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

• US 10,016,271 B2
• Filed: 10/19/2012
• Issued: 07/10/2018
• Est. Priority Date: 10/19/2011
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: Twelve, Inc. (Medtronic Plc)
• Inventors: Morriss, John, Gifford, III, Hanson, Fann, James I., Dueri, Jean-Pierre, McLean, Matt, Gittings, Darin, Luna, Michael, Deem, Mark, Sutton, Douglas, Grainger, Jeffry J.
• Primary Examiner(s): SCHALL, MATTHEW WAYNE
• Application Number:
  US14/352,969
• Publication Number:
  US 20150142100A1
• Time in Patent Office: 2,090 Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2/246 Devices for obstructing a leak through a native valve in a closed condition
• 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 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve (100) includes a flexible anchoring member (110) at least partially surrounding and coupled to an inner valve support (120). The device can further include a prosthetic valve (130) coupled to, mounted within, or otherwise carried by the valve support. The valve support includes a plurality of posts (122) connected circumferentially by a plurality of struts (124), where the posts extend along an axial direction generally parallel to the longitudinal axis (101) and the struts extend circumferentially around and transverse to the longitudinal axis. The posts extend an entire longitudinal height HI of the valve support 120. The device also includes one or more sealing members (140) and tissue engaging elements (170) like spikes.

Claims

1. A prosthetic heart valve device for implantation at a native heart valve, the native heart valve having an annulus and leaflets, comprising:

an anchoring member positionable in a location between the leaflets, the anchoring member having a first portion and a second portion, wherein the first portion of the anchoring member is expandable to a deployed configuration having a dimension larger than a corresponding dimension of the annulus such that upstream movement of the anchoring member is blocked by engagement of the first portion of the anchoring member with tissue on or near the annulus on an inward-facing side of the leaflets, wherein the first portion of the anchoring member comprises an upstream portion and the second portion of the anchoring member comprises a downstream portion; and

a valve support coupled to the second portion of the anchoring member and configured to support a prosthetic valve, the valve support having an expanded configuration in which the prosthetic valve is competent,

wherein, when the valve support is in the expanded configuration and the anchoring member is in the deployed configuration, an upstream end of the valve support is spaced radially inward from and longitudinally aligned with the first portion of the anchoring member such that if the anchoring member is deformed inwardly the upstream end of the valve support remains substantially undeformed.

2. The device of claim 1 wherein the first portion of the anchoring member is configured to engage valve tissue selected from an inward-facing surface of the annulus and an inward facing surface of the leaflets under the annulus.

3. The device of claim 1 wherein the valve support extends around a longitudinal axis, and wherein the first portion of the anchoring member flares outward from the longitudinal axis by a taper angle.

4. The device of claim 3 wherein the taper angle continuously changes between the first portion and the second portion.

5. The device of claim 3 wherein the taper angle varies around a circumference of the first portion.

6. The device of claim 3 wherein the taper angle is between approximately 30°

to about 75°

.

7. The device of claim 3 wherein the taper angle is between approximately 40°

to about 60°

.

8. The device of claim 1 wherein the first portion of the anchoring member includes a flared portion and a vertical portion, the vertical portion is configured to radially expand and engage the annulus.

9. The device of claim 8 wherein the flared portion includes tissue engaging elements configured to engage subannular tissue.

10. The device of claim 1 wherein the first portion is radially separated from the valve support by a gap.

11. The device of claim 1, further comprising a skirt overlying a surface of the anchoring member, the skirt configured to inhibit blood flow between the anchoring member and the valve support.

12. The device of claim 1, further comprising a sealing member coupled to the anchoring member configured to inhibit blood flow between the anchoring member and the tissue.

13. The device of claim 1, further comprising a valve coupled to the valve support to inhibit retrograde blood flow.

14. The device of claim 13 wherein the valve is a tri-leaflet valve.

15. The device of claim 1 wherein the first portion of the anchoring member has a first flexibility and the valve support has a second flexibility less than the first flexibility such that a region of the valve support remains substantially undistorted when the first portion of the anchoring member distorts to the native heart valve.

16. The device of claim 1 wherein:

the anchoring member is defined by a structure separate from the valve support;

the valve support is coupled to the anchoring member at the second portion of

the anchoring member; and

the second portion of the anchoring member is longitudinally spaced apart from the first portion of the anchoring member.

17. The device of claim 1 wherein the anchoring member resists upstream migration of the device without any element of the device extending behind the leaflets of the native mitral valve.

18. The device of claim 1, further comprising a plurality of tissue engaging elements configured to engage tissue of the annulus or leaflets.

19. The device of claim 18 wherein the tissue engaging elements have:

a piercing configuration in which the tissue engaging elements have a low profile for penetrating the tissue; and

a retaining configuration in which the tissue engaging elements have an expanded profile for maintaining the tissue engaging element within the tissue.

20. The device of claim 1, further comprising a second anchoring structure coupled to the first portion of the anchoring member and extending outwardly so as to engage tissue on or near the annulus.

21. The device of claim 1 wherein:

the valve support comprises an inner frame having an outer surface and an inner surface, the inner surface configured to support a prosthetic valve; and

the anchoring member comprises an outer frame coupled to the inner frame, the outer frame having a first portion with a cross-sectional dimension greater than a corresponding cross-sectional dimension of an annulus of the mitral valve, wherein the first portion is configured to engage tissue at or below the annulus of the heart valve and prevent migration of the device in an upward direction during ventricular systole, and wherein at least the first portion of the frame is mechanically isolated from the inner frame.

22. A device for repair or replacement of a native valve of a heart, the native valve having an annulus and leaflets coupled to the annulus, comprising:

an anchoring member including a first portion and a second portion, wherein the first portion is configured to engage tissue on or under the annulus so as to inhibit movement of the device in an upstream direction and to deform into a non-circular shape to at least partially conform to the shape of the native valve; and

a valve support coupled to the second portion of the anchoring member and configured to support a prosthetic valve, wherein the valve support has a cross-sectional shape, wherein the anchoring member extends upwardly and flares outwardly apart from the valve support from a downstream portion of the valve support;

wherein, when the anchoring member and valve support are in a fully expanded configuration, the first portion of the anchoring member is longitudinally aligned with an upstream end of the valve support and mechanically isolated from the valve support such that the cross-sectional shape of the valve support remains sufficiently stable that the prosthetic valve remains competent when the anchoring member is deformed in the non-circular shape.

23. A prosthetic heart valve device for repair or replacement of a native heart valve of a patient, the heart valve having a native annulus and leaflets, comprising:

an anchoring member having an upstream portion having a first cross-sectional dimension and a downstream portion having a second cross-sectional dimension less than the first cross-sectional dimension, wherein the upstream portion is configured to engage cardiac tissue at the native annulus to restrain the anchoring member from movement in an upstream direction;

a valve support coupled to the downstream portion of the anchoring member and configured to support a prosthetic valve, wherein the valve support has an upstream region and a downstream region, and wherein, with the anchoring member and valve support in a fully expanded configuration, an upstream end of the valve support is radially spaced apart from and longitudinally aligned with the upstream portion of the anchoring member such that the upstream portion of the anchoring member can deform inwardly without substantially deforming the upstream region of the valve support.

24. A device for repair or replacement of a native valve having an annulus and a plurality of leaflets, the device comprising:

an expandable valve support configured for placement between the leaflets, the support having a first region, a second region, and an interior in which a valve may be coupled; and

an anchoring member having a first portion and a second portion, wherein the second portion of the anchoring member is coupled to the second region of the valve support, and wherein the first portion of the anchoring member extends outwardly away from the second region of the expandable valve support, the first portion of the anchoring member having a first perimeter configured to engage tissue between the leaflets on or near the annulus to inhibit movement of the device in an upstream direction;

wherein the second portion of the anchoring member and the second region of the valve support are attached to each other at a location spaced apart longitudinally a substantial distance from the first portion of the anchoring member and the first region of the valve support,

wherein the first region of the valve support and the first portion of the anchoring member overlap, and

wherein with the support and the anchoring member in a fully expanded configuration the anchoring member is mechanically isolated from the valve support such that a force exerted radially at or near the first perimeter will not substantially alter a shape of the valve support.