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

• US 9,295,552 B2
• Filed: 02/20/2015
• Issued: 03/29/2016
• 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:
  US14/627,566
• Publication Number:
  US 20150164640A1
• Time in Patent Office: 403 Days
• Field of Search: 623/1.24, 623/2.1
• US Class Current: 1/1
• 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 device for replacing a native valve having an annulus and native leaflets, the prosthetic device configured to move from a collapsed configuration to an expanded configuration, the prosthetic device comprising:

a radially collapsible valve support, the valve support having a longitudinal axis and a lumen in the expanded configuration;

a plurality of valve leaflets carried by the valve support and configured to allow blood flow through the lumen in a downstream direction and to block fluid flow through the lumen in an upstream direction when the valve support is in the expanded configuration;

an outer member having, in the expanded configuration, a downstream portion coupled to a downstream portion of the valve support and an upstream portion, the upstream portion of the outer member being a ring-shaped frame in an unbiased expanded state spaced radially outward of the valve support such that an inner wall of the upstream portion of the outer member is separated from the valve support, the upstream portion of the outer member having an outer wall facing laterally and configured to exert an outward force against an inward-facing surface of the native leaflets in the expanded configuration, and the outer member being configured to at least partially conform to a non-circular shape of the annulus; and

an atrial retainer extending from an upstream region of the upstream portion of the outer member and biased into a deployed shape in which the atrial retainer extends radially outwardly from the upstream region of the outer member, and the atrial retainer being configured to inhibit downstream movement of the prosthetic device.

2. The device of claim 1 wherein the outer wall of the upstream portion of the outer member extends in a direction at least substantially along a direction of the lumen of the valve support and the atrial retainer extends transversely with respect to the outer wall.

3. The device of claim 1 wherein, in the deployed shape, the atrial retainer comprises a flange configured to extend over an atrial side of the native annulus and engage a supra-annular surface of the native annulus.

4. The device of claim 1 wherein, in the deployed shape, the atrial retainer is configured to:

extend transversely with respect to the outer wall of the upstream portion of the outer member; and

engage a supra-annular surface in an atrium of the heart and thereby inhibit downstream movement of the prosthetic device.

5. The device of claim 4 wherein the atrial retainer comprises a metallic frame formed by an extension of the outer member.

6. The device of claim 4 wherein the outer wall of the upstream portion of the outer member comprises a vertical portion configured to engage the inward-facing surface of the native annulus in the expanded configuration.

7. The device of claim 1 wherein, in the expanded configuration, the downstream portion of the outer member is configured to be positioned downstream of the native annulus and the outer wall of the upstream portion of the outer-member is configured to be juxtaposed to the inward-facing surface of the native annulus.

8. The device of claim 1 wherein, in the expanded configuration, the downstream portion of the outer member flares radially outwardly from a downstream region of the valve support, and the upstream portion of the outer member comprises a cylindrical ring having the second diameter positioned concentrically around the valve support.

9. The device of claim 1 wherein, in the expanded configuration:

the upstream portion of the outer member comprises a cylindrical ring positioned concentrically around the valve support; and

the atrial retainer comprises a flange extending transversely from an upstream end of the upstream portion.

10. The device of claim 1 wherein the valve support comprises a cylindrically shaped frame that is circular in cross-section.

23. The prosthetic device of claim 1 wherein the second diameter of the upstream portion of the outer member is sized such that an inner wall of the upstream portion of the outer member is separated from the valve support by a gap.

24. The prosthetic device of claim 23, further comprising a fabric that covers the gap between the inner wall of the upstream portion of the outer member and the valve support.

11. A prosthetic device for replacing a native mitral valve having an annulus and native leaflets, the prosthetic device being configured to move from a collapsed configuration to an expanded configuration, and the prosthetic device comprising:

a valve support having a downstream region, an upstream region, and in the expanded configuration a lumen along a longitudinal direction;

a plurality of valve leaflets carried by the valve support and configured to allow blood flow through the lumen in a downstream direction and to block fluid flow through the lumen in an upstream direction when the valve support is in the expanded configuration;

an outer member, the outer member and the valve support being coupled with respect to each other at the downstream region of the valve support, the outer member having a ring-shaped frame in an unbiased expanded state, wherein in the expanded configuration (a) the ring-shaped frame has an upstream area spaced apart from the valve support, and (b) the ring-shaped frame has an outward-facing engagement surface configured to exert an outward force against the native leaflets; and

an atrial retainer, wherein in the expanded configuration the atrial retainer extends transversely with respect to the outward-facing engagement surface and is configured to contact a supra-annular surface of the native mitral valve annulus in an atrium of the heart.

12. The device of 11 wherein, in the expanded configuration:

the outward-facing engagement surface of the ring-shaped frame extends in a direction along the longitudinal direction of the lumen; and

the atrial retainer comprises a flange having a metal frame that is configured to inhibit downstream movement of the prosthetic device.

13. The device of 11 wherein the outward-facing engagement surface of the ring-shaped frame comprises a vertical portion configured to engage the inward-facing surface of the native annulus in the expanded configuration.

14. The device of 11 wherein the outer member further comprises a connection structure coupled to the downstream region of the valve support, and wherein the ring-shaped frame extends from the connection structure.

15. The device of 11 wherein, in the expanded configuration, the ring-shaped frame is positioned concentrically outward from the valve support and the atrial retainer projects radially outwardly from the upstream area of the ring-shaped frame, and wherein the atrial retainer comprises a metal structure configured to inhibit downstream movement of the prosthetic device.

16. The device of 11 wherein, in the expanded state, the ring-shaped frame has a cylindrical shape with a circular cross-section in an unbiased state.

17. A prosthetic device for replacing a native mitral valve of a heart, the native mitral valve having a native annulus with an inward-facing surface and native leaflets, the prosthetic device being configured to move from a collapsed configuration to an expanded configuration, and the prosthetic device comprising:

an expandable inner frame having a downstream section and an upstream section relative to a blood flow direction through the native annulus, and the inner frame having a lumen in the expanded configuration;

a plurality of valve leaflets carried by the inner frame, the valve leaflets being arranged to allow blood flow through the lumen in a downstream direction and to block fluid flow through the lumen in an upstream direction when the valve support is in the expanded configuration;

an outer frame having a first portion and a second portion, the first portion of the outer frame and the inner frame being coupled with respect to each other at the downstream section of the inner frame and the second portion of the outer member being ring-shaped in an unbiased expanded state and having an outward-facing engagement surface, wherein in the expanded configuration the second portion of the outer frame is spaced apart from the inner frame, and wherein the outward-facing engagement surface of the second portion is configured to press outwardly against leaflets; and

an atrial flange extending radially outwardly transverse to the outward-facing engagement surface of the upstream portion in the expanded configuration, and in the expanded configuration the atrial flange being configured to extend over a supra-annular surface of the native mitral valve annulus in the atrium.

18. The device of 17 wherein the first portion of the outer frame comprise a connection structure and the second portion of the outer frame comprises a cylindrical ring-shaped frame.

19. The device of 17 wherein the cylindrical ring-shaped frame comprises a plurality of struts formed in diamond-shaped structural elements.

20. The device of 17 wherein, in the expanded configuration:

the outward-facing engagement surface of the second portion extends in a direction along the blood flow direction; and

the atrial flange comprises a metal frame and is configured to inhibit downstream movement of the prosthetic device.

21. The device of 17 wherein the outward-facing engagement surface comprises a vertical portion configured to engage the inward-facing surface of the native annulus in the expanded configuration.

22. The device of 17 wherein, in the expanded configuration, the second portion of the outer frame comprises a ring-shaped frame positioned concentrically outward from the inner frame and the atrial flange projects radially outwardly from an upstream end of the ring-shaped frame, and wherein the atrial flange comprises a metal structure configured to inhibit downstream movement of the prosthetic device.