Percutaneously implantable replacement heart valve device and method of making same

• US 8,790,398 B2
• Filed: 12/20/2013
• Issued: 07/29/2014
• Est. Priority Date: 01/04/2002
• Status: Expired due to Fees

• Current Assignee: Colibri Heart Valve, LLC
• Original Assignee: Colibri Heart Valve, LLC
• Inventors: Paniagua, David, Fish, R. David
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US14/136,516
• Publication Number:
  US 20140114395A1
• Time in Patent Office: 221 Days
• Field of Search: 623/1.24, 623/1.26, 623 212- 219, 623/900
• US Class Current: 623/2.18
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• 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 2/2415 Manufacturing methods
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• 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 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/0095 : Saddle-shaped
• CPC Class Codes: A61F 2240/001 : Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2310/00371 : Collagen
• CPC Class Codes: A61L 27/3604 : characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3683 : subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/3687 : characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
• CPC Class Codes: A61L 27/3691 : characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
• CPC Class Codes: Y10S 623/917 : Collagen
• CPC Class Codes: Y10S 623/918 : Heart
• CPC Class Codes: Y10T 29/49412 : with assembly, disassembly or composite article making

Abstract

A method of making a replacement heart valve device whereby a fragment of biocompatible tissue material is treated and soaked in one or more alcohol solutions and a solution of glutaraldehyde. The dried biocompatible tissue material is folded and rehydrated in such a way that forms a two- or three-leaflet/cusp valve without affixing of separate cusps or leaflets or cutting slits into the biocompatible tissue material to form the cusps or leaflets. After the biocompatible tissue material is folded, it is affixed at one or more points on the outer surface to the inner cavity or a stent.

Claims

1. A percutaneously implantable replacement heart valve for implantation in a patient, comprising:

a stent member having an inner channel, the stent member collapsible, expandable and configured for percutaneous delivery, wherein the stent member includes a tubular structure away from its central portion that flares at both ends in a trumpet-like configuration; and

a valve means residing entirely within the inner channel of the stent member, the valve means including an outer cuff layer and two to four individual leaflets, wherein each of the two to four individual leaflets is rectangular in shape in side elevation view, wherein each of the two to four individual leaflets is bounded by lengthwise-oriented lines of sutures, wherein a crease is located between the two to four individual leaflets and the outer cuff layer at a base of the two to four individual leaflets, and wherein after implantation in the patient, the valve means resides as a single element entirely within the inner channel of the stent member, and wherein only the two to four individual leaflets reside radially inward from the outer cuff layer.

2. The percutaneously implantable replacement heart valve of claim 1, wherein the outer cuff layer and the two to four individual leaflets comprise a single continuous sheet of material.

3. The percutaneously implantable replacement heart valve of claim 1, wherein the outer cuff layer and the two to four individual leaflets are made of a biocompatible material.

4. The percutaneously implantable replacement heart valve of claim 3, wherein the biocompatible material comprises a treated pericardium tissue.

5. The percutaneously implantable replacement heart valve of claim 3, wherein the biocompatible material comprises a synthetic material.