Tissue grafts modified with a cross-linking agent and method of making and using the same

Patent metadata

Field	Value
Publication number	US-10869952-B2
Application number	US-201916260738-A
Country	US
Kind code	B2
Filing date	Jan 29, 2019
Priority date	Feb 14, 2011
Publication date	Dec 22, 2020
Grant date	Dec 22, 2020

Abstract

Described herein are tissue grafts derived from the placenta that possess good adhesion to biological tissues and are useful in would 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 amnion 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 method for enhancing adhesion of a tissue graft to a biological tissue of a patient, said method comprising applying a tissue graft to said biological tissue of a patient, wherein said tissue graft comprises at least two layers of placental tissue, wherein said at least two layers of placental tissue comprise two or more layers of chorion, wherein at least one layer of chorion is treated with a cross-linking agent and comprises a cross-linking group; wherein one or more of said cross-linking groups forms a covalent bond with said biological tissue, thereby enhancing adhesion of the tissue graft to the biological tissue; wherein at least one layer of placental tissue has not been treated with a cross-linking agent; and wherein the tissue graft is not decellularized.

2. The method of claim 1 , wherein more than one layer of placental tissue is treated with a cross-linking agent and comprises a cross-linking group, and the placental tissue layers are treated with the same cross-linking agent.

3. The method of claim 1 , wherein more than one layer of placental tissue is treated with a cross-linking agent and comprises a cross-linking group, and the placental tissue layers are treated with different cross-linking agents.

4. The method of claim 1 , wherein the cross-linking agent comprises a sugar, a dialdehyde, a carbodiimide, or a combination thereof.

5. The method of claim 4 , 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.

6. The method of claim 1 , wherein the tissue graft includes an embossed texture or design.

7. The method of claim 1 , wherein the tissue graft comprises one or more additional membranes treated with a cross-linking agent.

8. The method of claim 7 , wherein the one or more additional membranes comprise amnion, chorion, allograft pericardium, allograft acellular dermis, amniotic membrane, Wharton's jelly, purified xenograft Type-1 collagen, biocellulose polymers or copolymers, biocompatible synthetic polymer or copolymer films, purified small intestinal submucosa, bladder acellular matrix, cadaveric fascia, or any combination thereof.

9. The method of claim 7 , wherein the one or more additional membranes comprise an amnion membrane.

10. The method of claim 1 , wherein the biological tissue comprises a wound and said tissue graft is a wound dressing.

11. The method of claim 1 , wherein the biological tissue is the spinal dura of the patient or a region near the spine, and the tissue graft is applied after a surgical procedure to prevent or reduce scar formation on or near the spine.

12. The method of claim 11 , wherein the surgical procedure comprises a posterior procedure.

13. The method of claim 12 , wherein the posterior procedure is a laminectomy, discectomy, a Posterior Lumbar Interbody Fusion, or a Transforaminal Lumbar Interbody Fusion.

14. The method of claim 11 , wherein the surgical procedure comprises an anterior procedure.

15. The method of claim 1 , wherein the tissue graft is applied to the biological tissue without the use of a suture.

16. The method of claim 1 , wherein the biological tissue is the spinal dura of the patient, and the tissue graft is applied after a dural tear.

17. The method of claim 1 , wherein the biological tissue comprises a wound and the tissue graft is applied to the wound, wherein the wound is in the cranial dura, a wound resulting from a perioplastic procedure, a frenum pull, lost patella tissue, associated with the Schneiderian membrane in the sinus cavity, or associated with the soft tissue around dental implants, wherein the tissue graft promotes healing of the wound.

18. The method of claim 1 , wherein the biological tissue comprises a wound associated with a dental surgical procedure, an orthopedic application, an ENT application, a gynecological application, an urological application, or general surgery, or wherein the biological tissue comprises an extremity having a wound, or wherein the biological tissue comprises an eye.

Assignees

• Mimedx Group Inc

Inventors

• Morse Brenda S
• Sith Somaly
• Spencer Randall
• Daniel John

Classifications

• A61K35/50 Primary

  Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells · CPC title

• A61F2/02

  Prostheses implantable into the body · 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

• A61L27/3687

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