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

• US 10,076,318 B2
• Filed: 02/19/2015
• Issued: 09/18/2018
• 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, Levi, Nicole H, Morykwas, Michael J, Jordan, James Eric, Wagner, William D, Liu, Jie
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US14/626,313
• Publication Number:
  US 20150164492A1
• Time in Patent Office: 1,307 Days
• 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. An apparatus for treating damaged cardiac tissue, comprising:

a porous bio-incorporable material for treating damaged cardiac tissue having a pore structure configured to permit gaseous communication between one or more pores of the porous material and the cardiac tissue to be treated;

a cover for placement over the damaged cardiac tissue and porous bio-incorporable material for maintaining sub-atmospheric pressure at the damaged cardiac tissue, wherein the cover comprises a bio-incorporable material; and

a vacuum source for producing sub-atmospheric pressure disposed in gaseous communication with the porous material for distributing the sub-atmospheric pressure to the cardiac tissue to be treated,

wherein the rate of bio-incorporation of the porous material is higher at the periphery of the porous material than at the center of the porous material.

2. The apparatus according to claim 1, wherein the porous material comprises an open-cell foam.

3. The apparatus according to claim 1, where in the porous material comprises myocardial, peripheral muscle cells, or combinations thereof.

4. The apparatus according to claim 1, comprising a porous intermediate material for contacting the damaged heart tissue, the porous intermediate material disposed below and in contact with the porous material.

5. The apparatus according to claim 1, wherein the cover comprises a vacuum port disposed in gaseous communication with the vacuum source for receiving sub-atmospheric pressure from the vacuum source.

6. The apparatus according to claim 1, wherein the cover comprises an adhesive sealing for adhering and sealing the cover to cardiac tissue surrounding the damaged cardiac tissue.

7. The apparatus according to claim 1, wherein the cover comprises a self-adhesive sheet.

8. The apparatus according to claim 1, wherein the cover comprises a cast material.

9. The apparatus according to claim 1, wherein the cover comprises collagen.

10. The apparatus according to claim 1, wherein the cover comprises a diol citrate.

11. The apparatus according to claim 1, wherein the cover comprises poly 1,8-octanediol citrate.

12. The apparatus according to claim 1, wherein the cover comprises chitosan.

13. The apparatus according to claim 1, wherein the cover comprises polylactic acid.

14. The apparatus according to claim 1, wherein the vacuum source is configured to maintain a sub-atmospheric pressure of about 50 mm Hg below atmospheric pressure at the damaged cardiac tissue.

15. The apparatus according to claim 1, wherein the vacuum source is configured to maintain sub-atmospheric pressure of between about 50 and 125 mm Hg below atmospheric pressure at the damaged cardiac tissue.

16. The apparatus according to claim 1, wherein the porous material comprises pores sufficiently small to prevent the ingrowth of tissue therein.

17. The apparatus according to claim 16, wherein the porous material comprises a pore size smaller than the size of fibroblasts.

18. The apparatus according to claim 1, wherein the porous material comprises collagen.

19. The apparatus according to claim 1, wherein the porous material comprises chitosan.

20. The apparatus according to claim 1, wherein the porous material comprises polycaprolactone.

21. The apparatus according to claim 1, wherein the porous material comprises a polyglycolic acid, polylactic acid, or a combination thereof.

22. The apparatus according to claim 1, wherein the porous material comprises a porous, open-cell collagen material.

23. The apparatus according to claim 1, wherein the porous material comprises a porous synthetic polymer material.

24. The apparatus according to claim 1, wherein the porous material comprises at least one of a porous sheet and a flexible, sheet-like mesh.

25. The apparatus according to claim 1, wherein the porous material comprises a cast material, a printed material, or a combination thereof.

26. The apparatus according to claim 1, 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.

27. The apparatus according to claim 26, wherein the porous material comprises a pore size sufficiently large to promote the formation of granulation tissue at a selected surface of the porous material.

28. The apparatus according to claim 1, wherein the porous material comprises pores sufficiently small at a surface of the porous material for placement proximate the damaged cardiac tissue to prevent the growth of tissue therein.

29. The apparatus according to claim 1, 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.

30. The apparatus according to claim 1, wherein the porous material is sealed to prevent the transmission of sub-atmospheric pressure through all surfaces but one.

31. The apparatus according to claim 1, wherein the vacuum source comprises a vacuum pump.

43. The apparatus according to claim 1, wherein the cover comprises an electrospun material.

44. The apparatus according to claim 1, wherein the cover comprises a printed material.

32. A degradable or resorbable vacuum appliance for treating injured or diseased tissues in a body, comprising:

a dressing configured to be implanted in the body, the dressing having a void structure configured to permit the transmission of sub-atmospheric pressure therethrough; and

a bio-incorporable cover configured to be implanted in the body to cover and enclose the dressing to provide a chamber about the dressing in which sub-atmospheric pressure may be maintained,

wherein the rate of bio-incorporation of the dressing is higher at the periphery of the dressing than at the center of the dressing.

33. The vacuum appliance according to claim 32, wherein the dressing comprises a bio-incorporable material.

34. The vacuum appliance according to claim 32, wherein the dressing comprises a cast material, printed material, or a combination thereof.

35. The vacuum appliance according to claim 32, wherein the dressing comprises synthetic molecules.

36. The vacuum appliance according to claim 32, wherein the dressing comprises naturally occurring molecules.

37. The vacuum appliance according to claim 32, wherein the dressing comprises a combination of synthetic and naturally occurring molecules.

38. The vacuum appliance according to claim 32, wherein the cover comprises a cast material.

39. The vacuum appliance according to claim 32, wherein the cover comprises synthetic molecules.

40. The vacuum appliance according to claim 32, wherein the cover comprises naturally occurring molecules.

41. The vacuum appliance according to claim 32, wherein the cover comprises a combination of synthetic and naturally occurring molecules.

42. The vacuum appliance according to claim 32, comprising an evacuation tube in gaseous communication with the dressing.

45. The vacuum appliance according to claim 32, wherein the cover comprises an electrospun material.