Methods and apparatus for endovascularly replacing a heart valve

• US 8,858,620 B2
• Filed: 06/10/2011
• Issued: 10/14/2014
• 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, Dueri, Jean-Pierre, Valencia, Hans F., Hildebrand, Daniel, Brandt, Brian D., Morejohn, Dwight P., Argento, Claudio, Saul, Tom, Haug, Ulrich R.
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US13/157,733
• Publication Number:
  US 20120016469A1
• Time in Patent Office: 1,222 Days
• Field of Search: 623/2.11, 623/2.18, 623/1.11, 623/1.24, 623/1.26, 606191-198
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/243 Deployment by mechanical expansion
• 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 2/90 characterised by a net-like or mesh-like structure
• 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 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal
• 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-hydraulically expanding or non-pneumatically expanding 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. Another aspect of the invention provides an apparatus including a replacement valve; an anchor; and a deployment tool comprising a plurality of anchor actuation elements adapted to apply a non-hydraulically expanding or non-pneumatically expanding actuation force on the anchor to reshape the anchor.

Claims

1. A system comprising:

an implantable medical device, the implantable medical device is a replacement valve, the replacement valve comprising an expandable anchor configured to be implantable within a patient;

a post engaged to the anchor, a proximal end of the post comprising an actuator attachment element;

at least two release actuators, each release actuator defining lumen;

an actuator extending through the lumen of at least one of the release actuators, a distal end of the actuator comprising a post attachment element comprising a distal protrusion element, the post attachment element configured to releaseably engage the actuator attachment element of the post, the actuator attachment element defines a post hole;

at least one valve engaged to the post; and

wherein the actuator attachment element extends into the lumen of a distal end of the at least one of the release actuators.

2. The system of claim 1, wherein the post hole is substantially round, and wherein the distal protrusion element is a knob or bulb.

3. The system of claim 1, wherein the anchor comprises a braided wire.

4. The system of claim 1 comprising three or more release actuators.

5. The system of claim 4 wherein the three or more release actuators are adapted to apply an actuation force on the proximal portion of the anchor.

6. The system of claim 4 wherein the three or more release actuators are adapted to apply an actuation force on a distal portion of the anchor.

7. The system of claim 1 wherein the post comprises a valve attachment structure.

8. The system of claim 7 wherein the valve attachment structure comprises a plurality of holes formed in the post.

9. The system of claim 7 wherein the valve attachment structure comprises a tab extending from the post.

10. The system of claim 1 wherein the anchor comprises a plurality of anchor lock elements.

11. The system of claim 10 wherein the post comprises a plurality of lock elements adapted to engage the anchor lock elements to lock the anchor in a deployed shape.

12. A system comprising:

an implantable medical device, the implantable medical device is a replacement valve, the replacement valve comprising an expandable anchor configured to be implantable within a patient;

a post engaged to the anchor, a proximal end of the post comprising an actuator attachment element;

at least two release actuators, each release actuator defining a lumen;

an actuator extending through the lumen of at least one of the release actuators, a distal end of the actuator comprising a post attachment element comprising a distal protrusion element, the distal protrusion element is a knob or bulb, the post attachment element configured to releaseably engage the actuator attachment element of the post, the actuator attachment element defines a post hole, the post hole is substantially round;

at least one valve engaged to the post; and

wherein the actuator attachment element extends into the lumen of a distal end of the at least one of the release actuators.

13. The system of claim 12 comprising three or more release actuators.

14. The system of claim 13 wherein the three or more release actuators are adapted to apply an actuation force on the proximal portion of the anchor.

15. The system of claim 13 wherein the three or more release actuators are adapted to apply an actuation force on a distal portion of the anchor.

16. The system of claim 12 wherein the post comprises a valve attachment structure.

17. The system of claim 16 wherein the valve attachment structure comprises a plurality of holes formed in the post.

18. The system of claim 16 wherein the valve attachment structure comprises a tab extending from the post.

19. The system of claim 12 wherein the anchor comprises a plurality of anchor lock elements.

20. The system of claim 19 wherein the post comprises a plurality of lock elements adapted to engage the anchor lock elements to lock the anchor in a deployed shape.