阅读说明：本技术 一种人工心脏瓣膜 (Artificial heart valve ) 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,包括多片瓣叶和人工心脏瓣膜支架,瓣叶与人工心脏瓣膜支架相连。支架为可径向收缩及扩张的环形支架,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。(The invention provides a heart valve prosthesis, which comprises a plurality of valve leaflets and a heart valve prosthesis support, wherein the valve leaflets are connected with the heart valve prosthesis support. The stent is a radially collapsible and expandable annular stent comprising 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 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 has the advantages of good use effect, rich applicable scenes and the like, and has huge market potential.)

1. A prosthetic heart valve comprising a plurality of leaflets and a prosthetic heart valve stent, the leaflets being attached to the prosthetic heart valve stent; the stent is a radially collapsible and expandable annular stent comprising an inflow end and an outflow end, characterized in that,

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 of claim 1, wherein the inflow end frame unit further comprises a first connection between the first boss and the inflow end connection region and a second connection 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 of claim 2, wherein the length of the inflow end connection region in the axial direction of the stent is 1 to 3 times an average of the widths of the first and second connection portions in the circumferential direction of the stent.

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

5. The prosthetic heart valve 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 of claim 2, wherein the outflow end connection region has a width in the circumferential direction of the stent that is less than a width of the inflow end connection region in the circumferential direction of the stent.

7. The prosthetic heart valve 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.

8. The prosthetic heart valve of claim 7, 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 arc-shaped or elliptical-arc-shaped.

9. The prosthetic heart valve of claim 7, wherein there is a radiused 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.

10. The prosthetic heart valve of claim 7, wherein at least one of the outflow end connection regions is provided with a suture 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.

11. The prosthetic heart valve of claim 10, wherein the third connecting portion and the adjacent sutured portion and/or the fourth connecting portion and the adjacent sutured portion are connected by a circular arc.

12. The prosthetic heart valve of claim 1, wherein 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 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.

13. The prosthetic heart valve of claim 12, 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.

14. The prosthetic heart valve of claim 12, 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.

15. The prosthetic heart valve of claim 14, wherein the transition frame unit further comprises a fifth connector between the fifth boss and the transition connection region and a sixth connector 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.

16. The prosthetic heart valve of claim 15, wherein the ratio of the length of the transition connection region in the axial direction of the stent to the average of the widths of the fifth and sixth connecting portions in the circumferential direction of the stent is 1-1.1.

17. The prosthetic heart valve of claim 1, wherein the leaflet comprises:

the outer side of the valve leaflet tail part is provided with a protruding structure, and the outer side edge of the protruding structure is connected with the artificial heart valve stent;

the sealing strip is of a bendable structure, the outer side of the sealing strip is connected with the inner side of the tail part of the valve leaflet, the side surface where the inner side is located is perpendicular to the plane where the tail part of the valve leaflet is located, fixed ends are respectively arranged on the other two opposite side surfaces of the sealing strip, the fixed ends are turned over and wrapped with clamping pieces to form a fixing piece, and the fixing piece is fixedly connected with the artificial heart valve support;

two adjacent valve leaflets are sequentially connected through the fixing piece to form a valve body, and the end parts of the inner side surfaces of the sealing strips in the two adjacent valve leaflets are contacted to realize that the middle parts of the valve body can be opened and closed in a one-way mode.

18. The prosthetic heart valve of claim 1, further comprising a first sewing membrane sewn to the entire inflow end frame unit of the prosthetic heart valve stent and completely covering the hollow region of the inflow end frame unit.

19. The prosthetic heart valve of claim 1, further comprising an outer skirt having a serrated structure at one end that matches the shape of the inflow end of the prosthetic heart valve holder and is sutured to the prosthetic heart valve holder.

20. The prosthetic heart valve of claim 17, wherein the projecting structure on the outside of the leaflet tails is an inner skirt sutured to the outside of the leaflet tails, the inner skirt matching the shape of the outside edge of the leaflet tails.

Technical Field

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

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 ten thousand people die of cardiovascular diseases every year, accounting for 45 percent 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 deficiencies of the prior art, the present application provides a prosthetic heart valve. This artificial heart valve can avoid artificial heart valve to appear the thick middle part thin bone column structure in both ends through using this application to relate to the unique design of 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 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 has the advantages of good use effect, rich applicable scenes and the like, and has great market potential.

One aspect of the present application is to provide a prosthetic heart valve including a plurality of leaflets and a prosthetic heart valve stent, the leaflets being attached to the prosthetic heart valve stent. The stent is 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 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 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, 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, 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.

In some embodiments, the leaflet comprises: the outer side of the valve leaflet tail part is a protruding structure, and the outer side edge of the protruding structure is connected with the artificial heart valve support. The sealing strip, the sealing strip is the structure of can buckling, and the inboard of valve leaflet afterbody is connected to the outside of sealing strip, and the side at inboard place is perpendicular with the plane at valve leaflet afterbody place, and two other counter side of sealing strip are provided with the stiff end respectively, and the stiff end turns over and forms the mounting after the parcel has the clamping piece, through mounting and artificial heart valve support fixed connection. Two adjacent valve leaflets connect gradually through the mounting and form the valve body, but the middle part one-way opening and shutting of the sealing strip medial surface tip contact in order to realize the valve body in two adjacent valve leaflets.

In some embodiments, the prosthetic heart valve further comprises a first sewing membrane that is sewn to all of the inflow end frame units of the prosthetic heart valve stent and completely covers the hollow region of the inflow end frame units.

In some embodiments, the prosthetic heart valve further includes an outer skirt, one end of the outer skirt including a serrated structure that matches a shape of the inflow end of the prosthetic heart valve holder and is sutured to the prosthetic heart valve holder.

In some embodiments, the projecting structure on the outer side of the valve leaflet tail is an inner skirt fixed on the outer side of the valve leaflet tail by sewing, and the shape of the outer side edge of the valve leaflet tail is matched with that of the inner skirt.

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 structural view of a prosthetic heart valve in one embodiment of the present application;

FIG. 2 is a schematic view of a four-layered prosthetic heart valve stent in an embodiment as shown in FIG. 1;

FIG. 3 is a schematic perspective view of a four-layered prosthetic heart valve stent according to one embodiment shown in FIG. 2;

FIG. 4 is a front view of a four-layered prosthetic heart valve stent of the embodiment shown in FIG. 2;

FIG. 5 is an enlarged partial schematic view of the inflow end of the prosthetic heart valve stent of one embodiment as shown in FIG. 2;

FIG. 6 is an enlarged partial schematic view of the outflow end of the prosthetic heart valve stent of one embodiment as shown in FIG. 2;

FIG. 7 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. 6;

FIG. 8 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. 6;

FIG. 9 is an enlarged partial schematic view of a transition section of the prosthetic heart valve stent in one embodiment as shown in FIG. 2;

FIG. 10 is a structural diagram illustrating a crimped state of a prosthetic heart valve stent in one embodiment as shown in FIG. 2;

FIG. 11 is a schematic view of a top-shaped hollow frame unit of an inflow end of a prosthetic heart valve stent in one embodiment as shown in FIG. 2;

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

FIG. 13 is a schematic view of a three-layered prosthetic heart valve stent in an embodiment of the present application in an expanded configuration;

fig. 14 is a schematic view of an installation structure of a plurality of leaflets as in the embodiment shown in fig. 1;

figure 15 is a schematic structural view of a leaflet according to one embodiment shown in figure 1;

FIG. 16 is a schematic view of the clip of one embodiment as shown in FIG. 1;

fig. 17 is a schematic view of the relative positions of the clip and leaflets in one embodiment as shown in fig. 1;

fig. 18 is a schematic view of another leaflet of the embodiment shown in fig. 1;

FIG. 19 is a schematic view of the structure of a first sewing film in one embodiment as shown in FIG. 1;

FIG. 20 is a schematic view of the construction of the outer skirt in one embodiment as shown in FIG. 1; and

FIG. 21 is a schematic view of the inner skirt of FIG. 1 in one embodiment.

The reference numbers illustrate:

100: a leaflet; 110: a valve body; 121: a leaflet tail; 122: a sealing strip; 123: a fixing member; 124: a fixed end; 125: a clip; 126: the clamping piece is sewed with the hole; 131: a leaflet main body; 132: a sealing strip; 134: a fixed end; 200: a prosthetic heart valve stent; 210: an inflow end; 211: an inflow end frame unit; 212: an inflow end connection area; 213: a first boss portion; 214: a second boss portion; 215: a first connection portion; 216: a second connecting portion; 220: an outflow end; 221: an outflow end frame unit; 222: an outflow end connection region; 223: a third boss portion; 224: a fourth boss; 225: a third connecting portion; 226: a fourth connecting portion; 227: a suture section; 228: sewing the hole; 230: a transition section; 231: a transition section frame unit; 232: a transition section connection region; 233: a fifth boss; 234: a sixth boss; 235: a fifth connecting part; 236: a sixth connecting portion; 300: a first sewing film; 400: an outer skirt; 500: an inner skirt edge; 600: a prosthetic heart valve stent; 610: an inflow end; 620: an outflow end; 630: a transition section; 700: a prosthetic heart valve stent; 710: an inflow end; 720: an outflow end; 730: 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 as shown in fig. 1, which includes a plurality of leaflets 100 and a prosthetic heart valve stent 200 as shown in fig. 1 to 11, the leaflets 100 being connected to the prosthetic heart valve stent 200. The prosthetic heart valve stent 200 is a radially collapsible and expandable annular stent, and the prosthetic heart valve stent 200 includes an inflow end 210 and an outflow end 220.

The inflow end 210 shown in fig. 5 includes a plurality of interconnected inflow end frame units 211 and a plurality of inflow end connection regions 212, the plurality of interconnected inflow end frame units 211 being gyro-shaped hollow frame units, and the inflow end connection regions 212 being regions where adjacent two inflow end frame units 211 are connected to each other. The inflow end frame unit 211 includes a first protrusion 213 and a second protrusion 214, the first protrusion 213 protrudes in the axial direction of the stent toward the outflow end 220, the second protrusion 214 protrudes in the axial direction of the stent away from the outflow end 220, and a perpendicular distance between the first protrusion 213 and a line connecting two adjacent inflow end connection regions 212 is smaller than or equal to a perpendicular distance between the second protrusion 214 and a line connecting two adjacent inflow end connection regions 212.

In some embodiments, the toroidal internal profile of the gyro-shaped hollow frame element is as shown in fig. 11. Referring to fig. 11, 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 220 and includes a maximum P1. In one embodiment, the third conic FG is a parabolic curve projecting away from the outflow end 220 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, second conic DE is an arc that bulges circumferentially outward away from the longitudinal axis of inflow end frame element 211 and includes a maximum P2. In one embodiment, the fourth conic HA is an arc that bulges circumferentially outward away from the longitudinal axis of the inflow end frame element 211 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 211 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 211.

The outflow end 220 shown in fig. 6 includes a plurality of outflow end frame units 221 connected to each other and a plurality of outflow end connection regions 222, the plurality of outflow end frame units 221 connected to each other are hexagonal hollow frame units, and the outflow end connection regions 222 are regions where two adjacent outflow end frame units 221 are connected to each other.

In some embodiments, the inflow end frame unit 211 further includes a first connection part 215 and a second connection part 216, the first connection part 215 being located between the first protrusion part 213 and the inflow end connection region 212, and the second connection part 216 being located between the second protrusion part 214 and the inflow end connection region 212. The width of the inflow end connection region 212 in the stent circumferential direction is greater than 2 times the average of the widths of the first connection portion 215 and the second connection portion 216 in the stent circumferential direction.

In some embodiments, the length of the inflow end connection region 212 in the stent axial direction is 1 to 3 times the average of the widths of the first and second connection portions 215 and 216 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 212 to a distance between the first protrusion 213 and the second protrusion 214 of the inflow end frame unit 211 is 0.8 to 1, and may be 0.9, for example.

In some embodiments, the inflow end 210 has the same width except for the inflow end connection region 212.

In some embodiments, the top inside of the first protrusion 213, the top inside of the second protrusion 214, and/or the top outside of the second protrusion 214 is arc-shaped or elliptical-arc-shaped. In particular embodiments, the top inside of the first protrusion 213, the top inside of the second protrusion 214, and/or the top outside of the second protrusion 214 may be a circular arc of 130 ° to 150 °, for example, 130 °, 140 °, or 150 °. Through the arc-shaped or elliptical-arc-shaped structural design of the first protrusion 213, the occurrence of unfavorable conditions such as structural deformation or abnormal expansion caused by excessive crimping of the prosthetic heart valve stent 200 in the crimping process can be avoided. Furthermore, by the circular arc or elliptical arc design of the second lobe 214, puncturing of the outer balloon may be avoided.

In some embodiments, the width of the outflow end connection region 222 in the circumferential direction of the stent is less than the width of the inflow end connection region 212 in the circumferential direction of the stent. Preferably, the width of the outflow end connection region 222 in the circumferential direction of the stent is less than half the width of the inflow end connection region 212 in the circumferential direction of the stent. In a specific embodiment, two adjacent outflow end frame units 221 may share one side as the outflow end connection region 222.

In some embodiments, the outflow end frame unit 221 includes a third projection 223 and a fourth projection 224, the third projection 223 projecting in the axial direction of the stent toward the outflow end 220, and the fourth projection 224 projecting in the axial direction of the stent away from the outflow end 220. The outflow end frame unit 221 further includes a third connection portion 225 and a fourth connection portion 226, the third connection portion 225 being located between the third projection 223 and the outflow end connection region 222, and the fourth connection portion 226 being located between the fourth projection 224 and the outflow end connection region 222.

In some embodiments, the top inside of the third convex portion 223, the top outside of the third convex portion 223, and/or the top inside of the fourth convex portion 224 are circular arc shaped or elliptical arc shaped. In some specific embodiments, the top inside of the third convex portion 223, the top outside of the third convex portion 223, and/or the top inside of the fourth convex portion 224 may be a circular arc shape of 130 ° to 150 °, for example, 130 °, 140 °, or 150 °. As shown in fig. 7, the enlarged view of a part of the third protrusion 223 is an arc or elliptical arc structure design of the third protrusion 223, so that the third protrusion 223 can be prevented from contacting and clamping the balloon after being pressed and held in the conveying or expanding process, the balloon can be prevented from being broken due to uneven stress in the expanding 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 225, between two adjacent fourth connection portions 226, between a third connection portion 225 and an adjacent outflow end connection region 222, and/or between a fourth connection portion 226 and an adjacent outflow end connection region 222. 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 225 and between the third connection portions 225 and the adjacent outflow end connection region 222 may be as shown in fig. 8. 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 220 is the same width except for the outflow end connection region 222. Through the structural design, the artificial heart valve stent 200 can be in a symmetrical and uniform crimped state as shown in fig. 10 in the crimped state, and the phenomenon that the crimped abnormal state, namely the crimped state is asymmetrical, which is caused by overlarge local supporting force due to different widths can be avoided.

In some embodiments, at least one of the outflow end connection regions 222 is provided with a suture 227, and the suture 227 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, the suture 227 has at least two suture holes 228 disposed therein.

In some embodiments, there is a radiused connection between the third connecting portion 225 and the adjacent stitching 227 and/or between the fourth connecting portion 226 and the adjacent stitching 227. 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 230 as shown in fig. 9 disposed between the inflow end 210 and the outflow end 220, the transition section 230 comprising a plurality of interconnected transition section frame units 231 and a plurality of transition section connection regions 232, the plurality of interconnected transition section frame units 231 being gyro-shaped hollow frame units, the transition section connection regions 232 being regions where two adjacent transition section frame units 231 are interconnected. In some specific embodiments, the rack may further include a single row, double row, or multiple rows of interconnected transition section frame elements 231 and transition section connection regions 232.

The transition frame unit 231 includes a fifth boss 233 and a sixth boss 234, the fifth boss 233 protruding in the axial direction of the holder toward the outflow end 220, and the sixth boss 234 protruding in the axial direction of the holder away from the outflow end 220.

In some specific embodiments, the perpendicular distance between the fifth lobe 233 and the line connecting two adjacent transition connecting regions 232 is equal to the perpendicular distance between the sixth lobe 234 and the line connecting two adjacent transition connecting regions 232.

In some embodiments, the ratio of the distance between two adjacent transition connection regions 232 to the distance between the fifth and sixth bosses 233, 234 is greater than 1. Preferably, the ratio of the distance between two adjacent transition connection regions 232 to the distance between the fifth and sixth bosses 233, 234 is greater than 1.2. Through the structural design, the longitudinal length and the axial length of the transition section frame unit 231 can be shortened, so that the support can be prevented from being expanded difficultly, a bone-shaped structure with thick ends and thin middle parts is prevented, the support is expanded more uniformly, and the using effect is good.

In some embodiments, the transition frame element 231 further includes a fifth connection portion 235 and a sixth connection portion 236, the fifth connection portion 235 being located between the fifth boss 233 and the transition connection region 232, and the sixth connection portion 236 being located between the sixth boss 234 and the transition connection region 232. In some embodiments, when the stent includes a single row of transition frame elements 231 and transition connection regions 232, the fifth connection 235 coincides with the fourth connection 226 of the outflow end 220, and the sixth connection 236 coincides with the first connection 215 of the inflow end 210.

The ratio of the length of the transition section connecting area 232 along the axial direction of the stent to the average value of the widths of the fifth connecting part 235 and the sixth connecting part 236 along the circumferential direction of the stent is 0.8-1.3. Preferably, the ratio of the length of the transition section connecting region 232 along the axial direction of the stent to the average value of the widths of the fifth connecting part 235 and the sixth connecting part 236 along the circumferential direction of the stent is 1-1.1. The transition section connecting region 232 is too long, which easily causes the transition section 230 not to be easily expanded, and causes the situation that the two ends of the stent diameter are large and the transition section is small, and 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 to cause the failure of valve implantation. Therefore, the special structure design of the transition section connection region 232 according to the present application can ensure the expansion performance of the transition section 230, 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. 12. The prosthetic heart valve stent 600 includes an inflow end 610, an outflow end 620, and a transition section 630 comprising a double layer of transition section frame cells and transition section attachment regions. The structure of the prosthetic heart valve stent 600 may be similar to the prosthetic heart valve stent 200 described in fig. 1-11.

Embodiments of the present application are also directed to a prosthetic heart valve stent as shown in fig. 13. The prosthetic heart valve stent 700 includes an inflow end 710, an outflow end 720, and a transition section 730 comprising a single layer of transition section frame cells and transition section connection regions. The structure of the prosthetic heart valve stent 700 may be similar to the prosthetic heart valve stent 200 described in fig. 1-11.

In the installation structure of the plurality of valve leaflets 100 shown in fig. 14, the plurality of valve leaflets 100 shown in fig. 15 are sequentially connected to form a valve body 110 with an outer circumference of a circular ring structure, the valve body 110 is fixedly connected with the inner side wall of the artificial heart valve stent 200, and the middle parts of the valve body 110 can be opened and closed in one direction. In some embodiments, a valve body 110, which is a circular ring structure, is enclosed by a plurality of valve leaflets 100, for example three valve leaflets 100, and functions like a "one-way valve".

The leaflets 100 shown in fig. 15 each include a leaflet tail 121, a sealing strip 122 and a securing member 123. The outer side of the leaflet tails 121 is a protruding structure, the outer side edge of the protruding structure is connected to the artificial heart valve stent 200, and in particular, the outer side edge of the protruding structure can be connected to the inner side wall of the artificial heart valve stent 200. The sealing strip 122 is of a bendable structure, the outer side of the sealing strip 122 is connected with the inner side of the leaflet tail 121, the side where the inner side of the sealing strip 122 is located is perpendicular to the plane where the leaflet tail 121 is located, the other two opposite sides of the sealing strip 122 are respectively provided with a fixed end 124, the fixed ends 124 are folded and wrapped with clips 125 to form a fixing piece 123, and the fixing piece 123 is fixedly connected with the heart valve prosthesis support 200. As shown in fig. 15, in the leaflet 100 with the sealing strip 122 in an unfolded state, fixing ends 124 are formed by extending outward from both left and right sides of the sealing strip 122. The thickness of the clip 125 shown in fig. 16 is preferably 0.1 mm to 0.5 mm, and the clip 125 is provided with at least one clip sewing hole 126 through which the fixing end 124 is sewn and wraps the clip 125.

In other embodiments, the leaflet can also be as shown in fig. 18, the leaflet comprising a leaflet body 131, a sealing strip 132, and a securing member. The outer side edge of the leaflet main body 131 is connected with the inner side wall of the prosthetic heart valve stent 200. The sealing strip 132 is a bendable structure, the outer side of the sealing strip 132 is connected to the inner side of the leaflet main body 131, and the side of the inner side of the sealing strip 132 is perpendicular to the plane of the leaflet main body 131. The other two opposite side surfaces of the sealing strip 132 are respectively provided with a fixing end 134, and the fixing end 134 is folded and wrapped with a clip to form a fixing piece and is fixedly connected with the artificial heart valve support 200 through the fixing piece.

Referring to fig. 17, two adjacent leaflets 100 are connected in sequence by a fixing member 123 through a clip suture hole 126 by suture to form a valve body 110, and the inner side end parts of sealing strips 122 in the two adjacent leaflets 100 are contacted to realize that the middle part of the valve body 110 can be opened and closed in one direction. When the plurality of leaflets 100 are fixedly connected to the heart valve prosthesis holder 200 by the fixing members 123, the plurality of leaflets 100 are also connected and fixed to the heart valve prosthesis holder 200 by sewing with sutures through the clip suture holes 126, and when the plurality of leaflets 100 are fixed in the heart valve prosthesis holder 200 in the blood flow direction. Although the native valve is a mitral valve, in consideration of structural stability, the mitral valve device designed by the invention is designed into a plurality of leaflets 100, the leaflets 100 are fixed by clips 125 to form fixing pieces 123, and then the fixing pieces are sewn into the artificial heart valve stent 200, so that the strength and stability of the axial leaflets 100 are enhanced, the point contact of the leaflets 100 and the artificial heart valve stent 200 is changed into line contact, and the pulling force of local leaflets 100, especially distal leaflets 100 during blood flow is reduced, so that the structure is more stable. The longitudinal sewing mode ensures the function of a one-way valve and effectively improves the bearing capacity of the one-way valve to reverse pressure.

In some specific embodiments, the prosthetic heart valve further includes a first sewing film 300 as shown in fig. 19, and the first sewing film 300 may be a polymeric film. The first sewing film 300 may be sewn to the entire inflow end frame unit 211 of the prosthetic heart valve stent 200 and completely cover the hollow portion of the inflow end frame unit 211. The first sewing film 300 may also be sewn to at least a portion of the transition frame element 231 and completely cover the hollow portion of the transition frame element 231. The first suture film 300 can prevent paravalvular leakage and avoid blocking coronary arteries. In embodiments where the prosthetic heart valve stent includes a four-layer structure, the first sewing film may cover all inflow end frame cells of the fourth layer, all transition section frame cells of the third layer, and a portion of the transition section frame cells of the second layer. For example, a first stitching film may be spaced over the transition frame elements of the second layer. In embodiments where the prosthetic heart valve stent includes a three-layer structure, the first sewing film may cover all of the inflow end frame cells of the third layer and a portion of the transition section frame cells of the second layer. For example, a first stitching film may be spaced over the transition frame elements of the second layer.

In some specific embodiments, the prosthetic heart valve further includes an outer skirt 400 as shown in fig. 20, and the outer skirt 400 may be a polymer film and is disposed outside the prosthetic heart valve stent 200. One end of the outer skirt 400 includes a serrated structure that matches the shape of the inflow end 210 of the prosthetic heart valve holder 200 and is secured to the prosthetic heart valve holder 200 by sewing, and in particular, the serrated structure is secured to the second protrusions 214 and the second connecting portions 216 of the prosthetic heart valve holder 200 by sewing. The outer skirt 400 may be used to prevent paravalvular leakage.

In some specific embodiments, the prosthetic heart valve further includes an inner skirt 500 as shown in fig. 21. The outer side of the valve tail 121 is provided with a protruding structure which is an inner skirt 500 fixed outside the valve tail 121 by sewing, and the inner skirt 500 matches with the shape of the outer side edge of the valve tail 121. The inner skirt 500 may be a polymer film, and the inner skirt 500 may be used to prevent leakage around the valve.

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.