Implantable valve prosthesis with independent frame elements

• US 8,372,140 B2
• Filed: 01/07/2010
• Issued: 02/12/2013
• Est. Priority Date: 01/07/2009
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Hoffman, Grant T., Chambers, Sean D., Melsheimer, Jeffry S.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Mathew, Seema
• Application Number:
  US12/683,670
• Publication Number:
  US 20100174364A1
• Time in Patent Office: 1,132 Days
• Field of Search: 623/1.24, 623/1.3, 623/2.17, 623/1.13, 623/1.26, 623/2.18
• US Class Current: 623/1.26
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/0054 V-shaped

Abstract

An implantable valve prosthesis is provided. The valve prosthesis includes a frame structure having first and second independent frame elements. A graft member is attached to both the first and second frame elements and includes a closure member, such as a valve leaflet. The closure member is movable between a first position that allows fluid flow through the prosthesis in a first, antegrade direction and a second position that restricts flow through the prosthesis in a second, retrograde direction.

Claims

1. A valve prosthesis adapted for implantation in a body vessel and having a lengthwise axis, said valve prosthesis comprising:

a first frame element defining a serpentine path comprising a series of substantially straight strut portions interconnected by bends;

a second frame element defining a path that includes first and second substantially straight struts disposed substantially parallel to each other and third and fourth substantially straight struts disposed substantially parallel to each other, the first and second substantially straight struts disposed circumferentially opposite the third and fourth substantially straight struts with respect to said lengthwise axis;

one of the first and second frame elements further comprising an elongate strut that defines an outwardly-projecting curve with respect to said lengthwise axis, the outwardly-projecting curve adapted to define a sinus in said body vessel when said valve prosthesis is implanted therein; and

a graft member attached to the first frame element and the second frame element, the graft member comprising a closure member adapted to move between a first position that allows fluid flow through said implantable valve prosthesis in a first, antegrade direction and a second position that restricts fluid flow through said implantable valve prosthesis in a second, retrograde direction;

wherein the first and second frame elements are connected to each other only by attachments of the graft member to the first and second frame elements.

2. The valve prosthesis of claim 1, wherein the first frame has a first frame expanded diameter and the second frame has a second frame expanded diameter;

and

wherein the first frame expanded diameter is different than the second frame expanded diameter.

3. The valve prosthesis of claim 1, wherein the graft member is a flexible material selected from the group consisting of polymeric material, collagen, extracellular matrix material, and mixtures thereof.

4. The valve prosthesis of claim 3, wherein the polymeric material is a polyester.

5. The valve prosthesis of claim 3, wherein the extracellular matrix material is selected from the group consisting of:

small intestine submucosa, stomach submucosa, uterine submucosa, urinary bladder submucosa, tissue mucosa, basement membrane materials, renal capsule, serosa, peritoneum, dura matter, pericardium, elastin, elastin-like polypeptides, and mixtures thereof.

6. The valve prosthesis of claim 1, wherein one of the first and second frame elements is constructed from a shape-memory alloy material selected from the group consisting of:

Ni—

Ti, Au—

Cd, Cu—

Zn, In—

Ti, Cu—

Zn—

Al, Ti—

Nb, Au—

Cu—

Zn, Cu—

Zn—

Sn, Cu—

Zn—

Si, Cu—

Al—

Ni, Ag—

Cd, Cu—

Sn, Cu—

Zn—

Ga, Ni—

Al, Fe—

Pt, U—

Nb, Ti—

Pd—

Ni, Fe—

Mn—

Si, Ni—

Ti—

Cr, and alloy mixtures thereof.

7. The valve prosthesis of claim 1, wherein one of the first and second frame elements is constructed from a material selected from the group consisting of:

tantalum, stainless steel, titanium, niobium, gold, platinum, cobalt, and mixtures thereof.

8. The valve prosthesis of claim 1, wherein one of the first and second frame elements is constructed from a polymer selected from the group consisting of polyethylene, polypropylene, polyisobutylene, poly(alpha olefin), alkyl acrylates, polymethyl acrylate, polymethyl methacrylate, parylene, ethyl vinyl acetate;

polyethylene-co-vinyl acetate, polyesters, polycarbonates, polyoxaesters, polyanhydrides, polyamino acids, polyphosphazenes, phosphorylcholine, phosphatidylcholine, hydrogels, polydioxanone, poly(DTE carbonate, fibrin, collagens, extracellular matrix materials, dextrans, polysaccharides, hyaluronic acid, bioabsorbable polymers, and mixtures thereof.

9. The valve prosthesis of claim 1, wherein the graft member comprises at least one leaflet and a contiguous wall portion harvested from a natural valve.

10. The valve prosthesis of claim 9, wherein the contiguous wall portion is attached to the elongate strut that defines an outwardly-projecting curve.

11. The valve prosthesis of claim 10, wherein the contiguous wall portion is attached to the elongate strut that defines an outwardly-projecting curve by a continuous attachment between the contiguous wall portion and the strut that defines an outwardly-projecting curve.

12. The valve prosthesis of claim 11, wherein the strut that defines an outwardly-projecting curve has a strut length and wherein the continuous attachment comprises sutures attaching the contiguous wall portion to the strut that defines an outwardly-projecting curve along the strut length.

13. The valve prosthesis of claim 11, wherein the outwardly-projecting curve has a curve length and wherein the continuous attachment comprises sutures attaching the contiguous wall portion to the strut that defines an outwardly-projecting curve along the curve length.

14. The valve prosthesis of claim 1, wherein the second frame element comprises the elongate strut that defines an outwardly-projecting curve.

15. A valve prosthesis adapted for implantation in a body vessel and having a lengthwise axis, said valve prosthesis comprising:

a first frame element defining a serpentine path comprising a series of substantially straight strut portions interconnected by bends;

a second frame element defining a path that includes first and second substantially straight struts disposed substantially parallel to each other and third and fourth substantially straight struts disposed substantially parallel to each other, the first and second substantially straight struts disposed circumferentially opposite the third and fourth substantially straight struts with respect to said lengthwise axis;

the second frame element further comprising an elongate strut that defines an outwardly-projecting curve with respect to said lengthwise axis, the elongate strut disposed circumferentially between the first and second substantially straight struts and the third and fourth substantially straight struts with respect to said lengthwise axis, the outwardly-projecting curve adapted to define a sinus in said body vessel when said valve prosthesis is implanted therein; and

a graft member attached to the first frame element and the second frame element, the graft member comprising a closure member adapted to move between a first position that allows fluid flow through said implantable valve prosthesis in a first, antegrade direction and a second position that restricts fluid flow through said implantable valve prosthesis in a second, retrograde direction;

wherein the first and second frame elements are connected to each other only by attachments of the graft member to the first and second frame elements.

16. The valve prosthesis of claim 15, wherein the graft member comprises at least one leaflet and a contiguous wall portion harvested from a natural valve.

17. A valve prosthesis adapted for implantation in a body vessel and having a lengthwise axis, said valve prosthesis comprising:

a first frame element defining a serpentine path comprising a series of substantially straight strut portions interconnected by bends;

a second frame element independent of the first frame element and defining a path that includes first and second substantially straight struts disposed substantially parallel to each other and third and fourth substantially straight struts disposed substantially parallel to each other, the first and second substantially straight struts disposed circumferentially opposite the third and fourth substantially straight struts with respect to said lengthwise axis;

the second frame element further comprising an elongate strut that defines an outwardly-projecting curve with respect to said lengthwise axis, the elongate strut disposed circumferentially between the first and second substantially straight struts and the third and fourth substantially straight struts with respect to said lengthwise axis, the outwardly-projecting curve adapted to define a sinus in said body vessel when said valve prosthesis is implanted therein; and

a graft member attached to the first frame element and the second frame element, the graft member comprising at least one leaflet and a contiguous wall portion harvested from a natural valve, the contiguous wall portion attached to the elongate strut that defines an outwardly-projecting curve;

wherein the first and second frame elements are connected to each other only by attachments of the graft member to the first and second frame elements.