PROSTHETIC HEART VALVE DEVICES, PROSTHETIC MITRAL VALVES AND ASSOCIATED SYSTEMS AND METHODS

• US 20150335424A1
• Filed: 07/31/2015
• Published: 11/26/2015
• 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
• Granted Patent: US 10,052,204 B2
• Time in Patent Office: Days
• 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 heart valve device for treating a mitral valve of a human heart having a native annulus and native leaflets, comprising:

a valve support having an upstream region and a downstream region;

a prosthetic valve within the valve support; and

an anchoring member having a connection structure and a fixation portion, the connection structure being attached to the valve support and at least a portion of the connection structure extends laterally outward from the valve support in a deployed state, the fixation portion having an annular engagement surface configured to engage an inner surface of the native annulus; and

wherein the fixation portion is configured to deflect with respect to the connection structure inwardly toward the valve support in the deployed state when the annular engagement surface engages the inner surface of the native annulus.

2. The device of claim 1 wherein the connection structure is attached to the downstream region of the valve support and the fixation portion deflects inwardly toward the valve support in the deployed state when it engages the inner surface of the native annulus such that an upstream end of the fixation portion is closer to the valve support than a downstream end of the fixation portion.

3. The device of claim 1 wherein the upstream region of the valve support has an upstream end and the engagement surface has an upstream end, and the upstream end of the valve support and the upstream end of the engagement surface are at approximately the same elevation in the deployed state.

4. The device of claim 1 wherein the valve support comprises an inner annular frame and the fixation portion comprises an outer annular frame spaced radially outward apart from the inner annular frame in the deployed state.

5. The device of claim 4 wherein the outer annular frame is configured to exert a radially outward force against an inner surface of the native annulus that secures the device to the native annulus during ventricular systole without tethers.

6. The device of claim 5 wherein the outer annular frame has a downstream end and an upstream end, and the outer frame is configured such than the downstream end is below the native annulus and the upstream end is proximate the native annulus in the deployed state.

7. The device of claim 4 wherein the inner annular frame and the outer annular frame extend in a longitudinal direction in an unbiased expanded state, and wherein the outer annular frame is deflectable up to 30°

inwardly from the longitudinal direction in the deployed state.

8. The device of claim 4 wherein the outer annular frame has a downstream end, an upstream end, and a height between the downstream and upstream ends of 10 mm-20 mm.

9. The device of claim 8 wherein the outer annular frame has a first flexibility and the connection structure has a second flexibility different than the first flexibility.

10. The device of claim 4 wherein the inner annular frame is a first right cylinder and the outer annular frame is a second right cylinder surrounding the first right cylinder.

11. The device of claim 4 wherein the outer annular frame has tissue engaging elements projecting outwardly from the engagement surface in an upstream direction.

12. A prosthetic heart valve device for treating a mitral valve of a human heart having a native annulus and native leaflets, comprising:

an inner frame with an upstream region and a downstream region relative to a direction of blood flow through the inner annular frame;

a prosthetic valve within the inner frame; and

an anchoring member having an outer frame including a downstream section, an upstream section, and an outwardly facing engagement surface configured to engage an inwardly facing surface of the native annulus in a deployed state;

wherein the anchoring member is configured such that, when the engagement surface engages the inwardly facing surface of the native annulus in the deployed state, the downstream section of the outer frame is spaced radially outward from the downstream portion of the inner frame by a first distance and the upstream section of the outer frame is spaced radially apart from the upstream portion of inner frame by a second distance less than the first distance.

13. The device of claim 12 wherein the anchoring member further comprises a connection structure attached to the downstream portion of the inner frame, and the outer frame comprises an annular ring extending upstream from the connection structure to an elevation at least proximate the upstream region of the inner frame.

14. The device of claim 13 wherein the anchoring member further comprises a connection structure attached to the downstream portion of the inner frame, and the annular ring extends proximally from the connection structure and is configured to deflect inwardly toward the inner frame when the engagement surface exerts the radially outward force against the inner surface of the native annulus.

15. The device of claim 12 wherein the anchoring member further comprises a connection structure attached to the downstream portion of the inner frame, and the inner frame and the outer frame extend in a longitudinal direction in an unbiased expanded state, and wherein the outer frame is deflectable through a range of angles such that the outer frame inclines inwardly from the connection structure toward the inner frame in the deployed state.

16. The device of claim 12 wherein the outer frame has a downstream end, an upstream end, and a height between the downstream and upstream ends of 10 mm-20 mm.

17. The device of claim 16 wherein the outer frame is configured to deflect inwardly by an angle up to 30°

in the deployed state.

18. The device of claim 12 wherein the inner frame is a first right cylinder and the outer frame is a second right cylinder surrounding the first right cylinder.

19. The device of claim 12 wherein the outer frame has tissue engaging elements projecting outwardly from the engagement surface in an upstream direction.

20. A method for treating a mitral valve of a human heart having a native annulus and native leaflets, comprising:

positioning a prosthetic heart valve device in a collapsed configuration in the native annulus of the mitral valve, the prosthetic heart valve device having an inner frame, a prosthetic heart valve with a plurality of leaflets within the inner frame, and an anchoring member;

expanding the anchoring member such that (a) an outer frame of the anchoring member surrounds and is spaced apart from an upstream portion of the inner frame, (b) an outwardly facing engagement surface of the outer frame exerts a radially outward force against the inner surface of the native annulus, and (c) the outer frame deflects inwardly so that an upstream section of the outer frame is closer to the inner frame than a downstream section of the outer frame.

21. The method of claim 20 wherein the engagement surface contacts the native annulus between the upstream section of the outer frame and the downstream section of the outer frame.

22. The method of claim 20 wherein the downstream section of the outer frame is below the native annulus.

23. The method of claim 20 wherein the outer frame deflects upon contacting native annulus such that the engagement surface converges from a location downstream of the native annulus toward the inner frame at an angle of up to 30°

.

24. The method of claim 20 wherein the engagement surface is the sole anchor that resists blood flow during ventricular systole.

25. The method of claim 20 wherein the prosthetic heart valve device is anchored without tethers.

26. The method of claim 20 wherein the outer frame has a height of 10 mm-20 mm.

27. A prosthetic heart valve device for treating a mitral valve of a human heart having a native annulus and native leaflets, comprising:

a valve support having an upstream region and a downstream region, wherein the valve support is configured to retain a prosthetic valve;

a connection structure attached to the valve support, wherein at least a portion of the connection structure extends laterally outward from the valve support in a deployed state; and

a fixation portion having an annular engagement surface configured to engage an inner surface of the native annulus, wherein the fixation portion extends from the connection structure and is configured to deflect with respect to the connection structure inwardly toward the valve support in the deployed state when the annular engagement surface engages the inner surface of the native annulus.