Composition, apparatus, kit and method and uses thereof

Abstract

A curable composition for use in wound care comprising, apportioned between at least one Part A and at least one Part B: one or more alkenyl-group containing polymers (i) having at least one alkenyl group or moiety per molecule, one or more SiH-containing polymers (ii) having at least one Si—H unit per molecule; and a catalyst (iii) for curing by addition of alkenyl-containing polymer (i) to SiH-containing polymer (ii), Part A and Part B independently having viscosity at 23° C. in the range 5-300 Pa·s, preferably 10-100 Pa s, at a shearing rate of 10 s −1 , and when combined in one Part having cure time at 23° C. in the range from 0.5 min to 25 min, wherein when dispensed into a location about a wound dressing, said wound dressing overlying a wound site and skin thereabout, said dispensing being so as to intimately contact and overlie an edge of said dressing and skin about said edge, the composition cures in contact with said edge and skin at 32° C. to an elastomer exhibiting zero or low tack at a time in the range from 0.5 to less than 30 minutes, apparatus for use with said composition comprising dispensing apparatus or wound dressing, a kit comprising the same, and methods of dispensing and curing the same and of using the same in sealing a wound dressing and in treating a wound site of a human in need thereof.

1 - 69 . (canceled) 
     
     
         70 . A sealing system for providing a seal between a wound dressing and a patient's skin, the system comprising a curable composition apportioned between at least one Part A and at least one Part B, wherein the curable composition comprises:
 one or more alkenyl-group containing polymers having at least one alkenyl group or moiety per molecule;   one or more SiH-containing polymers having at least one Si—H unit per molecule; and   a catalyst for curing by addition of the one or more alkenyl-group containing polymers to the one or more SiH-containing polymers;   wherein Part A and Part B independently have a viscosity at 23° C. between 5 Pa·s up to 300 Pa·s at a shearing rate of 10 s −1 ;   wherein a combination of Parts A and B has a cure time at 23° C. between 0.5 min to approximately 25 min; and   wherein the curable composition cures at 32° C. to an elastomer exhibiting zero or low tack at a time ranging from 0.5 minutes to 30 minutes.   
     
     
         71 . The system of  claim 70 , wherein, after curing, a sample of the curable composition with a height of 1 mm has extensibility such that the load required to produce a 20% extension at a rate of extension of 300 mm per minute is in the range of less than or equal to 1.4 kgf per cm width (kgfcm −1 ) to produce 20% extension. 
     
     
         72 . The system of  claim 70 , wherein, after curing, elongation at break for a sample of the curable composition is between 50% to 1200%. 
     
     
         73 . The system of  claim 70 , wherein, after curing, the tensile strength for a sample of the curable composition is greater than or equal to 5 kgfcm −2 . 
     
     
         74 . The system of  claim 70 , wherein, after curing, permanent set for a sample of the cured composition is in a range between 20% to 0%. 
     
     
         75 . The system of  claim 70 , wherein the curable composition comprises a RTV-2 silicone incorporating a viscosity modifier. 
     
     
         76 . The system of  claim 70 , further comprising a device for dispensing the curable composition. 
     
     
         77 . The system of  claim 76 , wherein the device is configured to dispense the curable composition in the form of a discrete or continuous bead or film to bridge an interface between the wound dressing and skin. 
     
     
         78 . The system of  claim 76 , wherein the device comprises a first sealed receptacle configured to house the at least one Part A and a second sealed receptacle configured to house the at least one Part B, the first sealed receptacle and the second sealed receptacle configured for cooperatively dispensing the at least one Part A and the at least one Part B. 
     
     
         79 . The system of  claim 78 , wherein the device comprises a double barrel syringe, the first sealed receptacle and the second sealed receptacle comprising barrels of the double barrel syringe. 
     
     
         80 . The system of  claim 78 , further comprising first advancing means for advancing the at least one Part A outward from the first sealed receptacle and second advancing means for advancing the at least one Part B outward from the second sealed receptacle. 
     
     
         81 . The system of  claim 70 , further comprising means for mixing Parts A and B together. 
     
     
         82 . The system of  claim 70 , further comprising an applicator with an integral spreader. 
     
     
         83 . A kit suitable for use in the field of topical negative pressure wound care comprising a topical negative pressure wound dressing for overlying a wound site and skin thereabout and a skin-compatible sealant;
 wherein the sealant comprises a curable composition apportioned between at least one Part A and at least one Part B, wherein the curable composition comprises:
 one or more alkenyl-group containing polymers having at least one alkenyl group or moiety per molecule; 
 one or more SiH-containing polymers having at least one Si—H unit per molecule; and 
 a catalyst for curing by addition of the one or more alkenyl-group containing polymers to the one or more SiH-containing polymers; 
 wherein Part A and Part B independently have a viscosity at 23° C. between 5 Pa·s up to 300 Pa·s at a shearing rate of 10 s −1 ; 
 wherein a combination of Parts A and B has a cure time at 23° C. between 0.5 min to 25 min; and 
 wherein the composition cures at 32° C. to an elastomer exhibiting zero or low tack at a time ranging from 0.5 minutes to 30 minutes; and 
   wherein the dressing comprises:
 a wound contact surface configured to be applied inwardly with respect to the wound site; and 
 a cover surface to be applied outwardly with respect to the wound site. 
   
     
     
         84 . A method of treating a wound site, comprising:
 applying a topical negative pressure wound dressing to the wound site, wherein the dressing comprises an outer perimeter adapted to be placed in contact with skin surrounding the wound site; and   dispensing a sealant composition to at least a portion of the outer perimeter of the wound dressing, wherein the sealant composition cures in intimate contact with and overlying both the wound dressing at the outer perimeter and skin surrounding the outer perimeter, wherein the sealant composition is apportioned between at least one Part A and at least one Part B and comprises:
 one or more alkenyl-group containing polymers having at least one alkenyl group or moiety per molecule; 
 one or more SiH-containing polymers having at least one Si—H unit per molecule; and 
 a catalyst for curing by addition of the one or more alkenyl-group containing polymers to the one or more SiH-containing polymers; and 
   wherein dispensing the sealant composition comprises combining Part A and Part B, wherein a combination of Parts A and B has a cure time at 23° C. between 0.5 min to 25 min and the composition cures to an elastomer exhibiting zero or low tack at a time ranging from 0.5 minutes to 30 minutes.