# US 2021/0330455 A1 · Devices, systems, and methods for a collapsible replacement heart valve

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- Number: US 2021/0330455 A1
- Document ID: US20210330455A1
- Status: Published application
- Kind: A1
- Application number: 17/240,914
- Filed: 2021-04-26
- Published: 2021-10-28
- Earliest claimed: 2020-04-24
- Assignees: ReValve Solutions Inc.
- Applicants: ReValve Solutions Inc.
- Inventors: Julie Logan Sands; Kenneth Eugene Perry; Edward Ian Wulfman; Phillip Andrew Ahrens
- Web page: https://patentgrep.com/patent/US20210330455A1

## CPC

- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/2415: {Manufacturing methods}
- A61F 2/2439: {Expansion controlled by filaments}
- A61F 2/90: characterised by a net-like or mesh-like structure
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- 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

Disclosed herein are systems and methods for a replaceable heart-valve system comprising a tubular braided frame, wherein the tubular braided frame comprises an inflow end, an outflow end, and comprising one or more commissure posts extending vertically away from the inflow end. The valve system further comprises a leaflet assembly, wherein the leaflet assembly comprises at least one valve leaflet, wherein the at least one leaflet comprises an inflow end, an outflow end, and one or more commissure tabs extending horizontally away from the inflow end; and wherein the one or more commissure tabs of the at least one leaflet is connected to the one or more commissure posts of the tubular braided frame.

## Claims

### Claim 1

A replacement heart-valve system comprising:
a tubular braided frame, wherein the tubular braided frame comprises an inflow end and an outflow end;
a leaflet assembly, wherein the leaflet assembly comprises at least one valve leaflet, wherein the at least one leaflet comprises an inflow end, an outflow end, and one or more commissure tabs extending horizontally away from the inflow end;
wherein the one or more commissure tabs of the at least one leaflet is connected to the inflow end of the tubular braided frame.

### Claim 2 (depends on 1)

The replacement heart-valve system of claim 1, wherein the tubular braided frame further comprises one or more commissure posts extending vertically away from the inflow end, wherein the one or more commissure tabs of the at least one leaflet is connected to the one or more commissure posts of the tubular braided frame.

### Claim 3 (depends on 1)

The replacement heart-valve system of claim 1, wherein the tubular braided frame further comprises one or more looping structures on one or both of the inflow end and the outflow end.

### Claim 4 (depends on 2)

The replacement heart-valve system of claim 2, wherein the tubular braided frame further comprises one or more looping structures within the one or more commissure posts.

### Claim 5 (depends on 1)

The replacement heart-valve system of claim 1, wherein the tubular braided frame further comprises one or more wire coils extending horizontally away from one or both of the inflow end and outflow end.

### Claim 6 (depends on 1)

The replacement heart-valve system of claim 1, wherein the tubular braided frame is a braid of one or more wires;
wherein the braid of the one or more wires is either a zig-zag braid or an over-under braid; and
wherein the one or more wires consists of one of: nitinol wire, stainless steel, cobalt chrome, and nylon.

### Claim 7 (depends on 1)

The replacement heart-valve system of claim 1, further comprising a cuff along one or both of the inflow end and the outflow end of the tubular braided frame, wherein the cuff is positioned either on the inside or the outside of the tubular braided frame.

### Claim 8 (depends on 1)

The replacement heart-valve system of claim 1, further comprising a skirt along one or both of the inflow end and the outflow end of the tubular braided frame.

### Claim 9 (depends on 1)

The replacement heart-valve system of claim 1, wherein the leaflet assembly comprises two or more valve leaflets, wherein the one or more commissure tabs of the two or more leaflets are connected and wherein the outflow end of the two or more valve leaflets are connected to form a y-shape.

### Claim 10 (depends on 9)

The replacement heart-valve system of claim 9, wherein the connected one or more commissure tabs and the connected outflow end of the two or more valve leaflets are connected by one or more of: sewing, fusing, and stitching.

### Claim 11 (depends on 1)

The replacement heart-valve system of claim 1, wherein the at least one valve leaflet is made of one or both of: an animal tissue and a polymer.

### Claim 12 (depends on 1)

The replacement heart-valve system of claim 1, wherein one or more rows of stitching connects the leaflet assembly to the tubular braided frame, wherein the one or more rows of stitching is circumferentially positioned in accordance with one or more of the following: along the inflow end of the tubular braided frame, along the outflow end of the tubular braided frame, and between the inflow end and outflow end of the tubular braided frame.

### Claim 13

A method of preparing a replacement heart-valve system, comprising:
a tubular braided frame, wherein the tubular braided frame comprises an inflow end, an outflow end; and
a leaflet assembly, wherein the leaflet assembly comprises at least one valve leaflet, wherein the at least one leaflet comprises an inflow end, an outflow end, and one or more commissure tabs extending horizontally away from the inflow end; and
connecting the one or more commissure tabs of the at least one leaflet to the inflow end of the tubular braided frame.

### Claim 14 (depends on 13)

The method of claim 13, wherein the tubular braided frame further comprises one or more commissure posts extending vertically away from the inflow end, and wherein the method further comprises connecting the one or more commissure tabs of the at least one leaflet to the one or more commissure posts of the tubular braided frame.

### Claim 15 (depends on 13)

The method of claim 13, wherein the tubular braided frame further comprises one or more looping structures on one or both of the inflow end and the outflow end.

### Claim 16 (depends on 14)

The method of claim 14, wherein the tubular braided frame further comprises one or more looping structures within the one or more commissure posts.

### Claim 17 (depends on 13)

The method of claim 13, wherein the tubular braided frame further comprises one or more wire coils extending horizontally away from one or both of the inflow end and outflow end.

### Claim 18 (depends on 13)

The method of claim 13, wherein the tubular braided frame is a braid of one or more wires;
wherein the braid of the one or more wires is either a zig-zag braid or an over-under braid; and
wherein the one or more wires consists of one of: nitinol wire, stainless steel, cobalt chrome, and nylon.

### Claim 19 (depends on 13)

The method of claim 13, further comprising connecting a cuff along one or both of the inflow end and the outflow end of the tubular braided frame, wherein the cuff is connected either on the inside or the outside of the tubular braided frame.

### Claim 20 (depends on 13)

The method of claim 13, further comprising connecting a skirt along one or both of the inflow end and the outflow end of the tubular braided frame.
