Composition i - i and products and uses thereof

Abstract

A curable composition apportioned between at least one Part A and at least one Part B, the Parts sealed within barrier means in manner to prevent contamination thereof, the composition comprising: (i) one or more alkenyl-containing prepolymers having at least one alkenyl moiety per molecule, ii) one or more SiH-containing prepolymers having at least one SiH unit per molecule, and additionally: (iii) a catalyst for curing by addition of alkenyl-containing prepolymer (i) to SiH-containing prepolymer (ii), wherein the at least one Part A and at least one Part B are provided within or upon at least two respective receptacles or supports and are adapted to be dispensed or released therefrom in cooperative manner facilitating intimate contact and curing thereof, wherein the receptacle(s) or support(s) for at least one of Part A and Part B is thermally stable at elevated temperature of 123 C for a period in excess of 18 hours, 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 . A curable composition, apportioned between at least one Part A and at least one Part B, the composition comprising:
 one or more alkenyl-containing polymers having at least one, or at least two, alkenyl moiety per molecule,   one or more SiH-containing polymers having at least one, or at least two, SiH unit per molecule,   a catalyst for curing by addition of an alkenyl-containing polymer to a SiH-containing polymer (ii), and   a blowing agent configured to evolve gas as part of or during the curing reaction,   wherein the at least one Part A and the at least one Part B are provided in at least two respective receptacles configured to prevent contamination, and the at least one Parts A and B are adapted to be dispensed or released therefrom in cooperative manner facilitating intimate contact and curing thereof, wherein the receptacle for the at least one of Part A and Part B is thermally stable at an elevated temperature of 123° C. for a period in excess of 18 hours.   
     
     
         2 . A curable composition as claimed in  claim 1 , wherein the receptacles for the at least one Part A and the at least one Part B are both thermally stable at the elevated temperature of 123° C. for a period in excess of 18 hours. 
     
     
         3 . A curable composition as claimed in any of  claim 1 , wherein the receptacles are thermally stable at one or more of the following conditions: an elevated temperature of 121° C. for a period of 30 hours, an elevated temperature of 123° C. for a period of 24 hours, an elevated temperature of 134° C. for a period of 6 hours, and an elevated temperature of 160° C. for a period of 1 hour. 
     
     
         4 . (canceled) 
     
     
         5 . (canceled) 
     
     
         6 . A curable composition as claimed in  claim 1 , wherein the receptacles comprise thermally stable receptacles, comprised of materials selected from the group consisting of PE, PP PMP, COC's, metal foil, glass, solid phase silicone polymer and the like and from composites, laminates and combinations thereof which are thermally stable at elevated temperature of 123° C. for a period in excess of 18 hours. 
     
     
         7 . A curable composition as claimed in  claim 1 , wherein the one or more alkenyl-containing polymers and the one or more SiH-containing polymers are selected from the group consisting of silicones, including siloxanes and modified siloxanes, polyurethanes (PU) including polyester and polyether urethanes, elastomeric polyether polyesters, polyglycolic acid, polyacetates such as ethyl vinyl acetate, polyacrylate, polyacid derivatives of polysaccharides, such as carboxyalkylcellulose, carboxyalkylchitosan and copolymers thereof, and their hybrids including copolymers, entangled systems and mixtures thereof. 
     
     
         8 . (canceled) 
     
     
         9 . (canceled) 
     
     
         10 . (canceled) 
     
     
         11 . (canceled) 
     
     
         12 . (canceled) 
     
     
         13 . (canceled) 
     
     
         14 . A curable composition as claimed in  claim 1 , wherein the composition is configured for medical or non-medical, dental or non-dental use including use as dyes; preservatives; gels; foams; aerosols; pharmaceuticals; adhesives; encapsulants; hair/skin care; cosmetic use; dental use; release coatings; coatings; adhesives and sealants; wound care including wound dressings; skin care including scar reduction; cavity care; medical device encapsulation such as electronic device encapsulation for biomedical applications; mould making; orthopaedics; drug delivery systems including antimicrobial systems; haemostatic and pharmaceutical systems; nutrition including manufacture of foodstuffs; aerospace, marine and submarine applications; ecologically sensitive applications; confined or isolated organisms, or their habitats, or confined or isolated medium or atmosphere such as those having low immunity; sterile, clean or aseptic applications; germination or propagation of living matter such as plants or organisms; including manufacture and repair of equipment, apparatus or components for any of the above and in particular aerospace, submarine sterile, clean or aseptic, germination or propagation; including for use as foams, aerosols, adhesives, release coatings, coatings, adhesives and sealants, wound care in relation to NPWT, most particularly in a sterile field or environment; including use as a wound filler or wound packing material or cavity foam dressing, adhesive or sealant; and use as a negative pressure wound therapy filling material, adhesive or sealant, wherein the at least one Part A and the at least one Part B are adapted to be dispensed in cooperative manner facilitating intimate contact and curing thereof and formation of a porous foam configured to transmit negative pressure, adhering a negative pressure wound therapy drape or which is substantially air-tight. 
     
     
         15 . (canceled) 
     
     
         16 . (canceled) 
     
     
         17 . A method of preparing the composition as claimed in  claim 1 , comprising:
 combining the one or more alkenyl-containing polymers, the one or more SiH-containing polymers, the catalyst, and the blowing agent to form the at least one Part A and the at least one Part B; and   sealing the at least one Part A and the at least one Part B in the receptacles.   
     
     
         18 . A method for sterilizing the composition as claimed in  claim 1 , comprising subjecting the at least one of Part A and the at least Part B, provided in or on a thermally stable receptacle to at least one of: an elevated temperature in excess of 121° C. for a period of up to 28 hours, an elevated temperature of 123° C. for a period of up to 24 hours, and an elevated temperature of 160° C. for a period of up to 100 minutes. 
     
     
         19 . (canceled) 
     
     
         20 . A method of preparing an elastomer comprising combining the at least one Part A and the at least one Part B of the composition as claimed in  claim 1  with curing or crosslinking thereof. 
     
     
         21 . (canceled) 
     
     
         22 . (canceled) 
     
     
         23 . An elastomer comprising the cured or crosslinked composition as claimed in  claim 1 . 
     
     
         24 . (canceled) 
     
     
         25 . (canceled) 
     
     
         26 . (canceled) 
     
     
         27 . The medical or non-medical use of the composition as claimed in  claim 1  selected from the group consisting of use as dyes; preservatives; gels; foams; aerosols; pharmaceuticals; adhesives; encapsulants; hair/skin care; cosmetic use; dental use; release coatings; coatings; adhesives and sealants; wound care including wound dressings; skin care including scar reduction; cavity care; medical device encapsulation such as electronic device encapsulation for biomedical applications; mould making; orthopaedics; drug delivery systems including antimicrobial systems; haemostatic and pharmaceutical systems; nutrition including manufacture of foodstuffs; aerospace, marine and submarine applications; ecologically sensitive applications; confined or isolated organisms, or their habitats, or confined or isolated medium or atmosphere such as those having low immunity; sterile, clean or aseptic applications; germination or propagation of living matter such as plants or organisms; including manufacture and repair of equipment, apparatus or components for any of the above and in particular aerospace, submarine sterile, clean or aseptic, germination or propagation; a wound filler or wound packing material or cavity foam dressing, adhesive or sealant for NPWT. 
     
     
         28 . (canceled) 
     
     
         29 . (canceled) 
     
     
         30 . (canceled) 
     
     
         31 . (canceled) 
     
     
         32 . (canceled) 
     
     
         33 . (canceled) 
     
     
         34 . (canceled) 
     
     
         35 . (canceled) 
     
     
         36 . A method of providing negative pressure wound therapy, comprising dispensing the composition as claimed in  claim 1  directly or indirectly into a wound and allowing the composition to foam and cure, sealing the wound including the foamed cured composition, and applying negative pressure to the wound. 
     
     
         37 . (canceled) 
     
     
         38 . (canceled) 
     
     
         39 . (canceled) 
     
     
         40 . (canceled) 
     
     
         41 . (canceled) 
     
     
         42 . (canceled) 
     
     
         43 . (canceled) 
     
     
         44 . (canceled) 
     
     
         45 . (canceled) 
     
     
         46 . (canceled) 
     
     
         47 . (canceled) 
     
     
         48 . (canceled) 
     
     
         49 . (canceled) 
     
     
         50 . (canceled) 
     
     
         51 . (canceled) 
     
     
         52 . (canceled) 
     
     
         53 . (canceled) 
     
     
         54 . (canceled) 
     
     
         55 . (canceled) 
     
     
         56 . (canceled) 
     
     
         57 . (canceled) 
     
     
         58 . (canceled) 
     
     
         59 . (canceled) 
     
     
         60 . A curable composition as claimed in  claim 1 , wherein the composition is terminally sterile, wherein a sterility level of the composition 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 . 
     
     
         61 . A curable composition as claimed in  claim 1 , wherein:
 the one or more alkenyl-containing polymers and the one or more SiH-containing polymers are organosiloxanes; 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, copolymeric, entagled, and mixed polymer systems.   
     
     
         62 . A curable composition as claimed in  claim 61 , wherein the one or more alkenyl-containing polymers and the one or more SiH-containing polymers are poly organosiloxanes. 
     
     
         63 . A device for dispensing the curable composition as claimed in  claim 1 , the device comprising a mixing head configured to receive two or more cartridges comprising Parts A and B. 
     
     
         64 . The device as claimed in  claim 63 , the device comprising a double barreled syringe configured for loading with 40 g of the polymers. 
     
     
         65 . A method of providing negative pressure wound therapy, the method comprising:
 dispensing a terminally sterile foamable composition into at least a portion of a wound site, wherein the foamable composition is configured to form a porous foam material configured to transmit negative pressure;   sealing the wound site with a substantially fluid-tight seal; and   applying negative pressure to the wound site from a source of negative pressure.   
     
     
         66 . The method of  claim 65 , further comprising covering the wound site with the substantially fluid-tight drape, the drape covering at least a portion of the dispensed terminally sterile composition and forming a fluid-tight seal over the wound site. 
     
     
         67 . The method of  claim 65 , wherein the composition comprises a first part and a second part, the first and second parts configured to be combined to form the porous form material. 
     
     
         68 . The method of  claim 67 , further comprising:
 releasing the first part from a support and exposing the first part;   exposing the second part; and   covering the wound site with the drape and adhering the drape around the wound site, thereby causing the exposed first and second parts to come into contact.   
     
     
         69 . A NPWT kit comprising a substantially fluid-tight wound dressing, a dispensable or releasable curable or cured foamable composition as claimed in  claim 1 , and a port configured to be connected to a source of negative pressure. 
     
     
         70 . The elastomer as claimed in  claim 23 , wherein the elastomer comprises wound dressing.