Devices and methods for heart valve treatment

• US 7,112,219 B2
• Filed: 11/10/2003
• Issued: 09/26/2006
• Est. Priority Date: 11/12/2002
• Status: Active Grant

• Current Assignee: Edwards Lifesciences LLC (Edwards Lifesciences Corporation)
• Original Assignee: Myocor, Inc. (Edwards Lifesciences Corporation)
• Inventors: Vidlund, Robert M., Mortier, Todd J., Schweich, Cyril J. Jr., Schroeder, Richard, Ekvall, Craig, Kalgreen, Jason, Matthees, Edward, Kusz, David
• Primary Examiner(s): Gherbi, Suzette J-J
• Application Number:
  US10/704,143
• Publication Number:
  US 20040148019A1
• Time in Patent Office: 1,051 Days
• Field of Search: 623 236- 237, 623/2.42, 623/11.11, 623/2.1, 623/23.74, 633/23.74, 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 device for improving heart valve function, the device comprising:

a first anchor;

a second member anchor;

a flexible member configured to connect the first and second anchors, the flexible member being further configured to be positioned adjacent an external surface of a heart wall; and

at least one inflatable protrusion configured to be positioned in contact with an external surface of the heart wall such that the at least one protrusion exerts an inward force against the heart wall proximate a valve,

wherein the inward force is sufficient to alter valve function.

2. The device of claim 1, wherein the device is configured such that the device exerts a force substantially opposite to the inward force by securing the device to the heart wall.

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

4. The device of claim 1, wherein the device is configured such that the device exerts a force substantially opposite to the inward force against anatomical structure outside the heart wall.

5. The device of claim 4, wherein the force exerted substantially opposite the inward force is substantially equal to the inward force.

6. The device of claim 1, wherein the protrusion is expandable.

7. The device of claim 6, wherein the protrusion defines an interior.

8. The device of claim 7, further comprising a coil disposed in the interior of the protrusion.

9. The device of claim 7, further comprising a foam disposed in the interior of the protrusion.

10. The device of claim 7, further comprising a sponge disposed in the interior of the protrusion.

11. The device of claim 7, further comprising a liquid disposed in the interior of the protrusion.

12. The device of claim 11, wherein the liquid is a curable liquid.

13. The device of claim 7, further comprising a mechanical reinforcement member disposed in the interior of the protrusion.

14. The device of claim 7, further comprising means for selectively adding or removing material from the interior.

15. The device of claim 1, wherein the protrusion includes a balloon.

16. The device of claim 14, wherein the means is transdermally accessible.

17. The device of claim 1, wherein the at least one protrusion comprises a plurality of protrusions.

18. The device of claim 17, wherein the plurality of protrusions form an integral structure.

19. The device of claim 17, wherein the plurality of protrusions are separate from each other.

20. The device of claim 17, wherein the plurality of protrusions are arranged so as to avoid cardiac veins and coronary arteries when positioned in contact with the heart wall.

21. The device of claim 1, wherein the at least one protrusion protrudes from the flexible member.

22. The device of claim 1, wherein the at least one protrusion is expandable between a relatively small delivery configuration and a relatively large deployed configuration.

23. The device of claim 1, wherein the device is configured to be delivered to the heart via a delivery catheter.

24. The device of claim 23, wherein the device is configured to be releasably connected to the delivery catheter.

25. The device of claim 1, wherein the at least one protrusion is configured to exert an inward force sufficient to draw leaflets of the valve together.

26. The device of claim 1, wherein the anchors are configured to secure the device to the heart.

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

providing a device comprising a first anchor, a second anchor, a flexible member connecting the first and second anchors, and at least one inflatable protrusion between the first and second anchors

positioning the flexible member adjacent an external surface of a heart wall; and

positioning the at least one inflatable protrusion in contact with an external surface of the heart wall such that the at least one inflatable protrusion exerts an inward force against the heart wall proximate a valve, wherein the inward force is sufficient to alter valve function.

28. The method of claim 27, 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.

29. The method of claim 28, wherein the force exerted substantially opposite the inward force is substantially equal to the inward force.

30. The method of claim 27, 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.

31. The method of claim 30, wherein the force exerted substantially opposite the inward force is substantially equal to the inward force.

32. The method of claim 27, wherein the inward force is sufficient to draw leaflets of the valve together.

33. The method of claim 32, 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.

34. The method of claim 27, wherein the valve is a mitral valve.

35. The method of claim 27, further comprising adjusting a position of the device while observing the valve function.

36. The method of claim 27, wherein the inward force is exerted on an annulus of the valve.

37. The method of claim 27, wherein the inward force is sufficient to reposition papillary muscles of the valve.

38. The method of claim 27, further comprising positioning the device outside the epicardium of the heart.

39. The method of claim 38, further comprising positioning the device between the epicardium and the 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. The method of claim 27, further comprising delivering the device to the heart via a surgical approach.

43. The method of claim 27, further comprising delivering the device to the heart via a subthoracic approach.

44. The method of claim 43, wherein the subthoracic approach includes a subxiphoid approach.

45. The method of claim 43, wherein the subthoracic approach includes a posterior approach.

46. The method of claim 27, further comprising delivering the device via a transluminal approach.

47. The method of claim 46, wherein the transluminal approach is via the superior or inferior vena cava, the right atrium, the coronary sinus, and a cardiac vein.

48. The method of claim 46, wherein the transluminal approach is via the superior or inferior vena cava, into the right atrium or right atrial appendage, through the right atrial wall and into the pericardial space.

49. The method of claim 46, wherein the transluminal approach is via the aorta, into the left ventricle, through the left ventricular wall, and into the pericardial space.

50. The method of claim 46, wherein the transluminal approach is via the azygos vein.

51. The method of claim 46, wherein the transluminal approach is via the esophagus.

52. The method of claim 27, wherein the inward force is exerted throughout the cardiac cycle.