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

• US 10,299,917 B2
• Filed: 01/26/2017
• Issued: 05/28/2019
• 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, Trask, David, Valley, Kirsten
• Primary Examiner(s): Schall, Matthew
• Application Number:
  US15/416,387
• Publication Number:
  US 20170128209A1
• Time in Patent Office: 852 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 comprising:

an expandable inner frame having a first end region and a second end region, the inner frame comprising a generally tubular body portion having an inner surface and an outer surface;

an expandable outer frame having a first end region and a second end region, the outer frame comprising a generally tubular body portion having an inner surface and an outer surface, the outer frame comprising a plurality of interconnected closed cells extending circumferentially around the inner frame, wherein the inner surface of the outer frame is spaced from the outer surface of the inner frame;

a connection structure extending between and connecting the second end region of the outer frame to the second end region of the inner frame, wherein the connection structure is configured to allow movement of the outer frame relative to the inner frame;

a valve member attached to the inner frame;

wherein the first end region of the outer frame is mechanically isolated from the first end region of the inner frame such that the first end region of the inner frame is configured to maintain a cross-sectional shape while the first end region of the outer frame deforms from a first cross-sectional shape into a second cross-sectional shape.

2. The device of claim 1, further comprising a plurality of tissue engagement elements extending outward from the outer frame.

3. The device of claim 1, further comprising a plurality of barbs extending outward from the outer frame.

4. The device of claim 1, further comprising a plurality of spikes extending outward from the outer frame.

5. The device of claim 1, wherein the outer frame is biased radially outward to apply a compressive force to native tissue at the implant location.

6. The device of claim 1, wherein the connection structure comprises a plurality of struts each having an inner end connected to the inner frame and an outer end connected to the outer frame.

7. The device of claim 6, wherein each strut comprises at least one bend.

8. The device of claim 1, wherein the connection structure is attached to the inner frame by a fastener configured to pivot, rotate or flex.

9. The device of claim 1, wherein the connection structure has a flared portion that flares outwardly from the inner frame.

10. The device of claim 1, wherein the connection structure has a flared portion that flares inwardly from the outer frame.

11. The device of claim 1, wherein the connection structure has a flared portion that flares outwardly from the inner frame and a flared portion that flares inwardly from the outer frame.

12. The device of claim 1, wherein the connection structure comprises a flexible web coupling the outer frame to the inner frame.

13. The device of claim 1, wherein the outer frame is deflectable through a range of angles relative to the connection structure.

14. The device of claim 1, further comprising a sealing member extending around the outer frame.

15. The device of claim 1, further comprising a sealing member extending around the inner frame.

16. The device of claim 1, further comprising a sealing member extending between the inner and outer frames.

17. The device of claim 1, further comprising a brim extending radially outward from the first end region of the outer frame.

18. The device of claim 17, wherein the brim comprises one or more stiffening members.

19. The device of claim 18, wherein the brim comprises a fabric coupling the stiffening members to the outer frame.

20. The device of claim 1, further comprising a shape memory material.