Methods and apparatus for endovascularly replacing a heart valve

• US 7,824,442 B2
• Filed: 11/05/2004
• Issued: 11/02/2010
• 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: Valencia, Hans F., Morejohn, Dwight P., Hildebrand, Daniel, Argento, Claudio, Haug, Ulrich R., Brandt, Brian D., Salahieh, Amr, Dueri, Jean-Pierre, Saul, Tom
• Primary Examiner(s): Stewart; Alvin J.
• Application Number:
  US10/982,692
• Publication Number:
  US 20050137699A1
• Time in Patent Office: 2,188 Days
• Field of Search: 623/1.24, 623/1.26, 623 21- 218, 606192-198
• US Class Current: 623/2.11
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 in an unexpanded configuration within a sheath to a vicinity of the heart valve; deploying the anchor from the sheath; expanding the anchor with a deployment tool comprising a plurality of actuation elements to contact tissue at an anchor site; and retrieving the anchor into the sheath. Another aspect of the invention provides apparatus including a sheath; a deployment tool comprising a plurality of anchor actuation elements; a replacement valve configured to be disposed within the sheath for delivery to a vicinity of the heart valve; and an expandable anchor configured to be disposed within the sheath for delivery to the vicinity of the heart valve, to be deployed from the sheath, to be expanded by the deployment tool to contact tissue at an anchor site and to be retrieved back into the sheath after having been expanded.

Claims

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

providing a replacement heart valve comprising an expandable anchor and replacement leaflets;

providing a delivery system comprising a first plurality of actuation elements and a second plurality of actuation elements;

endovascularly delivering the replacement heart valve in an unexpanded configuration within a sheath to a vicinity of the heart valve while maintaining a releasable coupling of the first plurality of actuation elements to a proximal region of the replacement heart valve and while maintaining a releasable coupling of the second plurality of actuation elements to the replacement heart valve at a location distal to where the first plurality of actuation elements are coupled to the replacement heart valve;

deploying the replacement heart valve from the sheath in the vicinity of the heart valve;

expanding the expandable anchor in the vicinity of the heart valve by applying an axially directed force on the replacement heart valve with at least one of the first plurality of actuation elements and the second plurality of actuation elements, wherein expanding the expandable anchor occurs after deploying the replacement heart valve; and

uncoupling the first plurality of actuation elements and the second plurality of actuation elements from the replacement heart valve after the expanding step to release the replacement heart valve from the delivery system

wherein the expanding step comprises expanding the anchor with at least one of the first plurality of actuation elements and the second plurality of actuation elements without passing any of the first and second plurality of actuation elements through a center opening of the replacement heart valve.

2. The method of claim 1 wherein the expanding step comprises applying a distally directed force on the proximal region of the replacement heart valve with the first plurality of actuation elements.

3. The method of claim 2 wherein the applying step comprises moving the proximal end of the anchor distally.

4. The method of claim 1 wherein the expanding step comprises applying a proximally directed force on a distal region of the replacement heart valve with the second plurality of actuation elements.

5. The method of claim 4 wherein the applying step comprises moving the distal end of the anchor proximally.

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

7. The method of claim 6 wherein the replacement heart valve further comprises first and second lock elements, and wherein the locking step comprises mating the first and second lock elements.

8. The method of claim 7 wherein the locking step further comprises engaging first and second lock element camming surfaces.

9. The method of claim 7 wherein the locking step comprises moving at least one of the first lock element and the second lock element towards the other lock element.

10. The method of claim 6 wherein the locking step comprises operating a lock actuator.

11. The method of claim 6 further comprising unlocking the anchor.

12. The method of claim 11 wherein the unlocking step comprises operating an unlocking actuator.

13. The method of claim 1 wherein the expanding step comprises expanding the anchor with at least one of the first plurality of actuation elements and the second plurality of actuation elements after the anchor is delivered completely outside of the sheath.

14. The method of claim 1 further comprising locking the anchor in an expanded configuration, wherein applying an axially directed force on the replacement heart valve comprises moving a first lock element towards a second lock element to engage the first and second lock elements and thereby lock the anchor in the expanded configuration.

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

providing a replacement heart valve comprising an anchor and replacement leaflets;

providing a delivery system comprising a first plurality of actuation elements and a second plurality of actuation elements;

endovascularly delivering the replacement heart valve in an unexpanded configuration within a sheath to a vicinity of the heart valve while maintaining a releasable coupling of the first plurality of actuation elements to a proximal region of the replacement heart valve and while maintaining a releasable coupling of the second plurality of actuation elements to the replacement heart valve at a location distal to where the first plurality of actuation elements are coupled to the replacement heart valve;

deploying the replacement heart valve from the sheath in the vicinity of the heart valve;

foreshortening the anchor by applying an axially directed force on the replacement heart valve with at least one of the first plurality of actuation elements and the second plurality of actuation elements; and

uncoupling the first plurality of actuation elements and the second plurality of actuation elements from the replacement heart valve to release the replacement heart valve from the delivery system,

wherein the foreshortening step comprises foreshortening the anchor with at least one of the first plurality of actuation elements and the second plurality of actuation elements without passing any of the first and second plurality of actuation elements through a center opening of the replacement heart valve.

16. The method of claim 15 wherein the foreshortening step comprises applying a distally directed force on the proximal region of the replacement heart valve with the first plurality of actuation elements.

17. The method of claim 15 wherein the foreshortening step comprises applying a proximally directed force on a distal region of the replacement heart valve with the second plurality of actuation elements.

18. The method of claim 15 further comprising locking the replacement heart valve in a foreshortened configuration.

19. The method of claim 18 wherein foreshortening the anchor by applying an axially directed force on the replacement heart valve comprises moving a first lock element towards a second lock element and engaging the first and second lock elements to lock the replacement heart valve in the foreshortened configuration.

20. The method of claim 15 wherein the foreshortening step comprises foreshortening the anchor with at least one of the first plurality of actuation elements and the second plurality of actuation elements after the anchor is delivered completely outside of the sheath.