Custom elastomeric earmold with secondary material infusion

Abstract

A method of manufacturing a custom elastomeric earmold with a secondary material infusion and said custom elastomeric earmold is disclosed. The method can include establishing a representation of a shape of the ear concha, the outer canal and the inner ear canal cavity. The method may further include casting a custom shaped injection mold. The injection mold may be used to cast a custom shape of the inner and outer ear from an elastomeric material such as silicone or urethane. An additional injection step can be performed to infuse foam into the interior of the elastomeric material.

What is claimed is: 
     
         1 . A method comprising:
 establishing a digital representation of a shape of an ear concha, an outer ear canal and an inner ear canal cavity;   casting a custom-shaped injection mold from the digital representation;   casting a custom shape of the inner ear canal cavity and outer ear canal from an elastomeric material in the injection mold;   infusing foam into an interior of the elastomeric material.   
     
     
         2 . The method as in  claim 1  further comprising supplementing the injection mold with a specialized sprue and controlling a flow and placement of the foam infusion into the interior of the elastomeric material. 
     
     
         3 . The method as in  claim 2  where infusing the foam into an interior of the elastomeric material comprises injecting the infused foam into an interior area of the elastomeric material to displace the elastomeric material from the interior area. 
     
     
         4 . A method as in  claim 1  where the elastomeric material is at least one of silicone or urethane. 
     
     
         5 . A method as in  claim 2  further comprising forming a canal area on the order of 5 mm past a second bend of an ear. 
     
     
         6 . A method as in  claim 1  further comprising permitting an infusion of materials such as liquids and gels into a final device. 
     
     
         7 . A method as in  claim 1  further comprising:
 applying a temporary infusion of materials comprising at least one of liquids and air into the injection mold to remove the elastomeric material and leave an evacuated interior, and 
 permanently filling the evacuated interior with the secondary material comprising at least one of liquids and gels into the mold. 
 
     
     
         8 . A method of manufacturing a custom composite earmold comprising:
 establishing a digital representation of a shape of an ear concha, an outer ear canal and an inner ear canal cavity;   casting a custom-shaped injection mold from the digital representation, the injection mold having a plurality of sprues for carrying materials having different properties;   introducing a primary material into the injection mold through at least one of the plurality of injection sprues, and   introducing a secondary material different from the primary material into the injection mold though a second one of the plurality of injection spures and into an interior area of the primary material, the primary material being around the perimeter of the interior area.   
     
     
         9 . The method of  claim 8  where the primary material is a biocompatible material selected from a group consisting of silicone and urethane. 
     
     
         10 . The method of  claim 8  where the primary materials is elastomeric. 
     
     
         11 . The method of  claim 8  where the secondary material is a material that is softer than the primary material. 
     
     
         12 . The method of  claim 8  where the secondary material is compressible foam. 
     
     
         13 . The method of  claim 8  where the primary material has a greater surface tension than the secondary material and adheres to an interior side of a wall of the mold and the secondary material has more fluidity than the primary material, the secondary material only displacing the primary material in the interior area. 
     
     
         14 . The method of  claim 8  further comprising controlling the flow and placement of the secondary material into the interior of the area, said controlling being carried out by the second one of the plurality of injection spures. 
     
     
         15 . The method of  claim 8  where the earmold is comprised of a composite design comprising an outer portion formed by the primary material and an inner portion formed by the secondary material in a predetermined area, the composite design having more softness in the predetermined area than a conventional earmold comprised of only the primary material. 
     
     
         16 . The method of  claim 8  further comprising evacuating the interior area by introducing a medium into the interior area before introducing the secondary material, the medium being introduced through one of the plurality of sprues. 
     
     
         17 . The method of  claim 16  where the medium is at least one of compressed air and pressurized liquid. 
     
     
         18 . A custom composite earmold comprising:
 an outer skin layer comprised of a biocompatible elastomeric material;   at least one interior area comprised of a compressible foam having greater softness than the elastomeric material, the at least one interior area surrounded by the elastomeric material, and   the earmold being formed by:   establishing a digital representation of a shape of an ear concha, an outer ear canal and an inner ear canal cavity;   casting a custom-shaped injection mold from the digital representation, the injection mold having a plurality of sprues for carrying materials having different properties;   introducing a primary material into the injection mold through at least one of the plurality of injection sprues, and
 introducing a secondary material different from the primary material into the injection mold though a second one of the plurality of injection spures and into the at least one interior area.