阅读说明：本技术 瓣膜支架及心脏瓣膜 (Valve support and heart valve ) 是由 刘香东 周涵 于 2018-06-29 设计创作，主要内容包括：本发明涉及一种瓣膜支架,其包括瓣叶支架及裙边支架,所述瓣叶支架具有第一端及与所述第一端相对的第二端,所述裙边支架自所述瓣叶支架沿所述瓣叶支架的径向向外延伸,所述裙边支架靠近所述瓣叶支架的所述第一端设置,所述瓣膜支架还包括设于所述瓣叶支架上且靠近所述第二端的倒刺,所述倒刺向所述瓣叶支架的径向向外延伸并朝所述第一端延伸,所述倒刺靠近所述瓣叶支架的一端与所述裙边支架靠近所述瓣叶支架的一端之间的轴向距离范围为10mm～20mm。上述瓣膜支架能够有效防止移位。本发明还涉及一种心脏瓣膜。(The invention relates to a valve support, which comprises a valve leaf support and a skirt support, wherein the valve leaf support is provided with a first end and a second end opposite to the first end, the skirt support extends outwards from the valve leaf support along the radial direction of the valve leaf support, the skirt support is arranged close to the first end of the valve leaf support, the valve support also comprises barbs arranged on the valve leaf support and close to the second end, the barbs extend outwards towards the radial direction of the valve leaf support and extend towards the first end, and the axial distance range between one end of the barbs close to the valve leaf support and one end of the skirt support close to the valve leaf support is 10-20 mm. The valve support can effectively prevent displacement. The invention also relates to a heart valve.)

1. A valve stent comprising a leaflet stent and a skirt stent, 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, the skirt stent being proximal to the leaflet stent the first end being disposed, the valve stent further comprising barbs located on the leaflet stent and proximal to the second end, the barbs extending radially outward from the leaflet stent and toward the first end, the barbs being proximal to one end of the leaflet stent and the skirt stent being proximal to an axial distance between one end of the leaflet stent ranging from 10mm to 20 mm.

2. The valve stent of claim 1, wherein the barbs have a length in a range from 2mm to 3mm, or from 3mm to 5mm, or from 5mm to 10 mm.

3. The valve stent of claim 1, wherein the barbs are at an angle ranging from 20 ° to 45 °, or from 45 ° to 60 °, or from 60 ° to 70 °.

4. The valve stent of claim 1, wherein the barbs have a width to thickness ratio in a range of 0.75 to 1, or 1 to 1.2, or 1.2 to 1.5.

5. The valve stent according to claim 1, wherein the barb includes a fixing portion and a bending portion, one end of the fixing portion is connected to the leaflet stent and the other end is connected to the bending portion, the bending portion is bent toward a longitudinal central axis of the leaflet stent, and an included angle between the bending portion and the fixing portion ranges from 110 ° to 160 °.

6. The valve stent of claim 1, wherein the leaflet stent is provided with rounded corners at positions where the barbs are connected, and the radius of the rounded corners ranges from 0.02mm to 0.30 mm.

7. The valve stent of claim 1, wherein the distance between the end of the skirt stent proximate to the leaflet stent and the first end is 1/4-1/2 of the leaflet stent axial length.

8. The valve stent of claim 1, wherein the leaflet stent includes a plurality of wave rings arranged at intervals in an axial direction of the leaflet stent and a plurality of connecting rods connecting the plurality of wave rings, the connecting rods extending in the axial direction of the leaflet stent, the barbs being provided on the connecting rods.

9. The valve stent of claim 1, further comprising a link and a connector, wherein one end of the link is connected to the second end and an end of the link distal from the second end is connected to the connector.

10. The valve stent of claim 9, further comprising a tether coupled to the connector.

11. A heart valve prosthesis comprising the valve stent of any one of claims 1 to 10, and further comprising a flow blocking element and leaflets, wherein the flow blocking element covers the leaflet stent and the skirt stent, and the leaflets are located inside the leaflet stent and are fixedly connected to the leaflet stent and/or the flow blocking element.

Technical Field

The invention relates to the field of medical equipment, in particular to a valve stent and 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 technology has a short time, so that more problems are faced at present. For example, existing heart valves are prone to shifting under blood flow pressure after implantation.

Disclosure of Invention

In view of the above, it is necessary to provide a valve stent and a heart valve to reduce the probability of displacement of the heart valve after implantation.

A valve support, includes leaflet support and shirt rim support, leaflet support have first end and with the relative second end of first end, the shirt rim support certainly leaflet support is followed leaflet support's radial outside extension, the shirt rim support is close to leaflet support first end sets up, valve support is still including locating on the leaflet support and near the barb of second end, the barb to leaflet support's radial outside extension and court first end extension, the barb is close to leaflet support's one end with the shirt rim support is close to the axial distance scope between leaflet support's the one end is 10mm ~ 20 mm.

In one embodiment, the length of the barbs ranges from 2mm to 3mm, or from 3mm to 5mm, or from 5mm to 10 mm.

In one embodiment, the barbs can be at an angle ranging from 20 ° to 45 °, or 45 ° to 60 °, or 60 ° to 70 °.

In one embodiment, the ratio of the width to the thickness of the barbs ranges from 0.75 to 1, or from 1 to 1.2, or from 1.2 to 1.5.

In one embodiment, the barb includes a fixing portion and a bending portion, one end of the fixing portion is connected to the leaflet brace, the other end is connected to the bending portion, the bending portion bends toward a longitudinal central axis of the leaflet brace, and an included angle between the bending portion and the fixing portion ranges from 110 ° to 160 °.

In one embodiment, the leaflet braces are provided with a round angle at the position where the barbs are connected, and the radius of the round angle ranges from 0.02mm to 0.30 mm.

In one embodiment, the distance between the end of the skirt stent near the leaflet stent and the first end is 1/4-1/2 of the axial length of the leaflet stent.

In one embodiment, the leaflet brace includes a plurality of wave rings arranged at intervals in an axial direction of the leaflet brace and a plurality of connecting rods connecting the plurality of wave rings, the connecting rods extending in the axial direction of the leaflet brace, and the barbs are disposed on the connecting rods.

In one embodiment, the valve stent further comprises a connecting rod and a connecting piece, wherein one end of the connecting rod is connected with the second end, and the end of the connecting rod far away from the second end is connected with the connecting piece.

In one embodiment, the valve stent further comprises a tether connected to the connector.

A heart valve prosthesis comprises the valve support, a flow blocking element and valve leaflets, wherein the flow blocking element covers the valve leaflet support and the skirt support, and the valve leaflets are positioned inside the valve leaflet support and fixedly connected with the valve leaflet support and/or the flow blocking element.

According to the valve support and the heart valve, after the heart valve is implanted into a heart of a human body, the mitral valve leaflets of the human body can be squeezed on a ventricular wall by the leaflet support and keep an open state, the skirt support of the heart valve can be clamped on the mitral valve annulus to prevent the heart valve from falling into a left ventricle, the barbs arranged at the second end of the leaflet support can hook the lower edges of the leaflets of the human body, the axial freedom degree of the heart valve can be bound under the tension of valve chordae tendineae, the heart valve is prevented from moving towards a left atrium, the probability of displacement of the heart valve after implantation is effectively reduced, and the barbs can be hung on the mitral valve leaflets of the human body without penetrating into ventricular tissue, so that the barbs and the ventricular tissue are prevented from rubbing to damage myocardial tissue around the ventricle, and the risk of puncturing the ventricular wall is avoided.

Drawings

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

FIG. 2 is a schematic representation of the heart valve of FIG. 1 after implantation in the heart;

FIG. 3 is a partial, schematic structural view at another perspective of the heart valve of FIG. 2 after implantation in the heart;

FIG. 4 is a partial, schematic structural view of another perspective of the heart valve of FIG. 1;

FIG. 5 is a partial schematic structural view of a valve stent of the heart valve shown in FIG. 1;

FIG. 6 is a partial schematic structural view of the valve stent of FIG. 5 during fabrication;

FIG. 7 is a partial, schematic, cross-sectional view of the valve stent of FIG. 5 from another perspective;

FIG. 8 is a partial schematic structural view of another embodiment of a valve stent;

FIG. 9 is a partial schematic structural view of yet another embodiment of a valve stent;

FIG. 10 is a partial schematic structural view of yet another embodiment of a valve stent;

FIG. 11 is a schematic view of the elastic member shown in FIG. 5;

FIG. 12 is a partial cross-sectional view of one embodiment of a heart valve coupled to a hollow wire cable;

fig. 13 is an angled configuration of the connector of the heart valve of fig. 12.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present invention comprehensible, embodiments accompanied with figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.

It will be understood that when an element is referred to as being "secured to" or "disposed on" 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," and the like as used herein are for illustrative purposes only and do not represent the only embodiments.

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 herein in the description of the invention 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 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, an aortic valve stent, and the like.

With continued reference to fig. 1, the heart valve 10 includes a valve support 100, a flow blocking element 200, and a valve leaflet 300, wherein the flow blocking element 200 covers the valve support 100, and the valve leaflet 300 is located inside the valve support 100 and is fixedly connected to the valve support 100 and/or the flow blocking element 200.

Referring to fig. 4 and 5, the valve stent 100 includes a leaflet stent 110, a skirt stent 120, a connecting rod 130, a connecting member 140 and a tether 150, wherein the skirt stent 120 and the connecting rod 130 are respectively connected to the leaflet stent 110, the connecting member 140 is connected to the connecting rod 130, and the tether 150 is connected to the connecting member 140.

The leaflet holder 110 is generally cylindrical having a first end and a second end disposed opposite the first end. In this application, the first end is an inflow end and the second end is an outflow end. The skirt stent 120 extends from the leaflet stent 110 radially outward of the leaflet stent 110, the skirt stent 120 is disposed near a first end of the leaflet stent 110, the valve stent 100 further includes barbs 111 disposed on the leaflet stent 110 and near a second end, the barbs 111 extend radially outward of the leaflet stent 110 and toward the first end, and an axial distance between one end of the barbs 111 near the leaflet stent 110 and one end of the skirt stent 120 near the leaflet stent 110 is in a range of 10mm to 20 mm. In one embodiment, the axial distance between the end of the barbs 111 near the leaflet braces 110 and the end of the skirt braces 120 near the leaflet braces 110 ranges from 10mm to 16 mm. Specifically, the barbs 111 are located at a second end of the leaflet braces 110.

Referring to fig. 2 and 3 together, when the heart valve is implanted into the human heart 20, the mitral valve leaflets 21 of the human body are squeezed by the leaflet holders 110 against the ventricular wall and kept open, and the skirt holder 120 of the heart valve 10 can be clamped on the mitral valve annulus 22 to prevent the heart valve 10 from falling into the left ventricle, and the barbs 111 provided at the second end of the leaflet holders 110 can catch the lower edge of the leaflet of the human body itself, the axial freedom degree of the heart valve 10 can be restrained under the tension of the valve chordae 23, the heart valve 10 is prevented from moving towards the left atrium, the probability of displacement of the heart valve after implantation is effectively reduced, and since the barbs 111 can be caught on the mitral valve leaflets 21 of the human body without penetrating into the ventricular tissue, the barbs can be prevented from rubbing with the ventricular tissue to damage the myocardial tissue around the ventricle, and the risk of puncturing the ventricular wall is avoided.

Specifically, the leaflet brace 110 includes a plurality of wave rings 112 arranged at intervals along the axial direction of the leaflet brace 110 and a plurality of connecting rods 113 connecting the plurality of wave rings 112, the connecting rods 113 extend along the axial direction of the leaflet brace 110, each connecting rod 113 is fixedly connected with all the wave rings 113, and the barbs 111 are arranged on the connecting rods 113. By disposing the barbs 113 on the connecting rods 113, the rigidity is high because the connecting rods 113 penetrate the first and second ends of the leaflet brace 110, and when the barbs 111 are stressed, the connecting rods 113 can bear the force transmitted from the roots of the barbs 111 without local deformation of the leaflet brace 110 due to the moment generated on the barbs.

In the illustrated embodiment, the leaflet brace 110 includes three wave rings 112, the three wave rings 112 are connected and fixed by a plurality of connecting rods 113, the number of the connecting rods 113 is the same as the number of the wave troughs of the wave rings 112, and one connecting rod 113 is simultaneously fixedly connected with the wave troughs of the three wave rings 112. Of course, in other embodiments, the connecting rod 1123 may be fixedly connected to other positions of the wave ring 112, such as between the wave crest and the wave trough.

The barbs 111 are cut. Referring to fig. 6, the cutting pattern of the barbs 111 is located at the end of the connecting rod 113 of the leaflet brace 110 away from the first end, and the barbs 111 are broken off during shaping. The connecting rod 113 of the leaflet brace 110 is provided with a round angle 114 at the position connected with the barb 111, and the radius of the round angle 114 is 0.02 mm-0.30 mm, so that the phenomenon that the root of the barb 111 is too large in deformation caused by stress concentration generated by the load on the barb 111 during processing or after implantation can be avoided, and the risk that the barb 111 is broken is reduced. In one embodiment, the radius of the rounded corner 114 is 0.03mm to 0.10mm, which can satisfy the fatigue resistance and strength of the barb 111, and can reduce the risk of fracture of the barb 111 during the manufacturing process and after implantation. Specifically, the number of the barbs 111 is 6 to 18, and the barbs are uniformly distributed in the circumferential direction of the leaflet brace 110. In this embodiment, the number of the barbs 111 is 9, and the ends of the barbs 111 that are connected to the leaflet braces 110 are located at the same height as the leaflet braces 110.

In the illustrated embodiment, there are two rounded corners 114, two rounded corners being located on either side of the barb 111 at the rounded corners 114. It should be noted that in one embodiment, there may be only one rounded corner 114.

Referring to FIG. 7, the length a of the barbs 111 is 2mm to 3mm, or 3mm to 5mm, or 5mm to 10 mm. In the present application, the length a of the barb 111 refers to the length of a line between the end point of the end of the barb 111 connected to the leaflet brace 110 and the end point of the end of the barb 111 remote from the leaflet brace 110. Preferably, the length a of the barb 111 is 3 mm-5 mm, so that the barb 111 cannot be easily loosened after being hooked on the valve leaflet of the human body, and the barb 111 cannot penetrate into the tissue to cause perforation or damage to the blood vessel. The included angle A between the barb 111 and the valve leaflet bracket 110 is 20-45 degrees, or 45-60 degrees, or 60-70 degrees. Preferably, the included angle A between the barbs 111 and the leaflet braces 110 is 45-60 degrees, so that the barbs 111 can be more easily hooked on the leaflets of the human body without significantly affecting the sheathing force. The width of the barb 111 is 0.2 mm-1.0 mm, preferably, the width b of the barb 111 is 0.3 mm-0.5 mm, which can not affect the sheath feeding force of the heart valve and can also provide effective axial supporting force. In this embodiment, the barbs 111 are of uniform width (end not considered) design, and the width of the barbs 111 in this application is the width at a location excluding the ends. The thickness c of the barb 111 is the same as the whole thickness of the leaflet brace 110, is 0.2 mm-0.6 mm, and is better, and the thickness c is 0.3 mm-0.5 mm, so that the strength of the barb 111 can be ensured, and larger axial supporting force can be provided. The ratio of the width b to the thickness c of the barb 111 is 0.75-1, or 1-1.2, or 1.2-1.5, so that the amount of strain of the barb 111 when bearing a blood pressure load is small, and the strength and fatigue resistance of the barb 111 are improved. Preferably, the ratio of the width b to the thickness c of the barb 111 is in the range of 1 to 1.2, and the barb 111 has excellent strength and fatigue resistance.

To prevent the barbs 111 from abrading the surrounding tissue, the ends of the barbs 111 may be passivated. For example, referring to FIG. 8, the end of the barb 111 may be spheroidized, such as by argon arc welding. For another example, referring to fig. 9, after the end of the barb 111 is shaped, it is chamfered or cut using a pattern with a chamfer. Referring to fig. 10, the barb 111 includes a fixed portion 111a and a bent portion 111b, one end of the fixed portion 111a is connected to the leaflet brace 110, the other end is connected to the bent portion 111b, the bent portion 111b is bent toward the longitudinal central axis of the leaflet brace 110, and an included angle between the bent portion 111b and the fixed portion 111a ranges from 110 ° to 160 °. Bend through the one end of keeping away from leaflet support 110 to barb 111, can be so that barb 111's end can not be with great angle direct contact ventricular wall, can reduce in the very big degree with ventricular wall frictional resistance or ventricular wall's possibility, in addition, the probability that the barb blocked the sheath pipe and scratched the sheath pipe when reduction that can also be very big was released or was retrieved. More specifically, the length of the bending part 111b is 0.2 to 0.5 times of the total length of the barb 111. The bent portion 111b may be formed by being bent toward the inside of the leaflet holder 110 at the time of heat-setting at the time of processing.

The distance between one end of the skirt stent 120 close to the leaflet stent 110 and the first end is 1/4-1/2 of the axial length of the leaflet stent 110. Referring to fig. 4 and 5, the skirt support 120 includes a support portion 121 and a tilting portion 122. The support portion 121 extends outward from the leaflet support 110 in a radial direction of the leaflet support 110, and the raised portion 122 extends from an end of the support portion 121 away from the leaflet support 110 to a first end of the leaflet support 110. The support portion 121 is used for fixation of the heart valve 10 at the human mitral annulus 22 of the heart 20, and the raised portion 122 is used for preventing abrasion of left atrial tissue by the edge (i.e., distal edge) of the support portion 121 away from the leaflet holders 110. Without the raised portion 122, the distal edge of the radial support portion 121 is in direct contact with the atrial tissue, and under long-term heart beating, the distal edge of the support portion 121 may create a cutting effect on the atrial tissue, causing damage to the atrial tissue. By providing the raised portion 122, the line contact between the skirt support 120 and the atrial tissue is changed to surface contact, increasing the contact area, reducing the contact pressure, avoiding the cutting effect of the skirt support 120 on the cardiac tissue and the resulting abrasion.

In the embodiment shown in fig. 4, the support portion 121 of the skirt stent 120 is secured to the trough of the undulating ring 112 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 110 can be located in the left atrium, thereby avoiding the left ventricular outflow tract from being narrow or even blocked due to the fact that the leaflet frame 110 is excessively implanted in the left ventricle.

The width of the support part 121 of the skirt stent 120 is 2mm to 6mm, so as to sufficiently ensure the fixation of the heart valve 100 on the mitral valve annulus 22 of the human heart. Here, the width of the support portion 121 refers to a distance between one end of the support portion 121 near the raised portion 122 and the leaflet brace 112. In the present embodiment, the width of the support portion 121 is 4 mm. The height of the raised part 122 is 2mm to 6 mm. Here, the height of the tilted part 122 refers to a distance between one end of the tilted part 122 distant from the support part 121 and one end close to the support part 121. If the height of the raised portion 122 is less than 2mm, abrasion of the edge of the skirt stent 120 to heart tissue cannot be prevented, and if the height is more than 6mm, other tissue of the left atrium may be injured. In this embodiment, the height of the tilted portion 122 is 4 mm.

In this embodiment, the outer contour of the support portion 121 of the skirt holder 120 is circular when viewed from the inflow side of the valve blood flow. Of course, in other embodiments, the outer contour of the supporting portion 121 may have other shapes, such as a D-shape or a D-like shape.

Referring to fig. 4, the valve stent 10 further includes an elastic member 160 disposed between the second end of the leaflet stent 110 and the skirt stent 120, the elastic member 160 protruding radially outward of the leaflet stent 110. Specifically, the elastic member 160 includes a plurality of elastic wires disposed around the outer circumference of the leaflet frame 110, the elastic wires extending outward from the leaflet frame 110 in the radial direction of the leaflet frame 110, one end of the elastic wires being connected to the leaflet frame 110, and the other end of the elastic wires being connected to the skirt frame 120. Referring to fig. 11, the elastic wires are connected to each other to form a ring of corrugated ring, the corrugated ring includes a plurality of distal vertices 161, a plurality of proximal vertices 163, and a support 162 connecting the adjacent distal vertices 161 and proximal vertices 163, the distal vertices 161 are respectively connected to the skirt stent 120, and the proximal vertices 163 are respectively connected to the leaflet stent 110, so as to reduce the number of connection points between the elastic element 160 and the leaflet stent 110 and the skirt stent 120, and improve the connection strength between the elastic element 160 and the leaflet stent 110 and the skirt stent 120. 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 apices 163 are located on the same circumferential plane perpendicular to the longitudinal central axis of the leaflet brace 110, i.e., the points of attachment of the plurality of proximal apices 163 to the leaflet brace 110 have no height difference in the axial direction of the leaflet brace 110. Each proximal apex 163 is fixed at a trough of the leaflet brace 110.

It should be noted that the elastic member 160 is not necessarily limited to an elastic wire. The elastic member 160 may be configured to be deformable under a certain force. For example, elastic coating films with both ends fixed to the leaflet holders 110 and the skirt holders 120, respectively; as another example, an annular elastic sponge is disposed between the leaflet braces 110 and the skirt braces 120. The sponge has an inner diameter equal to the outer diameter of the leaflet holders 110 and an outer diameter equal to the outer diameter of the support portions 121 of the skirt holders 120. The sponge is fixed to the leaflet holders 110 and the support parts 121 by a suture method, or fixed to the spoiler 200 by a suture method.

Of course, in other embodiments, the distal apices 161 may not be connected anywhere in the skirt stent 120, and only the proximal apices 163 are connected to the leaflet stent 110. In other embodiments, the distal apices 161 can also be connected to other locations of the skirt stent 120, and the proximal apices 163 can also be connected to axially different locations of the leaflet stent 110. The position of each of the distal apices and the proximal apices in the leaflet framework 110 and skirt framework 120 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 110 are provided at the outer circumference thereof with a plurality of elastic wires parallel to each other, each of which has one end connected to the leaflet holders 110 and the other end connected to the skirt holder 120.

To facilitate the insertion of the heart valve 10 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 skirt stent 120 where the elastic wire is fixed to the leaflet stent 110 and the axial distance from the position where the leaflet stent 110 is fixed to the elastic wire to the end of the skirt stent 120 close to the leaflet stent 110, and the length of each elastic wire is equal to the distance from the position where the skirt stent is fixed to the elastic wire to the position where the leaflet stent 110 is fixed to the elastic wire after the heart valve 10 is compressed into the sheath, regardless of the circumferential lengths of the two ends of the elastic wire after the insertion into the sheath. Specifically, in the present embodiment, the length of the support 162 is substantially equal to the sum of the distance from the distal vertex 161 connected to the support 162 to the leaflet holder 110 and the axial distance from the proximal vertex 163 connected to the support 162 to the end of the skirt holder 120 close to the leaflet holder 110, so as to avoid the folding of the support 162 after being mounted in the sheath, and facilitate the mounting of the heart valve 10 in the sheath.

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 again to fig. 5 and 12, the link 130 includes a proximal link 132, a leaflet brace link 134, and a joint 136. The proximal link 132 is generally rod-shaped. The leaflet support links 134 are generally V-shaped and include two struts extending from one end of the proximal link 132 to the leaflet support 110, wherein one end of the two struts distal from the proximal link 132 is fixedly connected to two troughs adjacent to the undulating rings of the leaflet support 110 near the second end, and each trough is connected to one strut, so that the plurality of links 130 are uniformly distributed along the second end, thereby guiding the heart valve 10 when it is retracted into the sheath, and preventing the troughs from being caught outside the sheath. If the leaflet support links 134 are attached to the leaflet support 110 near the peaks of the coils at the second end, the troughs can become lodged outside the sheath when the heart valve 10 is being sheathed.

It will be appreciated that the leaflet bracket links 134 can also have other shapes, for example, can be in a straight line extending from one end of the proximal link 132 directly to connect with the valleys of the second end of the leaflet bracket, i.e., the number of struts corresponds to the number of proximal links 132.

In the illustrated embodiment, the leaflet holders 110, skirt holders 120, and links 130 are cut from the same tube and are integrally formed. The integrated cutting is split relatively and then assembled, so that the valve stent 100 has the advantages of small radial size after compression and easiness in sheathing, and meanwhile, welding or splicing structures do not exist among all parts formed integrally, so that the fatigue resistance of the valve stent 100 is improved. In this embodiment, the valve stent 100 can be cut and shaped from a superelastic nickel-titanium metal tube with a diameter of 6mm to 10mm and a wall thickness of 0.3mm to 0.5 mm.

Referring to fig. 1, 5, 12 and 13, the joint 136 of the connecting rod 130 is connected to the connecting member 140. The connecting member 140 includes a socket 142 and a connecting cover 144. In the illustrated embodiment, the socket 142 is substantially cylindrical, and has a receiving groove 1422 recessed at one end and a screw hole 1424 formed at the other end. The screw hole 1424 communicates with the receiving groove 1422. In the illustrated embodiment, the end of the socket 142 with the screw hole 1424 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 10 further comprises a hollow steel cable 30 for assisting in the delivery of the heart valve 10. The screw hole 1424 is connectable 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 screw hole 1324, so that 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 10 when the heart valve 10 is being delivered in the delivery sheath, allowing the heart valve 10 to move within the delivery sheath lumen, and the heart valve 10 can be pulled back again into the delivery sheath by the hollow wire cable 30 after the heart valve 10 is released from the delivery sheath.

The connection cover 144 is disposed and fixed in the receiving groove 1422. In the illustrated embodiment, the connection cover 144 is received in the receiving groove 1422 and is fixed to a groove wall of the receiving groove 1422 by welding. The connecting cover 144 has a plurality of limiting holes 1442. The connecting rod 130 penetrates through the limiting hole 1442, and the joint 136 is accommodated in the accommodating groove 1422. The joint 136 abuts against a side surface of the connection cover 144 adjacent to the screw hole 1424. In the illustrated embodiment, the size of the fitting 136 in at least one dimension is larger than the diameter of the stop bore 1442 to prevent the fitting 136 from falling out of the stop bore 1442.

A stopper 152 is formed at one end of the tether 150, and the tether 150 is fixed to the connector 140 through the stopper 152. The tether 150 is inserted into the screw hole 1424 and the blocking portion 152 is received in the receiving groove 1422. The size of the blocking portion 152 in one dimension is larger than the inner diameter of the screw hole 1424, so that the blocking portion 152 is prevented from falling off the screw hole 1424. 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, tether 150 extends outwardly from receptacle 1422 and through the inner bore of hollow cable 30.

It should be noted that in one embodiment, the heart valve 10 may also be provided without the tether 150, if desired. For example, tether 150 may be removed after barbs 111 have been fully secured to heart valve 10 as determined by a pull test.

Referring again to fig. 2, the heart valve 10 may also include a spacer 170. The material of the gasket 170 is at least one selected from the group consisting of silica gel, polyester, nylon, ultra-high molecular weight polyethylene, nickel titanium, and stainless steel woven wire. The gasket 170 may be a felt-like disc, a titanium-nickel wire woven disc, or a polymer injection molded disc. When the heart valve 10 is implanted in the human heart 20, the end of the tether 150 remote from the rod 130 is tied through the heart 20 and the pad 170 and then fixed to the pad 170.

With continued reference to fig. 4, the flow-blocking element 200 covers the surface of the leaflet braces 110, and the flow-blocking element 200 is used to block the blood flow flowing out through the leaflet braces 110 and cooperate with the leaflets 300 to ensure the unidirectional flow of blood in the heart valve 10. The choke piece 200 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 200 may be coated by a heat pressing process or fixed to the leaflet frame 110 by sewing, depending on the material. In the present embodiment, referring to fig. 1 and 2, the flow-blocking element 200 wraps the inner and outer surfaces of the leaflet holders 110 and the skirt holders 120 and covers the elastic element 160. By covering the choke piece 200 on the surface of the skirt stent 120, the contact area between the skirt stent 120 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 10 can be accelerated, so that the thrombogenicity of the heart valve 10 can be reduced. In one embodiment, to accelerate the coating of endothelial tissue on the surface of the heart valve 10, the non-biological tissue surface of the heart valve 10 can be deposited with a parylene layer. In one embodiment, the surface of the flow resistor 200 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 also be disposed between the flow blocker 200 and the leaflet braces 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 flow resistor 200 adjacent to the leaflet braces 110. Of course, in other embodiments, the hydrogel layer may also be secured between the flow blocker 200 and the leaflet braces 110 by means of stitching. When the heart valve 10 is implanted into the human heart 20, the hydrogel swells in the presence of water, thereby swelling the site of the resistive element 200. If a gap exists between the heart valve 10 and the mitral valve tissue after being implanted into the human heart 20, the expanding hydrogel layer causes the flow blocking member 200 to bulge outward, thereby blocking the gap and reducing the risk of paravalvular leakage.

With continued reference to fig. 4, the profile of the end of the flow resistance element 200 near the second end of the leaflet brace 110 is the same as the profile of the second end of the leaflet brace 110. In the illustrated embodiment, the wave ring 112 is located at one end of the leaflet bracket close to the link 130 and is fixedly connected to the link 130, the profile of the second end of the leaflet bracket 110, i.e., the profile of the wave ring 112, is saw-toothed, and the profile of one end of the obstructing component 200 close to the second end of the leaflet bracket 110 is saw-toothed and is the same as the profile of the second end of the leaflet bracket 110, so that the obstructing component 200 is prevented from protruding out of the sheath when the heart valve 10 is radially compressed into the sheath, and the left ventricular outflow tract is prevented from being narrowed due to excessive obstructing component 200 in the left ventricle. The end of the flow blocking element 200 near the second end of the leaflet brace 110 is secured by stitching with the crimp 112. Preferably, the resistive element 200 is sewn on the inside of the wave ring 112 to prevent the resistive element 200 from protruding when the heart valve 10 is retracted into the sheath, causing it to get stuck outside the sheath.

Of course, in other embodiments, the second end of the leaflet support 110 is not serrated, and the shape of the end of the flow blocking element 200 near the second end of the leaflet support 110 may be modified accordingly, so long as the two profiles are the same and the flow blocking element 200 is sewn inside the wave ring 112, the flow blocking element 200 may be prevented from protruding when the sheath is retracted.

Referring again to fig. 4, the leaflet 300 is positioned inside the leaflet support 110 and fixed to the flow resisting element 200 on the surface of the leaflet support 110. The leaflet 300 is cut from an animal pericardium. In the illustrated embodiment, the leaflet 300 has a generally fan-shaped configuration with three segments in series along the circumference of the leaflet support 110. One ends of the adjacent two leaflets 300 near the inner surface of the leaflet holders 110 are joined together to form a leaflet angle, the peripheries of the leaflets 300 are fixed to the leaflet holders 110 and the flow blocking member 200 by sewing, and the leaflet angle is fixed to the connection point of the link rod 130 and the leaflet holders 110.

Referring to fig. 2 and 3 together, when the heart valve 10 is implanted in the human heart 20, the mitral valve leaflet 21 of the human body is squeezed against the ventricular wall by the leaflet support 110 and kept open, the skirt support 120 of the heart valve 10 fixes the heart valve 10 on the mitral valve annulus 22 to prevent the heart valve 10 from falling into the left ventricle, one end of the tether 150 away from the connecting rod 130 is fixed through the heart 20 and the spacer 170 to prevent the heart valve 10 from moving towards the left atrium, the barbs 111 disposed at the second end of the leaflet support 110 can catch the lower edge of the mitral valve leaflet, the axial freedom of the valve support 10 can be restricted under the pulling force of the valve chordae 23 to prevent the valve support 10 from moving towards the left atrium, which effectively reduces the probability of the heart valve 10 shifting after implantation, and furthermore, the elastic element 160 is located at the position of the mitral valve annulus 22, the elastic element can be concaved or convexed in the radial direction and/or towards the direction of the first end, so as to adapt to the contour of the mitral valve annulus 22 and keep the outer surface thereof attached to the contact surface of the mitral valve annulus 22, thereby playing the role of blocking blood flow and preventing 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.