Methods and apparatus for endovascularly replacing a heart valve

• US 9,320,599 B2
• Filed: 09/24/2014
• Issued: 04/26/2016
• Est. Priority Date: 12/23/2003
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Salahieh, Amr, Dueri, Jean-Pierre, Valencia, Hans F., Hildebrand, Daniel K., Brandt, Brian D., Morejohn, Dwight P., Argento, Claudio, Saul, Tom, Haug, Ulrich R.
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US14/494,922
• Publication Number:
  US 20150073540A1
• Time in Patent Office: 580 Days
• Field of Search: 623/1.11, 623/2.1, 623/1.26, 623/2.14, 623/2.18, 606191-194, 606/198
• US Class Current: 1/1
• 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 for endovascularly delivering a heart valve, the system comprising:

an outer delivery sheath;

an implantable replacement valve disposed within the delivery sheath, the valve comprising an expandable anchor configured to be implantable within a patient, the anchor comprising a distal end and a proximal end; and

a deployment tool comprising a first plurality of anchor actuation elements coupled to the distal end or the proximal end of the anchor and adapted to apply a non-hydraulically expanding or non-pneumatically expanding actuation force on the anchor to reshape the anchor, the anchor is foreshortened by applying a distally directed force on the proximal end of the anchor by one or more of the first plurality of anchor actuation elements or the anchor may be foreshortened by applying a proximally directed force on the distal end of the anchor by one or more of the first plurality of anchor actuation elements,

wherein the first plurality of actuation elements are coupled to the proximal end of the anchor,

wherein the first plurality of actuation elements are coupled to the proximal end of the anchor via releasable attachment mechanisms; and

a second plurality of actuation elements coupled to the distal end of the anchor.

2. The system of claim 1 wherein the second plurality of actuation elements are coupled to the distal end of the anchor via releaseable attachment mechanisms.

3. A system for endovascularly delivering a heart valve, the system comprising:

an outer delivery sheath;

an implantable replacement valve disposed within the delivery sheath, the valve comprising an expandable anchor configured to be implantable within a patient, the anchor comprising a distal end and a proximal end;

a deployment tool comprising a first plurality of anchor actuation elements coupled to the distal end or the proximal end of the anchor and adapted to apply a non-hydraulically expanding or non-pneumatically expanding actuation force on the anchor to reshape the anchor; and

a control handle coupled to an inner multi-lumen catheter shaft comprising, the control handle is coupled to first release actuators coupled to the first plurality of actuation elements.

4. The system of claim 3 wherein the control handle comprises a first slot and a first knob disposed within the first slot for manipulating the first plurality of actuation elements.

5. The system of claim 4 wherein the first release actuators are movable relative to the anchor actuation elements via the control handle.

6. The system of claim 3 wherein the control handle is coupled second release actuators coupled to the second plurality of actuation elements.

7. The system of claim 6 wherein the control handle comprises a second slot and a second knob disposed within the slot for manipulating a second plurality of actuation elements coupled to the distal end of the anchor, the first plurality of actuation elements, wherein the first plurality of actuation elements and the second plurality of actuation elements pass through one or more lumens of the multi-lumen shaft.

8. The system of claim 7 wherein the second release actuators are movable relative to the second plurality of actuation elements via the control handle.