Three-dimensional resorbable implants for tissue reinforcement and hernia repair

Patent metadata

Field	Value
Publication number	US-12109100-B2
Application number	US-201916427096-A
Country	US
Kind code	B2
Filing date	May 30, 2019
Priority date	Apr 30, 2014
Publication date	Oct 8, 2024
Grant date	Oct 8, 2024

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.

First claim

We claim:

1. A porous implant consisting of:
a self-anchoring patch to position over a muscle or tissue wall defect, the patch comprising a textile fabricated with first and second fibers of poly-4-hydroxybutyrate or copolymer thereof, wherein the first fiber used to fabricate the patch is stiffer than the second fiber used to fabricate the patch, the textile having a first side and a second side, wherein the first fiber is on at least one of the first side and the second side of the textile, wherein the first fiber is configured to self-anchor the patch to muscle or tissue, and wherein the first side comprises a first exposed surface extending across a central portion of the first side, and the second side comprises a second exposed surface extending across a central portion of the second side, the first and second exposed surfaces facing in opposite directions.

2. The implant of claim 1 , wherein the textile is a mesh, monofilament mesh, multifilament mesh, woven mesh, knitted mesh, braid or mesh comprising a barbed suture.

3. The implant of claim 1 , wherein the first fiber comprises one or more of the following: barbs, fleece, micro grips, hooks, anchoring devices, shaved half-loops, and self-fixating tips.

4. The implant of claim 1 , wherein the first fiber is on the second side of the textile.

5. The implant of claim 1 , wherein the first fiber includes a plurality of tissue engaging barbs.

6. The implant of claim 1 , wherein the patch 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.

7. The implant of claim 1 , wherein the patch is packaged and sterilized using ethylene oxide, gamma-irradiation or electron beam radiation.

8. The implant of claim 1 , wherein the patch includes a continuous or interrupted ring at an outlying border of the textile, wherein the continuous or interrupted ring reinforces the outlying border of the textile.

9. The implant of claim 8 , wherein the ring is formed of an unoriented P4HB fiber extrudate.

10. The implant of claim 1 , wherein at least one of the first or second exposed surfaces is convex, and wherein the other of the first or second exposed surfaces is concave.

11. The implant of claim 1 , wherein the patch is shaped to conform to inguinal anatomy.

12. The implant of claim 1 , wherein the patch has one or more of the following properties:
(i) a suture pullout strength of at least 10 N;
(ii) a burst strength of at least 1 Kg;
(iii) pore diameters of at least 50 μm; and
(iv) a Taber stiffness that is less than 100 Taber stiffness units.

13. A porous implant consisting of:
a self-anchoring patch to position over a muscle or tissue wall defect, the patch comprising a textile fabricated with first and second fibers of poly-4-hydroxybutyrate or copolymer thereof, and wherein the first fiber used to fabricate the patch is stiffer than the second fiber used to fabricate the patch, the textile having a first side and a second side, wherein the first fiber is on at least one of the first side and the second side of the textile, wherein the first fiber is configured to self-anchor the patch to muscle or tissue, wherein at least one of a surface of the first or second side is convex, wherein the other of a surface of the first or second side is concave, and wherein the patch is shaped to conform to inguinal anatomy.

14. A porous implant consisting of:
a self-anchoring patch to position over a muscle or tissue wall defect, the patch comprising a textile fabricated with first and second fibers of poly-4-hydroxybutyrate or copolymer thereof, and wherein the first fiber used to fabricate the patch is stiffer than the second fiber used to fabricate the patch, the textile having a first side and a second side, wherein the first fiber is on at least one of the first side and the second side of the textile, wherein the first fiber is configured to self-anchor the patch to muscle or tissue, wherein the patch has one or more of the following properties:
(i) a suture pullout strength of at least 10 N (2.248 lbf); and
(ii) a burst strength of at least 1 Kg (2.204 lbf).

15. The porous implant of claim 14 , wherein the patch has one or more of the following properties:
(i) pore diameters of at least 50 μm; and
(ii) a Taber stiffness that is less than 100 Taber stiffness units.

Assignees

• Tepha Inc

Inventors

• Rizk Said
• Ganatra Amit
• Fosco Antonio
• Martin David P
• Williams Simon F

Classifications

• A61F2230/0093

  Umbrella-shaped, e.g. mushroom-shaped · CPC title

• A61F2240/004

  Using a positive or negative model, e.g. moulds · CPC title

• A61F2/0063 Primary

  Implantable repair or support meshes, e.g. hernia meshes · CPC title