Devices and methods for heart valve treatment

• US 7,666,224 B2
• Filed: 07/07/2005
• Issued: 02/23/2010
• Est. Priority Date: 11/12/2002
• Status: Active Grant

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Inventors: Ekvall, Craig, Kalgreen, Jason, Matthees, Edward, Vidlund, Robert M., Mortier, Todd J., Schweich, Cyril J. Jr., Schroeder, Richard, Kusz, David
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US11/175,270
• Publication Number:
  US 20060036317A1
• Time in Patent Office: 1,692 Days
• Field of Search: 623 211- 237, 623/904, 600/16, 600/37
• US Class Current: 623/2.1
• 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 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• CPC Class Codes: A61B 17/1325 with means for applying local pressure pressure pads A61F5/30
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: Y10S 623/904 Heart

Abstract

Devices and methods for improving the function of a valve (e.g., mitral valve) by positioning a spacing filling device outside and adjacent the heart wall such that the device applies an inward force against the heart wall acting on the valve. A substantially equal and opposite force may be provided by securing the device to the heart wall, and/or a substantially equal and opposite outward force may be applied against anatomical structure outside the heart wall. The inward force is sufficient to change the function of the valve, and may increase coaptation of the leaflets, for example. The space filling device may be implanted by a surgical approach, a transthoracic approach, or a transluminal approach, for example. The space filling portion may be delivered utilizing a delivery catheter navigated via the selected approach, and the space filling portion may be expandable between a smaller delivery configuration and a larger deployed configuration.

Claims

1. A method for improving heart valve function, the method comprising:

providing a device comprising at least one expandable protrusion; and

positioning the expandable protrusion in contact with an external surface of the heart wall such that the protrusion exerts an inward force against the heart wall proximate a valve, wherein the force is sufficient to alter valve function and draw leaflets of the valve together, and wherein the valve leaflets define a line of coaptation and positioning the expandable protrusion includes positioning the expandable protrusion such that the inward force is exerted substantially orthogonal to the line of coaptation.

2. The method of claim 1, further comprising positioning the device such that the device exerts a force substantially opposite to the inward force as a result of securing the device to the heart wall.

3. The method of claim 1, further comprising positioning the device such that the device exerts a force substantially opposite to the inward force on anatomical structure external to the heart wall.

4. The method of claim 1, wherein the valve is a mitral valve.

5. The method of claim 1, further comprising adjusting a position of the device while observing the valve function.

6. The method of claim 1, wherein the inward force is exerted on an annulus of the valve.

7. The method of claim 1, wherein the inward force is sufficient to reposition papillary muscles of the valve.

8. The method of claim 1,further comprising positioning the device outside an epicardium of the heart.

9. The method of claim 8, further comprising positioning the device between the epicardium and a pericardium of the heart.

10. The method of claim 9, further comprising attaching the device to the epicardium.

11. The method of claim 10, further comprising maintaining the device free of the pericardium.

12. The method of claim 1, further comprising delivering the device to the heart via a surgical approach.

13. The method of claim 2, wherein the force exerted substantially opposite the inward force is substantially equal to the inward force.

14. The method of claim 3, wherein the force exerted substantially opposite the inward force is substantially equal to the inward force.

15. The method of claim 1, wherein the inward force is exerted throughout the cardiac cycle.

16. A method for improving heart valve function, the method comprising:

providing a device having at least one protrusion; and

positioning the device relative to the heart such that the at least one protrusion is in contact with an external surface of a heart wall and exerts an inward force against the heart wall proximate the valve and such that the device exerts a force substantially opposite to the inward force against an anatomical structure outside the heart wall, wherein the inward force is sufficient to draw leaflets of the valve together, and wherein the valve leaflets define a line of coaptation and positioning the protrusion includes positioning the protrusion such that the inward force is exerted substantially orthogonal to the line of coaptation.

17. The method of claim 16, wherein the at least one protrusion exerts an inward force sufficient to alter valve function.

18. The method of claim 16, wherein the valve is a mitral valve.

19. The method of claim 16, further comprising adjusting a position of the device while observing the valve function.

20. The method of claim 16, wherein the inward force is exerted on an annulus of the valve.

21. The method of claim 16, wherein the inward force is sufficient to reposition papillary muscles of the valve.

22. The method of claim 16, further comprising positioning the device outside an epicardium of the heart.

23. The method of claim 22, further comprising positioning the device between the epicardium and a pericardium of the heart.

24. The method of claim 23, further comprising attaching the device to the epicardium.

25. The method of claim 24, further comprising maintaining the device free of the pericardium.

26. The method of claim 16, further comprising delivering the device to the heart via a surgical approach.

27. The method of claim 16, wherein the force exerted substantially opposite the inward force is substantially equal to the inward force.

28. The method of claim 16, wherein the inward force is exerted throughout the cardiac cycle.

29. A method for treating a heart valve, comprising

providing a passive external heart device having a balloon and an elongate base;

positioning the external heart device adjacent the heart valve;

securing the external heart device to an external surface of a patient'"'"'s heart; and

adjusting a size of the balloon to apply a force on the heart valve, throughout a cardiac cycle, wherein positioning the external heart device adjacent the heart valve includes positioning the external heart device adjacent an atrioventricular groove.

30. The method of claim 29, wherein no portion of the external heart device is placed within a chamber of the patient'"'"'s heart.

31. The method of claim 29, wherein the heart valve is a mitral valve.

32. The method of claim 29, wherein adjusting a size of the balloon includes inflating the balloon.

33. The method of claim 29, further comprising the step of monitoring an effect of the external heart device on the heart valve.

34. The method of claim 29, further comprising the step of positioning the external heart device between an external heart wall and a pericardium.

35. The method of claim 29, wherein securing the external heart device to an external surface of the patient'"'"'s heart includes piercing an external wall of the patient'"'"'s heart.

36. The method of claim 29, wherein the external heart device surrounds a portion of the patient'"'"'s heart.

37. A method of adjusting heart valve function, comprising:

providing a passive external heart device having a chamber and an elongate base;

positioning the external heart device adjacent the heart valve and proximate an atrioventricular groove;

securing the external heart device to an external surface of a patient'"'"'s heart, such that the chamber is disposed between a heart wall and the elongate base;

adjusting a size of the chamber to apply a force on the heart wall, throughout a cardiac cycle; and

monitoring an effect of the external heart device on the heart valve.

38. A method for improving heart valve function, the method comprising:

providing a device comprising at least one expandable protrusion;

positioning the expandable protrusion in contact with an external surface of the heart wall such that the protrusion exerts an inward force against the heart wall proximate a valve, wherein the force is sufficient to alter valve function; and

positioning the device outside an epicardium of the heart.

39. The method of claim 38, further comprising positioning the device between the epicardium and a pericardium of the heart.

40. The method of claim 39, further comprising attaching the device to the epicardium.

41. The method of claim 40, further comprising maintaining the device free of the pericardium.

42. A method for improving heart valve function, the method comprising:

providing a device having at least one protrusion;

positioning the device relative to the heart such that the at least one protrusion is in contact with an external surface of a heart wall and exerts an inward force against the heart wall proximate the valve and such that the device exerts a force substantially opposite to the inward force against an anatomical structure outside the heart wall; and

positioning the device outside an epicardium of the heart.

43. The method of claim 42, further comprising positioning the device between the epicardium and a pericardium of the heart.

44. The method of claim 43, further comprising attaching the device to the epicardium.

45. The method of claim 44, further comprising maintaining the device free of the pericardium.

46. A method for treating a heart valve, comprising

providing a passive external heart device having a balloon and an elongate base;

positioning the external heart device adjacent the heart valve;

securing the external heart device to an external surface of a patient'"'"'s heart;

adjusting a size of the balloon to apply a force on the heart valve, throughout a cardiac cycle; and

positioning the external heart device between an external heart wall and a pericardium.

47. A method for treating a heart valve, comprising

providing a passive external heart device having a balloon and an elongate base;

positioning the external heart device adjacent the heart valve;

securing the external heart device to an external surface of a patient'"'"'s heart; and

adjusting a size of the balloon to apply a force on the heart valve, throughout a cardiac cycle, wherein securing the external heart device to an external surface of the patient'"'"'s heart includes piercing an external wall of the patient'"'"'s heart.