SYSTEM AND METHOD FOR CARDIAC VALVE REPAIR AND REPLACEMENT

• US 20150025623A1
• Filed: 01/31/2014
• Published: 01/22/2015
• Est. Priority Date: 07/17/2013
• Status: Active Grant

• Current Assignee: Cephea Valve Technologies, Inc. (Abbott Laboratories)
• Original Assignee: Alaide Chieffo, Dan Wallace, Gary Erzberger, Juan F. Granada, Matteo Montorfano, Michael P. Corcoran, Robert Laduca
• Inventors: GRANADA, Juan F., MONTORFANO, Matteo, CHIEFFO, Alaide, LaDUCA, Robert, ERZBERGER, Gary, CORCORAN, Michael P., WALLACE, Dan
• Granted Patent: US 9,561,103 B2
• Time in Patent Office: Days
• 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 2/2427 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:

delivering a distal anchor from a delivery sheath such that the distal anchor self-expands to a fully expanded configuration inside a ventricular heart chamber on a first side of the mitral valve annulus;

proximally moving the distal anchor by retracting a delivery device to cause the distal anchor to self-align within the mitral valve annulus and directly contact tissue of the ventricular heart chamber; and

delivering a proximal anchor from the delivery sheath to an atrial heart chamber on a second side of the mitral valve annulus so that the proximal anchor self-expands to a fully expanded configuration, wherein the proximal anchor self-expansion causes 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 and distal anchor, and wherein in the fully expanded configuration the proximal anchor is 10 mm or less from the self-expanded distal anchor and is substantially parallel with the fully expanded configuration of the distal anchor.

2. (canceled)

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

securing a prosthetic valve within a delivery device by extending a plurality of wires of the delivery device through a proximal anchor so as to collapse the proximal anchor;

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

pulling the sheath proximally to expose a distal anchor of the prosthetic valve, thereby allowing the distal anchor to self-expand on a first side of the mitral valve annulus in a ventricular heart chamber;

proximally moving the distal anchor by retracting a delivery device to cause the distal anchor to self-align within the mitral valve annulus and directly contact tissue of the ventricular heart chamber;

pulling the sheath proximally to expose the proximal anchor and maintaining a proximal end of the proximal anchor in a collapsed configuration after exposing the proximal anchor;

loosening the wires of the delivery device so as to allow the proximal anchor to self-expand on a second side of the mitral valve annulus in an atrial heart chamber, wherein the loosening step occurs at a time after the sheath is pulled to expose the proximal anchor, and wherein the proximal anchor self-expansion causes 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 and distal anchor, and wherein in the fully expanded configuration the proximal anchor is 10 mm or less from the self-expanded distal anchor and is substantially parallel with the fully expanded configuration of the distal anchor; and

removing the delivery device from the heart.

4. The method of claim 3, further comprising:

tightening the wires after loosening the wires 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 wires 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.

5. The method of claim 3, wherein extending a plurality of wires of the delivery device through a proximal anchor so as to collapse the proximal anchor comprises extending a plurality of wires through arcs of the proximal anchor.

6. The method of claim 5, wherein neighboring retention wires extend through neighboring arcs.

7. The method of claim 3, further comprising extending a guidewire down a central lumen of the delivery device before extending the prosthetic delivery device into the heart.

8. The method of claim 3, wherein tightening and loosening the wires of the delivery device is performed with a control on a handle of the delivery device.

9. A delivery device, comprising:

a central longitudinal structure having a plurality of tubes extending therethrough, each tube having a tubular wall and an aperture in the tubular wall;

a retention wire extending within each tube, each retention wire configured to extend through a portion of a medical device at the aperture;

a sheath configured to fit over and slide relative to the central longitudinal structure and the medical device;

a handle connected to the central longitudinal structure; and

a control on the handle configured to tighten the wires to collapse at least a portion of the medical device and to loosen the wires to expand the portion of the medical device.

10. The delivery device of claim 9, further comprising a central lumen extending through the central longitudinal structure, the central lumen configured to house a guidewire.

11. The delivery device of claim 9, wherein the retention wires are made of nitinol or liquid crystal polymer fiber.

12. The delivery device of claim 9, wherein there are between 4 and 20 retention wires and tubes.

13. The delivery device of claim 9, further comprising a tapered distal tip connected to the central longitudinal structure.

14. The delivery device of claim 9, wherein the control is further configured to retighten the wires after loosening to collapse the portion of the medical device again.

15. The delivery device of claim 9, wherein the aperture is a side aperture.

16. (canceled)

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

providing a prosthetic valve within a delivery device such that a plurality of wires of the delivery device extend through a proximal anchor and maintain the proximal anchor in a collapsed configuration;

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

pulling the sheath proximally to expose a distal anchor of the prosthetic valve, thereby allowing the distal anchor to self-expand on a first side of the mitral valve annulus in a ventricular heart chamber;

proximally moving the distal anchor by retracting a delivery device to cause the distal anchor to self-align within the mitral valve annulus and directly contact tissue of the ventricular heart chamber;

pulling the sheath proximally to expose the proximal anchor and maintaining a proximal end of the proximal anchor in a collapsed configuration after exposing the proximal anchor;

loosening the wires of the delivery device so as to allow the proximal anchor to self-expand on a second side of the mitral valve annulus in an atrial heart chamber, wherein the proximal anchor self-expansion causes 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 and distal anchor, and wherein in the fully expanded configuration the proximal anchor is 10 mm or less from the self-expanded distal anchor and is substantially parallel with the fully expanded configuration of the distal anchor, and

wherein loosening the wires occurs at a time after the sheath is pulled proximally to expose the proximal anchor and comprises retracting distal ends of each of the plurality of wires from a position distal to a proximal end of the proximal anchor to a position proximal to the proximal end of the proximal anchor.