Peripheral point-shaped stent catheter and preparation method thereof

Abstract

The present invention provides a peripheral point-shaped stent catheter and a preparation method, which belongs to the field of medical device technology and solves the problem that the peripheral point-shaped stent is released in an improper position during the release operation, and the surgical operation is complicated and time-consuming. The solution includes: an inner tube with a hollow interior, the first end of the inner tube is fixedly connected to an inner hollow tip, the inner tube and the interior of the tip are mutually connected, and the guide wire passes through the inner tube along the inner cavity of the tip; multiple stents, multiple stent development identification rings and limiting tubes are sleeved on the outer surface of the inner tube, wherein the multiple stents and the multiple stent development identification rings are alternately arranged on the outer surface of the inner tube, and the first end of the limiting tube is adjacent to the stent development identification ring farthest from the first end of the inner tube among the multiple stent development identification rings; a release tube sleeved on the outer surface of the multiple stents; a reinforcement tube sleeved on the outer surface of the release tube. The solution provides a stent catheter with a multi-layer structure, which realizes the precise release of the peripheral point-shaped stent, simplifies the surgical operation, and shortens the operation time.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a peripheral point-shaped stent catheter and a preparation method thereof. Background Art

[0002] Among the current peripheral stent products, the stent is usually laser-cut from a nickel-titanium tube, pre-installed on the delivery system, and released with one hand using an ergonomically designed handle. The handle is also equipped with a locking device that can switch the product between locked and unlocked states in any state. This allows the system to be locked when adjusting the delivery system position after releasing any stent, and to be unlocked when any stent needs to be released. When the stent is exposed to body temperature, it expands to fit tightly against the blood vessel wall. Through the expansion and expansion of the stent, a continuous and moderate radial support force is generated after reaching the pre-set diameter, thereby establishing blood vessel patency. However, during the release operation, current peripheral stent products are prone to problems such as improper stent release position, the need to repeatedly enter and exit the blood vessel, and the surgical operation is complicated and time-consuming. Summary of the Invention

[0003] The present invention provides a peripheral point-shaped stent catheter and a preparation method thereof, which solve the problems of improper stent release position during the release operation of the peripheral point-shaped stent, complicated surgical operation and long time consumption.

[0004] In order to solve the above technical problems, the technical solutions of the present invention are as follows:

[0005] An embodiment of the present invention provides a peripheral point-shaped stent catheter, comprising:

[0006] An inner tube having a hollow interior, wherein a first end portion of the inner tube is fixedly connected to a tip having a hollow interior, the inner tube and the interior of the tip being interconnected, and a guide wire passing through the inner tube along the inner cavity of the tip;

[0007] a plurality of brackets, a plurality of bracket development identification rings, and a limiting tube sleeved on the outer surface of the inner tube, wherein the plurality of brackets and the plurality of bracket development identification rings are alternately arranged on the outer surface of the inner tube, an end of each bracket is adjacent to a bracket development identification ring, and a first end of the limiting tube is adjacent to a bracket development identification ring farthest from the first end of the inner tube among the plurality of bracket development identification rings;

[0008] a release tube sleeved on the outer surfaces of the plurality of stents;

[0009] a reinforcing tube sleeved on the outer surface of the release tube;

[0010] Wherein, a release tube identification ring is provided at the end of the release tube close to the tip.

[0011] Optionally, the middle position of the outer surface of the tip has a stepped structure, the inner surface of the tip is provided with an inner tube mounting groove, the first end of the inner tube is inserted into the inner tube mounting groove, and the inner tube is fixedly connected to the tip.

[0012] Optionally, the inner surface of the limiting tube is in contact with and fixedly connected to the outer surface of the inner tube.

[0013] Optionally, the release tube comprises at least one of an inner layer, a middle layer and an outer layer; wherein,

[0014] The inner layer is a hollow structure and is made of polymer material;

[0015] The intermediate layer is sleeved on the outer surface of the inner layer and includes a release tube identification ring and a metal braided wire;

[0016] The outer layer is sleeved on the outer surface of the middle layer. The portion of the outer layer close to the tip is made of a polyether block polyamide material, and the portion of the outer layer away from the tip is made of a nylon material.

[0017] Optionally, the end of the release tube away from the tip is fixedly connected to the release tube seat.

[0018] Optionally, the release tube seat is fixedly connected to the rack;

[0019] The release tube seat includes an anti-rotation rib, a concentric shaft, and a first buckle structure;

[0020] The rack includes an anti-rotation groove, a concentric hole, and a second buckle structure;

[0021] In which, when the anti-rotation rib is inserted into the anti-rotation groove, the release tube seat is locked with the rack, and the concentric shaft is inserted into the concentric hole to maintain the center line of the release tube seat and the rack coaxially, and the first buckle structure cooperates with the second buckle structure to achieve a fixed connection between the release tube seat and the rack.

[0022] Optionally, the second end of the inner tube is fixedly connected to the inner tube seat.

[0023] Optionally, a semicircular bonding structure and a full-circular bonding structure are provided on the top of the inner tube seat, and a third buckle structure is provided on the bottom of the inner tube seat.

[0024] Optionally, the second end portion of the inner tube is fixedly connected to the semicircular bonding structure and the full-circular bonding structure by gluing.

[0025] An embodiment of the present invention further provides a method for preparing a peripheral dot-shaped stent catheter, comprising:

[0026] A combination is formed, the combination comprising: an inner tube with a hollow interior, a first end portion of the inner tube fixedly connected to a hollow tip, the inner tube and the interior of the tip being interconnected, and a guide wire passing through the inner tube along the inner cavity of the tip; a plurality of stent development identification rings and a limiting tube sleeved on the outer surface of the inner tube, wherein the plurality of stent development identification rings are arranged on the outer surface of the inner tube at preset intervals, the length of the preset intervals being equal to the length of the stent, and the first end portion of the limiting tube being adjacent to the stent development identification ring farthest from the first end portion of the inner tube among the plurality of stent development identification rings;

[0027] Providing a tooling mandrel to form a release tube;

[0028] The combination and multiple stents are inserted into the inner cavity of the release tube, wherein the stents are sleeved within the preset intervals on the outer surface of the inner tube; the reinforcement tube is sleeved on the outer surface of the release tube to obtain the peripheral point-shaped stent catheter.

[0029] The technical solution of the present invention includes at least the following effects:

[0030] (1) The present invention proposes a peripheral dot-shaped stent catheter. The dot-shaped stent design ensures that the stent can be implanted in blood vessels such as the femoral and popliteal regions, which are prone to bending and twisting, without kinking or breaking. This reduces irritation and damage to the blood vessels and reduces the risk of restenosis due to endothelial hyperplasia.

[0031] (2) By designing a stent catheter with a multi-layer structure and providing an opaque stent imaging identification ring and a release tube identification ring, visibility is improved during the operation, achieving precise stent release and avoiding the situation where multiple sets of products are repeatedly inserted and exited from the blood vessel through puncture.

[0032] (3) The peripheral point-shaped stent catheter of the present invention can be used in peripheral point-shaped stent products. The peripheral point-shaped stent products are composed of a stent, a delivery system and a handle, which realizes the treatment of multiple lesion locations in one interventional treatment, simplifies the surgical operation and shortens the operation time. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1 Schematic diagram of a delivery device including a peripheral dot-shaped stent catheter provided by an embodiment of the present invention;

[0034] Figure 2 This is a structural diagram of a peripheral dot-shaped stent catheter provided by an embodiment of the present invention;

[0035] Figure 3 This is a structural diagram of the tip of a peripheral point-shaped stent catheter provided by an embodiment of the present invention;

[0036] Figure 4is a transverse cross-sectional view of a peripheral point-shaped stent catheter release tube provided by an embodiment of the present invention;

[0037] Figure 5 is a longitudinal cross-sectional view of a peripheral point-shaped stent catheter release tube provided by an embodiment of the present invention;

[0038] Figure 6 This is a schematic diagram of the connection between the peripheral point-shaped stent catheter release tube and the rack provided by an embodiment of the present invention;

[0039] Figure 7 This is a structural diagram of a peripheral point-shaped stent catheter release tube seat provided by an embodiment of the present invention;

[0040] Figure 8 This is a schematic diagram of the connection between the inner tube and the inner tube seat of the peripheral point-shaped stent catheter provided by an embodiment of the present invention;

[0041] Figure 9 This is a structural diagram of the inner tube seat of the peripheral point-shaped stent catheter provided by an embodiment of the present invention;

[0042] Figure 10 This is a flow chart of a method for preparing a peripheral dot-shaped stent catheter provided by an embodiment of the present invention;

[0043] Among them, 1. tip; 2. bracket development identification ring; 3. bracket; 4. rotary switch; 5. thumbwheel; 6. outer shell; 7. Luer connector; 8. release tube; 9. limit tube; 10. inner tube; 11. reinforcement tube; 12. guide wire hole; 13. step structure; 14. inner tube installation groove; 15. inner layer; 16. middle layer; 17. outer layer; 18. metal braided wire; 19. release tube seat; 20. rack; 21. anti-rotation rib; 22. concentric axis; 23. first buckle structure; 24. second buckle structure; 25. anti-rotation groove; 26. concentric hole; 27. stainless steel tube; 28. inner tube seat; 29. semicircular bonding structure; 30. full-circle bonding structure; 31. third buckle structure; 32. release tube identification ring. DETAILED DESCRIPTION

[0044] Exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although exemplary embodiments of the present invention are shown in the accompanying drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the present invention and to fully convey the scope of the present invention to those skilled in the art.

[0045] like Figure 1 and Figure 2 As shown, an embodiment of the present invention provides a peripheral point-shaped stent catheter, comprising:

[0046] An inner tube 10 having a hollow interior, wherein a first end portion of the inner tube 10 is fixedly connected to a tip 1 having a hollow interior, wherein the inner tube 10 and the interior of the tip 1 are interconnected, and a guide wire passes through the inner tube 10 along the inner cavity of the tip 1;

[0047] A plurality of brackets 3, a plurality of bracket development identification rings 2, and a limiting tube 9 are sleeved on the outer surface of the inner tube 10, wherein the plurality of brackets 3 and the plurality of bracket development identification rings 2 are alternately arranged on the outer surface of the inner tube 10, the end of each bracket is adjacent to a bracket development identification ring, and the first end of the limiting tube 9 is adjacent to the bracket development identification ring farthest from the first end of the inner tube 10 among the plurality of bracket development identification rings 2;

[0048] a release tube 8 sleeved on the outer surface of the plurality of brackets 3;

[0049] A reinforcement tube 11 sleeved on the outer surface of the release tube 8;

[0050] The end of the release tube 8 close to the tip 1 is provided with a release tube identification ring 32 .

[0051] In this example, the peripheral point-shaped stent catheter is composed of four layers of catheters coaxially sleeved, which are an inner tube 10, a limiting tube 9, a release tube 8, and a reinforcement tube 11 from the inside to the outside; wherein, the inner tube 10 is an internal hollow structure, which can pass through a guide wire or be injected with saline. Passing through the guide wire can improve the passing ability of the peripheral point-shaped stent catheter and can reach the lesion location more accurately. By injecting saline, the inside of the peripheral point-shaped stent catheter can be flushed; the first end of the inner tube 10 is fixedly connected to an internal hollow tip 1 (also called Tip head), which is a conical design with good guiding ability for guiding the peripheral point The stent catheter enters the target blood vessel and also plays a role of support and positioning, ensuring that the stent can be accurately placed in the narrowed or diseased blood vessel, thereby restoring blood vessel patency and improving blood flow; the inner tube 10 and the tip 1 are interconnected, and the guide passes through the inner tube 10 along the inner cavity of the tip 1, and the injected physiological saline also passes through the inner tube 10 and flows out from the tip 1; the outer surface of the inner tube 10 is provided with a plurality of stents 3, a plurality of stent development identification rings 2 and a limiting tube 9, and a maximum of 6 stents 3 can be installed. The plurality of stents 3 and the plurality of stent development identification rings 2 are alternately arranged on the outer surface of the inner tube 10, and the end of each stent 3 is aligned with a stent development identification ring. The bracket 3 is positioned so that the bracket 3 can be positioned in the desired direction and the bracket 3 can be released. Stent 3 is released, and the release tube 8 is retracted to complete the release of the stent 3. A release tube identification ring 32 is provided at the end of the release tube 8 near the tip 1; a reinforcing tube 11 is also sleeved on the outer surface of the release tube 8, and the reinforcing tube 11 is the outermost layer, which plays a role in protecting and strengthening the stent delivery system. At the same time, it can reduce the friction between the release tube 8 and the blood vessel and the sheath when releasing the stent 3, making the release more stable; the stent catheter with a multi-layer structure, by providing an opaque stent development identification ring and a release tube identification ring, helps to improve visibility during operation, realizes the precise release of the point-shaped stent, simplifies the surgical operation, and shortens the operation time.

[0052] like Figure 3 As shown, in an optional embodiment of the present invention, the middle position of the outer surface of the tip 1 has a stepped structure 13, the inner surface of the tip 1 is provided with an inner tube mounting groove 14, and the first end of the inner tube 10 is inserted into the inner tube mounting groove 14 to fix the inner tube 10 to the tip 1.

[0053] In this example, the middle position of the outer surface of the tip 1 has a stepped structure 13, which can make the outer diameter of the tip 1 flush and smooth with the outer diameter of the release tube 8, preventing the release tube 8 from getting stuck during the release process, and ensuring the smooth progress of the operation; at the same time, the design of the stepped structure 13 makes the tip 1 have better guidance in the blood vessel or other biological conduits; this design helps doctors to more accurately manipulate the catheter in complex anatomical structures, so that it can smoothly pass through narrow or curved blood vessel segments and reach the target position; a guide wire hole 12 is provided inside the tip 1, and an inner tube mounting groove 14 is provided on the inner surface of the tip 1. The first end of the inner tube 10 is provided with a guide wire hole 12, and the inner surface of the tip 1 is provided with an inner tube mounting groove 14. The end is inserted into the inner tube mounting groove 14, and the surface activity is enhanced by plasma treatment, and the tip 1 and the inner tube 10 are bonded together, or the tip 1 and the inner tube 10 are integrally injection-molded to achieve a fixed connection between the inner tube 10 and the tip 1, thereby improving the firmness of the connection between the inner tube 10 and the tip 1; the inner tube mounting groove 14 and the guide wire hole 12 are concentric structures, so that the guide wire hole 12 is concentrically aligned with the guide wire cavity of the inner tube 10, ensuring smooth passage of the guide wire; the stepped structure 13 of the tip 1 can be aligned with the release tube 8, ensuring that the outer diameter of the release tube 8 is flush with the outer diameter of the tip 1 without steps, and the front end of the tip 1 is designed with a tapered structure to reduce resistance and enhance guidance, thereby ensuring smooth pushing in the blood vessel.

[0054] In an optional embodiment of the present invention, the inner surface of the limiting tube 9 is in contact with and fixedly connected to the outer surface of the inner tube 10 .

[0055] In this example, the inner surface of the limiting tube 9 is adhered to the outer surface of the inner tube 10 and fixedly connected. The adhesion method can be hot melting or gluing, so that the limiting tube 9 and the inner tube 10 form an integrated structure.

[0056] like Figure 4 and Figure 5 As shown, in an optional embodiment of the present invention, the release tube 8 includes at least one layer of an inner layer 15, a middle layer 16 and an outer layer 17; wherein,

[0057] The inner layer 15 is a hollow structure made of polymer material;

[0058] The intermediate layer 16 is sleeved on the outer surface of the inner layer 15 and includes a release tube identification ring 32 and a metal braided wire 18;

[0059] The outer layer 17 is sleeved on the outer surface of the middle layer 16 . The portion of the outer layer 17 close to the tip 1 is made of a polyether block polyamide material, and the portion of the outer layer 17 away from the tip 1 is made of a nylon material.

[0060] In this example, the release tube 8 has a three-layer structure design, and the inner layer 15 is made of a polymer material with high strength, smooth surface and low friction coefficient, which can reduce the friction between the stent 3 and the inner wall of the release tube 8, thereby improving the stability of the stent 3 during release; the outer layer 17 is made of polyether block polyamide (PEBAX) material near the tip 1, and the part away from the tip 1 is made of nylon material (PA), wherein the hardness of the PEBAX material is low and the hardness of the PA material is high. Through this design, the part of the release tube 8 near the tip 1 can be taken into account while ensuring a certain softness and good pushing performance; the middle layer 16 includes a release tube identification ring 32 and a metal braided wire 18, wherein the release tube identification ring 32 is set at one end near the tip 1, which can be used to remind the surgeon the distal position of the release tube 8 during surgery, which helps to accurately release the stent 3, and the metal braided wire 18 can improve the strength of the stent catheter tube body, so that the tube body has good anti-axial tensile performance and controllability, thereby improving the release performance of the stent 3.

[0061] like Figure 6 As shown, in an optional embodiment of the present invention, the end of the release tube 8 away from the tip 1 is fixedly connected to the release tube seat 19.

[0062] In this example, the release tube 8 and the release tube seat 19 are both made of polymer materials with similar melting points. The release tube 8 and the release tube seat 19 adopt an integrated injection molding process. The two materials are melted and mixed at the same time under the high temperature during injection molding, and are fully fused together after cooling to form a fixed connection with stable quality and super tensile strength.

[0063] like Figure 7 As shown, in an optional embodiment of the present invention, the release tube seat 19 is fixedly connected to the rack 20;

[0064] The release tube seat 19 includes an anti-rotation rib 21, a concentric shaft 22, and a first buckle structure 23;

[0065] The rack 20 includes an anti-rotation groove 25, a concentric hole 26, and a second buckle structure 24;

[0066] In which, when the anti-rotation rib 21 is inserted into the anti-rotation groove 25, the release tube seat 19 is locked with the rack 20, and the concentric shaft 22 is inserted into the concentric hole 26 to maintain the center lines of the release tube seat 19 and the rack 20 coaxial, and the first buckle structure 23 cooperates with the second buckle structure 24 to achieve a fixed connection between the release tube seat 19 and the rack 20.

[0067] In this example, the release tube seat 19 is designed with a concentric shaft 22, an anti-rotation rib 21 and a first buckle structure 23, and the rack 20 is designed with a concentric hole 26, an anti-rotation groove 25 and a second buckle structure 24. The concentric shaft 22 of the release tube seat 19 is inserted into the concentric hole 26 of the rack 20 to ensure that the two are concentric on the axis; the first buckle structure 23 and the second buckle structure 24 work together to ensure that the release tube seat 19 and the rack 20 have super strong tensile performance in the axial direction; the anti-rotation rib 21 and the anti-rotation groove 25 work together to ensure the circumferential stability of the two, and the release tube seat 19 and the rack 20 are locked and will not rotate relative to each other.

[0068] like Figure 8 and Figure 9 As shown, in an optional embodiment of the present invention, the second end of the inner tube 10 is fixedly connected to the inner tube seat 28; the top of the inner tube seat 28 is provided with a semicircular bonding structure 29 and a full-circular bonding structure 30, and the bottom of the inner tube seat 28 is provided with a third buckle structure 31; the second end of the inner tube 10 is fixedly connected to the semicircular bonding structure 29 and the full-circular bonding structure 30 by gluing.

[0069] In this example, the inner tube 10 and the inner tube seat 28 are connected together by bonding. The inner tube seat 28 is designed with a full-circle bonding structure 30, a semi-circle bonding structure 29, and a third buckle structure 31. The full-circle bonding structure 30 can ensure that after the inner tube 10 is inserted into it and glued, the guide wire cavity of the inner tube 10 is concentric with the inner tube seat 28, and the guide wire can pass smoothly. The semi-circle bonding structure 29 ensures that the glue at the joint between the inner tube 10 and the inner tube seat 28 is full and the glue length is controllable, which can solve the problem of insufficient glue coating in the gap; the third buckle structure 31 of the inner tube seat 28 is inserted into the buckle mounting groove of the handle for locking, so as to achieve a stable connection between the inner tube seat 28 and the handle.

[0070] like Figure 10 As shown, an embodiment of the present invention further provides a method for preparing a peripheral point-shaped stent catheter, comprising:

[0071] Step 101, forming a combination, the combination comprising: an inner tube 10 with a hollow interior, a first end portion of the inner tube 10 fixedly connected to a tip 1 with a hollow interior, the inner tube 10 and the interior of the tip 1 mutually interpenetrating, and a guide wire passing through the inner tube 10 along the inner cavity of the tip 1; a plurality of stent development identification rings 2 and a limiting tube 9 sleeved on the outer surface of the inner tube 10, wherein the plurality of stent development identification rings 2 are arranged on the outer surface of the inner tube 10 at preset intervals, the length of the preset intervals being equal to the length of the stent, and the first end portion of the limiting tube 9 being adjacent to the stent development identification ring farthest from the first end portion of the inner tube 10 among the plurality of stent development identification rings 2;

[0072] Step 102, providing a tooling mandrel to form a release tube 8;

[0073] Step 103, inserting the combination and multiple stents 3 into the inner cavity of the release tube 8, wherein the stents are sleeved within the preset intervals on the outer surface of the inner tube 10; sleeve the reinforcing tube 11 on the outer surface of the release tube 8 to obtain the peripheral point-shaped stent catheter.

[0074] In this embodiment, a peripheral point-shaped stent catheter is formed by forming a combination and a release tube, and assembling the combination with the stent, the release tube, and the reinforcement tube. This can improve the preparation efficiency of the peripheral point-shaped stent catheter. At the same time, the prepared peripheral point-shaped stent catheter can better fit the blood vessel wall and reduce blood vessel damage through precise combination and assembly. The catheter has good flexibility and adaptability, can better adapt to the complexity of blood vessel morphology, and reduce complications caused by mismatch between the stent and the blood vessel wall.

[0075] In the embodiment of the method, in step 101, the specific implementation process of forming the combination is as follows:

[0076] Step 1011, providing the inner tube 10;

[0077] Step 1012: insert the first end of the inner tube 10 into the inner tube mounting groove 14 of the tip 1, and sleeve a plurality of stent display identification rings 2 and the limiting tube 9 on the outer surface of the inner tube 10, wherein the plurality of stent display identification rings 2 are arranged at preset intervals on the outer surface of the inner tube 10, and the length of the preset intervals is equal to the length of the stent, and the first end of the limiting tube 9 is adjacent to the stent display identification ring farthest from the first end of the inner tube 10 among the plurality of stent display identification rings 2, to form a combination;

[0078] In this embodiment, the process of forming the assembly includes: first providing the inner tube 10, which is an internal hollow structure for passing a guide wire or cleaning saline; inserting the first end of the inner tube 10 into the inner tube mounting groove 14 of the tip 1, and forming a fixed connection between the two by bonding; a plurality of development identification rings 2 are sleeved on the outer surface of the inner tube 10 close to the tip 1, wherein a plurality of stent development identification rings 2 are arranged at preset intervals on the outer surface of the inner tube 10, and the length of the preset interval is equal to the length of the stent, and a maximum of 7 stent development identification rings 2 can be set; a limiting tube 9 is sleeved on the inner tube 10, and the end of the limiting tube 9 closest to the tip 1 is adjacent to the development identification ring farthest from the tip 1, and the limiting tube 9 is used to provide an axial thrust to the stent 3 along the inner tube 10 to prevent the stent 3 from being displaced during the release process; through the above steps, the inner tube 10, the plurality of development identification rings 2, and the limiting tube 9 can be formed into an assembly, thereby improving the preparation efficiency of the peripheral point-shaped stent catheter.

[0079] In an embodiment of the method, step 102 may specifically include:

[0080] Step 1021, providing a tooling mandrel;

[0081] Step 1022 , sleeve a first polymer material tube on the outer surface of the tooling mandrel to form an inner layer 15 ;

[0082] Step 1023 , weaving metal wires on the outer surface of the first polymer material tube to form metal braided wires 18 ;

[0083] Step 1024 , sleeve a release tube identification ring 32 on the first end of the first polymer material tube, and tightly contact the second end surface of the release tube identification ring 32 with the first end surface of the metal braided wire 18 to form the intermediate layer 16 ;

[0084] Step 1025 , sheathing a second polymer material tube on the outer surface of the intermediate layer 16 and performing a heat treatment to form an outer layer 17 , thereby obtaining a release tube 8 ;

[0085] In this embodiment, the tooling mandrel plays the role of supporting and guiding the bending or forming of the catheter. It is mainly placed inside the catheter to support the inner wall of the catheter bending radius and prevent the catheter from deformation, instability or cross-sectional distortion during the bending or forming process. A first polymer material tube is sleeved on the outer surface of the tooling mandrel to form an inner layer 15, wherein the first polymer material can be any one of polytetrafluoroethylene (PTFE), polyurethane (PU), high-density polyethylene (HDPE), and polyetheretherketone (PEEK); metal wires are woven on the outer surface of the first polymer material tube to form metal braided wires 18, wherein The metal braided wire 18 is used to improve the strength, rigidity and durability of the catheter, so as to ensure stable operation of the catheter in complex environments. The material of the metal braided wire 18 can be stainless steel wire or nickel-titanium alloy wire, etc.; the first end of the first polymer material tube, that is, the end close to the tip 1, is sleeved with a release tube identification ring 32, and the second end face of the release tube identification ring 32 is tightly attached to the first end face of the metal braided wire 18 to form the intermediate layer 16, wherein the release tube identification ring 32 is located on the release tube, and through X-ray fluoroscopy or other imaging technology, the doctor can clearly see the position of the release tube identification ring 32 in the body. This helps doctors to accurately locate the lesion that needs treatment in a complex vascular network, ensuring that the stent 3 can be accurately released to the predetermined position. At the same time, during the release process of the stent 3, the release tube identification ring 32 serves as a visual reference point to guide the doctor to operate according to the predetermined path and depth, reducing operational errors and unnecessary risks; a second polymer material tube is sleeved on the outer surface of the intermediate layer 16 and heat-treated to form an outer layer 17 to obtain a release tube 8, wherein the second polymer material includes polyether block polyamide (PEBAX) and nylon material (PA), the portion of the outer layer 17 close to the tip 1 is made of polyether block polyamide (PEBAX) material, and the portion away from the tip 1 is made of nylon material (PA), wherein the PEBAX material has a low hardness and the PA material has a high hardness. Through this design, it can be taken into account that the portion of the release tube 8 close to the tip 1 has a certain softness while also ensuring good pushing performance.

[0086] In an embodiment of the method, step 103 may specifically include:

[0087] Step 1031, insert the combination and multiple stents 3 into the inner cavity of the release tube 8, wherein the stents are sleeved within the preset intervals on the outer surface of the inner tube 10; sleeve the reinforcing tube 11 on the outer surface of the release tube 8 to obtain the peripheral point-shaped stent catheter.

[0088] In this embodiment, during the process of manufacturing the peripheral point-shaped stent catheter, the assembly and multiple stents 3 are inserted into the inner cavity of the release tube 8, and a reinforcing tube 11 is sheathed on the outer surface of the release tube 8. The specific process includes: performing necessary pretreatments on the assembly, the release tube 8 and the reinforcing tube 11, such as cleaning, disinfection, lubrication, etc., to ensure that they can cooperate smoothly and maintain good performance in subsequent operations; multiple stents 3 are installed in sequence from far to near from the tip 1 of the assembly, and the equipment is used to compress the stent 3 and sheath it on the outer diameter of the inner tube 10, and between the two stent development identification rings 2 to ensure that the compressed stents The bracket 3 is aligned with the axis of the release tube 8, and the release tube 8 is pushed at the same time to receive the bracket 3 into the inner cavity of the release tube 8 to complete the loading of the bracket 3; during this process, it is necessary to avoid damage or deformation of the assembly or the release tube 8; when the assembly is completely inserted into the release tube 8, it is fixed in a predetermined position to prevent displacement during subsequent operations; then the reinforcement tube 11 is sleeved on the outer surface of the release tube 8. During this process, it is necessary to ensure that the reinforcement tube 11 is tightly fitted with the release tube 8, and it is also necessary to pay attention to avoid damage or deformation of the reinforcement tube or the release tube, and finally the peripheral point-shaped bracket catheter is obtained.

[0089] Optionally, the end of the release tube 8 away from the tip 1 is fixedly connected to the release tube seat 19 .

[0090] Optionally, the release tube seat 19 is fixedly connected to the rack 20;

[0091] The release tube seat 19 includes an anti-rotation rib 21, a concentric shaft 22, and a first buckle structure 23;

[0092] The rack 20 includes an anti-rotation groove 25, a concentric hole 26, and a second buckle structure 24;

[0093] In which, when the anti-rotation rib 21 is inserted into the anti-rotation groove 25, the release tube seat 19 is locked with the rack 20, and the concentric shaft 22 is inserted into the concentric hole 26 to maintain the center lines of the release tube seat 19 and the rack 20 coaxial, and the first buckle structure 23 cooperates with the second buckle structure 24 to achieve a fixed connection between the release tube seat 19 and the rack 20.

[0094] Optionally, the second end of the inner tube 10 is fixedly connected to the inner tube seat 28 .

[0095] Optionally, a semicircular bonding structure 29 and a full-circular bonding structure 30 are provided on the top of the inner tube seat 28 , and a third buckle structure 31 is provided on the bottom of the inner tube seat 28 .

[0096] Optionally, the second end of the inner tube 10 is fixedly connected to the semicircular bonding structure 29 and the full-circular bonding structure 30 by gluing.

[0097] In the above-mentioned embodiment of the present invention, the release tube 8 is fixedly connected to the release tube seat 19, and the release tube seat 19 is fixedly connected to the rack 20, and the inner tube 10 is fixedly connected to the inner tube seat 28. The inner tube seat 28 is inserted into the buckle mounting groove of the handle through the third buckle structure 31, so that the inner tube seat 28 is fixedly connected to the operating handle, and the peripheral point-shaped stent catheter and the operating handle are combined into a whole. During use, the guide wire is passed through the catheter sheath and guided along the path of the blood vessel or lesion site; the inner tube 10 and the delivery sleeve connected thereto are delivered into the body along the guide wire until they reach the predetermined position; during the delivery process, the direction and position of the guide wire can be adjusted to ensure that the delivery system can accurately reach the target area; when the delivery system reaches the predetermined position, the rack 20 and the release tube seat 19 and the release tube 8 fixedly connected to the rack 20 are driven to retreat by turning the finger wheel 5, thereby releasing the stent 3; the stent 3 will gradually expand during the release process to support the blood vessel or related tissue; at this time, the release status and position of the stent 3 can be observed through the stent development identification ring 2; the stent catheter with a multi-layer structure, by setting an opaque stent development identification ring and a release tube identification ring, helps to improve visibility during operation, realizes the precise release of the point-shaped stent, simplifies the surgical operation, and shortens the operation time.

[0098] The above is a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. A peripheral point stent catheter, characterized in that: include: An inner tube (10) having a hollow interior, wherein a first end portion of the inner tube (10) is fixedly connected to a tip (1) having a hollow interior, the inner tube (10) and the interior of the tip (1) being interconnected, and a guide wire passing through the inner tube (10) along the inner cavity of the tip (1); A plurality of brackets (3), a plurality of bracket development identification rings (2) and a position limiting tube (9) are sleeved on the outer surface of the inner tube (10), wherein the plurality of brackets (3) and the plurality of bracket development identification rings (2) are alternately arranged on the outer surface of the inner tube (10), the end of each bracket is adjacent to a bracket development identification ring, and the first end of the position limiting tube (9) is adjacent to the bracket development identification ring farthest from the first end of the inner tube (10) among the plurality of bracket development identification rings (2); a release tube (8) sleeved on the outer surfaces of the plurality of brackets (3); a reinforcing tube (11) sleeved on the outer surface of the release tube (8); Wherein, a release tube identification ring (32) is provided at the end of the release tube (8) close to the tip (1); Wherein, the end of the release tube (8) away from the tip (1) is fixedly connected to the release tube seat (19); Wherein, the release tube seat (19) is fixedly connected to the rack (20); The release tube seat (19) comprises an anti-rotation rib (21), a concentric shaft (22), and a first buckle structure (23); The rack (20) includes an anti-rotation groove (25), a concentric hole (26), and a second buckle structure (24); Wherein, when the anti-rotation rib (21) is inserted into the anti-rotation groove (25), the release tube seat (19) and the rack (20) are locked, the concentric shaft (22) is inserted into the concentric hole (26) to maintain the center lines of the release tube seat (19) and the rack (20) coaxial, and the first buckle structure (23) cooperates with the second buckle structure (24) to achieve a fixed connection between the release tube seat (19) and the rack (20); Wherein, the second end of the inner tube (10) is fixedly connected to the inner tube seat (28); The top of the inner tube seat (28) is provided with a semicircular bonding structure (29) and a full-circular bonding structure (30), and the bottom of the inner tube seat (28) is provided with a third buckle structure (31); the third buckle structure (31) is inserted into the buckle mounting groove of the handle for locking, thereby achieving a stable connection between the inner tube seat (28) and the handle; The second end of the inner tube (10) is fixedly connected to the semicircular bonding structure (29) and the full-circular bonding mechanism (30) by gluing.

2. The peripheral point stent catheter according to claim 1, characterized in that: The tip (1) has a stepped structure (13) at a middle position on the outer surface, and an inner tube mounting groove (14) is provided on the inner surface of the tip (1). The first end of the inner tube (10) is inserted into the inner tube mounting groove (14) to fix the inner tube (10) to the tip (1).

3. The peripheral point stent catheter according to claim 1, characterized in that: The inner surface of the limiting tube (9) is attached to and fixedly connected to the outer surface of the inner tube (10).

4. The peripheral point stent catheter according to claim 1, characterized in that: The release tube (8) comprises at least one of an inner layer (15), an intermediate layer (16) and an outer layer (17); wherein, The inner layer (15) is a hollow structure and is made of a polymer material; The intermediate layer (16) is sleeved on the outer surface of the inner layer (15), and includes a release tube identification ring (32) and a metal braided wire (18); The outer layer (17) is sleeved on the outer surface of the middle layer (16); the portion of the outer layer (17) close to the tip (1) is made of a polyether block polyamide material, and the portion of the outer layer (17) away from the tip (1) is made of a nylon material.

5. A method for preparing a peripheral point-shaped stent catheter, characterized in that: include: A combination is formed, the combination comprising: an inner tube (10) with a hollow interior, the first end of the inner tube (10) being fixedly connected to a tip (1) with a hollow interior, the inner tube (10) and the tip (1) being interconnected, and a guide wire passing through the inner tube (10) along the inner cavity of the tip (1); a plurality of stent development identification rings (2) and a limiting tube (9) sleeved on the outer surface of the inner tube (10), wherein the plurality of stent development identification rings (2) are arranged on the outer surface of the inner tube (10) at preset intervals, the length of the preset intervals being equal to the length of the stent, and the first end of the limiting tube (9) being adjacent to the stent development identification ring farthest from the first end of the inner tube (10) among the plurality of stent development identification rings (2); Providing a tooling mandrel to form a release tube (8); The assembly and a plurality of stents (3) are inserted into the inner cavity of the release tube (8), wherein the stents are sheathed within the preset intervals on the outer surface of the inner tube (10); a reinforcing tube (11) is sheathed on the outer surface of the release tube (8) to obtain the peripheral point-shaped stent catheter; Wherein, the end of the release tube (8) away from the tip (1) is fixedly connected to the release tube seat (19); Wherein, the release tube seat (19) is fixedly connected to the rack (20); The release tube seat (19) comprises an anti-rotation rib (21), a concentric shaft (22), and a first buckle structure (23); The rack (20) includes an anti-rotation groove (25), a concentric hole (26), and a second buckle structure (24); Wherein, when the anti-rotation rib (21) is inserted into the anti-rotation groove (25), the release tube seat (19) and the rack (20) are locked, the concentric shaft (22) is inserted into the concentric hole (26) to maintain the center lines of the release tube seat (19) and the rack (20) coaxial, and the first buckle structure (23) cooperates with the second buckle structure (24) to achieve a fixed connection between the release tube seat (19) and the rack (20); Wherein, the second end of the inner tube (10) is fixedly connected to the inner tube seat (28); The top of the inner tube seat (28) is provided with a semicircular bonding structure (29) and a full-circular bonding structure (30), and the bottom of the inner tube seat (28) is provided with a third buckle structure (31); the third buckle structure (31) is inserted into the buckle mounting groove of the handle for locking, thereby achieving a stable connection between the inner tube seat (28) and the handle; The second end of the inner tube (10) is fixedly connected to the semicircular bonding structure (29) and the full-circular bonding mechanism (30) by gluing.

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