Percutaneously implantable replacement heart valve device and method of making same

• US 20050113910A1
• Filed: 07/10/2004
• Published: 05/26/2005
• Est. Priority Date: 01/04/2002
• Status: Active Grant

• Current Assignee: Colibri Heart Valve, LLC
• Original Assignee: Colibri Heart Valve, LLC
• Inventors: Induni, Eduardo, Mejia, Carlos, Lopez-Jimenez, Francisco, Fish, R. David, Paniagua, David
• Granted Patent: US 8,308,797 B2
• Time in Patent Office: Days
• US Class Current: 623/2.140
• 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

The present invention comprises a percutaneously implantable replacement heart valve device and a method of making same. The replacement heart valve device comprises a stent member made of stainless steel or self-expanding nitinol, a biological tissue artificial valve means disposed within the inner space of the stent member. An implantation and delivery system having a central part which consists of a flexible hollow tube catheter that allows a metallic wire guide to be advanced inside it. The endovascular stented-valve is created from a glutaraldehyde fixed biocompatible tissue material which has two or three cusps that open distally to permit unidirectional blood flow. The present invention also comprises a novel method of making a replacement heart valve by taking a fragment of biocompatible tissue material and treating, drying, folding and rehydrating it in such a way that forms a two- or three-leaflet/cusp valve with the leaflets/cusps formed by folding, thereby eliminating the extent of suturing required, providing improved durability and function.

Claims

1. A percutaneously implantable replacement heart valve device comprising an expandable stent member and a flexible, compressible artificial valve made of biocompatible tissue material and disposed within the inner cavity of said stent member affixed at one or more points on said artificial valve'"'"'s outer surface to said stent member, said artificial valve having cusps or leaflets formed by folding of a sheet of said biocompatible tissue material without affixing of separate cusps or leaflets or cutting slits into said material to form said cusps or 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 artificial valve comprises mammal pericardium tissue.

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

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

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

7. The percutaneously implantable heart valve device of claim 1, wherein said biocompatible tissue material of said artificial valve comprises a synthetic biocompatible material.

8. The percutaneously implantable heart valve device of claim 7, wherein said synthetic biocompatible material is selected from the group consisting of polytetrafluoroethylene, polyester, metal, metal alloy including combinations thereof.

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

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

11. A method of making a percutaneously implantable replacement heart valve device comprising the following steps:

obtaining a sheet of biocompatible tissue material;

drying said biocompatible tissue material;

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

affixing said folded biocompatible tissue material at one or more points on its outer surface to the inner cavity of a stent; and

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

12. The method of making a percutaneously implantable replacement heart valve device of claim 11, wherein said soaking step comprises soaking said biocompatible tissue material in a solution of isopropyl alcohol, a solution of ethanol, a solution of glycerol and a solution of gluteraldehyde.

13. The method of making a percutaneously implantable replacement heart valve device of claim 11, wherein said biocompatible tissue material comprises bovine pericardium tissue.

14. The method of making a percutaneously implantable replacement heart valve device of claim 11, wherein said biocompatible tissue material comprises porcine pericardium tissue.

15. The method of making a percutaneously implantable replacement heart valve device of claim 11, wherein said biocompatible tissue material is obtained from a juvenile animal pericardium.

16. The method of making a percutaneously implantable replacement heart valve device of claim 11, wherein said biocompatible tissue material comprises autologous tissue obtained from the patient into whom said replacement heart valve device will be implanted.

17. The percutaneously implantable heart valve device of claim 11, wherein said biocompatible tissue material of said artificial valve comprises a synthetic biocompatible material.

18. The percutaneously implantable heart valve device of claim 17, wherein said synthetic biocompatible material is selected from the group consisting of polytetrafluoroethylene, polyester, metal, metal alloy including combinations thereof.

19. The method of making a percutaneously implantable replacement heart valve device of claim 11, 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.

20. The method of making a percutaneously implantable replacement heart valve device of claim 11, wherein said stent is self-expanding when implanted.

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

22. The method of making a percutaneously implantable replacement heart valve device of claim 11, further comprising the step of cleaning said biocompatible tissue material using hydromechanical force means.

23. The method of making a percutaneously implantable replacement heart valve of claim 11, further comprising the step of compressing said biocompatible tissue material.

24. The method of making a percutaneously implantable replacement heart valve of claim 11, further comprising the step of gas sterilization of said biocompatible tissue material.

25. The method of making a percutaneously implantable replacement heart valve of claim 11, wherein said drying step comprises photomechanical compression of said biocompatible tissue material.

26. The method of making a percutaneously implantable replacement heart valve of claim 11, wherein said folding step comprises folding of a first piece of said biocompatible tissue material to create an outer tubular cuff structure, folding of a second separate piece of biocompatible tissue material to create inner cusps or leaflets without affixing of separate cusps or cutting slits into said second separate piece of biocompatible tissue material, and afixing said second separate piece to said first piece.

27. A percutaneously implantable replacement heart valve device comprising an expandable stent member and a flexible, compressible artificial valve made of biocompatible tissue material and disposed within the inner cavity of said stent member affixed at one or more points on said artificial valve'"'"'s outer surface to said stent member, said artificial valve comprising a leaflet or cusp portion formed by folding of a first sheet portion of said biocompatible tissue material without affixing of separate cusps or leaflets or cutting slits into said sheet to form said cusps or leaflets, and an outer tubular cuff structure formed by folding a second sheet portion of biocompatible tissue material, said first and second sheet portions being affixed together.

28. The device of claim 27, wherein said first sheet portion and said second sheet portions are affixed together by suturing.

29. The device of claim 28, wherein said suturing is in the form of double continuous sutures.

30. A percutaneously implantable replacement heart valve device comprising an outer cylindrical cuff portion and an inner uncut/unslit leaflet layer attached within said outer cuff portion.

31. The device of claim 30, wherein said leaflet layer is attached within said outer cuff portion by suturing.

32. The device of claim 31, wherein said suturing is in the form of double continuous sutures.

33. A percutaneously implantable replacement heart valve device comprising an expandable stent member and a flexible, compressible artificial valve made of biocompatible tissue material and disposed within the inner cavity of said stent member affixed at one or more points on said artificial valve'"'"'s outer surface to said stent member, said artificial valve comprising a leaflet or cusp portion formed by folding of a first sheet portion of said biocompatible tissue material without affixing of separate cusps or leaflets or cutting slits into said sheet to form said cusps or leaflets.