Multi-layer tissue patches

• US 9,480,549 B2
• Filed: 03/11/2013
• Issued: 11/01/2016
• Est. Priority Date: 04/25/2008
• Status: Active Grant

• Current Assignee: AlloSource
• Original Assignee: AlloSource
• Inventors: Samaniego, Adrian C.
• Primary Examiner(s): Woo, Julian W
• Assistant Examiner(s): PAEZ, LUCAS M
• Application Number:
  US13/793,331
• Publication Number:
  US 20130204393A1
• Time in Patent Office: 1,331 Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2/105 Skin implants, e.g. artificial skin
• CPC Class Codes: A61K 35/50 Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
• CPC Class Codes: A61L 26/0061 Use of materials characterised by their function or physical properties
• CPC Class Codes: A61L 27/00 Materials for grafts or prostheses or for coating grafts or prostheses dental prostheses A61C13/00; shape or structure of prostheses A61F2/00; use of preparations for artificial teeth A61K6/80; artificial kidneys A61M1/14
• 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: A61L 27/3687 characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents

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:

obtaining a first 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 first tissue layer is treated with a glutaraldehyde exposure process;

obtaining a second 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 second tissue layer is not treated with a glutaraldehyde exposure process;

compressing the treated first amnion tissue layer with the untreated second amnion tissue layer so as to form the patch, such that the epithelial layers of the first and second amnion tissue layers define first and second opposing outer surfaces of the patch, respectively, wherein a compressed, coupled fibroblast region is disposed between at least a portion of the first and second opposing outer surfaces of the patch, and wherein the compressed, coupled fibroblast region comprises fibers of at least a portion of the first fibroblast layer entangled with fibers of at least a portion of the second fibroblast layer.

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

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

4. The method according to claim 3, wherein 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.

5. The method according to claim 4, wherein the first orientation is angularly offset from the second orientation by about 90 degrees.

6. The method according to claim 1, wherein the glutaraldehyde exposure process comprises exposing the first tissue layer to a glutaraldehyde solution for up to about 15 minutes.

7. The method according to claim 6, wherein the glutaraldehyde solution comprises 1% glutaraldehyde.

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

a first 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 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;

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

wherein the first amnion tissue layer is treated with a glutaraldehyde protocol and the second amnion tissue layer is not treated with a glutaraldehyde protocol.

9. A method of treating a patient with a multi-layer amnion tissue patch, the method comprising:

obtaining the multi-layer amnion tissue patch of claim 8; and

administering the multi-layer tissue patch to the patient.

10. The method according to claim 9, wherein the multi-layer tissue patch is administered to a patient tissue that is injured, damaged, crushed, sutured, inflamed, or ligated.

11. The method according to claim 9, wherein the administering step comprises a member selected from the group consisting of:

placing the patch at a surgical site within or on the patient'"'"'s body,

placing the patch at a trauma site within or on the patient'"'"'s body,

suturing the patch to the patient,

wrapping the patch about a patient nerve,

wrapping the patch about a patient tendon,

onlaying the patch over a patient bone defect,

placing the patch within a patient tarsal tunnel,

applying the patch to the patient'"'"'s spine during a laminectomy procedure,

applying the patch to the patient'"'"'s spine during an anterior lumbar interbody fusion procedure,

applying the patch to the patient'"'"'s spine during a laminotomy procedure,

positioning the patch between two similar tissues,

positioning the patch between two dissimilar tissues,

positioning the patch at a dural tear,

positioning the patch at a knee cap so as to maintain a space in the knee cap area,

positioning the patch between two surfaces which are intended to remain separated after any healing phase,

contacting the patch with a patient peripheral nerve,

contacting the patch with a patient iliotibial band,

contacting the patch with a patient meniscus, and

contacting the patch with a patient extensor halgus longus tendon.

12. The method according to claim 9, wherein the first amnion tissue layer and the second amnion tissue layer are each part of a single piece of amnion tissue, the single piece of amnion tissue folded over on itself so that a portion of the first amnion tissue layer at least partially overlaps a portion of the second amnion tissue layer.

13. The method according to claim 9, wherein the first amnion tissue layer and the second amnion tissue layer are each separate pieces of amnion tissue, and a portion of the first amnion tissue layer at least partially overlaps a portion of the second amnion tissue layer.

14. The multi-layer tissue patch according to claim 8, wherein the compressed, coupled fibroblast region has an increased fiber density relative to a non-compacted fibroblast layer.

15. The multi-layer tissue patch according to claim 8, wherein the patch is wet and contained within a sealed pouch along with an amount of saline solution.

16. The multi-layer tissue patch according to claim 8, wherein the first amnion tissue layer and the second amnion tissue layer are each part of a single piece of amnion tissue, the single piece of amnion tissue folded over on itself so that a portion of the first amnion tissue layer at least partially overlaps a portion of the second amnion tissue layer.

17. The multi-layer tissue patch according to claim 8, wherein the first amnion tissue layer and the second amnion tissue layer are each separate pieces of amnion tissue, and a portion of the first amnion tissue layer at least partially overlaps a portion of the second amnion tissue layer.