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

• US 9,655,722 B2
• Filed: 03/14/2014
• Issued: 05/23/2017
• Est. Priority Date: 10/19/2011
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: Twelve, Inc. (Medtronic Plc)
• Inventors: Morriss, John, McLean, Matt, Bensing, Maureen, Dueri, Jean-Pierre, Gifford, III, Hanson, Miyashiro, Katie, Scott, David Jerry, Valley, Kirsten, Trask, David
• Primary Examiner(s): Schall, Matthew
• Application Number:
  US14/776,575
• Publication Number:
  US 20160038280A1
• Time in Patent Office: 1,166 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 2/2433 using balloon catheter
• 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 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• 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

Prosthetic heart valve devices for percutaneous replacement of native heart valves and associated systems and method are disclosed herein. A prosthetic heart valve device configured in accordance with a particular embodiment of the present technology can include an anchoring member having an upstream portion configured to engage with tissue on or near the annulus of the native heart valve and to deform in a non-circular shape to conform to the tissue. The device can also include a mechanically isolated valve support coupled to the anchoring member and configured to support a prosthetic valve. The device can further include an atrial extension member extending radially outward from the upstream portion of the anchoring member and which is deformable without substantially deforming the anchoring member. In some embodiments, the upstream portion of the anchoring member and the extension member may be deformed while the valve support remains sufficiently stable.

Claims

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

a valve support having an upstream region and a downstream region relative to blood flow direction through a native heart valve of a human heart, the upstream region being configured to support a prosthetic valve, the prosthetic valve having a plurality of leaflets and having an undeformed shape in which the leaflets coapt sufficiently to prevent backflow through the prosthetic valve;

an anchoring member arranged around the valve support and including an outwardly-facing fixation portion having an engagement surface configured to engage tissue at an implant site proximate the native annulus, the fixation portion having a first cross-sectional shape in an unbiased condition and being deformable into a second cross-sectional shape to adapt to a shape of the tissue at the implant site in a deployed state; and

a connection structure interconnecting the fixation portion to the valve support, the fixation portion extending from the connection structure at a transition zone, and the transition zone being configured to be positioned at a subannular location below the native annulus and to allow the fixation portion to deflect angularly relative to the connection structure;

wherein the tissue fixation portion of the anchoring member is mechanically isolated from the upstream region of the valve support such that the upstream region of the valve support maintains the undeformed shape if the anchoring member has deformed into the second cross-sectional shape.

2. The prosthetic heart valve device of claim 1 further comprising a plurality of barbs extending in an upstream direction from the fixation surface.

3. The prosthetic heart valve device of claim 1 wherein the fixation portion is biased radially outward to apply a compressive force to native tissue at the implant location.

4. The prosthetic heart valve device of claim 1 wherein, in an unbiased condition, the connection structure extends in a transverse direction relative to the blood flow direction, and the engagement surface is disposed in a longitudinal direction at a different angle relative to the blood flow direction than the connection structure.

5. The prosthetic heart valve device of claim 1 wherein the fixation portion has at least one tissue engagement feature configured to engage tissue on a subannular aspect of the native annulus.

6. The prosthetic heart valve device of claim 1 wherein the transition zone is configured to be positioned under the native annulus and the fixation portion is deflectable such that the engagement surface is tapering inward in the upstream direction.

7. The prosthetic heart valve device of claim 1 wherein the connection structure comprises a plurality of struts each having an inner end connected to the valve support and an outer end connected to the anchoring member.

8. The prosthetic heart valve device of claim 1 wherein the fixation portion and the connection structure comprise metal struts, and the transition zone comprises a bend in the metal struts from the connection structure to the fixation portion.

9. The prosthetic heart valve of claim 1 wherein the fixation portion is attached to the connection structure by a fastener configured to pivot, rotate or flex to an inward and/or outward orientation.

10. The prosthetic heart valve device of claim 1 wherein the connection structure has a flared portion that flares outwardly in the upstream direction.

11. The prosthetic heart valve of claim 10 wherein the flared portion of the connection structure extends inwardly in a downstream direction from the fixation portion such that the connection structure is disposed entirely downstream of the native annulus when the anchoring member is at the implant site.

12. The prosthetic heart valve device of claim 10 wherein the connection structure has an upstream end connected to the anchoring member, and the upstream end being configured for positioning at or below the native annulus when the anchoring member is at the implant site.

13. The prosthetic heart valve device of claim 1 wherein the connection structure comprises a flexible web coupling the fixation portion to the valve support.

14. The prosthetic heart valve device of claim 13 wherein the flexible web comprises a first portion at the upstream end of the valve support and a second portion at the downstream end of the valve support.

15. The prosthetic heart valve device of claim 1 wherein the engagement surface is deflectable through a range of angles relative to the connection structure.

16. The prosthetic heart valve device claim 1 wherein:

the fixation portion comprises a skirt covering an inward-facing surface thereof;

the valve support includes a tubular valve cover extending around the valve support; and

the skirt is attached to the valve cover so as to inhibit blood flow therebetween.

17. The prosthetic heart valve device of claim 1 wherein the fixation surface extends in a direction at least generally parallel to a longitudinal axis of the anchoring member.

18. The prosthetic heart valve device of claim 1 wherein the transition zone is configured to be positioned under the native annulus.