Footbed with non-denatured collagen

Abstract

The invention relates to a composition comprised of a prepolymer, at least one additive, and non-denatured collagen fibers and a method of making the same. The composition of the instant invention is for use as a footbed to augment the shock absorption already provided to the human body via a shoe and the collagenous, fatty pad of the human foot.

1 . A method for providing a footbed with non-denatured collagen comprising the steps of:
 forming an aqueous mixture having at least a predetermined amount of non-denatured collagen and water;   metering a predetermined amount of a prepolymer with said aqueous mixture to form a foam layer.   
     
     
         2 . The method of  claim 1 , further comprising the step of adding to the aqueous mixture an agent from the group consisting of: a cross-linking agent, a catalyst, and a combination thereof. 
     
     
         3 . The method of  claim 2 , further comprising the following steps:
 depositing the aqueous mixture on releasable bottom paper disposed on a movable carrier;   covering the upper surface of the aqueous mixture with releasable top paper as the aqueous mixture is moved with the movable carrier;   advancing the foam layer in the top and bottom release paper by moving the carrier;   sizing the foam layer to the desired thickness;   removing the top and bottom releasable paper and simultaneously drying the sized and formed footbed to remove moisture.   
     
     
         4 . The method of  claim 1 , dispersing the non-denatured collagen throughout the foam layer. 
     
     
         5 . The method of  claims 1 , dispersing at least one additive within the aqueous mixture. 
     
     
         6 . The method of  claim 5 , wherein the at least one additive is selected from the group consisting of: skin care agents, hydrocolloid absorptive agents, medicaments, proteins, enzymes, nucleic acids, vitamins, soaps, hemostatic agents, antibacterial agents, antifungal agents; surfactants, pH buffers, rubber particles, disinfecting and sterilizing agents, thermal phase change particles, and combinations thereof. 
     
     
         7 . A composite material for use as a footbed comprising a prepolymer, a non-denatured collagen, and at least one additive. 
     
     
         8 . The composite material of  claim 7 , wherein the non-denatured collagen is dispersed throughout the composite material. 
     
     
         9 . The composite material of  claim 7 , wherein the non-denatured collagen is separated from a natural source and comprises non-denatured collagen fibrils, and wherein an inter-fibril bond and an intra-fibril bond for retaining the structural rigidity of the non-denatured collagen are unbroken after separation. 
     
     
         10 . The composite material of  claim 7 , wherein a concentration of the at least one additive in the reaction composition is approximately 0.5% to approximately 15% by weight. 
     
     
         11 . The composite material of  claim 7 , wherein the non-denatured collagen has a denaturation temperature above 54 degrees Celsius. 
     
     
         12 . The composite material of  claim 11 , wherein the non-denatured collagen has a denaturation temperature above 64 degrees Celsius. 
     
     
         13 . The composite material of  claim 7 , wherein the non-denatured collagen is comprised of a cross-linked non-denatured collagen fiber in a configuration substantially similar to a naturally occurring collagen fiber. 
     
     
         14 . The composite material of  claim 7 , wherein the composite material is produced by a polymerization reaction composition further comprising a cross-linking agent for stabilizing a chemical and a physical interaction between the polymer and the non-denatured collagen. 
     
     
         15 . The composite material of  claim 7 , wherein a concentration of the prepolymer in the reaction composition is between approximately 10% and approximately 75% by weight. 
     
     
         16 . The composite material of  claim 15 , wherein the composite material further includes a superabsorbent polymer. 
     
     
         17 . The composite material of  claim 7 , further comprising at least one layer adjacent to the composite material. 
     
     
         18 . The composite material of  claim 7 , wherein the at least one additive is selected from the group consisting of: skin care agents, hydrocolloid absorptive agents, medicaments, proteins, enzymes, nucleic acids, vitamins, soaps, hemostatic agents, antibacterial agents, antifungal agents, surfactants, pH buffers, rubber particles, disinfecting and sterilizing agents, thermal phase change particles, and combinations thereof. 
     
     
         19 . The composite of  claim 17 , wherein the at least one layer is disposed as a cover layer. 
     
     
         20 . A reaction composition for use in producing a composite footbed comprising the following:
 a urethane prepolymer;   a non-denatured collagen fibril;   an additive selected from the group consisting of: skin care agents, hydrocolloid absorptive agents, medicaments, proteins, enzymes, nucleic acids, vitamins, soaps, hemostatic agents, antibacterial agents, antifungal agents, surfactants, pH buffers, rubber particles, disinfecting and sterilizing agents, thermal phase change particles, and combinations thereof;   a cross-linking agent selected from the group consisting of:   carbodiimides, acyl azides, glutaraldehyde, and combinations thereof;   and a catalyst;   wherein the composite footbed further comprises a layer disposed proximate to at least one portion of said footbed, and the layer is a cover layer.