STRUCTURAL MEMBERS FOR PROSTHETIC MITRAL VALVES

• US 20170196688A1
• Filed: 03/29/2017
• Published: 07/13/2017
• Est. Priority Date: 05/30/2013
• Status: Active Grant

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Inventors: PERRIN, Chad, TEGELS, Zachary, EKVALL, Craig, CHRISTIANSON, Mark, VIDLUND, Robert
• Granted Patent: US 10,405,976 B2
• Time in Patent Office: 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. A support structure for a prosthetic cardiovascular valve, comprising:

an outer frame formed of expanded shape memory alloy; and

an inner frame formed of shape memory alloy having a first portion expanded from an initial shape and a second portion compressed from an initial shape, the inner frame configured to support a prosthetic valve leaflet assembly within the first portion, the inner frame configured to engage a tether within the second portion,

the inner frame coupled to the outer frame.

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

3. The support structure of claim 1, further comprising a valve leaflet assembly supported within the inner frame.

4. The support structure of claim 1, further comprising a tether received within the second portion of the inner frame.

5. The support structure of claim 1, wherein the inner frame is connected to the outer frame by mechanical fasteners.

6. A method, comprising:

inserting into a ventricle of a heart of a patient a support structure for a prosthetic cardiovascular valve;

allowing an inner frame of the support structure to expand from a first configuration to a second configuration when the inner frame is disposed within an annulus of the heart, the inner frame formed of shape memory allow and having a first portion expanded from an initial shape and a second portion compressed from an initial shape;

anchoring the inner frame to an apex of the heart using a tether coupled to the inner frame, tether extending from the inner frame to the apex when the inner frame is disposed within the annulus of the heart.

7. The method of claim 6, wherein the inner frame is coupled to an outer frame formed of expanded shape memory allow, the inner frame configured to support a prosthetic valve leaflet assembly.

8. The method of claim 7, further comprising:

viewing from outside the patient a radiopaque indicator formed on the outer frame;

rotating the inner frame within the annulus of the heart in response to the viewing.

9. A self-expanding wire frame for a pre-configured compressible transcatheter prosthetic cardiovascular valve, which comprises a cylindrical framework defining a lumen, the cylindrical framework including three generally diamond-shaped members, each diamond-shaped member defining two lateral vertices and two longitudinal vertices, each diamond-shaped member directly connected to or having at least one connecting member connecting to each of the other two diamond-shaped members, said connection at or about each of the lateral vertices of the diamond-shaped members.

10. The self-expanding wire frame of claim 9, wherein at least one of the diamond-shaped members is a rhombus.