# US 12,599,479 B2 · Heart valve comprising a crown piece interconnected to leaflets, a top cuff and a bottom cuff; and a medical implant

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- Number: US 12,599,479 B2
- Document ID: US12599479B2
- Status: Granted
- Kind: B2
- Application number: 16/888,776
- Filed: 2020-05-31
- Published: 2020-09-17
- Granted: 2026-04-14
- Earliest claimed: 2016-09-14
- Assignees: Venus Medtech (Hangzhou), Inc.
- Applicants: Venus Medtech (Hangzhou), Inc.
- Inventors: Hou-Sen Lim; Wolfgang Gotz
- Web page: https://patentgrep.com/patent/US12599479B2

## CPC

- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/2439: {Expansion controlled by filaments}
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- A61F 2250/006: modular
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

Heart valve comprising a crown piece interconnected to leaflets, a top cuff and a bottom cuff; and a medical implant. The present invention relates to a heart valve (100), comprising at least two leaflets (101, 101′, 101″); at least one crown piece (111) interconnected to the leaflets (101, 101′, 101″) and intended to be interconnected to a frame (1) of a medical implant or a heart valve assembly; a top cuff (121); and a bottom cuff (131), the crown piece (111), the top cuff (121) and the bottom cuff (131) each being ring-shaped, and each of the top cuff (121) and the bottom cuff (131) being interconnected with the crown piece (111).

## Claims

### Claim 1

A foldable and/or unfoldable medical implant comprising a heart valve (100) and a foldable and/or unfoldable frame (1) being interconnected to the heart valve (100), by sewing or sewing alone, the frame (1) comprising:
a first ring structure (2a),
a second ring structure (2b),
at least one first tension thread (5) guided by the first ring structure (2a) for folding and/or unfolding the frame (1) around or along the frame (1) at an outside or an outer circumference thereof;
at least one second tension thread (5) guided by the second ring structure (2b) for folding and/or unfolding the frame (1) around or along the frame (1) at an outside or an outer circumference thereof;
posts (3), the posts (3) being arranged between the first and the second ring structures (2a, 2b) in order to interconnect the first and the second ring structures (2a, 2b) with each other and/or to maintain a distance between the first and the second ring structures (2a, 2b);
and the heart valve (100), comprising:
a ring-shaped crown piece (111), the ring-shaped crown piece (111) having opposing first and second axial ends, the first axial end of the ring-shaped crown piece having a plurality of connecting rims that are arranged one after another along a circumferential direction of the ring-shaped crown piece (111);
leaflets (101, 101′, 101″) connected to the first axial end of the ring-shaped crown piece (111) at the plurality of connecting rims respectively, each of the leaflets (101, 101′, 101″) having a fixed first end connected to a respective one of the plurality of connecting rims of the ring-shaped crown piece (111) and a free second end opposite to the fixed first end;
a ring-shaped top cuff (121); and
a ring-shaped bottom cuff (131), wherein the ring-shaped crown piece (111), the ring-shaped top cuff (121) and the ring-shaped bottom cuff (131) are separate pieces, with each of the ring-shaped top cuff (121) and the ring-shaped bottom cuff (131) being interconnected with the second axial end of the ring-shaped crown piece (111), and the ring-shaped top cuff (121) and the ring-shaped bottom cuff (131) covering a same radial side of the frame (1),
wherein the ring-shaped crown piece (111) has a plurality of connecting portions that are arranged corresponding to and sewed to the posts (3).

### Claim 2 (depends on 1)

The medical implant according to claim 1, wherein at least one of the ring-shaped top cuff (121) and the ring-shaped bottom cuff (131) is formed from or comprises a stripe, wherein the stripe is curved along its length.

### Claim 3 (depends on 1)

The medical implant according to claim 1, wherein the ring-shaped top cuff (121) has a width (wtc) that is smaller than a width (wbc) of the ring-shaped bottom cuff (131).

### Claim 4 (depends on 1)

The medical implant according to claim 1, wherein all of the leaflets (101, 101′, 101″) are sewed to the ring-shaped crown piece (111) by means of one common suture or one suture each.

### Claim 5 (depends on 1)

The medical implant according to claim 1, wherein both the ring-shaped top cuff (121) and the ring-shaped bottom cuff (131) are sewed to the ring-shaped crown piece (111) by one suture.

### Claim 6 (depends on 1)

The medical implant according to claim 1, wherein the ring-shaped crown piece (111) or a section thereof is interposed between the ring-shaped top cuff (121) and the ring-shaped bottom cuff (131).

### Claim 7 (depends on 1)

The medical implant according to claim 1, wherein the ring-shaped crown piece (111) is sewed to the posts (3) via through holes (8) of the posts (3) by one suture (201).

### Claim 8 (depends on 7)

The medical implant according to claim 7, wherein the suture (201) was started from an outer side (30) of the posts (3) to an inner side (3i) of the posts (3), such that an only knot (203) that interconnects both ends of the suture (201) is arranged on the outer side (30) of the posts (3).

### Claim 9 (depends on 1)

The medical implant according to claim 1, wherein the posts (3) are arranged inside a circle or an area circumscribed by the ring-shaped crown piece (111).

### Claim 10 (depends on 1)

The medical implant according to claim 1, wherein the posts (3) are arranged outside a circle or an area circumscribed by at least one of the ring-shaped top cuff (121) and the ring-shaped bottom cuff (131).

### Claim 11 (depends on 1)

The medical implant according to claim 1, wherein each of the first and the second ring structures (2a, 2b) comprises or consists of bars (11) that are interconnected to each other, so as to form a zig-zag pattern or an undulating or meandering pattern, and wherein the bars (11) are arranged outside a circle or an area circumscribed by at least one of the ring-shaped top cuff (121) and the ring-shaped bottom cuff (131).

### Claim 12 (depends on 1)

The medical implant according to claim 1, wherein each of the leaflets (101, 101′, 101″) has a first tab (103c, 103c′, 103c″) and a second tab (103d, 103d′, 103d″) arranged at opposite ends, and wherein tabs (103c, 103c′, 103c″, 103d, 103d′, 103d″) are sewed onto the posts (3) of the frame (1).

### Claim 13 (depends on 1)

The medical implant according to claim 1, wherein two neighboring tabs (103c, 103c′, 103c″, 103d, 103d′, 103d″) of two adjacent leaflets (101, 101′, 101″) are sewed to a same one of the posts (3) in an overlapping manner.

### Claim 14 (depends on 13)

The medical implant according to claim 13, wherein the two neighboring tabs includes a first neighboring tab and a second neighboring tab, wherein the first neighboring tab (103d′) is sewed onto the same post (3) first, and wherein the second neighboring tab (103c) is sewed onto both the first neighboring tab (103d′) and the same post (3) with one suture (165).

### Claim 15 (depends on 1)

The medical implant according to claim 1, wherein peripheries of the frame (1), the ring-shaped crown piece (111), the ring-shaped top cuff (121) and the ring-shaped bottom cuff (131) conform one another in the circumferential direction of the ring-shaped crown piece (111).

### Claim 16 (depends on 1)

The medical implant according to claim 1, wherein the ring-shaped top cuff (121) and the ring-shaped bottom cuff (131) are partially offset in an axial direction of the frame (1).