Valve component, frame component and prosthetic valve device including the same for implantation in a body lumen

• US 10,575,945 B2
• Filed: 01/23/2018
• Issued: 03/03/2020
• Est. Priority Date: 03/26/2010
• Status: Active Grant

• Current Assignee: Thubrikar Aortic Valve, Inc.
• Original Assignee: Thubrikar Aortic Valve, Inc.
• Inventors: Thubrikar, Mano J., Darekar, Yogesh
• Primary Examiner(s): Stewart, Alvin J
• Application Number:
  US15/877,736
• Publication Number:
  US 20180243088A1
• Time in Patent Office: 770 Days
• 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 or catheter
• 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 method for treating, preventing or ameliorating a symptom associated with a disease, disorder, or condition caused by a dysfunctional mammalian valve, comprising:

providing a prosthetic valve device comprising;

a frame comprising a tubular body; and

a valve component disposed within and anchored to the tubular body of the frame, the valve component comprising;

an annular sleeve having an annular inner wall that forms a fluid passageway along an axis from an inlet edge to an outlet edge, the annular sleeve folded over at the inlet edge to form an annular cuff that is concentric to and surrounds the annular inner wall and extends from the inlet edge toward the outlet edge; and

an annular belt positioned between the annular inner wall and the annular cuff and having a bottom edge adjacent to a bight portion of the annular sleeve that forms the inlet edge; and

delivering said prosthetic valve device to an implantation site in a mammalian subject in need thereof.

2. The method according to claim 1, wherein the annular sleeve and the annular belt comprise a biological tissue.

3. The method according to claim 1, wherein the prosthetic valve device is configured for transluminal delivery.

4. The method according to claim 1, wherein the disease, disorder, or condition is caused by a dysfunctional valve selected from:

an aortic valve, a mitral valve; and

a pulmonary cardiac valve.

5. The method according to claim 4, wherein the dysfunctional valve is an aortic valve.

6. The method according to claim 1, wherein the disease, disorder, or condition is selected from:

aortic stenosis;

valve regurgitation; and

calcification of the leaflets.

7. The method according to claim 1, wherein the leaflets are free of affixing penetrations.

8. The method according to claim 1, wherein the leaflets are free of anchoring penetrations.

9. The method according to claim 1, wherein the implantation site is a degenerated valve.

10. The method according to claim 1, wherein a compression fit between the prosthetic valve device and the body lumen is created at the implantation site.

11. The method according to claim 10, wherein the frame comprises a shape memory metal.