Artificial Valve Prosthesis with a Free Leaflet Portion

• US 20120109291A1
• Filed: 01/09/2012
• Published: 05/03/2012
• Est. Priority Date: 02/15/2007
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Paul, Ram H. Jr., Shirley, Gary B.
• Granted Patent: US 8,679,175 B2
• Time in Patent Office: Days
• US Class Current: 623/2.17
• 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2250/0036 differing in thickness

Abstract

One embodiment of the present invention provides an implantable valve prosthesis. The valve prosthesis includes a frame defining a lumen extending between a proximal frame end and a distal frame end along a longitudinal axis, and a first valve leaflet positioned within the lumen and having a distal edge attached to the frame and a proximal edge free of the frame. The first valve leaflet comprises a first and a second slit extend distally from the proximal edge and defining a free portion of the first valve leaflet between the first and second slits. The first valve leaflet is movable between a first position that allows fluid flow in a first, antegrade, direction and a second position that restricts flow in a second, retrograde direction.

Claims

1. An implantable valve prosthesis comprising:

a frame having a proximal frame end and a distal frame end, the frame defining a lumen extending between the proximal frame end and the distal frame end along a longitudinal axis; and

a first valve leaflet positioned within the lumen and having a distal edge attached to the frame and a proximal edge free of the frame, wherein the first valve leaflet comprises at least one material having a first slit and a second slit through the first valve leaflet, each slit of the first and second slits comprising an opening in the first valve leaflet extending proximally along the first valve leaflet from a distal slit end proximal of the distal edge of the first valve leaflet to a proximal slit end distal of and not continuous with the proximal edge of the first valve leaflet, the first and second slits cooperatively defining a free portion of the first valve leaflet between the first and second slits;

wherein the first valve leaflet is movable between a first position that allows fluid flow in a first, antegrade, direction and a second position that restricts flow in a second, retrograde direction.

2. The implantable valve prosthesis of claim 1, wherein the first valve leaflet is reinforced at the distal slit end points.

3. The implantable valve prosthesis of claim 1, further comprising a second valve leaflet positioned within the lumen and having a distal edge attached to the frame and a proximal edge free of the frame;

wherein the first and second valve leaflets are movable between a first position that allows fluid flow in a first, antegrade, direction and a second position wherein the proximal edges of the first and second valve leaflets co-apt to restrict flow in a second, retrograde direction.

4. The implantable valve prosthesis of claim 2, wherein the second valve leaflet comprises a third slit and a fourth slit, each slit of the third and fourth slits comprising an opening in the second valve leaflet extending proximally along the second valve leaflet from a distal slit end proximal of the distal edge of the second valve leaflet to a proximal slit end distal of and not continuous with the proximal edge of the second valve leaflet, the third and fourth slits cooperatively defining a second free portion of the second valve leaflet between the third and fourth slits

5. The implantable valve prosthesis of claim 4, wherein, in the second position, portions of the first and second valve leaflets co-apt at a location extending distally from the proximal edges of the first and second valve leaflets to beyond the distal slit ends of the first and second valve leaflets.

6. The implantable valve prosthesis of claim 1, wherein the first valve leaflet comprises a first portion comprising the free portion of the first valve leaflet and a second portion comprising the distal edge of the first valve leaflet.

7. The implantable valve prosthesis of claim 6, wherein the first portion and the second portion of the first valve leaflet comprise the same material.

8. The implantable valve prosthesis of claim 6, wherein the first portion and the second portion of the first valve leaflet comprise different materials and wherein the first portion is attached to the second portion.

9. The implantable valve prosthesis of claim 8, wherein the first portion or the second portion of the first valve leaflet comprises 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, polylactic acid, polyglycolic acid or copolymers thereof, polyanhydride, polycaprolactone, polyhydroxy-butyrate valerate, polyhydroxyalkanoate, polyetherurethane urea, naturally derived or synthetic collagenous material, 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 material, liver basement membrane and mixtures or copolymers thereof.

10. The implantable valve prosthesis of claim 9, wherein the material is selected from the group consisting of a synthetic biocompatible polymer, a polyurethane, small intestinal submucosa and a naturally derived or synthetic collagenous material.

11. The implantable valve prosthesis of claim 6, wherein the first portion of the first valve leaflet is thinner than the second portion of the first valve leaflet.

12. The implantable valve prosthesis of claim 6, wherein the first portion of the first valve leaflet is more flexible than the second portion of the first valve leaflet.

13. The implantable valve prosthesis of claim 1, further comprising a bioactive material releasably attached to at least a portion of the implantable valve.

14. The implantable valve prosthesis of claim 1, wherein the frame is an expandable frame.

15. The implantable valve prosthesis of claim 1, wherein the frame comprises a material selected from the group consisting of stainless steel, nickel, silver, platinum, gold, titanium, tantalum, iridium, tungsten, a nickel titanium alloy, and inconel.

16. An implantable valve prosthesis comprising:

a frame having a proximal frame end and a distal frame end, the frame defining a lumen extending between the proximal frame end and the distal frame end along a longitudinal axis;

a first valve leaflet positioned within the lumen and having a first distal edge attached to the frame and a first proximal edge free of the frame, wherein the first valve leaflet comprises at least one material having a first slit and a second slit through the first valve leaflet, each slit of the first and second slits comprising an opening in the first valve leaflet extending proximally along the first valve leaflet from a distal slit end proximal of the first distal edge of the first valve leaflet to a proximal slit end distal of and not continuous with the first proximal edge of the first valve leaflet, the first and second slits cooperatively defining a first free portion of the first valve leaflet between the first and second slits; and

a second valve leaflet positioned within the lumen and having a second distal edge attached to the frame and a second proximal edge free of the frame, wherein the second valve leaflet comprises at least one material having a third slit and a fourth slit through the second valve leaflet, each slit of the third and fourth slits comprising an opening in the second valve leaflet extending proximally along the second valve leaflet from a distal slit end proximal of the second distal edge of the second valve leaflet to a proximal slit end distal of and not continuous with the second proximal edge of the second valve leaflet, the third and fourth slits cooperatively defining a second free portion of the second valve leaflet between the third and fourth slits;

wherein the first and second valve leaflets are movable between a first position that allows fluid flow in a first, antegrade, direction and a second position that restricts flow in a second, retrograde direction; and

wherein the first valve leaflet comprises a first leaflet portion comprising the free portion of the first valve leaflet and a second leaflet portion comprising the distal edge of the first valve leaflet, and the second valve leaflet comprises a third leaflet portion comprising the free portion of the second valve leaflet and a fourth leaflet portion comprising the distal edge of the second valve leaflet.

17. The implantable valve prosthesis of claim 16, wherein at least one of the first and second valve leaflets comprises first and second materials;

wherein the first material is different from and is attached to the second material.

18. The implantable valve prosthesis of claim 16, further comprising a bioactive material releasably attached to at least a portion of the implantable valve.

19. The implantable valve prosthesis of claim 18, wherein the bioactive material is releasably attached to at least one of the first valve leaflet and the second valve leaflet.

20. An implantable valve prosthesis comprising:

a frame having a proximal frame end and a distal frame end, the frame defining a lumen extending between the proximal frame end and the distal frame end along a longitudinal axis;

a first valve leaflet positioned within the lumen and having a first distal edge attached to the frame and a first proximal edge free of the frame, wherein the first valve leaflet comprises at least one material having a first slit and a second slit through the first valve leaflet, each slit of the first and second slits comprising an opening in the first valve leaflet extending proximally along the first valve leaflet from a distal slit end proximal of the first distal edge of the first valve leaflet to a proximal slit end distal of and not continuous with the first proximal edge of the first valve leaflet, the first and second slits cooperatively defining a first free portion of the first valve leaflet between the first and second slits; and

a second valve leaflet positioned within the lumen and having a second distal edge attached to the frame and a second proximal edge free of the frame, wherein the second valve leaflet comprises at least one material having a third slit and a fourth slit through the second valve leaflet, each slit of the third and fourth slits comprising an opening in the second valve leaflet extending proximally along the second valve leaflet from a distal slit end proximal of the second distal edge of the second valve leaflet to a proximal slit end distal of and not continuous with the second proximal edge of the second valve leaflet, the third and fourth slits cooperatively defining a second free portion of the second valve leaflet between the third and fourth slits;

wherein the first and second valve leaflets are movable between a first position that allows fluid flow in a first, antegrade, direction and a second position that restricts flow in a second, retrograde direction;

wherein the first valve leaflet comprises a first leaflet portion comprising the free portion of the first valve leaflet and a second leaflet portion comprising the distal edge of the first valve leaflet, and the second valve leaflet comprises a third leaflet portion comprising the free portion of the second valve leaflet and a fourth leaflet portion comprising the distal edge of the second valve leaflet; and

wherein, in the second position, portions of the first and second valve leaflets co-apt at a location extending distally from the proximal edges of the first and second valve leaflets to beyond the distal slit ends of the first and second valve leaflets.