CN116407354A

CN116407354A - Artificial valve

Info

Publication number: CN116407354A
Application number: CN202111677377.7A
Authority: CN
Inventors: 齐明
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Shenzhen Jianxin Medical Technology Co ltd
Priority date: 2021-12-31
Filing date: 2021-12-31
Publication date: 2023-07-11

Abstract

The present invention relates to a prosthetic valve for implantation in a human heart at an annulus corresponding to a mitral valve, the annulus having a proximal side disposed proximate to an aortic valve and a distal side disposed distal from the aortic valve; the artificial valve comprises a main body support and a sealing support, wherein the sealing support is connected with the main body support in a surrounding mode, a longitudinal section passing through the central axis of the main body support is intersected with the surface of the sealing support to form a near bus and a far bus, the near bus is abutted against the near side, the far bus is abutted against the far side, the same cross section perpendicular to the longitudinal section and used for cutting the sealing support is taken as a reference, and the intersection point of the far bus and the cross section is far away from the central axis relative to the intersection point of the near bus and the cross section. So can make up the gap that exists between distal bus and the distal side because of main part support slope very much, finally improve prosthetic valve to the sealing performance of valve annulus.

Description

Artificial valve

Technical Field

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

Background

The mitral valve of the heart is located in the left ventricle, a "one-way valve" between the left atrium and the left ventricle, for ensuring blood flow from the left atrium to the left ventricle. Mitral valves are susceptible to stenosis, which can cause a decrease in the flow of blood from the atria into the ventricles, and insufficiency, which can cause mitral regurgitation, both of which can cause serious heart diseases such as pulmonary edema, heart failure, and other complications. Mitral valve lesions often occur in elderly patients and the rate of disease is high. In response to the above problems, a method of replacing a prosthetic heart valve is generally used clinically to replace a diseased mitral valve. However, with conventional prosthetic valves, when implanted at the annulus corresponding to the mitral valve, there is a high probability that a gap will occur between the prosthetic valve and the annulus, i.e., the tightness of the prosthetic valve to the annulus will be affected, resulting in blood being able to flow from the gap to form a paravalvular leak.

Disclosure of Invention

One technical problem addressed by the present invention is how to improve the sealing of a prosthetic valve against the annulus.

The utility model provides a prosthetic valve, the prosthetic valve includes main part support and sealing support, sealing support encircles main part support connects, the process the longitudinal section of main part support axis with sealing support's surface is crossing and is formed nearly generating line and far away generating line, with perpendicular the longitudinal section and cut sealing support's same cross section is the reference, far away generating line with the crossing point of cross section is relative nearly generating line with the crossing point of cross section is more distant from the axis.

In one embodiment, the near bus and the far bus each have an upper end point and a lower end point, a connection line between the upper end points of the near bus and the far bus is an upper connection line, and a connection line between the lower end points of the near bus and the far bus is a lower connection line.

In one embodiment, the distal busbar comprises a first distal segment and a second distal segment which are linear, and a third distal segment which is curved, wherein the third distal segment is connected between the first distal segment and the second distal segment, an end point of the first distal segment, which is far away from the third distal segment, is connected with the upper connecting line, and an end point of the second distal segment, which is far away from the third distal segment, is connected with the lower connecting line.

In one embodiment, the proximal busbar comprises a first proximal segment and a second proximal segment which are linear, and a third proximal segment which is curved, wherein the third proximal segment is connected between the first proximal segment and the second proximal segment, an end point of the first proximal segment, which is far away from the third proximal segment, is connected with the upper connecting line, and an end point of the second proximal segment, which is far away from the third proximal segment, is connected with the lower connecting line.

In one embodiment, the first distal segment intersects the upper line at an obtuse angle.

In one embodiment, the angle at which the first proximal segment intersects the upper line is greater than or equal to 90 ° and less than the obtuse angle at which the first distal segment intersects the upper line.

In one embodiment, the length of the upper connecting line is greater than the length of the lower connecting line, and an obtuse angle formed by the intersection of the second proximal section and the lower connecting line is smaller than an obtuse angle formed by the intersection of the second distal section and the lower connecting line.

In one embodiment, the upper and lower links are parallel to each other and perpendicular to the central axis, and when the longitudinal section is perpendicular to the upper link, the longitudinal section passes through the midpoints of both the upper and lower links.

In one embodiment, the length of the first distal segment in the direction of the central axis extension is greater than or equal to the length of the first proximal segment in the direction of the central axis extension.

In one embodiment, the first proximal section occupies a length H1 in the direction of the central axis extension, and the second proximal end and the third proximal end together occupy a length H2 in the direction of the central axis extension, wherein H2 is greater than or equal to H1.

In one embodiment, the third proximal segment and the third distal segment are each curved in a direction away from the central axis.

In one embodiment, the proximal busbar includes an arc curved away from the central axis, an angle formed between a tangent line at an end point of the proximal busbar intersecting the upper line and the upper line is less than or equal to 90 °, and a tangent line at an end point of the proximal busbar intersecting the lower line and the lower line form an obtuse angle.

In one embodiment, the prosthetic valve has an inflow end and an outflow end, the sealing stent comprises an elastic framework and a flow blocking piece, the flow blocking piece is attached to the elastic framework, the elastic framework comprises support rods and connecting rods which are connected smoothly with each other, the support rods are arranged at intervals along the circumferential direction of the main body stent, and the connecting rods are in smooth transition everywhere and are connected between two adjacent support rods.

In one embodiment, the three support rods adjacently arranged are marked as a first support rod, a second support rod and a third support rod which are sequentially arranged; when the connecting rod is connected between the ends of the first support rod and the second support rod, which are close to the inflow end, the connecting rod is connected between the ends of the second support rod and the third support rod, which are far away from the inflow end; when the connecting rod is connected between the end parts of the first supporting rod and the second supporting rod, which are close to the outflow end, the connecting rod is connected between the end parts of the second supporting rod and the third supporting rod, which are far away from the outflow end.

In one embodiment, the seal further includes barbs disposed about the seal holder, the barbs extending outwardly away from the body holder and toward the inflow end, the barbs including spikes extending in a straight line and perpendicular to the central axis.

In one embodiment, the barb further comprises a fixing portion and a buffer portion, wherein the fixing portion extends along a straight line and is fixed on the main body support and/or the sealing support, and the buffer portion is curved and is smoothly connected between the fixing portion and the spike portion.

In one embodiment, the fixing portion is attached to the seal holder.

In one embodiment, the seal further comprises a skirt hanger connected to and extending outwardly relative to the body hanger, the skirt hanger being closer to the inflow end than the seal hanger, the junction of the skirt hanger and the body hanger being an upper junction, the barb being connected to and forming a lower junction with the body hanger, the seal hanger being located in a range between the upper junction and the lower junction.

In one embodiment, the distance between the upper connection and the lower connection along the central axis is M, and the distance between the upper connection and the outflow end of the main body support along the central axis is M, wherein the value of M/M is 0.85 to 1.5.

In one embodiment, a sealed open cavity is defined between the sealing stent and the main body stent, the opening of the open cavity being disposed toward the inflow end of the prosthetic valve.

One technical effect of one embodiment of the present invention is: in view of the abutment of the proximal generatrix with the proximal side, the distal generatrix abuts against the distal side, and the intersection of the distal generatrix with the cross section is farther from the central axis than the intersection of the proximal generatrix with the cross section. So make the seal support be asymmetric structure, after prosthetic valve release, even though there is certain contained angle and makes the main part support slope in the axis of main part support and the axis of valve ring, when guaranteeing near generating line and near side to offset and press and exert sealing function, the far bus is because of the distance axis is farther, can fine make up the clearance that leads to between far bus and the distal side because of main part support slope for the far bus can offset with the distal side and press and exert sealing function, finally improves prosthetic valve to valve ring's sealing performance. The whole artificial valve has relatively high fault tolerance, the operation difficulty in the implantation process can be reduced, the implantation efficiency is improved, and the probability of causing paravalvular leakage risk is greatly reduced.

Drawings

FIG. 1 is a schematic perspective view of a prosthetic valve according to one embodiment;

FIG. 2 is a schematic plan view of the prosthetic valve of FIG. 1;

FIG. 3 is a schematic perspective view of a body stent of the prosthetic valve of FIG. 1;

FIG. 4 is a schematic illustration of the structure of the prosthetic valve at the point of implantation of the annulus;

FIG. 5 is a schematic plan cross-sectional view of the prosthetic valve at the position of the annulus;

FIG. 6 is a schematic perspective view of the elastic framework of the prosthetic valve of FIG. 1;

FIG. 7 is a schematic illustration of the connection of proximal and distal chords of a first example sealing stent of the prosthetic valve of FIG. 1;

FIG. 8 is a schematic illustration of the connection of proximal and distal chords of a second example sealing stent of the prosthetic valve of FIG. 1;

FIG. 9 is a schematic illustration of the connection of proximal and distal chords of a third example sealing stent of the prosthetic valve of FIG. 1;

FIG. 10 is a schematic view of a first exemplary plan cross-sectional configuration of the prosthetic valve of FIG. 1 at an annular position;

FIG. 11 is a schematic plan cross-sectional view of a second example of the prosthetic valve of FIG. 1 in an annular position;

figure 12 is a schematic perspective view of the barbs of the prosthetic valve of figure 1;

figure 13 is a schematic plan view of the barbs of the prosthetic valve of figure 1.

Detailed Description

In order that the invention may be readily understood, a more complete description of the invention will be rendered by reference to the appended drawings. The drawings illustrate preferred embodiments of the invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

It will be understood that when an element is referred to as being "fixed to" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "inner", "outer", "left", "right" and the like are used herein for illustrative purposes only and do not represent the only embodiment.

Referring to fig. 4, an embodiment of the present invention provides a prosthetic valve 10 for implantation in a human heart at an annulus 20 corresponding to a mitral valve, wherein implantation of the prosthetic valve 10 can function as a "one-way valve" to ensure unidirectional blood flow from the left atrium to the left ventricle. The valve ring 20 has oppositely disposed proximal and

distal sides

21, 22, the proximal side 21 being disposed closer to the aortic valve than the distal side 22, it being understood that the proximal side 21 is disposed closest to the aortic valve and the distal side 22 is disposed furthest from the aortic valve. Referring to fig. 1, a prosthetic valve 10 has an inflow end (the end into which blood flows) and an outflow end (the end from which blood flows), and includes a body stent 100, a covering membrane 200, a skirt stent 300, a seal stent 400, barbs 500, and leaflets 600.

Referring to fig. 1, 2 and 3, the cover film 200 may be covered on the main body support 100 by stitching, and the cover film 200 may be made of polyester fiber, so that the cover film 200 has a good flow blocking effect on blood, and also ensures that the blood can flow in the flow channel defined by the main body support 100, so that the blood smoothly flows from the left atrium to the left ventricle through the main body support 100. The cover 200 may be attached to the inside and/or outside of the body stent 100. The body mount 100 may be similarly of a solid of revolution construction such that the body mount 100 has a central axis 110. The body frame 100 has an upper end (inflow end) disposed proximate the left atrium, and the skirt frame 300 is attached to the body frame 100 proximate the upper end, the skirt frame 300 extending outwardly away from the central axis 110 relative to the body frame 100, the skirt frame 300 being adapted for anchoring within the left atrium to anchor the entire prosthetic valve 10. The barb 500 is secured to the body hanger 100 with the barb 500 being farther away from the left atrium than the skirt hanger 300. The junction of skirt hanger 300 and body hanger 100 is designated as upper junction 301 and the junction of barb 500 and body hanger 100 is designated as lower junction 501. In other embodiments, the barbs 500 may be secured to the seal holder 200 or may be fixedly coupled to both the body holder 100 and the seal holder 200.

Referring to fig. 2, 3 and 4, the sealing stent 400 is adapted to the shape of the annulus 20 such that the sealing stent 400 presses against the annulus 20 to seal the annulus 20. The sealing stent 400 is fixed to the main body stent 100 and disposed around the main body stent 100 such that the main body stent 100 is penetrated in the sealing stent 400, the sealing stent 400 is located in a range between the upper junction 301 and the lower junction 501, for example, an end of the sealing stent 400 remote from the left atrium may be fixed near the lower junction 501, and an end of the sealing stent 400 near the inflow end may be fixed to the skirt stent 300. In view of the fact that the extending direction of the central axis 110 of the main body support 100 is the axial direction of the main body support 100, the length occupied by the sealing support 400 in the axial direction of the main body support 100 may be equal to the interval m between the upper connection 301 and the lower connection 501 in the axial direction. The distance between the upper connection 301 and the outflow end of the main body stent 100 along the axial direction of the main body stent 100 is M, so as to reduce the influence on left indoor tissues (such as chordae tendineae and papillary muscles) or the occurrence of left indoor outflow obstruction after the implantation of the prosthetic valve 10, and the value of M should not be too large under the condition of ensuring that the prosthetic valve 10 can work normally, so that the value range of M/M can be 0.85 to 1.5.

The leaflet 600 is positioned within the flow channel defined by the body stent 100, the leaflet 600 can be secured to the body stent 100 and/or the cover 200, and the fixation of the leaflet 600 can be within the range between the superior junction 301 and the inferior junction 501. When the leaflets 600 open, gaps exist between the leaflets 600 through which blood entering the flow channel of the body stent 100 from the left atrium enters the left ventricle; when the leaflets 600 close, gaps between the leaflets 600 are eliminated and blood in the left ventricle cannot enter the left atrium through the leaflets 600, thus allowing the one-way valve function of the entire prosthetic valve 10.

Referring to fig. 1, 2 and 7, referring to the longitudinal section 120 of the body bracket 100, it is apparent that the longitudinal section 120 passes through the central axis 110 of the body bracket 100. The longitudinal section 120 intersects the outer surface of the sealing stent 400 to form two generatrix, designated as proximal generatrix 410 and distal generatrix 420, the proximal generatrix 410 being pressed against the proximal side 21 of the annulus 20 and the distal generatrix 420 being pressed against the distal side 22 of the annulus 20 when the sealing stent 400 seals against the annulus 20. Referring to the same cross section 401 that is perpendicular to the longitudinal section 120 and cuts the sealing stent 400, the intersection of the distal generatrix 420 and the cross section 401 is farther from the central axis 110 than the intersection of the proximal generatrix 410 and the cross section 401. In other words, the distance between the intersection of the distal generatrix 420 and the cross section 401 and the central axis 110 is denoted as N, and the distance between the intersection of the proximal generatrix 410 and the cross section 401 and the central axis 110 is denoted as N, where N is greater than N. When the cross section 401 intersects the middle portion of the proximal busbar 410 and the distal busbar 420, it can be understood that the cross section 401 cuts the seal holder 400; when the cross section 401 intersects the end points at both ends of the proximal busbar 410 and the distal busbar 420, it is understood that the cross section 401 does not cut the seal holder 400.

Referring to fig. 4 and 5, during implantation of the prosthetic valve 10, the prosthetic valve 10 is first carried through the ribs 32 by the conveyor 31, and the angle of the conveyor 31 is adjusted to allow the prosthetic valve 10 to be delivered to the annulus 20, such that it is difficult for the conveyor 31 to remain fully coaxially disposed with the annulus 20 due to the limited range of adjustment of the operating angle of the conveyor 31 by the position of the ribs 32. If the prosthetic valve 10 is generally symmetrical, the central axis 110 of the prosthetic valve 10 will be at an angle α to the central axis of the annulus 20 after the prosthetic valve 10 is released, such that the prosthetic valve 10 is tilted. At this time, although the prosthetic valve 10 can be pressed against the proximal side 21 of the annulus 20 to perform a sealing function, it will be difficult for the prosthetic valve 10 to be pressed against the distal side 22 of the annulus 20 to perform a sealing function, such that a gap 33 exists between the prosthetic valve 10 and the distal side 22, resulting in a failure of the prosthetic valve 10 to seal the annulus 20 well, and blood will flow within the gap 33 to cause paravalvular leakage. Thus, the prosthetic valve 10, being of a generally symmetrical construction, is less tolerant of error, resulting in greater difficulty in handling during implantation and increased risk of paravalvular leakage.

Referring to fig. 10, for the prosthetic valve 10 of the above embodiment, considering that the intersection point of the distal generatrix 420 and the cross section 401 of the sealing stent 400 is farther from the central axis 110 than the intersection point of the proximal generatrix 410 and the cross section 401, the sealing stent 400 is in an asymmetric structure, which can be generally understood that the distal generatrix 420 is generally farther from the central axis 110 than the proximal generatrix 410. After the prosthetic valve 10 is released, even if the central axis 110 of the main body support 100 and the central axis 110 of the annulus 20 form a certain included angle α so that the main body support 100 is inclined, the distal generatrix 420 can well compensate for the gap 33 existing between the distal generatrix 420 and the distal side 22 of the annulus 20 due to the inclination of the main body support 100 while the proximal generatrix 410 is ensured to be pressed against the proximal side 21 of the annulus 20 to perform a sealing function, so that the distal generatrix 420 can be pressed against the distal side 22 of the annulus 20 to perform a sealing function, and finally the sealing performance of the prosthetic valve 10 on the annulus 20 is improved. Therefore, the sealing bracket 400 with an asymmetric structure exists on the artificial valve 10, so that the whole artificial valve 10 has relatively high fault tolerance, the operation difficulty in the implantation process can be reduced, the implantation efficiency can be improved, and the probability of causing paravalvular leakage is greatly reduced.

Referring to fig. 2 and 6, in some embodiments, the sealing bracket 400 includes an elastic backbone 450 and a flow blocking member, and the elastic backbone 450 may be made of a nickel-titanium alloy, such that the entire sealing bracket 400 has good superelasticity and flexibility. The elastic frame 450 is surrounded to form a ring structure, and the flow blocking member can be attached to the outer side and/or the inner side of the elastic frame 450 in a weaving manner, so that the flow of blood between the inner side and the outer side of the sealing bracket 400 is ensured due to the fact that the blood cannot penetrate the flow blocking member, and the whole sealing bracket 400 has good sealing performance.

The elastic framework 450 includes a plurality of support rods 451 and a plurality of connecting rods 452, the support rods 451 and the connecting rods 452 are arranged at intervals along the circumferential direction of the elastic framework 450, and the connecting rods 452 can be curved in a smooth transition manner everywhere, so that edges or spikes on the connecting rods 452 can be avoided, for example, the connecting rods 452 can be semicircular. The connection rod 452 is connected between the adjacent two support rods 451, for example, only one connection rod 452 may be connected between the adjacent two support rods 451. The smooth connection of the connecting rod 452 to the supporting rod 451 is simply understood to mean that the supporting rod 451 is tangential to the connecting rod 452 at the connection, so that the presence of corners or spikes at the connection can be eliminated.

In order to facilitate understanding of the connection rule between the support rods 451 and the connection rods 452 in the ring-shaped elastic frame 450, three support rods 451 disposed adjacently may be referred to as a first support rod 4511, a second support rod 4512 and a third support rod 4513, and the first support rod 4511, the second support rod 4512 and the third support rod 4513 are sequentially arranged, i.e. the second support rod 4512 is located between the first support rod 4511 and the third support rod 4513. The connection law may be abstracted as follows: when the connecting rod 452 is connected between the ends of the first support rod 4511 and the second support rod 4512 near the inflow end, then the connecting rod 452 is also connected between the ends of the second support rod 4512 and the third support rod 4513 far from the inflow end; when the connecting rod 452 is connected between the ends of the first support rod 4511 and the second support rod 4512 near the outflow end, the connecting rod 452 is also connected between the ends of the second support rod 4512 and the third support rod 4513 remote from the outflow end.

In some embodiments, the support bar 451 includes an upper support section 451a, a lower support section 451b, and a middle support section 451c, the upper support section 451a and the lower support section 451b being straight, the middle support section 451c being curved, the upper support section 451a being closer to the skirt hanger 300 than the lower support section 451b, the middle support section 451c being connected between the upper support section 451a and the lower support section 451 b. The middle support section 451c is recessed to form a curve in a direction away from the central axis 110 of the body bracket 100. The connecting rod 452 attached to the upper support segment 451a may secure the skirt hanger 300 and the connecting rod 452 attached to the lower support segment 451b may secure the body hanger 100. The maximum caliber of the elastic framework 450 enclosed by the upper support section 451a will be greater than the caliber of the elastic framework 450 enclosed by the lower support section 451 b; the minimum caliber of the elastic framework 450 enclosed by the lower support section 451b will be smaller than the caliber of the elastic framework 450 enclosed by the upper support section 451 a.

Referring to fig. 1, in some embodiments, an open chamber 130 is defined between the entire sealing stent 400 and the main body stent 100, and an outflow end of the open chamber 130 has sealing properties, and an opening of the open chamber 130 is disposed toward the left atrium (i.e., inflow end). During the flow of blood, blood will enter the open chamber 130, so that the open chamber 130 has a certain storage function for blood. The blood in the open cavity 130 can form a certain external expansion pressure, so that the sealing bracket 400 can be well clung to the valve annulus 20, and the sealing performance of the artificial valve 10 is further improved. Further, a membrane body (not shown) may be provided at the opening of the open chamber 130, which allows inflow of blood but prevents outflow of thrombus.

Referring to fig. 7, in some embodiments, the end points of the near bus 410 and the far bus 420 near the inflow end are the upper end points, and the connection line between the upper end points is the upper connection line 430; the endpoints of both proximal and

distal generatrix

410, 420 distal from the left atrium are lower endpoints, and the connection between the lower endpoints is lower connection 440. The upper and

lower wires

430 and 440 may be parallel to each other and perpendicular to the central axis 110 of the body support 100, and the length of the upper wire 430 is greater than the length of the lower wire 440, such that when the longitudinal section 120 of the body support 100 is perpendicular to the upper wire 430, the longitudinal section 120 bisects both the upper and

lower wires

430 and 440, i.e., the longitudinal section 120 passes through the midpoints of both the upper and

lower wires

430 and 440. It is also understood that the upper end points of both the proximal and

distal buses

410 and 420 are each approximately equidistant from the central axis 110 of the body mount 100, and the lower end points of both the proximal and

distal buses

410 and 420 are each approximately equidistant from the central axis 110 of the body mount 100.

In some embodiments, the shape of both the proximal busbar 410 and the distal busbar 420 are substantially the same, the proximal busbar 410 comprising a first proximal segment 411, a second proximal segment 412 and a third proximal segment 413, the first proximal segment 411 and the second proximal segment 412 being both rectilinear and the third proximal segment 413 being curvilinear. The first proximal segment 411 is closer to the inflow end and skirt hanger 300 than the second proximal segment 412. A third proximal segment 413 is connected between the first proximal segment 411 and the second proximal segment 412, the third proximal segment 413 being concavely curved away from the central axis 110 of the body mount 100. Whereas the support bar 451 comprises an upper support section 451a and a lower support section 451b in a straight line, and a middle support section 451c in a curved line, such that the first proximal section 411 corresponds to the upper support section 451a, the second proximal section 412 corresponds to the lower support section 451b, and the third proximal section 413 corresponds to the middle support section 451c. The distal bus bar 420 includes a first distal segment 421, a second distal segment 422, and a third distal segment 423, both the first and second

distal segments

421 and 422 being straight, the third distal segment 423 being curved, the third distal segment 423 being concavely curved in a direction away from the central axis 110 of the body mount 100. The first distal segment 421 is closer to the inflow end and skirt hanger 300 than the second distal segment 422. The third distal segment 423 is connected between the first distal segment 421 and the second distal segment 422. The first distal segment 421 corresponds to the upper support segment 451a, the second distal segment 422 corresponds to the lower support segment 451b, and the third distal segment 423 corresponds to the middle support segment 451c. The upper connection 301 is connected between the upper end points of the first proximal segment 411 and the first distal segment 421, and the lower connection 440 is connected between the lower end points of the second proximal segment 412 and the second distal segment 422.

Referring to fig. 7 and 10, the first proximal section 411 perpendicularly intersects the upper connection line 430, and the first distal section 421 and the upper connection line 430 intersect to form an obtuse angle a, and the obtuse angle a has a value ranging from 100 ° to 120 °, and may specifically have a value ranging from 100 °, 110 ° or 120 °, etc., so that the distances from the lower portion of the first distal section 421 and the third distal section 423 to the central axis 110 of the main body support 100 can be properly increased. In other embodiments, an obtuse angle may be formed between the first proximal section 411 and the upper connecting line 430, and no matter what angle is formed between the first proximal section 411 and the upper connecting line 430, the obtuse angle a is smaller than the above-mentioned obtuse angle a to prevent over-extrusion of the annulus 20.

When the angle α between the central axis 110 of the main body stent 100 and the central axis 110 of the annulus 20 is relatively small during implantation, it can be understood that the inclination of the main body stent 100 is small, considering that the distance from the lower portion of the first distal segment 421 and the third distal segment 423 to the central axis 110 of the main body stent 100 is properly increased, thereby effectively eliminating the gap 33 between the third distal segment 423 and the first distal segment 421 and the annulus 20, so that the third distal segment 423 and the first distal segment 421 are pressed against the annulus 20, and improving the sealability of the sealing stent 400 and the entire prosthetic valve 10.

Referring to fig. 8 and 11, the second proximal segment 412 and the lower connecting line 440 intersect to form an obtuse angle C, the second distal segment 422 and the lower connecting line 440 also intersect to form an obtuse angle B, the obtuse angle C formed by the intersection of the second proximal segment 412 and the lower connecting line 440 is smaller than the obtuse angle B formed by the intersection of the second distal segment 422 and the lower connecting line 440, and the value of the obtuse angle B formed by the intersection of the second distal segment 422 and the lower connecting line 440 can be 120 ° to 135 °, for example, the specific value can be 120 °, 130 ° or 135 °, etc., so that the distance from the upper portion of the second distal segment 422 to the central axis 110 of the main body support 100 is reasonably increased. During implantation, when the angle α between the central axis 110 of the main body stent 100 and the central axis 110 of the annulus 20 is relatively large, it can be understood that when the inclination of the main body stent 100 is large, the third distal segment 423 will not be able to press against the annulus 20 to be located outside the annulus 20, and in view of the reasonable increase of the distance from the upper portion of the second distal segment 422 to the central axis 110 of the main body stent 100, the gap 33 between the upper portion of the second distal segment 422 and the annulus 20 is effectively eliminated, so that the second distal segment 422 is pressed against the annulus 20, and the tightness of the sealing stent 400 and the entire prosthetic valve 10 is improved.

In some embodiments, referring to fig. 8, for example, the first proximal segment 411 occupies a length H1 in the axial direction of the body stent 100, and the second proximal and third proximal ends both occupy a length H2 in the axial direction of the body stent 100, H2 being greater than or equal to H1. With the length occupied by the seal holder 400 in the axial direction of the body holder 100 unchanged, a reasonable reduction in the value of H1 can be achieved by reasonably reducing the compressive force of the proximal busbar 410 against the proximal side 21 of the annulus 20. Excessive extrusion on the aortic valve side is avoided, and central reflux of the aortic valve occurs. Referring to fig. 9, for another example, the distal busbar 420 still includes first and second

distal segments

421 and 422 that are rectilinear, and a third distal segment 423 that is curvilinear. While the proximal busbar 410 is an arc curved away from the axial recess of the main body support 100, the proximal busbar 410 is perpendicular to the upper connecting line 430 with the tangent 402 at the upper end point where the connecting line 430 intersects (in other embodiments, the angle formed by the tangent 402 at the upper end point where the proximal busbar 410 intersects with the upper connecting line 430 may be greater than or equal to 60 ° and less than 90 °), and the tangent 403 at the lower end point where the proximal busbar 410 intersects with the lower connecting line 440 forms an obtuse angle with the lower connecting line 440, so that the presence of the first proximal segment 411 in a straight line may be eliminated, thereby enabling H1 to become zero, and thus the value of H1 may be further reduced, so as to further reduce the abutment pressure of the proximal busbar 410 against the proximal side 21 of the annulus 20. For another example, the length of the first distal segment 421 occupied in the axial direction of the main body stent 100 is H3, where H3 may be equal to the value of H1 (fig. 7), and H3 may be greater than the value of H1 (fig. 8).

In some embodiments, the barbs 500 extend outwardly away from the central axis 110 and toward the inflow end relative to the body scaffold 100, with the understanding that the barbs 500 extend obliquely upward. The number of barbs 500 is plural, for example, the number of barbs 500 may be nine to twelve, and a plurality of barbs 500 may be disposed around the body stent 100. The barb 500 includes a spike portion 510, a fixing portion 520, and a buffer portion 530, the lower end of the fixing portion 520 is fixed on the main body bracket 100, the buffer portion 530 is connected between the spike portion 510 and the fixing portion 520, the buffer portion 530 is curved, for example, the buffer portion 530 may be a circular arc line, and the buffer portion 530 is smoothly connected with the spike portion 510 and the fixing portion 520, thereby eliminating the corner and spike at each connection. Both the spike 510 and the fixation 520 are straight, i.e. both extend along a straight line.

Referring to fig. 2, 12 and 13, the spike 510 is disposed perpendicular to the central axis 110 of the main body stent 100, so that secondary displacement (e.g., displacement toward the inflow end) of the spike 510 penetrating into the self-tissue can be avoided, that is, secondary displacement of the implanted prosthetic valve 10 can be prevented, and implantation stability and reliability of the prosthetic valve 10 can be improved. In other embodiments, the angle between the spike 510 and the central axis 110 of the body mount 100 may be 60-90.

The design of the cushioning portion 530 reduces the stress loading on the entire barb 500 and improves the fatigue resistance of the barb 500 due to the curvilinear cushioning portion 530. The fixing portions 520 of the barbs 500 may be entirely attached to the sealing stent 400, thereby further increasing the strength of the barbs 500 and effectively preventing the prosthetic valve 10 from being displaced during systole and diastole.

It will be appreciated that the prosthetic valve of the invention is not limited to use with mitral valves, but may be used with aortic valves, pulmonary valves, etc.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims

1. The prosthetic valve is characterized by comprising a main body support and a sealing support, wherein the sealing support is connected around the main body support, a longitudinal section passing through a central axis of the main body support is intersected with the surface of the sealing support to form a near bus and a far bus, the same cross section perpendicular to the longitudinal section and cutting the sealing support is taken as a reference, and an intersection point of the far bus and the cross section is far away from the central axis relative to an intersection point of the near bus and the cross section.

2. The prosthetic valve of claim 1, wherein the proximal and distal bus bars each have an upper end and a lower end, wherein a connection between the upper end of the proximal bus bar and the upper end of the distal bus bar is an upper connection, and wherein a connection between the lower end of the proximal bus bar and the lower end of the distal bus bar is a lower connection.

3. The prosthetic valve of claim 2, wherein the distal generatrix comprises first and second distal segments in a straight line, and a third distal segment in a curve, the third distal segment connected between the first and second distal segments, an end of the first distal segment distal from the third distal segment connected to the upper link, and an end of the second distal segment distal from the third distal segment connected to the lower link.

4. The prosthetic valve of claim 3, wherein the proximal busbar comprises first and second rectilinear proximal segments and a curvilinear third proximal segment connected between the first and second proximal segments, an end of the first proximal segment distal from the third proximal segment being connected to the upper wire, and an end of the second proximal segment distal from the third proximal segment being connected to the lower wire.

5. The prosthetic valve of claim 3, wherein the first distal segment intersects the superior line at an obtuse angle.

6. The prosthetic valve of claim 5, wherein the angle at which the first proximal segment intersects the superior line is greater than or equal to 90 ° and less than the obtuse angle at which the first distal segment intersects the superior line.

7. The prosthetic valve of claim 4, wherein the length of the superior wire is greater than the length of the inferior wire, and wherein an obtuse angle at which the second proximal segment intersects the inferior wire is less than an obtuse angle at which the second distal segment intersects the inferior wire.

8. The prosthetic valve of claim 2, wherein the upper and lower links are parallel to each other and perpendicular to the central axis, the longitudinal section passing through a midpoint of both the upper and lower links simultaneously when the longitudinal section is perpendicular to the upper link.

9. The prosthetic valve of claim 4, wherein the first distal segment occupies a length in the direction of the central axis extension that is greater than or equal to a length occupied by the first proximal segment in the direction of the central axis extension.

10. The prosthetic valve of claim 4, wherein the first proximal segment occupies a length H1 in the direction of central axis extension, and the second proximal end and the third proximal end together occupy a length H2 in the direction of central axis extension, wherein H2 is greater than or equal to H1.

11. The prosthetic valve of claim 4, wherein the third proximal segment and the third distal segment are each curved in a direction away from the central axis.

12. The prosthetic valve of claim 2, wherein the proximal generatrix comprises an arc curved away from the central axis, an angle formed between a tangent at an end of the proximal generatrix intersecting the superior connecting line and the superior connecting line is less than or equal to 90 °, and a tangent at an end of the proximal generatrix intersecting the inferior connecting line intersects the inferior connecting line at an obtuse angle.

13. The prosthetic valve of claim 1, wherein the prosthetic valve has an inflow end and an outflow end, the sealing stent comprises a resilient skeleton and a flow blocking member attached to the resilient skeleton, the resilient skeleton comprises support bars and connecting bars smoothly connected to each other, the support bars are arranged at intervals along the circumference of the main body stent, and the connecting bars smoothly transition everywhere and are connected between adjacent two of the support bars.

14. The prosthetic valve of claim 13, wherein three of the support struts disposed adjacent are designated as a first support strut, a second support strut, and a third support strut in a sequential arrangement; when the connecting rod is connected between the ends of the first support rod and the second support rod, which are close to the inflow end, the connecting rod is connected between the ends of the second support rod and the third support rod, which are far away from the inflow end; when the connecting rod is connected between the end parts of the first supporting rod and the second supporting rod, which are close to the outflow end, the connecting rod is connected between the end parts of the second supporting rod and the third supporting rod, which are far away from the outflow end.

15. The prosthetic valve of claim 1, further comprising barbs disposed about the sealing stent, the barbs extending outwardly away from the body stent and toward the inflow end, the barbs including spikes extending in a straight line and perpendicular to the central axis.

16. The prosthetic valve of claim 15, wherein the barb further comprises a fixation portion extending in a straight line and secured to the body and/or sealing stent and a cushioning portion curved and smoothly connected between the fixation portion and the spike.

17. The prosthetic valve of claim 16, wherein the fixation portion is affixed to the sealing stent.

18. The prosthetic valve of claim 15, further comprising a skirt hanger connected to and extending outwardly relative to the body hanger, the skirt hanger being closer to the inflow end relative to the seal hanger, the connection of the skirt hanger to the body hanger being an upper connection, the barb being connected to and forming a lower connection with the body hanger, the seal hanger being located in a range between the upper connection and the lower connection.

19. The prosthetic valve of claim 18, wherein a spacing between the upper and lower junctions along the central axis is M, and a spacing between the upper junction and the body stent outflow end along the central axis is M, wherein M/M has a value of 0.85 to 1.5.

20. The prosthetic valve of any one of claims 1-19, wherein an open cavity with an outflow end sealed is enclosed between the sealing stent and the main body stent, the opening of the open cavity being disposed toward the inflow end of the prosthetic valve.