Compositions i - i and products and uses thereof

Abstract

methods for preparing the composition, methods for sterilisation thereof, medical and non-medical use thereof, a device incorporating the composition, and a precursor therefor including its sterilisable precursor composition, in particular a terminally sterilisable or terminally sterile composition for medical use, particularly in wound therapy, more particularly as a wound packing material which can be shaped and configured to the shape of a wound, most particularly for application in negative pressure wound therapy (NPWT).

1 - 59 . (canceled) 
     
     
         60 . A wound therapy system comprising:
 a first receptacle in which at least one part A is sealed;   a second receptacle in which at least one part B is sealed;   a curable composition, apportioned between the at least one Part A and the at least one Part B, the composition comprising:
 one or more alkenyl-containing prepolymers including at least one, or at least two, alkenyl moiety per molecule, 
 one or more SiH-containing prepolymers including at least one, or at least two, SiH unit per molecule, 
 a catalyst facilitating curing by addition of alkenyl-containing prepolymer to SiH-containing prepolymer, and 
 a blowing agent configured to evolve gas as part of or during a curing reaction; 
   wherein the first receptacle and the second receptacle are configured to dispense or release the at least one Part A and the at least one Part B of the curable composition in cooperative manner facilitating intimate contact and curing thereof;   wherein each of the first receptacle, the second receptacle, the at least one Part A, and the at least one the Part B are thermally stable at elevated temperature of at least 123° C. for a period in excess of 18 hours, allowing the at least one Part A and the at least one Part B to be kept sealed within the first and second receptacles, respectively, without degrading or interacting with the first and second receptacles; and   wherein the curable composition is configured to form during the curing as a porous foam.   
     
     
         61 . The system of  claim 60 , wherein at least one of the first receptacle or the second receptacle comprises materials selected from the group consisting of polycarbonates, polypropylene, polymethylpentene, cyclic olefin copolymers, metal foil, glass, solid phase silicone polymer and the like and from composites, laminates and combinations thereof. 
     
     
         62 . The system of  claim 60 , wherein the one or more alkenyl-containing prepolymers and the one or more SiH-containing prepolymers include silicones comprising siloxanes and modified siloxanes, polyurethanes (PU) comprising polyester and polyether urethanes, elastomeric polyether polyesters, polyglycolic acid, polyacetates comprising ethyl vinyl acetate, polyacrylate, polyacid derivatives of polysaccharides comprising carboxyalkylcellulose, carboxyalkylchitosan and copolymers thereof, and their hybrids comprising copolymers, entangled systems and mixtures thereof. 
     
     
         63 . The system of  claim 60 , wherein the one or more alkenyl-containing polymers and the one or more SiH-containing polymers comprise polyorganosiloxanes, and wherein the curing comprises curing between organohydrogensiloxane units and organoalkenylsiloxane units incorporated into polymeric, coplymeric, entagled, and mixed polymer systems. 
     
     
         64 . The system of  claim 60 , further comprising a device configured to dispense the curable composition, the device comprising a mixing head configured to receive two or more cartridges comprising the at least one Part A and the at least one Part B. 
     
     
         65 . The system of  claim 64 , wherein the device further comprises a double-barreled syringe configured to be loaded with polymers. 
     
     
         66 . The system of  claim 60 , wherein the first and second receptacles are configured to be thermally stable during dry-heat sterilization. 
     
     
         67 . The system of  claim 60 , wherein the blowing agent is selected from the group consisting of methanol, ethanol, n-propanol, isopropanol, n-butanol, 2-butanol, tert-butanol, n-hexanol, n-octanol, benzyl alcohol, 4-butanediol, 1,5-pentanediol, 1,7-heptanediol, silane including at least one silanol group, polysilane including at least one silanol group, water, and combination thereof. 
     
     
         68 . The system of  claim 60 , wherein the at least one Part B does not comprise water, steam or air. 
     
     
         69 . The system of  claim 60 , wherein the porous foam comprises 70% to 90% free internal volume. 
     
     
         70 . The system of  claim 60 , wherein the porous foam is resiliently deformable. 
     
     
         71 . A method for treating a wound, the method comprising:
 providing a curable composition apportioned between at least one Part A and at least one Part B, the composition comprising:
 one or more alkenyl-containing prepolymers including at least one, or at least two, alkenyl moiety per molecule, 
 one or more SiH-containing prepolymers including at least one, or at least two, SiH unit per molecule, 
 a catalyst facilitating curing by addition of alkenyl-containing prepolymer to SiH-containing prepolymer, and 
 a blowing agent configured to evolve gas as part of or during a curing reaction, 
 wherein the Part A is sealed within a first receptacle, and 
 wherein the Part B is sealed within a second receptacle; 
   heating the first receptacle and the second receptacle at an elevated temperature of 123° C. or higher for a period of 18 hours or longer, wherein the at least one Part A and the at least one part Part B are terminally sterile and kept sealed within the first receptacle and the second receptacle without degrading or interacting with the first receptacle and the second receptacle, respectively, during or after heating;   dispensing the at least one Part A and the at least one Part B of the curable composition directly or indirectly into the wound; and   causing the curable composition to form as a porous foam.   
     
     
         72 . The method of  claim 71 , further comprising combining the at least one Part A and the at least one Part B subsequent to dispensing. 
     
     
         73 . The method of  claim 71 , further comprising sealing the wound including the porous foam and applying negative pressure to the wound. 
     
     
         74 . The method of  claim 71 , wherein heating is conducted in a conventional oven or autoclave. 
     
     
         75 . The method of  claim 71 , wherein a sterility level of the curable composition after heating corresponds to a sterility assurance level (SAL) of 10 −6  such that the theoretical probability of there being a viable microorganism present is equal to or less than 1×10 −6 . 
     
     
         76 . The method of  claim 71 , wherein at least one of the first receptacle or the second receptacle comprises materials selected from the group consisting of polycarbonates, polypropylene, polymethylpentene, cyclic olefin copolymers, metal foil, glass, solid phase silicone polymer and the like and from composites, laminates and combinations thereof. 
     
     
         77 . The method of  claim 71 , wherein the one or more alkenyl-containing prepolymers and the one or more SiH-containing prepolymers include silicones comprising siloxanes and modified siloxanes, polyurethanes (PU) comprising polyester and polyether urethanes, elastomeric polyether polyesters, polyglycolic acid, polyacetates comprising ethyl vinyl acetate, polyacrylate, polyacid derivatives of polysaccharides comprising carboxyalkylcellulose, carboxyalkylchitosan and copolymers thereof, and their hybrids comprising copolymers, entangled systems and mixtures thereof. 
     
     
         78 . The method of  claim 71 , the one or more alkenyl-containing polymers and the one or more SiH-containing polymers comprise polyorganosiloxanes; and curing by addition of the alkenyl-containing polymer to the SiH-containing polymer further comprises curing between organohydrogensiloxane units and organoalkenylsiloxane units incorporated into polymeric, coplymeric, entagled, and mixed polymer systems. 
     
     
         79 . The method of  claim 71 , wherein each of the at least one Part A, the at least one Part B, the first receptacle and the second receptacle are thermally stable at the elevated temperature of 123° C. for the period in excess of 18 hours. 
     
     
         80 . The method of  claim 71 , wherein the blowing agent is selected from the group consisting of methanol, ethanol, n-propanol, isopropanol, n-butanol, 2-butanol, tert-butanol, n-hexanol, n-octanol, benzyl alcohol, 4-butanediol, 1,5-pentanediol, 1,7-heptanediol, silane including at least one silanol group, polysilane including at least one silanol group, water, and combination thereof. 
     
     
         81 . The method of  claim 71 , wherein the porous foam comprises 70% to 90% free internal volume. 
     
     
         82 . The method of  claim 71 , wherein the porous foam is resiliently deformable.