Shunt for treating hydrocephalus and system thereof

Abstract

A shunt for treating hydrocephalus and a system thereof. The shunt (1) comprises a distal portion (13) provided with a cerebrospinal fluid inlet, a proximal portion (12) provided with a cerebrospinal fluid outlet, and a tube body (11) provided with a flow lumen (15). The distal portion (13) is provided with a limiting part (14) for contacting a dura mater. The maximum radial dimension of the limiting part (14) in a delivery state is greater than the minimum radial dimension of a puncture orifice and the tube body. The shunt system comprises the shunt (1) and a delivery system. The delivery system is used for delivering the shunt (1) to a designated position in a venous system and a ventricular system. In the delivery process, the shunt (1) is placed within the delivery system. By means of the distal portion (13) of the shunt (1), the dural puncture orifice is dilated, and the limiting part (14), whose dimension is larger than that of the puncture orifice, is pressed into a cistern. By utilizing the elastic recovery capability of the biological membrane itself, the limiting part (14) and the dura mater form a locking anchorage. The limiting part (14) is limited by its own dimensions. The structure and the operation are simple, thereby simplifying the delivery process and the delivery system.

Description

A shunt and system for treating hydrocephalus Technical Field

[0001] The present invention relates to the technical field of medical equipment, and in particular to a shunt and a system thereof for treating hydrocephalus. Background Art

[0002] Hydrocephalus is one of the most common and important neurosurgical conditions affecting children and adults. Hydrocephalus, meaning "water on the brain," refers to the abnormal accumulation of cerebrospinal fluid (CSF) in the brain. Excessive intracranial pressure caused by hydrocephalus can lead to numerous significant symptoms, ranging from headaches to neurological impairment, coma, and death. CSF is a clear physiological fluid that bathes the entire nervous system, including the brain and spinal cord. Cells in the choroid plexus, located within the ventricles of the brain, produce CSF. In normal patients, cells within the arachnoid granulations reabsorb CSF produced in the choroid plexus. Arachnoid granulations span the surface of the brain's intracranial venous drainage system and reabsorb CSF present in the subarachnoid space into the venous system. Approximately 450 to 500 mL of CSF are produced and reabsorbed daily, maintaining a steady-state volume and pressure of approximately 8-16 cm HO within the intracranial ventricles. This reabsorption pathway has been termed the "third loop" due to its importance to central nervous system homeostasis.

[0003] Hydrocephalus most commonly develops due to impaired reabsorption of CSF, but sometimes also due to its excessive secretion. Impaired reabsorption is called communicating hydrocephalus. Hydrocephalus can also develop due to partial or complete blockage of one of the CSF pathways, such as the cerebral aqueduct of Selva, resulting in a condition known as obstructive hydrocephalus. Normal pressure hydrocephalus (NPH) is a form of communicating hydrocephalus. Unlike other forms of communicating hydrocephalus, patients with NPH may experience 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 volume of CSF in the subarachnoid space.

[0004] In recent years, a percutaneous / vascular interventional approach to shunting cerebrospinal fluid has been proposed. This involves deploying a shunt in the patient's inferior petrosal sinus (IPS) and cerebellopontine angle cistern (CP angle cistern). Specifically, the distal portion of the shunt is introduced through the IPS and secured in the CP angle cistern, which contains CSF. The proximal portion of the shunt is secured in or near the patient's jugular vein (JV). CSF flows from the CP angle cistern into the JV through the shunt's flow channel, maintaining a normal pressure differential between the patient's subarachnoid space and venous system. However, currently, shunt systems suitable for this treatment approach are limited and pose challenges such as high cost and complex structure.

[0005] Therefore, there is an urgent need for a shunt for treating hydrocephalus. Summary of the Invention

[0006] In view of this, the present invention proposes a shunt and a system thereof for treating hydrocephalus, which are conducive to simplifying the shunt structure and optimizing the system.

[0007] The technical solution of the present invention is implemented as follows: a shunt for treating hydrocephalus, which is used to be deployed in the patient's ventricular system and venous system to discharge cerebrospinal fluid in the patient's ventricular system into the venous system. The dura mater between the ventricular system and the venous system is provided with a puncture hole, including a distal portion provided with a cerebrospinal fluid inlet, a proximal portion provided with a cerebrospinal fluid outlet, and a tube body provided with a flow cavity. The distal portion is used to be deployed in the ventricular system, and the proximal portion is used to be deployed in the venous system. The tube body connects the distal portion and the proximal portion, and the flow cavity communicates with the cerebrospinal fluid inlet and the cerebrospinal fluid outlet. The distal portion is provided with a limiting portion for contacting the dura mater, and the maximum radial dimension of the limiting portion in the transport state is greater than the minimum radial dimension of the puncture hole and the tube body.

[0008] Based on the above technical solution, preferably, the maximum radial dimension of the distal end of the tube body is greater than the minimum radial dimension of the puncture hole.

[0009] On the basis of the above technical solution, preferably, the distal part is provided with an expansion part connected to the limiting part, the expansion part is away from the proximal part relative to the limiting part, and the radial size of the expansion part gradually increases in the direction from the distal part to the proximal part.

[0010] Based on the above technical solution, preferably, the minimum radial dimension of the expansion portion is less than or equal to the maximum radial dimension of the puncture opening.

[0011] On the basis of the above technical solution, preferably, the limiting portion is a frustum, an ellipsoid, a prism, a cylinder, or a cone;

[0012] And / or, the distal end of the tube body close to the distal end portion is round or flat;

[0013] And / or, the limiting portion coincides with or does not coincide with the central axis of the tube body.

[0014] On the basis of the above technical solution, preferably, the limiting portion is made of elastic material; or, the limiting portion includes an elastic structure, and the elastic structure is located at the distal end of the limiting portion.

[0015] Based on the above technical solution, preferably, the difference between the maximum radial dimension of the limiting portion and the minimum radial dimension of the puncture hole is the maximum limiting dimension, the difference between the minimum radial dimension of the limiting portion and the maximum radial dimension of the puncture hole is the minimum limiting dimension, and the range of the maximum limiting dimension and the minimum limiting dimension is 0-3mm.

[0016] Based on the above technical solution, preferably, the tube body is provided with a step surface near the distal portion, the step surface is used to form a limit with the side of the dura mater away from the ventricular system, and the distal end section of the tube body has a minimum radial dimension between the step surface and the limit portion that is smaller than the maximum radial dimension of the tube body.

[0017] On the basis of the above technical solution, preferably, a repair agent is provided between the tube body and the puncture hole.

[0018] On the basis of the above technical solution, preferably, the shunt also includes a flow direction control component, which only allows cerebrospinal fluid to flow from the cerebral cistern into the venous system through the shunt cavity, and the flow direction control component is arranged in the flow cavity or the proximal part or the distal part or a combination thereof.

[0019] On the basis of the above technical solutions, preferably, the flow direction control component is a one-way valve, a one-way flow channel, a one-way flow surface or a spring valve.

[0020] Based on the above technical solutions, preferably, the one-way valve is a duckbill valve, a slit valve, a double-valve valve or a single-valve valve, the one-way flow channel is a Tesla valve, and the one-way flow surface is set as a one-way flow microstructure, a hydrophilic-hydrophobic alternating structure or a one-way damping increased surface structure.

[0021] Based on the above technical solution, preferably, a semipermeable membrane is provided in the distal portion, the proximal portion or the tube body, and the semipermeable membrane restricts the flow, diffusion or exchange of some components of the ventricular system and the venous system;

[0022] And / or, further comprising a polymer liner and / or an anti-coagulation layer, wherein the polymer liner and / or the anti-coagulation layer are arranged on the tube body, the proximal portion and the distal portion;

[0023] And / or, the proximal portion is provided with a shielding protection device, which is a stent, a balloon or a film;

[0024] And / or, the shunt is provided with at least one radiopaque marker.

[0025] Another technical solution of the present invention is a system for treating hydrocephalus, comprising the above-mentioned shunt and a delivery system, wherein the delivery system is used to deliver the shunt to a designated position in the venous system and the ventricular system. During the delivery process, the shunt is placed in the delivery system.

[0026] On the basis of the above technical solution, preferably, the delivery system includes a delivery catheter, a shunt tube pusher, a puncture member and a guide member. During the delivery process, the shunt, the shunt tube pusher, the puncture member and the guide member are all located inside the delivery catheter, and the puncture member is arranged outside the shunt or inside the shunt or at the distal end.

[0027] Based on the above technical solution, preferably, the distal end of the puncture member is provided with a puncture tip with a blade, the puncture tip punctures the dura mater to form a puncture hole on the dura mater, and the puncture tip is a round or flat sheet.

[0028] On the basis of the above technical solution, preferably, a puncture protection sleeve is provided outside the puncture tip;

[0029] And / or, the distal end of the puncture member is provided with a radiopaque marker.

[0030] On the basis of the above technical solution, preferably, the distal end of the guide member is connected to a distal anchoring member, and / or the proximal end of the guide member is connected to a proximal deflecting member.

[0031] On the basis of the above technical solution, preferably, the delivery system further comprises an expansion member for expanding the puncture opening;

[0032] and / or, the delivery system comprises at least one radiopaque marker;

[0033] And / or, the delivery system is connected to an operating handle, and the operating handle is used to control the delivery system to deliver the diverter.

[0034] The shunt and system for treating hydrocephalus of the present invention have the following beneficial effects compared with the prior art:

[0035] The present invention expands the dura mater puncture opening by means of the distal portion of the shunt and squeezes a larger stopper into the cerebral cisternae. The stopper utilizes the elastic recovery capability of the biofilm itself to form a locking anchor between the stopper and the dura mater. The stopper does not expand when deployed in the ventricular system, i.e., it does not expand before or after entering the cerebral cisternae. The stopper is limited by its own size, resulting in a simple structure and operation, simplifying the delivery process and delivery system. The maximum radial dimension of the stopper, both in the delivery state before entering the ventricle and in the deployed state after entering the ventricle, is greater than the size of the puncture opening. The limiting portion described in the present invention does not expand, which means that the limiting portion does not undergo a large deformation that affects the limiting portion, and does not cover the small deformation of the limiting portion caused by factors such as the material itself at different temperatures. The puncture hole here is the hole formed on the dura mater when the puncture member punctures the dura mater. According to the experimental tests of the present invention, since the dura mater has a certain elastic deformation ability, the dura mater elastically deforms during puncture and elastically recovers after puncture, that is, there is a certain deformation recovery space in the puncture hole. Therefore, the size of the puncture hole formed in the dura mater after puncture is smaller than the size of the puncture member used, and the limiting portion of the shunt is larger than the size of the puncture hole, so the limiting portion can form a locking position with the dura mater. Even if the puncture member causes the dura mater to tear due to excessive elastic deformation, since the dura mater is made of soft membrane material, a shunt with a larger tube body can be used to expand the puncture hole, thereby further closing the tearing location. Specifically, using a 0.9mm outer diameter, lancet-bladed puncture needle, the puncture hole diameter is only 0.45mm; using a 0.9mm outer diameter, semi-puncture tip puncture needle, the puncture hole diameter is less than 0.6mm. Therefore, using a limiter larger than the diameter of the puncture needle and a tube body slightly larger than the puncture hole, the shunt can be fixed and sealed. In addition, according to calculations, the force on the shunt in the venous system is very small, so the anchoring force requirement is small, and thus the size requirement for the distal limiter is relatively low.

[0036] The radial dimension of the distal end of the tube body of the present invention is larger than the puncture hole. Due to the elastic deformation ability of the dura mater, the tube body and the puncture hole achieve an interference fit to achieve a sealing effect.

[0037] When the puncture member is set to a flat thin sheet shape in the present invention, the flat thin sheet puncture member can make full use of the flow cavity space of the diverter while maximizing the space occupied, that is, the puncture hole formed is small in size, which is more conducive to the limiting part to achieve limiting; at the same time, because the size of the flat thin sheet puncture member is the smallest, the puncture hole formed is small in size, which is more conducive to the sealing between the tube body and the puncture hole; the puncture needle protector acts as a push rod of the diverter tube while providing protection for the diverter lining, avoiding the puncture needle from cutting and damaging the inner wall of the diverter and the duckbill valve; the puncture member can also be set to a circular shape. The puncture hole formed by the circular puncture member is larger than the puncture hole formed by the flat thin sheet puncture member, and it is necessary to select a relatively large size limiting part and tube body and puncture hole for limiting and sealing. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0039] FIG1 is a schematic structural diagram of a shunt for treating hydrocephalus in Example 1 of the present invention;

[0040] Figure 2 is a left side view of Figure 1;

[0041] FIG3 is a right side view of FIG1;

[0042] FIG4 is a schematic structural diagram of a system for treating hydrocephalus in Example 1 of the present invention;

[0043] FIG5 is a schematic structural diagram of a puncture member in Example 1 of the present invention;

[0044] FIG6 is a schematic diagram of the structure of the puncture member disposed at the distal end of the shunt in Example 1 of the present invention;

[0045] FIG7 is a schematic structural diagram of a shunt for treating hydrocephalus in Example 2 of the present invention;

[0046] FIG8 is a schematic structural diagram of a system for treating hydrocephalus in Example 2 of the present invention;

[0047] FIG9 is a schematic structural diagram of a system for treating hydrocephalus in Example 2 of the present invention when in use;

[0048] FIG10 is a schematic structural diagram of a system for treating hydrocephalus in Example 3 of the present invention;

[0049] FIG11 is a schematic structural diagram of a puncture member with a tubular main body and a flat tip in a system for treating hydrocephalus in Example 3 of the present invention;

[0050] FIG12 is a schematic structural diagram of a system for treating hydrocephalus in Example 3 of the present invention, wherein both the main body and the tip of the puncture member are flat;

[0051] FIG13 is a schematic structural diagram of the tip of a puncture member of a system for treating hydrocephalus in Example 3 of the present invention;

[0052] FIG14 is a schematic structural diagram of a system for treating hydrocephalus in Example 4 of the present invention;

[0053] FIG15 is a schematic structural diagram of a system for treating hydrocephalus in Example 5 of the present invention;

[0054] FIG16 is a size comparison diagram of the puncture needle and the puncture orifice in Example 5 of the present invention.

[0055] In the figure, 1-diverter, 11-tube body, 12-proximal part, 13-distal part, 14-limiting part, 15-flow cavity, 16-rounded rectangular cross-section structure, 17-circular tube cross-section structure, 2-delivery catheter, 3-diverter tube pusher, 4-puncture member, 5-guide member, 6-main body, 7-tip, 8-puncture protection sleeve. DETAILED DESCRIPTION

[0056] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0057] The radial dimensions in all the following embodiments refer to the length, width, diameter, area, etc. along the radial direction of the shunt. Since the dura mater and arachnoid mater are usually closely connected in the human body, the term "dura mater" is used in the present invention to refer to both the dura mater and the arachnoid mater to avoid overly lengthy descriptions.

[0058] Example 1:

[0059] As shown in Figures 1-5, a shunt and system for treating hydrocephalus are provided. The system includes a shunt 1 and a delivery system for delivering the shunt 1 to a designated location in a blood vessel. During delivery, the shunt 1 is placed within the delivery system. Once the shunt reaches the designated location, the delivery system positions the shunt 1 there. The puncture member of the delivery system punctures the dura mater between the ventricular system and the venous system to form a puncture orifice.

[0060] The shunt 1 includes a distal portion 13 provided with a cerebrospinal fluid inlet, a proximal portion 12 provided with a cerebrospinal fluid outlet, and a tubular body 11 provided with a flow lumen 15. The distal portion 13 is intended for deployment within a patient's cerebral cisterns, while the proximal portion 12 is intended for deployment within or near the patient's jugular vein. The flow lumen 15 connects the cerebrospinal fluid inlet and outlet, and the tubular body 11 connects the distal portion 13 and the proximal portion 12. When the distal portion 13 is deployed within the cerebral cisterns and the proximal portion 12 is deployed within or near the jugular vein, the cerebrospinal fluid in the cerebral cisterns can be discharged into the jugular vein through the cerebrospinal fluid inlet, flow lumen 15, and cerebrospinal fluid outlet. Both the cerebrospinal fluid inlet and the cerebrospinal fluid outlet can be configured to be one or more, and the number can be set according to actual needs.

[0061] The distal portion 13 has a stopper 14 for contacting the dura mater. The maximum radial dimension of stopper 14 in both the delivery and deployment states is greater than the minimum radial dimension of the puncture orifice and the tube body 11. In this embodiment, stopper 14 is configured as a frustum with a maximum stopper outer diameter of 0.9 mm. The cross-sectional area of ​​the distal end of the frustum is smaller than that of the proximal end, gradually increasing from the distal end to the proximal end. The cross-sectional area of ​​the distal end of the frustum is configured to approximate the size of the puncture orifice.

[0062] The distal portion 13 is provided with an expansion portion connected to the limiting portion 14. The expansion portion is spaced apart from the proximal portion 12 relative to the limiting portion. The radial dimension of the expansion portion gradually increases from the distal portion 13 toward the proximal portion 12, and the minimum radial dimension of the expansion portion is less than or equal to the maximum radial dimension of the puncture opening. In this embodiment, the expansion portion is formed by a frustum structure whose cross-sectional area gradually increases from the distal end to the proximal end. The cross-sectional area of ​​the distal end of the frustum structure is set to a size close to the size of the puncture opening, facilitating the frustum structure to enter the puncture opening and expand the puncture opening. The frustum structure can expand the puncture opening, limit and fix the distal portion 13 of the shunt to the side of the cerebral cisterns, and protect against cutting damage to tissue or instruments by the puncture member.

[0063] The maximum radial dimension of the distal end of the tube body 11 is greater than the minimum radial dimension of the puncture opening, thereby achieving a better seal between the distal end of the tube body 11 and the puncture opening. In this embodiment, the tube body 11 has a rounded rectangular cross-section, and the flow chamber 15 is a through-hole with a cross-sectional dimension of 0.25 mm by 0.14 mm. The size of the flow chamber 15 is determined by the required flow rate, which is less than 20 ml / h.

[0064] In clinical practice, the puncture openings formed by the puncture member are often irregularly shaped holes with non-uniform radial dimensions. The maximum limiting dimension is the difference between the maximum radial dimension of the limiting portion 14 and the minimum radial dimension of the puncture opening, while the minimum limiting dimension is the difference between the minimum radial dimension of the limiting portion 14 and the maximum radial dimension of the puncture opening. The range between the maximum limiting dimension and the minimum limiting dimension is 0-3 mm. This allows the limiting portion 14 to be well positioned within the puncture opening, including irregularly shaped holes, achieving fixed positioning of the distal portion 13.

[0065] In this embodiment, the limiting portion 14 coincides with the central axis of the tube body 11. In other embodiments, the limiting portion 14 may be configured to not coincide with the central axis of the tube body 11. This non-coincidence arrangement allows the limiting portion to pass through the puncture hole with a smaller size, while the limiting portion and the puncture hole form a larger difference in limiting size to form a limiting position.

[0066] In this embodiment, a non-projection line mark is provided on the surface of the frustum structure, or the frustum structure is marked with a non-projection line mark material, or a developing ring with a non-projection line mark is provided at the far end of the frustum structure.

[0067] In other embodiments, the distal portion 13 may also be provided with other shapes that can provide a limiting portion and an expansion portion as the limiting portion and the expansion portion, including but not limited to a frustum, an ellipsoid, a prism, a cylinder, a cone, etc. The frustum, the ellipsoid, the prism, the cylinder, and the cone have a smaller distal end to facilitate passage through the puncture hole.

[0068] The distal end of the tube body 11 can be round or flat, including but not limited to circular, rectangular, prismatic, elliptical, half-moon, trapezoidal, crescent, and other generalizable shapes such as wavy, double-wavy, bullet-shaped, and right-angled trapezoidal. Compared to a round distal end, a flat distal end can provide a larger limit dimension, further optimizing the limit. The distal end of the tube body can also be configured to match the puncture orifice.

[0069] Specifically, the shunt 1 is provided with a flow control member that only allows cerebrospinal fluid to flow from the cistern through the inner lumen of the shunt into the venous system (particularly in or near the jugular vein). The flow control member can be configured as a one-way valve, a one-way flow channel, a one-way flow surface, or a spring valve. The one-way valve can be configured as a duckbill valve, a slit valve, a double-valve valve, a single-valve valve, etc.; the one-way flow channel can be configured as a Tesla valve; and the one-way flow surface can be configured as a one-way flow microstructure, a hydrophilic-hydrophobic alternating structure, or a one-way damping-enhancing surface structure.

[0070] Preferably, the flow direction control member is disposed at the proximal end of the diverter and in the flow cavity 15 of the diverter 1. In other embodiments, the flow direction control member can be disposed at the distal end of the diverter or in the flow cavity 15 as needed.

[0071] A shielding protection device may also be provided at the proximal end of the shunt to isolate the endothelial cells of the venous system from the proximal outlet of the shunt, including but not limited to a stent, a balloon, the same device as the distal end, a film, etc.

[0072] The stopper 14 includes an elastic structure, which is a structure that contracts under force and may include, but is not limited to, a spring, a bracket, a wire, or a ball. The elastic structure is located at the distal end of the stopper 14. This allows the distal end to be compressed by the dura mater as it passes through the puncture hole, causing the dura mater to elastically deform, thereby minimizing the expansion of the puncture hole. Alternatively, the stopper 14 may be made of an elastic material, including, but not limited to, a spring, a bracket, a wire, or a ball.

[0073] A patch is provided between the shunt 1 and the dura mater puncture hole, and is configured to repair the puncture hole, including but not limited to degradable hydrogels, medical glues, etc., including but not limited to natural ingredient sealants (such as fibrin glues), semi-synthetic glues (such as gelatin and albumin glues), fully synthetic glues (acrylates and polyethylene glycol glues), etc. and their combinations.

[0074] Among them, polyethylene glycol glue includes but is not limited to four-arm polyethylene glycol (such as four-arm polyethylene glycol succinimidyl glutarate) and its derivatives, eight-arm polyethylene glycol and its derivatives, etc. and their combinations.

[0075] Shunt 1 is also equipped with a semipermeable membrane, including but not limited to a porous PTFE membrane or an ePTFE membrane, to restrict the flow, diffusion, and exchange of components within the cerebral cisterns and venous system. The membrane is disposed within distal portion 13, proximal portion 12, or tubular body 11. Specifically, the membrane is disposed within flow cavity 15 of shunt 1, with CSF flowing through the shunt's cerebrospinal fluid inlet, the membrane, and the cerebrospinal fluid outlet. Alternatively, the membrane is disposed at the shunt's cerebrospinal fluid inlet, outlet, or both.

[0076] The shunt further includes a polymer liner disposed on the tubular body 11, the proximal portion 12, and the distal portion 13. Specifically, the polymer liner is disposed on part or all of the outer surface and inner surface of the lumen of the shunt 1. The polymer liner is selected from a material that minimizes protein and / or cell adhesion. More specifically, the polymer liner is made of PTFE, PET, or the like. Furthermore, the polymer liner is disposed on the outer surface of the shunt 1 and / or the inner surface of the flow lumen 15.

[0077] The shunt also includes an anticoagulant layer, which is arranged on the tube body 11, the proximal part 12 and the distal part 13. Specifically, the anticoagulant layer is arranged on part or all of the outer surface and the inner surface of the cavity of the shunt 1. The anticoagulant layer can be an anticoagulant coating, have an anticoagulant component or an anticoagulant structure, or a combination thereof.

[0078] The delivery system includes a delivery catheter 2, a shunt pusher 3, a puncture member 4, and a guide member 5. During delivery, the shunt 1, shunt pusher 3, puncture member 4, and guide member 5 are located within the lumen of the delivery catheter 2. The puncture member 4 is positioned outside, within, or at the distal end 13 of the shunt 1. The delivery catheter 2 delivers the puncture member 4 and shunt 1 to a designated location. The guide member 5 guides the delivery catheter 2 within the venous system. The shunt pusher 3 pushes the shunt 1 along the delivery catheter 2. After moving along the delivery catheter 2 to the designated location, the puncture member 4 punctures the dura mater to form a puncture orifice.

[0079] The guide member 5 can be configured as a member including, but not limited to, a guidewire, a distally shaped microcatheter, a guide catheter, a catheter with a unilateral balloon, a black loach guidewire, an angiographic catheter, a stent with an inner lumen, or a balloon. In this embodiment, the shunt pusher 3 is configured as a shunt push rod, and the guide member 5 is configured as a guide rod. The shunt 1, shunt push rod, puncture member 4, and guide rod are all disposed within the delivery catheter 2. The delivery catheter 2 has an inner lumen, which may include an inner lumen for accommodating the shunt 1 and an inner lumen for accommodating the guide rod.

[0080] In this embodiment, a puncture member 4 is disposed within the flow chamber 15. The puncture member 4 comprises a main body and a puncture tip with a blade at its distal end. The distal end of the main body is connected to the puncture tip. The main body of the puncture member comprises a distal end and a proximal end. The distal end of the main body of the puncture member is configured as a hypotube structure, a braided belt structure, or the like. The puncture member is configured as a circular or angular thin sheet. Specifically, the puncture tip punctures the dura mater to form a puncture opening. The cross-sectional shape of the puncture tip can be circular (or an unclosed circular shape with a seam) or a flat thin sheet, including but not limited to circular, rectangular, prismatic, elliptical, half-moon, trapezoidal, crescent-shaped, and other generalizable shapes such as wavy, double-wavy, bullet-shaped, and right-angled trapezoidal. The puncture tip is configured as a circular sheet. Since most conventional puncture needles are circular and simple, it is more convenient to use, and conventional puncture needles can be directly used in the present invention. Preferably, the puncture tip is configured as a flat thin sheet. The puncture opening formed by puncturing the dura mater has a small radial dimension, thereby providing a maximum possible limit size.

[0081] The puncture tip in this embodiment is configured as a puncture flat sheet, as shown in FIG5 . The puncture flat sheet is rectangular in shape corresponding to the flow cavity, and has a cross-sectional size of 0.3 mm*0.1 mm. Two cutting edges are provided at the distal end of the puncture flat sheet.

[0082] In other embodiments, the relative position of the puncture member 4 and the shunt 1 includes but is not limited to the puncture member being located outside the shunt tube, inside the shunt tube, or at the distal end of the shunt.

[0083] In this embodiment, the diverter tube push rod is configured to be tubular, with a rectangular cavity in the middle of the tube corresponding to the flow cavity 15 of the diverter 1. The diverter 1 is disposed in the rectangular cavity of the diverter tube push rod, and the distal end of the diverter 1 is located at one end of the diverter tube push rod.

[0084] The delivery system includes an expandable anchoring member, which is connected to a guide member. The expandable anchoring member includes but is not limited to a balloon, a stent, etc. During the delivery process, the guide member is connected to the expandable anchoring member located at the distal end of the inferior petrosal sinus.

[0085] The delivery system further comprises an expansion member configured to move along the guide member and / or the puncture member and / or the shunt 1 to expand the puncture opening formed by the puncture member.

[0086] The delivery system includes at least one radiopaque marker positioned and sized to indicate the trajectory of the penetrating tip, and in particular, the distal end of the puncture member is provided with the radiopaque marker.

[0087] The conveying system also includes an operating handle, and some or all of the proximal ends of the components in the conveying system are connected to the operating handle, and the conveying system is operated through the operating handle.

[0088] The use of the conveying system is as follows:

[0089] After femoral vein puncture, an interventional pathway is constructed and the guide member of the delivery system, such as a guide catheter, is delivered to the internal jugular vein. The delivery system can then enter the inferior petrosal sinus in one of four ways.

[0090] Method (1) Under the dual C-arm anteroposterior and lateral venous phase maps, the micro-guidewire guides the micro-catheter into the inferior petrosal sinus.

[0091] Method (2) The single-curved angiographic catheter is guided to the inferior petrosal sinus using a black loach guidewire. The black loach guidewire is then withdrawn. Under the guidance of the common carotid artery anteroposterior view, the microcatheter is guided through the angiographic catheter to the inferior petrosal sinus and advanced approximately 30 mm from the exit of the internal jugular vein catheter. The microguidewire is withdrawn and the expandable anchoring member of the delivery system is pushed in. The microcatheter, carrying the anchoring member, reaches a depth of approximately 30 mm.

[0092] Method (3) In the case of stenosis of the entrance to the inferior petrosal sinus: an exchangeable loach guidewire is inserted into the guide catheter, the guide catheter is withdrawn, and the exchange is made for a single-curved angiography catheter. With the strong support of the angiography catheter, the loach guidewire is inserted into the inferior petrosal sinus; the angiography catheter is withdrawn, and the coaxial exchange is made for the guide catheter and the multifunctional angiography catheter. The multifunctional angiography catheter passes over the stenosis of the inferior petrosal sinus and brings the guide catheter into the inferior petrosal sinus. A microcatheter is inserted along the guide catheter, and the microcatheter, carrying the expandable anchoring structure - the anchoring stent, reaches a depth of approximately 30 mm, and the microcatheter is withdrawn.

[0093] Method (4) When the inferior petrosal sinus is not visualized, the entrance of the inferior petrosal sinus is explored using an angiographic guidewire or a loach guidewire, and then the microcatheter is guided into the inferior petrosal sinus to deploy the stent according to the above operation.

[0094] The process of delivering the shunt 1 to the specified position in this embodiment is as follows: the delivery catheter enters the inferior petrosal sinus along the guide member; the shunt 1 enters the inferior petrosal sinus along the inner cavity of the delivery catheter under the pushing action of the shunt tube push rod; after imaging, it is determined whether the position of the distal frustum structure of the shunt is appropriate. If the position of the distal frustum structure is appropriate, the proximal end of the puncture member is pushed forward to puncture the dura mater and arachnoid mater to form a puncture opening and enter the cerebral cistern; the shunt tube push rod is pushed, and the distal frustum structure of the shunt moves forward along the puncture member, the frustum structure squeezes the dura mater puncture opening, and the expansion part of the frustum structure gradually expands the dura mater puncture opening to enter the cerebral cistern; the shunt tube push rod is withdrawn, and the tissue near the dura mater puncture opening elastically rebounds and squeezes the shunt tube body of 1; then the delivery catheter and the guide member are withdrawn in turn; since the tube body is larger than the puncture opening, the tube body and the puncture opening form a seal; since the limiting part and the puncture opening have a space-occupying size, the limiting part and the puncture opening form a blocking position.

[0095] When the shunt 1 is deployed in the venous system, the distal portion of the shunt 1 is disposed in the cerebral cistern, and the proximal portion of the shunt 1 is disposed in or near the jugular vein, cerebrospinal fluid flows from the cerebellopontine angle cistern into the jugular vein through one or more cerebrospinal fluid inlets at the distal end of the shunt, the flow cavity of the shunt, and the cerebrospinal fluid outlet at the proximal end of the shunt.

[0096] Example 2:

[0097] As shown in Figures 1-3, 7 and 8, a shunt and a system thereof for treating hydrocephalus include a shunt 1 and a delivery system for delivering the shunt 1 to a designated location in a blood vessel.

[0098] For other structures, see Example 1. The shunt 1 of this embodiment differs from Example 1 in that the tube body 11 includes a distal rounded rectangular cross-sectional structure 16 and a remaining circular tubular cross-sectional structure 17. The rounded rectangular cross-sectional structure measures 0.6 mm by 0.4 mm. A flow cavity 15 is provided within the tube body. The flow cavity 15 is a through cavity measuring 0.25 mm by 0.14 mm. The size of the through cavity is determined by the flow rate requirement, which is less than 20 ml / h. A stepped surface is provided near the distal end 13 of the tube body 11, forming a stepped surface between the distal end and the remaining portion. This stepped surface serves to form a stop with the side of the dura mater away from the ventricular system, preventing the shunt from excessively moving into the cerebral cisterns and preventing significant displacement of the shunt 1 after deployment. There is a distal section of the tube body between the step surface and the limiting portion 14, whose minimum radial dimension is smaller than the maximum radial dimension of the tube body 11. In this embodiment, the above-mentioned step surface is formed between the rounded rectangular cross-sectional structure 16 of the tube body 11 and the remaining circular tube cross-sectional structures 17. The rounded rectangular cross-sectional structure 16 is the distal section of the tube body, and part of the radial dimension of the rounded rectangular cross-sectional structure 16 is smaller than the radial dimension of the remaining circular tube cross-sectional structures 17.

[0099] The conveying system of this embodiment is different from that of embodiment 1 in that the puncture member is arranged outside the shunt 1 and parallel to the shunt 1, the puncture member is arranged to be tubular or flat, the cross-sectional size of the puncture member is set to be 0.3mm*0.1mm, the puncture tip is a flat sheet, and is provided with two cutting edges. Specifically, the puncture member is a puncture needle; the shunt tube pushing member is arranged to be a shunt tube push rod, which is located on the outer side or proximal end of the shunt 1 and can push the distal end or proximal end of the shunt to play the role of pushing the shunt; the anchoring member is arranged to be an anchoring bracket.

[0100] The delivery system includes a delivery catheter, a shunt tube push rod, a puncture needle, a guide rod and an anchoring bracket. The shunt 1, the delivery catheter, the shunt tube push rod, the puncture needle and the guide rod are all arranged inside the delivery catheter. The anchoring bracket is connected to the distal end of the guide rod. The anchoring bracket is used to be arranged at the distal end of the inferior petrosal sinus.

[0101] The guiding member may also include but is not limited to a guide wire, a distally shapeable microcatheter, a guide catheter, a catheter with a unilateral balloon, a stent or balloon with an inner lumen, and the like.

[0102] The process of using the conveying system to convey the diverter 1 to the actuation position in this embodiment is as follows:

[0103] The delivery catheter enters the inferior petrosal sinus along the guide rod. Under the action of the proximal end of the puncture member and the shunt tube push rod, the shunt 1 and the puncture member enter the inferior petrosal sinus along the inner cavity of the delivery catheter. After imaging, it is determined whether the position of the truncated cone structure at the distal end of the shunt 1 is appropriate. If the position of the truncated cone structure is appropriate, the proximal end of the puncture member is pushed forward to puncture the dura mater and arachnoid membrane to form a puncture opening and enter the cerebral cistern; the shunt tube push rod is pushed, and the truncated cone structure at the distal end of the shunt moves forward along the puncture member, the truncated cone structure squeezes the dura mater puncture opening, and the truncated cone structure The dura mater puncture opening is gradually expanded to enter the brain cistern; the shunt tube push rod is withdrawn, and the tissue near the dura mater puncture opening is squeezed by elastic rebound to squeeze the shunt tube body 1; then the delivery catheter and the guide rod are withdrawn in sequence; since the distal end of the tube body that matches the puncture opening is larger than the size of the puncture opening, the tube body and the puncture opening form a seal; since there is a space occupied by the frustum structure and the puncture opening, the limit part and the puncture opening form a blocking position; since the size of the step surface between the distal end of the tube body and the circular tube is larger than the size of the puncture opening, the step surface and the puncture opening form a limit.

[0104] Example 3:

[0105] A shunt and a system thereof for treating hydrocephalus include a shunt 1 and a delivery system for delivering the shunt 1 to a designated position in a blood vessel.

[0106] For other structures, see Example 2. The delivery system of this embodiment differs from that of Example 2 in that the puncture member 4 includes a main body 6 and a tip 7. The main body 6 of the puncture member 4 is configured to be tubular, flat, or an unclosed slit tubular shape, and the tip 7 of the puncture member 4 has a cross-sectional shape configured to be a flat half-moon shape. The tip 7 has a cutting edge, which is arranged relatively close to the axis of the diverter 1, as shown in Figures 11, 12, and 13. In this way, the puncture member can occupy a smaller space within the delivery catheter, and the radial size of the puncture hole formed is smaller, which can provide a larger limit size.

[0107] Specifically, the tip of the crescent-shaped flat puncture member is a puncture needle with an outer diameter of 0.9 mm and an angled wall thickness of 0.1 mm. The puncture opening formed by the puncture needle is smaller than the diameter of 0.64 mm. The puncture needle is pre-plasticized and can move forward toward the axis of the diverter 1, or the frustum structure of the diverter 1 is tilted toward the puncture needle. The proximal end of the puncture needle body is divided into a sea wave tube structure.

[0108] As shown in Figure 10, the delivery system includes a delivery catheter 2, a shunt push rod, a puncture member 4, and a guide rod 5. The shunt 1, shunt push rod, puncture member 4, and guide rod 5 are all disposed within the delivery catheter 2. The delivery catheter 2 has an inner lumen, which includes an inner lumen for accommodating the puncture member 4, an inner lumen portion for accommodating the shunt 1, and an inner lumen portion for accommodating the guide rod 5. The puncture member 4 is located to one side between the shunt 1 and the delivery catheter 2, the shunt push rod is located outside the shunt 1, and the guide rod 5 is located in the corresponding delivery lumen.

[0109] The process of using the conveying system to convey the diverter 1 to the actuation position in this embodiment is as follows:

[0110] The delivery catheter 2 enters the inferior petrosal sinus along the guide rod 5. The shunt 1 and the puncture member 4 enter the inferior petrosal sinus along the inner cavity of the delivery catheter 2 under the action of the proximal end of the puncture member and the shunt tube push rod. After imaging, it is determined whether the position of the truncated cone structure at the distal end of the shunt 1 is appropriate. If the position of the truncated cone structure is appropriate, the proximal end of the puncture needle is pushed forward to puncture the dura mater and arachnoid membrane to form a puncture opening and enter the brain cistern; the shunt tube push rod is pushed, and the truncated cone structure at the distal end of the shunt moves forward along the puncture member, the truncated cone structure squeezes the dura mater puncture opening, and the truncated cone structure is pushed forward. The expansion part gradually expands the dura mater puncture opening into the brain cistern; the shunt tube push rod is withdrawn, and the tissue near the dura mater puncture opening is squeezed by elastic rebound to squeeze the shunt tube body 1; then the delivery catheter 2 and the guide rod 5 are withdrawn in sequence; since the distal end of the tube body that matches the puncture opening is larger than the size of the puncture opening, the tube body and the puncture opening form a seal; since there is a space occupied by the frustum structure and the puncture opening, the limiting part and the puncture opening form a blocking position; since the size of the step surface between the distal end of the tube body and the circular tube is larger than the size of the puncture opening, the step surface and the puncture opening form a limit.

[0111] Example 4:

[0112] As shown in FIG14 , a shunt and a system thereof for treating hydrocephalus include a shunt 1 and a delivery system for delivering the shunt 1 to a designated location in a blood vessel.

[0113] The rest is the same as Example 3. The difference between the delivery system of this embodiment and Example 3 is that the puncture member is located in the diverter 1, and a puncture protection sleeve 8 is provided between the entire inner wall of the diverter 1 that accommodates the inner cavity of the puncture member and the puncture member.

[0114] Example 5:

[0115] As shown in FIG15 , a shunt and a system thereof for treating hydrocephalus include a shunt 1 and a delivery system for delivering the shunt 1 to a designated location in a blood vessel.

[0116] The rest is the same as Example 4. The difference between the delivery system of this embodiment and Example 4 is that the puncture member 4 is located in the diverter 1, and a puncture protection sleeve 8 is provided between the inner wall of the diverter 1 that accommodates the puncture member and the puncture member 4, and the puncture protection sleeve 8 also serves as a diverter push tube.

[0117] Experimental testing of the present invention revealed that the puncture openings in the dura mater are primarily half-moon, crescent, or arc-shaped. Consequently, the puncture openings undergo significant compressive elastic deformation due to the extrusion of the tube body. Furthermore, the puncture opening formed in the dura mater is smaller than the diameter of the puncture member, leaving the dura mater with a certain amount of elastic deformation space. Therefore, after the shunt 1 passes through the puncture opening, it can be retained in place due to the elastic deformation of the dura mater. Furthermore, even if the puncture opening tears due to excessive elastic deformation, since the dura mater is made of soft material, the larger tube body can expand the puncture opening, further closing the tear.

[0118] For example, a puncture needle with a lancet blade having an outer diameter of 0.9 mm can obtain a puncture hole size of 0.45 mm; a puncture needle with a half-puncture tip having an outer diameter of 0.9 mm can obtain a puncture hole size of less than 0.6 mm. If the distal end of the shunt adopts a cone larger than the outer diameter of the puncture needle, and the tube body adopts a size slightly larger than the puncture hole, the shunt 1 can be fixed and sealed. In addition, according to calculations, the force exerted on the shunt 1 in the venous system is very small, so the anchoring force requirement is small, and thus the size requirement for the distal limit part is relatively low. The size comparison of the puncture needle and the puncture hole is shown in Figure 16. Taking the circular puncture tip and the puncture hole as an example, since the dura mater has a certain elastic deformation ability, the puncture tip of the puncture member punctures the dura mater and forms a puncture hole on the dura mater with a radial size smaller than the radial size of the puncture tip.

[0119] When the puncture tip of the puncture member of the present invention is configured as a thin sheet, the puncture member of this structure can fully utilize the flow cavity space of the diverter 1 while maximizing the space provided. At the same time, due to the minimal size of the puncture sheet and the large tube body, it can achieve a sealing function with the tube body. In addition, when the puncture needle protective cover is placed in the flow cavity 15 of the diverter 1, the puncture needle protective cover can serve as the shunt tube push rod while providing protection for the lining of the diverter 1, preventing the puncture needle from cutting and damaging the inner wall of the flow cavity 15 of the diverter 1 and the flow control member.

[0120] Finally, it should be noted that the above descriptions are merely preferred embodiments of the present invention and are not intended to limit the present invention. The examples of implementation methods, including portions not described in detail, are common knowledge to those skilled in the art. Those skilled in the art can modify the technical solutions described in the aforementioned embodiments or substitute equivalent features for some of the technical features. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention shall be included within the scope of protection of the present invention.

[0121] Finally, it should be noted that the above descriptions are merely preferred embodiments of the present invention and are not intended to limit the present invention. The examples of implementation methods, including portions not described in detail, are common knowledge to those skilled in the art. Those skilled in the art can modify the technical solutions described in the aforementioned embodiments or substitute equivalent features for some of the technical features. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention shall be included within the scope of protection of the present invention.

Claims

1. A shunt for treating hydrocephalus, which is deployed in the ventricular system and venous system of a patient to discharge cerebrospinal fluid in the ventricular system of the patient to the venous system, and the dura mater between the ventricular system and the venous system is provided with a puncture hole, characterized in that: The invention comprises a distal portion (13) provided with a cerebrospinal fluid inlet, a proximal portion (12) provided with a cerebrospinal fluid outlet, and a tube body (11) provided with a flow cavity, wherein the distal portion (13) is used for being deployed in the ventricular system, the proximal portion (12) is used for being deployed in the venous system, the tube body (11) connects the distal portion (13) and the proximal portion (12), the flow cavity communicates with the cerebrospinal fluid inlet and the cerebrospinal fluid outlet, and the distal portion (13) is provided with a limiting portion (14) for contacting the dura mater, wherein the maximum radial dimension of the limiting portion (14) in the transport state is greater than the minimum radial dimension of the puncture hole and the tube body (11).

2. The shunt for treating hydrocephalus according to claim 1, characterized in that: The maximum radial dimension of the distal end of the tube body (11) is greater than the minimum radial dimension of the puncture hole.

3. The shunt for treating hydrocephalus according to claim 1, characterized in that: The distal portion (13) is provided with an expansion portion connected to the limiting portion (14); the expansion portion is farther away from the proximal portion (12) relative to the limiting portion (14); and the radial dimension of the expansion portion gradually increases in a direction from the distal portion (13) to the proximal portion (12).

4. The shunt for treating hydrocephalus according to claim 3, characterized in that: The minimum radial dimension of the expansion portion is less than or equal to the maximum radial dimension of the puncture hole.

5. The shunt for treating hydrocephalus according to claim 1, characterized in that: The limiting portion (14) is a truncated cone, an ellipsoid, a prism, a cylinder, or a cone; And / or, the distal end of the tube body (11) close to the distal end portion (13) is circular or flat; And / or, the limiting portion (14) coincides with or does not coincide with the central axis of the tube body (11).

6. The shunt for treating hydrocephalus according to claim 1, characterized in that: The limiting portion (14) is made of elastic material; Alternatively, the limiting portion (14) comprises an elastic structure, and the elastic structure is located at the far end of the limiting portion (14).

7. The shunt for treating hydrocephalus according to claim 1, characterized in that: The difference between the maximum radial dimension of the limiting portion (14) and the minimum radial dimension of the puncture hole is the maximum limiting dimension, and the difference between the minimum radial dimension of the limiting portion (14) and the maximum radial dimension of the puncture hole is the minimum limiting dimension. The range between the maximum limiting dimension and the minimum limiting dimension is 0-3 mm.

8. The shunt for treating hydrocephalus according to claim 1, characterized in that: The tube body (11) is provided with a step surface near the distal portion (13), the step surface being used to form a limit with a side of the dura mater away from the ventricular system, and the tube body distal section between the step surface and the limit portion (14) has a minimum radial dimension that is smaller than the maximum radial dimension of the tube body (11).

9. The shunt for treating hydrocephalus according to claim 1, characterized in that: A repair agent is provided between the tube body (11) and the puncture hole.

10. The shunt for treating hydrocephalus according to claim 1, characterized in that: It also includes a flow control component, which only allows cerebrospinal fluid to flow from the cerebral cistern into the venous system through the flow cavity. The flow control component is arranged in the flow cavity or the proximal part (12) or the distal part (13) or a combination thereof.

11. The shunt for treating hydrocephalus according to claim 10, characterized in that: The flow direction control component is a one-way valve, a one-way flow channel, a one-way flow surface or a spring valve.

12. The shunt for treating hydrocephalus according to claim 11, characterized in that: The one-way valve is a duckbill valve, a slit valve, a double-valve diaphragm valve or a single-valve diaphragm valve, the one-way flow channel is a Tesla valve, and the one-way flow surface is configured as a one-way flow microstructure, a hydrophilic-hydrophobic alternating structure or a one-way increased damping surface structure.

13. The shunt for treating hydrocephalus according to claim 1, characterized in that: A semipermeable membrane is provided in the distal portion (13), the proximal portion (12) or the tube body (11), and the semipermeable membrane restricts the flow, diffusion or exchange of some components of the ventricular system and the venous system; And / or, further comprising a polymer liner and / or an anti-coagulation layer, wherein the polymer liner and / or the anti-coagulation layer are arranged on the tube body (11), the proximal portion (12) and the distal portion (13); And / or, the proximal portion (12) is provided with a shielding protection device, the shielding protection device being a stent, a balloon or a film; And / or, also includes at least one radiopaque marker.

14. A system for treating hydrocephalus, characterized in that: It comprises the shunt and delivery system as described in any one of claims 1-13, wherein the delivery system delivers the shunt to a designated position in the venous system and the ventricular system, and during the delivery process, the shunt is placed in the delivery system.

15. The system for treating hydrocephalus according to claim 14, characterized in that: The delivery system comprises a delivery catheter (2), a shunt tube pusher (3), a puncture member (4) and a guide member (5). During the delivery process, the shunt, the shunt tube pusher (3), the puncture member (4) and the guide member (5) are all located inside the delivery catheter (2), and the puncture member (4) is arranged outside the shunt or inside the shunt or at the distal end.

16. The system for treating hydrocephalus according to claim 15, characterized in that: The distal end of the puncture member (4) is provided with a puncture tip with a blade, and the puncture tip punctures the dura mater to form a puncture hole on the dura mater. The puncture tip is a round or flat sheet.

17. The system for treating hydrocephalus according to claim 16, characterized in that: A puncture protection sleeve is arranged outside the puncture tip; And / or, the distal end of the puncture member (4) is provided with a radiopaque marker.

18. The system for treating hydrocephalus according to claim 15, characterized in that: The distal end of the guide member (5) is connected to a distal anchoring member, and / or the proximal end of the guide member (5) is connected to a proximal deflecting member.

19. The system for treating hydrocephalus according to claim 15, characterized in that: The delivery system further comprises an expansion member for expanding the puncture opening; and / or, the delivery system comprises at least one radiopaque marker; And / or, the conveying system is connected to an operating handle, and the operating handle is used to control the conveying system to convey the diverter.

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