Methods of using pericardial inserts

• US 20080027269A1
• Filed: 03/30/2007
• Published: 01/31/2008
• Est. Priority Date: 04/04/2006
• Status: Abandoned Application

• Current Assignee: Michael Gertner
• Original Assignee: Michael Gertner
• Inventors: Gertner, Michael
• Application Number:
  US11/731,529
• Publication Number:
  US 20080027269A1
• Time in Patent Office: Days
• US Class Current: 600/16
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy

Abstract

Devices, systems and methods are provided which are capable of applying pressure and constraint to the heart and use the pericardium to assist in the application of the pressure and force to the heart.

Claims

1. A method of managing a heart failure patient, the patient anatomically having skin, a costal cartilage, a xiphoid and a heart, the heart comprising a left ventricle, a right ventricle, a left atrium, a right atrium, an epicardium, a pericardium and a pericardial space between the epicardium and the pericardium, the method comprising:

placing a support structure between the epicardium and the pericardium such that a force is transmitted from the pericardium through the support structure to a selected region of the epicardium; and

leaving the support structure in place between the epicardium and the pericardium postoperatively.

2. The method of claim 1 wherein placing the support structure comprises:

placing a guide wire into the pericardial space through a puncture in the skin;

positioning the guide wire over a region of the heart intended to be supported;

delivering the support structure over the guide wire to the pericardial space; and

removing the guide wire.

3. The method of claim 1 wherein placing the support structure comprises:

placing a flexible sheath into the pericardial space through an opening in the skin;

positioning the sheath adjacent to a region of the heart to support;

delivering the support structure through the sheath to the pericardial space; and

removing the sheath.

4. The method of claim 3 wherein the sheath is placed through an incision made in close proximity to the xiphoid.

5. The method of claim 1 wherein the support structure further comprises an extrapericardial extension and wherein the extrapericardial extension further comprises at least one securing portion that secures the support structure outside the pericardium.

6. The method of claim 1 further comprising securing the support structure in place without sutures.

7. The method of claim 1 wherein the support structure is delivered through an opening in the pericardium no larger than about 1.5 cm.

8. The method of claim 1 wherein the pericardium is maintained substantially intact while placing the support structure.

9. The method of claim 1 wherein the support structure is held in place inside the pericardium by friction between the support structure and the pericardium, said friction created by instillation of fluid into the support structure.

10. The method of claim 1 wherein the support structure is expandable.

11. The method of claim 10 wherein the support structure is expandable with a fluid.

12. The method of claim 10 wherein said support structure is constructed to substantially cover one of the ventricles but not the other.

13. The method of claim 11 wherein said fluid expandable support structure is set at the time of implantation to reach a pressure of less than about 20 mm Hg when the heart is expanded during diastole.

14. The method of claim 1 wherein said support structure applies a force substantially only to the left ventricle and not to the right ventricle.

15. The method of claim 1 further comprising the step of adjusting said support structure such that said support structure transmits less than 30 mm Hg to the selected region of the epicardium through transfer of force from the pericardium through the support structure to the selected region of the epicardium.

16. The method of claim 15 wherein said selected region of the epicardium is the left ventricle.

17. The method of claim 15 wherein said selected region of the epicardium includes at least a portion of one of the atria.

18. The method of claim 2 wherein the support structure comprises a plurality of separate segments.

19. The method of claim 18 wherein the plurality of separate segments is delivered over the guide wire one segment at a time.

20. The method of claim 18 further comprising interconnecting the separate segments after they are delivered over the guide wire.

21. The method of claim 20 wherein the separate segments are interconnected by joining magnets located on the segments.

22. The method of claim 1 further comprising removing the support structure at some time post-operatively.

23. The method of claim 1 further comprising post-operative adjustment of said force transmitted between the pericardium and the epicardium by the support structure to modulate a therapeutic effect of the support structure.

24. The method of claim 1 wherein said support structure further comprises an electrical conducting portion and said electrical conducting portion is activateable after implantation to create a desired therapeutic effect.

25. A method of cardiac treatment comprising:

providing an implantable insert having an inflated state and a deflated state;

placing the insert into a patient'"'"'s body in the deflated state and positioning the insert over a selected region of the patient'"'"'s heart;

inflating the insert to put pressure on the selected region without applying substantial pressure to other regions of the heart; and

maintaining pressure in the insert for an extended period of time to create a desired therapeutic effect on the region.

26. The method of claim 25 wherein the desired therapeutic effect comprises inhibiting cardiac dilation of the region.

27. The method of claim 25 wherein the insert is placed between the epicardium and the pericardium.

28. The method of claim 25 flurther comprising deflating and removing the insert.

29. The method of claim 28 wherein pressure is maintained in the insert for at least 1 month before removal.

30. The method of claim 28 wherein pressure is maintained in the insert for at least 6 months before removal.

31. The method of claim 28 wherein pressure is maintained in the insert for at least 2 years before removal.

32. The method of claim 25 wherein pressure is maintained in the insert such that it does not exceed a maximum of about 5 mm Hg.

33. The method of claim 25 wherein pressure is maintained in the insert such that it does not exceed a maximum of about 25 mm Hg.

34. The method of claim 25 wherein pressure is maintained in the insert such that it does not exceed a maximum of about 40 mm Hg.

35. The method of claim 25 wherein a minimum pressure of about 5 mm Hg is maintained in the insert.

36. The method of claim 25 wherein a minimum pressure of about 10 mm Hg is maintained in the insert.

37. The method of claim 25 wherein a minimum pressure of about 20 mm Hg is maintained in the insert.

38. The method of claim 25 wherein a minimum pressure of about 5 mm Hg is maintained in the insert.

39. The method of claim 25 wherein the selected region is the left ventricle.

40. The method of claim 25 further comprising placing a reservoir port in the patient'"'"'s skin and changing the pressure in the insert by adding fluid to or removing fluid from the insert through the port.

41. The method of claim 25 further comprising placing a fluid pump in the patient'"'"'s body in fluid communication with the insert.

42. The method of claim 25 further comprising placing at least one sensor in the patient'"'"'s body for monitoring a parameter associated with the insert.

43. The method of claim 42 wherein the parameter is pressure.

44. The method of claim 42 wherein the parameter is strain.

45. The method of claim 42 wherein the parameter is volume.