Percutaneously implantable replacement heart valve device and method of making same

• US 9,610,158 B2
• Filed: 11/13/2012
• Issued: 04/04/2017
• Est. Priority Date: 01/04/2002
• Status: Active Grant

• Current Assignee: Colibri Heart Valve, LLC
• Original Assignee: Colibri Heart Valve, LLC
• Inventors: Lopez-Jimenez, Fransisco, Paniagua, David, Fish, R. David, Induni, Eduardo, Meija, Carlos
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US13/675,665
• Publication Number:
  US 20140005766A1
• Time in Patent Office: 1,603 Days
• 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 device for implantation in a patient, comprising:

an expandable stent member having an inner channel, the expandable stent member collapsible and configured for percutaneous delivery; and

a valve means made of biocompatible tissue material and attached to the expandable 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 a crease is located between a base of the two to four individual leaflets and the outer cuff layer, and wherein after implantation in the patient, the valve means resides as a single element entirely within the inner channel of the expandable stent member, wherein only the two to four individual leaflets reside radially inward from the outer cuff layer, and wherein the valve means is formed without cutting slits into said biocompatible tissue material to form said leaflets.

2. The percutaneously implantable replacement heart valve device of claim 1, wherein said expandable stent member is made of a metal or alloy of metals selected from the group consisting of nickel-titanium alloy, titanium and stainless steel.

3. The percutaneously implantable replacement heart valve device of claim 1, wherein said biocompatible tissue material of said valve means comprises porcine pericardium tissue.

4. The percutaneously implantable replacement heart valve device of claim 1, wherein said biocompatible tissue material of said valve means comprises autologous tissue obtained from the patient into whom said replacement heart valve device will be implanted.

5. The percutaneously implantable heart valve device of claim 1, wherein said expandable stent member is self-expanding when implanted.

6. The percutaneously implantable heart valve device of claim 1, wherein said expandable stent member is balloon catheter expandable when implanted.