Multi-layer tissue systems and methods

• US 9,616,152 B2
• Filed: 05/15/2013
• Issued: 04/11/2017
• 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): Davis, Ruth
• Assistant Examiner(s): Clarke, Trent
• Application Number:
  US13/894,637
• Publication Number:
  US 20130247517A1
• Time in Patent Office: 1,427 Days
• Field of Search: None
• 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 method of manufacturing a multi-layer amnion tissue patch, the method comprising:

contacting 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, with 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;

placing the contacted first and second fetal sac amnion tissue layers in a pouch;

removing air from the pouch while keeping the contacted first and second fetal sac amnion tissue layers moist;

placing the pouch containing the contacted first and second fetal sac amnion tissue layers in a press mechanism; and

pressing the pouch with the press mechanism, so that the first amnion tissue layer and the second amnion tissue layer are pressed against each other so as to form the multi-layer amnion tissue patch, such that the epithelial layers of the first and second tissue layers define first and second opposing outer surfaces of the patch, respectively, and a compressed, coupled fibroblast region is disposed between the first and second opposing outer surfaces of the patch, the compressed, coupled fibroblast region having an interface of entangled fibers of the first and second fibroblast layers.

2. The method according to claim 1, wherein the first amnion tissue layer and the second amnion tissue layer are pressed against each other by the press mechanism with a force within a range from about 10 psi to about 50 psi.

3. The method according to claim 1, wherein the first amnion tissue layer and the second amnion tissue layer are pressed against each other by the press mechanism for a duration within a range from about 5 seconds to about 24 hours.

4. The method according to claim 1, wherein the first tissue layer and the second tissue layer are pressed against each other by the press mechanism with a force of about 38 psi for a duration of about 15 minutes.

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

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

7. The method according to claim 1, wherein the first fetal sac amnion tissue layer and the second fetal sac amnion tissue layer are each part of a single piece of tissue, and the contacting step comprises folding the single piece of tissue over on itself so that a portion of the first tissue amnion layer at least partially overlaps a portion of the second amnion tissue layer.

8. The method according to claim 1, wherein the first amnion tissue layer and the second amnion tissue layer are each separate pieces of tissue, and the contacting step comprises approximating the first and second amnion tissue layers so that a portion of the first amnion tissue layer at least partially overlaps a portion of the second amnion tissue layer.

9. The method according to claim 8, wherein upon approximation the first amnion tissue layer is disposed in a first orientation, and the second amnion tissue layer is disposed in a second orientation that is angularly offset from the first orientation.

10. The method according to claim 9, wherein the first orientation is angularly offset from the second orientation by about 90 degrees.

11. The method according to claim 10, wherein the multi-layer amnion tissue patch has a tensile strength within a range from about 9 MPa to about 47.2 MPa.

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

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