Percutaneously implantable replacement heart valve device and method of making same

• US 8,308,797 B2
• Filed: 07/10/2004
• Issued: 11/13/2012
• Est. Priority Date: 01/04/2002
• Status: Active Grant

• Current Assignee: Colibri Heart Valve, LLC
• Original Assignee: Colibri Heart Valve, LLC
• Inventors: Induni, Eduardo, Lopez-Jimenez, Francisco, Fish, R. David, Paniagua, David, Mejia, Carlos
• Primary Examiner(s): Koharski, Christopher
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US10/887,688
• Publication Number:
  US 20050113910A1
• Time in Patent Office: 3,048 Days
• Field of Search: 623/1.24, 623/1.26, 623/900, 623 21- 219
• 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

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 a glutaraldehyde fixed bovine pericardium 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 rectangular fragment of bovine pericardium 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 for deployment in a patient, comprising:

a collapsible and expandable stent member including an inner channel; and

a single sheet of biocompatible pericardium tissue attached to the stent member by a plurality of sutures, the single sheet of biocompatible pericardium tissue partitioned by a transverse linear crease to form an outer cuff layer and an inner leaflet layer, the transverse linear crease oriented substantially parallel to a first edge and a second edge of the single sheet of biocompatible pericardium tissue, wherein the first edge includes a free edge of the inner leaflet layer, wherein at least portions of the inner leaflet layer reside substantially radially adjacent and in contact with the outer cuff layer within the stent member to form a contiguous double-layer folded construct, the inner leaflet layer partitioned by an additional linear crease oriented substantially perpendicular to the transverse linear crease to form two individual valve leaflets wherein the two individual valve leaflets are bordered in part by the additional linear crease, the additional linear crease located from the transverse linear crease to the free edge of the inner leaflet layer, wherein the inner leaflet layer resides in contact with the outer cuff layer along the additional linear crease, wherein a first lateral edge of the single sheet of biocompatible pericardium tissue adjoins a second lateral edge of the single sheet of biocompatible pericardium tissue, and wherein after deployment in the patient, the contiguous double-layer folded construct with the inner leaflet layer located radially within the outer cuff layer resides as a single element entirely within the inner channel of the stent member, and wherein only the inner leaflet layer resides radially inward from the outer cuff layer.

2. The percutaneously implantable replacement heart valve device of claim 1, wherein the single sheet of biocompatible pericardium tissue comprises one of treated bovine pericardium tissue or treated porcine pericardium tissue.

3. The percutaneously implantable replacement heart valve device of claim 1, wherein the stent member comprises a metal alloy.

4. The percutaneously implantable replacement heart valve device of claim 1, wherein the stent member comprises stainless steel.

5. The percutaneously implantable replacement heart valve device of claim 1, wherein the stent member comprises a shape memory alloy.

6. The percutaneously implantable replacement heart valve device of claim 5, wherein the shape memory alloy comprises nitinol.

7. The percutaneously implantable replacement heart valve device of claim 1, wherein the plurality of sutures includes sutures at axially distal and proximal ends of the contiguous double-layer folded construct.

8. The percutaneously implantable replacement heart valve device of claim 1, wherein the single sheet of biocompatible pericardium tissue forming the contiguous double-layer folded construct is continuous between the first edge to the transverse linear crease and back to the second edge.

9. The percutaneously implantable replacement heart valve device of claim 1, further comprising a second additional linear crease oriented substantially perpendicular to the transverse linear crease, wherein the additional linear crease and the second additional linear crease collectively form three individual valve leaflets.

10. A percutaneously implantable replacement heart valve device for deployment in a patient, comprising:

a collapsible and expandable stent member including an inner channel; and

a single sheet of biocompatible pericardium tissue attached to the stent member by a plurality of sutures, the single sheet of biocompatible pericardium tissue partitioned by a transverse linear crease to form an outer cuff layer and an inner leaflet layer, the transverse linear crease oriented substantially parallel to a first edge and a second edge of the single sheet of biocompatible pericardium tissue, wherein the first edge includes a free edge of the inner leaflet layer, wherein at least portions of the inner leaflet layer reside substantially radially adjacent and in contact with the outer cuff layer within the stent member to form a contiguous double-layer folded construct, the inner leaflet layer partitioned by two additional linear creases oriented substantially perpendicular to the transverse linear crease to form 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 located from the transverse linear crease to the free edge of the inner leaflet layer, wherein the inner leaflet layer resides in contact with the outer cuff layer along the two additional linear creases, wherein a first lateral edge of the single sheet of biocompatible pericardium tissue adjoins a second lateral edge of the single sheet of biocompatible pericardium tissue, and wherein after deployment in the patient, the contiguous double-layer folded construct with the inner leaflet layer located radially within the outer cuff layer resides as a single element entirely within the inner channel of the stent member, and wherein only the inner leaflet layer resides radially inward from the outer cuff layer.

11. The percutaneously implantable replacement heart valve device of claim 10, wherein the single sheet of biocompatible pericardium tissue comprises one of treated bovine pericardium tissue or treated porcine pericardium tissue.

12. The percutaneously implantable replacement heart valve device of claim 10, wherein the stent member comprises a metal alloy.

13. The percutaneously implantable replacement heart valve device of claim 10, wherein the stent member comprises stainless steel.

14. The percutaneously implantable replacement heart valve device of claim 10, wherein the stent member comprises a shape memory alloy.

15. The percutaneously implantable replacement heart valve device of claim 14, wherein the shape memory alloy comprises nitinol.

16. The percutaneously implantable replacement heart valve device of claim 10, wherein the plurality of sutures includes sutures at axially distal and proximal ends of the contiguous double-layer folded construct.

17. The percutaneously implantable replacement heart valve device of claim 10, wherein the single sheet of biocompatible pericardium tissue forming the contiguous double-layer folded construct is continuous between the first edge to the transverse linear crease and back to the second edge.