Heart valve

Abstract

The application discloses a heart valve which is at least partially degradable. In the technical scheme, the minimally invasive interventional implantation of the heart valve can be used for treating heart valve diseases. In actual application, the heart valve can be fixed by endothelial dense matter and original tissue close connection. By setting the heart valve as at least partially degradable, the heart valve can select a degradable part according to an actual application scene, the size of the part is gradually reduced until the part is completely degraded and disappears. In this way, the outflow tract obstruction can be effectively reduced, the influence on hemodynamics is reduced, and the probability of thrombosis and hemolysis is avoided.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more particularly to a heart valve. Background Technology

[0002] The heart is divided into left and right ventricular septa, each containing a ventricle and an atrium. The ventricles and atria are separated by the interventricular septum and interatrial septum, respectively. Valves prevent backflow of blood between the atria, ventricles, and arteries. Specifically, the mitral valve is located between the left atrium and left ventricle; the tricuspid valve is located between the right atrium and right ventricle; the aortic valve is located between the left ventricle and the great artery; and the pulmonary valve is located between the right ventricle and the pulmonary artery. Heart valves are the valves between the atria and ventricles or between the ventricles and arteries. Valves play a crucial role in the heart's blood circulation, acting as one-way valves. They open and close in response to the heart's contraction and relaxation, ensuring unidirectional blood flow.

[0003] Heart valve disease is a common heart condition, especially with the aging population. Valvular heart disease in the elderly, as well as valvular diseases caused by coronary heart disease and myocardial infarction, are becoming increasingly common and deserve everyone's attention. Specifically, heart valve disease refers to lesions in the mitral, tricuspid, aortic, and pulmonary valves caused by various congenital and acquired factors. These lesions prevent the valves from closing completely or opening fully, thus affecting normal blood flow and causing abnormal heart function.

[0004] Currently, minimally invasive interventional implantation of artificial heart valves has become one of the most common methods for treating valvular heart disease. However, ongoing clinical research has revealed that external stents, as metal components in direct contact with the native tissue, can, to some extent, hinder the free movement of cardiac tissue. For example, an excessively long stent can cause outflow tract obstruction, while an excessively short stent can affect fixation and cause displacement of the artificial valve. Furthermore, a large stent size significantly impacts hemodynamic performance, greatly increasing the risk of thrombosis and hemolysis.

[0005] In order to ensure effective fixation of the artificial valve in the early stage of implantation, and to effectively reduce outflow tract obstruction as the external stent degrades, thereby reducing the impact on hemodynamics and avoiding the probability of thrombosis and hemolysis, the applicant proposes a heart valve in this invention. Summary of the Invention

[0006] The purpose of this invention is to provide a heart valve that solves the technical problems of existing valves causing outflow tract obstruction and large external stent sizes affecting hemodynamic performance, thereby causing thrombosis or hemolysis.

[0007] The technical solution provided by this invention is as follows:

[0008] A heart valve, said heart valve being at least partially degradable.

[0009] In this technical solution, minimally invasive interventional implantation of a heart valve can be used to treat valvular heart disease. In practical applications, heart valves are tightly connected and fixed by endothelialized densities and native tissue. By making the heart valve at least partially biodegradable, the biodegradable site can be selected according to the actual application scenario. The size of this site gradually shrinks due to degradation until it disappears completely. This effectively reduces outflow tract obstruction, lowers the impact on hemodynamics, and thus avoids the likelihood of thrombosis and hemolysis.

[0010] More preferably, it includes: an external support; the external support includes 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-support and / or the second sub-support can be completely or partially degradable.

[0011] In this technical solution, the external stent, comprising a first sub-stent, a second sub-stent, and a third sub-stent, is assembled into a single unit using a splicing method. Compared to a one-piece structure, this facilitates production and processing, reducing costs. The second sub-stent is used to adhere to the atrial wall, ensuring that the external stent does not detach from the atrial wall during dynamic changes in the atrium, thus assisting in the fixation of the heart valve. This allows for easier growth of new endothelial cells at the contact point between the second sub-stent and the atrial wall, forming an endothelialized dense layer. Furthermore, the first and / or second sub-stents of the external stent are fully or partially degradable. Thus, after the heart valve is implanted in the atrium, with the continuous formation of the endothelialized dense layer and the continuous degradation and ablation of the first and / or second sub-stents, the heart valve eventually becomes tightly connected and fixed to the native tissue by the endothelialized dense layer. This effectively reduces the obstruction of the outflow tract by the external stent, and the degradation of the larger-sized external stent effectively avoids changes in cardiac hemodynamics caused by the artificial heart valve, thereby reducing the probability of thrombosis or hemolysis.

[0012] More preferably, the third sub-support is made of a non-degradable metal material; wherein the material of the third sub-support is at least one of nickel-titanium alloy, stainless steel and cobalt-based alloy; and / or the material of the first sub-support is at least one of magnesium alloy, iron alloy and zinc alloy; and / or the material of the second sub-support is at least one of magnesium alloy, iron alloy and zinc alloy.

[0013] In this technical solution, after the external stent is implanted into the human atrium, as the first and / or second stents continuously degrade and ablate, the third stent can be endothelialized through the sealing membrane and native tissue and formed into one piece. On the one hand, it can effectively fix the valve leaflets; on the other hand, it can reduce the size of the external stent, which can effectively avoid changes in cardiac hemodynamics caused by the heart valve, thereby reducing the probability of thrombosis or hemolysis.

[0014] More preferably, the first sub-bracket is a V-shaped annular grid formed by connecting multiple V-shaped pieces end to end; the connecting ends of each pair of adjacent V-shaped pieces are used to connect to the third sub-bracket; the crests of the multiple V-shaped pieces are provided with barbs extending outward, and the barbs are degradable; and / or the connecting ends of the multiple V-shaped pieces are provided with barbs extending outward, the barbs are fixedly connected to the third sub-bracket, and the barbs are non-degradable.

[0015] In this technical solution, the first sub-stent is designed as a V-shaped annular mesh. This structure facilitates the fixation of the third sub-stent while reducing the weight of the first sub-stent. The original valve leaflets are hooked by outward-extending barbs on the crests and / or mating ends of multiple V-shaped components, thus securing the heart valve without causing it to tilt. Furthermore, the barbs at the crests of the V-shaped components are biodegradable, while those at the mating ends are non-biodegradable. These barbs are fixedly connected to the third sub-stent, effectively preventing the first sub-stent from completely degrading before sufficient endothelialization, which could lead to insecure fixation of the external stent to the heart valve.

[0016] More preferably, the V-shaped annular mesh contains 12-24 V-shaped elements.

[0017] The number of V-shaped components is set within a certain range to ensure the stability of the structure within a certain volume.

[0018] More preferably, the third sub-support includes multiple main connecting rods and multiple leaflet connecting rods; between each pair of adjacent leaflet connecting rods, there are multiple main connecting rods of equal number and spacing; one end of each of the multiple main connecting rods and the multiple leaflet connecting rods is used to connect to the mating ends of the multiple V-shaped parts, and the other end is used to connect to the second sub-support.

[0019] More preferably, the second sub-support has an outwardly flared, wave-shaped annular structure; each peak of the second sub-support is provided with a second sub-support connector; each docking end of the first sub-support is provided with a first sub-support connector; the two ends of each main connecting rod and each leaflet connecting rod are respectively connected to a second sub-support connector and a first sub-support connector in opposite positions; and each main connecting rod and each leaflet connecting rod are located inside the second sub-support connector and the first sub-support connector; and / or the connection between the second sub-support connector and the peak of the second sub-support has an arc transition; and / or the number of leaflet connecting rods is three, and they are spaced apart along the periphery of the third sub-support.

[0020] In this technical solution, the lower part of the leaflet connecting rod is used to fix the leaflet, while its upper structure, together with the main connecting rod, provides radial support. The second sub-stent is used to conform to the atrial wall, ensuring that the external stent does not detach from the atrial wall when the atrium undergoes dynamic changes, thus assisting in the fixation of the heart valve. This allows for easier growth of new endothelial cells at the contact point between the second sub-stent and the atrial wall, resulting in a high cell adhesion rate and facilitating endothelialization. The connection between the second sub-stent connector and the crest of the second sub-stent is curved to fit the contour of the atrial wall, preventing rigid compression of the atrial wall.

[0021] More 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 bent rod; or a portion of the plurality of main connecting rods is a straight rod, and another portion of the plurality of main connecting rods is an S-shaped bent rod; or a portion of the plurality of leaflet connecting rods is a straight rod, and another portion of the plurality of leaflet connecting rods is an S-shaped bent rod; and / or each of the leaflet connecting rods has a suture hole at one end facing the first sub-support; and the suture hole extends to the inner side of the first sub-support.

[0022] In this technical solution, the S-shaped curved rod can be used to increase the contact area with the native tissue, which is beneficial for the fixation of the heart valve. The suture hole is set to extend to the inside of the first sub-stent to prevent the leaflet from being blocked by multiple main connecting rods and multiple leaflet connecting rods during the suturing process.

[0023] More preferably, it further includes: a first sealing film and a leaflet; the first sealing film covers the inner surface and / or outer surface of the outer support; the leaflet is disposed on the inner side of the outer support.

[0024] More preferably, it further includes an inner support and a second sealing membrane; the inner support is disposed inside the outer support and is used to assemble the leaflets; the second sealing membrane covers the outer surface of the inner support and is used to connect the outer support and the inner support.

[0025] The technical advantages of this invention are as follows:

[0026] 1. In this patent, the heart valve, in practical applications, can be tightly connected and fixed by endothelialized dense material and native tissue. By making the heart valve at least partially biodegradable, the biodegradable portion of the heart valve can be selected according to the actual application scenario. This portion gradually shrinks due to degradation until it disappears completely. In this way, outflow tract obstruction can be effectively reduced, the impact on hemodynamics can be decreased, and the probability of thrombosis and hemolysis can be avoided.

[0027] 2. In this patent, when the heart valve consists only of an external stent, the first and / or second sub-stents are fully or partially degradable, while the third sub-stent is non-degradable. Thus, after the external stent is implanted into the human atrium, with the continuous formation of endothelialized densification and the continuous degradation and ablation of the first and / or second sub-stents, the third sub-stent of the heart valve is eventually firmly fixed to the original tissue by the endothelialized densification. This effectively reduces the volume of the external stent, thereby reducing obstruction of the outflow tract.

[0028] 3. In this patent, when the heart valve includes an external stent and an internal stent, the external stent can be completely or partially degradable, while the internal stent is not degradable. In this way, the volume of the heart valve can be effectively reduced, the obstruction of the outflow tract by the external stent can be avoided, and the impact on hemodynamics can be reduced, thereby avoiding the probability of thrombosis and hemolysis.

[0029] 4. This patent innovatively incorporates a second sub-stent that adheres to the atrial wall, ensuring that the external stent does not detach from the atrial wall during dynamic changes in the atrium, thus assisting in the fixation of the heart valves. This also facilitates the growth of new endothelial cells at the contact point between the second sub-stent and the atrial wall, forming an endothelialized dense structure.

[0030] 5. This patent designs the first sub-support as a V-shaped annular mesh, which is beneficial for fixing the third sub-support and also reduces the weight of the first sub-support.

[0031] 6. This patent utilizes outwardly extending barbs on the crests and / or mating ends of multiple V-shaped components to hook onto the original valve leaflets, thereby securing the heart valve without causing it to tilt. Furthermore, the barbs at the crests of the V-shaped components are biodegradable, while the barbs at the mating ends are non-biodegradable, and these barbs are fixedly connected to the third sub-stent. This effectively prevents the first sub-stent from completely degrading before sufficient endothelialization, which could easily lead to insecure fixation of the external stent to the heart valve.

[0032] 7. This patent sets the number of V-shaped parts within a certain range to ensure the stability of the structure within a certain volume.

[0033] 8. In this patent, the V-shaped annular mesh is set as one layer. By reducing the number of layers of the first sub-support, the length of the outer support is reduced, which can further reduce the risk of the outflow channel being blocked.

[0034] 9. In this patent, the first, second and third sub-supports of the outer support are assembled into one piece by splicing. Compared with the integrated structure, this is more conducive to production and processing and reduces costs.

[0035] 10. In this patent, by adding a second sub-branch connector and a first sub-branch connector, the fixation between the main connecting rod and the leaflet connecting rod and the second sub-branch and the first sub-branch can be strengthened.

[0036] 11. In this patent, the connection between the second sub-stent connector and the peak of the second sub-stent is set as an arc transition, which can effectively prevent the part from rigidly compressing the atrial wall. Attached Figure Description

[0037] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments:

[0038] Figure 1 This is a schematic diagram of the structure of the heart valve of the product of the present invention in one embodiment;

[0039] Figure 2 yes Figure 1 The diagram shown is a structural schematic of the external support in one state.

[0040] Figure 3 yes Figure 2 A magnified view of the local area A shown;

[0041] Figure 4 yes Figure 2 A magnified view of the local area B shown;

[0042] Figure 5 yes Figure 1 The diagram shows the external support structure in another configuration.

[0043] Figure 6 yes Figure 1 The diagram shows a heart valve (first stent and second stent degradation) after being implanted in the human atrium for a period of time.

[0044] Figure 7 This is a three-dimensional structural schematic diagram of the heart valve of the product of the present invention in another embodiment;

[0045] Figure 8 yes Figure 7 The diagram shown is a structural schematic of the external support in one state.

[0046] Figure 9 yes Figure 7 The diagram shows the external support structure in another configuration.

[0047] Figure 10 yes Figure 7 The diagram shows a heart valve (showing the first sealing membrane) implanted in a human atrium for a period of time.

[0048] Figure 11 yes Figure 7 The diagram shows an artificial heart valve (with the first sealing membrane hidden) implanted in the human atrium for a period of time.

[0049] Figure 12 yes Figure 7 The diagram shows an artificial heart valve (external stent degradation) implanted in the human atrium for a period of time.

[0050] Explanation of icon numbers:

[0051] 100. External stent; 101. Blood inflow end; 102. Blood outflow end; 110. First sub-stent; 111. V-shaped component; 112. Connecting end; 113. Crest; 114. Barb; 115. First sub-stent connector; 120. Second sub-stent; 121. Crest; 122. Second sub-stent connector; 130. Third sub-stent; 131. Main connecting rod; 132. Leaflet connecting rod; 1321. Suture hole;

[0052] 200. Endothelialized dense material; 300. Leaflet; 410. First sealing membrane; 420. Second sealing membrane; 500. Internal stent; 600. Rivet; 700. Heart;

[0053] 100', outer support; 110', first sub-support; 120', second sub-support; 130', third sub-support. Detailed Implementation

[0054] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0055] Minimally invasive interventional implantation of heart valves can be used to treat valvular heart disease. Existing valve stents, as metal components that come into direct contact with the native tissue, can, to some extent, hinder the free movement of heart tissue. For example, a stent that is too long can cause outflow tract obstruction, increasing the stent's impact on cardiac hemodynamics; however, a stent that is too short can affect fixation, causing the artificial valve to shift.

[0056] Based on the above understanding, this patent provides a heart valve to address the technical problems of existing valves, such as outflow tract obstruction and thrombosis or hemolysis due to excessive stent size. The heart valve provided by this patent ensures effective fixation in the early stages of implantation, and as the heart valve degrades, it effectively reduces outflow tract obstruction, lowers the impact on hemodynamics, and thus avoids the likelihood of thrombosis and hemolysis.

[0057] Specifically, such as Figures 1 to 12 As shown, the present invention provides a heart valve that is at least partially degradable.

[0058] In this technical solution, the heart valve, in practical application, can be tightly connected and fixed to the native tissue by the endothelialized dense material 200. Specifically, after the heart valve is implanted into the human atrium, as the endothelialized dense material 200 continuously forms, the heart valve is tightly connected and fixed to the native tissue by the endothelialized dense material 200. However, after the heart valve is tightly fixed, its large size can easily lead to obstruction of the outflow tract. Therefore, making the heart valve biodegradable can effectively avoid changes in cardiac hemodynamics, thereby reducing the probability of thrombosis or hemolysis. Furthermore, the biodegradable stent site of the heart valve can be selected according to actual usage needs. The structure of the stent is not limited, nor is the biodegradable site of the stent. For example, the biodegradable site of the stent can be regular or irregular, and the specific degradation profile can be specifically set according to the patient's actual situation. Therefore, any partially or completely biodegradable heart valve is within the protection scope of this patent, and the heart valve can be of any type and style, which will not be elaborated further here.

[0059] As a preferred embodiment of this patent, see [link to relevant documentation]. Figure 1 and Figure 2The heart valve may include a hollow tubular external stent 100 having a blood inflow end 101 and a blood outflow end 102. Further, the external stent 100 may include a first sub-stent 110, a second sub-stent 120, and a third sub-stent 130 for connecting the first sub-stent 110 and the second sub-stent 120. The blood inflow end 101 is formed at the port of the second sub-stent 120; and the blood outflow end 102 is formed at the port of the first sub-stent 110.

[0060] In this patent, the first sub-support 110, the second sub-support 120 and the third sub-support 130 of the outer support 100 are assembled into one piece by splicing. Compared with the one-piece structure, this is more conducive to production and processing and reduces costs.

[0061] Furthermore, the first sub-stent 110 is used to fix the original valve leaflet, so that the heart valve can be tightly connected and fixed to the original tissue. The second sub-stent 120 is used to conform to the atrial wall, so that the external stent 100 will not detach from the atrial wall when the atrium undergoes dynamic changes, thus assisting in the fixation of the heart valve. In this way, new endothelial cells are more likely to grow at the contact point between the second sub-stent 120 and the atrial wall. The first sub-stent 110 and / or the second sub-stent 120 are wholly or partially degradable, while the third sub-stent 130 is non-degradable. In a preferred example, the first sub-stent 110 and the second sub-stent 120 of the external stent 100 are both made of biodegradable metal material, while 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 endothelialized dense material 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 eventually firmly connected and fixed to the native tissue by the endothelialized dense material 200. This effectively reduces the volume of the external stent 100, thereby reducing obstruction of the outflow tract. In another preferred example, one of the first sub-stent 110 and the second sub-stent 120 is made of a biodegradable metal material, and the other is made of a non-biodegradable metal material. Of course, it is also possible for part of the first sub-stent 110 to be made of a biodegradable metal material and another part of it to be made of a non-biodegradable metal material, and for part of the second sub-stent 120 to be made of a biodegradable metal material and another part of it to be made of a non-biodegradable metal material; no limitations are imposed here.

[0062] Preferably, see Figure 2Based on the good biodegradability of metals such as magnesium alloys, iron alloys, and zinc alloys, the first sub-support 110 and the second sub-support 120 can preferably be made of at least one of the above-mentioned materials, but are not limited thereto. Based on the non-biodegradable properties of materials such as nickel-titanium alloys, stainless steel, and cobalt-based alloys, the third sub-support 130 can preferably be made of at least one of the above-mentioned materials. Of course, other non-biodegradable metal materials can also be used to make the third sub-support 130, without any restrictions.

[0063] As a further optimization of this embodiment, see Figure 1 and Figure 2 The heart valve also includes a first sealing membrane 410 and leaflets 300. After the external stent 100 is implanted into the human atrium, as the first sub-stent 110 and the second sub-stent 120 continuously degrade and ablate, the third sub-stent 130 can be endothelialized through the first sealing membrane 410 and the native tissue, forming an integral unit. Thus, on the one hand, the heart valve can be effectively fixed; on the other hand, the size of the external stent 100 can be reduced. Specifically, the first sealing membrane 410 can cover the inner and / or outer surface of the external stent 100, and the leaflets 300 are located on the inner side of the external stent 100, and can be endothelialized through the first sealing membrane 410 and the native tissue, forming an integral unit, thereby effectively fixing the heart valve.

[0064] In this embodiment, the external stent 100 is a hollow tubular structure to form a flow channel for blood flow. See also... Figure 2 The blood inflow end 101 is formed at the port of the second sub-stent 120; and the blood outflow end 102 is formed at the port of the first sub-stent 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.

[0065] As a further optimization of this embodiment, see Figure 2 The first sub-support 110 can be a V-shaped annular mesh formed by connecting multiple V-shaped pieces 111 end to end. The mating ends 112 of every two adjacent V-shaped pieces 111 are used to connect to the third sub-support 130. In this technical solution, the first sub-support 110 is set as a V-shaped annular mesh. This structure is beneficial for fixing the third sub-support 130 and can also reduce the weight of the first sub-support 110, thus reducing the burden on the atrium. It is worth mentioning that the V-shaped annular mesh can be integrally formed, or it can be formed by welding multiple V-shaped pieces 111 end to end, and is not limited to this.

[0066] Specifically, considering the overall stability of the first sub-stent 110 and the internal space of the atrium, the number of V-shaped components 111 included in the V-shaped annular mesh can be 12-24. In this embodiment, 24 are preferred. Of course, in other embodiments, there can also be 12, 15 or 18, and it is not limited to this.

[0067] In this preferred embodiment, barbs 114 extending outwards can be provided on the mating ends 112 of the plurality of V-shaped members 111. These barbs 114 are fixedly connected to the third sub-support 130, and are non-degradable. Each mating end 112 can be provided with one barb 114. This effectively prevents the first sub-support 110 from completely degrading before the heart valve and native tissue have fully undergone endothelialization, which could easily lead to insecure fixation of the outer support 100 to the heart valve. Therefore, by adding barbs 114 at the connection between the first sub-support 110 and the third sub-support 130, the barbs 114 can continue to fix the heart valve even after the first sub-support 110 has completely degraded.

[0068] Further, see Figure 2 Furthermore, barbs 114 extending outwards can be provided on the crests 113 of multiple V-shaped members 111, and these barbs 114 are biodegradable. This provides initial fixation for the heart valve during implantation, and as the endothelialized dense material 200 gradually forms, the barbs 114 can degrade together with the first sub-stent 110. As a preferred example of this embodiment, each crest 113 of the V-shaped member 111 is connected to an outwardly extending barb 114, thus ensuring that the barbs 114 are evenly distributed at the blood outflow end 102 for hooking the original leaflet and thus for fixing the heart valve. Of course, a barb 114 can also be connected every two crests 113 of the V-shaped members 111, which saves costs without reducing the tightness of the barb 114 connection.

[0069] In this embodiment, the V-shaped annular mesh is set as one layer. By reducing the number of layers of the first sub-stent 110, the length of the outer stent 100 is reduced, which further reduces the risk of outflow obstruction. Specifically, when the V-shaped annular mesh is set as multiple layers, that is, the first sub-stent 110 includes multiple layers of V-shaped annular mesh. Among them, the multiple layers of V-shaped annular mesh are stacked along their respective axes to form a mesh-like structure. In this way, the extension length of the first sub-stent 110 increases, which in turn leads to the length of the outer stent 100. During the contraction or relaxation of the heart 700, the outer stent 100 occupies too much ventricular area, obstructing the area of ​​the outflow tract and easily causing obstruction of the blood outflow tract. Of course, if the extension length of the first sub-stent 110 is set to be shorter, it is easy for the outer stent 100 to be unstable and displaced, which will also lead to obstruction of the blood outflow tract. Therefore, the extension length of the first sub-stent 110 should be controlled within a certain range. Specifically, the first sub-stent 110 can be specifically limited according to the actual heart structure. That is, the V-shaped annular mesh is not limited to one layer, but can be multiple layers. It is only necessary to ensure that the extension length of the first sub-stent 110 is adapted to the heart structure, and it is not limited to this.

[0070] In this embodiment, see Figure 2 and Figure 3 The third sub-support 130 may include a plurality of main connecting rods 131 and a plurality of leaflet connecting rods 132 arranged in parallel with each other. Between each pair of adjacent leaflet connecting rods 132, there are a plurality of main connecting rods 131 of equal number and spacing. One end of each of the plurality of main connecting rods 131 and leaflet connecting rods 132 is used to connect to the mating ends 112 of a plurality of V-shaped pieces 111, and the other end is used to connect to the second sub-support 120.

[0071] It is worth mentioning that the materials of the multiple main connecting rods 131 and the multiple leaflet connecting rods 132 can be the same or different, and no restriction is placed here. Thus, after the external stent 100 is implanted into the human atrium, with the continuous formation of the endothelialized dense material 200 and the continuous degradation and ablation of the first sub-stent 110 and / or the second sub-stent 120, the heart valve eventually becomes tightly connected and fixed to the native tissue by the endothelialized dense material 200. At this time, the multiple main connecting rods 131 and the multiple leaflet connecting rods 132 are tightly located within the endothelialized dense material 200 and the native tissue. Furthermore, since the positional constraints between the multiple main connecting rods 131 and the multiple leaflet connecting rods 132 are removed, during the contraction or relaxation of the heart 700, the multiple main connecting rods 131 and the multiple leaflet connecting rods 132 can contract or relax synchronously with the heart 700, thereby improving its application effect.

[0072] As a further optimization of this embodiment, the total number of the multiple main connecting rods 131 and the multiple leaflet connecting rods 132 is equal to the number of V-shaped members 111 included in the first sub-support 110, which is also 12-24. This can improve the structural stability between the first sub-support 110 and the third sub-support 130. Of course, the number of V-shaped members 111 can also be two or three times the total number of the multiple main connecting rods 131 and the multiple leaflet connecting rods 132. The specific number of rods used can be selected and adjusted according to the actual application scenario, and no specific provisions are made here.

[0073] It is worth noting that the more rods the main connecting rod 131 and leaflet connecting rod 132 have, the greater the stiffness of the external stent 100 and the greater the supporting force. Conversely, the fewer the rods, the softer the external stent 100 and the smaller the supporting force. Therefore, the number of rods needs to be designed within a reasonable range to ensure the overall supporting force of the external stent 100 without damaging the original valve annulus tissue due to excessive force.

[0074] As a further optimization of this embodiment, see Figure 2 and Figure 3There are three leaflet connecting rods 132, and they are spaced apart around the periphery of the third sub-support 130. Thus, the three leaflet connecting rods 132 are evenly distributed along the circumference of the third sub-support 130 at 120°, providing radial support together with the main connecting rod 131. Of course, the number of leaflet connecting rods 132 is not limited to three; it can be any number that is desired.

[0075] As a preferred example of this embodiment, one of the plurality of main connecting rods 131 and the plurality of leaflet connecting rods 132 is a straight rod, and the other of the plurality of main connecting rods 131 and the plurality of leaflet connecting rods 132 is an S-shaped curved rod. Preferably, all the plurality of main connecting rods 131 are straight rods and all the plurality of leaflet connecting rods 132 are S-shaped curved rods. In this way, compared to having all the main connecting rods 131 and the leaflet connecting rods 132 be straight rods, having all the leaflet connecting rods 132 be S-shaped curved rods can increase the contact area with the original tissue, which is beneficial to the fixation of the heart valve. Of course, all the main connecting rods 131 can be S-shaped curved rods and all the leaflet connecting rods 132 can be straight rods, which can achieve the same effect as described above, and will not be elaborated further here.

[0076] As another preferred example of this embodiment, a portion of the plurality of main connecting rods 131 are straight rods, and another portion of the plurality of main connecting rods 131 are S-shaped bent rods. That is, the plurality of main connecting rods 131 can be composed of a plurality of straight rods and a plurality of S-shaped bent rods, and can also be used to strengthen the fixation of artificial heart valves.

[0077] Of course, as a further optimization of the above example, some of the multiple leaflet connecting rods 132 can be straight rods, and other parts of the multiple leaflet connecting rods 132 can be S-shaped curved rods. That is, the multiple leaflet connecting rods 132 can be composed of multiple straight rods and multiple S-shaped curved rods, which can also be used to strengthen the fixation of artificial heart valves.

[0078] In this embodiment, see Figure 2 and Figure 5 The second sub-support 120 has an outward-curving wave-shaped ring structure, that is, the second sub-support 120 is rolled outward toward the multiple main connecting rods 131 and multiple leaflet connecting rods 132 to form an angle of 100-150 degrees with the multiple main connecting rods 131 and multiple leaflet connecting rods 132.

[0079] In this technical solution, the second sub-stent 120 is used to adhere to the atrial wall and fix the outer stent 100, so that the outer stent 100 will not detach from the atrial wall when the atrium undergoes dynamic changes, thus assisting in the fixation of the heart valves. This makes it easier for new endothelial cells to grow at the contact point between the second sub-stent 120 and the atrial wall, resulting in a high cell adhesion rate on the surface of the second sub-stent 120 adhered to the atrial wall, facilitating endothelialization.

[0080] Preferably, based on the structure at the junction of the atrial wall and ventricle, the second sub-stent 120 can form a 120-degree angle with the multiple main connecting rods 131 and the multiple leaflet connecting rods 132, allowing the second sub-stent 120 to fit more tightly against the atrial wall, but this is not a limitation. Designing the second sub-stent 120 as a wave-shaped annular structure can reduce the burden on the heart 700, while simultaneously, the wave-shaped annular structure can significantly increase the contact area with the atrial wall, improving the fixation effect.

[0081] As a further optimization of the above embodiments, see Figures 2 to 4 In order to effectively strengthen the fixation between the main connecting rod 131 and the leaflet connecting rod 132 and the second sub-support 120 and the first sub-support 110, the multiple main connecting rods 131, the multiple leaflet connecting rods 132 and the multiple V-shaped parts 111 and the second sub-support 120 can be fixed by welding or riveting.

[0082] In a preferred embodiment, a second sub-branch connector 122 may be provided at each peak 121 of the second sub-branch 120, and correspondingly, a first sub-branch connector 115 may be provided at each mating end 112 of the first sub-branch 110. The multiple second sub-branch connectors 122 and the multiple first sub-branch connectors 115 are arranged in a one-to-one correspondence. The two ends of each main connecting rod 131 and each leaf connecting rod 132 are respectively connected to a corresponding second sub-branch connector 122 and a first sub-branch connector 115. The main connecting rod 131 and the leaf connecting rod 132 can be fixed to the second sub-branch connector 122 and the first sub-branch connector 115 using rivets 600; alternatively, they can be fixed by welding, and are not limited to this method.

[0083] As a further optimization, each main connecting rod 131 and each leaflet connecting rod 132 is located inside the second sub-stent connector 122 and the first sub-stent connector 115. That is, the main connecting rod 131 and the leaflet connecting rod 132 are located at the ends of the main connecting rod 131 and the leaflet connecting rod 132 facing inward towards the outer stent 100. In this way, the rigid compression of the atrial wall by the main connecting rod 131 and the leaflet connecting rod 132 can be largely avoided.

[0084] For further optimization, see Figure 2 and Figure 3 The arc-shaped transition at the connection between the second stent connector 122 and the peak 121 of the second stent 120 can effectively prevent this part from rigidly compressing the atrial wall, so as to ensure that the external stent 100 is better suited to the human heart 700.

[0085] In a preferred embodiment, see [link to previous document]. Figures 1 to 4Each leaflet connecting rod 132 has a suture hole 1321 at its end facing the first sub-support 110, which is also the end used to connect the V-shaped piece 111, for suturing the leaflet 300. Preferably, to prevent the leaflet 300 from being blocked by multiple main connecting rods 131 and multiple leaflet connecting rods 132 during the suturing process, the suture hole 1321 can be designed to extend to the inner side of the first sub-support 110, that is, the inner side of the V-shaped annular mesh, which facilitates the suturing of the leaflet 300. Preferably, a connector (not shown) can be detachably assembled at the end of each leaflet connecting rod 132 facing the first sub-support 110. This connector can have one, two, or even more suture holes 1321 for suturing the leaflet 300. The connector can be fixed to the leaflet connecting rod 132 by screwing, but is not limited to this method.

[0086] It is worth mentioning that the leaflet 300 provided in this embodiment can be a tricuspid valve. Thus, the three suture holes 1321 corresponding to the three leaflet connecting rods 132 respectively correspond to the three arcuate edges of the tricuspid valve, facilitating the suture fixation of the leaflet 300. Of course, in other embodiments, the leaflet 300 can also be a bicuspid valve or other numbers of leaflets, and is not limited thereto. Furthermore, the leaflet 300 is made of biological tissue, such as bovine or porcine pericardium. Of course, the leaflet 300 can also be a valve made of polymer materials or a tissue-engineered valve, both are acceptable. Further, the first sealing membrane 410 provided in this embodiment can be made of polymer materials, such as PTE, but is not limited thereto.

[0087] Further, see Figure 2 and Figure 6 In this embodiment, after the heart valve is implanted in the heart 700 for a period of time, the first stent 110 and / or the second stent 120 continuously degrade and ablate, while the third stent 130 can be endothelialized through the first sealing membrane 410 and the native tissue, forming a single unit. Thus, on the one hand, the heart valve can be effectively fixed; on the other hand, the size of the external stent 100 can be reduced, effectively reducing outflow tract obstruction and decreasing the impact on hemodynamics, thereby avoiding the probability of thrombosis and hemolysis.

[0088] In another preferred embodiment, see Figures 7 to 9 This embodiment also includes an inner support 500 and a second sealing membrane 420. Specifically, the inner support 500 is disposed inside the outer support 100' and is used to assemble the leaflet 300. Further, the second sealing membrane 420 covers the outer surface of the inner support 500 and is used to connect the outer support 100' and the inner support 500. Specifically, the second sealing membrane 420 fixes the inner support 500 by connecting the outer support 100' and the inner support 500.

[0089] In this embodiment, the structure of the outer support 100' is the same as that of the outer support 100 in the above embodiment, except that it does not have the suture hole 1321, and the first sub-support 110', the second sub-support 120' and the third sub-support 130' included in the outer support 100' of this embodiment are all made of biodegradable metal material. The rest of the structure is the same as that of the outer support 100 in the above embodiment, and will not be described in detail here. For details, please refer to the above description of the structure of the outer support 100.

[0090] Furthermore, the internal stent 500 provided in this embodiment is made of non-degradable metal. A suture hole (not shown) can be added to the internal stent 500 for suturing the leaflets 300. The specific location of the suture hole can be determined according to the actual application scenario, and will not be elaborated further here.

[0091] After the artificial heart valve provided in this embodiment is implanted in the heart 700 for a period of time, as the implantation time progresses, because the second sealing membrane 420 seals the inner stent 500 and the outer stent 100', as blood continuously deposits between the inner stent 500 and the outer stent 100' and as the second sealing membrane 420 becomes endothelialized with the native tissue, an endothelialized dense material 200 will form between the inner stent 500 and the outer stent 100'.

[0092] like Figures 10 to 12 As shown, with the continuous formation of the endothelialized dense material 200 and the continuous degradation and ablation of the external stent 100', the heart valve eventually becomes tightly connected and fixed to the original tissue by the endothelialized dense material 200. This effectively reduces the obstruction of the outflow tract by the external stent 100', and the degradation of the larger external stent 100' can effectively avoid changes in the hemodynamics of the heart 700 caused by the heart valve, thereby reducing the probability of thrombosis or hemolysis.

[0093] Further, see Figures 6 to 8 The first sub-branch 110', the second sub-branch 120', and the third sub-branch 130' can be fixed together by welding or riveting. The specific structure can be referred to the above description regarding the connection of the first sub-branch 110', the second sub-branch 120', and the third sub-branch 130', and will not be repeated here. Preferably, riveting is used, wherein the rivet 600 should also be made of a biodegradable metal material so that it can degrade and dissolve together with the first sub-branch 110', the second sub-branch 120', and the third sub-branch 130', avoiding residue.

[0094] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A heart valve, characterized in that, The heart valve is at least partially degradable; External support; The outer support includes a first sub-support, a second sub-support, and a third sub-support for connecting the first sub-support and the second sub-support; The first sub-stent is used to fix the original leaflet so that the heart valve can be tightly connected and fixed to the original tissue; the second sub-stent is used to conform to the atrial wall so that the external stent will not detach from the atrial wall when the atrium undergoes dynamic changes, thereby assisting in the fixation of the heart valve; the first sub-stent and / or the second sub-stent are degradable so that the size of the external stent can be gradually reduced after implantation in the human body, thereby reducing obstruction of the outflow tract and reducing the impact on hemodynamics; The third sub-support is made of non-degradable metal.

2. The heart valve according to claim 1, characterized in that, The material of the third sub-bracket is 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.

3. The heart valve according to claim 1 or 2, characterized in that, The first sub-support is a V-shaped ring-shaped grid formed by connecting multiple V-shaped pieces end to end; The mating ends of each pair of adjacent V-shaped pieces are used to connect the third sub-bracket; The crests of the multiple V-shaped members are provided with outwardly extending barbs, which are biodegradable; The mating ends of one or more of the V-shaped members are provided with outwardly extending barbs, which are fixedly connected to the third sub-bracket and are non-degradable.

4. The heart valve according to claim 3, characterized in that, The V-shaped annular mesh contains 12-24 V-shaped elements.

5. The heart valve according to claim 4, characterized in that, The third sub-support includes multiple main connecting rods and multiple leaflet connecting rods; Between each pair of adjacent leaflet connecting rods, there are multiple main connecting rods of equal number and spacing; One end of each of the main connecting rods and the leaflet connecting rods is used to connect to the mating ends of the V-shaped parts, and the other end is used to connect to the second sub-bracket.

6. The heart valve according to claim 5, characterized in that, The second sub-support has an outward-curving, ring-shaped structure; Each peak of the second sub-bracket is provided with a second sub-bracket connector; Each of the docking ends of the first sub-bracket is provided with a first sub-bracket connector; Each of the main connecting rods and each of the leaflet connecting rods is connected at both ends to a second sub-branch connector and a first sub-branch connector in opposite positions; and Each of the main connecting rods and each of the leaflet connecting rods is located inside the second sub-branch connector and the first sub-branch connector; and / or The connection between the second sub-bracket connector and the crest of the second sub-bracket has an arc-shaped transition; and / or The number of leaflet connecting rods is three, and they are spaced apart along the periphery of the third sub-branch.

7. The heart valve according to claim 6, characterized in that, 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 A portion of the plurality of main connecting rods is a straight rod, and another portion of the plurality of main connecting rods is an S-shaped bent rod; or A portion of the plurality of leaflet connecting rods is a straight rod, and another portion of the plurality of leaflet connecting rods is an S-shaped bent rod; and / or Each of the leaflet connecting rods has a suture hole at one end facing the first sub-support; and The suture hole extends to the inside of the first sub-branch.

8. The heart valve according to claim 1, characterized in that, Also includes: First sealing membrane and leaflets; The first sealing film covers the inner and / or outer surfaces of the outer bracket; The leaflets are located on the inner side of the outer support.

9. The heart valve according to claim 8, characterized in that, It also includes an inner support and a second sealing membrane; The inner support is disposed inside the outer support and is used to assemble the leaflets; The second sealing film covers the outer surface layer of the inner support and is used to connect the outer support and the inner support.

Images