Repositionable heart valve method

• US 8,840,663 B2
• Filed: 12/23/2003
• Issued: 09/23/2014
• Est. Priority Date: 12/23/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Sadra Medical, Inc. (Boston Scientific Corporation)
• Inventors: Salahieh, Amr, Brandt, Brian D., Morejohn, Dwight P., Haug, Ulrich R., Dueri, Jean-Pierre, Valencia, Hans F., Geshlider, Robert A., Krolik, Jeff
• Primary Examiner(s): PREBILIC, PAUL B
• Application Number:
  US10/746,280
• Publication Number:
  US 20050137688A1
• Time in Patent Office: 3,927 Days
• Field of Search: 623/1.26, 623/2.1, 623/2.17
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• 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 2220/0083 using hook and loop-type fasteners
• 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 2250/0039 differing in diameter

Abstract

A method for percutaneously replacing a heart valve of a patient. In some embodiments the method includes the steps of percutaneously delivering a replacement valve and an expandable anchor to a vicinity of the heart valve in an unexpanded configuration; expanding the anchor to a deployed configuration in which the anchor contacts tissue at a first anchor site; repositioning the anchor to a second anchor site; and deploying the anchor at the second anchor site.

Claims

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

endovascularly delivering a replacement heart valve comprising replacement leaflets and an expandable anchor to a vicinity of the heart valve in an unexpanded configuration, in the unexpanded configuration the replacement heart valve is disposed within and coupled to the expandable anchor; and

deploying the anchor to a deployed configuration in which the anchor contacts tissue at a first anchor site by applying a distally directed and proximally directed non-hydraulic and non-pneumatic actuation force on the replacement heart valve after the anchor is completely out of a delivery sheath, wherein applying the distally directed and proximally directed non-hydraulic and non-pneumatic actuation force radially expands the anchor, and wherein, in the deployed configuration, the replacement heart valve is seated within the expandable anchor.

4. The method of claim 1 further comprising releasing the anchor from a deployment tool.

5. The method of claim 1 wherein the delivering step comprises delivering the replacement leaflets coupled to the anchor.

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

7. The method of claim 1 further comprising locking the anchor in an expanded configuration.

8. The method of claim 1 wherein the anchor comprises a proximal region and a distal region and wherein the deploying step comprises expanding the proximal and distal regions separately.

22. The method of claim 1 further comprising locking the anchor, unlocking the anchor, and adjusting its position in an expanded configuration before relocking the anchor and releasing a deployment mechanism.

23. The method of claim 1 further comprising locking the anchor, unlocking the anchor, and adjusting its position in an expanded configuration.

24. The method of claim 1 further comprising locking the anchor and unlocking the anchor.

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

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

deploying the anchor to a deployed configuration in which the anchor contacts tissue at an anchor site at the vicinity of the heart valve by applying a distally directed and a proximally directed non-hydraulic and non-pneumatic actuation force on the replacement heart valve after the anchor is completely outside of a delivery sheath, wherein applying the distally directed and proximally directed non-hydraulic and non-pneumatic actuation force radially expands the anchor;

repositioning the anchor wherein repositioning comprises at least partially contracting the anchor and expanding the anchor.

12. The method of claim 2 wherein the contracting step comprises applying an external non-hydraulic or non-pneumatic actuation force on the anchor.

13. The method of claim 2 further comprising releasing the anchor from a deployment tool.

14. The method of claim 2 wherein the delivering step comprises delivering the replacement leaflets coupled to the anchor.

15. The method of claim 2 wherein the heart valve is an aortic valve and wherein the delivering step comprises endovascularly delivering the expandable anchor and replacement leaflets to the vicinity of the aortic valve along a retrograde approach.

16. The method of claim 2 further comprising locking the anchor in an expanded configuration.

17. The method of claim 2 further comprising registering the anchor with the anchor site.

18. The method of claim 17 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.

19. The method of claim 2 wherein the anchor comprises a proximal region and a distal region and wherein the deploying step comprises expanding the proximal and distal regions separately.

20. The method of claim 2 further comprising visually observing the anchor location.

21. The method of claim 20 wherein the step of observing occurs prior to locking the anchor.

25. The method of claim 2 further comprising locking the anchor, unlocking the anchor, and adjusting its position in an expanded configuration before locking the anchor and releasing a deployment mechanism.

26. The method of claim 2 further comprising locking the anchor, unlocking the anchor, and adjusting its position in an expanded configuration.

27. The method of claim 2 further comprising locking the anchor and unlocking the anchor.

3. 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;

radially expanding the anchor to a deployed configuration in which the anchor contacts tissue at an anchor site in the vicinity of the heart valve by applying an axially directed actuation force on the anchor with a deployment tool, wherein the deployment tool is releasably coupled to the anchor and is adapted to apply a distally and a proximally directed force on the anchor after the anchor is completely out of a delivery catheter;

repositioning the anchor at a second anchor site, wherein repositioning comprises contracting the anchor and re-expanding the anchor;

deploying the anchor at the second anchor site; and

releasing the anchor from the deployment tool.

9. The method of claim 3 wherein the expanding step comprises applying an external non-hydraulic or non-pneumatic actuation force on the anchor.

10. The method of claim 3 further comprising registering the anchor with the anchor site.

11. The method of claim 3 wherein the delivering step comprises delivering the replacement heart valve coupled to the anchor.