Anti-aspiration prosthesis

• US 10,231,819 B2
• Filed: 03/02/2016
• Issued: 03/19/2019
• Est. Priority Date: 04/27/2012
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Inventors: Liddy, Alison, Ryan, Michael, Treacy, Gerard, Houlihan, Ger, Lavelle, Shay, Neilan, John
• Primary Examiner(s): Tran, Binh X
• Assistant Examiner(s): Gates, Bradford M
• Application Number:
  US15/059,041
• Publication Number:
  US 20160324624A1
• Time in Patent Office: 1,112 Days
• Field of Search: None
• 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 method of manufacturing a prosthesis for controlling flow through a bodily lumen, the method comprising:

forming an inner layer of a valve, the valve having a lumen therethrough, a proximal portion and a distal portion;

positioning a material portion on the inner layer of the valve, the material portion providing increased stiffness to the valve relative to the valve alone;

coating the material portion and the inner layer to form an outer layer of the valve, and

connecting the valve to a body comprising a stent, the body having a lumen operably connected to the lumen of the valve.

2. The method of claim 1, further comprising curing the inner layer.

3. The method of claim 1, further comprising heat setting the material portion.

4. The method of claim 3, comprising heat setting the material portion in a different shape than the inner layer of the valve so that the material portion forces the valve into a configuration controlled by the material portion.

5. The method of claim 1, comprising forming the inner layer of the valve by dipping a mandril in a solution.

6. The method of claim 5, comprising dipping the mandril in a solution comprising a silicone or a polyurethane polymer dispersion.

7. The method of claim 1, comprising forming the outer layer of the valve by dipping the inner layer and the material portion in a polymer dispersion.

8. The method of claim 1, comprising connecting the material portion to the body.

9. The method of claim 1, further comprising connecting the valve to the body, wherein the material portion is free from direct connection to the body.

10. The method of claim 1, wherein the material portion comprises a coil.

11. The method of claim 1, wherein the material portion comprises a plurality of peaks or a coil.

12. The method of claim 1, wherein the material portion comprises a wire.

13. The method of claim 1, wherein the material portion is u-shaped.

14. The method of claim 1, comprising providing the material portion having a difference in flexibility between a distal portion of the material portion and a proximal portion of the material portion.

15. The method of claim 14, comprising heat treating, etching, grinding or electropolishing the material portion to provide the difference in flexibility.

16. The method of claim 1, comprising coating the body.

17. The method of claim 1, comprising positioning the material portion around a periphery of the inner layer.

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

providing a material portion comprising a proximal portion and a distal portion;

coating the material portion with a solution and forming an outer layer of a valve with the solution, the valve having a lumen extending therethrough, a valve proximal portion and a valve distal portion, and the material portion providing increased stiffness to the valve relative to the valve alone, and

connecting the valve to a body comprising a stent, the body having a lumen operably connected to the lumen of the valve.

19. The method of claim 18, comprising forming an inner layer of the valve before coating the material portion.