System and method for cardiac valve repair and replacement

• US 9,561,103 B2
• Filed: 01/31/2014
• Issued: 02/07/2017
• Est. Priority Date: 07/17/2013
• Status: Active Grant

• Current Assignee: Cephea Valve Technologies, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Cephea Valve Technologies, Inc. (Abbott Laboratories Incorporated)
• Inventors: Granada, Juan F., Erzberger, Gary, Corcoran, Michael P., Wallace, Dan, Montorfano, Matteo, Chieffo, Alaide, LaDuca, Robert
• Primary Examiner(s): OU, JING RUI
• Application Number:
  US14/170,407
• Publication Number:
  US 20150025623A1
• Time in Patent Office: 1,103 Days
• Field of Search: 623/2.11, 623/2.1, 623/1.11, 623/1.12
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• 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 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped

Abstract

A method of delivering a prosthetic mitral valve includes delivering a distal anchor from a delivery sheath such that the distal anchor self-expands inside a first heart chamber on a first side of the mitral valve annulus, pulling proximally on the distal anchor such that the distal anchor self-aligns within the mitral valve annulus and the distal anchor rests against tissue of the ventricular heart chamber, and delivering a proximal anchor from the delivery sheath to a second heart chamber on a second side of the mitral valve annulus such that the proximal anchor self-expands and moves towards the distal anchor to rest against tissue of the second heart chamber. The self-expansion of the proximal anchor captures tissue of the mitral valve annulus therebetween.

Claims

1. A method of delivering a prosthetic mitral valve comprising:

securing the prosthetic mitral valve within a delivery device by extending a plurality of elongate retention members of the delivery device through a proximal anchor of the prosthetic mitral valve when the proximal anchor is in an expanded annular configuration and tightening the elongate retention members to pull an outer perimeter of the proximal anchor in the expanded annular configuration proximally away from a distal anchor of the prosthetic mitral valve so as to collapse the proximal anchor from the expanded annular configuration to a collapsed funnel shaped configuration at a proximal end of the distal anchor, wherein the outer perimeter of the proximal anchor when in the expanded annular configuration forms a cinched end of the proximal anchor when in the collapsed funnel shaped configuration;

wherein the elongate retention members pass through a multi-lumen central structure of the delivery device, then through arcs of the proximal anchor, and then back into the multi-lumen central structure;

extending the delivery device into a heart with the prosthetic mitral valve covered by a sheath of the delivery device;

pulling the sheath proximally to expose the distal anchor of the prosthetic mitral valve, thereby allowing the distal anchor to self-expand to an expanded annular configuration on a first side of a mitral valve annulus and directly contact tissue of a ventricular heart chamber;

pulling the valve proximally to seat the distal anchor in the expanded annular configuration against the mitral valve annulus;

pulling the sheath proximally to expose the proximal anchor while maintaining a proximal end of the proximal anchor in the collapsed funnel-shaped configuration with the plurality of elongate retention members after exposing the proximal anchor;

loosening the plurality of elongate retention members of the delivery device so as to allow the proximal anchor to self-expand from the collapsed funnel shaped configuration to the expanded annular configuration on a second side of the mitral valve annulus, the expansion of the proximal anchor causing the proximal anchor to move towards the distal anchor, directly contact tissue of the atrial heart chamber, and capture tissue of the mitral valve annulus between the proximal anchor and the distal anchor, wherein the loosening step occurs at a time after the sheath is pulled to expose the proximal anchor; and

removing the delivery device from the heart.

2. The method of claim 1, further comprising:

tightening the elongate retention members after loosening the elongate retention members so as to collapse the proximal anchor again;

repositioning the proximal anchor to a second location on the second side of the mitral valve annulus; and

loosening the elongate retention members of the delivery device so as to allow the proximal anchor to self-expand into place at the second location on the second side of the mitral valve annulus.

3. The method of claim 1, wherein neighboring elongate retention members extend through neighboring arcs.

4. The method of claim 1, further comprising extending a guidewire down a central lumen of the delivery device before extending the delivery device into the heart.

5. The method of claim 1, wherein tightening and loosening the elongate retention members of the delivery device is performed with a control on a handle of the delivery device.

6. The method of claim 1, wherein self-expanding the proximal anchor to a fully expanded configuration comprises self-expanding the proximal anchor such that it is 10 mm or less from the self-expanded distal anchor.

7. The method of claim 1, wherein the proximal anchor in the expanded annular configuration and the distal anchor in the expanded annular configuration both extend radially outward from a central portion of the prosthetic mitral valve.

8. The method of claim 1, wherein peaks of the arcs form the outer perimeter of the proximal anchor in the expanded annular configuration.