Method and system for pericardial enhancement

• US 6,463,332 B1
• Filed: 09/14/2000
• Issued: 10/08/2002
• Est. Priority Date: 09/17/1999
• Status: Expired due to Fees

• Current Assignee: Gateway Edi (Cognizant Technology Solutions Corp.)
• Original Assignee: Core Medical Incorporated
• Inventors: Aldrich, William N.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/661,987
• Time in Patent Office: 754 Days
• Field of Search: 607/96, 607/98, 607/99, 607/100, 607/101, 607/102, 607/104, 607/113, 607/115, 607/120
• US Class Current: 607/101
• CPC Class Codes: A61B 17/320708 Curettes, e.g. hollow scraping instruments
• CPC Class Codes: A61B 18/148 having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
• CPC Class Codes: A61B 2017/00044 Sensing electrocardiography, i.e. ECG
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2018/00291 using suction
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2210/122 Pericardium
• CPC Class Codes: A61M 60/871 Energy supply devices; Converters therefor

Abstract

The invention modifies the pericardium to treat patients suffering from or at risk of heart failure of the type wherein constraining forces of the pericardium around the heart are inadequate to prevent remodeling of the heart. The pericardium is enhanced by restoring, increasing, or improving its ability to restrain the heart and prevent dilation of the chambers of the heart. Methods and apparatus are provided for stiffening, strengthening, tightening, reshaping, and/or shrinking the pericardium to enhance the restraining and supporting capability of the pericardium around the heart. Specific embodiments enhance the pericardium by heating the pericardial tissue using radiofrequency energy and the like, treating the pericardium with a chemical such as glutaraldehyde, plicating the pericardium, or some combination of the above.

Claims

1. A method for treating a patient to inhibit remodeling of the heart, the method comprising modifying pericardial tissue within the heart'"'"'s pericardium under conditions to inhibit remodeling of the heart.

2. A method as in claim 1, wherein the modifying step comprises heating at least a portion of the pericardium.

3. A method as in claim 2, wherein the pericardium is heated under conditions that shrink collagen within the pericardial tissue while retaining tissue viability.

4. A method as in claim 2, wherein the heating step comprises contacting the pericardial tissue with a probe that applies radio frequency energy to the pericardial tissue.

5. A method as in claim 4, wherein the probe is placed in contact with pericardial tissue on an outer surface of the pericardium.

6. A method as in claim 5, further comprising removing fat on the outside of the pericardium.

7. A method as in claim 6, wherein the step of removing fat comprises at least one of mechanically abrading the fat, thermally ablating the fat, applying a fat-dissolving chemical to the fat, or applying a suction to the fat.

8. A method as in claim 4, wherein the probe is placed in contact with the pericardial tissue from within a pericardial space of the heart.

9. A method as in claim 2, wherein the heating step comprises placing a heating element in contact with or in close proximity to the pericardial tissue and circulating a heated fluid through the heating element.

10. A method as in claim 2, wherein the pericardium is heated in a pattern of spaced-apart lines.

11. A method as in claim 10, wherein the spaced-apart lines are in a grid.

12. A method as in claim 2, wherein the entire pericardium is heated.

13. A method as in claim 2, wherein the pericardium is heated selectively below an AV groove of the heart.

14. A method as in claim 2, where the pericardium is heated selectively in a region overlying at least one of the ventricles.

15. A method as in claim 1, further comprising accessing a region of the pericardium.

16. A method as in claim 15, wherein the step of accessing the pericardium comprises at least one of surgically opening a patient'"'"'s chest, forming an intercostal incision, or forming a subxiphoid access channel.

17. A method as in claim 15, wherein the pericardium is accessed transvascularly via the venous system.

18. A method as in claim 1, wherein the modifying step comprises applying a chemical to the pericardial tissue to reduce compliance of the pericardium.

19. A method as in claim 18, further comprising removing the chemical from the patient.

20. A method as in claim 19, wherein the chemical is removed substantially contemporaneously with applying the chemical.

21. A method as in claim 18, wherein the chemical includes glutaraldehyde.

22. A method as in claim 1, wherein the modifying step comprises plicating the pericardium.

23. A method as in claim 22, wherein the plicating step comprises suturing or clipping the pericardium.

24. A method as in claim 1, further comprising stopping the heart while modifying the pericardium.

25. A method as in claim 1, wherein the heart remains beating while modifying the pericardium.

26. A method as in claim 1, further comprising isolating a target region of the pericardium to be modified.

27. A method as in claim 26, wherein the isolating step comprises anchoring a portion of the pericardium surrounding the target region to the myocardium.

28. A method as in claim 27, wherein the anchoring step comprises suturing or clipping the portion of the pericardium surrounding the target region to the myocardium.

29. A method as in claim 27, wherein the anchoring step comprises coupling a ring of the pericardium with the myocardium around an anastomosis.

30. A method as in claim 29, wherein the step of coupling a ring comprises attaching the ring of pericardium to an annular piece of biomedical material and attaching the annular piece of biomedical material to the myocardium around the anastomosis.

31. A method for treating patients suffering from or at risk of heart failure, the method comprising:

providing a device having a heating member;

placing the heating member in contact with or in close proximity to a pericardium of the heart; and

supplying energy to the heating member to cause heating of the pericardium under conditions and for a time selected to reduce or eliminate remodeling of the heart.

32. A method as in claim 31, wherein the heating member includes an electrode and supplying energy to the heating member comprises applying radiofrequency energy through the electrode to the pericardium.

33. A method as in claim 31, wherein the heating member includes a circulation path and supplying energy to the heating member comprises circulating a heated fluid through the circulation path of the heating member.

34. A method as in claim 31, wherein the heating member is placed in contact with or in close proximity to an outside surface of the pericardium.

35. A method as in claim 31, wherein the heating member is placed in contact with or in close proximity to an inside surface of the pericardial sac of the pericardium.

36. A method as in claim 31, wherein the device includes a fluid delivery port and the method further comprises introducing a chemical through the fluid delivery port to the pericardium to reduce compliance of the pericardium.

37. A method as in claim 36, wherein the device includes a suction port and the method further comprises withdrawing through the suction port the chemical introduced to the pericardium.

38. In a method for treating patients suffering from or at risk of heart failure, of the type involving provision of constraint around the heart wherein constraining forces of a pericardium around the heart are inadequate to prevent remodeling of the heart, the improvement comprising modifying pericardial tissue of the pericardium in a manner sufficient to inhibit remodeling of the heart while retaining viability of the heart.

39. A method as in claim 38, wherein the modifying step comprises introducing a stiffening chemical to stiffen the pericardium.

40. A method as in claim 38, wherein the modifying step comprises shrinking at least a portion of the pericardium.

41. A method as in claim 40, wherein the shrinking step comprises applying thermal energy to the pericardium under conditions that shrink collagen within the pericardial tissue while retaining tissue viability.

42. A method as in claim 40, wherein the shrinking step comprises tensioning the pericardium to restrain the heart.

43. A device for treating a pericardium of a heart, the device comprising:

a heating member configured to be placed in contact with or in close proximity to the pericardium, the heating member including a fluid delivery port;

a source of energy coupled with the heating member for providing energy to the heating member to cause heating;

a fluid delivery line extending from the fluid delivery port;

a source of chemical communicating with the fluid delivery line for introducing the chemical through the fluid delivery port to the pericardium, the chemical being configured for stiffening the pericardium.

44. The device of claim 43, further comprising a suction line extending from a suction port, and a vacuum source communicating with the suction line for withdrawing through the suction port the chemical introduced to the pericardium.

45. The device of claim 43, wherein the heating member includes a passive electrode spaced from an active electrode, and wherein the source of energy comprises a radiofrequency source for providing radiofrequency energy through the electrodes to the pericardium.