Support tube and sheath tube for interventional operation

Abstract

The invention relates to the technical field of medical instruments, and provides a supporting tube and a sheathing canal for an interventional operation, and the supporting tube for the interventional operation comprises a body section and an expandable section located at the far end of the body section; the expandable section comprises a plurality of through holes, the through holes located in the same row in the circumferential direction form a circumferential through hole group, and a plurality of rows of circumferential through hole groups are formed in the expandable section in the axial direction; and the sizes of the through holes in the plurality of rows of circumferential through hole groups are gradually reduced from the far end to the near end. According to the technical scheme, the problem of stress concentration of the sheathing canal in the process of releasing and recovering the valve prosthesis can be solved.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and more specifically, to a support tube and sheath tube for interventional surgery. Background Art

[0002] The transcatheter aortic valve delivery system is mainly used to deliver specific devices such as artificial valve prostheses to the heart through blood vessels during minimally invasive interventional treatment. The sheath is used to establish a channel between the diseased part of the patient's body and the external operating end or to drain body fluids from the diseased part, so as to achieve the purpose of reaching the diseased part without using surgical operation.

[0003] The sheath of the artificial valve delivery system currently on the market is generally composed of a three-layer structure. The middle layer is a sea wave tube cut from nickel-titanium alloy or stainless steel tube. Before the artificial valve prosthesis is released, the sheath needs to be bent to achieve a coaxial position with the diseased valve ring. The distal end of the sheath is used to accommodate the compressed artificial valve prosthesis. When the artificial valve prosthesis is released and recovered, the distal end of the sheath is trumpet-shaped due to the force, and the sheath needs to withstand a lot of pressure to compress the artificial valve prosthesis. Therefore, the distal end of the sheath needs to be easy to expand to facilitate the recovery and release of the artificial valve prosthesis. Summary of the Invention

[0004] The technical problem to be solved by the present application is to provide a support tube and sheath for interventional surgery that are conducive to distal expansion.

[0005] In order to solve the above technical problems, this application adopts the following technical solutions: In the first aspect, the present application provides a support tube for interventional surgery, comprising a main body section and an expandable section located at the distal end of the main body section; the expandable section comprises a plurality of through holes, and a plurality of through holes located in the same row in the circumferential direction constitute a circumferential through hole group, and the expandable section is provided with a plurality of rows of circumferential through hole groups along the axial direction; the size of the through holes in the plurality of rows of circumferential through hole groups gradually decreases from the distal end to the proximal end.

[0006] In the process of implementing the above technical solution, the support tube for interventional surgery includes a main body section and an expandable section located at the distal end of the main body section, the expandable section is used to expand outward in a direction at an angle to the radial direction of the main body section when transporting and / or recovering the valve prosthesis, and the main body section is used to bend during the process of transporting and / or recovering the valve prosthesis; the expandable section includes a plurality of through holes, and the plurality of through holes located in the same row in the circumferential direction are a circumferential through hole group, and the expandable section is provided with a plurality of rows of circumferential through hole groups along the axial direction. In this way, when the expandable section squeezes the valve prosthesis, the expansion force generated by the valve prosthesis on the expandable section makes the expandable section easier to expand radially outward, thereby facilitating the release or recovery of the valve prosthesis; the size of the through holes in the plurality of rows of circumferential through hole groups gradually decreases from the distal end to the proximal end, so that the valve prosthesis is released from the proximal end to the distal end. The size of the through hole gradually increases from the proximal end to the distal end, making it easier to expand. The squeezing force on the valve prosthesis is relatively reduced, and the valve prosthesis is easier to release. During the recovery process, the size of the through hole is the largest at the distal end, and the valve prosthesis is easier to recover. Therefore, during the release and collection of the valve prosthesis, the force between the expandable section and the valve prosthesis changes gradually with the degree of entry and exit of the valve prosthesis, that is, when a smaller force is needed for release, a smaller force is applied; when a larger force is needed for collection, a larger force is applied. This reduces the excessive concentration of local force during the release and collection of the valve prosthesis, making the sheath easier to expand, thereby reducing the challenge of excessive overall force strength of the delivery system and the risk of failure caused by excessive overall force on the product during surgery.

[0007] As an embodiment, the through hole is in the shape of a polygonal structure.

[0008] In the process of implementing the above technical solution, the shape of the through hole is a polygonal structure, which makes the expandable section have better toughness and elastic resilience in the circumferential, axial and other directions, thereby reducing the problem of stress concentration. It can also be applied to valve prostheses with larger specifications and greater radial support force, and has wider applicability compared to long hollow structures. In addition, designing the through hole into a polygonal structure can increase the contact area between the inner tube inside the support tube and the outer tube outside the support tube, thereby improving the structural stability and durability of the sheath tube.

[0009] As an embodiment, the through hole includes a quadrilateral through hole, and a line connecting two vertices of the quadrilateral extends axially.

[0010] In the process of implementing the above technical solution, the through hole includes a quadrilateral through hole, and the line connecting two vertices of the quadrilateral extends axially, that is, the line connecting the two vertices of the through hole in the axial direction is parallel to the axis of the support tube. In this way, the expandable section can have good tensile resilience in the axial direction, and when releasing and recovering the valve prosthesis, it can reduce the problem of stress concentration, improve adaptability, and enable the expandable section to release and recover valve prostheses of different specifications.

[0011] As an embodiment, at least one curved connecting rib is provided in at least a portion of the through holes.

[0012] In the process of implementing the above technical solution, at least one curved connecting rib is provided in at least part of the through hole. By providing the curved connecting rib, two of the sides in the through hole can be connected, supporting the through hole, thereby improving the stability of the through hole; at the same time, since the connecting rib is a curved structure, the length of the connecting rib is increased compared to the straight-line connecting rib. In this way, the curved connecting rib, compared to the straight-line connection, can reduce the impact on the circumferential and axial expansion of the through hole when connected to the two sides, and also improve the stability of the through hole.

[0013] As an embodiment, the connecting rib includes two connecting segments, one end of the two connecting segments converges to form a convergence point, and the other two ends are respectively connected to the two edges forming the through hole to form connection points, and the line connecting the two connection points and the convergence point are at different positions in the axial direction.

[0014] In the process of implementing the above technical solution, the connecting rib includes two connecting segments, one end of the two connecting segments converges to form a convergence point, and the other two ends are respectively connected to the two sides forming the through hole to form a connection point. The connecting line of the two connection points and the convergence point are at different positions in the axial direction, so that the through hole is connected to the two sides of the through hole through the two connecting segments, forming a small quadrilateral structure, which increases the stability of the through hole; at the same time, the formation of a small quadrilateral structure in the through hole can make the expandable segment have better toughness and elastic resilience in the circumferential, axial and other directions, thereby reducing the problem of stress concentration, and can also be applied to valve prostheses with larger specifications and greater radial support force, and has wider applicability than the long hollow structure.

[0015] As an embodiment, at least part of the through holes include two first sides and one arc-shaped side, one end of the two first sides are connected to each other, and the other two ends are respectively connected to two ends of the arc-shaped side.

[0016] In the process of implementing the above technical solution, in the expandable section, at least part of the through hole includes two first sides and an arc-shaped side, one end of the two first sides is connected, and the other two ends are respectively connected to the two ends of the arc-shaped sides, so that the formed through hole structure is similar to the shape of a water droplet. Compared with the quadrilateral through hole shape, the cutting area of ​​the expandable section can be reduced, so that the expandable section can retain most of the metal material, thereby improving the structural stability of the expandable section.

[0017] As an embodiment, the angle formed by the two first sides of the plurality of through holes in the circumferential through hole group located at the farthest end is located at the far end of the through holes.

[0018] In the process of implementing the above technical solution, the angle formed by the two first sides of multiple through holes in the row of circumferential through hole groups located at the farthest end is located at the farthest end of the through holes. In this way, the angle of the through holes in the through hole group of the farthest section of the expandable segment is directed to the farthest end. When the valve prosthesis is in the process of releasing or recovering, the expansion force of the valve prosthesis can expand the two first sides at the farthest end, and cooperate with the arc-shaped sides to make the through holes close to a circle, making it easier to release and recover the valve prosthesis.

[0019] As an embodiment, the through hole includes a first area, the first area is located at the distal end of the through hole, and the circumferential width of the first area gradually decreases from the distal end to the proximal end.

[0020] In the process of implementing the above technical solution, the through hole includes a first area, which is located at the distal end of the through hole. The circumferential width of the first area gradually decreases from the distal end to the proximal end, so that in the process of releasing the valve prosthesis from the proximal end to the distal end, the size of the first area gradually increases from the proximal end to the distal end, and it is easier to expand. Its squeezing force on the valve prosthesis is relatively reduced, and the valve prosthesis is easier to release; and in the recovery process, the size of the first area at the distal end is the largest, and it is also easier to recover the valve prosthesis. Therefore, in the process of releasing and collecting the valve prosthesis, the force between the expandable section and the valve prosthesis presents a corresponding gradual process as the degree of entry and exit of the valve prosthesis, that is, when a smaller force is needed for release, a smaller force is presented; when a larger force is needed for collection, a larger force is presented; reducing the excessive concentration of local force during the release and collection of the valve prosthesis, thereby reducing the challenge of excessive overall force strength of the delivery system and the risk of failure caused by excessive overall force of the product during the operation.

[0021] As an embodiment, the through hole further includes a second region, the second region is connected to the first region, and the width of the second region along the circumferential direction is greater than the width of the first region along the circumferential direction.

[0022] In the process of implementing the above technical solution, the through hole also includes a second area, the second area is connected to the first area, the second area is located at the proximal end of the first area, the circumferential width of the second area is greater than the circumferential width of the first area, and can provide circumferential expansion force for the through hole. At the same time, the second area is connected to the first area. When the first area is expanding, the circumferential width of the second area is greater than the circumferential width of the first area, which can provide transition compliance for the first area, avoid stress concentration in the first area, and improve the service life of the support tube.

[0023] As an embodiment, the through hole further includes a third region, the third region is connected to the second region, and the width of the third region along the circumferential direction gradually increases from the distal end to the proximal end.

[0024] In the process of implementing the above technical solution, the through hole also includes a third area, the third area is connected to the second area, the third area is located at the proximal end of the second area, and the width of the third area along the circumferential direction gradually increases from the distal end to the proximal end. In this way, the circumferential width of the distal area of ​​the through hole between two adjacent third areas also gradually decreases from the distal end to the proximal end. In this way, when the valve prosthesis is released from the proximal end to the distal end, it is easier to expand, and the squeezing force on the valve prosthesis is relatively reduced, so the valve prosthesis is easier to release; and in the recovery process, it is also easier to recover the valve prosthesis. Therefore, during the release and collection process of the valve prosthesis, the force between the expandable section and the valve prosthesis presents a corresponding gradual process as the degree of entry and exit of the valve prosthesis.

[0025] 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.

[0026] During the implementation of the above technical solution, the inner tube is a lubricating layer, which is in direct contact with the implant, can reduce the friction between the delivery sheath and the implant, and facilitate the release of the implant; the support tube is a reinforcing layer, which mainly plays a supporting role, so that the sheath maintains good radial and axial strength, which is conducive to pushing the sheath forward and loading and releasing the implant; the outer tube is a protective layer, which is in direct contact with the blood and has good biocompatibility. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] 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.

[0028] Figure 1 This is a schematic structural diagram of the support tube of the first embodiment of the present application; Figure 2 This is a schematic structural diagram of a support tube according to a second embodiment of the present application; Figure 3 This is a schematic structural diagram of a support tube according to a third embodiment of the present application; Figure 4 This is a schematic structural diagram of a support tube according to a fourth embodiment of the present application; Figure 5 for Figure 4 Schematic diagram of a local enlarged structure; Figure 6 A schematic diagram of the partial structure of the support tube provided in an embodiment of the present application.

[0029] Icon: 1-expandable section; 11-through hole; 12-connecting rib; 121-connecting section; 13-first edge; 14-arc-shaped edge; 15-first area; 16-second area; 17-third area; 2-main body section; 22-slot; 221-main slot portion; 222-wing slot portion; 3-connecting portion. DETAILED DESCRIPTION

[0030] 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.

[0031] 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.

[0032] 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.

[0033] like Figures 1 to 5As shown, the support tube for interventional surgery includes a main body section 2 and an expandable section 1 located at the distal end of the main body section 2, the expandable section 1 is used to expand outward in a direction at an angle to the radial direction of the main body section 2 when transporting and / or recovering the valve prosthesis, and the main body section 2 is used to bend during the process of transporting and / or recovering the valve prosthesis; the expandable section 1 includes a plurality of through holes 11, and the plurality of through holes 11 located in the same row in the circumferential direction are a circumferential through hole group, and the expandable section 1 is axially provided with a plurality of rows of circumferential through hole groups. In this way, when the expandable section 1 squeezes the valve prosthesis, the expansion force generated by the valve prosthesis on the expandable section 1 makes the expandable section 1 more easily expand radially outward, thereby facilitating the release or recovery of the valve prosthesis; the size of the through holes 11 in the plurality of rows of circumferential through hole groups gradually decreases from the distal end to the proximal end, so that the valve prosthesis is released from the proximal end to the distal end. The size of the through hole 11 gradually increases from the proximal end to the distal end, making it easier to expand. The squeezing force on the valve prosthesis is relatively reduced, making the valve prosthesis easier to release. During the recovery process, the through hole 11 is the largest at the distal end, making it easier to recover the valve prosthesis. Therefore, during the release and collection of the valve prosthesis, the force between the expandable section 1 and the valve prosthesis changes gradually with the degree of entry and exit of the valve prosthesis, that is, when a smaller force is needed for release, a smaller force is applied; when a larger force is needed for collection, a larger force is applied. This reduces the excessive concentration of local force during the release and collection of the valve prosthesis, making it easier to expand the sheath, thereby reducing the challenge of excessive overall force strength of the delivery system and the risk of failure caused by excessive overall force on the product during surgery.

[0034] Optionally, the expandable section 1 is provided with a plurality of circumferential through hole groups from the distal end to the proximal end.

[0035] like Figures 1 to 5 As shown, as an embodiment, the through hole 11 is in the shape of a polygonal structure, which makes the expandable section 1 have better toughness and elastic resilience in the circumferential, axial and other directions, thereby reducing the problem of stress concentration. It can also be applied to valve prostheses with larger specifications and greater radial support force, and has wider applicability compared to long hollow structures. In addition, the through hole 11 is designed to have a polygonal structure, which can increase the contact area between the inner tube inside the support tube and the outer tube outside the support tube, thereby improving the structural stability and durability of the sheath tube.

[0036] Optionally, the shape of the through hole 11 can be a triangle, a quadrilateral, a pentagon or a hexagon.

[0037] like Figures 1 to 4As shown, as an embodiment, the through hole 11 includes a triangular through hole, and the triangular through hole is located at the nearest end of the expandable segment 1, that is, at the proximal end of the expandable segment 1, a row of triangular through hole groups are provided along the circumferential direction, and any triangular through hole is axially staggered with the two adjacent through holes 11 corresponding to the triangular through hole in the adjacent circumferential through hole group, that is, the triangular through hole can hollow out the area of ​​the expandable segment 1 that is not hollowed out by the two adjacent through holes 11 in the adjacent circumferential through hole group, so that the triangular through hole can hollow out the expandable segment 1 as much as possible, reduce the metal material of the expandable segment 1, and facilitate the expandable segment 1 to expand more easily in the axial and radial directions.

[0038] Optionally, the top angle of the triangular through hole points to the distal end, so that one side of the triangular through hole is located at the proximal end, which facilitates the transition between the expandable section 1 and the main body section 2 and improves the stability of the support tube.

[0039] like Figure 1 As shown, as an embodiment, the through hole 11 includes a quadrilateral through hole, and the line connecting two vertices of the quadrilateral extends axially, that is, the line connecting the two vertices of the through hole 11 in the axial direction is parallel to the axis of the support tube. In this way, the expandable segment 1 can have good tensile resilience in the axial direction, and when releasing and recovering the valve prosthesis, it can reduce the problem of stress concentration and improve adaptability, so that the expandable segment 1 can release and recover valve prostheses of different specifications.

[0040] Optionally, the through hole 11 may be a diamond-shaped structure, so that the expandable portion has better toughness in the circumferential direction and axial elasticity. Of course, in some cases, it may also be a rectangle or a square. As a preferred embodiment, the through hole 11 is a diamond-shaped structure.

[0041] like Figure 2 As shown, as an embodiment, at least one curved connecting rib 12 is provided in at least part of the through hole 11. By providing the curved connecting rib 12, two of the sides of the through hole 11 can be connected, and the through hole 11 can be supported and connected, thereby improving the stability of the through hole 11. At the same time, since the connecting rib 12 is a curved structure, the length of the connecting rib 12 is increased compared to the straight-line connection. In this way, the curved connecting rib 12 can reduce the impact on the circumferential and axial expansion of the through hole 11 when connected to the two sides, compared to the straight-line connection, and also improves the stability of the through hole 11.

[0042] Optionally, when the connecting rib 12 is connected to the two edges on the same side in the axial direction, it can mainly reduce the influence of the tensile rebound performance of the through hole 11 in the axial direction, and can also reduce the influence of the tensile rebound of the through hole 11 in the circumferential direction; when the connecting rib 12 is connected to the two edges on the same side in the circumferential direction, it can mainly reduce the influence of the tensile rebound performance of the through hole 11 in the circumferential direction, and can also reduce the influence on the tensile rebound of the through hole 11 in the axial direction.

[0043] Optionally, the connecting rib 12 may be connected to the edges of two through holes 11 in the same circumferential direction, or may be connected to two edges on the same side in the same axial direction.

[0044] Optionally, one connecting rib 12 may be provided in the through hole 11 , or multiple connecting ribs 12 may be provided.

[0045] Optionally, at least one connecting rib 12 may be provided in each through hole 11 , or at least one connecting rib 12 may be provided in a portion of the through holes 11 .

[0046] Optionally, the shape of the connecting rib 12 may be a curved wave shape, a bent shape, or a continuous bent shape.

[0047] like Figure 2 As shown, as an embodiment, the connecting rib 12 includes two connecting segments 121, one end of the two connecting segments 121 converges to form a convergence point, and the other two ends are respectively connected to the two sides forming the through hole 11 to form a connection point, and the connecting line of the two connection points and the convergence point are at different positions in the axial direction, so that the through hole 11 is connected to the two sides of the through hole 11 through the two connecting segments 121, forming a small quadrilateral structure, which increases the stability of the through hole 11; at the same time, the formation of a small quadrilateral structure in the through hole 11 can make the expandable segment 1 have better toughness and elastic resilience in the circumferential, axial and other directions, thereby reducing the problem of stress concentration, and can also be applied to valve prostheses with larger specifications and greater radial support force, and has wider applicability than the long hollow structure.

[0048] Optionally, the confluence point and the axial vertex of the through hole 11 are on the same axial connecting line, which improves the stability of the through hole 11 while enabling the expandable segment 1 to have good tensile resilience in the axial direction. When releasing and recovering the valve prosthesis, the problem of stress concentration can be reduced, the adaptability can be improved, and the expandable segment 1 can release and recover valve prostheses of different specifications.

[0049] Optionally, the quadrilateral structure formed by the two connecting segments 121 and the two sides in the through hole 11 can be a rhombus, a square, or a rectangle. As a preferred embodiment, the quadrilateral structure formed by the two connecting segments 121 and the two sides is a rhombus. In this way, the small quadrilateral in the through hole 11 can also have better circumferential toughness and axial elasticity, and can be suitable for valve prostheses with larger specifications and greater radial support force during the release and collection process of the valve prosthesis.

[0050] Optionally, in some cases, in the quadrilateral structure formed by connecting the two connecting segments 121 with the two sides of the through hole 11, the convergence point may also be directed toward one of the vertices of the through hole 11, that is, the two vertices in the quadrilateral structure formed by connecting the two connecting segments 121 with the two sides of the through hole 11 point in the same direction, rather than opposite to each other.

[0051] like Figure 3 As shown, as an embodiment, in the expandable segment 1, at least part of the through hole 11 includes two first sides 13 and an arcuate side 14, one end of the two first sides 13 is connected, and the other two ends are respectively connected to the two ends of the arcuate side 14, so that the formed through hole 11 structure is similar to the shape of a water droplet. Compared with the quadrilateral shape of the through hole 11, the cutting area of ​​the expandable segment 1 can be reduced, so that the expandable segment 1 can retain most of the metal material, thereby improving the structural stability of the expandable segment 1.

[0052] In an embodiment, triangular through holes 11 may be provided in other areas of the expandable segment 1 to improve the circumferential toughness and axial telescopic resilience of the expandable segment 1 .

[0053] Optionally, in the embodiment of the present application, all of the through holes 11 may include two first sides 13 and one arcuate side 14 . Of course, some of the through holes 11 may include two first sides 13 and one arcuate side 14 .

[0054] like Figure 3 As shown, as an embodiment, the angle formed by the two first sides 13 of the plurality of through holes 11 in the row of circumferential through hole groups located at the farthest end is located at the farthest end of the through hole 11. In this way, the angle in the through hole 11 in the through hole group at the farthest end of the expandable segment 1 is directed to the farthest end. When the valve prosthesis is in the process of releasing or recovering, the expansion force of the valve prosthesis can expand the two first sides 13 at the farthest end, and cooperate with the arcuate side 14 to make the through hole 11 approach a circle, making it easier to release and recover the valve prosthesis.

[0055] Optionally, the angles of multiple through holes 11 in the circumferential through hole group at the farthest end of the expandable section 1 can point to the far end, while the angles of other circumferential through hole groups can point to the proximal end. Of course, the angles of all through holes 11 can also point to the far end.

[0056] Optionally, the included angles of all the through holes 11 may point toward the distal end, or the included angles of multiple through holes 11 in a row of circumferential through hole groups located at the distal end may point toward the distal end.

[0057] like Figure 4 and 5 As shown, as an embodiment, the through hole 11 includes a first area 15, which is located at the distal end of the through hole 11. The circumferential width of the first area 15 gradually decreases from the distal end to the proximal end, so that in the process of releasing the valve prosthesis from the proximal end to the distal end, the size of the first area 15 gradually increases from the proximal end to the distal end, making it easier to expand, and its squeezing force on the valve prosthesis is relatively reduced, making the valve prosthesis easier to release; and in the recovery process, the size of the first area 15 at the distal end is the largest, and it is also easier to recover the valve prosthesis. Therefore, in the process of releasing and collecting the valve prosthesis, the force between the expandable section 1 and the valve prosthesis presents a corresponding gradual process as the degree of entry and exit of the valve prosthesis, that is, when a smaller force is needed for release, a smaller force is presented; when a larger force is needed for collection, a larger force is presented; reducing the excessive concentration of local force during the release and collection of the valve prosthesis, thereby reducing the challenge of excessive overall force strength of the delivery system and the risk of failure caused by excessive overall force on the product during the operation.

[0058] like Figure 4 and 5 As shown, as an embodiment, the through hole 11 also includes a second area 16, which is connected to the first area 15. The second area 16 is located at the proximal end of the first area 15, and the circumferential width of the second area 16 is greater than the circumferential width of the first area 15, which can provide a circumferential expansion force for the through hole 11. At the same time, the second area 16 is connected to the first area 15. When the first area 15 is expanding, the circumferential width of the second area 16 is greater than the circumferential width of the first area 15, which can provide transitional compliance for the first area 15, avoid stress concentration in the first area 15, and improve the service life of the support tube.

[0059] like Figure 4 and 5As shown, as an embodiment, the through hole 11 also includes a third area 17, which is connected to the second area 16, and the third area 17 is located at the proximal end of the second area 16. The circumferential width of the third area 17 gradually increases from the distal end to the proximal end. In this way, the circumferential width of the distal area of ​​the through hole 11 between two adjacent third areas 17 also gradually decreases from the distal end to the proximal end. In this way, when the valve prosthesis is released from the proximal end to the distal end, it is easier to expand, and the squeezing force on the valve prosthesis is relatively reduced, so the valve prosthesis is easier to release; and during the recovery process, it is also easier to recover the valve prosthesis. Therefore, during the release and collection process of the valve prosthesis, the force between the expandable section 1 and the valve prosthesis presents a corresponding gradual process as the degree of entry and exit of the valve prosthesis.

[0060] Optionally, in the embodiment of the present application, triangular through holes 11 and diamond through holes 11 may be provided in other areas, or a semi-diamond structure may be provided to connect the edges of two adjacent third areas 17 to form a new through hole 11 structure.

[0061] Optional, such as Figure 1 As shown, the body segment 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 body segment 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 body segment 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 body segment 2, so that there is a certain distance between two adjacent slots 22 in any radial direction of the body segment 2. While ensuring the stability of the structure, the body segment 2 is uniformly stressed in the circumferential direction, and when subjected to tension or pressure, the stress at each circumferential position can be the same.

[0062] Optional, such as Figure 1 As shown, the support tube in the embodiment of the present application has a symmetrical structure, and the structure of the main body section 2 is symmetrical and uniform, so that when the main body section 2 is subjected to tension or pressure, the force at each position in the circumferential direction can be the same.

[0063] like Figure 1 and 6As shown, the slot 22 optionally includes a main slot portion 221 and two wing slot portions 222 located on either side of the main slot portion 221, allowing the main body segment 2 to bend in any direction. The slot 22 can prevent the support tube from being twisted by the shape of the blood vessel when the main body segment 2 is bent, thereby affecting the release or recovery of the valve prosthesis and posing a safety hazard. The wing slot portion 222 is axially smaller than the main slot portion 221, so 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. Therefore, the entire tube body has consistent axial strength, enabling the main body segment 2 to achieve consistent tensile and compressive resistance at all circumferential locations while maintaining its structural strength.

[0064] Optionally, the ends of the two wing grooves 222 are arc edges, thereby preventing stress concentration.

[0065] like Figure 6 As shown, optionally, the circumferentially overlapping portions of two circumferentially adjacent narrow slot rows are wing slot portions 222, so that the main body segment 2 can meet the same bending performance in all directions and reduce the influence of the overlapping portions 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 main body segment 2 is consistent, so that the main body segment 2 can have the same tensile and compressive performance at various circumferential positions and can also maintain its own structural strength.

[0066] like Figure 1 As shown, optionally, 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, in the same axial direction, so that the bending performance, tensile performance and compressive performance of the main body segment 2 in any direction are the same.

[0067] like Figure 1 As shown, optionally, multiple connecting parts 3 are arranged in a conical shape that shrinks toward the proximal end around the axis of the body section 2. In this way, the body section 2 can fit tightly with the delivery catheter, reducing the possibility of falling off and improving the safety and stability of the delivery system.

[0068] like Figure 1 As shown, optionally, the connecting portion 3 comprises a plurality of triangular sheets, so that the plurality of 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.

[0069] 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.

[0070] 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.

[0071] 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.

[0072] 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.

[0073] It should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply the existence of any such actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article, or device comprising a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or device. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of other identical elements in the process, method, article, or device comprising the element.

Claims

1. A support tube for interventional surgery, characterized in that: The device comprises a main body section and an expandable section located at the distal end of the main body section; the expandable section comprises a plurality of through holes, wherein a plurality of through holes located in the same row in the circumferential direction constitute a circumferential through hole group, and the expandable section is provided with a plurality of rows of circumferential through hole groups in the axial direction; The sizes of the through holes in the multiple rows of circumferential through hole groups gradually decrease from the distal end to the proximal end.

2. The support tube for interventional surgery according to claim 1, characterized in that: The through hole is in a polygonal shape.

3. The support tube for interventional surgery according to claim 2, characterized in that: The through holes include a triangular through hole, the triangular through hole is located at the proximal end of the expandable section, and the triangular through hole is axially staggered from two adjacent through holes in an adjacent circumferential through hole group.

4. The support tube for interventional surgery according to claim 2 or 3, characterized in that: The through holes include quadrilateral through holes, and a line connecting two vertices of the quadrilateral extends axially.

5. The support tube for interventional surgery according to claim 4, characterized in that: At least one curved connecting rib is provided in at least part of the through holes.

6. The support tube for interventional surgery according to claim 5, characterized in that: The connecting rib includes two connecting segments, one end of the two connecting segments converges to form a convergence point, and the other two ends are respectively connected to the two sides forming the through hole to form connection points, and the line connecting the two connection points and the convergence point are at different positions in the axial direction.

7. The support tube for interventional surgery according to claim 2 or 3, characterized in that: At least part of the through holes includes two first sides and one arc-shaped side, one end of the two first sides is connected to each other, and the other two ends are respectively connected to the two ends of the arc-shaped side.

8. The support tube for interventional surgery according to claim 7, characterized in that: The angle formed by the two first sides of the plurality of through holes in the row of circumferential through hole groups located at the farthest end is located at the far end of the through holes.

9. The support tube for interventional surgery according to claim 2 or 3, characterized in that: The through hole includes a first area, which is located at the distal end of the through hole. The circumferential width of the first area gradually decreases from the distal end to the proximal end.

10. The support tube for interventional surgery according to claim 9, characterized in that: The through hole further includes a second region, the second region is connected to the first region, and a width of the second region along the circumferential direction is greater than a width of the first region along the circumferential direction.

11. The support tube for interventional surgery according to claim 10, characterized in that: The through hole further includes a third region, the third region is connected to the second region, and the width of the third region along the circumferential direction gradually increases from the distal end to the proximal end.

12. A sheath for interventional surgery, characterized in that: A support tube for interventional surgery comprising any one of claims 1 to 11; 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.

Images