Percutaneously Implantable Replacement Heart Valve Device and Method of Making Same

• US 20120310041A1
• Filed: 02/06/2012
• Published: 12/06/2012
• Est. Priority Date: 01/04/2002
• Status: Active Grant

• Current Assignee: Colibri Heart Valve, LLC
• Original Assignee: Colibri Heart Valve, LLC
• Inventors: PANIAGUA, David, INDUNI, Eduardo, FISH, R. David
• Granted Patent: US 9,186,248 B2
• Time in Patent Office: Days
• US Class Current: 600/36
• 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 device comprising:

obtaining a sheet of biocompatible tissue material;

cleaning said biocompatible tissue material using distilled water;

drying said biocompatible tissue material;

after drying said biocompatible tissue material, folding said biocompatible tissue material to form inner leaflets and an outer tubular cuff structure without affixing of separate cusps or leaflets or cutting slits into said biocompatible tissue material to form said inner leaflets;

after folding said biocompatible tissue material, affixing said biocompatible tissue material to a stent such that said biocompatible tissue material resides as a single element entirely within an inner channel of said stent, wherein only said inner leaflets reside radially inward from said outer tubular cuff structure; and

soaking said biocompatible tissue material in one or more alcohol solutions and a solution of glutaraldehyde.

2. The method of making a percutaneously implantable replacement heart valve device of claim 1, wherein said soaking occurs after said cleaning.

3. The method of making a percutaneously implantable replacement heart valve device of claim 1, wherein said biocompatible tissue material comprises bovine pericardium tissue.

4. The method of making a percutaneously implantable replacement heart valve device of claim 1, wherein said biocompatible tissue material comprises porcine pericardium tissue.

5. The method of making a percutaneously implantable replacement heart valve device of claim 1, wherein said biocompatible tissue material is obtained from a juvenile animal pericardium.

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

10. The method of making a percutaneously implantable replacement heart valve device of claim 1, wherein said stent is self-expanding when implanted.

11. The method of making a percutaneously implantable replacement heart valve device of claim 1, wherein said stent is balloon catheter expandable when implanted.

12. The method of making a percutaneously implantable replacement heart valve device of claim 1, wherein said cleaning said biocompatible tissue material using distilled water includes using hydromechanical force.

13. The method of making a percutaneously implantable replacement heart valve of claim 1, further comprising compressing said biocompatible tissue material.

14. The method of making a percutaneously implantable replacement heart valve of claim 1, further comprising gas sterilization of said biocompatible tissue material.

15. The method of making a percutaneously implantable replacement heart valve of claim 13, further comprising exposing said biocompatible tissue material to light.

6-8. -8. (canceled)

16. (canceled)

17. A method of making a percutaneously implantable replacement heart valve, comprising:

(a) treating a tissue membrane in the following order;

(i) cleaning said tissue membrane using distilled water;

(ii) soaking said tissue membrane in an isopropyl alcohol solution; and

(iii) soaking said tissue membrane in a glutaraldehyde solution;

(b) after said treating, drying said tissue membrane;

(c) after said drying, folding said tissue membrane to form inner leaflets and an outer tubular cuff structure; and

(d) after said folding, attaching said tissue membrane to a stent member.

18. The method of making a percutaneously implantable replacement heart valve of claim 17, wherein said treating further comprises soaking the tissue membrane in an ethanol solution after soaking said tissue membrane in the isopropyl alcohol solution and before soaking said tissue membrane in the glutaraldehyde solution.

19. The method of making a percutaneously implantable replacement heart valve of claim 17, wherein said treating further comprises soaking the tissue membrane in a glycerol solution after soaking said tissue membrane in the isopropyl alcohol solution and before soaking said tissue membrane in the glutaraldehyde solution.

20. The method of making a percutaneously implantable replacement heart valve of claim 17, wherein after said attaching, the tissue membrane resides as a single element entirely within an inner channel of the stent member.

21. The method of making a percutaneously implantable replacement heart valve of claim 17, wherein the tissue membrane comprises one of bovine pericardium tissue or porcine pericardium tissue.

22. The method of making a percutaneously implantable replacement heart valve of claim 17, further comprising exposing said tissue membrane to light.

23. The method of making a percutaneously implantable replacement heart valve of claim 17, further comprising:

(e) after said attaching, collapsing said stent member for use with a catheter.

24. A method of making a percutaneously implantable replacement heart valve, comprising:

(a) cleaning a tissue membrane by contacting the tissue membrane using distilled water such that a first solution contacting the tissue membrane is the distilled water;

(b) drying said tissue membrane;

(c) folding said tissue membrane; and

(d) attaching said tissue membrane to a stent member.

25. The method of making a percutaneously implantable replacement heart valve of claim 24, further comprising treating the tissue membrane in an isopropyl alcohol solution and soaking said tissue membrane in a glutaraldehyde solution.