Externally expandable heart valve anchor and method

• US 20050137686A1
• Filed: 12/23/2003
• Published: 06/23/2005
• Est. Priority Date: 12/23/2003
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Sadra Medical, Inc. (Boston Scientific Corporation)
• Inventors: Krolik, Jeff, Valencia, Hans F., Morejohn, Dwight P., Haug, Ulrich R., Brandt, Brian D., Geshlider, Robert A., Salahieh, Amr, Dueri, Jean-Pierre
• Application Number:
  US10/746,120
• Publication Number:
  US 20050137686A1
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/006 modular

Abstract

The invention includes methods of and apparatus for endovascularly replacing a heart valve of a patient. One aspect of the invention provides a method including the steps of endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve in an unexpanded configuration; and applying an external non-hydraulic or non-pneumatic actuation force on the anchor to change the shape of the anchor, such as by applying proximally and/or distally directed force on the anchor using a releasable deployment tool to expand and contract the anchor or parts of the anchor.

Claims

1. A method for endovascularly replacing a heart valve of a patient, the method comprising:

endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve in an unexpanded configuration; and

applying an external non-hydraulic or non-pneumatic actuation force on the anchor to change the shape of the anchor.

2. The method of claim 1 wherein the replacement valve is coupled to the anchor, the delivering step comprising endovascularly delivering the coupled anchor and replacement valve to the vicinity of the heart valve.

3. The method of claim 2 wherein the delivering step comprises endovascularly delivering the anchor and replacement valve to the vicinity of the heart valve in a catheter having a diameter no more than 21 french.

4. The method of claim 1 wherein the heart valve comprises an aortic valve, the delivering step comprising endovascularly delivering the expandable anchor and replacement valve to the vicinity of the aortic valve along a retrograde approach.

5. The method of claim 1 wherein the applying step comprises applying a proximally directed force on the anchor.

6. The method of claim 5 wherein the step of applying a proximally directed force comprises applying a proximally directed force on the anchor to move a distal end of the anchor proximally.

7. The method of claim 5 wherein the step of applying a proximally directed force comprises applying a proximally directed force on the anchor to move a distal end of the anchor proximally to expand the anchor.

8. The method of claim 5 wherein the step of applying a proximally directed force comprises applying a proximally directed force on the anchor to move a proximal end of the anchor proximally.

9. The method of claim 5 wherein the step of applying,a proximally directed force comprises applying a proximally directed force on the anchor to move a proximal end of the anchor proximally to contract the anchor.

10. The method of claim 1 wherein the applying step comprises applying a distally directed force on the anchor.

11. The method of claim 10 wherein the step of applying a distally directed force comprises applying a distally directed force on the anchor to move a proximal end of the anchor distally.

12. The method of claim 10 wherein the step of applying a distally directed force comprises applying a distally directed force on the anchor to move a proximal end of the anchor distally to expand the anchor.

13. The method of claim 1 further comprising applying a radially outwardly directed force on the anchor to expand the anchor.

14. The method of claim 13 wherein the step of applying a radially outwardly directed force comprises expanding a balloon within the anchor.

15. The method of claim 14 wherein the step of expanding a balloon comprises expanding a balloon to apply a force of at least one pound on tissue surrounding the anchor.

16. The method of claim 1 wherein the applying step comprises applying the external non-hydraulic or non-pneumatic actuation force on the anchor to expand the anchor.

17. The method of claim 16 further comprising locking the anchor in an expanded configuration.

18. The method of claim 17 wherein the locking step comprises releasing a lock prevention element.

19. The method of claim 1 further comprising permitting the anchor to self-expand prior to applying the actuation force.

20. The method of claim 1 further comprising registering the anchor with an anatomical landmark in an anchor location and deploying the anchor at the anchor location.

21. The method of claim 20 wherein the registering step comprises contacting tissue of the heart valve to resist movement of the anchor in at least a proximal or a distal direction prior to deploying the anchor.

22. The method of claim 21 wherein the contacting step comprises contacting a native valve leaflet with a registration element extending from a catheter.

23. The method of claim 21 wherein the contacting step comprises contacting a native valve leaflet with registration element extending from the anchor.

24. The method of claim 1 further comprising expanding the anchor to apply 1 to 2 pounds of anchoring force on tissue surrounding the anchor.

25. The method of claim 24 further comprising locking the anchor after the expanding step.

26. The method of claim 25 wherein the locking step comprises releasing a lock prevention element.

27. Apparatus for endovascularly replacing a patient'"'"'s heart valve comprising:

a replacement valve;

an anchor; and

a deployment tool adapted to apply a non-hydraulic or non-pneumatic actuation force on the anchor to reshape the anchor.

28. The apparatus of claim 27 wherein the deployment tool is adapted to deliver a proximally directed actuation force on the anchor.

29. The apparatus of claim 28 wherein the deployment tool comprises a control member adapted to move a distal end of the anchor proximally.

30. The apparatus of claim 28 wherein at least a portion of the anchor is adapted to expand in response to application of the proximally directed actuation force.

31. The apparatus of claim 28 wherein the deployment tool comprises a control member adapted to move a proximal end of the anchor proximally.

32. The apparatus of claim 28 wherein at least a portion of the anchor is adapted to contract in response to application of the proximally directed actuation force.

33. The apparatus of claim 27 wherein the deployment tool is adapted to deliver a distally directed actuation force on the anchor.

34. The apparatus of claim 33 wherein the deployment tool comprises a control member adapted to move a proximal end of the anchor distally.

35. The apparatus of claim 33 wherein at least a portion of the anchor is adapted to expand in response to application of the distally directed actuation force.

36. The apparatus of claim 27 further comprising a releasable connection between the deployment tool and the anchor.

37. The apparatus of claim 27 wherein the anchor comprises self-expanding shape memory material.

38. The apparatus of claim 27 further comprising an anchor lock adapted to lock the anchor in a deployed configuration.

39. The apparatus of claim 38 further comprising a lock prevention element actuatable from outside the patient.

40. The apparatus of claim 27 wherein the anchor comprises barbs adapted to penetrate tissue when the anchor is in an expanded configuration.

41. The apparatus of claim 27 further comprising a registration element adapted to determine a position of the replacement valve with respect to the heart valve.

42. The apparatus of claim 41 further comprising a catheter adapted to deliver the anchor and the replacement valve to a vicinity of the heart valve, the registration element being disposed on the catheter.

43. The apparatus of claim 41 wherein the registration element is disposed on the anchor.

44. The apparatus of claim 41 wherein the registration element is adapted to extend radially outward from the anchor to entrap at least part of the heart valve.

45. Apparatus for endovascularly replacing a patient'"'"'s heart valve, the apparatus comprising:

an anchor having a collapsed delivery configuration and an expanded deployed configuration; and

a replacement valve coupled to the anchor,

wherein the anchor comprises enhanced radial strength in the expanded deployed configuration as compared to the collapsed delivery configuration due to imposed foreshortening.

46. The apparatus of claim 45 further comprising a locking mechanism for maintaining imposed foreshortening.

47. The apparatus of claim 46, wherein the apparatus is configured for retrieval prior to actuation of the locking mechanism.

48. The apparatus of claim 46, wherein the locking mechanism is configured to maintain a degree of imposed foreshortening selected in vivo.

49. The apparatus of claim 45 further comprising a delivery system configured for percutaneous delivery, deployment and foreshortening of the anchor.

50. The apparatus of claim 49 further comprising a leaflet engagement element coupled to the delivery system to provide positive registration of the apparatus relative to an anatomical landmark.

51. The apparatus of claim 49, wherein the delivery system is releasably coupled to the anchor in a manner facilitating dynamic repositioning and retrieval of the anchor post-deployment.

52. The apparatus of claim 45, wherein the anchor is at least partially covered by a biocompatible film.

53. The apparatus of claim 45, wherein the replacement valve comprises a valve chosen from the group consisting of mechanical valves, biologic valves, and combinations thereof.

54. The apparatus of claim 45, wherein the anchor is fabricated from materials chosen from the group consisting of self-expanding materials, balloon-expandable materials, and combinations thereof.

55. The apparatus of claim 45, wherein the anchor further comprises barbs adapted to engage tissue at the heart valve when the anchor is disposed in the expanded deployed configuration.

56. The apparatus of claim 45 further comprising a leaflet engagement element coupled to the anchor to provide positive registration of the apparatus relative to anatomical landmarks.

57. The apparatus of claim 45, wherein the anchor further comprises an element configured to reduce paravalvular leakage or regurgitation.

58. A method for endovascularly replacing a patient'"'"'s heart valve, the method comprising:

providing apparatus comprising an expandable anchor having a replacement valve coupled thereto;

endovascularly delivering the apparatus to a vicinity of the heart valve in a collapsed delivery configuration;

expanding the apparatus to a partially deployed configuration; and

actively foreshortening the anchor to a fully deployed configuration comprising enhanced radial strength, such that the anchor displaces the patient'"'"'s heart valve, and the replacement valve regulates blood flow.

59. The method of claim 58 further comprising maintaining imposed foreshortening via a locking mechanism.

60. The method of claim 58 further comprising dynamically repositioning the apparatus.

61. The method of claim 58 further comprising retrieving the apparatus.

62. The method of claim 58 further comprising positively registering the apparatus relative to anatomical landmarks.

63. The method of claim 58, wherein endovascularly delivering the apparatus further comprises endovascularly delivering the apparatus in a retrograde fashion.

64. (Canceled)

65. (Canceled)