Placental tissue grafts and improved methods of preparing and using the same

Patent metadata

Field	Value
Publication number	US-10874697-B2
Application number	US-201715716135-A
Country	US
Kind code	B2
Filing date	Sep 26, 2017
Priority date	Sep 7, 2007
Publication date	Dec 29, 2020
Grant date	Dec 29, 2020

Abstract

Described herein are tissue grafts derived from the placenta. The grafts are composed of at least one layer of amnion tissue where the epithelium layer has been substantially removed in order to expose the basement layer to host cells. By removing the epithelium layer, cells from the host can more readily interact with the cell-adhesion bio-active factors located onto top and within of the basement membrane. Also described herein are methods for making and using the tissue grafts. The laminin structure of amnion tissue is nearly identical to that of native human tissue such as, for example, oral mucosa tissue. This includes high level of laminin-5, a cell adhesion bio-active factor show to bind gingival epithelia-cells, found throughout upper portions of the basement membrane.

First claim

What is claimed is:

1. A tissue graft comprising a first membrane comprising an amnion and one or more additional membranes laminated to the first membrane, wherein the first membrane comprises an exposed basement membrane and a fibroblast layer, and the one or more additional membranes are adjacent to the fibroblast layer;
wherein said graft comprises a plurality of holes.

2. The graft of claim 1 , wherein the at least one additional membrane comprises 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.

3. The graft of claim 1 , wherein the at least one additional membrane comprises amnion, chorion, or a combination thereof.

4. The graft of claim 1 , wherein the at least one additional membrane comprises chorion.

5. The graft of claim 1 , wherein the tissue graft comprises a second membrane comprising an exposed basement membrane and stromal layer, wherein the stromal layer of the second membrane is laminated to the exposed additional membrane.

6. The graft of claim 1 , wherein at least one of the membranes comprises a naturally occurring growth factor, a platelet concentrate, a bone marrow aspirate, stem cells, or an antibiotic.

7. The graft of claim 1 , wherein the number of membranes laminated to the first membrane is from 1 to 10.

8. The tissue graft of claim 1 for use in eliminating frenum pull, patella regeneration, treating mouth sores and oral lesions, guide tissue bone regeneration, periodontal regeneration, oral reconstruction, vestibuloplasty, tissue regeneration around dental implants, esophagus reconstruction, plastic surgery, cosmetic surgery, peripheral arterial disease, bladder reconstruction, orbital floor repair, treatment of foot ulcers, corneal repair, adhesion barrier in spinal implant procedures, adhesion barrier in general surgery, use as vascular conduits, increasing the zone of gingival, or genitourinary reconstruction.

9. The graft of claim 1 , wherein the holes have a diameter from 0.2-2.0 mm.

10. The graft of claim 1 , wherein the holes have a diameter from 0.2-0.5 mm.

11. The graft of claim 1 , wherein the holes are spaced from 1 mm to 5 mm apart.

12. The graft of claim 1 , wherein the holes are spaced from 2 mm to 4 mm apart.

13. A method for preparing the tissue graft of claim 1 , comprising the steps:
(a) obtaining a placenta from a subject, wherein the placenta comprises an amniotic membrane layer and a chorion tissue layer;
(b) cleaning the placenta;
(c) separating the chorion tissue layer from the amnion layer, wherein one side of the amnion comprises epithelium cells adjacent to a basement membrane;
(d) physically cleaning the amnion to remove blood clots and other contaminates, so as to provide an amnion having a fibroblast layer on a second side of the amnion:
(e) removing substantially all of the epithelium cells to expose the basement membrane of the amnion to produce a first membrane having an exposed basement membrane on a first side and a fibroblast layer on a second side;
(f) mounting the first membrane onto a surface of a drying fixture, wherein the basement membrane of the first membrane is adjacent to the surface of the drying fixture;
(g) mounting one or more additional membranes on the second side of the first membrane to produce a layered tissue graft;
(h) dehydrating the layered tissue graft on the drying fixture; and
(i) perforating the tissue graft to produce a plurality of holes.

14. The method of claim 13 , wherein step (c) is performed prior to step (e), and further comprising, after step (c) but prior to step (e), soaking the amnion in an antibiotic solution.

15. The method of claim 14 , further comprising the step of rinsing the amnion to remove the antibiotic solution.

16. The method of claim 13 , wherein step (e) comprises scraping the epithelium layer to substantially remove the epithelium layer.

17. The method of claim 13 , wherein the one or more additional membranes comprises 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.

18. The method of claim 13 , wherein the one or more additional membranes comprises chorion, amnion, or a combination thereof.

19. A method for treating a wound present on mucosal tissue of a subject, or for treating a dental defect in a subject, comprising applying the tissue graft of claim 1 to the wound or defect.

Assignees

• Mimedx Group Inc

Inventors

• Daniel John
• Spencer Randall
• Russo John
• Tofe Robert

Classifications

• A61L27/3683 Primary

  subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment · 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

• A61P41/00

  Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution · CPC title

• A61F2230/00

  Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof · CPC title

• A61L27/56

  Porous materials, {e.g. foams or sponges} · CPC title