Artificial valve with center leaflet attachment

• US 7,503,928 B2
• Filed: 10/17/2006
• Issued: 03/17/2009
• Est. Priority Date: 10/21/2005
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Biotech Incorporated (Cook Group Incorporated), Cook Incorporated (Cook Group Incorporated)
• Inventors: Case, Brian C., Obermiller, Joseph F.
• Primary Examiner(s): Pellegrino; Brian E.
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US11/582,248
• Publication Number:
  US 20070093887A1
• Time in Patent Office: 882 Days
• Field of Search: 623/1.24, 623/1.25, 623/1.26, 623 21- 219
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0095 Saddle-shaped

Abstract

The present invention provides self-expanding or otherwise expandable artificial valve prostheses for deployment within a bodily passageway, such as a vessel or duct of a patient. The valve prostheses include a support structure having an outer frame and supporting a valve leaflet.

Claims

1. An artificial valve prosthesis for regulating fluid flow through a body vessel, comprising:

a support structure comprising an outer frame defining a lumen and a transverse member traversing the lumen and dividing the lumen into a first lumen segment and a second lumen segment;

a first valve leaflet and a second valve leaflet, wherein portions of a perimeter of the first valve leaflet and portions of a perimeter of the second valve leaflet are attached to the transverse member and to the outer frame proximally of the traverse member, and wherein portions of the perimeter of the first and the second valve leaflets are not attached to the transverse member or the outer frame,

wherein the first valve leaflet is positioned within the first lumen segment and the second valve leaflet is positioned within the second lumen segment, and wherein the first and second valve leaflets are deformable between a first position allowing fluid flow in a first, antegrade, direction to a second position restricting fluid flow in a second, retrograde, direction.

2. The artificial valve prosthesis of claim 1, wherein fluid flow in the first, antegrade, direction in the first lumen segment occurs through an opening defined by the outer frame and the portion of the perimeter of the first valve leaflet not attached to the transverse member or the outer frame and in the second lumen segment occurs through an opening between the outer frame and the portion of the perimeter of the second valve leaflet not attached to the transverse member or the outer frame.

3. The artificial valve prosthesis of claim 1, wherein the support structure comprises a polymeric material.

4. The artificial valve prosthesis of claim 1, wherein the support structure comprises a material selected from a group consisting of stainless steel, nickel, silver, platinum, gold, titanium, tantalum, iridium, tungsten, a self-expanding nickel titanium alloy, and inconel.

5. The artificial valve prosthesis of claim 4, wherein the support structure comprises a self-expanding nickel titanium alloy.

6. The artificial valve prosthesis of claim 1, wherein the first valve leaflet and the second valve leaflet comprise a material selected from the group consisting of a synthetic biocompatible polymer, cellulose acetate, cellulose nitrate, silicone, polyethylene, teraphthalate, polyurethane, polyamide, polyester, polyorthoester, poly anhydride, polyether sulfone polycarbonate, polypropylene, high molecular weight polyethylene, a fluoroplastic material, polytetrafluoroethylene, or mixtures or copolymers thereof;

polylactic acid, polyglycolic acid or copolymers thereof, a polyanhydride, polycaprolactone, polyhydroxy-butyrate valerate, polyhydroxyalkanoate, a polyetherurethane urea, naturally derived or synthetic collagenous material, an extracellular matrix material, submucosa, small intestinal submucosa, stomach submucosa, urinary bladder submucosa, uterine submucosa, renal capsule membrane, dura mater, pericardium, serosa, peritoneum or basement membrane materials, and liver basement membrane.

7. The artificial valve prosthesis of claim 1, where the first valve leaflet and the second valve leaflet comprise a bioremodelable material.

8. The artificial valve prosthesis of claim 1, wherein the first valve leaflet and the second valve leaflet comprise small intestinal submucosa.

9. The artificial valve prosthesis of claim 1, wherein the first valve leaflet and the second valve leaflet comprise a polyurethane.

10. An artificial valve prosthesis for regulating fluid flow through a body vessel, comprising:

a support structure comprising an outer frame defining a lumen and a plurality of radial members each having a first end and a second end, wherein the first ends of the plurality of radial members are joined within the lumen and wherein the second end of each of the plurality of radial members is attached to the outer frame at a position proximal of the first ends of the radial members;

a plurality of valve leaflets, wherein a first portion of a perimeter of each of the plurality of valve leaflets is attached to adjacent radial members, wherein a second portion of the perimeter of each of the plurality of valve leaflets extends between the adjacent radial members and wherein the plurality of valve leaflets form an enclosure having an proximal opening defined by the portions of the perimeter of the plurality of valve leaflets extending between the adjacent radial members,

wherein each of the plurality of valve leaflets is deformable between a first position allowing fluid flow in a first, antegrade, direction to a second position restricting fluid flow in a second, retrograde, direction.

11. The artificial valve prosthesis of claim 10, wherein the first ends of the plurality of radial members are joined at a common position within the lumen, wherein the second end of each of the plurality of radial members is attached to the outer frame at an equal proximal distance from the common position and wherein the second ends of the plurality of radial members are attached to the outer frame at positions equally spaced around a circumference of the outer frame.

12. The artificial valve prosthesis of claim 10, comprising three valve leaflets.

13. The artificial valve prosthesis of claim 10, wherein the support structure comprises a polymeric material.

14. The artificial valve prosthesis of claim 10, wherein the support structure comprises a material selected from a group consisting of stainless steel, nickel, silver, platinum, gold, titanium, tantalum, iridium, tungsten, a self-expanding nickel titanium alloy, and inconel.

15. The artificial valve prosthesis of claim 14, wherein the support structure comprises a self-expanding nickel titanium alloy.

16. The artificial valve prosthesis of claim 10, wherein the plurality of valve leaflets comprise a material selected from the group consisting of a synthetic biocompatible polymer, cellulose acetate, cellulose nitrate, silicone, polyethylene, teraphthalate, polyurethane, polyamide, polyester, polyorthoester, poly anhydride, polyether sulfone, polycarbonate, polypropylene, high molecular weight polyethylene, a fluoroplastic material, polytetrafluoroethylene, or mixtures or copolymers thereof;

polylactic acid, polyglycolic acid or copolymers thereof, a polyanhydride, polycaprolactone, polyhydroxy-butyrate valerate, polyhydroxyalkanoate, a polyetherurethane urea, naturally derived or synthetic collagenous material, an extracellular matrix material, submucosa, small intestinal submucosa, stomach submucosa, urinary bladder submucosa, uterine submucosa, renal capsule membrane, dura mater, pericardium, serosa, peritoneum or basement membrane materials, and liver basement membrane.

17. The artificial valve prosthesis of claim 10, wherein the valve leaflets comprise a polyurethane or small intestinal submucosa.

18. An artificial valve prosthesis for regulating fluid flow through a blood vessel, comprising:

a support structure comprising an outer frame which defines a lumen with two ends and comprises a transverse member located near one end of the lumen and attached to the outer frame so as to divide the lumen into two portions,

two valve leaflets each having an end attached to the transverse member, an end partially attached to the outer frame near the end opposite the transverse member and two sides attached along a length of the outer frame proximally of the transverse member,

wherein the valve leaflets are deformable between a first position that permits fluid flow in an antegrade direction through the blood vessel and a second position that restricts fluid flow in a retrograde direction.

19. An artificial valve prosthesis for regulating fluid flow through a blood vessel, comprising:

a support structure comprising an outer frame defining a lumen with a proximal end and a distal end,

two valve leaflets attached along a portion of their perimeter to form a join, the join extending across the lumen near the distal end of the lumen so as to divide the lumen into two portions, each valve leaflet having leaflet end partially attached to the outer frame near the proximal end of the lumen and two sides attached along a length of the outer frame,

wherein the valve leaflets are deformable between a first position that permits fluid flow in an antegrade direction through the blood vessel and a second position that restricts fluid flow in a retrograde direction.

20. A method of treating a subject, the method comprising:

providing an artificial valve prosthesis comprising;

a support structure comprising an outer frame defining a lumen and a transverse member traversing the lumen and dividing the lumen into a first lumen segment and a second lumen segment;

a first valve leaflet and a second valve leaflet, wherein portions of a perimeter of the first valve leaflet and portions of a perimeter of the second valve leaflet are attached to the transverse member and to the outer frame proximally of the traverse member, and wherein portions of the perimeter of the first and the second valve leaflets are not attached to the transverse member or the outer frame,

wherein the first valve leaflet is positioned within the first lumen segment and the second valve leaflet is positioned within the second lumen segment, and wherein the first and second valve leaflets are deformable between a first position allowing fluid flow in a first, antegrade, direction to a second position restricting fluid flow in a second, retrograde, direction,

delivering the artificial valve prosthesis to a region of a body vessel in a compressed state; and

deploying the artificial valve prosthesis in an expanded state.