# US 2019/0314130 A1 · Three-dimensional resorbable implants for tissue reinforcement and hernia repair

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- Number: US 2019/0314130 A1
- Document ID: US20190314130A1
- Status: Published application
- Kind: A1
- Application number: 16/427,096
- Filed: 2019-05-30
- Published: 2019-10-17
- Earliest claimed: 2014-04-30
- Assignees: Tepha, Inc.
- Applicants: Tepha, Inc.
- Inventors: Said Rizk; Amit Ganatra; Antonio Fosco; David P. Martin; Simon F. Williams
- Web page: https://patentgrep.com/patent/US20190314130A1

## CPC

- A61F 2/0063: {Implantable repair or support meshes, e.g. hernia meshes}
- A61F 2230/0093: Umbrella-shaped, e.g. mushroom-shaped
- A61F 2240/004: Using a positive or negative model, e.g. moulds
- 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

Resorbable three-dimensional implants that can be temporarily deformed, implanted by minimally invasive means, and resume their original shape in vivo, have been developed. These implants are particularly suitable for use in minimally invasive procedures for tissue reinforcement, repair of hernias, and applications where it is desirable for the implant to contour in vivo to an anatomical shape, such as the inguinofemoral region. In the preferred embodiment, the implants are made from meshes of poly-4-hydroxybutyrate monofilament that have reinforced outlying borders that allow the meshes to form three-dimensional shapes that can be temporarily deformed. These implants can resume three-dimensional shapes after being temporarily deformed that contour to the host's tissue or an anatomical shape, for example, in the repair of a hernia, and particularly a hernia in the inguinofemoral region. The implants can contour to the host's tissue for example, of the inguinofemoral region, without the implants wrinkling, bunching or folding.

## Claims

### Claim at position 1

1-33. (canceled)

### Claim 34

A porous implant comprising a self-fixating system, wherein the implant further comprises poly-4-hydroxybutyrate or copolymer thereof, and wherein the self-fixating system comprises a textile.

### Claim 35 (depends on 34)

The implant of claim 34, wherein the textile is a mesh, monofilament mesh, multifilament mesh, woven mesh, knitted mesh, braid or mesh comprising a barbed suture.

### Claim 36 (depends on 35)

The implant of claim 35, wherein the textile further comprises one or more of the following: barbs, fleece, micro grips, hooks, anchoring devices, and self-fixating tips.

### Claim 37 (depends on 34)

The implant of claim 34, wherein the textile has a self-fixating system on one side of the textile or both sides of the textile.

### Claim 38 (depends on 35)

The implant of claim 35, wherein the mesh is a looped knitted mesh and loops of the mesh have been shaved or cut on one side of the mesh to form the self-fixating system on one side of the mesh, or the loops of the mesh have been shaved or cut on both sides of the mesh to form a self-fixating system on both sides of the mesh.

### Claim 39 (depends on 38)

The implant of claim 38, wherein the loops of the mesh are cut to form a plurality of tissue engaging barbs.

### Claim 40 (depends on 35)

The implant of claim 35, wherein the mesh is formed with two or more fibers, and the self-fixating system is formed by cutting one of the fibers.

### Claim 41 (depends on 40)

The implant of claim 40, wherein the mesh is formed from two or more fibers, wherein one of the fibers is stiffer than the other fibers, wherein the stiffer fiber is incorporated as loops in the mesh, and the stiffer fiber is cut to form the self-fixating system.

### Claim 42 (depends on 41)

The implant of claim 41, wherein the stiffer fiber has been inserted into the mesh during fabrication of the mesh, or wherein the stiffer fiber has been inserted into the mesh after the mesh has been fabricated.

### Claim 43 (depends on 34)

The implant of claim 34, wherein the implant is used in tissue reinforcement, hernia repair, can be temporarily deformed and unaided assume its original shape after implantation, or is shaped to contour to a patient's anatomy.

### Claim 44 (depends on 34)

The implant of claim 34, wherein the implant further comprises one or more of the following: plasticizer, nucleant, dye, medical marker, bioactive agent, therapeutic agent, diagnostic agent, prophylactic agent, contrast agent, radiopaque marker, radioactive substance, hyaluronic acid or derivative thereof, collagen, hydroxyapatite, or an absorbable polymer comprising one or more of the following monomeric units: glycolic acid, lactic acid, trimethylene carbonate, p-dioxanone, and caprolactone.

### Claim 45 (depends on 34)

The implant of claim 34, wherein the implant is packaged and sterilized using ethylene oxide, gamma-irradiation or electron beam radiation.

### Claim 46 (depends on 34)

A method of forming the implant of claim 34, the method comprising the steps of: (a) preparing a textile by knitting monofilament fiber of poly-4-hydroxybutyrate or copolymer thereof into a mesh, and (b) cutting fiber of the mesh to form a self-fixating system comprising a plurality of tissue engaging barbs, fleece, micro grips, hooks, anchoring devices, and self-fixating tips.

### Claim 47 (depends on 46)

The method of claim 46, wherein the mesh is a looped knitted mesh, and the loops are shaved or cut to form the self-fixating system.

### Claim 48 (depends on 46)

The method of claim 46, wherein the mesh is knit from more than one fiber including at least one stiffer fiber, and wherein mesh loops formed from a stiffer fiber are shaved or cut to form a self-fixating system comprising a plurality of barbs.

### Claim 49 (depends on 34)

A method of implanting the implant of claim 34, wherein the self-fixating system is engaged in the patient's tissue to reinforce tissue.

### Claim 50 (depends on 49)

The method of claim 49, wherein the implant is used in the closure of a laparotomy, or to reinforce a hernia repair.
