅能够限制可控弯曲段 5被前推出导引 导管 7还有助于引导独立结构 8从斜孔 74处被前推出。若推送消融导管 1或回退导引导管 7 , 如图 10C所示,独立结构 8将从斜孔 74内向外呈辐散状被推入血管,独立结构 8头部的消融 头 9将优先与血管壁接触;通过控制推送消融导管 1或回退导引导管 7的距离以及斜孔 74的 倾斜度, 即可控制独立结构 8远端相互分离的距离及消融头 9与血管壁接触的压力。 对于独 立结构 8的远端汇集于消融段头端 17的情况, 图 11A、 图 11B为纵剖面示意图, 图 11C为透 视图。 如图 11A、 图 11C所示, 当独立结构 8的远端汇集于消融段头端 17时, 导引导管 7的 头端开口优选通过结构设计的方式限制消融段头端 17被前推出导引导管 7 , 优选可设置缩口 结构 73使导引导管 7头端开口的孔径小于消融段头端 17的外径(图 11A所示), 抑或用堵头 72封闭导引导管 7的头端开口(图 11B、 图 11C所示); 如图 11所示, 导引导管 7的头端侧壁 上优选地设置有与独立结构 8 的长度相近且与血管相通的侧槽 76 , 侧槽 76 的长度一般为 11— 13mm, 该侧槽 76优选与独立结构 8平行对应, 侧槽 76的宽度略大于独立结构 8的外径, 一般为 1. 4—2. 4隱, 并且侧槽 76的数量优选等于独立结构 8的数量。 若推送消融导管 1或 回退导引导管 7 , 如图 11B所示, 消融段头端 17因为堵头 72的限制将使得独立结构 8从相 应的侧槽 76处隆起膨出, 将使得消融头 9优先与血管壁相接触; 通过控制推送消融导管 1或 回退导引导管 7的距离, 即可控制独立结构 8中间部分相对隆起的间隔距离及消融头 9与血 管壁接触的压力。 对于独立结构 8的中间某处连接在一起远端再相互分离的情况, 导引导管 7头部的设计方案结合了图 10、 图 11所示意的设计方案。 如图 12A所示, 在导引导管 7的头 部侧壁上设置若干与血管相通小的斜孔 74或者在导引导管 7的头端设置若干小的斜孔 74 (类 似图 10A、 图 10D所示) , 然后在斜孔 74之后一定距离的导引导管 7的侧壁上再设置与斜孔 74相对应且与独立结构 8相平行的侧槽 76 ,斜孔 74与侧槽 76的间隔距离一般为 2. 5—5. 5mm, 每个斜孔的内径略大于独立结构 8的外径, 一般为 1. 4—2. 4隱, 每个斜孔 74的倾斜角度一 般为 30—50度, 斜孔间的连接部分 75优选呈锥状, 连接部分 75不仅能够限制连接点 18和 可控弯曲段 5被前推出导引导管 7还有助于引导独立结构 8从斜孔 74处被前推出, 侧槽 76 的宽度优选略大于独立结构 8的外径, 一般为 1. 4—2. 4隱, 侧槽 76的长度与独立结构 8近 端到连接点 18的部分的长度相近, 一般为 10—22mm, 斜孔 74和侧槽 76的数量优选等于独 立结构 8的数量。 若推送消融导管 1或回退导引导管 7 , 独立结构 8远端到连接点 18之间的 部分将从斜孔 74内向外呈辐散状被推入血管,独立结构 8头部的消融头 9将优先与血管壁接 触, 独立结构 8近端到连接点 18之间的部分将从对应的侧槽 76处隆起膨出, 隆起最明显的 地方将优先与血管壁接触;通过控制推送消融导管 1或回退导引导管 7的距离以及斜孔 74的 倾斜度能够控制独立结构 8远端相互分离的距离及消融头 9与血管壁接触的压力。 上述设计 方案中的斜孔 74和侧槽 76也具有向血管内注药或注射造影剂的作用。 为了方便独立结构 8 形成设计形变, 可以通过调整独立结构 8的结构设计或通过改变制造材料硬度使设计形变更 容易实现。 图 10、 图 11、 图 12是以两条独立结构 8为例进行设计方案说明的, 因此不局限 于两条条独立结构 8的情况, 对于多于两条独立结构 8的情况只需要按照图 10、 图 11、 图 12所示意的设计思路调整斜孔 74与侧槽 76的数量和设置位置。 The angle is in four directions, and the magnitude of the pulling force can be adjusted to the bending direction. Referring to Figures 10-12, for the case where the guiding catheter 7 can provide a fulcrum for the deformation of the ablation catheter 1, the head of the guiding catheter 7 is guided. It is preferable to provide an inclined hole 74 or/and a side groove 76 that communicates with the blood vessel. The inclined hole 74 and the side groove 76 mainly serve as a separate structure 8 to guide the outwardly extending passage of the guide tube 7, and the independent structure 8 is brought into contact with the blood vessel wall. Of course, the oblique hole 74 and the side groove 76 can also be used as an injection into the blood vessel or/and The channel into which the contrast agent is injected. The manner in which the inclined holes 74 and the side grooves 76 of the head of the guiding catheter 7 are different according to the number of the independent structures 8 and the interconnection of the two independent structures 8 is also different. 10A, 10B, and 10C are schematic longitudinal cross-sectional views, and Figs. 10D and 10E are perspective views. As shown in FIG. 10, when the individual structures 8 are separated from each other, a plurality of inclined holes 74 corresponding to the individual structures 8 are formed on the head end (distal end) or the head side wall of the guiding catheter 7; As shown in FIG. 10D, the inclined hole 74 can be opened at the head end of the guiding catheter 7, as shown in FIG. 10B and FIG. 10C, and the inclined hole 74 can also be opened on the side wall of the guiding catheter 7, each oblique hole. The inner diameter of 74 is greater than the outer diameter of the independent structure 8, generally 1.4 - 2. 4mm, the angle of inclination of each inclined hole 74 is generally 30 - 50 degrees, and the number of inclined holes 74 is preferably equal to the number of independent structures 8, oblique The connecting portion 75 between the holes 74 is preferably tapered, and the connecting portion 75 not only limits the ability of the controllable curved section 5 to be pushed out of the guiding catheter 7 but also helps guide the independent structure 8 to be pushed forward from the inclined hole 74. If the ablation catheter 1 or the retraction guide catheter 7 is pushed, as shown in Fig. 10C, the independent structure 8 will be diverged into the blood vessel from the inside of the oblique hole 74, and the ablation head 9 of the head of the independent structure 8 will preferentially The blood vessel wall contact; by controlling the distance between the push ablation catheter 1 or the retraction guide catheter 7 and the inclination of the oblique hole 74, the distance separating the distal ends of the independent structures 8 from each other and the pressure at which the ablation head 9 is in contact with the blood vessel wall can be controlled. 11A, 11B are longitudinal cross-sectional views, and Fig. 11C is a perspective view. As shown in FIGS. 11A and 11C, when the distal end of the independent structure 8 is collected at the ablation section head end 17, the head end opening of the guiding catheter 7 preferably limits the ablation section head end 17 to be pushed forward by a structural design. Catheter 7, preferably can be set to shrink The structure 73 allows the opening of the tip end of the guiding catheter 7 to be smaller than the outer diameter of the ablation section head end 17 (shown in Fig. 11A), or to close the head end opening of the guiding catheter 7 with the plug 72 (Fig. 11B, Fig. 11C) As shown in FIG. 11, the side wall of the leading end of the guiding catheter 7 is preferably provided with a side groove 76 which is close to the length of the independent structure 8 and communicates with the blood vessel, and the length of the side groove 76 is generally 11-13 mm. The side groove 76 preferably corresponds to the independent structure 8 in parallel. The width of the side groove 76 is slightly larger than the outer diameter of the individual structure 8, generally 1. 4 - 2. 4 hidden, and the number of side grooves 76 is preferably equal to the number of the independent structures 8. If the ablation catheter 1 or the retraction guide catheter 7 is pushed, as shown in FIG. 11B, the ablation section head end 17 will cause the individual structures 8 to bulge from the respective side grooves 76 due to the restriction of the plug 72, which will cause the ablation head to be ablated. 9 preferentially in contact with the vessel wall; by controlling the distance between the ablation catheter 1 or the retraction guide catheter 7, the distance between the intermediate portion of the independent structure 8 and the pressure at which the ablation head 9 is in contact with the vessel wall can be controlled. For the case where the middle of the independent structure 8 is connected to the distal end and then separated from each other, the design of the head of the guiding catheter 7 is combined with the design shown in Figs. As shown in Fig. 12A, a plurality of oblique holes 74 communicating with the blood vessel are provided on the side wall of the guiding catheter 7, or a plurality of small oblique holes 74 are provided at the head end of the guiding catheter 7 (similar to Fig. 10A, Fig. 10D). The side groove 76 corresponding to the inclined hole 74 and parallel to the independent structure 8 is disposed on the side wall of the guiding duct 7 at a certain distance after the inclined hole 74, and the spacing between the inclined hole 74 and the side groove 76 is provided. The distance is generally between 2. 5 and 5. 5 mm, the inner diameter of each inclined hole is slightly larger than the outer diameter of the independent structure 8, generally 1. 4 - 2. 4 hidden, the inclined angle of each inclined hole 74 is generally 30 - 50 The connecting portion 75 between the inclined holes is preferably tapered, and the connecting portion 75 can not only restrict the connection point 18 and the controllable curved portion 5 from being pushed out of the guiding duct 7 but also help guide the independent structure 8 from the inclined hole 74. The length of the side groove 76 is preferably slightly larger than the outer diameter of the independent structure 8, generally 1. 4 - 2. 4 hidden, the length of the side groove 76 is similar to the length of the portion of the proximal end of the independent structure 8 to the connection point 18, Typically 10-22 mm, the number of inclined holes 74 and side grooves 76 is preferably equal to the number of individual structures 8. If the ablation catheter 1 or the retraction guide catheter 7 is pushed, the portion of the distal end of the independent structure 8 from the connection point 18 will be divergently pushed into the blood vessel from the inside of the oblique hole 74, and the ablation head of the head of the independent structure 8 9 will preferentially contact the vessel wall, and the portion between the proximal end of the independent structure 8 and the junction 18 will bulge from the corresponding side groove 76, and the most prominent place of the ridge will preferentially contact the vessel wall; the ablation catheter is controlled by push 1 or the distance of the retracting guide catheter 7 and the inclination of the oblique hole 74 can control the distance separating the distal ends of the individual structures 8 from each other and the pressure at which the ablation head 9 is in contact with the vessel wall. The oblique holes 74 and the side grooves 76 in the above design also have the effect of injecting a drug into a blood vessel or injecting a contrast agent. In order to facilitate the formation of the design deformation of the individual structure 8, the design shape change can be easily realized by adjusting the structural design of the individual structure 8 or by changing the hardness of the manufactured material. 10, FIG. 11, and FIG. 12 illustrate the design of two independent structures 8 as an example, and thus are not limited to the case of two independent structures 8. For more than two independent structures 8, only the map is required. 10. The design concept illustrated in FIG. 11 and FIG. 12 adjusts the number and arrangement positions of the inclined holes 74 and the side grooves 76.
参见图 13所示,对于导引导管 7不能够为消融导管 1的形变提供支点的情况,独立结构 8还可设置预制形变, 可控弯曲段 5可以设置预制形变, 然后将消融导管 1压入导引导管 7 内, 当导引导管 7的头端到达指定位置后, 消融导管 1可从导引导管 7头端的开口被推送出 来, 恢复预制形变。 如图 13所示, 将远端汇集于消融段头端 17的两条独立结构 8预制成类 似纺锤形, 将该消融导管 1压入导引导管 7内, 由于导引导管 7的限制, 预制成纺锤形的两 条独立结构 8的中间部分将相互靠拢; 当导引导管 7到达肾动脉 a在主动脉 b上的开口处时, 将消融段 6从导引导管 7头端开口内推送出来, 此时两条独立结构 8将恢复成预制的类似纺 锤形, 附着消融头 9的突出部分将优先与血管壁接触。 当可控弯曲段 5预制成 C形时, 导引 导管 7可在接近肾动脉 a在主动脉 b上的开口处时即将消融段 6从导引导管 7头端开口内推 送出来, 由于可控弯曲段 5的 C形弯曲的存在, 消融段 6也能够顺利从主动脉 b进入肾动脉 a。 以远端连接于消融段头端 17的两条独立结构 8为例进行设计方案说明的, 因此不局限于 两条独立结构 8的情况,也不局限于独立结构 8远端连接于消融段头端 17这一种两两独立结 构 8的连接方式, 对于多于两条独立结构 8的情况和两两独立结构 8其他的连接方式也同样 适用, 例如对于相互分离的独立结构 8 , 需要将独立结构 8预制成以头端及其附近位置相互 远离最为明显的状态, 然后压入导引导管 7 , 又例如对于独立结构 8 的中间某处连接在一起 远端再相互分离的情况,需要将独立结构 8远端到连接点 18之间的部分预制成以头端及其附 近位置相互远离最为明显的状态,而将独立结构 8近端到连接点 18之间的部分预制成纺锤形, 然后压入导引导管 7。 此外也可以在导引导管 7的头部设置与独立结构 8相对应的斜孔 74或 /和侧槽 76 , 这样在不将消融段 6前推出导引导管 7的情况下, 也可以实现独立结构 8恢复 预制形变。 Referring to Figure 13, for the case where the guiding catheter 7 cannot provide a fulcrum for the deformation of the ablation catheter 1, the independent structure 8 can also be provided with a pre-formed deformation, the controllable curved section 5 can be prefabricated, and then the ablation catheter 1 can be pressed In the guiding catheter 7, after the head end of the guiding catheter 7 reaches the designated position, the ablation catheter 1 can be pushed out from the opening of the leading end of the guiding catheter 7 to restore the prefabrication deformation. As shown in Figure 13, the two separate structures 8 that collect the distal end at the head end 17 of the ablation section are preformed into a spindle-like shape, and the ablation catheter 1 is pressed into the guiding catheter 7, due to the limitation of the guiding catheter 7, The intermediate portions of the two separate structures 8 pre-formed into a spindle shape will be brought closer together; when the guiding catheter 7 reaches the opening of the renal artery a at the aorta b, the ablation section 6 is opened from the opening of the leading end of the guiding catheter 7. Pushed out, the two separate structures 8 will now return to a prefabricated spindle-like shape, with the protruding portion of the attached ablation head 9 preferentially contacting the vessel wall. When the controllable curved section 5 is pre-formed into a C-shape, the guiding catheter 7 can push the ablation section 6 out of the opening of the guiding end of the guiding catheter 7 when approaching the opening of the renal artery a at the aorta b, since By controlling the presence of the C-bend of the curved section 5, the ablation section 6 can also smoothly enter the renal artery a from the aorta b. The two independent structures 8 connected at the distal end to the ablation section head end 17 are taken as an example for design, and thus are not limited to the case of two independent structures 8, and are not limited to the independent structure 8 distal end connected to the ablation section head. The connection mode of the two-independent structure 8 of the end 17 is also applicable to the case of more than two independent structures 8 and the other connection modes of the two independent structures 8. For example, for the separate structures 8 separated from each other, it is necessary to be independent. The structure 8 is prefabricated in such a manner that the head end and its vicinity are far from each other in the most obvious state, and then pressed into the guiding duct 7, and for example, in the case where the middle of the independent structure 8 is connected to the distal end and then separated from each other, it is necessary to The portion of the individual structure 8 between the distal end and the attachment point 18 is prefabricated in a state in which the head end and its vicinity are far apart from each other, and the portion between the proximal end of the individual structure 8 and the connection point 18 is pre-formed into a spindle shape. , The guiding catheter 7 is then pressed into it. Furthermore, it is also possible to provide an oblique hole 74 or/and a side groove 76 corresponding to the individual structure 8 at the head of the guiding catheter 7, so that independence can also be achieved without pushing the guiding catheter 7 before the ablation section 6 is pushed out. Structure 8 restores the prefabricated deformation.
其中图 14、 图 15显示了可控弯曲段 5为 C形弯曲设计时的线控结构, 图 14所示, 当可 控弯曲段 5釆用 C形弯曲设计时,导向丝 11的头端固定点 111优选设置在可控弯曲段 5靠近 消融段 6的地方, 且应根据需要弯曲的方向选择相应的离心固定位置, 导向丝 11优选地走行 于可控弯曲段 5内, 并至少有一个导向丝 11与一个牵引丝 10共平面。 如图 15A所示, 当可 控弯曲段 5釆用虚线部分的 C形弯曲设计时, 可釆用牵引丝 10发挥导向丝 11的功能, 并将 牵引丝 10的头端固定点 110设置在消融段头端 17 ; 当然图 15所示的 C形弯曲结构也可以釆 用图 14所示的导向丝 11的固定方式, 此时牵引丝 10的排布及走行也可以按照图 14所示意 的设计方式进行安排。  14 and 15 show the wire-controlled structure when the controllable curved section 5 is a C-shaped curved design. As shown in FIG. 14, when the controllable curved section 5 is designed by a C-shaped bending, the tip end of the guiding wire 11 is fixed. The point 111 is preferably disposed where the controllable curved section 5 is adjacent to the ablation section 6, and the corresponding centrifugally fixed position should be selected according to the direction in which the bend is desired. The guide wire 11 preferably travels within the controllable curved section 5 and has at least one guide. The wire 11 is coplanar with a pulling wire 10. As shown in Fig. 15A, when the controllable curved section 5 is designed with a C-shaped curved portion of a broken line portion, the pulling wire 10 can be used to function as the guiding wire 11, and the head end fixing point 110 of the pulling wire 10 is set at the ablation. The tip end 17 of the segment; of course, the C-shaped curved structure shown in FIG. 15 can also be fixed by the guiding wire 11 shown in FIG. 14, and the arrangement and running of the pulling wire 10 can also be designed according to FIG. Ways to arrange.
图 16显示了可控弯曲段 5为 S形弯曲设计时的线控结构, 如图 16A所示, 当可控弯曲段 5釆用 S形弯曲设计时, 在图 14A所示意的 C形弯曲设计导向丝 11布置的基础上, 可在需要 形成 S形弯曲的第二个弯曲的远端另加一 导向丝 1 附着于此,这条导向丝 1 应才艮据需 要弯曲的方向选择相应离心附着位置, 且最好和至少一条导向丝 11共平面; 如图 16B所示, 也可以不增加导向丝 11的数量, 通过调整导向丝 11的走行路径以及通过调整可控弯曲段 5 的硬度分布, 使得通过其中一条导向丝 11可以实现 " S "形弯曲。  Figure 16 shows the wire-controlled structure of the controllable curved section 5 in the S-shaped curved design. As shown in Fig. 16A, when the controllable curved section 5 is designed with an S-shaped curve, the C-shaped curved design shown in Fig. 14A is shown. On the basis of the arrangement of the guide wire 11, a guide wire 1 may be attached to the distal end of the second bend which needs to form an S-shaped bend, and the guide wire 1 should be selected according to the direction of bending required to select the corresponding centrifugal attachment. The position is preferably coplanar with at least one of the guide wires 11; as shown in Fig. 16B, the number of the guide wires 11 may not be increased, by adjusting the running path of the guide wire 11, and by adjusting the hardness distribution of the controllable curved segment 5, The "S"-shaped bending can be achieved by one of the guide wires 11.
图 17、 图 18、 图 19显示了本发明中通过结构设计的方式促进消融导管 1和导引导管 7 的形变。 这种通过结构设计的方式促进消融导管 1和导引导管 7的形变并不要求各个部分的 制造材料本身的硬度不同。  Figures 17, 18 and 19 show the deformation of the ablation catheter 1 and the guiding catheter 7 in a manner designed by the present invention. This manner of structurally facilitating the deformation of the ablation catheter 1 and the guiding catheter 7 does not require the hardness of the material of the respective parts to be different.
如图 17A、 图 17B所示, 在消融导管 1 内部设置图 17A和图 17B所示的鸡肋样结构, 即 间隔 d5距离设置一个横截面为图 17B所示的结构,该结构中斜线表示的部分被有一定弹性的 材料填充, 优选高分子聚合物, 空白区域 al在消融导管 1内将形成一个腔室, 主要用于牵引 丝 10的走行以及抗弯曲形变较差的或易与牵引丝 10或导向丝 11缠结的结构的走行,例如导 线、 导管、 光纤等, 当然空白区域 al并不局限于圆形, 也不局限于仅有一个腔室, 才艮据情况 可以设置成其他形状(例如椭圆形、长方形等) , 也可以设置更多的腔室分别走行不同的构件。 如图 17A、 图 17B所示, 空白区域 bl在消融导管 1内也将形成一个腔室, 主要用于导向丝 11 或 /和牵引丝 10的走行, 当然空白区域 al并不局限于半圆形, 也不局限于仅有一个腔室, 根 据情况可以设置成其他形状(例如椭圆形、 长方形等) , 也可以设置更多的腔室分别走行不同 的构件, 如果希望牵引丝 10或导向丝 11互不影响, 牵引丝 10和导向丝 11可分别走行于不 同腔室内。 如图 17A所示, 由于 d5所包括的区域内缺乏图 17B中 d3和 d4所包含区域内的 弧形结构, 因此在纵轴方向上, 每个 d5所包括的区域将容易发生弯曲, 所有 d5所包括的区 域的弯曲将使图 17A所示结构形成整体弯曲; 以可控弯曲段 5为例, 如果可控弯曲段 5的预 制形变弯曲方向为图 17A中箭头所指示的方向, 那么牵拉从空白区域 bl中靠近 d4走行的导 向丝 11将使得可控弯曲段 5向图 17A中箭头所示的相反方向发生弯曲,这样就通过一根导向 丝 11实现了两个方向的弯曲。 类似地, 如图 17C所示, d3、 d4、 d3'、 d4'所包括的区域内设 置两个图 17B中 bl样的空白区域即空白区域 bl、 b2 , 而此时空白区域 al位于空白区域 bl、 b2之间, 处在 dl所包括的区域内(主要在 d2和 d2'围成的区域内), 图 17A中 d6所包括区域 内的结构将被图 17C所示的结构替代, 而图 17A中 d5所包括区域内的结构将是图 17C中 dl 所包括区域内的结构的延伸; 空白区域 al在消融导管 1内将形成一个腔室, 用于牵引丝 10、 抗弯曲形变较差的结构或易与牵引丝 10或导向丝 11缠结的结构的走行,当然空白区域 al并 不局限于椭圆形, 也不局限于仅有一个腔室; 空白区域 bl和 b2在消融导管 1 内也将形成两 个腔室, 主要用于导向丝 11或 /和牵引丝 10的走行, 当然空白区域 bl和 b2并不局限于半圆 形, 也不局限于仅有一个腔室, 如果希望牵引丝 10和导向丝 11互不影响, 牵引丝 10和导向 丝 11可分别走行不同的腔室内; 由于在 d5所包括的区域内缺乏图 17C中 d3、 d4、 d3'、 d4' 区域所包含区域内的弧形结构, 因此在纵轴方向上, 每个 d5 所包括的区域将容易在牵引丝 10或导向丝 11的作用下发生弯曲, 所有 d5所包括的区域的弯曲将使图 17A所示结构形成整 体弯曲, 此时由于 d5 两侧均缺少支撑结构, 因此能够发生双向弯曲, 且通过调整空白区域 bl和 b2 的大小将使得向两个方向弯曲的难易程度不同; 当然类似地也可以在三个不同方向 上设置三个图 17B所示意的 bl样空白区域, 以实现至少三个方向的弯曲, 且这种设计结构还 可以以此类推。 如图 17D、 图 17E所示, 当消融导管 1某些部分的横截面不为圆形时, 鸡肋 样结构同样可以在这些消融导管 1部分中实现, 图 17D、 图 17E以半圆形结构为例说明了鸡 肋样结构在除圆形之外的其他形状中的实现方式, 根据弯曲方向的不同空白区域 al和 bl安 排的位置有所不同。 例如, 如图 17D所示, 将空白区域 bl安排在空白区域 al的左边, 图 17A 中 d6所包括区域内的结构将被图 17D所示的结构替代, 而图 17A中 d5所包括区域内的结构 将是图 17D中 dl所包括区域内的结构的延伸,这样在走行于空白区域 bl的牵引丝 10或导向 丝 11的牵拉下整个立体结构将容易向空白区域 bl侧弯曲或减弱向空白区域 al侧弯曲的程 度; 如图 17E所示, 将空白区域 bl安排在空白区域 al的右边, 图 17A中 d6所包括区域内的 结构将被图 ΠΕ所示的结构替代, 而 d5所包括区域内的结构将是图 17E中 dl所包括区域内 的结构的延伸,这样在走行于空白区域 bl的牵引丝 10或导向丝 11的牵拉下整个立体结构将 容易向空白区域 bl侧弯曲或减弱向空白区域 al侧弯曲的程度。在图 17所示的结构中, 通过 改变空白区域 al、 bl、 b2的大小、 数量, 以及通过改变 dl、 d2、 d3、 d4、 d5、 d6的大小, 可以实现各段硬度的不同, 例如在图 17A中的某一段加宽 dl , 缩小 d3或 d4将使得这一段不 容易形变, 再例如某一段加宽 d5 将使得, 这一段更容易形变; 通过改变不同段内空白区域 al和 bl的相对位置可以实现不同段非同向弯曲, 例如将图 17A所示意结构的下半部水平旋 转 180度, 将使得下半部空白区域 bl在图 17A中的箭头侧, 这样改进后的结构将有助于实现 S形弯曲。 总之, 鸡肋样结构的实质是通过减少或 /和增加某些导管小段的内部结构进而选择 性的降低或 /和提高某些导管小段内部某一侧或者某几侧的抗弯曲能力,以使得导管更易向某 些方向弯曲或 /和形成某些弯曲形态。 As shown in Figs. 17A and 17B, the chicken rib-like structure shown in Figs. 17A and 17B is disposed inside the ablation catheter 1, i.e., a cross-sectional distance d5 is provided as a structure shown in Fig. 17B, and the structure is indicated by oblique lines. Partially filled with a material having a certain elasticity, preferably a high molecular polymer, the blank area a1 will form a chamber in the ablation catheter 1, mainly for the running of the traction wire 10 and the poor bending resistance or the easy traction with the wire 10 Or the running of the structure in which the guiding wire 11 is entangled, such as a wire, a conduit, an optical fiber, etc., of course, the blank area a1 is not limited to a circular shape, nor is it limited to only one chamber, and may be set to other shapes according to the situation ( For example, elliptical, rectangular, etc., it is also possible to provide more chambers to travel different components. As shown in Fig. 17A and Fig. 17B, the blank region bl will also form a chamber in the ablation catheter 1, mainly for guiding the guide wire 11 or/and the traction wire 10, and of course the blank region a1 is not limited to a semicircle. It is not limited to only one chamber, and may be set to other shapes (for example, elliptical, rectangular, etc.) depending on the situation. It is also possible to provide more chambers to travel different members separately, if it is desired to pull the wire 10 or the guide wire 11 Without affecting each other, the pulling wire 10 and the guiding wire 11 can respectively travel in different chambers. As shown in Fig. 17A, since the area included in d5 lacks the curved structure in the area included in d3 and d4 in Fig. 17B, the area included in each d5 will be easily bent in the longitudinal direction, all d5 The bending of the included area will cause the structure shown in Fig. 17A to be integrally curved; taking the controllable curved section 5 as an example, if the pre-formed bending direction of the controllable curved section 5 is the direction indicated by the arrow in Fig. 17A, then the pulling The guide wire 11 running from the blank area bl near d4 will cause the controllable curved section 5 to be bent in the opposite direction as indicated by the arrow in Fig. 17A, so that the bending in both directions is achieved by one guide wire 11. Similarly, as shown in FIG. 17C, two blank regions bl, b2 in FIG. 17B are disposed in the region included in d3, d4, d3', and d4', and the blank region a1 is located in the blank region. Between b1 and b2, in the region covered by dl (mainly in the region surrounded by d2 and d2'), the structure in the region included in d6 in Fig. 17A will be replaced by the structure shown in Fig. 17C. The structure in the region included in d5 of 17A will be an extension of the structure in the region included by dl in Fig. 17C; the blank region a1 will form a chamber in the ablation catheter 1 for pulling the wire 10, which is resistant to bending deformation. The structure or the structure which is easy to be entangled with the pulling wire 10 or the guiding wire 11 is of course not limited to an elliptical shape, nor is it limited to only one chamber; the blank areas bl and b2 are also in the ablation catheter 1 Two chambers will be formed, mainly for guiding the wire 11 or/and the pulling wire 10, of course, the blank areas bl and b2 are not limited to a semicircular shape, nor are they limited to only one chamber, if it is desired to pull the wire 10 and the guide wire 11 do not affect each other, the traction wire 10 and the guide wire 11 can be divided Take different rows chamber; FIG lack in the region of 17C included in d5 d3, d4, d3 ', d4' The arcuate structure in the area contained in the area, so in the direction of the longitudinal axis, the area included in each d5 will easily bend under the action of the pulling wire 10 or the guiding wire 11, and the bending of all the areas included in the d5 will make The structure shown in Fig. 17A forms an overall curvature, and since the support structure is lacking on both sides of d5, bidirectional bending can occur, and the difficulty of bending in two directions is different by adjusting the sizes of the blank areas bl and b2; Similarly, three bl-like blank regions as illustrated in Fig. 17B can be disposed in three different directions to achieve bending in at least three directions, and such a design structure can be deduced by analogy. As shown in Figs. 17D and 17E, when the cross section of some portions of the ablation catheter 1 is not circular, the chicken rib-like structure can also be realized in the ablation catheter 1 portions, and Figs. 17D and 17E are in a semicircular configuration. The example illustrates the implementation of the chicken rib-like structure in shapes other than a circle, and the positions of the different blank areas a1 and bl are different depending on the direction of the bending. For example, as shown in Fig. 17D, the blank area bl is arranged to the left of the blank area a1, and the structure in the area included in d6 in Fig. 17A will be replaced by the structure shown in Fig. 17D, and the area included in d5 in Fig. 17A The structure will be an extension of the structure in the region covered by dl in Fig. 17D, so that the entire three-dimensional structure will be easily bent or weakened toward the blank area bl side under the pulling of the pulling wire 10 or the guiding wire 11 running in the blank area bl. The degree of bending of the region a side; as shown in Fig. 17E, the blank region bl is arranged to the right of the blank region a1, and the structure in the region included in d6 in Fig. 17A will be replaced by the structure shown in Fig. ,, and the region included in d5 The inner structure will be an extension of the structure in the area covered by dl in Fig. 17E, so that the entire three-dimensional structure will easily bend or weaken toward the blank area bl side under the pulling of the pulling wire 10 or the guide wire 11 running in the blank area bl. The degree of bending to the blank area a side. In the structure shown in FIG. 17, by changing the size and number of the blank areas a1, bl, b2, and by changing the sizes of dl, d2, d3, d4, d5, d6, the hardness of each section can be different, for example, In Figure 17A, a certain section is widened by dl. If d3 or d4 is reduced, the segment will not be easily deformed. For example, if a segment is widened by d5, the segment will be easier to deform. By changing the relative positions of the blank regions a1 and bl in different segments. The position can achieve different segments of non-co-directional bending, for example, horizontally rotating the lower half of the structure shown in Fig. 17A by 180 degrees, so that the lower half blank area bl is on the side of the arrow in Fig. 17A, so that the improved structure will help To achieve S-shaped bending. In summary, the essence of the chicken rib-like structure is to selectively reduce or/and increase the resistance to bending on one side or sides of certain catheter segments by reducing or/and increasing the internal structure of certain catheter segments so that the catheter It is easier to bend or/and form certain curved forms in certain directions.
图 18显示了本发明中另一种通过结构设计的方式改变硬度分布进而促进消融导管 1和导 引导管 7的多向弯曲的设计方案。 该结构设计优选用于需要控制可控弯曲段 5多向弯曲的情 况。其中图 18A为该结构的立体示意图, 图 18B为该结构 d6所包括区域水平中线的横截面示 意图, 也即图 18C、 图 18D中 cc2横截面放大的截面图, 图 18C和图 18D为该结构的纵剖面 示意图, 也即图 18B中 ccl横截面的截面图。 该设计结构的思路与鸡肋样结构相似, 也是在 间隔 d5距离设置一个 d6区域所包含的结构, 如图 18A、 图 18C、 图 18D所示, 整个立体结构 为双凸圆盘重叠构成。如图 18所示, 该结构中斜线或横线表示的部分被有一定弹性的材料填 充, 优选高分子聚合物。 如图 18A和图 18B所示, 圆盘中心空白区域 al在消融导管 1内将形 成一个腔室, 主要用于牵引丝 10、 抗弯曲形变较差的结构或易与导向丝 11缠结的结构的走 行, 当然空白区域 al并不局限于圆形, 也不局限于仅有一个腔室, 根据情况可以设置成其他 形状(例如椭圆形、 长方形等), 也可以设置更多的腔室分别走行不同的构件; 圆盘四周空白 区域 bl、 b2、 b3、 b4在消融导管 1 内将形成四个间断的管道, 主要用于导向丝 11走行, 该 管道的管径为 d3 , 当双凸圆盘重叠结构用于其他部分时空白区域 bl、 b2、 b3、 b4也可走行 牵引丝 10等; 如果希望牵引丝 10和导向丝 11互不影响, 牵引丝 10和导向丝 11可分别走行 于不同腔室中。 如图 18C所示, 由于相邻两个双凸圆盘在 d4包括的区域内是相对的斜面, 存 在一定的距离 d7 , 因此在某个方向上的导向丝 11或牵引丝 10的作用下, 整体结构将容易发 生弯曲, 在几根导向丝 11或牵引丝 10的同时作用下, 整体结构会容易向更多的方向发生弯 曲; 当然整个设计不局限于四个 bl样空白区域(bl、 b2、 b3、 b4) , 根据弯曲方向的需要可以 进行增加和减少; bl样空白区域的设置位置也可以有所不同, 这样可以调节整体结构形变所 需导向丝 11或牵引丝 10的张力和应力大小, 例如有些 bl样空白区域可以更靠近空白区域 al , 这样该方向上的弯曲需要的导向丝 11或牵引丝 10的张力将更大; bl样空白区域在每个 双凸圆盘上设置的位置也可以有所不同, 或者同一个导向丝 11或牵引丝 10可以在整个结构 中走行于不同的 bl样空白区域, 这样可以调整整个结构的弯曲形态, 实现扭曲等。 同时如图 18D所示相邻两个飞碟样圆盘可以设置 d5区域, 使得整体结构更易发生弯曲。 通过改变空白 区域 a l、 bl、 b2、 b 3、 b4的大小、 数量, 以及改变 dl、 d2、 d3、 d4、 d5、 d6、 d7的大小, 可以使各段硬度不同, 例如在图 17A中的某一段加宽 dl , 缩小 d4将使得这一段不容易形变, 再例如某一段加宽 d5将使得, 这一段更容易形变。 此外, 这种结构设计同样适用于其他一些 横截面非圆形结构的情况, 例如半圆等, 但此时需要考虑到不对称结构对导向丝 11、 牵引丝 10 以及结构本身硬度的影响。 同样地, 双凸圆盘重叠结构的实质也是通过减少或 /和增加某 些导管小段的内部结构进而选择性的降低或 /和提高某些导管小段内部某一侧或者某几侧的 抗弯曲能力, 以使得导管更易向某些方向弯曲或 /和形成某些弯曲形态。 Fig. 18 shows another design of the present invention which changes the hardness distribution by means of structural design to promote the multi-directional bending of the ablation catheter 1 and the guiding catheter 7. This structural design is preferably used in situations where it is desirable to control the multi-directional bending of the controllable curved section 5. 18A is a schematic perspective view of the structure, and FIG. 18B is a schematic cross-sectional view of the horizontal center line of the structure included in the structure d6, that is, a cross-sectional view of the cc2 cross section in FIGS. 18C and 18D, and FIGS. 18C and 18D are the structure. A schematic longitudinal section, that is, a cross-sectional view of the ccl cross section in Fig. 18B. The design structure is similar to the chicken rib-like structure, and is also a structure included in a d6 region at a distance d5. As shown in Figs. 18A, 18C, and 18D, the entire three-dimensional structure is a double convex disk overlap. As shown in Fig. 18, the portion indicated by the oblique line or the horizontal line in the structure is filled with a material having a certain elasticity, and a polymer is preferable. As shown in Figs. 18A and 18B, the disc center blank area a1 will form a chamber in the ablation catheter 1, mainly for the traction wire 10, a structure resistant to bending deformation or a structure easily entangled with the guide wire 11. The walking area, of course, the blank area a1 is not limited to a circle, nor is it limited to only one chamber, and may be set to other shapes (for example, elliptical, rectangular, etc.) depending on the situation, or more chambers may be provided separately. Different components; the blank areas bl, b2, b3, b4 around the disc will form four interrupted pipes in the ablation duct 1, mainly for guiding the wire 11, the diameter of the pipe is d3, when the double convex disk When the overlapping structure is used for other parts, the blank areas bl, b2, b3, b4 can also travel the pulling wire 10, etc.; if the pulling wire 10 and the guiding wire 11 are not affected by each other, the pulling wire 10 and the guiding wire 11 can respectively travel in different chambers. In the room. As shown in Fig. 18C, since the adjacent two lenticular discs are opposite slopes in the region covered by d4, there is a certain distance d7, so that under the action of the guide wire 11 or the pulling wire 10 in a certain direction, The overall structure will be prone to bending. Under the action of several guiding wires 11 or pulling wires 10, the overall structure will easily bend in more directions; of course, the whole design is not limited to four bl-like blank areas (bl, b2) , b3, b4), can be increased and decreased according to the need of the bending direction; the setting position of the bl-like blank area can also be different, so that the tension and stress of the guiding wire 11 or the pulling wire 10 required for the deformation of the overall structure can be adjusted. For example, some bl-like blank areas may be closer to the blank area a1, so that the tension in the direction of the guide wire 11 or the pulling wire 10 will be greater; the bl-like blank area is in each The position of the double convex disc may also be different, or the same guiding wire 11 or the pulling wire 10 can travel in different bl-like blank areas in the whole structure, so that the bending shape of the entire structure can be adjusted, and distortion can be realized. . At the same time, as shown in Fig. 18D, adjacent two UFO-like disks can be provided with a d5 region, so that the overall structure is more susceptible to bending. By changing the size and number of the blank areas a1, bl, b2, b3, b4, and changing the sizes of dl, d2, d3, d4, d5, d6, d7, the hardness of each segment can be made different, for example, in Fig. 17A. If a segment is widened by dl, reducing d4 will make this segment not easy to deform. For example, if a segment is widened by d5, this segment will be easier to deform. In addition, this structural design is equally applicable to other cross-sectional non-circular structures, such as semi-circles, etc., but in this case, the influence of the asymmetrical structure on the hardness of the guide wire 11, the pulling wire 10, and the structure itself needs to be considered. Similarly, the essence of the lenticular disc overlap structure is also to selectively reduce or/and increase the resistance to bending on one or both sides of certain duct segments by reducing or/and increasing the internal structure of certain duct segments. To make it easier for the catheter to bend in some directions and/or to form certain curved forms.
图 19 显示了本发明中另一种通过改变结构设计进而改变硬度分布使弯曲更易实现的设 计。 该设计结构是鸡肋样结构在中空管状结构中的实现方式, 该种结构优选用于中空管状结 构(例如导引导管 7等)。 该结构主要通过改变消融导管 1和导引导管 7管壁中的金属丝网在 不同导管小段内的排布或通过改变消融导管 1和导引导管 7管壁在不同导管小段中的厚度来 实现的, 当然这里所述的金属丝网应该理解为加固导管管壁硬度的设计结构, 例如也可以是 高分子材料网等,因此该种设计的实质是通过减少或 /和增加某些导管小段管壁的结构进而选 择性的降低或 /和提高某些导管小段管壁的某一侧或者某几侧的抗弯曲能力,以使得导管更易 向某些方向弯曲或形成某些弯曲形态。图 19是以改变消融导管 1或导引导管 7管壁中的金属 丝网在不同导管小段内的排布为例进行说明的。 如图 19A所示, 图中网线表示金属丝网, 从 图 19A的左下图可以看到, 导管管壁中的金属丝网是完全覆盖导管管壁的, 从图 19A的左上 图可以看到,导管的一侧管壁中没有金属丝网,将两个导管小段间隔相叠在一起,构成图 19A 的右图所示的结构, 由于上方的一小段导管的一侧管壁中没有金属丝网, 因此导管更易向没 有金属丝网的一侧弯曲。 当然也不局限于导管的一侧管壁中没有金属丝网的设计方式, 如图 19D所示, 在两个有完整的金属丝网的导管小段之间有四个 S形金属丝 f l、 f 2、 f 3、 f 4 , 可 以在 f l、 f 2间和 f 3、 f4间设置金属丝网, 而在 f 2、 f 3间和 f l、 f 4间不设置金属丝网, 这 样导管更易向没有金属丝网的两侧弯曲, 同理也可以在每相邻两个 S形金属丝间只设置一半 的金属丝网, 这样导管更易向没有金属丝网的四个方向弯曲, 还可以只有四个 S形金属丝而 没有金属丝网, 这样整个导管将容易向多个方向弯曲, 如果配合四个方向上的导引丝 70、 牵 引丝 10或导向丝 11将可以实现控制多向弯曲。 此外也不局限于某些导管小段管壁的某一侧 或某几侧没有金属丝网的情况, 这可以通过改变金属丝网的孔径、 密度、 金属丝的宽窄等方 式实现某些导管小段的导管壁的某一侧或某几侧较其他导管壁软或硬; 根据情况 S形金属丝 的数量可以调整, 同时 S形金属丝也可以是其他形态, 例如 "Z" 形等。 图 19A的结构可以按 照图 19B所示的侧面观图排布, 这样整个导管段的弯曲方向将是一致的; 图 19A的结构可以 按照图 19C所示的侧面观图排布, 这样整个导管段上下部分的弯曲方向不一致的, 通过这种 方式就可以借助一根导引丝 70实现复杂弯曲, 例如将导向丝 11从图 19C中 d3和 d3'相交的 区域穿过将实现 S形弯曲。 如图 19B和图 19C所示, 还可以通过调整 dl、 d3、 d3'、 d4、 d5 的宽度来改变导管各段弯曲的难易程度。此外整个结构也不局限于导管横截面为圆形的情况, 导管横截面为半圆、 正方形等形状时仍然可以按照该思路进行设计, 但此时需要考虑到这些 形状对牵引丝 10、 导向丝 11、 导引丝 70以及鸡肋样结构本身硬度的影响。  Fig. 19 shows another design of the present invention which makes the bending easier to achieve by changing the structural design and thereby changing the hardness distribution. The design structure is an implementation of a chicken rib-like structure in a hollow tubular structure, which is preferably used for a hollow tubular structure (e.g., guiding catheter 7, etc.). The structure is achieved by changing the arrangement of the wire mesh in the tube wall of the ablation catheter 1 and the guiding catheter 7 in different catheter segments or by varying the thickness of the ablation catheter 1 and the guiding catheter 7 wall in different catheter segments. Of course, the wire mesh described herein should be understood as a design structure for reinforcing the wall hardness of the pipe wall, for example, a polymer material mesh, etc., so the essence of the design is to reduce or/and increase certain conduit segments. The structure of the wall, in turn, selectively reduces or/and increases the resistance to bending of one or both sides of certain conduit segments to make the catheter more susceptible to bending or forming certain curved configurations in certain directions. Fig. 19 is an illustration of changing the arrangement of the wire mesh in the tube wall of the ablation catheter 1 or the guiding catheter 7 in different catheter segments. As shown in Fig. 19A, the wire in the figure indicates a wire mesh. As can be seen from the lower left view of Fig. 19A, the wire mesh in the wall of the catheter tube completely covers the wall of the catheter tube, as can be seen from the upper left diagram of Fig. 19A. There is no wire mesh in one side of the pipe wall, and the two ducts are stacked at a small interval to form the structure shown in the right figure of Fig. 19A, because there is no wire mesh in one side wall of a small section of the upper pipe. Therefore, the catheter is more likely to bend to the side without the wire mesh. Of course, it is not limited to the design of the wire mesh in the side wall of the pipe. As shown in Fig. 19D, there are four S-shaped wires fl, f between the two small sections of the pipe with the complete wire mesh. 2, f 3, f 4 , can set the wire mesh between fl, f 2 and f 3, f4, and no wire mesh between f 2, f 3 and fl, f 4, so that the catheter is easier to There is no bending on both sides of the wire mesh. Similarly, only half of the wire mesh can be placed between each adjacent two S-shaped wires, so that the pipe is more easily bent in four directions without the wire mesh, and only four can be bent. The S-shaped wire without the wire mesh, so that the entire pipe will be easily bent in a plurality of directions, if the guide wire 70, the pulling wire 10 or the guide wire 11 in the four directions is matched, it is possible to control the multi-directional bending. In addition, it is not limited to the case where there is no wire mesh on one side or some sides of some small pipe walls. This can be achieved by changing the aperture, density, width and width of the wire mesh. One side or some sides of the duct wall are softer or harder than the other duct walls; the number of S-shaped wires can be adjusted according to the situation, and the S-shaped wire can also be in other forms, such as "Z" shape. The structure of Fig. 19A can be arranged in a side view as shown in Fig. 19B, so that the bending direction of the entire duct section will be uniform; the structure of Fig. 19A can be arranged in accordance with the side view shown in Fig. 19C, so that the entire duct section Inconsistent bending directions of the upper and lower portions, in this way, a complicated bending can be achieved by means of a guide wire 70, for example, passing the guide wire 11 through the region where d3 and d3' intersect in Fig. 19C will effect S-shaped bending. As shown in Fig. 19B and Fig. 19C, it is also possible to change the difficulty of bending each section of the catheter by adjusting the widths of dl, d3, d3', d4, d5. In addition, the entire structure is not limited to the case where the cross section of the conduit is circular. When the cross section of the conduit is semicircular, square or the like, the design can still be designed according to the idea, but in this case, the shape of the traction wire 10 and the guide wire 11 need to be considered. The influence of the hardness of the guide wire 70 and the chicken rib-like structure itself.
图 17、 图 18、 图 19所显示的通过结构设计的方式改变消融导管 1和导引导管 7的硬度 分布, 还可以通过改变制造材料的硬度来实现, 例如导管各段的横截面可以均是图 17B的设 计方式, 但是某些段的横截面上 d3、 d4所包括的区域制造材料较另一些段硬, 那么这些段将 不容易发生弯曲, 再例如图 33D所示的结构中, 第二个双凸圆盘的制造材料较第一个和第三 个软, 那么在第二个飞碟样圆盘的地方将更易发生弯曲。  The manner in which the ablation catheter 1 and the guiding catheter 7 are hardened by the structural design shown in Figs. 17, 18, and 19 can also be achieved by changing the hardness of the manufactured material. For example, the cross sections of the segments of the catheter can be The design of Figure 17B, but the cross-section d3, d4 of some segments of the region of the manufacturing material is harder than the other segments, then these segments will not easily bend, for example, in the structure shown in Figure 33D, the second The material of the lenticular disc is softer than the first and third, so the bend will be more likely to occur in the second UFO-like disc.
图 20、 图 21、 图 11以两个独立结构 8为例, 结合硬度分部调整, 显示了本发明中消融 段 6的线控结构。 图 20、 图 21、 图 11中独立结构 8上的空白部分应理解为独立结构 8间隔 一定距离的结构硬度降低, 这种硬度下降不仅可以通过改变结构设计的方式实现同样可以通 过改变材料硬度的方式实现。 对于仅设置预制形变的情况, 只需要去掉图 20、 图 21、 图 22 中的线控结构即可。 Figure 20, Figure 21, and Figure 11 show the ablation of the present invention by taking two independent structures 8 as an example and combining the hardness division adjustment. The wire control structure of segment 6. The blank portion on the individual structure 8 in Figs. 20, 21, and 11 should be understood as a decrease in the hardness of the structure of the independent structure 8 at a certain distance. This hardness reduction can be achieved not only by changing the structural design but also by changing the hardness of the material. Way to achieve. For the case where only the prefabricated deformation is set, only the line control structure in Fig. 20, Fig. 21, Fig. 22 needs to be removed.
图 20是以两个独立结构 8的远端连接于消融段头端 17为例, 结合硬度分部调整, 显示 了本发明中消融段 6的线控结构。 如图 20D所示, 当牵引丝 10走行于独立结构 8外时, 牵引 丝 10的头端固定点 110优选地设置于消融段头端 17 , 并沿消融段 6的长轴中心线走行, 牵 引丝 10在除消融段 6以外的消融导管 1内也最好走行于长轴中心线,此时优选地只需要一个 牵引丝 10。 如图 20A、 图 20B、 图 20C所示, 当牵引丝 10走行于独立结构 8内时, 牵引丝 10 的头端固定点 110优选地设置于消融段头端 17至消融头 9之间独立结构 8上(包含端点),图 中所示的是固定于消融段头端 17的情况, 牵引丝 10可沿各独立结构 8靠消融段 6长轴中心 线的部分走行,对于图中所示的两个独立结构 8的情况,独立结构 8内均设置一个牵引丝 10 , 对于多于两个独立结构 8的情况,可将至少两个牵引丝 10分别设置在相对的独立结构 8内或 者在每个独立结构 8内均设置一个牵引丝 10 ,这些牵引丝 10在除消融段 6以外的消融导管 1 内最好合并成一个, 并优选地走行于这些消融导管 1段的长轴中心线。 如图 15所示, 牵引丝 10也可沿各独立结构 8远离消融段 6长轴中心线的部分走行, 此时牵引丝 10可以发挥导向 丝 11的作用; 对于图 15所示的两个独立结构 8的情况, 每个独立结构 8内均设置一个牵引 丝 10 , 对于多于两个独立结构 8的情况, 可将至少两个牵引丝 10分别在相对的独立结构 8 内, 或者在每个独立结构 8内均设置一个牵引丝 10; 如图 15所示, 用作导向丝的牵引丝 10 在除消融段 6以外的消融导管 1 内最好分别走行, 不合并成一个, 并优选地走行于这些消融 导管 1段相应的远离长轴中心线的部分,此时若同时增加所有牵引丝 10的张力或在独立结构 8有预制形变的情况下同时增加所以牵引丝 10应力则发挥的牵引丝的作用, 若分别增加每个 牵引丝 10的张力或分别增加每个牵引丝 10应力则发挥导向丝的作用。 结合结构设计, 如图 20A所示, 两个独立结构 8a、 8b弯曲形态彼此相互对称, 为了方便为半圆柱形的两个独立结 构 8a、 8b向外凸起, 可以釆用图 17或 /和图 19所示意的鸡肋样结构, 当釆用图 17所示意的 鸡肋样结构时,独立结构 8可釆用图 17D所示的设计方案, 其中虚线 cc所示的横截面的形态 优选为图 17D所示, 此时如果牵引丝 10走行于独立结构 8内, 则走行于图 17D所示的空白区 域 bl ; 当釆用图 19所示意的鸡肋样结构时, 独立结构 8 中的空白部分应理解为独立结构 8 管壁间隔一定距离的结构硬度降低, 例如通过去掉金属丝网、 改变金属丝网的密度等。 如图 20B、 图 20C、 图 20D所示, 两个独立结构 8的弯曲形态也可不对称, 这对于独立结构 8多于 两个时是十分必要的, 它有助于使得消融点处在不同的肾动脉横截面上; 与图 19所示的鸡肋 样结构类似, 图 20B、 图 20C、 图 20D所示的设计方案也可釆用图 17或 /和图 19所示意的鸡 肋样结构设计, 为了实现不同的弯曲形态, 可以通过调整各独立结构 8上鸡肋样结构的布置 方式实现各段硬度的不同, 在曲率较大的地方硬度优选较小, 更易实现弯曲。 图 20中独立结 构 8a、 8b的空白部分表示各独立结构 8上硬度较小的部分, 因此通过调整独立结构 8a、 8b 上空白部分的大小、 形态、 分部密度等即可改变鸡肋样结构的硬度分布, 进而改变弯曲形态。 如图 20B所示,在独立结构 8a中消融头 9至独立结构 8a尾端的部分和独立结构 8b中消融头 9至消融段头端 17的部分曲率较大, 因此空白部分的也较大和较密。 类似地, 图 20C中, 为 了实现独立结构 8形变后两个消融头 9到消融段 6长轴中心线的距离相等, 在两个独立结构 8长度相等的情况下, 独立结构 8b设计成了近端不易弯曲而远端及中间部分易发生弯曲, 因 此独立结构 8b的远端及中间部分空白部分也更密集, 使其更易弯曲。 图 20D中, 独立结构 8 形变后两个消融头 9到消融段 6长轴的中心线距离不相等, 在两个独立结构 8长度相等的情 况下, 独立结构 8的中间隆起最明显的部分在两个独立结构 8上的长度不同,独立结构 8b中 间隆起最明显的部分较长, 这就要求独立结构 8b的其他部分曲率更大, 更易弯曲, 因此独立 结构 8b的远端及近端的空白部分也更大、 更密集。 如图 20所示, 空白部分的形状也可以是 多变的, 可以是图 20B所示的形状, 也可以是图 20A、 图 20C、 图 20D所示的形状, 当然技术 人员还可以根据具体实际设计其他形状。 此外还可以釆取将消融头 9设置在对称的两独立结 构 8的不同位置来实现消融点不共平面。图 20是以两个独立结构 8为例进行设计方案说明的, 因此不局限于两个独立结构 8的情况, 对于多于两个独立结构 8的情况也同样适用。 对于技 术人员需要独立结构 8形成其他弯曲形态的情况,可以对图 20中独立结构 8的空白部分进行 相应调整。 Figure 20 is a diagram showing the remote control of the ablation section 6 of the present invention with the distal end of the two separate structures 8 attached to the ablation section head end 17 as an example. As shown in Fig. 20D, when the pulling wire 10 travels outside the independent structure 8, the head end fixing point 110 of the pulling wire 10 is preferably disposed at the ablation section head end 17 and travels along the long axis center line of the ablation section 6, pulling Preferably, the filament 10 also travels in the ablation catheter 1 other than the ablation section 6 on the long axis centerline, in which case only one traction wire 10 is preferred. As shown in FIGS. 20A, 20B, and 20C, when the pulling wire 10 travels in the independent structure 8, the head end fixing point 110 of the pulling wire 10 is preferably disposed between the ablation section head end 17 and the ablation head 9 independently. 8 (including the end points), shown in the figure is fixed to the ablation section head end 17, the traction wire 10 can travel along the independent structure 8 by the ablation section 6 long axis centerline, as shown in the figure In the case of two separate structures 8, one traction wire 10 is provided in each of the individual structures 8, and for more than two separate structures 8, at least two traction wires 10 may be respectively disposed in the opposite independent structure 8 or in each Each of the individual structures 8 is provided with a pulling wire 10 which is preferably combined into one in the ablation catheter 1 other than the ablation section 6, and preferably travels to the long axis centerline of the ablation catheter 1 section. As shown in Fig. 15, the pulling wire 10 can also travel along the portion of each of the independent structures 8 away from the center line of the long axis of the ablation section 6, at which time the pulling wire 10 can function as the guiding wire 11; for the two independents shown in Fig. 15. In the case of structure 8, one traction wire 10 is provided in each individual structure 8, and for more than two separate structures 8, at least two traction wires 10 may be respectively in the opposite independent structure 8, or in each Each of the individual structures 8 is provided with a pulling wire 10; as shown in Fig. 15, the pulling wire 10 serving as the guiding wire preferably travels separately in the ablation catheter 1 except for the ablation section 6, does not merge into one, and preferably travels. In the section of the ablation catheter 1 corresponding to the center line of the long axis, if the tension of all the traction wires 10 is simultaneously increased or the independent structure 8 is prefabricated, the traction wire of the traction wire 10 is exerted. The effect of each of the traction wires 10 is increased or the stress of each traction wire 10 is increased to play the role of the guide wire. In combination with the structural design, as shown in FIG. 20A, the two independent structures 8a, 8b are symmetrical with each other, and in order to facilitate the outward bulging of the two independent structures 8a, 8b of the semi-cylindrical shape, FIG. 17 or/and The chicken rib-like structure illustrated in Fig. 19, when the chicken rib-like structure illustrated in Fig. 17 is used, the independent structure 8 can adopt the design shown in Fig. 17D, wherein the shape of the cross section indicated by the broken line cc is preferably Fig. 17D. As shown, at this time, if the pulling wire 10 travels in the independent structure 8, it travels to the blank area bl shown in Fig. 17D; when the chicken rib-like structure shown in Fig. 19 is used, the blank portion in the independent structure 8 should be understood. The structural rigidity of the wall of the independent structure 8 is separated by a certain distance, for example, by removing the wire mesh, changing the density of the wire mesh, and the like. As shown in Fig. 20B, Fig. 20C, and Fig. 20D, the bending forms of the two independent structures 8 can also be asymmetric, which is necessary for more than two independent structures 8, which helps to make the ablation points different. The renal artery cross-section; similar to the chicken-ribbed structure shown in Fig. 19, the design shown in Fig. 20B, Fig. 20C, and Fig. 20D can also be designed with the chicken rib-like structure shown in Fig. 17 or/and Fig. 19, To achieve different bending modes, the hardness of each segment can be different by adjusting the arrangement of the chicken rib-like structure on each individual structure 8. In the place where the curvature is large, the hardness is preferably small, and the bending is more easily realized. The blank portion of the individual structures 8a, 8b in Fig. 20 indicates the portion having a small hardness on each of the individual structures 8, so that the size of the blank portion on the individual structures 8a, 8b, the shape, the density of the portions, etc. can be adjusted to change the structure of the chicken rib-like structure. The hardness distribution, which in turn changes the bending shape. As shown in Fig. 20B, the portion of the ablation head 9 to the end of the individual structure 8a in the independent structure 8a and the portion of the ablation head 9 to the ablation section head end 17 in the independent structure 8b have a larger curvature, so that the blank portion is also larger and denser. . Similarly, in Fig. 20C, in order to achieve the equal distance between the two ablation heads 9 and the long axis centerline of the ablation section 6 after the deformation of the independent structure 8, the independent structure 8b is designed to be nearly the same when the lengths of the two independent structures 8 are equal. The end is not easily bent and the distal end and the intermediate portion are susceptible to bending, so that the distal end and the intermediate portion of the separate structure 8b are also denser, making it more flexible. In Fig. 20D, the center line distances of the two ablation heads 9 to the long axis of the ablation section 6 after the deformation of the independent structure 8 are not equal. In the case where the lengths of the two independent structures 8 are equal, the most obvious part of the intermediate ridge of the independent structure 8 is The lengths of the two separate structures 8 are different, and the most obvious portion of the intermediate structure 8b is longer, which requires that the other portions of the independent structure 8b have a larger curvature and are more flexible, so the distal end and the proximal end of the independent structure 8b are blank. The parts are also larger and denser. As shown in FIG. 20, the shape of the blank portion may also be The shape may be as shown in FIG. 20B, or may be the shape shown in FIG. 20A, FIG. 20C, and FIG. 20D. Of course, the skilled person may design other shapes according to specific conditions. In addition, it is also possible to achieve that the ablation head 9 is disposed at different positions of the symmetrical two independent structures 8 to achieve an ablation point that is not coplanar. Fig. 20 illustrates the design of two independent structures 8 as an example, and therefore is not limited to the case of two independent structures 8, and the same applies to the case of more than two independent structures 8. For the case where the technician needs the separate structure 8 to form other curved forms, the blank portion of the independent structure 8 in Fig. 20 can be adjusted accordingly.
图 21是以两个独立结构 8的远端相互分离为例, 结合硬度分部调整, 显示了本发明中消 融段 6的线控结构。 如图 21C所示, 当牵引丝 10走行于独立结构 8外时, 牵引丝 10优选靠 消融段 6的长轴中心线走行, 此时每个独立结构 8优选地需要一个牵引丝 10 , 牵引丝 10的 头端固定点 110优选设置在消融头 9或邻近的独立结构 8上, 头端固定点 110靠消融段 6的 长轴中心线, 一般距消融头 9在 0—8隱, 对于没有设置消融头 9的独立结构 8 , 牵引丝 10的 头端固定点 110优选设置在独立结构 8头端或其邻近的独立结构 8上, 头端固定点 110靠消 融段 6的长轴中心线, 一般距离独立结构 8头端在 0—8隱; 如图 21所示, 这些牵引丝 10在 除消融段 6以外的消融导管 1段内最好合并成一个, 并优选地走行于这些消融导管 1段的长 轴中心线。 如图 21A、 图 21B、 图 21D所示, 当牵引丝 10走行于独立结构 8内时, 牵引丝 10 的头端固定点 110才艮据牵引丝 10的走行路径的不同优选有所不同; 如图 21A、 图 21B所示, 当牵引丝 10在靠消融段 6长轴中心线的独立结构 8内走行时,头端固定点 110优选设置在消 融头 9或邻近的独立结构 8上, 头端固定点 110靠消融段 6的长轴中心线, 一般距消融头 9 在 0—8隱, 对于没有设置能量触头的独立结构 8 , 头端固定点 110优选设置在独立结构 8头 端或其邻近的独立结构 8上, 头端固定点 110靠消融段 6的长轴中心线, 一般距离独立结构 8头端在 0—8隱; 如图 21D所示, 当牵引丝 10在远离消融段 6的长轴中心线的独立结构 8内 走行时, 头端固定点 110优选设置在消融头 9或邻近的独立结构 8上, 头端固定点 110远离 消融段 6的长轴中心线, 一般距消融头 9在 0—8隱, 对于没有设置能量触头的独立结构 8 , 头端固定点 110优选设置在独立结构 8头端或其邻近的独立结构 8上, 头端固定点 110远离 消融段 6的长轴中心线, 一般距离独立结构 8头端在 0—8隱; 如图 21所示, 这些牵引丝 10 在除消融段 6以外的消融导管 1段内最好合并成一个, 并优选地走行于这些消融导管 1段的 长轴中心线。 图 21A、 图 21B、 图 21C将主要依靠增加牵引丝 10的应力(即推送牵引丝 10或 回退消融导管 1除牵引丝 10外的部分)实现独立结构 8相互远离最终使消融头 9与血管壁接 触,而图 41C将主要依靠增加牵引丝 10的张力(即牵拉牵引丝 10或前送消融导管 1除牵引丝 10外的部分)实现独立结构 8相互远离最终使消融头 9与血管壁接触; 当然如果将独立结构 8 的初始形变制成相互远离的状态, 图 21A、 图 21B、 图 21C将主要依靠增加牵引丝 10的张力 实现独立结构 8远端相互靠拢使得消融头 9与血管壁分离; 而图 21D将主要依靠增加牵引丝 10的应力实现独立结构 8远端相互靠拢使得消融头 9与血管壁分离, 如果为了使消融头 9与 血管壁接触更紧密, 也可增加牵引丝 10的张力。 如图 21所示, 为了使在牵引丝 10作用下独 立结构 8更易发生弯曲进而方便消融头 9与血管壁接触, 与前述独立结构 8连接于消融段头 端 17相似, 优选地釆用鸡肋样结构, 釆用图 17所示或 /和图 19所示的鸡肋样设计均可; 其 中在图 21A、 图 21B、 图 21C所示的独立结构 8上将空白部分安排在独立结构 8靠消融段 6中 心线的部分, 而在图 21D所示的独立结构 8上头端固定点 110至独立结构 8近端的部分, 空 白部分将安排在独立结构 8远离消融段 6中心线的部分;图 21所示的独立结构 8中在头端固 定点 110至独立结构 8远端的部分上, 空白部分的主要目的是通过使该部分易于发生弯曲緩 冲消融头 9与血管壁接触的压力, 保护血管壁。 图 21B、 图 21C、 图 21D是以两个独立结构 8 为例说明如何实现消融点在不同的肾动脉横截面上。 如图 21B所示, 此时两个独立结构 8a、 8b的长度是相等的、 内部结构基本是镜面对称的, 只是消融头 9的固定位置有所不同, 独立 结构 8a上的消融头 9a更靠近独立结构 8的远端, 通过这种方式即可实现消融点在不同的肾 动脉横截面上。 如图 21C、 图 21D所示, 也可以釆用不等长的两个独立结构 8a、 8b , 由于两 个独立结构 8的长度不同而消融头 9均设置在每个独立结构 8的头部, 因此也可实现消融点 在不同的肾动脉横截面上;图 21C与图 21D的区别主要在于图 21C所示的牵引丝 10的长度相 等, 而图 21D所示的牵引丝 10的长度不等。 图 21是以两个独立结构 8为例进行设计方案说 明的, 因此不局限于两个独立结构 8的情况, 对于多于两个独立结构 8的情况也同样适用。 此外对于技术人员需要独立结构 8形成其他弯曲形态的情况或需要改变牵引丝 10对独立结构 8控制形式的情况, 可以对图 21中独立结构 8的空白部分进行相应调整。 Fig. 21 shows an example in which the distal ends of the two independent structures 8 are separated from each other, and combined with the hardness division adjustment, the wire-controlled structure of the ablation section 6 of the present invention is shown. As shown in Fig. 21C, when the pulling wire 10 travels outside the separate structure 8, the pulling wire 10 preferably travels along the long axis centerline of the ablation section 6, in which case each individual structure 8 preferably requires a pulling wire 10, a pulling wire The head end fixing point 110 of 10 is preferably disposed on the ablation head 9 or the adjacent independent structure 8, and the head end fixing point 110 is located on the long axis center line of the ablation section 6, generally at 0-8 in the ablation head 9, for no setting The independent structure 8 of the ablation head 9, the head end fixing point 110 of the pulling wire 10 is preferably disposed on the head end of the independent structure 8 or the adjacent independent structure 8 thereof, and the head end fixing point 110 is located on the long axis center line of the ablation section 6, generally The distance between the 8 ends of the independent structure is 0-8; as shown in Fig. 21, the traction wires 10 are preferably combined into one in the ablation catheter 1 except the ablation segment 6, and preferably travels to the ablation catheter 1 segment. The long axis centerline. As shown in FIG. 21A, FIG. 21B, and FIG. 21D, when the pulling wire 10 travels in the independent structure 8, the head end fixing point 110 of the pulling wire 10 is different depending on the traveling path of the pulling wire 10; 21A and 21B, when the pulling wire 10 travels within the independent structure 8 of the long axis centerline of the ablation section 6, the head end fixing point 110 is preferably disposed on the ablation head 9 or the adjacent independent structure 8, the head end. The fixed point 110 is located on the long axis centerline of the ablation section 6, generally at 0-8 in the ablation head 9, and for the independent structure 8 without the energy contacts, the head end fixed point 110 is preferably disposed at the end of the independent structure 8 or On the adjacent independent structure 8, the head end fixing point 110 is located on the long axis center line of the ablation section 6, and generally the head end of the independent structure 8 is hidden at 0-8; as shown in Fig. 21D, when the pulling wire 10 is away from the ablation section 6 When traveling in the independent structure 8 of the long axis center line, the head end fixing point 110 is preferably disposed on the ablation head 9 or the adjacent independent structure 8, and the head end fixing point 110 is away from the long axis center line of the ablation section 6, generally ablated Head 9 is hidden at 0-8, for independent structure 8 without energy contacts The head end fixing point 110 is preferably disposed on the independent structure 8 at the head end of the independent structure 8, or the head end fixing point 110 is away from the long axis center line of the ablation section 6, and the distance from the head end of the independent structure 8 is generally 0-8. As shown in Fig. 21, the traction wires 10 are preferably combined into one in the ablation catheter 1 section other than the ablation section 6, and preferably travels to the long axis centerline of the ablation catheter 1 section. 21A, 21B, and 21C will mainly rely on increasing the stress of the traction wire 10 (i.e., pushing the traction wire 10 or the portion of the retraction ablation catheter 1 other than the traction wire 10) to achieve independent structure 8 away from each other and finally ablation head 9 and blood vessel. Wall contact, while Figure 41C will rely primarily on increasing the tension of the traction wire 10 (i.e., pulling the traction wire 10 or the portion of the ablation catheter 1 other than the traction wire 10) to achieve independent structure 8 away from each other and ultimately ablation head 9 and vessel wall Contact; of course, if the initial deformation of the independent structure 8 is made to be away from each other, FIGS. 21A, 21B, and 21C will mainly rely on increasing the tension of the pulling wire 10 to realize that the distal ends of the independent structures 8 are close to each other such that the ablation head 9 and the blood vessel wall Separating; and Fig. 21D will mainly rely on increasing the stress of the pulling wire 10 to achieve the separation of the distal ends of the independent structures 8 so that the ablation head 9 is separated from the blood vessel wall. If the ablation head 9 is brought into closer contact with the blood vessel wall, the pulling wire 10 can also be increased. The tension. As shown in Fig. 21, in order to make the independent structure 8 more susceptible to bending under the action of the pulling wire 10 and to facilitate the contact of the ablation head 9 with the blood vessel wall, it is similar to the aforesaid independent structure 8 connected to the ablation section head end 17, preferably using a chicken rib-like shape. The structure, the chicken rib-like design shown in FIG. 17 or/and FIG. 19 can be used; wherein the blank portion is arranged on the independent structure 8 shown in FIGS. 21A, 21B, and 21C in the ablation section of the independent structure 8 6 part of the centerline, and in the portion of the independent structure 8 shown in Fig. 21D where the head end is fixed at a point 110 to the proximal end of the individual structure 8, the blank portion will be arranged in a portion of the separate structure 8 away from the centerline of the ablation section 6; In the illustrated separate structure 8 on the portion of the tip end fixed point 110 to the distal end of the separate structure 8, the primary purpose of the blank portion is to protect the vessel wall by making the portion susceptible to bending buffering the pressure of the ablation head 9 in contact with the vessel wall. . 21B, 21C, and 21D illustrate two different structures 8 as an example of how to achieve ablation points on different renal artery cross sections. As shown in Fig. 21B, at this time, the lengths of the two independent structures 8a, 8b are equal, and the internal structure is substantially mirror-symmetrical, except that the fixing position of the ablation head 9 is different, and the ablation head 9a on the independent structure 8a is closer. In this way, the ablation point can be achieved on different renal artery cross-sections. As shown in FIG. 21C and FIG. 21D, two independent structures 8a, 8b of unequal length may also be used, as two The lengths of the individual structures 8 are different and the ablation heads 9 are disposed at the head of each individual structure 8, so that the ablation points can also be realized on different renal artery cross-sections; FIG. 21C differs from FIG. 21D mainly in FIG. 21C. The lengths of the traction wires 10 are shown to be equal, while the lengths of the traction wires 10 shown in Fig. 21D are not equal. Fig. 21 is an illustration of two independent structures 8 as an example. Therefore, it is not limited to the case of two independent structures 8, and the same applies to the case of more than two independent structures 8. Further, for the case where the technician needs the independent structure 8 to form other curved forms or the case where the control of the pulling wire 10 to the independent structure 8 is required, the blank portion of the independent structure 8 in Fig. 21 can be adjusted accordingly.
图 22是以两个独立结构 8为例, 结合硬度分部调整, 显示了本发明中独立结构 8中间某 处连接在一起远端再相互分离时线控结构的特点。 如图 22A所示, 当牵引丝 10走行于独立结 构 8外时,优选将牵引丝 10的头端固定点 110设置于各独立结构 8头端或其邻近的独立结构 8上, 头端固定点 110靠消融段 6的长轴中心线, 一般距独立结构 8头端在 0—8隱, 如果消 融头 9设置于独立结构 8的头部, 则头端固定点 110优选位于消融头 9或其邻近的独立结构 8上, 头端固定点 110靠消融段 6的长轴中心线, 一般距消融头 9在 0--8mm; 每个独立结构 8上优选均设置一个牵引丝 10 ,这些牵引丝 10在头端固定点 110的远端反折合并成一个牵引 丝, 该个牵引丝 10沿消融段 6的长轴中心线走行, 穿过独立结构 8的连接点 18 , 最终在可 控弯曲段 5进入消融导管 1 内, 此后沿消融导管 1的长轴中心线走行。 如图 22B所示, 当牵 引丝 10走行于独立结构 8内时, 优选地将牵引丝 10的头端固定点 110设置于设置于各独立 结构 8头端或其邻近的独立结构 8上, 头端固定点 110远离消融段 6的长轴中心线, 一般距 独立结构 8头端在 0—8隱, 如果消融头 9设置于独立结构 8的头部, 则头端固定点 110优选 位于消融头 9或其邻近的独立结构 8上, 头端固定点 110远离消融段 6的长轴中心线, 一般 距消融头 9在 0—8隱; 牵引丝 10在连接点 18以前尽量沿各独立结构 8远离消融段 6长轴中 心线的部分走行, 牵引丝 10在连接点 18以后尽量沿各独立结构 8靠消融段 6长轴中心线的 部分走行, 此时优选地在每个独立结构 8 内均设置一个牵引丝 10 , 这些牵引丝 10在除消融 段 6以外的消融导管 1段内最好合并成一个, 并优选地走行于这些消融导管 1段的长轴中心 线。 如图 22C所示, 当牵引丝 10部分走行于独立结构 8内而部分走行于独立结构 8外时, 优 选地在独立结构 8的连接点 18以前的部分走行于独立结构 8内,并沿各独立结构 8远离消融 段 6长轴中心线的部分走行, 而后在连接点 18处合并成一个牵引丝 10 , 走行于独立结构 8 外, 沿消融段 6长轴中心线走行, 最终在可控弯曲段 5进入消融导管 1 内, 此后优选地沿消 融导管 1的长轴中心线走行; 如图 22C所示,优选地将牵引丝 10的头端固定点 110设置于各 独立结构 8头端或其邻近的独立结构 8上, 头端固定点 110远离消融段 6的长轴中心线, 一 般距独立结构 8头端在 0—8隱, 如果消融头 9设置于独立结构 8的头部, 则头端固定点 110 优选位于消融头 9或其邻近的独立结构 8上, 头端固定点 110远离消融段 6的长轴中心线, 一般距消融头 9在 0—8隱。 图 22将主要依靠增加牵引丝 10的张力(即牵拉牵引丝 10或前送 消融导管 1除牵引丝 10外的部分)实现独立结构 8远端相互远离而中间及尾部呈类似纺锤形 , 并最终使消融头 9与血管壁接触。 如图 22A、 图 22B、 图 22C所示, 为了使在牵引丝 10应力 增加的情况下独立结构 8更易发生弯曲进而方便消融头 9与血管壁接触, 优选地釆用鸡肋样 结构, 与前述独立结构 8相互连接于消融段头端 17相似, 釆用图 17所示或 /和图 19所示的 鸡肋样结构均可;其中在图 22A所示意的连接点 18至头端固定点 110的独立结构 8上将空白 部分安排在独立结构 8靠消融段 6中心线的部分, 而在图 22B、 图 22C所示意的连接点 18至 头端固定点 110的独立结构 8上, 空白部分安排在独立结构 8远离消融段 6中心线的部分; 图 22A、 图 22B、 图 22C所示意的独立结构 8上头端固定点 110至独立结构 8远端的部分, 空 白部分安排在独立结构 8靠近消融段 6中心线的部分, 主要目的是通过使该部分易于发生弯 曲緩冲消融头 9与血管壁接触的压力, 保护血管壁。 图 22D、 图 22E、 图 22F是以两个独立结 构 8且牵引丝 10走行于独立结构 8内为例说明如何实现消融点在不同的肾动脉横截面上。如 图 22D所示, 此时两个独立结构 8a、 8b的长度是相等的, 结构基本是镜面对称的, 只是消融 头 9的固定位置有所不同, 独立结构 8a上的消融头 9a更靠近独立结构 8的远端, 通过这种 方式即可实现消融点在不同的肾动脉横截面上。 如图 22E、 图 22F所示, 也可以釆用不等长 的两个独立结构 8a、 8b , 两个独立结构 8在连接点 18到独立结构 8远端的部分优选不等长, 而连接点 18到独立结构 8近端的部分优选等长; 由于两个独立结构 8在连接点 18远端的部 分的长度不同而消融头 9均设置在每个独立结构 8的头部, 因此也可实现消融点在不同的肾 动脉横截面上; 图 22E与图 22F的区别主要在于图 22E所示的两个牵引丝 10的长度相等, 而 图 22F所示的两个牵引丝 10的长度不等。 图 11是以两个独立结构 8为例进行设计方案说明 的, 因此不局限于两个独立结构 8的情况, 对于多于两个独立结构 8的情况也同样适用。 图 22D、 图 22E、 图 22F是以两个独立结构 8且牵引丝 10走行于独立结构 8内为例进行设计方 案说明的, 因此不局限于两个独立结构 8的情况, 对于多于两个独立结构 8的情况也同样适 用, 同样也不局限于牵引丝 10走行于独立结构 8内的情况, 对于牵引丝 10走行于独立结构 8外或部分走行于独立结构 8外也同样适用。 此外对于技术人员需要独立结构 8形成其他弯 曲形态的情况, 可以对图 47中截面图的空白部分和图 48中独立结构 8的空白部分进行相应 调整。 Fig. 22 is an illustration of two independent structures 8 combined with hardness section adjustment, showing the characteristics of the wire control structure in the middle of the independent structure 8 in the present invention when the middle portion is connected to the distal end and then separated from each other. As shown in FIG. 22A, when the pulling wire 10 travels outside the independent structure 8, the head end fixing point 110 of the pulling wire 10 is preferably disposed on the head end of each independent structure 8 or its adjacent independent structure 8, the head end fixing point. 110 depends on the long axis centerline of the ablation section 6, generally at a distance of 0-8 from the head end of the independent structure 8. If the ablation head 9 is disposed at the head of the independent structure 8, the head end fixed point 110 is preferably located at the ablation head 9 or On the adjacent independent structure 8, the head end fixing point 110 is located on the long axis center line of the ablation section 6, generally 0 to -8 mm from the ablation head 9, and each of the independent structures 8 is preferably provided with a pulling wire 10, and these pulling wires are provided. 10 reversing at the distal end of the head end fixed point 110 into a traction wire that travels along the long axis centerline of the ablation section 6, through the attachment point 18 of the separate structure 8, and ultimately in the controllable curved section. 5 Enters the ablation catheter 1 and thereafter travels along the long axis centerline of the ablation catheter 1. As shown in FIG. 22B, when the pulling wire 10 travels in the independent structure 8, the head end fixing point 110 of the pulling wire 10 is preferably disposed on the independent structure 8 disposed at or adjacent to the head end of each of the independent structures 8, the head The end fixing point 110 is away from the long axis center line of the ablation section 6, and is generally hidden from 0 to 8 at the head end of the independent structure 8. If the ablation head 9 is disposed at the head of the independent structure 8, the head end fixing point 110 is preferably located at the ablation head. 9 or its adjacent independent structure 8, the head end fixed point 110 is away from the long axis centerline of the ablation section 6, generally at 0-8 hidden from the ablation head 9; the traction wire 10 is along the individual structures 8 as far as possible before the connection point 18. Moving away from the portion of the long axis centerline of the ablation section 6, the traction wire 10 travels along the portion of the long axis centerline of the ablation section 6 along each of the individual structures 8 as far as possible after the connection point 18, preferably in each individual structure 8 A traction wire 10 is provided which preferably merges into one of the ablation catheters 1 except for the ablation section 6, and preferably travels the longitudinal axis of the ablation catheter 1 section. As shown in Fig. 22C, when the portion of the pulling wire 10 travels within the separate structure 8 and partially travels outside of the individual structure 8, it is preferred to run within the separate structure 8 at a portion prior to the point of attachment 18 of the individual structure 8, and along each The independent structure 8 travels away from the portion of the long axis centerline of the ablation section 6, and then merges into a pulling wire 10 at the joint 18, travels outside the independent structure 8, and travels along the long axis centerline of the ablation section 6, ultimately in controlled bending. The segment 5 enters the ablation catheter 1 and thereafter preferably travels along the long axis centerline of the ablation catheter 1; as shown in Figure 22C, the tip end fixation point 110 of the traction wire 10 is preferably placed at the tip end of each individual structure 8 or On the adjacent independent structure 8, the head end fixing point 110 is away from the long axis center line of the ablation section 6, and is generally hidden from 0 to 8 at the head end of the independent structure 8. If the ablation head 9 is disposed at the head of the independent structure 8, the head The end fixation point 110 is preferably located on the ablation head 9 or its adjacent independent structure 8, the head end fixation point 110 being remote from the long axis centerline of the ablation section 6, generally at 0-8 from the ablation head 9. Figure 22 will rely primarily on increasing the tension of the traction wire 10 (i.e., pulling the traction wire 10 or the portion of the forward ablation catheter 1 other than the traction wire 10) to achieve that the distal ends of the individual structures 8 are remote from each other and that the middle and the tail are similarly spindle-shaped, and Eventually the ablation head 9 is brought into contact with the vessel wall. As shown in Fig. 22A, Fig. 22B, and Fig. 22C, in order to make the independent structure 8 more susceptible to bending in the case where the stress of the pulling wire 10 is increased to facilitate the contact of the ablation head 9 with the blood vessel wall, it is preferable to use a chicken rib-like structure, independent of the foregoing. The structure 8 is similar to the ablation section head end 17 and is similar to the chicken rib-like structure shown in FIG. 17 or/and FIG. 19; wherein the connection point 18 to the head end fixing point 110 shown in FIG. 22A is independent. The blank portion of the structure 8 is arranged in the portion of the independent structure 8 which is centered on the ablation section 6, and on the independent structure 8 of the connection point 18 to the head end fixed point 110 illustrated in Figs. 22B and 22C, the blank portion is arranged independently. The portion of the structure 8 that is away from the centerline of the ablation section 6; the portion of the independent structure 8 illustrated in Figures 22A, 22B, and 22C that is fixed to the distal end of the individual structure 8 and the blank portion disposed adjacent to the ablation section 6 The main purpose of the portion of the centerline is to protect the vessel wall by exposing the portion to the pressure of the bending buffer ablation head 9 in contact with the vessel wall. 22D, 22E, and 22F illustrate how the ablation points are on different renal artery cross-sections by taking two separate structures 8 and pulling the wire 10 in the separate structure 8 as an example. As shown in Fig. 22D, at this time, the lengths of the two independent structures 8a, 8b are equal, the structure is substantially mirror-symmetrical, except that the fixed position of the ablation head 9 is different, and the ablation head 9a on the independent structure 8a is closer to independence. The distal end of structure 8, through this The way to achieve ablation points in different renal artery cross sections. As shown in FIG. 22E and FIG. 22F, two independent structures 8a, 8b of unequal lengths may also be used, and the portions of the two independent structures 8 at the distal end of the connection point 18 to the independent structure 8 are preferably unequal lengths, and the connection points are The portion of the proximal end of the individual structure 8 is preferably of equal length; since the lengths of the portions of the two separate structures 8 at the distal end of the joint 18 are different and the ablation heads 9 are disposed at the head of each individual structure 8, it is also possible The ablation points are on different renal artery cross-sections; Figure 22E differs from Figure 22F primarily in that the lengths of the two traction wires 10 shown in Figure 22E are equal, while the lengths of the two traction wires 10 shown in Figure 22F are not equal. Figure 11 illustrates the design of two separate structures 8 and is therefore not limited to the case of two separate structures 8, as is the case for more than two independent structures 8. 22D, 22E, and 22F are illustrated by taking two independent structures 8 and the pulling wire 10 running in the independent structure 8 as an example, and thus are not limited to the case of two independent structures 8, for more than two The same applies to the case of the individual structure 8, and is also not limited to the case where the pulling wire 10 travels within the individual structure 8, as is the case with the pulling wire 10 running outside the partial structure 8 or partially running outside the independent structure 8. Further, for the case where the technician needs the separate structure 8 to form other curved forms, the blank portion of the cross-sectional view in Fig. 47 and the blank portion of the independent structure 8 in Fig. 48 can be adjusted accordingly.
根据具体情况, 技术人员可以对上述这些牵引丝 10和空白部分的设计方案进行融合、 改 进及交叉使用, 这些等效变化和修饰同样落入本发明权利要求所限定的范围。  Depending on the circumstances, the skilled artisan may incorporate, modify and cross-use the design of the traction wire 10 and the blank portion described above, and such equivalent variations and modifications are also within the scope defined by the claims of the present invention.
图 23是以 C形弯曲设计时的结构为例,显示了本发明是如何通过调整可控弯曲段 5的硬 度分布使设计形变更易实现。图 23中可控弯曲段 5上的空白部分应理解为可控弯曲段 5间隔 一定距离的结构硬度降低, 这种硬度下降不仅可以通过改变结构设计的方式实现也可以通过 改变材料硬度的方式实现, 因此可以通过调整可控弯曲段 5上空白部分的大小、 形态、 分部 密度等改变可控弯曲段 5的硬度分布使其更易弯曲成为所需要的形态。 当可控弯曲段 5为 C 形弯曲设计时, 优选根据需要弯曲方向的数量设计可控弯曲段 5的结构, 图 23A、 图 23B、 图 23C是以导向丝 11通过增加张力的方式控制一个方向的弯曲为例进行说明的, 其中图 23B、 图 23C为可控弯曲段 5的鸡肋样结构放大后的侧视图。如图 23A所示, 导向丝 11头端固定点 111优选设置在可控弯曲段 5靠近消融段 6的地方并位于弯曲方向侧的离心位置, 与图 20、 图 21、 图 22所示意的独立结构 8的设计方案类似, 可控弯曲段 5也优选釆用鸡肋样结构; 当釆用图 17所示的鸡肋样结构时, 可控弯曲段 5可釆用图 17A和图 17B所示的设计方案, 其 中图 23B中虚线 ccl所示的横截面的截面形态优选为图 17B所示,此时如果导向丝 11走行于 可控弯曲段 5 内, 则优选走行于图 17A和图 17B所示意的空白区域 bl , 也即图 23B、 图 23C 中的 d3部分, 当然根据情况导向丝 11也可以走行于可控弯曲段 5外或部分走行于可控弯曲 段 5外; 当釆用图 19所示的鸡肋样结构时, 图 23A、 图 23B、 图 23C中可控弯曲段 5的空白 部分应理解为可控弯曲段 5管壁间隔一定距离的结构硬度下降, 例如通过去掉金属丝网、 改 变金属丝网的密度等, 导向丝 11优选走行于可控弯曲段 5的弯曲侧; 若需要弯曲的方向与图 23B箭头 aol所示的方向相反(即箭头 ao2所示方向) , 则可釆用图 23C所示的设计方式, 此 时导向丝 11同样走行于 d3部分。 如果通过推送导向丝 11或回退消融导管 1使可控弯曲段 5 发生弯曲, 即增加导向丝 11的应力, 则在同样的设计方案中发生弯曲的方向将与增加导向丝 11的张力导致的可控弯曲段 5的弯曲方向相反。若需要可控弯曲段 5向两侧都比较容易弯曲, 可釆用图 23D所示的设计方案, 即优选在可控弯曲段 5相对的两侧分别设置图 17或 /和图 19 所示意的鸡肋样结构; 当釆用图 17所示意的鸡肋样结构时, 其设计方式类似图 17C所示, 只 是各区域的大小稍有调整(如图 23D中间图所示) ,两个导向丝 11优选分别走行于图 23D中间 截面图所示的空白区域 bl和 b2 , 由于可弯控曲段 5两侧的硬度比较小, 因此增加某侧导向 丝 11的张力将使可控弯曲段 5向该侧弯曲, 而增加某侧导向丝 11的应力将使可控弯曲段 5 向对侧弯曲; 当釆用图 19所示的鸡肋样结构时, 图 23D中可控弯曲段 5的空白部分应理解为 可控弯曲段 5管壁间隔一定距离的结构硬度下降, 例如通过去掉金属丝网、 改变金属丝网的 密度等, 导向丝 11优选走行于可控弯曲段 5的弯曲侧。 如图 23D的左右两幅侧视图所示, 两 侧鸡肋样结构的排布不一定完全对称, 可以有一定的错位。 对于图 29所示意的牵引丝 10发 挥导向丝 11作用的设计方案中的可控弯曲段 5即可釆用图 23D所示的设计, 若釆用图 17所 示意的鸡肋样结构时, 两个牵引丝 10优选分别走行于空白区域 bl和 b2 , 若釆用图 19所示 的鸡肋样结构时, 两个牵引丝 10优选走行于可控弯曲段 5的弯曲侧。对于需要实现多向控制 弯曲(大于等于 3个方向)可空弯曲段 5可釆用图 18所示意的双凸圆盘重叠结构的设计方案, 导向丝 11即走行通过 bl样空白区域(bl、 b2、 b 3、 b4) , 根据需要可以增加 bl样空白区域的 数量, 当然可空弯曲段 5也可釆用图 19D所示的鸡肋样结构来帮助实现控制多向弯曲。 当可 控弯曲段 5为 S形弯曲设计时仿与 C形弯曲设计即可。 技术人员可根据实际情况调整可控弯 曲段 5上空白部分的大小、 形态、 分部密度等以改变其弯曲形态。 Fig. 23 is an example of a structure in a C-shaped curved design, showing how the present invention can easily realize the design change by adjusting the hardness distribution of the controllable curved section 5. The blank portion of the controllable curved section 5 in Fig. 23 is understood to mean that the structural hardness of the controllable curved section 5 is reduced by a certain distance. This hardness reduction can be achieved not only by changing the structural design but also by changing the hardness of the material. Therefore, the hardness distribution of the controllable curved section 5 can be changed to make it more flexible by adjusting the size, shape, and partial density of the blank portion on the controllable curved section 5. When the controllable curved section 5 is of a C-shaped curved design, it is preferable to design the structure of the controllable curved section 5 according to the number of required bending directions, and FIGS. 23A, 23B, and 23C control the direction by the tension wire 11 by increasing the tension. The bending is taken as an example, wherein FIG. 23B and FIG. 23C are enlarged side views of the chicken rib-like structure of the controllable curved section 5. As shown in Fig. 23A, the tip end fixing point 111 of the guide wire 11 is preferably disposed at a position where the controllable curved section 5 is near the ablation section 6 and is located at the centrifugation side on the side of the bending direction, which is independent of the meaning shown in Figs. 20, 21, and 22. The design of the structure 8 is similar, and the controllable curved section 5 is also preferably a chicken rib-like structure; when the chicken rib-like structure shown in Fig. 17 is used, the controllable curved section 5 can adopt the design shown in Figs. 17A and 17B. The cross-sectional shape of the cross section indicated by the broken line ccl in FIG. 23B is preferably as shown in FIG. 17B. In this case, if the guide wire 11 travels within the controllable curved section 5, it is preferable to travel as shown in FIGS. 17A and 17B. The blank area bl, that is, the part d3 in FIG. 23B and FIG. 23C, of course, the guide wire 11 can also travel outside the controllable curved section 5 or partially outside the controllable curved section 5 according to the situation; In the chicken rib-like structure, the blank portion of the controllable curved section 5 in FIGS. 23A, 23B, and 23C should be understood as a decrease in the hardness of the structure of the controllable curved section 5 at a certain distance from the wall, for example, by removing the wire mesh and changing the metal. The density of the screen, etc., the guide wire 11 preferably walks On the curved side of the controllable curved section 5; if the direction of the bend is opposite to the direction indicated by the arrow aol in Fig. 23B (i.e., the direction indicated by the arrow ao2), the design shown in Fig. 23C can be used, and the guide is used. The wire 11 also travels in the d3 part. If the controllable bending section 5 is bent by pushing the guiding wire 11 or the retracting ablation catheter 1, that is, increasing the stress of the guiding wire 11, the direction in which the bending occurs in the same design will be caused by the increase of the tension of the guiding wire 11. The bending direction of the controllable curved section 5 is opposite. If it is required that the controllable curved section 5 is relatively easy to bend to both sides, the design shown in FIG. 23D can be used, that is, the opposite sides of the controllable curved section 5 are preferably disposed respectively as shown in FIG. 17 or/and FIG. Chicken rib-like structure; When the rib-like structure shown in Fig. 17 is used, the design is similar to that shown in Fig. 17C, except that the size of each area is slightly adjusted (as shown in the middle of Fig. 23D), and the two guide wires 11 are preferably Moving the blank areas bl and b2 shown in the middle section of Fig. 23D respectively, since the hardness of both sides of the bendable curved section 5 is relatively small, increasing the tension of the side guide wire 11 will cause the controllable curved section 5 to the side. Bending, while increasing the stress of a certain side guide wire 11 will bend the controllable curved section 5 to the opposite side; when the chicken rib-like structure shown in Fig. 19 is used, the blank portion of the controllable curved section 5 in Fig. 23D should be understood as The structural rigidity of the controllable curved section 5 at a certain distance from the wall is reduced, for example, by removing the wire mesh, changing the density of the wire mesh, etc., the guide wire 11 preferably travels on the curved side of the controllable curved section 5. As shown in the left and right side views of Fig. 23D, the arrangement of the chicken rib-like structures on both sides is not necessarily completely symmetrical, and may have a certain misalignment. For the traction wire 10 shown in Figure 29 The controllable curved section 5 in the design of the swinging wire 11 can be designed as shown in Fig. 23D. If the chicken rib-like structure shown in Fig. 17 is used, the two pulling wires 10 preferably travel in blank areas respectively. Bl and b2, if the chicken rib-like structure shown in Fig. 19 is used, the two pulling wires 10 preferably travel on the curved side of the controllable curved section 5. For the design of the multi-directional control bending (greater than or equal to 3 directions), the hollow curved section 5 can adopt the design of the double convex disk overlapping structure illustrated in FIG. 18, and the guiding wire 11 travels through the bl-like blank area (bl, B2, b3, b4), the number of bl-like blank areas can be increased as needed. Of course, the hollow curved section 5 can also use the chicken rib-like structure shown in Fig. 19D to help control the multi-directional bending. When the controllable curved section 5 is S-shaped curved design, it can be similar to the C-shaped curved design. The technician can adjust the size, shape, and partial density of the blank portion on the controllable curved section 5 according to the actual situation to change the bending shape.
图 24显示了本发明中导引导管 7尾部的主要设计特点。 如图 24A所示, 根据实际需要, 导引导管 7的末端(尾端、 近端)可设有侧孔 77 , 侧孔 77与一段导管 20连接后与注射器或注 液装置相连, 注射器或注液装置可通过侧孔 77行血管内注药或注射血管内造影剂, 侧孔 77 不使用时导管 20是封闭的。 如图 24A、 图 24B、 图 24C所示, 导引导管 7的尾部最好有密封 设计, 例如密封圏或密封套 79 , 防止血液经导引导管 7漏出和经导引导管 7向血管内注射的 药物或注射的造影剂漏出, 其中图 24A、 图 24B显示的是没有插入消融导管 1的情况, 图 24C 显示的是插入消融导管 1的情况, 图 24B、 图 24C为导引导管 7尾部的放大图; 此外导引导 管 7的尾部周围最好有加固套 78 , 使导引导管 7尾部不易形变, 便于操作, 同时也方便与其 他结构进行连接或贴附在其他结构上。  Figure 24 shows the main design features of the tail of the guiding catheter 7 of the present invention. As shown in Fig. 24A, according to actual needs, the end (tail end, proximal end) of the guiding catheter 7 can be provided with a side hole 77, which is connected with a section of the catheter 20 and connected to a syringe or a liquid injection device, a syringe or a syringe. The fluid device can be intravascularly injected or injected with an intravascular contrast agent through the side hole 77, and the catheter 20 is closed when the side hole 77 is not in use. As shown in Figures 24A, 24B, and 24C, the tail of the guiding catheter 7 is preferably sealed, such as a sealing jaw or sealing sleeve 79, to prevent blood from leaking through the guiding catheter 7 and to be injected intravascularly through the guiding catheter 7. The drug or the injected contrast agent leaks out, wherein Figs. 24A and 24B show the case where the ablation catheter 1 is not inserted, Fig. 24C shows the case where the ablation catheter 1 is inserted, and Fig. 24B and Fig. 24C show the tail of the guide catheter 7. In addition, there is preferably a reinforcing sleeve 78 around the tail of the guiding catheter 7, so that the tail portion of the guiding catheter 7 is not easily deformed, is easy to operate, and is also convenient to be connected or attached to other structures.
导引导管 7本身也可以发生单向或多向主动控制形变或 /和被动控制形变,同时也可设置 预制形变。 如图 24A所示, 对于导引导管 7仅有预制形变的情况, 优选不设置导引导管控制 柄 27 (后述), 其末端仅设置连接接头 76 , 连接接头 76可与注射器、 注液装置、 消融导管 1 等连接。导引导管 7的主动控制形变优选通过在导引导管 7的管壁上加入智能材料 (如形状记 忆合金)实现, 例如: 釆用形状记忆合金设计分布方案。 导引导管 7的被动控制形变优选通过 线控结构设计和磁控结构设计实现; 其中线控结构设计即是过在导引导管 7管壁中穿入导引 丝 70 (类似于消融导管 1的导向丝 11)实现; 此外为了方便导引导管 7形成设计的形变形态, 还可以改变导引导管 7的硬度分布。图 25显示了本发明中导引导管 7线控结构设计的主要结 构特点以及如何通过调整导引导管 7的硬度分布促进导引导管 7形成所需要形变形态。 在导 引导管 7的一侧管壁中设有导引丝 70 , 当增加导引丝 70的张力时(牵拉导引丝 70或前送导 引导管 7除导引丝 70外的其他部分), 导引导管 7将向设置导引丝 70的一侧发生弯曲, 也即 图中箭头 aol所示方向, 如果需要多向控制弯曲可在导引导管 7的几个方向上分别设置导引 丝 70。 为了方便导引导管 7形成需要的形变形态, 可以改变导引导管 7小段的硬度分布, 这 种硬度分布的改变不仅可以通过改变结构设计的方式实现也可以通过改变材料硬度的方式实 现。  The guiding catheter 7 itself can also undergo one-way or multi-directional active control deformation or/and passive control deformation, as well as prefabrication deformation. As shown in FIG. 24A, in the case where the guiding catheter 7 is only prefabricated, it is preferable not to provide the guiding catheter control handle 27 (described later), and only the connecting joint 76 is provided at the end, and the connecting joint 76 can be combined with the syringe and the liquid filling device. , ablation catheter 1 and other connections. The active control deformation of the guiding catheter 7 is preferably achieved by incorporating a smart material (e.g., a shape memory alloy) on the wall of the guiding catheter 7, for example: 形状 Designing a distribution scheme using a shape memory alloy. The passive control deformation of the guiding catheter 7 is preferably achieved by a wire-controlled structural design and a magnetron structure design; wherein the wire-controlled structure is designed to penetrate the guiding wire 70 in the wall of the guiding catheter 7 (similar to the ablation catheter 1) The guide wire 11) is realized; in addition, in order to facilitate the formation of the designed deformation shape of the guiding catheter 7, the hardness distribution of the guiding catheter 7 can also be changed. Fig. 25 shows the main structural features of the guiding structure design of the guiding catheter 7 in the present invention and how to optimize the formation of the guiding catheter 7 by adjusting the hardness distribution of the guiding catheter 7. A guide wire 70 is provided in one side wall of the guiding catheter 7, when the tension of the guiding wire 70 is increased (the pulling guide wire 70 or the other portion of the feeding guide catheter 7 except the guiding wire 70) ), the guiding catheter 7 will be bent toward the side where the guiding wire 70 is disposed, that is, the direction indicated by the arrow aol in the figure, and if the multi-directional control bending is required, the guiding can be separately set in several directions of the guiding catheter 7. Silk 70. In order to facilitate the formation of the desired deformation mode of the guiding catheter 7, the hardness distribution of the guiding catheter 7 can be changed. This change in hardness distribution can be achieved not only by changing the structural design but also by changing the hardness of the material.
图 26是以线控结构为例,示意了控制手柄 1能够控制可控弯曲段 5向一个方向弯曲情况 下控制手柄 2的主要结构特点, 其中图 26B、 图 26C分别为为图 26A中虚线 ccl、 cc2横截面 放大的截面图。 如图 26A所示, 控制手柄 2优选设计成图示形状, 主要由操作柄 211和操作 柄 257组成, 其中操作柄 211—般位于控制手柄 1的前部, 主要负责控制可控弯曲段 5的形 变, 而操作柄 257—般位于控制手柄 1的后部, 主要负责控制独立结构 8的形变,操作柄 211 和操作柄 257优选为中空的结构。 如图 26A所示, 消融导管 1通过导管体段 4 (图 1示)与操 作柄 211相连, 类似于导引导管 7的加固套 78 , 在消融导管 1的近端也设有加固套 48 , 以使 消融导管 1与控制手柄 2连接的地方不易形变, 便于操作。 如图 26A所示, 操作柄 211上设 置有用于控制可控弯曲段 5形变的控制钮 230 , 控制钮 230环绕操作柄 211的一部分, 并可 以在操作柄 211上滑动, 由于控制钮 230卡在操作柄 211上, 因此控制钮 230不会滑出操作 柄 211。 如图 26A所示, 导向丝 11经操作柄 211上的连接通道 217与控制钮 230上的导向丝 固定盘 204相连, 当控制钮 230向箭头 aol所示方向滑动时, 即可牵拉导向丝 11。 如图 26A、 图 26C所示,牵引丝固定盘 205位于横截面成辐射状展开的连接杆 258的交汇处,连接杆 258 穿过操作柄 257上的一段导向槽 258与环形控制钮 257相连,环形控制钮 257环绕操作柄 257 方便在旋转时仍能控制环形控制钮 257 , 由于导向槽 258能限制连接杆 258的转动, 因此环 形控制钮 257和操作柄 21 3能够一起转动; 连接杆 258和导向槽 258的数量不一定为四个, 可以根据实际需要进行调整。 如图 26A所示, 能量交换接头 201优选设置于控制手柄 2的尾 部, 能量交换接头 201通过缆线 23 (内含导线、 导管、 光纤等, 图 1示)与消融发生装置 3相 连, 负责接收由消融发生装置 3传来的能量并将该能量通过控制手柄 2内的导线、 导管、 光 纤 ac等传输至消融头 9、 消融导管 1上其他需要能量供应的部分及控制手柄 1上需要能量供 应的部分。 如图 26A所示, 在能量交换接头 201邻近的位置根据情况还可设置液体灌注接头 202 , 其与消融导管 1内的导管相连, 用于向消融导管 1提供冷却液、 造影剂等。 如图 26A所 示,操作柄 211和操作柄 257通过图中虚线矩形框 ar标示的槽齿滑动结构进行连接,槽齿滑 动结构由操作柄 211尾部的环形钩状结构 212和操作柄 257头部的环形钩状结构 256相互吻 合组成, 因此连接后两者能够相对转动。 为了避免导向丝 11受到过分牵拉导致消融导管 1的 弯曲伤及血管壁,优选设置緩冲结构, 例如将走行在连接通道 217内的导向丝 11的中间一段 用弹簧或具有弹力的细线代替, 图 26是以弹簧 208为例进行说明的; 如图 26A所示, 在弹簧 208处的连接通道 217直径稍粗于弹簧 208 ,当控制钮 230向箭头 aol所示方向滑动牵拉导向 丝 11时, 弹簧 208可以伸展, 这样能够起到緩冲牵拉力的作用, 同时由于弹簧 208的螺旋直 径大于两边连接通道 217的直径, 因此弹簧 208的伸展距离不会超过连接通道 117的膨大部 分, 这就使得导向丝 11的张力不至于超过弹簧 208最大伸展距离下所产生的拉力, 也就相当 于设定了一个拉力限值; 同样地, 这样的设计思路也可以用于其他线控结构, 例如将控制手 柄 1内牵引丝 10的中间一段用弹簧或具有弹力的细线代替, 如图 26A所示, 牵引丝 10在小 腔室 207内靠控制手柄 1前部的一段被弹簧 209替代, 当环形控制钮 257向箭头 ao2所示方 向滑动牵拉牵引丝 10时, 弹簧 209可以伸展, 这样能够起到緩冲牵拉力的作用, 同样地, 由 于弹簧 209的螺旋直径大于小腔室 207两端开口的直径, 因此弹簧 208的伸展距离不会超过 小腔室 207。 当然为了避免牵引丝 10和导向丝 11受到过分牵拉或 /和推送导致消融导管 1的 弯曲伤及血管壁, 还可以在牵引丝 10和导向丝 11上连接张力传感器。 为了能够通过控制钮 230控制消融导管 1的转动, 最好控制钮 230和操作柄 211能够一起转动, 此时优选在控制 钮 230与操作柄 211间设置槽齿滑动结构; 如图 26B所示, 小虚线矩形框 rc即指示了槽齿滑 动结构, 槽齿滑动结构的设置位置与凹槽 216以及凹槽 284的设置位置不同, 优选将槽齿滑 动结构在圆周上平均分布; 图 26B中大虚线矩形框显示了槽齿滑动结构的放大图, 槽齿滑动 结构由凹槽 285和突出齿 286组成,图 26B是以凹槽 285和突出齿 286分别设置于控制钮 230 和操作柄 211上为例进行说明的, 根据具体情况也可将凹槽 285和突出齿 286分别设置于操 作柄 211和控制钮 230上; 这样的槽齿滑动结构就保证了控制钮 230能够在操作柄 211上自 由滑动, 同时控制钮 230也能带动操作柄 211—起转动。 为方便操作, 在操作柄 211上或 / 和控制钮 230上可标示控制钮 230移动距离以及移动方向, 在操作柄 211上、 操作柄 257上 或 /和控制钮 230上可标示操作柄 211与操作柄 257相对旋转角度及转动方向, 在操作柄 257 上或 /和环形控制钮 257上可标示环形控制钮 257移动距离以及移动方向。对于通过在第二个 弯曲处增设导向丝 11 '使可控弯曲段 5形成 S形弯曲的情况, 可将导向丝 11 '与导向丝 11的 在控制钮 230上的导向丝固定盘 204相连, 这样牵拉该个导向丝 11将同时牵拉导向丝 11 ' , 当然还可以调节导向丝 11 '与导向丝 11的松紧程度, 这样就能够实现先牵拉导向丝 11或导 向丝 11 '; 此外导向丝 11 '也可以通过独立的连接通道最终固定于控制钮 230上独立的位置。 对于通过磁控结构设计控制可控弯曲段 5或 /和独立结构 8形变的情况, 去掉图 26所示意的 控制手柄 1的设计方案中相应的线控结构, 将控制钮 230改为用于控制可控弯曲段 5的磁控 结构设计的被动控制形变, 将环形控制钮 257改为用于控制独立结构 8的磁控结构设计的被 动控制形变。对于通过主动控制形变控制可控弯曲段 5或 /和独立结构 8形变的情况, 去掉图 26所示意的控制手柄 2的设计方案中相应的线控结构, 将控制钮 230改为用于控制可控弯曲 段 5的主动控制形变, 将环形控制钮 257改为用于控制独立结构 8的主动控制形变。 FIG. 26 is a schematic diagram showing the main structural features of the control handle 2 in the case where the control handle 1 can control the bending of the controllable curved section 5 in one direction, wherein FIG. 26B and FIG. 26C are respectively the broken line ccl in FIG. 26A. , cc2 cross section enlarged view. As shown in Fig. 26A, the control handle 2 is preferably designed in a shape, mainly composed of an operating handle 211 and an operating handle 257, wherein the operating handle 211 is generally located at the front of the control handle 1, and is mainly responsible for controlling the controllable curved section 5. The deformation, and the operating handle 257 is generally located at the rear of the control handle 1, and is mainly responsible for controlling the deformation of the independent structure 8. The operating handle 211 and the operating handle 257 are preferably hollow structures. As shown in Fig. 26A, the ablation catheter 1 is connected to the operating handle 211 via a catheter body section 4 (shown in Fig. 1), similar to the reinforcing sleeve 78 of the guiding catheter 7, and a reinforcing sleeve 48 is also provided at the proximal end of the ablation catheter 1, The place where the ablation catheter 1 is connected to the control handle 2 is not easily deformed and is easy to handle. As shown in FIG. 26A, the operating handle 211 is provided with a control button 230 for controlling the deformation of the controllable curved section 5. The control button 230 surrounds a part of the operating handle 211 and can slide on the operating handle 211, since the control button 230 is stuck. The handle 211 is operated so that the control knob 230 does not slide out of the operating handle 211. As shown in Fig. 26A, the guide wire 11 is connected to the guide wire fixing disk 204 on the control knob 230 via the connecting passage 217 on the operating handle 211, and when the control button 230 slides in the direction indicated by the arrow aol, the guide wire can be pulled. 11. As shown in FIGS. 26A and 26C, the wire fixing disk 205 is located at the intersection of the connecting rods 258 which are radially expanded in cross section, and the connecting rod 258 is connected. A plurality of guiding grooves 258 passing through the operating handle 257 are connected to the ring control button 257. The ring control button 257 surrounds the operating handle 257 to facilitate control of the ring control button 257 while rotating. Since the guiding groove 258 can restrict the rotation of the connecting rod 258, Therefore, the ring control button 257 and the operating handle 21 3 can be rotated together; the number of the connecting rod 258 and the guiding groove 258 is not necessarily four, and can be adjusted according to actual needs. As shown in Fig. 26A, the energy exchange joint 201 is preferably disposed at the tail of the control handle 2, and the energy exchange joint 201 is connected to the ablation generating device 3 via a cable 23 (including a wire, a catheter, an optical fiber, etc., as shown in Fig. 1), and is responsible for receiving The energy transmitted by the ablation generating device 3 and transmitted to the ablation head 9 through the wires, catheters, optical fibers ac, etc. in the control handle 2, the other portions of the ablation catheter 1 that require energy supply, and the control handle 1 require energy supply. part. As shown in Fig. 26A, a liquid perfusion joint 202, which is connected to a catheter in the ablation catheter 1 for providing cooling fluid, contrast agent or the like to the ablation catheter 1, may also be provided at a position adjacent to the energy exchange joint 201, as the case may be. As shown in Fig. 26A, the operating handle 211 and the operating handle 257 are connected by a slot sliding structure indicated by a broken-line rectangular frame ar in the figure. The slot sliding structure is formed by the annular hook-shaped structure 212 at the rear of the operating handle 211 and the handle 257. The annular hook-like structures 256 are formed to coincide with each other, so that the two can be relatively rotated after the connection. In order to prevent the guide wire 11 from being excessively pulled to cause bending of the ablation catheter 1 and the blood vessel wall, it is preferable to provide a cushioning structure, for example, to replace the middle portion of the guide wire 11 traveling in the connecting passage 217 with a spring or a thin elastic wire. 26 is an example of the spring 208; as shown in FIG. 26A, the connecting passage 217 at the spring 208 is slightly thicker than the spring 208, and the control button 230 slides the pulling guide 11 in the direction indicated by the arrow aol. When the spring 208 can be extended, the buffering force can be buffered, and since the diameter of the spring 208 is larger than the diameter of the connecting channel 217, the spring 208 does not extend beyond the bulk of the connecting passage 117. This makes the tension of the guide wire 11 not exceed the tensile force generated by the maximum extension distance of the spring 208, which is equivalent to setting a tensile limit; similarly, such a design idea can also be applied to other wire-controlled structures. For example, the middle section of the pulling wire 10 in the control handle 1 is replaced by a spring or a thin elastic wire. As shown in Fig. 26A, the pulling wire 10 is placed inside the small chamber 207. A section of the front portion of the handle 1 is replaced by a spring 209. When the ring control button 257 slides the pulling wire 10 in the direction indicated by the arrow ao2, the spring 209 can be extended, which can buffer the pulling force, and the like. Since the diameter of the spring 209 is larger than the diameter of the opening at both ends of the small chamber 207, the spring 208 does not extend beyond the small chamber 207. Of course, in order to prevent the traction wire 10 and the guide wire 11 from being excessively pulled or/and pushed to cause bending of the ablation catheter 1 to damage the vessel wall, a tension sensor may be connected to the traction wire 10 and the guide wire 11. In order to control the rotation of the ablation catheter 1 through the control button 230, it is preferable that the control knob 230 and the operating handle 211 can be rotated together. At this time, it is preferable to provide a groove sliding structure between the control button 230 and the operating handle 211; as shown in Fig. 26B, The small dashed rectangular frame rc indicates the slot sliding structure. The position of the slot sliding structure is different from the position of the groove 216 and the groove 284. Preferably, the slot sliding structure is evenly distributed on the circumference; the large dotted line in FIG. 26B The rectangular frame shows an enlarged view of the groove sliding structure, and the groove sliding structure is composed of a groove 285 and a protruding tooth 286. FIG. 26B is an example in which the groove 285 and the protruding tooth 286 are respectively disposed on the control button 230 and the operating handle 211. For example, the groove 285 and the protruding tooth 286 can be respectively disposed on the operating handle 211 and the control button 230 according to a specific situation; such a slot sliding structure ensures that the control button 230 can freely slide on the operating handle 211. At the same time, the control button 230 can also drive the operating handle 211 to rotate. For convenience of operation, the control button 230 can be marked on the operating handle 211 or/and the control button 230 by the moving distance and the moving direction. The operating handle 211 can be marked on the operating handle 211, the operating handle 257 or/and the control button 230. The relative rotation angle and the direction of rotation of the operating handle 257 indicate the movement distance and the moving direction of the ring control button 257 on the operating handle 257 or/and the ring control button 257. For the case where the controllable curved section 5 is formed into an S-shaped bend by adding a guide wire 11' at the second bend, the guide wire 11' can be connected to the guide wire fixing disk 204 of the guide wire 11 on the control knob 230, Thus pulling the guide wire 11 will simultaneously pull the guide wire 11', and of course, the degree of tightness of the guide wire 11' and the guide wire 11 can be adjusted, so that the guide wire 11 or the guide wire 11' can be pulled first; The guide wire 11' can also be finally fixed to a separate position on the control button 230 via a separate connecting channel. For the case where the controllable curved section 5 or/and the independent structure 8 are controlled by the magnetron structure design, the corresponding line control structure in the design scheme of the control handle 1 illustrated in FIG. 26 is removed, and the control button 230 is changed for control. The passive control deformation of the magnetron structure design of the controllable curved section 5 changes the ring control knob 257 to a passive control deformation for controlling the design of the magnetron structure of the individual structure 8. For the case where the controllable curved section 5 or/and the independent structure 8 are deformed by actively controlling the deformation, the corresponding wire control structure in the design of the control handle 2 illustrated in FIG. 26 is removed, and the control button 230 is changed for control. Controlled bending The active control deformation of segment 5 changes the ring control knob 257 to control the active control deformation of the individual structure 8.
图 27是以导引导管控制柄 27能够控制导引导管 7向一个方向弯曲情况下的线控结构为 例,显示了导引导管控制柄 27的主要结构特点及如何与控制手柄 2进行分拆和接合,图 27B、 图 27C为虚线 ccl、 cc2横截面放大的截面示意图。 如图 27A所示, 导引导管控制柄 27主要 由操作柄 211'、 操作柄 242和控制钮 230'组成, 其中操作柄 211'和控制钮 230'的设计方案 与操作柄 211和控制钮 230的设计方案类似, 只是导向丝 11换成了导引丝 70。 如图 27A所 示, 导引丝固定盘 279设置在控制钮 230'上, 导引丝 70经过操作柄 211'上的连接通道 217' 与控制钮 230'上的导引丝固定盘 279相连, 类似地可以在导引丝 70上设置緩冲结构, 例如 将导引丝 70的一段用弹簧 278代替, 或者在导引丝 70上连接张力传感器; 当控制钮 230'向 箭头 ao所示方向滑动时导引丝 70将受到牵拉。为了使控制钮 230'与操作柄 211'能够一起转 动, 优选设置图 27B中虚线矩形框 rc所示意的槽齿滑动结构。 如图 27A所示, 类似地, 操作 柄 211'和操作柄 242通过虚线矩形框 arl所示的槽齿滑动结构相连, 该槽齿滑动结构由操作 柄 211'上的环形钩状结构 212'和操作柄 242上的环形钩状结构 241相互吻合组成,因此操作 柄 211'与操作柄 242能够相对转动。 为了使导引导管控制柄 27和控制手柄 2实现接合, 控 制手柄 2的前端需要进行改进; 如图 27D所示, 控制手柄 2的前端设有倒 "L" 字形的两个钩 状卡齿 210a、 210b , 两个钩状卡齿 210a、 210b优选在圆周的相对位置设置; 当然根据实际 情况, 钩状卡齿 210的数量及设置位置可以进行调整。 如图 27A、 图 27B、 图 27C所示, 操作 柄 242的末端设有用于卡住钩状卡齿 210的卡槽 243 , 卡槽 243有两个, 优选在圆周的相对 位置设置, 当然如果钩状卡齿 210的数量和分布方式进行了调整, 卡槽 243的数量和分布方 式也应进行相应的调整, 以使得钩状卡齿 210和卡槽 243能够顺利对合; 卡槽 243靠近操作 柄 242末端的地方较窄(图 27C所示) , 正好能够通过钩状卡齿 210; 卡槽 243远离操作柄 242 末端的地方较宽(图 27B所示) , 因此钩状卡齿 210在卡槽 243远离操作柄 242末端的地方有 一定的活动空间; 操作柄 211'的内径优选刚好够消融导管 1通过, 操作柄 242的内径稍大于 消融导管 1的外径, 但略小于消融导管 1的加固套 48的外径, 因此加固套 48能够卡入操作 柄 242。 如图 27A、 图 27B、 图 27C、 图 27D所示, 当需要导引导管控制柄 27和控制手柄 2接 合时, 消融导管 1穿入导引导管控制柄 27内的空管道中然后进入导引导管 7中, 当控制手柄 2的前端接近导引导管控制柄 27末端时, 将钩状卡齿 210对准卡槽 243 , 然后向前推送控制 手柄 2使得钩状卡齿 210接触到卡槽 243的底, 此时旋转控制手柄 2 , 钩状卡齿 210将被锁 在卡槽 243远离操作柄 242末端的较宽的地方, 再加上此时加固套 48已卡入操作柄 242 , 因 此导引导管控制柄 27和控制手柄 2能够稳定的接合; 当需要导引导管控制柄 27和控制手柄 2分离时, 反向旋转控制手柄 2 , 使钩状卡齿 210对准卡槽 243较窄的地方, 回退控制手柄 1 即可。 对于图 27所示意的导引导管控制柄 27的设计方案, 将导引导管控制柄 27换为图 27、 图 54所示意的控制手柄 2前部的设计形式并将导向丝 11替换为导引丝 70能够实现对导引导 管 7双向或多向弯曲的控制。 为了方便导引导管控制柄 27的操作, 可以在控制导引丝 70的 控制钮 230'或控制盘 231'上、 操作柄 211'上标示控制钮 230'或控制盘 231'的移动距离和移 动方向或转动距离和转动方向, 在控制钮 230'或控制盘 231 '上、 操作柄 211 '上、 操作柄 142 上标示操作柄 211'与操作柄 242相对旋转角度和旋转方向; 为了方便导引导管控制柄 27与 控制手柄 2接合, 可以在导引导管控制柄 27上与控制手柄 2上分别标示两者接合的对位线、 对位标志等。对于通过磁控结构设计控制导引导管 7形变的情况, 去掉导引导管控制柄 27中 相应的线控结构,将控制钮 230'或控制盘 231'改为用于控制导引导管 7的磁控结构设计的被 动控制形变, 并在导引导管控制柄 27设立用于向导引导管 7及导引导管控制柄 27提供能量 的能量交换接头。 对于通过主动控制形变控制导引导管 7形变的情况, 去掉导引导管控制柄 27中相应的线控结构, 将控制钮 230'或控制盘 231'改为用于控制导引导管 7的主动控制形 变, 并在导引导管控制柄 27设立用于向导引导管 7及导引导管控制柄 27提供能量的能量交 换接头。 所述的消融导管 1和导引导管 7外表面可以标记显影刻度, 以指示消融导管 1和导引导 管 7进入血管的深度以及方便在超声、 X射线等影像设备下间接测量人体结构的长度、 宽度 等。 消融导管 1和导引导管 7上还可设置不同的显影标记用于在超声、 X射线等影像设备下 区分不同的导管。 各独立结构 8上优选设置不同的显影标记用于在超声、 X射线等影像设备 下区分不同的独立结构 8 , 例如在一个独立结构 8上标三角形, 而另一个独立结构 8标正方 形, 或在一个独立结构 8上标三个带, 而另一个独立结构 8标两个带。 此外消融导管 1和导 引导管 7上还可设置显影标记用于在超声、 X射线等影像设备下区分不同的轴向旋转状态, 例如在消融导管 1 的左侧面设置一个在超声、 X射线等影像设备下能够显影的短线, 在消融 导管的右侧面设置另一个在超声、 X射线等影像设备下能够显影的短线, 当消融导管 1处于 水平位置时两个短线重合, 当消融导管 1轴向旋转一定角度时, 短线则分开一定距离。 为了 低消融导管 1和导引导管 7对血管造成损伤的可能性, 优选地, 消融导管 1和导引导管 7 与血管壁接触的地方应尽量光滑, 同时形态应尽量的圆滑, 此外消融导管 1和导引导管 7的 头部最好比较软。 27 is an example of a wire control structure in which the guiding catheter control handle 27 can control the guiding catheter 7 to bend in one direction, and shows the main structural features of the guiding catheter control handle 27 and how to separate from the control handle 2. And bonding, FIGS. 27B and 27C are schematic cross-sectional views showing enlarged cross sections of the broken lines ccl and cc2. As shown in FIG. 27A, the guiding catheter control handle 27 is mainly composed of an operating handle 211', an operating handle 242 and a control button 230', wherein the design of the operating handle 211' and the control button 230' and the operating handle 211 and the control button 230 are shown. The design is similar, except that the guide wire 11 is replaced with a guide wire 70. As shown in Fig. 27A, the guide wire fixing plate 279 is disposed on the control button 230', and the guide wire 70 is connected to the guide wire fixing plate 279 on the control button 230' via the connecting passage 217' on the operating handle 211'. Similarly, a cushioning structure can be provided on the guide wire 70, for example, a section of the guide wire 70 is replaced by a spring 278, or a tension sensor is connected to the guide wire 70; when the control knob 230' slides in the direction indicated by the arrow ao The guide wire 70 will be pulled. In order to enable the control knob 230' to rotate together with the operating handle 211', it is preferable to provide a groove sliding structure as illustrated by the broken rectangular frame rc in Fig. 27B. As shown in Fig. 27A, similarly, the operating handle 211' and the operating handle 242 are connected by a slot sliding structure shown by a dashed rectangular frame arl, which is formed by an annular hook-like structure 212' on the operating handle 211' and The annular hook-like structures 241 on the operating handle 242 are formed to coincide with each other, so that the operating handle 211' and the operating handle 242 are relatively rotatable. In order to achieve engagement between the guiding catheter handle 27 and the control handle 2, the front end of the control handle 2 needs to be improved; as shown in Fig. 27D, the front end of the control handle 2 is provided with two hook-shaped latches 210a of inverted "L" shape. 210b, the two hook-shaped latches 210a, 210b are preferably disposed at opposite positions of the circumference; of course, the number and position of the hook-shaped latches 210 can be adjusted according to actual conditions. As shown in Fig. 27A, Fig. 27B, and Fig. 27C, the end of the operating handle 242 is provided with a card slot 243 for catching the hook-shaped latch 210. The card slot 243 has two slots, preferably disposed at opposite positions of the circumference, of course, if the hook The number and distribution of the shaped teeth 210 are adjusted, and the number and distribution of the slots 243 should be adjusted accordingly so that the hook-shaped latch 210 and the slot 243 can be smoothly engaged; the slot 243 is close to the handle The end of 242 is narrower (shown in Fig. 27C), and can pass through the hook-shaped latch 210; the slot 243 is wider away from the end of the handle 242 (shown in Fig. 27B), so the hook-shaped latch 210 is in the slot. 243 is far from the end of the operating handle 242 has a certain movable space; the inner diameter of the operating handle 211' is preferably just enough for the ablation catheter 1 to pass, the inner diameter of the operating handle 242 is slightly larger than the outer diameter of the ablation catheter 1, but slightly smaller than the ablation catheter 1 The outer diameter of the sleeve 48 allows the reinforcement sleeve 48 to snap into the handle 242. As shown in Figures 27A, 27B, 27C, and 27D, when the guiding catheter handle 27 and the control handle 2 are required to be engaged, the ablation catheter 1 penetrates into the empty conduit in the guiding catheter control handle 27 and then enters the guide. In the catheter 7, when the front end of the control handle 2 approaches the end of the guiding catheter handle 27, the hook-shaped latch 210 is aligned with the slot 243, and then the control handle 2 is pushed forward so that the hook-shaped latch 210 contacts the slot 243. The bottom of the control handle 2, the hook-shaped latch 210 will be locked in the wider position of the slot 243 away from the end of the operating handle 242, and then the reinforcing sleeve 48 has been snapped into the operating handle 242, thus guiding The guiding tube handle 27 and the control handle 2 can be stably engaged; when the guiding catheter control handle 27 and the control handle 2 are required to be separated, the control handle 2 is reversely rotated to make the hook-shaped engaging teeth 210 align with the narrowing of the card slot 243. Place, roll back the control handle 1. For the design of the guiding catheter control handle 27 illustrated in FIG. 27, the guiding catheter control handle 27 is replaced with the design of the front part of the control handle 2 illustrated in FIGS. 27 and 54 and the guide wire 11 is replaced with a guide. The wire 70 enables control of bidirectional or multi-directional bending of the guiding catheter 7. In order to facilitate the operation of the guiding catheter handle 27, the movement distance and movement of the control button 230' or the control panel 231' may be marked on the control knob 230' or the control panel 231' of the control guide wire 70, the operating handle 211'. Direction or rotation distance and direction of rotation, on the control button 230' or the control panel 231', on the operating handle 211', the operating handle 142 indicates the relative rotation angle and rotation direction of the operating handle 211' and the operating handle 242; The catheter handle 27 is engaged with the control handle 2, and the alignment line, the alignment mark, and the like, which are engaged with each other, can be respectively indicated on the guiding catheter control handle 27 and the control handle 2. For the case where the guiding guide 7 is deformed by the magnetron structure design, the corresponding wire control structure in the guiding catheter control handle 27 is removed, and the control knob 230' or the control panel 231' is changed to the magnetic force for controlling the guiding catheter 7. The passive control of the structural design is controlled, and an energy exchange joint for guiding the guide tube 7 and the guide catheter handle 27 to provide energy is provided at the guide catheter handle 27. For the case where the deformation of the guiding catheter 7 is controlled by the active control, the corresponding wire control structure in the guiding catheter control handle 27 is removed, and the control button 230' or the control panel 231' is changed to control the active control of the guiding catheter 7. Deformation, and an energy exchange joint for guiding the guide tube 7 and the guide catheter handle 27 to provide energy is provided at the guide catheter handle 27. The ablation catheter 1 and the outer surface of the guiding catheter 7 may be marked with a development scale to indicate the depth of the ablation catheter 1 and the guiding catheter 7 into the blood vessel and to facilitate indirect measurement of the length of the human body structure under imaging equipment such as ultrasound and X-ray, Width and so on. Different development marks may be provided on the ablation catheter 1 and the guiding catheter 7 for distinguishing different catheters under imaging devices such as ultrasound and X-ray. Different development marks are preferably provided on each of the individual structures 8 for distinguishing different independent structures 8 under ultrasound, X-ray, etc., for example, a separate structure 8 is marked with a triangle, and the other independent structure is marked with a square, or One independent structure 8 is labeled with three bands, and the other independent structure 8 is labeled with two bands. In addition, a development mark may be disposed on the ablation catheter 1 and the guiding catheter 7 for distinguishing different axial rotation states under imaging devices such as ultrasound and X-ray, for example, an ultrasound, X-ray is disposed on the left side of the ablation catheter 1. A short line that can be developed under the imaging device, and another short line that can be developed under the imaging device such as ultrasound or X-ray on the right side of the ablation catheter. When the ablation catheter 1 is in the horizontal position, the two short lines coincide, when the ablation catheter 1 When the axis rotates at a certain angle, the short lines are separated by a certain distance. In order to reduce the possibility of damage to the blood vessel by the ablation catheter 1 and the guiding catheter 7, preferably, the ablation catheter 1 and the guiding catheter 7 should be as smooth as possible in contact with the blood vessel wall, and the shape should be as smooth as possible, and the ablation catheter 1 Preferably, the head of the guiding catheter 7 is relatively soft.
消融导管 1和导引导管 7中可能直接或间接与人体体液或组织接触的部分都必须达到相 应的与人体体液或组织接触材料的国家标准, 对于不能达到上述要求又可能直接或间接与人 体体液或组织接触的消融导管 1和导引导管 7的部分, 其外面必须用符合与人体体液或组织 相接触材料的国家标准的材料包裹。 消融导管 1和导引导管 7可能与人体直接或间接接触部 分的制造材料应能够耐受至少一种医用消毒方法。 消融导管 1和导引导管 7可能与人体直接 或间接接触的部分应该是绝缘的, 对于不能达到绝缘要求的地方可以外包裹绝缘材料。  The parts of the ablation catheter 1 and the guiding catheter 7 that may directly or indirectly contact the body fluid or tissue of the human body must meet the national standards for contacting the human body fluid or tissue, and may directly or indirectly be in contact with the human body fluid for failing to meet the above requirements. Or the portion of the ablation catheter 1 and the guiding catheter 7 that are in contact with the tissue, the outside of which must be wrapped with a material that meets the national standards for materials in contact with human body fluids or tissues. The material from which the ablation catheter 1 and the guiding catheter 7 may be in direct or indirect contact with the human body should be able to withstand at least one medical sterilization method. The ablation catheter 1 and the guiding catheter 7 may be insulatively in direct or indirect contact with the human body, and the insulating material may be overwrapped where insulation requirements are not met.
上述可控弯曲段 5的作用在导管体段 4不设置可控弯曲段 5时, 可以由导管体段 4代为 行使, 只需要将上述可控弯曲段 5的设计方案运用于导管体段 4即可。  When the controllable curved section 5 is not provided with the controllable curved section 5, the catheter body section 4 can be used for exercise, and only the design of the controllable curved section 5 is applied to the catheter body section 4 can.
技术人员可以根据实际要求对上述这些消融导管 1和导引导管 7的设计方案进行融合、 改进以及交叉使用, 这些等效变化和修饰同样落入本发明权利要求所限定的范围。  The skilled person can combine, improve and cross-use the design of the above-mentioned ablation catheter 1 and the guiding catheter 7 according to actual requirements, and these equivalent variations and modifications also fall within the scope defined by the claims of the present invention.
技术人员可以根据实际要求对上述这些控制手柄 1和导引导管控制柄 27的设计方案进行 融合、 改进以及交叉使用, 这些等效变化和修饰同样落入本发明权利要求所限定的范围。  The skilled person can combine, improve and cross-use the design of the above-mentioned control handle 1 and the guiding catheter control handle 27 according to actual requirements, and these equivalent variations and modifications also fall within the scope defined by the claims of the present invention.
如图 1所示, 消融发生装置 3是为消融导管 1、 导引导管 7、 控制手柄 2、 导引导管控制 柄 27上需要能量供应的部分提供相应形式的能量,例如当导引导管 7需要智能材料改变形状 时, 消融发生装置 3能够提供诱导智能材料改变形状所需要的能量。 同时消融发生装置 3能 够接收和处理消融导管 1、 导引导管 7、 控制手柄 1、 导引导管控制柄 27传来的信息, 处理 后的信息能够部分或全部显示在消融发生装置 3的显示器 320上, 而且该处理后的信息还能 够反馈调节消融发生装置 3的能量输出, 消融发生器包括射频消融发生器、 电阻加热发生器、 冷冻消融发生器、 超声消融发生器、 激光消融发生器、 光动力治疗发生器或微波消融发生器, 所述消融发生装置 3可以是以上发生器的一种, 也可以是以上两个或者两个以上发生器的结 合。 消融发生装置 3的控制参数能够通过消融发生装置的显示器 320进行触屏控制或通过参 数设置按钮 330进行调节; 消融发生装置 3应设有能量输出的接头和传感器信号输入的接头 311 , 同时还应设有与外接电源相接的接头 321 , 用于接收由供电电路传来的电能。 对于消融 导管 1、 控制手柄 2、 导引导管 7和导引导管控制柄 27需要能量供应而又未在控制手柄 1或 导引导管控制柄 27上设有工作开关的设备, 在消融发生装置 3上优选设有工作开关。对于消 融导管 1或 /和导引导管 7需要的冷却剂、 复温剂和灌注液的情况, 消融发生装置 3或 /和导 引导管 7可以设有灌注器进行自动或手动向消融导管 1灌注冷却剂、 复温剂和灌注液, 此时 消融发生装置 3应有相应的管路与提供冷却剂、 复温剂和灌注液原料或成品的容器相通。 对 于导引导管 7的末端开孔 77连接的注液装置设置在消融发生装置 3的情况, 消融发生装置 3 应对该注液装置进行控制并设置相应的控制面板或控制按钮。 消融发生装置 3可以是融合上 述功能于一体的整机, 也可以是分别行使不同功能的分体机, 例如将为消融头 9供能的部分 独立为一个分机, 将灌注器独立为另一个分机。  As shown in Figure 1, the ablation generating device 3 provides a corresponding form of energy for the ablation catheter 1, the guiding catheter 7, the control handle 2, and the portion of the guiding catheter handle 27 that requires energy supply, such as when the guiding catheter 7 is needed. When the smart material changes shape, the ablation generating device 3 can provide the energy required to induce the smart material to change shape. At the same time, the ablation generating device 3 can receive and process the information from the ablation catheter 1, the guiding catheter 7, the control handle 1, and the guiding catheter control handle 27. The processed information can be partially or completely displayed on the display 320 of the ablation generating device 3. And the processed information can also feedback adjust the energy output of the ablation generating device 3. The ablation generator comprises a radio frequency ablation generator, a resistance heating generator, a cryoablation generator, an ultrasound ablation generator, a laser ablation generator, and light. The power treatment generator or the microwave ablation generator may be one of the above generators or a combination of the above two or more generators. The control parameters of the ablation generating device 3 can be controlled by the display 320 of the ablation generating device or by the parameter setting button 330; the ablation generating device 3 should be provided with a connector for energy output and a connector 311 for sensor signal input, and A connector 321 is connected to the external power supply for receiving electrical energy transmitted by the power supply circuit. For the ablation catheter 1, the control handle 2, the guiding catheter 7 and the guiding catheter handle 27, an energy supply is provided without a device having a working switch on the control handle 1 or the guiding catheter handle 27, in the ablation generating device 3 A working switch is preferably provided. For the case of the ablation catheter 1 or/and the coolant, rewarming agent and perfusate required for the guiding catheter 7, the ablation generating device 3 or/and the guiding catheter 7 may be provided with a perfusion device for automatic or manual perfusion of the ablation catheter 1 The coolant, the rewarming agent and the perfusate, at which point the ablation generating device 3 should have a corresponding line communicating with a container providing a coolant, a rewarming agent and a perfusate material or finished product. The infusion device for connecting the distal end opening 77 of the guiding catheter 7 is provided in the ablation generating device 3, and the ablation generating device 3 should control the infusion device and set a corresponding control panel or control button. The ablation generating device 3 may be a whole machine that integrates the above functions, or may be a separate machine that performs different functions respectively, for example, the part that supplies the ablation head 9 is independently an extension, and the perfusion device is independently another extension. .

Claims

权 利 要 求 Rights request
1、 一种肾脏去交感神经多功能消融导管系统, 其特征在于包括: 1. A renal sympathetic denervation multifunctional ablation catheter system, characterized by including:
消融导管 (1)、 控制手柄 (2)及消融发生装置 (3) , 其中消融导管 (1)包括导管体段(4)和 消融段(6) , 其中 Ablation catheter (1), control handle (2) and ablation generating device (3), where the ablation catheter (1) includes a catheter body segment (4) and an ablation segment (6), where
所述导管体段 (4)与控制手柄(2)相连; The catheter body section (4) is connected to the control handle (2);
所述消融段(6)包括至少两个独立结构(8) , 在至少一个独立结构(8)上安装有消融头 (9);所述消融头(9)通过导线、导管、微波天线或光纤与控制手柄(2)上的能量交换接头(201) 相连, 所述能量交换接头(201)通过导线、 导管、 微波天线或光纤与消融发生装置(3)相连; 所述独立结构(8)通过牵拉或 /和推送一端固定在独立结构(8)上、 另一端由手柄控制的 牵引丝(10)控制发生形变而使消融头(9)贴合或离开指定的消融位置; 或所述独立结构(8)含 有可被磁铁吸引的物质, 通过外加磁场使独立结构(8)发生形变而使消融头(9)贴合或离开指 定的消融位置;或所述独立结构(8)含有通过外部刺激而发生形变的智能材料而使消融头(9) 贴合或离开指定的消融位置; The ablation section (6) includes at least two independent structures (8), and an ablation head (9) is installed on at least one independent structure (8); the ablation head (9) passes through a wire, catheter, microwave antenna or optical fiber Connected to the energy exchange joint (201) on the control handle (2), the energy exchange joint (201) is connected to the ablation generating device (3) through wires, catheters, microwave antennas or optical fibers; the independent structure (8) is connected through Pull or/and push one end to be fixed on the independent structure (8), and the other end is deformed by the pulling wire (10) controlled by the handle to make the ablation head (9) fit or leave the designated ablation position; or the independent structure The structure (8) contains substances that can be attracted by magnets, and the independent structure (8) is deformed by an external magnetic field to cause the ablation head (9) to fit or leave the designated ablation position; or the independent structure (8) contains materials that pass through the external The smart material that deforms due to stimulation causes the ablation head (9) to fit into or leave the designated ablation position;
以上独立结构(8)的控制还包括独立结构设置(8)预制形变; The control of the above independent structure (8) also includes the prefabricated deformation of the independent structure setting (8);
或包括消融导管(1)、控制手柄(2)及消融发生装置(3)及可套在消融导管(1)外的导引导 管(7) , 其中消融导管(1)包括导管体段(4)、 和消融段(6) , 其中: Or it includes an ablation catheter (1), a control handle (2), an ablation generating device (3), and a guiding catheter (7) that can be placed outside the ablation catheter (1), where the ablation catheter (1) includes a catheter body segment (4 ), and ablation segment (6), where:
所述导管体段 (4)与控制手柄(2)相连; The catheter body section (4) is connected to the control handle (2);
所述消融段(6)包括至少两个独立结构(8) , 在至少一个独立结构(8)上安装有消融头 The ablation section (6) includes at least two independent structures (8), and an ablation head is installed on at least one independent structure (8).
(9);所述消融头(9)通过导线、导管、微波天线或光纤与控制手柄(2)上的能量交换接头(201) 相连, 所述能量交换接头(201)通过导线、 导管、 微波天线或光纤与消融发生装置(3)相连; 所述独立结构(8)通过牵拉或 /和推送一端固定在独立结构(8)上、 另一端由手柄控制的 牵引丝(10)控制发生形变而使消融头(9)贴合或离开指定的消融位置; 或所述独立结构(8)含 有可被磁铁吸引的物质, 通过外加磁场使独立结构(8)发生形变而使消融头(9)贴合或离开指 定的消融位置;或所述独立结构(8)含有通过外部刺激而发生形变的智能材料而使消融头(9) 贴合或离开指定的消融位置; (9); The ablation head (9) is connected to the energy exchange joint (201) on the control handle (2) through wires, catheters, microwave antennas or optical fibers, and the energy exchange joint (201) is connected through wires, catheters, microwaves The antenna or optical fiber is connected to the ablation generating device (3); the independent structure (8) is fixed on the independent structure (8) by pulling or/and pushing one end, and the other end is controlled by a pulling wire (10) controlled by a handle to deform. The ablation head (9) is made to fit or leave the designated ablation position; or the independent structure (8) contains substances that can be attracted by magnets, and the independent structure (8) is deformed by applying an external magnetic field to cause the ablation head (9) to be deformed. Fit or leave the designated ablation position; or the independent structure (8) contains smart materials that are deformed by external stimulation to cause the ablation head (9) to fit or leave the designated ablation position;
以上独立结构(8)的控制还包括独立结构设置(8)预制形变; The control of the above independent structure (8) also includes the prefabricated deformation of the independent structure setting (8);
所述导引导管(7)通过牵拉或推送一端固定在导引导管(7)头部,另一端由手柄控制的导 引丝(70)控制弯曲; 或所述导引导管(7)含有能够被磁铁吸引的物质, 通过外加磁场使得导引 导管(7)发生形变;或通过对导引导管(7)上能感知外部刺激的智能材料进行控制; 或 /和导引 导管(7)发生顺应性弯曲; 或 /和导引导管(7)设置预制形变; The guide catheter (7) is fixed on the head of the guide catheter (7) by pulling or pushing one end, and the other end is bent by a guide wire (70) controlled by a handle; or the guide catheter (7) contains Substances that can be attracted by magnets deform the guiding catheter (7) by applying an external magnetic field; or by controlling smart materials on the guiding catheter (7) that can sense external stimuli; or/and deforming the guiding catheter (7) Compliant bending; or/and the guide catheter (7) is provided with prefabricated deformation;
所述导引导管(7)由导引导管控制柄(27)或控制手柄(2)控制以及不通过手柄进行控制。 The guide catheter (7) is controlled by a guide catheter control handle (27) or a control handle (2) or not by a handle.
2、 根据权利要求 1所述的肾脏去交感神经多功能消融导管系统, 其特征在于: 所述导 管体段(4)的远端还包括与消融段近端连接的可控弯曲段(5) ,所述可控弯曲段(5)通过牵拉或 /和推送一端固定在可控弯曲段(5)上、 另一端由手柄控制的导向丝(11)控制发生形变; 或所 述可控弯曲段(5)通过牵拉或 /和推送一端固定在独立结构(8)上、另一端由手柄控制的牵引丝2. The renal sympathetic denervation multifunctional ablation catheter system according to claim 1, characterized in that: the distal end of the catheter body segment (4) also includes a controllable bending segment (5) connected to the proximal end of the ablation segment. , the controllable bending section (5) is fixed on the controllable bending section (5) by pulling or/and pushing one end, and the other end is controlled by a guide wire (11) controlled by a handle to deform; or the controllable bending The segment (5) pulls or/and pushes a traction wire with one end fixed on the independent structure (8) and the other end controlled by a handle.
(10)控制发生形变; 或所述可控弯曲段(5)含有可被磁铁吸引的物质, 通过外加磁场使得可控 弯曲段(5)发生形变;或所述可控弯曲段(5)含有通过外部刺激而发生形变的智能材料; 或 /和 通过控制手柄(2)控制可控弯曲段(5)发生顺应性弯曲; 或 /和可控弯曲段(5)设置预制形变。 (10) Control the deformation; or the controllable bending section (5) contains substances that can be attracted by magnets, and the controllable bending section (5) is deformed by applying an external magnetic field; or the controllable bending section (5) contains A smart material that deforms through external stimulation; or/and controls the controllable bending section (5) to undergo compliant bending through the control handle (2); or/and sets the prefabricated deformation of the controllable bending section (5).
3、 根据权利要求 1所述的肾脏去交感神经多功能消融导管系统, 其特征在于: 所述消 融导管(1)或 /和控制手柄(2)、 导引导管(7)或 /和导引导管控制柄(27)上还安装有传感器 (92)。 3. The renal sympathetic denervation multifunctional ablation catheter system according to claim 1, characterized in that: the ablation catheter (1) or/and the control handle (2), the guiding catheter (7) or/and the guiding A sensor (92) is also installed on the conduit control handle (27).
4、 根据权利要求 1所述的肾脏去交感神经多功能消融导管系统, 其特征在于: 所述独 立结构(8)之间在近端相连, 两个独立结构(8)之间包括四种形式: 两个独立结构(8)的远端连 接为一体而构成消融段头端(17) ; 或者两个独立结构(8)远端彼此独立相互分离; 或者两个独 立结构(8)的中间部分连接在一起, 远端再相互分离; 或者两个独立结构(8)的近端相连, 远 端分别连在牵引丝(10)的不同位置上。 4. The renal sympathetic denervation multifunctional ablation catheter system according to claim 1, characterized in that: the independent structures (8) are connected at the proximal end, and there are four forms between the two independent structures (8) : The distal ends of the two independent structures (8) are connected into one body to form the head end of the ablation segment (17); or the distal ends of the two independent structures (8) are independent and separated from each other; or the middle part of the two independent structures (8) are connected together, and the distal ends are separated from each other; or the proximal ends of the two independent structures (8) are connected, and the distal ends are connected to different positions of the pulling wire (10).
5、 根据权利要求 1所述的肾脏去交感神经多功能消融导管系统, 其特征在于: 所述消融 头(9)选自射频消融电极头、 电阻加热消融头、 液冷灌注射频电极头、 冷冻消融头、 超声消融 探头、 聚焦超声消融探头、 激光消融头、 聚焦激光消融头、 光动力治疗消融头或微波消融头; 其中所述射频消融电极头包括射频消融电极(91)。 5. The renal sympathetic denervation multifunctional ablation catheter system according to claim 1, characterized in that: the ablation head (9) is selected from the group consisting of radiofrequency ablation electrode head, resistance heating ablation head, liquid-cooled infusion frequency electrode head, and frozen Ablation head, ultrasonic ablation probe, focused ultrasound ablation probe, laser ablation head, focused laser ablation head, photodynamic therapy ablation head or microwave ablation head; wherein the radiofrequency ablation electrode head includes a radiofrequency ablation electrode (91).
6、 根据权利要求 1所述的肾脏去交感神经多功能消融导管系统, 其特征在于: 所述独立 结构(8)上设置有用于发放或 /和接收电脉冲的检测电极(19); 或 /和所述消融头(9)兼用于发 放或 /和接收电脉冲。 6. The renal sympathetic denervation multifunctional ablation catheter system according to claim 1, characterized in that: the independent structure (8) is provided with a detection electrode (19) for emitting or/and receiving electrical pulses; or/ The ablation head (9) is also used to send out or/and receive electrical pulses.
7、 根据权利要求 2所述的肾脏去交感神经多功能消融导管系统, 其特征在于: 所述可控 弯曲段(5)上设置有用于发放或 /和接收电脉冲的检测电极(19) 。 7. The renal sympathetic denervation multifunctional ablation catheter system according to claim 2, characterized in that: the controllable bending section (5) is provided with a detection electrode (19) for issuing and/or receiving electrical pulses.
8、 根据权利要求 1所述的所述的肾脏去交感神经多功能消融导管系统, 其特征在于: 牵引丝(10)走行于独立结构(8)外或 /和走行于独立结构(8)内,牵引丝(10)的头端附着点(110) 设置于消融段头端(17) , 或设置于独立结构(8)头部到连接点(18)的独立结构(8)上, 或设置 于消融头 (9)到连接点 (18)的独立结构 (8)上,或消融段头端 (17)至消融头 (9)之间的独立结构 (8)上, 或设置于消融头(9)或其邻近的独立结构(8)上, 或设置在两条独立结构(8)的连接点 (18)设置的连接关节上, 所述牵引丝(10)在可控弯曲段(5)、 导管体段(4)内合并成一条或分 别走行于可控弯曲段(5)、 导管体段(4)的长轴中心线, 最后与控制手柄(2)的控制钮(230)或 控制盘(231)连接。 8. The renal sympathetic denervation multifunctional ablation catheter system according to claim 1, characterized in that: the pulling wire (10) runs outside the independent structure (8) or/and runs inside the independent structure (8) , the head end attachment point (110) of the pulling wire (10) is set at the head end of the ablation segment (17), or is set on an independent structure (8) from the head of the independent structure (8) to the connection point (18), or is set on On the independent structure (8) from the ablation head (9) to the connection point (18), or on the independent structure (8) between the ablation segment head (17) and the ablation head (9), or set on the ablation head ( 9) or its adjacent independent structure (8), or is provided on the connecting joint provided at the connecting point (18) of the two independent structures (8), the traction wire (10) is in the controllable bending section (5) , the catheter body section (4) is merged into one or runs along the controllable bending section (5), the long axis center line of the catheter body section (4), and finally connects with the control button (230) or the control handle (2) The disk (231) is connected.
9、 根据权利要求 1所述的肾脏去交感神经消融导管系统, 其特征在于: 当导引导管(7) 为消融导管(1)形变提供支点时, 导引导管(7)的头部设置与血管相通的斜孔(74)或 /和侧槽 (76)。 9. The renal desympathetic denervation ablation catheter system according to claim 1, characterized in that: when the guiding catheter (7) provides a fulcrum for the deformation of the ablation catheter (1), the head of the guiding catheter (7) is arranged in line with the The oblique hole (74) or/and the side groove (76) that the blood vessels communicate with.
10、 根据权利要求 1或 5所述的肾脏去交感神经消融导管系统, 其特征在于: 当独立结 构(8)的远端连接为一体而构成消融段头端(17)时,导引导管头端设置缩口结构(73)或者堵头 (72) ,导引导管(7)的头部侧壁上设置侧槽(76) ; 当独立结构(8)彼此独立相互分离时, 导引 导管(7)的头端或头部侧壁上设置斜孔(74); 当独立结构(8)的中间部分连接在一起, 远端再 相互分离时, 导引导管(7)的头端或头部侧壁设置与血管相通的斜孔(74) ,斜孔(74)之后导引 导管(7)的侧壁上再设置侧槽(76) 。 10. The renal desympathetic denervation ablation catheter system according to claim 1 or 5, characterized in that: when the distal ends of the independent structures (8) are connected into one body to form the ablation segment head (17), the guiding catheter head A shrinking structure (73) or a plug (72) is provided at the end, and a side groove (76) is provided on the head side wall of the guide catheter (7); when the independent structures (8) are independent of each other and separated from each other, the guide catheter (7) An inclined hole (74) is provided on the head end or head side wall of 7); when the middle parts of the independent structures (8) are connected together and the distal ends are separated from each other, the head end or head of the guide catheter (7) The side wall is provided with an oblique hole (74) communicating with the blood vessel. After the oblique hole (74), a side groove (76) is provided on the side wall of the guide catheter (7).
11、 根据权利要求 1所述的所述的肾脏去交感神经多功能消融导管系统, 其特征在于: 根据需要控制弯曲方向的数量设置导引丝(70)的数量, 导引丝(70)的头端附着点设置在导引 导管(7)的头部, 且根据需要弯曲的方向选择相应的离心位置附着, 导引丝(70)走行于导引导 管(7)管壁内或 /和管壁外。 11. The kidney desympathetic denervation multifunctional ablation catheter system according to claim 1, characterized in that: the number of guide wires (70) is set according to the number of bending directions required to control, and the number of guide wires (70) is The head end attachment point is set at the head of the guide catheter (7), and the corresponding centrifugal position is selected for attachment according to the desired bending direction. The guide wire (70) runs in the wall of the guide catheter (7) or/and the tube. outside the wall.
12、 根据权利要求 1所述的所述的肾脏去交感神经多功能消融导管系统, 其特征在于: 导向丝(11)走行于可控弯曲段(5)内或 /和可控弯曲段(5)外,根据需要控制弯曲方向的数量设 置导向丝(11)数量, 当可控弯曲段(5)釆用 C形弯曲设计时, 导向丝(11)的头端附着点(111) 设置在可控弯曲段(5)靠近消融段(6)的地方, 且根据需要弯曲的方向选择相应的离心位置附 着; 12. The renal sympathetic denervation multifunctional ablation catheter system according to claim 1, characterized in that: the guide wire (11) runs within or/and the controllable bending section (5) ), the number of guide wires (11) is set according to the number of bending directions needed to be controlled. When the controllable bending section (5) adopts a C-shaped bend design, the head end attachment point (111) of the guide wire (11) is set at a controllable bending section (5). Control the bending section (5) close to the ablation section (6), and select the corresponding centrifugal position for attachment according to the required bending direction;
当可控弯曲段(5)釆用 S形弯曲设计时, 在 C形弯曲设计导向丝(11)的基础上, 在需要 形成 S形弯曲的第二个弯曲的远端另加一根导向丝(11' )附着于此, 该导向丝(11' )根据需 要弯曲的方向选择相应的离心位置附着; 或不增加导向丝(11)的数量, 通过调整可控弯曲段 (5)的内部结构使得一条导向丝(11)可以实现 S形弯曲。 When the controllable bending section (5) adopts an S-shaped bend design, on the basis of the C-shaped bend design guide wire (11), an additional guide wire is added to the distal end of the second bend that needs to form an S-shaped bend. (11') is attached here, and the guide wire (11') is attached at the corresponding centrifugal position according to the desired bending direction; or without increasing the number of guide wires (11), by adjusting the internal structure of the controllable bending section (5) So that a guide wire (11) can achieve S-shaped bending.
13、 根据权利要求 1所述的所述的肾脏去交感神经多功能消融导管系统, 其特征在于: 所述导引导管(7)的尾部侧壁上还设有用于连接注射器或注液装置进行血管内注药或注射血 管内造影剂的开孔(77) , 或通过导引导管(7)末端开口与注射器或 /和注液装置相连进行血管 内注药或 /和注射血管内造影剂;或 /和所述导引导管(7)末端设置连接接头(76) ,连接接头(76) 与注射器、 注液装置、 消融导管(1)或控制手柄(2)连接。 13. The renal sympathetic denervation multifunctional ablation catheter system according to claim 1, characterized in that: The tail side wall of the guide catheter (7) is also provided with an opening (77) for connecting a syringe or an injection device for intravascular injection of medicine or intravascular contrast agent, or through the end of the guide catheter (7) The opening is connected to a syringe or/and an injection device for intravascular injection of medicine or/and intravascular contrast agent; or/and a connecting joint (76) is provided at the end of the guide catheter (7), and the connecting joint (76) is connected to the syringe , the injection device, the ablation catheter (1) or the control handle (2) are connected.
14、 根据权利要求 1所述的肾脏去交感神经多功能消融导管系统, 其特征在于: 所述消 融导管(1)或 /和导引导管(7)制造时通过选用不同硬度的材料, 或者是通过选择性的减少或 / 和增加部分导管小段的内部结构或 /和管壁的结构,或者是通过在消融导管(1)或 /和导引导管 (7)内植入容易发生形变的结构。 14. The renal sympathetic denervation multifunctional ablation catheter system according to claim 1, characterized in that: the ablation catheter (1) or/and the guiding catheter (7) is manufactured by selecting materials with different hardnesses, or By selectively reducing or/and increasing the internal structure of part of the catheter section or/and the structure of the tube wall, or by implanting a structure that is prone to deformation in the ablation catheter (1) or/and the guiding catheter (7).
15、 根据权利要求 1所述的肾脏去交感神经多功能消融导管系统, 其特征在于: 所述消 融导管(1)或 /和导引导管(7)上标记刻度, 以指示消融导管(1)或 /和导引导管(7)进入血管的 深度以及在超声或 X射线影像设备下间接测量人体结构的长度、 宽度; 消融导管(1)或 /和导 引导管(7)上设置不同的显影标记用于在超声或 X射线影像设备下区分消融导管(1)或 /和导 引导管(7);或 /和各独立结构(8)上设置不同的显影标记用于在超声或 X射线影像设备下区分 不同的独立结构(8); 消融导管(1)或 /和导引导管(7)上还设置标记用于在超声或 X射线影像 设备下区分不同的轴向旋转状态。 15. The renal sympathetic denervation multifunctional ablation catheter system according to claim 1, characterized in that: the ablation catheter (1) or/and the guiding catheter (7) is marked with a scale to indicate the ablation catheter (1) Or/and the depth of the guide catheter (7) entering the blood vessel and indirect measurement of the length and width of the human body structure under ultrasound or X-ray imaging equipment; Different imaging devices are set on the ablation catheter (1) or/and the guide catheter (7) The mark is used to distinguish the ablation catheter (1) or/and the guiding catheter (7) under ultrasound or X-ray imaging equipment; or/and different development marks are set on each independent structure (8) for use in ultrasound or X-ray imaging equipment. Different independent structures (8) are distinguished under the equipment; marks are also provided on the ablation catheter (1) and/or the guiding catheter (7) for distinguishing different axial rotation states under the ultrasound or X-ray imaging equipment.
16、 根据权利要求 1所述的肾脏去交感神经多功能消融导管系统, 其特征在于: 消融导 管(1)通过导管体段(4)与控制手柄(2)上端固定, 控制手柄(2)的下端或下侧面具有能量交换 接头(201) , 来自消融头(9)的导线、 导管、微波天线或光纤穿过控制手柄(2)在所述能量交换 接头(201)汇集。 16. The renal sympathetic denervation multifunctional ablation catheter system according to claim 1, characterized in that: the ablation catheter (1) is fixed to the upper end of the control handle (2) through the catheter body section (4), and the control handle (2) The lower end or lower side has an energy exchange joint (201), and the wires, catheters, microwave antennas or optical fibers from the ablation head (9) pass through the control handle (2) and converge at the energy exchange joint (201).
17、 根据权利要求 1或 16所述的肾脏去交感神经多功能消融导管系统, 其特征在于: 所述控制手柄(2)包括操作柄(211)和操作柄(247); 操作柄(211)上设置有用于控制可控弯曲 段(5)形变的控制钮(230)或控制盘(231) , 所述控制钮(230)或控制盘(231)与导向丝 ( 11 )连 接, 通过控制钮(230)的上下移动, 或通过控制盘(231)的多向转动实现对可控弯曲段(5)的控 制; 或 /和包括操作柄(247)上的环形控制钮(257) , 所述环形控制钮(257)通过连接杆(258) 与牵引丝(10)连接, 所述连接杆(258)位于控制手柄(2)中的导向槽(248)内, 通过上下移动环 形控制钮(257) ,实现对独立结构的控制; 还包括可防止过度牵拉的緩冲结构; 17. The renal sympathetic denervation multifunctional ablation catheter system according to claim 1 or 16, characterized in that: the control handle (2) includes an operating handle (211) and an operating handle (247); the operating handle (211) There is a control button (230) or a control panel (231) for controlling the deformation of the controllable bending section (5). The control button (230) or the control panel (231) is connected to the guide wire (11). Through the control button (230) moves up and down, or controls the controllable bending section (5) through multi-directional rotation of the control panel (231); or/and includes a ring-shaped control button (257) on the operating handle (247), the The annular control button (257) is connected to the traction wire (10) through a connecting rod (258). The connecting rod (258) is located in the guide groove (248) in the control handle (2). By moving the annular control button (257) up and down ) to achieve control of independent structures; also includes a buffer structure to prevent excessive pulling;
所述导引导管控制柄(27)包括操作柄(211' )和操作柄(242) , 操作柄(211' )上设置有用 于控制导引导管(7)形变的控制钮(230' )或控制盘(231 ' ) ,所述控制钮(230' )或控制盘(231 ' ) 与导引丝(70 )连接, 通过控制钮(230' ) 的上下移动, 或通过控制盘(231' )的多向转动实现 对导引导管(7)的控制; 还包括可防止过度牵拉的緩冲结构; 所述导引导管控制柄(27)与控制 手柄(2)还分别包括卡槽(243)、 钩状卡齿(210) , 通过卡槽(243)、 钩状卡齿(210)进行分拆与 结合。 The guiding catheter control handle (27) includes an operating handle (211') and an operating handle (242). The operating handle (211') is provided with a control button (230') for controlling the deformation of the guiding catheter (7) or Control panel (231'), the control button (230') or the control panel (231') is connected to the guide wire (70), through the up and down movement of the control button (230'), or through the control panel (231') The multi-directional rotation of the guide catheter (7) realizes the control of the guide catheter (7); it also includes a buffer structure that can prevent excessive pulling; the guide catheter control handle (27) and the control handle (2) also include a slot (243) respectively. ), hook-shaped teeth (210), are disassembled and combined through the slot (243) and hook-shaped teeth (210).
18、 根据权利要求 1所述的肾脏去交感神经多功能消融导管系统, 其特征在于: 所述消 融发生装置(3)设有能量输出的接头和传感器信号输入的接头(311) , 同时还设有与外接电源 相接的接头(321); 所述消融发生装置(3)含有通过进行触屏控制来控制参数以及部分或全部 信息能显示在其上的显示器( 320)和调节参数的按钮(330)。 18. The renal sympathetic denervation multifunctional ablation catheter system according to claim 1, characterized in that: the ablation generating device (3) is provided with a joint for energy output and a joint for sensor signal input (311), and is also provided with a joint for energy output and a joint for sensor signal input (311). There is a connector (321) connected to an external power supply; the ablation generating device (3) contains a display (320) on which parameters can be controlled through touch screen control and part or all of the information can be displayed, and buttons (320) for adjusting parameters ( 330).
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CN201210313132.0A CN102908189B (en) 2012-08-29 2012-08-29 Multifunctional ablation catheter system for denervation of renal sympathetic nerves
CN201220431913.0 2012-08-29
CN201210313087.9 2012-08-29
CN201210312999.4A CN102885649B (en) 2012-08-29 2012-08-29 Radio frequency cable controlled ablation catheter system for removing sympathetic nerve from kidney
CN201210312649.8 2012-08-29
CN 201220431913 CN202726990U (en) 2012-08-29 2012-08-29 Staggered multi-group band saw paper cutter
CN201220434502.1 2012-08-29
CN 201220434502 CN202761434U (en) 2012-08-29 2012-08-29 Kidney sympathetic denervation multifunctional ablation catheter system
CN201210313132.0 2012-08-29
CN201210312649.8A CN102885648B (en) 2012-08-29 2012-08-29 Sympathetic nerve denervation ablation catheter system for kidneys
CN201210312999.4 2012-08-29
CN201210313087.9A CN102908188B (en) 2012-08-29 2012-08-29 Radio frequency ablation (RFA) catheter system for denervation of renal sympathetic nerves

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