CN114681133A

CN114681133A - Heart valve

Info

Publication number: CN114681133A
Application number: CN202011605401.1A
Authority: CN
Inventors: 徐双虎; 虞奇峰; 秦涛
Original assignee: Shanghai Newmed Medical Co Ltd
Current assignee: Shanghai Newmed Medical Co Ltd
Priority date: 2020-12-29
Filing date: 2020-12-29
Publication date: 2022-07-01
Also published as: WO2022141789A1

Abstract

The present patent discloses a heart valve that is at least partially degradable. In the technical scheme, the minimally invasive interventional implantation heart valve can be used for treating heart valve diseases. In practical application, the heart valve can be tightly connected and fixed by virtue of the endothelialization compact substance and the native tissue. By making the heart valve at least partially degradable, it is possible to make the heart valve able to select a degradable site according to the actual application scenario, the site being gradually reduced in size until complete degradation disappears. Therefore, the outflow tract obstruction can be effectively reduced, and the influence on the hemodynamics is reduced, so that the probability of occurrence of thrombus and hemolysis is avoided.

Description

Heart valve

Technical Field

The invention relates to the technical field of medical instruments, in particular to a heart valve.

Background

The heart is divided into left and right portions, each including a ventricle and an atrium, the ventricles being separated from the ventricles and the atria from the atria by the interatrial and ventricular spaces, and valves preventing regurgitation of blood being provided between the atria, the chambers and the arteries. Wherein, the valve between the left atrium and the left ventricle is a mitral valve, the valve between the right atrium and the right ventricle is a tricuspid valve, the valve between the left ventricle and the aorta is an aortic valve, and the valve between the right ventricle and the pulmonary artery is a pulmonary valve. By heart valve is meant a valve between the atrium and the ventricle or between the ventricle and the artery. Valves play a key role in the heart's blood circulation activity, acting as one-way valves. The heart valve can correspondingly open and close along with the contraction and the relaxation of the heart, so that the unidirectional flowing of the blood flow is ensured.

The heart valve disease is a common heart disease, especially with the aggravation of the aging of the population, the senile heart valve disease and the valve disease caused by coronary heart disease and myocardial infarction are more and more common, and the heart valve disease deserves attention of everyone. Specifically, the heart valve disease refers to abnormal heart function caused by abnormal complete closure or full opening of the valves due to pathological changes of the mitral valve, the tricuspid valve, the aortic valve and the pulmonary valve caused by various congenital and acquired reasons.

At present, minimally invasive intervention implantation of a prosthetic heart valve has become one of the most common means for treating heart valve diseases, however, in continuous clinical research, it is found that the extra-valvular stent, as a metal part in direct contact with native tissues, can obstruct the free movement of the heart tissues to some extent. For example, an excessively long stent can cause obstruction of the outflow tract, while an excessively short stent can affect fixation and cause displacement of the prosthetic valve. Meanwhile, the large size of the external stent has great influence on the dynamic performance of blood flow, and the problems of thrombus and hemolysis are easily caused.

The heart valve aims to ensure that the artificial valve is effectively fixed in the early implantation period, effectively reduces the obstruction of an outflow tract along with the continuous degradation of the outer support, and reduces the influence on the blood flow dynamics so as to avoid the occurrence probability of thrombus and hemolysis.

Disclosure of Invention

The invention aims to provide a heart valve, which is used for solving the technical problems that the existing valve is easy to cause obstruction of an outflow channel, and the size of an external support is large, so that the hemodynamic performance is influenced, and thrombus or hemolysis is caused.

The technical scheme provided by the invention is as follows:

a heart valve that is at least partially degradable.

In the technical scheme, the minimally invasive interventional implantation heart valve can be used for treating heart valve diseases. In practical application, the heart valve can be tightly connected and fixed by virtue of the endothelialization compact substance and the native tissue. By making the heart valve at least partially degradable, it is possible to make the heart valve select a degradable site according to the actual application scenario, the size of which site gradually shrinks due to degradation until it disappears completely. Therefore, the outflow tract obstruction can be effectively reduced, and the influence on the hemodynamics is reduced, so that the probability of occurrence of thrombus and hemolysis is avoided.

Further preferably, it comprises: an outer support; the outer support comprises a first sub support, a second sub support and a third sub support for connecting the first sub support and the second sub support; wherein the first sub-scaffold and/or the second sub-scaffold is fully or partially degradable.

Among this technical scheme, first branch support, second branch support and the third branch support that the outer support includes adopt the mode of concatenation to assemble in an organic whole, compare in integral type structure, do benefit to production and processing, reduce the cost. The second sub-support is used for being attached to the atrium wall, so that when the atrium is dynamically changed, the outer support can be prevented from being separated from the atrium wall, and the second sub-support is used for assisting the fixation of the heart valve. This makes it easier to grow new endothelial cells where the second stent is in contact with the atrial wall to form an endothelialized compact. And the first sub-stent and/or the second sub-stent of the outer stent can be completely or partially degraded, so that after the heart valve is implanted into the atrium of the human body, the heart valve is finally tightly connected and fixed with native tissues by means of the endothelialization compact objects along with the continuous formation of the endothelialization compact objects and the continuous degradation and ablation of the first sub-stent and/or the second sub-stent. Therefore, the blocking of the outer support to the outflow channel can be effectively reduced, and the degradation of the outer support with larger size can effectively avoid the change of the artificial heart valve on the heart blood flow dynamics, thereby reducing the probability of occurrence of thrombus or hemolysis.

Further preferably, the third branch frame is made of a non-degradable metal material; the third branch frame is made of at least one of nickel-titanium alloy, stainless steel and cobalt-based alloy; and/or the first sub-bracket is made of at least one of magnesium alloy, iron alloy and zinc alloy; and/or the second sub bracket is made of at least one of magnesium alloy, iron alloy and zinc alloy.

In the technical scheme, after the outer stent is implanted into the human atrium, the third branch stent can be endothelialized through the sealing membrane and the native tissue along with the continuous degradation and ablation of the first branch stent and/or the second branch stent and is formed into a whole, so that the valve leaflet can be effectively fixed on one hand; on the other hand, the size of the external stent can be reduced, and the change of the heart valve on the heart hemodynamics can be effectively avoided, so that the probability of occurrence of thrombus or hemolysis is reduced.

Further preferably, the first sub-frame is a V-shaped annular grid formed by a plurality of V-shaped pieces in an end-to-end abutting manner; the butt ends of every two adjacent V-shaped parts are used for connecting the third branch frame; barbs extending outwards are arranged on the wave crests of the V-shaped pieces and are degradable; and/or a plurality of V-shaped spare be equipped with the barb that extends to the outside on the butt joint end, barb fixed connection in the third bifurcation frame, just the barb is nondegradable.

In this technical scheme, establish first branch support into V-arrangement annular net, this structure both had been favorable to fixed third branch frame, can reduce the weight of first branch support again. The barbs extending towards the outer side are arranged on the wave crests and/or the butt ends of the V-shaped pieces to hook the native valve leaflets, so that the V-shaped pieces are used for fixing the heart valve and cannot cause the heart valve to roll over. Further, locate the barb degradable of V-arrangement crest position, locate the barb on the butt joint end and can not degrade, and the barb fixed connection in the third subframe of this position, so, when can effectively prevent not having abundant endothelialization, first subframe has degraded completely, leads to the outer support to the fixed insecure of heart valve like this easily.

Further preferably, the number of the V-shaped pieces contained in the V-shaped annular mesh is 12 to 24.

The number of the V-shaped parts is set within a certain range, so that the structural stability under a certain volume is ensured.

Further preferably, the third branch frame comprises a plurality of main connection rods and a plurality of leaflet connection rods; a plurality of main connecting rods with the same number and spacing are arranged between every two adjacent valve leaflet connecting rods; the same-direction ends of the main connecting rods and the leaflet connecting rods are respectively used for connecting the butt ends of the V-shaped pieces, and the other ends of the main connecting rods and the leaflet connecting rods are respectively used for connecting the second sub-bracket.

Further preferably, the second sub-stent is in an everted wavy annular structure; each wave crest of the second sub-bracket is provided with a second sub-bracket connecting piece; each butt joint end of the first sub-bracket is provided with a first sub-bracket connecting piece; two ends of each main connecting rod and each valve leaflet connecting rod are respectively connected with one second sub-bracket connecting piece and one first sub-bracket connecting piece which are opposite; and each main connecting rod and each leaflet connecting rod are positioned inside the second sub-bracket connecting piece and the first sub-bracket connecting piece; and/or the connection part of the second sub bracket connecting piece and the second sub bracket wave crest is in arc transition; and/or the leaflet connecting rods are three in number and are arranged at intervals along the peripheral side of the third branch frame.

In the technical scheme, the lower part of the valve leaflet connecting rod is used for fixing the valve leaflets, and the upper structure of the valve leaflet connecting rod and the main connecting rod provide radial supporting force together. The second sub-frame is used for fitting the atrium wall, so that the outer frame can be prevented from being separated from the atrium wall when the atrium is dynamically changed, and the second sub-frame is used for assisting the fixation of the heart valve. Therefore, new endothelial cells can grow more easily at the contact part of the second branch stent and the atrial wall, and the cell adhesion rate of the surface of the second branch stent adhered on the atrial wall is higher, so that endothelialization is easy. The second branch bracket connecting piece and the connecting part of the second branch bracket wave crest are in arc transition so as to be adapted to the outline of the atrial wall and prevent hard extrusion of the atrial wall.

Further preferably, one of the plurality of main connecting rods and the plurality of leaflet connecting rods is a straight rod, and the other of the plurality of main connecting rods and the plurality of leaflet connecting rods is an S-shaped curved rod; or one part of the main connecting rods is a straight rod, and the other part of the main connecting rods is an S-shaped bent rod; or one part of the valve leaflet connecting rods is a straight rod, and the other part of the valve leaflet connecting rods is an S-shaped bent rod; and/or one end of the valve leaflet connecting rod facing the first sub-bracket is provided with a suture hole; and the suture hole extends to the inner side of the first sub-support.

In the technical scheme, the S-shaped bent rod can be used for increasing the contact area with native tissues, and is beneficial to fixing the heart valve. The suture hole is provided to extend to the inner side of the first sub-stent in order to prevent the leaflets from being blocked by the plurality of main connection rods and the plurality of leaflet connection rods during the suture process.

Further preferably, the method further comprises the following steps: a first sealing membrane and a leaflet; the first sealing film covers the inner surface and/or the outer surface of the outer support; the valve leaf is arranged on the inner side of the outer support.

Further preferably, the sealing device also comprises an inner support and a second sealing film; the inner support is arranged at the inner side of the outer support and is used for assembling the valve blades; the second sealing film covers the outer surface layer of the inner support and is used for connecting the outer support and the inner support.

The invention has the technical effects that:

1. in the patent, the heart valve can be tightly connected and fixed by the endothelialization compact substance and the native tissue in practical application. By making the heart valve at least partially degradable, it is possible to make the heart valve select a degradable site according to the actual application scenario, which site is gradually reduced by degradation until it disappears completely. Therefore, the outflow tract obstruction can be effectively reduced, and the influence on the hemodynamics is reduced, so that the probability of occurrence of thrombus and hemolysis is avoided.

2. In this patent, when the heart valve only comprises the outer stent, the first branch stent and/or the second branch stent can be completely or partially degraded, and the third branch stent is not degraded, so that after the outer stent is implanted into the atrium of the human body, along with the continuous formation of the endothelialization compact objects and the continuous degradation and ablation of the first branch stent and/or the second branch stent, the third branch stent of the heart valve is finally tightly connected and fixed with the native tissue by the endothelialization compact objects. Therefore, the volume of the outer support can be effectively reduced, and the blocking of the outflow channel is further reduced.

3. In this patent, when heart valve includes outer support and inner support, the outer support can be wholly or partly degraded, and the inner support is nondegradable, so, can effectively reduce the volume of heart valve, avoid the outer support to the obstruction of outflow channel, thereby reduce the probability to avoiding thrombus and hemolysis emergence to the influence of hemodynamics.

4. The second sub-support is creatively arranged to be attached to the atrial wall, so that the outer support can not be separated from the atrial wall when the atrium is dynamically changed, and the second sub-support is used for assisting the fixation of the heart valve. This makes it easier to grow new endothelial cells where the second stent is in contact with the atrial wall to form an endothelialized compact.

5. This patent is through establishing first branch support into V-arrangement annular net, and this structure both had been favorable to fixed third branch frame, can reduce the weight of first branch support again.

6. This patent is through being equipped with the barb that extends to the outside on the crest and/or the butt joint end of a plurality of V-arrangement pieces and come the hook native valve leaf, and then be used for fixed heart valve, can not cause heart valve's side to turn on one's side. Further, locate the barb of V-arrangement peak of the wave position and can degrade, locate the barb on the butt joint end and can not degrade, and the barb fixed connection in third branch frame of this position, so, when can effectively preventing not having abundant endothelialization, first branch frame has degraded completely, leads to the outer support to the fixed insecure of heart valve like this easily.

7. This patent sets up the quantity of V-arrangement spare in certain within range, guarantees the steadiness of structure under certain volume.

8. In this patent, V-arrangement annular net sets up to the one deck, reduces the length of outer support through reducing the number of piles of first branch support, can further reduce the risk that the outflow tract is blockked.

9. In this patent, the mode that first branch support, second branch support and the third branch frame of outer support adopted the concatenation is assembled in an organic whole, compares in integral type structure, does benefit to production and processing, reduces the cost.

10. In this patent, through addding second branch support connector and first branch support connector, can strengthen the main connecting rod and the leaflet connecting rod and divide the support and first branch fixed between the support with the second.

11. In this patent, divide the junction of support connecting piece and the second branch support crest to establish into the arc transition, can prevent effectively that this position from hard extrusion atrium wall.

Drawings

The invention is described in further detail below with reference to the following figures and detailed description:

FIG. 1 is a schematic view of a heart valve of the present invention in one embodiment;

FIG. 2 is a schematic view of the outer stent of FIG. 1 in one state;

FIG. 3 is an enlarged view of the partial area A shown in FIG. 2;

FIG. 4 is an enlarged view of the detail area B shown in FIG. 2;

FIG. 5 is a schematic view of the outer stent of FIG. 1 in another configuration;

FIG. 6 is a schematic representation of the heart valve of FIG. 1 (first sub-stent, second sub-stent degraded) implanted in a human atrium over time;

FIG. 7 is a schematic perspective view of a heart valve of the present invention in another embodiment;

FIG. 8 is a schematic view of the outer stent of FIG. 7 in one state;

FIG. 9 is a schematic view of the outer stent of FIG. 7 in another configuration;

FIG. 10 is a schematic view of the heart valve of FIG. 7 (showing the first sealing membrane) implanted in a human atrium over time;

FIG. 11 is a schematic representation of the prosthetic heart valve of FIG. 7 (concealing the first sealing membrane) implanted in an atrium of a human atrium over time;

figure 12 is a schematic representation of the prosthetic heart valve of figure 7 (with the outer stent degraded) implanted in a human atrium over time.

The reference numbers illustrate:

100. an outer support; 101. a blood inflow end; 102. a blood outflow end; 110. a first sub-mount; 111. a V-shaped piece; 112. a butt joint end; 113. wave crest; 114. a barb; 115. a first sub-mount connection; 120. a second sub-mount; 121. wave crest; 122. a second sub-mount connection; 130. a third sub-frame; 131. a main connecting rod; 132. a leaflet connecting rod; 1321. sewing the hole;

200. endothelialization densification; 300. a leaflet; 410. a first sealing film; 420. a second sealing film; 500. an inner support; 600. riveting; 700. a heart;

100', an outer support; 110', a first sub-mount; 120', a second sub-mount; 130' and a third sub-frame.

Detailed Description

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.

Minimally invasive interventional implantation of heart valves can be used to treat heart valve disease. Existing valve stents, as a metallic component in direct contact with the native tissue, can impede free movement of the heart tissue to some extent. For example, too long a stent can cause obstruction of outflow tracts, increasing the influence of the stent on the heart blood flow mechanics, but too short a stent can influence fixation and cause the displacement of the artificial valve.

Based on foretell cognition, this patent now provides a heart valve for solve current valve easily cause the outflow tract to obstruct, cause the technical problem of thrombus or hemolysis because of the support size is too big. The heart valve that this patent now provided both can guarantee implanting early effective fixed, and can effectively reduce the outflow tract again along with the heart valve constantly degrades and obstruct, thereby reduce the probability of avoiding thrombus and hemolysis to the influence of blood flow mechanics to take place.

Specifically, as shown in fig. 1 to 12, the present invention provides a heart valve that is at least partially degradable.

In the technical scheme, the heart valve can be tightly connected and fixed by the endothelialization compact substance 200 and the native tissue in practical application. Specifically, after the heart valve is implanted into a human atrium, the heart valve is tightly connected and fixed with native tissues by means of the endothelialization compact 200 along with the continuous formation of the endothelialization compact 200. However, when the heart valve is tightly fixed, the larger size of the heart valve easily causes the obstruction of the outflow channel, so that the heart valve is designed to be degradable, so that the change of the hemodynamics of the heart can be effectively avoided, and the occurrence probability of thrombus or hemolysis is reduced. Further, the position of the degradable stent of the heart valve can be selected according to the actual use requirement, the structure of the stent is not limited, and the position of the degradable stent is not limited. For example, the degradation site of the stent may be regular or irregular, and the specific degradation profile may be specifically set according to the actual condition of the patient. Therefore, any heart valve that can be partially or completely degraded is within the scope of the present disclosure, and the heart valve can be of any type, and will not be described in any greater detail herein.

As a preferred embodiment of the present patent, referring to FIGS. 1 and 2, a heart valve may include an outer stent 100 in the shape of a hollow tube, the outer stent 100 having a blood inflow end 101 and a blood outflow end 102. Further, the external bolster 100 may include a first sub-bolster 110, a second sub-bolster 120, and a third sub-bolster 130 for connecting the first sub-bolster 110 and the second sub-bolster 120. A blood inflow end 101 is formed at a port of the second sub-stent 120; and a blood outflow end 102 is formed at a port of the first sub-mount 110.

In this patent, first branch support 110, second branch support 120 and third branch support 130 of outer support 100 adopt the mode of concatenation to assemble in an organic whole, compare in integral type structure, do benefit to production and processing, reduce the cost.

Further, the first sub-stent 110 is used for fixation with the native valve leaflet so that the heart valve can be tightly connected and fixed with the native tissue. The second sub-frame 120 is used to fit the atrial wall to ensure that the outer frame 100 will not detach from the atrial wall when the atrium dynamically changes, and is used to assist in the fixation of the heart valve. This makes it easier to grow new endothelial cells where the second stent section 120 contacts the atrial wall. Wherein the first sub-stent 110 and/or the second sub-stent 120 are fully or partially degradable and the third sub-stent 130 is not degradable. In a preferred example, the first and

second sub-stents

110 and 120 of the external stent 100 are made of degradable metal material, and the third sub-stent 130 is made of non-degradable metal material. Thus, after the external stent 100 is implanted into the human atrium, with the continuous formation of the endothelialization compact 200 and the continuous degradation and ablation of the first sub-stent 110 and the second sub-stent 120, the third sub-stent 130 of the heart valve is finally tightly connected and fixed with the native tissue by means of the endothelialization compact 200. This effectively reduces the volume of the external bolster 100, which in turn reduces the obstruction to the outflow tract. In another preferred example, one of the first sub bracket 110 and the second sub bracket 120 is made of a degradable metal material, and the other is made of a non-degradable metal material. Of course, it is also possible to make one part of the first sub-bracket 110 of degradable metal material and the other part of the first sub-bracket of non-degradable metal material. And a part of the second sub-stent 120 may be made of a degradable metal material, and the other part may be made of a non-degradable metal material, which is not limited herein.

Preferably, referring to fig. 2, the first sub-mount 110 and the second sub-mount 120 may be preferably manufactured by using at least one of the above-mentioned materials, because of the good degradability of metals such as magnesium alloy, iron alloy, and zinc alloy, but not limited thereto. And the third branch frame 130 may be preferably made of at least one of the above materials based on the non-degradable properties of nitinol, stainless steel, cobalt-based alloy, etc., however, other non-degradable metal materials may be used to make the third branch frame 130, and the invention is not limited thereto.

As a further optimization of the present embodiment, referring to fig. 1 and 2, the heart valve further comprises a first sealing membrane 410 and leaflets 300. After the outer stent 100 is implanted into the human atrium, the third stent 130 can be endothelialized through the first sealing membrane 410 and the native tissue and formed as one body as the first stent 110 and the second stent 120 are continuously degraded and ablated. As such, in one aspect, the heart valve can be effectively secured; in another aspect, the size of external bolster 100 can be reduced. Specifically, the first sealing membrane 410 may cover the inner surface and/or the outer surface of the outer stent 100, and the leaflet 300 is disposed inside the outer stent 100, and may be endothelialized with native tissue through the first sealing membrane 410 and formed in one body, so that the heart valve may be effectively fixed.

In this embodiment, the external frame 100 is a hollow tubular structure to form a flow passage for blood to flow. Wherein, referring to fig. 2, the blood inflow end 101 is formed at a port of the second sub-mount 120; and a blood outflow end 102 is formed at a port of the first sub-mount 110. Thus, during the contraction or relaxation of the heart 700, blood flows in from the blood inflow end 101 and flows out from the blood outflow end 102.

As a further optimization of this embodiment, referring to fig. 2, the first sub-frame 110 may be a V-shaped annular grid formed by a plurality of V-shaped members 111 abutting end to end. The butt ends 112 of every two adjacent chevrons 111 are used for connecting the third branch frame 130. In this embodiment, the first sub-frame 110 is formed into a V-shaped mesh, which is advantageous for fixing the third sub-frame 130, and reduces the weight of the first sub-frame 110 and the load on the atrium. It should be noted that the V-shaped annular grid can be formed integrally, and of course, the V-shaped pieces 111 can also be formed by welding end to end, which is not limited thereto.

Specifically, the number of the V-shaped members 111 included in the V-shaped annular grid may be 12-24, and the present embodiment is preferably 24, based on the overall stability of the first sub-frame 110 and the atrial internal space, but of course, in other embodiments, the number may be 12, 15 or 18, and is not limited thereto.

As a most preferable aspect of this embodiment, a plurality of barbs 114 extending outward may be provided on the abutting ends 112 of the V-shaped members 111, the barbs 114 are fixedly connected to the third branch frame 130, and the barbs 114 are not degradable. Each abutting end 112 can be provided with a barb 114, so that the first sub-stent 110 can be effectively prevented from being completely degraded when the heart valve and the native tissue are not fully endothelialized, which easily causes the external stent 100 to be insecure in fixing the heart valve. Thus, the addition of barbs 114 at the junction of the first and

third stent sections

110, 130 allows the barbs 114 to continue to secure the heart valve even after the first stent section 110 has completely degraded.

Further, referring to fig. 2, barbs 114 extending outward may be provided on the peaks 113 of the plurality of V-shaped members 111, and the barbs 114 may be degraded. This holds the heart valve early during implantation and the barbs 114 may degrade with the first stent component 110 as the endothelialized compact 200 grows. As a preferred example of this embodiment, the peak 113 of each V-shaped member 111 is connected with a barb 114 extending outward, so as to ensure that the barbs 114 are uniformly distributed on the blood outflow end 102 for hooking the native valve leaflets, and further for fixing the heart valve, of course, a barb 114 can be connected to every two peaks 113 of the V-shaped member 111, so as to save the cost and not reduce the tightness of the connection of the barbs 114.

In this embodiment, the V-shaped annular mesh is arranged in one layer, and the length of the external stent 100 is reduced by reducing the number of layers of the first sub-stent 110, so that the risk of blocking the outflow tract is further reduced. Specifically, when the V-shaped annular mesh is provided in multiple layers, it is the first sub-mount 110 that includes the multiple layers of V-shaped annular mesh. Wherein, the multilayer V-shaped annular grids are overlapped along the respective axial direction to form a net tubular structure. Thus, the extension length of the first sub-stent 110 is increased, which in turn increases the length of the outer stent 100, and the outer stent 100 occupies an excessively large area of the ventricle during contraction or relaxation of the heart 700, blocking the area of the outflow tract, which easily causes obstruction of the blood outflow tract. Of course, setting the extension length of the first sub-stent 110 to be short easily causes unstable fixation and displacement of the outer stent 100, and thus also causes obstruction of the blood outflow tract. Therefore, the extension length of the first sub-stent 110 should be controlled within a certain range, and specifically, the first sub-stent 110 may be specifically limited according to the actual heart structure, that is, the V-shaped annular grid is not limited to one layer, but may be multiple layers, and it is only necessary to ensure that the extension length of the first sub-stent 110 is adapted to the heart structure, but not limited thereto.

In this embodiment, referring to fig. 2 and 3, the third sub-frame 130 may include a plurality of main connection rods 131 and a plurality of leaflet connection rods 132 that are arranged in parallel with each other. A plurality of main connecting rods 131 with the same number and spacing are arranged between every two adjacent leaflet connecting rods 132. One end of the main connecting rods 131 and one end of the leaflet connecting rods 132, which are in the same direction, are respectively used for connecting the butting ends 112 of the V-shaped pieces 111, and the other end is respectively used for connecting the second sub-bracket 120.

It should be noted that the material of the main connecting rods 131 and the leaflet connecting rods 132 may be the same or different, and is not limited herein. Thus, after the external stent 100 is implanted into the human atrium, with the continuous formation of the endothelialization compact 200 and the continuous degradation and ablation of the first sub-stent 110 and/or the second sub-stent 120, the heart valve is finally fixed by the tight connection of the endothelialization compact 200 and the native tissue. At this time, the plurality of main connection rods 131 and the plurality of leaflet connection rods 132 are closely located within the endothelialization compact 200 and the native tissue, and since the position limitation is released between the plurality of main connection rods 131 and the plurality of leaflet connection rods 132, the plurality of main connection rods 131 and the plurality of leaflet connection rods 132 can be synchronously contracted or expanded along with the heart 700 in the contraction or expansion process of the heart 700, thereby improving the application effect thereof.

As a further optimization of the present embodiment, the sum of the number of the main connecting rods 131 and the number of the leaflet connecting rods 132 is equal to the number of the V-shaped members 111 included in the first sub-frame 110, and is also 12 to 24, so that the structural stability between the first sub-frame 110 and the third sub-frame 130 can be improved. Of course, the number of the V-shaped members 111 may be two or three times of the sum of the number of the main connecting rods 131 and the leaflet connecting rods 132, and the number of the connecting rods may be selected and adjusted according to the actual application, and is not specifically limited herein.

It is worth mentioning that the greater the number of rods for providing the main connection rod 131 and the leaflet connection rod 132, the greater the rigidity of the outer stent 100 and the greater the support force. Conversely, the fewer the number of rods, the softer the outrigger 100, and the less the support force. Therefore, the number of rods needs to be designed within a reasonable range, so that the native valve annulus tissue can not be damaged due to excessive force while the overall supporting force of the outer stent 100 is ensured.

As a further optimization of the present embodiment, referring to fig. 2 and 3, the number of the leaflet connecting rods 132 is three, and the peripheral sides of the third racks 130 are disposed at intervals. As such, the three leaflet connecting rods 132 may be evenly distributed along the circumferential direction of the third sub-frame 130 by 120 ° for providing a radial supporting force together with the main connecting rod 131. Of course, the number of the leaflet connecting rods 132 is not limited to three, and may be any desired number.

As a preferable example of the present embodiment, one of the plurality of main connection rods 131 and the plurality of leaflet connection rods 132 is a straight rod, and the other of the plurality of main connection rods 131 and the plurality of leaflet connection rods 132 is an S-shaped curved rod. Preferably, the main connecting rods 131 are straight rods, and the leaflet connecting rods 132 are S-shaped curved rods, so that, compared to the case where the main connecting rods 131 and the leaflet connecting rods 132 are straight rods, the leaflet connecting rods 132 are all set to be S-shaped curved rods, which can be used to increase the contact area with native tissues, and is beneficial to the fixation of heart valves. Of course, the main connecting rods 131 may be all S-shaped bent rods, and the leaflet connecting rods 132 may be all straight rods, which can achieve the same effect as above, and thus, redundant description is not repeated here.

As another preferred example of the present embodiment, a portion of the plurality of main connection bars 131 is a straight bar, and another portion of the plurality of main connection bars 131 is an S-shaped bent bar. That is, the main connecting rods 131 may be composed of a plurality of straight rods and a plurality of S-shaped bent rods, and may also be used to strengthen the fixation of the prosthetic heart valve.

Of course, as a further optimization of the above example, it is also possible that a part of the plurality of leaflet connecting rods 132 is a straight rod and another part of the plurality of leaflet connecting rods 132 is an S-shaped curved rod. That is, the leaflet attachment rods 132 may be formed of straight rods and S-shaped curved rods, and may also be used to strengthen the fixation of the prosthetic heart valve.

In this embodiment, referring to fig. 2 and 5, the second sub-stent 120 has an everted wavy ring structure, that is, the second sub-stent 120 is rolled toward the outer sides of the plurality of main connecting rods 131 and the plurality of leaflet connecting rods 132 to form an included angle of 100 degrees and 150 degrees with the plurality of main connecting rods 131 and the plurality of leaflet connecting rods 132.

In this technical solution, the second sub-frame 120 is used for fitting the atrial wall and fixing the outer frame 100, so that when the atrium changes dynamically, the outer frame 100 is not separated from the atrial wall, and is used for assisting the fixation of the heart valve. Therefore, new endothelial cells can grow more easily at the contact position of the second sub-stent 120 and the atrial wall, and the second sub-stent 120 attached to the atrial wall has a higher cell attachment rate and is easy to endothelialize.

Preferably, the second sub-stent 120 may form an angle of 120 degrees with the plurality of main connection rods 131 and the plurality of leaflet connection rods 132 based on the configuration of the atrial wall and the ventricular junction, so that the second sub-stent 120 can be more closely attached to the atrial wall, but is not limited thereto. The second sub-stent 120 has a wavy annular structure, which can reduce the burden on the heart 700 and increase the contact area with the atrial wall to a large extent, thereby improving the fixation effect.

As a further optimization of the above embodiment, referring to fig. 2 to 4, in order to effectively strengthen the fixation between the main connecting rods 131 and the leaflet connecting rods 132 and the

second sub-brackets

120 and 110, the main connecting rods 131, the leaflet connecting rods 132 and the V-shaped pieces 111 and the second sub-brackets 120 may be fixed by welding or riveting.

As a preferred aspect of the present embodiment, a second sub-bracket connecting member 122 may be disposed at each peak 121 of the second sub-bracket 120, and correspondingly, a first sub-bracket connecting member 115 may be disposed at each abutting end 112 of the first sub-bracket 110. The plurality of second sub bracket connection members 122 and the plurality of first sub bracket connection members 115 are disposed in one-to-one correspondence from top to bottom. Both ends of each main connecting rod 131 and each leaflet connecting rod 132 are connected to a second sub-stent connecting member 122 and a first sub-stent connecting member 115, respectively, at opposite positions. The main link 13 and the leaflet link 132 may be fixed to the second sub-frame link 122 and the first sub-frame link 115 by the rivet 600, but may be fixed by welding, which is not limited thereto.

As a further optimization, each main connecting rod 131 and each leaflet connecting rod 132 are located inside the second sub-frame connecting member 122 and the first sub-frame connecting member 115. That is, the main link rod 131 and the leaflet link rod 132 are located at the ends of the main link rod 131 and the leaflet link rod 132 facing the inside of the outer stent 100. In this way, hard pressing of the main link rod 131 and the leaflet link rod 132 against the atrial wall can be largely prevented.

As a further optimization, referring to fig. 2 and 3, the arc transition at the connection between the second sub-stent connecting member 122 and the wave crest 121 of the second sub-stent 120 can effectively prevent the part from hard pressing the atrial wall, so as to ensure that the external stent 100 is better suitable for the human heart 700.

In a preferred embodiment, referring to fig. 1 to 4, each leaflet connecting rod 132 is provided with a suture hole 1321 for suturing the leaflet 300 toward one end of the first sub-frame 110, i.e., the end for connecting the V-shaped member 111. Preferably, in order to prevent the leaflet 300 from being blocked by the plurality of main connection rods 131 and the plurality of leaflet connection rods 132 during the suturing process, the suture hole 1321 may be provided to extend to the inside of the first sub-holder 110, that is, the inside of the V-shaped annular mesh, which may facilitate the suturing of the leaflet 300. Preferably, a connection head (not shown) may be detachably assembled to an end of each leaflet connecting rod 132 facing the first sub-frame 110, and one, two, or even a plurality of suture holes 1321 may be opened on the connection head for suturing the leaflets 300. The connection head may be fixed to the leaflet connecting rod 132 by means of a screw, but is not limited thereto.

It should be noted that the leaflet 300 provided in this embodiment may be a tricuspid leaflet, and thus the three suture holes 1321 corresponding to the three leaflet connecting rods 132 respectively correspond to three arc edges of the tricuspid valve, which is beneficial for suturing and fixing the leaflet 300. Of course, in other embodiments, the leaflet 300 can be a bilobal leaflet or other number of leaflets, and is not limited thereto. The leaflet 300 is made of biological tissue, such as bovine pericardium or porcine pericardium. Of course, the leaflet 300 may also be a valve or tissue-engineered valve made of a polymer material. Further, the first sealing film 410 provided in this embodiment may be made of a polymer material, such as, but not limited to, PTE.

Further, referring to fig. 2 and 6, the present embodiment provides a heart valve in which the first stent component 110 and/or the second stent component 120 are degraded and ablated after being implanted in the heart 700 for a certain period of time, and the third stent component 130 can be endothelialized through the first sealing film 410 and the native tissue and formed integrally. As such, in one aspect, the heart valve can be effectively secured; on the other hand, the size of the external stent 100 can be reduced, the obstruction of the outflow tract can be effectively reduced, and the influence on the blood flow mechanics is reduced, so that the probability of occurrence of thrombus and hemolysis is avoided.

In another preferred embodiment, referring to fig. 7-9, the present embodiment further includes an inner support 500 and a second sealing membrane 420. Specifically, the inner stent 500 is disposed inside the outer stent 100' for assembling the leaflet 300. Further, a second sealing film 420 is coated on the outer surface layer of the inner frame 500 for connecting the outer frame 100' and the inner frame 500. Specifically, the second sealing film 420 is fixed by connecting the outer holder 100' and the inner holder 500 to each other.

In this embodiment, compared with the structure of the external stent 100 in the above embodiment, except that the suture hole 1321 is not provided, and the first branch stent 110 ', the second branch stent 120' and the third branch stent 130 'included in the external stent 100' of this embodiment are made of degradable metal materials, the rest of the structure is the same as the external stent 100 in the above embodiment, and redundant description is not repeated herein, and specific reference may be made to the description of the structure of the external stent 100.

Further, the inner frame 500 provided in this embodiment is made of a non-degradable metal material. Among them, suture holes (not shown) may be added to the inner frame 500 for suturing the leaflets 300. The specific opening position of the suture hole can be specifically set according to the actual application scene, and is not described in detail herein.

After the heart 700 is implanted for a period of time, the endothelialization densification product 200 is formed between the inner stent 500 and the outer stent 100 ' as the second sealing membrane 420 seals the inner stent 500 and the outer stent 100 ' and blood is continuously deposited between the inner stent 500 and the outer stent 100 ' and the second sealing membrane 420 is endothelialized with the native tissue as the time goes by.

As shown in fig. 10-12, with the formation of the endothelialization density 200 and the degradation ablation of the outer stent 100', the heart valve is finally fixed by the close connection of the endothelialization density 200 and the native tissue. Thus, the blocking of the outflow tract by the external stent 100 'can be effectively reduced, and the degradation of the external stent 100' with a larger size can effectively avoid the change of the hemodynamics of the heart 700 caused by the heart valve, so as to reduce the occurrence probability of thrombus or hemolysis.

Further, referring to fig. 6 to 8, the first sub bracket 110 ', the second sub bracket 120 ' and the third sub bracket 130 ' may be fixed by welding or riveting. The detailed structure can refer to the above description about the connection of the first sub-frame 110, the second sub-frame 120 and the third sub-frame 130, and will not be described herein again. Preferably, the rivet 600 may be riveted, wherein the rivet is made of a degradable metal material, so as to degrade and ablate the first sub-bracket 110 ', the second sub-bracket 120 ' and the third sub-bracket 130 ', thereby avoiding residue.

The foregoing is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.

Claims

1. A heart valve, wherein the heart valve is at least partially degradable.

2. The heart valve of claim 1, comprising:

an outer support;

the outer support comprises a first sub support, a second sub support and a third sub support for connecting the first sub support and the second sub support;

wherein the first and/or the second sub-scaffold is fully or partially degradable.

3. The heart valve of claim 2,

the third branch frame is made of non-degradable metal materials; wherein, the first and the second end of the pipe are connected with each other,

the third branch frame is made of at least one of nickel-titanium alloy, stainless steel and cobalt-based alloy;

and/or

The first sub-bracket is made of at least one of magnesium alloy, iron alloy and zinc alloy;

and/or

The second sub-bracket is made of at least one of magnesium alloy, iron alloy and zinc alloy.

4. The heart valve of claim 2 or 3,

the first sub-bracket is a V-shaped annular grid formed by butt joint of a plurality of V-shaped pieces end to end;

the butt ends of every two adjacent V-shaped parts are used for connecting the third branch frame;

barbs extending outwards are arranged on the wave crests of the V-shaped pieces and are degradable;

and/or a plurality of V-shaped spare be equipped with the barb that extends to the outside on the butt joint end, barb fixed connection in the third bifurcation frame, just the barb is nondegradable.

5. The heart valve of claim 4,

the number of the V-shaped pieces contained in the V-shaped annular grid is 12-24.

6. The heart valve of claim 5,

the third spider comprises a plurality of main connecting rods and a plurality of leaflet connecting rods;

a plurality of main connecting rods with the same number and spacing are arranged between every two adjacent valve leaflet connecting rods;

the same-direction ends of the main connecting rods and the leaflet connecting rods are respectively used for connecting the butt ends of the V-shaped pieces, and the other ends of the main connecting rods and the leaflet connecting rods are respectively used for connecting the second sub-bracket.

7. The heart valve of claim 6,

the second sub-bracket is of an eversion wave-shaped annular structure;

each wave crest of the second sub-bracket is provided with a second sub-bracket connecting piece;

each butt joint end of the first sub-bracket is provided with a first sub-bracket connecting piece;

two ends of each main connecting rod and each valve leaflet connecting rod are respectively connected with one second sub-bracket connecting piece and one first sub-bracket connecting piece which are opposite; and

each of the main connecting rods and each of the leaflet connecting rods are located inside the second sub-frame connector and the first sub-frame connector;

and/or

The connection part of the second sub-bracket connecting piece and the second sub-bracket wave crest is in arc transition; and/or

The number of the leaflet connecting rods is three, and the leaflet connecting rods are arranged at intervals along the peripheral side of the third branch frame.

8. The heart valve of claim 7,

one of the plurality of main connecting rods and the plurality of leaflet connecting rods is a straight rod, and the other of the plurality of main connecting rods and the plurality of leaflet connecting rods is an S-shaped bent rod; or

One part of the main connecting rods is a straight rod, and the other part of the main connecting rods is an S-shaped bent rod; or

One part of the valve leaflet connecting rods is a straight rod, and the other part of the valve leaflet connecting rods is an S-shaped bent rod; and/or

One end of the valve leaflet connecting rod facing the first sub-support is provided with a suture hole; and

the suture holes extend to the inside of the first sub-mount.

9. The heart valve of claim 2, further comprising:

a first sealing membrane and a leaflet;

the first sealing film covers the inner surface and/or the outer surface of the outer support;

the valve leaf is arranged on the inner side of the outer support.

10. The heart valve of claim 9,

also comprises an inner bracket and a second sealing film;

the inner support is arranged at the inner side of the outer support and is used for assembling the valve blades;

the second sealing film covers the outer surface layer of the inner support and is used for connecting the outer support and the inner support.