Puncture device and hydrocephalus interventional therapy system

Abstract

The invention relates to the technical field of medical instruments, and discloses a puncture device and a hydrocephalus interventional therapy system. The puncture device comprises a needle tip, a sheath, a puncture catheter and a first handle; the puncture catheter is composed of an inner layer, a hypotube and an outer layer, the outer layer is provided with a wire drawing cavity and a traction wire, the far end of the hypotube is connected with the needle tip, the far end of the traction wire is connected with the sheath, and the first handle controls the traction wire through the sliding block to achieve controllable recovery of the sheath. The hydrocephalus interventional therapy system is integrated with a puncture device. According to the puncture device, hardness gradient distribution is achieved through multiple sections of cutting areas of the hypotube, and the trafficability in a bent blood vessel is improved; the outer layer symmetrical wire drawing cavity balances the stress of the drawing wire; and a handle knob transmission mechanism realizes linear accurate control. The control precision, safety and stability of puncture operation in the hydrocephalus interventional therapy process are improved, accurate exposure of the needle tip is achieved, the tissue damage risk is reduced, and the overall operation efficiency is improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a puncture device and an interventional treatment system for hydrocephalus. Background Technology

[0002] Hydrocephalus is a pathological condition caused by the abnormal accumulation of cerebrospinal fluid in the subarachnoid space or ventricles of the brain, leading to increased intracranial pressure. It often causes neurological dysfunction and can be life-threatening in severe cases. Currently, the treatment of hydrocephalus mainly relies on surgery, with shunt surgery being considered the standard treatment due to its low technical threshold, wide range of indications, and rapid efficacy. Shunt surgery typically involves implanting a shunt device into the patient to establish a drainage channel for cerebrospinal fluid from the ventricles or arachnoid cisterns to body cavities (such as the abdominal cavity, atrium, or pleural cavity) to reduce intracranial pressure.

[0003] In shunt procedures, puncture is a crucial step, establishing a pathway for instrument access, such as delivering the shunt to the target site via a transvascular route. Existing puncture devices typically consist of a needle tip, sheath, and catheter structure to penetrate tissue and protect surrounding vessels. However, these devices have certain limitations in clinical application: for example, the sheath retrieval mechanism may rely on manual operation, leading to inaccurate needle tip exposure and increasing the risk of tissue damage; uneven rigidity of the puncture catheter may affect its passage through tortuous vessels; furthermore, the complex handle control method is prone to operational errors, affecting surgical efficiency and safety. Summary of the Invention

[0004] To address the above problems, this invention provides a puncture device and a hydrocephalus interventional treatment system, aiming to solve the problems of improving the control precision, operational safety, and passability of puncture in hydrocephalus interventional treatment.

[0005] The first aspect of this invention provides a puncture device, including a needle tip, a sheath, a puncture catheter, and a first handle. The needle tip is located at the distal end of the puncture device; the sheath covers the needle tip; the puncture catheter consists of an inner layer, a hypochlorous acid tube, and an outer layer arranged radially from the inside out, the outer layer having a drawstring cavity extending from the proximal end to the distal end, in which a drawstring is disposed; the inner layer is fitted and fixed to the inner side of the hypochlorous acid tube, the distal end of the drawstring is connected to the sheath, and the distal end of the hypochlorous acid tube is connected to the needle tip; the first handle is located at the proximal end of the puncture device and includes a catheter seat and a first slider arranged sequentially from the proximal end to the distal end, the slider being able to slide back and forth in the direction from the proximal end to the distal end and being fixedly connected to the drawstring, the catheter seat being fixedly connected to the inner layer. The structure of the puncture device enables controllable retrieval of the sheath and precise exposure of the needle tip, enhancing the stability and safety during operation.

[0006] Optionally, the hypotube has multiple cutting zones along its axial direction, with the cutting pitch increasing from the distal to the proximal end. This design results in a gradual distribution of hypotube stiffness, improving the catheter's passage and compliance in tortuous blood vessels.

[0007] Optionally, two drawing cavities are symmetrically arranged at both ends of the outer layer in the diameter direction. The symmetrical arrangement of the drawing cavities helps to balance the force on the drawn fibers, ensuring the synchronicity and stability during sheath recovery.

[0008] Optionally, the first handle includes a knob, a fixed base, a threaded sleeve, and a limiting rod. The knob has a limiting groove inside, and the threaded sleeve has a limiting rib on its outer surface. The limiting groove and the limiting rib cooperate to cause the threaded sleeve to rotate when the knob is turned. The limiting rod is positioned between the threaded sleeve and the first slider, and a limiting groove is provided in the center of the limiting rod. The first slider is positioned in the limiting groove and can slide axially. This mechanical transmission structure enables precise control of the handle, allowing the operator to linearly control the position of the sheath by rotating the knob.

[0009] A second aspect of this invention provides an interventional treatment system for hydrocephalus, comprising any of the aforementioned puncture devices. By integrating the puncture device, the hydrocephalus interventional treatment system simplifies the surgical procedure and improves the overall efficiency and reliability of hydrocephalus interventional treatment.

[0010] Optionally, the hydrocephalus interventional treatment system also includes a shunt device, which comprises a shunt and a push rod. The front end of the push rod is engaged with the rear end of the shunt, and the push rod is configured to push the shunt through the puncture catheter. The shunt includes a connector, a shunt tube, a one-way valve, and an anchor. One end of the shunt tube is fixedly connected to the front end of the connector, and the other end is fixedly connected to the rear end of the one-way valve. The front end of the one-way valve is fixedly connected to the rear end of the anchor. The push rod has a clasp at its front end, and the connector has a slot at its rear end. The shunt engages with the push rod via the slot in the connector. This structure enables controlled release and stable implantation of the shunt, reducing surgical risks.

[0011] Optionally, the manifold comprises an inner layer, a middle layer, and an outer layer from the inside out; the middle layer is a hyaluronic acid tube with multiple cut sections along the axial direction, and the cut pitch decreases from the end near the connector to the end near the check valve. The hyaluronic acid tube's gradient stiffness design improves the manifold's flexibility and durability, adapting to complex in-body environments.

[0012] Optionally, the one-way valve includes a valve body, a valve core, and a pressure ring; an annular groove is provided on the outer circumference of the valve core, and the valve core is assembled inside the valve body through the annular groove and pressed and fixed by the pressure ring; a cross slit is cut on the concave surface at the center of the valve core, allowing fluid to flow unidirectionally from the inlet side to the outlet side of the valve core. The cross slit structure can achieve elastic opening and closing of the valve disc under pressure, ensuring unidirectional flow of cerebrospinal fluid and preventing blood backflow.

[0013] Optionally, the one-way valve includes a valve body, a valve core, a tension spring, and a tail seat; the tail seat is fixedly connected to the valve body, and both the valve body and the tail seat are provided with flow holes; the valve core is connected to the tail seat via the tension spring to block or release the flow holes of the valve body. The tension spring mechanism provides a stable valve opening and closing function, further ensuring the reliability of unidirectional flow.

[0014] Optionally, the hydrocephalus interventional treatment system also includes a delivery device comprising a delivery tube and a second handle connected to the proximal end of the delivery tube. The second handle includes a push button and a second slider. The push button is configured to move the second slider by sliding, thereby controlling the bending angle of the distal end of the delivery tube. The adjustable bending function of the delivery device enhances the guiding ability of the device within the blood vessel, supporting precise positioning. Attached Figure Description

[0015] Figure 1 This is a schematic diagram of a puncture catheter structure provided for some embodiments of the present invention.

[0016] Figure 2 This is a schematic diagram of the three beveled surfaces of a needle tip provided for some embodiments of the present invention.

[0017] Figure 3 This is a schematic diagram of the five beveled surfaces of a needle tip provided for some embodiments of the present invention.

[0018] Figure 4 This is a schematic diagram of the cutting area of ​​the sodium hypochlorite tube provided for some embodiments of the present invention.

[0019] Figure 5 This is a schematic diagram illustrating the development ring configuration for some embodiments of the present invention.

[0020] Figure 6 This is a schematic diagram of the cutting groove shape of a hyaluronic acid tube provided for some embodiments of the present invention.

[0021] Figure 7 A schematic diagram of the cutting groove pitch of a hyaluronic acid tube provided for some embodiments of the present invention.

[0022] Figure 8 This is a schematic diagram of the outer drawing cavity structure provided for some embodiments of the present invention.

[0023] Figure 9 This is a schematic diagram of the inner layer and the sodium hypotube assembly provided for some embodiments of the present invention.

[0024] Figure 10 This is a schematic diagram of the assembly of the outer layer and the sodium hypochlorite tube for some embodiments of the present invention.

[0025] Figure 11 This is a schematic diagram of the sheath and drawn wire assembly provided for some embodiments of the present invention.

[0026] Figure 12A schematic diagram of a first handle structure provided for some embodiments of the present invention.

[0027] Figure 13 A schematic diagram of a first slider structure provided for some embodiments of the present invention.

[0028] Figure 14 This is a schematic diagram of a limiting rod structure provided for some embodiments of the present invention.

[0029] Figure 15 This is a schematic diagram of a threaded sleeve structure provided for some embodiments of the present invention.

[0030] Figure 16 A schematic diagram of a knob structure provided for some embodiments of the present invention.

[0031] Figure 17 A schematic diagram of a fixing base structure provided for some embodiments of the present invention.

[0032] Figure 18 This is a schematic diagram of a connector structure provided for some embodiments of the present invention.

[0033] Figure 19 This is a schematic diagram illustrating the connection between the connector and the mounting base according to some embodiments of the present invention.

[0034] Figure 20 This is a schematic diagram of a card block structure provided for some embodiments of the present invention.

[0035] Figure 21 This is a schematic diagram of the card block limiting rib provided for some embodiments of the present invention.

[0036] Figure 22 This is a schematic diagram illustrating the connection between the card block and the mounting base in some embodiments of the present invention.

[0037] Figure 23 This is a schematic diagram of the mounting base structure provided for some embodiments of the present invention.

[0038] Figure 24 This is a schematic diagram of the card block and mounting base assembly provided for some embodiments of the present invention.

[0039] Figure 25 A schematic diagram of the tail cap structure provided for some embodiments of the present invention.

[0040] Figure 26 A schematic diagram of the tail cap groove provided for some embodiments of the present invention.

[0041] Figure 27 A schematic diagram of a sleeve structure provided for some embodiments of the present invention.

[0042] Figure 28This is a schematic diagram of a sleeve limiting groove provided for some embodiments of the present invention.

[0043] Figure 29 This is a schematic diagram of a catheter seat structure provided for some embodiments of the present invention.

[0044] Figure 30 This is a schematic diagram of the assembly of the guide seat and tail cap provided for some embodiments of the present invention.

[0045] Figure 31 A schematic diagram of a diversion device provided for some embodiments of the present invention.

[0046] Figure 32 This is a schematic diagram of a shunt structure provided for some embodiments of the present invention.

[0047] Figure 33 This is a schematic diagram of a connector slot provided for some embodiments of the present invention.

[0048] Figure 34 This is a schematic diagram of the anchor development ring provided for some embodiments of the present invention.

[0049] Figure 35 This is a schematic diagram showing the connection between the anchor and the one-way valve provided for some embodiments of the present invention.

[0050] Figure 36 This is a schematic diagram of a one-way ball valve structure provided for some embodiments of the present invention.

[0051] Figure 37 This is a schematic diagram of a shunt pipe structure provided for some embodiments of the present invention.

[0052] Figure 38 This is a schematic diagram of a single-layer flat yarn braided layer provided for some embodiments of the present invention.

[0053] Figure 39 This is a schematic diagram of a single layer of circular yarn in a braided layer, provided for some embodiments of the present invention.

[0054] Figure 40 This is a schematic diagram of a double-layer woven structure provided for some embodiments of the present invention.

[0055] Figure 41 A schematic diagram of a push rod structure provided for some embodiments of the present invention.

[0056] Figure 42 This is a schematic diagram of the welding of the push tube provided for some embodiments of the present invention.

[0057] Figure 43 This is a schematic diagram of the push tube clamp provided for some embodiments of the present invention.

[0058] Figure 44This is a schematic diagram of the cutting of the push tube provided for some embodiments of the present invention.

[0059] Figure 45 This is a schematic diagram of the push tube cutting groove provided for some embodiments of the present invention.

[0060] Figure 46 This is a schematic diagram of the heat treatment of the push tube clamp provided in some embodiments of the present invention.

[0061] Figure 47 A schematic diagram of the conveying pipe structure provided for some embodiments of the present invention.

[0062] Figure 48 This is a schematic diagram of the inner layer of the submersible tube being cut, provided for some embodiments of the present invention.

[0063] Figure 49 This is a schematic diagram of the cutting of the outer layer of the submersible tube, provided for some embodiments of the present invention.

[0064] Figure 50 This is a schematic diagram of the cutting groove shape of a hyaluronic acid tube provided for some embodiments of the present invention.

[0065] Figure 51 This is a schematic diagram of the cutting groove pitch provided for some embodiments of the present invention.

[0066] Figure 52 This is a schematic diagram of the bending area of ​​the outer layer of the submersible tube provided for some embodiments of the present invention.

[0067] Figure 53 This is a schematic diagram of the bending area of ​​the inner layer of the submersible tube provided for some embodiments of the present invention.

[0068] Figure 54 This is a schematic diagram of the tube hardness range provided for some embodiments of the present invention.

[0069] Figure 55 This is a schematic diagram of the tail end tube covering provided for some embodiments of the present invention.

[0070] Figure 56 This is a schematic diagram of a single developing ring configuration provided for some embodiments of the present invention.

[0071] Figure 57 This is a schematic diagram illustrating the arrangement of multiple developing rings according to some embodiments of the present invention.

[0072] Figure 58 A schematic diagram of a second handle structure provided for some embodiments of the present invention.

[0073] Figure 59 A schematic diagram of a push button structure provided for some embodiments of the present invention.

[0074] Figure 60This is a schematic diagram of the lower surface of the push button provided for some embodiments of the present invention.

[0075] Figure 61 This is a schematic diagram of a limiting block structure provided for some embodiments of the present invention.

[0076] Figure 62 This is a schematic diagram of the cylindrical hole of the limiting block provided for some embodiments of the present invention.

[0077] Figure 63 This is a schematic diagram of the push button and limit block assembly provided for some embodiments of the present invention.

[0078] Figure 64 This is a schematic diagram showing the engagement of a limiting block and an upper shell in some embodiments of the present invention.

[0079] Figure 65 This is a schematic diagram of the upper shell structure provided for some embodiments of the present invention.

[0080] Figure 66 This is a schematic diagram of the upper shell conical platform provided for some embodiments of the present invention.

[0081] Figure 67 This is a schematic diagram of the lower shell structure provided for some embodiments of the present invention.

[0082] Figure 68 This is a schematic diagram of the conical groove of the sheath provided for some embodiments of the present invention.

[0083] Figure 69 This is a schematic diagram of a catheter seat structure provided for some embodiments of the present invention.

[0084] Figure 70 A schematic diagram of a second slider structure provided for some embodiments of the present invention.

[0085] Figure 71 A schematic diagram of the center hole of the second slider provided for some embodiments of the present invention.

[0086] Figure 72 A schematic diagram of the conveying device provided for the first embodiment.

[0087] Figure 73 Another schematic view of the conveying device provided in the first embodiment.

[0088] Figure 74 A schematic diagram of the conveying device provided for the first embodiment.

[0089] Figure 75 A schematic diagram of the conveying pipe assembly provided for the first embodiment.

[0090] Figure 76 A schematic diagram of the conveying pipe assembly provided for the first embodiment.

[0091] Figure 77 A schematic diagram of the puncture device provided in the first embodiment.

[0092] Figure 78 A schematic diagram of the puncture device provided in the first embodiment.

[0093] Figure 79 A schematic diagram of the puncture catheter assembly provided for the first embodiment.

[0094] Figure 80 A schematic diagram of the insertion of the drawing wire provided for the first embodiment.

[0095] Figure 81 A schematic diagram of the drawing wire fixing provided for the first embodiment.

[0096] Figure 82 A schematic diagram of the drawing wire fixing provided for the first embodiment.

[0097] Figure 83 A schematic diagram of knob rotation provided for the first embodiment.

[0098] Figure 84 A schematic diagram of sheath recycling provided for the first embodiment.

[0099] Figure 85 A schematic diagram showing the exposed needle tip provided for the first embodiment.

[0100] Figure 86 A schematic diagram of the shunt release provided for the first embodiment.

[0101] Figure 87 A schematic diagram of the transport path provided for the first embodiment.

[0102] Figure 88 A schematic diagram of the sheath recycling operation provided for the first embodiment.

[0103] Figure 89 A schematic diagram of the puncture process provided for the first embodiment.

[0104] Figure 90 A schematic diagram of the distributor conveying process provided for the first embodiment.

[0105] Figure 91 A schematic diagram of puncture catheter retrieval provided for the first embodiment.

[0106] Figure 92 A schematic diagram of shunt implantation provided for the first embodiment.

[0107] Figure 93 A schematic diagram illustrating the completed implantation process for the first embodiment.

[0108] Figure 94 A schematic diagram of the shunt pipe structure provided for the second embodiment.

[0109] Figure 95 A schematic diagram of the cutting of a sodium hypochlorite tube provided for the second embodiment.

[0110] Figure 96 A schematic diagram of the cutting groove provided for the second embodiment.

[0111] Figure 97 A schematic diagram of the developing ring welding provided for the second embodiment.

[0112] Figure 98 A schematic diagram of a one-way valve structure provided for the third embodiment.

[0113] Figure 99 A schematic diagram of the valve core annular groove provided for the third embodiment.

[0114] Figure 100 A schematic diagram of the valve core cross-slot provided for the third embodiment.

[0115] Figure 101 A schematic diagram of a one-way valve structure provided for the fourth embodiment.

[0116] Figure 102 A schematic diagram of the valve core structure provided for the fourth embodiment.

[0117] Figure 103 A schematic diagram of the tailstock cutout provided for the fourth embodiment. Detailed Implementation

[0118] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0119] <Puncture Catheter 21> like Figure 1 As shown, the puncture catheter 21 includes an inner layer 211, a middle layer 212, and an outer layer 213 from the inside out.

[0120] The inner layer 211 of the puncture catheter is formed by heat-sealing at least two different polymer tubes together to create a polymer composite tube. The inner layer of the composite tube is lined with a self-lubricating PTFE tube, while the outer polymer tube can be either TPU or Pebax, or a combination of both. The TPU material has a hardness of 60 A to 80 A, and the Pebax material has a hardness of 25 D to 40 D. The outer polymer tubes can be of the same material and hardness; or they can be of the same material but with different hardnesses in multiple segments (at least two segments); or they can be of different materials and with different hardnesses in multiple segments (at least two segments). When using different materials or different hardnesses in multiple segments, the hardness of the composite tube should increase sequentially from one end to the other to ensure a smooth transition in the hardness of the inner layer 211. When subsequently assembled with the intermediate layer 212, the softest end of the polymer composite tube should be located at the tip 25.

[0121] The intermediate layer 212 is a sodium hypochlorite tube, and a needle tip 25 is provided at one end of the sodium hypochlorite tube. The shape of the needle tip 25 can be three-sided, such as... Figure 2 It includes a first inclined plane 251, a second inclined plane 252, and a third inclined plane 253; it can also be a five-inclined-plane configuration, such as... Figure 3 As shown, it includes a first inclined plane 251, a second inclined plane 252, a third inclined plane 253, a fourth inclined plane 254, and a fifth inclined plane 255. There are at least five sets of cutting regions with different pitches D along the axial direction of the sodium hypochlorite tube. Each cutting region contains multiple cutting grooves 4, and each set of cutting pitches D is different. By cutting different pitches D and lengths L, the purpose of gradually changing the hardness at the distal end of the tube is achieved, such as... Figure 4 As shown, the pitch D of each cutting groove gradually increases from the tip 25 end, and the transition of the cutting groove 4 at each segment is smooth.

[0122] The first segment cut length L1 is 15 mm to 40 mm, and the cutting pitch D1 is 0.1 mm to 0.21 mm; the second segment cut length L2 is 70 mm to 110 mm, and the cutting pitch D2 is 0.15 mm to 0.26 mm; the third segment cut length L3 is 55 mm to 95 mm, and the cutting pitch D3 is 0.18 mm to 0.32 mm; the fourth segment cut length L4 is 70 mm to 130 mm, and the cutting pitch D4 is 0.23 mm to 0.37 mm; the fifth segment cut length L5 is 85 mm to 120 mm, and the cutting pitch D5 is 0.27 mm to 0.42 mm.

[0123] At least one developing ring 5 is also provided at the distal end of the sodium hypochlorite tube, such as Figure 5As shown, the developing ring 5 is fixed to the sodium hypochlorite tube by laser welding. The distance A between the farthest developing ring 5 and the needle tip 25 is 15 mm to 30 mm, and the distance between two developing rings 5 ​​is at least 30 mm. The developing ring 5 is made of any one of platinum-iridium alloy, tantalum, or tungsten alloy, and its structure can be a circular ring or an open circular ring. The sodium hypochlorite tube is made of one or a combination of 304 stainless steel, 316 stainless steel, 304L stainless steel, nickel-titanium alloy, or cobalt-chromium alloy. After the hardness gradient section of the sodium hypochlorite tube body is laser-cut, the shape of its cutting groove 4 is as shown. Figure 6 As shown; after the cut submersible tube is unfolded into a flat state, the slit pitch D of each cut groove 4 can be observed, as shown. Figure 7 As shown.

[0124] The outer layer 213 is made of a polymer material, which can be either TPU or Pebax, or a combination of both. The TPU material has a hardness of 60 A to 80 A, and the Pebax material has a hardness of 25 D to 55 D. The outer layer 213 can be made of the same material and with the same hardness; it can also be made of the same material but with different hardnesses in multiple segments (at least two segments); or it can be made of different materials and with different hardnesses in multiple segments (at least two segments). When using different materials or different hardnesses in multiple segments, the hardness of the outer layer 213 increases gradually from one end to the other to ensure a smooth transition in the hardness of the polymer tube. When covering the outer layer 213, the softest end should face the needle tip 25 of the sodium hypochlorite tube to ensure a one-to-one correspondence between the hardness changes of the outer layer 213 and the sodium hypochlorite tube. The outer layer 213 is a multi-cavity tube with two symmetrical drawing cavities 2131 on both sides of the main channel 214, such as... Figure 8 As shown, it is used to accommodate the pull wire 24 during subsequent assembly with the first handle 22.

[0125] When the inner layer 211 is assembled into the cavity of the intermediate layer 212, an adhesive (such as adhesive resin) is evenly applied to the cavity of the intermediate layer 212 or the outer wall of the inner layer 211, so that the adhesive application area completely covers the inner layer 211. A matching mandrel is inserted into the cavity of the inner layer 211 as a liner, and then inserted into the cavity of the intermediate layer 212 together, with the distance B between the softest end of the inner layer 211 and the needle tip 25 of the intermediate layer 212 being 7 mm to 15 mm. Figure 9 As shown, an FEP thermoplastic tube is fitted onto the outer surface of the intermediate layer 212, and the outer surface of the inner layer 211 is bonded and fixed to the inner wall of the intermediate layer 212 using a conduit heat shrinking device.

[0126] When the outer layer 213 is assembled onto the outer surface of the intermediate layer 212, an adhesive is evenly applied to the outer surface of the intermediate layer 212, and then the outer layer 213 is inserted onto the surface of the intermediate layer 212, such that the distance C between the softest end of the outer layer 213 and the needle tip 25 of the intermediate layer 212 is 15 mm to 25 mm, and the outer layer 213 covers the developing ring 5 welded on the intermediate layer 212, as shown. Figure 10 As shown, FEP heat shrink tubing is then fitted onto the surface of the outer layer 213, and the outer layer 213 is melt-coated and bonded to the surface of the middle layer 212 using a conduit heat shrinking device.

[0127] The sheath 23 is formed by fusing at least two different polymer tubes together using a heat-sealing process to create a polymer composite tube. The inner layer of the sheath 23 is lined with a self-lubricating PTFE tube, and the outer layer is composed of polymer tubes. The outer polymer tubes can be TPU, Pebax, or nylon, with TPU having a hardness of 80 A to 95 A and Pebax having a hardness of 40 D to 72 D. The outer polymer tubes can be of the same material and hardness; or they can be of the same material but with different hardnesses in multiple segments (at least two segments); or they can be of different materials and with different hardnesses in multiple segments (at least two segments). When using different materials or different hardnesses in multiple segments, the hardness of the composite tube increases sequentially from one end to the other to ensure a smooth gradual change in the hardness of the inner tube. A drawing wire 24 is symmetrically arranged between the inner and outer layers of the sheath 23, and each drawing wire 24 has at least one developing ring 5. Figure 11 As shown, the developing ring 5 is fixed to the drawing wire 24 by welding, bonding, or pressing. The drawing wire 24 is wrapped between the inner and outer layers of the sheath 23 by a heat sealing process. The drawing wire 24 can be made of 304 stainless steel wire, 316 stainless steel wire, 304L stainless steel wire, nickel-titanium wire, or nylon wire, with a diameter ranging from 0.3 mm to 0.7 mm. The developing ring 5 can be made of platinum-iridium alloy, tantalum, or tungsten alloy.

[0128] <First Handle 22> like Figure 12 As shown, the first handle 22 includes a knob 221, a first slider 222, a limiting rod 223, a threaded sleeve 224, a fixing seat 225, a connecting seat 226, a mounting seat 227, a locking block 228, a tail cap 229, a sleeve 220, and a guide seat 215.

[0129] The first slider 222 is provided with an incomplete toothed thread 2221, and through holes 2222 for fixing are symmetrically provided on both sides of the central hole of the first slider 222. Figure 13 As shown, the two fixing holes 2222 are used for fixed connection with the tail end of the drawing wire 24. Figure 14As shown, the limiting rod 223 has connecting threads 2232 at both ends, and a limiting groove 2231 is provided on the limiting rod 223. The limiting groove 2231 is an elongated hole that axially penetrates the pipe wall, and one end of the limiting rod 223 is open. The first slider 222 can slide back and forth in the limiting groove 2231 of the limiting rod 223. The first slider 222 is placed inside the limiting rod 223, and its toothed thread 2221 passes through the limiting groove 2231 and protrudes outward, thereby engaging with the internal thread 2242 of the threaded sleeve 224 sleeved on the outside. Figure 15 As shown, a limiting rib 2241 is provided on the outer surface of the threaded sleeve 224, and an internal thread 2242 is provided inside to match the toothed thread 2221 of the first slider 222. The threaded sleeve 224 is screwed onto the first slider 222. Figure 16 As shown, a limiting groove 2211, which extends symmetrically along the axial direction of the knob 221, is symmetrically arranged inside the knob 221. An anti-slip groove 2212 is provided on the outside. The limiting groove 2211 inside the knob 221 matches the limiting rib 2241 on the threaded sleeve 224. A thread 2251 is provided inside the fixing base 225, which connects with the connecting thread 2232 on the limiting rod 223. Figure 14 The connecting thread 2232 on the left side of the middle matches, and a decorative groove 2252 is also provided on the outer surface of the fixing seat 225, such as Figure 17 As shown, it is used to enhance torque transmission during rotation.

[0130] like Figure 18 As shown, each end of the connecting seat 226 is provided with a connecting thread 2261 and a limiting post 2263. The internal connecting thread 2261 at one end is connected to the connecting thread 2232 at the opening end of the upper limit groove 2231 of the limiting rod 223, and the external connecting thread 2262 at the other end is connected to the internal connecting thread 2271 at one end of the mounting seat 227, as shown. Figure 19 As shown, the limiting post 2263 is used to limit the position of the first slider 222.

[0131] like Figure 20 and Figure 21 As shown, a limiting rib 2281 is provided on the outer surface of the locking block 228, and a limiting groove 2282 and a locking opening 2283 are provided on its inner surface. Figure 22 As shown, the slot 2283 on the card block 228 is engaged with the slot position 2274 on the mounting base 227.

[0132] like Figure 22 As shown, one end of the mounting base 227 is provided with an internal connecting thread 2271, and the other end is provided with an external connecting thread 2272. An annular buckle 2273 is also provided at the end with the external connecting thread 2272. A limit groove 2275 and a bayonet position 2274 are provided on the inner surface. Limit ribs 2276 are provided on the outer surface of the mounting base 227. Figure 23 As shown. The latch 228 engages with the latch position 2274 on the mounting base 227 via its latches, as... Figure 24 As shown, this integrates the card block and the mounting base into a single unit.

[0133] like Figure 25 As shown, a limiting platform 2291 is provided at one end of the tail cap 229 for limiting the axial position of the guide seat 215; a connecting thread 2292 is provided inside the tail cap 229 for connecting to the end of the mounting base 227 with the external connecting thread 2272. A decorative groove 2293 is also provided on the outer surface of the tail cap 229, such as... Figure 26 As shown.

[0134] like Figure 27 and Figure 28 As shown, a limiting groove 2201 is symmetrically provided inside the sleeve 220. The limiting groove 2201 matches the limiting ribs 2281 and 2276 on the locking block 228 and the mounting base 227. A snap-fit ​​groove 2202 is also provided at one end of the sleeve 220. The snap-fit ​​groove 2202 engages with the annular buckle 2273 on the mounting base 227 and fixes the sleeve 220 on the mounting base 227.

[0135] A limiting rib 2151 is symmetrically provided at one end of the guide tube seat 215, and an injection hole 2152 is provided in the direction perpendicular to the limiting rib 2151; a limiting disc 2153 is provided at the other end, such as Figure 29 As shown. One end of the limiting rib 2151 of the guide tube seat 215 is engaged in the limiting groove 2275 of the locking block 228 and the mounting base 227. The limiting disc 2153 is partially axially limited on the limiting platform 2291 of the tail cover 229, as shown. Figure 30 As shown.

[0136] <Diverter 3> like Figure 31 and Figure 32 As shown, the diversion device 3 includes a diverter 31 and a push rod 32. The diverter 31 includes a connecting seat 311, a diversion pipe 312, a one-way valve 313, and an anchor 314. The anchor 314 is fixedly connected to one end of the diversion pipe 312 through the one-way valve 313, and the connecting seat 311 is fixedly connected to the other end of the diversion pipe 312.

[0137] Evenly distributed arc-shaped slots 3111 are provided at the tail end of the connector 311, such as... Figure 33 As shown, it is used to connect to the arc-shaped retaining lug 3221 at the front end of the push rod 32. The front end of the connector 311 is inserted into the tail end of the diverter tube 312 and is bonded and fixed to the diverter tube 312. The material of the connector 311 can be any one of nickel-titanium alloy, 316L stainless steel or cobalt-chromium alloy.

[0138] A developing ring 5 is laser-welded into the front end ring of the anchor 314, and at least two weld points 6 are welded onto the front end ring of the anchor 314. Figure 34 As shown. The tail end of the anchor 314 is inserted into the front of the one-way valve 313 and is fixedly connected to the one-way valve 313 (e.g., by bonding or laser welding), as shown. Figure 35 As shown, at least two weld points 6 are welded to the ring at the tail end of the anchor 314. The anchor 314 is made of nickel-titanium alloy; the developing ring 5 is made of platinum-iridium alloy, platinum-tungsten alloy, tantalum, or tungsten.

[0139] In this embodiment, the one-way valve 313 adopts a ball valve structure, such as Figure 36 As shown, the valve includes a tail cap 3131, a spring 7, a valve body 3133, and a ball valve core 3134. The ball valve core 3134, under the action of the spring 7, presses against the inlet of the check valve 313. The ball valve core 3134 is only opened when the inlet pressure of the check valve 313 is greater than the outlet pressure. The tail end of the check valve 313 is inserted into the front of the diverter pipe 312 and is bonded and fixed to the diverter pipe 312. All components of the check valve 313 are made of metal materials, such as 316L stainless steel, titanium alloy, or nickel-titanium alloy.

[0140] The shunt tube 312 has a braided tube structure, consisting of an inner layer 3121, a middle layer 3122, and an outer layer 3123 from the inside out. A developing ring 5 is also provided between the middle layer 3122 and the outer layer 3123 at both ends of the shunt tube 312. Figure 37 As shown. The inner layer 3121 is a self-lubricating PTFE pipe liner. The middle layer 3122 is a braided metal wire layer located on the outer surface of the inner layer 3121. The metal wire can be made of 304 stainless steel, 304L stainless steel, 316 stainless steel, or 316L stainless steel. The braided layer can be made of a single layer of flat wire, such as... Figure 38 As shown; it can also be woven using a single layer of round yarn, such as Figure 39 As shown; a double-layer structure of round wire coiled spring and flat wire braid can also be used, with the braided layer located on the outer surface of the coiled spring layer, such as... Figure 40 As shown.

[0141] The braided layers can be woven throughout the entire structure using the same braid density; alternatively, they can be woven in combination using multiple braid densities, with at least two segments having different densities. The PPI of the braided layers ranges from 80 to 120. When using multiple braid densities in combination, the PPI should increase sequentially to ensure smooth transitions between segments of each braided layer.

[0142] The spring pitch of the spring layer can be the same for the entire spring; or it can be a combination of multiple springs with different pitches, with at least two springs having different pitches. The spring pitch range is 0.15 mm to 0.38 mm. When using multiple pitches for a combination of springs, the pitch variation should also follow the principle of increasing sequentially to ensure a smooth transition between the segments of the spring layer.

[0143] The outer layer 3123 is a polymer tube, which can be made of either TPU or Pebax, or a combination of both. The TPU material has a hardness of 60 A to 80 A, and the Pebax material has a hardness of 25 D to 55 D. The polymer tubes can be made of the same material and have the same hardness; they can also be made of the same material but with different hardnesses in multiple segments (at least two segments); or they can be made of different materials and with different hardnesses in multiple segments (at least two segments). When using different materials or different hardnesses in multiple segments, the hardness of the polymer tube increases sequentially from one end to the other to ensure a smooth change in the hardness of the outer layer 3123. Through a heat-sealing process, the outer layer 3123 polymer tube melts and permeates through the mesh of the middle layer 3122, bonding to the inner layer 3121. The surface of the outer layer 3123 polymer tube is also coated with an anti-coating coating, such as phosphocholine or heparin-PEG hydrogel.

[0144] The push rod 32 includes a push wire 321 and a push tube 322, such as Figure 41 The end of the push wire 321 is inserted into the proximal end of the push tube 322 and welded to the push tube 322 for fixation. There are at least two weld points 6 on the circumference of the push tube 322, such as... Figure 42 As shown, a polymer tube is coated on the outer surface of the push tube 322. Both the push wire 321 and the push tube 322 are made of nickel-titanium alloy.

[0145] The push tube 322 consists of a double-layer structure with an inner and outer layer. The inner layer is a sodium hypochlorite tube, and the outer layer is a polymer tube. An arc-shaped latch 3221 is provided at one end of the sodium hypochlorite tube. This arc-shaped latch 3221 engages with the arc-shaped groove 3111 at the tail end of the diverter tube 312. Figure 43 As shown. The tube body of the sodium hypochlorite is laser-cut with grooves 4 along its axial direction. The cutting area can be cut using the same pitch D; alternatively, it can be laser-cut in at least two segments. Within the same segment, the pitch D of the cutting grooves is the same, while the pitch D of the laser-cut grooves differs between different segments. By cutting at different pitches D, the purpose of gradually varying the hardness of the sodium hypochlorite tube is achieved, such as... Figure 44As shown. When using segmented cutting, the cutting groove pitch D increases sequentially from one end of the circular arc lug 3221 to the other. The first laser cutting segment has a length L6 of 15 mm to 30 mm and a cutting pitch D6 of 0.13 mm to 0.20 mm; the second laser cutting segment has a length L7 of 25 mm to 40 mm and a cutting pitch D7 of 0.18 mm to 0.25 mm. A schematic diagram of the cutting groove 4 after laser cutting of the sodium hypochlorite tube is shown below. Figure 45 As shown, its material is nickel-titanium alloy. The laser-cut push tube 322 requires heat treatment of the arc-shaped catch 3221 to enable it to automatically unfold. The effect after heat treatment is as follows... Figure 46 As shown. The arc-shaped clasp 3221 on the push tube 322 is in a contracted state under the constraint of the lumen of the puncture catheter 21. The arc-shaped clasp 3221 automatically unfolds only when the push tube 322 is removed from the puncture catheter 21.

[0146] The outer layer of the push tube 322 is made of a polymer material, which can be either TPU or Pebax, or a combination of both. The TPU material has a hardness of 60 A to 80 A, and the Pebax material has a hardness of 25 D to 55 D. The outer layer can be made of the same material and with the same hardness; it can also be made of the same material but with different hardnesses in multiple segments (at least two segments); or it can be made of different materials and with different hardnesses in multiple segments (at least two segments). When using different materials or different hardnesses in multiple segments, the hardness of the outer layer should increase sequentially from one end to the other.

[0147] When assembling the outer layer onto the surface of the submersible tube (inner layer of push tube 322), a layer of adhesive is evenly applied to the surface of the submersible tube, ensuring that the adhesive application area completely covers the outer layer. The outer layer is then fitted onto the surface of the submersible tube, aligning the softest end of the outer layer with the segment of the submersible tube with the smallest cutting groove pitch D, and ensuring that the outer layer completely covers the cutting area. Then, an FEP heat-shrink tubing is fitted onto the surface of the outer layer, and a tubing heat-shrinking device is used to melt-coat and bond the outer layer to the surface of the submersible tube.

[0148] <Transport Pipe 11> like Figure 47 As shown, the delivery tube 11 includes an inner layer 111, a middle layer 112, and an outer layer 113 from the inside out. One or more imaging rings 5 ​​are provided at the distal end of the delivery tube 11, and a tail tube 114 covers the proximal end.

[0149] The inner layer 111 is formed by fusing at least two different polymer tubes together using a heat-sealing process to create a polymer composite tube. The inner layer of the polymer composite tube uses a self-lubricating PTFE tube as a liner. The outer layer of the polymer composite tube can be either TPU or Pebax, or a combination of both. The TPU material has a hardness of 60 A to 80 A, and the Pebax material has a hardness of 25 D to 40 D. The outer layer of the polymer composite tube can use the same material and hardness; it can also use the same material with different hardnesses in multiple segments (at least two segments); or it can use different materials with different hardnesses in multiple segments (at least two segments). When using different materials or different hardnesses in multiple segments, the hardness of the inner layer 111 polymer tube should increase gradually from one end to the other to ensure a smooth transition in hardness.

[0150] The intermediate layer 112 includes an inner thiocyanate tube 1121 and an outer thiocyanate tube 1122 arranged coaxially. The inner thiocyanate tube 1121 and the outer thiocyanate tube 1122 are flush at their distal ends, and the length of the inner thiocyanate tube 1121 is greater than the length of the outer thiocyanate tube 1122. At least one developing ring 5 is provided at the distal end of the two thiocyanate tubes, with the distalest developing ring 5 located between the inner thiocyanate tube 1121 and the outer thiocyanate tube 1122, and flush with their distal ends. The developing ring 5 is welded to the inner thiocyanate tube 1121 and the developing ring is welded to the outer thiocyanate tube 1122 by laser welding, thereby forming a whole and constituting the intermediate layer 112.

[0151] The inner layer of the sodium hypochlorite tube 1121 and the outer layer of the sodium hypochlorite tube 1122 can be made of 304 stainless steel, 316 stainless steel, 304L stainless steel, nickel-titanium alloy or cobalt-chromium alloy; the inner layer of the sodium hypochlorite tube 1121 and the outer layer of the sodium hypochlorite tube 1122 can be made of the same material to form the intermediate layer 112, or they can be made of different materials mentioned above and combined in pairs.

[0152] At least five sets of laser-cut regions with different pitches are made along the central axis on the inner layer of the submersible tube 1121. Each cut region contains multiple cutting grooves 4, and the length (cutting length L) of each set of cut regions is different. Furthermore, the cutting pitch D (width of the cutting groove 4) of each set of cut regions increases sequentially from the far end to the near end of the inner layer of the submersible tube 1121 to achieve a gradual change in tube hardness. Figure 48As shown, the cutting slit pitch and segment lengths from the distal end to the proximal end of the inner layer of the submersible tube 1121 are as follows: the first segment cutting length L8 is 30 mm to 60 mm, and the cutting pitch D8 is 0.10 mm to 0.15 mm; the second segment cutting length L9 is 80 mm to 145 mm, and the cutting pitch D9 is 0.15 mm to 0.23 mm; the third segment cutting length L10 is 50 mm to 100 mm, and the cutting pitch D10 is 0.20 mm to 0.27 mm; the fourth segment cutting length L11 is 65 mm to 90 mm, and the cutting pitch D11 is 0.25 mm to 0.36 mm; the fifth segment cutting length L12 is 75 mm to 105 mm, and the cutting pitch D12 is 0.32 mm to 0.42 mm.

[0153] At least five sets of laser-cut regions with different pitches D are made along the central axis on the outer layer of the sodium hypochlorite tube 1122. Each set has a different cut length L, and the cut pitch D increases sequentially from the far end to the near end of the outer layer of the sodium hypochlorite tube 1122 to achieve a gradual change in tube hardness. For example... Figure 49 As shown, the cutting slit pitch and segment lengths from the distal end to the proximal end of the outer layer of the submersible tube 1122 are as follows: the first segment cutting length L13 is 45 mm to 75 mm, and the cutting pitch D13 is 0.10 mm to 0.15 mm; the second segment cutting length L14 is 60 mm to 125 mm, and the cutting pitch D14 is 0.18 mm to 0.26 mm; the third segment cutting length L15 is 65 mm to 110 mm, and the cutting pitch D15 is 0.23 mm to 0.30 mm; the fourth segment cutting length L16 is 85 mm to 105 mm, and the cutting pitch D16 is 0.28 mm to 0.40 mm; the fifth segment cutting length L17 is 60 mm to 100 mm, and the cutting pitch D17 is 0.37 mm to 0.45 mm.

[0154] After laser cutting, the inner layer 1121 and the outer layer 1122 have the following shapes for the tube body cutting groove 4: Figure 50 As shown, when the cut submersible tube is unfolded into a flat state, the slit pitch D of each cut area can be observed, such as... Figure 51 As shown.

[0155] At the farthest ends of the inner and outer sodium hypochlorite tubes 1121 and 1122 respectively, bending areas are laser-cut. The bending area 11221 of the outer sodium hypochlorite tube has a cutting length of 15 mm to 35 mm, and the cutting groove 4 has a structure that is wider in the middle and narrower at both ends, similar to an elongated ellipse. The cutting pitch D is 0.15 mm to 0.35 mm, the width of the cutting groove in the middle is 0.15 mm to 0.30 mm, and the width at both ends is 0.08 mm to 0.15 mm. Figure 52As shown. The cutting groove 4 in the bending area 11211 of the inner layer of the submersible tube has a uniform width structure, with a cutting pitch D of 0.15 mm to 0.35 mm and a cutting groove width of 0.12 mm to 0.25 mm, as shown. Figure 53 As shown.

[0156] After the two sodium hypochlorite tubes are assembled, based on the different cutting lengths L and cutting pitches D of each region in the inner sodium hypochlorite tube 1121 and the outer sodium hypochlorite tube 1122, the tube body is ultimately constructed into various hardness sections, such as... Figure 54 As shown.

[0157] A tail end tube 114 is wrapped around the proximal end of the delivery tube 11 to wrap the proximal end of the inner layer 111 with the proximal end of the inner layer sodium thiosulfate tube 1121 of the intermediate layer, thereby fixing the proximal end of the inner layer 111. Figure 55 As shown. The material of the tail tube 114 can be TPU, Pebax, or nylon. The hardness of TPU can be selected from 70 A to 98 A, the hardness of Pebax can be selected from 55 D to 72 D, and the hardness of nylon can be selected from 85 A to 75 D. When the outer layer 113 is heat-sealed, its distal end is also heat-sealed and fused together with the distal end of the inner layer 111, thereby fixing the distal end of the inner layer 111.

[0158] The outer layer 113 covers the surface of the outer submersible tube 1122, which is located on the middle layer 112. The material of the outer layer 113 can be either TPU or Pebax, or a combination of both. The hardness of the TPU material can be selected from 60 A to 85 A, and the hardness of the Pebax material can be selected from 25 D to 40 D. The outer layer 113 can be made of the same material and with the same hardness; it can also be made of the same material but with different hardnesses in multiple segments (at least two segments); or it can be made of different materials and with different hardnesses in multiple segments (at least two segments). When using different materials or hardnesses in multiple segments, the hardness distribution of the outer layer 113 from the distal end to the proximal end of the tube should follow a progressively increasing principle. The distal portion of the outer layer 113 is wrapped together with the inner layer 111, while the remaining portion covers the outer submersible tube 1122, with a covering length A of 60 cm to 100 cm. The entire outer layer 113 is coated with a hydrophilic coating.

[0159] At least one developing ring 5 is provided at the distal end of the tube body. When there is only one developing ring 5, the developing ring 5 is located between the inner layer 1121 and the outer layer 1122, and is flush with the distal end face of the two 1122 tubes, such as... Figure 56 As shown. When at least two developing rings 5 ​​are provided, one developing ring 5 is configured as described above, and the remaining developing rings 5 ​​are all located on the outer layer of the sodium hypotube 1122, with the distance between two adjacent developing rings 5 ​​being 20 mm to 50 mm, as shown. Figure 57As shown. The developing ring 5 can be made of platinum-iridium alloy, tantalum, or tungsten, and can have an open or circular structure.

[0160] <Second handle 12> like Figure 58 As shown, the second handle 12 includes a push button 121, an upper shell 122, a limiting block 123, a lower shell 124, a second slider 125, a sheath 13, and a guide tube seat 126.

[0161] The upper shell 122 and the lower shell 124 are mated. The upper shell 122 is provided with an axially penetrating push-button groove 1225, and the lower shell 124 is provided with a slide rail 1243. The upper surface of the push-button 121 is provided with anti-slip ribs 1211, such as... Figure 59 As shown, an arc-shaped buckle 1212 is provided on the central cylinder of the lower surface of the push button 121, and limit arms 1213 are also provided on both sides of the central cylinder symmetrically, as shown. Figure 60 As shown.

[0162] The limiting block 123 is provided with a limiting rib 1231, a limiting groove 1232, and a push arm 1233, such as Figure 61 As shown; an arc-shaped latch 1234 is provided in the cylindrical hole above the limiting block 123, and a cylindrical hole 1235 is also provided inside the lower part of the limiting block 123, as shown. Figure 62 As shown.

[0163] The upper part of the limiting block 123 is inserted into the push button groove 1225 of the upper shell 122, then the limiting arm 1213 of the push button 121 is inserted into the limiting groove 1232 of the limiting block 123, and the push button 121 is pressed down so that the arc-shaped buckle 1212 on the push button 121 is engaged in the arc-shaped buckle position 1234 of the limiting block 123. Figure 63 As shown. A spring 7 is inserted into the cylindrical hole 1235 of the limiting block 123. Under the action of the spring 7, the limiting block 123 is pushed upward, so that the limiting rib 1231 on the limiting block 123 engages with the limiting rib 1223 inside the upper shell 122, as shown. Figure 64 As shown.

[0164] The upper shell 122 has nut holes 1221 at both the front and rear, and nuts are inserted into them; positioning posts 1222 are symmetrically arranged at the front of the upper shell 122, a limiting rib 1223 is provided in the middle of the upper shell 122, and a limiting groove 1224 for installing the conveying device guide seat 126 is also provided at the rear of the upper shell 122. Figure 65 As shown. A through push-button groove 1225 is also provided in the middle of the upper shell 122, and a conical truncated platform 1226 is also provided on the cylindrical surface at the front of the upper shell 122, as shown. Figure 66 .

[0165] The lower shell 124 has screw holes 1241 at both the front and rear. A positioning hole 1242 is also provided at the front of the lower shell 124. A slide rail 1243 is provided in the middle of the lower shell 124. A limiting groove 1244 for assembling the guide tube seat 126 is provided on the outside of the lower shell 124. A conical platform 1226 is also provided on the cylinder at the front of the lower shell 124. Figure 67 As shown. The sheath 13 has a conical groove 131 inside, as... Figure 68 As shown, the conical groove 131 interlocks with the conical platform 1226 at the front of the upper shell 122 and the lower shell 124, for fixing the sheath 13. The guide tube seat 126 is provided with a limiting rib 1261 and an injection hole 1262, as shown... Figure 69 As shown, the limiting rib 1261 is engaged in the limiting grooves 1224 and 1244 at the tail of the upper shell 122 and lower shell 124. The bottom of the second slider 125 is provided with a slide table 1251, as shown... Figure 70 As shown; a cylindrical hole 1252 is provided at the center of the upper part of the slide table 1251, which is used to place the spring 7; limit arms 1253 are symmetrically arranged on both sides of the cylindrical hole 1252 to limit the position of the limit block 123; the center of the second slider 125 is also provided with a fully penetrating central hole 1254, as shown. Figure 71 .

[0166] <First Implementation Method> This embodiment provides an interventional treatment system for hydrocephalus, including a delivery device 1, a puncture device 2, and a shunt device 3.

[0167] like Figures 72-74 As shown, the conveying device 1 includes a conveying pipe 11 and a second handle 12 connected to the proximal end of the conveying pipe 11. The second handle 12 is mainly used to control the bending angle of the distal end of the conveying pipe 11; by pushing the push button 121 forward, the bending angle of the distal end of the conveying pipe 11 can be adjusted.

[0168] like Figure 75 and Figure 76 As shown, the tail end tube 114 and the inner layer thiocyanate tube 1121 of the delivery tube 11 are inserted into the assembly hole of the guide tube seat 126 and bonded together. The outer layer thiocyanate tube 1122 of the delivery tube 11 is inserted into the assembly hole of the second slider 125, so that the end face of the outer layer thiocyanate tube 1122 is flush with the end face of the second slider 125 and bonded together.

[0169] The push button 121 is slidably inserted into the push button slot 1225, and the limiting block 123 is elastically connected to the second slider 125. The bottom of the second slider 125 is provided with a slide table 1251, and the second slider 125 slides along the slide rail 1243. By pushing the push button 121 forward, the bending angle of the distal end of the conveying pipe 11 can be adjusted, and its maximum bending angle is 180°. By rotating the second handle 12 clockwise or counterclockwise as a whole, the direction of the bending section of the distal end of the conveying pipe 11 can be adjusted.

[0170] like Figure 77 and Figure 78 As shown, the puncture device 2 includes a puncture catheter 21 and a first handle 22 connected to the proximal end of the puncture catheter 21. A sheath 23 is also provided on the puncture catheter 21 to protect the needle tip 25. The sheath 23 is connected to the first handle 22 via a pull wire 24. The sheath 23 can be retracted by rotating the knob 221 on the first handle 22 clockwise, so that the needle tip 25 at the distal end of the puncture catheter 21 is exposed to facilitate subsequent puncture operations.

[0171] like Figure 79 As shown, the proximal end of the puncture catheter 21 (i.e., the non-needle tip 25 end) is inserted into the assembly hole of the catheter seat 215. UV adhesive or quick-drying adhesive is injected into the injection hole 2152 of the catheter seat 215 to bond and fix the proximal end of the puncture catheter 21 to the catheter seat 215. The catheter seat 215 is secured in the limiting groove 2275 of the locking block 228 and the mounting base 227 by its limiting rib 2151, and is secured in the limiting platform 2291 of the tail cap 229 by its limiting disc 2153. The first slider 222 passes through the thallium tube at the proximal end of the puncture catheter 21, and the first slider 222 can slide relative to the thallium tube under the action of the knob 221.

[0172] Two pull wires 24 on the sheath 23 are inserted into the pull wire cavity 2131 on the outer layer 213 of the distal end of the puncture catheter 21, such as Figure 80 As shown, it passes through the center hole of the fixing seat 225 and into the fixing hole 2222 of the first slider 222, as... Figure 81 and Figure 82 As shown, the end of the drawing wire 24 is fixed to the first slider 222 by injecting UV glue or quick-drying glue into the fixing hole 2222 of the first slider 222. After the puncture catheter 21 is assembled with the first handle 22, the outer layer 213 end face of the proximal end of the puncture catheter 21 is aligned with the end face of the fixing seat 225 at the foremost part of the first handle 22.

[0173] like Figure 83As shown, rotating knob 221 clockwise causes the first slider 222, driven by the threaded sleeve 224, to move from one end of the fixed seat 225 toward the guide tube seat 215. The pulling wire 24, driven by the first slider 222, also moves toward the guide tube seat 215. The sheath 23, driven by the pulling wire 24, slowly moves toward the guide tube seat 215 until the end face of the first slider 222 abuts against the limiting post 2263 of the connecting seat 226. Figure 84 As shown. At this point, the proximal end face of the sheath 23 also abuts against the outer layer 213 end face of the puncture catheter 21, thus the distal needle tip 25 of the puncture catheter 21 is fully exposed, as shown. Figure 85 As shown.

[0174] The shunt 31 is delivered into the lumen of the puncture catheter 21 via the push rod 32. Once the shunt 31 reaches the target area, the push rod 32 is fixed in place, and the puncture catheter 21 is retracted until the connection between the push rod 32 and the shunt 31 is fully exposed within the puncture catheter 21. At this point, the arc-shaped clasp 3221 on the push rod 32 automatically pops open, releasing the shunt 31. Figure 86 As shown, the shunt 31 is implanted into the target site.

[0175] The procedure for using the hydrocephalus interventional treatment system is as follows: First, the operator performs a femoral vein puncture, inserts the delivery tube 11 of the delivery device 1 through the femoral vein entry point, and pushes the delivery tube 11 into the vena cava in the abdomen, through the chest and heart, and into the right jugular vein 8. The distal end of the delivery tube 11 then passes through the junction of the jugular vein and the inferior petrosal sinus 9 to enter the inferior petrosal sinus 9. Figure 87 As shown. During the process of pushing the delivery tube 11, the direction of the distal end of the delivery tube 11 needs to be adjusted by pushing the push button 121 on the second handle 12 and rotating the handle 12 in coordination, according to the curvature of the vein, so that the travel path of the delivery tube 11 is consistent with the direction of the vein, and finally the distal end of the delivery tube 11 is sent into the inferior petrosal sinus 9.

[0176] Next, the puncture catheter 21 of the puncture device 2 is pushed along the inner lumen of the delivery tube 11 until the puncture device sheath 23 at the distal end of the puncture catheter 21 is pushed out from the distal outlet of the delivery tube 11. At this time, the knob 221 on the first handle 22 is turned clockwise to retract the puncture device sheath 23. Figure 88 As shown, the needle tip 25 of the puncture catheter 21 is fully exposed. The puncture catheter 21 is continued to be advanced, allowing the needle tip 25 to penetrate the dura mater 10 and the arachnoid mater 20 sequentially, and ensuring the needle tip 25 of the puncture catheter 21 is fully inserted into the cerebellopontine angle cistern 30. Figure 89 As shown.

[0177] Then, the shunt device 3 is pushed along the inner lumen of the puncture catheter 21 until the anchor 314 on the shunt device 3 is completely exposed from the needle tip 25 of the puncture catheter 21, as shown. Figure 90 As shown. With the push rod 32 stationary, retract the puncture catheter 21, completely retracting the needle tip 25 of the puncture catheter 21 into the inner cavity of the delivery tube 11, as shown. Figure 91 As shown. By pulling back the push rod 32, the position of the anchor 314 on the diversion device 3 in the cerebellopontine angle cistern 30 is adjusted so that the proximal end of the anchor 314 abuts against the arachnoid membrane 20.

[0178] Keeping the push rod 32 stationary, retract the delivery tube 11 and puncture catheter 21 sequentially until the connection between the push rod 32 and the diverter 31 is fully exposed. Figure 92 As shown. At this point, the arc-shaped clasp 3221 on the push rod 32 automatically pops open, releasing the shunt 31. Finally, the push rod 32 is completely retracted into the puncture catheter 21, and the puncture catheter 21 is completely retracted into the delivery tube 11, and the entire device is withdrawn from the blood vessel. Thus, the shunt 31 implantation is complete, as shown. Figure 93 As shown.

[0179] When the pressure of the cerebrospinal fluid is greater than the pressure in the venous blood vessels, the valve core 3134 of the one-way valve 313 is forward-biased under the action of pressure, allowing the cerebrospinal fluid to flow into the venous blood vessel system through the shunt tube 312; when the pressure of the cerebrospinal fluid is less than the pressure in the venous blood vessel system, the valve core 3134 of the one-way valve 313 closes the channel to prevent blood from flowing into the subarachnoid space.

[0180] This embodiment achieves a complete operation process for interventional treatment of hydrocephalus by integrating the delivery device 1, puncture device 2, and shunt device 3, significantly improving the control precision and safety of the surgery. At the same time, the sheath 23 retrieval mechanism of the puncture catheter 21 is controlled by the knob 221 to achieve precise exposure of the needle tip 25, reducing the risk of tissue damage and thus improving the overall surgical efficiency.

[0181] <Second Implementation Method> This embodiment provides another type of shunt tube 312.

[0182] like Figure 94 As shown, the shunt tube 312 consists of an inner layer 3121, a middle layer 3122, and an outer layer 3123 from the inside out. A developing ring 5 is also provided between the middle layer 3122 and the outer layer 3123 at both ends of the shunt tube 312.

[0183] The inner 3121 layer is a polymer composite tube, formed by fusing at least two different polymer tubes together using a heat-sealing process. The inner layer of the composite tube is lined with a self-lubricating PTFE tube. The outer layer of the composite tube can be either TPU or Pebax, or a combination of both. The TPU material has a hardness of 60 A to 80 A, and the Pebax material has a hardness of 25 D to 40 D. The outer polymer tubes can be of the same material and hardness; or they can be of the same material but with different hardnesses in multiple segments (at least two segments); or they can be of different materials and with different hardnesses in multiple segments (at least two segments). When using different materials or different hardnesses in multiple segments, the hardness of the composite tube should increase sequentially from one end to the other to ensure a smooth gradual change in the hardness of the inner 3121 tube.

[0184] The intermediate layer 3122 is a sodium hypochlorite tube structure, with evenly distributed arc-shaped grooves 3111 at one end of the tube. The sodium hypochlorite tube body is laser-cut into at least three sections along the axial direction. Within the same section, the pitch D of the cutting grooves is the same; the pitch D differs between different sections, and the cutting length L of each section is also different. By cutting different pitches D and lengths L, the purpose of gradually varying the hardness of the sodium hypochlorite tube is achieved. Figure 95 As shown, the cutting groove pitch D of the segmented cutting gradually decreases from one end of the arc groove 3111, and the cutting groove 4 at each segment transitions smoothly.

[0185] The length of the first cutting groove, L18, is 15 mm to 30 mm, and the cutting pitch, D18, is 0.15 mm to 0.27 mm; the length of the second cutting groove, L19, is 35 mm to 50 mm, and the cutting pitch, D19, is 0.13 mm to 0.23 mm; the length of the third cutting groove, L20, is 30 mm to 40 mm, and the cutting pitch, D20, is 0.1 mm to 0.18 mm. A schematic diagram of the cutting groove 4 after laser cutting of the sodium hypochlorite tube is shown below. Figure 96 As shown.

[0186] At each end of the sodium hypochlorite tube, there is a developing ring 5, such as... Figure 97 As shown, the developing ring 5 is fixed to the sodium hypochlorite tube by laser welding, with at least two weld points 6 welded on the circumference of the developing ring 5. The developing ring 5 is made of any one of platinum-iridium alloy, tantalum, or tungsten alloy, and its structure can be a circular ring or an open circular ring. The sodium hypochlorite tube is made of any one of nickel-titanium alloy, cobalt-chromium alloy, or 316L stainless steel.

[0187] When assembling the inner layer 3121 into the inner cavity of the sodium hypochlorite tube, a layer of adhesive is evenly applied to the inner cavity of the sodium hypochlorite tube or the outer wall of the inner layer 3121, ensuring that the adhesive application area completely covers the inner layer 3121. A matching mandrel is inserted into the inner cavity of the inner layer 3121 as a liner, and then inserted into the inner cavity of the sodium hypochlorite tube together, aligning the softest end of the inner layer 3121 with the section of the sodium hypochlorite tube with the smallest pitch of the cut groove. The outer surface of the inner layer 3121 is then bonded and fixed to the inner wall of the sodium hypochlorite tube by covering the outer surface of the sodium hypochlorite tube with an FEP thermoplastic tube and using a conduit heat shrinking device.

[0188] The outer layer 3123 is a polymer material, which can be either TPU or Pebax, or a combination of both. The TPU material has a hardness of 60 A to 80 A, and the Pebax material has a hardness of 25 D to 55 D. The outer layer 3123 can be made of the same material and with the same hardness; it can also be made of the same material with different hardnesses in multiple segments (at least 2 segments); or it can be made of different materials with different hardnesses in multiple segments (at least 2 segments). When using different materials or different hardnesses in multiple segments, the hardness of the outer layer 3123 should increase sequentially from one end to the other to ensure a smooth transition in the hardness of the polymer tube. When the outer layer 3123 is applied to the surface of the sodium hypochlorite tube, the softest end should correspond to the end with the smallest pitch D of the sodium hypochlorite tube's cutting groove to ensure a smooth transition in hardness when the outer layer is applied to the surface of the sodium hypochlorite tube (middle layer 3122).

[0189] When assembling the outer layer 3123 onto the outer surface of the hyaluronic acid tube, a layer of adhesive is evenly applied to the outer surface of the hyaluronic acid tube, ensuring that the adhesive application area completely covers the outer layer 3123. The outer layer 3123 is then fitted onto the surface of the hyaluronic acid tube, with the softest end of the outer layer 3123 corresponding to the section of the hyaluronic acid tube with the smallest cutting groove pitch D. Then, an FEP heat shrink tubing is fitted onto the surface of the outer layer 3123, and finally, a tubing heat shrinking device is used to melt-coat and bond the outer layer 3123 to the surface of the hyaluronic acid tube.

[0190] This embodiment optimizes the structure of the inner layer 3121, middle layer 3122, and outer layer 3123 of the shunt tube 312, and adopts a multi-segment hardness gradient design and a contrast ring 5 setting, thereby improving the flexibility and contrast effect of the shunt tube 312, enhancing the durability and positioning accuracy of the shunt tube 312 in the complex environment of the body; at the same time, the reasonable arrangement of the contrast ring 5 facilitates real-time monitoring during the operation, reduces implantation errors, and thus improves the reliability of treatment.

[0191] <Third Implementation Method> This embodiment provides another one-way valve 313.

[0192] like Figure 98As shown, the one-way valve 313 includes a valve housing 3133, a valve core 3134, and a pressure ring 3135. The valve core 3134 is assembled inside the valve housing 3133 through an annular groove 31341, and is pressed tightly by the pressure ring 3135. Both the valve housing 3133 and the pressure ring 3135 are made of metal, and can be selected from nickel-titanium alloy or 316L stainless steel. The valve housing 3133 and the pressure ring 3135 can be connected by threads, that is, corresponding connecting threads are provided on the valve housing 3133 and the pressure ring 3135 respectively; the valve housing 3133 and the pressure ring 3135 can also be fixed by laser welding, that is, at least two weld points 6 are welded on the circumference of the valve housing 3133 to fix the pressure ring 3135 inside the valve housing 3133 and press the valve core 3134.

[0193] An annular groove 31341 is provided on the outer circumference of the valve core 3134, such as Figure 99 As shown, it is used for assembly with valve housing 3133. A cross-shaped slit 31342 is cut on the concave surface at the center of valve core 3134, as shown... Figure 100 As shown, the four valve discs of the cross-shaped slit 31342 are tightly fitted together under the action of the material's own elastic force, and the cut is a line contact seal, so the valve is closed and the fluid cannot pass through. When the pressure on the inlet side rises to the opening pressure value, the pressure acts on the center of the diaphragm, causing the four valve discs to bend outward, the cross-shaped cut opens, forming an approximately circular hole, and the fluid passes through smoothly. When the inlet pressure disappears or reverse pressure appears on the outlet side, the elastic diaphragm quickly rebounds, the valve discs refit, the cut closes, and backflow is prevented.

[0194] The valve core 3134 uses an elastic diaphragm, which can be made of TPU with a hardness of 60 A to 80 A; liquid silicone rubber (LSR) with a hardness of 5 A to 70 A can also be selected; or an expanded polytetrafluoroethylene (ePTFE) + elastomer sandwich structure can be selected, in which the outer surface of the valve core 3134 is made of ePTFE material to provide bio-inertness, and the inner layer is made of silicone or TPU material to provide resilience; the diaphragm thickness is 0.05 mm to 0.15 mm.

[0195] This embodiment achieves reliable unidirectional flow of cerebrospinal fluid by using a cross-slit design for the one-way valve 313 and the elastic opening and closing mechanism of the valve core 3134, effectively preventing fluid backflow and improving treatment safety; at the same time, this structure simplifies assembly, enhances durability, and reduces the risk of failure.

[0196] <Fourth Implementation Method> This embodiment provides another one-way valve 313.

[0197] like Figure 101As shown, the one-way valve 313 includes a valve housing 3133, a valve core 3134, a tension spring 3136, and a tail seat 3137. The valve core 3134 is connected to the tail seat 3137 via the tension spring 3136. Under the action of the tension spring 3136, the valve core 3134 blocks the flow hole inside the valve housing 3133. The tail seat 3137 is welded to the valve housing 3133, and at least two weld points 6 are welded to the outer circumference of the valve housing 3133. The valve core 3134 consists of a valve plate 31343 and a metal core rod 31344, as shown... Figure 102 As shown, the core rod 31344 and the valve plate 31343 are integrally injection molded. A through hole is provided on the core rod 31344 for attaching the tension spring 3136. The tailstock 3137 is provided with a perforated hole 31371 and a through hole for attaching the tension spring 3136, as shown. Figure 103 As shown.

[0198] The valve plate 31343 can be made of TPU or LSR, with TPU having a hardness of 60 A to 80 A and LSR having a hardness of 5 A to 70 A. The valve core 3134, tail seat 3137, and valve body 3133 are all made of metal, with the option of 316L stainless steel, 316LVM stainless steel, or nickel-titanium alloy.

[0199] When the fluid pressure is greater than the venous pressure, the fluid pushes the valve core 3134 to overcome the elastic force of the tension spring 3136, causing the valve core 3134 to leave the flow hole of the valve body 3133, and the fluid flows in through the hollow hole 31371 of the tail seat 3137; when the pressure is balanced or reversed, the tension spring 3136 pulls the valve core 3134 back, sealing the flow hole and preventing backflow.

[0200] This embodiment introduces a one-way valve 313 with a tension spring mechanism, and uses the tension spring 3136 to control the opening and closing action of the valve core 3134, providing a stable valve function and further ensuring the reliability of unidirectional fluid flow. At the same time, this design adapts to different pressure environments, enhances the response speed and sealing performance of the one-way valve 313, and ensures the stability of long-term implantation.

[0201] The above are merely optional embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A puncture device, characterized in that, include: The needle tip is located at the distal end of the puncture device; A sheath is provided to cover the needle tip; The puncture catheter includes an inner layer, a thiopancreatic tube, and an outer layer arranged radially from the inside to the outside. The outer layer has a draw-wire cavity extending through the outer layer from the proximal end to the distal end. A draw-wire is disposed in the draw-wire cavity. The inner layer is fitted and fixed to the inner side of the thiopancreatic tube. The distal end of the draw-wire is connected to the sheath. The distal end of the thiopancreatic tube is connected to the needle tip. The first handle is located at the proximal end of the puncture device and includes a catheter seat and a first slider arranged sequentially from the proximal end to the distal end. The slider can slide back and forth in the direction from the proximal end to the distal end and is fixedly connected to the pulling wire. The catheter seat is fixedly connected to the inner layer.

2. The puncture device as described in claim 1, characterized in that, The hygrometer tube is provided with multiple cut sections along the axial direction, and the cut pitch increases from the far end to the near end.

3. The puncture device as described in claim 1, characterized in that, Two drawing cavities are symmetrically arranged at both ends of the outer layer in the diameter direction.

4. The puncture device as described in claim 1, characterized in that, The first handle includes a knob, a fixed base, a threaded sleeve, and a limiting rod; The outer edge of the first slider is provided with a toothed thread, and the inner wall of the threaded sleeve is provided with a thread that matches the toothed thread; The knob has a limiting groove inside, and the threaded sleeve has a limiting rib on its outer surface. The limiting groove and the limiting rib cooperate so that when the knob is rotated, the threaded sleeve is rotated through the limiting groove and the limiting rib. The limiting rod is arranged radially between the threaded sleeve and the first slider. A limiting groove is provided in the center of the limiting rod. The first slider is disposed in the limiting groove and can slide axially. An opening is provided on the side of the limiting rod. The outer edge of the first slider engages with the threaded inner wall of the threaded sleeve through the opening.

5. A hydrocephalus interventional treatment system, characterized in that, Includes the puncture device as described in any one of claims 1-4.

6. The hydrocephalus interventional treatment system as described in claim 5, characterized in that, It also includes a diversion device, which includes a diverter and a push rod. The front end of the push rod is snapped into the tail end of the diverter. The push rod is configured to push the diverter to be delivered in the puncture catheter. The diverter includes a connecting seat, a diversion tube, a one-way valve, and an anchor. One end of the diversion pipe is fixedly connected to the front end of the connector, and the other end is fixedly connected to the tail end of the one-way valve. The front end of the one-way valve is fixedly connected to the tail end of the anchor. The push rod has a locking lug at its front end and the connector has a slot at its rear end. The splitter engages with the push rod through the slot of the connector.

7. The hydrocephalus interventional treatment system as described in claim 6, characterized in that, The diversion pipe comprises an inner layer, a middle layer, and an outer layer from the inside out; The intermediate layer is a sodium hypochlorite tube, and the tube body is provided with multiple cut sections along the axial direction, with the cut pitch decreasing from the end near the connector to the end near the check valve.

8. The hydrocephalus interventional treatment system as described in claim 6, characterized in that, The one-way valve includes a valve body, a valve core, and a pressure ring; The valve core is provided with an annular groove on its outer circumference. The valve core is assembled inside the valve housing through the annular groove and is pressed and fixed by the pressure ring. A cross slit is cut on the concave surface at the center of the valve core, allowing fluid to flow unidirectionally from the inlet side to the outlet side of the valve core.

9. The hydrocephalus interventional treatment system as described in claim 6, characterized in that, The one-way valve includes a valve body, a valve core, a tension spring, and a tailstock; The tailstock is fixedly connected to the valve housing, and both the valve housing and the tailstock are provided with flow holes; The valve core is connected to the tailstock via the tension spring to block or release the flow hole of the valve housing.

10. The hydrocephalus interventional treatment system as described in claim 5, characterized in that, It also includes a conveying device, comprising a conveying tube and a second handle connected to the proximal end of the conveying tube, the second handle comprising a push button and a second slider, the push button being configured to move the second slider by sliding to control the bending angle of the distal end of the conveying tube.

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