A sinus stent assembly and method of release

Abstract

The application provides a cerebral venous sinus stent assembly and releasing method, and relates to the technical field of medical devices, which comprises a stent body made of memory alloy wires, a fixed part arranged at the proximal end of the stent body, and a control part for controlling the expansion and contraction of the fixed part. The fixed part comprises connecting wires arranged on the peripheral surface of the proximal end of the stent body and extending towards the proximal end, a push block arranged at the middle part of the proximal end of the stent body, and a plurality of memory alloy wires connected to the distal end of the push block. The control part comprises a control catheter, the connecting wires are connected to the inner wall of the control catheter through a window, the control catheter is provided with a control guide wire, the control guide wire is provided with a cutting block located at the distal end of the window, and the control guide wire is pushed towards the distal end to expand the proximal end of the stent body. The control part and the fixed part are matched to realize the secondary expansion of the proximal end of the stent body, better stenting and fixing can be realized, and the proximal end of the stent body is in a controllable state and is not prone to displacement in the whole releasing process.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and particularly relates to a venous sinus stent assembly and a releasing method. BACKGROUND

[0002] Brain venous sinus stenosis has been confirmed to be closely related to partial pulsatile tinnitus, intracranial hypertension, and the generation and progression of cerebral venous sinus thrombosis. Due to the stenosis of the venous sinus, the return of venous blood is blocked, which causes the intracranial venous pressure to rise, further causing intracranial hypertension. The generation of pulsatile tinnitus is related to the turbulent flow easily generated after the venous sinus stenosis.

[0003] In the prior art, for the case of venous sinus stenosis, mainly interventional surgery or thrombolytic therapy is used. For chronic venous sinus stenosis, if thrombolytic therapy in the venous sinus is difficult to achieve results, it is necessary to use interventional surgery for treatment.

[0004] At present, there is no stent specially used for treating venous sinus stenosis on the market at home and abroad. When interventional surgery is used to treat venous sinus stenosis, an intracranial artery stent or a carotid artery stent is usually selected as a substitute.

[0005] Since the radial support force of the intracranial artery stent is relatively low, it is not enough to completely expand the stenotic venous sinus blood vessels. The radial support force of the carotid artery stent is too large, which is easy to cause damage to the venous sinus blood vessels, resulting in headache of the patient. At the same time, in the process of use, due to the insufficient adaptability of the stent to the venous sinus, the stent will be displaced under the action of blood flow, affecting the fixation of the stent.

[0006] Therefore, it is necessary to provide an improved technical solution for the above-mentioned deficiencies of the prior art. SUMMARY

[0007] The purpose of the present application is to provide a venous sinus stent assembly and a releasing method to solve the problem that the existing stent is difficult to fully expand the venous sinus blood vessels and has little damage to the venous sinus blood vessels.

[0008] In order to achieve the above-mentioned purpose, the present application provides the following technical solution:

[0009] A venous sinus stent assembly, comprising a stent body made of a plurality of memory alloy wires;

[0010] A fixed part is arranged at the proximal end of the stent body;

[0011] A control part controls the expansion and contraction of the fixed part;

[0012] The fixed part comprises a connecting wire arranged on the outer circumferential surface of the proximal end of the stent body and extending towards the proximal end, a push block arranged at the middle part of the proximal end of the stent body, and the plurality of memory alloy wires are connected to the distal end of the push block;

[0013] The control part comprises a control catheter, a window is formed on the side wall of the control catheter, the connecting wire is connected to the inner wall of the control catheter through the window, the control catheter is provided with a control guide wire, and a cutting block is arranged on the control guide wire and located at the distal end of the window; and the control guide wire is pushed to the distal end to expand the proximal end of the stent body.

[0014] Preferably, a protrusion is arranged on the inner wall of the control catheter and located between the window and the connecting position of the connecting wire on the control catheter.

[0015] Preferably, a developing ring is arranged on the side wall of the stent body, and developing points are arranged on the proximal end and the distal end of the stent body.

[0016] Preferably, the developing ring is located at the distal end of the stent body, and the position of the developing ring in the crimped state of the stent body is located proximally to the position of the distal end of the stent body in the maximum expansion state.

[0017] Preferably, the connecting wire is a component made of PGA (polyglycolic acid).

[0018] Preferably, the radial width of the stent body is 6-8 mm.

[0019] Preferably, the length of the stent body is 60-80 mm.

[0020] Preferably, the stent body is mixedly made of cobalt alloy wires and nickel-titanium alloy wires, and the number of the nickel-titanium alloy wires is at least three.

[0021] Preferably, the metal coverage of the stent body is preferably 35%.

[0022] A releasing method of a venous sinus stent assembly, comprising the following steps:

[0023] S101: In the gathered state, the stent body is crimped in a microcatheter, the microcatheter passes through the internal jugular vein to reach the strait of the sigmoid sinus and the transverse sinus;

[0024] S102: The microcatheter is withdrawn, and the stent body is released and gradually expanded;

[0025] S103: Whether the stent body completely covers the strait position is determined by a developing device;

[0026] S104: The proximal end of the stent body is connected to the control catheter through the connecting wire, the control guide wire is pushed to the distal end, the pushing block moves to the distal end to extrude the memory alloy wire, the stent body is secondarily expanded in the radial direction and fully abuts against the inner wall of the blood vessel;

[0027] S105: Withdraw the control guide wire, and a recovery resistance is felt during the withdrawal process. The control guide wire is rotated to drive the cutting block to rotate, so that the cutting block cuts the connecting wire, and the release between the stent body and the control catheter is realized.

[0028] Advantages:

[0029] (1) The stent body is connected with the control catheter through the connecting wire around the periphery of the stent body by pushing the push block to advance, so that the secondary expansion of the proximal end of the stent body is realized, better expansion and fixation can be realized, and the proximal end of the stent body is in a controllable state during the entire release process, displacement is not easy to occur, and the possibility of displacement of the stent body under the washing of blood flow is reduced.

[0030] (2) The proximal end of the stent body is in a controllable state during the entire release process by cooperation of the control part and the fixing part, displacement is not easy to occur, and the possibility of displacement of the stent body under the washing of blood flow is reduced.

[0031] (3) The position of the developing ring is set at the distal end of the stenosis, so that the developing ring and the proximal end of the stent body completely cover the stenosis. When the stent body is released, even if the stent body shrinks, it will not shrink to the position of the developing ring in the pressing state. The proximal end and the distal end completely cover the stenosis position, so as to ensure full coverage and improve the operation effect. BRIEF DESCRIPTION OF DRAWINGS

[0032] The drawings accompanying the specification of this application form a part thereof, serve to provide further understanding of the application, and together with the description of the exemplary embodiments of the application given below, make an explanation of the application. In the drawings:

[0033] Figure 1 It is a schematic diagram of the overall structure of the venous sinus stent assembly in the embodiment of the application;

[0034] Figure 2 It is a schematic diagram of the overall structure of the venous sinus stent assembly in the embodiment of the application;

[0035] Figure 3 It is a schematic diagram of the connecting structure for showing the stent body and the fixing part in the embodiment of the application;

[0036] Figure 4 It is a schematic diagram of the structure for showing the control part and the fixing part in the embodiment of the application;

[0037] Figure 5 It is an enlarged view of the structure at A of the stent body in the embodiment of the application; Figure 4

[0038] Figure 6 It is a schematic diagram of the structure for showing the control part and the connecting wire in the embodiment of the application; ​

[0039] Figure 7 A schematic diagram of the anatomical structure of the cerebral venous sinus with narrowing;

[0040] Figure 8 This is a schematic diagram of the anatomical structure of the cerebral venous sinus after the installation of this venous sinus stent.

[0041] In the figure: 1. Stent body; 11. Imaging ring; 12. Imaging point; 2. Fixation part; 21. Connecting wire; 22. Push block; 3. Control part; 31. Control catheter; 311. Protrusion; 32. Window; 33. Control guide wire; 34. Cutting block. Detailed Implementation

[0042] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention are within the scope of protection of the present invention.

[0043] In the description of this invention, it should be understood that the orientation descriptions, such as up, down, front, back, left, right, etc., are based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting this invention.

[0044] In the description of this invention, "several" means one or more, "more than" means two or more, "greater than," "less than," and "exceeding" are understood to exclude the stated number, while "above," "below," and "within" are understood to include the stated number. The use of "first" and "second" in the description is merely for distinguishing technical features and should not be construed as indicating or implying relative importance, or implicitly indicating the number of indicated technical features, or implicitly indicating the order of the indicated technical features.

[0045] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Therefore, a feature defined as "first" and "second" may explicitly or implicitly include one or more features.

[0046] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the term "connection" should be interpreted broadly. For example, it can be a fixed connection or a movable connection, a detachable connection or a non-detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection or a connection that allows communication between the two components; it can be a direct connection or an indirect connection through an intermediate medium; it can be a connection within two components, an indirect connection, or an interaction between two components.

[0047] In the description of the present application, the "distal end" refers to the end far from the doctor during the operation, and the "proximal end" refers to the end close to the doctor during the operation.

[0048] In the description of the present application, "before use" refers to the state of the venous sinus stent assembly and the releasing method before use, before entering the human body, or before contacting with the body fluid such as blood, interstitial fluid, etc. in the human body, and "during use" refers to the state of the venous sinus stent assembly and the releasing method after entering the human body or contacting with the body fluid such as blood, interstitial fluid, etc. in the human body.

[0049] In the description of the present application, the "gathered state" refers to the state of the "stent body" being attached together within the local length range or the entire length range.

[0050] In the description of the present application, the "in vivo environment" refers to the environment below the epidermis of the skin, where the body fluid exists, such as the dermis layer and subcutaneous tissue, or the inside of the blood vessels and organs, etc.

[0051] The present application will be described in detail below with reference to the embodiments. It should be noted that the embodiments in the present application and the features in the embodiments can be combined with each other without conflict.

[0052] The present application aims at the problem that the existing stent is difficult to fully expand the venous sinus blood vessels and causes little damage to the venous sinus blood vessels.

[0053] With reference to Figures 1 to 3 , the present application provides a venous sinus stent assembly, which comprises a stent body 1 made of a plurality of memory alloy wires;

[0054] A fixed part 2 is arranged at the proximal end of the stent body 1;

[0055] A control part 3 controls the expansion and contraction of the fixed part 2;

[0056] The fixed part 2 comprises a connecting wire 21 arranged on the outer circumferential surface of the proximal end of the stent body 1 and extending towards the proximal end, a push block 22 arranged at the middle part of the proximal end of the stent body 1, and a plurality of memory alloy wires connected to the distal end of the push block 22;

[0057] The control part 3 comprises a control catheter 31, a window 32 is arranged on the side wall of the control catheter 31, the connecting wire 21 is connected to the inner wall of the control catheter 31 through the window 32, the control catheter 31 is provided with a control guide wire 33, and the control guide wire 33 is provided with a cutting block 34 located at the distal end of the window 32; the control guide wire 33 is pushed towards the distal end to make the proximal end of the stent body 1 expand.

[0058] The memory alloy wire is preferably made of cobalt alloy. The cobalt alloy has a certain shape memory function and can automatically expand after release to form a mesh with a grid surface. The stent body 1 can prop open the narrow part of the vein after expansion to complete the treatment.

[0059] In a preferred embodiment, two cobalt alloy wires are woven on one cobalt alloy wire to improve the structural strength of the stent body 1 and improve the support.

[0060] Referring to Figures 1 to 5 , the fixing part 2 includes a connecting wire 21 bonded to the stent body 1. The connecting wire 21 is preferably made of a line that can be degraded in the blood vessel, which can be PGA (polyglycolic acid). The PGA is degraded in the blood vessel after a period of time and then metabolized and excreted. The connecting wire 21 is uniformly distributed around the proximal end of the stent body 1. The proximal end of the stent body 1 can be controlled by the connecting wire 21.

[0061] Referring to Figure 5 and Figure 6 , the fixing part 2 further includes a push block 22 bonded to the middle part of the proximal end of the stent body 1. The push block 22 is preferably made of stainless steel to make the chemical stability of the push block 22 strong and have less impact on the environment in the blood vessel. Specifically, the proximal end of the stent body 1 is provided with a plurality of memory alloy wires connected to the push block 22.

[0062] The control catheter 31 is preferably made of PTFE or PU. The control catheter 31 is provided with a window 32 on the side wall. The proximal end of the connecting wire 21 passes through the window 32 and is bonded to the inner wall of the control catheter 31. The control catheter 31 is provided with a cavity extending in the length direction of the control catheter 31. The control guide wire 33 passes through the cavity and can slide forward and backward along the cavity. The control guide wire 33 is integrally formed with a cutting block 34. The proximal end of the cutting block 34 is ground to cut the connecting wire 21. Preferably, the control guide wire 33 and the cutting block 34 are made of stainless steel to make the control guide wire 33 and the cutting block 34 have a certain hardness. The control guide wire 33 can stably push the push block 22 forward during movement to the distal end.

[0063] Referring to Figure 1 , Figure 2 , Figure 3 , Figure 7 and Figure 8, the stent body 1 is pressed in the microcatheter, the microcatheter passes through the internal jugular vein, the sigmoid sinus and the transverse sinus in turn, the microcatheter is withdrawn, the stent body 1 is released, gradually expands and props open the narrow part of the sigmoid sinus or / and the transverse sinus, and whether the stent body 1 completely covers the narrow position is judged by the developing device after the stent body 1 is completely released. It should be noted that the length of the connecting wire 21 is sufficient to allow the proximal end of the stent body 1 to expand. The connecting wire 21 is connected at the control catheter 31, so that the proximal end of the stent body 1 is in a fixed state after expansion. At this time, compared with the release of the stent body 1 in the prior art, the stent body 1 in the scheme does not bounce to the distal end at the moment of complete release, which improves the stability of the release of the stent body 1. In the stent assembly, the distal end of the stent body 1 will contract a distance to the proximal end after being completely released. Since the proximal end of the stent body 1 is in a fixed state in the axial direction, the control guide wire 33 is pushed to the distal end, the push block 22 is moved to the distal end to extrude the memory alloy wire, the memory alloy wire is deformed and transmits force to the outer periphery of the stent body 1, and since the connecting wire 21 is connected to the control catheter 31, only the control catheter 31 needs to be kept fixed to realize the limitation of the movement of the stent body 1 in the axial direction, so that the proximal end of the stent body 1 is further expanded in the radial direction. The stent body 1 after further expansion has better support effect. In this state, the diameter of the proximal end of the stent body 1 is greater than the diameter of the control catheter 31, and retracting the control guide wire 33 and pulling the stent body 1 to the proximal end can make the proximal end of the stent body 1 contract, which is convenient for adjusting the position of the stent body 1.

[0064] Specifically, the push block 22 extrudes the memory alloy wire in the middle during movement to the distal end, the memory alloy wire is deformed and transmits force to the outer periphery of the stent body 1, and since the connecting wire 21 is connected to the control catheter 31, only the control catheter 31 needs to be kept fixed to realize the limitation of the movement of the stent body 1 in the axial direction, so that the proximal end of the stent body 1 is further expanded in the radial direction. The stent body 1 after further expansion has better support effect. In this state, the diameter of the proximal end of the stent body 1 is greater than the diameter of the control catheter 31, and retracting the control guide wire 33 and pulling the stent body 1 to the proximal end can make the proximal end of the stent body 1 contract, which is convenient for adjusting the position of the stent body 1.

[0065] Before the control catheter 31 exits, the control guide wire 33 is first retracted to extrude the cutting block 34 and the connecting wire 21, and the user can judge that the cutting block 34 and the connecting wire 21 are extruded when the user feels that the retraction is difficult, the control guide wire 33 is rotated to drive the cutting block 34 to cut the connecting wire 21, so that the cutting operation is realized, and then the control guide wire 33 and the control catheter 31 are withdrawn. By setting the control part 3 to make the proximal end of the stent body 1 be secondarily expanded, better prop opening and fixing effects can be realized, the stent body 1 is kept controllable during the whole release process, displacement is not easy to occur, and better surgical effects can be realized.

[0066] In the preferred embodiment of the present application, a protrusion 311 is arranged on the inner wall of the control conduit 31, and is located between the window 32 and the connection between the connecting wire 21 and the control conduit 31. The protrusion 311 is made of platinum-iridium alloy and is bonded to the inner wall of the control conduit 31. The position of the protrusion 311 can be observed under the developing device. When the cutting block 34 contacts the connecting wire 21, the contact position is at the distal end of the protrusion 311. With the aid of the developing device, the cutting block 34 can be rotated by rotating the control guide wire 33, so as to assist in extruding and cutting the connecting wire 21.

[0067] In the preferred embodiment of the present application, the stent body 1 is provided with a developing ring 11 on the side wall, and the stent body 1 is provided with developing points 12 at the proximal end and the distal end. The developing ring 11 and the developing points 12 are preferably made of platinum-iridium alloy and are bonded to the stent body 1, which is used to assist the doctor in judging the position of the stent body 1 and facilitate the operation of the doctor. It should be noted that the developing ring 11 is composed of a plurality of blocks made of platinum-iridium alloy and bonded to the stent body 1. This arrangement can reduce the influence of the developing ring 11 on the expansion of the stent body 1.

[0068] In the preferred embodiment of the present application, the developing ring 11 is located at a position close to the distal end of the stent body 1, and the position of the developing ring 11 in the compressed state of the stent body 1 is located at a position close to the position of the distal end of the stent body 1 in the maximum expansion rate. Before entering the human body, the stent body 1 is allowed to expand to the maximum in a natural state without external force. The distal end of the stent body 1 is in the maximum expansion rate, and the distal end of the stent body 1 is marked at this time. The developing ring 11 is bonded to the stent body 1 and marked at the proximal end. The purpose of this arrangement is to judge the position of the developing ring 11 and the proximal end of the stent body 1 after the stent body 1 is in place, so that the developing ring 11 and the proximal end of the stent body 1 completely cover the stenosis. At this time, the stent body 1 is released. Even if the stent body 1 shrinks, it will not shrink to the position of the developing ring 11 in the compressed state. It can be ensured that the proximal end and the distal end completely cover the stenosis, thereby ensuring full coverage and improving the operation effect.

[0069] It should be noted that the developing ring 11 will move towards the proximal end during the expansion of the stent body 1, so the position of the developing ring 11 during the expansion of the stent body 1 is not used as a reference.

[0070] In the preferred embodiment of the present application, the connecting wire 21 is a component made of PGA (polyglycolic acid). The connecting wire 21 is allowed to degrade through hydrolysis, thereby reducing the probability of thrombosis at the connecting wire 21.

[0071] In the preferred embodiment of the present application, the radial width of the stent body 1 is 6-8 mm. The stent body 1 with a diameter of 6-8 mm is sufficient to support the stenosis of the transverse sinus and the sigmoid sinus. The specific diameter to be selected is determined according to the actual lesion position of the patient.

[0072] The length of the stent body 1 is 60-80 mm in the preferred embodiment of the present application. The stent body 1 with the length of 60-80 mm is enough to cover the narrow part of the transverse sinus and the sigmoid sinus, and the length is determined according to the actual length of the lesion of the patient.

[0073] The stent body 1 is made of mixed cobalt alloy wires and nickel-titanium alloy wires in the preferred embodiment of the present application, and the number of the nickel-titanium alloy wires is at least three. The developing effect of the nickel-titanium alloy wires is better, and the structure strength is relatively soft. The structure strength of the cobalt alloy wires is higher, and the developing effect is relatively poor. The stent body 1 made of the cobalt alloy wires is interwoven with at least three nickel-titanium alloy wires, which is used to enhance the developing effect and ensure the structure strength.

[0074] The metal coverage of the stent body 1 is preferably 35% in the preferred embodiment of the present application. The radial support force of the stent with the metal coverage of 35% is strong, which can effectively expand the narrow or diseased blood vessel and reduce the probability of restenosis of the blood vessel after treatment.

[0075] The inner surface of the stent body 1 is provided with a hydrophilic coating in the preferred embodiment of the present application, and the hydrophilic coating is a hydrogel coating. The main component of the hydrogel coating used in the present application is a commercially available medical-grade hydrogel. The hydrogel can be made of polysaccharide, polypeptide, polymer and the like, and has certain adhesion. The hydrogel with the same purpose can also be self-made. The hydrophilic coating is used to reduce the friction coefficient of the inner surface of the stent body 1, thereby reducing the possibility of displacement of the stent body 1 caused by the washing of the stent body 1 by the blood flow.

[0076] A method for releasing a venous sinus stent assembly, comprising the following steps:

[0077] S101: In the gathered state, the stent body 1 is pressed and held in the microcatheter, and the microcatheter passes through the internal jugular vein to reach the narrow part of the transverse sinus and the sigmoid sinus;

[0078] S102: The microcatheter is withdrawn, and the stent body 1 is released and gradually expands;

[0079] S103: Whether the stent body 1 completely covers the narrow position is determined by the developing device;

[0080] S104: The proximal end of the stent body 1 is connected to the control catheter 31 through the connecting wire 21, the control guide wire 33 is pushed to the distal end, the push block 22 moves to the distal end to extrude the memory alloy wire, the stent body 1 is forced to expand in the radial direction, and the stent body 1 is fully abutted with the inner wall of the blood vessel;

[0081] S105: The control guide wire 33 is withdrawn, and the recovery resistance is felt during the withdrawal process. The control guide wire 33 is rotated to drive the cutting block 34 to rotate, the cutting block 34 cuts the connecting wire 21, and the stent body 1 is released from the control catheter 31.

[0082] The following will describe a venous sinus stent assembly and releasing method according to the present application through specific embodiments.

[0083] Embodiment 1

[0084] The present embodiment provides a venous sinus stent assembly, referring to Figure 1 , Figure 2 and Figure 3 , which comprises a stent body 1 woven by a plurality of memory alloy wires, preferably cobalt alloy wires and nickel-titanium alloy wires, and the weaving method is to press two cobalt alloy wires on one cobalt alloy wire, so that the structural strength of the stent body 1 is better, and the supportability can be improved. The metal coverage of the stent body 1 is 35%, which can stabilize the expansion of the blood vessel stenosis. The stent body 1 is mixedly woven by cobalt alloy wires and nickel-titanium alloy wires, and the nickel-titanium alloy wires are at least three. The developing effect of the nickel-titanium alloy wires is better, and the structural strength is relatively soft, while the structural strength of the cobalt alloy wires is higher, and the developing effect is poorer. At least three nickel-titanium alloy wires are interwoven on the stent body 1 made of cobalt alloy wires, which is used to enhance the developing effect and ensure a certain structural strength.

[0085] Preferably, the radial width of the stent body 1 is 6-8mm (which can be 6mm, 7mm, 8mm). The length of the stent body 1 is 60-80mm (which can be 60mm, 61mm, 62mm, 63mm, 64mm, 65mm, 66mm, 67mm, 68mm, 69mm, 70mm, 71mm, 72mm, 73mm, 74mm, 75mm, 76mm, 77mm, 78mm, 79mm, 80mm).

[0086] Referring to Figure 2 , Figure 3 and Figure 4 , the fixing part 2 comprises a connecting wire 21 adhered to the outer peripheral surface of the proximal end of the stent body 1, and the connecting wire 21 is arranged in a ring shape at equal intervals. The connecting wire 21 is preferably made of a line that can be degraded in the blood vessel, which can be PGA (polyglycolic acid). The PGA is degraded after a period of time in the blood vessel, and then metabolized and discharged. The proximal end of the stent body 1 can be controlled through the connecting wire 21. The fixing part 2 further comprises a push block 22 adhered to the proximal end of the stent body 1, and a plurality of memory alloy wires are concentrated in the radial middle part and adhered to the push block 22. The push block 22 is preferably made of stainless steel, and the surface is provided with a hydrophilic coating for reducing the influence on the blood flow in the blood vessel.

[0087] The control part 3 comprises a control catheter 31, which is preferably made of PTFE or PU. The side wall of the control catheter 31 is provided with a window 32, and the connecting wire 21 passes through the window 32 and is adhered to the inner wall of the control catheter 31.

[0088] Preferably, a protrusion 311 is adhered to the side wall of the control catheter 31, and is located between the window 32 and the connection between the connecting wire 21 and the control catheter 31. The portion of the connecting wire 21 in the control catheter 31 is in close contact with the surface of the protrusion 311. The protrusion 311 is made of platinum-iridium alloy, and can be clearly seen under the developing device, which is convenient for the doctor to judge.

[0089] Referring to Figure 2 , Figure 3 , Figure 4 and Figure 5 , the control catheter 31 is provided with a cavity extending along the length direction of the control catheter 31, and the control guide wire 33 passes through the cavity and can slide in the cavity. The control guide wire 33 is integrally formed with a cutting block 34, and the outer circumferential surface of the proximal end of the cutting block 34 is provided with a sharp edge by grinding. After the control guide wire 33 is pulled towards the proximal end, the cutting block 34 can extrude and cut the connecting wire 21. In the process of retracting the control guide wire 33, when the resistance of the abutment between the cutting block 34 and the protrusion 311 is felt, rotating the control guide wire 33 can achieve faster and more effective cutting, and the cutting of the connecting wire 21 is more convenient.

[0090] Referring to Figures 2 to 8 , in the gathering state, the stent body 1 is pressed and held in the microcatheter, and the microcatheter passes through the internal jugular vein, the sigmoid sinus and the transverse sinus in sequence; the microcatheter is retracted, so that the stent body 1 is released, gradually expands and opens the narrow part of the sigmoid sinus or / and the transverse sinus, and whether the stent body 1 completely covers the narrow position is judged by the developing device after the stent body 1 is completely released. It should be noted that the length of the connecting wire 21 at least meets the requirement that the proximal end of the stent body 1 can expand. The connecting wire 21 is connected to the control catheter 31, and the connecting wire 21 is taut after the proximal end of the stent body 1 expands, so that the proximal end of the stent body 1 is in a fixed state. Compared with the release of the stent body 1 in the prior art, the stent body 1 in this scheme does not bounce towards the distal end at the moment of complete release, which improves the stability of the release of the stent body 1. In this stent assembly, the distal end of the stent body 1 will contract towards the proximal end by a distance after the stent body 1 is completely released.

[0091] When the position of the stent body 1 needs to be adjusted, the control guide wire 33 and the control catheter 31 are retracted, the connecting wire 21 pulls the proximal end of the stent body 1, the proximal end of the stent body 1 is slightly contracted in the radial direction, the contact between the stent body 1 and the blood vessel wall is released, so that the stent body 1 is conveniently pulled towards the proximal end. It should be noted that the diameter of the proximal end of the stent body 1 in the fully expanded state is greater than the diameter of the control catheter 31, and there is a certain angle between the connecting wire 21 and the axial direction of the stent body 1. In the process of pulling the control catheter 31, the proximal end of the stent body 1 will contract in the radial direction, which is convenient for pulling back the stent body 1.

[0092] During the retracting process, the control guide wire 33 is retracted first, and the retraction resistance is increased, at this time, the cutting block 34 is located at the convex block 311, the cutting block 34 is extruded with the connecting wire 21, the control guide wire 33 is rotated to drive the cutting block 34 to rotate, the cutting block 34 cuts the connecting wire 21, and the release between the stent body 1 and the control catheter 31 is realized. Then the control guide wire 33 and the control catheter 31 can be retracted.

[0093] The proximal end of the stent body 1 is in an axially fixed state, the control guide wire 33 is pushed to the distal end, the push block 22 is moved to the distal end and extruded with the memory alloy wire, the stent body 1 is forced to expand in the radial direction, and is fully abutted with the inner wall of the vein, so that the fixation is realized.

[0094] Preferably, the distal end of the control guide wire 33 is provided with a groove, the groove is matched with the push block 22, and in the process of pushing the control guide wire 33 to the distal end, the push block 22 is embedded in the groove, so that the deviation is avoided.

[0095] The application cooperates the control part 3 and the fixing part 2, drives the push block 22 to advance, and pulls the outer periphery of the stent body 1 through the connecting wire 21, so that the secondary expansion of the proximal end of the stent body 1 is realized, the better expansion and fixation are realized, the proximal end of the stent body 1 is in a controllable state during the whole release process, the displacement is not easy to occur, and the possibility of displacement of the stent body 1 under the blood flow is reduced.

[0096] Meanwhile, the stent body 1 can be positioned multiple times, so that the stent body 1 can cover the narrow / lesion area, and the operation effect is ensured.

[0097] In the embodiment, in order to facilitate the judgment of the position of the stent body 1, the stent body 1 is inlaid or bonded with a developing point 12, the developing point 12 is a member made of platinum-iridium alloy, and under the developing equipment, the developing point 12 can display a light point different from other parts in brightness, so as to assist the doctor to judge the position of the stent body 1.

[0098] Embodiment 2

[0099] Referring to Figures 1 to 3 , the positioning of the stent body 1 is further described based on the embodiment 1.

[0100] The side wall of the stent body 1 is bonded with a developing ring 11, the developing ring 11 is made of platinum-iridium alloy, and the developing ring 11 presents a ring shape under the developing equipment, so that the doctor can conveniently judge the position of the developing ring 11 under the developing equipment. Preferably, the developing equipment is a DSA device.

[0101] The position of the developing ring 11 in the compressed state of the stent body 1 is proximal to the position of the distal end of the stent body 1 in the maximum expansion rate. Before entering the human body, the stent body 1 is expanded to the maximum in the natural state without external force, at this time, the stent body 1 is in the maximum expansion rate, the distal end of the stent body 1 is marked, the developing ring 11 is bonded to the stent body 1 and the proximal end of the marked position. After the stent body 1 is in place, the position of the developing ring 11 and the proximal end of the stent body 1 is determined to make the developing ring 11 and the proximal end of the stent body 1 completely cover the stenosis, at this time, the stent body 1 is released, even if the stent body 1 shrinks, it will not shrink to the position of the developing ring 11 in the compressed state, which is used to ensure that the proximal end and the distal end completely cover the stenosis position, thereby ensuring full coverage and improving the operation effect.

[0102] In summary: the control part 3 and the fixed part 2 are matched, the push block 22 is pushed forward, the outer periphery of the stent body 1 is pulled by the connecting wire 21, the proximal end of the stent body 1 is secondarily expanded, better expansion and fixation can be achieved, the proximal end of the stent body 1 is in a controllable state during the entire release process, displacement is not easy to occur, and the possibility of displacement of the stent body 1 under the scouring of blood flow is reduced. At the same time, during the release process of the stent body 1, the position of the developing ring 11 is set at the distal end of the stenosis, which ensures that the stent body 1 can cover and ensures the operation effect.

[0103] The above only describes the preferred embodiments of the present application and is not used to limit the present application. For those skilled in the art, the present application can have various changes and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the present application shall be included in the protection scope of the present application.

Claims

1. A sinus stent assembly, comprising: The stent body (1) is made of a plurality of memory alloy wires; The fixing part (2) is arranged at the proximal end of the stent body (1), and the fixing part (2) comprises a connecting wire (21) arranged on the outer circumferential surface of the proximal end of the stent body (1) and extending towards the proximal end, and a push block (22) arranged at the middle part of the proximal end of the stent body (1), and the plurality of memory alloy wires are connected to the distal end of the push block (22); The control part (3) comprises a control catheter (31), a window (32) is arranged on the side wall of the control catheter (31), the connecting wire (21) is connected to the inner wall of the control catheter (31) through the window (32), the control catheter (31) is provided with a control guide wire (33), the control guide wire (33) is provided with a cutting block (34) located at the distal end of the window (32), the control guide wire (33) is pushed towards the distal end, the push block (22) is moved towards the distal end to extrude the memory alloy wire, and the stent body (1) is radially stressed to be expanded again and fully abuts against the inner wall of the blood vessel.

2. A sinus stent assembly according to claim 1, wherein, The inner wall of the control catheter (31) is provided with a protrusion (311), and the protrusion (311) is located between the window (32) and the connecting position of the connecting wire (21) on the control catheter (31).

3. The sinus stent assembly of claim 1, wherein, The side wall of the stent body (1) is provided with a developing ring (11), and the proximal end and the distal end of the stent body (1) are provided with developing points (12).

4. The sinus stent assembly of claim 3, wherein, The developing ring (11) is located at the distal end of the stent body (1), and the position of the developing ring (11) in the compressed state of the stent body (1) is located at the proximal end of the position of the stent body (1) in the maximum expansion state.

5. The sinus stent assembly of claim 1, wherein, The connecting wire (21) is a component made of polyglycolic acid.

6. The sinus stent assembly of claim 2, wherein, The radial width of the stent body (1) is 6-8mm.

7. The sinus stent assembly of claim 6, wherein, The length of the stent body (1) is 60-80mm.

8. The sinus stent assembly of claim 1, wherein, The stent body (1) is made of cobalt alloy wires and nickel-titanium alloy wires, and the number of the nickel-titanium alloy wires is at least three.

9. The sinus stent assembly of any of claims 1-8, wherein, The metal coverage of the stent body (1) is 35%.

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