A card-type shunt and interventional medical device
By setting up large and small cavity in the delivery system of the separating shunt for hydrocephalus treatment, and setting up shunt installation grooves and limits on the puncture catheter, the problems of complex operation, low safety and high cost in the prior art are solved, and the smooth deployment and efficient anchoring of the separating shunt are achieved.
Patent Information
- Application Number
- CN202411987196.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-31
- Publication Date
- 2025-04-04
AI Technical Summary
In the prior art, when deploying a separating shunt for hydrocephalus treatment, there are problems such as complex operation, low safety and high cost. Especially when delivering equipment in tortuated blood vessels, it is difficult to control the movement of the protective member, and the risk of using the shunt push rod is high.
By setting a large and small cavity on the delivery catheter, a shunt tube installation groove is set on the puncture catheter, and a limit piece that can cooperate with the shunt tube installation groove is set on the punt diversion device to achieve smooth deployment of the punt diversion device, and automatically hang the meningeal squeezed on the outer wall of the punt tube when the punt catheter exits.
The number of components of medical devices is simplified, the risk of using shunt push rods is reduced, the deployment safety and anchoring force of the retaining shunt are improved, and the complexity and duration of surgical operations are reduced.
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Figure CN119746251A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of medical devices, and in particular to a clamping type shunt and an interventional medical device. Background Art
[0002] Hydrocephalus is one of the most common and important neurosurgical conditions affecting children and adults. Hydrocephalus, meaning "water in the brain," refers to the abnormal accumulation of cerebrospinal fluid (CSF) in the brain. Excessive intracranial pressure caused by hydrocephalus can lead to a number of significant symptoms, ranging from headaches to neurological dysfunction, coma, and death. Cerebrospinal fluid is a clear physiological fluid in which the entire nervous system, including the brain and spinal cord, is bathed. CSF is produced by cells of the choroid plexus, which resides within the ventricles of the brain. In normal patients, cells within the arachnoid granulations reabsorb the CSF produced in the choroid plexus. The arachnoid granulations span the surface of the intracranial venous drainage system of the brain and reabsorb CSF present in the subarachnoid space into the venous system. Approximately 450 mL to 500 mL of CSF are produced and reabsorbed each day, enabling a steady-state volume and pressure of approximately 8-16 cm H2O to be produced in the intracranial chambers.
[0003] Hydrocephalus most often occurs due to impaired reabsorption of CSF, but sometimes also due to its overproduction. A condition in which reabsorption is impaired is called communicating hydrocephalus. Normal pressure hydrocephalus (NPH) is a form of communicating hydrocephalus. Unlike other forms of communicating hydrocephalus, patients with NPH may show little or no increase in intracranial pressure. It is believed that in patients with NPH, the CSF-filled ventricles in the brain enlarge to accommodate the increased CSF volume in the subarachnoid space.
[0004] Typically, CSF is "shunted" (diverted) using the following types of shunts: A ventriculoperitoneal shunt diverts CSF from the ventricles of the brain to the abdominal cavity. A ventriculo-atrial shunt diverts CSF from the ventricles of the brain to the cavities of the heart. A lumbar-peritoneal shunt diverts CSF from the lower back to the abdominal cavity.
[0005] In recent years, a percutaneous / vascular interventional treatment method for shunt of cerebrospinal fluid has been proposed. The specific treatment method is to deploy a shunt in the patient's ventricles and adjacent veins, such as the cerebellopontine angle cistern and the inferior petrosal sinus. The distal part of the shunt is introduced through the IPS and fixed in the patient's cerebellopontine (CP) angle cistern, which contains cerebrospinal fluid (CSF); the proximal part of the shunt is fixed in or near the patient's jugular vein (JV); CSF flows from the CP angle cistern into the JV through the flow channel of the shunt to maintain a normal pressure difference between the patient's subarachnoid space and venous system.
[0006] During the deployment process, it is necessary to enter from the femoral vein to reach the internal jugular vein and then to reach the inferior petrosal sinus. The deployment of the shunt requires a puncture needle to control the puncture of the dura mater from outside the body. For example, the patent document with the publication number CN108136164B discloses a system and method for treating hydrocephalus, which partially exposes or covers the penetrating element by adding a layer of protective member at the distal needle tip position. The protective member and the needle tip can slide relative to each other. After reaching the position, the protective member slides backward by pulling the pull wire at the proximal end of the protective member to expose the needle tip. However, when delivering the device in a tortuous blood vessel, it is difficult to control the movement of the protective member by using only a pull wire to control the protective member, especially when the thin wire is pushed The protective member is prone to bending, folding, twisting, or even entangled on the puncture needle body. The too thin wire can only provide pulling force, but not pushing force, so the needle tip cannot be repeatedly exposed and the blood vessel cannot be protected during the withdrawal process of the needle tip. In terms of operation, the guide wire needs to first pass through the guide wire hole of the protective member and then pass into the guide wire hole of the puncture needle, which is difficult to operate during the process. In addition, it is necessary to push the shunt tube through the slender pusher in the second cavity of the delivery catheter, which causes friction and elastic deformation. If the elastic deformation of the slender pusher is too large, the shunt tube will be released suddenly, which is difficult to control and will push the shunt tube deep into the ventricle, posing a risk of falling off. At the same time, when the slender pusher is withdrawn, the slender pusher is easily pulled from the ventricle side to the vein under the restriction of the delivery catheter, seriously affecting the safety of the operation. And there is an extra step to push the shunt tube, which poses a risk of using the shunt tube push rod.
[0007] For another example, the patent document with publication number CN117282004A discloses a shunt and its system for treating hydrocephalus. The delivery system also needs to push the shunt through the shunt push rod. The operation steps are relatively complicated and the above problems also exist. In addition, because the positioning shunt is placed in the needle tube, the limit size of the positioning shunt is small, so that the anchoring force of the shunt limit part on the biofilm is small (in order to obtain a higher anchoring force, the limit part of the positioning shunt should be as large as possible). When the shunt is located in the puncture member, the expansion part at the distal end of the shunt does not expand the meninges and is a redundant structure. When a half-split needle is used, the shunt is placed at the half-split needle. When the needle is punctured, the needle is very likely to be deformed, thereby posing a surgical risk. At the same time, the shunt limit part will be restricted to the venous side and cannot be deployed. At the same time, the shunt is in a free state during transportation and may fall off in the venous system.
[0008] In order to solve the problems existing in the above-mentioned prior art, a more convenient, safer and lower-cost card-type shunt and interventional medical device are proposed. Summary of the invention
[0009] In order to solve the above technical problems, the present invention provides a clamping type shunt and an interventional medical device, which are implemented by the following technical solutions: The present invention provides a positioning shunt, which is transported by a delivery system and deployed in the patient's ventricular system and venous system to discharge cerebrospinal fluid in the patient's ventricular system to the venous system. The dura mater between the ventricular system and the venous system is provided with a puncture hole. The delivery system includes a puncture catheter provided with a puncture needle. During the delivery process, the positioning shunt is arranged in the puncture catheter. The proximal side wall of the puncture needle is provided with at least one shunt tube mounting groove. The positioning shunt includes a shunt tube body for deployment in the venous system and a distal part for deployment in the ventricular system. The distal part is provided with a stopper for contacting the dura mater in the axial direction and having a radial size larger than the puncture hole. The stopper penetrates the shunt tube mounting groove and extends in the radial direction to the peripheral side wall protruding from the puncture catheter. The meninges in this application are referred to as abbreviations, referring to the dura mater, arachnoid membrane, venous sinus wall, inferior petrosal sinus wall, etc., to avoid too lengthy descriptions. The limiter can not only increase the anchoring force, but also drive the shunt tube body into the ventricle through the shunt tube installation groove without the need for an additional push rod, and can also automatically hang on the meninges squeezed on the outer wall of the puncture catheter when the puncture catheter is withdrawn.
[0010] Specifically, the limiting member includes an expansion portion and a limiting portion, the expansion portion extends along the axial direction of the shunt tube body, and is used to guide the limiting member through the dura mater; the limiting portion extends along the radial direction of the shunt tube body and protrudes from the outer peripheral side wall of the shunt tube body, and is used to form an axial limit with the shunt tube mounting groove to push the locking shunt to the deployment position.
[0011] As a further improvement of the above solution, the limiting portion includes an enlarged limiting portion and a basic limiting portion, the basic limiting portion extends from the radial direction of the shunt tube body, and the enlarged limiting portion extends from the basic limiting portion along the circumferential direction of the shunt tube body.
[0012] As a further improvement of the above solution, the amplified limiting portion is an annular developing ring or a wing-shaped developing sheet, so that the amplified limiting portion can achieve both limiting and developing.
[0013] Specifically, the limiting portion is arranged parallel to the radial direction of the blocking diverter, or the limiting portion is arranged inclined toward the proximal end relative to the radial direction of the blocking diverter. The enlarged limiting portion is an inclined surface, which can increase the contact surface and improve the anchoring force.
[0014] As a further improvement of the above solution, the radial dimension of the expansion portion gradually decreases from the limiting portion to the distal end surface of the locking diverter.
[0015] The present invention also provides an interventional medical device, comprising the above-mentioned positioning shunt and a delivery system for delivering the positioning shunt; the delivery system comprises a distal anchoring structure for deployment at the distal end of the vein site to be punctured, a guide wire connected to the distal anchoring structure, a double-lumen delivery catheter provided with a large cavity and a small cavity, and a puncture catheter provided with a puncture needle, the puncture catheter is arranged in the large cavity and the puncture needle does not protrude from the large cavity in the axial direction during the delivery process, the positioning shunt is arranged in the puncture catheter, the guide wire passes through the small cavity, and the proximal end of the puncture needle is provided with at least one shunt tube mounting groove; the limit member passes through the shunt tube mounting groove and extends in the radial direction to the outer peripheral side wall protruding from the puncture catheter.
[0016] As a further improvement of the above scheme, the length L1 from the distal end face of the small cavity to the proximal end of the delivery system minus the length L2 from the distal end face of the large cavity to the proximal end of the delivery system is set as the distance X0, X0=L1-L2, and the distance X0 satisfies: -D≤X0≤30 mm, where D is the diameter at the entrance of the target venous system.
[0017] As a further improvement of the above scheme, the small cavity has a long axis direction and a short axis direction with different lengths. The small cavity is arranged at the distal end of the double-lumen delivery catheter and has an axial length smaller than that of the large cavity. The guide wire is arranged as a flat wire at least at the distal end.
[0018] As a further improvement of the above solution, the distance between the distal tip of the puncture needle and the proximal end of the distal end surface of the double-lumen delivery catheter is less than or equal to the distance between the target puncture position and the entrance of the target venous system.
[0019] As a further improvement of the above scheme, the puncture catheter is provided with a puncture stop structure to prevent the puncture catheter from puncturing too deeply, and the puncture stop has a stop surface for abutting and limiting the position with the dura mater, and the distance L between the stop surface and the tip of the puncture needle is less than or equal to 8 mm.
[0020] As a further improvement of the above solution, a friction-increasing structure is provided between the puncture catheter and the shunt tube body, so as to prevent the locking shunt from being separated from the puncture catheter during transportation.
[0021] As a further improvement of the above solution, the friction-increasing structure is a step tube, and the step tube includes a step tube section, a shaft and a handle.
[0022] As a further improvement of the above solution, the friction-increasing structure includes but is not limited to a gap less than 0.1 mm or a step tube. In a tiny tube diameter or tiny gap, the shear stress of the fluid can provide friction as a way to increase friction.
[0023] As a further improvement of the above solution, the distal end of the small cavity is provided with an introduction structure, such as an oblique incision or an introduction sheath, to facilitate the insertion of a guide wire.
[0024] As a further improvement of the above solution, the distal end of the large cavity is configured as an arc-shaped cross-section, thereby reducing the risk of the blocking shunt getting stuck at the inlet of the double-lumen delivery catheter.
[0025] As a further improvement of the above scheme, the double-lumen delivery catheter includes a first lockable structure and a delivery catheter body. The proximal end of the delivery catheter body is locked and connected to the puncture catheter through the first lockable structure. The large cavity and the small cavity are axially overlapped and arranged on the delivery catheter body to form a double-lumen section, thereby avoiding misoperation or displacement of the puncture catheter during use and reducing accidental exposure.
[0026] As a further improvement of the above solution, a TIP head is provided at the distal end of the double-lumen delivery catheter, so that the double-lumen delivery catheter can protect the blood vessel and will not scratch the blood vessel when entering the blood vessel.
[0027] As a further improvement of the above scheme, a delivery sheath and a guide wire locking piece are also provided on the guide wire. The delivery sheath is fixedly connected or locked with the guide wire locking piece. The delivery sheath is used to assist the guide wire to enter the inferior petrosal sinus through the catheter to avoid bending during delivery, and the delivery sheath can lock or loosen the guide wire through the guide wire locking piece.
[0028] As a further improvement of the above solution, the guide wire is provided with a developable structure, including but not limited to a gold plating layer, a developing ring, a developing platinum tungsten wire, a developing platinum iridium wire, etc.
[0029] As a further improvement of the above solution, the distal anchoring structure is rotationally connected or fixedly connected to the guide wire.
[0030] As a further improvement of the above solution, a limiting structure for limiting the axial movement of the guide wire is provided at the proximal end of the distal anchoring structure, and the distal end of the guide wire and the distal anchoring structure are rotatably connected via the limiting structure.
[0031] As a further improvement of the above solution, a puncture stop structure is provided on the puncture catheter, and the puncture stop structure is an externally embedded developing ring, so that the puncture stop structure can both develop and prevent the puncture catheter from puncturing too deeply.
[0032] As a further improvement of the above solution, an introduction sheath is arranged in the small cavity to assist the guide wire to pass through the double-lumen delivery catheter.
[0033] As a further improvement of the above scheme, the puncture catheter includes an operating component and a puncture catheter body, the puncture needle is arranged at the end of the puncture catheter body, and the operating component includes but is not limited to a catheter seat, a handle, a Y valve (i.e., a second lockable structure), etc.
[0034] Compared with the prior art, the present invention has the following beneficial effects: The present invention provides a large cavity and a small cavity on the delivery catheter, a shunt tube installation groove on the puncture catheter, and a stopper that can cooperate with the shunt tube installation groove on the clamping type shunt, so that the stopper of the clamping type shunt can protrude from the puncture catheter through the shunt tube installation groove, thereby increasing the stopper size, which can not only realize the smooth deployment of the clamping type shunt, but also the stopper will not cause too much influence on the puncture of the puncture needle, reduce the shunt tube push rod, and simplify the number of components of the delivery system; In addition, the pushing function of the shunt tube push rod is replaced by a puncture catheter provided with a shunt tube installation groove (the shunt tube push rod in the prior art is elastic. When the pushing force is large, the push rod elastically deforms too much, and the shunt tube is suddenly released, which is difficult to control, and the shunt tube is pushed deep into the ventricle, which poses a risk of falling off, and an extra step of pushing the shunt tube is required). By reducing the shunt tube push rod as a component, the use risk of the shunt tube push rod is reduced; At the same time, the positioning shunt can also automatically hook the meninges squeezed on the outer wall of the puncture catheter when the puncture catheter is withdrawn. Compared with the existing technology, this solution can maximize the upper limit of the limit part and the tube body size under the limited double-lumen catheter large lumen inner diameter, thereby improving the anchoring force of the shunt tube and the sealing ability of the tube body. BRIEF DESCRIPTION OF THE DRAWINGS
[0035] Figure 1 A schematic diagram of a delivery system for an interventional drainage shunt; Figure 2 It is a display diagram of the conveying system and the card-type diverter; Figure 3 A display diagram of the puncture catheter and the shunt tube installation slot; Figure 4 This is a diagram showing the delivery system in the internal jugular vein; Figure 5 This is a diagram showing the layout of the large and small cavities at the bifurcation of the venous sinus. Figure 6 This is a display diagram of the step tube; Figure 7 This is a diagram showing the first type of distal structure of the large lumen and small lumen in the double lumen delivery catheter; Figure 8 This is a diagram showing the second type of distal structure of the large lumen and small lumen in the double lumen delivery catheter; Fig. 9 This is a structural display diagram of a card-type diverter; Fig.10 This is a display diagram of a stopper for a clamping type flow divider; Fig.11 This is a display diagram of different types of stoppers for the card-type diverter; Fig.12 A diagram showing the connection structure between the distal anchoring structure and the guide wire; Fig.13 A diagram showing a puncture needle and a puncture stop structure; Fig.14 A diagram showing a detachable introduction sheath; Fig.15 A diagram showing a peelable introduction sheath; Fig.16 It is a display diagram of the card-type diverter and the friction-increasing structure; Fig.17 A diagram showing the guide wire and the distal anchoring structure; Fig.18 This is a diagram showing the different structures of the large lumen and small lumen in a double-lumen delivery catheter; Fig.19 It is an end view showing the small and large lumens in the double-lumen delivery catheter; Fig. 20 This is the angle diagram of the double-lumen delivery catheter and the puncture catheter after shaping; Fig.21 This is a diagram showing the body of the puncture catheter; Fig. 22 This is a diagram showing the puncture catheter.
[0036] Description of main symbols: 1. distal anchoring structure; 11. anchoring development ring; 12. connecting ring; 2. Guide wire; 21. Clamping rod; 22. Limit block; 23. Developing ring; 24. PTFE coating; 3. Double-lumen delivery catheter; 30. First lockable structure; 31. Large cavity; 32. Small cavity; 33. Delivery catheter body; 34. Embedded developing ring; 35. Quick exchange interface; 36. Tip head; 37. Arc-shaped cross section; 4. puncture catheter; 40. second lockable structure; 41. puncture needle; 42. puncture stop structure; 43. puncture catheter body; 44. shunt tube installation groove; 5. Friction-increasing structure; 51. Step pipe section; 52. Rod body; 53. Handle; 7. Delivery cannula; 8. Guidewire locking piece; 92, introduction sheath; 921, expansion introduction port; 922, removal slot; 923, insertion port; 924, contraction introduction port; 925, tearable removal slot; 926, insertion sleeve port; 10. Positioning shunt; 101. Shunt tube body; 102. Distal part; 103. Limiting piece; 104. Shunt tube metal reinforcement structure; 105. Shunt tube proximal developing ring; 106. Shunt tube distal developing ring; 107. Cerebrospinal fluid inlet; 108. Cerebrospinal fluid outlet; 1031. Expansion part; 1032. Limiting part; 1032-1. Amplified limiting part; 1032-2. Basic limiting part. DETAILED DESCRIPTION
[0037] In order to enable those skilled in the art to better understand the solution of the present application, the technical solution in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work should fall within the scope of protection of the present application.
[0038] In this application, the terms "proximal" and "distal" refer to the relative position, location, and direction of components or actions relative to each other from the perspective of an operator using the medical device. Although "proximal" and "distal" are not restrictive, "proximal" usually refers to the end of the medical device that is close to the operator during normal operation, while "distal" usually refers to the end that first enters the patient's body. In this application, meninges is used as a shorthand to refer to dura mater, arachnoid membrane, venous sinus wall, inferior petrosal sinus wall, etc., to avoid overly lengthy descriptions.
[0039] It should be understood by those skilled in the art that the discussion of any of the above embodiments is merely illustrative and is not intended to imply that the scope of the present invention (including the claims) is limited to these examples. Under the concept of the present invention, the technical features in the above embodiments or different embodiments may be combined, the steps may be implemented in any order, and there are many other variations of the different aspects of the present invention as described above, which are not provided in detail for the sake of simplicity.
[0040] The present invention is further described below in conjunction with the accompanying drawings and specific implementation methods.
[0041] Please combine Figures 1 to 22 , card-type shunts and interventional medical devices.
[0042] A positioning shunt is deployed in the patient's ventricular system and venous system through a delivery system to discharge cerebrospinal fluid in the patient's ventricular system into the venous system. A puncture hole is provided in the dura mater between the ventricular system and the venous system. The delivery system includes a puncture catheter 4 provided with a puncture needle 41. The positioning shunt 10 is arranged in the puncture catheter 4. The proximal side wall of the puncture needle 41 is provided with at least one shunt tube mounting groove 44. The positioning shunt 10 includes a shunt tube body 101 for deployment in the venous system and a distal part 102 for deployment in the ventricular system. The distal part 102 is provided with a limiting member 103 for contacting the dura mater in the axial direction and having a radial size larger than the puncture hole. The limiting member 103 passes through the shunt tube mounting groove 44 and extends in the radial direction to the outer peripheral side wall protruding from the puncture catheter 4. On the one hand, since the limiting member is set to protrude radially from the side wall of the shunt tube, the radial size upper limit of the clamping shunt 10 is increased, and the anchoring force of the clamping shunt 10 can be increased. On the other hand, the shunt tube installation groove 44 can limit the shunt, so that the shunt tube body can be driven into the ventricle through the shunt tube installation groove without the need for an additional push rod, and it can also automatically hang the meninges squeezed on the outer wall of the puncture catheter when the puncture catheter is withdrawn. In this way, the shunt tube push rod can be reduced, the medical device can be simplified, the risks that may be caused by the use of the push rod can be avoided, the safety of the deployment of the clamping shunt 10 can be improved, and the surgical operation can be simplified and the operation time can be shortened.
[0043] Furthermore, the width of the shunt tube installation groove 44 is 1 / 3 to 1 / 5 of the diameter of the puncture catheter.
[0044] Furthermore, the limiting member 103 includes an expansion portion 1031 and a limiting portion 1032, the expansion portion extends along the axial direction of the shunt tube body 101, and is used to guide the limiting member 103 through the dura mater; the limiting portion 1032 extends along the radial direction of the shunt tube body 101 and protrudes from the outer peripheral side wall of the shunt tube body 101, and is used to form an axial limit with the shunt tube mounting groove 44 to push the card-type shunt 10 to the deployment position.
[0045] Preferably, combine Figures 9 to 11 The limiting portion 1032 includes an enlarged limiting portion 1032-1 and a basic limiting portion 1032-2. The basic limiting portion 1032-2 extends from the shunt tube body 101 in the axial direction, and the enlarged limiting portion 1032-1 extends from the basic limiting portion 1032-2 along the circumferential direction of the shunt tube body 101.
[0046] Specifically, the limiting portion 1032 is arranged parallel to the radial direction of the blocking diverter 10, or the limiting portion 1032 is arranged proximally inclined relative to the radial direction of the blocking diverter 10. Preferably, the enlarged limiting portion 1032-1 is an inclined surface, which can increase the contact surface and improve the anchoring force.
[0047] Preferably, the amplified limiting portion 1032-1 is an annular developing ring or a wing-shaped developing film, so that the amplified limiting portion 1032-1 can achieve both limiting and developing.
[0048] Preferably, the size of the expansion portion 1031 gradually decreases from the limiting portion 1032 to the distal end surface of the locking diverter 10, and the expansion portion 1031 is configured as an inclined surface or an arc surface.
[0049] The interventional medical device comprises: the above-mentioned blocking type shunt 10 and a delivery system for delivering the blocking type shunt 10; The delivery system includes a distal anchoring structure 1, a guide wire 2, a double-lumen delivery catheter 3, and a puncture catheter 4. The distal anchoring structure 1 is used to be deployed at the distal end of the vein site to be punctured. The distal anchoring structure 1 is a nickel-titanium alloy stent or a balloon; the guide wire 2 is a hollow elliptical capillary, and the balloon is a compliant balloon; the distal anchoring structure 1 is a nickel-titanium alloy stent, the guide wire 2 is a flat wire or the distal end of the guide wire 2 is a flat wire, and the long dimension of the flat wire is 1.2-3 times the short dimension, for example, the size is 0.1*0.2mm (or 0.15*0.25mm or 0.15*0.30mm, 0.15*0.35mm, 0.15*0.40mm, 0.3mm* 0.4mm, etc.), the surface of the flat wire has a PTFE coating 24, and the length is 1.5m-3m. Specifically, the distal end of the guide wire 2 is a flat wire, and the proximal end is a round wire. The length of the flat wire is 1.4m, and the diameter of the round wire is the maximum long dimension of the flat wire. The length is greater than or equal to the length of the flat wire, for example, the length is 1.6m. After the distal anchoring structure 1 is deployed, the thick round wire is used to cut or break the guide wire 2 at the connection position (or prefabricated easy-to-break position) to obtain a flat wire connection end. The distal cross-section of the guide wire 2 is also a right-angled rectangle, a rounded rectangle, a rectangle or other quadrilaterals, and a circle is a secondary choice. The flat wire has directionality and can assist in the placement and positioning of the double-lumen delivery catheter 3.
[0050] The double-lumen delivery catheter 3 includes a first lockable structure 30 and a delivery catheter body 33. The delivery catheter body 33 is provided with a large cavity 31, a small cavity 32, an embedded developing ring 34 and a quick exchange interface 35. The large cavity 31 and the small cavity 32 are axially overlapped and arranged on the delivery catheter body 33 to form a double-lumen section. The guide wire 2 passes through the small cavity 32. The puncture catheter 4 is located in the large cavity 31 of the double-lumen delivery catheter 3. The distance between the distal tip of the puncture needle 41 and the proximal end of the distal end face of the double-lumen delivery catheter 3 is less than or equal to the distance between the target puncture position and the entrance of the target venous system. During the delivery process and before puncture, the needle tip of the puncture needle 41 of the puncture catheter 4 is about 1-5 mm away from the distal end of the double-lumen delivery catheter 3 and is completely retracted in the large cavity 31 of the double-lumen delivery catheter 3. The puncture catheter 4 is used to puncture the wall of the venous sinus such as the dura mater. The puncture catheter 4 includes a second lockable structure 40 (which can be a catheter seat or solid handle) and a puncture catheter body 43, a puncture needle 41 is provided at the end of the puncture catheter body 43, the blocking shunt 10 is arranged in the puncture catheter 4, and at least one shunt tube mounting groove 44 is provided at the proximal end of the puncture needle 41. The shape of the shunt tube mounting groove 44 includes but is not limited to a rectangle, an arc, a gradient shape, etc. The arc shape can reduce the risk of the shunt tube falling off during the transportation process, and the gradient shape can facilitate installation, increase the friction with the blocking shunt 10, and reduce the risk of the blocking shunt 10 falling off during the transportation process.
[0051] The clamping shunt 10 comprises a shunt tube body 101 for deployment in the venous system and a distal portion 102 for deployment in the ventricular system. The clamping shunt 10 is provided with a shunt tube metal reinforcement structure 104, a shunt tube proximal end developing ring 105, a shunt tube distal end developing ring 106, a cerebrospinal fluid inlet 107, and a cerebrospinal fluid outlet 108. The shunt tube metal reinforcement structure 104 can be set as a coil spring, a hypotube, a braided mesh, etc., and the cerebrospinal fluid outlet 108 can be provided. The opening 108 is a slit valve, and a limiter 103 for contacting the dura mater is provided on the distal portion 102. The limiter 103 passes through the shunt tube mounting groove 44 and extends to the outside of the puncture catheter 4. The limiter 103 can not only increase the anchoring force, but also drive the shunt tube body 101 into the ventricle through the shunt tube mounting groove 44 without the need for an additional push rod, and can also automatically hang on the meninges squeezed on the outer wall of the puncture catheter 4 when the puncture catheter 4 is withdrawn.
[0052] Through the above technical scheme, compared with the prior art, the shunt tube push rod is reduced, the number of components of the delivery system is simplified, and the pushing function of the shunt tube push rod is replaced by the puncture catheter 4 provided with the shunt tube mounting groove 44. In addition, the shunt tube push rod of the prior art is elastic. When the pushing force is large, the elastic deformation of the push rod is too large, and the shunt tube will be suddenly released and difficult to control. The shunt tube will be pushed deep into the ventricle, and there is a risk of falling off. In addition, there is an extra step of pushing the shunt tube. By reducing the component of the shunt tube push rod, the risk of using the shunt tube push rod is reduced.
[0053] The puncture catheter 4 is pre-installed in the double-lumen delivery catheter 3; the distance between the tip of the puncture needle 41 of the puncture catheter 4 and the proximal end of the distal end of the double-lumen delivery catheter 3 is less than or equal to the distance between the target puncture position and the entrance of the venous system. If the distance between the target puncture position and the entrance of the venous system is 15 mm, the distance between the tip of the puncture needle 41 of the puncture catheter 4 and the proximal end of the distal end of the double-lumen delivery catheter 3 does not exceed 15 mm. (The confluence of the inferior petrosal sinus and the internal jugular vein is a corner. The puncture catheter 4 needs a higher hardness for puncturing the dura mater. The puncture catheter 4 mainly advances along the inner wall of the double-lumen delivery catheter 3 in the double-lumen delivery catheter 3. If the double-lumen delivery catheter 3 bends into a certain blood vessel branch, the puncture needle 41 is pushed in from the proximal end of the double-lumen delivery catheter 3. At the bend of the blood vessel, the sharp puncture needle 41 will pierce the lining blood vessel wall of the inner wall of the double-lumen delivery catheter 3. Although the double-lumen delivery catheter 3 itself is used for transportation and protection, not pre-installing it will seriously affect the operation of the instrument and increase the trial risk. In particular, when the turning radius of the venous sinus is small, the distance between the targeted puncture position and the entrance of the blood vessel branch is about 5-15mm (anatomical structure law). When the distance between the pre-installed position of the puncture needle 41 and the proximal end point of the distal end face of the double-lumen delivery catheter 3 is greater than X=15mm, the puncture needle 41 is pushed forward, and the puncture needle 41 will pierce the tube wall and the blood vessel wall, and cannot be delivered to the designated position). A secondary method is that when X>15mm, the double-lumen delivery catheter 3 is delivered to a length exceeding X, and then the puncture needle 41 is pushed so that X is less than the distance from the target puncture position to the entrance of the vascular branch. This method requires redundant pushing and withdrawal operations to achieve the same delivery and puncture target position.
[0054] Please combine Fig.18 The large cavity 31 runs through the entire length of the double-lumen delivery catheter 3, and the structure of the small cavity 32 includes but is not limited to the full-length structure (such as Fig.18 -a), distal local structures (such as Fig.18 -b), distributed structure (such as Fig.18 -c), combined structures (such as Fig.18 ad), etc. The full-length structure refers to a small cavity 32 that runs through the entire tube body of the double-lumen delivery catheter 3. The distal local structure refers to a small cavity 32 that is only located at the distal position of the double-lumen delivery catheter 3, such as a small cavity 32 with a length of 5-10mm; the distributed structure refers to a structure in which there are at least two small cavities 32 on the double-lumen delivery catheter 3 distributed at different positions of the double-lumen delivery catheter 3, such as by setting small cavities 32 near multiple blood vessel branches to form a tube body structure with multiple small cavities 32, each with a length of 10-20mm. The combined structure refers to a small cavity 32 and a large cavity tube body that are bonded together (such as Fig.18 -d), heat shrink (such as Fig.18 ac) and other combinations;
[0055] The double-lumen delivery catheter 3 delivers the puncture catheter 4, the shunt tube push rod 5 and the locking shunt 10 to the designated venous sinus along the guide wire 2, and a specific puncture angle needs to be formed between the puncture catheter 4 and the guide wire 2. Influenced by the characteristics of the human anatomical structure, in order to better realize the function, the outer diameter D (such as Figure 8 (as shown) is less than or equal to 1.7mm. If the diameter exceeds 1.7mm, it is usually difficult to enter the inferior petrosal sinus and other venous sinuses, such as the outer diameter D of 1.66mm, 1.45mm, 1.32mm, 1.25mm, 1.18mm, etc.;
[0056] Please combine Fig.19 , set the length L1 from the distal end face of the small cavity 32 to the proximal end of the delivery system minus the length L2 from the distal end face of the large cavity 31 to the proximal end of the delivery system to be the distance X0, that is, X0=L1-L2. Since the target position is mostly not far from the entrance of the vascular bifurcation, the end face distance X0 between the small cavity 32 of the double-cavity delivery catheter 3 and the large cavity 31 satisfies: -D≤X0≤30 mm, so as to avoid the double-cavity delivery catheter 3 getting stuck at the vascular branch and unable to reach the target position. Furthermore, a lip-shaped end face is set at the distal end face of the large cavity 31 of the double-cavity delivery catheter 3 to further reduce the risk of the vascular branch being stuck when being delivered to the target position. Specific implementation case: (such as Fig.19 -a) The end faces of the large cavity 31 are flush, and the small cavity 32 extends to the far end by X0 = 5-25mm. Fig.19 -b) The distal end of the tube presents a gradual lip shape (arc-shaped cross section 37), and the small cavity 32 extends to the distal end by X0=5-20mm. Fig.19 -c) The end surfaces of the small cavity 32 and the large cavity 31 are flush, X0=0mm (in this case, a quick exchange interface 35 can be set up in the distal small cavity 32); (such as Fig.19 -d) The end surface of the large cavity 31 is flush, and the large cavity 31 extends to the far end by X0 = -6mm or -4mm or -2mm. Fig.19 -e) The distal end of the tube presents a gradual lip shape, and the large cavity 31 can be extended to the distal end to a maximum of X0 = -Dmm, where D is the maximum diameter of the entrance of the inferior petrosal sinus;
[0057] The inner diameter of the large lumen 31 of the double-lumen delivery catheter 3 is 0.8-1.1mm, and the tube body structure includes but is not limited to a composite tube structure and a co-extrusion structure. The composite tube structure includes an inner lining layer, a metal layer, and an outer tube layer structure. The co-extrusion structure includes a metal layer and an appearance layer. The metal layer includes but is not limited to a spring tube structure, a braided tube structure, a sea wave tube structure, etc. The outer tube layer is made of PA, TPU, etc. The outer tube layer structure includes but is not limited to a single-lumen tube (including but not limited to elliptical, rectangular, rectangular, circular, etc.), a flat-lumen-round-lumen double-lumen tube, a round-lumen-round-lumen double-lumen tube, and a composite thereof (such as a single-lumen tube is used at the proximal end of the delivery catheter tube body 33, and a flat-lumen-round-lumen double-lumen tube or a round-lumen-round-lumen double-lumen tube is used at the distal double-lumen section of the delivery catheter tube body 33).
[0058] The small cavity 32 of the double-lumen delivery catheter 3 is made of a material with a smooth surface, such as a PTFE lining and a PI structure. The small cavity 32 is wrapped together with the large cavity 31 through the outer tube layer of the large cavity 31 (the cross-section includes a single-lumen tube or a double-lumen tube), or the small cavity 32 is connected to the large cavity 31 by bonding.
[0059] The double-lumen delivery catheter 3 or the puncture catheter 4 can be pre-shaped to be suitable for entering the inferior petrosal sinus. The angle α of the double-lumen delivery catheter 3 and the puncture catheter 4 after shaping is ≤105°, such as 10°, 20°, 25°, 80°, etc.; preferably α≤30°, such as Fig. 20 As shown, in order to reduce the influence of the guide wire on the puncture catheter 4, after shaping, the small cavity 32 should be away from the wall of the venous sinus on the ventricular side to be punctured.
[0060] Please combine Figure 2 The small cavity 32 of the double-lumen delivery catheter 3 is a cavity with different lengths in two directions, that is, the small cavity 32 has different lengths in the long axis direction and the short axis direction, such as a flat cavity or an elliptical cavity, the short axis direction is shorter than the long axis direction, and the short axis direction faces the large cavity 31. The long axis direction of the flat cavity or the elliptical cavity is at an angle to the radial direction, preferably perpendicular to the radial direction. The flat cavity and the flat guide wire 2 can guide the harder double-lumen delivery catheter 3 and the puncture catheter 4 into the narrow inferior petrosal sinus, providing a stable direction and certain support for the puncture needle 41 during puncture. When the long axis direction of the flat cavity or the elliptical cavity is perpendicular to the radial direction, a smaller outer diameter of the distal end of the double-lumen delivery catheter 3 can be obtained. The small cavity 32 is arranged at the distal end of the double-lumen delivery catheter 3 and has a shorter axial length than the large cavity 31.
[0061] Please combine Figure 4 and Figure 5 , at the bifurcation of the venous sinus, especially at the entrance of the inferior petrosal sinus, it is relatively narrow and has a small angle. When the structure of the large cavity 31 and the small cavity 32 is unreasonable, the large cavity 31, especially the side of the large cavity 31 away from the small cavity 31, will get stuck at the branch of the blood vessel, such as Figure 5 As shown. Therefore, at this time, -D≤X0≤30 mm is satisfied. When X0≥0mm, that is, the small cavity 32 is in front, the small cavity 32 of the double-lumen delivery catheter 3 will enter the target venous sinus first. At this time, when the maximum outer diameter of the double-lumen delivery catheter 3 is smaller than the inner diameter at the entrance of the venous sinus, the double-lumen delivery catheter 3 enters smoothly along the flat wire; the puncture catheter 4 needs to be deployed in the inferior petrosal sinus and needs to be protected by the double-lumen delivery catheter 3 before entering the inferior petrosal sinus. The length of the inferior petrosal sinus is about 30mm, but when X0>30mm, the puncture catheter 4 is exposed at the entrance of the venous sinus or even in the upper vein, and the delivery to the target position cannot be achieved, so the upper limit of X0 is set to 30mm;
[0062] like Figure 5As shown, when the large lumen 31 is in front, that is, X0<0mm, the end surface distance X0 between the small lumen 32 of the double-lumen delivery catheter 3 and the large lumen 31 should not be greater than the diameter D at the entrance of the venous sinus. Specifically, if the entrance of the inferior petrosal sinus is 1.6mm, then D = 1.6 is a secondary choice, and there is a risk of not being able to enter the inferior petrosal sinus. (The positive and negative signs also represent directions, and a coordinate system is established in the figure).
[0063] Please combine Figure 7-Figure 8 The distal end of the small cavity 32 is set as an oblique incision to facilitate the insertion of the guide wire 2, and the distal end of the large cavity 31 is set as an arc section 37, so as to reduce the risk of the blocking shunt 10 getting stuck at the entrance of the double-lumen delivery catheter 3.
[0064] Please combine Fig.12 The double-lumen delivery catheter 3 includes a first lockable structure 30 and a delivery catheter body 33. The delivery catheter body 33 is provided with an embedded developing ring 34 and a quick exchange interface 35. The large cavity 31 and the small cavity 32 are axially overlapped and arranged on the delivery catheter body 33 to form a double-lumen section. The first lockable structure 30 includes but is not limited to components such as a Y valve, a guide wire torque controller and similar lockable structures.
[0065] Through the above technical solution, the embedded developing ring 34 can guide the conveying position of the conveying system, and is not easy to get stuck on the limiting piece 103 of the positioning diverter 10, and will not hinder the normal deployment of the positioning diverter 10.
[0066] Please combine Figure 7 The proximal end of the double-lumen delivery catheter 3 is locked and connected to the puncture catheter 4 through the first lockable structure 30, thereby avoiding misoperation or displacement of the puncture catheter 4 during use and reducing accidental exposure.
[0067] Through the above technical solution, in the prior art, since the shunt tube (the latching shunt 10) is located inside the puncture catheter 4 and has no relative friction relationship with the double-lumen delivery catheter 3, the shunt tube will not be separated from the puncture catheter 4 due to the relative movement of the puncture catheter 4 and the double-lumen delivery catheter 3. In the present technical solution, the distal end of the latching shunt 10 is outside the puncture catheter 4 and has a relative friction relationship with the double-lumen delivery catheter 3, and a locking structure 30 should be provided to avoid relative displacement of the puncture catheter 4 and the double-lumen delivery catheter 3, and to avoid accidental exposure of the latching shunt 10 leading to deployment failure.
[0068] Please combine Figure 8 A TIP head 36 made of soft material is arranged at the distal end of the double-lumen delivery catheter 3. The TIP head 36 can be made of soft materials such as Pebax, so that the double-lumen delivery catheter 3 can protect the blood vessel when entering the blood vessel and will not scratch the blood vessel.
[0069] Please combine Fig.12A delivery sheath 7 and a guide wire locking piece 8 are also provided on the guide guide wire 2. The delivery sheath 7 is fixedly connected or locked with the guide wire locking piece 8. The delivery sheath 7 can assist the guide guide wire 2 to enter the inferior petrosal sinus to avoid bending, and the delivery sheath 7 can lock or loosen the guide guide wire 2 through the guide wire locking piece 8. A guide wire torque controller can be used to lock or loosen the guide guide wire 2. When the distal anchoring structure 1 is deployed, the guide guide wire 2 is locked with the delivery sheath 7 through the guide wire locking piece 8. After the distal anchoring structure 1 is deployed, the guide guide wire 2 is loosened from the delivery sheath 7 and the delivery sheath 7 is withdrawn.
[0070] Through the above technical solution, in order to enter the inferior petrosal sinus, the guide wire 2 is selected as a flat wire, which is extremely soft and small in size. When other instruments (such as guide catheters, long sheaths, etc.) are inserted proximally, it is easy to bend and it is difficult to push the distal anchoring structure 1 with a large radial force. The provision of a delivery sheath 7 can assist the guide wire 2 in entering and prevent it from bending.
[0071] Please combine Fig.12 , the distal anchoring structure 1 is rotatably connected or fixedly connected to the guide wire 2. The proximal end of the distal anchoring structure 1 is provided with a limiting structure for limiting the axial movement of the guide wire 2, and the distal end of the guide wire 2 is rotatably connected to the distal anchoring structure 1 through the limiting structure. The proximal end of the distal anchoring structure 1 is provided with an anchoring developing ring 11 and a connecting ring 12; the anchoring developing ring 11 can be inside or outside the connecting ring 12, and the anchoring developing ring 11 is made of a developable material such as platinum-iridium alloy, gold, silver, barium sulfate, etc. A clamping rod 21 and a limiting structure arranged at one end of the clamping rod 21 are provided in the anchoring developing ring 11, and the limiting structure includes a glue block 22 or a limiting developing ring 23, so that the guide wire 2 cannot move forward and backward, but can rotate. The rotatable connection can allow the flat guide wire 2 to rotate under force, thereby preventing the guide wire 2 from being entangled with the puncture catheter 4 and the clamping shunt 10.
[0072] Please combine Fig.13 , Fig.16 as well as Fig. 22The puncture catheter 4 includes a second lockable structure 40 and a puncture catheter body 43. The second lockable structure 40 includes but is not limited to components such as a Y valve, a guide wire torque controller, and similar lockable structures. The puncture needle 41 is arranged at the end of the puncture catheter body 43. The specification of the puncture needle 41 is 18-23G, the material is stainless steel, and the shape is a lancet tip. The puncture catheter 4 is provided with a puncture stop structure 42 for preventing the puncture catheter 4 from puncturing too deeply. The puncture stop structure 42 has a stop surface for abutting against the dura mater, and the distance L between the stop surface and the tip of the puncture needle 41 is less than or equal to 8mm. Further, the puncture stop structure 42 is arranged as an externally embedded developing ring, so that the puncture stop structure 42 can both develop and prevent the puncture catheter 4 from puncturing too deeply. The puncture stop structure 42 is made of a developable material such as platinum-iridium alloy, tantalum, gold, silver, barium sulfate, etc.; Please combine Fig.21 The puncture catheter body 43 is a body having a hypotube structure at least partially, and is provided with a plurality of hypotube sections with gradually varying cutting intervals, and the hypotube structure includes but is not limited to an I-shaped hypotube structure ( Fig.21 b) Spiral hypotube structure ( Fig.21 c) Spiral knife cutting the hypotube structure ( Fig.21 d), etc., with an inner diameter of 0.7-0.8 mm and a three-stage gradient structure, with the length gradually increasing from the distal end to the proximal end.
[0073] Please combine Fig.14 and Fig.15 An introduction sheath 92 is arranged in the small cavity 32 to assist the guide wire 2 to pass through the double-lumen delivery catheter 3. The introduction sheath 92 includes but is not limited to a detachable introduction sheath and a peelable introduction sheath. The detachable introduction sheath includes an expansion introduction port 921, a disassembly groove 922 and an embedding port 923. The peelable introduction sheath includes a contraction introduction port 924, a tearable and removable groove 925 and an embedding sleeve port 926.
[0074] Through the above technical solution, the detachable introduction sheath is connected to the small cavity 32 of the double-lumen delivery catheter 3 through the insertion port 923, the guide wire 2 is introduced into the small cavity 32 of the double-lumen delivery catheter 3 through the expansion introduction port 921, and the guide wire 2 leaves the removal groove 922, thereby removing the detachable introduction sheath; The peelable introduction sheath is connected to the small cavity 32 of the double-lumen delivery catheter 3 by inserting the sleeve opening 926, and the guide wire 2 is introduced into the small cavity 32 of the double-lumen delivery catheter 3 through the contraction introduction opening 924. The peelable introduction sheath can be removed by tearing the tearable disassembly groove 925.
[0075] Please combine Figure 6 , Fig.16 as well as Fig.21A friction-increasing structure 5 is provided between the puncture catheter 4 and the shunt tube body 101, so as to prevent the blocking shunt 10 from detaching from the puncture catheter 4 during transportation. The friction-increasing structure 5 is a step tube, which includes a step tube section 51, a rod 52 and a handle 53. The step tube section 51 is a stainless steel hypotube, and the rod 52 is a stainless steel wire or a stainless steel tube. The rod 52 and the step tube section 51 are connected by welding or integrally connected, and the rod 52 and the handle 53 are bonded by glue. The outer diameter is smaller than the inner diameter of the puncture catheter 4, and the inner diameter is greater than or equal to the outer diameter of the shunt tube body. The friction-increasing structure 5 can also be set to other fillers (such as silicone, friction-increasing coating, etc.).
[0076] The above-mentioned embodiments are only preferred embodiments of the present invention and cannot be used to limit the scope of protection of the present invention. Any non-substantial changes and substitutions made by technicians in this field on the basis of the present invention shall fall within the scope of protection required by the present invention.
Claims
1. A card-type shunt, which is delivered by a delivery system and deployed in the patient's ventricular system and venous system to discharge cerebrospinal fluid in the patient's ventricular system into the venous system, and a puncture hole is provided in the dura mater between the ventricular system and the venous system, characterized in that: The delivery system comprises a puncture catheter (4) provided with a puncture needle (41). During the delivery process, the locking shunt (10) is arranged in the puncture catheter (4). The proximal side wall of the puncture needle (41) is provided with at least one shunt tube installation groove (44). The locking shunt (10) comprises a shunt tube body (101) for deployment in the venous system and a distal portion (102) for deployment in the ventricular system. The distal portion (102) is provided with a stopper (103) for contacting the dura mater in the axial direction and having a radial dimension larger than the puncture hole. The stopper (103) passes through the shunt tube installation groove (44) and extends in the radial direction to protrude from the outer peripheral side wall of the puncture catheter (4).
2. The clamping type diverter according to claim 1, characterized in that: The limiting member (103) comprises an expansion portion (1031) and a limiting portion (1032); the expansion portion extends along the axial direction of the shunt tube body (101) and is used to guide the limiting member (103) to pass through the dura mater; the limiting portion (1032) extends along the radial direction of the shunt tube body (101) and protrudes from the outer peripheral side wall of the shunt tube body (101), and is used to form an axial limit with the shunt tube installation groove (44) so as to push the locking shunt (10) to a deployment position.
3. The clamping type diverter according to claim 2, characterized in that: The limiting portion (1032) comprises an amplified limiting portion (1032-1) and a basic limiting portion (1032-2), wherein the basic limiting portion (1032-2) extends from the shunt tube body (101) in a radial direction, and the amplified limiting portion (1032-1) extends from the basic limiting portion (1032-2) along a circumferential direction of the shunt tube body (101).
4. The clamping type diverter according to claim 2, characterized in that: The limiting portion (1032) is arranged parallel to the radial direction of the locking type diverter (10), or the limiting portion (1032) is arranged inclined toward the proximal end relative to the radial direction of the locking type diverter (10).
5. The clamping type diverter according to claim 2, characterized in that: The radial dimension of the expansion portion (1031) gradually decreases from the limiting portion (1032) to the distal end surface of the locking type flow divider (10).
6. An interventional medical device, characterized in that: include: A positioning diverter (10) and a conveying system for conveying the positioning diverter (10) as claimed in any one of claims 1 to 5; The delivery system comprises a distal anchoring structure (1) for deployment at the distal end of a vein site to be punctured, a guide wire (2) connected to the distal anchoring structure (1), a double-lumen delivery catheter (3) provided with a large lumen (31) and a small lumen (32), and a puncture catheter (4) provided with a puncture needle (41), wherein the puncture catheter (4) is arranged in the large lumen (31) and the puncture needle (41) does not protrude from the large lumen (31) in the axial direction during the delivery process, the positioning shunt (10) is arranged in the puncture catheter (4), the guide wire (2) passes through the small lumen (32), and the proximal end of the puncture needle (41) is provided with at least one shunt tube installation groove (44), and the stopper (103) passes through the shunt tube installation groove (44) and extends in the radial direction to the outer peripheral side wall protruding from the puncture catheter (4).
7. The interventional medical device according to claim 6, characterized in that: The length L1 from the distal end face of the small cavity (32) to the proximal end of the delivery system minus the length L2 from the distal end face of the large cavity (31) to the proximal end of the delivery system is set as the distance X0, X0=L1-L2, and the distance X0 satisfies: -D≤X0≤30 mm, where D is the diameter at the entrance of the target venous system.
8. The interventional medical device according to claim 7, characterized in that: The small cavity (32) has a long axis direction and a short axis direction of different lengths. The small cavity (32) is arranged at the distal end of the double-lumen delivery catheter (3) and has an axial length smaller than that of the large cavity (31). At least the distal end of the guide wire (2) is arranged as a flat wire.
9. The interventional medical device according to claim 7, characterized in that: The distance between the distal tip of the puncture needle (41) and the proximal end of the distal end surface of the double-lumen delivery catheter (3) is less than or equal to the distance between the target puncture position and the entrance of the target venous system.
10. The interventional medical device according to claim 6, characterized in that: The puncture catheter (4) is provided with a puncture stop structure (42) for preventing the puncture catheter (4) from puncturing too deeply, the puncture stop having a stop surface for abutting against the dura mater to limit position, and a distance L between the stop surface and the tip of the puncture needle (41) is less than or equal to 8 mm.
11. The interventional medical device according to claim 6, characterized in that: A friction-increasing structure (5) is provided between the puncture catheter (4) and the shunt tube body (101), thereby preventing the latching shunt (10) from being separated from the puncture catheter (4) during transportation.
12. The interventional medical device according to claim 6, characterized in that: The double-lumen delivery catheter (3) comprises a first lockable structure (30) and a delivery catheter body (33); the proximal end of the double-lumen delivery catheter (3) is lockably connected to the puncture catheter (4) via the first lockable structure (30); the large lumen (31) and the small lumen (32) are axially overlapped and arranged on the delivery catheter body (33) to form a double-lumen section.
13. The interventional medical device according to claim 6, characterized in that: The guide wire (2) is also provided with a delivery sleeve (7) and a guide wire locking piece (8), wherein the delivery sleeve (7) is fixedly connected or locked to the guide wire locking piece (8), and the delivery sleeve (7) is used to assist the guide wire (2) to enter the inferior petrosal sinus through the catheter to avoid bending during delivery, and the delivery sleeve (7) can lock or loosen the guide wire (2) through the guide wire locking piece (8).
14. The interventional medical device according to claim 6, characterized in that: The proximal end of the distal anchoring structure (1) is provided with a limiting structure for limiting the axial movement of the guide wire (2), and the distal end of the guide wire (2) and the distal anchoring structure (1) are rotatably connected via the limiting structure.
Citation Information
Patent Citations
Systems and methods for treating hydrocephalus
CN108136164B
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