Methods and apparatus for endovascular heart valve replacement comprising tissue grasping elements

• US 8,828,078 B2
• Filed: 09/20/2005
• Issued: 09/09/2014
• Est. Priority Date: 12/23/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Sadra Medical, Inc. (Boston Scientific Corporation)
• Inventors: Salahieh, Amr, Hildebrand, Daniel, Saul, Tom
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): PRESTON, REBECCA STRASZHEIM
• Application Number:
  US11/232,441
• Publication Number:
  US 20060253191A1
• Time in Patent Office: 3,276 Days
• Field of Search: None
• US Class Current: 623/2.17
• 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

A method for endovascularly replacing a patient'"'"'s heart valve including the following steps: endovascularly delivering an anchor and a replacement valve supported within the anchor to a vicinity of the heart valve in a collapsed delivery configuration, the anchor having grasping elements adapted to grasp tissue in a vicinity of the heart valve; expanding the anchor, thereby rotating the grasping elements; and grasping the tissue with the rotating grasping elements.

Claims

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

endovascularly delivering an anchor and a replacement valve supported within the anchor to a vicinity of the heart valve in a collapsed delivery configuration, the anchor comprising a distal end and proximal end, and at least one grasping element adapted to grasp tissue in the vicinity of the heart valve;

deploying the anchor by removing a constraint on the anchor such that the anchor self-expands from the collapsed delivery configuration to a larger diameter at-rest configuration and actively expanding the anchor to an even larger diameter deployed configuration, wherein deploying the anchor comprises rotating the at least one grasping element from a delivery configuration that is substantially parallel with the anchor in the collapsed delivery configuration to a second configuration, wherein in the second configuration the at least one grasping element extends distally from the proximal end of the anchor and wherein in the second configuration the at least one grasping element is at a first angle relative to the anchor, wherein deploying the anchor further comprises positioning the proximal end of the anchor further from a left ventricle than the distal end of the anchor; and

wherein actively expanding the anchor further comprises rotating the at least one grasping element from the second configuration to a third configuration at a second angle with the anchor in the deployed configuration wherein the second angle is larger than the first angle;

grasping the tissue between the at least one grasping element and the anchor.

3. The method of claim 1, further comprising locking the anchor in the deployed configuration after the deploying and grasping steps.

4. The method of claim 1, wherein grasping the tissue between the at least one grasping element and the anchor comprises grasping valve leaflets of the patient'"'"'s heart valve between the at least one grasping element and the anchor.

5. The method of claim 3, wherein grasping valve leaflets further comprises pulling the valve leaflets toward the anchor during diastole.

6. The method of claim 1, further comprising grasping an annulus of the patient'"'"'s heart valve with at least one distal grasping element.

7. The method of claim 1, wherein grasping the tissue comprises grasping valve leaflets of the patient'"'"'s heart valve with the at least one grasping element and grasping an annulus of the patient'"'"'s heart valve with at least one distal grasping element.

8. The method of claim 1, further comprising sealing the at least one grasping element against the tissue.

9. The method of claim 8, wherein sealing the at least one grasping element further comprises capturing at least a portion of a seal between leaflets of the heart valve and a wall of the heart.

10. The method of claim 8, wherein sealing the at least one grasping element further comprises capturing at least a portion of a seal against an annulus of the heart valve.

11. The method of claim 8, wherein sealing the at least one grasping element further comprises reducing blood flow around the replacement valve when the anchor and replacement valve are fully deployed.

12. The method of claim 1, wherein rotating the at least one grasping element comprises moving a first and a second grasping element radially relative to one another.

13. The method of claim 1, wherein rotating the at least one grasping element comprises moving the at least one grasping element laterally relative to at least one distal grasping element.

14. The method of claim 1, wherein grasping the tissue comprises resisting movement of the anchor in at least one direction via the at least one grasping element.

15. The method of claim 1, wherein grasping the tissue comprises grasping the tissue during transition of the anchor from the at-rest configuration to the deployed configuration.

16. The method of claim 1, wherein endovascularly delivering the anchor and the replacement valve further comprises endovascularly delivering the anchor and the replacement valve within a delivery sheath, and wherein removing the constraint on the anchor further comprises deploying the anchor and the replacement valve from the delivery sheath.

17. The method of claim 16, further comprising resheathing the anchor and the replacement valve within the delivery sheath after self-expansion of the anchor to the at-rest configuration.

18. The method of claim 1, wherein grasping the tissue comprises distributing forces applied to the tissue amongst more than one grasping element, thereby reducing a risk of misalignment.

19. The method of claim 1, wherein rotating the at least one grasping element from the delivery configuration to the second configuration comprises allowing the at least one grasping element to self-expand to the second configuration.

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

endovascularly delivering an anchor and a replacement valve supported within the anchor to a vicinity of the heart valve in a collapsed delivery configuration, the anchor comprising a distal end and proximal end, and at least one grasping element adapted to grasp tissue in the vicinity of the heart valve;

deploying the anchor, wherein deploying the anchor comprises rotating the at least one grasping element from a delivery configuration to a second configuration, wherein in the second configuration the at least one grasping element extends distally from the proximal end of the anchor and wherein in the second configuration the at least one grasping element is at a first angle relative to the anchor, wherein deploying the anchor further comprises positioning the proximal end of the anchor further from a left ventricle than the distal end of the anchor; and

removing a constraint on the anchor such that the anchor self-expands from the collapsed delivery configuration to a larger diameter at-rest configuration, wherein removing the constraint on the anchor further comprises rotating the at least one grasping element from a position substantially parallel with the anchor in the delivery configuration to the second configuration; and

actively expanding the anchor to an even larger diameter deployed configuration, wherein actively expanding the anchor further comprises rotating the at least one grasping element from the second configuration to a third configuration at a second angle with the anchor in the deployed configuration, the second angle is larger than the first angle; and

grasping the tissue between the at least one grasping element and the anchor.