PROSTHETIC HEART VALVE DEVICES AND ASSOCIATED SYSTEMS AND METHODS

• US 20130310928A1
• Filed: 07/23/2013
• Published: 11/21/2013
• Est. Priority Date: 06/21/2011
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: Foundry Newco XII, Inc. (Medtronic Plc)
• Inventors: Morriss, John, Gifford, Hanson III
• Granted Patent: US 9,125,740 B2
• Time in Patent Office: Days
• US Class Current: 623/2.12
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0015 Kidney-shaped, e.g. bean-shaped
• 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 2250/0037 differing in height or in length
• 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 expandable support having an outer surface and configured for placement between leaflets of the native valve. The device can also include a plurality of asymmetrically arranged arms coupled to the expandable support and configured to receive the leaflets of the native valve between the arms and the outer surface. In some embodiments, the arms can include tip portions for engaging a subannular surface of the native valve.

Claims

1. A prosthetic treatment apparatus for treating a native mitral valve having a native annulus and native leaflets, comprising:

an expandable support having a downstream end configured to be positioned toward a left ventricle, an upstream end configured to be positioned toward a left atrium, and an interior;

a prosthetic valve having a tri-leaflet assembly mounted to the expandable support and adapted to allow blood flow in the downstream direction and to block blood flow in the upstream direction;

a plurality of elongated members coupled to a downstream portion of the support and extending outwardly from the support in an upstream direction, wherein the elongated members have sufficient flexibility to deflect inwardly or outwardly relative to the support to accommodate expansion or distortion of the native annulus, and wherein the elongated members are configured to inhibit movement of the support toward the left atrium; and

a skirt coupled to a downstream portion of the support and extending around the support, wherein the skirt is oriented on the device as to inhibit blood flow between the prosthetic treatment device and the native valve.

2. The prosthetic treatment apparatus of claim 1 wherein the skirt extends in an upstream direction around the outside of the elongated members.

3. The prosthetic treatment apparatus of claim 1 wherein the skirt extends in an upstream direction on an inner side of the elongated members.

4. The prosthetic treatment apparatus of claim 1 wherein the elongated members comprise arms configured to be implanted entirely below the native annulus.

5. The prosthetic treatment apparatus of claim 1 wherein the elongated members comprise arms configured to remain on an inner surface of the native leaflets.

6. The prosthetic treatment apparatus of claim 1 wherein the elongated members are configured to be positioned behind the native leaflets.

7. The prosthetic treatment apparatus of claim 1 wherein the elongated members are configured to engage the annulus so as to inhibit movement of the support toward the atrium.

8. The prosthetic treatment apparatus of claim 1 wherein the skirt flares outwardly in an upstream direction.

9. The prosthetic treatment apparatus of claim 1 wherein the skirt is attached to a mid-portion of the support.

10. The prosthetic treatment apparatus of claim 1 further comprising one or more wires coupled to the skirt to maintain the shape of the skirt.

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

a tubular stent body having a ventricular end, an atrial end, and an interior;

a leaflet assembly having a tricuspid valve coupled to the stent body and movable between an open configuration allowing blood flow through the interior of the stent body and a closed position blocking blood flow through the interior of the stent body; and

a band-shaped collar structure attached to and encircling the stent body, the collar structure having a first portion configured to expand in diameter away from the ventricular end of the stent body toward the atrial end of the stent body and a second portion with a diameter larger than a diameter of the stent body, the collar structure being configured to exert a compressive force and seal against the native valve annulus, and the collar structure being adapted to articulate along a lateral axis relative to the stent body to conform to changes in shape of the native valve annulus during the cardiac cycle.

12. The prosthetic heart valve device of claim 11 wherein the collar structure forms a V-shape when viewed in cross-section with an exterior wall of the stent body.

13. The prosthetic heart valve device of claim 11 wherein the collar structure comprises a metal material covered by a tissue or synthetic material.

14. The prosthetic heart valve device or claim 13 wherein the metal material comprises a wire web.

15. The prosthetic heart valve device of claim 13 wherein the metal material is superelastic.

16. The prosthetic heart valve device of claim 11 wherein the collar structure is configured to remain on an inner side of the native leaflets.

17. The prosthetic heart valve device of claim 16 wherein the collar structure comprises a metal material covered by a tissue or synthetic material, and the collar structure is configured to establish a cork-type structure that immobilizes the prosthetic heart valve device in the native annulus.

18. The prosthetic heart valve device of claim 17 wherein the collar structure comprises a shuttlecock structure.

19. The prosthetic heart valve device of claim 11 wherein the collar structure has a diameter equal to that of the stent body where the collar structure is attached to the stent body and the collar structure has a maximum diameter at an atrial end thereof.

20. The prosthetic heart valve device of claim 11 wherein the collar structure is perforated, woven, or laser cut to provide a mesh-like surface.

21. The prosthetic heart valve device of claim 11 wherein the collar structure is integrally formed with the stent body.

22. The prosthetic heart valve device of claim 11 wherein the collar structure is separate from the stent body and attached thereto at a joint.

23. The prosthetic heart valve device of claim 22 wherein the joint is at a distal end of the stent body.

24. The prosthetic heart valve device of claim 22 wherein the joint is spaced proximally from the distal end of the stent body.

25. The prosthetic heart valve device of claim 11 wherein:

the collar structure comprises a circular band connected at one edge to the stent body and extending circumferentially around an exterior of the stent body at or near a ventricular end of the stent body; and

at least a portion of the collar extends laterally beyond the stent body at an angle of 5°

to about 45°

for a distance of about 2-10 mm.

26. The prosthetic heart valve device of claim 25 wherein the first portion of the collar structure has an inner rim attached to a ventricular end of the stent body and the second portion of the collar structure has an outer rim spaced apart from an atrial portion of the stent body.

27. The prosthetic heart valve device of claim 25 wherein the leaflet assembly is located at or near an atrial end of the stent body such that the stent body and leaflet assembly are configured to reduce LVOT obstruction.

28. The prosthetic heart valve device of claim 27 wherein the collar structure is an inverted flange.

29. The prosthetic heart valve device of claim 27 wherein the collar structure is an inverted gasket.

30. The prosthetic heart valve device of claim 27 wherein the collar structure is an inverted spring panel.