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

• US 9,039,757 B2
• Filed: 03/15/2013
• Issued: 05/26/2015
• 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:
  US13/842,785
• Publication Number:
  US 20130325114A1
• Time in Patent Office: 802 Days
• Field of Search: 623/1.24
• US Class Current: 623/1.24
• 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. One embodiment of the device includes a valve support having a first region and a second region, and anchoring member having a longitudinal dimension with 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 transverse to the longitudinal dimension between the first portion and the second portion. The anchoring member and the valve support are configured to move from a 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 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 device for implantation at a native mitral valve, the native mitral valve having a non-circular annulus and leaflets, comprising:

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 extending from the first region, wherein the first region defines an inlet and the second region defines an outlet;

an anchoring member having a longitudinal dimension and including a first portion configured to contact tissue at the non-circular annulus and a second portion having a lateral portion between the first portion and the valve support;

wherein the first 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 second portion of the anchoring member is attached to the valve support while in a low-profile configuration in which the anchoring member and the valve support are configured to be passed through a lumen;

wherein the lateral portion is transverse to the longitudinal dimension and is between the valve support and the first portion of the anchoring member;

wherein 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 is at least partially adaptable 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; and

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

2. The device of claim 1 wherein the first portion of the anchoring member comprises a fixation portion having an outwardly-facing engagement surface.

3. The device of claim 2 wherein the fixation portion extends at least substantially parallel to the longitudinal dimension of the anchoring member.

4. The device of claim 2 wherein the longitudinal dimension is a central longitudinal axis of the anchoring member and the fixation portion extends at an angle inclined inwardly toward the central longitudinal axis.

7. The device of claim 2 wherein the lateral portion comprises a plurality of struts each having an inner end connected to the valve support and an outer end connected to the fixation member.

8. The device of claim 7 wherein the struts flare outwardly in an upstream direction relative to flow through the valve support.

9. The device of claim 8 wherein the flared struts are configured to be disposed entirely downstream of the native annulus when the anchoring member is implanted at a target implant site.

10. The device of claim 2 wherein the lateral portion has an upstream end connected to the fixation portion, and the upstream end of the lateral portion is configured to be positioned below the native annulus when the anchoring member is implanted at a target implant site.

11. The device of claim 2 wherein the fixation portion is deflectable through a range of angles relative to the longitudinal axis such that upon engagement with tissue the fixation portion is movable from an unbiased orientation to an implanted orientation.

12. The device of claim 2 wherein the fixation portion is deflectable through a range of angles relative to the lateral portion.

13. The device of claim 2 wherein the fixation portion has a first flexibility and the lateral portion has a second flexibility.

14. The device of claim 2 wherein the fixation portion has a downstream region with a first flexibility and an upstream region with a second flexibility different than the first flexibility.

15. The device of claim 2 wherein the fixation portion comprises a skirt covering and inward-facing surface thereof.

16. The device of claim 15 wherein the skirt further covers an inward-facing side of the lateral portion.

17. The device of claim 15, further comprising a tubular valve cover extending around the valve support, the skirt being attached to the valve cover so as to inhibit blood flow therebetween.

18. The device of claim 17 wherein the valve cover is disposed on an inward-facing surface of the valve support.

19. The device of claim 1 wherein the second portion of the anchoring member has (a) a first transition zone between the valve support and the lateral portion and (b) a second transition zone between the lateral portion and the first portion of the anchoring member.

20. The device of claim 19 wherein (a) the first portion of the anchoring member comprises a fixation portion, (b) the first transition zone bends from the lateral portion in a downstream direction to the valve support, and (c) the second transition zone bends from the lateral portion in an upstream direction to the fixation portion.

5. A device for implantation at a native mitral valve, the native mitral valve having a non-circular annulus and leaflets, comprising:

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 extending from the first region, wherein the first region defines an inlet and the second region defines an outlet;

an anchoring member having a longitudinal dimension and including a first portion configured to contact tissue at the non-circular annulus and a second portion having a lateral portion between the first portion and the valve support;

wherein the first 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 second portion of the anchoring member is attached to the valve support while in a low-profile configuration in which the anchoring member and the valve support are configured to be passed through a lumen;

wherein the lateral portion is transverse to the longitudinal dimension;

wherein 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 is at least partially adaptable 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, wherein the first portion of the anchoring member comprises a complete ring having a right cylindrical shape and a plurality of barbs projecting from the ring; and

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

6. The device of claim 5 wherein the fixation portion has a height and the outwardly-facing engagement surface is generally flat along the height.