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

• US 10,335,278 B2
• Filed: 05/22/2015
• Issued: 07/02/2019
• 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, III, Hanson
• Primary Examiner(s): Schall, Matthew
• Application Number:
  US14/720,335
• Publication Number:
  US 20150328001A1
• Time in Patent Office: 1,502 Days
• 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 valve of a human heart having a native annulus and native leaflets, comprising:

a valve support having an upstream region and a downstream region with respect to a direction of blood flow;

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 in an undeployed state and at least a portion of the connection structure extending laterally outward with respect to the valve support in a deployed state, the fixation portion having a plurality of interconnected struts that define an annular engagement surface and that are spaced laterally apart and outward from the valve support by the connection structure in the deployed state, wherein

at least a portion of the connection structure extends transverse with respect to the direction of blood flow,

the fixation portion extends upstream with respect to the connection structure and generally along the direction of blood flow, and

the annular engagement surface anchors the device to the native annulus.

2. 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.

3. 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.

4. The device of claim 3 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.

5. The device of claim 4 wherein the outer annular frame is configured to deflect inwardly toward the inner annular frame when the engagement surface exerts the radially outward force against the inner surface of the native annulus.

6. The device of claim 3 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 through a range of angles such that the outer annular frame inclines inwardly in an upstream direction from the connection structure toward the inner annular frame in the deployed state.

7. The device of claim 3 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.

8. The device of claim 7 wherein the outer annular frame has a first radial flexibility and the connection structure has a second radial flexibility different than the first flexibility such that the outer annular frame is deflectable with respect to the connection structure through a range of angles in the deployed state.

9. The device of claim 3 wherein, in an unbiased expanded state, the inner annular frame is a first right cylinder and the outer annular frame is a second right cylinder surrounding the first right cylinder.

10. The device of claim 3 wherein the outer annular frame has a plurality of tissue engaging elements projecting outwardly from the engagement surface in an upstream direction.

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

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

a prosthetic valve within the inner annular frame; and

an anchoring member having a connection structure fixedly attached to the inner annular frame in an undeployed state and an outer annular frame having interconnected struts that define an outwardly facing engagement surface configured to engage an inwardly facing surface of the native annulus, wherein, in a deployed state, the connection structure spaces the outer annular frame laterally apart from the inner frame and such that the engagement surface is configured to exert a radially outward force against an inner surface of the native annulus that secures the device to the native annulus.

12. The device of claim 11 wherein the connection structure is attached to the downstream region of the inner annular frame and the outer annular frame extends upstream from the connection structure to an elevation at least proximate the upstream region of the inner annular frame, and the outer annular frame extends at a transverse angle with respect to the connection structure.

13. The device of claim 12 wherein the outer annular frame extends from the connection structure proximally in a longitudinal direction of the device and is configured to deflect inwardly in an upstream direction toward the inner annular frame when the engagement surface exerts the radially outward force against the inner surface of the native annulus.

14. The device of claim 11 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 through a range of angles such that the outer annular frame inclines in an upstream direction inwardly from the connection structure toward the inner annular frame in the deployed state.

15. The device of claim 11 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.

16. The device of claim 15 wherein the outer annular frame is configured to deflect inwardly in the deployed state.

17. The device of claim 11 wherein, in an unbiased expanded state, the inner annular frame is a first right cylinder and the outer annular frame is a second right cylinder surrounding the first right cylinder.

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

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

a valve support having a cylindrical inner frame extending around a longitudinal axis, wherein the valve support has an upstream region and a downstream region;

a prosthetic valve having a plurality of leaflets within the inner frame; and

an anchoring member having an outer frame completely surrounding a portion of the inner frame, the outer frame having an engagement surface that faces laterally outward in an unbiased expanded state, wherein the anchoring member is resiliently biased to a deployed state in which the outer frame is spaced radially apart from the inner frame and is thereby configured to exert a radially outward force against an inner surface of the native annulus facing the valve support that secures the heart valve device against ventricular systole forces without tethers; and

an atrial retainer extending laterally outward from an upstream end of the outer frame.

20. The device of claim 19 wherein the outer frame comprises a plurality of interconnected struts that extend circumferentially about the outer frame.

21. The device of claim 20 wherein the interconnected struts have a diamond-like configuration.

22. The device of claim 19 wherein the outer frame is configured to be between the native annulus and the inner frame in the deployed state when the engagement surface engages the inner surface of the native annulus.

23. The device of claim 19, further comprising an atrial retainer coupled to the outer frame, and wherein the atrial retainer extends laterally outward from an upstream end of the outer frame.

24. The device of claim 19, further comprising a plurality of engagement elements projecting outwardly from the engagement surface.

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

an inner cylindrical frame with an upstream region and a downstream region relative to a direction of blood flow, wherein the inner cylindrical frame is configured to retain a prosthetic valve;

a connection structure attached to the inner cylindrical frame; and

an outer cylindrical frame having interconnected struts that define an outwardly facing engagement surface configured to engage an inwardly facing surface of the native annulus, wherein, in a deployed state, the connection structure spaces the outer cylindrical frame laterally apart and outward from the inner cylindrical frame such that the engagement surface is configured to exert a radially outward force against an inner surface of the native annulus that secures the device to the native annulus, and

wherein, in an undeployed state, the connection structure fixedly attaches the inner cylindrical frame to the outer cylindrical frame.

26. The device of claim 25 wherein, in an unbiased expanded state, the inner cylindrical frame has a first diameter and the outer cylindrical frame has a second diameter greater than the first diameter.

27. The device of claim 26 wherein the inner and outer cylindrical frames are first and second right cylinders, respectively.

28. The device of claim 25 wherein the outer frame comprises a plurality of interconnected struts that extend circumferentially about the outer frame.

29. The device of claim 28 wherein the interconnected struts have a diamond-like configuration.

30. The device of claim 25, further comprising an atrial retainer coupled to the outer frame, and wherein the atrial retainer extends laterally outward from an upstream end of the outer frame.