PROSTHETIC VALVES AND RELATED INVENTIONS

• US 20140214159A1
• Filed: 08/13/2012
• Published: 07/31/2014
• Est. Priority Date: 08/11/2011
• Status: Active Grant

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories)
• Inventors: Vidlund, Robert, Schankereli, Kemal, Lozonschi, Lucian, Lutter, Georg
• Granted Patent: US 9,480,559 B2
• Time in Patent Office: Days
• US Class Current: 623/2.14
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0091 : helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00077 : Copper or Cu-based alloys
• 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 27/34 : Macromolecular materials
• CPC Class Codes: A61L 27/3625 : Vascular tissue, e.g. heart valves
• CPC Class Codes: A61L 27/3629 : Intestinal tissue, e.g. small intestinal submucosa
• CPC Class Codes: A61L 33/0011 : Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
• CPC Class Codes: C08L 67/04 : Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

This invention relates to the design and function of a compressible valve replacement prosthesis, collared or uncollared, which can be deployed into a beating heart without extracorporeal circulation using a transcatheter delivery system. The design as discussed focuses on the deployment of a device via a minimally invasive fashion and by way of example considers a minimally invasive surgical procedure preferably utilizing the intercostal or subxyphoid space for valve introduction. In order to accomplish this, the valve is formed in such a manner that it can be compressed to fit within a delivery system and secondarily ejected from the delivery system into the annulus of a target valve such as a mitral valve or tricuspid valve.

Claims

1-197. -197. (canceled)

198. A prosthetic heart valve which comprises a compressible self-expanding outer wire frame, and an inner leaflet wire frame, wherein the outer wire frame is a laser-cut mesh tube made of nickel-titanium alloy, said outer wire frame is covered on an exterior surface with a fabric mesh layer made of synthetic polymer material, the inner leaflet wire frame is made of nickel-titanium alloy wire and is disposed within the lumen of the outer wire frame, said inner leaflet wire frame has one or more panels of stabilized tissue sewn onto the inner leaflet wire frame to form a valve, said inner leaflet wire frame is also sewn to the outer wire frame to form sealed joint, wherein the outer wire frame has an annular collar at or near a distal (atrial) end of the outer wire frame, said annular collar comprises a wire frame collar support structure made of nickel-titanium alloy and having stabilized tissue sewn thereon to form an asymmetric semi-circular band extending radially around the exterior of the outer wire frame, said annular collar having an inner border segment sewn to the sealed joint, said annular collar having at least one flat-sided outer anterior segment, and said annular collar having a fabric mesh layer of synthetic fabric material on an exterior surface of the annular collar.

199. The prosthetic heart valve of claim 198, wherein the stabilized tissue of the inner leaflet wire frame and the annular collar is the same or different, and is derived from adult, 90-day old, or 30 day old, bovine, ovine, equine or porcine pericardium, or from animal small intestine submucosa.

200. The prosthetic heart valve of claim 198, wherein the synthetic fabric material is selected from the group of polymer compounds consisting of polyester, polyurethane, and polytetrafluoroethylene.

201. The prosthetic heart valve of claim 198, wherein the fabric mesh layer is made from an electrospun polymer.

202. The prosthetic heart valve of claim 198, wherein the stabilized tissue or synthetic fabric material is treated with anticoagulant.

203. The prosthetic heart valve of claim 198, wherein the angle of the annular collar to the exterior wall of the tubular outer wire frame comprises a range of between about 5 and about 45 degrees.

204. The prosthetic heart valve of claim 198, wherein the tubular outer wire frame has a uncompressed inner diameter of between about 18 millimeters and about 32 millimeters.

205. The prosthetic heart valve of claim 198, wherein the annular collar extends radially beyond the exterior wall of the expanded tubular outer wire frame a length of between about 2 millimeters and about 20 millimeters.

206. The prosthetic heart valve of claim 198, further comprising an epicardial tether apparatus comprising a single epicardial anchor and one or more tethers connecting the epicardial anchor to the prosthetic heart valve.

207. The prosthetic heart valve of claim 198, wherein the one or more tethers comprises between 1 and 8 adjustable length tethers.

208. The prosthetic heart valve of claim 206, wherein the one or more tethers connect the epicardial anchor to one or more prosthetic heart structures selected from the leaflet wire frame, the tubular outer frame, the integral collar support structure, or combinations thereof.

209. The prosthetic heart valve of claim 198, further comprising a wire spring-type anchor attached to a proximal (ventricular) end of the prosthetic heart valve, said wire spring-type anchor drawn or formed into a wire or band with shape-memory characteristics fashioned for attachment to native subvalvular tissue structures, wherein the wire spring-type anchor is fabricated from a shape-memory alloy, a surgical-grade alloy, a shape-memory polymer, ceramic or combinations thereof.

210. The prosthetic valve of claim 209, wherein the wire spring-type anchor is coil-shaped.

211. The prosthetic valve of claim 209, wherein the wire spring-type anchor is covered with biocompatible stabilized tissue, synthetic fabric material, or both.

212. The prosthetic heart valve of claim 198, wherein the outer wire frame has a three-dimensional structure that is a D-shape or a kidney-shape in lateral cross-section.

213. The prosthetic heart valve of claim 198, further comprising a plurality of piercing attachment clamps, said piercing attachment clamps mounted on the exterior of the outer wire frame to engage and attach to native valvular tissue.

214. A method of treating heart valve disease, which comprises the step of performing a transcatheter delivery of the prosthetic heart valve of claim 198 into the heart of a patient in need thereof.

215. The method of claim 214, wherein the heart valve disease is mitral regurgitation or tricuspid regurgitation.