Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods

• US 9,034,032 B2
• Filed: 07/19/2013
• Issued: 05/19/2015
• Est. Priority Date: 10/19/2011
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: Twelve, Inc. (Medtronic Plc)
• Inventors: McLean, Matt, Morriss, John, Gifford, Hanson III
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US13/946,552
• Publication Number:
  US 20130304200A1
• Time in Patent Office: 669 Days
• Field of Search: 623/2.12
• US Class Current: 623/2.12
• CPC Class Codes: A61B 2017/1157 applying the staples radially
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/006 : modular
• CPC Class Codes: A61F 2250/0069 : Sealing means

Abstract

Devices and methods for implantation at a native mitral valve having a non-circular annulus and leaflets. One embodiment of the device includes a valve support having a first region configured to be attached to a prosthetic valve with a plurality of prosthetic leaflets and a second region. The device can further include an anchoring member having a longitudinal dimension and including a first portion configured to contact tissue at the non-circular annulus, a second portion configured to be attached to the valve support, and a lateral portion between the first portion and the second portion. The second portion of the anchoring member is attached to the second region of the valve support while in a low-profile configuration in which the anchoring member and the valve support are configured to pass through vasculature of a human. The lateral portion is transverse to the longitudinal dimension. The anchoring member and the valve support are configured to move from the low-profile configuration to an expanded configuration in which the first portion of the anchoring member at least partially adapts to the non-circular annulus of the native mitral valve and the first region of the valve support is spaced inwardly from the first portion of the anchoring member relative to the longitudinal dimension of the anchoring member such that a shape of the first region of the valve support is at least partially independent of a shape of the first portion of the anchoring member.

Claims

1. A prosthetic heart valve device for treating a native heart valve having a native annulus and native leaflets, comprising:

a valve support having an upstream region and a downstream region relative to a blood flow direction through a native heart valve of a human heart, the upstream region being configured to support a prosthetic valve, the prosthetic valve having a plurality of leaflets and having an undeformed shape in which the leaflets coapt sufficiently to prevent backflow through the prosthetic valve; and

an anchoring member arranged around a circumference of the valve support and including a connection structure and a fixation portion, the connection structure having an inner end connected to the downstream region of the valve support, an outer end connected to the fixation portion, and an intermediate portion between the inner end and the outer end which flares outwardly from the valve support in a transverse direction relative to the blood flow direction, the fixation portion having an outwardly-facing engagement surface configured to engage tissue at an implant site on or below a native annulus of the native heart valve, the engagement surface extending in a longitudinal direction different than the transverse direction of the connection structure, and the fixation portion having a first cross-sectional shape in an unbiased condition and being deformable into a second cross-sectional shape to adapt to a shape of the tissue at the implant site in a deployed state, wherein the fixation portion of the anchoring member is configured to exert a radially outward force against the native valve annulus that prevents the device from moving in an upstream direction;

wherein the fixation portion of the anchoring member is mechanically isolated from the upstream region of the valve support such that the upstream region of the valve support maintains the undeformed shape if the anchoring member has deformed into the second cross-sectional shape;

wherein the fixation portion comprises a skirt covering an inward-facing surface thereof and the valve support includes a tubular valve cover extending around the valve support, the skirt being attached to the valve cover so as to inhibit blood flow therebetween; and

wherein the valve support comprises a first cylinder and the fixation portion comprises a second cylinder having a larger diameter than the first cylinder in the expanded configuration.

2. The prosthetic heart valve device of claim 1 wherein the connection structure comprises a web extending between the valve support and the fixation portion.

3. The prosthetic heart valve device of claim 1 wherein:

the fixation portion comprises a first frame having a metal struts defining an inner surface and the outwardly-facing engagement surface, and a skirt covering the inner surface of the frame;

the valve support comprises a cylindrically shaped second frame having metal struts and a valve cover extending around the valve support; and

the connection structure comprises metal struts extending laterally from the valve support to the fixation portion.

4. The prosthetic heart valve device of claim 1 wherein the intermediate portion of the connection structure that flares outwardly from the valve support is configured to be disposed entirely downstream of the native annulus when the anchoring member is at the implant site.

5. The prosthetic heart valve device of claim 1 wherein the outer end of the connection structure is an upstream end configured to be positioned below the native annulus when the anchoring member is at the implant site.

6. The prosthetic heart valve device of claim 1 wherein the anchoring member is configured to secure the prosthetic heart valve device in the native annulus against the forces during ventricular systole.

7. The prosthetic heart valve device of claim 1 wherein the anchoring member further comprises tissue engaging elements projecting from the fixation portion, and the anchoring member is configured to engage tissue on a downstream surface of the native annulus so that upstream forces against the prosthetic heart valve device during ventricular systole are resisted by a combination of a resulting upward force against the native annulus, friction between the fixation portion and the native annulus, and engagement of tissue engaging elements with native tissue.

8. The prosthetic heart valve device of claim 1 wherein the longitudinal direction in which the outwardly-facing engagement surface extends is parallel to a longitudinal axis of the anchoring member.

9. The prosthetic heart valve device of claim 1 wherein the outwardly-facing engagement surface tapers inwardly in an upstream direction.

10. The prosthetic heart valve device of claim 1 wherein the connection structure comprises a plurality of struts each having an inner end connected to the valve support and an outer end connected to the anchoring member.

11. The prosthetic heart valve device of claim 1 wherein the outwardly-facing engagement surface is deflectable through a range of angles relative to the connection structure.