Structural members for prosthetic mitral valves

• US 9,610,159 B2
• Filed: 11/24/2015
• Issued: 04/04/2017
• Est. Priority Date: 05/30/2013
• Status: Active Grant

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories)
• Inventors: Christianson, Mark, Perrin, Chad, Tegels, Zachary, Ekvall, Craig, Vidlund, Robert
• Primary Examiner(s): Matthews, Howie
• Application Number:
  US14/950,656
• Publication Number:
  US 20160074160A1
• Time in Patent Office: 497 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0083 using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/0019 rectangular
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 2300/236 Glycosaminoglycans, e.g. heparin, hyaluronic acid, chondroitin
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/00 Materials for grafts or prostheses or for coating grafts or prostheses dental prostheses A61C13/00; shape or structure of prostheses A61F2/00; use of preparations for artificial teeth A61K6/80; artificial kidneys A61M1/14
• CPC Class Codes: A61L 27/06 Titanium or titanium alloys
• CPC Class Codes: A61L 27/14 Macromolecular materials
• CPC Class Codes: A61L 27/34 : Macromolecular materials
• CPC Class Codes: A61L 27/3629 : Intestinal tissue, e.g. small intestinal submucosa
• CPC Class Codes: A61L 27/50 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 33/0011 : Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate

Abstract

A self-expanding wire frame for a pre-configured compressible transcatheter prosthetic cardiovascular valve, a combined inner frame/outer frame support structure for a prosthetic valve, and methods for deploying such a valve for treatment of a patient in need thereof, are disclosed.

Claims

1. An apparatus, comprising:

an outer frame formed of expanded shape memory alloy;

an inner frame formed of shape memory alloy and coupled to the outer frame;

a prosthetic valve leaflet assembly disposed within a first portion of the inner frame; and

a tether, a second portion of the inner frame compressed about an end of the tether along a flow axis defined in part by the prosthetic valve leaflet assembly.

2. The apparatus of claim 1, further comprising a radiopaque indicator formed on the outer frame.

3. The apparatus of claim 1, wherein the inner frame is connected to the outer frame by mechanical fasteners.

4. The apparatus of claim 1, wherein the outer frame is formed separately from and then coupled to the inner frame.

5. The apparatus of claim 1, wherein the end of the tether is a first end, a second end of the tether extending away from the second portion of the inner frame.

6. The apparatus of claim 5, wherein the outer frame, the inner frame, and the prosthetic valve leaflet assembly are configured to be delivered to a native annulus of an atrioventricular valve of a heart, the tether having a length sufficient to extend from the second portion of the inner frame through an opening in a wall of a ventricle of the atrioventricular valve and out of the wall when the outer frame is disposed in the native annulus of the atrioventricular valve of the heart.

7. The apparatus of claim 1, wherein a distal end of the outer frame is disposed distal to a distal end of the inner frame.

8. The apparatus of claim 1, wherein the flow axis extends at least from a distal end of the outer frame to a proximal end of the outer frame, and through an opening defined by the prosthetic valve leaflet assembly.