WO2006111056A1 - An invasive assembly for draining cerebro-spinal fluid - Google Patents

An invasive assembly for draining cerebro-spinal fluid

Info

Publication number
WO2006111056A1
WO2006111056A1 PCT/CN2005/002316 CN2005002316W WO2006111056A1 WO 2006111056 A1 WO2006111056 A1 WO 2006111056A1 CN 2005002316 W CN2005002316 W CN 2005002316W WO 2006111056 A1 WO2006111056 A1 WO 2006111056A1
Authority
WO
WIPO (PCT)
Prior art keywords
drainage
tube
cerebrospinal fluid
puncture
needle
Prior art date
Application number
PCT/CN2005/002316
Other languages
French (fr)
Chinese (zh)
Inventor
Mingli He
Original Assignee
Mingli He
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mingli He filed Critical Mingli He
Publication of WO2006111056A1 publication Critical patent/WO2006111056A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A61M27/002Implant devices for drainage of body fluids from one part of the body to another
    • A61M27/006Cerebrospinal drainage; Accessories therefor, e.g. valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3415Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters

Definitions

  • a cerebrospinal fluid interventional drainage device A cerebrospinal fluid interventional drainage device
  • the present invention relates to a medical device, and more particularly to a cerebrospinal fluid interventional drainage device. It is mainly used for drainage or dredge of blood clots caused by hemorrhagic cerebrovascular diseases (such as subarachnoid hemorrhage and intraventricular hemorrhage), various meningitis (tuberculous, purulent, fungal and lymphatic choroid plexus). Inflammatory substance contamination or cerebrospinal fluid circulation is blocked, and it can also be used for the treatment of demyelinating diseases of the nervous system.
  • hemorrhagic cerebrovascular diseases such as subarachnoid hemorrhage and intraventricular hemorrhage
  • various meningitis tuberculous, purulent, fungal and lymphatic choroid plexus
  • Inflammatory substance contamination or cerebrospinal fluid circulation is blocked, and it can also be used for the treatment of demyelinating diseases of the nervous system.
  • Subarachnoid hemorrhage and ventricular hemorrhage are common cerebrovascular diseases. It is characterized by sudden headache, seizures, mental disorders or disturbances of consciousness. Blood accumulates in the ventricular system and subarachnoid space, causing cerebrospinal fluid blood staining, ventricle cast, cerebrospinal fluid circulation, acute high intracranial pressure, and even cerebral palsy. Survivors often suffer from normal intracranial pressure hydrocephalus, most cranial neuritis, spinal arachnoiditis, and reabsorption of blood, resulting in cerebral vasospasm, secondary neuronal secondary injury, etc. due to accumulation of blood in the subarachnoid space. Symptoms, leading to serious consequences.
  • Various meningitis are also very common and difficult to treat.
  • Group of major diseases of the central nervous system due to the direct release of various pathogenic bacteria and their inflammatory secretions into the cerebrospinal fluid, not only increase the difficulty of antibacterial treatment, but also cause acute or normal intracranial pressure due to inflammatory clot blocking cerebrospinal fluid circulation Hydrocephalus, leading to serious consequences.
  • lateral ventricle-peritoneal shunt is often used for this pathological state. Because the cerebrospinal fluid circulation cannot be dredged fundamentally, the drainage effect is not good, and complications such as dissociation, tube occlusion, or epilepsy are often present.
  • the technical problem to be solved by the present invention is to address the deficiencies of the prior art, and to provide a cerebrospinal fluid-introducing drainage device for lumbar puncture and ventricle puncture in clinical practice.
  • a cerebrospinal fluid interventional drainage device including a drainage device for a puncture drainage device, a dredge device and a peripheral device, wherein: the puncture drainage device is provided with a puncture needle Core, puncture needle sheath, guide wire and drainage tube, ⁇
  • the puncture needle and the needle sheath are made of plastic and stainless steel materials, and the needle sheath is sleeved outside the needle core for common use for piercing;
  • the guide wire is used to replace the needle core and guide the drainage tube, and the guide wire is made of plastic steel.
  • plastic steel Made of materials (such as twisted plastic), tungsten wire and twisted silica gel, its special flexibility and low radial hardness are easy to shape, and it has shape memory function.
  • the steel material is easy to develop.
  • Its head end is made of twisted silica gel. Soft and soft can reduce the damage of the operative tissue, and the development is good; various head-end shapes can be selected for a variety of complicated conditions, which reduces the difficulty of insertion.
  • the outer layer is a hydrophilic coating J to improve the passability;
  • the drainage tube is used to replace the needle sheath and drainage, and is a channel for the operation of the jet tube.
  • the compliance is good, the tube head is blunt, to reduce tissue damage, and it is convenient to feed the outer diameter of the guide wire into the chamber to be drained.
  • the needle sheath is placed outside the needle core for piercing.
  • the needle core is taken out, the guide wire is inserted from the inner hole of the needle sheath, and the needle sheath is pulled out from the body, and then the drainage tube is guided along the guide wire.
  • the outer diameter is fed into the chamber to be drained, or
  • D S A monitors the deeper part of the lateral ventricle.
  • the technical problem to be solved by the present invention can be further realized by the following technical solutions.
  • the drainage tube is made of materials such as platinum, tungsten wire, plastic and stainless steel, and the entire lumen is covered with a hydrophilic coating (such as PTFE) to Enhance the passability of the device, improve the contrast agent flow rate and development performance; the head end is soft to avoid operational damage; the head end 50 mm is designed from the front to the back in five stages, and the toughness is gradually enhanced to improve compliance and support.
  • the head end 50 mm is composed of a hydrophilic coating, an inner plastic layer, a metal layer and an outer plastic layer from the inside to the outside. Among them, the metal layer of the head end of 10 mm is wound with platinum wire to improve the flexibility and the folding resistance.
  • the remaining 4 segments are made of tungsten wire wound into different densities; the stainless steel braid at the end makes the push performance and the twist control good; the full-layer five-fold structure of the pipe wall to enhance the support and flexibility; the coarse mesh weave and the dense
  • the mesh weave is woven from tungsten wire and stainless steel wire respectively, which makes the visibility, support force and torque control strong.
  • Each head shape can be used for a variety of complex conditions, reducing the difficulty of insertion.
  • the technical problem to be solved by the present invention can be further achieved by the following technical solutions, wherein the outer surfaces of the puncture needle sheath, the guide wire and the drainage tube are marked with a scale. In order to observe the depth of penetration.
  • the technical problem to be solved by the present invention can further realize that the outer end of the drainage tube is connected to the drainage device through the guiding device of the guide and the peripheral device through the following technical solutions.
  • 5-10 side drainage holes are opened in the wall of the head end of the drainage tube to increase the drainage speed and avoid blood clot blocking.
  • the injection core is hollow and the observation chamber is connected to the rear.
  • the observation chamber is connected to the rear.
  • the technical problem to be solved by the present invention can be further achieved by the following technical solution.
  • the jet tube is made of soft twisted silica gel and has good development performance.
  • the head end is round and has a fine hole in the center for jet rinsing. Blocking with dredging; the outer membrane is covered with a water coating to improve slidability and passability for easy insertion.
  • the drainage device is provided with a cerebrospinal fluid drainage bag, the upper part of the cerebrospinal fluid drainage bag is provided with a suspension device, and the bottom portion is internally provided with an introduction tube, and the lower end of the introduction tube Adjacent to the drainage tube, the height of the introduced upper port from the center of the lateral ventricle is 15 to 20 cm, and the lower portion of the cerebrospinal fluid drainage bag is also connected with a liquid collection bag, and the introduction tube is marked with a scale through the pair of introduction tubes. Height adjustment of the upper mouth from the center of the lateral ventricle to control the pressure of the chamber to be drained, reducing the incidence of complications
  • a puncture hole sealer is arranged outside the drainage tube and the human puncture hole, and a drainage tube holder is arranged on the drainage tube outside the puncture hole.
  • the puncture hole sealer is made of silica gel, and is set at the scalp of the drainage tube at the end of the operation.
  • the puncture hole sealer is provided with a pressing hole for pressing and fixing the drainage tube, and one of the left and right sides of the pressing hole is provided.
  • a fixing arm for attaching a tape, and a pressure pad is provided below the inner edge of the pressing hole.
  • the puncture tissue is closed by the tightening of the inner hole and the compression of the bottom pressure pad to prevent the cerebrospinal fluid from being externally Leakage and drain tube displacement.
  • the drainage tube holder is provided with a pinch tube made of elastic silica gel, and each side of the pinch tube is provided with a fixing piece for fixing the drainage tube to the body surface to prevent pulling off.
  • the core principle of cerebrospinal fluid interventional drainage technology is to monitor the anatomical channel and DSA of the cerebrospinal fluid circulation of the human brain and spinal canal.
  • the principle of chamber twisting control of coaxial guide wire and catheter is used to guide the catheter to bend, rotate and Advance and retreat to adapt to the deep, complex, dangerous and extensive structural features of the ventricular system or subarachnoid system to place the catheter into the chamber, at the jet cutting action or thrombolytic agent (recombinant tissue plasminogen activator or Under the thrombolytic effect of urokinase, etc., crushing, dissolving and draining to absorb clots and substances, to achieve smooth cerebrospinal fluid circulation and clear blood, inflammatory and immune harmful substances
  • the present invention in contrast to the prior art, discloses a cerebrospinal fluid interventional drainage device comprising a lancing device, a dredge device, a drainage device for the peripheral device, and a fixture.
  • the piercing device has a puncture needle core, a puncture needle sheath, a guide wire and a drainage needle sheath which are set outside the needle core for puncture.
  • the needle core is taken out and the guide wire is inserted through the inner hole of the needle sheath. Then the needle sheath is pulled out from the body, and then the drainage tube is sent along the outer surface of the guide wire into the chamber to be drained.
  • the guide wire and the drainage tube are made of stainless steel, tungsten wire and the like according to a specific structure, which is soft and easy to shape and develop, and has Shape memory function.
  • the drainage tube can be placed into the third ventricle from the interventricular space under the guidance of the guide wire under the guidance of the guide wire, or further placed into the fourth ventricle via the midbrain aqueduct. If necessary, the cerebrospinal fluid circulation can be cleared by a jet tube. After the peripheral drainage device is installed after the surgery, the liquid control valve can be used to control the opening.
  • the complete device of the present invention has the functions of continuous drainage, dredge obstruction, pressure measurement, administration, replacement of cerebrospinal fluid, sampling, and dynamic observation of rebleeding.
  • FIG. 1 3 ⁇ 4 ventricle interventional drainage device structure diagram
  • Figure 2 3 ⁇ 4 Schematic diagram of the ventricle piercing needle sheath structure.
  • Figure 4 is a schematic view of the structure of the ventricle guide wire.
  • Fig. 5 is a schematic view showing the shape of the head end of each type of ventricle.
  • Figure 6 is a schematic view of the structure of the ventricular drainage tube.
  • Figure 7 is a schematic view of the head end of each type of ventricular drainage tube.
  • Figure 8 is a schematic view of the structure of the ventricle jet tube.
  • Figure 9 is a schematic view showing the structure of the puncture hole closure.
  • Figure 10 is a schematic view of the structure of the drainage tube holder.
  • Figure 1 1 shows the structure of the connecting pipe.
  • Figure 1 2 is a schematic diagram of the structure of the cerebrospinal fluid drainage bag.
  • Figure 1 3 is a schematic diagram of the overall placement of the ventricular interventional drainage device.
  • Figure 14 is a schematic diagram of the structure of the lumbar intervening drainage device.
  • Figure 15 is a schematic diagram of the waist tube drainage tube and the tip end of the guide wire.
  • Figure 1 6 is a schematic diagram of the overall placement of the lumbar intervening drainage device.
  • a cerebrospinal fluid interventional drainage device comprises a drainage device for puncturing drainage device, a dredging device and a peripheral device, and the puncture device is provided with a puncture needle sheath 1, a puncture needle 2, a guide wire 3 and a drainage tube 4.
  • the needle core 2 and the needle sheath 1 are made of stainless steel material, and the needle sheath 1 is placed outside the needle core 2 for common puncture;
  • the guide wire 3 is used for replacing the needle core 2 and guiding the drainage tube 4, the guide wire 3 is convenient for shaping and has a shape memory function, and the outer layer of the guide wire 3 is coated with a hydrophilic drainage tube 4 for replacing the needle sheath 1 and drainage. And for the channel operated by the jet tube, the compliance is good, the tube head is blunt, to reduce the tissue damage, and it is convenient to feed the outer diameter of the guide wire 3 into the chamber to be drained.
  • the needle sheath 1 is placed outside the needle core 2 for piercing.
  • the needle core 2 is taken out, the guide wire 3 is inserted through the inner hole of the needle sheath 1, and the needle sheath 1 is pulled out from the body.
  • the drainage tube 4 is fed along the outer diameter of the guide wire 3 into the chamber to be drained.
  • the outer end of the drainage tube 4 is connected to the drainage bag 1 1 of the peripheral device through the connecting tube 10, and the control tube 10 is provided with a liquid control tank.
  • Example 1 ventricular interventional drainage device
  • the ventricular interventional drainage device includes a puncture and drainage device, a dredging device and a peripheral drainage device and a fixing device, and the puncture device is provided with a ventricle puncture needle 2, a ventricle puncture needle sheath 1, various ventricle guide wires 3, and various types of ventricles
  • the drainage tube 4, the dredging device is provided with a jet tube 18, the peripheral drainage device is provided with a drainage bag 32 and a connecting tube 28, and the fixing device is provided with a puncture hole closure 21 and a drainage tube holder 25. . Placed in a box, sterilized and sealed, disposable.
  • Other interventional devices such as various types of ventricular guidewires and various types of ventricular drainage tubes, are separately sterilized and packaged for single use. Uses: This device is designed for ventricular interventional drainage, ventricular obstruction, intracranial pressure monitoring, cerebrospinal fluid replacement and ventricle administration.
  • Ventricular needle sheath It consists of a sheath rod and a sheath, made of stainless steel. Full length 118 mm.
  • Figure 2
  • Sheath hole 7 The hole for the core, 2.64 legs, inner diameter 2.31 leg (puncture needle No. 9). .
  • Sheath rod 8 cylindrical, length 110 hidden, outer diameter 2.64, inner diameter 2.31 blue (no. 9 needle), inner cavity is cylindrical, smooth, rounded at the tip, smooth with the core 2, in case Damage to tissue.
  • Base 9 Conical, large outer diameter 4 blue, inner diameter 3.4 mm, wall thickness 0.3 leg, length 8 legs, small head end outer diameter 2.64 mm, inner diameter 2.31 legs (no. 9 piercing needle), inner cavity Funnel-shaped, smooth, and smooth with the lumen of the sheath 8.
  • Ventricle puncture needle It consists of a needle bar and an observation chamber made of stainless steel and transparent plastic material. Full length 126 mm.
  • Figure 3
  • Observation Room 6 It is a transparent hard plastic cylindrical cavity with a length of 5 mm, an outer diameter of 6 mm, an inner diameter of 5, and a small hole with a 1-leg diameter at the bottom for exhausting.
  • Needle bar 10 121 legs long, 2.2 OD outer diameter, 1.6 leg inner diameter, inserted into the outer sheath of the puncture needle, the tip of which can be exposed 3 mm.
  • cerebral guide wire guide wire 3 is used to replace the needle 2 and guide the drainage tube 4 Placement, the guide wire 3 is made of inner core plastic material (such as twisted plastic) plus peripherally wound tungsten wire.
  • inner core plastic material such as twisted plastic
  • the head end is made of silicone, soft and soft to reduce the operative tissue damage; various head-end modeling for a variety of complex conditions , reducing the difficulty of insertion.
  • the outer layer is a hydrophilic coating to improve the passability. Diameter 0. 83 mm, solid, length 600 mm.
  • Guide wire tip 1 1 Made of soft twisted silicone. Diameter 0. 83 mm, solid, 5 sa.
  • Guide wire 3 Made of solid steel material (twisted plastic) core wound with tungsten wire. The diameter is 0.83 mm, solid and 595 ⁇ long.
  • Figure 5 shows the shape of each type of guide wire.
  • A is straight, mostly used for lateral ventricle body placement
  • B is microbend, mostly used for lateral ventricle angle and fourth ventricle lateral hole placement
  • C is oblique bending, mostly used for midbrain aqueduct placement
  • D For the inverted curve, it is mostly used for the contralateral side ventricle.
  • ventricle drainage tube 4 is used to replace the needle sheath 1 and the drainage or jet tube operation channel, the drainage tube 4 is made of platinum wire, tungsten wire, plastic, stainless steel and other materials.
  • the outer diameter is 2.64 mm, the inner diameter is 2.3 1 leg, and the length of the drainage tube is 4 10 0 legs.
  • the whole process consistency cavity is covered with a hydrophilic coating (such as PT FE) to enhance the passability of the device, improve the contrast agent flow and development performance; the head end is soft to avoid operational damage; the head end 10 mm is wrapped by platinum wire, It has good flexibility and good bending resistance; the 50mm head end is designed from the front to the back in five sections, and the rigidity is gradually increased to improve the compliance and support.
  • a hydrophilic coating such as PT FE
  • the head end 50 mm is composed of a hydrophilic coating, an inner plastic layer, a wire braid layer and an outer plastic layer from the inside to the outside.
  • the wire braid of 10 mm at the head end is wound with platinum wire to improve the flexibility and the folding resistance.
  • the remaining 4 segments are made of tungsten wire wound into different densities; the stainless steel braid at the end makes the push performance good and the twist control is good; the stainless steel braid at the end makes the push performance and the twist control good; the full-layer five-fold structure of the pipe wall, To enhance the support and flexibility; the rough layer and the dense layer are woven from tungsten wire and stainless steel wire respectively, which makes the visibility, support force and torque control strong.
  • Drain pipe head end 12 The head end is 50 mm without thick and fine braided layer structure, but consists of platinum wire or tungsten wire wound with different flexibility, and is divided into five sections from front to back. Designed to enhance flexibility and resistance to breakage. Among them, the head end 10 mm is wound by platinum wire, the other 40 mm is wound by tungsten wire, and the toughness is gradually enhanced to improve the compliance and support force.
  • Drain hole 5 1 leg in diameter, 6 openings in the end of the pipe, 6 mm spacing between adjacent sides.
  • Insert depth scale 13 every 10 orchids, from front to back, a total of 400 legs 0
  • Drainage wall 14 Outer diameter 2.64 mm, inner diameter 2.31 awake, length 400 mm.
  • the remaining tail segments are a-hydrophilic coating, b-internal plastic layer, c-coarse woven layer (tungsten wire), d-mesh woven layer from inside to outside. (stainless steel wire) and e-outer plastic layer.
  • the control panel 15 made of hard plastic, is used to rotate the drainage tube during operation. ⁇ 8. 64 mm, length 5 mm.
  • the drainage tube connector 16 is funnel-shaped and connected to the coupling tube nipple. Its large end has an outer diameter of 4 legs, an inner diameter of 3.4 mm, a wall thickness of 0.3 ship, a length of 5 legs, a small head end outer diameter of 2.64 mm, and an inner diameter of 2.31 mm.
  • the inner cavity is funnel-shaped, smooth, and smoothly continues with the inner lumen of the drainage tube.
  • Figure 7 shows the shape of the head of each type of drainage tube.
  • A is straight, mostly used for lateral ventricle body implantation;
  • B is microbend, mostly used for lateral ventricle angle and fourth ventricle lateral hole placement;
  • C is small bend, mostly used for midbrain aqueduct placement;
  • D is medium Bend, for anatomical variation for operational selection.
  • E large bend, mostly used for the contralateral side ventricle.
  • the jet tube 18 is made of soft twisted silica gel, the head end is round, the center has a tiny hole for jet flushing and dredging blockage; the outer membrane is covered with a hydrophilic coating to improve Slidability and passability for easy insertion.
  • Figure 8 the jet tube 18 is made of soft twisted silica gel, the head end is round, the center has a tiny hole for jet flushing and dredging blockage; the outer membrane is covered with a hydrophilic coating to improve Slidability and passability for easy insertion.
  • the jet hole 17 in the center of the jet tube, the diameter of 0. 4 mm, through The high pressure fluid is cut and pulverized to achieve its flushing and dredging functions.
  • the jet tube 18, made of silicone, has an outer diameter of 2.30 legs, an inner diameter of 1.70 legs and a length of 461 mm.
  • Base 19 Made of silicone, conical, 4 mm outer diameter, 3.4 legs, 0.3 mm thick, 8 mm long, 2.30 mm small tip, 1.70 mm inner diameter ), the inner cavity is funnel-shaped, smooth, and smoothly continues with the lumen of the jet tube. .
  • Substrate 20 Made of silica gel, expanded in a disk shape to enhance the hand feeling during operation.
  • the outer diameter is 6 mm
  • the inner diameter is 3.4 mm
  • the wall thickness is 0.3 mm
  • the length is 3 legs.
  • the inner cavity of the jet tube base is smoothly continued.
  • Puncture hole sealer 21 It is made of silica gel. At the end of the operation, it is placed at the scalp of the drainage tube 4, and the puncture tissue is closed by the compression of the inner hole 24 and the compression of the bottom pressure pad 23 to prevent leakage and drainage of the cerebrospinal fluid. Tube shift.
  • Figure 9 Figure 9:
  • Fixed arm 22 For attaching tape, one on each side.
  • Insertion hole 24 For the pressure-fixing drainage tube 4, it has a certain extension. The diameter is 2.62mm and the length is 5 mm.
  • FIG. 8-3 Pressure pad 23: Made of soft twisted silicone. When set in the drainage tube, the pressure can close the puncture hole to prevent leakage of cerebrospinal fluid.
  • the fixing piece 27 is made of elastic silicone.
  • the pinch tube 26 is made of elastic silicone. Its function is to clamp the drain tube to prevent pull-out.
  • the inner cavity has a diameter of 2.62 mm, an outer diameter of 5 mm and a length of 15 mm.
  • the connecting tube 28 is made of a polypropylene material and is a passage connecting the drainage tube 4 and the drainage bag 32. With the liquid control valve 29, its switch can directly limit/open the cerebrospinal fluid into the drainage bag 32, so that the ventricle can be opened and closed after the injection.
  • Figure 11
  • Tail end interface nipple of shape and size with the introduction port of the drainage bag Match, the inner cavity is funnel shaped.
  • the outer end of the large end is 4 awake, the inner diameter is 3.4, the wall thickness is 0.3 mm, the length is 5 mm, the outer diameter of the small head end is 2.64 mm, and the inner diameter is 2.31 legs.
  • the inner cavity is funnel-shaped and smooth.
  • Control valve 29 Its structure and function are the same as ordinary infusion tube switch, its size is matched with this connection tube.
  • Connection tube 28 Tube length 300 mm, outer diameter 4 mm, inner diameter 3 mm.
  • Nipple It is shaped and sized to match the connector of the catheter. It is funnel-shaped, 5 mm long, 2.4 mm proximal diameter, 3 mm outer diameter, 2. 64 mm outer diameter tip, and 2 inner diameter.
  • the cerebrospinal fluid drainage bag 32 consists of a transparent rectangular bag made of soft, thin polypropylene plastic and two hard plastic tubes. In addition to the introduction and exit of the two tubes 33, 34, there is no other channel to communicate, which is conducive to sealing and anti-pollution.
  • the introduction and discharge of the two tubes are not connected, and are not at the same level, in order to eliminate the "suction" effect of the pipeline, and to facilitate the constant and maintenance of intraventricular pressure.
  • the introduction tube 33 is engraved with a height scale (cm) to facilitate monitoring of intracranial pressure.
  • Hanging mouth 31 The continuation of the double drainage wall, the outer edge is semi-circular, with a diameter of 40 legs, the opening is round and the diameter is 20 legs. Used for hanging.
  • Drainage cavity A cavity with a rectangular fillet. It is 100 mm long and 40 legs wide.
  • Inlet tube 33 is a vertical inverted "L" type with a high scale (cm) from bottom to top and an empty needle nipple at the entrance that matches the shape and size of the end of the connecting tube.
  • the introduction tube has an outer diameter of 4 legs, an inner diameter of 3.4 mm, a wall thickness of 0.3 legs, a vertical length of 90 legs, and a bending of 20 legs.
  • the extraction tube 34 is a vertical tube, the outlet is empty needle-shaped, and its shape and size match the interface of other common medical drainage bags (such as urine bags).
  • the outlet tube has an outer diameter of 4 mm, an inner diameter of 3.4 legs, and a wall thickness of 0.3 awake.
  • Embodiment 2 lumbar intervening drainage device
  • the lumbar intervening drainage device comprises a puncture and drainage device, a peripheral drainage device and a fixing device, and the puncture device is provided with a lumbar puncture needle 2 a lumbar puncture needle sheath 1, a lumbar guide wire 3 and a lumbar drainage tube 4, the peripheral drainage device is provided with a drainage bag 32 and a connecting tube 28, and the fixing device is provided with a puncture hole closure 21 and drainage Tube holder 25. Placed in the box, sterilized and sealed, disposable application. Uses: This device is specially designed for continuous drainage of the lumbar cistern, cerebrospinal fluid replacement and lumbar cistern administration.
  • Needle sheath 1 Made of stainless steel with a beveled tip that facilitates penetration into the lumbar pool. The total length of the needle sheath is 105 legs. As shown in Figure 14.
  • Base 4 mm outer diameter, 3 mm inner diameter, 5 mm long, cylindrical, distal end funnel-shaped, continuous with needle dry.
  • Needle dry Cylindrical, length 100 mm, outer diameter 1. 22 legs, inner diameter 1.06 mm (passing needle 18), the inner cavity is cylindrical and smooth. The tip is beveled. A long ⁇ scale (in centimeters) is engraved backwards from the tip to facilitate observation of the depth of the needle.
  • Needle 2 Made of stainless steel, solid, connected to its tailstock. The tip is slanted to facilitate penetration into the waist pool. The total length of the core is 107 mm. As shown in Figure 13-B.
  • Substrate Made of stainless steel, solid, connected to its tailstock, cylindrical, with an outer diameter of 8 mm and a thickness of 2 mm, which helps to control the depth of the needle.
  • Tailstock Made of stainless steel, connected to the core and the base plate, it has a cylindrical solid body with an outer diameter of 3 legs and a length of 5 mm. The distal end has a sloped slope that matches the corresponding position of the needle sheath.
  • Needle core 102 mm long, 1. 0 mm in diameter, the tip can be exposed 2 coffee.
  • Guide wire 3 Made of plastic steel material, soft and easy to shape, and has a shape memory function. The tip is rounded to reduce damage to the tissue, the surface is smooth, and the hydrophilic coating is applied for insertion. Diameter 0. 83 mm, solid, 1000 mm long. A length scale (in centimeters) is engraved from the tip to the back.
  • Drain tube 4 Made of soft twisted silicone, with good compliance and rounded head for feeding into the deep pool. A length scale (in centimeters) is engraved from the tip backwards to facilitate viewing of the insertion depth. The tip has a side hole for drainage. The inner diameter of the outer diameter is 4. 4 mm, the inner diameter is 3. 4 ⁇ , the wall thickness is 0.3 mm, the length is 5 mm, the small head end is 1.22 mm, and the inner diameter is 1. 06 mm. The cavity is funnel-shaped, smooth, and smoothly continues with the lumen of the catheter.
  • Dry conduit outer diameter 1. 22 mm, inner diameter 1. 06 legs, length 800 coffee, tip blunt.
  • Drainage side hole diameter 0. 5 legs, opening at the end of the catheter, a total of 6 holes, the adjacent side holes are 10 legs apart.
  • Figure 15 shows the shape of the tube head of the lumbar intervening drainage guide wire and catheter, which is in a curved shape, which facilitates the insertion of the guide wire or catheter into the subarachnoid space of the spinal cord.
  • connection tube 28 the cerebrospinal fluid drainage bag 32, the puncture hole closure 21 and the drainage tube holder 25 have the same structure as the corresponding device of the ventricular interventional drainage device, and the size is matched with the drainage tube.

Abstract

An invasive assembly for draining cerebro-spinal fluid comprises a puncture device, a conduit device, and an additional drainage device. The puncture device includes a puncture sheath (1), a puncture needle (2), a guide wire (3), and a drainage tube (4). The guide wire (3) is flexible and of good visibility and shape-memory function. The outer layer of the guide wire (3) is coated with a hydrophilic layer. The drainage tube (4) is formed of plastic, platinum, stainless steel, or the like, the head of which is blunt. The drainage tube (4) is of good compliancy and visibility. When the needle (2) and the sheath (1) which covers the needle (2) puncture into a proper position of the body, the needle (2) is withdrawn. Then the guide wire (3) is inserted through the inner hole of the sheath (1). After the sheath (2) is withdrawn from the body, the drainage tube (4) is guided along the guide wire (3) into the lumen to be drained or into the side cerebral ventricle or a deeper position beyond the lumbar with DSA monitoring. The outer end of the drainage tube (4) connects with the additional drainage device via a catheter (28).

Description

一种脑脊液介入引流器 技术领域 ,  A cerebrospinal fluid interventional drainage device,
本发明涉及一种医疗设备, 特别是一种脑脊液介入 引流器。 主要用于引流或疏通由出血性脑血管疾病 (如 蛛网膜下腔出血和脑室出血)、 各种脑膜炎 (结核性、 化 脓性、 霉菌性和淋巴脉络膜丛性等) 导致的脑脊液血染、 炎性物质污染或脑脊液循环受阻, 也可试用于神经系统 脱髓鞘性疾病的治疗。  The present invention relates to a medical device, and more particularly to a cerebrospinal fluid interventional drainage device. It is mainly used for drainage or dredge of blood clots caused by hemorrhagic cerebrovascular diseases (such as subarachnoid hemorrhage and intraventricular hemorrhage), various meningitis (tuberculous, purulent, fungal and lymphatic choroid plexus). Inflammatory substance contamination or cerebrospinal fluid circulation is blocked, and it can also be used for the treatment of demyelinating diseases of the nervous system.
背景技术  Background technique
蛛网膜下腔出血和脑室出血是常见脑血管疾病。 其 特点为突发头痛、 癫痫发作、 精神异常或意识障碍等。 血液积聚于脑室系统和蛛网膜下腔, 引起脑脊液血染、 脑室铸型、 脑脊液循环受阻、 急性高颅压症, 甚至脑疝 死亡。 幸存者常因积血储存于蛛网膜下腔而致正常颅压 脑积水、 多数颅神经炎、 脊髓蛛网膜炎和血液的重吸收 而致脑血管痉挛、 广泛神经元继发性损伤等并发症, 导 致严重后果。 因此, 及时清除积血、 疏通脑脊液循环是 早期救治的关键。 但现用的引流技术和引流器具难以达 到侧脑室以远的第三、 四脑室, 引流效果不佳。 用腰椎 穿刺清除蛛网膜下腔积血也是当今所推崇的一种重要方 法, 但抽取脑脊液后不能留置和持续引流, 只有反复穿 剌才能清除不断产生的积血, 增加了病人的痛苦和损伤, 有时还会加重病情, 增加医源性感染的机会, 也不能随 时观察蛛网膜下腔的出血情况及压力变化, 其引流作用 局限, 效率甚低。 各种脑膜炎 (结核性、 化脓性、 霉菌 性和淋巴脉络膜丛性等) 也是十分常见而治疗棘手的一 组中枢神经系统重大疾病, 因各种致病菌及其炎性分泌 物直接释入脑脊液, 不但增加.了抗菌治疗难度, 而且常 因炎性凝块阻塞脑脊液循环而致急性或正常颅压性脑积 水, 导致严重后果。 目前对这种病理状态多采取侧脑室- 腹腔分流。 由于无法从根本上疏通脑脊液循环, 其引流 效果不佳, 且常有脱管、 堵管或 ^发癫痫等并发症, 故 大多数并发脑脊液循环受阻的脑膜炎患者的预后甚差 (如死亡、 植物人或痴呆等)。 神经系统免疫性或脱髓鞘 性疾病 (如急、 慢性炎性脱髓鞘性神经病等), 因神经组 织中的大量有害抗体和抗体-抗原复合物的产生, 导致神 经髓鞘脱失和病理生理 "瀑布效应 " 而导致严重后果 目 刖无特效疗法, 但人们发现用血浆置换的办法间接降 低血浆有害物质的浓度可使部分病例症状改善 既然这Subarachnoid hemorrhage and ventricular hemorrhage are common cerebrovascular diseases. It is characterized by sudden headache, seizures, mental disorders or disturbances of consciousness. Blood accumulates in the ventricular system and subarachnoid space, causing cerebrospinal fluid blood staining, ventricle cast, cerebrospinal fluid circulation, acute high intracranial pressure, and even cerebral palsy. Survivors often suffer from normal intracranial pressure hydrocephalus, most cranial neuritis, spinal arachnoiditis, and reabsorption of blood, resulting in cerebral vasospasm, secondary neuronal secondary injury, etc. due to accumulation of blood in the subarachnoid space. Symptoms, leading to serious consequences. Therefore, timely removal of blood and dredge cerebrospinal fluid circulation is the key to early treatment. However, the current drainage technique and drainage device are difficult to reach the third and fourth ventricles of the lateral ventricle, and the drainage effect is not good. The use of lumbar puncture to remove subarachnoid hemorrhage is also an important method advocated today, but after the extraction of cerebrospinal fluid can not be indwelled and continuous drainage, only repeated piercing can clear the continuous accumulation of blood, increasing the patient's pain and injury, Sometimes it will aggravate the condition, increase the chance of iatrogenic infection, and can not observe the bleeding and pressure changes in the subarachnoid space at any time. The drainage effect is limited and the efficiency is very low. Various meningitis (tuberculous, suppurative, fungal, and choroidal plexus) are also very common and difficult to treat. Group of major diseases of the central nervous system, due to the direct release of various pathogenic bacteria and their inflammatory secretions into the cerebrospinal fluid, not only increase the difficulty of antibacterial treatment, but also cause acute or normal intracranial pressure due to inflammatory clot blocking cerebrospinal fluid circulation Hydrocephalus, leading to serious consequences. At the present time, lateral ventricle-peritoneal shunt is often used for this pathological state. Because the cerebrospinal fluid circulation cannot be dredged fundamentally, the drainage effect is not good, and complications such as dissociation, tube occlusion, or epilepsy are often present. Therefore, most patients with meningitis complicated by cerebrospinal fluid circulation have a poor prognosis (such as death, Vegetative or dementia, etc.). Neurological immune or demyelinating diseases (such as acute and chronic inflammatory demyelinating neuropathy), due to the production of a large number of harmful antibodies and antibody-antigen complexes in nerve tissue, leading to neuromyelin loss and pathology The physiological "waterfall effect" leads to serious consequences and no specific treatment, but it has been found that the use of plasma exchange to indirectly reduce the concentration of harmful substances in the plasma can improve the symptoms in some cases.
}Ά有害物质能从血浆中清除而达到治疗作用, 可否从脑 脊液中直接清除而发挥治疗作用呢? 我们通过置换病况 脑脊液对多例急、 慢性炎性脱髓鞘性神经病患者进行定 期脑脊液置换治疗, 发现此法的疗效优于血浆置换 但 同样因 目前无规范化技术及专用器具可用, 使其治疗作 用和推广价值严重受限。 } Ά harmful substances can be removed from the plasma to achieve therapeutic effects, can it be directly removed from the cerebrospinal fluid to play a therapeutic role? We have treated patients with acute and chronic inflammatory demyelinating neuropathy with regular cerebrospinal fluid replacement by replacing the condition of cerebrospinal fluid. It is found that this method is superior to plasma exchange, but it is also available because of the current non-standardized technology and special instruments. And the value of promotion is severely limited.
发明内容  Summary of the invention
本发明要解决的技术问题是针对现有技术的不足 , 提出了一种临床中用于腰池穿刺和脑室穿刺的脑脊液介 入引流器具。  The technical problem to be solved by the present invention is to address the deficiencies of the prior art, and to provide a cerebrospinal fluid-introducing drainage device for lumbar puncture and ventricle puncture in clinical practice.
本发明要解决的技术问题是通过以下技术方案来实 现的 , 种脑脊液介入引流器, 包括穿刺引流设备 、 疏 通设备和外设的引流装置, 其特点是: 所述的穿刺引流 设备设有穿刺针芯、 穿刺针鞘、 导丝和引流管 , □  The technical problem to be solved by the present invention is achieved by the following technical solutions, a cerebrospinal fluid interventional drainage device, including a drainage device for a puncture drainage device, a dredge device and a peripheral device, wherein: the puncture drainage device is provided with a puncture needle Core, puncture needle sheath, guide wire and drainage tube, □
穿刺针芯和针鞘由塑料和不锈钢材料制成 , 针鞘套 装于针芯外, 共同用于穿剌;  The puncture needle and the needle sheath are made of plastic and stainless steel materials, and the needle sheath is sleeved outside the needle core for common use for piercing;
导丝用于替换针芯和引导引流管置入, 导丝由塑钢 材料 (如加钡塑料)、 钨丝和加钡硅胶制成, 其特殊的柔 韧性和低径向硬度便于塑形, 并有形状记忆功能 塑钢 材料便于显影 , 其头端由加钡硅胶制成, 弱软可减轻操 作性组织损伤 , 且显影好; 各种头端造型可供多种复杂 情况插管选择 , 降低了插入难度。 外层为亲水涂层 J 以 提高通过性; The guide wire is used to replace the needle core and guide the drainage tube, and the guide wire is made of plastic steel. Made of materials (such as twisted plastic), tungsten wire and twisted silica gel, its special flexibility and low radial hardness are easy to shape, and it has shape memory function. The steel material is easy to develop. Its head end is made of twisted silica gel. Soft and soft can reduce the damage of the operative tissue, and the development is good; various head-end shapes can be selected for a variety of complicated conditions, which reduces the difficulty of insertion. The outer layer is a hydrophilic coating J to improve the passability;
引流管用于置换针鞘和引流, 并为射流管操作的通 道, 顺应性好, 管头圆钝, 以减少组织损伤, 便于沿导 丝外径送入需引流的腔室内。  The drainage tube is used to replace the needle sheath and drainage, and is a channel for the operation of the jet tube. The compliance is good, the tube head is blunt, to reduce tissue damage, and it is convenient to feed the outer diameter of the guide wire into the chamber to be drained.
针鞘套装于针芯外用于穿剌, 当剌入适当位置时, 取出针芯, 将导丝从针鞘的内孔穿入, 再将针鞘从体拔 出, 再将引流管沿导丝外径送入需引流的腔室内 , 或在 The needle sheath is placed outside the needle core for piercing. When the needle is inserted into the proper position, the needle core is taken out, the guide wire is inserted from the inner hole of the needle sheath, and the needle sheath is pulled out from the body, and then the drainage tube is guided along the guide wire. The outer diameter is fed into the chamber to be drained, or
D S A监视下送入侧脑室以远的更深部位。 D S A monitors the deeper part of the lateral ventricle.
本发明要解决的技术问题还可以通过以下技术方案 来进一步实现, 引流管由铂金、 钨丝、 塑料和不锈钢等 材料制成, 全程一致性内腔被覆有亲水涂层 (如 P T F E ), 以增强器具的通过性, 提高造影剂流量和显影性能; 头 端柔软避免操作性损伤; 头端 5 0毫米由前至后分五段设 计, 刚韧性逐渐增强, 以提高顺应性和支撑力。 头端 5 0 毫米从内至外分别为亲水涂层、 内塑料层、 金属层和外 塑料层四层构成。 其中, 头端 1 0毫米的金属层由铂金丝 缠绕而成, 以提高柔顺性和抗折力。 其余 4 段由钨丝缠 绕为不同密度而成; 尾端不锈钢编织使推送性能好和扭 控性佳; 管壁全层五重式结构, 以增强支撑力和柔顺性; 粗网编织层和密网编织层分别由钨丝和不锈钢丝编织而 成, 使可视性、 支撑力及扭控性均强。 各钟头端造型可 供多种复杂情况置管选择, 降低了插入难度。  The technical problem to be solved by the present invention can be further realized by the following technical solutions. The drainage tube is made of materials such as platinum, tungsten wire, plastic and stainless steel, and the entire lumen is covered with a hydrophilic coating (such as PTFE) to Enhance the passability of the device, improve the contrast agent flow rate and development performance; the head end is soft to avoid operational damage; the head end 50 mm is designed from the front to the back in five stages, and the toughness is gradually enhanced to improve compliance and support. The head end 50 mm is composed of a hydrophilic coating, an inner plastic layer, a metal layer and an outer plastic layer from the inside to the outside. Among them, the metal layer of the head end of 10 mm is wound with platinum wire to improve the flexibility and the folding resistance. The remaining 4 segments are made of tungsten wire wound into different densities; the stainless steel braid at the end makes the push performance and the twist control good; the full-layer five-fold structure of the pipe wall to enhance the support and flexibility; the coarse mesh weave and the dense The mesh weave is woven from tungsten wire and stainless steel wire respectively, which makes the visibility, support force and torque control strong. Each head shape can be used for a variety of complex conditions, reducing the difficulty of insertion.
本发明要解决的技术问题还可以通过以下技术方案 来进一步实现, 所述的穿刺针鞘、 导丝和引流管的外表 面都标有刻度。 以便于观察剌进深度。 本发明要解决的技术问题还可以通过以下技术方案 来进一步实现 引流管的外端通过导官与外设的引流装 置相接 导官上装有控液阀。 The technical problem to be solved by the present invention can be further achieved by the following technical solutions, wherein the outer surfaces of the puncture needle sheath, the guide wire and the drainage tube are marked with a scale. In order to observe the depth of penetration. The technical problem to be solved by the present invention can further realize that the outer end of the drainage tube is connected to the drainage device through the guiding device of the guide and the peripheral device through the following technical solutions.
本发明要解决的技术问题还可以通过以下技术方案 来进一步实现 , 引流管的头端管壁上开有 5—1 0 个侧引 流孔, 以增加引流速度 , 避免血块堵管。  The technical problem to be solved by the invention can be further realized by the following technical solutions: 5-10 side drainage holes are opened in the wall of the head end of the drainage tube to increase the drainage speed and avoid blood clot blocking.
本发明要解决的技术问题还可以通过以下技术方窭 山 来进一步实现 所述的针芯是中空的注射式针芯, 后 连接有 个观察室。 以便于观察是否有脑脊液流入 ,  The technical problem to be solved by the present invention can be further realized by the following technique: the injection core is hollow and the observation chamber is connected to the rear. In order to observe whether there is cerebrospinal fluid inflow,
本发明要解决的技术问题还可以通过以下技术方案 来进一步实现 , 所述的射流管由柔软的加钡硅胶制成 显影性能好 头端圆形 , 其中心开有一细微小孔, 用于 射流冲洗与疏通阻塞; 外膜覆盖有 水涂层, 以提高滑 动性和通过性 便于插入。  The technical problem to be solved by the present invention can be further achieved by the following technical solution. The jet tube is made of soft twisted silica gel and has good development performance. The head end is round and has a fine hole in the center for jet rinsing. Blocking with dredging; the outer membrane is covered with a water coating to improve slidability and passability for easy insertion.
本发明要解决的技术问题还可以通过以下技术方案 来进一步实现, 所述的引流装置设有一个脑脊液引流袋, 脑脊液引流袋的上部设有悬挂装置, 底部向 内装有一个 引入管, 引入管下端与所述的引流管相接, 引入 的上 端口距侧脑室中心的高度为 1 5〜 20 c m , 脑脊液引流袋的 下部还与 个集液袋相连通, 引入管上标有刻度 通过 对引入管上 口距侧脑室中心的高度调节来控制需引流 的腔室的压力 , 减少并发症的发生机率  The technical problem to be solved by the present invention can be further achieved by the following technical solution. The drainage device is provided with a cerebrospinal fluid drainage bag, the upper part of the cerebrospinal fluid drainage bag is provided with a suspension device, and the bottom portion is internally provided with an introduction tube, and the lower end of the introduction tube Adjacent to the drainage tube, the height of the introduced upper port from the center of the lateral ventricle is 15 to 20 cm, and the lower portion of the cerebrospinal fluid drainage bag is also connected with a liquid collection bag, and the introduction tube is marked with a scale through the pair of introduction tubes. Height adjustment of the upper mouth from the center of the lateral ventricle to control the pressure of the chamber to be drained, reducing the incidence of complications
本发明要解决的技术问题还可以通过以下技术方案 来进一步实现, 在引流管与人体穿刺孔外侧设有穿刺孔 密封器, 在穿刺孔外的引流管上装有引流管固定器。 所 述的穿刺孔密封器为硅胶制成, 手术结束时套装于引流 管出头皮处, 穿刺孔密封器设有一个嵌压固定引流管的 嵌压孔, 嵌压孔的左右两边各设有一个用于粘贴胶布的 固定臂, 在嵌压孔内缘下方设有压垫。 借其内孔的紧缩 及底部压垫的压迫作用封闭穿刺 口组织, 防止脑脊液外 漏和引流管移位。 所述的引流管固定器设有一个由弹性 硅胶制成的夹管, 夹管两侧各设有一个固定片, 用以将 引流管固定在体表, 防止拉脱。 The technical problem to be solved by the present invention can be further achieved by the following technical solutions: a puncture hole sealer is arranged outside the drainage tube and the human puncture hole, and a drainage tube holder is arranged on the drainage tube outside the puncture hole. The puncture hole sealer is made of silica gel, and is set at the scalp of the drainage tube at the end of the operation. The puncture hole sealer is provided with a pressing hole for pressing and fixing the drainage tube, and one of the left and right sides of the pressing hole is provided. A fixing arm for attaching a tape, and a pressure pad is provided below the inner edge of the pressing hole. The puncture tissue is closed by the tightening of the inner hole and the compression of the bottom pressure pad to prevent the cerebrospinal fluid from being externally Leakage and drain tube displacement. The drainage tube holder is provided with a pinch tube made of elastic silica gel, and each side of the pinch tube is provided with a fixing piece for fixing the drainage tube to the body surface to prevent pulling off.
脑脊液介入引流技术的核心原理是 1曰助人脑与椎管 唯一的脑脊液循环的解剖腔道和 D S A 的监视作用 , 利用 同轴导丝与导管的腔室扭控原理 , 引导导管打弯 、 旋转 和进退, 以适应脑室系统或蛛网膜下腔系统深在、 复杂、 危险和广泛的结构特点使导管置入任辰、部位, 又在射流 切割作用或溶栓剂 (重组组织纤维蛋白酶原激活剂或尿 激酶等 ) 的溶栓作用下进行击碎、 溶解和引流而吸出凝 块及有 物质, 达到畅通脑脊液循环和清除血性、 炎性 和免疫性有害物质的目的  The core principle of cerebrospinal fluid interventional drainage technology is to monitor the anatomical channel and DSA of the cerebrospinal fluid circulation of the human brain and spinal canal. The principle of chamber twisting control of coaxial guide wire and catheter is used to guide the catheter to bend, rotate and Advance and retreat to adapt to the deep, complex, dangerous and extensive structural features of the ventricular system or subarachnoid system to place the catheter into the chamber, at the jet cutting action or thrombolytic agent (recombinant tissue plasminogen activator or Under the thrombolytic effect of urokinase, etc., crushing, dissolving and draining to absorb clots and substances, to achieve smooth cerebrospinal fluid circulation and clear blood, inflammatory and immune harmful substances
本发明与现有技术相比, 它公开了 种脑脊液介入 引流器 , 包括穿刺设备、 疏通设备、 外设的引流装置和 固定装置 。 穿剌设备设有穿刺针芯、 穿刺针鞘、 导丝和 引流官 针鞘套装于针芯外用于穿刺 当刺入适当位置 时, 取出针芯, 将导丝从针鞘的内孔穿入 , 再将针鞘从 体拔出 , 再将引流管沿导丝外表送入需引流的腔室内 导丝和引流管由不锈钢、 钨丝等材料按特定结构制成 柔软便于塑形和显影, 并有形状记忆功能 。 引流管可在 导丝的引导下,在 D SA的监视下自室间孔置入第三脑室, 或进一步经中脑导水管置入第四脑室。 必要时, 可用射 流管疏通脑脊液循环。 当术毕安置好外设引流装置后, 可用控液阀来控制关开。 本发明的全套装置具有持续引 流、 疏通阻塞、 测压、 给药、 置换脑脊液、 取样和动态 观察再出血情况等功能。  The present invention, in contrast to the prior art, discloses a cerebrospinal fluid interventional drainage device comprising a lancing device, a dredge device, a drainage device for the peripheral device, and a fixture. The piercing device has a puncture needle core, a puncture needle sheath, a guide wire and a drainage needle sheath which are set outside the needle core for puncture. When the puncture is in place, the needle core is taken out and the guide wire is inserted through the inner hole of the needle sheath. Then the needle sheath is pulled out from the body, and then the drainage tube is sent along the outer surface of the guide wire into the chamber to be drained. The guide wire and the drainage tube are made of stainless steel, tungsten wire and the like according to a specific structure, which is soft and easy to shape and develop, and has Shape memory function. The drainage tube can be placed into the third ventricle from the interventricular space under the guidance of the guide wire under the guidance of the guide wire, or further placed into the fourth ventricle via the midbrain aqueduct. If necessary, the cerebrospinal fluid circulation can be cleared by a jet tube. After the peripheral drainage device is installed after the surgery, the liquid control valve can be used to control the opening. The complete device of the present invention has the functions of continuous drainage, dredge obstruction, pressure measurement, administration, replacement of cerebrospinal fluid, sampling, and dynamic observation of rebleeding.
附图说明  DRAWINGS
图 1 ¾脑室介入引流设备结构简图  Figure 1 3⁄4 ventricle interventional drainage device structure diagram
图 2 ¾脑室穿剌针鞘结构示意图。  Figure 2 3⁄4 Schematic diagram of the ventricle piercing needle sheath structure.
3 ¾脑室穿刺针结构不意图。 图 4为脑室导丝结构示意图。 3 3⁄4 ventricle puncture needle structure is not intended. Figure 4 is a schematic view of the structure of the ventricle guide wire.
图 5为脑室各型导丝头端造型示意图。  Fig. 5 is a schematic view showing the shape of the head end of each type of ventricle.
图 6为脑室引流管结构示意图。  Figure 6 is a schematic view of the structure of the ventricular drainage tube.
图 7为脑室引流管各型头端造型示意图。  Figure 7 is a schematic view of the head end of each type of ventricular drainage tube.
图 8为脑室射流管结构示意图。  Figure 8 is a schematic view of the structure of the ventricle jet tube.
图 9为穿刺孔封闭器结构示意图。  Figure 9 is a schematic view showing the structure of the puncture hole closure.
图 1 0为引流管固定器结构示意图。  Figure 10 is a schematic view of the structure of the drainage tube holder.
图 1 1 为连接管结构示意图。  Figure 1 1 shows the structure of the connecting pipe.
图 1 2为脑脊液引流袋结构示意图。  Figure 1 2 is a schematic diagram of the structure of the cerebrospinal fluid drainage bag.
图 1 3 为脑室介入引流器整体安置示意图。  Figure 1 3 is a schematic diagram of the overall placement of the ventricular interventional drainage device.
图 14为腰池介入引流设备结构简图。  Figure 14 is a schematic diagram of the structure of the lumbar intervening drainage device.
图 1 5为腰池引流管和导丝头端造型示意图。  Figure 15 is a schematic diagram of the waist tube drainage tube and the tip end of the guide wire.
图 1 6 为腰池介入引流器整体安置示意图。  Figure 1 6 is a schematic diagram of the overall placement of the lumbar intervening drainage device.
体实施方式  Body embodiment
一种脑脊液介入引流器, 包括穿刺引流设备、 疏通 设备和外设的引流装置, 所述的穿刺设备设有穿刺针鞘 1、 穿刺针芯 2、 导丝 3和引流管 4。  A cerebrospinal fluid interventional drainage device comprises a drainage device for puncturing drainage device, a dredging device and a peripheral device, and the puncture device is provided with a puncture needle sheath 1, a puncture needle 2, a guide wire 3 and a drainage tube 4.
穿剌针芯 2 和针鞘 1 由不锈钢材料制成, '针鞘 1 套 装于针芯 2外, 共同用于穿刺;  The needle core 2 and the needle sheath 1 are made of stainless steel material, and the needle sheath 1 is placed outside the needle core 2 for common puncture;
导丝 3 用于替换针芯 2和引导引流管 4置入, 导丝 3 便于塑形并有形状记忆功能, 导丝 3 外层涂覆有亲水 引流管 4 用于置换针鞘 1 和引流, 并为射流管操作 的通道, 顺应性好, 管头圆钝, 以减少组织损伤, 便于 沿导丝 3外径送入需引流的腔室内。  The guide wire 3 is used for replacing the needle core 2 and guiding the drainage tube 4, the guide wire 3 is convenient for shaping and has a shape memory function, and the outer layer of the guide wire 3 is coated with a hydrophilic drainage tube 4 for replacing the needle sheath 1 and drainage. And for the channel operated by the jet tube, the compliance is good, the tube head is blunt, to reduce the tissue damage, and it is convenient to feed the outer diameter of the guide wire 3 into the chamber to be drained.
针鞘 1 套装于针芯 2 外用于穿剌, 当剌入适当位置 时, 取出针芯 2, 将导丝 3 从针鞘 1 的内孔穿入, 再将 针鞘 1 从体拔出, 再将引流管 4沿导丝 3 外径送入需引 流的腔室内。 引流管 4 的外端通过连接管 1 0与外设的引 流袋 1 1相接, 连接管 1 0上装有控液阔。 实施例 1, 脑室介入引流器 The needle sheath 1 is placed outside the needle core 2 for piercing. When the needle is inserted into the proper position, the needle core 2 is taken out, the guide wire 3 is inserted through the inner hole of the needle sheath 1, and the needle sheath 1 is pulled out from the body. The drainage tube 4 is fed along the outer diameter of the guide wire 3 into the chamber to be drained. The outer end of the drainage tube 4 is connected to the drainage bag 1 1 of the peripheral device through the connecting tube 10, and the control tube 10 is provided with a liquid control tank. Example 1, ventricular interventional drainage device
脑室介入引流器包括穿刺与引流设备、 疏通设备和 外设引流装置及固定装置, 所述的穿刺设备设有脑室穿 刺针芯 2、 脑室穿刺针鞘 1、 各型脑室导丝 3 和各型脑室 引流管 4, 所述的疏通设备设有射流管 18, 所述的外设 引流装置设有引流袋 32 和连接管 28, 所述的固定装置 设有穿刺孔封闭器 21 和引流管固定器 25。 放置于包装 盒内, 消毒密封, 一次性应用。 其他介入器具, 如各型 脑室导丝和各型脑室引流管分别单独消毒封装, 一次性 使用。 用途: 本器具专供脑室介入引流、 脑室梗阻疏通、 颅压监测、 脑脊液置换和脑室给药使用。  The ventricular interventional drainage device includes a puncture and drainage device, a dredging device and a peripheral drainage device and a fixing device, and the puncture device is provided with a ventricle puncture needle 2, a ventricle puncture needle sheath 1, various ventricle guide wires 3, and various types of ventricles The drainage tube 4, the dredging device is provided with a jet tube 18, the peripheral drainage device is provided with a drainage bag 32 and a connecting tube 28, and the fixing device is provided with a puncture hole closure 21 and a drainage tube holder 25. . Placed in a box, sterilized and sealed, disposable. Other interventional devices, such as various types of ventricular guidewires and various types of ventricular drainage tubes, are separately sterilized and packaged for single use. Uses: This device is designed for ventricular interventional drainage, ventricular obstruction, intracranial pressure monitoring, cerebrospinal fluid replacement and ventricle administration.
1、 脑室穿刺针鞘: 由鞘杆和鞘座组成, 由不锈钢材 料制成。 全长 118毫米。 如图 2:  1. Ventricular needle sheath: It consists of a sheath rod and a sheath, made of stainless steel. Full length 118 mm. Figure 2:
鞘孔 7: 为针芯的出孔, 外经 2.64 腿 , 内径 2.31 腿 ( 9号穿刺针)。 .  Sheath hole 7: The hole for the core, 2.64 legs, inner diameter 2.31 leg (puncture needle No. 9). .
刻度: 由前至后刻于鞘杆上, 用以观察进针深度。 鞘杆 8: 成圆柱形, 长 110 隱 , 外径 2.64 議 , 内径 2.31 蘭 ( 9 号穿剌针), 内腔呈圆柱形, 光滑, 头端圆钝, 与针芯 2平滑延续, 以防损伤组织。  Scale: Engraved from the front to the back on the sheath rod to observe the depth of the needle. Sheath rod 8: cylindrical, length 110 hidden, outer diameter 2.64, inner diameter 2.31 blue (no. 9 needle), inner cavity is cylindrical, smooth, rounded at the tip, smooth with the core 2, in case Damage to tissue.
基坐 9: 呈圆锥形, 大头端外径 4 蘭 , 内径 3.4 mm , 壁厚 0.3 腿 , 长 8 腿 , 小头端外径 2.64 mm, 内径 2.31 腿 ( 9 号穿剌针), 内腔呈漏斗状, 光滑, 与鞘杆 8 内腔平 滑延续。  Base 9: Conical, large outer diameter 4 blue, inner diameter 3.4 mm, wall thickness 0.3 leg, length 8 legs, small head end outer diameter 2.64 mm, inner diameter 2.31 legs (no. 9 piercing needle), inner cavity Funnel-shaped, smooth, and smooth with the lumen of the sheath 8.
2、 脑室穿刺针芯: 由针杆和观察室组成, 由不锈钢 和透明塑料材料制成。 全长 126 毫米。 如图 3:  2. Ventricle puncture needle: It consists of a needle bar and an observation chamber made of stainless steel and transparent plastic material. Full length 126 mm. Figure 3:
观察室 6: 为透明硬塑料圆柱形空腔, 长 5 mm, 外径 6 mm, 内径 5 讓 , 底端有一 1 腿直径的小孔, 用以排气。  Observation Room 6: It is a transparent hard plastic cylindrical cavity with a length of 5 mm, an outer diameter of 6 mm, an inner diameter of 5, and a small hole with a 1-leg diameter at the bottom for exhausting.
针杆 10: 长 121 腿 , 外径 2.2 腿 , 内径 1.6 腿 , 插 入穿刺针外鞘中, 其尖端可外露 3 mm。  Needle bar 10: 121 legs long, 2.2 OD outer diameter, 1.6 leg inner diameter, inserted into the outer sheath of the puncture needle, the tip of which can be exposed 3 mm.
3、 脑室导丝: 导丝 3 用于替换针芯 2 和引导引流管 4 置入, 导丝 3 由内芯塑钢材料 (如加钡塑料) 加外周 缠绕钨丝制成。 柔软、 径向硬度低, 便于塑形和显影, 并有形状记忆功能, 其头端由硅胶制成, 弱软可减轻操 作性组织损伤; 各种头端造型可供多种复杂情况置管选 择, 降低了插入难度。 外层为亲水涂层, 提高通过性。 直径 0. 83 mm, 实心, 长 600 mm。 图 4、 5 : 3, cerebral guide wire: guide wire 3 is used to replace the needle 2 and guide the drainage tube 4 Placement, the guide wire 3 is made of inner core plastic material (such as twisted plastic) plus peripherally wound tungsten wire. Soft, low radial hardness, easy to shape and develop, and shape memory function, the head end is made of silicone, soft and soft to reduce the operative tissue damage; various head-end modeling for a variety of complex conditions , reducing the difficulty of insertion. The outer layer is a hydrophilic coating to improve the passability. Diameter 0. 83 mm, solid, length 600 mm. Figures 4 and 5:
导丝头端 1 1 : 由柔软的加钡硅胶制成。 直径 0. 83 mm , 实心, 长 5 薩 。  Guide wire tip 1 1 : Made of soft twisted silicone. Diameter 0. 83 mm, solid, 5 sa.
导丝 3: 由实心的塑钢材料 (加钡塑料) 芯缠绕钨丝 制成。 直径 0.83 mm , 实心, 长 595 誦 。  Guide wire 3: Made of solid steel material (twisted plastic) core wound with tungsten wire. The diameter is 0.83 mm, solid and 595 长 long.
图 5 是各型导丝头端造型。 其中, A为直头, 多用于 侧脑室体部置入; B 为微弯, 多用于侧脑室角和第四脑 室侧孔置入; C 为斜弯, 多用于中脑导水管置入; D 为 倒弯, 多用于对侧侧脑室置入。  Figure 5 shows the shape of each type of guide wire. Among them, A is straight, mostly used for lateral ventricle body placement; B is microbend, mostly used for lateral ventricle angle and fourth ventricle lateral hole placement; C is oblique bending, mostly used for midbrain aqueduct placement; D For the inverted curve, it is mostly used for the contralateral side ventricle.
4、 脑室引流管: 脑室引流管 4用于置换针鞘 1 和引 流或射流管操作通道, 引流管 4 由铂金丝、 钨丝、 塑料、 不锈钢等材料特制而成。 外径 2.64 mm , 内径 2.3 1 腿 , 引 流管全长 4 1 0 腿 。 全程一致性内腔被覆有亲水涂层 (如 P T FE ) , 以增强器具的通过性, 提高造影剂流量和显影性 能; 头端柔软避免操作性损伤; 头端 1 0毫米由铂金丝缠 绕, 使柔顺性好和抗折力强; 头端 50毫米由前至后分五 段设计, 刚性逐渐增强, 以提高顺应性和支撑力。 头端 50毫米从内至外分别为亲水涂层、 内塑料层、 金属丝编 织层和外塑料层四层构成。 其中, 头端 1 0毫米的金属丝 编织层由铂金丝缠绕而成, 以提高柔顺性和抗折力。 其 余 4 段由钨丝缠绕为不同密度而成; 尾端不锈钢编织使 推送性能好和扭控性佳; 尾端不锈钢编织使推送性能好 和扭控性佳; 管壁全层五重式结构, 以增强支撑力和柔 顺性; 粗编层和密编层分别由钨丝和不锈钢丝编织而成, 使可视性、 支撑力及扭控性均强。 各钟头端造型可供多 种复杂情况置管选择, 降低了插入难度。 如图 6、 7: 引流管头端 12: 头端 50毫米无粗、 细编层结构, 而 是由铂金丝或不同柔度的钨丝缠绕内塑料层等组成, 由 前至后分五段设计, 以增强柔顺性和抗折力。 其中, 头 端 10 毫米由铂金丝缠绕, 其余 40 毫米由钨丝缠绕, 刚 韧性逐渐增强, 以提高顺应性和支撑力。 4, ventricle drainage tube: ventricle drainage tube 4 is used to replace the needle sheath 1 and the drainage or jet tube operation channel, the drainage tube 4 is made of platinum wire, tungsten wire, plastic, stainless steel and other materials. The outer diameter is 2.64 mm, the inner diameter is 2.3 1 leg, and the length of the drainage tube is 4 10 0 legs. The whole process consistency cavity is covered with a hydrophilic coating (such as PT FE) to enhance the passability of the device, improve the contrast agent flow and development performance; the head end is soft to avoid operational damage; the head end 10 mm is wrapped by platinum wire, It has good flexibility and good bending resistance; the 50mm head end is designed from the front to the back in five sections, and the rigidity is gradually increased to improve the compliance and support. The head end 50 mm is composed of a hydrophilic coating, an inner plastic layer, a wire braid layer and an outer plastic layer from the inside to the outside. Among them, the wire braid of 10 mm at the head end is wound with platinum wire to improve the flexibility and the folding resistance. The remaining 4 segments are made of tungsten wire wound into different densities; the stainless steel braid at the end makes the push performance good and the twist control is good; the stainless steel braid at the end makes the push performance and the twist control good; the full-layer five-fold structure of the pipe wall, To enhance the support and flexibility; the rough layer and the dense layer are woven from tungsten wire and stainless steel wire respectively, which makes the visibility, support force and torque control strong. Each hour can be shaped more A complicated situation to control the selection, reducing the difficulty of insertion. Figure 6 and 7: Drain pipe head end 12: The head end is 50 mm without thick and fine braided layer structure, but consists of platinum wire or tungsten wire wound with different flexibility, and is divided into five sections from front to back. Designed to enhance flexibility and resistance to breakage. Among them, the head end 10 mm is wound by platinum wire, the other 40 mm is wound by tungsten wire, and the toughness is gradually enhanced to improve the compliance and support force.
引流孔 5: 直径 1 腿 , 开口于导管端头, 共 6个, 相 邻两侧孔间距 6 mm。  Drain hole 5: 1 leg in diameter, 6 openings in the end of the pipe, 6 mm spacing between adjacent sides.
置入深度刻度 13, 每 10 蘭一格, 从前至后共 400 腿 0  Insert depth scale 13, every 10 orchids, from front to back, a total of 400 legs 0
引流管壁 14: 外径 2.64 mm , 内径 2.31 醒 , 长 400 mm。 除头端 50毫米为分段设计外, 其余尾段由内至外分 别为 a-亲水涂层、 b-内塑料层、 c-粗网编织层 (钨丝)、 d -密网编织层 (不锈钢丝) 和 e-外塑料层。  Drainage wall 14: Outer diameter 2.64 mm, inner diameter 2.31 awake, length 400 mm. In addition to the 50mm front-end design, the remaining tail segments are a-hydrophilic coating, b-internal plastic layer, c-coarse woven layer (tungsten wire), d-mesh woven layer from inside to outside. (stainless steel wire) and e-outer plastic layer.
操控板 15, 由硬塑料制成, 用于操作时转动引流管。 夕卜径 8. 64 mm, 长 5 mm。  The control panel 15, made of hard plastic, is used to rotate the drainage tube during operation.夕卜径 8. 64 mm, length 5 mm.
引流管连接体 16: 呈漏斗形, 与联结管乳头相连。 其大头端外径 4 腿 , 内径 3.4 mm, 壁厚 0.3 舰 , 长 5 腿 , 小头端外径 2.64 mm, 内径 2.31 mm, 内腔呈漏斗状, 光滑, 与引流管内腔平滑延续。  The drainage tube connector 16: is funnel-shaped and connected to the coupling tube nipple. Its large end has an outer diameter of 4 legs, an inner diameter of 3.4 mm, a wall thickness of 0.3 ship, a length of 5 legs, a small head end outer diameter of 2.64 mm, and an inner diameter of 2.31 mm. The inner cavity is funnel-shaped, smooth, and smoothly continues with the inner lumen of the drainage tube.
图 7为各型引流管头端造型。 A为直头, 多用于侧脑 室体部置入; B 为微弯, 多用于侧脑室角和第四脑室侧 孔置入; C为小弯, 多用于中脑导水管置入; D为中弯, 解剖变异时供操作选择。 E—大弯, 多用于对侧侧脑室置 入。  Figure 7 shows the shape of the head of each type of drainage tube. A is straight, mostly used for lateral ventricle body implantation; B is microbend, mostly used for lateral ventricle angle and fourth ventricle lateral hole placement; C is small bend, mostly used for midbrain aqueduct placement; D is medium Bend, for anatomical variation for operational selection. E—large bend, mostly used for the contralateral side ventricle.
5、 射流管 18: 射流管 18 由柔软的加钡硅胶制成, 头端圆形, 其中心开有一细微小孔, 用于射流冲洗与疏 通阻塞; 外膜覆盖有亲水涂层, 以提高滑动性和通过性, 便于插入。 如图 8:  5, the jet tube 18: The jet tube 18 is made of soft twisted silica gel, the head end is round, the center has a tiny hole for jet flushing and dredging blockage; the outer membrane is covered with a hydrophilic coating to improve Slidability and passability for easy insertion. Figure 8:
射流孔 17: 位于射流管头中央, 直径 0. 4 mm, 通过 高压流体的切割与粉碎作用而实现其冲洗与疏通功能。 射流管 18, 为硅胶制成, 外径 2.30 腿 , 内径 1.70 腿 , 长 461 mm。 4毫米的过。 The jet hole 17: in the center of the jet tube, the diameter of 0. 4 mm, through The high pressure fluid is cut and pulverized to achieve its flushing and dredging functions. The jet tube 18, made of silicone, has an outer diameter of 2.30 legs, an inner diameter of 1.70 legs and a length of 461 mm.
基座 19 :为硅胶制成, 呈圆锥形, 大头端外径 4 mm , 内径 3.4 腿 , 壁厚 0.3 mm, 长 8 咖 , 小头端夕卜径 2.30 mm, 内径 1.70 mm ( 7号穿刺针), 内腔呈漏斗状, 光滑, 与射 流管内腔平滑延续。 .  Base 19: Made of silicone, conical, 4 mm outer diameter, 3.4 legs, 0.3 mm thick, 8 mm long, 2.30 mm small tip, 1.70 mm inner diameter ), the inner cavity is funnel-shaped, smooth, and smoothly continues with the lumen of the jet tube. .
基板 20: 为硅胶制成, 呈盘形扩大, 以增强操作时 的手感.外径 6 mm , 内径.3.4 mm, 壁厚 0.3 mm, 长 3 腿 , 与射流管基坐内腔平滑延续。  Substrate 20: Made of silica gel, expanded in a disk shape to enhance the hand feeling during operation. The outer diameter is 6 mm, the inner diameter is 3.4 mm, the wall thickness is 0.3 mm, and the length is 3 legs. The inner cavity of the jet tube base is smoothly continued.
6、 穿刺孔密封器 21 : 为硅胶制成, 手术结束时套 装于引流管 4 出头皮处, 借助内孔 24 的紧缩及底部压垫 23 的压迫作用封闭穿刺口组织, 防止脑脊液外漏和引流 管移位。 如图 9:  6. Puncture hole sealer 21: It is made of silica gel. At the end of the operation, it is placed at the scalp of the drainage tube 4, and the puncture tissue is closed by the compression of the inner hole 24 and the compression of the bottom pressure pad 23 to prevent leakage and drainage of the cerebrospinal fluid. Tube shift. Figure 9:
固定臂 22: 用于粘贴胶布, 左右各一。  Fixed arm 22: For attaching tape, one on each side.
嵌压孔 24: 用于嵌压固定引流管 4, 具有一定的延 伸性。 直径 2.62mm, 长 5 mm。  Insertion hole 24: For the pressure-fixing drainage tube 4, it has a certain extension. The diameter is 2.62mm and the length is 5 mm.
图 8-3: 压垫 23: 柔软的加钡硅胶制成, 当套装于 引流管后, 加压能封闭穿刺孔, 防止脑脊液外漏。  Figure 8-3: Pressure pad 23: Made of soft twisted silicone. When set in the drainage tube, the pressure can close the puncture hole to prevent leakage of cerebrospinal fluid.
7、 引流管固定器 25 ■  7. Drainage tube holder 25 ■
用以加固引流管 4, 防止拉脱。 图 10: Used to reinforce the drain tube 4 to prevent pull-out. Figure 10 :
固定片 27, 由弹性硅胶制成。  The fixing piece 27 is made of elastic silicone.
夹管 26, 由弹性硅胶制成。 其功能是夹紧引流管防 止拉脱。 内腔直径 2.62mm, 外径 5 mm, 长 15mm。  The pinch tube 26 is made of elastic silicone. Its function is to clamp the drain tube to prevent pull-out. The inner cavity has a diameter of 2.62 mm, an outer diameter of 5 mm and a length of 15 mm.
8、 连接管 28  8, connecting pipe 28
连接管 28 由聚丙烯材料制成,是连接引流管 4与引流 袋 32 的通道。 带有控液阀 29, 其开关可直接限制 /开通 脑脊液流入引流袋 32, 以便脑室注药后的定时开闭。 图 11:  The connecting tube 28 is made of a polypropylene material and is a passage connecting the drainage tube 4 and the drainage bag 32. With the liquid control valve 29, its switch can directly limit/open the cerebrospinal fluid into the drainage bag 32, so that the ventricle can be opened and closed after the injection. Figure 11:
尾端接口: 其形状和大小与引流袋之引入口的乳头 匹配, 内腔成漏斗状。 大头端外径 4 醒 , 内径 3.4 讓 , 壁厚 0. 3 mm , 长 5 mm, 小头端外径 2. 64 mm , 内径 2. 31 腿 , 内腔呈漏斗状, 光滑。 Tail end interface: nipple of shape and size with the introduction port of the drainage bag Match, the inner cavity is funnel shaped. The outer end of the large end is 4 awake, the inner diameter is 3.4, the wall thickness is 0.3 mm, the length is 5 mm, the outer diameter of the small head end is 2.64 mm, and the inner diameter is 2.31 legs. The inner cavity is funnel-shaped and smooth.
控液阀 29: 其结构及功能与普通输液管开关无异, 其大小与本连接管匹配。  Control valve 29: Its structure and function are the same as ordinary infusion tube switch, its size is matched with this connection tube.
连接管 28: 管长 300 mm, 外径 4 mm, 内径 3 mm。 乳头: 其形状和大小与导管的连接体匹配, 呈漏斗 状, 长 5 mm, 近端内径 2.4 mm , 外径 3 mm, 尖端外径 2. 64 mm, 内径 2 讓 。  Connection tube 28: Tube length 300 mm, outer diameter 4 mm, inner diameter 3 mm. Nipple: It is shaped and sized to match the connector of the catheter. It is funnel-shaped, 5 mm long, 2.4 mm proximal diameter, 3 mm outer diameter, 2. 64 mm outer diameter tip, and 2 inner diameter.
9、 脑脊液引流袋 32  9, cerebrospinal fluid drainage bag 32
脑脊液引流袋 32 由一个软薄型聚丙烯塑料制成的 透明长方形袋和两根硬塑料管组成。 除引入、 出两管 33、 34外, 再无其他通道相通, 利于密闭防污染。 引入、 出 两管不相接, 且不在同一水平, 是为了消除管道的 "吸 引 " 效应, 有利脑室内压力的恒定和维持。 引入管 33上 刻有高度刻度 (厘米), 有利于监控颅内压。 如图 12: 挂口 31 : 为双引流腔壁延续而成, 外缘呈半圆型, 直径为 40 腿 , 挂口为圆形, 直径为 20 腿 。 用于悬挂。  The cerebrospinal fluid drainage bag 32 consists of a transparent rectangular bag made of soft, thin polypropylene plastic and two hard plastic tubes. In addition to the introduction and exit of the two tubes 33, 34, there is no other channel to communicate, which is conducive to sealing and anti-pollution. The introduction and discharge of the two tubes are not connected, and are not at the same level, in order to eliminate the "suction" effect of the pipeline, and to facilitate the constant and maintenance of intraventricular pressure. The introduction tube 33 is engraved with a height scale (cm) to facilitate monitoring of intracranial pressure. Figure 12: Hanging mouth 31: The continuation of the double drainage wall, the outer edge is semi-circular, with a diameter of 40 legs, the opening is round and the diameter is 20 legs. Used for hanging.
引流腔: 为长方形圆角的空腔。 长 100 mm , 宽 40 腿 。 引入管 33: 为垂直的倒 " L" 型, 自下而上刻有高 度刻度 (厘米), 入口呈空针乳头状, 其形状和大小与连 接管之尾端接口匹配。 引入管外径 4 腿 , 内径 3.4 mm, 壁厚 0.3 腿 , 垂直部长 90 腿 , 弯曲部长 20 腿 。  Drainage cavity: A cavity with a rectangular fillet. It is 100 mm long and 40 legs wide. Inlet tube 33: is a vertical inverted "L" type with a high scale (cm) from bottom to top and an empty needle nipple at the entrance that matches the shape and size of the end of the connecting tube. The introduction tube has an outer diameter of 4 legs, an inner diameter of 3.4 mm, a wall thickness of 0.3 legs, a vertical length of 90 legs, and a bending of 20 legs.
引出管 34: 为一垂直的管道, 出口呈空针乳头状, 其形状和大小与其他普通医用引流袋 (如尿袋) 的接口 匹配。 引出管外径 4 mm, 内径 3.4 腿 , 壁厚 0.3 醒 。  The extraction tube 34: is a vertical tube, the outlet is empty needle-shaped, and its shape and size match the interface of other common medical drainage bags (such as urine bags). The outlet tube has an outer diameter of 4 mm, an inner diameter of 3.4 legs, and a wall thickness of 0.3 awake.
10、 脑室介入引流器及整体安放方式如图 13所示。 实施例 2, 腰池介入引流器  10, ventricle interventional drainage device and overall placement as shown in Figure 13. Embodiment 2, lumbar intervening drainage device
腰池介入引流器包括穿刺与引流设备、 外设引流装 置和固定装置, 所述的穿刺设备设有腰池穿刺针芯 2、 腰池穿刺针鞘 1、 腰池导丝 3和腰池引流管 4, 所述的外 设引流装置设有引流袋 32 和连接管 28, 所述的固定装 置设有穿刺孔封闭器 21 和引流管固定器 25。 放置于包 装盒内, 消毒密封, 一次性应用。 用途: 本器具专供腰 池穿剌持续引流、 脑脊液置换和腰池给药使用。 The lumbar intervening drainage device comprises a puncture and drainage device, a peripheral drainage device and a fixing device, and the puncture device is provided with a lumbar puncture needle 2 a lumbar puncture needle sheath 1, a lumbar guide wire 3 and a lumbar drainage tube 4, the peripheral drainage device is provided with a drainage bag 32 and a connecting tube 28, and the fixing device is provided with a puncture hole closure 21 and drainage Tube holder 25. Placed in the box, sterilized and sealed, disposable application. Uses: This device is specially designed for continuous drainage of the lumbar cistern, cerebrospinal fluid replacement and lumbar cistern administration.
针鞘 1 : 由不锈钢制成, 针尖呈斜面, 有利于刺入 腰池。 针鞘总长度为 105 腿 。 如图 14。  Needle sheath 1 : Made of stainless steel with a beveled tip that facilitates penetration into the lumbar pool. The total length of the needle sheath is 105 legs. As shown in Figure 14.
基座: 外径 4 mm, 内径 3 mm, 长 5 蘭 , 呈圆柱状, 远端呈漏斗状, 与针干相延续。  Base: 4 mm outer diameter, 3 mm inner diameter, 5 mm long, cylindrical, distal end funnel-shaped, continuous with needle dry.
针干: 成圆柱形, 长 100 mm, 外径 1. 22 腿 , 内径 1.06 mm ( 18 号穿剌针), 内腔呈圆柱形, 光滑。 尖端呈 斜形。 由尖端向后刻有长麁刻度 (厘米数) ,有利于观察 进针深度。  Needle dry: Cylindrical, length 100 mm, outer diameter 1. 22 legs, inner diameter 1.06 mm (passing needle 18), the inner cavity is cylindrical and smooth. The tip is beveled. A long 麁 scale (in centimeters) is engraved backwards from the tip to facilitate observation of the depth of the needle.
针芯 2: 由不锈钢制成, 实心, 与其尾座相连。 尖 端呈斜形, 有利于刺入腰大池。 针芯总长度为 107 mm。 如图 13-B。  Needle 2: Made of stainless steel, solid, connected to its tailstock. The tip is slanted to facilitate penetration into the waist pool. The total length of the core is 107 mm. As shown in Figure 13-B.
基板: 由不锈钢制成, 实心, 与其尾座相连, 呈圆 柱形, 外径 8 mm, 厚 2 mm, 有利于控制进针深度。  Substrate: Made of stainless steel, solid, connected to its tailstock, cylindrical, with an outer diameter of 8 mm and a thickness of 2 mm, which helps to control the depth of the needle.
尾座: 由不锈钢制成, 与针心及基板相连, 呈圆柱 形实心体, 外径 3 腿 , 长 5 mm, 其远端有与针鞘相应部 位匹配的斜形坡度。  Tailstock: Made of stainless steel, connected to the core and the base plate, it has a cylindrical solid body with an outer diameter of 3 legs and a length of 5 mm. The distal end has a sloped slope that matches the corresponding position of the needle sheath.
针芯: 长 102 mm, 直径 1. 0 mm, 其尖端可外露 2 咖 。 导丝 3、: 由塑钢材料制成, 柔软便于塑形, 并有形 状记忆功能。 尖端圆钝, 以减轻对组织的损伤, 表面光 滑, 被覆亲水涂层, 以便插入。 直径 0. 83 mm, 实心, 长 1000 mm。 自尖端向后刻有长度刻度 (厘米数)。  Needle core: 102 mm long, 1. 0 mm in diameter, the tip can be exposed 2 coffee. Guide wire 3,: Made of plastic steel material, soft and easy to shape, and has a shape memory function. The tip is rounded to reduce damage to the tissue, the surface is smooth, and the hydrophilic coating is applied for insertion. Diameter 0. 83 mm, solid, 1000 mm long. A length scale (in centimeters) is engraved from the tip to the back.
引流管 4: 为柔软的加钡硅胶制成, 顺应性好, 管 头圆钝, 以便送入腰大池深处。 自尖端向后刻有长度刻 度 (厘米数) ,有利于观察插入深度。 其尖端有侧孔, 以 便引流。 导管连接体: 呈漏斗形, 大头端外径 4 mm, 内径 3. 4 ■, 壁厚 0. 3 腿 , 长 5 mm , 小头端夕卜径 1. 22 mm , 内径 1. 06 mm , 内腔呈漏斗状, 光滑,与导管内腔平滑延续。 Drain tube 4: Made of soft twisted silicone, with good compliance and rounded head for feeding into the deep pool. A length scale (in centimeters) is engraved from the tip backwards to facilitate viewing of the insertion depth. The tip has a side hole for drainage. The inner diameter of the outer diameter is 4. 4 mm, the inner diameter is 3. 4 ■, the wall thickness is 0.3 mm, the length is 5 mm, the small head end is 1.22 mm, and the inner diameter is 1. 06 mm. The cavity is funnel-shaped, smooth, and smoothly continues with the lumen of the catheter.
导管干: 外径 1. 22 mm, 内径 1. 06 腿 , 长 800 咖 , 尖端圆钝。  Dry conduit: outer diameter 1. 22 mm, inner diameter 1. 06 legs, length 800 coffee, tip blunt.
引流侧孔: 直径 0. 5 腿 , 开口于导管端头, 共 6个, 相邻两侧孔间距 10 腿 。  Drainage side hole: diameter 0. 5 legs, opening at the end of the catheter, a total of 6 holes, the adjacent side holes are 10 legs apart.
图 15 为腰池介入引流导丝和导管的管头造型, 呈中 弯形, 有利于导丝或导管在脊髓蛛网膜下腔插入定位。  Figure 15 shows the shape of the tube head of the lumbar intervening drainage guide wire and catheter, which is in a curved shape, which facilitates the insertion of the guide wire or catheter into the subarachnoid space of the spinal cord.
5、 连接管 28、 脑脊液引流袋 32、 穿刺孔封闭器 21 和引流管固定器 25 的结构与脑室介入引流器的相应器 具相同, 尺寸与其引流管匹配。  5. The connection tube 28, the cerebrospinal fluid drainage bag 32, the puncture hole closure 21 and the drainage tube holder 25 have the same structure as the corresponding device of the ventricular interventional drainage device, and the size is matched with the drainage tube.
6、 腰池介入引流整体装置安放方式如图 16所示。  6. The installation method of the lumbar pool interventional drainage device is shown in Figure 16.

Claims

权 利 要 求 Rights request
1、 一种脑脊液介入引流器, 包括穿刺引流设备、 疏 通设备和外设的引流装置, 其特征在于: 所述的穿刺引 流设备设有穿刺针芯 ( 2 )、 穿刺针鞘 ( 1 )、 导丝 ( 3 ) 和 引流管 ( 4), 1. A cerebrospinal fluid interventional drainage device, comprising a drainage device for puncturing drainage device, a dredging device and a peripheral device, characterized in that: the puncture drainage device is provided with a puncture needle core (2), a puncture needle sheath (1), a guide Silk (3) and drainage tube (4),
穿刺针芯 ( 2 ) 和针鞘 ( 1 ) 由不锈钢材料制成, 针 鞘 ( 1 ) 套装于针芯 ( 2 ) 外, 共同用于穿刺;  The puncture needle (2) and the needle sheath (1) are made of stainless steel, and the needle sheath (1) is set outside the needle core (2) for common puncture;
导丝 ( 3) 用于替换针芯 ( 2) 和引导引流管 (4) 置 入, 导丝 ( 3 ) 便于塑形并有形状记忆功能, 导丝 ( 3 ) 外层涂覆有亲水涂层;  The guide wire (3) is used for replacing the needle core (2) and guiding the drainage tube (4), the guide wire (3) is convenient for shaping and has a shape memory function, and the outer layer of the guide wire (3) is coated with a hydrophilic coating Floor;
引流管 ( 4 ) 用于置换针鞘 ( 1 ) 和引流, 并为射流 管 ( 18) 操作的通道, 顺应性好, 便于沿导丝 ( 3) 外径 送入需引流的腔室内。  The drainage tube (4) is used to replace the needle sheath (1) and the drainage, and is a channel for the operation of the jet tube (18). The compliance is good, and it is convenient to feed the outer diameter of the guide wire (3) into the chamber to be drained.
2、 根据权利要求 1所述的脑脊液介入引流器, 其特 征在于: 引流管 ( 4) 由铂金、 钨丝、 塑料和不锈钢等材 料制成, 全程一致性内腔被覆有亲水涂层; 头端柔软避 免操作性损伤; 头端 50毫米由前至后分五段设计, 刚韧 性逐渐增强, 从内至外分别为亲水涂层、 内塑料层、 金 属层和外塑料层四层构成, 其中, 头端 10毫米的金属层 由铂金丝缠绕而成, 其余 4 段由钨丝缠绕而成; 尾端不 锈钢编织; 头端 50毫米以后的管壁由内至外依次由亲水 涂层、 内塑料层、 粗网编织层、 密网编织层和外塑料层 五层构成; 粗网编织层和密网编织层分别由钨丝和不锈 钢丝编织而成。  2. The cerebrospinal fluid interventional drainage device according to claim 1, wherein: the drainage tube (4) is made of a material such as platinum, tungsten wire, plastic, and stainless steel, and the entire lumen is covered with a hydrophilic coating; The end is soft to avoid operational damage; the head end 50 mm is designed from the front to the back in five stages, and the toughness is gradually enhanced. From the inside to the outside, it is composed of a hydrophilic coating, an inner plastic layer, a metal layer and an outer plastic layer. Among them, the metal layer of the head end 10 mm is wound by platinum wire, and the other 4 sections are made of tungsten wire; the tail end is made of stainless steel; the wall of the head end 50 mm later is made of hydrophilic coating from the inside to the outside. The inner plastic layer, the coarse mesh woven layer, the dense mesh woven layer and the outer plastic layer are composed of five layers; the coarse mesh woven layer and the dense mesh woven layer are respectively woven from tungsten wire and stainless steel wire.
3、 根据权利要求 1所述的脑脊液介入引流器, 其特 征在于: 所述的穿刺针鞘 ( 1)、 导丝 ( 3) 和引流管 ( 4) 的外表面都标有刻度。  3. The cerebrospinal fluid interventional drainage device according to claim 1, wherein: the outer surfaces of the puncture needle sheath (1), the guide wire (3) and the drainage tube (4) are marked with a scale.
4、 根据权利要求 1所述的脑脊液介入引流器, 其特 征在于: 引流管 ( 4) 的外端通过导管 ( 28) 与外设的引 流装置相接, 导管 ( 28) 上装有控液阀 ( 29)。 4. The cerebrospinal fluid interventional drainage device according to claim 1, wherein The outer end of the drainage tube (4) is connected to the peripheral drainage device through a conduit (28), and the control valve (29) is mounted on the conduit (28).
5、 根据权利要求 1所述的脑脊液介入引流器, 其特 征在于: 引流管 ( 4) 的头端管壁上开有 5— 10个侧引流 孔 ( 5)。  The cerebrospinal fluid interventional drainage device according to claim 1, characterized in that: 5 to 10 side drainage holes (5) are formed in the head end wall of the drainage tube (4).
6、 根据权利要求 1所述的脑脊液介入引流器, 其特 征在于: 所述的针芯 ( 2) 是中空的注射式针芯, 后端连 接有一个观察室 ( 6)。  6. The cerebrospinal fluid interventional drainage device according to claim 1, wherein: the needle core (2) is a hollow injection needle core, and an observation chamber (6) is connected to the rear end.
7、 根据权利要求 1所述的脑脊液介入引流器, 其特 征在于: 所述的射流管 ( 18) 由柔软的硅胶制成, 头端 圆形, 其中心开有一细微小孔 ( 117), 用于射流, 外膜 覆盖有亲水涂层。  7. The cerebrospinal fluid interventional drainage device according to claim 1, wherein: the jet tube (18) is made of soft silicone, has a rounded tip end, and has a fine hole (117) at the center thereof. For the jet, the outer membrane is covered with a hydrophilic coating.
8、 根据权利要求 1所述的脑脊液介入引流器, 其特 征在于: 所述的外设引流装置设有一个脑脊液引流袋 8. The cerebrospinal fluid interventional drainage device according to claim 1, wherein: said peripheral drainage device is provided with a cerebrospinal fluid drainage bag.
( 32), 脑脊液引流袋 ( 32) 的上部设有悬挂装置 ( 31), 脑脊液引流袋 ( 32) 的底部向内装有一个引入管 ( 33), 引入管( 33 )下端与所述的引流管( 4 )相接, 引入管( 33 ) 的上端口距侧脑室中心的高度为 15〜 20cm, 脑脊液引流 袋 ( 32) 的下部还通过引出管 ( 34) 与一个集液袋 (.30) 相连通, 引入管 ( 33) 上标有刻度。 (32), the upper part of the cerebrospinal fluid drainage bag (32) is provided with a suspending device (31), and the bottom of the cerebrospinal fluid drainage bag (32) is provided with an introduction tube (33) inwardly, and the lower end of the introduction tube (33) and the drainage tube (4) In contact, the upper port of the introduction tube (33) is 15 to 20 cm from the center of the lateral ventricle, and the lower portion of the cerebrospinal fluid drainage bag (32) is also connected to a collection bag (.30) through the outlet tube (34). Pass, the inlet tube (33) is marked with a scale.
9、 根据权利要求 1所述的脑脊液介入引流器, 其特 征在于: 在引流管 ( 4) 与人体穿刺孔外侧设有穿刺孔密 封器 ( 21), 在穿剌孔外的引流管 ( 4) 上装有引流管固 定器 ( 25), 所述的穿刺孔密封器 ( 21) 为硅胶制成, 套 装于引流管 ( 4) 出头皮处, 穿刺孔密封器 ( 21) 设有一 个嵌压固定引流管 ( 4) 的嵌压孔 ( 24), 嵌压孔 ( 24) 的左右两边各设有一个用于粘贴胶布的固定臂 ( 22), 在 嵌压孔 ( 24) 内缘下方设有压垫 ( 23); 所述的引流管固 定器 ( 25) 设有一个由弹性硅胶制成的夹管 ( 26), 夹管 The cerebrospinal fluid interventional drainage device according to claim 1, characterized in that: a drainage hole sealer (21) is arranged outside the drainage tube (4) and the human puncture hole, and a drainage tube outside the perforation hole (4) A drainage tube holder (25) is mounted thereon, the puncture hole sealer (21) is made of silica gel, and is placed at the scalp of the drainage tube (4), and the puncture hole sealer (21) is provided with a fixed pressure drainage. a pressing hole (24) of the tube (4), and a fixing arm (22) for attaching the adhesive tape on the left and right sides of the pressing hole (24), and a pressure pad under the inner edge of the pressing hole (24) (23); the drainage tube holder (25) is provided with a pinch tube (26) made of elastic silicone, the tube is clamped
( 26) 两侧各设有一个固定片 ( 27)。 ( 26) One fixing piece ( 27) is provided on each side.
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