CN118304056A

CN118304056A - Leak-proof artificial heart valve

Info

Publication number: CN118304056A
Application number: CN202310882498.8A
Authority: CN
Inventors: 张维; 赵曼曼; 孙振飞
Original assignee: Hangzhou Qiming Medical Devices Co ltd
Current assignee: Hangzhou Qiming Medical Devices Co ltd
Priority date: 2023-01-09
Filing date: 2023-01-09
Publication date: 2024-07-09
Also published as: CN115887068A; CN115887068B

Abstract

The application discloses a heart valve prosthesis, which comprises a bracket, valve leaflets and an inner covering film, wherein the bracket comprises an annular part and a plurality of guide parts, an opening part is arranged between two adjacent guide parts, the shape of the outflow side of each guide part gradually converges to a first cell at the tail end for a traction wire to pass through, and the first cell is provided with a first vertex at the inflow side and is connected with two branch frame strips which further extend to the inflow side through the first vertex; two edge frame strips extending to the inflow side are connected to two circumferential sides of the first unit cell, the unit cell frame strips in the annular portion have a first inclination trend relative to the axis of the support, the inner covering film is connected to the inner side of the support, the inner covering film is formed by weaving two groups of wires, each group of wires has a second inclination trend relative to the axis of the support, and the second inclination trend is identical to the first inclination trend. The improvement of the support structure is more suitable for adopting a wire control mode, and the coordination of the deformation of the support structure and the inner covering film can be considered by combining the arrangement characteristics of the inner covering film, so that the comprehensive performance of the valve is improved.

Description

Leak-proof artificial heart valve

The application discloses a divisional application of an artificial heart valve aiming at the application number 2023100237196 and the application date 2023, 1 and 9.

Technical Field

The application relates to the technical field of medical equipment, in particular to a peripheral leakage prevention artificial heart valve.

Background

With the development of medical conditions, the artificial heart valve has been widely used, and generally comprises a deformable support and valve leaflets connected in the support, wherein a blood flow channel is arranged in the support, a plurality of valve leaflets are mutually matched to control the opening and closing degree of the blood flow channel in the support, and a positioning structure which can act with peripheral native tissues, such as an anchor, an arm and the like, can be arranged on the periphery of the support for in-vivo positioning.

The delivery and retraction of the prosthetic heart valve in the body can be controlled by a sheath wrapped around the periphery of the stent, and correspondingly controlled by different positions of the stent exposed to the sheath, and can also be controlled by a stay wire, i.e., the stay wire passes through a structural gap or a wire hole structure of the stent, and the stay wire is regulated by a control handle at the proximal end (the end close to an operator) so as to change the expansion degree and retraction progress of the stent.

When stay wire control is adopted, and particularly recovery is needed, higher requirements are put on the deformation trend of the support, and besides, the peripheral walls of some supports are provided with a film covering structure, and when the support is radially folded, the film covering structure is correspondingly pulled to deform or fold, so that the stress distribution and deformation trend of the support are further optimized.

Disclosure of Invention

The artificial heart valve optimizes the arrangement mode of the bracket structure and the covering film, and is more beneficial to the wire control operation of the artificial heart valve.

The application provides a heart valve prosthesis, which comprises a bracket and valve leaves, wherein the bracket is of a net barrel structure as a whole, a blood flow channel is arranged in the bracket, the valve leaves are multiple, and the valve leaves are positioned in the blood flow channel and are mutually matched to control the blood flow channel; the edges of the valve leaflets comprise fixed edges connected to the bracket and free edges which are matched with other valve leaflets to control the blood flow channel;

The support comprises an annular part and a plurality of guide parts which are arranged at intervals on the outflow side of the annular part, an opening part is arranged between every two adjacent guide parts, the shape of the outflow side of each guide part gradually converges to a first cell at the tail end, and the first cell is provided with a first vertex at the inflow side and is connected with two branch frame strips which further extend towards the inflow side through the first vertex;

Two edge frame strips extending to the inflow side are connected to two circumferential sides of the first cell, a sparse area is arranged between the branch frame strips and the edge frame strips in the same guide part, the annular part is provided with a plurality of rows of cells, and the sparse area has a larger cell area relative to the annular part;

The cell frame strips in the loop have a first inclination with respect to the stent axis, the prosthetic heart valve further comprising an inner covering attached to the inside of the stent, the inner covering comprising a first set of wires and a second set of wires, each set of wires having a second inclination with respect to the stent axis, the second inclination being the same as the first inclination.

The following alternatives are provided, but are not as additional limitations to the overall scheme described above, but are merely further additions or preferences, and each alternative may be combined individually for the overall scheme described above, or between multiple alternatives, without technical or logical contradictions.

The outer side of the inner coating film is fixedly provided with peripheral leakage prevention components, and each peripheral leakage prevention component is matched with the corresponding cell position on the annular part and radially protrudes outwards from the corresponding cell.

Optionally, along the circumferential direction of the annular part, each guiding part is provided with a symmetry axis of the structure, and the fixed edges of two adjacent valve leaves are intersected with the symmetry axis of the guiding part;

along the direction of the symmetry axis, the inflow side of the first cell is a second cell, and the fixed edge ends of the two connected valve leaves are intersected with the second cell.

Optionally, two branch frame strips connected with the first vertex are opened towards the inflow side and uniformly distributed on two sides of the symmetry axis, and an opening included angle of the two branch frame strips is consistent with the two edge frame strips in the guiding part.

Optionally, the sparse region includes a third cell and a fourth cell distributed on two sides of the symmetry axis, and cell areas of the third cell and the fourth cell are 1.5-6 times of cell areas in the annular portion.

Optionally, the edge frame strips on two sides of the same opening part extend to the inflow side respectively to cross the third cell and the fourth cell and then meet at the second vertex of the opening part.

Optionally, the inner covering film has a single-layer structure or a multi-layer structure, and at least one layer is a PET fabric layer;

The peripheral leakage prevention component is made of porous materials, and is fixed on the inner covering film in a plurality of mutually-spaced mode.

Optionally, the inner covering film has a three-layer structure and comprises a central PET fabric layer and surface layers positioned on two sides, wherein the surface layers and the PET fabric layer are made of the same or different materials and are formed in a hot-pressing or dip-coating mode;

The density of each set of threads is the same in the two sets of threads constituting the PET fabric layer.

Optionally, the leakage preventing member includes:

The first group of circumference leakage prevention parts are distributed around the support, and included angle areas are formed between two adjacent circumference leakage prevention parts along the circumferential direction of the support.

Optionally, the peripheral leakage preventing members in the same group are arranged circumferentially, and the cell nodes in the rack are located at the spacing regions of adjacent peripheral leakage preventing members.

Alternatively, the inner cover is generally in the shape of a circumferentially extending band and is split end to end, with the end to end sides of the inner cover having generally complementary circuitous shapes.

Optionally, the peripheral leakage preventing component further includes a second set of peripheral leakage preventing components, and the second set of peripheral leakage preventing components are distributed around the bracket in the included angle area.

Optionally, the same peripheral leakage prevention member has a different convex height.

Optionally, the distance between the maximum position of the convex height and the inflow side of the cell is S1, and the distance between the maximum position of the convex height and the outflow side of the cell is S2, where S1: s2 is 0.2-0.8.

Optionally, an included angle between the extending directions of the two groups of wires in the inner coating is 30-90 degrees, and the direction of the included angle is the axial direction of the bracket.

Optionally, the outflow side of the inner covering film is spliced with the fixing edge of the valve leaflet, and the peripheral leakage preventing component is directly fixed to the inner covering film, or the peripheral leakage preventing component is provided with a wrapping layer at the periphery and is fixed to the inner covering film together with the wrapping layer;

the wrapping layer is of a single-layer structure and integrally clings to the outer side of the peripheral leakage prevention component, or the wrapping layer is of a multi-layer structure and wraps the inner side and the outer side of the peripheral leakage prevention component.

The artificial heart valve is more suitable for adopting a wire control mode through the improvement of the support structure, and the combination of the arrangement characteristics of the inner covering film can give consideration to the coordination of the deformation of the support structure and the inner covering film, so that the comprehensive performance of the valve is improved.

Drawings

FIG. 1a is a perspective view of a stent in a prosthetic heart valve in accordance with one embodiment of the present application;

FIG. 1b is a front view of a portion of the bracket of FIG. 1 a;

FIG. 2 is a side view of the bracket of FIG. 1 a;

FIG. 3 is a schematic view of a prosthetic heart valve according to an embodiment of the present disclosure;

FIG. 4 is an enlarged view of portion A of FIG. 3;

FIG. 5 is a schematic representation of a linear weave architecture of a prosthetic heart valve according to an embodiment of the application;

FIG. 6 is a partial front view of the prosthetic heart valve of FIG. 3;

FIG. 7 is a left side view of the bracket of FIG. 1 b;

FIG. 8 is a top view of a guide portion of a stent in a prosthetic heart valve in accordance with one embodiment of the present application;

FIG. 9 is a front view of a stent in a prosthetic heart valve in accordance with one embodiment of the present application;

FIG. 10a is a schematic view of an inner covering membrane of a prosthetic heart valve according to an embodiment of the present disclosure;

FIG. 10b is a schematic view of the inner covering membrane and stent of FIG. 10a after being sutured;

FIG. 11 is a front view of a prosthetic heart valve according to an embodiment of the present disclosure;

FIG. 12 is a schematic view of a partial structure of a leak protection component in a prosthetic heart valve according to an embodiment of the present application;

FIG. 13 is an enlarged view of portion B of FIG. 11;

FIG. 14 is an enlarged view of portion C of FIG. 11;

FIG. 15 is a schematic view of a flattened configuration of a leak-proof member and an inner covering membrane in a prosthetic heart valve in accordance with an embodiment of the present application;

FIG. 16 is a schematic illustration of the attachment of a sheath to an inner covering film, stent in a prosthetic heart valve according to an embodiment of the present application;

FIG. 17 is a schematic view of the attachment between a sheath and an inner covering film, stent in a prosthetic heart valve according to another embodiment of the present application;

FIG. 18 is a schematic view of the attachment between a sheath and an inner covering film, stent in a prosthetic heart valve according to another embodiment of the present application;

FIG. 19 is a front view of a stent in a prosthetic heart valve in accordance with another embodiment of the present application;

Fig. 20 is a side view of fig. 19.

Reference numerals in the drawings are described as follows:

1. a prosthetic heart valve; 10. a bracket; 100. a blood flow channel; 101. an inflow side; 102. an outflow side; 110. an annular portion; 111. a cell; 112. a cell node; 1111. a frame strip;

120. a guide section; 121. an opening part; 122. a symmetry axis; 123. a connection side; 125. at the maximum outer diameter; 1211. a second vertex;

131. A first cell; 1311. a first vertex; 1312. a pulling section; 1313. a transition section; 1314. a frame strip;

132. a second cell; 133. A third cell; 134. A fourth cell;

141. branching frame strips; 142. Edge frame strips; 151. A sparse region;

160. A leakage prevention member; 161. a first set of leak protection components; 162. a second set of leak protection components; 162a, a second-turn leak-proof member; 162b, a third-turn leakage prevention component; 167. a spacer; 168. a wrapping layer; 169. an included angle region;

170. a waist portion; 171. a first set of wires; 172. a second set of wires; 181. a first inclination trend; 182. a second inclination trend;

210. valve leaves; 201. a fixed edge; 202. a free edge; 211. splicing parts;

220. An inner coating film; 221. a fabric layer; 222. a surface layer; 223. a circuitous shape; 224. a circuitous shape;

31. A suture; 32. and (5) pulling the wire.

Detailed Description

The following description of the embodiments of the present application will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. When an element is referred to as being "disposed on" another element, it can be directly on the other element or intervening elements may also be present.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the description of the application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.

Referring to fig. 1a to fig. 4, an embodiment of the present application provides a prosthetic heart valve 1, which includes a stent 10 and leaflets 210, wherein the stent is of a mesh-tube structure as a whole, a blood flow channel 100 is arranged in the stent 10, the leaflets 210 are multiple, and the leaflets 210 are mutually matched in the blood flow channel 100 to control the blood flow channel 100; the edges of the leaflets 210 include a fixed edge 201 attached to the stent 10 and a free edge 202 that cooperates with the other leaflets 210 to control the flow path of blood;

The bracket 10 comprises an annular part 110 and a plurality of guide parts 120 which are arranged on the outflow side 102 of the annular part at intervals, an opening part 121 is arranged between two adjacent guide parts 120, the shape of the outflow side 102 of each guide part 120 (the guide part 120 in fig. 1b is positioned below the opening part 121) gradually converges to a terminal first cell 131, the first cell 131 is used for the traction wire 32 to pass through in a linear control mode, and the first cell 131 is provided with a first vertex 1311 positioned on the inflow side 101 and is connected with two branch frame bars 141 which further extend towards the inflow side 101 through the first vertex 1311;

two edge frame strips 142 extending towards the inflow side 101 are connected to two circumferential sides of the first cell 131, cells between the branch frame strips 141 and the edge frame strips 142 in the same guide part 120 are sparse zones 151, the annular part 110 is provided with multiple rows of cells (namely multiple rows of cells are distributed along the axial direction of the bracket), and the sparse zones 151 have larger cell areas relative to the annular part 110;

the cell area in the annulus 110 becomes progressively smaller along the outflow side 102 of the stent, i.e. the inflow end of the annulus 110 has the largest cell area.

The cell frame strips in the ring-shaped portion 110 have a first inclination tendency 181 with respect to the stent axis, the prosthetic heart valve 1 further comprises an inner covering film 220 attached to the inner side of the stent, the inner covering film 220 comprising a first set of wires 171 and a second set of wires 172, each set of wires having a second inclination tendency 182 with respect to the stent axis, the second inclination tendency 182 being identical to the first inclination tendency 181 (see fig. 4).

The outer side of the inner coating 220 is fixed with the peripheral leakage preventing members 160, and each peripheral leakage preventing member 160 is matched with the corresponding cell 111 on the annular portion 110 in position and protrudes radially outward from the corresponding cell.

In this embodiment, the gradual change of shape of the guiding portion 120 is preferably controlled by a wire control method, taking the stent 10 as an example of a self-expandable shape memory material (nickel-titanium alloy), when the valve is delivered in vivo, the stent is wrapped and bound to deform by the outer sheath, the first cell 131 on the outflow side 102 (i.e. near the proximal end of the operator) of the stent is positioned on the delivery system (fig. 3 shows the connection of the pull wire to the stent) by the pull wire, after reaching the predetermined position in vivo, the outer sheath is retracted proximally to gradually expose the valve, the stent is correspondingly expanded, the expansion trend of the proximal end of the stent 10 can be controlled by the pull wire, the valve can be recovered if necessary, for example, the proximal end of the stent is refolded by tightening the pull wire, so that the outer sheath can push and receive the whole valve distally, the shape of the guiding portion 120 is particularly important, on one hand, the annular portion is pulled to make the valve approach to the cone on the whole, in addition, obvious radial turning or protruding is avoided in the process of pushing the outer sheath tube, the resistance of the outer sheath tube is reduced, the pulling force of the pulling wire is transmitted to the whole guiding portion through the first unit cell 131, in the deformation process of the guiding portion, the two branch frame strips 141 and the two edge frame strips 142 need to be compatible with each other in terms of deformation process and provide necessary structural strength for the guiding portion 120, in this embodiment, the acting force exerted by the pulling wire is transmitted to the internal structural unit of the guiding portion 120 through the two branch frame strips 141, so that the two branch frame strips 141 and the edge frame strips 142 on two sides have the same deformation trend, and the two adopted branch frame strips 141 do not cause local protruding generation of the edge frame strips 142 in comparison with other modes, such as a single frame strip or more complex multi-root forms, creating additional resistance to the sheath.

The inner coating is generally connected to the corresponding frame strip at the position of the bracket in a stitching manner, the unit cells of the bracket also correspondingly pull the inner coating to deform when deforming, larger stress can be generated at the wire hole part of the threading suture, even the risk of local tearing of the inner coating exists, the unit cell shapes in the annular part 110 of the embodiment are more regular and uniform, for example, similar quadrilaterals are adopted, so that the deformation of each part of the inner coating is more approximate, and in addition, the deformation of the inner coating, the suture and the bracket in the relative movement or deformation process is more favorably released by virtue of the second inclination trend 182 being the same as the first inclination trend 181, so that the risk of damage of the inner coating is reduced.

The first inclination trend 181 is understood to be the inclination of the unit cell strips in the ring portion 110 with respect to the axial direction of the stent in the flattened state of the stent, such as the two strips thickened in fig. 3 and 4, which are regarded as the same inclination trend due to the same acute angle with respect to the axial direction of the stent although the extending trends are different. The second inclination trend 182 corresponds to the same way as the two sets of lines.

For example, in fig. 5, the knitting angle α of the two sets of threads (the first set of threads 171 and the second set of threads 172) is 30 to 90 degrees (the included angle is the axial direction toward the stent in the drawing) and is arranged to be close to or equal to the cell apex angle (apex angle on the axial side) of the annular portion 110, and the knitting angle α is preferably 45 degrees.

In the proportional relation of the whole guide portion, referring to the embodiment shown in fig. 8 to 9, the stent is based on radial deformation, and has a relatively compressed state and an expanded state, in the expanded state, the axial direction of the annular portion is taken as the length direction, the length of the guide portion 120 is L2, the length of the annular portion 110 is L1, and the following conditions are satisfied: l2=1:0.5 to 1.5. In certain products, L1: l2=1:0.8 to 1.2.

In the connection form of the guide parts 120, one side of each guide part 120 is a connection side 123 butted with a corresponding cell in the axial direction of the ring part 110, and the connection sides 123 of two adjacent guide parts 120 are engaged with each other.

Along the circumferential direction of the annular portion 110, the circumferential length of the connecting side 123 (the junction between the two guide portions 120) is L3 and satisfies L1: l3=0.5 to 1.5:1, for example, 0.7 to 1:1. wherein the circumferential length L3 of the connecting side 123 is to be understood as the arc length in the circumferential direction of the stent.

Uniform convergence in the shape of the guide 120 is understood to be an overall trend, not excluding the edges of the guide 120 being provided with protrusions or depressions at individual locations. Referring to the embodiment shown in fig. 9, the guide 120 extends axially from the annular portion 110 along the annular portion 110, and the path of the extension expands radially outward from the annular portion 110 to a maximum outer diameter 125 before gradually converging.

The annular portion 110 has an axial length of 1 to 2.5 cells. The annular portion 110 is shown as having an axial length of 2.5 cells. The annular portion 110 has a greater axial length near the inflow side than the outflow side. Radial compression during this end recovery or loading is facilitated.

In one embodiment, as shown in fig. 6, in the guiding portion 120, the frame strip 1314 on the outflow side of the first cell 131 has the greatest strength, i.e., the frame strip 1314 on the outflow side is reinforced, e.g., widened and/or thick, to avoid local folding of the clip line during wire control. The outflow side frame 1314 is V-shaped and has an opening facing the inflow side, and when the wire control method is adopted, the force application point of the pulling wire is mainly concentrated at the sharp corner of the V-shape, so that in the preferred embodiment, the strength of the outflow side frame 1314 gradually decreases from the sharp corner of the V-shape to the inflow side, and the deformation trend of the compliance of the guiding part during wire clamping and recovery can be avoided, wherein the change of the strength of the frame can adopt a width gradual change method. For the whole support, the strength (radial rigidity) of the waist is the lowest and gradually strengthens towards the two axial ends of the support, the deformation trend of the guide part during wire control traction is mainly considered about the strength of the outflow side, the strength of the inflow side can ensure good abutting and positioning with peripheral tissues, the stronger radial supporting force of the support is realized, and the displacement after release is avoided.

In order to accommodate compression of the inflow end during stent loading, the inflow side cells have a larger cell area than the outflow side cells. For example, each unit cell on the inflow side is denoted as an end unit cell, and each end unit cell includes four frame strips, two of which are inflow side frame strips, and the other two of which are outflow side frame strips, where the length of the inflow side frame strips is greater than that of the outflow side frame strips, and developing marks may be provided at the intersection of the inflow side frame strips and the outflow side frame strips, for example, the developing marks may be provided in plurality along the circumferential direction.

As shown in fig. 1b, 3 and 6, along the circumferential direction of the annular portion, each guide portion 120 has its own symmetry axis, and the fixed edges 201 of two adjacent leaflets 210 meet at the symmetry axis 122 of the guide portion 120; along the direction of the symmetry axis, the inflow side of the first cell 131 is the second cell 132, the ends of the fixing edges between the two connected leaflets 210 are spliced with each other, and the spliced part 211 is positioned in the second cell 132;

The two branch frame bars 141 connected with the first vertex are uniformly distributed on two sides of the symmetry axis 122 towards the inflow side Zhang Kaiju, and the opening included angle of the two branch frame bars 141 is consistent with the included angle of the two edge frame bars 142 in the guiding part 120.

As shown in fig. 7, the sparse zone 151 includes third cells 133 and fourth cells 134 distributed on both sides of the symmetry axis, the third cells 133 and fourth cells 134 being substantially quadrangular, the cell (third cells and fourth cells) area being 1.5 to 6 times, for example 1.6 to 3.5 times, the cell 111 area in the annular portion 110;

the edge frame strips 142 on both sides of the same opening 121 extend to the inflow side beyond the third cell 133 and the fourth cell 134, respectively, and then meet at the second vertex 1211 of the opening 121.

In the embodiment shown in fig. 9, the first unit cell 131 is a pulling section 1312 on a side remote from the annular portion 110, and the pulling section 1312 is arc-shaped. In the drawing, the first cell 131 has a transition section 1313 shared by the peripheral cells on the side near the annular portion 110, and the transition section 1313 is V-shaped and meets the first vertex 1311.

Referring again to fig. 6, in the overall configuration of the stent 10, the stent 10 is generally a mesh tube structure with a reduced diameter waist 170 in an axially central region. In the figures, the interface of both the guide portion 120 and the annular portion 110 is at the waist portion 170. Further, the interface between the guide portion 120 and the annular portion 110 is adjacent to the minimum outer diameter of the waist 170. In the embodiment shown in the figures, the interface between the guide portion 120 and the annular portion 110 is located at the minimum outer diameter of the waist 170. The opening 121 is further flared and opened away from the annulus 110 by the waist 170, with all of the leaflets 210 converging at the axis of the annulus 110 when closed, the point of intersection being adjacent the waist 170 at a location axially of the annulus 110.

The inner covering film 220 is of a single-layer structure or a multi-layer structure, at least one layer of the inner covering film 220 is a PET fabric layer 221, the inner covering film 220 and the bracket 10 are sewed and fixed by adopting a sewing thread 31, and the sewing thread 31 at least penetrates through the PET fabric layer 221;

The peripheral leakage prevention component is made of PU materials, is fixed on the inner coating film in a plurality of mutually spaced mode, and is fixed with the inner coating film in at least one mode of bonding, thermal fusion, sewing, infiltration or dip coating.

As shown in fig. 10a and 10b, of the two sets of threads constituting the PET fabric layer 221, the respective sets of threads (the first set of threads 171 and the second set of threads 172) have the same density and are woven by a woven method. The suture 31 is threaded through the needle to at least one set of threads to be sutured to the stent 10.

The inner covering film 220 is in a three-layer structure in the figure, and comprises a central PET fabric layer and surface layers 222 on two sides, wherein the surface layers 222 and the PET fabric layer 221 are made of the same or different materials, and are formed in a hot-pressing or dip-coating mode.

As shown in fig. 11, 13 and 14, the peripheral leakage preventing members include a first set of peripheral leakage preventing members 161, which are distributed around the frame 10 and are distributed over the corresponding unit cells 111, and an included angle area 169 (a dashed line frame in fig. 14) is formed between two adjacent peripheral leakage preventing members (for example, the first set of peripheral leakage preventing members 161) along the frame circumferential direction. The perimeter leakage prevention features in the same set are spaced apart circumferentially along the stent with the cell nodes 112 (shaded blocks in fig. 13) in the stent 10 at the spacing 167 (dashed boxes in fig. 13) of adjacent perimeter leakage prevention features. The leakage preventing member 160 is made of a porous material, such as PU.

The peripheral leakage prevention feature 160 may also include a second set of peripheral leakage prevention features 162 distributed about the support in an angled region 169. The second group of peripheral leakage preventing members 162 includes a second turn of peripheral leakage preventing members 162a adjacent to the outflow side of the first group of peripheral leakage preventing members 161 and a third turn of peripheral leakage preventing members 162b on the inflow side. Wherein the first group of peripheral leakage preventing members 161 is arranged to cover the entire unit cell 111, the second group of peripheral leakage preventing members 162 has a triangular outer contour, and the axial length of the second ring of peripheral leakage preventing members 162a and the third ring of peripheral leakage preventing members 162b is half of the unit cell 111.

The inner coating 220 has a thickness variation in the flattened state as a whole with the leakage preventing member 160; the peripheral leakage preventing member 160 is positioned to have a greater thickness. As shown in fig. 12, the same leakage preventing member 160 has different convex heights at different positions, and gradually increases in thickness from the outflow side 102 to the inflow side 101, and gradually decreases in thickness from the position where the convex (in the radial direction of the stent) is highest. The change in thickness facilitates recovery of the highest protruding portion. The point of greatest outward elevation is closer to the inflow side 101.

The distance between the maximum point of the convex height and the inflow side 101 of the cell 111 is S1, and the distance between the maximum point of the convex height and the outflow side 102 of the cell 111 is S2, wherein S1: s2 is 0.2-0.8.

As shown in fig. 15, the inner film 220 is formed in a strip shape extending in the circumferential direction as a whole, and the front and rear sides of the inner film 220 are formed with substantially complementary detour shapes 223 and 224 at the front and rear split positions. The width of the roundabout shape 223 and 224 corresponds to the shape of the side edge of the leakage preventing member 160.

In fig. 16-18, the outflow side 102 of the inner covering film 220 is spliced with the fixation edge 201 of the leaflet 210, and the peripheral leakage preventing member 160 is directly fixed to the inner covering film 220, or the peripheral leakage preventing member 160 has a wrapping layer 168 on the outer periphery thereof, and is fixed to the inner covering film 220 together with the wrapping layer 168;

The wrapping layer 168 is of a single-layer structure and integrally abuts against the outer side of the peripheral leakage preventing member 160, or the wrapping layer 168 is of a multi-layer structure and wraps the inner side and the outer side of the peripheral leakage preventing member 160, and the multi-layer structure is fixedly stacked by adopting split sheet materials.

In some embodiments, different connection means between the peri-leak prevention member, the wrap, the inner cover and the stent are provided:

As shown in fig. 16, the wrapping layer 168 is of a single-layer structure and is abutted against the outer side of the peripheral leakage preventing member 160, the edge of the wrapping layer 168 is abutted against and fixed with the outer side of the inner covering film 220, for example, stitching or the like is adopted, and the abutted portion is located at the inner side of the frame strip 1111;

As shown in fig. 17, the wrapping layer 168 has a two-layer structure and is disposed on both inner and outer sides of the peripheral leakage preventing member 160, i.e., the peripheral leakage preventing member 160 is wrapped in its entirety. Wherein the two layers are in an integrated structure and are folded at the inflow side of the peripheral leakage preventing member 160 and wrapped at the inner and outer sides of the peripheral leakage preventing member.

As shown in fig. 18, the wrapping layer 168 is a single layer structure and is abutted against the outer side of the peripheral leakage preventing member 160, and wraps the adjacent unit cell frame strips 1111 together.

An embodiment of the present application further provides another prosthetic heart valve, as shown in fig. 19 and 20, where only the stent 10 is illustrated, the stent includes an annular portion 110 and a plurality of guide portions 120 disposed at intervals on an outflow side 102 of the annular portion, an opening portion 121 is disposed between two adjacent guide portions 120, the outflow side 102 of each guide portion 120 gradually converges to a distal first cell 131 for guiding a pulling wire, the first cell 131 has a first vertex 1311 at an inflow side 101, two branch frame bars 141 extending further toward the inflow side 101 are connected through the first vertex 1311, and two edge frame bars 142 extending toward the inflow side 101 are connected to two circumferential sides of the first cell 131.

Each of the guide portions 120 has its own symmetry axis 122 along the circumferential direction of the annular portion, and the inflow side of the first cell 131 is the second cell 132 along the symmetry axis direction. The guide 120 further includes third cells 133 and fourth cells 134 distributed on both sides of the symmetry axis.

Compared with the previous embodiment, the difference is mainly that the third cell 133 and the fourth cell 134 are characterized by their shape, on the basis of being parallelograms in general, the difference between the long side and the short side is more obvious, the length ratio of the two is 1.5-3, and one long side is the edge frame strip 142. And the area is about 1.5 to 3 times that of the first unit cell.

The number of cells in the circumferential direction of the annular portion 110 is 12, but the number of cells may be adjusted according to the size of the stent, for example, 15 cells, and the axial length of the annular portion 110 is 2 cells.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description. When technical features of different embodiments are embodied in the same drawing, the drawing can be regarded as a combination of the embodiments concerned also being disclosed at the same time.

The above examples illustrate only a few embodiments of the application, which are described in detail and are not to be construed as limiting the scope of the claims. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the application, which are all within the scope of the application.

Claims

1. The artificial heart valve is characterized by comprising a bracket and valve blades, wherein the bracket is of a net barrel structure as a whole, a blood flow channel is arranged in the bracket, the valve blades are multiple, and the valve blades are positioned in the blood flow channel and are mutually matched to control the blood flow channel; the edges of the valve leaflets comprise fixed edges connected to the bracket and free edges which are matched with other valve leaflets to control the blood flow channel;

The support comprises an annular part and a plurality of guide parts which are arranged at intervals on the outflow side of the annular part, an opening part is arranged between two adjacent guide parts, and the shape of the outflow side of each guide part gradually converges to a first cell at the tail end;

the prosthetic heart valve further comprises an inner covering film connected to the inner side of the support, and the inner covering film is of a multi-layer structure.

2. The prosthetic heart valve of claim 1, wherein the stent is of a self-expandable shape memory material, wherein the prosthetic heart valve is delivered in vivo by wrapping and constraining the stent deformation with an outer sheath, and wherein the first cell is positioned in the delivery system by a pull wire.

3. The prosthetic heart valve of claim 1, wherein the cells in the annulus are uniform in shape and take the form of an approximate quadrilateral.

4. The prosthetic heart valve of claim 1, wherein the inner covering comprises a first set of wires and a second set of wires, the wires of the two sets having a braid angle oriented in a stent axial direction, the braid angle being approximately or equal to a cell apex angle of the annulus.

5. The prosthetic heart valve of claim 4, wherein the braid angle is 30-90 degrees, preferably 45 degrees.

6. The prosthetic heart valve of claim 1, wherein the inner covering comprises a first set of wires and a second set of wires, the two sets of wires having a braid angle oriented in a stent axial direction, the braid angle being between 30 and 90 degrees.

7. The prosthetic heart valve of claim 6, wherein the braid angle is 45 degrees.

8. The prosthetic heart valve of claim 1, wherein the inner cover is a three-layer structure comprising a central PET fabric layer and two side skin layers, the skin layers being of the same or different materials as the PET fabric layer.

9. The prosthetic heart valve of claim 8, wherein the PET fabric layer is comprised of the first set of threads and the second set of threads, and wherein the density of the threads of each set is the same in the two sets of threads comprising the PET fabric layer.

10. The prosthetic heart valve of claim 8, wherein the skin layer and the PET fabric layer are formed by hot pressing or dip coating.

11. The prosthetic heart valve of claim 10, wherein the PET fabric layer is comprised of the first set of threads and the second set of threads, and wherein the density of the threads of each set is the same in the two sets of threads comprising the PET fabric layer.

12. The prosthetic heart valve of claim 1, wherein the inner cover has peripheral leakage prevention members secured to an outer side thereof, each peripheral leakage prevention member being positioned to mate with and radially outwardly protrude from a corresponding cell on the annular portion.

13. The prosthetic heart valve of claim 12, wherein the leak-proof member has a wrap around a periphery.

14. The prosthetic heart valve of claim 13, wherein the wrap layer abuts an outer side of the peripheral leak resistant member.

15. The prosthetic heart valve of claim 13, wherein the wrap is a two-layer structure, the wrap wrapping surrounding the leak-resistant member on both the inner and outer sides of the leak-resistant member.

16. The prosthetic heart valve of claim 12, wherein the leak-resistant member is secured to the inner cover by at least one of bonding, thermal fusion, sewing, infiltration, or dip coating.

17. The prosthetic heart valve of claim 12, wherein the leak-proof member is a plurality of pieces and is secured to the inner cover in spaced relation to one another.

18. The prosthetic heart valve of claim 17, wherein the perileak-resistant member comprises a plurality of axially-distributed sets.

19. The prosthetic heart valve of claim 18, wherein the perileak prevention component comprises:

The first group of peripheral leakage prevention components are distributed around the bracket, and an included angle area is formed between two adjacent peripheral leakage prevention components along the circumferential direction of the bracket;

the second group of peripheral leakage prevention components are distributed in the included angle area around the bracket;

The peripheral leakage preventing members in the same group are arranged along the circumferential direction, and the cell nodes in the bracket are positioned at the interval regions of the adjacent peripheral leakage preventing members.

20. The prosthetic heart valve of claim 12, wherein the leak-proof member is a porous material.

21. The prosthetic heart valve of claim 12, wherein the peripheral leak prevention member is located on the inflow side of the annulus to match a cell location corresponding to the distal-most end of the stent.