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

• US 20130204359A1
• Filed: 03/28/2011
• Published: 08/08/2013
• 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
• Granted Patent: US 8,992,599 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 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

A prosthetic valve device, including a valve component, frame and methods of manufacturing the same. The present invention, in some embodiments, 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

1-167. -167. (canceled)

168. A prosthetic valve device for implantation into a body lumen 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.

169. The prosthetic valve device according to claim 168 wherein the annular belt is affixed to the annular sleeve only along the annular cuff and at an axial distance from the inlet edge.

170. The prosthetic valve device according to claim 168 wherein an inlet portion of the valve component is anchored to the tubular body of the frame by penetrating only the annular cuff and the annular belt.

171. The prosthetic valve device according to claim 168 wherein the annular inner wall is free of anchoring penetrations from the inlet edge to commissures at the outlet edge, the commissures forming a plurality of collapsible leaflets for opening and sealing the fluid passageway, each of the commissures anchored to the tubular body of the frame.

172. The prosthetic valve device according to claim 171 wherein each of the commissures is formed by a cinched portion of the annular inner wall that is located between opposing legs of a commissure strip.

173. The prosthetic valve device according to claim 168 wherein the annular sleeve and the annular belt are formed of a pliable material.

174. The prosthetic valve device according to claim 168 wherein the annular sleeve and the annular belt are formed of the same material.

175. The prosthetic valve device according to claim 168 wherein the annular sleeve and the annular belt are formed of a material selected from a group consisting of a biological tissue and a biocompatible polymer.

176. The prosthetic valve device according to claim 168 wherein the annular cuff is located within the tubular body of the frame.

177. The prosthetic valve device according to claim 168 wherein the frame extends along the axis from a bottom edge to a top edge, the inlet edge located at an axial location between the top and bottom edges of the tubular body of the frame.

178. The prosthetic valve device according to claim 168 wherein the inlet edge defines a fluid inlet and the outlet edge defines a fluid outlet, the fluid inlet having a diameter that is larger than a diameter of the fluid outlet.

179. The prosthetic valve device according to claim 168 wherein the annular cuff terminates in a saw-toothed edge.

180. The prosthetic valve device according to claim 168 wherein a top portion of the annular belt is affixed to the annular cuff.

181. The prosthetic valve device according to claim 168 wherein a bottom portion of the annular belt is affixed to the annular cuff and anchored to the tubular body.

182. The prosthetic valve device according to claim 168 wherein a top edge of the annular cuff is affixed to the tubular body.

183. The prosthetic valve device according to claim 182 wherein the top edge of the annular cuff is anchored to the tubular body at a first axial distance from a bottom edge of the tubular body of the frame, the top portion of the annular belt is affixed to the annular cuff at a second axial distance from the bottom edge of the tubular body of the frame, the bottom portion of the annular belt is affixed to the annular cuff and anchored to the tubular body at a third axial distance from the bottom edge of the tubular body of the frame, the first axial distance being greater than the second axial distance, and the second axial distance being greater than the third axial distance.

184. The prosthetic valve device according to claim 168 wherein the outlet edge comprises a plurality of commissures anchored to the tubular body of the frame and forming a plurality of collapsible leaflets for opening and sealing the fluid passageway.

185. The prosthetic valve device according to claim 184 wherein the tubular body of the frame comprises a post structure for each commissure, the post structures of the frame radially aligned with the commissures of the valve component.

186. A prosthetic valve device for implantation into a body lumen 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 comprising an annular inner wall that forms a fluid passageway along an axis from a fluid inlet to a fluid outlet;

a plurality of commissures arranged in a spaced-apart manner about a circumference of the fluid outlet and anchored to the tubular body, the commissures forming a plurality of collapsible leaflets for opening and sealing the fluid passageway, wherein the fluid outlet has a first diameter and the fluid inlet has a second diameter that is greater than the first diameter; and

wherein the fluid inlet forms a lower plane of a reference truncated cone and the fluid outlet forms an upper plane of the reference truncated cone, the reference truncated cone having a height and being a portion of a 9°

to 11°

cone, wherein a ratio of the second diameter to the height is in a range of 1.3;

1 to 1.5;

1.

187. A prosthetic valve device for implantation into a body lumen 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;

wherein the annular belt is affixed to the annular sleeve only along the annular cuff and at an axial distance from the inlet edge; and

wherein an inlet portion of the valve component is anchored to the tubular body of the frame by penetrating only the annular cuff and the annular belt.