Apparatus and method for cardiac tissue modulation by topical application of vacuum to minimize cell death and damage

• US 9,289,193 B2
• Filed: 07/16/2009
• Issued: 03/22/2016
• Est. Priority Date: 07/18/2008
• Status: Active Grant

• Current Assignee: Wake Forest University Health Sciences
• Original Assignee: Wake Forest University Health Sciences
• Inventors: Argenta, Louis C., Carroll, David L., Jordan, James E., Levi, Nicole H., Liu, Jie, Morykwas, Michael J., Wagner, William D.
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): LEE, WENG WAH
• Application Number:
  US12/504,076
• Publication Number:
  US 20100121229A1
• Time in Patent Office: 2,441 Days
• Field of Search: 606/213, 606/215, 604/11, 604/500, 424/423
• US Class Current: 1/1
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• CPC Class Codes: A61F 13/05 specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
• CPC Class Codes: A61F 2013/0028 applying of mechanical pressure; passive massage
• CPC Class Codes: A61M 1/74 Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/75 Intermittent or pulsating suction A61M1/63, A61M1/772 take precedence
• CPC Class Codes: A61M 1/915 Constructional details of the pressure distribution manifold
• CPC Class Codes: A61M 1/916 specially adapted for deep wounds
• CPC Class Codes: A61M 1/917 specially adapted for covering whole body parts
• CPC Class Codes: A61M 1/96 Suction control thereof
• CPC Class Codes: A61M 1/984 portable on the body
• CPC Class Codes: A61M 2210/1082 Kidney
• CPC Class Codes: A61M 2210/125 Heart

Abstract

A method and apparatus are provided for treating cardiac tissue to modulate ischemic heart tissue with topical sub-atmospheric pressure to minimize cell death and damage.

Claims

1. A method for treating damaged cardiac tissue using sub-atmospheric pressure, comprising:

i. placing a porous material proximate the damaged cardiac tissue to provide gaseous communication between one or more pores of the porous material and the damaged cardiac tissue, the porous material comprising at least one of an electrospun material, a cast material, an open-cell foam, and a printed material;

ii. sealing the porous material in situ over the damaged cardiac tissue to provide a region about the damaged cardiac tissue for maintaining sub-atmospheric pressure at the damaged cardiac tissue, and locating a bio-incorporable cover over the damaged cardiac tissue and sealing the bio-incorporable cover to cardiac tissue proximate the damaged cardiac tissue;

iii. operably connecting a vacuum source in gaseous communication with the porous material for producing sub-atmospheric pressure at the damaged cardiac tissue; and

iv. activating the vacuum source to provide sub-atmospheric pressure at the damaged cardiac tissue.

2. The method for treating damaged cardiac tissue according to claim 1, wherein the porous material comprises a bio-incorporable material.

3. The method for treating damaged cardiac tissue according to claim 2, wherein the rate of bio-incorporation of the dressing is higher at the periphery of the dressing than at the center of the dressing.

4. The method for treating damaged cardiac tissue according to claim 1, wherein the porous material comprises a polyethylene, polyurethane, polyester material, or combinations thereof.

5. The method for treating damaged cardiac tissue according to claim 1, wherein the step of placing a porous material proximate the damaged cardiac tissue comprises placing a polyvinyl alcohol foam in direct contact with the damaged cardiac tissue.

8. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises myocardial, peripheral muscle cells, or combinations thereof.

9. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the step of operably connecting a vacuum source comprises connecting a tube between the vacuum source and the porous material, the tube having a distal end in contact with the porous material.

10. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the step of placing a porous material proximate the damaged cardiac tissue comprises placing the porous material in direct contact with the damaged cardiac tissue.

11. The method for treating damaged cardiac tissue according to claim 10, wherein the porous material comprises an open-cell foam.

12. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the step of placing a porous material proximate the damaged cardiac tissue comprises placing the porous material in indirect contact with the damaged cardiac tissue by locating a porous intermediate material between the porous material and the damaged heart tissue, with the porous intermediate material disposed in contact with both the porous material and the damaged heart tissue.

13. The method for treating damaged cardiac tissue according to claim 12, wherein the porous material comprises an open-cell foam.

14. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the cover comprises a vacuum port for receiving sub-atmospheric pressure from the vacuum source, and wherein the step of operably connecting a vacuum source in gaseous communication with the porous material comprises connecting the vacuum source with the vacuum port.

15. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the step of sealing the cover to tissue surrounding the damaged cardiac tissue comprises adhesively sealing and adhering the cover to cardiac tissue surrounding the damaged cardiac tissue.

16. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the step of locating a cover comprises locating a self-adhesive sheet over the damaged cardiac tissue, and wherein the step of sealing the cover comprises adhesively sealing and adhering the self-adhesive sheet to cardiac tissue surrounding the damaged cardiac tissue to form a seal between the sheet and surrounding cardiac tissue.

17. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the cover comprises an electrospun material.

18. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the cover comprises a cast material.

19. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the cover comprises collagen.

20. The method for treating damaged cardiac tissue according to claim 17, wherein the cover comprises collagen.

21. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the cover comprises a diol citrate.

22. The method for treating damaged cardiac tissue according to claim 17 wherein the cover comprises a diol citrate.

23. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the cover comprises poly 1,8-octanediol citrate.

24. The method for treating damaged cardiac tissue according to claim 17, wherein the cover comprises poly 1,8-octanediol citrate.

25. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the cover comprises chitosan.

26. The method for treating damaged cardiac tissue according to claim 19, wherein the cover comprises chitosan.

27. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the cover comprises polylactic acid.

28. The method for treating damaged cardiac tissue according to claim 17, wherein the cover comprises polylactic acid.

29. The method for treating damaged cardiac tissue according to claim 1 or 6, comprising maintaining the sub-atmospheric pressure at the damaged cardiac tissue for a time sufficient to decrease edema in the damaged cardiac tissue.

30. The method for treating damaged cardiac tissue according to claim 1 or 6, comprising maintaining the sub-atmospheric pressure at the damaged cardiac tissue for a time sufficient to decrease mediators, degradation products, toxins, or combinations thereof that enhance the inflammatory and pathophysiological response in the damaged cardiac tissue.

31. The method for treating damaged cardiac tissue according to claim 1 or 6, comprising maintaining a sub-atmospheric pressure of about 25 mm Hg below atmospheric pressure at the damaged cardiac tissue.

32. The method for treating damaged cardiac tissue according to claim 1 or 6, comprising maintaining sub-atmospheric pressure of between about 25 and 125 mm Hg below atmospheric pressure at the damaged cardiac tissue.

33. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the step of placing a porous material comprises placing a porous material having pores sufficiently small to prevent the ingrowth of tissue therein.

34. The method for treating damaged cardiac tissue according to claim 33, wherein the step of placing a porous material comprises placing a porous material having a pore size smaller than the size of fibroblasts.

35. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises collagen.

36. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises chitosan.

37. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises polycaprolactone.

38. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises a polyglycolic, polylactic acid, or combinations thereof.

39. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises a porous, open-cell collagen material.

40. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises a porous synthetic polymer material.

41. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises at least one of a porous sheet and a flexible, sheet-like mesh.

42. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises two or more layers, with the layer closest to the damaged cardiac tissue containing pores sufficiently small at the interface between the porous material and the damaged cardiac tissue to prevent the growth of tissue therein.

43. The method for treating damaged cardiac tissue according to claim 42, wherein the porous material comprises a pore size sufficiently large to promote the formation of granulation tissue at other tissues in the spaces surrounding the damaged cardiac tissue.

44. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises pores sufficiently small at the interface between the porous material and the damaged cardiac tissue to prevent the growth of tissue therein.

45. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material comprises a pore size large enough to allow movement of proteins the size of albumin therethrough to permit undesirable compounds to be removed.

46. The method for treating damaged cardiac tissue according to claim 1 or 6, wherein the porous material is sealed to prevent the transmission of sub-atmospheric pressure on all surfaces but one.

47. The method for treating damaged cardiac tissue according to claim 1 or 6, comprising infusing peripheral muscle cells into the damaged cardiac tissue.

48. The method for treating damaged cardiac tissue according to claim 1 or 6, comprising infusing myocardial cells into the damaged cardiac tissue.

49. The method for treating damaged cardiac tissue according to claim 1 or 6, comprising infusing pleuripotent progenitor cells into the damaged cardiac tissue.

6. A method for treating damaged cardiac tissue using sub-atmospheric pressure, comprising:

i. placing a porous bio-incorporable material proximate the damaged cardiac tissue to provide gaseous communication between one or more pores of the porous material and the damaged cardiac tissue;

ii. sealing the porous material in situ over the damaged cardiac tissue to provide a region about the damaged cardiac tissue for maintaining sub-atmospheric pressure at the damaged cardiac tissue, and locating a bio-incorporable cover over the damaged cardiac tissue and sealing the bio-incorporable cover to cardiac tissue proximate the damaged cardiac tissue;

iii. operably connecting a vacuum source in gaseous communication with the porous material for producing sub-atmospheric pressure at the damaged cardiac tissue; and

iv. activating the vacuum source to provide sub-atmospheric pressure at the damaged cardiac tissue.

7. The method for treating damaged cardiac tissue according to claim 6, wherein the rate of bio-incorporation of the dressing is higher at the periphery of the dressing than at the center of the dressing.