MULTI-LAYER TISSUE SYSTEMS AND METHODS

• US 20120083900A1
• Filed: 07/20/2011
• Published: 04/05/2012
• Est. Priority Date: 04/25/2008
• Status: Active Grant

• Current Assignee: AlloSource
• Original Assignee: AlloSource
• Inventors: Samaniego, Adrian C., Wilkins, Ross M.
• Granted Patent: US 9,358,320 B2
• Time in Patent Office: Days
• US Class Current: 623/23.72
• 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 tissue patch, comprising:

a first tissue layer having an epithelial layer and a basement membrane; and

a second tissue layer having an epithelial layer and a basement membrane,

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

2. The multi-layer tissue patch according to claim 1, wherein each of the first and second tissue layers comprise an amnion tissue layer.

3. The multi-layer tissue patch according to claim 2, wherein the amnion layer of the first tissue layer comprises a fibroblast layer, the amnion layer of the second tissue layer comprises a fibroblast layer, and 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.

4. The multi-layer tissue patch according to claim 2, wherein at least a portion of a fibroblast layer of the first amnion layer is coupled with at least a portion of a fibroblast layer of the second amnion layer so as to form an interface disposed between the epithelial layer of the first amnion layer and the epithelial layer of the second amnion layer.

5. The multi-layer tissue patch according to claim 1, wherein each of the first and second tissue layers comprise a member selected from the group consisting of an amnion tissue layer, an intestine tissue layer, and an umbilical cord tissue layer.

6. 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.

7. 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.

8. 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.

9. 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.

10. The multi-layer tissue patch according to claim 9, wherein the first orientation is angularly offset from the second orientation by about 90 degrees.

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

12. A method of manufacturing a multi-layer tissue patch, the method comprising:

contacting a first tissue layer having an epithelial layer and a basement membrane with a second tissue layer having an epithelial layer and a basement membrane so as to form the patch, such that the epithelial layers of the first and second tissue layers define first and second opposing outer surfaces of the patch, respectively.

13. The method according to claim 12, wherein the first tissue layer and the second 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 layer at least partially overlaps a portion of the second tissue layer.

14. The method according to claim 12, wherein the first tissue layer and the second tissue layer are each separate pieces of tissue, and the contacting step comprises approximating the first and second layers so that a portion of the first tissue layer at least partially overlaps a portion of the second tissue layer.

15. The method according to claim 14, wherein upon approximation 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.

16. The method according to claim 15, wherein the first orientation is angularly offset from the second orientation by about 90 degrees.

17. The method according to claim 12, wherein each of the first and second tissue layers comprises a fibroblast layer, and the contacting step comprises approximating the first and second tissue layers such that at least a portion of the fibroblast layer of the first tissue layer is mated with at least a portion of the fibroblast layer of the second tissue layer, so as to form a fibroblast region disposed between the epithelial layer of the first tissue layer and the epithelial layer of the second tissue layer.

18. The method according to claim 12, wherein each of the first and second tissue layers comprise an amnion tissue layer.

19. The method according to claim 12, wherein each of the first and second tissue layers comprise a member selected from the group consisting of an amnion tissue layer, an intestine tissue layer, and an umbilical cord tissue layer.

20. The method according to claim 12, further comprising pressing the first tissue layer and the second tissue layer against each other.

21. The method according to claim 20, wherein the first tissue layer and the second tissue layer are pressed against each other with a force within a range from about 10 psi to about 50 psi.

22. The method according to claim 20, wherein the first tissue layer and the second tissue layer are pressed against each other for a duration within a range from about 5 seconds to about 24 hours.

23. The method according to claim 20, wherein the first tissue layer and the second tissue layer are pressed against each other with a force of about 38 psi for a duration of about 15 minutes.

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

obtaining the multi-layer tissue patch, wherein the patch comprises a first tissue layer having an epithelial layer and a basement membrane, and a second tissue layer having an epithelial layer and a basement membrane, wherein the epithelial layers of the first and second tissue layers define first and second opposing outer surfaces of the patch, respectively; and

administering the multi-layer tissue patch to the patient.

25. The method according to claim 24, wherein the multi-layer tissue patch is administered to a patient tissue that is injured, damaged, crushed, sutured, inflamed, or ligated.

26. The method according to claim 24, 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.

27. The method according to claim 24, wherein, wherein each of the first and second tissue layers comprise an amnion tissue layer.

28. The method according to claim 27, wherein the amnion layer of the first tissue layer comprises a fibroblast layer, the amnion layer of the second tissue layer comprises a fibroblast layer, and 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.

29. The method according to claim 27, wherein at least a portion of a fibroblast layer of the first amnion layer is coupled with at least a portion of a fibroblast layer of the second amnion layer so as to form an interface disposed between the epithelial layer of the first amnion layer and the epithelial layer of the second amnion layer.

30. The method according to claim 24, wherein each of the first and second tissue layers comprise a member selected from the group consisting of an amnion tissue layer, an intestine tissue layer, and an umbilical cord tissue layer.