SIX CELL INNER STENT DEVICE FOR PROSTHETIC MITRAL VALVES

• US 20140358224A1
• Filed: 01/15/2014
• Published: 12/04/2014
• Est. Priority Date: 05/30/2013
• Status: Abandoned Application

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Inventors: TEGELS, Zachary J., EKVALL, Craig A., VIDLUND, Robert M.
• Application Number:
  US14/155,417
• Publication Number:
  US 20140358224A1
• Time in Patent Office: Days
• US Class Current: 623/2.14
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• 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 2/2487 Devices within the heart chamber, e.g. splints
• 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 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• 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 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/0069 Sealing means
• 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 2430/20 for reconstruction of the heart, e.g. heart valves
• 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 27/54 : 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

This invention relates to a self-expanding wire frame for a pre-configured compressible transcatheter prosthetic cardiovascular valve, a combined inner valve-outer collar component system, and methods for deploying such a valve for treatment of a patient in need thereof.

Claims

1. 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.

2. The self-expanding wire frame of claim 1, wherein the self-expanding wire frame is made of a self-expanding compressible nickel-titanium biocompatible alloy.

3. The self-expanding wire frame of claim 1, further comprising at least one internal spanning member, said internal spanning member joining loci within at least one of the diamond-shaped members.

4. The self-expanding wire frame of claim 1, wherein at least one of the diamond-shaped members is a rhombus.

5. The self-expanding wire frame of claim 1, wherein the at least one connecting member is a generally V-shaped connecting member.

6. The self-expanding wire frame of claim 1, wherein the at least one connecting member is a generally V-shaped connecting member, and the generally V-shaped connecting member has two joined legs defining an open end and a joined end, each open end of said joined legs connected to one of the diamond-shaped members at about each lateral vertex.

7. The self-expanding wire frame of claim 1, wherein one of said two longitudinal vertices of said diamond-shaped members is an upper vertex of the diamond-shaped member and the other is a lower vertex of the diamond-shaped member, wherein the at least one connecting member is a generally V-shaped connecting member, and the generally V-shaped connecting member has two joined legs defining an open end and a joined end, each open end of said joined legs connected to one of the diamond-shaped members at about each lateral vertex, and wherein the joined end of said generally V-shaped connecting member points along a longitudinal axis that is generally parallel to a perpendicular bisector of the lower vertex of the diamond-shaped member.

8. The self-expanding wire frame of claim 1, further comprising at least one internal spanning member, each diamond-shaped member comprised of four non-intersecting rods joined at the two longitudinal vertices and the two lateral vertices, said internal spanning member connecting two non-adjacent rods within each of the diamond-shaped members.

9. The self-expanding wire frame of claim 1, further comprising a leaflet assembly affixed to the self-expanding wire frame, said leaflet assembly comprised of stabilized tissue or synthetic material, said leaflet assembly disposed within the lumen of the cylindrical framework and having a plurality of articulating adjacent leaflet structures defining a valve.

10. The self-expanding wire frame of claim 9, further comprising wherein the stabilized tissue is derived from adult, 90-day old, or 30 day old, bovine, ovine, equine or porcine pericardium, or from animal small intestine submucosa.

11. The self-expanding wire frame of claim 9, further comprising wherein the synthetic material is selected from the group consisting of polyester, polyurethane, and polytetrafluoroethylene.

12. The self-expanding wire frame of claim 9, wherein the stabilized tissue or synthetic material is treated with anticoagulant.

13. A pre-configured compressible transcatheter prosthetic cardiovascular valve, which comprises the self-expanding wire frame of claim 9 mounted as an inner valve component within a outer mitral annulus collar component, said mitral annulus collar component comprising an self-expanding stent having at a distal end a plurality of articulating collar support structures having a tissue covering to form an atrial collar, wherein deployment of the pre-configured compressible transcatheter prosthetic cardiovascular valve forms a valvular seal within the mitral annulus.

14. The prosthetic cardiovascular valve of claim 13, further comprising wherein the prosthetic cardiovascular valve has a low height to width profile.

15. The prosthetic cardiovascular valve of claim 13, further comprising wherein the outer mitral annulus collar component is a half-round D-shape in cross-section.

16. The prosthetic cardiovascular valve of claim 13, wherein the self-expanding wire frame and self-expanding stent of the outer mitral annulus collar component are formed from the same piece of superelastic metal.

17. The prosthetic cardiovascular valve of claim 13, further comprising wherein the self-expanding wire frame and self-expanding stent of the outer mitral annulus collar component are covered with stabilized tissue is derived from adult, 90-day old, or 30 day old, bovine, ovine, equine or porcine pericardium, or from animal small intestine submucosa.

18. The prosthetic cardiovascular valve of claim 13, further comprising wherein the self-expanding wire frame and self-expanding stent of the outer mitral annulus collar component are covered with synthetic material is selected from the group consisting of polyester, polyurethane, and polytetrafluoroethylene.

19. The prosthetic cardiovascular valve of claim 18, wherein the elastomeric material, stabilized tissue or synthetic material is treated with anticoagulant.

20. The prosthetic cardiovascular valve of claim 18, wherein the elastomeric material, the stabilized tissue or synthetic material is heparinized.

21-36. -36. (canceled)