Biodegradable elastomeric patch for treating cardiac or cardiovascular conditions

• US 20080009830A1
• Filed: 06/27/2007
• Published: 01/10/2008
• Est. Priority Date: 06/27/2006
• Status: Active Grant

• Current Assignee: University of Pittsburgh of The Commonwealth System of Higher Education
• Original Assignee: University of Pittsburgh of The Commonwealth System of Higher Education
• Inventors: Wagner, William, Fujimoto, Kazuro, Guan, Jianjun, Tobita, Kimimasa, Keller, Bradley
• Granted Patent: US 8,974,542 B2
• Time in Patent Office: Days
• US Class Current: 604/522
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence

Abstract

Provided herein is a biodegradable elastomeric patch that can be implanted on a heart or other portions of the cardiovascular system to repair tissue deficiencies or tissue damage. The biodegradable elastomeric patch may be engineered to have mechanical properties similar to that of soft tissue and to provide mechanical support to the damaged tissue. The biodegradable elastomeric patch also may comprise therapeutic agents to aid in the healing process. Methods also are provided for using a biodegradable elastomeric patch for treating patients suffering from tissue damage or tissue deficiencies in the cardiac or cardiovascular system.

Claims

1. A method for treating damage or a defect in cardiac or cardiovascular tissue, comprising implanting a biodegradable, elastomeric patch at or adjacent to the tissue damage or defect.

2. The method according to claim 1, wherein the damage or defect is in a left ventricular region of a heart.

3. The method of claim 1, wherein the damage or defect in the cardiac or cardiovascular tissue is damage resulting from a myocardial infarction.

4. The method of claim 1, wherein the damage or defect in the cardiac or cardiovascular tissue is a deficiency resulting from a congenital defect.

5. The method of claim 1, wherein the damage or defect in the cardiac or cardiovascular tissue is a right ventricular outflow tract of a heart.

6. The method of claim 1, wherein damage or defect is in a heart valve.

7. The method of claim 1, wherein said biodegradable elastomeric patch comprises a polymer composition comprising one or both of a poly(ester urethane) urea elastomer or a poly(ether ester urethane) urea elastomer.

8. The method of claim 7, wherein the elastomer comprises a diamine.

9. The method of claim 8, wherein the diamine is putrescine.

10. The method of claim 8, wherein the diamine is lysine ethyl ester.

11. The method of claim 7, wherein the elastomer comprises a polycaprolactone.

12. The method of claim 7, wherein the elastomer comprises a polycaprolactone diol.

13. The method of claim 11, wherein the elastomer comprises a triblock copolymer comprising polycaprolactone.

14. The method of claim 13, wherein the elastomer comprises a polycaprolactone-b-polyethylene glycol-b-polycaprolactone triblock copolymer.

15. The method of claim 7, wherein the polymer composition is functionalized with an adhesion-promoting peptide.

16. The method of claim 15, wherein the adhesion-promoting peptide comprises RGD.

17. The method of claim 7, wherein the polymer composition has a porosity of approximately 85%.

18. The method of claim 7, wherein the elastomer comprises an isocyanate derivative, a polycaprolactone diol, and a diamine chain extender.

19. The method of claim 18, wherein the ratio of isocyanate derivative:

polycaprolactone diol;

diamine chain extender is 2;

1;

1.

20. The method of claim 7, wherein the elastomer comprises an isocyanate derivative, a triblock copolymer comprising polycaprolactone, and a diamine chain extender.

21. The method of claim 20, wherein the ratio of isocyanate derivative:

triblock copolymer;

diamine chain extender is 2;

1;

1.

22. The method of claim 1, wherein the patch comprises a therapeutic agent.

23. The method of claim 22, wherein the therapeutic agent is one or more of basic fibroblast growth factor (bFGF), acidic fibroblast growth factor (aFGF), vascular endothelial growth factor (VEGF), pleiotrophin protein, midkine protein, anti-inflammatories, and anti-clotting agents.

24. The method of claim 22, wherein the biodegradable elastomeric patch comprises cells that release a therapeutic agent

25. The method of claim 22, wherein the therapeutic agent is in the form of cells.

26. The method of claim 25, wherein the cells are one or more of stem cells, precursor stem cells, smooth muscle cells, skeletal myoblasts, myocardial cells, endothelial cells, and genetically modified cells.

27. The method of claim 22, wherein the therapeutic agent is covalently linked to a polymer in the polymer composition and is released during degradation of the patch.

28. The method of claim 27, wherein the therapeutic agent is putrescine that is covalently linked to the polymer.

29. The method of claim 1, wherein the biodegradable elastomeric patch is produced by electrospinning.

30. The method of claim 1, wherein the biodegradable elastomeric patch is produced by thermally induced phase separation.

31. The method of claim 1, wherein the biodegradable elastomeric patch is produced by solvent casting/salt leaching.

32. The method of claim 7, wherein the patch comprises a therapeutic agent.

33. The method of claim 32, wherein the therapeutic agent is one or more of basic fibroblast growth factor (bFGF), acidic fibroblast growth factor (aFGF), vascular endothelial growth factor (VEGF), pleiotrophin protein, midkine protein, anti-inflammatories, and anti-clotting agents.

34. The method of claim 32, wherein the biodegradable elastomeric patch comprises cells that release a therapeutic agent.

35. The method of claim 32, wherein the therapeutic agent is in the form of cells.

36. The method of claim 35, wherein the cells are one or more of stem cells, precursor stem cells, smooth muscle cells, skeletal myoblasts, myocardial cells, endothelial cells, and genetically modified cells.

37. The method of claim 32, wherein the therapeutic agent is covalently linked to a polymer in the polymer composition and is released during degradation of the patch.

38. The method of claim 37, wherein the therapeutic agent is putrescine that is covalently linked to the polymer.

39. The method of claim 7, wherein the biodegradable elastomeric patch is produced by electrospinning.

40. The method of claim 7, wherein the biodegradable elastomeric patch is produced by thermally induced phase separation.

41. The method of claim 7, wherein the biodegradable elastomeric patch is produced by solvent casting/salt leaching.