CARDIAC SUPPORT DEVICE

• US 20050119519A9
• Filed: 06/07/2002
• Published: 06/02/2005
• Est. Priority Date: 06/13/2000
• Status: Active Grant

• Current Assignee: Acorn Cardiovascular, Inc.
• Original Assignee: Acorn Cardiovascular, Inc.
• Inventors: Girard, Michael J., Shapland, J. Edward, Palme, Donald F. II
• Granted Patent: US 6,951,534 B2
• Time in Patent Office: Days
• US Class Current: 600/37
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands

Abstract

A highly compliant and elastic cardiac support device is provided. The device is constructed from a biocompatible material is applied to an external surface of a heart. The device can be used to resist dilatation of the heart, to provide acute wall support, or to enhance reduction in the size of the heart using stored potential energy, without interfering with systolic contraction.

Claims

1. A device for treating diseases of a heart, said device comprising:

a biocompatible material sized to surround an external surface of said heart;

said material having an elasticity and a compliance reflecting a tendency to return to a rest state and an ability to deform under strain, respectively;

said elasticity and compliance selected for said material to be placed surrounding said external surface with a tightness selected for energy to be stored in said material to assist chronic remodeling of said heart and to avoid significant acute resistance to diastolic filling of said heart.

2. The device according to claim 1 wherein said remodeling includes a reduction in a volume of said heart.

3. The device according to claim 1 wherein said remodeling includes a specific or directed altering of a shape of said heart.

4. The device according to claim 1 wherein the material has a compliance greater than a compliance of a normal myocardium where compliance is the inverse of stiffness, wherein said biocompatible material conforms to an external surface of the heart and is sized to provide resistance to circumferential expansion of the heart without impeding systolic contraction.

5. The device according to claim 4, wherein the material has a stiffness of less than about 3.8 lbs/in when subjected to a uniaxial load at a strain of less than 30%.

6. The device according to claim 1 wherein the device has a compliance greater than a compliance of a normal latissimus dorsi where compliance is the inverse of stiffness, wherein said biocompatible material conforms to an external surface of the heart and is sized to provide resistance to circumferential expansion of the heart without impeding systolic contraction.

7. The device according to claim 6, wherein the material has a stiffness of less than about 0.5 lbs/in when subjected to a uniaxial load at a strain of less than 30%.

8. The device according to claim 1, wherein the biocompatible material has a stiffness of less than 0.5 lbs/in when subjected to a uniaxial load at a strain of less than 30%.

9. The device according to claim 1, wherein the biocompatible material has a stiffness between about 0.05 lbs/in and about 0.2 lbs/in when subjected to a uniaxial load at a strain of less than 30%.

10. The device according to claim 1, wherein the material has a compliance that allows at least a 3% increase in volume for every 1 mm Hg change in applied pressure.

11. The device according to claim 1, wherein the material has a compliance between about 5%/mm Hg and about 15%/mm Hg.

12. The device according to claim 1, wherein the material is sized to be smaller than the external surface of the heart to which it is applied, wherein the material is configured to exert a pressure on the external surface of the heart that is no greater than an end diastolic pressure of aright ventricle of the heart.

13. The device according to claim 12, wherein the material defines a resting volume and is stretched to provide a stretched volume that is at least 20% greater than the resting volume.

14. The device according to claim 1, wherein the material is sized to be larger than the external surface of the heart to which it is applied and adapted to be sized by adjustment during implantation.

15. The device according to claim 1, wherein the material is capable of an elastic recovery of at least about 50%.

16. The device according to claim 1, wherein the material is capable of an elastic recovery of at least about 70%.

17. The device according to claim 1, wherein said material is configured to cover a ventricular portion of the heart.

18. The device according to claim 1, wherein said material is configured as a jacket having an upper and a lower end, wherein said jacket is open at said upper and defines an internal volume between said upper and lower end capable of receiving the heart.

19. The device according to claim 18, wherein said material is closed at said lower end.

20. The device according to claim 18, wherein said material is open at said lower end.

21. The device according to claim 1, wherein said material is configured to cover at least one ventricle of said heart.

22. The device according to claim 21, wherein said material is configured to cover a left ventricle of said heart.

23. The device according to claim 21, wherein said material is configured to cover a right ventricle of said heart.

24. The device according to claim 21, wherein said material is configured to cover a right and a left ventricle of said heart.

25. The device according to claim 1, wherein said material is configured as a patch.

26. The device according to claim 1, wherein said material comprises intertwined fibers.

27. The device according to claim 26, wherein said material comprises a knit.

28. The device according to claim 26, wherein said material comprises a weave.

29. The device according to claim 1, wherein said material comprises polyethylene terephthalate (PET) or other polymeric or biological materials with said properties.

30. The device according to claim 26, wherein said fibers are crimped.

31. The device according to claim 30, wherein said crimped fibers are produced by stretch texturizing.

32. The device according to claim 31 wherein the fibers consist of a stretch textured polyester or PET or other polymeric materials.

33. The device according to claim 1, wherein said material is configured to apply a pressure to the external surface of the heart at end diastole of less than 10 mm Hg.

34. The device according to claim 1, wherein said material is configured to apply a pressure to the external surface of the heart at end diastole of between about 5 mm Hg and about 7 mm Hg.

35. The device according to claim 1, wherein the material is applied over a pericardium of the heart.

36. The device according to claim 1 further comprising a less compliant material sized to limit diastolic expansion beyond a maximum.

37. A method for treating diseases of a heart, said method comprising:

surgically accessing the heart;

applying a cardiac support device to an external surface of the heart where said cardiac support device includes;

a biocompatible material sized to surround an external surface of said heart;

said material having an elasticity and a compliance reflecting a tendency to return to a rest state and an ability to deform under strain, respectively;

said elasticity and compliance selected for said material to be placed surrounding said external surface with a tightness selected for energy to be stored in said material to assist chronic remodeling of said heart and to avoid significant acute resistance to diastolic filling of said heart.

38. The method according to claim 37 wherein said remodeling includes a reduction in a volume of said heart.

39. The method according to claim 37 wherein said remodeling includes an altering of a shape of said heart.

40. The method according to claim 37 wherein said material has a compliance greater than the compliance of a normal latissimus dorsi, wherein said biocompatible material conforms to an external surface of the heart and is sized to provide resistance to circumferential expansion of the heart without impeding systolic contraction.

41. The method according to claim 37, wherein the material is configured to resist dilatation of the heart.

42. The method according to claim 37, wherein the material is sized to be larger than the external surface of the heart to which it is applied during diastole, said method further comprising a step of adjusting a size of said material to conform to the external surface of the heart.

43. The method according to claim 42, wherein the material is adjusted to exert a pressure on the external surface of the heart of less than about 10 mm Hg.

44. The method according to claim 42, wherein the material is adjusted to exert a pressure on the external surface of the heart of less than about 5 mm Hg.

45. The method according to claim 42, wherein the material is adjusted to exert a pressure on the external surface of the heart of less than about 2 mm Hg.

46. The method according to claim 37, wherein said material is configured to acutely support the external surface of the heart without custom fitting.

47. The method according to claim 46, wherein said material is sized to be smaller than the external surface of the heart to which it is applied during diastole.

48. The method according to claim 47, wherein said material exerts a pressure on the external surface of the heart that is less than an end diastolic pressure of a right ventricle of the heart.

49. The method according to claim 47, wherein said material is configured to impose between about a 5% to about a 10% reduction in maximum diastolic volume of the heart upon implantation.

50. The method according to claim 47, wherein said material is configured to exert a pressure on the external surface of the heart at end diastole between about 2 mm Hg and about 20 mm Hg.

51. The method according to claim 47, wherein said material is configured to exert a pressure on the external surface of the heart at end diastole between about 5 mm Hg and about 15 mm Hg.

52. The method according to claim 47, wherein said material is configured to exert a pressure on the external surface of the heart at end diastole between about 5 mm Hg and about 10 mm Hg.

53. The method according to claim 37, wherein said material is configured to enhance a reduction in a size of the heart.

54. The method according to claim 53, wherein said material is sized to be smaller than the external surface of the heart to which it is applied during diastole.

55. The method according to claim 54, wherein the material defines a resting volume, said method further comprising a step of stretching the material to provide a stretched volume that is at least 20% greater than the resting volume.

56. The method according to claim 55, wherein said material exerts a pressure on the external surface of the heart that is less than an end diastolic pressure of a right ventricle of the heart.

57. The method according to claim 54, wherein said step of stretching the material provides the material with potential energy to mechanically reduce a size of the heart.