WO2016163676A1

WO2016163676A1 - Medical double balloon catheter electrode device

Info

Publication number: WO2016163676A1
Application number: PCT/KR2016/003184
Authority: WO
Inventors: 강봉수
Original assignee: 주식회사 지에이치바이오
Priority date: 2015-04-09
Filing date: 2016-03-29
Publication date: 2016-10-13
Also published as: KR101556119B1

Abstract

The present invention relates to a medical double balloon catheter electrode device comprising: a tube which is a flexible member extending in the longitudinal direction so as to be inserted into a body; a first expansion part provided on the front end of the tube; a second expansion part located outside the first expansion part so that the first expansion part can be located inside the same; a first air supply line supplying at least one between gas and liquid to the first expansion part; and a second air supply line supplying at least one between gas and liquid to the second expansion part.

Description

Medical Dual Balloon Catheter Electrode Device

The present invention relates to a medical double balloon catheter electrode device for medical use, and more particularly to a medical double balloon catheter electrode device provided with a double structure of the expansion portion of the balloon catheter used for spinal stenosis balloon surgery.

In general, injured vertebrae are treated by bed rest, physical therapy, activity control and pain medication during the actual treatment period. There are also many treatments that attempt to repair the damaged spine to avoid surgical removal of the damaged disc.

However, these treatments tend to disintegrate around devices and devices inserted into the spine, making it difficult to treat or diagnose conditions, and there is a problem that movement and viewing ability may be limited when the device is inserted. Balloon catheter is used for this purpose.

Techniques related to such a balloon catheter have been proposed in Patent Publication No. 0476972 and Patent Publication No. 145283.

Hereinafter, the catheter structure and balloon catheter of the balloon spine surgery described in the prior art Patent Publication No. 0476972 and Patent No. 145283 and a catheter device having the balloon catheter will be briefly described.

First, Figure 1 is a cross-sectional view of the catheter of the balloon chiroplasty in the Patent Publication No. 0476972 (hereinafter referred to as 'prior art 1'), the catheter structure of the balloon chiroplasty is a cavity inside the vertebral bones In the balloon spine surgery to form and treat the bone cement to treat, the balloon catheter forming the cavity is a handle (10) formed in a curved shape to facilitate gripping with one hand; A trigger 11 coupled to the hinge shaft 12 at the front of the handle 10 and installed by the return member 13; A support rod 22 fixed to the front end of the handle 10 in the longitudinal direction; A hollow tubular expansion structure (20) fastened to an outer circumference of the support rod (22) and moved forward and backward to the support point and fixed at the upper end of the trigger (11) by a push rod; It is characterized in that it comprises a; an expansion member (24) for inflating the balloon is fastened to the outer circumference is installed in the circumferential direction by the elastic body in the distal end of the expansion structure (20).

However, the catheter structure of the balloon chiroplasty according to the prior art 1 is a balloon according to the resistance because the contact area with the treatment area is large when penetrating the blocked portion of the spine in the expanded state provided in a single form 20 Treatment of the spinal surgery is difficult, and if the expansion structure 20 is damaged there was a problem that can be used to maintain after separation from the human body.

Next, FIG. 2 is a view illustrating a principle of operation of the balloon member in Korean Patent No. 145283 (hereinafter referred to as 'Prior Art 2'), and the balloon catheter is inserted in the body in the longitudinal direction. The flexible member extended to the end, having a constant inner diameter and open at both ends, serves as a passage for ejecting the chemical liquid injected from the outside to the front end, and receives an endoscope camera or a laser treatment device inserted through the rear end. A main passage 55a serving as a guide leading to the distal end portion and formed at a side of the main passage 55a and extending in parallel with the main passage 55a, the both ends of which are open to distal end portions of the main passage 55a. And a drain passage 55b which allows continuous injection of the intracorporeal chemical liquid through the main passage 55a by receiving the chemical liquid ejected from the tube and draining it to the rear end through the inside thereof. It is provided on the opposite side of the drain passage 55b with the main passage 55a interposed therebetween, and the rear end is opened and the front end is opened laterally through the side hole to receive the fluid injected into the rear end and discharge it to the side hole. A flexible tube having a passageway 55c; Expanded in the state of being inserted into the stenosis of the body by the operator to open a narrowed portion of the stenosis, it is expanded by the fluid flowing through the side hole through the pressure passage (55c) and surrounds a portion of the flexible tube, but transparent A balloon member 57 made of material; The tip portion extends to the rear of the flexible tube in a fixed state in the tip portion of the flexible tube, and includes a pair of steering wires that pull and bend the tip of the flexible tube when it is tensioned backward by an external force, and the flexible tube includes: ; An extension portion extending in the longitudinal direction and having a constant cross-sectional shape along the longitudinal direction, the extension portion having a wire mounting hole for passing the main passage 55a, the drain passage 55b, the pressure passage 55c, and the steering wire; It has the same cross-sectional shape as the part and is joined to the end of the extension part, and is wrapped by the balloon member 57 with the side hole at the side thereof, and the balloon member by the endoscope camera in the state entered into the main passage 55a. (57) It is configured to be bonded to the balloon expansion portion 53 formed of a transparent material and the end of the balloon expansion portion 53, similar to the balloon member 57 so that the external stenosis can be photographed, the main passage ( 55a) and the drain passage 55b are opened to their distal ends and the pressurization passage of the balloon inflation portion 53 is blocked so that the fluid injected into the pressurization passage is discharged only through the side holes. Doha is characterized by consisting of the tip (59).

However, the balloon catheter according to the prior art 2 also has a balloon member 57 as in the prior art 1 is provided in a single form, the contact area with the treatment area when entering through the adhesion or narrowing part of the spine, the balloon according to the resistance Treatment of the spinal surgery is difficult, and if the balloon member 57 is damaged, it is possible to use it after maintenance, thereby having an inefficient problem.

Prior art literature

Patent Literature

(Patent Document 1) Republic of Korea Patent Publication No. 10-0476972

(Patent Document 2) Republic of Korea Patent Publication No. 10-1452683

The present invention has been made to solve the above problems, and when the catheter is pushed into the epidural space, the first expansion part of the double structure of the expansion portion is pre-expanded so that the second expansion part can be easily reached while being blocked by foreign matters. The purpose is to expand the intervertebral cavity by inflation.

In addition, the purpose is to be able to treat by minimally invasive by grafting the double bulge to expand the intervertebral cavity and the electrode to remove the intervertebral cavity.

In order to achieve the above object, the tube is a flexible member extending in the longitudinal direction to be inserted into the body; A first expansion part provided at the tip of the tube; A second expansion part located outside of the first expansion part such that the first expansion part is located inside; A first air supply line supplying at least one of gas or liquid to the first expansion portion; And a second air supply line supplying at least one of gas or liquid to the second expansion part.

And a drug injection line formed in the longitudinal direction in the center of the tube; A first electrode which is an anode provided at one end of the tube; A second electrode which is a cathode provided at the other end of the tube; And a direction control wire provided in the length direction inside the tube, the direction control wire being provided for changing the direction of the electrode device.

In addition, the first expansion part may be disposed behind the second expansion part.

In addition, the distance between the tip of the second inflation section and the tip of the first inflation section is provided within the range of 10% to 80% of the entire length of the second inflation section, and with the tube for the rear end of the first and second inflation sections. Bonding length may be formed in the range of 1 to 70% over the entire length of the second inflation portion.

In addition, the first and second inflation portions may be bonded to the tube by an adhesive or a stainless ring.

In addition, the first inflation portion may be pre-expanded, the second inflation portion may be expanded later, or only the second inflation portion may be expanded.

According to the present invention, when the catheter is pushed into the epidural space, the first expanded portion of the double-structured expansion portion is pre-expanded to easily reach the blocked portion by foreign matters, and then expands the second expansion portion to expand the intervertebral cavity. Not only can penetrate the well, but any one of the expansion portion is damaged there is an effect that can be used as a spare.

In addition, there is an effect that can be treated by minimally invasive by grafting the double expansion portion to expand the intervertebral cavity and the electrode to remove the intervertebral cavity.

1 is a cross-sectional view showing a catheter of the conventional balloon spinal surgery.

2 is a view for explaining the operation principle of a conventional balloon member.

Figure 3 is a perspective view of a medical double balloon catheter electrode device according to the present invention.

Figure 4 is a cross-sectional view showing a medical double balloon catheter electrode device according to the present invention.

5 and 6 are cross-sectional views showing a state before and after expansion of the first and second inflation portions of the medical double balloon catheter electrode device according to the present invention.

Figure 7 is a schematic diagram showing a state before and after the expansion of the first, second inflation portion of the medical double balloon catheter electrode device according to the present invention.

8 is a schematic diagram showing a catheter to which the medical double balloon catheter electrode device according to the present invention is applied.

Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings so that those skilled in the art may easily implement the present invention. As those skilled in the art would realize, the described embodiments may be modified in various different ways, all without departing from the spirit or scope of the present invention. Like parts are designated by like reference numerals throughout the specification.

Hereinafter, the configuration of the present invention with reference to the accompanying drawings, Figure 3 is a perspective view showing a medical double balloon catheter electrode device according to the invention, Figure 4 is a cross-sectional view showing a medical double balloon catheter electrode device according to the present invention. 5 and 6 are cross-sectional views showing a state before and after expansion of the first and second inflation portions of the medical double balloon catheter electrode device according to the present invention, and FIG. 7 is a first cross section of the medical double balloon catheter electrode device according to the present invention. 2 Schematic diagram showing the state of expansion and expansion before and after expansion part.

Medical dual balloon catheter electrode device 100 of the present invention is the tube 110, the first and second electrodes (120a, 120b), the direction control wire 130, the first, the second air supply line (140a, 140b) and the first And two

expansion portions

150a and 150b, and the tube 110, the first and

second electrodes

120a and 120b, the direction control wire 130, and the first and second

air supply lines

140a, 140b) and the material, size, shape, etc. for the configuration of the first, second expansion portion (150a, 150b) and the like are not used separately because they use those commonly used in the industry.

The tube 110 is a flexible member that extends in the longitudinal direction to be inserted into the body and is configured to be oriented by manipulation of the operation unit when the rear end is connected to an operation unit (not shown) and inserted into the body. .

In this case, the tube 110 may be formed of a polymer material such as urethane, nylon series, polytetrafluoroethylene (PTFE: Polytetrafluoroethylene), polyether ether ketone (PEEK_Polyetheretherketone), Pebec (PEBAX, Poly Ether Block Amides), or the like. Can be.

In addition, a longitudinal drug injection line 112 is formed at an inner center of the tube 110 to allow drug injection for treatment from the outside.

In this case, the drug injection line 112 receives a drug from a drug supply device (not shown in the drawing) when a treatment such as removing a portion of the narrowed intervertebral cavity by burning or injecting a drug in an expanded state of the intervertebral cavity is required. To be injected.

The first and

second electrodes

120a and 120b are provided at the front end of the tube 110 and are electrically positive and negative electrodes, which generate output values of 0.1 V to 3 V to diagnose pain nerves caused by stenosis by an applied power source. Or burn part of the intervertebral cavity narrowed by narrowing.

In this case, the first electrode 120a is formed in a cylindrical shape so as to be inserted into the front end of the tube 110, and the first power supply line 122 for power supply is connected to one end thereof.

Here, the first electrode 120a is not particularly limited as long as the radiation frequency current can flow substantially, and examples thereof include stainless steel, general alloy steel, titanium steel, and shape memory alloy.

In addition, the second electrode 120b is formed in a cylindrical shape located inside the first electrode 120a, and one end of the second electrode 120b is connected to the second power supply line 124 to supply power.

Here, the second electrode 120b is manufactured by selecting the same material or a different material from the first electrode 120a.

On the other hand, the first power supply line 122 and the second power supply line 124 may be formed of a material such as copper, silver, gold, aluminum, stainless steel.

Direction control wire 130 is provided in parallel in the longitudinal direction inside the tube 110 is provided in a state in which a pair is opposed to the direction of the balloon catheter electrode device 100 is connected to the control unit for one end direction control And the other end is connected to the first electrode 120a, respectively. Here, the direction control wire 130 is formed of a material such as stainless, iron, titanium, tungsten.

That is, the direction control wire 130 is a balloon catheter electrode device 100 is inserted into the spine, etc., configured to go to the correct position through the change of direction, a material that can be easily bent in the desired direction in the human body with only a relatively small force Is produced by.

The first and second

air supply lines

140a and 140b are provided in a state parallel to the inside of the tube 110, and each of the first and

second expansion parts

150a and 150b to be described later may be a gas or physiological saline solution. A passage for selectively supplying the same liquid is connected to an external air supply unit (not shown) to supply air.

In other words, the first air supply line 140a is a pipe for injecting air into the first expansion part 150a so that the first air outlet 142 is formed on the surface so as to communicate with the inside of the first expansion part 150a. do.

In addition, the second air supply line 140b is a pipe for injecting air into the second expansion part 150b and a second air outlet 144 is formed on the surface so as to communicate with the inside of the second expansion part 150b.

The first and

second inflating parts

150a and 150b are disposed in a double structure at a rear of the tube 110 spaced apart from the front end by a predetermined distance so that air is injected into the inside by the first and second

air supply lines

140a and 140b. It is formed in the form of a balloon. Here, the first inflation portion 150a and the second inflation portion 150b may be disposed at the same position in double, but as shown in the drawing, it is preferable that the first inflation portion is disposed behind the second inflation portion.

That is, the first expansion unit 150a is expanded by the air introduced through the first air outlet 142 of the first air supply line 140a, and the second expansion unit 150b is supplied with the second air. It is expanded by the air flowing through the second air outlet 144 of the line (140b). In this case, the second expansion portion 150b has a larger expansion volume than the first expansion portion 150a.

To further explain this, the first expansion portion 150a is pre-expanded so as to be pushed into the epidural space and expands the narrowed intervertebral cavity, and the second expansion portion 150b is used to control the expansion order so as to expand later. Only the second expansion part 150b may be inflated and used.

At this time, one end of the first expansion unit 150a is in close contact with the second expansion unit 150b when inflated.

As described above, the first inflation portion 150a is first inflated so that a sharp tip is inserted into the vertebral space narrowed by narrowing so that the electrode device can be inserted smoothly, and then the inflation portion of the second inflation portion 150b is expanded. Will be able to expand.

In this case, the distance between the front end of the second expansion unit 150b and the front end of the first expansion unit 150a is preferably provided within 10 to 80% of the total length of the second expansion unit 150b. If it is less than 10%, when the first expansion portion is substantially expanded, the second expansion portion is almost similarly expanded, so that it is different from the prior art, and if it exceeds 80%, the effect of expansion of the first expansion portion is reduced.

In addition, it is preferable that the joining length with the tube 110 to the rear ends of the first and

second inflation portions

150a and 150b is formed within 1 to 70% of the total length of the second inflation portion 150b. Do. If less than 1% may cause a problem in the bonding of the second expansion portion, if more than 70% there is a problem that it is difficult to form the shape as shown in Fig. 7 (a) when only the first expansion portion is injected.

Thus, the distance between the tip of the second inflation section 150b and the tip of the first inflation section 150a and the joint length of the tube 110 with respect to the rear ends of the first and

second inflation sections

150a and 150b are determined. When inflating only the first inflation part 150a, the inflation shape of the second inflation part 150b may be formed in a pointed shape, and is formed in a pointed shape and pushed into the intervertebral cavity (neural passage). Easy to close and insert into the part blocked by foreign matter.

Meanwhile, when both ends of the first and

second expansion parts

150a and 150b are joined to the tube 110, the first and

second expansion parts

150a and 150b may be compressed and fixed by using an adhesive or a stainless ring.

Next, with reference to an embodiment of a medical double balloon catheter electrode device configured as described above as follows.

First, when a problem occurs in a specific part of the spine and the use of a balloon catheter is required, the tube 110 is inserted into the treatment area.

In this case, the tube 110 inserted into the body can be adjusted in a desired direction by the direction control wire 130 connected to the operation unit.

When the pain nerve caused by stenosis is diagnosed or when partial removal of the intervertebral cavity narrowed due to stenosis is required, it is performed by electricity generated by applying power to the first and

second electrodes

120a and 120b.

Next, when the intervertebral cavity (neural passage) is required to be blocked and drilled, air is supplied through the first air supply line 140a and the first inflation part 150a is first inflated.

In this way, since the expansion order of the expansion portion can be adjusted, the first expansion portion 150a positioned inside the second rear portion 150b of the first and

second expansion portions

150a and 150b is linearly expanded while the second expansion portion 150a is linearly expanded. Appearance of the inflating portion (150b) is the front point is formed in the shape of a triangular shape is bulky.

As a result, when it is pushed into the intervertebral cavity (neural passage), only the first expansion part 150a is inflated so that it can be easily approached and inserted into the part blocked by the foreign matter by the front of the pointed second expansion part 150b. This is because the front of the second inflating portion 150b is not in an inflated state, so that it can easily enter the intervertebral cavity, and is expanded by the first inflating portion 150a as it is gradually inserted, thereby opening the intervertebral cavity.

Next, when the air is supplied through the second air supply line 140b and the second expansion part 150b is expanded, foreign matter in the intervertebral cavity is opened, and thus foreign matter is easily removed.

In conclusion, the first and

second expansion parts

150a and 150b are provided in a double structure to penetrate the foreign matter of the intervertebral cavity in the state in which the first expansion part 150a is inflated, and then the second expansion part 150b is second. In the process of inflation, the intervertebral cavity can be widened to penetrate narrow areas.

Furthermore, by supplying electrical energy to the first and

second electrodes

120a and 120b, it is possible to remove some of the intervertebral holes narrowed by stenosis, and to physically alleviate coalescence and stenosis by inserting the first and

second expansion portions

150a and 150b. The first and

second electrodes

120a and 120b may generate an output value of 0.1 V to 3 V to diagnose and treat pain nerves caused by stenosis.

Meanwhile, the catheter 10 to which the medical double balloon catheter electrode device 100 of the present invention is applied has a plurality of channels, as shown in FIG. 8, and includes a catheter body 12, a power supply line 14, and a It includes a first inflation gas or liquid supply passage 16, a drug injection or endoscope input passage 18 and a second inflation gas or liquid supply passage (20).

The power supply line 14 is provided in the catheter body 12 and ends at a wire for supplying electricity through the first power supply line 122 and the second power supply line 124 connected to the first and

second electrodes

120a and 120b. The plug is provided.

The first expansion part gas or liquid supply passage 16 is provided in the catheter body 12 to supply gas or liquid so that the first expansion part 150a can be expanded.

The drug injection or endoscope input passage 18 is provided in the catheter body 12 to be connected to the drug injection line 112 of the catheter electrode device 100 and may be injected with an endoscope in addition to drug injection.

The second expansion part gas or liquid supply passage 20 is provided in the catheter body 12 to supply gas or liquid so that the second expansion part 150b can be expanded.

Furthermore, the direction control wire 130 of the catheter electrode device 100 is extended inside the catheter body 12 to control the direction by the operation unit.

In the above description with reference to the accompanying drawings, the medical double balloon catheter electrode device of the present invention was described mainly in a specific shape and direction, the present invention can be variously modified and changed by those skilled in the art, such modifications and changes are the present invention It should be construed as being included in the scope of the right.

In addition, while the above description has been described based on spinal stenosis balloon surgery, it can be used as a treatment tool for various diseases.

Explanation of the sign

100: balloon catheter electrode device,

110: tube,

120a, 120b: first and second electrodes,

130: directional control wire,

140a, 140b: first and second air supply lines,

150a, 150b: first and second inflation portions.

Claims

A tube that is a flexible member extending longitudinally to be inserted into the body;

A first expansion part provided at the tip of the tube;

A second expansion part located outside of the first expansion part such that the first expansion part is located inside;

A first air supply line supplying at least one of gas or liquid to the first expansion portion;

A second air supply line supplying at least one of gas or liquid to the second expansion portion;

A drug injection line formed in a longitudinal direction at the center of the tube;

A first electrode which is an anode provided at one end of the tube;

A second electrode which is a cathode provided at the other end of the tube; And

Medical double balloon catheter electrode device characterized in that it comprises a direction control wire which is provided in the longitudinal direction inside the tube is provided with a plurality for changing the direction of the electrode device.
The method of claim 1,

The medical inflatable double balloon catheter electrode device is disposed in the rear of the second expansion portion.
The method of claim 1,

The distance between the distal end of the second inflation section and the distal end of the first inflation section is provided within the range of 10% to 80% of the total length of the second inflation section, and is joined to the tube to the rear end of the first and second inflation sections. Medical double balloon catheter electrode device of the length is formed in the range of 1 ~ 70% of the total length of the second inflation portion.
The method of claim 3,

Medical first balloon catheter electrode device for the first and second inflated portion is bonded to the tube by an adhesive or a stainless ring (stainless ring).
The method of claim 1,

Medical double balloon catheter electrode device wherein the first inflation is pre-expanded, the second inflation is inflated, or only the second inflation is inflated.