Stents modified with material comprising amnion tissue and corresponding processes

• US 9,205,177 B2
• Filed: 02/26/2010
• Issued: 12/08/2015
• Est. Priority Date: 03/04/2009
• Status: Active Grant

• Current Assignee: Peytant Solutions, Inc.
• Original Assignee: Peytant Solutions, Inc.
• Inventors: Schorgl, John, Thompson, Paul, Healy, Steven J., Thatcher, Robert
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US12/713,666
• Publication Number:
  US 20100228335A1
• Time in Patent Office: 2,111 Days
• Field of Search: 623 144- 146, 623/1.13, 623/1.15, 623/1.47
• US Class Current: 1/1
• CPC Class Codes: A61F 2/062 Apparatus for the production of blood vessels made from natural tissue or with layers of living cells prostheses made from natural tissue or living cells A61L27/507
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2310/00982 Coating made of collagen
• CPC Class Codes: A61L 2300/30 Compounds of undetermined constitution extracted from natural sources, e.g. Aloe Vera
• CPC Class Codes: A61L 2300/412 Tissue-regenerating or healing or proliferative agents
• CPC Class Codes: A61L 2300/64 Animal cells
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• 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 27/3813 Epithelial cells, e.g. keratinocytes, urothelial cells
• CPC Class Codes: A61L 27/3834 Cells able to produce different cell types, e.g. hematopoietic stem cells, mesenchymal stem cells, marrow stromal cells, embryonic stem cells
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 31/08 Materials for coatings
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

A stent scaffold combined with amniotic tissue provides for a biocompatible stent that has improved biocompatibility and hemocompatibility. The amnion tissue can be variously modified or unmodified form of amnion tissue such as non-cryo amnion tissue, solubilized amnion tissue, amnion tissue fabric, chemically modified amnion tissue, amnion tissue treated with radiation, amnion tissue treated with heat, or a combination thereof. Materials such as polymer, placental tissue, pericardium tissue, small intestine submucosa can be used in combination with the amnion tissue. The amnion tissue can be attached to the inside, the outside, both inside and outside, or complete encapsulation of the stent scaffold. In some embodiments, at least part of the covering or lining comprises a plurality of layers of amnion tissue. The method of making the biocompatible stent and its delivery and deployment are also discussed.

Claims

1. A biocompatible stent for placement in a vessel of a living subject comprising:

a stent scaffold, and

a biocompatible material that completely encapsulates the stent scaffold, wherein the biocompatible material comprises intact non-denuded amnion tissue that has been processed to allow for preservation of viable native cells, and wherein the biocompatible material has not been cryopreserved at a temperature of −

60 to −

100 °

C.

2. The biocompatible stent of claim 1 wherein the biocompatible material comprises a covering, a lining, or a combination thereof.

3. The biocompatible stent of claim 2 wherein at least part of the covering or lining comprises a plurality of layers of amnion tissue.

4. The biocompatible stent of claim 2 wherein the covering and/or lining is joined via welded seam and/or adhesive bond seam.

5. The biocompatible stent of claim 2 wherein the stent scaffold comprises an inside and an outside that are connected by ends wherein the biocompatible material is attached to the inside and outside of the stent scaffold via folding the biocompatible material over the ends of the scaffold.

6. The biocompatible stent of claim 1 wherein the biocompatible material further comprises small intestinal submucosa tissue, pericardium tissue, placental tissue, polymeric material, or a combination thereof.

7. The biocompatible stent of claim 1 wherein the biocompatible stent is bio-absorbable.

8. The biocompatible stent of claim 1 further comprising a thrombolytic agent, an anti-restenosis agent, cellular material, or a combination thereof.

9. The biocompatible stent of claim 1 wherein the amnion tissue comprises amnion epithelial cells.

10. A method for modifying a stent scaffold to form a biocompatible stent of claim 1 for placement in a vessel of a living subject, comprising

completely encapsulating the stent scaffold with a processed biocompatible material, wherein the processed biocompatible material is processed from the biocompatible material.

11. The method of claim 10 wherein the processed biocompatible material is formed in a method comprising forming a covering or lining from the biocompatible material and wherein the encapsulating step comprises covering the stent scaffold with the covering or lining via mechanical, electronic, adhesive, energy based method, or a combination thereof.

12. The biocompatible stent of claim 11 wherein the stent scaffold comprises an inside and an outside that are connected by ends wherein the biocompatible material is attached to the inside and outside of the stent scaffold via folding the biocompatible material over the ends of the scaffold.

13. The method of claim 10 wherein the amnion tissue comprises amnion epithelial cells.

14. A method of deploying the biocompatible stent of claim 1 comprising delivering the biocompatible stent into a site of treatment and deploying the biocompatible stent into a deployed configuration.

15. The biocompatible stent of claim 1 wherein the amnion tissue has holes.

16. The biocompatible stent of claim 1 wherein the amnion tissue does not comprise chorion tissue.

17. A biocompatible stent for placement in a vessel of a living subject comprising:

a stent scaffold designed to facilitate opening of a vessel, the stent scaffold having a first configuration and second configuration, and

a biocompatible material associated with the stent scaffold, wherein the biocompatible material comprises intact non-denuded amnion tissue that has been processed to allow for preservation of viable native cells, wherein the biocompatible material has not been cryo-preserved at a temperature of −

60 to −

100 °

C., and wherein the biocompatible material does not comprise chorion tissue;

wherein the first configuration of the stent scaffold has a first diameter and the second configuration has a second diameter, and the first diameter is smaller than the second diameter.

18. The biocompatible stent of claim 17 wherein the stent scaffold further comprises an inside and an outside and the biocompatible material is attached to the inside, the outside, or both inside and outside of the stent scaffold and wherein the stent scaffold is generally cylindrical.

19. The biocompatible stent of claim 18 wherein the biocompatible material is attached to the inside and outside of the stent scaffold via folding the material over ends of the stent scaffold.

20. The biocompatible stent of claim 18 wherein the biocompatible material comprises an amnion tissue covering or lining.

21. The biocompatible stent of claim 20 wherein the covering and/or lining is joined via welded seam and/or adhesive bond seam.

22. The biocompatible stent of claim 17 wherein the biocompatible material comprises a plurality of layers of amnion tissue.

23. The biocompatible stent of claim 17 further comprising a thrombolytic agent, an anti-restenosis agent, cellular material, or a combination thereof.

24. The biocompatible stent of claim 23 wherein the cellular material is stem cells.

25. The biocompatible stent of claim 17 wherein the biocompatible material further comprises small intestinal submucosa tissue, pericardium tissue, placental tissue, polymeric material, or a combination thereof.

26. The biocompatible stent of claim 17 wherein the stent scaffold comprises metal, alloy, polymer, or a combination thereof.

27. The biocompatible stent of claim 17 wherein the stent scaffold is bio-absorbable.

28. The biocompatible stent of claim 17 wherein the stent scaffold is bifurcated, segmented, continuous, crimped or a combination thereof.

29. The biocompatible stent of claim 17 wherein the amnion tissue comprises amnion epithelial cells.

30. A method for modifying a stent scaffold to form the biocompatible stent of claim 17 for placement in a vessel of a living subject, comprising:

associating the biocompatible material with the stent scaffold.

31. The method of claim 30 wherein the biocompatible material is processed by a method to form a covering or lining and the associating step comprising attaching the covering or lining to an inside, outside, or both inside and outside, of the stent scaffold.

32. The method of claim 31 wherein the covering or lining comprises multiple layers of processed biocompatible material.

33. The method of claim 31 wherein the covering or lining is attached to the stent scaffold via mechanical, electronic, adhesive, energy based method, or a combination thereof.

34. The biocompatible stent of claim 31 wherein the stent scaffold comprises an inside and an outside that are connected by ends wherein the biocompatible material is attached to the inside and outside of the stent scaffold via folding the biocompatible material over the ends of the scaffold.

35. The method of claim 30 wherein the amnion tissue comprises amnion epithelial cells.

36. A method of deploying the biocompatible stent of claim 17 comprising delivering the biocompatible stent into a site of treatment and deploying the biocompatible stent into a deployed configuration.

37. The method of claim 36 wherein the biocompatible stent is self-expanding.

38. The method of claim 36 wherein the biocompatible stent is deployed by a balloon.

39. The method of claim 36 further comprising treating the site of treatment prior to delivering the biocompatible stent into the site of treatment.

40. The biocompatible stent of claim 17 wherein the amnion tissue retains viable cells.