CN110731836B

CN110731836B - Heart valve

Info

Publication number: CN110731836B
Application number: CN201810800778.9A
Authority: CN
Inventors: 刘香东
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Shenzhen Jianxin Medical Technology Co ltd
Priority date: 2018-07-20
Filing date: 2018-07-20
Publication date: 2021-10-12
Anticipated expiration: 2038-07-20
Also published as: CN110731836A

Abstract

The invention relates to a heart valve, which comprises a valve support, a choke piece covering the valve support and a plurality of valve leaflets arranged in the valve support, wherein the valve support comprises a plurality of fixing columns extending along the axial direction, each valve leaflet comprises an upper edge, a lower edge and two valve angle fixing areas, the valve angle fixing areas are respectively connected with the upper edge and the lower edge, the lower edge is fixed on the inner surface of the choke piece, the two adjacent valve leaflets are mutually attached at the positions of the fixing columns, the valve angle fixing areas are attached to the inner surface of the choke piece after being bent at the positions of the fixing columns, the heart valve further comprises fixing pieces and fixing lines, the surface of each valve angle fixing area, which is far away from the choke piece, is provided with a fixing piece, the fixing pieces extend along the circumferential direction of the valve support, and the fixing pieces and the valve angle fixing areas are sewn on the fixing columns through the fixing lines. The heart valve can not occupy more radial sizes, thereby avoiding the influence on the effective opening area of the heart valve and preventing the increase of the sheathing force.

Description

Heart valve

Technical Field

The invention relates to the field of medical instruments, in particular to a prosthetic 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 surgery is performed by an interventional and minimally invasive method, so that the patients avoid the pain of an open chest surgery. However, after the existing heart valve is implanted into a human body, valve leaflets are easily torn after a plurality of movements, and the service life of the heart valve is influenced.

Disclosure of Invention

In view of the above, there is a need for a heart valve that can improve leaflet life.

A heart valve comprises a valve support, a flow blocking piece covering the valve support and a plurality of valve leaflets arranged in the valve support, the valve support comprises a plurality of fixing columns extending along the axial direction, the valve leaf comprises an upper edge, a lower edge and two valve angle fixing areas, the petal angle fixing area is respectively connected with the upper edge and the lower edge, the lower edge is fixed on the inner surface of the flow resisting part, two adjacent valve blades are mutually attached at the position of the fixing column, the petal angle fixing area is bent at the position of the fixing column and then attached to the inner surface of the flow resisting part, the heart valve also comprises a fixing piece and a fixing line, the surface of each valve angle fixing area far away from the flow resisting piece is provided with the fixing piece, the fixing piece extends along the circumferential direction of the valve leaflet bracket, and the fixing sheet and the petal angle fixing area are sewn on the fixing column through the fixing line.

In one embodiment, the fixing piece includes a first sewing region, a second sewing region and a fixing groove located between the first sewing region and the second sewing region, one end portions of the first sewing region and the second sewing region are connected to each other, the fixing groove is engaged with two adjacent valve leaflets, and the first sewing region and the second sewing region are respectively attached to the valve corner fixing regions of the two adjacent valve leaflets.

In one embodiment, the width of the fixing groove is approximately equal to the sum of the thicknesses of the adjacent two valve leaflets.

In one embodiment, the other ends of the first and second stitched regions are also connected to each other.

In one embodiment, the sides of the first sewn region and the second sewn region, which are close to each other, are partially folded in a direction perpendicular to the first sewn region to form an L shape.

In one embodiment, the first and second suture regions cover at least 60% of the area of the flap angle fixation region.

In one embodiment, the flap angle fixing area is provided with a plurality of threading holes, the first sewing area and the second sewing area are respectively provided with a plurality of fixing holes correspondingly, and the fixing thread penetrates through the fixing holes and the threading holes to sew the fixing piece and the flap angle fixing area on the fixing column.

In one embodiment, through holes are correspondingly formed in the fixing column, and the number of the through holes is not less than the sum of the number of the threading holes of the two petal angle fixing areas fixed on the fixing column.

In one embodiment, the fixing piece is further disposed between the lobe angle fixing area and the spoiler.

In one embodiment, the thickness of the fixing sheet is 0.2mm to 0.6 mm.

According to the heart valve, the fixing pieces are arranged on the valve corner fixing areas, and the radial connecting force of the valve leaflets in the opening and closing processes can be dispersed through the fixing pieces, so that the valve leaflets can be prevented from being torn, and the service life of the valve leaflets is prolonged; in addition, the fixing piece extends along the circumferential direction of the valve support, so that the fixing piece does not occupy more radial sizes, the influence on the effective opening area of the heart valve can be avoided, and the increase of the sheathing force can be prevented.

Drawings

Fig. 1 is a schematic structural view of a heart valve according to a first embodiment of the present disclosure;

FIG. 2 is a schematic view of the heart valve of FIG. 1 from another perspective;

FIG. 3 is a partial schematic structural view of the heart valve of FIG. 2;

FIG. 4 is a schematic structural view of a valve support of the heart valve shown in FIG. 1;

FIG. 5 is a schematic view of the valve stent of FIG. 4 after deployment;

FIG. 6 is a schematic view of a leaflet of the heart valve of FIG. 1;

FIG. 7 is a schematic structural view of a fixing piece of the heart valve shown in FIG. 1;

fig. 8 is a partial structural schematic view of a heart valve according to the second embodiment of the present application;

FIG. 9 is a schematic structural view of a fixing piece of the heart valve shown in FIG. 8;

fig. 10 is a schematic structural view of a fixing piece of a heart valve according to a third embodiment of the present application;

fig. 11 is a partial structural view of a heart valve according to a fourth embodiment of the present application.

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, 2, 3 and 6, a heart valve 100 according to an embodiment of the present invention includes a valve holder 110, a flow blocking element 120 covering the valve holder, a plurality of valve leaflets 130 disposed in the valve holder 110, a fixing piece 140 and a fixing line 150. The valve stent 110 includes a plurality of fixing posts 111 extending along an axial direction, the leaflet 130 includes an upper edge 131, a lower edge 132 and two leaflet fixing regions 133, the leaflet fixing regions 133 are respectively connected with the upper edge 131 and the lower edge 132, the lower edge 132 is fixed on the inner surface of the flow blocking element 120, two adjacent leaflets 130 are attached to each other at the positions of the fixing posts 111, the leaflet fixing regions 133 are bent at the positions of the fixing posts 111 and then attached to the inner surface of the flow blocking element 120, a fixing tab 140 is disposed on a surface of each leaflet fixing region 133 away from the flow blocking element 120, the fixing tabs 140 extend along a circumferential direction of the leaflet stent 110, and the fixing tabs 140 and the leaflet fixing regions 133 are sewn on the fixing posts 111 through fixing lines 150.

In the heart valve, the fixing pieces 140 are arranged on the valve corner fixing areas 133, so that the radial connecting force of the valve leaflets 130 in the opening and closing processes can be dispersed through the fixing pieces 140, the tearing of the valve leaflets 130 can be reduced, and the service life of the valve leaflets 130 can be prolonged; in addition, the fixing pieces 140 extend along the circumferential direction of the valve holder 110, so that the valve holder does not occupy more radial dimensions, thereby avoiding the influence on the effective opening area of the heart valve and preventing the increase of the sheathing force.

Referring also to fig. 4, the valve holder 110 is generally cylindrical. The valve stent 110 is formed by laser cutting and expanding and heat setting a nickel titanium metal tube. Fig. 5 is a cut pattern of valve stent 110 on a nitinol tube. Specifically, the valve holder 110 includes a plurality of wave rings 112, a plurality of connecting rods 113 connecting the plurality of wave rings 112, and fixing posts 111, and the wave rings 112 provide radial support force for the valve holder 112. The plurality of wave rings 112 include a first wave ring 1121 at the inflow end, a second wave ring 1122 at the outflow end, and a third wave ring 1123 between the first wave ring 1121 and the second wave ring 1122, the first wave ring 1121, the second wave ring 1121, and the third wave ring 1123 are arranged at intervals in the axial direction of the valve stent 110, the first wave ring 1121 and the third wave ring 1123 are connected by a plurality of connecting rods 113, and the fixing posts 111 are disposed between the second wave ring 1122 and the third wave ring 1123. The inflow end and the outflow end of the present application are defined in the direction of blood flow, i.e., the inflow end of blood flows into the heart valve 100 and the outflow end of blood flows out of the heart valve 100.

In the illustrated embodiment, the wave troughs of the first wave ring 1121 and the third wave ring 1123 are connected by a connecting rod 113, three wave troughs of the second wave ring 1122 and the third wave ring 1123 are connected by a fixing column 111, and the rest of the wave troughs are connected by the connecting rod 113. The fixing post 111 is provided with a plurality of through holes 1113. It is understood that the fixing post 111 and the connecting rod 113 may be used only for distinguishing purposes, and the fixing post 111 and the connecting rod 113 may have the same structure. In the illustrated embodiment, two rows of through holes 1113 are disposed in parallel on the fixing post 111, and the two rows of through holes 1113 are respectively used for fixing with the two petal angle fixing areas 133.

It should be noted that the structure of the valve holder 110 can also be adjusted according to actual needs, and it is only necessary to ensure that the outflow end of the valve holder 110 is provided with the fixing post 111.

With continued reference to fig. 1, the resistive element 120 is secured to the inner and/or outer surface of the valve stent 110 by sewing or bonding. In the illustrated embodiment, the resistive element 120 is secured to the inner surface of the valve holder 110 by sewing. Choker 120 acts to block the flow of blood escaping through valve stent 110, and also acts to hold leaflets 130, which cooperate with leaflets 130 to ensure a unidirectional flow of blood within heart valve 110. The choked flow element 120 may be made of various materials, such as ultra-high molecular weight polyethylene, nylon, PU, PTFE, silica gel, etc., and may have an appearance of a knitted fabric tube, a film, etc. In this embodiment, the choke 120 is a tightly woven plain dacron cloth tube.

There are three leaflets 130. The lower edges 132 of the leaflets 130, which are located at the inflow end of the valve holder 110, are attached to the inner surface of the flow preventing element 120 and are fixed to the flow preventing element 120 and the valve holder 110 by sewing. The upper edge 131 of the leaflet 130, which is located at the outflow end of the valve stent 110, controls the unidirectional flow of blood by being freely opened and closed. With continued reference to figure 6, the lower edge 132 of the leaflet 130 is pre-perforated to avoid tearing of the suture needle as it passes through the leaflet 130, which can help improve the fatigue resistance of the leaflet 130. The angle fixing regions 133 of the two adjacent leaflets 130 are attached to each other at the fixing post positions and extend in a direction away from each other along the circumferential direction. The flap angle fixing region 133 is provided with a threading hole 1331, in the illustrated embodiment, the flap angle fixing region 133 is provided with a row of threading holes 1331, and the threading holes 1331 of two adjacent flap angle fixing regions 133 are respectively in one-to-one correspondence with a row of through holes 1113 on the fixing column 111.

The material of the valve leaflet 130 can be bovine pericardium, porcine pericardium, ultra-high molecular weight polyethylene, nylon, PU, PTFE, silica gel, or the like, and the appearance form can also be membrane, knitted fabric, woven plain cloth, woven twill cloth, or the like. In the present embodiment, the leaflet 130 is preferably bovine pericardial tissue having a thickness of 0.2mm to 0.5mm, and may be formed by laser cutting.

Referring also to fig. 7, the fixing member 140 is substantially U-shaped. Specifically, the fixing member 140 includes a first sewing region 141, a second sewing region 142, and a fixing groove 143 between the first sewing region 141 and the second sewing region 142, one end portions of the first sewing region 141 and the second sewing region 142 are connected to each other, the fixing groove 143 is engaged with two adjacent valve leaflets 130, and the first sewing region 141 and the second sewing region 142 are respectively attached to the valve corner fixing regions 133 of two adjacent valve leaflets 130. Specifically, the fixing groove 143 is used to catch two adjacent valve leaflets 130, and plays a limiting role, which helps to ensure the normal closing of the valve leaflets 130. The width of the fixing groove 143 is substantially equal to the sum of the thicknesses of the adjacent two leaflets 130. That is, the width of the fixing groove 143 may be slightly greater or slightly smaller than the sum of the thicknesses of the two leaflets 130 engaged in the fixing groove 143. For example, the deviation between the width of the fixing groove 130 and the sum of the thicknesses of the two leaflets 130 engaged with the fixing groove 143 is within 5%. The fixing piece 140 may be made of PA, PP, PET, PTFE, UHMWPE (ultra high molecular weight polyethylene), or the like, and has a thickness of 0.2mm to 0.6 mm.

The first suture region 141 and the second suture region 142 cover at least 60% of the area of the flap angle fixation region 133. That is, the first suture region 141 or the second suture region 142 covers at least 60% of the area of the valve angle fixation region 133, and the radial force of the leaflet 130 during opening and closing can be dispersed to a region where the valve angle fixation region 133 is large by the first suture region 141 and the second suture region 142. In the illustrated embodiment, the area of the first suture region 141 and the second suture region 142 is slightly smaller than the area of the flap angle fixing region 133, and the first suture region 141 and the second suture region 142 are symmetrical. Referring to fig. 1 and 7, the first suture region 141 and the second suture region 142 are respectively provided with a plurality of fixing holes 144, the fixing holes 144 correspond to the threading holes 1331 of the flap angle fixing region 133 one by one, and the fixing thread 150 passes through the fixing holes 144 and the threading holes 1331 to suture the fixing piece 140 and the flap angle fixing region 133 on the fixing post 111.

Referring to fig. 1, the fixing plate 140 has a plurality of fixing holes 144, threading holes 1331 of the flap angle fixing regions 133 corresponding to the through holes 1113 of the fixing post 111, and the number of the through holes 1113 of the fixing post 111 is not less than the sum of the threading holes 1331 of the two flap angle fixing regions fixed on the fixing post 111. In the illustrated embodiment, the first suture region 141 and the second suture region 142 of the fixing piece 140 are provided with 6 fixing holes, the flap angle fixing region 133 is provided with 6 threading holes, the fixing post 111 is provided with at least 12 corresponding through holes, the fixing thread 150 sequentially passes through the flow blocking piece 120, the threading hole 1331 of the flap angle fixing region 133 and the fixing hole 144 of the first suture region 141 from the through hole 1113 of the fixing post 111 near the inflow end, and sequentially passes through the second fixing hole 144, the threading hole 1331 and the fixing hole 144 adjacent to the first suture region 141, and repeats this way, and finally passes through the fixing hole 144 of the second suture region 142, the threading hole 1331 of the flap angle fixing region 133 and the through hole 1113 of the fixing post 111 and is fixed. The fixing wire 150 may be made of, for example, PA, PP, PET, PTFE, UHMWPE, etc., and may be in the form of a multi-strand wire or a single-strand wire. In this embodiment, PP single-strand wires are preferred, and the single-strand wires have a smooth surface relative to the multi-strand wires, and have a small cutting effect on the leaflet 130, thereby improving the fatigue resistance of the leaflet 130.

Referring to fig. 8, a heart valve 200 according to the second embodiment of the present disclosure has substantially the same structure as the heart valve 100 according to the first embodiment, except that: the sides of the first sewn region 241 and the second sewn region 242 adjacent to each other are partially folded in a direction perpendicular to the plane of the first sewn region 241 or the second sewn region 242 to form an L shape. One part of the first suturing region 241 covers the corner fixing region 233, and the other part of the first suturing region 241 is tightly attached to the upper edge (not shown) of the valve leaflet 230. similarly, the second suturing region 242 has a structure similar to the first suturing region 241, so as to clamp the two valve leaflets 230, which helps to ensure the normal closing of the valve leaflets 230, and prevent the valve leaflets 230 from being unable to close after being opened. Specifically, the width of the portions of the first and

second sewing regions

241 and 242 adjacent to the upper edge of the leaflet 230 is not greater than 3 times the thickness of the first and

second sewing regions

241 and 242.

Referring to fig. 9, the fixing piece 240 is different from the fixing piece 140 of the first embodiment in that there is no space between the first sewing region 241 and the second sewing region 242, a T-shaped broken line 245 is disposed at a middle position of the fixing piece 240, and the first sewing region 241 and the second sewing region 242 can be folded along the broken line 245 to form a fixing groove (not shown) in the middle for being engaged with the leaflet 230.

The heart valve of the third embodiment of the present application has substantially the same structure as the heart valve 100 of the first embodiment, except for the structure of the fixing pieces 340. Referring to fig. 10, the difference between the fixing sheet 140 of the first embodiment is: the other ends of the first suture region 341 and the second suture region 342 are also connected with each other, and a fixing groove 343 is formed at the middle position, so that the axial displacement of the valve leaflets can be limited, the fixing precision of the valve leaflets can be improved, the opening and closing consistency of each valve leaflet can be ensured, the normal closing of the valve leaflets can be ensured, and the valve leaflets can be prevented from being closed after being opened. In the illustrated embodiment, the first and

second seam regions

341 and 342 are connected to each other at both ends thereof with a substantially rectangular fixing groove 343 being formed therebetween.

Referring to fig. 11, a heart valve 400 according to the fourth embodiment of the present disclosure has substantially the same structure as the heart valve 100 according to the first embodiment, except that: also be provided with stationary blade 440 between valve angle fixed area 433 and the choker piece 420, namely, the surface of two relative settings of valve angle fixed area 433 all is provided with stationary blade 440, grasp valve angle fixed area 433 through two stationary blades 440, can increase the frictional force of valve angle fixed area 433 on the circumferential direction, reduce valve leaf 430 and lead to the removal of valve angle fixed area 433 on the circumferential direction at the switching in-process, and then can effectively avoid the tractive of fixed line 450 to valve angle fixed area 433, improve the fatigue life of valve angle fixed area 433.

It should be noted that the fixing pieces 440 disposed on the two opposite surfaces of the corner fixing regions 433 may have the same size and shape, or may have different sizes and shapes, for example, the fixing piece disposed on the side close to the spoiler 420 may have a rectangular structure, and the fixing piece 440 disposed on the side far from the spoiler 420 may have a U-shaped structure.

It should be particularly noted that the technical solutions of the above four embodiments can be combined without contradiction, for example, it is understood that one of the fixing pieces of the heart valve is the structure of the first embodiment, and the other is the structure of the second embodiment.

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 valve support, a choke element covering the valve support and a plurality of valve leaflets arranged in the valve support, wherein the valve support comprises a plurality of fixing columns extending along the axial direction, each valve leaflet comprises an upper edge, a lower edge and two valve leaflet fixing areas, the valve leaflet fixing areas are respectively connected with the upper edge and the lower edge, the lower edge is fixed on the inner surface of the choke element, the two adjacent valve leaflets are mutually attached at the positions of the fixing columns, the valve leaflet fixing areas are attached to the inner surface of the choke element after being bent at the positions of the fixing columns, the heart valve is characterized by further comprising fixing pieces and fixing lines, the fixing pieces are arranged on the surfaces, far away from the choke element, of the valve leaflet fixing areas, and extend along the circumferential direction of the valve leaflet support, the fixing piece and the petal angle fixing area are sewn on the fixing column through the fixing line; the fixing piece comprises a first sewing area, a second sewing area and a fixing groove located between the first sewing area and the second sewing area, one end portions of the first sewing area and the second sewing area are connected with each other, the fixing groove is clamped on two adjacent valve leaflets, and the first sewing area and the second sewing area are respectively attached to the valve corner fixing areas of the two adjacent valve leaflets.

2. The heart valve of claim 1, wherein the width of the fixation groove is approximately equal to the sum of the thicknesses of the adjacent two leaflets.

3. The heart valve of claim 1, wherein the other ends of the first and second sewing zones are also connected to each other.

4. The heart valve of claim 1, wherein the sides of the first and second commissural regions adjacent to each other are partially folded in a direction perpendicular to the plane of the first or second commissural regions to form an L-shape.

5. The heart valve of claim 1, wherein the first and second sewing regions cover at least 60% of the area of the valve angle fixation region.

6. The heart valve as claimed in claim 1, wherein the valve angle fixing region has a plurality of threading holes, the first sewing region and the second sewing region have a plurality of fixing holes respectively, and the fixing thread passes through the fixing holes and the threading holes to sew the fixing pieces and the valve angle fixing region on the fixing posts.

7. The heart valve as set forth in claim 6, wherein the fixing posts are correspondingly provided with through holes, and the number of the through holes is not less than the sum of the number of the threading holes of the two valve angle fixing areas fixed on the fixing posts.

8. The heart valve of claim 1, wherein the securing tabs are further disposed between the valve angle securing region and the spoiler.

9. The heart valve of any one of claims 1 to 8, wherein the thickness of the fixing piece is 0.2mm to 0.6 mm.