# US 11,439,502 B2 · Medical valve and leaflet promoting tissue ingrowth

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 11,439,502 B2
- Document ID: US11439502B2
- Status: Granted
- Kind: B2
- Application number: 16/129,671
- Filed: 2018-09-12
- Published: 2019-05-02
- Granted: 2022-09-13
- Earliest claimed: 2017-10-31
- Assignees: W. L. Gore & Associates, Inc.
- Applicants: W. L. Gore & Associates, Inc.
- Inventors: Karl Busalacchi; Benjamin D. Campbell; Kyle W. Colavito; Carl M. Conway; Cody L. Hartman; Roy Manygoats, Jr.; Frank E. Myers; Vi T. Pham; Joshua A. Sprinkle; David M. Warlop; Nathan L. Bennett
- Web page: https://patentgrep.com/patent/US11439502B2

## CPC

- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/0077: {Special surfaces of prostheses, e.g. for improving ingrowth (A61F2/30767 takes precedence)}
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2415: {Manufacturing methods}
- A61F 2/2427: {Devices for manipulating or deploying heart valves during implantation}
- A61F 2/2463: {Implants forming part of the valve leaflets}
- A61L 27/16: obtained by reactions only involving carbon-to-carbon unsaturated bonds
- A61L 27/507: {for artificial blood vessels (apparatus for applying cells on a blood vessel prosthesis A61F2/062)}
- A61L 27/56: Porous materials, {e.g. foams or sponges}
- A61F 2/24: Heart valves {; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body}
- A61F 2/246: {Devices for obstructing a leak through a native valve in a closed condition}
- A61F 2/2466: {Delivery devices therefor}
- A61F 2002/009: {for hindering or preventing attachment of biological tissue}
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2210/0076: multilayered, e.g. laminated structures
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2220/005: using adhesives
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- A61F 2230/0069: cylindrical
- A61F 2240/001: Designing or manufacturing processes
- A61F 2250/0051: differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts
- A61F 2250/0069: Sealing means
- A61L 27/28: Materials for coating prostheses
- 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)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

Described embodiments are directed toward centrally-opening leaflet prosthetic valve devices having synthetic leaflets that are configured to promote and encourage tissue ingrowth thereon and/or therein. The leaflets are coupled to a leaflet frame to form a prosthetic valve suitable for use in biological anatomy.

## Claims

### Claim 1

A prosthetic valve, comprising:
a leaflet frame;
a leaflet construct coupled to the leaflet frame and including a synthetic leaflet comprising a TFE-PMVE copolymer that exhibits elastomer, elastomeric, or non-elastomeric properties, each leaflet including a portion configured to promote tissue ingrowth thereon such that tissue is encouraged to grow between the leaflet frame and the leaflet, wherein the synthetic leaflet includes a base and a free edge and a boundary defined therebetween, wherein the synthetic leaflet includes a porous membrane having a first zone between the free edge and the boundary and a second zone between the boundary and the base, and wherein a first elastomeric material is contained within the first zone of the porous membrane of the leaflet, and wherein the second zone of the porous membrane of the synthetic leaflet is free of the first elastomeric material; and
a tissue ingrowth curtain coupled to an underlying leaflet base of the synthetic leaflet, and wherein the tissue ingrowth curtain is configured to promote tissue ingrowth and the TFE-PMVE copolymer includes an elastomer and/or an elastomeric material.

### Claim 2 (depends on 1)

The prosthetic valve of claim 1, wherein the leaflet includes a plurality of tissue ingrowth curtains coupled to the underlying leaflet base, and wherein each tissue ingrowth curtain of the plurality of tissue ingrowth curtains is configured to promote tissue ingrowth and the TFE/PMVE copolymer is an elastomer comprising essentially of between 73 and 20 weight percent tetrafluoroethylene and respectively between 27 and 80 weight percent perfluoromethyl vinyl ether.

### Claim 3 (depends on 2)

The prosthetic valve of claim 2, wherein the plurality of ingrowth curtains includes a first tissue ingrowth curtain and a second tissue ingrowth curtain, and wherein the first tissue ingrowth curtain is coupled to a first side of the underlying leaflet base of the leaflet, and wherein the second tissue ingrowth curtain is coupled to a second side of the underlying leaflet base of the leaflet.

### Claim 4 (depends on 1)

The prosthetic valve of claim 1, wherein the tissue ingrowth curtain comprises a porous membrane.

### Claim 5 (depends on 4)

The prosthetic valve of claim 4, wherein the tissue ingrowth curtain comprises a fluoropolymer membrane.

### Claim 6 (depends on 5)

The prosthetic valve of claim 5, wherein the fluoropolymer membrane includes an expanded fluoropolymer.

### Claim 7 (depends on 6)

The prosthetic valve of claim 6, wherein the expanded fluoropolymer membrane comprises ePTFE.

### Claim 8 (depends on 1)

The prosthetic valve of claim 1, wherein the tissue ingrowth curtain is bonded to the underlying leaflet base.

### Claim 9 (depends on 1)

The prosthetic valve of claim 1, wherein the leaflet frame is configured to promote tissue ingrowth.

### Claim 10 (depends on 1)

The prosthetic valve of claim 1, wherein the leaflets construct is attached to the leaflet frame to encourage tissue growth across the leaflet frame onto the leaflet.

### Claim 11 (depends on 10)

The prosthetic valve of claim 10, wherein the portion configured to promote tissue ingrowth is a fabric.

### Claim 12 (depends on 1)

The prosthetic valve of claim 1, wherein the leaflet frame is covered with a tissue ingrowth promoting material.

### Claim 13 (depends on 1)

The prosthetic valve of claim 1, wherein the tissue ingrowth curtain is coupled to the underlying leaflet base with an adhesive.

### Claim 14 (depends on 1)

The prosthetic valve of claim 1, wherein the tissue ingrowth curtain is coupled to the second zone of the porous membrane of the leaflet.

### Claim 15 (depends on 14)

The prosthetic valve of claim 14, wherein the tissue ingrowth curtain is coupled to the second zone of the porous membrane of the leaflet with an adhesive.

### Claim 16 (depends on 1)

The prosthetic valve of claim 1, wherein the porous membrane of the leaflet includes a first side and a second side and wherein the tissue ingrowth curtain completely covers the second zone of the porous membrane of the leaflet on the first side of the porous membrane of the leaflet.

### Claim 17 (depends on 1)

The prosthetic valve of claim 1, wherein the porous membrane is a fluoropolymer membrane.

### Claim 18 (depends on 17)

The prosthetic valve of claim 17, wherein the fluoropolymer membrane includes an expanded fluoropolymer.

### Claim 19 (depends on 18)

The prosthetic valve of claim 18, wherein the expanded fluoropolymer comprises ePTFE.

### Claim 20 (depends on 1)

The prosthetic valve of claim 1, wherein the first elastomeric material is a fluoroelastomer.

### Claim 21 (depends on 1)

The prosthetic valve of claim 1, wherein the first elastomeric material is a TFE/PMVE copolymer.

### Claim 22 (depends on 1)

The prosthetic valve of claim 1, wherein a second elastomeric material is contained within the first zone of the porous membrane of the leaflet.

### Claim 23 (depends on 1)

The prosthetic valve of claim 1, wherein the tissue ingrowth curtain is coupled to the underlying leaflet base with an adhesive such that the adhesive forms a transition between one or more edges of the tissue ingrowth curtain and the underlying leaflet base.

### Claim 24

A prosthetic valve comprising:
a leaflet frame;
a leaflet construct having a base and a free edge coupled to the leaflet frame including,
a porous membrane having a first zone, a second zone, and a boundary between the first and second zones, the first zone being between the free edge and the boundary and the second zone being between the boundary and the base, and
a synthetic leaflet material that includes at least one of an elastomer and an elastomeric material, the synthetic leaflet material being associated with the first zone of the porous membrane and not associated with the second zone of the porous membrane; and
a tissue ingrowth curtain coupled to the second zone of the porous membrane, the tissue ingrowth curtain configured to promote tissue ingrowth between the leaflet frame and the leaflet construct.

### Claim 25 (depends on 24)

The prosthetic valve of claim 24, wherein the tissue ingrowth curtain comprises a porous membrane.

### Claim 26 (depends on 24)

The prosthetic valve of claim 24, wherein the tissue ingrowth curtain includes an expanded fluoropolymer.

### Claim 27 (depends on 24)

The prosthetic valve of claim 24, wherein the porous membrane of the leaflet construct includes a first side and a second side, and further wherein the tissue ingrowth curtain completely covers the second zone of the porous membrane of the leaflet construct on the first side of the porous membrane of the leaflet construct.