Support tube and sheath tube for interventional operation

Abstract

The utility model relates to the technical field of medical instruments, and provides a supporting tube and a sheathing canal for an interventional operation, the supporting tube for the interventional operation comprises a tube body and an expandable section located at the far end of the tube body, the expandable section comprises a plurality of ribs arranged at intervals in the circumferential direction of the tube body, and every two adjacent ribs are connected through at least one bent connecting section; a plurality of slots are formed in the pipe body, a row of slots arranged in order in the axial direction is a slot row, and the pipe body is provided with a plurality of slot rows; in the circumferential direction, no interval exists between the narrow groove rows, every two adjacent narrow groove rows in the circumferential direction have an overlapped part in the circumferential direction, and the narrow grooves in every two adjacent narrow groove rows in the circumferential direction are arranged at intervals in the axial direction. According to the technical scheme, the bending performance, the tensile performance and the compression resistance of the sheathing canal in all directions can be the same.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a support tube and a sheath tube for interventional surgery. BACKGROUND

[0002] The transcatheter aortic valve delivery system is mainly used for delivering specific surgical instruments into blood vessels in minimally invasive interventional therapy, establishing a channel between the lesion site in the patient's body and the external operating end or leading out the body fluid of the lesion site, so as to reach the lesion site without using surgical operation.

[0003] The catheter distal end is a sheath tube for accommodating a compressed artificial valve prosthesis, which needs to be inserted into the blood vessel and is responsible for the release or recovery of the valve prosthesis.

[0004] The sheath tube of the patent has two longitudinal structural ribs in the axial direction, so that the bending performance in each direction in the circumferential direction is inconsistent, and when bending perpendicular to the structural rib, sudden elastic deformation will occur, which will affect the use performance of the delivery system. Therefore, it is necessary to improve it. CONTENT OF THE UTILITY MODEL

[0005] The technical problem to be solved by the present application is to provide a support tube and a sheath tube for interventional surgery, which have the same bending performance, tensile and compressive performance in all directions.

[0006] In order to solve the above technical problems, the present application adopts the following technical solutions:

[0007] In a first aspect, the present application provides a support tube for interventional surgery, the tube body and the expandable section located at the distal end of the tube body, the expandable section comprising a plurality of ribs arranged along the circumferential direction of the tube body, and the adjacent two ribs being connected by at least one curved connecting section; the tube body is provided with a plurality of slots, and a row of slots arranged in the axial direction is a slot row, and the tube body is provided with a plurality of slot rows; in the circumferential direction, there is no interval between the slot rows, and each two adjacent slot rows in the circumferential direction has an overlapping part in the circumferential direction, and the slots in each two adjacent slot rows in the circumferential direction are arranged in the axial direction.

[0008] In the process of implementing the above technical solution, the support tube includes a tube body and an expandable segment located at the distal end, wherein the expandable segment includes a plurality of ribs arranged at intervals along the circumference of the tube body, and two adjacent ribs are connected by at least one curved connecting segment. In this way, when the expandable segment bends in any direction, the connecting segment can tighten the two adjacent ribs, so that the expandable segment is subjected to the same tensile force when bending in any direction; when the ribs are subjected to tension or pressure, the connecting segment will also provide corresponding tension and support force, so that the expandable segment has the same bending performance, tensile and compressive resistance in all directions; in addition, the expandable segment can expand outward in the radial direction when releasing or recovering the heart valve prosthesis, and the connecting segment can pull the two adjacent ribs to limit the expansion force of the valve prosthesis, thereby realizing the delivery and recovery of the valve prosthesis;

[0009] The tube body is provided with a plurality of slots, and a row of a plurality of slots neatly arranged in the axial direction is a slot row. The tube body is provided with a plurality of slot rows in the circumferential direction. In the circumferential direction, there is no spacing between the slot rows, but every two adjacent slot rows in the circumferential direction have overlapping parts in the circumferential direction, so that the tube body has the same bending performance in all directions. The slots in every two circumferentially adjacent slot rows are spaced in the axial direction, so that there is a certain distance between two adjacent slots in any radial direction of the tube body, which meets the result strength of the tube body and also makes the tube body uniformly stressed in the circumferential direction. When subjected to tension or pressure, the stress at each position in the circumferential direction can be the same.

[0010] As an embodiment, the narrow slot includes a main slot portion and two wing slot portions respectively located on both sides of the main slot portion; the main slot portion has an axial size larger than that of the wing slot portion.

[0011] In the process of implementing the above technical solution, the narrow groove includes a main groove portion and two wing groove portions located on both sides of the main groove portion, so that the tube body can be bent in any direction, and the wing groove portion is smaller in the axial direction than the main groove portion, so that the sum of the sizes of three consecutive wing groove portions on the same axis in the axial direction is the same as the sum of the sizes of two consecutive main groove portions on another axis, that is, in the axial direction, the sizes of the two main groove portions will correspond to the sizes of the three wing groove portions. Therefore, as far as the entire tube body is concerned, the axial strength of the tube body is consistent, so that the tube body can have the same tensile and compressive resistance at each circumferential position, and can also maintain its own structural strength.

[0012] As an embodiment, the circumferentially overlapping portion of two circumferentially adjacent narrow slot rows is a wing slot portion.

[0013] In the process of implementing the above technical solution, the overlapping parts of two circumferentially adjacent narrow slot rows in the circumferential direction are wing groove parts, so that the tube body can meet the same bending performance in all directions and reduce the influence of the overlapping parts on the axial tensile and compressive performance; at the same time, the sum of the sizes of the three consecutive wing groove parts in the axial direction is the same as the size of the two consecutive main groove parts on the same axis, so that the axial strength of the tube body is consistent, so that the tube body can have the same tensile and compressive performance at various positions in the circumferential direction and maintain its own structural strength.

[0014] As an embodiment, the slots in the slot rows on both sides of each slot row are aligned one by one in the circumferential direction.

[0015] In the process of implementing the above technical solution, the slots in the slot rows on both sides of each slot row are aligned one by one in the circumferential direction, that is, they are in the same axial direction, so that the bending performance, tensile performance and compressive performance of the tube body in any direction are the same.

[0016] As an embodiment, the distal end of the tube body is provided with a plurality of through holes extending axially along the tube body.

[0017] In the process of implementing the above technical solution, the contact area between the inner tube and the outer tube is increased by providing the through hole, which facilitates the fixed connection between the inner tube and the outer tube and reduces the delamination of the sheath tube.

[0018] As an embodiment, the connecting segment includes at least two connected arc segments, and the opening directions of the two arc segments are opposite.

[0019] In the process of implementing the above technical solution, the connecting section includes at least two connected arc segments, and the opening directions of the two arc segments are opposite, so that the connecting section can connect the two adjacent ribs together, and the connecting section is composed of arc segments, so that the expandable section has a certain elasticity. When subjected to radial outward force, it will be in an expanded state, and the connecting section will tighten the two adjacent ribs to limit further expansion of the expandable section.

[0020] As an embodiment, among two adjacent ribs, the length of one rib is greater than the length of the other rib, and the connecting sections on both sides of each rib are symmetrically arranged.

[0021] In the process of implementing the above technical solution, the length of one of the two adjacent ribs is greater than that of the other rib, so that the connecting section can conveniently connect the extended ends of the two adjacent ribs. At the same time, the connecting sections on both sides of each rib are symmetrically arranged, so that the expandable section can be subjected to balanced force and can be subjected to the same tensile force when the rib expands outward.

[0022] As an embodiment, a plurality of connecting portions are provided at the proximal end of the tube body, and a radial dimension surrounded by the connecting portions is smaller than a radial dimension of the tube body.

[0023] In the process of implementing the above technical solution, the multiple connecting parts are arranged in a conical shape around the axis of the tube body and shrink toward the proximal end. In this way, the tube body can fit tightly with the delivery catheter, reducing the possibility of falling off and improving the safety and stability of the delivery system.

[0024] As an embodiment, the connecting portion includes a triangular sheet and a connecting ring located at the proximal end of the triangular sheet.

[0025] In the process of implementing the above technical solution, the multiple triangular sheets at the connecting part can be narrowed into a conical structure. At the same time, each triangular sheet is connected with a connecting ring, which can reduce the problem of the support tube scratching the inner tube and the outer tube.

[0026] In a second aspect, the present application provides a sheath for interventional surgery, comprising the support tube for interventional surgery provided in the first aspect; an inner tube and an outer tube, the support tube being located between the inner tube and the outer tube; the support tube being a metal part; and the inner tube and the outer tube being both elastic layers.

[0027] In the implementation of the above technical solution, the support tube is a metal component; both the inner and outer tubes are elastic layers. The inner tube is a highly elastic thin film tube that provides elastic force. Because the support tube has a cut pattern structure, the inner tube is required to isolate the support tube from direct contact with blood. The inner tube generally has good biocompatibility and plasticity, as well as good adhesion to the hydrophilic coating. The outer and inner tubes protect the support tube, and both are elastic layers that can enhance the elastic deformation of the sheath tube. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following is a brief introduction to the drawings required for use in the embodiments of the present application. It should be understood that the following drawings only show certain embodiments of the present application 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.

[0029] Figure 1 A schematic diagram of the support tube structure provided in an embodiment of the present application;

[0030] Figure 2 for Figure 1 Schematic diagram of a local enlarged structure;

[0031] Figure 3 Schematic diagram of the structure of the support tube provided in the embodiment of the present application from different perspectives.

[0032] Icon: 1-expandable section; 11-rib; 12-connecting section; 2-tube body; 21-through hole; 22-slot; 221-main slot; 222-wing slot; 3-connecting portion. DETAILED DESCRIPTION

[0033] The technical solutions in the embodiments of the present application will be described below in conjunction with the drawings in the embodiments of the present application.

[0034] It should be noted that similar reference numerals and letters represent similar items in the following figures. Therefore, once an item is defined in one figure, it does not need to be further defined or explained in subsequent figures. Furthermore, in the description of this application, the term "distal end" refers to the end of the components of the delivery system that is closest to the cardiac tissue, and "proximal end" refers to the end of the delivery system that is closest to the operator. The terms "first" and "second" are used only to distinguish between the descriptions and should not be understood to indicate or imply relative importance.

[0035] On the first aspect, the embodiments of the present application provide a support tube for interventional surgery, which serves as an intermediate layer structure of the sheath and plays a supporting role. The sheath is generally composed of a three-layer structure, wherein the innermost layer is made of PTFE (Polytetrafluoroethylene), the middle layer is a support tube cut from a nickel-titanium alloy or a stainless steel tube, and the outermost layer is a coated polymer layer. In order to meet the requirements of the operation, before the valve prosthesis is released, the sheath needs to be bent to achieve a coaxial position with the diseased valve ring. After the valve prosthesis is released, it needs to be recovered. The distal end of the sheath is trumpet-shaped due to the force, and the sheath needs to withstand a large pressure to compress the stent to enable the successful recovery of the artificial valve prosthesis.

[0036] like Figure 1 As shown, the support tube provided by the embodiment of the present application includes a tube body 2 and an expandable segment 1 located at the distal end of the tube body 2, the expandable segment is used to expand outward in a direction angled to the radial direction of the support tube when transporting and / or recovering the valve prosthesis, the expandable segment 1 includes a plurality of ribs 11 arranged at intervals along the circumference of the tube body 2, and two adjacent ribs 11 are connected by at least one curved connecting segment 12, so that when the expandable segment 1 bends in any direction, the connecting segment 12 can tighten the two adjacent ribs 11, so that the expandable segment 1 is subjected to the same tension when bending in any direction; secondly, when the ribs 11 are subjected to tension or pressure, the connecting segment 12 will also provide corresponding tension and support force, so that the expandable segment 1 has the same bending performance, tensile and compressive resistance in all directions; in addition, the expandable segment 1 can expand outward in the radial direction when releasing or recovering the heart valve prosthesis, and the connecting segment 12 can pull the two adjacent ribs 11 to limit the expansion force of the valve prosthesis, thereby realizing the transportation and recovery of the valve prosthesis;

[0037] like Figure 1 As shown, the tube body 2 is provided with a plurality of slots 22, and a row of a plurality of slots 22 neatly arranged in the axial direction is a slot row. The tube body 2 is provided with a plurality of slot rows in the circumferential direction. In the circumferential direction, there is no spacing between the slot rows, but every two adjacent slot rows in the circumferential direction have overlapping parts in the circumferential direction, so that the tube body 2 has the same bending performance in all directions. The slots 22 in every two circumferentially adjacent slot rows are spaced apart in the axial direction, that is, the two slots 22 in two adjacent slot rows are on different cross sections of the tube body 2, so that there is a certain distance between the two adjacent slots 22 in any radial direction of the tube body 2, while ensuring the stability of the structure, so that the tube body 2 is uniformly stressed in the circumferential direction, and when subjected to tension or pressure, the stress at each position in the circumferential direction can be the same.

[0038] like Figure 1 As shown, optionally, two connecting sections 12 may be spaced apart on both sides of each rib 11 , thereby improving the structural strength of the support tube and, at the same time, improving the elastic deformation performance of the expandable section 1 .

[0039] Optional, such as Figure 1 and 3 As shown, the support tube in the embodiment of the present application has a symmetrical structure, and the structure of the tube body 2 is symmetrical and uniform, so that when the tube body 2 is subjected to tension or pressure, the force at each position in the circumferential direction can be the same.

[0040] like Figure 1 and 2 As shown, as an embodiment, the slot 22 includes a main slot portion 221 and two wing slot portions 222 located on either side of the main slot portion 221, allowing the tube body 2 to bend in any direction. The slot 22 prevents the support tube from being distorted by the shape of the blood vessel when the tube body 2 is bent, which could affect the release or retrieval of the valve prosthesis and pose a safety hazard. The wing slot portions 222 are axially smaller than the main slot portion 221, ensuring that the sum of the dimensions of three consecutive wing slot portions 222 on the same axial axis is the same as the sum of the dimensions of two consecutive main slot portions 221 on another axial axis. In other words, the axial dimensions of the two main slot portions 221 correspond to the dimensions of the three wing slot portions 222. As a result, the entire tube body has consistent axial strength, ensuring that the tube body 2 maintains consistent tensile and compressive strength at all circumferential locations while maintaining its structural strength.

[0041] Optionally, the ends of the two wing grooves 222 are arc edges, thereby preventing stress concentration.

[0042] like Figure 1As shown, as an embodiment, the circumferentially overlapping portion of two circumferentially adjacent narrow slot rows is a wing slot portion 222, so that the tube body 2 can meet the same bending performance in all directions and reduce the influence of the overlapping portion on the axial tensile and compressive performance; at the same time, the sum of the sizes of the three axially continuous wing slot portions 222 is made the same as the size of the two continuous main slot portions 221 on the same axis, so that the axial strength of the tube body 2 is consistent, so that the tube body 2 can have the same tensile and compressive performance at various circumferential positions and can also maintain its own structural strength.

[0043] like Figure 1 As shown, as an embodiment, the slots 22 in the slot rows on both sides of each slot row are aligned one by one in the circumferential direction, that is, they are in the same axial direction, so that the tube body 2 can have the same bending performance, tensile performance and compressive performance in any direction.

[0044] like Figure 1 As shown, as an embodiment, the distal end of the tube body 2 is provided with a plurality of through holes 21 extending axially along the tube body 2. By providing the through holes 21, the contact area between the inner tube and the outer tube is increased, which facilitates the fixed connection between the inner tube and the outer tube and reduces the occurrence of stratification of the sheath tube.

[0045] like Figure 1 As shown, as an embodiment, the connecting section 12 includes at least two connected arc segments, so that the connecting section 12 is S-shaped, and the opening directions of the two arc segments are opposite, so that the connecting section 12 can connect the two adjacent ribs 11 together, and the connecting section 12 is composed of arc segments, so that the expandable section 1 has a certain elasticity. When subjected to radial outward force, it will be in an expanded state, and the connecting section 12 will tighten the two adjacent ribs 11 to limit further expansion of the expandable section 1.

[0046] like Figure 1 As shown, as an embodiment, the length of one of the two adjacent ribs 11 is greater than the length of the other rib 11, so that the connecting section 12 can conveniently connect the extended ends of the two adjacent ribs 11. At the same time, the connecting sections 12 on both sides of each rib 11 are symmetrically arranged, so that the expandable section 1 can be subjected to balanced force and can be subjected to the same tensile force when the rib 11 expands outward.

[0047] like Figure 1 As shown, as an embodiment, multiple connecting parts 3 are arranged in a conical shape around the axis of the tube body 2, which shrinks toward the proximal end. In this way, the tube body 2 can fit tightly with the delivery catheter, reducing the possibility of falling off and improving the safety and stability of the delivery system.

[0048] like Figure 1As shown, as an embodiment, the connecting portion 3 has multiple triangular sheets, so that the multiple triangular sheets can be narrowed into a conical structure. At the same time, each triangular sheet is connected with a connecting ring, which can reduce the problem of the support tube scratching the inner tube and the outer tube.

[0049] In a second aspect, an embodiment of the present application provides a sheath for interventional surgery, comprising the support tube for interventional surgery provided in the first aspect; further comprising an inner tube and an outer tube, wherein the support tube is located between the inner tube and the outer tube. The sheath of the embodiment of the present application is a three-layer structure, specifically an inner tube, a support tube, and an outer tube arranged sequentially from the inside to the outside. The inner tube is a lubricating layer that directly contacts the implant, can reduce friction between the delivery sheath and the implant, and facilitates the release of the implant; the support tube is a reinforcing layer that primarily serves as a support, allowing the sheath to maintain good radial and axial strength, facilitating the forward pushing of the sheath and the loading and release of the implant; the outer tube is a protective layer that directly contacts the blood and has good biocompatibility.

[0050] The support tube is metal; both the inner and outer layers are elastic. The inner layer is a highly elastic thin film tube made of materials such as thermoplastic polyurethane rubber, thermoplastic elastomer, or silicone. This provides elasticity. Because the support tube has a cut pattern, it is required to isolate it from direct contact with blood. The inner layer generally exhibits good biocompatibility and plasticity, as well as good adhesion to the hydrophilic coating. Support tube materials include stainless steel, nickel-titanium, and polymer fibers, while the outer layer can be made of thermoplastic polyurethane rubber, thermoplastic elastomer, silicone, nylon, Pebax, polyethylene, and others.

[0051] The above description is merely an embodiment of the present application and is not intended to limit the scope of protection of the present application. For those skilled in the art, various modifications and variations of the present application are possible. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present application shall be included in the scope of protection of the present application.

[0052] The above description is merely a specific embodiment of the present application, but the scope of protection of the present application is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in the present application should be included in the scope of protection of the present application. Therefore, the scope of protection of the present application should be based on the scope of protection of the claims.

[0053] It is to be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a component" can include a combination of two or more components. Additionally, the terms "comprise," "comprises," and "comprising," or any variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to those elements, but can include other elements not expressly listed or inherent to such process, method, article, or apparatus. Furthermore, unless otherwise indicated herein, the terms "first," "second," "third," etc., are used herein merely as labels, and are not intended to impose ordinal import.

Claims

1. A support tube for interventional surgery, characterized in that: include: A tube body and an expandable segment located at a distal end of the tube body, the expandable segment comprising a plurality of ribs spaced apart along the circumference of the tube body, with two adjacent ribs connected by at least one curved connecting segment; The tube body is provided with a plurality of slots, and a row of slots neatly arranged in the axial direction is a slot row. The tube body is provided with a plurality of slot rows; in the circumferential direction, there is no spacing between the slot rows, and every two adjacent slot rows in the circumferential direction have overlapping parts in the circumferential direction, and the slots in every two circumferentially adjacent slot rows are spaced apart in the axial direction.

2. The support tube for interventional surgery according to claim 1, characterized in that: The narrow slot includes a main slot portion and two wing slot portions respectively located on both sides of the main slot portion; the main slot portion has a larger axial size than the wing slot portion.

3. The support tube for interventional surgery according to claim 2, characterized in that: The overlapping portion in the circumferential direction of two adjacent narrow slot rows in the circumferential direction is the wing slot portion.

4. The support tube for interventional surgery according to claim 3, characterized in that: The slots in the slot rows on both sides of each slot row are aligned one by one in the circumferential direction.

5. The support tube for interventional surgery according to any one of claims 1 to 4, characterized in that: The distal end of the tube body is provided with a plurality of through holes extending along the axial direction of the tube body.

6. The support tube for interventional surgery according to any one of claims 1 to 4, characterized in that: The connecting section includes at least two connected arc sections, and the opening directions of the two arc sections are opposite.

7. The support tube for interventional surgery according to claim 6, characterized in that: Among two adjacent ribs, the length of one rib is greater than the length of the other rib, and the connecting sections on both sides of each rib are symmetrically arranged.

8. The support tube for interventional surgery according to any one of claims 1 to 4, characterized in that: The proximal end of the tube body is provided with a plurality of connecting parts, and the radial dimension surrounded by the connecting parts is smaller than the radial dimension of the tube body.

9. The support tube for interventional surgery according to claim 8, characterized in that: The connecting portion includes a triangular sheet and a connecting ring located at the proximal end of the triangular sheet.

10. A sheath for interventional surgery, characterized in that: A support tube for interventional surgery comprising any one of claims 1 to 9; An inner tube and an outer tube, wherein the support tube is located between the inner tube and the outer tube; the support tube is a metal part; The inner tube and the outer tube are both elastic layers.

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