Systems and methods for heart valve therapy

• US 9,750,606 B2
• Filed: 03/30/2015
• Issued: 09/05/2017
• Est. Priority Date: 10/23/2014
• Status: Active Grant

• Current Assignee: Caisson Interventional, LLC (LivaNova Plc)
• Original Assignee: Caisson Interventional, LLC (LivaNova Plc)
• Inventors: Ganesan, Kavitha, Venkatasubramanian, Ramji, Forsberg, Andrew T., Schweich, Jr., Cyril J., Mortier, Todd J., Martz, Erik O., Krone, Douglas J.
• Primary Examiner(s): Severson, Ryan J
• Application Number:
  US14/673,055
• Publication Number:
  US 20160113766A1
• Time in Patent Office: 890 Days
• 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 2250/006 modular

Abstract

Prosthetic mitral valves described herein can be deployed using a transcatheter mitral valve delivery system and technique to interface and anchor in cooperation with the anatomical structures of a native mitral valve. This document describes prosthetic heart valve designs that interface with native mitral valve structures to create a fluid seal, thereby minimizing mitral regurgitation and paravalvular leaks. This document also describes prosthetic heart valve designs and techniques to manage blood flow through the left ventricular outflow tract. In addition, this document describes prosthetic heart valve designs and techniques that reduce the risk of interference between the prosthetic valves and chordae tendineae.

Claims

1. A mitral valve replacement system for a heart, comprising:

an expandable anchor assembly configured to implant at a native mitral valve, the expandable anchor assembly including a first expandable frame that is adjustable from a delivery condition to an expanded condition;

a first delivery sheath device having a distal end insertable into a left atrium and being configured to express the anchor assembly out from the distal end such that the anchor assembly expands within the left atrium to the expanded condition;

a pusher instrument releasably attachable to the first expandable frame and being configured to longitudinally advance the anchor assembly within the left atrium towards an annulus of the native mitral valve while the anchor assembly is in the expanded condition; and

an artificial valve assembly comprising a second expandable frame that is slidably engaged with an exterior of the pusher instrument and adjustable from a compressed condition to a deployed condition to selectively engage with the anchor assembly while the anchor assembly is in the expanded condition.

2. The system of claim 1, wherein the anchor assembly comprises a plurality of sub-annular projections configured to engage tissue proximate to the annulus of the native mitral valve while preserving natural function of anterior and posterior leaflets of the native mitral valve.

3. The system of claim 1, further comprising a second delivery sheath device having a distal end insertable into a left atrium and being configured to express the artificial valve assembly out from the distal end such that the artificial valve assembly at least expands within the left atrium.

4. The system of claim 1, wherein the artificial valve assembly comprises a guide structure to slidably engage with an exterior of the pusher instrument while the pusher instrument is releasably attached to the first expandable frame.

5. The system of claim 1, wherein the second expandable frame of the artificial valve assembly is separately expandable from the anchor assembly and further comprises:

a generally D-shaped outer peripheral region, and a circular valve orifice located radially inward from the generally D-shaped outer peripheral region and carrying valve leaflets that define a circular perimeter at the circular valve orifice.

6. The system of claim 1, wherein the artificial valve assembly is releasably coupled to a control catheter that defines a lumen, and wherein the artificial valve assembly is slidably engaged with an exterior of the pusher instrument by slidably disposing the pusher instrument within the lumen of the control catheter.

7. The system of claim 1, further comprising a guidewire slidably disposable within the pusher instrument.

8. A mitral valve replacement system for a heart, comprising:

an expandable anchor assembly configured to implant at a native mitral valve, the expandable anchor assembly including a first expandable frame that is adjustable from a delivery condition to an expanded condition;

a first delivery sheath device having a distal end insertable into a left atrium and being configured to express the anchor assembly out from the distal end such that the anchor assembly expands within the left atrium to the expanded condition;

a pusher instrument releasably attachable to the first expandable frame and being configured to longitudinally advance the anchor assembly within the left atrium towards an annulus of the native mitral valve while the anchor assembly is in the expanded condition;

an anchor assembly control wire slidably disposable within the first delivery sheath device, wherein the anchor assembly control wire is coupled with the anchor assembly; and

an artificial valve assembly comprising a second expandable frame that is adjustable from a compressed condition to a deployed condition to selectively engage with the anchor assembly while the anchor assembly is in the expanded condition.

9. A mitral valve replacement system for a heart, comprising:

an expandable anchor assembly configured to implant at a native mitral valve, the expandable anchor assembly including a first expandable frame that is adjustable from a delivery condition to an expanded condition;

a first delivery sheath device having a distal end insertable into a left atrium and being configured to express the anchor assembly out from the distal end such that the anchor assembly expands within the left atrium to the expanded condition;

a pusher instrument releasably attachable to the first expandable frame and being configured to longitudinally advance the anchor assembly within the left atrium towards an annulus of the native mitral valve while the anchor assembly is in the expanded condition;

a secondary deflectable catheter slidably disposed between the first delivery sheath device and the pusher instrument; and

an artificial valve assembly comprising a second expandable frame that is adjustable from a compressed condition to a deployed condition to selectively engage with the anchor assembly while the anchor assembly is in the expanded condition.

10. The system of claim 9, wherein a distal end portion of the secondary deflectable catheter is controllably laterally deflectable.

11. An implantable medical device delivery system comprising:

a first deflectable catheter defining a first lumen therethrough, wherein a distal end portion of the first deflectable catheter is controllably laterally deflectable;

a first device delivery sheath slidably disposable within the first lumen, the first device delivery sheath defining a second lumen therethrough;

a first device control sheath slidably disposable within the second lumen, the first device control sheath defining a third lumen therethrough and one or more first device control wire lumens;

a second deflectable catheter slidably disposable within the third lumen, the second deflectable catheter defining a fourth lumen therethrough, wherein a distal end portion of the second deflectable catheter is controllably laterally deflectable; and

a device pusher catheter slidably disposable within the fourth lumen, the device pusher catheter defining a fifth lumen therethrough, a distal end portion of the device pusher catheter configured to releasably couple with a first implantable medical device.

12. The delivery system of claim 11, further comprising a guidewire slidably disposable within the fourth lumen.

13. The delivery system of claim 11, further comprising a second device delivery sheath slidably disposable within the first lumen, the second device delivery sheath defining a sixth lumen therethrough.

14. The delivery system of claim 13, further comprising a second device control sheath slidably disposable within the sixth lumen, the second device control sheath defining a seventh lumen therethrough and one or more second device control wire lumens, the distal pusher catheter being slidably disposable within the seventh lumen.

15. The delivery system of claim 14, further comprising a first device control wire slidably disposable within the one or more first device control wire lumens and a second device control wire slidably disposable within the one or more second device control wire lumens.