Anti-aspiration prosthesis
View Patent ↗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.
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.