Percutaneous implantable nuclear prosthesis
A multi-chamber balloon for a nuclear implant has an elastomeric membrane defining inner and outer chambers integral with a valve body. The valve body includes a core portion and sealing membrane for sealing the inner and outer chambers. An assembly for manufacturing the multi-chamber balloon includes a balloon mandrel which may be dip coated in a silicone dispersion to create an elastomeric membrane for the inner and outer chambers integral with the valve body. The elastomeric membrane formed on the mandrel is partially inverted to form a coaxial elastomeric structure with the smaller inner chamber disposed within the larger outer chamber. The valve is incorporated into the inner and outer chambers to form a unitary structure.
1. A method of producing an implantable prosthetic device comprising:
forming a prosthesis blank comprising:
an outer membrane section with a proximal end and a distal end,
an inner membrane section with a proximal end and a distal end,
a valve section disposed between the proximal end of the outer membrane section and the proximal end of the inner membrane section, wherein the valve section comprises a conduit having a sidewall with at least one opening extending through the sidewall;
a distal plug inner section at the distal end of the inner membrane section, and
a distal plug outer section at the distal end of the outer membrane section; and
partially inverting the prosthesis blank so that the outer membrane section encloses the inner membrane section so that the outer membrane section forms an outer balloon surrounding an inner balloon formed by the inner membrane section.
2. The method of claim 1 , further comprising:
providing a mandrel with a profiled outer surface configured to form the prosthesis blank;
coating the mandrel with a material to form the prosthesis blank; and
stripping the prosthesis blank from the mandrel.
3. The method of claim 2 , wherein the mandrel comprises two separable pieces coupled to a valve core.
4. The method of claim 3 , wherein the valve core is integrally molded with the prosthesis blank.
5. The method of claim 4 , wherein the step of stripping the prosthesis blank from the mandrel comprises separating the mandrel pieces from the valve core and removing the separable pieces from the prosthesis blank.
6. The method of claim 2 , wherein coating the mandrel comprises dipping the mandrel into a polymer liquid.
7. The method of claim 2 , wherein stripping the prosthesis blank from the mandrel comprises removing the material coating the mandrel.
8. The method of claim 1 , further comprising inserting a distal plug into the distal plug outer section to seal the distal plug outer section.
9. The method of claim 8 , further comprising:
joining a reinforcing band to the distal plug;
inserting the reinforcing band, distal plug, and distal plug outer section into the distal plug inner section.
10. The method of claim 9 , wherein the reinforcing band is joined to the distal plug with a fastener.
11. The method of claim 8 , further comprising inserting the distal plug and distal plug outer section into the distal plug inner section.
12. The method of claim 1 , wherein the prosthesis blank is formed by injection molding.
13. The method of claim 1 , further comprising gluing a valve core into the valve section.
14. The method of claim 1 , further comprising applying a reinforcing band around the periphery of the outer balloon.