阅读说明：本技术 一种人工心脏瓣膜支架 (Artificial heart valve stent ) 是由 吴明明 吴意 王春光 陈大凯 于 2021-09-28 设计创作，主要内容包括：本发明一方面在于提供一种人工心脏瓣膜支架,支架包括流入端和流出端。流入端包括多个相互连接的流入端框架单元和多个流入端连接区域,多个相互连接的流入端框架单元为陀螺形的中空框架单元。流出端包括多个相互连接的流出端框架单元和多个流出端连接区域,多个相互连接的流出端框架单元为六边形的中空框架单元。该人工心脏瓣膜支架在不显著增加成本的情况下大幅提升使用安全性,为患者的身体健康提供更加强有力的支持,其具有使用效果好、适用场景丰富等优点,具有巨大的市场潜力。(In one aspect, the present invention provides a prosthetic heart valve stent including an inflow end and an outflow end. The inflow end includes a plurality of interconnected inflow end frame units and a plurality of inflow end connection regions, the plurality of interconnected inflow end frame units being gyro-shaped hollow frame units. The outflow end includes a plurality of interconnected outflow end frame cells and a plurality of outflow end connection regions, the plurality of interconnected outflow end frame cells being hexagonal hollow frame cells. The use safety of the artificial heart valve support is greatly improved under the condition that the cost is not remarkably increased, more powerful support is provided for the physical health of a patient, and the artificial heart valve support has the advantages of good use effect, rich applicable scenes and the like, and has huge market potential.)

1. A prosthetic heart valve stent, the stent being a radially collapsible and expandable annular stent comprising an inflow end and an outflow end,

the inflow end comprises a plurality of interconnected inflow end frame units and a plurality of inflow end connecting areas, the plurality of interconnected inflow end frame units are gyro-shaped hollow frame units, and the inflow end connecting areas are areas where two adjacent inflow end frame units are interconnected; the inflow end frame unit comprises a first bulge part and a second bulge part, the first bulge part protrudes towards the direction of the outflow end along the axial direction of the bracket, the second bulge part protrudes towards the direction far away from the outflow end along the axial direction of the bracket, and the vertical distance between the first bulge part and the connecting line of two adjacent inflow end connecting areas is smaller than or equal to the vertical distance between the second bulge part and the connecting line of two adjacent inflow end connecting areas;

the outflow end comprises a plurality of outflow end frame units and a plurality of outflow end connecting areas, wherein the outflow end frame units are connected with each other, the outflow end frame units are hexagonal hollow frame units, and the outflow end connecting areas are areas formed by connecting two adjacent outflow end frame units with each other.

2. The prosthetic heart valve stent of claim 1, wherein the inflow end frame unit further comprises a first connection portion and a second connection portion, the first connection portion being located between the first boss and the inflow end connection region, the second connection portion being located between the second boss and the inflow end connection region; the width of the inflow end connection region in the circumferential direction of the stent is greater than 2 times the average value of the widths of the first connection portion and the second connection portion in the circumferential direction of the stent.

3. The prosthetic heart valve stent of claim 2, wherein a length of the inflow end connection region in the stent axial direction is 1 to 3 times an average of widths of the first and second connection portions in the stent circumferential direction.

4. The prosthetic heart valve stent of claim 1, wherein a ratio of a distance between adjacent two of the inflow end connection regions to a distance between the first boss and the second boss of the inflow end frame unit is 0.8-1.

5. The prosthetic heart valve stent of claim 1, wherein a top inside of the first boss, a top inside of the second boss, and/or a top outside of the second boss is arc-shaped or elliptical-arc-shaped.

6. The prosthetic heart valve stent of claim 2, wherein the width of the outflow end connection region in the circumferential direction of the stent is smaller than the width of the inflow end connection region in the circumferential direction of the stent.

7. The prosthetic heart valve stent of claim 6, wherein the width of the outflow end connection region in the circumferential direction of the stent is less than half the width of the inflow end connection region in the circumferential direction of the stent.

8. The prosthetic heart valve stent of claim 1, wherein the outflow-end frame unit includes a third boss protruding in the axial direction of the stent in the direction of the outflow end, and a fourth boss protruding in the axial direction of the stent in the direction away from the outflow end; the outflow end frame unit further includes a third connection portion located between the third protrusion and the outflow end connection region, and a fourth connection portion located between the fourth protrusion and the outflow end connection region.

9. The prosthetic heart valve stent of claim 8, wherein a top inside of the third boss, a top outside of the third boss, and/or a top inside of the fourth boss is circular arc-shaped or elliptical arc-shaped.

10. The prosthetic heart valve stent of claim 8, wherein there is a circular arc connection between two adjacent third connection portions, between two adjacent fourth connection portions, between the third connection portions and adjacent outflow end connection regions, and/or between the fourth connection portions and adjacent outflow end connection regions.

11. The stent for a prosthetic heart valve according to claim 8, wherein at least one of the outflow end connection regions is provided with a sewn portion having a sheet-like structure with a wide middle portion and narrow ends, the sheet-like structure being provided in an axial direction of the stent.

12. The prosthetic heart valve stent of claim 11, wherein the suture portion has at least two suture holes formed therein.

13. The prosthetic heart valve stent of claim 11, wherein the third connecting portion and the adjacent sutured portions and/or the fourth connecting portion and the adjacent sutured portions are connected by a circular arc.

14. The prosthetic heart valve stent of claim 1, further comprising a transition section disposed between the inflow end and the outflow end, the transition section comprising a plurality of interconnected transition section frame units that are gyro-shaped hollow frame units and a plurality of transition section connection regions that are areas where two adjacent transition section frame units are interconnected; the transition section frame unit comprises a fifth bulge and a sixth bulge, the fifth bulge protrudes towards the direction of the outflow end along the axial direction of the bracket, and the sixth bulge protrudes towards the direction far away from the outflow end along the axial direction of the bracket.

15. The prosthetic heart valve stent of claim 14, wherein a perpendicular distance of the fifth boss from a line connecting two adjacent transition connection regions is equal to a perpendicular distance of the sixth boss from a line connecting two adjacent transition connection regions.

16. The prosthetic heart valve stent of claim 14, wherein a ratio between a distance between two adjacent transition connection regions and a distance between the fifth boss and the sixth boss is greater than 1.

17. The prosthetic heart valve stent of claim 16, wherein a ratio of a distance between adjacent two transition connection regions to a distance between the fifth boss and the sixth boss is greater than 1.2.

18. The prosthetic heart valve stent of claim 14, wherein the transition section frame cell further comprises a fifth connector between the fifth boss and the transition section connection region and a sixth connector between the sixth boss and the transition section connection region; the ratio of the length of the transition section connecting area in the axial direction of the support to the average value of the widths of the fifth connecting part and the sixth connecting part in the circumferential direction of the support is 0.8-1.3.

19. The prosthetic heart valve stent of claim 18, wherein a ratio of a length of the transition section connection region in the stent axial direction to an average of widths of the fifth and sixth connection portions in the stent circumferential direction is 1-1.1.

Technical Field

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

Background

Cardiovascular disease is the first health killer worldwide. At present, cardiovascular disease patients in China approach 3 hundred million people. According to incomplete statistics, about 300 million people die of cardiovascular diseases each year, accounting for 45% of the total death rate of all diseases.

Clinically, common cardiovascular diseases mainly include coronary heart disease and heart valve disease. The heart valve disease is a very common heart disease in China, and valve damage caused by rheumatic fever is the most common. With the increasing aging of the population, senile valvular diseases and heart valvular disease diseases caused by coronary heart disease and myocardial infarction are more and more common.

According to epidemiological investigation statistics, the incidence rate of heart valvular diseases in China is 2.5% -3.2%, wherein the incidence rate of valvular heart diseases of old people over 75 years old is 13.3%. For valvular heart disease with mild symptoms, medication can be used, but for severe valvular heart disease, only surgical replacement of the heart valve can be used.

Conventional surgical procedures for replacing heart valves require an open chest procedure while the patient's heart is arrested and an extracorporeal circulation system is established. Such surgical procedures are highly traumatic and require long recovery times in the later stages, which are not tolerated by all patients, especially elderly patients.

Currently, transcatheter aortic replacement, also known as TAVR replacement, has become the most effective means and mainstream trend for the treatment of cardiovascular disease. The method mainly comprises the steps of pre-crimping the artificial heart valve, puncturing the femoral artery or other suitable blood vessels, conveying the artificial heart valve to a diseased aortic valve by using a conveying system, moving the crimped artificial heart valve to a balloon after the artificial heart valve is conveyed to a target position, pumping high-pressure liquid or gas into the balloon to expand the balloon, and driving the valve to expand so as to complete the placement of the artificial heart valve. It belongs to minimally invasive surgery, has small surgical wound, short surgical process and quick postoperative recovery.

However, in practice, it is often found that existing prosthetic heart valves present difficulties in use. For example, because the ends of a prosthetic heart valve are typically subjected to less pressure during use, the expansion typically begins at both ends and gradually expands the middle, in some cases, resulting in a thick, thin bone-like structure. In addition, in some cases, during the delivery or expansion of the artificial heart valve, the inclined support rods at two sides of the cap end contact and clamp the balloon after being pressed, so that the balloon is broken due to uneven stress during the later expansion process. In addition, in the use process, it is also found that in the case where the other portions are already crimped while crimping, the suture portion is still held in a vertical state and the crimping is not symmetrical.

Therefore, a new technology to solve the above problems is urgently needed.

Disclosure of Invention

In order to make up for the defects of the prior art, the application provides a prosthetic heart valve stent. This artificial heart valve support can avoid artificial heart valve to appear the thick middle part thin bone column structure in both ends through using the unique design that this application relates to inflow end, outflow end and other parts, also can avoid the sacculus in the inflation in-process because of the inhomogeneous condition that breaks of atress, simultaneously, under the pressure state of holding, artificial heart valve can realize more even pressurized contraction. In addition, the use safety of the artificial heart valve support and the artificial heart valve comprising the same is greatly improved under the condition that the cost is not remarkably increased, more powerful support is provided for the physical health of a patient, and the artificial heart valve support has the advantages of good use effect, rich applicable scenes and the like, and has huge market potential.

One aspect of the present application is to provide a prosthetic heart valve stent, which is a radially collapsible and expandable annular stent including an inflow end and an outflow end. The inflow end comprises a plurality of interconnected inflow end frame units and a plurality of inflow end connecting areas, the plurality of interconnected inflow end frame units are gyro-shaped hollow frame units, and the inflow end connecting areas are areas where two adjacent inflow end frame units are connected with each other. The inflow end frame unit comprises a first protruding portion and a second protruding portion, the first protruding portion protrudes towards the direction of the outflow end along the axial direction of the support, the second protruding portion protrudes towards the direction far away from the outflow end along the axial direction of the support, and the vertical distance between the first protruding portion and the connecting line of two adjacent inflow end connecting areas is smaller than or equal to the vertical distance between the second protruding portion and the connecting line of two adjacent inflow end connecting areas. The outflow end comprises a plurality of outflow end frame units and a plurality of outflow end connecting areas, wherein the outflow end frame units are connected with each other, the outflow end frame units are hexagonal hollow frame units, and the outflow end connecting areas are areas formed by connecting two adjacent outflow end frame units with each other.

In some embodiments, the inflow end frame unit further includes a first connection portion between the first protrusion portion and the inflow end connection region and a second connection portion between the second protrusion portion and the inflow end connection region. The width of the inflow end connection region in the circumferential direction of the stent is greater than 2 times the average of the widths of the first and second connection portions in the circumferential direction of the stent.

In some embodiments, the length of the inflow end connection region in the axial direction of the stent is 1 to 3 times the average of the widths of the first and second connection portions in the circumferential direction of the stent.

In some embodiments, the ratio of the distance between two adjacent inflow end connection regions to the distance between the first and second protrusions of the inflow end frame unit is 0.8-1.

In some embodiments, the top inside of the first boss, the top inside of the second boss, and/or the top outside of the second boss is arc-shaped or elliptical-arc-shaped.

In some embodiments, the width of the outflow end connection region in the circumferential direction of the stent is smaller than the width of the inflow end connection region in the circumferential direction of the stent.

In some embodiments, the width of the outflow end connection region in the circumferential direction of the stent is less than half of the width of the inflow end connection region in the circumferential direction of the stent.

In some embodiments, the outflow end frame unit includes a third projection projecting in the axial direction of the stent toward the direction of the outflow end, and a fourth projection projecting in the axial direction of the stent away from the outflow end. The outflow end frame unit further includes a third connection portion between the third protrusion and the outflow end connection region, and a fourth connection portion between the fourth protrusion and the outflow end connection region.

In some embodiments, the top inner side of the third lobe, the top outer side of the third lobe, and/or the top inner side of the fourth lobe is arc-shaped or elliptical-arc-shaped.

In some embodiments, the second connecting portion is connected to the first connecting portion by a circular arc, and the second connecting portion is connected to the second connecting portion by a circular arc.

In some embodiments, at least one of the outflow end connection regions is provided with a suture portion, and the suture portion is a sheet-like structure which is wide in the middle and narrow at both ends and is arranged in the axial direction of the stent.

In some embodiments, at least two suture holes are provided on the suture portion.

In some embodiments, the third connecting portion and the adjacent seam and/or the fourth connecting portion and the adjacent seam are connected by a circular arc.

In some embodiments, the stent further comprises a transition section disposed between the inflow end and the outflow end, the transition section comprising a plurality of interconnected transition section frame units and a plurality of transition section connection regions, the plurality of interconnected transition section frame units being gyro-shaped hollow frame units, the transition section connection regions being regions where two adjacent transition section frame units are interconnected. The transition section frame unit comprises a fifth bulge and a sixth bulge, the fifth bulge protrudes towards the direction of the outflow end along the axial direction of the support, and the sixth bulge protrudes towards the direction far away from the outflow end along the axial direction of the support.

In some embodiments, the perpendicular distance between the fifth lobe and the line connecting the adjacent two transition section connecting regions is equal to the perpendicular distance between the sixth lobe and the line connecting the adjacent two transition section connecting regions.

In some embodiments, a ratio of a distance between two adjacent transition connection regions to a distance between the fifth lobe and the sixth lobe is greater than 1.

In some embodiments, a ratio of a distance between two adjacent transition connection regions to a distance between the fifth lobe and the sixth lobe is greater than 1.2.

In some embodiments, the transition frame unit further comprises a fifth connection between the fifth boss and the transition connection region and a sixth connection between the sixth boss and the transition connection region. The ratio of the length of the transition section connecting area in the axial direction of the support to the average value of the widths of the fifth connecting part and the sixth connecting part in the circumferential direction of the support is 0.8-1.3.

In some embodiments, the ratio of the length of the transition section connecting area along the axial direction of the stent to the average value of the widths of the fifth connecting part and the sixth connecting part along the circumferential direction of the stent is 1-1.1.

Another aspect of the present application is to provide a prosthetic heart valve. The artificial heart valve comprises a plurality of valve leaflets and any one of the artificial heart valve supports, wherein the valve leaflets are connected with the artificial heart valve support.

Drawings

The present application may be better understood by describing embodiments thereof in conjunction with the following drawings, in which:

FIG. 1 is a schematic view of a four-layered prosthetic heart valve stent in an embodiment of the present application in a deployed configuration;

FIG. 2 is a schematic perspective view of a four-layered prosthetic heart valve stent according to one embodiment shown in FIG. 1;

FIG. 3 is a front view of a four-layered prosthetic heart valve stent of the embodiment shown in FIG. 1;

FIG. 4 is an enlarged partial schematic view of the inflow end of the embodiment shown in FIG. 1;

FIG. 5 is an enlarged partial view of the outflow end of the embodiment shown in FIG. 1;

FIG. 6 is an enlarged partial schematic view of region A of the outflow end of the prosthetic heart valve stent of one embodiment as shown in FIG. 5;

FIG. 7 is an enlarged partial view of the area B of the outflow end of the prosthetic heart valve stent of one embodiment as shown in FIG. 5;

FIG. 8 is an enlarged partial schematic view of a transition section in one embodiment as shown in FIG. 1;

FIG. 9 is a structural diagram illustrating a crimped state of a prosthetic heart valve stent in one embodiment as shown in FIG. 1;

FIG. 10 is a schematic structural view of the top-shaped hollow of the inflow end frame unit of the inflow end of the prosthetic heart valve stent in one embodiment as shown in FIG. 1;

FIG. 11 is a schematic view of a four-layered prosthetic heart valve stent in an embodiment of the present application in a deployed configuration; and

FIG. 12 is a schematic view of a three-layered prosthetic heart valve stent in an embodiment of the present application in a deployed configuration.

The reference numbers illustrate:

100: an inflow end;

110: an inflow end frame unit;

120: an inflow end connection area;

130: a first boss portion;

140: a second boss portion;

150: a first connection portion;

160: a second connecting portion;

200: an outflow end;

210: an outflow end frame unit;

220: an outflow end connection region;

230: a third boss portion;

240: a fourth boss;

250: a third connecting portion;

260: a fourth connecting portion;

270: a suture section;

280: sewing the hole;

300: a transition section;

310: a transition section frame unit;

320: a transition section connection region;

330: a fifth boss;

340: a sixth boss;

350: a fifth connecting part;

360: a sixth connecting portion;

400: a prosthetic heart valve stent;

410: an inflow end;

420: an outflow end;

430: a transition section;

500: a prosthetic heart valve stent;

510: an inflow end;

520: an outflow end;

530: a transition section.

Detailed Description

Unless otherwise defined, technical or scientific terms used herein in the specification and claims should have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

All numerical values recited herein as between the lowest value and the highest value are intended to mean all values between the lowest value and the highest value in increments of one unit when there is more than two units difference between the lowest value and the highest value.

In the description of the present invention, it is to be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like, indicate orientations or positional relationships based on those shown in the drawings, and are used only for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the referenced devices or elements must have a particular orientation, be constructed and operated in a particular orientation, and thus, are not to be construed as limiting the present invention.

Furthermore, the terms "first", "second", etc. are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first," "second," etc. may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless otherwise specified.

In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art through specific situations.

The present invention will be described in detail below with reference to the embodiments with reference to the attached drawings. It is noted that in the detailed description of these embodiments, in order to provide a concise description, all features of an actual implementation may not be described in detail.

Embodiments of the present application relate to a prosthetic heart valve stent as shown in fig. 1-10. The stent is a radially collapsible and expandable annular stent comprising an inflow end 100 and an outflow end 200.

The inflow end 100 shown in fig. 4 includes a plurality of interconnected inflow end frame units 110 and a plurality of inflow end connection regions 120, the plurality of interconnected inflow end frame units 110 being hollow frame units in a gyro shape, and the inflow end connection regions 120 being regions where adjacent two inflow end frame units 110 are connected to each other. The inflow end frame unit 110 includes a first protrusion 130 and a second protrusion 140, the first protrusion 130 protrudes in the axial direction of the stent toward the outflow end 200, the second protrusion 140 protrudes in the axial direction of the stent away from the outflow end 200, and a perpendicular distance between the first protrusion 130 and a line connecting two adjacent inflow end connection regions 120 is less than or equal to a perpendicular distance between the second protrusion 140 and a line connecting two adjacent inflow end connection regions 120.

In some embodiments, the toroidal internal profile of the gyro-shaped hollow frame element is as shown in fig. 10. Referring to fig. 10, the annular inner contour of the gyro-shaped hollow frame element may be composed of a smoothly connected first straight line AB, a first quadratic curve BC, a second straight line CD, a second quadratic curve DE, a third straight line EF, a third quadratic curve FG, a fourth straight line GH, and a fourth quadratic curve HA. In one embodiment, the first line AB is equal in length to the second line CD, and the third line EF is equal in length to the fourth line GH. The length of the first straight line AB or the second straight line CD is greater than or equal to the length of the third straight line EF and the third straight line GH. In one embodiment, the first conic BC is a parabolic curve convex toward the outflow end 200 and includes a maximum P1. In one embodiment, the third conic FG is a parabolic curve convex away from the outflow end 200 and includes a maximum P3. In one embodiment, the parabolic opening of the first quadratic curve BC is smaller than or equal to the parabolic opening of the third quadratic curve FG. In one embodiment, the second conic DE is an arc that projects circumferentially outward away from the longitudinal axis of the inflow end frame element 110 and includes a maximum P2. In one embodiment, the fourth conic HA is an arc that projects circumferentially outward away from the longitudinal axis of the inflow end frame element 110 and includes a maximum P4. In one embodiment, the second quadratic curve DE and the fourth quadratic curve HA are symmetrical to each other. In one embodiment, the maxima P2 and P4 are at the same horizontal height, and the vertical distance of the maximum P1 to the horizontal height is greater than or equal to the vertical distance of the maximum P3 to the horizontal height. In one embodiment, the vertical distance from the maximum P1 to the horizontal height may be 1-2.5 times the vertical distance from the maximum P3 to the horizontal height. In other words, the length of the frame profile formed by P4-P1-P2 extending along the longitudinal axis of the inflow end frame cell 110 is greater than or equal to the length of the frame profile formed by P4-P3-P2 extending along the longitudinal axis of the inflow end frame cell 110.

The outflow end 200 shown in fig. 5 includes a plurality of outflow end frame units 210 connected to each other, the plurality of outflow end frame units 210 being hexagonal hollow frame units, and a plurality of outflow end connection regions 220, the outflow end connection regions 220 being regions where two adjacent outflow end frame units 210 are connected to each other.

In some embodiments, the inflow end frame unit 110 further includes a first connection portion 150 and a second connection portion 160, the first connection portion 150 being located between the first protrusion portion 130 and the inflow end connection region 120, and the second connection portion 160 being located between the second protrusion portion 140 and the inflow end connection region 120. The width of the inflow end connection region 120 in the stent circumferential direction is greater than 2 times the average of the widths of the first and second connection portions 150 and 160 in the stent circumferential direction.

In some embodiments, the length of the inflow end connection region 120 in the stent axial direction is 1 to 3 times the average of the widths of the first and second connection parts 150 and 160 in the stent circumferential direction. For example, it may be 1-fold, 1.2-fold, 1.5-fold, 1.6-fold, 1.8-fold, 2-fold, 2.2-fold, 2.5-fold, 2.6-fold, 2.8-fold, or 3-fold.

In some embodiments, a ratio of a distance between two adjacent inflow end connection regions 120 to a distance between the first and second protrusions 130 and 140 of the inflow end frame unit 110 is 0.8 to 1, and may be 0.9, for example.

In some embodiments, the inflow end 100 has the same width except for the inflow end connection region 120.

In some embodiments, the top inside of the first boss 130, the top inside of the second boss 140, and/or the top outside of the second boss 140 is arc-shaped or elliptical-arc-shaped. In particular embodiments, the top inside of the first boss 130, the top inside of the second boss 140, and/or the top outside of the second boss 140 may be a circular arc shape of 130 ° to 150 °, for example, 130 °, 140 °, or 150 °. Through the arc-shaped or elliptical arc-shaped structural design of the first protruding part 130, the occurrence of unfavorable conditions such as structural deformation or abnormal expansion caused by excessive clamping of the artificial heart valve stent in the clamping process can be avoided. Furthermore, by the circular arc or elliptical arc design of the second lobe 140, puncturing of the outer balloon may be avoided.

In some embodiments, the width of the outflow end connection region 220 in the circumferential direction of the stent is smaller than the width of the inflow end connection region 120 in the circumferential direction of the stent. Preferably, the width of the outflow end connection region 220 in the circumferential direction of the stent is less than half of the width of the inflow end connection region 120 in the circumferential direction of the stent. In a specific embodiment, two adjacent outflow end frame units 210 may share one edge as the outflow end connection region 220.

In some embodiments, the outflow end frame unit 210 includes a third protrusion 230 and a fourth protrusion 240, the third protrusion 230 protrudes in the axial direction of the stent toward the outflow end 200, and the fourth protrusion 240 protrudes in the axial direction of the stent away from the outflow end 200. The outflow end frame unit 210 further includes a third connection part 250 and a fourth connection part 260, the third connection part 250 being located between the third protrusion part 230 and the outflow end connection region 220, and the fourth connection part 260 being located between the fourth protrusion part 240 and the outflow end connection region 220.

In some embodiments, the top inside of the third lobe 230, the top outside of the third lobe 230, and/or the top inside of the fourth lobe 240 is arc-shaped or elliptical-arc-shaped. In particular embodiments, the top inside of the third boss 230, the top outside of the third boss 230, and/or the top inside of the fourth boss 240 may be a circular arc shape of 130 ° to 150 °, for example, 130 °, 140 °, or 150 °. As shown in fig. 6, the enlarged view of a part of the third protrusion 230 is an arc or elliptical arc structure design of the third protrusion 230, so that the third protrusion 230 can be prevented from contacting and clamping the balloon after being pressed and held during the transportation or expansion process, the balloon can be prevented from being broken due to uneven stress during the expansion process, and the stent can be prevented from being expanded unsuccessfully due to over-pressing and holding.

In some embodiments, there is a circular arc connection between two adjacent third connection portions 250, between two adjacent fourth connection portions 260, between a third connection portion 250 and an adjacent outflow end connection region 220, and/or between a fourth connection portion 260 and an adjacent outflow end connection region 220. The angle of the arc may be 130 ° to 150 °, for example, 130 °, 140 °, or 150 °. Wherein the circular arc connection between two adjacent third connection portions 250 and between the third connection portions 250 and the adjacent outflow end connection region 220 may be as shown in fig. 7. Through the arc arrangement, the problem that the stent cannot be expanded smoothly due to excessive pressure holding can be avoided.

In some embodiments, the outflow end 200 has the same width in the remaining portion outside the outflow end connection area 220. Through the structural design, the artificial heart valve stent can be in a symmetrical and uniform crimping state as shown in fig. 9 in the crimping state, and the phenomenon that the crimping is asymmetrical, namely the abnormal state after the crimping due to overlarge local supporting force caused by different widths can be avoided.

In some embodiments, at least one of the outflow end connection regions 220 is provided with a suture 270, and the suture 270 is a sheet-like structure having a wide middle portion and narrow ends arranged in the axial direction of the stent. In some embodiments, at least two suture holes 280 are provided on the suture 270.

In some embodiments, the third connection portion 250 and the adjacent seam 270 and/or the fourth connection portion 260 and the adjacent seam 270 are connected by a circular arc. The angle of the arc may be 130 ° to 150 °, for example, 130 °, 140 °, or 150 °.

In some embodiments, the stent further comprises a transition section 300 as shown in fig. 8 disposed between the inflow end 100 and the outflow end 200, the transition section 300 comprising a plurality of interconnected transition section frame units 310 and a plurality of transition section connection regions 320, the plurality of interconnected transition section frame units 310 being gyro-shaped hollow frame units, the transition section connection regions 320 being regions where two adjacent transition section frame units 310 are interconnected. In some particular embodiments, the rack may further include a single row, double row, or multiple rows of interconnected transition section frame elements 310 and transition section connection regions 320.

The transition frame unit 310 includes a fifth boss 330 and a sixth boss 340, the fifth boss 330 protruding in the axial direction of the stent toward the outflow end 200, and the sixth boss 340 protruding in the axial direction of the stent away from the outflow end 200.

In some specific embodiments, the perpendicular distance between the fifth protrusion 330 and the line connecting the two adjacent transition connecting regions 320 is equal to the perpendicular distance between the sixth protrusion 340 and the line connecting the two adjacent transition connecting regions 320.

In some embodiments, the ratio of the distance between two adjacent transition connection regions 320 to the distance between the fifth boss 330 and the sixth boss 340 is greater than 1. Preferably, the ratio of the distance between two adjacent transition connection regions 320 to the distance between the fifth boss 330 and the sixth boss 340 is greater than 1.2. Through the structural design, the longitudinal length and the axial length of the transition section frame unit 310 can be shortened, so that the phenomenon that the support is difficult to expand and has thick ends and thin middle parts due to bone-shaped structures can be prevented, the support is expanded more uniformly, and the using effect is good.

In some embodiments, the transition frame element 310 further includes a fifth connector 350 and a sixth connector 360, the fifth connector 350 being located between the fifth boss 330 and the transition connection region 320, the sixth connector 360 being located between the sixth boss 340 and the transition connection region 320. In some embodiments, when the stent includes a single row of transition frame cells 310 and transition connection regions 320, the fifth connection 350 coincides with the fourth connection 260 of the outflow end 200, and the sixth connection 360 coincides with the first connection 150 of the inflow end 100.

The ratio of the length of the transition section connecting area 320 in the axial direction of the stent to the average value of the widths of the fifth connecting part 350 and the sixth connecting part 360 in the circumferential direction of the stent is 0.8-1.3. Preferably, the ratio of the length of the transition section connecting region 320 in the axial direction of the stent to the average value of the widths of the fifth connecting part 350 and the sixth connecting part 360 in the circumferential direction of the stent is 1-1.1. The transition section connecting region 320 is too long, which easily causes the transition section 300 not to expand easily, and causes the situation that the transition sections at two ends of the stent diameter are large and the transition sections are small, so that the risk of loose clamping with the valve annulus is easily generated after the artificial valve is implanted into a human body, and the risk of falling off is easily generated, thereby causing the failure of valve implantation. Therefore, the special structure design of the transition section connecting region 320 according to the present application can ensure the expansion performance of the transition section 300, and improve the safety and reliability of the operation.

Embodiments of the present application are also directed to a prosthetic heart valve stent as shown in fig. 11. The prosthetic heart valve stent 400 includes an inflow end 410, an outflow end 420, and a transition section 430 comprising a double layer of transition section frame cells and transition section connection regions. The structure of the prosthetic heart valve stent 400 may be similar to the prosthetic heart valve stent described in fig. 1-11.

Embodiments of the present application are also directed to a prosthetic heart valve stent as shown in fig. 12. The prosthetic heart valve stent 500 includes an inflow end 510, an outflow end 520, and a transition section 530 comprising a single layer of transition section frame cells and transition section connection regions. The structure of the prosthetic heart valve stent 500 may be similar to the prosthetic heart valve stent described in fig. 1-11.

The above embodiments are provided to further explain the objects, technical solutions and advantages of the present invention in detail, it should be understood that the above embodiments are only examples of the present invention and are not intended to limit the present invention, and any modifications, equivalents, improvements and the like made within the spirit and principle of the present invention should be included in the protection scope of the present invention.