Device for percutaneous intervention in hydrocephalus with one-way valve

Abstract

The application discloses a device for percutaneous interventional treatment of hydrocephalus with a one-way valve, which comprises a drainage tube and a one-way valve; the drainage tube comprises a distal end interface at a distal end, at least one flow outlet at a proximal end and a cavity in communication with the distal end interface and the at least one flow outlet; the one-way valve comprises a flow inlet and a proximal end interface, and is designed to allow liquid to flow to the proximal end interface through the flow inlet only and cannot flow reversely; the distal end interface of the drainage tube is in sealed connection with the proximal end interface of the one-way valve and is placed in a subarachnoid cavity, and the proximal end flow outlet of the drainage tube is placed in a venous system. The one-way valve is arranged in the subarachnoid cavity, and the one-way valve is arranged in a cerebrospinal fluid environment and cannot be attached by endothelial cells, so that the one-way valve is not easy to be blocked.

Description

TECHNICAL FIELD

[0001] The present application relates to a medical device, in particular to a device for percutaneous treatment of hydrocephalus with a one-way valve. BACKGROUND

[0002] Hydrocephalus refers to the abnormal accumulation of cerebrospinal fluid in the intracranial subarachnoid space or ventricle, which causes part or all of the abnormal expansion to be called hydrocephalus. The causes of hydrocephalus can be caused by cerebrospinal fluid circulation disorder, cerebrospinal fluid absorption disorder, excessive cerebrospinal fluid secretion, and brain parenchymal atrophy. For hydrocephalus, the main means is surgical treatment, the purpose of which is to drain excess cerebrospinal fluid. Specifically, it includes shunt and three ventricle bottom fistula.

[0003] As the current preferred treatment method, shunt is divided into ventriculoperitoneal shunt and atrial shunt, which drains cerebrospinal fluid out of the subarachnoid space through a shunt tube, allowing the body to naturally absorb it. The advantage is that there is a pressure-adjustable shunt pump, which can adjust the flow rate after surgery by adjusting the pressure of the shunt pump to avoid excessive drainage causing low cranial pressure, even bleeding. But it is easy to cause complications such as infection and pipe blockage, and patients may experience multiple implantation and shunt adjustment surgeries throughout their lives.

[0004] The cerebrospinal fluid circulation constructed by three ventricle bottom fistula is closer to physiological circulation, with the advantages of less trauma and shorter operation time. But the selection of patients is strict, mainly for obstructive hydrocephalus, and the clinical development is less.

[0005] In addition, patent CN107148293B discloses an implantable shunt for treating hydrocephalus, which comprises a cerebrospinal fluid (CSF) inlet opening and a self-expanding structure located at a distal portion of the shunt, a CSF inlet opening and a one-way valve located at a proximal portion of the shunt. The shunt is configured for implantation into a patient such that the one or more CSF inlet openings are disposed within the cerebellopontine (CP) angle cistern, the body of the shunt is disposed within the inferior petrosal sinus (IPS), and the proximal portion of the shunt is disposed within or adjacent to the jugular vein (JV) such that CSF flows from the CP angle cistern to the JV via a lumen of the shunt. With this shunt, it is possible to treat hydrocephalus that can only be effectively treated by open surgery using a minimally invasive interventional method, thereby reducing the risk of postoperative infection. The flow rate is mainly regulated by the physiological pressure difference between the ventricle and the vein, the stroke is short, and the postoperative excessive drainage is avoided. However, this scheme has the following disadvantages: the distal portion has a structure that is self-expanded from a folded delivery structure to an expanded deployment structure, and the expanded deployment structure increases in volume when it is expanded in the subarachnoid space, thereby increasing the risk of surgical operation and damage to the central nervous system by the product; at the same time, if the instrument needs to be recovered during the operation, the dura mater at the puncture point is easily torn, thereby increasing the risk of the operation; and the connection position of the implant and the delivery system is closer to the distal end of the drainage tube, and the delivery system may interfere with the drainage tube when it is withdrawn. In addition, the one-way valve is arranged at the proximal end of the shunt, and after implantation, the one-way valve is located in the venous blood environment, which is very easy to cause endothelial cell adhesion and cause the one-way valve to fail or be blocked.

[0006] To this end, we propose a percutaneous interventional device for treating hydrocephalus with a one-way valve to solve the above problems. SUMMARY

[0007] Under physiological conditions, cerebrospinal fluid is distributed in the choroid plexus of the lateral ventricle, the third ventricle, and the fourth ventricle, and each ventricle is connected through the interventricular foramen and the aqueduct of Sylvius. The cerebrospinal fluid flows from the bilateral lateral ventricles to the third ventricle and the fourth ventricle in turn, and finally enters the subarachnoid space. A part of it circulates through the central canal of the spinal cord, and most of the cerebrospinal fluid in the subarachnoid space circulates to the vicinity of the superior sagittal sinus, is absorbed through the arachnoid granulations and arachnoid villi, and then enters the venous sinus to return to the blood circulation. The intracranial venous sinus is a cavity formed by the folding of the dura mater at a specific anatomical site, which collects intracranial blood and cerebrospinal fluid and then flows into the jugular vein. The venous sinus is adjacent to the subarachnoid space. In the intracranial cavity, the subarachnoid space is expanded at the brain grooves and fissures, and the cerebrospinal fluid accumulates to form the cisterns, such as the cisterna ambiens, the cisterna magna, and the cisterna magna. Figure 60As shown, the petrous sinus (0002) is adjacent to the cerebellopontine angle cistern (0005). In particular, if a puncture is made on the venous sinus, the dura mater (0003) and arachnoid membrane (0004) are broken, and an opening is formed between the cerebellopontine angle cistern (0005) and the petrous sinus (0002), and the cerebrospinal fluid can flow from the subarachnoid space to the venous sinus, to the jugular vein (0001) to the heart, participating in blood circulation. In addition, other similar anatomical structures, such as the transverse sinus-sigmoid sinus (0007) adjacent to the cerebellopontine cistern, can also be used as a puncture implantation site.

[0008] The present application aims to provide a percutaneous interventional device for treating hydrocephalus with a one-way valve to solve the problems raised in the background art.

[0009] To achieve the above-mentioned purpose, the present application adopts the following technical solutions:

[0010] The percutaneous interventional device for treating hydrocephalus with a one-way valve comprises a drainage tube and a one-way valve;

[0011] The drainage tube comprises a distal end interface at the distal end, at least one flow outlet at the proximal end, and a cavity communicating with the distal end interface and the at least one flow outlet;

[0012] The one-way valve comprises a flow inlet and a proximal end interface, and is designed to allow liquid to flow only from the flow inlet to the proximal end interface and not in the opposite direction;

[0013] The distal end interface of the drainage tube is in sealed connection with the proximal end interface of the one-way valve and is placed in the subarachnoid space, and the proximal end flow outlet of the drainage tube is placed in the venous system.

[0014] Preferably, the one-way valve comprises a valve body and at least one diaphragm structure;

[0015] The valve body is a tubular structure made of a rigid thin-walled tube and comprising at least one cavity, the distal end of the valve body is closed, the proximal end is provided with a proximal end interface and is in sealed connection with the distal end interface of the drainage tube, and at least one flow inlet is provided on the valve body wall;

[0016] The diaphragm structure comprises at least one movable part and at least one fixed part; the at least one fixed part is fixed to the inner surface of the cavity of the valve body, the at least one movable part completely covers the at least one flow inlet on the valve body and is in close contact with the inner surface of the cavity of the valve body near the flow inlet, forming a close contact area with a certain width.

[0017] Preferably, when the liquid pressure outside the valve body is 1-5 mmHg higher than the liquid pressure inside the valve body, the movable part of the diaphragm structure in the close contact area starts to form a gap with the inner surface of the cavity of the valve body, allowing the liquid outside the valve body to flow into the valve body.

[0018] Preferably, the distal end of the one-way valve is substantially spherical.

[0019] Preferably, the valve body is made of a biocompatible metal material, which is one of stainless steel, nickel-titanium alloy, and cobalt-based alloy.

[0020] Preferably, the valve body is made of a biocompatible, relatively hard polymer material, which is PEEK.

[0021] Preferably, the membrane structure is a planar flexible film structure.

[0022] Preferably, the membrane structure is a curved or tubular flexible film structure.

[0023] Preferably, the membrane structure is made of a biocompatible flexible material, which is one or a combination of expanded polytetrafluoroethylene film, polytetrafluoroethylene film, silicone film, TPU film, etc.

[0024] Preferably, the one-way valve is provided with an inner lining, which is lined with the membrane structure fixed part and mechanically presses the membrane structure fixed part against the valve body cavity surface.

[0025] Preferably, the inner lining is an extension of the distal end of the drainage tube.

[0026] Preferably, the one-way valve is provided with a limiting structure that limits the movement range of the movable part of the membrane structure.

[0027] Preferably, the limiting structure is a limiting rod or a limiting net composed of multiple limiting rods.

[0028] Preferably, the limiting structure is arranged in the valve body side wall hole and radially placed outside the movable part of the membrane structure, which blocks the movable part of the membrane structure from excessive outward bending deformation when the internal pressure of the valve body is too large.

[0029] Preferably, the limiting structure is arranged in the valve body cavity and radially placed inside the movable part of the membrane structure, which blocks the movable part of the membrane structure from excessive inward bending when the external pressure of the valve body is too large.

[0030] Preferably, the limiting structure is one or more limiting cables, one end of which is connected to the edge of the movable part of the membrane structure of the one-way valve, and the other end is connected to the valve body cavity; the limiting cable is in a straight state when not working, limiting the movable part of the membrane structure from excessive outward and inward bending.

[0031] Preferably, the drainage tube on or near the one-way valve is provided with a material that is visible under X-ray.

[0032] Preferably, a visualization point is provided at the outlet of the shunt.

[0033] Preferably, an anchoring stent is further provided, which is connected to the shunt or the one-way valve.

[0034] Preferably, the anchoring stent is made of a shape memory alloy or / and a bioabsorbable material.

[0035] Preferably, the anchoring stent is arranged at the proximal segment of the device.

[0036] Preferably, a visualization point is provided on the anchoring stent.

[0037] Preferably, at least part or all of the inner and outer surfaces of the device are provided with an anticoagulant coating.

[0038] Compared with the prior art, the present application has the following advantages:

[0039] The present application can perform sinus puncture into the subarachnoid space in the cranial cavity without damaging the brain at a proper anatomical position through a catheter delivery device, and then deliver a device capable of realizing one-way drainage, so that the brain hydrocephalus can be treated by an interventional method. Since no open operation is involved, the intraoperative trauma is reduced, the operation time is saved, and the possibility of postoperative infection is greatly reduced. Since the travel distance is short, pressure fluctuations caused by post-implantation body position changes of the patient can also be avoided. Moreover, the amount of cerebrospinal fluid drainage is dynamically adjusted by the difference between the subdural pressure and the sinus pressure of the shunt device, which simulates the natural physiological state of cerebrospinal fluid absorption and avoids postoperative excessive drainage.

[0040] Compared with the existing devices for interventional treatment of brain hydrocephalus, the one-way valve of the brain hydrocephalus shunt disclosed in the present application can be delivered through a microcatheter and implanted in the subarachnoid space (in a cerebrospinal fluid environment), while the existing devices set the one-way valve in the venous system (in a blood environment), and endothelial cells easily attach to the one-way valve and cause functional failure or blockage of the one-way valve. Compared with the prior art, the present application does not cause endothelial cell attachment, does not cause functional failure of the one-way valve, and is not prone to blockage. BRIEF DESCRIPTION OF DRAWINGS

[0041] Figure 1 Front view of the percutaneous interventional brain hydrocephalus treatment device with a one-way valve described in Example 1;

[0042] Figure 2 Left cross-sectional view of the percutaneous interventional brain hydrocephalus treatment device with a one-way valve described in Example 1;

[0043] Figure 3 Front view of the valve body of the percutaneous interventional brain hydrocephalus treatment device with a one-way valve described in Example 1;

[0044] Figure 4 Valve body left section view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve according to example 1 ;

[0045] Figure 5 Membrane structure planar development of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve according to example 1 ;

[0046] Figure 6 Membrane structure front view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve according to example 1 ;

[0047] Figure 7 Membrane structure 3D view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve according to example 1 ;

[0048] Figure 8 Unidirectional valve left section view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve according to example 1 ;

[0049] Figure 9 Partial left section view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve according to example 1 ;

[0050] Figure 10 Unidirectional valve in closed condition view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve according to example 1 ;

[0051] Figure 11 Unidirectional valve in open condition view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve according to example 1 ;

[0052] Figure 12 Improved solution of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve according to example 1, membrane free edge with cable connection;

[0053] Figure 13 Improved solution of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve according to example 1, membrane with cable 3D view;

[0054] Figure 14 Improved solution of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve according to example 1, unidirectional valve section view with cable

[0055] Figure 15 Front view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve according to example 2;

[0056] Figure 16 Left section view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve according to example 2;

[0057] Figure 17Valve body front view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 2;

[0058] Figure 18 Valve body left section view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 2;

[0059] Figure 19 Connection piece section view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 2, connecting the drainage tube and the unidirectional valve;

[0060] Figure 20 Membrane structure 3D view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 2;

[0061] Figure 21 Lining tube piece front view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 2;

[0062] Figure 22 Lining tube piece left section view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 2;

[0063] Figure 23 Lining tube piece 3D view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 2;

[0064] Figure 24 Unidirectional valve in closed state view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 2;

[0065] Figure 25 Unidirectional valve in open state view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 2;

[0066] Figure 26 Internal limiting piece front view of the improved device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 2;

[0067] Figure 27 Internal limiting piece left section view of the improved device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 2;

[0068] Figure 28 Internal limiting piece 3D view of the improved device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 2;

[0069] Figure 29 Cooperation and connection of the internal limiting piece and the lining tube piece of the improved device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 2;

[0070] Figure 30Structure of the unidirectional valve of the improved device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in Example 2;

[0071] Figure 31 Structure of the anchoring support of the improved device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in Example 2;

[0072] Figure 32 Front view of the improved device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve designed with anchoring support described in Example 2;

[0073] Figure 33 3D view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in Example 3;

[0074] Figure 34 Front view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in Example 3;

[0075] Figure 35 Left section view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in Example 3;

[0076] Figure 36 Front view of the valve body of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in Example 3;

[0077] Figure 37 Left section view of the valve body of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in Example 3;

[0078] Figure 38 Planar development of the diaphragm structure of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in Example 3;

[0079] Figure 39 3D view of the diaphragm structure of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in Example 3;

[0080] Figure 40 Sectional enlarged view of the unidirectional valve of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in Example 3 in the closed condition;

[0081] Figure 41 Sectional enlarged view of the unidirectional valve of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in Example 3 in the open condition;

[0082] Figure 42 Front view of the valve body of the improved device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in Example 3;

[0083] Figure 43 Front view of the improved device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in Example 3;

[0084] Figure 44 3D view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 4;

[0085] Figure 45 Front view of the drainage tube of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 4;

[0086] Figure 46 3D view of the drainage tube of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 4;

[0087] Figure 47 Front view of the valve body of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 4;

[0088] Figure 48 Left section view of the valve body of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 4;

[0089] Figure 49 Section view of the connection between the drainage tube and the unidirectional valve of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 4;

[0090] Figure 50 Section view of the distal plug of the unidirectional valve of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 4;

[0091] Figure 51 Left section view of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 4;

[0092] Figure 52 Enlarged section view of the unidirectional valve in the closed state of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 4;

[0093] Figure 53 Enlarged section view of the unidirectional valve in the open state of the device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 4;

[0094] Figure 54 Front view of the improved device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve provided with a limiting protection net described in example 4;

[0095] Figure 55 Front view of the external limiting element of another improved device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 4;

[0096] Figure 56 3D view of the external limiting element of another improved device for percutaneous intervention in the treatment of hydrocephalus with unidirectional valve described in example 4;

[0097] Figure 57 Improved device for percutaneous intervention of hydrocephalus with unidirectional valve and external limiting member according to example 4;

[0098] Figure 58 Improved device for percutaneous intervention of hydrocephalus with unidirectional valve and external limiting member according to example 4;

[0099] Figure 59 Improved device for percutaneous intervention of hydrocephalus with unidirectional valve and external limiting member according to example 4;

[0100] Figure 60 Schematic diagram of local anatomy of petrosal sinus and cerebellopontine angle cistern. DETAILED DESCRIPTION

[0101] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments in the present application, all the other embodiments obtained by those skilled in the art without creative effort belong to the scope of protection of the present application.

[0102] In the description of the present application, the "proximal end" refers to the end close to the connection position of the delivery device, and the "distal end" refers to the end far from the connection position of the delivery device. The axial direction refers to the direction of the central axis of the device, and the radial direction refers to the direction perpendicular to the central axis. The definition is only for the convenience of description, and cannot be understood as a limitation of the present application.

[0103] Embodiment one:

[0104] Please refer to Figures 1-2 is a structural schematic diagram of the device for percutaneous intervention of hydrocephalus with unidirectional valve provided by the first embodiment of the present application. The present application provides a device for percutaneous intervention of hydrocephalus with unidirectional valve 1000, which comprises a drainage tube 1100 and a unidirectional valve 1200.

[0105] The drainage tube 1100 is made of elastic polymer material (such as TPU, silicone) with good biocompatibility, which comprises a distal end part 1110 and a proximal end part 1120.

[0106] The distal portion 1110 includes a distal interface 1111 connected to a proximal end of the one-way valve 1200. The proximal portion 1120 includes a flow outlet 1121 to be placed in the venous system (including the venous sinus, venous vessels, etc.). The drainage tube further includes a lumen 1101 in communication with the distal interface 1111 and the flow outlet 1121. After implantation, the distal portion 1110 and the one-way valve 1200 are located in the subarachnoid space, and the proximal portion 1120 is located in the venous system (including the venous sinus, venous vessels, etc.).

[0107] The one-way valve 1200 includes a valve body 1210 and a diaphragm structure 1220.

[0108] As shown in Figures 3-4 , the valve body 1210 is a tubular structure made of a thin-walled PEEK tube, and includes a smooth inner cavity 1211, a closed end 1212 at the distal end, and a round rectangular side hole 1213 provided at the side wall. The two long sides 1214 of the rectangular side hole 1213 are straight lines parallel to the axis of the valve body 1210, and the two short sides 1215 are perpendicular to the axis of the valve body 1210.

[0109] The proximal end of the valve body 1210 is provided with a proximal interface 1216, which is connected to the distal interface 1111 of the drainage tube 1100 by adhesion to realize sealed connection, so that the inner cavity 1211 of the valve body is in communication with the lumen 1101 of the drainage tube 1100.

[0110] As shown in Figure 5 , the diaphragm structure 1220 is a planar rectangular soft PEEK film when the one-way valve 1200 is not assembled, and its outer surface is smooth, including two long sides 1221 and two short sides 1222. Figures 6-8 As shown in Figures 6-8 , after assembly, the two long sides 1221 of the diaphragm structure 1220 remain straight lines parallel to the axis of the valve body, and the short sides 1222 conform to the inner cavity 1211 of the valve body 1210 and are perpendicular to the axis of the valve body. In the axial direction, the length of the long side 1221 of the diaphragm structure 1220 is greater than the length of the long side 1214 of the rectangular side hole 1213, and the length of the short side 1222 of the diaphragm structure 1220 is greater than the length of the short side 1215 of the rectangular side hole 1213.

[0111] The diaphragm structure 1220 can be divided into a fixed part 1223 and a movable part 1224 according to function. The fixed part 1223 is fixed to the inner cavity 1211 of the valve body 1210, as Figures 5-7The non-shaded part in the figure includes the proximal fixed part 12231 and the two side fixed parts 12232. The proximal fixed part 12231 is located at the proximal end of the short side of the rectangular side hole 1213 of the valve body 1210, and the two side fixed parts 12232 are respectively located at the outside of the two long sides 1214 of the rectangular side hole 1213 in the circumferential direction. In this embodiment, the fixed part 1223 is connected and fixed with the inner cavity 1211 of the valve body 1210 by high polymer welding.

[0112] Figure 8 The figure shows the cross-sectional view of the one-way valve 1200. After the fixed part 1223 of the diaphragm structure 1220 is fixed in the inner cavity 1211 of the valve body 1210, the movable part 1224 of the diaphragm structure 1220 completely adheres to the inner cavity 1211 of the valve body 1210 and completely covers the side hole 1213 when it is not subjected to external force. In the area adjacent to the distal end of the short side of the side hole 1213, the movable part 1224 of the diaphragm structure 1220 and the inner cavity 1211 of the valve body 1210 form a covering area 1203 with a width of about 0.2-0.5 mm.

[0113] Figures 9-11 The figure shows the working principle of the one-way valve 1220. As shown in the figure, Figure 11 When the pressure of the cerebrospinal fluid is greater than the pressure of the venous blood, the movable part 1224 of the diaphragm structure 1220 is driven by force, the movable part 1224 of the diaphragm structure 1220 in the covering area 1203 and the inner cavity 1211 of the valve body 1210 form a small gap, the valve is opened, allowing the cerebrospinal fluid to flow into the inner cavity of the one-way valve 1200 and then flow into the venous system through the drainage tube 1100; conversely, as shown in the figure, Figure 10 When the pressure of the cerebrospinal fluid is less than the pressure of the venous blood, the movable part 1224 of the diaphragm structure 1220 is subjected to reverse action, the movable part 1224 of the diaphragm structure 1220 in the covering area 1203 is tightly attached to the valve body cavity, so that the gap disappears, the valve is closed, and the liquid is not allowed to flow, thereby preventing the blood from flowing back into the subarachnoid space.

[0114] As shown in the figure, Figures 12-14 As an improvement of this embodiment, a cable 1227 is arranged on the distal end of the movable part 1224 of the diaphragm structure 1220 to limit the displacement of the adjacent area of the distal end of the movable part 1224 of the diaphragm structure 1220. The proximal end of the cable 1227 is connected with the distal end of the movable part 1224 of the diaphragm structure 1220, and the distal end is connected with the cable fixed part 1228 welded in the inner cavity 1211 of the valve body 1210.

[0115] When the one-way valve is in a natural state, the pull cable 1227 is just straightened. The pull cable 1227 limits the movement of the movable part 1224 of the diaphragm structure 1220, which can protect the movable part 1224 from being damaged and the function of the movable part 1224 from being affected when the pressure changes dramatically, especially when the venous pressure may change suddenly, such as when coughing, straining, holding breath, etc.

[0116] Example Two

[0117] The main difference between the example one and the example two is that the design of the one-way valve 1200 is different. As shown in Figures 15-16 the one-way valve 1200 in this example includes a valve body 1210, a diaphragm structure 1220, a hose joint 1230, and an inner liner 1240.

[0118] As shown in Figures 17-18 the valve body 1210 is a tubular structure made of a thin-walled stainless steel tube. The valve body 1210 includes a smooth inner cavity 1211, a distal end sealing end 1212, and a sealing material which is a platinum visible point 12121 visible under X-ray. By welding the distal end and forming a spherical contour weld point 12122 at the distal end, the risk of damaging brain tissue during implantation of the implant can be reduced. Two symmetrical side holes 1213 are provided at the side wall, and the two long sides 1214 of the rectangular side hole 1213 are straight lines parallel to the axis of the valve body 1210, and the two short sides 1215 are circular sides perpendicular to the axis of the valve body 1210.

[0119] The proximal end of the valve body 1210 is provided with a proximal end interface 1216, which is in mechanical communication with the distal end interface 1111 of the drainage tube through the hose joint 1240, and the inner cavity 1211 of the valve body is in communication with the cavity 1101 of the drainage tube 1100.

[0120] As shown in Figure 19 the hose joint 1230 includes a cylindrical cavity 1231 extending through the entire length, and the outer surface is designed with three tapered steps 1233 facing the distal end, and the minimum outer diameter of the tapered steps 1233 is approximately equal to the inner diameter of the drainage tube 1100. The distal end interface 1111 of the drainage tube 1100 is located in the proximal end interface 1216 of the valve body, and the hose joint 1230 is lined in the distal end interface 1111, and the tapered steps 1233 extrude the material of the distal end interface 1111, so that the distal end interface 1111 further extrudes the inner cavity 1211 of the valve body 1210, completing the mechanical connection of the drainage tube 1100 and the one-way valve 1200, and at the same time realizing the sealing of the joint.

[0121] As shown in Figure 20As shown, the diaphragm structure 1220 is a soft TPU tubular film with excellent elasticity, and its outer surface 1221 is smooth. The diaphragm structure 1220 is divided into a fixed part 1223 and a movable part 1224, and the fixed part 1223 is further divided into a proximal fixed part 12231 and a distal fixed part 12232. The proximal fixed part 12231 of the diaphragm structure 1220 is located in the lumen of the valve body 1210 and is proximal to the proximal edge 1214 of the side hole 1213. The movable part 1224 of the diaphragm structure 1220 completely covers the side hole 1213, and the area outside the two side holes 1213 is the distal fixed part 12232.

[0122] The diaphragm structure 1220 is fixed in the lumen of the valve body 1210 by the mechanical action of the inner lining tube 1240. As shown, Figures 21-23 The inner lining tube 1240 is a thin-walled laser-cut nickel-titanium alloy tube, both ends 1241 are open and pass through the inner cavity 1242, and two symmetrical rectangular side holes 1243 are provided on the side wall. The long side 1244 of the rectangular side hole 1243 is parallel to the axis of the inner lining tube 1240, and the short side 1245 is perpendicular to the axis of the inner lining tube 1240. The long side 1244 of the side hole 1243 is longer than the long side 1214 of the rectangular side hole 1213 of the valve body 1210, and the short side 1245 is approximately equal to the short side 1215 of the rectangular side hole 1213 of the valve body 1210 in the circumferential direction. Two notches 1246 are provided on both ends of the inner lining tube 1240, between the two rectangular side holes 1243, so that the inner lining tube 1240 is a diameter-compressible elastic element.

[0123] The outer diameter of the inner lining tube 1240 is slightly larger than the inner diameter of the valve body 1210, so that after assembly, the fixed part 1223 of the diaphragm structure 1220 can be pressed against the inner surface of the inner cavity 1211 of the valve body by the radial elastic force. After assembly, the long side 1244 of the side hole 1243 of the inner lining tube 1240 coincides with the long side 1214 of the side hole 1213 of the valve body 1210 in the circumferential direction, and the proximal short side 1245 coincides with the proximal short side of the rectangular side hole 1213 of the valve body 1210 in the axial direction. The length of the inner lining tube 1240 is greater than the length of the diaphragm structure 1220. After assembly, the proximal end of the inner lining tube 1240 is approximately flush with the proximal end of the diaphragm structure 1220, and the distal end of the diaphragm structure 1220 is proximal to the distal short side 1244 of the side hole 1243, and distal to the distal short side of the rectangular side hole 1213 of the valve body 1210.

[0124] As described above, the proximal and distal portions of the diaphragm structure 1220, located outside the holes 1243 on both sides of the inner liner tube 1240, constitute the distal fixing portion 12232, both of which are fixed by mechanical pressure between the inner liner tube 1240 and the valve body 1210. The distal portion of the diaphragm structure 1220, located within the holes 1243 on both sides of the inner liner tube 1240, constitutes the movable portion 1224. It can be seen that the distal end of the movable portion 1224 is located at the distal end of the short side of the rectangular side hole of the valve body 1210, allowing the diaphragm 1220 to completely cover the side hole 1213 of the valve body 1210, and forming a 0.2-0.5mm coverage area 1203 at the distal end of the side hole 1213.

[0125] The proximal ends of the diaphragm structure 1220 and the inner liner tube 1240 can be designed to be partially located between the inner cavity 1211 of the valve body 1210 and the distal outer surface of the drainage tube 1100. By adding the hose connector 1230 to support the inner liner tube 1240, the support for the diaphragm structure 1220 is strengthened, ensuring that the diaphragm structure 1220 and the inner cavity 1211 of the valve body 1210 can better form a natural fit when no force is applied.

[0126] like Figure 25 As shown, when the pressure of cerebrospinal fluid is greater than the pressure of venous blood, the movable part 1224 of the diaphragm structure 1220 is driven by force, and the movable part 1224 of the diaphragm structure 1220 within the covered area 1203 forms a tiny gap with the inner cavity 1211 of the valve body 1210, opening the valve and allowing cerebrospinal fluid to flow into the inner cavity of the one-way valve 1200 and into the venous system through the drainage tube 1100; conversely, if the pressure is greater than the pressure of venous blood, the valve opens, allowing cerebrospinal fluid to flow into the inner cavity of the one-way valve 1200 and into the venous system through the drainage tube 1100; conversely, if the pressure is less than the pressure of venous blood, the valve opens, allowing cerebrospinal fluid to flow into the inner cavity of the one- Figure 24 As shown, when the pressure of cerebrospinal fluid is less than the pressure of venous blood, the movable part 1224 of the diaphragm structure 1220 is subjected to a reverse action. The movable part 1224 of the diaphragm structure 1220 in the covered area 1203 is tightly attached to the valve body cavity, so that the gap disappears, the valve is closed, and the liquid is not allowed to flow, thereby preventing blood from flowing back into the subarachnoid space.

[0127] like Figures 26-30 As shown, as an improvement in this embodiment, the one-way valve 1200 is also designed with an inner limiting member 1260. The inner limiting member 1260 is made of a thin-walled stainless steel tube by laser cutting, and its outer diameter is approximately the same as that of the inner liner tube 1240, forming an overfit relationship. The distal end of the inner limiting member 1260 is a circular connecting part 1261, which is used to weld and connect with the distal end of the inner liner tube 1240; the middle part is a window part 1263, including two windows 1264, with the distal edge 1222 of the movable part 1224 of the diaphragm structure 1220 located exactly in the middle of the middle window 1264; the proximal end is a limiting block 1262, which is suspended on the inner surface of the movable part 1224 of the diaphragm structure 1220 to prevent excessive deformation of the movable part 1224 of the diaphragm structure 1220.

[0128] Without the limiting block 1262, when the external pressure of the one-way valve is too large, it can cause excessive deformation of the movable part 1224 of the diaphragm structure 1220, which can cause the movable part 1224 of the diaphragm structure 1220 to fail to return to its original position or return too slowly under reverse pressure, causing blood to flow back into the intracranial cavity and causing complications. The limiting block 1262 can limit the deformation of the movable part 1224 of the diaphragm structure 1220, protect the structure and function of the device, and thus reduce the relevant risks.

[0129] As shown in Figures 31-32 , as an improvement of the present embodiment, an anchoring stent 1300 is arranged on the proximal end portion 1120 of the drainage tube 1100.

[0130] The anchoring stent 1300 is configured to have a compressed shape in the delivery state and an expanded shape in the released state. Figure 31 As shown, the anchoring stent 1300 is composed of 5 wave-shaped structures 1310, each wave-shaped structure 1310 is composed of 4 rods 1311, each wave-shaped rod is connected at both ends and forms a node 1312, adjacent wave-shaped structure circles are connected to each other through the node 1312 to form a stent structure.

[0131] As shown in Figure 32 , a tubular connecting ring 1320 is arranged at the proximal end of the anchoring stent 1300, and the node 1312 at the proximal end of the stent is connected to the distal end of the connecting ring 1320 through a connecting rod 1313. The anchoring stent 1300 is located on the proximal end portion 1120 of the drainage tube 1100 after self-expansion.

[0132] Embodiment Three

[0133] Please refer to Figures 33-35 , the present application provides a percutaneous interventional treatment of hydrocephalus device 1000 with a one-way valve, which comprises a drainage tube 1100 and a one-way valve 1200.

[0134] As shown in Figure 34 , the drainage tube 1100 is made of elastic polymer material (such as TPU) with good biocompatibility, including a distal end portion 1110 and a proximal end portion 1120.

[0135] The distal end portion 1110 includes a distal end interface 1111 connected to the one-way valve 1200. The proximal end portion 1120 includes a cerebrospinal fluid outlet 1121, which is placed in the venous system (including the venous sinus, venous vessels, etc.). The drainage tube also includes a cavity 1101 connected to the distal end interface 1111 and the flow outlet 1121. After implantation, the distal end portion 1110 and the one-way valve 1200 are located in the subarachnoid space, and the proximal end portion 1120 is located in the venous system (including the venous sinus, venous vessels, etc.).

[0136] The one-way valve 1200 includes a valve body 1210 and a diaphragm structure 1220.

[0137] like Figures 36-37 The valve body 1210 is a tubular structure made of a thin-walled nickel-titanium alloy tube. The valve body 1210 includes an inner cavity 1211, and its distal end is sealed with adhesive via a radiopaque point 12121. A spherical contoured endpoint 12122 is formed at the distal end of the valve body 1210 using adhesive, which can reduce the risk of implant damage to brain tissue.

[0138] A generally elliptical side hole 1213 is provided on the side wall of the valve body 1210. The major axis 1214 of the elliptical side hole 1213 is a straight line parallel to the axis of the valve body 1210, and the minor axis 1215 is perpendicular to the axis of the valve body 1210. A proximal interface 1216 is provided at the proximal end of the valve body 1210, which is connected to the distal interface 1111 of the drainage tube by adhesive bonding, so that the inner cavity 1211 of the valve body is connected to the cavity 1101 of the drainage tube 1100.

[0139] like Figure 38 When the one-way valve 1200 is not assembled, the diaphragm structure 1220 is a planar rectangular thin-film structure. For example... Figure 39 After assembly, the diaphragm structure 1220 has its long side 1221 parallel to the valve body axis, and its short side 1222 perpendicular to the valve body axis 1210. The lengths of the long side 1221 and the short side 1222 are greater than the lengths of the major axis 1214 and the minor axis 1215 of the elliptical side hole, respectively.

[0140] The proximal portion 1223 of the diaphragm structure 1220 is fixed to the proximal end of the one-way valve side hole 1213, located between the inner cavity 1211 of the valve body 1210 and the distal outer surface of the drainage tube 1100, and is fixed by adhesive during the connection process between the valve body 1210 and the drainage tube 1100.

[0141] The distal end 1224 of the diaphragm structure 1220 is fixed to the distal end of the one-way valve side hole 1213, located between the inner cavity 1211 of the valve body 1210 and the outer surface of the developing point 12121, and is fixed by adhesive during the connection process between the valve body 1210 and the developing point 12121.

[0142] The middle portion 1225 of the diaphragm structure 1220 is not fixed and is a movable part. When no external force is applied, because the proximal end 1223 and the distal end 1224 are fixed, the middle movable part 1225 is completely attached to the inner cavity 1211 of the valve body 1210, and the diaphragm 1220 completely covers the side hole 1213, forming a coverage area 1203 with a width of 0.1-0.8 mm around the side hole 1213.

[0143] like Figure 41As shown, when the pressure of the cerebrospinal fluid is greater than the pressure of the venous blood, the middle movable part 1225 of the diaphragm 1220 is subjected to force, the edge of the movable part 1225 of the diaphragm in the covering area 1203 leaves the side edge of the valve body to form a small gap, the valve is opened, and the cerebrospinal fluid can pass through the one-way valve 1200 and flow into the venous system through the drainage tube 1100; on the contrary, as shown, Figure 40 As shown, when the pressure of the cerebrospinal fluid is less than the pressure of the venous blood, the middle movable part 1225 of the diaphragm 1220 is subjected to reverse force, the edge of the movable part 1225 of the diaphragm in the covering area 1203 is tightly attached to the cavity of the valve body, so that the gap disappears, the valve is closed, and the liquid is not allowed to flow, thereby preventing the blood from flowing back into the subarachnoid space.

[0144] As shown, Figures 42-43 As shown, as an improvement of the embodiment, a protection rod 1218 is arranged in the side hole 1213 of the valve body 1210, which is used to protect the diaphragm structure 1220 from being damaged by external force. More importantly, when the reverse pressure at both ends of the one-way valve is too large, the diaphragm structure 1220 can be protected from being damaged by excessive deformation caused by excessive force.

[0145] Embodiment Four

[0146] As shown, Figure 44 As shown, the present example is similar to embodiment three. The drainage tube 1100 is made of elastic polymer material (such as TPU) with good biocompatibility, including a distal end part 1110 and a proximal end part 1120. The distal end part 1110 includes a distal end interface 1111 connected to the proximal end 1201 of the one-way valve 1200. The proximal end part 1120 includes a cerebrospinal fluid outlet 1121, which is placed in the venous system (including the venous sinus, venous vessels, etc.). The drainage tube further includes a cavity 1101 communicating with the distal end interface 1111 and the flow outlet 1121. After implantation, the distal end part 1110 and the one-way valve 1200 are located in the subarachnoid space, and the proximal end part 1120 is located in the venous system (including the venous sinus, venous vessels, etc.).

[0147] As shown, Figures 45-46 As shown, different from embodiment three, a rectangular side hole 1112 is designed on the distal end interface 1111 of the drainage tube 1100, the long side 1113 of the rectangular side hole 1112 is a straight line parallel to the axis of the drainage tube 1100, and the short side 1114 is a curve perpendicular to the axis of the drainage tube 1100.

[0148] The one-way valve 1200 includes a valve body 1210, a diaphragm structure 1220, a hose joint 1230, and a blocking plug 1250.

[0149] As shown, Figures 47-48As shown, the valve body 1210 is a tubular structure made of thin-walled chromium alloy pipe. The valve body 1210 includes an inner cavity 1211, through which the distal end interface 1111 penetrates, and the distal end 1212 end surface is flush with the distal end surface of the drainage tube 1100.

[0150] A rounded rectangular side hole 1213 is provided on the side wall of the valve body 1210. The two long sides 1214 of the rectangular side hole 1213 are straight lines parallel to the axis of the valve body 1210, and the two short sides 1215 are circular lines perpendicular to the axis of the valve body 1210.

[0151] The long side 1214 of the side hole 1213 is equal in length to the long side 1113 of the side hole 1112, the short side 1215 of the side hole 1213 is shorter than the short side 1114 of the side hole 1112, the long axis 1214 of the side hole 1213 coincides with the long axis of the side hole 1213 in the circumferential direction, and the short side of the side hole 1213 coincides with the short side 1114 of the side hole 1112 in the axial direction.

[0152] As in Example Three, the diaphragm structure 1220 is a planar rectangular TPU film structure when the one-way valve 1200 is not assembled. After assembly, the long side 1221 is parallel to the axis of the valve body, and the short side 1222 is perpendicular to the axis of the valve body 1210. The length of the long side 1221 is greater than the length of the long side 1214 of the rectangular side hole, the length of the short side 1222 is greater than the length of the short side 1215 of the rectangular side hole, and less than the length of the short side 1114 of the side hole 1112, so that the diaphragm structure 1220 can completely cover the oval side hole 1213 of the valve body 1210 on the inner surface, and the two side edges of the diaphragm structure 1220 are not fixed in the rectangular side hole 1112.

[0153] The proximal end portion 1223 of the diaphragm structure 1220 is fixed to the proximal end 1201 of the one-way valve 1200, between the inner cavity 1211 of the valve body 1210 and the outer surface of the distal end of the drainage tube 1100, and is fixed by mechanical compression through the hose joint 1240 during the connection of the valve body 1210 and the drainage tube 1100.

[0154] As Figure 49As shown, the hose fitting piece 1230 is made of gold, including a cylindrical cavity 1231 through the whole length, and the outer surface is designed with three tapered steps 1233 towards the proximal end, the minimum outer diameter of the tapered steps 1233 is substantially equal to the inner diameter of the drainage tube 1100. The distal end interface 1111 of the drainage tube 1100 is located in the valve body proximal end interface 1216, the hose fitting piece 1230 is lined in the inner cavity of the distal end interface 1111 of the drainage tube 1100, the proximal end portion 1223 of the diaphragm structure 1220 is fixed to the proximal end 1201 of the one-way valve 1200, and is located between the inner cavity 1211 of the valve body 1210 and the outer surface of the distal end of the drainage tube 1100. Under the mechanical pressure of the valve body proximal end interface 1216 and the tapered steps 1233 of the hose fitting piece, the drainage tube 1100 and the proximal end portion 1223 of the diaphragm structure 1220 are mechanically fixed, pressed and sealed with the valve body 1210.

[0155] The distal end 1224 of the diaphragm structure 1220 is fixed to the distal end 1202 of the one-way valve 1200, and is located between the inner cavity 1211 of the valve body 1210 and the outer surface of the distal end of the drainage tube 1100. It is fixed by mechanical pressing through the blocking plug 1250 during the connection of the valve body 1210 and the distal end of the drainage tube 1100.

[0156] As shown, Figure 50 The blocking plug 1250 is made of gold that is visible under X-ray, and the side surface is designed with three tapered steps 1251 towards the proximal end, the minimum outer diameter of the tapered steps 1251 is substantially equal to the inner diameter of the drainage tube 1100; the distal end is a spherical end point 1252, and the outer diameter is substantially equal to the outer diameter of the valve body 1210. The blocking plug 1250 is located at the distal end of the device for percutaneous interventional treatment of hydrocephalus with a one-way valve, and will be implanted into the subarachnoid space during the operation. The spherical end point 1252 can reduce the risk of brain tissue damage caused by the implant. The distal end connection port 1111 of the drainage tube 1100 is located in the inner cavity of the valve body, the blocking plug 1250 is lined in the inner cavity of the distal end of the drainage tube 1100, the distal end portion 1224 of the diaphragm structure 1220 is fixed to the distal end 1202 of the one-way valve 1200, and is located between the inner cavity 1211 of the valve body 1210 and the outer surface of the distal end of the drainage tube 1100. Under the mechanical pressure of the valve body inner cavity and the tapered steps 1240 of the hose fitting piece, the drainage tube 1100 and the distal end portion 1224 of the diaphragm structure 1220 are mechanically fixed, pressed and sealed with the valve body 1210.

[0157] As shown, Figure 51 The middle portion 1225 of the diaphragm structure 1220 is not fixed, and is a movable portion. When not subjected to external force, because the proximal end 1223 and the distal end 1224 are fixed, the middle movable portion 1225 is completely attached to the inner cavity 1211 of the valve body 1210, and the diaphragm 1220 completely covers the side hole 1213, and forms a coverage area 1203 with a width of about 0.1-0.8mm on both sides of the long side 1214 of the side hole 1213.

[0158] As Figure 53 shown, when the pressure of the cerebrospinal fluid is greater than the pressure of the venous blood, the middle movable part 1225 of the diaphragm 1220 is subjected to force, the edge of the movable part 1225 of the diaphragm structure in the covering area 1203 leaves the side edge of the valve body to form a small gap, the valve is open, and the cerebrospinal fluid can pass through the one-way valve 1200 and flow into the venous system through the drainage tube 1100; on the contrary, as Figure 52 shown, when the pressure of the cerebrospinal fluid is less than the pressure of the venous blood, the middle movable part 1225 of the diaphragm 1220 is subjected to reverse force, the edge of the movable part 1225 of the diaphragm structure in the covering area 1203 is tightly attached to the cavity of the valve body, so that the gap disappears, the valve is closed, and the liquid is not allowed to pass, thereby preventing the blood from flowing backward into the subarachnoid space.

[0159] As Figure 54 shown, as an improvement of the embodiment, a limiting protection net 1218 is arranged in the side hole 1213 of the valve body 1210, which is composed of a long rod 12181 and a short rod 12182 staggered.

[0160] The limiting protection net 1218 is used to protect the diaphragm structure 1220 from being damaged by external force. Because when a person uses his hand, holds his breath, or coughs, the venous pressure will suddenly rise, which makes the reverse pressure at both ends of the one-way valve too large, and the movable part of the diaphragm structure 1220 may be deformed too much due to the action of the force, and the function of the one-way valve is damaged. The limiting protection net 1218 can limit the movable part of the diaphragm structure 1220 from being deformed too much and protect its structure and function.

[0161] As Figures 55-57 shown, as another improvement of the embodiment, an external limiting member 1270 is arranged on the outer surface of the valve body 1210. The limiting member 1270 is made of a thin-walled tube of nickel-titanium alloy by laser engraving. Both ends 1272 of the limiting member 1270 retain the tubular structure, and a window 1271 aligned with the periphery of the side hole 1213 is arranged at the middle position of the external limiting member 1270. Inside the window 1271, a limiting protection net 1275 is arranged, which is composed of two parallel long rods 1273 and two parallel short rods 1274 staggered.

[0162] The limiting protection net 1275 is used to protect the diaphragm structure 1220 from being damaged by external force. Because when a person uses his hand, holds his breath, or coughs, the venous pressure will suddenly rise, which makes the reverse pressure at both ends of the one-way valve too large, and the movable part of the diaphragm structure 1220 may be deformed too much due to the action of the force, and the function of the one-way valve is damaged. The limiting protection net 1275 can limit the movable part of the diaphragm structure 1220 from being deformed too much and protect its structure and function.

[0163] As shown in Figures 58-59 As a further improvement of the present improvement, an anchoring stent 1300 is provided on the proximal end portion 1120 of the drainage tube 1100.

[0164] The anchoring stent 1300 is configured to have a compressed shape in a delivery state and an expanded shape in a released state, and is made of a nickel-titanium alloy material. The anchoring stent 1300 is composed of a plurality of wave-shaped structures 1310, each wave-shaped structure 1310 being composed of 8 rods 1311, each wave-shaped rod being connected at its ends to form a node 1312, and adjacent wave-shaped structures being connected at their proximal and distal nodes to form a stent structure. A tubular connecting ring 1320 is provided at the distal end of the anchoring stent, and a connecting rod 1321 is designed at the distal end of the connecting ring 1320, the distal end of the connecting rod 1321 being connected to the proximal end of an external limiting member 1700. The distal most node 1312 of the stent is connected to the proximal end of the connecting ring 1320 through a connecting rod 1313. Four connecting clasps 1330 are provided at the proximal nodes 1312 of the anchoring stent, and each clasp 1330 is embedded with a developing point 1331 for stent development.

[0165] Compared with the stented improvement scheme of Example Two, the connection of the distal end of the anchoring stent to the drainage tube in the present improvement scheme makes the support point of the drainage tube closer to the distal end of the drainage device and the flow inlet at the distal end, thereby ensuring that the flow inlet is located in the subarachnoid space and ensuring the effective operation of the device.

Claims

1. A device for percutaneous intervention in the treatment of hydrocephalus with a one-way valve, characterized in that: The device comprises a drainage tube and a one-way valve; the drainage tube comprises a distal end interface at the distal end, at least one flow outlet at the proximal end, and a cavity communicating with the distal end interface and the at least one flow outlet; the one-way valve comprises a flow inlet and a proximal end interface, and is designed to allow liquid to flow from the flow inlet to the proximal end interface only, and not in the reverse direction; the distal end interface of the drainage tube is in sealed connection with the proximal end interface of the one-way valve, and is placed in the subarachnoid space, and the proximal end flow outlet of the drainage tube is placed in the venous system; The one-way valve comprises a valve body and at least one diaphragm structure; the valve body is a tubular structure comprising at least one cavity, and is made of a rigid thin-walled tube; the distal end of the valve body is closed, the proximal end is provided with a proximal end interface and is in sealed connection with the distal end interface of the drainage tube; at least one flow inlet is arranged on the wall of the valve body; the diaphragm structure comprises at least one movable part and at least one fixed part; the at least one fixed part is fixed to the inner surface of the cavity of the valve body, and the at least one movable part completely covers the at least one flow inlet on the valve body, and the movable part is in close contact with the inner surface of the cavity of the valve body near the flow inlet, forming a close contact area with a width of 0.1-0.8 mm; the diaphragm structure is made of one or more of polytetrafluoroethylene film, silica gel film, and TPU film; When the liquid pressure outside the valve body is 1-5 mmHg higher than the liquid pressure inside the valve body, the movable part of the diaphragm structure in the close contact area starts to form a gap with the inner surface of the cavity of the valve body, allowing the liquid outside the valve body to flow into the valve body; The one-way valve is provided with a limiting structure for limiting the movement range of the movable part of the diaphragm structure, and the limiting structure is one or more limiting pull wires, one end of the limiting pull wire being connected to the edge of the movable part of the diaphragm structure, and the other end being connected to the inner surface of the cavity of the valve body; the limiting pull wire is in a straight state when not working, limiting the excessive bending of the movable part of the diaphragm structure outward and inward.

2. The apparatus for percutaneous treatment of hydrocephalus with a check valve according to claim 1, characterized in that: The distal end of the one-way valve is generally spherical.

3. The apparatus for percutaneous treatment of hydrocephalus with a check valve according to claim 1, characterized in that: The valve body is made of a biocompatible metal material, and the biocompatible metal material is one of stainless steel, nickel-titanium alloy, and cobalt-based alloy.

4. The apparatus for percutaneous treatment of hydrocephalus with a check valve according to claim 1, characterized in that: The valve body is made of a biocompatible, relatively hard polymer material, and the biocompatible, relatively hard polymer material is PEEK, ultra-high molecular weight polyethylene, or a combination thereof.

5. The apparatus for percutaneous treatment of hydrocephalus with a check valve according to claim 1, characterized in that: The diaphragm structure is a planar flexible film structure.

6. The apparatus for percutaneous treatment of hydrocephalus with a check valve according to claim 1, characterized in that: The diaphragm structure is a curved or tubular flexible film structure.

7. The apparatus for percutaneous treatment of hydrocephalus with a check valve according to claim 1, characterized in that: The one-way valve is provided with an inner lining part, which is lined with the fixed part of the diaphragm structure and mechanically presses the fixed part of the diaphragm structure against the inner surface of the cavity of the valve body.

8. The apparatus for percutaneous treatment of hydrocephalus with a check valve according to claim 7, characterized in that: The inner lining part is an extension of the distal end of the drainage tube.

9. The apparatus for percutaneous treatment of hydrocephalus with a check valve according to claim 1, characterized in that: The one-way valve or the drainage tube near the one-way valve is provided with a material that can be developed under X-ray.

10. The apparatus for percutaneous treatment of hydrocephalus with a check valve according to claim 1, characterized in that: An imaging point is arranged at the flow outlet of the drainage tube.

11. The apparatus for percutaneous treatment of hydrocephalus with a check valve according to claim 1, characterized in that: An anchoring stent is further included, and the anchoring stent is connected to the drainage tube or the one-way valve.

12. The apparatus for percutaneous treatment of hydrocephalus with a check valve according to claim 11, characterized in that: The anchoring stent is made of a shape memory alloy or / and a biodegradable material.

13. The apparatus for percutaneous treatment of hydrocephalus with a check valve according to claim 11, characterized in that: The anchoring stent is arranged at the proximal end section of the device.

14. The apparatus for the percutaneous treatment of hydrocephalus with a one-way valve according to claim 11, characterized in that: An imaging point is arranged on the anchoring stent.

15. The apparatus for the percutaneous treatment of hydrocephalus with a check valve according to claim 1, characterized in that: Part or all of the inner and outer surfaces of the device are provided with an anticoagulant coating.

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