Cushioned Resilient Intravaginal Urinary Incontinence Device and Method of Making Same

A method of making an injection molded intravaginal urinary incontinence device comprising the steps of:

• a. assembling a mold comprising a primary male mold half and a primary female mold half to define a primary mold cavity;
• b. injecting a fluid high modulus polymeric material into the primary mold cavity and permitting the high modulus polymeric material to solidify to form a device frame;
• c. removing the primary female mold half and replacing it with a secondary female mold half to provide a first overmold cavity defined by the primary male mold half, the secondary female mold half, and the device frame;
• d. restraining the device frame in the first overmold cavity and injecting a fluid cushioning polymeric material into the first overmold cavity and permitting the cushioning polymeric material to solidify to sufficiently to form a first portion of an outer layer that retains the shape of the first overmold cavity;
• e. removing the primary male mold half and replacing it with a secondary male mold half to provide a second overmold cavity defined by the secondary male mold half, the secondary female mold half, the device frame, and the first portion of the outer layer;
• f. injecting an additional amount of the fluid cushioning polymeric material into the second overmold cavity and permitting the cushioning polymeric material to unite with the first portion of the outer layer to form a sufficiently integral outer layer about the device frame.