Methods and apparatus for endovascularly replacing a heart valve

• US 7,959,666 B2
• Filed: 11/05/2004
• Issued: 06/14/2011
• Est. Priority Date: 12/23/2003
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Sadra Medical, Inc. (Boston Scientific Corporation)
• Inventors: Valencia, Hans F., Hildebrand, Daniel, Brandt, Brian D, Saul, Tom, Morejohn, Dwight P., Argento, Claudio, Haug, Ulrich R., Salahieh, Amr, Dueri, Jean-Pierre
• Primary Examiner(s): Stewart; Alvin J.
• Application Number:
  US10/982,388
• Publication Number:
  US 20050143809A1
• Time in Patent Office: 2,412 Days
• Field of Search: 623/2.11, 623/1.24, 623/1.26, 623/1.11, 623/1.12, 623/2.18, 623/1.1, 623/1.13, 623/1.23, 606191-200
• US Class Current: 623/1.26
• 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 method for endovascularly replacing a heart valve of a patient, the method comprising:

endovascularly delivering a replacement valve secured to an expandable anchor to a vicinity of the heart valve in a delivery configuration;

deploying the anchor from a delivery sheath while maintaining a coupling between a first plurality of actuation elements and a proximal region of the anchor and between a second plurality of actuation elements and a distal region of the anchor;

expanding the anchor by applying an axially directed non-hydraulic or non-pneumatic expanding force on the anchor through at least one of the first and second plurality of anchor actuation elements; and

moving a release actuator relative to at least one of the first and second plurality of actuation elements to thereby uncouple the at least one of the first and second plurality of actuation elements from the anchor.

2. The method of claim 1 wherein expanding the anchor comprises applying a proximally directed force on the anchor through the second plurality of actuation elements.

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

endovascularly delivering a replacement heart valve comprising an expandable anchor and replacement leaflets to a vicinity of a heart valve within a delivery device in a delivery configuration;

deploying the replacement heart valve from the delivery configuration to a deployed configuration within native heart valve leaflets; and

foreshortening the replacement heart valve by applying a distally directed non-hydraulic and non-pneumatic actuation force on a proximal portion of the replacement heart valve with a plurality of replacement heart valve actuation elements, wherein the non-hydraulic and non-pneumatic actuation force is an axially directed force.

4. The method of claim 3, wherein the foreshortening step comprises foreshortening the replacement heart valve by applying the non-hydraulic and non-pneumatic actuation force on the replacement heart valve with a plurality of replacement heart after the expandable anchor is outside of the delivery device.

5. The method of claim 3, wherein the foreshortening step comprises applying a non-hydraulic and non-pneumatic actuation force on a first portion of the replacement heart valve with three actuation elements.

6. The method of claim 3 further comprising locking the replacement heart valve in a foreshortened configuration by mating a first locking element and a second locking element.

7. The method of claim 3 wherein applying a non-hydraulic and non-pneumatic actuation force on the replacement heart valve with a plurality of replacement heart valve actuation elements comprises applying the non-hydraulic and non-pneumatic actuation force on the expandable anchor with a plurality of replacement heart valve actuation elements.

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

endovascularly delivering a replacement heart valve comprising an expandable anchor and replacement leaflets to a vicinity of a heart valve within a delivery device in a delivery configuration;

deploying the replacement heart valve from the delivery configuration to a deployed configuration within native heart valve leaflets; and

foreshortening the replacement heart valve by applying a non-hydraulic and non-pneumatic actuation force on the replacement heart valve with a plurality of replacement heart valve actuation elements, wherein the non-hydraulic and non-pneumatic actuation force is an axially directed force, wherein the axially directed non-hydraulic and non-pneumatic actuation force comprises a distally directed non-hydraulic and non-pneumatic actuation force on the replacement heart valve with the plurality of actuation elements and a proximally directed non-hydraulic and non-pneumatic actuation force on the replacement heart valve with the plurality of actuation elements.

9. The method of claim 8 wherein the plurality of actuation elements are a first plurality of actuation elements, and wherein the foreshortening step comprises applying the distally directed actuation force on the replacement heart valve with the first plurality of actuation elements and applying the proximally directed non-hydraulic and non-pneumatic actuation force on the replacement heart valve with a second plurality of actuation elements.

10. The method of claim 8 wherein the foreshortening step comprises applying the distally directed actuation force on a proximal region of the replacement heart valve with the plurality of actuation elements and applying the proximally directed actuation force on a distal region of the replacement heart valve with the plurality of actuation elements.

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

endovascularly delivering a replacement heart valve comprising an expandable anchor and replacement leaflets to a vicinity of a heart valve within a delivery device in a delivery configuration;

deploying the replacement heart valve from the delivery configuration to a deployed configuration within native heart valve leaflets; and

foreshortening the replacement heart valve by applying a proximally directed non-hydraulic and non-pneumatic actuation force on a distal portion of the replacement heart valve with a plurality of replacement heart valve actuation elements, wherein the non-hydraulic and non-pneumatic actuation force is an axially directed force.