VALVE COMPONENT, FRAME COMPONENT AND PROSTHETIC VALVE DEVICE INCLUDING THE SAME FOR IMPLANTATION IN A BODY LUMEN

• US 20150073543A1
• Filed: 11/12/2014
• Published: 03/12/2015
• Est. Priority Date: 03/26/2010
• Status: Active Grant

• Current Assignee: Thubrikar Aortic Valve, Inc.
• Original Assignee: Thubrikar Aortic Valve, Inc.
• Inventors: Darekar, Yogesh, Thubrikar, Mano J.
• Granted Patent: US 9,549,814 B2
• Time in Patent Office: Days
• US Class Current: 623/2.17
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• 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: B32B 1/08 Tubular products
• CPC Class Codes: B32B 2307/70 Other properties
• CPC Class Codes: B32B 25/00 Layered products comprising a layer of natural or synthetic rubber fibrous or filamentary layer made of a natural or synthetic rubber B32B5/02; particulate layer made of a natural or synthetic rubber B32B5/16; foamed layer made of a natural or synthetic rubber B32B5/18
• CPC Class Codes: B32B 2535/00 Medical equipment, e.g. bandage, prostheses, catheter medical patches B32B2556/00
• CPC Class Codes: B32B 37/16 with all layers existing as coherent layers before laminating
• CPC Class Codes: B32B 7/08 by mechanical means
• CPC Class Codes: B32B 7/09 by stitching, needling or sewing by mechanically connecting fibrous layers to another layer B32B5/06
• CPC Class Codes: B32B 7/12 using interposed adhesives or interposed materials with bonding properties

Abstract

Described herein is a prosthetic valve device having an optimized valve component for durability and functionality of the collapsible leaflets. Specially designed commissures contribute to the optimization along with identified parameters. In other embodiments, the invention is a frame formed from a unique cutting pattern.

Claims

1. A blank for forming a valve component of a prosthetic valve device for implantation into a body lumen, the blank comprising:

a single sheet of pliable material comprising a leaflet section comprising an arcuate top edge, an arcuate bottom edge, and linear left and right side edges extending between the arcuate top and bottom edges;

the arcuate top and bottom edges extending substantially parallel to one another and the left and right side edges extending at an angle between 31°

to 33°

with respect to one another.

2. The blank according to claim 1, wherein the left and right side edges have a length and the arcuate bottom edge has a radius of curvature, and wherein a ratio of the radius of curvature to the length is in a range of 8.1:

1 to 8.5;

1.

3. The blank according to claim 2, wherein the ratio of the radius of curvature to the length is approximately 8.3:

1.

4. The blank according to claim 1, wherein the single sheet of pliable material further comprises a cuff section.

5. The blank according to claim 1, wherein the leaflet section further comprises a subsection for each collapsible leaflet.

6. The blank according to claim 4, wherein the leaflet section and cuff section are separated by a fold line.

7. The blank according to claim 6, wherein the single sheet of pliable material further comprises a suture boundary line, and wherein a suture free section is formed between the fold line and the suture boundary line.

8. A frame for a prosthetic valve device comprising:

a tubular body comprising an axis;

a plurality of circumferentially spaced-apart axial posts; and

a lattice structure comprising open cells extending between each of the axial posts,

wherein the lattice structures and the axial posts are integrally formed as a unitary structure free of seams.

9. The frame according to claim 8, comprising three circumferentially equi-spaced axial posts.

10. The frame according to claim 8, wherein the tubular body is formed from a tube of shape memory material.

11. The frame according to claim 8, wherein the tube of shape memory metal comprises a pattern formed entirely of linear slits that extend substantially parallel to the axis.

12. The frame according to claim 11, wherein the pattern further comprises a plurality of post pattern sections arranged on the tube in a circumferentially spaced-apart manner and a plurality of lattice pattern sections extending between the post pattern sections.

13. The frame according to claim 11, wherein all of the linear slits of the pattern are arranged in axial columns.

14. The frame according to claim 13, wherein adjacent slits in the same axial columns of the lattice pattern sections are separated by gaps of a first axial distance, and wherein adjacent slits in the same axial columns of the post pattern sections are separated by gaps of a second axial distance that is greater than the first axial distance.

15. The frame according to claim 14, wherein the gaps of the lattice pattern sections form nodes within the lattice structure and wherein the gaps of the post pattern sections form axially elongated nodes within the axial posts.

16. A commissure for anchoring a valve component of a prosthetic valve device to a frame, comprising:

an elongated strip of pliable material;

a valve component comprising an annular sleeve having an annular inner wall; and

a fastening element;

wherein a portion of the annular inner wall is cinched between opposing legs of the elongated strip of pliable material.

17. The commissure according to claim 16, wherein each of the opposing legs comprises an inner edge having a bottom portion that tapers radially outward.

18. The commissure according to claim 16, wherein the elongated strip of pliable material is folded over the cinched portion of the annular inner wall and forms a general U-shape.

19. The commissure according to claim 18, wherein the elongated strip of pliable material and the cinched portion of the annular inner wall collectively form a multi-layer structure;

wherein the fastening element penetrates through each layer of the multi-layer structure, so as to fix the opposing legs and the cinched portion of the annular inner wall together; and

wherein the fastening element comprises free ends which are used to anchor the commissure to the frame.

20. The commissure according to claim 17, wherein the inner edge of each of the opposing legs of the elongated strip of pliable material is in surface contact with an outer surface of the cinched portion of the annular inner wall.