CN109549754B

CN109549754B - Heart valve

Info

Publication number: CN109549754B
Application number: CN201710872456.0A
Authority: CN
Inventors: 刘香东; 姚斌; 周涵; 蒋坤
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Shenzhen Jianxin Medical Technology Co ltd
Priority date: 2017-09-25
Filing date: 2017-09-25
Publication date: 2021-12-03
Anticipated expiration: 2037-09-25
Also published as: CN109549754A

Abstract

The present invention relates to a heart valve. A heart valve comprising a stent comprising a leaflet stent and a skirt stent, the leaflet stent and the skirt stent being integrally formed, the leaflet stent having a first end and a second end opposite the first end, the skirt stent extending radially outward from the leaflet stent along the leaflet stent, an end of the skirt stent proximate the leaflet stent being spaced apart from the first end by 1/2-1/4 of an axial length of the leaflet stent. The heart valve can avoid the stenosis of the ventricular outflow tract after implantation.

Description

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 valves can cause the ventricular outflow tract to be narrow and even blocked after being implanted into the human heart.

Disclosure of Invention

In view of the above, there is a need for a heart valve that avoids stenosis of the ventricular outflow tract after implantation.

A heart valve comprising a stent comprising a leaflet stent and a skirt stent, the leaflet stent and the skirt stent being integrally formed, the leaflet stent having a first end and a second end opposite the first end, the skirt stent extending radially outward from the leaflet stent along the leaflet stent, an end of the skirt stent proximate the leaflet stent being spaced apart from the first end by 1/2-1/4 of an axial length of the leaflet stent.

Above-mentioned heart valve, the skirt border support is close to the one end of leaflet support with the distance of first end is 1/2 ~ 1/4 of the axial length of leaflet support, under the prerequisite that satisfies leaflet support axial length, can avoid leading to the narrow or even the obstruction of ventricular outflow tract because the leaflet support is too much put into the ventricle, can avoid the valve that leaflet support axial length is not enough to lead to simultaneously to close incompletely. The skirt edge support and the valve leaflet support are integrally formed, the sheathing force and the fracture failure risk can be reduced, welding is not needed, and the structural strength reduction caused by insufficient welding and the like can be avoided.

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 partial cross-sectional view of a stent of the heart valve of FIG. 1;

FIG. 6 is a schematic contour view of a skirt stent of the heart valve of FIG. 1;

FIG. 7 is a schematic view of the bracket of FIG. 4 at another angle;

FIG. 8 is a schematic plan view of the stent of FIG. 4 in an expanded configuration;

FIG. 9 is a partial cross-sectional view of the heart valve of FIG. 1 after attachment to the hollow wire cable;

FIG. 10 is a schematic view of an angled configuration of a connector of the heart valve of FIG. 1;

fig. 11 is a schematic structural view of a leaflet brace of another embodiment of a heart valve;

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

FIG. 13 is a partial cross-sectional view of another embodiment of a heart valve coupled to a hollow wire cable;

FIG. 14 is an angled configuration of the connector of the heart valve of FIG. 13;

figure 15 is a partial cross-sectional view of another embodiment of a heart valve in cooperation with a hollow steel cable and sheath;

FIG. 16 is an exploded perspective view of the connector of the heart valve of FIG. 15;

FIG. 17 is a partial cross-sectional view of a stent of another embodiment of a heart valve;

FIG. 18 is a schematic structural view of a stent of another embodiment of a heart valve;

FIG. 19 is a schematic contour view of a skirt stent of the heart valve of FIG. 18;

FIG. 20 is a schematic assembled contour of the leaflets and skirt stent of the heart valve of FIG. 18;

FIG. 21 is a schematic view of a planar expanded configuration of a stent of another embodiment of a heart valve;

FIG. 22 is a schematic structural view of another embodiment of a heart valve;

FIG. 23 is a schematic structural view of another embodiment of a heart valve;

FIG. 24 is a schematic structural view of another embodiment of a heart valve;

FIG. 25 is a schematic structural view of another embodiment of a heart valve;

FIG. 26 is a schematic structural view of another embodiment of a heart valve;

FIG. 27 is a schematic structural view of another embodiment of a heart valve;

FIG. 28 is a schematic structural view of another embodiment of a heart valve;

fig. 29 is a schematic structural view of another embodiment of a heart valve.

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 stent as an example, but in other embodiments, the heart valve 100 is not limited to the mitral valve stent shown in fig. 1, and may also be other types of artificial valve stents, such as a pulmonary valve stent and an aortic valve stent.

Referring to fig. 2 and 3, the heart valve 100 includes a stent 110, a connecting member 130, a tether 150, a flow blocking member 170, and valve leaflets 190.

Referring to fig. 4, the stent 110 includes a leaflet stent 112, a skirt stent 114, and a link 116.

In the illustrated embodiment, the leaflet braces 112 are generally cylindrical in shape having a first end and a second end opposite the first end. In the illustrated embodiment, the first end is a distal end and the second end is a proximal end. Distal end means the end of the surgical procedure distal from the operator and proximal end means the end of the surgical procedure proximal to the operator. The leaflet brace 112 includes an undulating ring 1121 and a connecting rod 1123. The leaflet support 112 includes a plurality of undulating rings 1121 disposed at intervals along 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. In the illustrated embodiment, 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 to 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 and 5, the skirt bracket 114 includes a supporting portion 1141 and a tilting portion 1143. The support portion 1141 extends from the leaflet support 112 radially outward of the leaflet support 112, and the tilted portion 1143 extends from one end of the support portion 1141 away from the leaflet support 112 to a first end of the leaflet support 112. The support portion 1141 is used for fixation of the heart valve 100 to the human mitral annulus of the heart 20, and the raised portion 1143 is used for preventing abrasion of the left atrial tissue by the edge of the skirt stent 114. Without the raised portion 1143, the distal edge of the radial support portion 1141 directly contacts the atrial tissue, which may cause a cutting effect on the atrial tissue under long-term heart beating, resulting in damage to the atrial tissue. With the raised portion 1143, the contact between the skirt support 114 and the atrial tissue becomes a surface contact, which increases the contact area, reduces the contact pressure, and avoids the cutting effect of the skirt support 114 on the cardiac tissue and the resulting abrasion.

In the embodiment shown in fig. 4, the support portion 1141 of the skirt stent 114 is fixed to the trough of the wave ring 1121 near the first 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 positioned in the left atrium, thereby avoiding the left ventricle outflow tract from being narrowed or even blocked due to the excessive implantation in the left ventricle.

It should be noted that the leaflet holders 112 are not limited to include the wave ring 1121 and the connecting rod 1123, and may have other structures, and the skirt holders are not necessarily connected to the valleys of the wave ring 1121. So long as it is ensured that the distance between the end of the skirt stent 114 close to the leaflet stent 112 and the first end is approximately 1/4-1/2, preferably one third, of the axial length of the leaflet stent 112. Of course, if desired, the distance between the first end and the different positions of the end of the skirt stent 114 close to the leaflet stent 112 along the circumferential surface may not be exactly the same, i.e., the different positions of the end of the skirt stent 114 close to the leaflet stent 112 in different circumferential directions.

In one embodiment, the width of the support portion 1141 of the skirt hanger 114 is 2mm to 6 mm. Here, the width of the support portion 1141 refers to a distance between one end of the support portion 1141 near the raised portion 1143 and the leaflet brace 112. The width of the support portion 1141 is 2mm to 6mm, which is approximately equal to the width from the inner side of the mitral valve annulus to the atrial wall of the human heart 20, i.e. the radial width of the valve annulus, so as to sufficiently ensure the fixation of the heart valve 100 on the mitral valve annulus of the human heart.

In one embodiment, the height of the tilting portion 1143 is 2mm to 6 mm. Here, the height of the tilted portion 1143 refers to a distance between one end of the tilted portion 1143 away from the supporting portion 1141 and one end close to the supporting portion 1141. Too low a height of the upturned portion 1143 may not prevent well abrasion of the edge of the skirt hanger 114 to heart tissue, and too high a height may damage other tissue of the left atrium.

Referring to fig. 6, the supporting portion 1141 of the skirt frame 114 has a circular ring shape and a circular outer contour when viewed from the inflow side of the valve blood flow, although the outer contour of the supporting portion 1141 may have other shapes.

Referring to fig. 7, in the illustrated embodiment, the skirt stent 114 comprises a plurality of skirt subunits, the skirt subunits having a substantially petal shape, and the skirt subunits are uniformly distributed along the circumference of the leaflet stent 112. Each skirt subunit includes a support portion 1141 and a tilting portion 1143.

Referring again to fig. 4, 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, one ends of the two struts distal from the proximal link 1162 are respectively fixedly connected to two troughs adjacent to the undulating ring of the leaflet support 112 proximal to the second end, each trough is connected to one strut, such that the plurality of links 116 are uniformly distributed along the second end, thereby providing a guiding function when the heart valve 100 is received in the sheath, and preventing the troughs from being stuck outside the sheath. If the leaflet support links 1164 are attached to the leaflet support 112 at the peaks of the wave ring near the second end, the troughs can become lodged outside the sheath when the heart valve 100 is 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 of the second end of the leaflet bracket, i.e., the number of struts is the same as the number of proximal links 1162.

A joint 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 disc-shaped or spherical.

In the illustrated embodiment, the entire stent 110, i.e., the leaflet stent 112, the 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. 8. Of course, it should be noted that fig. 8 is an expanded view, and the stent 110 is still substantially tubular after being integrally cut from the tube, and is shaped into the shape shown in fig. 4 through a heat treatment process. The integrated cutting is split relatively and then assembled, so that the integrated cutting has the advantages of small radial size after compression and easiness in sheathing, and meanwhile, welding or splicing structures are cancelled at all parts of the support 100, so that the fatigue resistance of the support 100 is also 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. 1, 4, 9 and 10, 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, at which the screw hole 1324 is opened, gradually shrinks into a frustum shape. 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 covered and fixed on the accommodation 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 limiting hole 1342 to prevent the tab 1166 from falling out of the limiting 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 one-dimensional size of the blocking portion 152 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, other structures formed at one end of tether 150 may be used as long as they can avoid falling out of threaded hole 1324. In use, the tether 150 extends outwardly from the receptacle 1322 and through the inner bore of the hollow cable 30 to prevent the blocking portion 152 from being directly exposed to the ventricle and causing a thrombus; while also preventing unrestrained distal movement of stop 152.

Referring to fig. 5 again, fig. 5 is a partial cross-sectional view of the heart valve 100, and the angle α of the connecting rod 116 is 40 ° to 60 ° when the heart valve 100 is in the open state. The angle α of the link 116 refers to the angle between the line defined by the point of attachment of the link 116 to the leaflet brace 112 and the point of attachment of the link 116 to the connector 130 and the axis of the leaflet brace 112. In the illustrated embodiment, the link 116 is linear, and the angle α of the link 116 is the angle between the link 116 and the axis of the leaflet support 112. The valve leaflet supports 112 with the angles alpha of the connecting rods 116 with different angles are tested in the sheath tube with the inner diameter of 11mm, the relation between the sheathing force of the valve leaflet supports 112 with the angles alpha of the connecting rods 116 with different angles in the sheath tube with the inner diameter of 11mm and the supporting strength of the valve leaflet supports 112 is tested, and the fact that the sheathing force can be controlled in a lower range when the angles alpha of the connecting rods 116 are 40-60 degrees is found, and the radial supporting strength of the valve leaflet supports 112 can reach the maximum range. Of course, all parameters of the leaflet braces 112 tested using the angle α of each different link 116 are the same except for the angle α of the link 116. Preferably, the included angle α of the connecting rod 116 is 45 ° to 60 °.

Referring again to fig. 2, the heart valve 100 may also include a spacer 160. The material of the gasket 160 is at least one selected from 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 knitted 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.

The resistive element 170 is configured to block blood flow from escaping through the stent 110, and cooperates with the valve leaflets 190 to ensure unidirectional blood flow within the heart valve 100. The choke 170 is made of PTFE, PET, PU, casing or animal core. The choke 170 may be coated by a heat pressing process or fixed to the bracket 110 by sewing, depending on the material. Referring to fig. 5, in the illustrated embodiment, the flow-blocking elements 170 cover the surfaces of the leaflet holders 112 and skirt holders 114. Specifically, the flow inhibitor 170 may cover only at least one of the inner surface and the outer surface of the leaflet braces 112.

The surface of the skirt stent 114 is covered with the flow blocking part 170, so that the contact area of the skirt stent 114 and the heart tissue can be increased, the contact pressure can be reduced, the climbing of the heart endothelial tissue on the surface of the heart valve 100 can be accelerated, and the thrombus source of the heart valve 100 can be reduced. In one embodiment, to accelerate the coating of the endothelial tissue on the surface of the heart valve 100, the non-biological tissue surface of the heart valve 100 is formed with a parylene layer. In one embodiment, the surface of the flow resistor 170 is 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.

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 frame 112, the leaflet 190 may be directly fixed to the leaflet frame 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 the adjacent two 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 170 by sewing. In one embodiment, the angle 192 is fixed to the connection of the link 116 to the leaflet brace 112, thereby increasing the strength of the connection and ensuring proper opening and closing of the leaflets 190.

In one embodiment, a hydrogel layer (not shown) is disposed between the blocker 170 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 170 adjacent to the bracket 110. Of course, in other embodiments, the hydrogel layer may also be secured between the spoiler 170 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 corresponding to the flow stop 170. If a gap exists between the heart valve 100 and the mitral valve tissue after being implanted into the heart of a human body, the expanding hydrogel layer causes the flow blocking member 170 to bulge outward, thereby blocking the gap and reducing the risk of paravalvular leakage.

When the heart valve 100 is implanted in the human heart 20, the skirt support 114 of the heart valve 100 secures the heart valve 100 to the mitral annulus, and the end of the tether 150 distal to the link 116 is tied through the heart 20 and the spacer 160 and secured thereto to prevent the heart valve 100 from being dislodged. The skirt stent 114 is prevented from cutting and corroding heart tissue by the skirt stent 114 by the raised portion 1143.

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 needed, and the structural strength reduction caused by insufficient welding and the like can be avoided;

2) the support portion 1141 of the skirt support 114 is fixedly connected to the wave trough of the leaflet support 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 support 112 can be positioned in the left atrium, thereby avoiding the left ventricular outflow tract from being narrow or even blocked due to the fact that the leaflet support 112 is excessively implanted into the left ventricle;

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

4) the angle alpha of the connecting rod 116 is 40-60 degrees, the sheathing force can be controlled in a lower range, and the radial support strength of the leaflet brace 112 can reach the maximum range.

Referring to fig. 11, another embodiment of a heart valve 200 has substantially the same structure as the heart valve 100, except that: the leaflet support 212 of the heart valve 200 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 support 212 is composed of a plurality of rhombus frames arranged in an array.

At this time, the skirt stent is fixedly connected to the wave trough of the wave ring at one end of the leaflet stent 212. Of course, the leaflet braces 212 can have many other shapes, and it is only necessary to control the distance between the connection of the skirt brace and the leaflet brace 212 and the end of the leaflet brace 212 to be approximately one-third of the length of the leaflet brace 212.

Referring to fig. 12, another embodiment of a heart valve 300 has substantially the same structure as the heart valve 100, except that: tether 350 comprises a plurality of filaments secured together, with an end of tether 350 distal to attachment element 330 forming a petal-shaped anchor 354. The anchoring portion 354 may be deployed and secured at the apex of the heart to act as a pull on the heart valve 300 and prevent the heart valve 300 from falling off on the left atrium side.

It should be noted that the multi-strand monofilament of the tether 350 may be fixed by gluing, steel sleeve fixing and pressing, winding and fixing, heat shrink tube fixing, and the like.

Of course, in some embodiments, the petal-shaped anchors 354 may be formed by cutting a nitinol tube, and then heat treating to set the petals.

The compressed size of the anchoring portion 354 is smaller than the inner diameter of the hollow wire rope 30, so that the anchoring portion 354 can be contracted inside the hollow wire rope 30 and can be relatively moved.

Referring to fig. 13 and 14, another embodiment of a heart valve 400 has substantially the same structure as the heart valve 100, except that: the ends of the links 416 remote from the leaflet holders are not provided with a joint, and the ends of all the links 416 are welded to form a ball 4166, which is received in the receiving groove 4322 and abuts against the connecting cover 434.

Correspondingly, the number of the limiting holes 4342 is one.

In one embodiment, the connecting cover 434 is a two-piece structure, and the two pieces cooperate to form the limiting hole 4342, thereby facilitating installation.

Referring to fig. 15 and 16, another embodiment of a heart valve 500 has substantially the same structure as the heart valve 100, except that: the connection cap 534 includes a connection sleeve 5343 and a spherical crown 5344 formed at one end of the connection sleeve 5343, the connection sleeve 5343 is fixedly sleeved with the socket 532, and the limiting hole 5342 is a strip-shaped hole extending along the axial direction of the connection sleeve 5343.

In the illustrated embodiment, the socket 532 has a plug portion 5326, and the plug portion 5326 is received in the connecting sleeve 5343 and fixed thereto by welding. The limiting hole 5342 extends from one end of the connecting sleeve 5343 away from the spherical crown 5344 to the middle of the spherical crown 5344. Thus, when the linkage rod is connected to the connection cover 534, the angle of the linkage rod can deflect within the position-limiting hole 5342 by a small angle, and the linkage rod can adapt to different states of the heart valve through angle changes when the heart valve is in a compressed state and an uncompressed state.

In the illustrated embodiment, the connector 530 further includes a catch 536. The blocking piece 536 is accommodated in the connecting sleeve 5343 and is located at one end of the insertion portion 5326 close to the spherical cap 5344. The middle of the baffle 536 is provided with a through hole 5362 corresponding to the screw hole 5324. The stopper 552 at one end of the tether 550 is spherical and has a diameter greater than that of the through hole 5362. The blocking portion 552 is located on a side of the blocking piece 536 away from the inserting portion 5326 and abuts against the blocking piece 536.

In the illustrated embodiment, the connector 530 has hemispherical ends to reduce thrombus formation and reduce hemodynamic effects.

Referring to fig. 17, another embodiment of a heart valve 600 has substantially the same structure as the heart valve 100, except that: a gap is formed between the spoiler 670 at a side surface of the skirt hanger 614 remote from the second end and the skirt hanger 614.

In the illustrated embodiment, the flow-blocking element 670 is woven dacron fabric, the flow-blocking element 670 is wrapped around and sewn to the surfaces of the skirt stent 614 and the leaflet stent 612, and the flow-blocking element 670 forms a gap with the surface of the support portion 6141 of the skirt stent 614 away from the link 616. Specifically, one end of the blocker 670 is attached to the inner surface of the leaflet holder 612 from the second end of the leaflet holder 612 to the first end and is pulled radially from the first end toward the raised portion of the skirt holder 614, and is attached to the surface of the skirt holder 614 near the link 616 to the outer surface of the second end of the leaflet holder 612, and the two ends of the blocker 670 are secured together by a suture at the second end of the leaflet holder 612. Preferably, the height of the portion of the flow-blocking piece 670 corresponding to the support portion 6141 is approximately flush with the end surface of the first end of the leaflet brace 612.

The surface of the skirt stent 614 away from the connecting rod 616 is not contacted by the flow resisting element 670 and the surface of the skirt stent 614, so as to avoid blood flow disturbance caused by the protrusion of the end of the leaflet stent 612 away from the connecting rod relative to the support part 6141 of the skirt stent 614. Preferably, the pore size of the knitted polyester fabric on the side of the support portion away from the connecting rod 616 is smaller than the size of the thrombus formed, so that the thrombus formed in the cavity formed by the knitted polyester fabric in the skirt support 614 does not escape from the cavity, thereby preventing various complications caused by the thrombus.

Referring to fig. 18 and 19, another embodiment heart valve 700 has substantially the same structure as heart valve 600, except that: the outer profile of the support portion 7141 is D-like.

Here, the outer contour of the support portion 7141 in an orthogonal projection to a plane perpendicular to the axis of the leaflet brace 712 may also be considered to be D-like. It is understood that in some embodiments, the orthographic projection of the support portion 7141 on a plane perpendicular to the axis of the leaflet support 712 can also be discontinuous, in which case the outer contour refers to a smooth curve obtained by fitting a curve to the orthographic projection. In some embodiments, the support 7141 is surface-covered with flow-blocking elements, and the outer profile refers to the outer profile of the orthographic projection of the support 7141 of the skirt stent 714 surface-covered with flow-blocking elements in a plane perpendicular to the axis of the leaflet stent 712.

Because the contour of the mitral valve annulus to which the mitral valve of a human heart is attached is D-like, and the support portion 7141 of the skirt bracket 714 functions to fix the heart valve 700 on the mitral valve annulus, the support portion 7141 with the D-like outer contour can better conform to the contour of the mitral valve annulus, thereby preventing paravalvular leakage.

In one embodiment, the support portion 7141 has the same outer contour as the mitral annulus to which a human heart mitral valve is attached.

In one embodiment, the outer profile of the support portion 7141 in an orthographic projection of a plane perpendicular to the axis of the leaflet support 712 includes a first region 7144 that is circumferentially distributed and a second region 7145 connected to the first region 7144. In the illustrated embodiment, the angle β defined by both ends of the first region 7144 and the perpendicular to the axis of the leaflet brace 712 is between 100 ° and 140 °. The distance between the end of the support portion 7141 that is distal from the leaflet support 712 (i.e., the width of the support portion 7141) and the leaflet support 712 in the first region 7144 is less than the distance between the end of the support portion 7141 that is distal from the leaflet support 712 and the leaflet support 712 in the second region. Preferably, the width of the supporting portion 7141 positioned in the first region 7144 is 2 to 4 mm. The width of the supporting portion 7141 positioned in the first region 7144 is smallest at the middle line position of the first region 7144 and gradually increases toward both ends. The distances between the end of the support section 7141 located in the second region 7145 away from the leaflet braces 714 and the leaflet braces 712 are all equal and are 2mm to 6mm, i.e., the width of the support section 7141 located in the second region 7145 is 2mm to 6 mm. The angle defined by the two ends of the second region 7145 and the perpendicular to the axis of the leaflet braces 712 ranges from 220 deg. to 260 deg.. Particularly in the present embodiment, the width of the supporting portion 7141 located in the first region 7144 at the position of the midline of the first region 7144 is 50% of the width of the supporting portion 7141 located in the second region 7145.

Referring to fig. 20, in one embodiment, the leaflets 790 have three total flaps, wherein the angle γ defined by the perpendicular to the axis of the leaflet support 712 at the angle 792 and the perpendicular to the axis of the leaflet support 712 at the center of the first region 7144 is between 0 ° and 30 °. More preferably, one of the flap angles 792 corresponds to the center of the first region 7144, i.e., a line defined by one of the flap angles 792 and the center of the first region 7144 is perpendicular to the axis of the leaflet brace 712, when γ is 0 °. When the first region 7144 is subjected to radial pressure from heart tissue on the aortic root side of the mitral annulus, corresponding deformation of the corresponding side of the leaflet braces 712 can result in a change in the distance between the valve corners 792, resulting in a restricted opening and closing function of the leaflets 790, eventually resulting in the leaflets 790 not closing fully and regurgitating or opening stenosis. The angle y defined by one of the lobe angles 792 from 0 to 30, normal to the axis of the leaflet support 712 and the center of the first region 7144 from normal to the axis of the leaflet support 712 can minimize the effects of leaflet 790 deformation.

Referring to fig. 21, another embodiment heart valve 800 has substantially the same structure as heart valve 700, except that: the skirt support is provided with a positioning member 8147.

In one embodiment, the positioning element 8147 corresponds to the center of the first region, and when installing the valve leaflets, an included angle γ defined by a perpendicular line between one of the valve corners and the axis of the leaflet brace and a perpendicular line between the center of the first region and the axis of the leaflet brace is 0 ° to 30 °, and when releasing the heart valve, the position of the heart valve can be adjusted by the positioning element 8147 so that the valve corner is located at the center of the anterior leaflet of the mitral valve.

In one embodiment, the skirt hanger is further provided with an auxiliary member 8148 to facilitate positioning of the positioning member 8147 upon release. The auxiliary parts 8148 are two in number and are respectively positioned on two sides of the positioning part 8147, and the shapes of the positioning part 8147 and the auxiliary parts 8148 are different. In the illustrated embodiment, the positioning member 8147 is "8" shaped and the auxiliary member 8148 is circular.

Preferably, the angle defined by the perpendicular to the axis of the leaflet support 712 for each of the adjuncts 8148 and the perpendicular to the axis of the leaflet support 712 for the center of the first region 7144 is 30 °.

In one embodiment, the leaflet braces 712 are also provided with a leaflet mounting hole 8189. Preferably, there are three lobe angle mounting holes 8189, one of the lobe angle mounting holes 8189 corresponding to the positioning member 8147. What corresponds here is meant is that the projection of the perpendicular of the valve corner mounting hole 8189 to the axis of the leaflet support 712 and the perpendicular of the positioning member 8147 to the axis of the leaflet support onto a plane perpendicular to the axis of the leaflet support coincide with one another.

In this embodiment, the positioning member 8147 and the auxiliary member 8148 are formed by forming a mounting hole in the skirt hanger and embedding a developing material such as gold, platinum, or tantalum in the mounting hole. The shape of the positioning member 8147 is not limited to the "8" shape, and may be other shapes that can be easily observed under X-rays, such as a circle, a square, or a polygon, as long as the positioning member 8147 and the auxiliary member 8148 can be distinguished.

Referring to fig. 22, another embodiment heart valve 900 has substantially the same structure as heart valve 800, except that: the positioning member 9147 is disposed on the choke 970.

At this time, the positioning member 9147 made of gold, platinum, tantalum, or the like may be directly fixed to the choke member 970 without providing a positioning member on the holder 910. Of course, in some embodiments, the positioning members 9147 are a developed coating that is coated on the surface of the flow resisting member 970.

It is understood that the auxiliary element 8148 may also be disposed directly to the flow blocking element 970.

Referring to fig. 23, another embodiment heart valve 1000 has substantially the same structure as heart valve 700, except that: the stent 1010 of the heart valve 1000 also includes a fixation stent 1018. A fixation leg 1018 extends from the end of the leaflet leg 1012 distal from the skirt leg 1014, being bent outwardly.

In one embodiment, the fixed bracket 1018 is circular in profile. The outer profile of the skirt support 1014 is D-like.

In the illustrated embodiment, the locating member 10147 is provided on the skirt hanger 1014.

Referring to fig. 24, another embodiment heart valve 1100 has substantially the same structure as heart valve 700, except that: the leaflet holders 1112 are asymmetric in structure.

The leaflet brace 1112 includes a first pattern portion 11121 and a second pattern portion 11123, the pattern structure of the first pattern portion 11121 is different from the metal density of the second pattern portion 11123, the boundary between the first pattern portion 11121 and the second pattern portion 11123 corresponds to the center of the first region, and the boundary between the first pattern portion 11121 and the second pattern portion 11123 can be used to position the lobe angle.

Referring to fig. 25, another embodiment heart valve 1200 is substantially similar in structure to heart valve 100, except that: the linkage 1216 of the heart valve 1200 is S-shaped.

In the illustrated embodiment, the link 1216 extends from the leaflet bracket 1212 to the attachment member 1230 and the portion proximate to the leaflet bracket 1212 protrudes outward and the portion proximate to the attachment member 1230 is recessed inward. Of course, in other embodiments, the portion of the link 1216 adjacent the leaflet braces 1212 is recessed inward and the portion adjacent the attachment 1230 is protruding outward.

The angle of the link 1216 refers to the angle between the line defined by the point of attachment of the link 1216 to the leaflet holder 1212 and the point of attachment of the link 1216 to the attachment 1230 and the axis of the leaflet holder 1212.

Referring to fig. 26, another embodiment of a heart valve 1300 has substantially the same structure as the heart valve 100, except that: the surface of the skirt stent and the valve leaflet stent is covered with knitted polyester fabric as a flow resisting element 1370.

The woven terylene cloth as the flow resisting element 1370 can increase the flow resistance of the skirt stent and the valve leaflet stent, and reduce the risk of perivalvular leakage after the heart valve 1300 is implanted into the heart of a human body. Meanwhile, the surface roughness of the knitted polyester fabric is large, the circumferential friction force of the heart valve 1300 is large, and the heart valve is convenient to fix. Of course, in other embodiments, the portion covering the outer surface of the skirt stent and the outer surface from the connection point of the skirt stent and the leaflet stent to the second end of the leaflet stent may be polyester knitted fabric, and the other portion may be PTFE, PET, PU, casing, or a traditional film-coating material such as animal core.

In the illustrated embodiment, the obstructing member 1370 is pressed into the leaflet braces near one end of the link 1316. In the illustrated embodiment, the end of the obstructing element 1370 near the link 1316 presses into the coils 13121 of the leaflet holders near the second end, i.e., the coils 13121 of the leaflet holders near the second end are positioned outside of the obstructing element 1370 to press the end of the obstructing element 1370 near the link 1316 into the leaflet holders to avoid sheath damage to the outer obstructing element 1370 and to protect the obstructing element 1370 from damage when the heart valve 1300 is sheathed.

The end of the obstructing member 1370 adjacent the link 1316 is secured by a suture.

The knitted dacron fabric has radial variability as the choke member 1370, so that the brackets with different radial sizes can be wrapped by the same choke member 1370, for example, the skirt bracket and the leaflet bracket can be wrapped by the same choke member 1370, and the choke member 1370 is fixed by radial pressure.

It is understood that knitted polyester fabric can increase the flow resistance of the skirt stent and the leaflet stent, and thus other flow-resistant materials need not be used. In other embodiments, the flow resisting element 1370 may be a double-layer or multi-layer structure, such as in other embodiments, a conventional film coating material, such as PTFE, PET, PU, sausage casing, or animal core, is coated on the inner side of the knitted polyester fabric.

Referring to fig. 27, another embodiment of a heart valve 1400 has substantially the same structure as the heart valve 100, except that: the profile of one end of the flow blocker 1470 near the second end of the leaflet brace is the same as the profile of the second end of the leaflet brace.

In the illustrated embodiment, the wave ring 14121 is located at one end of the leaflet stent near the link 1416 and is fixed to the link 1416, the profile of the second end of the leaflet stent, i.e., the wave ring 14121, is saw-toothed, the profile of the end of the flow-blocking element 1470 near the second end of the leaflet stent is saw-toothed and is the same as the profile of the second end of the leaflet stent, and the end of the flow-blocking element 1470 near the second end of the leaflet stent is fixed to the wave ring 14121 by suturing.

Of course, in other embodiments, the second end of the leaflet frame is not serrated, and the shape of the end of the flow blocker 1470 near the second end of the leaflet frame may be modified accordingly, so long as the profiles are the same, the flow blocker 1470 may be prevented from protruding when the sheath is retracted.

Referring to fig. 28, another embodiment of a heart valve 1500 has substantially the same structure as the heart valve 100, except that: the flow-impeding element 1570 comprises a first flow-impeding membrane 1571 covering the inner surface of the leaflet braces 1512 and a second flow-impeding membrane 1572 covering the outer surface of the leaflet braces 1512 and the surface of the skirt braces 1514.

In the illustrated embodiment, the first flow-blocking membrane 1571 extends along the inner surface of the leaflet brace 1512 from the end of the leaflet brace 1512 distal from the link 1516 to the end of the leaflet brace 1512 proximal to the link 1516. The second blocker membrane 1572 wraps around the leaflet braces 1512 and skirt braces 1514 from the outer surface of the end of the leaflet brace 1512 distal to the link 1516 to the end of the leaflet brace 1512 proximal to the link 1516.

In the illustrated embodiment, an end of the second blocker membrane 1572 distal from the link 1516 is sewn to an end of the first blocker membrane 1571 distal from the link 1516, and an end of the second blocker membrane 1572 proximal to the link 1516 is sewn to an end of the first blocker membrane 1571 proximal to the link 1516.

In the illustrated embodiment, a gap is formed between the second blocker membrane 1572 of a side surface of the skirt hanger 1514 remote from the link 1516 and the skirt hanger 1514. Preferably, the height of the portion of the second blocker membrane 1572 corresponding to the support 15141 is approximately flush with the end of the leaflet braces 1512 distal from the links 1516.

In the illustrated embodiment, the first and second fluid-blocking

membranes

1571 and 1572 are made of fiber cloth, such as knitted polyester cloth or plain woven cloth, and the knitting density of the fiber threads of the first fluid-blocking membrane 1571 is greater than the knitting density of the fiber threads of the second fluid-blocking membrane 1572, and the count of the fiber threads of the first fluid-blocking membrane 1571 is greater than the count of the fiber threads of the second fluid-blocking membrane 1572, so that the friction coefficient of the first fluid-blocking membrane 1571 is smaller than the friction coefficient of the second fluid-blocking membrane 1572, thereby increasing the circumferential friction resistance of the heart valve and facilitating the fixation of the heart valve. Of course, in other embodiments, the first fluid resistant membrane 1571 may also be a traditional film-coated material such as PTFE, PET, PU, sausage casing, or animal core.

Referring to fig. 29, another embodiment of a heart valve 1600 has substantially the same structure as the heart valve 100, except that: the blocker 1670 includes first and

second blocker membranes

1671 and 1672, the first blocker membrane 1671 covering the inner surface of the leaflet stent 1612 and the surface of the skirt stent 1614 at the end distal from the rod 1616, and the second blocker membrane 1672 covering the outer surface of the leaflet stent 1612 and the surface of the skirt stent 1614 at the end proximal to the rod 1616.

In the illustrated embodiment, one end of a first occluding membrane 1671 is located at the junction of the leaflet stent 1612 and skirt stent 1614, and one end of a second occluding membrane 1672 is also located at the junction of the leaflet stent 1612 and skirt stent 1614. The other end of the second blocker film 1672 presses into the annulus of the leaflet braces 1612 near the rod 1616.

In the illustrated embodiment, the first and

second occluding membranes

1671 and 1672 are made of fiber cloth, such as knitted polyester cloth or plain woven cloth, and the knitting density of the fiber threads of the first occluding membrane 1671 is greater than the knitting density of the fiber threads of the second occluding membrane 1672, and the count of the fiber threads of the first occluding membrane 1671 is greater than the count of the fiber threads of the second occluding membrane 1672, so that the friction coefficient of the first occluding membrane 1671 is smaller than the friction coefficient of the second occluding membrane 1672, thereby increasing the circumferential friction resistance of the heart valve and facilitating the fixation of the heart valve. Of course, in other embodiments, the first flow resistant film 1671 may also be a conventional film coating material such as PET, PU, sausage casing, or animal core.

It should be noted that, the technical solutions of the 16 embodiments described above can be combined without contradiction, for example, the D-shaped support portion can be combined with the related solution of knitted polyester fabric, the D-shaped support portion can be combined with different shapes of connecting rods, or the connecting rods with different shapes and the solution of knitted polyester fabric can be combined.

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 comprises a support, and is characterized in that the support comprises a valve leaflet support and a skirt support, the valve leaflet support and the skirt support are integrally formed, the valve leaflet support is provided with a first end and a second end opposite to the first end, the skirt support extends outwards from the valve leaflet support along the radial direction of the valve leaflet support, the skirt support comprises a support part and a tilting part, one end, close to the valve leaflet support, of the skirt support is spaced from the first end, and the distance between one end, close to the valve leaflet support, of the skirt support and the first end is 1/4-1/2 of the axial length of the valve leaflet support; the heart valve also comprises a choke element, wherein the choke element is arranged on the surfaces of the valve leaflet bracket and the skirt bracket, the choke element covers the first end from the inner surface of the valve leaflet bracket and is pulled to the tilting part of the skirt bracket along the radial direction from the first end, and the choke element is attached to the surface, close to the connecting rod, of the skirt bracket and covers the outer surface of the valve leaflet bracket.

2. The heart valve of claim 1, wherein an end of the skirt stent proximate the leaflet stent is a distance of one-third of an axial length of the leaflet stent from the first end.

3. The heart valve of claim 1, wherein the leaflet frame includes three wave rings arranged sequentially in an axial direction of the leaflet frame, and the skirt frame is fixedly attached to troughs of the wave rings near the first end.

4. The heart valve of claim 1, wherein the support portion extends radially outward from the leaflet support, and the raised portion extends from an end of the support portion distal from the leaflet support to the first end of the leaflet support.

5. The heart valve of claim 4, wherein the skirt stent has an outer profile that is D-like.

6. The heart valve of claim 5, wherein the outer contour includes a first region and a second region connected to the first region, the first region has an end of the support portion away from the leaflet support that is a smaller distance from the leaflet support than the second region, the heart valve further includes three leaflets fixed to the leaflet support, two adjacent leaflets combine together to form a valve angle near the leaflet support, and an included angle γ defined by a perpendicular from one of the valve angle to the axis of the leaflet support and a perpendicular from the center of the first region to the axis of the leaflet support is 0-30 °.

7. The heart valve of any one of claims 1-6, further comprising a connector, wherein the stent further comprises a plurality of links, one end of each link is fixedly connected to the second end of the leaflet stent, and one ends of the links, which are far away from the second end, are connected to the connector.

8. The heart valve of claim 7, wherein the skirt stent, the leaflet stent, and the link are cut from the same tube.

9. The heart valve of claim 7, further comprising a hollow steel cable having one end removably secured to the connector.

10. The heart valve of claim 7, further comprising a tether having a stop formed at one end, the tether being secured to the connector by the stop.

11. The heart valve of claim 10, wherein the tether comprises a plurality of filaments secured together, an end of the tether remote from the connector forming a petal-shaped anchor.

12. The heart valve of claim 1, wherein an end of the obstructing element proximate to the second end of the leaflet stent has a profile that is the same as a profile of the second end of the leaflet stent.

13. The heart valve of claim 1, wherein a gap is formed between a flow stop on a surface of the skirt stent distal from the second end of the leaflet stent and the skirt stent.