Amnion tissue grafts and methods of preparing and using same

Patent metadata

Field	Value
Publication number	US-12263276-B2
Application number	US-202318154461-A
Country	US
Kind code	B2
Filing date	Jan 13, 2023
Priority date	Nov 2, 2016
Publication date	Apr 1, 2025
Grant date	Apr 1, 2025

Abstract

The invention provides method for preparing amnion tissue grafts, as well as the grafts themselves. In specific embodiments, the tissue graft comprises a single layer of dried amnion from an umbilical cord.

First claim

I claim:

1. An amnion tissue graft comprising:
a single membrane of umbilical cord amnion, wherein a smooth surface is created by Wharton's jelly, wherein the amnion tissue graft comprises less than about 20% water by weight and a thickness of about 150 μm to about 250 μm, and
wherein (1) the amnion tissue graft is formed by removing blood vessels and some, but not all, of the Wharton's jelly from the umbilical cord amnion or (2) the thickness of the amnion tissue graft, including the Wharton's jelly, varies by less than 20% across a surface of the amnion tissue graft when dried.

2. The amnion tissue graft, according to claim 1 , that does not comprise glycerol.

3. The amnion tissue graft, according to claim 1 , consisting essentially of a single layer of amnion, Wharton's jelly to create a smooth surface, less than about 20% of water by weight, and a thickness of about 150 μm to about 250 μm.

4. The amnion tissue graft, according to claim 1 , wherein the amnion tissue graft is configured to be sutured with an 8-0 USP suture.

5. The amnion tissue graft, according to claim 1 , comprising an indicium that distinguishes an epithelial side of the amnion tissue graft from a stromal side of the amnion tissue graft.

6. The amnion tissue graft, according to claim 5 , wherein the indicium is a protrusion out from a specified area of the amnion tissue graft.

7. The amnion tissue graft, according to claim 6 , wherein the protrusion is a rectangular, square, or triangular tab.

8. The amnion tissue graft, according to claim 6 , wherein the protrusion is designed to be suitable for being grasped by a forceps.

9. The amnion tissue graft, according to claim 1 , comprising similar levels of bioactive compounds as present in the amnion used to produce the amnion tissue graft.

10. The amnion tissue graft, according to claim 1 , further comprising one or more bioactive compounds, wherein the one or more bioactive compounds include one or more of: interleukins, tissue inhibitors of metalloproteinases, epidermal growth factor, fibroblast growth factor, platelet derived growth factor, vascular endothelial growth factor, and transforming growth factor.

11. The amnion tissue graft, according to claim 1 , wherein the amnion tissue graft, when placed on a tissue or an organ, is configured to conform and adhere to the tissue or organ.

12. The amnion tissue graft, according to claim 11 , wherein the amnion tissue graft, after conforming and adhering to the tissue or the organ, is configured to not disintegrate or break if repositioned by a user.

13. The amnion tissue graft, according to claim 11 , wherein the amnion tissue graft, when placed on the tissue or the organ, is configured to remain in place for at least 8 weeks.

14. The amnion tissue graft, according to claim 13 , wherein the amnion tissue graft, when placed on the tissue or the organ, is configured to remain in place for at least 16 weeks.

15. An amnion tissue graft comprising:
a single membrane of umbilical cord amnion, wherein Wharton's jelly substantially or completely fills valleys between ridges on a surface of the amnion, and wherein the amnion tissue graft comprises a thickness of about 150 μm to about 250 μm,
wherein the amnion tissue graft is formed by removing blood vessels and some but not all of the Wharton's jelly from the umbilical cord amnion,
wherein the thickness of the amnion tissue graft varies by less than 20% across the amnion tissue graft when dried.

16. The amnion tissue graft, according to claim 15 , wherein the amnion tissue graft does not comprise glycerol, wherein the amnion tissue graft comprises Wharton's jelly.

17. The amnion tissue graft, according to claim 15 , wherein the amnion tissue graft is formed by removing blood vessels and more than 50%, but not all, of Wharton's jelly from the umbilical cord amnion to form the amnion tissue graft.

18. The amnion tissue graft, according to claim 15 , comprising an indicium either on an epithelial side of the amnion tissue graft or on a stromal side of the amnion tissue graft, wherein the indicium distinguishes the epithelial side of the amnion tissue graft from the stromal side of the amnion tissue graft.

19. The amnion tissue graft, according to claim 15 , wherein the amnion tissue graft includes one or more bioactive compounds as present in an amnion of an umbilical cord used to produce the amnion tissue graft.

20. The amnion tissue graft, according to claim 19 , wherein the one or more bioactive compounds include one or more interleukins, tissue inhibitors of metalloproteinases, epidermal growth factor, fibroblast growth factor, platelet derived growth factor, vascular endothelial growth factor, or transforming growth factor.

21. The amnion tissue graft, according to claim 15 , wherein removing blood vessels and more than 50%, but not all, of Wharton's jelly includes removing more than at least one of 70%, 80%, 90%, 95%, or 99% of the Wharton's jelly.

22. An amnion tissue graft comprising:
a single membrane of umbilical cord amnion, wherein Wharton's jelly substantially or completely fills valleys between ridges on a surface of the amnion tissue graft, and wherein the amnion tissue graft comprises a thickness of about 150 μm to about 250 μm,
wherein the amnion tissue graft is formed by removing blood vessels and more than 50%, but not all, of the Wharton's jelly from the umbilical cord amnion to form the amnion tissue graft,
wherein the thickness of the amnion tissue graft varies by less than 20% across a surface of the amnion tissue graft when dried.

23. The amnion tissue graft, according to claim 22 , wherein the amnion tissue graft does not comprise glycerol.

24. The amnion tissue graft, according to claim 22 , comprising an indicium either on an epithelial side of the amnion tissue graft or on a stromal side of the amnion tissue graft, wherein the indicium distinguishes the epithelial side of the amnion tissue graft from the stromal side of the amnion tissue graft.

25. The amnion tissue graft, according to claim 22 , wherein the amnion tissue graft includes one or more bioactive compounds, wherein the one or more bioactive compounds include one or more interleukins, tissue inhibitors of metalloproteinases, epidermal growth factor, fibroblast growth factor, platelet derived growth factor, vascular endothelial growth factor, or transforming growth factor.

26. The amnion tissue graft, according to claim 22 , wherein removing blood vessels and more than 50%, but not all, of Wharton's jelly includes removing more than at least one of 70%, 80%, 90%, 95%, or 99% of the Wharton's jelly.

27. The amnion tissue graft, according to claim 15 , wherein the thickness of the amnion tissue graft varies by less than 10% across the amnion tissue graft when dried.

28. The amnion tissue graft, according to claim 22 , wherein the thickness of the amnion tissue graft varies by less than 5% across the amnion tissue graft when dried.

Assignees

• Axogen Corp

Inventors

• Deister Curt

Classifications

• A01N1/00

  Preservation of bodies of humans or animals, or parts thereof · CPC title

• A61K35/12

  Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells (vaccines or medicinal preparations containing antigens or antibodies A61K39/00) · CPC title

• A61L27/38 Primary

  containing added animal cells (organs or tissue containing native cells A61L27/36) · CPC title

• A61L27/3604 Primary

  characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel · CPC title

• A61L27/3895 Primary

  using specific culture conditions, e.g. stimulating differentiation of stem cells, pulsatile flow conditions · CPC title