Anti-Aspiration Prosthesis

• US 20130289740A1
• Filed: 03/08/2013
• Published: 10/31/2013
• Est. Priority Date: 04/27/2012
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Neilan, John, Liddy, Alison, Ryan, Michael, Treacy, Gerard, Houlihan, Ger, Lavelle, Shay Joseph
• Granted Patent: US 9,314,325 B2
• Time in Patent Office: Days
• US Class Current: 623/23.68
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• 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 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: B05D 1/18 performed by dipping
• CPC Class Codes: Y10T 29/49426 including metal shaping and diverse operation

Abstract

A prosthesis and a method of manufacturing the prosthesis for controlling flow through a bodily lumen are provided. The prosthesis includes a body having a proximal portion, a distal portion and a lumen extending therethrough. The prosthesis also includes a valve operably connected to the body. The valve has a proximal portion, a distal portion and a lumen extending through the valve, where the valve lumen is connected to the body lumen. The valve is configured to be closed in the absence of an antegrade pressure and a retrograde pressure, the retrograde pressure being greater than the antegrade pressure. The valve includes a material portion operably connected to the valve, the material portion providing increased stiffness to the valve relative to the valve alone, wherein the material portion is configured to facilitate self-reversion of the valve to the closed configuration.

Claims

1. A prosthesis for controlling flow through a bodily lumen, the prosthesis comprising:

a body having a proximal portion, a distal portion and a lumen extending therethrough; and

a valve operably connected to the body, the valve having a proximal portion, a distal portion and a lumen extending through the valve, the valve lumen connected to the body lumen;

the valve being configured to be closed in the absence of an antegrade pressure and a retrograde pressure, the retrograde pressure being greater than the antegrade pressure, the valve comprising a material portion operably connected to the valve, the material portion providing increased stiffness to the valve relative to the valve alone, wherein the material portion is configured to facilitate self-reversion of the valve to the closed configuration.

2. The prosthesis of claim 1, wherein the material portion comprises at least one material that is different from a valve material.

3. The prosthesis of claim 1, wherein the material portion comprises nitinol.

4. The prosthesis of claim 3, wherein the nitinol is heat set.

5. The prosthesis of claim 1, wherein the material portion is connected to the distal portion of the body.

6. The prosthesis of claim 1, wherein the material portion at least partially overlaps the body.

7. The prosthesis of claim 2, wherein the material portion comprises one arm.

8. The prosthesis of claim 2, wherein the material portion comprises one u-shaped arm.

9. The prosthesis of claim 2, wherein the material portion comprises a coil.

10. The prosthesis of claim 1, wherein the material portion comprises a proximal portion and a distal portion and the distal portion of the material portion is more flexible than the proximal portion of the material portion.

11. The prosthesis of claim 10, wherein the distal portion of the material portion is electropolished, ground or chemically etched to provide flexibility.

12. The prosthesis of claim 2, wherein the material portion comprises a first peak and a second peak and the first peak is positioned within second peak and extends in the same plane as the second peak.

13. The prosthesis of claim 2, wherein the material portion includes a plurality of peaks positioned about a perimeter of the body.

14. The prosthesis of claim 12, wherein each peak is independently operably connected to the body.

15. The prosthesis of claim 1, wherein a distal end of the material portion is movable proximally in response to the retrograde pressure to facilitate opening the valve in response to the retrograde pressure.

16. The prosthesis of claim 1, wherein the distal end of the material portion is movable to facilitate the return of the valve to a closed configuration after the retrograde pressure is removed.

17. A method of manufacturing a prosthesis for controlling flow through a bodily lumen, the method comprising:

forming a material portion of a valve on a first mandril;

heat setting the material portion;

forming an inner portion of the valve on a second mandril, the second mandril having a different shape than the first mandril;

curing the inner portion;

positioning the heat set material portion on the inner portion that is positioned on the second mandril; and

coating the inner portion and the material portion to form the outer portion of the valve.

18. The method of claim 17, further comprising connecting the valve to a body to form the prosthesis.

19. The method of claim 17, comprising forming the outer portion of the valve by dipping the inner portion and the material portion in a polymer dispersion.

20. The method of claim 17, comprising providing a body having a first axis extending longitudinally along the body and providing the material portion having a helical pitch that is different from the first axis.