Percutaneously implantable replacement heart valve device and method of making same

• US 8,109,995 B2
• Filed: 08/08/2008
• Issued: 02/07/2012
• Est. Priority Date: 01/04/2002
• Status: Expired due to Term

• Current Assignee: Colibri Heart Valve, LLC
• Original Assignee: Colibri Heart Valve, LLC
• Inventors: Paniagua, David, Induni, Eduardo, Mejia, Carlos, Lopez-Jimenez, Francisco, Fish, R. David
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Miller, Cheryl
• Application Number:
  US12/228,192
• Publication Number:
  US 20090030511A1
• Time in Patent Office: 1,278 Days
• Field of Search: 623/1.24, 623/1.26, 623 21- 219, 623/2.42, 623/900, 623915-918, 623/921, 623/922, 8 9/411, 8 9/42
• US Class Current: 623/2.14
• 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 method of making a percutaneously implantable replacement heart valve, comprising:

(a) forming a transverse linear crease in a sheet of tissue membrane to provide an outer cuff layer and an inner leaflet layer in the sheet of tissue membrane, wherein the transverse linear crease is oriented substantially parallel to a first edge and a second edge of the sheet of tissue membrane;

(b) partitioning the inner leaflet layer by forming two additional linear creases in the sheet of tissue membrane, the two additional linear creases oriented substantially perpendicular to the transverse linear crease to provide three individual valve leaflets, wherein the three individual valve leaflets are bordered in part by the two additional linear creases, the two additional linear creases extending from the transverse linear crease to a free edge of the inner leaflet layer; and

(c) attaching the sheet of tissue membrane with the transverse linear crease and the two additional linear creases to a collapsible and expandable stent member such that the sheet of tissue membrane resides as a single element entirely within an inner channel of the collapsible and expandable stent member, wherein only the inner leaflet layer resides radially inward from the outer cuff layer, and wherein a first lateral edge of the sheet of tissue membrane adjoins a second lateral edge of the sheet of tissue membrane;

wherein the inner leaflet layer contacts the outer cuff layer along each of the two additional linear creases; and

wherein the first edge includes the free edge of the inner leaflet layer, and wherein at least portions of the inner leaflet layer reside substantially radially adjacent and in contact with the outer cuff layer within the collapsible and expandable stent member to form a contiguous double-layer folded construct.

2. The method of making a percutaneously implantable replacement heart valve of claim 1, further comprising associating a catheter with the collapsible and expandable stent member after attaching the sheet of tissue membrane to the collapsible and expandable stent member.

3. The method of making a percutaneously implantable replacement heart valve of claim 1, wherein the sheet of tissue membrane comprises one of treated bovine pericardium tissue or treated porcine pericardium tissue.

4. The method of making a percutaneously implantable replacement heart valve of claim 1, wherein attaching the sheet of tissue membrane to the collapsible and expandable stent member comprises suturing the sheet of tissue membrane to the collapsible and expandable stent member at axially distal and proximal ends of the contiguous double-layer folded construct.

5. The method of making a percutaneously implantable replacement heart valve of claim 1, wherein each of the two additional linear creases corresponds to a leaflet commissure between adjacent individual valve leaflets.

6. The method of making a percutaneously implantable replacement heart valve of claim 1, wherein the collapsible and expandable stent member comprises a shape memory alloy.

7. The method of making a percutaneously implantable replacement heart valve of claim 6, wherein the shape memory alloy comprises nitinol.