Multi-layer tissue patches

• US 9,358,320 B2
• Filed: 07/20/2011
• Issued: 06/07/2016
• Est. Priority Date: 04/25/2008
• Status: Active Grant

• Current Assignee: AlloSource
• Original Assignee: AlloSource
• Inventors: Samaniego, Adrian C., Wilkins, Ross M.
• Primary Examiner(s): Rosen, Eric
• Assistant Examiner(s): Paez, Lucas
• Application Number:
  US13/186,661
• Publication Number:
  US 20120083900A1
• Time in Patent Office: 1,784 Days
• Field of Search: 623 2372- 2374, 606/151
• US Class Current: 1/1
• CPC Class Codes: A61L 26/0095 Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
• CPC Class Codes: A61L 27/3604 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 Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor

Abstract

Embodiments of the present invention encompass anti-adhesion wound dressings including patches made from amnion tissue obtained from human birth tissue. Exemplary amnion patches can be fabricated by folding a section of amnion over on itself with the epithelial layer on the outside of the folded patch and the fibroblast layer on the inside of the folded patch. Optionally, individual amnion tissue pieces can be sandwiched together to provide a multi-layer patch. Sufficient pressure is applied to the layered amnion to cause adherence between opposing faces of the fibroblast layers. The pressed fibroblast layers provide mechanical strength to hold the amnion patch together with the epithelial layers on the outsides of the amnion patch.

Claims

1. A multi-layer amnion tissue patch, comprising:

a first fetal sac amnion tissue layer having an epithelial layer, a basement membrane, a compact layer, and a fibroblast layer from which a spongy layer has been removed, the fibroblast layer including a loose network of reticulum; and

a second fetal sac amnion tissue layer having an epithelial layer, a basement membrane, a compact layer, and a fibroblast layer from which a spongy layer has been removed, the fibroblast layer including a loose network of reticulum,

wherein the epithelial layers of the first and second tissue layers define first and second opposing outer surfaces of the patch, respectively, and

wherein a compressed, coupled fibroblast region is disposed between the first and second opposing outer surfaces of the patch, the compressed, coupled fibroblast region comprising fibers of the first fibroblast layer entangled with fibers of the second fibroblast layer.

2. The multi-layer tissue patch according to claim 1, wherein at least a portion of the fibroblast layer of the first amnion layer is coupled with at least a portion of the fibroblast layer of the second amnion layer via the coupled fibroblast region.

3. The multi-layer tissue patch according to claim 1, wherein the patch has a thickness within a range from about 40 microns to about 500 microns.

4. The multi-layer tissue patch according to claim 1, wherein the patch has a 4.0 suture pullout force with a range from about 0.40 N to about 0.70 N.

5. The multi-layer tissue patch according to claim 1, wherein the compressed, coupled fibroblast region has an increased fiber density relative to a non-compacted fibroblast layer.

6. The multi-layer tissue patch according to claim 1, wherein the patch is wet and contained within a sealed pouch along with an amount of saline solution.

7. The multi-layer tissue patch according to claim 1, wherein the first fetal sac amnion tissue layer comprises tissue obtained from a location on the fetal sac that is opposite the placenta.

8. The multi-layer tissue patch according to claim 1, wherein the first fetal sac amnion tissue layer comprises tissue obtained from a location on the fetal sac that is not adjacent to the placenta.

9. The multi-layer tissue patch according to claim 1, wherein the patch does not contain umbilical cord tissue.

10. The multi-layer tissue patch according to claim 1, wherein the patch has a tensile strength with a range from about 18 MPa to about 23.6 MPa.

11. The multi-layer tissue patch according to claim 1, wherein the multi-layer amnion tissue patch has at least two-fold greater tensile strength as compared to a multi-layer amnion tissue that has not been compressed.

12. The multi-layer tissue patch according to claim 1, wherein the patch has a tensile strength with a range from about 3.3 MPa to about 36.4 MPa.

13. The multi-layer tissue patch according to claim 1, wherein the first tissue layer is disposed in a first orientation, and the second tissue layer is disposed in a second orientation that is angularly offset from the first orientation.

14. The multi-layer tissue patch according to claim 13, wherein the first orientation is angularly offset from the second orientation by about 90 degrees.

15. The multi-layer tissue patch according to claim 14, wherein the patch has a tensile strength within a range from about 9 MPa to about 47.2 MPa.