CN112754733A

CN112754733A - Heart valve

Info

Publication number: CN112754733A
Application number: CN202110103286.6A
Authority: CN
Inventors: 刘香东
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Shenzhen Jianxin Medical Technology Co ltd
Priority date: 2017-11-21
Filing date: 2017-11-21
Publication date: 2021-05-07
Anticipated expiration: 2037-11-21
Also published as: CN112754733B; CN109806028A; CN109806028B

Abstract

The invention relates to a heart valve, which comprises a support and a flow blocking element, wherein the support comprises a valve leaflet support and a first skirt support, the flow blocking element covers the valve leaflet support, the first skirt support extends outwards from the valve leaflet support along the radial direction of the valve leaflet support, the valve leaflet support is provided with an inflow end and an outflow end opposite to the inflow end, the support further comprises an elastic element arranged between the outflow end of the valve leaflet support and the first skirt support, and the elastic element protrudes outwards along the radial direction of the valve leaflet support and/or protrudes towards the direction of the outflow end. The heart valve can reduce the risk of paravalvular leakage after implantation.

Description

Heart valve

The invention is a divisional application with the application number of 201711167119.8, the application date of 2017-11-21 and the invention name of heart valve.

Technical Field

The invention relates to a medical apparatus, in particular to a heart valve.

Background

Heart valve disease is a very common heart condition, with valve damage from rheumatic heat being one of the most common causes. With the aging and the increasing population, senile valvular diseases and valvular diseases caused by coronary heart disease myocardial infarction are more and more common. These valvular lesions not only endanger life safety and affect quality of life, but also place a heavy burden and stress on the family and society. The heart of a human body is divided into four heart chambers, namely a left atrium, a left ventricle, a right atrium and a right ventricle, wherein the two atria are respectively connected with the two ventricles, and the two ventricles are connected with the two main arteries. The heart valve grows between the atrium and the ventricle and between the ventricle and the aorta, and plays the role of a one-way valve to help the blood flow move in a single direction. The four valves of the body are called the mitral valve, the tricuspid valve, the aortic valve, and the pulmonary valve, respectively. These valves, if diseased, can affect the movement of blood flow, causing cardiac dysfunction, ultimately leading to heart failure.

In recent years, percutaneous transcervical mitral valve replacement can be performed for patients with mitral stenosis and regurgitation, i.e. the procedure is performed by implanting a heart valve through an interventional and minimally invasive method, so that the patients avoid the pain of an open chest operation. However, the existing heart valve is not tightly attached to the mitral valve ring after being implanted into the heart of a human body, and is easy to cause paravalvular leakage.

Disclosure of Invention

In view of this, there is a need for a heart valve that reduces the risk of paravalvular leakage after implantation.

A heart valve comprising a stent including a leaflet stent and a first skirt stent extending outwardly from the leaflet stent, the leaflet stent having an inflow end and an outflow end opposite the inflow end, wherein the stent further comprises a resilient member disposed between the outflow end of the leaflet stent and the first skirt stent, the resilient member bulging outwardly and/or the resilient member bulging in a direction toward the outflow end;

the elastic part comprises a plurality of elastic wires arranged around the periphery of the valve leaflet bracket;

the elastic wires are connected with each other to form a circle of wavy ring, the wavy ring comprises a plurality of distal end vertexes, a plurality of proximal end vertexes and a support body for connecting the adjacent distal end vertexes and proximal end vertexes, and the proximal end vertexes are fixedly connected with the valve leaflet support;

and the distal end vertexes are fixedly connected with the first skirt edge support.

According to the heart valve, when a gap is formed between the leaflet bracket or the first skirt bracket and the mitral valve annulus, the elastic element can fill the gap between the leaflet bracket or the first skirt bracket and the mitral valve annulus, and when the leaflet bracket or the first skirt bracket is close to the mitral valve annulus, the elastic element can be sunken towards the radial direction or the axial direction so as to adapt to the shape of the mitral valve annulus, so that the effect of blocking blood flow and preventing paravalvular leakage is achieved.

Drawings

FIG. 1 is a schematic structural view of one embodiment of a heart valve;

FIG. 2 is a schematic view of the heart valve of FIG. 1 implanted in a heart;

FIG. 3 is a schematic partial structural view of the heart valve of FIG. 1;

FIG. 4 is a schematic structural view of a stent of the heart valve of FIG. 1;

FIG. 5 is a schematic structural view of the elastic member of FIG. 1;

FIG. 6 is a plan expanded view of the stand of FIG. 1;

FIG. 7 is a partial cross-sectional view of the heart valve of FIG. 1 after attachment to the hollow wire cable;

FIG. 8 is a schematic view of an angled configuration of a connector of the heart valve of FIG. 1;

FIG. 9 is a schematic view of the heart valve of FIG. 1 in engagement with the mitral annulus;

FIG. 10 is a schematic structural view of another embodiment of a heart valve;

FIG. 11 is a plan expanded view of the stand of FIG. 10;

FIG. 12 is a schematic structural view of another embodiment of a heart valve;

FIG. 13 is a schematic view of the heart valve of FIG. 12 in engagement with the mitral annulus;

FIG. 14 is a schematic structural view of another embodiment of a heart valve;

FIG. 15 is a schematic structural view of another embodiment of a heart valve;

figure 16 is a schematic view of the heart valve of figure 15 in engagement with the mitral annulus.

Detailed Description

To facilitate an understanding of the invention, the invention will now be described more fully with reference to the accompanying drawings. Preferred embodiments of the present invention are shown in the drawings. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

It will be understood that when an element is referred to as being "secured to" another element, it can be directly on the other element or intervening elements may also be present. 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. The terms "vertical," "horizontal," "left," "right," "up," "down," "far," "near," and the like as used herein are for illustrative purposes only.

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 invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items.

Referring to fig. 1 and fig. 2, in the present embodiment, the structure of the heart valve 100 is described by taking a mitral valve as an example, but in other embodiments, the heart valve 100 is not limited to the mitral valve shown in fig. 1, and may be other types of artificial valves, such as a pulmonary valve and an aortic valve.

Referring to fig. 2 and 3, the heart valve 100 includes a stent 110, a flow blocking element 120, a connecting element 130, a tether 150, and valve leaflets 190.

Referring to fig. 4, the frame 110 includes a leaflet frame 112, a first skirt frame 114, a link 116, and an elastic member 118.

The leaflet braces 112 are generally cylindrical in shape, having an inflow end and an outflow end disposed opposite the inflow end. In the illustrated embodiment, the leaflet support 112 includes a plurality of undulating rings 1121 and a plurality of connecting rods 1123 disposed at intervals in the axial direction of the leaflet support 112. The wave rings 1121 provide radial support for the leaflet brace 112, and in the illustrated embodiment, the leaflet brace 112 includes three wave rings 1121. The three wave rings 1121 are connected and fixed by a plurality of connecting rods 1123. The number of the connecting rods 1123 is the same as the number of the wave troughs of the wave rings 1121, and one connecting rod 1123 is fixedly connected with the wave troughs of three wave rings 1121 at the same time. Of course, in other embodiments, the connecting rod 1123 may be fixedly connected to other positions of the wave ring 1121, such as the wave crest.

Referring to fig. 4, the first skirt bracket 114 includes a first supporting portion 1141 and a first tilting portion 1143. The first support portion 1141 extends outward from the leaflet support 112 in a radial direction of the leaflet support 112, and the first tilting portion 1143 extends from one end of the first support portion 1141 away from the leaflet support 112 to an inflow end of the leaflet support 112. The first support 1141 is used for fixation of the heart valve 100 at the human mitral annulus of the heart 20, and the first raised portion 1143 is used to prevent abrasion of left atrial tissue by the edge (i.e., distal edge) of the first support 1141 away from the leaflet brace 112. Without the first raised portion 1143, the distal edge of the radial first support portion 1141 directly contacts the atrial tissue, and under long-term heart beating, the distal edge of the first support portion 1141 may have a cutting effect on the atrial tissue, causing damage to the atrial tissue. By providing the first raised portion 1143, the line contact between the first skirt support 114 and the atrial tissue is changed into surface contact, increasing the contact area, reducing the contact pressure, and avoiding the cutting effect of the first skirt support 114 on the cardiac tissue and the resulting abrasion.

In the embodiment shown in fig. 4, the first support portion 1141 of the skirt stent 114 is fixedly connected to the valley of the wave ring 1121 near the inflow end of the leaflet stent 112. Thus, when the heart valve 100 is implanted in the heart 20, approximately one third of the axial dimension of the leaflet frame 112 can be located in the left atrium, thereby avoiding the stenosis and even obstruction of the left ventricular outflow tract caused by the excessive implantation of the leaflet frame 112 in the left ventricle.

It should be noted that the leaflet bracket 112 is not limited to include the wave ring 1121 and the connecting rod 1123, and may also be in other structures, for example, the leaflet bracket 112 includes a plurality of wave rings, the wave troughs and the wave crests of two adjacent wave rings cooperate to form a quadrilateral structure, and the leaflet bracket 112 is formed by a plurality of diamond frames arranged in an array. Of course, the first skirt stent does not have to be connected to the valley of the wave ring 1121, as long as the distance between the end of the skirt stent 114 close to the leaflet stent 112 and the inflow end is approximately 1/4-1/2 of the axial length of the leaflet stent 112, preferably one third. Of course, it is also possible to adjust the distance between the end of the first skirt stent 114 near the leaflet stent 112 and the inflow end to be not exactly the same, i.e., the end of the skirt stent 114 near the leaflet stent 112 has a height difference in the axial direction of the leaflet stent 112, as desired.

The width of the first supporting portion 1141 of the skirt support 114 is 2mm to 6mm, so as to sufficiently ensure the fixation of the heart valve 100 at the mitral valve annulus of the human heart. Here, the width of the first support portion 1141 refers to a distance between one end of the first support portion 1141 near the first raised portion 1143 and the leaflet brace 112. In this embodiment, the width of the first supporting portion 1141 is 4 mm.

The height of the first tilting portion 1143 is 2mm to 6 mm. Here, the height of the first tilting portion 1143 refers to a distance between an end of the first tilting portion 1143 away from the first support portion 1141 and an end close to the first support portion 1141. If the height of the first raised portion 1143 is less than 2mm, abrasion of the edge of the skirt stent 114 to heart tissue cannot be prevented, and if the height is greater than 6mm, other tissue of the left atrium may be injured. In this embodiment, the height of the first tilting portion 1143 is 4 mm.

In this embodiment, the outer contour of the first support portion 1141 of the skirt holder 114 is circular when viewed from the inflow side of the valve blood flow. Of course, in other embodiments, the outer contour of the first supporting portion 1141 may have other shapes, such as a D shape or a D-like shape.

Referring again to fig. 3 and 6, links 116 include a proximal link 1162, a leaflet brace link 1164, and a joint 1166. The proximal link 1162 is substantially rod-shaped. The leaflet support link 1164 is substantially V-shaped and includes two struts extending from one end of the proximal link 1162 to the leaflet support 112, one end of the two struts distal from the proximal link 1162 is fixedly connected to two troughs adjacent to the wave ring of the leaflet support 112 near the outflow end, each trough is connected to one strut, so that the plurality of links 116 are uniformly distributed along the outflow end, thereby guiding when the heart valve 100 is retracted into the sheath tube and preventing the troughs from being stuck outside the sheath tube. If the leaflet support links 1164 are attached to the leaflet support 112 at the peaks of the wave circle near the outflow end, the troughs can become lodged outside the sheath when the heart valve 100 is being sheathed.

It is understood that the leaflet bracket links 1164 can also have other shapes, for example, can be in-line extending from one end of the proximal links 1162 directly to connect with the valleys at the outflow end of the leaflet bracket, i.e., the number of struts is the same as the number of proximal links 1162.

Referring to fig. 6, a junction 1166 is formed at an end of the proximal link 1162 distal to the leaflet brace link 1164. In the illustrated embodiment, the joint 1166 is generally rod-shaped and extends perpendicular to the proximal link 1162, although in other embodiments, the joint 1166 may be trapezoidal, triangular, disc-shaped, or spherical.

In the illustrated embodiment, the entire stent 110, i.e., the leaflet stent 112, the first skirt stent 114, and the link 116, are cut from the same tube and are formed as a single piece. A schematic plan-view unfolded structure of the stent 100 obtained by the integral cutting is shown in fig. 6. Of course, it should be noted that fig. 6 is an expanded view, and the stent 110 is still substantially tubular after being integrally cut from the tube, and is shaped by the heat treatment process under the action of the shaping mold to the shape shown in fig. 4. The relatively components of a whole that can function independently cutting of integrative cutting is assembled afterwards, has the advantage that radial dimension is little after the compression, goes into the sheath easily, does not have welding or mosaic structure between each part of integrated into one piece's support 100 simultaneously to the fatigue resistance ability of support 100 has also been improved. In the embodiment, the stent 110 is formed by cutting a superelastic nickel-titanium metal tube with a diameter of 6-10 mm and a wall thickness of 0.3-0.5 mm.

Referring to fig. 3, the flow blocking element 120 covers the surface of the leaflet support 112, and the flow blocking element 120 is used to block blood flow flowing out through the support 110, and cooperates with the leaflets 190 to ensure unidirectional blood flow in the heart valve 100. The choke piece 120 is made of PTFE cloth or film, PET cloth or film, PU cloth or film, PA cloth or film, casing or animal core. The flow blocking member 120 may be attached to the leaflet braces 112 by a heat and pressure process or by sewing, depending on the material. In the present embodiment, referring to fig. 1 and 2, the flow-blocking element 120 wraps around the inner and outer surfaces of the leaflet holders 112 and the first skirt holder 114. By covering the surface of the first skirt stent 114 with the obstructing component 120, the contact area of the first skirt stent 114 and the heart tissue can be increased, the contact pressure can be reduced, and the climbing of the heart endothelial tissue on the surface of the heart valve 100 can be accelerated, so that the thrombogenicity of the heart valve 100 can be reduced. In one embodiment, to accelerate the coating of endothelial tissue on the surface of the heart valve 100, the non-biological tissue surface of the heart valve 100 can be deposited with a parylene layer. In one embodiment, the surface of the baffle 120 may be formed with a parylene layer. The thickness of the parylene layer is 1-5 microns. Preferably, the material of the parylene layer is parylene C.

In one embodiment, a hydrogel layer (not shown) may be disposed between the spoiler 120 and the bracket 110. The material of the hydrogel layer is at least one selected from polyvinyl alcohol and polyurethane. In one embodiment, the hydrogel layer is coated on a surface of the spoiler 120 adjacent to the bracket 110. Of course, in other embodiments, the hydrogel layer may be secured between the spoiler 120 and the bracket 110 by stitching. When the heart valve 100 is implanted in the human heart 20, the hydrogel swells in the presence of water, expanding the site of the resistive element 120. If a gap exists between the heart valve 100 and the mitral valve tissue after being implanted in the heart of a human body, the expanding hydrogel layer causes the flow blocking member 120 to expand outward, thereby blocking the gap and reducing the risk of paravalvular leakage.

Referring to fig. 1, the flow blocking element 120 has the same contour at the end near the outflow end of the leaflet braces 112 as the outflow end of the leaflet braces 112. In the illustrated embodiment, the wave ring 1121 is located at one end of the leaflet bracket close to the connecting rod 116 and is fixedly connected to the connecting rod 116, the profile of the outflow end of the leaflet bracket 112, that is, the profile of the wave ring 1121, is saw-toothed, and the profile of the end of the spoiler 120 close to the outflow end of the leaflet bracket 112 is saw-toothed and is the same as the profile of the outflow end of the leaflet bracket 112, so that not only can the spoiler 120 be prevented from protruding and being stuck outside the sheath when the heart valve 100 is radially compressed into the sheath, but also the left ventricular outflow tract can be prevented from being narrowed due to excessive spoiler 120 in the left ventricle. The end of the obstructing component 120 near the outflow end of the leaflet brace 112 is sutured to the wave ring 1121 by a suture thread. Preferably, the resistive element 120 is sutured inside the loop 1121 to prevent the resistive element 120 from protruding when the heart valve 100 is retracted into the sheath, causing it to become lodged outside the sheath.

Of course, in other embodiments, the outflow end of the leaflet holder 112 is not serrated, and in this case, the shape of the end of the spoiler 120 near the outflow end of the leaflet holder 112 may be changed accordingly, and if the two profiles are the same and the spoiler 120 is sewn inside the wave ring 1121, the spoiler 120 may be prevented from protruding when the sheath is retracted.

Referring to fig. 4, the elastic member 118 is disposed between the outflow end of the leaflet holders 112 and the first skirt holder 114, and the elastic member 118 protrudes outward in the radial direction of the leaflet holders 112. Specifically, the elastic member 118 includes a plurality of elastic wires disposed around the outer circumference of the leaflet frame 112, the elastic wires extending outward from the leaflet frame 112 in the radial direction of the leaflet frame, one end of the elastic wires being connected to the leaflet frame 112, and the other end of the elastic wires being connected to the first skirt frame 114. Referring to fig. 5, a plurality of elastic wires are connected to each other to form a ring of corrugated ring, the corrugated ring includes a plurality of distal vertices 1181, a plurality of proximal vertices 1183, and a support 1182 connecting the adjacent distal vertices 1181 and proximal vertices 1183, the plurality of distal vertices 1181 are respectively connected to the first skirt frame 114, and the plurality of proximal vertices 1183 are respectively connected to the leaflet frame 112, so as to reduce the number of connection points between the elastic element 118 and the leaflet frame 112 and the first skirt frame 114, and improve the connection strength between the elastic element and the leaflet frame 112 and the first skirt frame 114. In the illustrated embodiment, a plurality of distal apices 1181 are each fixedly connected to an end of the first support portion 1141 distal to the leaflet brace 112. The plurality of proximal vertices 1183 are located on the same circumferential plane perpendicular to the central longitudinal axis of the leaflet brace 112, i.e., the points of attachment of the plurality of proximal vertices 1183 to the leaflet brace 112 have no height difference in the axial direction of the leaflet brace 112. In the illustrated embodiment, each proximal apex 1183 is secured at a trough of the leaflet brace 112.

It should be noted that the elastic member 118 is not necessarily limited to an elastic wire. The elastic member 118 may be configured to be deformable under a certain force. For example, an elastic covering membrane having two ends fixed to the leaflet holders 112 and the first skirt holder 114, respectively; as another example, an annular elastic sponge is disposed between the leaflet braces 112 and the first skirt brace 114. The sponge has an inner diameter equal to the outer diameter of the leaflet holders 112 and an outer diameter equal to the outer diameter of the first support portion 1141 of the skirt holder 114. The sponge is fixed to the leaflet brackets 112 and the first support portion 1141 by a suture method, or fixed to the spoiler 120 by a suture method. In order to achieve a better flow choking effect, the surface of the sponge can be also provided with a flow choking film.

Of course, in other embodiments, the distal apex 1181 may not be attached to the first skirt hanger 114 at any location, and only the proximal apex 1183 may be attached to the leaflet hanger 112. In other embodiments, the distal apex 1181 can be attached to the first skirt hanger 114 at other locations, and the proximal apex 1183 can be attached to the leaflet holders 112 at axially different locations. The position of each of the distal apices and the proximal apices in the leaflet braces 112 and the first skirt brace 114 can be adjusted as appropriate.

It is understood that in other embodiments, the plurality of elastic wires may not be connected. For example, the leaflet holders 112 are provided at their outer peripheries with a plurality of mutually parallel elastic wires, each of which has one end connected to the leaflet holder 112 and the other end connected to the first skirt holder 114.

To facilitate the insertion of the heart valve 100 into the sheath, for example, the length of each elastic wire is approximately equal to the sum of the distance from the end of the first skirt stent 114 where the elastic wire is fixed to the leaflet stent 112 and the axial distance from the position where the leaflet stent 112 is fixed to the elastic wire to the end of the first skirt stent 114 where the first skirt stent 114 is close to the leaflet stent 112, and the length of each elastic wire is equal to the distance from the position where the first skirt stent is fixed to the elastic wire to the position where the leaflet stent 112 is fixed to the elastic wire, ignoring the circumferential length of the two ends of the elastic wire after the heart valve 100 is compressed into the sheath. Specifically, in this embodiment, the length of the supporting body 1182 is substantially equal to the sum of the distance from the distal vertex 1181 connected to the supporting body 1182 to the leaflet frame 112 and the axial distance from the proximal vertex 1183 connected to the supporting body 1182 to the end of the first skirt frame 114 close to the leaflet frame 112, so as to avoid the situation that the supporting body 1182 is folded after being installed in the sheath, and facilitate the installation of the heart valve 100 in the sheath. Referring to fig. 6, the leaflet frame 112 and the first skirt frame 114 are formed with a plurality of fixing holes 115, and each elastic wire is fixed beside the corresponding fixing hole 115 by a suture thread passing through at least one of the fixing holes 115. Specifically, when the heart valve 100 is mounted in the sheath, the length of each elastic wire is substantially equal to the distance between the two fixing holes 115 fixed to the elastic wire. Specifically, each distal apex 1181 or proximal apex 1183 is secured to the respective first skirt stent 114 or leaflet stent 112 via two securing holes 115. For example, a suture can be secured to the leaflet brace 112 by passing through two of the securing holes 115 with one of the proximal vertices 1183.

With continued reference to fig. 1, the elastic filaments are also covered with a fluid-blocking film 119. In the illustrated embodiment, the obstructing membrane 119 covers all of the elastic wires, forming an annular structure around the periphery of the leaflet braces 112. It should be noted that in other embodiments, the flow blocking film 119 may be a discontinuous structure. For example, the flow-blocking film 119 may cover only a portion of the elastic filaments, or the flow-blocking film 119 may be broken between two adjacent elastic filaments. The material of the choke membrane 119 is PET, PU, PA, PTFE, or the like, and the material of the choke membrane 119 may be the same as or different from that of the choke element 120. In this embodiment, the current blocking films 119 are fixed to the inner and outer surfaces of the elastic wire by heat pressing. Of course, in other embodiments, stitching or the like may be used. The ends of the flow-blocking film 119 may be flush with or extend beyond the ends of the elastic wire.

Furthermore, elastic material may be filled between the obstructing membrane 119 and the leaflet holders 112 and/or the first skirt holders 114 to improve the fitting effect between the elastic member and the mitral valve annulus, and further improve the obstructing effect. The elastic material may be a sponge or the like.

In this embodiment, the elastic wire is the nickel titanium wire that the wire footpath is 0.002 ~ 0.006 inch, and deformability is better, can fully fill the clearance between mitral valve ring and the heart valve tissue, better prevention valve periphery is leaked.

Referring to fig. 1, 4, 7 and 8, the joint 1166 of the connecting rod 116 of the bracket 110 is connected to the connecting member 130. The connecting member 130 includes a socket 132 and a connecting cover 134. In the illustrated embodiment, the socket 132 has a substantially cylindrical shape, one end of which is recessed to form a receiving slot 1322, and the other end of which is opened with a screw hole 1324. The screw hole 1324 communicates with the receiving groove 1322. In the illustrated embodiment, the end of the socket 132 with the screw hole 1324 is gradually contracted to a frustum shape, so as to reduce the influence on the cardiac tissue or the sheath. In one embodiment, the heart valve 100 further comprises a hollow steel cable 30 for assisting in the delivery of the heart valve 100. The threaded hole 1324 can be connected to a hollow wire cable 30 for transporting the heart valve 100, and one end of the hollow wire cable 30 can be screwed into the threaded hole 1324, so that the one end of the hollow wire cable 30 is fixed to the connector 130 and can be disconnected by rotation. The hollow wire cable 30 can act to push and pull the heart valve 100 when the heart valve 100 is being delivered in the delivery sheath, allowing the heart valve 100 to move within the delivery sheath lumen, and the heart valve 100 can also be pulled back into the delivery sheath again by the hollow wire cable 30 after the heart valve 100 is released from the delivery sheath.

The connection cover 134 is disposed and fixed in the receiving groove 1322. In the illustrated embodiment, the connection cover 134 is accommodated in the accommodation groove 1322 and fixed to a groove wall of the accommodation groove 1322 by welding. The connecting cover 134 has a plurality of limiting holes 1342. The connecting rod 116 is disposed through the limiting hole 1342, and the joint 1166 is received in the receiving slot 1322. Tab 1166 abuts a side surface of connecting cover 134 adjacent to threaded bore 1324. In the illustrated embodiment, the tab 1166 has at least one dimension that is larger than the diameter of the retention hole 1342 to prevent the tab 1166 from falling out of the retention hole 1342.

A stopper 152 is formed at one end of the tether 150, and the tether 150 is fixed to the link 130 through the stopper 152. The tether 150 is inserted into the screw hole 1324 and the blocking portion 152 is received in the receiving slot 1322. The size of the blocking portion 152 in one dimension is larger than the inner diameter of the screw hole 1324, thereby preventing the blocking portion 152 from falling off from the screw hole 1324. The tether 150 is made of at least one material selected from polyester, nylon, ultra-high molecular weight polyethylene, nickel titanium, and stainless steel woven wires. In the illustrated embodiment, the blocking portion 152 is a knot formed by knotting one end of the tether 150. Of course, in other embodiments, the tether 150 may have another structure formed at one end thereof, as long as the tether 150 is prevented from falling off the screw hole 1324. In use, the tether 150 extends outwardly from the receptacle 1322 and through the inner bore of the hollow cable 30.

Referring again to fig. 2, the heart valve 100 may also include a spacer 160. The gasket 160 is made of at least one of silicone, polyester, nylon, ultra-high molecular weight polyethylene, nickel titanium, and stainless steel woven wire. The gasket 160 may be a felt-like disc, a titanium-nickel wire woven disc, or a polymer injection molded disc. When the heart valve 100 is implanted in the human heart 20, the end of the tether 150 remote from the rod 116 is passed through the heart 20 and the pad 160 and tied to form the anchor 154 fixed to the pad 160.

Referring again to fig. 3, the leaflets 190 are positioned within the leaflet braces 112 and are secured to the flow resistance elements 170 on the inner surface of the leaflet braces 112. Of course, in other embodiments, when the flow blocking element 170 is not disposed on the inner surface of the leaflet holders 112, the leaflets 190 can be directly fixed to the leaflet holders 112. The leaflet 190 is cut from the animal pericardium. In the illustrated embodiment, the leaflets 190 are generally fan-shaped, having a total of three pieces, arranged in series along the circumference of the leaflet brace 112. The ends of two adjacent leaflets 190 near the inner surface of the leaflet support 112 are joined together to form a leaflet angle 192, and the peripheral edges of the leaflets 190 are fixed to the leaflet support 112 and the flow preventing member 120 by sewing. In one embodiment, the petal angle 192 is fixed to the connection of the link 116 and the leaflet braces 112.

Referring also to fig. 2, when the heart valve 100 is implanted in a human heart 20, the skirt support 114 of the heart valve 100 secures the heart valve 100 to the mitral valve annulus 16, and the end of the tether 150 distal from the rod 116 is secured through the heart 20 and the spacer 160. Referring also to fig. 9, after the heart valve 100 is implanted, the resilient member 118 is positioned at the mitral annulus 16, as shown on the left side of fig. 9, when the leaflet holders 112 or the first skirt holder 114 are positioned close to the mitral valve annulus 16, the resilient element (which is obscured by the occluding membrane 119) and with it the occluding membrane 119 on the resilient element will be recessed in the radial direction and/or in the direction of the inflow end, to adapt to the contour of the mitral valve annulus 16, and to keep the outer surface thereof attached to the contact surface of the mitral valve annulus 16, so as to block blood flow and prevent paravalvular leakage, as shown in the right side of fig. 9, when the leaflet holders 112 or the first skirt holder 114 are gapped from the mitral valve annulus 16, since the elastic member is protruded toward the radial direction of the leaflet support 112 and/or toward the outflow end together with the flow blocking film 119 on the elastic member, to fill the gap between the leaflet brace 112 and the mitral annulus 16, blocking blood flow and preventing paravalvular leakage.

The heart valve 100 described above has the following advantages:

1) the bracket 110 is integrally cut and formed, so that sheathing force and the risk of fracture failure can be reduced, welding is not required, and the risk of structural strength reduction caused by insufficient welding and the like can be avoided;

2) the first supporting portion 1141 of the skirt stent 114 is fixedly connected to the wave trough of the leaflet stent 112 far from the wave ring 1121 of the connecting rod 116, so that when the heart valve 100 is implanted into the heart 20, approximately one third of the axial dimension of the leaflet stent 112 can be positioned in the left atrium, thereby avoiding the risk of left ventricular outflow stenosis and even obstruction caused by too much implantation of the leaflet stent 112 into the left ventricle;

3) the end of the connecting piece 130, which is far away from the connecting rod 116, is provided with a screw hole 1324, so that the connecting piece 130 and the hollow steel cable 30 can be fixed or released in a rotating mode, in the process of implanting the heart valve 100, the hollow steel cable 30 can play a role of pushing and pulling the heart valve 100, so that the heart valve 100 moves in the inner cavity of the delivery sheath, and after the heart valve 100 is released from the delivery sheath, the heart valve 100 can be pulled back to the delivery sheath again through the hollow steel cable 30;

4) when there is a gap between the leaflet holder 112 or the first skirt holder 114 and the mitral valve annulus, the elastic element 118 can fill the gap between the leaflet holder 112 or the first skirt holder 114 and the mitral valve annulus, and when the leaflet holder 112 or the first skirt holder 114 is close to the mitral valve annulus, the elastic element 118 can be depressed in the radial or axial direction to adapt to the contour of the mitral valve annulus, thereby blocking blood flow and preventing paravalvular leakage.

Referring to fig. 10, a heart valve 200 according to a second embodiment of the present invention has substantially the same structure as the heart valve 100, except that: the elastic member 218 is not attached to the first skirt stent 214, i.e., one end of the elastic member 218 is fixedly attached to the leaflet stent 212 and the other end remains free.

The resilient member 218 is integrally formed with the leaflet braces 212 and the first skirt brace 214. Specifically, the elastic member 218, the leaflet braces 212 and the first skirt braces 214 are all cut from the same tube, and the planar development view obtained by integral cutting is shown in fig. 11, the cut stent still has a substantially tubular shape, and the stent is shaped by a heat treatment process under the action of a shaping mold to form the shape shown in fig. 10.

One end of the elastic member 218 is fixedly connected to the leaflet brace 212 and extends radially outward along the leaflet brace 212, the extending width is 3-5 mm, and the edge end tilts towards the first skirt brace 214, and the tilting height is 3-5 mm. Specifically, the width of the elastic member 218 is 0.1-0.3 mm, and the thickness is 0.2-0.5 mm, so as to ensure that the elastic member 218 is tightly attached to the mitral valve annulus, thereby preventing the valve from leaking.

It should be noted that, in order to achieve a better sealing effect, the elastic member 218 is also covered with a flow-blocking film (not shown).

Referring to fig. 12, a heart valve 300 according to a third embodiment of the present invention has substantially the same structure as the heart valve 100, and mainly differs therefrom in that: the holder includes a leaflet holder 312, and a first skirt holder 314 and a second skirt holder 315 disposed on the leaflet holder 312. referring to fig. 13, the heart valve 300 does not include a tether and a connector, and the heart valve 300 is secured to the human mitral valve annulus 16 by the first skirt holder 314 and the second skirt holder 315 clamping together the upper and lower surfaces of the tissue of the mitral valve annulus 16.

A second skirt stent 315 extends radially outward from the leaflet stent 312 along the leaflet stent 312, the second skirt stent 315 being attached to the leaflet stent 312 at a location between the first skirt stent 312 and the outflow end. The second skirt stent 315 includes a second supporting portion 3151 and a second tilting portion 3153, the second supporting portion 3151 extends outward from the leaflet stent 312 in the radial direction of the leaflet stent 312, and the second tilting portion 3153 bends and extends from one end of the second supporting portion 3151 away from the leaflet stent 312 to the outflow end of the leaflet stent 312. In the illustrated embodiment, the first and

second skirt hangers

314, 315 are cut from the same tube.

The resilient member 318 is disposed between the first and

second skirt hangers

314, 315. The elastic member 318 includes a plurality of elastic wires disposed around the leaflet holders 312, and the plurality of elastic wires are arranged in two groups, one group of elastic wires is connected to the first skirt holder 314 and the leaflet holders 312 at both ends, and the other group of elastic wires is connected to the second skirt holder 315 and the leaflet holders 312. Preferably, the two sets of elastic wires are fixed to the leaflet holders 312 at positions on the same circumferential plane perpendicular to the longitudinal central axis of the leaflet holders 312. In the illustrated embodiment, one set of elastic wires is connected at one end to the end of the first support portion 3141 of the first skirt hanger 314 away from the leaflet holders 312, and another set of elastic wires is connected at one end to the end of the second support portion 3151 of the second skirt hanger 315 away from the leaflet holders 312. The elastic wires of each group may be connected to each other to form a ring of wavy loops.

It is understood that only one set of elastic wires may be provided, one end of which is connected to the first skirt stent 314 and the other end of which is connected to the leaflet stent 312, or one end of which is connected to the second skirt stent 315 and the other end of which is connected to the leaflet stent 312, as desired.

It should be noted that, in order to achieve a better sealing effect, each group of elastic wires may be covered with a flow-blocking film (not shown).

Referring to fig. 13, the heart valve 300 is implanted and secured to the mitral valve annulus by the clamping action of the first and

second skirt brackets

314, 315. As shown in the left side of fig. 13, when the leaflet support 312 is close to the mitral annulus, the elastic member 318 will be depressed in the radial direction to conform to the contour of the mitral annulus and keep its outer surface fitting to the contact surface of the mitral annulus 16, which acts as a blood blocking and paravalvular leakage preventing function, as shown in the right side of fig. 14, when the leaflet support 312 has a gap with the mitral annulus, the elastic member 318 will bulge in the radial direction of the leaflet support 312 to fill the gap between the leaflet support 312 and the mitral annulus 16, which can also block the blood flow and prevent paravalvular leakage.

Referring to fig. 14, a heart valve 400 according to a fourth embodiment of the present invention has substantially the same structure as the heart valve 300, except that: two sets of elastic wires of the elastic member 418 are provided at the two ends of the first skirt hanger 414 and the second skirt hanger 415, respectively. Two sets of elastic wires are interlaced between the first and

second skirt brackets

414, 415.

In this embodiment, the elastic wire is made of silicone and has a diameter of 0.1 to 1 mm.

Referring to fig. 15, a heart valve 500 according to a fifth embodiment of the present invention has substantially the same structure as the heart valve 100, except that: the resilient member 518 is disposed on the first skirt hanger 514 and projects toward the outflow end. Specifically, one end of the elastic member 518 is connected to one end of the first skirt frame 514 near the leaflet frame 512, and the other end is connected to one end of the first support portion 5141 away from the leaflet frame 512.

Referring to fig. 16, after the heart valve 500 is implanted, the resilient member 518 is located at the position of the mitral valve annulus 16, as shown in the left side of fig. 16, when the first skirt bracket 514 is close to the mitral valve annulus 16, the resilient member 518 and the flow blocking membrane 519 on the resilient member 518 are recessed toward the inflow end to conform to the mitral valve annulus, and keep their outer surfaces attached to the contact surface of the mitral valve annulus 16 to block blood flow and prevent paravalvular leakage, as shown in the right side of fig. 16, when there is a gap between the first skirt bracket 514 and the mitral valve annulus 16, the resilient member 518 and the flow blocking membrane 519 on the resilient member 518 are raised toward the outflow end to fill the gap between the first skirt bracket 514 and the mitral valve annulus 16, so as to block blood flow and prevent paravalvular leakage.

The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.

Claims

1. A heart valve comprising a stent including a leaflet stent and a first skirt stent extending outwardly from the leaflet stent, the leaflet stent having an inflow end and an outflow end opposite the inflow end, wherein the stent further comprises a resilient member disposed between the outflow end of the leaflet stent and the first skirt stent, the resilient member bulging outwardly and/or the resilient member bulging in a direction toward the outflow end;

2. The heart valve of claim 1, wherein the first skirt stent extends radially outward from the leaflet stent along the leaflet stent, and the resilient element bulges radially outward toward the leaflet stent and/or bulges in a direction toward the outflow end.

3. The heart valve of claim 1 or 2, wherein the elastic wire extends from the leaflet frame radially outward of the leaflet frame.

4. The heart valve of claim 1, wherein a plurality of the proximal apices are located on the same circumferential plane perpendicular to the leaflet holder longitudinal central axis.

5. The heart valve of claim 1, wherein the first skirt stent includes a first support portion extending outward from the leaflet stent and a first raised portion extending from an end of the first support portion distal from the leaflet stent to bend toward the inflow end of the leaflet stent, the distal apex being connected to an end of the first support portion distal from the leaflet stent.

6. The heart valve of claim 5, wherein the first support portion extends radially outward from the leaflet support.

7. The heart valve of claim 1, wherein each of the elastic wires has a length that is approximately equal to a sum of a distance from an end of the first skirt stent to which the elastic wire is fixed to the leaflet stent and an axial distance from a location at which the leaflet stent is fixed to the elastic wire to an end of the first skirt stent near the leaflet stent.

8. The heart valve of claim 1, wherein the leaflet frame defines a plurality of fixation holes, each of the elastic wires being secured adjacent to a respective one of the fixation holes by a suture passing through the fixation hole.

9. The heart valve of claim 1, wherein the stent further comprises a second skirt stent disposed on the leaflet stent, the second skirt stent extending radially outward from the leaflet stent along the leaflet stent, the second skirt stent attached to the leaflet stent at a location between the first skirt stent and the outflow end, the resilient element disposed between the first skirt and the second skirt stent.

10. The heart valve of claim 9, wherein the elastic member comprises a plurality of elastic wires surrounding the leaflet holders, both ends of the elastic wires being connected to the first skirt holder and the leaflet holders, respectively, or,

both ends of the elastic wire are respectively connected with the second skirt stent and the valve leaflet stent, or,

and two ends of the elastic wire are respectively connected with the first skirt edge support and the second skirt edge support.

11. A heart valve as in any of claims 1-2 and 4-10, wherein the elastic wire is further covered with a flow-blocking film.

12. The heart valve of claim 11, wherein an elastic material is filled between the flow blocking film and the leaflet stent and/or first skirt stent.

13. The heart valve of claim 1, further comprising a flow-impeding element that covers the leaflet braces.