Vascular sheath for assisting interventional therapy and conveyor

Abstract

The utility model discloses a vascular sheath and conveyor for assisting interventional therapy, which belongs to the technical field of medical instruments and comprises a sheath tube with a suction cavity in the middle, the sheath tube is sequentially formed by a lining layer, a middle layer and an outer tube layer from inside to outside in a sleeved composite mode, the lining layer and the outer tube layer are both high polymer material layers, the middle layer is a metal wire layer, and the outer tube layer is a metal wire layer. The middle layer has certain elastic restoring force; the middle layer is a woven net pipe of a net structure, the woven net pipe comprises a plurality of first woven wires and second woven wires, the first woven wires sequentially penetrate through the upper portions of the two second woven wires and then penetrate through the lower portions of the other two second woven wires, and the first woven wires are sequentially and circularly woven into a closed circular pipe. The sheath tube has the advantages that the first weaving wires and the second weaving wires are woven in a crossed mode to form the weaving net tube, so that the far end of the sheath tube has better radial elastic force and axial supporting strength, hardness and softness are achieved, and the outer diameter of the sheath tube can be reduced on the premise that the supporting strength of the sheath tube is guaranteed.

Description

Technical Field

[0001] The utility model belongs to the technical field of medical devices, and in particular relates to a vascular sheath and a conveyor for auxiliary interventional treatment. Background Art

[0002] Vascular sheaths are used to assist in delivering diagnostic or therapeutic devices into the heart cavity or to establish percutaneous access channels for intravascular devices. They possess excellent elasticity, corrosion resistance, and high biocompatibility, allowing them to conform smoothly to human blood vessels. During vascular interventional procedures, physicians insert vascular sheaths into target vessels to maintain patency and protect the vessel walls from damage. During clinical use, the structure, materials, and performance of vascular sheaths directly impact the incidence of clinical complications such as vascular spasm and occlusion. They also indirectly influence the physician's choice of surgical procedure and ease of operation, ultimately impacting the quality and success rate of the surgery.

[0003] When the inner diameter specifications of the vascular sheath are the same, the vascular sheath with a larger outer diameter has a thicker wall, which can better resist folding and bending. However, the vascular sheath with a larger outer diameter will cause greater stimulation to the blood vessels during the puncture process, resulting in a higher incidence of complications for patients who need repeated punctures and have high vascular fragility. When the hardness of the vascular sheath tip is low and the structure is excessively uneven, it will bring greater puncture resistance.

[0004] Some patents for vascular sheaths have been disclosed in the prior art. Among them, the utility model patent with patent publication number CN210383996U discloses a sheath with a smaller outer diameter and thinner wall thickness for reducing damage to skin, muscle tissue and blood vessels during puncture and catheterization, and reducing complications, but does not pay attention to the performance degradation and puncture difficulty caused by the thinner wall thickness; the utility model patent with patent publication number CN202876024U discloses a method of improving the sheath's anti-bending performance while ensuring the hardness of the sheath by adopting a double-layer extrusion structure of soft and hard materials, but does not pay attention to the clinical use problems caused by the sheath size. Therefore, this application proposes a vascular sheath with a moderate outer diameter and performance that meets the requirements.

[0005] In view of this, the present inventor conducted in-depth research on how to reduce the wall thickness of the vascular sheath while reducing the outer diameter of the vascular sheath, which led to the creation of the present invention. Utility Model Content

[0006] In order to overcome the problems in the prior art that the mechanical properties of the vascular sheath decrease when the wall thickness is thin, or the mechanical properties are improved but the wall thickness is large, the utility model provides a vascular sheath and a conveyor for auxiliary interventional treatment.

[0007] The utility model provides a sheath for assisted interventional treatment of blood vessels, comprising a sheath tube with a suction cavity in the middle, wherein the sheath tube is compositely formed from the inside to the outside by an inner lining layer, an intermediate layer, and an outer tube layer, wherein both the inner lining layer and the outer tube layer are polymer material layers, and the intermediate layer is a metal wire layer, and the intermediate layer has a certain elastic restoring force; the intermediate layer is a braided mesh tube with a mesh structure, and the braided mesh tube comprises a plurality of first braided wires and a plurality of second braided wires, wherein the first braided wires sequentially pass over two of the second braided wires and then pass under another two of the second braided wires, and are woven into a closed circular tube in a circular manner;

[0008] It also includes a valve seat and a three-way valve, the three-way valve is connected to the valve seat through a side branch pipe, the sheath tube is fixedly connected to the end of the valve seat, a stress release tube is provided at one end of the valve seat close to the sheath tube, and a radially tapered sheath tube end is provided at one end of the sheath tube away from the valve seat.

[0009] The first braided wire and the second braided wire are cross-woven to form a braided mesh tube. The simple braiding method can help improve production efficiency, so that the distal end of the sheath tube has better radial elasticity and axial support strength. In addition, because the first braided wire and the second braided wire are cross-fixed, they have better radial support strength, and have both hardness and softness, so that they can provide strong pushing performance, which can make the braided mesh tube thinner as a whole, which is conducive to reducing the overall outer diameter of the sheath tube without affecting the inner diameter of its suction cavity. The outer diameter can be reduced while ensuring the support strength of the sheath tube, so that it can reduce damage to the inner wall of the blood vessel during application.

[0010] Furthermore, several of the first braided wires arranged side by side pass through the top of several of the second braided wires arranged side by side in sequence, and then pass through the bottom of several other second braided wires arranged side by side again, and are woven into a closed circular tube in sequence. The number of the first braided wires and the second braided wires is the same.

[0011] Through the above technical solution, the braided structure of the sheath's middle layer is designed with braided mesh tubes obtained by different braiding methods, which not only improves the compliance of the sheath but also improves its flex resistance. In addition, by using a braided mesh tube to reduce the thickness of the sheath wall, the outer diameter of the catheter can be effectively reduced when the inner diameter of the catheter remains the same. By using a catheter with a smaller outer diameter, the outer diameter of the catheter sheath assembly can be effectively reduced, thereby effectively reducing damage to the skin, muscle tissue, and blood vessels during the puncture and catheterization process, effectively reducing the occurrence of vascular complications during interventional surgery. It is also suitable for small blood vessels, easy to operate, and has better puncture results.

[0012] Furthermore, the vascular sheath also includes a dilator, a guidewire and a puncture needle. The dilator includes a base and an expansion catheter connected to the base. The base abuts the valve seat. The expansion catheter passes through the suction cavity and extends to the outside of the suction cavity. The guidewire passes through the inside of the expansion catheter and exits from the end of the base. The head end of the guidewire is J-shaped. A first cavity is provided in the puncture needle for the guidewire to pass through.

[0013] Furthermore, the sheath tube end is integrally formed with the sheath tube, and the sheath tube end is compositely formed by sequentially wrapping an inner lining layer and an outer tube layer from the inside to the outside.

[0014] Through the above technical solution, in order to prevent the catheter sheath from damaging the inner wall of the blood vessel during the intubation operation, a radially tapered sheath tip is provided at the free end of the sheath. The tapered shape of the sheath tip better adapts to the movement of the intubation process. Moreover, by removing the intermediate layer at the sheath tip position, the sheath tip is softer than the sheath body, which can reduce damage to the inner wall of the blood vessel. Therefore, the catheter sheath provided by the utility model not only has a small outer diameter, but also takes into account flexibility, flex resistance, and stability of the sheath tip, making the sheath of the catheter sheath safe and reliable during the intubation process.

[0015] Furthermore, the valve seat is provided with a main channel and a side channel that are connected to each other, the sheath tube is connected to the main channel, the central axis of the sheath tube is coaxially arranged with the main channel, and the side branch tube is connected to the side channel.

[0016] Furthermore, the outer wall of the outer tube layer facing away from the valve seat and the outer surface of the sheath tube end are both provided with a hydrophilic coating, the outer wall of the outer tube layer close to the valve seat is provided with a protective coating, and the area of ​​the hydrophilic coating along the axial direction of the sheath tube is larger than the area of ​​the protective coating along the axial direction of the sheath tube.

[0017] Through the above technical solution, a hydrophilic coating is provided on the outer surface of the outer tube layer, which can reduce the friction coefficient of the outer tube layer, reduce the pushing resistance of the sheath tube inside the blood vessel, and reduce the difficulty of surgery for doctors.

[0018] Furthermore, the material of the hydrophilic coating is any one of polyethylene glycol, polyvinyl pyrrolidone, polyacrylamide, natural polysaccharide polymer and hyaluronic acid.

[0019] Furthermore, the outer tube layer is any one of PA material, PU material, PC material, polyether block polyamide, and thermoplastic polyurethane rubber;

[0020] The material of the inner lining layer is polytetrafluoroethylene or high-density polyethylene.

[0021] Furthermore, it is characterized in that the end of the dilatation catheter is a radially tapered sheath end.

[0022] The utility model also provides a conveyor, comprising the vascular sheath for auxiliary interventional treatment as described above.

[0023] The beneficial effects produced by adopting the technical solution of this utility model are as follows:

[0024] (1) A braided mesh tube is formed by cross-weaving the first braided wire and the second braided wire. The simple braiding method can improve production efficiency, so that the distal end of the sheath tube has better radial elasticity and axial support strength. In addition, the cross-fixation of the first braided wire and the second braided wire has better radial support strength, and has both hardness and softness, so that it can provide strong pushing performance, and can make the braided mesh tube thinner as a whole, which is conducive to reducing the overall outer diameter of the sheath tube without affecting the inner diameter of its suction cavity. The outer diameter of the sheath tube can be reduced while ensuring the support strength of the sheath tube, so that it can reduce damage to the inner wall of the blood vessel during application.

[0025] (2) The braided structure of the middle layer of the sheath is a braided mesh tube obtained by designing different braiding methods, which not only improves the compliance of the sheath but also improves its anti-bending property. In addition, by using a braided mesh tube to reduce the thickness of the sheath wall, the outer diameter of the catheter can be effectively reduced when the inner diameter of the catheter remains the same. By using a catheter with a smaller outer diameter, the outer diameter of the catheter sheath group can be effectively reduced, thereby effectively reducing the damage to the skin, muscle tissue and blood vessels during the puncture and catheterization process, effectively reducing the occurrence of vascular complications during interventional surgery, and being applicable to small blood vessels, it is easy to operate and has a better puncture effect.

[0026] (3) In order to prevent the catheter sheath from damaging the inner wall of the blood vessel during the intubation operation, a radially tapered sheath tip is provided at the free end of the sheath. The tapered shape of the sheath tip better adapts to the intubation movement process. In addition, the sheath tip obtained by removing the intermediate layer at the sheath tip position is softer than the sheath body, which can reduce damage to the inner wall of the blood vessel. Therefore, the catheter sheath provided by the utility model not only has a small outer diameter, but also takes into account flexibility, anti-bending properties and stability of the sheath tip, making the sheath of the catheter sheath safe and reliable during the intubation process. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following is a brief introduction to the drawings required for use in the embodiments. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without creative work.

[0028] Figure 1This is a schematic diagram of the structure of a vascular sheath used for auxiliary interventional treatment in the present utility model;

[0029] Figure 2 This is a schematic diagram of a sheath tube for assisting interventional treatment of a vascular sheath in the present invention;

[0030] Figure 3 yes Figure 2 A magnified schematic diagram of point A in the middle;

[0031] Figure 4 This is a schematic diagram of a dilator for assisting interventional treatment of vascular sheaths in the present utility model;

[0032] Figure 5 This utility model is a cross-section of a sheath for assisting interventional treatment of blood vessels;

[0033] Figure 6 This is a schematic diagram of a braided mesh tube for assisting interventional treatment of a vascular sheath in the present invention;

[0034] Figure 7 This is another schematic diagram of a braided mesh tube for assisting interventional treatment of a vascular sheath according to the present invention;

[0035] In the figure, 1. sheath; 2. inner lining layer; 3. middle layer; 4. outer tube layer; 5. first braided wire; 6. second braided wire; 7. valve seat; 8. three-way valve; 9. side branch tube; 10. stress relief tube; 11. sheath end; 12. dilator; 13. guide wire; 14. puncture needle; 15. dilation catheter; 16. base. DETAILED DESCRIPTION

[0036] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Therefore, the following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the utility model for protection, but merely represents the selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0037] This embodiment uses a first braided wire and a second braided wire to cross-weave into a braided mesh tube, so that the distal end of the sheath tube has better radial elasticity and axial support strength, and has both hardness and softness, so that it can provide strong pushing performance. While ensuring the support strength of the sheath tube, its outer diameter can be reduced, so that it can reduce damage to the inner wall of the blood vessel during application. The specific implementation is as follows:

[0038] like Figure 1-7 As shown, a sheath for assisted interventional treatment of blood vessels includes a sheath tube 1 with a suction cavity in the middle. The sheath tube 1 is compositely formed from the inside to the outside by an inner lining layer 2, an intermediate layer 3, and an outer tube layer 4. The inner lining layer 2 and the outer tube layer 4 are both polymer material layers, and the intermediate layer 3 is a metal wire layer. The intermediate layer 3 has a certain elastic restoring force. The intermediate layer 3 is a braided mesh tube with a mesh structure. The braided mesh tube includes a plurality of first braided wires 5 and a plurality of second braided wires 6. The first braided wires 5 sequentially pass through the upper end surfaces of two second braided wires 6 arranged at intervals, and then pass again under the other two second braided wires 6 arranged at intervals, and are woven in a circular manner to form a closed circular tube.

[0039] It also includes a valve seat 7 and a three-way valve 8. The three-way valve 8 is connected to the valve seat 7 through a side branch pipe 9. The sheath tube 1 is fixedly connected to the end of the valve seat 7. A stress release tube 10 is provided at one end of the valve seat 7 close to the sheath tube 1, and a radially tapered sheath tube end 11 is provided at the end of the sheath tube 1 away from the valve seat 7.

[0040] Here, the first braided wire 5 and the second braided wire 6 are cross-woven into a closed circular tube. During the weaving, the first braided wire 5 and the second braided wire 6 are equidistantly arranged and have braiding holes between each other. The simple weaving method can help improve production efficiency, so that the distal end of the sheath tube 1 has better radial elastic force and axial support strength. In addition, because the first braided wire 5 and the second braided wire 6 are cross-fixed, they have better radial support strength, both hardness and softness, so that they can provide strong pushing performance, which can make the braided mesh tube thinner as a whole, which is conducive to reducing the overall outer diameter of the sheath tube 1 without affecting the inner diameter of its suction cavity. The outer diameter of the sheath tube 1 can be reduced while ensuring the support strength of the sheath tube 1, so that it can reduce damage to the inner wall of the blood vessel during application.

[0041] Here, in order to prevent the catheter sheath from damaging the inner wall of the blood vessel during the intubation operation, a radially tapered sheath tip 11 is provided at the free end of the sheath tube 1. The tapered shape of the sheath tube tip 11 better adapts to the intubation movement process. In addition, by removing the intermediate layer 3 at the position of the sheath tube tip 11, the sheath tube 1 tip end obtained is softer than the sheath tube 1 body, which can reduce damage to the inner wall of the blood vessel. Therefore, the catheter sheath provided by the utility model not only has a small outer diameter, but also takes into account flexibility, folding resistance, and stability of the sheath tube 1 tip end, making the sheath tube 1 of the catheter sheath safe and reliable during the intubation process.

[0042] As a preferred embodiment, several first braided wires 5 arranged side by side pass through the upper end surfaces of several second braided wires 6 arranged side by side in sequence, and then pass through the bottom of several other second braided wires 6 arranged side by side in sequence to be woven into a closed circular tube. The number of first braided wires 5 and second braided wires 6 is the same.

[0043] Here, the braided structure of the middle layer 3 of the sheath 1 is such that two first braided wires 5 and two second braided wires 6 are arranged equidistantly during braiding and have braided holes between them. Braided mesh tubes obtained by different braiding methods are designed, which not only improves the compliance of the sheath 1 but also improves its flexural resistance. In addition, by using a braided mesh tube to reduce the thickness of the sheath 1 wall, the outer diameter of the catheter can be effectively reduced when the inner diameter of the catheter is the same. By using a catheter with a smaller outer diameter, the outer diameter of the catheter sheath group can be effectively reduced, thereby effectively reducing the damage to the skin, muscle tissue and blood vessels during the puncture and catheterization process, effectively reducing the occurrence of vascular complications in interventional surgery, and being applicable to small blood vessels, it is easy to operate and has a better puncture effect.

[0044] As a preferred embodiment, the vascular sheath also includes a dilator 12, a guide wire 13 and a puncture needle 14. The dilator 12 includes a base 16 and an expansion catheter 15 connected to the base 16. The base 16 abuts against the valve seat 7. The expansion catheter 15 passes through the suction cavity and extends to the outside of the suction cavity. The guide wire 13 passes through the inside of the expansion catheter 15 and exits from the end of the base 16. The head end of the guide wire 13 is J-shaped. A first cavity is provided in the puncture needle 14 for the guide wire 13 to pass through.

[0045] As a preferred embodiment, the sheath tube end 11 is integrally formed with the sheath tube 1 , and the sheath tube end 11 is compositely formed by sequentially wrapping the inner lining layer 2 and the outer tube layer 4 from the inside to the outside.

[0046] Here, in order to prevent the catheter sheath from damaging the inner wall of the blood vessel during the intubation operation, a radially tapered sheath tip 11 is provided at the free end of the sheath tube 1. The tapered shape of the sheath tube tip 11 better adapts to the intubation movement process. In addition, by removing the intermediate layer 3 at the position of the sheath tube tip 11, the sheath tube 1 tip end obtained is softer than the sheath tube 1 body, which can reduce damage to the inner wall of the blood vessel. Therefore, the catheter sheath provided by the utility model not only has a small outer diameter, but also takes into account flexibility, folding resistance, and stability of the sheath tube 1 tip end, making the sheath tube 1 of the catheter sheath safe and reliable during the intubation process.

[0047] As a preferred embodiment, the valve seat 7 is provided with a main channel and a side channel that are interconnected. The sheath tube 1 is connected to the main channel, the central axis of the sheath tube 1 is coaxially arranged with the main channel, and the side branch tube 9 is connected to the side channel.

[0048] As a preferred embodiment, the outer wall of the outer tube layer 4 facing away from the valve seat 7 and the outer surface of the sheath tube end 11 are both provided with a hydrophilic coating, and the outer wall of the outer tube layer 4 close to the valve seat 7 is provided with a protective coating, and the area of ​​the hydrophilic coating along the axial direction of the sheath tube 1 is larger than the area of ​​the protective coating along the axial direction of the sheath tube 1.

[0049] Here, providing a hydrophilic coating on the outer surface of the outer tube layer 4 can reduce the friction coefficient of the outer tube layer 4, reduce the pushing resistance of the sheath tube 1 inside the blood vessel, and reduce the difficulty of the doctor's operation.

[0050] As a preferred embodiment, the material of the hydrophilic coating is any one of polyethylene glycol, polyvinyl pyrrolidone, polyacrylamide, natural polysaccharide polymer and hyaluronic acid.

[0051] As a preferred embodiment, the outer tube layer 4 is any one of PA material, PU material, PC material, polyether block polyamide, and thermoplastic polyurethane rubber;

[0052] The material of the inner lining layer 2 is polytetrafluoroethylene or high-density polyethylene.

[0053] As a preferred embodiment, it is characterized in that the end of the dilatation catheter 15 is a radially tapered sheath tube end 11.

[0054] This embodiment also provides a delivery device, comprising the vascular sheath for assisting interventional treatment as described above.

[0055] The above is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, various modifications and variations of the present invention are possible. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention shall be included in the scope of protection of the present invention.

Claims

1. A vascular sheath for assisting interventional treatment, characterized in that: The invention comprises a sheath tube (1) with a suction cavity in the middle, wherein the sheath tube (1) is formed by wrapping an inner lining layer (2), an intermediate layer (3) and an outer tube layer (4) in sequence from the inside to the outside, wherein the inner lining layer (2) and the outer tube layer (4) are both polymer material layers, and the intermediate layer (3) is a metal wire layer, and the intermediate layer (3) has a certain elastic restoring force; the intermediate layer (3) is a braided mesh tube with a mesh structure, and the braided mesh tube comprises a plurality of first braided wires (5) and a plurality of second braided wires (6), wherein the first braided wires (5) sequentially pass through the upper part of two second braided wires (6) and then pass through the lower part of another two second braided wires (6) and are woven into a closed circular tube in a circular manner; The invention also includes a valve seat (7) and a three-way valve (8), wherein the three-way valve (8) is connected to the valve seat (7) through a side branch pipe (9), the sheath tube (1) is fixedly connected to the end of the valve seat (7), a stress release tube (10) is provided at one end of the valve seat (7) close to the sheath tube (1), and a radially tapered sheath tube end (11) is provided at one end of the sheath tube (1) away from the valve seat (7).

2. The vascular sheath for assisting interventional treatment according to claim 1, characterized in that: A plurality of the first braided wires (5) arranged side by side sequentially pass through the top of a plurality of the second braided wires (6) arranged side by side and then pass through the bottom of another plurality of the second braided wires (6) arranged side by side, and are woven into a closed circular tube in a circular manner. The number of the first braided wires (5) and the number of the second braided wires (6) are the same.

3. The vascular sheath for assisting interventional treatment according to claim 1, characterized in that: The vascular sheath also includes a dilator (12), a guide wire (13) and a puncture needle (14), the dilator (12) includes a base (16) and an expansion catheter (15) connected to the base (16), the base (16) abuts against the valve seat (7), the expansion catheter (15) passes through the suction cavity and extends to the outside of the suction cavity, the guide wire (13) passes through the inner side of the expansion catheter (15) and passes out from the end of the base (16), the head end of the guide wire (13) is J-shaped, and the puncture needle (14) is provided with a first cavity for the guide wire (13) to pass through.

4. The vascular sheath for assisting interventional treatment according to claim 1, characterized in that: The sheath tube end (11) is integrally formed with the sheath tube (1), and the sheath tube end (11) is compositely formed by sequentially wrapping an inner lining layer (2) and an outer tube layer (4) from the inside to the outside.

5. The vascular sheath for assisting interventional treatment according to claim 1, characterized in that: The valve seat (7) is provided with a main channel and a side channel that are connected to each other. The sheath tube (1) is connected to the main channel. The central axis of the sheath tube (1) is coaxially arranged with the main channel. The side branch tube (9) is connected to the side channel.

6. The vascular sheath for assisting interventional treatment according to claim 1, characterized in that: The outer wall of the outer tube layer (4) facing away from the valve seat (7) and the outer surface of the sheath tube end (11) are both provided with a hydrophilic coating, and the outer wall of the outer tube layer (4) close to the valve seat (7) is provided with a protective coating, and the area of ​​the hydrophilic coating along the axial direction of the sheath tube (1) is larger than the area of ​​the protective coating along the axial direction of the sheath tube (1).

7. The vascular sheath for assisting interventional treatment according to claim 6, characterized in that: The material of the hydrophilic coating is any one of polyethylene glycol, polyvinyl pyrrolidone, polyacrylamide, natural polysaccharide polymer and hyaluronic acid.

8. The vascular sheath for assisting interventional treatment according to claim 1, characterized in that: The outer tube layer (4) is made of any one of PA material, PU material, PC material, polyether block polyamide, and thermoplastic polyurethane rubber; The material of the inner lining layer (2) is polytetrafluoroethylene or high-density polyethylene.

9. The vascular sheath for assisting interventional treatment according to claim 3, characterized in that: The end of the dilatation catheter (15) is a radially tapered sheath tube end (11).

10. A conveyor, characterized in that: The method comprises the vascular sheath according to any one of claims 1 to 9.

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