Placental tissue grafts modified with a cross-linking agent and methods of making and using the same

Patent metadata

Field	Value
Publication number	US-11338063-B2
Application number	US-201313815747-A
Country	US
Kind code	B2
Filing date	Mar 15, 2013
Priority date	Aug 15, 2012
Publication date	May 24, 2022
Grant date	May 24, 2022

Abstract

Described herein are tissue grafts derived from the placenta that possess good adhesion to biological tissues and are useful in wound healing applications. In one aspect, the tissue graft includes (1) two or more layers of amnion, wherein at least one layer of amnion is cross-linked, (2) two or more layers of chorion, wherein at least one layer of chorion is cross-linked, or (3) one or more layers of amnion and chorion, wherein at least one layer of amnion and/or chorion is cross-linked. In another aspect, the grafts are composed of amnion and chorion cross-linked with one another. In a further aspect, the grafts have one or more layers sandwiched between the amnion and chorion membranes. The amnion and/or the chorion are treated with a cross-linking agent prior to the formation of the graft. The presence of the cross-linking agent present on the graft also enhances adhesion to the biological tissue of interest. Also described herein are methods for making and using the tissue grafts.

First claim

What is claimed is:

1. A dehydrated tissue graft consisting of:
(1) two layers of dehydrated amnion wherein one layer of dehydrated amnion has been treated with a cross-linking agent, or
(2) one layer of dehydrated amnion and one layer of dehydrated chorion, wherein one layer of dehydrated amnion or dehydrated chorion has been treated with a cross-linking agent,
wherein each layer of dehydrated amnion of said dehydrated tissue graft is not decellularized and comprises fibroblast cells and/or epithelial cells, or said layer of dehydrated chorion of said dehydrated tissue graft is not decellularized;
wherein one layer of dehydrated amnion or dehydrated chorion has not been treated with a cross-linking agent;
wherein the dehydrated tissue graft comprises a first external side and a second external side, where the first external side consists essentially of a basement membrane or an epithelial layer and the second external side consists essentially of a fibroblast layer or a chorion layer; and
wherein adjacent layers of dehydrated amnion and/or dehydrated chorion are not cross-linked with one another.

2. The graft of claim 1 , wherein one layer has been treated with a cross-linking agent comprising a sugar.

3. The graft of claim 2 , wherein the sugar comprises D-ribose, glycerose, altrose, talose, ertheose, glucose, lyxose, mannose, xylose, gulose, arabinose, idose, allose, galactose, maltose, lactose, sucrose, cellibiose, gentibiose, melibiose, turanose, trehalose, isomaltose, or any combination thereof.

4. The graft of claim 1 , wherein one layer has been treated with a cross-linking agent comprising a dialdehyde, a carbodiimide, or a combination thereof.

5. The dehydrated tissue graft of claim 1 , wherein either the first external side or the second external side is lightly cross-linked.

6. The dehydrated tissue graft of claim 1 , wherein one or more exposed surfaces of the graft is coated with micronized placental tissue.

7. A method for preventing or reducing scar formation on or near the spine after a surgical procedure, the method comprising applying to a subject a tissue graft of claim 1 directly to the spinal dura of the subject or a region near the spine.

8. The method of claim 7 , wherein the method does not include the use of a suture.

9. A method for treating a dural tear in a subject, the method comprising applying directly to the dural tear a tissue graft of claim 1 .

10. A method for promoting the healing of a wound in a subject, the method comprising applying to the wound the graft of claim 1 , wherein the wound is in the cranial dura, a wound resulting from a perioplastic procedure, for the elimination of a frenum pull, for the regeneration of lost patella tissue, for the repair of the Schneiderian membrane in the sinus cavity, or the soft tissue around dental implants.

11. A method for promoting wound healing associated with a dental surgical procedure, wherein the method comprises contacting the wound with the graft of claim 1 .

12. The method of claim 11 , wherein the graft is used with dental implants, in the treatment of advanced gingival recession defect, or in guided tissue regeneration.

13. A method for promoting wound healing associated with an orthopedic application, wherein the method comprises contacting the wound with the graft of claim 1 .

14. The method of claim 13 , wherein the graft is used in tendon repair, aiding in the repair of periostium, repairing ruptured/damaged bursa, or securing void filling materials during bone repair.

15. A method for promoting wound healing associated with an ENT application, wherein the method comprises contacting the wound with the graft of claim 1 .

16. The method of claim 15 , wherein the ENT application is tympanoplasty, a wound from an adenoidectomy, a wound from a tonsillectomy, or repair of the Sniderian membrane.

17. A method for promoting wound healing involving a subject's extremities, wherein the method comprises contacting the wound with the graft of claim 1 .

18. The method of claim 17 , wherein the graft is an anti-adhesion barrier for small bone fixation, an anti-adhesion barrier where metal plating or hardware is used, or promote the repair of ruptured/damaged bursa.

19. A method for promoting wound healing associated with an ophthalmological application, wherein the method comprises contacting the wound with the graft of claim 1 .

20. A method for promoting wound healing associated with a gynecological application, wherein the method comprises contacting the wound with the graft of claim 1 .

21. The method of claim 20 , wherein the graft is an anti-adhesion barrier after removal of ovarian cyst or aids in the repair of vaginal wall erosion.

22. A method for promoting wound healing associated with an urological application, wherein the method comprises contacting the wound with the graft of claim 1 .

23. The method of claim 22 , wherein the graft facilitates closure of the vas deferens during vasectomy reversal or facilitates closure of the vas deferens resulting from trauma.

24. A method for promoting wound healing associated with general surgery, wherein the method comprises contacting the wound with the graft of claim 1 .

25. The method of claim 24 , wherein the graft facilitates closure of anastomosis, is an anti-adhesion barrier for anastomosis, or is an anti-adhesion barrier for hernia repair.

26. A dehydrated tissue graft consisting of one layer of dehydrated amnion and one layer of dehydrated chorion membrane, wherein the dehydrated amnion and the dehydrated chorion are covalently attached to one another via a cross-linker, and wherein said dehydrated amnion and/or said dehydrated chorion is not decellularized;
wherein one of said dehydrated amnion and said dehydrated chorion has been internally cross-linked by a cross-linking agent;
wherein one of said dehydrated amnion and said dehydrated chorion has not been internally cross-linked by a cross-linking agent; and
wherein the dehydrated tissue graft comprises a first external side and a second external side, where the first external side consists essentially of a basement membrane or an epithelial layer and the second external side consists essentially of a fibroblast layer or a chorion layer.

27. A dehydrated tissue graft consisting of one layer of dehydrated amnion and one layer of dehydrated chorion, wherein one layer of dehydrated amnion and/or dehydrated chorion has been treated with a cross-linking agent, and wherein one layer of dehydrated amnion and/or dehydrated chorion has not been treated with a cross-linking agent, and wherein at least one layer of dehydrated amnion and/or dehydrated chorion is not decellularized; and
wherein the dehydrated tissue graft comprises a first external side and a second external side, where the first external side consists essentially of a basement membrane or an epithelial layer and the second external side consists essentially of a chorion layer; and
wherein said layer of dehydrated amnion and said layer of dehydrated chorion are not cross-linked with one another.

Assignees

• Mimedx Group Inc

Inventors

• Daniel John
• Spencer Randall
• Morse Brenda
• Koob Thomas J
• Sith Somaly

Classifications

• A61F2002/009

  for hindering or preventing attachment of biological tissue · CPC title

• A61B2090/0816

  for preventing adhesion · CPC title

• A61L27/3687

  characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents · CPC title

• A61L27/3604

  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

• A61L2430/16

  for reconstruction of eye parts, e.g. intraocular lens, cornea · CPC title