Methods and Apparatus for Endovascular Heart Valve Replacement Comprising Tissue Grasping Elements

• US 20120029627A1
• Filed: 09/22/2011
• Published: 02/02/2012
• 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: Salahieh, Amr, Hildebrand, Daniel, Saul, Tom
• Application Number:
  US13/240,784
• Publication Number:
  US 20120029627A1
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• 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 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

The present invention provides an apparatus for endovascularly replacing a patient'"'"'s heart valve. In some embodiments, the apparatus includes an expandable anchor supporting a replacement valve, the anchor and replacement valve being adapted for percutaneous delivery and deployment to replace the patient'"'"'s heart valve, the anchor having a braid having atraumatic grasping elements adapted to grasp tissue in a vicinity of the patient'"'"'s heart valve.

Claims

1-19. -19. (canceled)

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

an expandable anchor supporting a valve, the anchor and the valve being adapted for percutaneous delivery and deployment, the anchor having a proximal end, a distal end, a longitudinal axis, and an outer surface, the anchor being expandable from a collapsed delivery configuration to a fully deployed configuration; and

a proximal set of grasping elements attached to the expandable anchor and a distal set of grasping elements attached to the expandable anchor, wherein the proximal set of grasping elements is axially spaced apart from the distal set of grasping elements.

21. The apparatus of claim 20, wherein the grasping elements of the proximal set of grasping elements are attached to the expandable anchor near the proximal end of the expandable anchor and extends distally therefrom.

22. The apparatus of claim 21, wherein the grasping elements of the distal set of grasping elements are attached to the expandable anchor distally of the proximal set of grasping elements and extends distally therefrom.

23. The apparatus of claim 21, wherein the grasping elements of the distal set of grasping elements are attached to the expandable anchor near the distal end of the expandable anchor and extend proximally therefrom.

24. The apparatus of claim 20, wherein when the anchor is in the fully deployed configuration, the proximal set of grasping elements are adapted to grasp wall tissue, and the distal set of grasping elements are adapted to grasp native valve leaflets.

25. The apparatus of claim 20, wherein each of the proximal set of grasping elements and the distal set of grasping elements comprises a plurality of grasping elements circumferentially disposed about the anchor.

26. The apparatus of claim 20, wherein in the collapsed delivery configuration, the proximal set of grasping elements and the distal set of grasping elements each lie against the outer surface of the expandable anchor.

27. The apparatus of claim 20, wherein the anchor has an at-rest configuration between the collapsed delivery configuration and the fully deployed configuration, and, in the at-rest configuration, at least one grasping element of the proximal set of grasping elements is positioned at a first angle relative to the outer surface of the expandable anchor and at least one grasping element of the distal set of grasping elements is positioned at a first angle relative to the outer surface of the expandable anchor.

28. The apparatus of claim 27, wherein the first angle of the at least one grasping element of the proximal set of grasping elements is the same as the first angle of the at least one grasping element of the distal set of grasping elements.

29. The apparatus of claim 27, wherein the first angle of the at least one grasping element of the proximal set of grasping elements is different than the first angle of the at least one grasping element of the distal set of grasping elements.

30. The apparatus of claim 27, wherein, in the fully deployed configuration, at least one grasping element of the proximal set of grasping elements is positioned at a second angle relative to the outer surface of the expandable anchor, the second angle of the at least one grasping element of the proximal set of grasping elements being greater than the first angle of the at least one grasping element of the proximal set of grasping elements.

31. The apparatus of claim 27, wherein, in the fully deployed configuration, at least one grasping element of the distal set of grasping elements is positioned at a second angle relative to the outer surface of the expandable anchor, the second angle of the at least one grasping element of the distal set of grasping elements being greater than the first angle of the at least one grasping element of the distal set of grasping elements.

32. The apparatus of claim 20, wherein the outer surface of the expandable anchor is a braided outer surface.

33. The apparatus of claim 20, further comprising a seal disposed about at least a portion of the outer surface of at least one grasping element.

34. The apparatus of claim 33, wherein the seal is disposed about at least a portion of the outer surface of the grasping elements of only the distal set of grasping elements.

35. The apparatus of claim 33, wherein the seal the seal covers at least a portion of the outer surface of the proximal set of grasping elements and the outer surface of the distal set of grasping elements and extends between the proximal set of elements and the distal set of elements.

39. The system of claim 35, wherein the first set of grasping elements is attached to the expandable anchor near the proximal end of the expandable anchor and the grasping elements of the first set of grasping elements extend distally therefrom, and wherein the second set of grasping elements is attached to the expandable anchor distally of the first set.

36. A system for endovascularly replacing a patient'"'"'s heart valve, an apparatus comprising:

an expandable anchor supporting a valve, the anchor and the valve being adapted for percutaneous delivery and deployment, the anchor having a proximal end, a distal end, a longitudinal axis, and an outer surface, the anchor being expandable from a collapsed delivery configuration to a fully deployed configuration;

a first set of grasping elements attached to the expandable anchor and a second set of grasping elements attached to the expandable anchor, wherein the first set of grasping elements is axially spaced apart from the second set of grasping elements; and

a sheath disposed about the expandable anchor, wherein in the collapsed delivery configuration, the first set of grasping elements and the second set of grasping elements each lie against the outer surface of the expandable anchor.

37. The system of claim 36, wherein when the sheath is retracted, the expandable anchor, the first set of grasping elements attached to the expandable anchor, and the second set of grasping elements self-expand;

and wherein the first set of grasping elements moves laterally away from the second set of grasping elements.

38. The system of claim 37, wherein when the sheath is fully retracted, the anchor has an at-rest configuration, and, in the at-rest configuration, at least one grasping element of the first set of grasping elements is positioned at a first angle relative to the outer surface of the expandable anchor and at least one grasping element of the distal set of grasping elements is positioned at a second angle relative to the outer surface of the expandable anchor.