Silicone foam compositions rapidly cross-linkable at ambient temperatures and methods of making and using same

A method of adjusting the volume of an implanted medical device in situ, comprising:

• providing a dual syringe hypodermic device comprising a first syringe containing a catalyst fluid, a second syringe containing a cross-linker suspension not in physical or reactive contact with the catalyst fluid, a connector, a static mixer, and an 18 to 21 gauge hypodermic needle, the dual syringe hypodermic device being configured to mix and inject the catalyst fluid and the cross-linker suspension substantially simultaneously at point of use,
• the catalyst fluid comprising
• a first low viscosity vinyl terminated polydimethylsiloxane present in an amount of from about 97 wt % to about 99.5 wt % based on the weight of the catalyst fluid and having a viscosity of from about 1 to about 150 cPs, and
• a platinum divinyl disiloxane complex comprising Pt[(CH2═CH)(CH3)2SiOSi(CH3)2(CH═CH2)]3 having a platinium content of from about 2 ppm to about 32 ppm based on the catalyst fluid,
• wherein the catalyst fluid has a viscosity of from about 1 to about 150;
• and
• the cross-linker suspension comprising
• a second low viscosity vinyl terminated polydimethylsiloxane present in an amount of from about 1 wt % to about 40 wt % based on the weight of the cross-linker fluid and having a viscosity of from about 1 to about 150 cPs,
• a low viscosity hydride terminated polydimethylsiloxane present in an amount of from about 60 wt % to about 90 wt % based on the weight of the cross-linker fluid and having a viscosity of from about 1 to about 150 cPs,
• a silicone cross-linker comprising polymethylhydrosiloxane polydimethylsiloxane copolymer present in an amount of from about 0.32 wt % to about 5.0 wt % based on the weight of the cross-linker fluid, and having a viscosity of from about 1 to about 150 cPs, and
• a population of gas-filled microcapsules,
• wherein the cross-linker fluid has a viscosity of from about 1 to about 150 cPs, and
• wherein post-preparation, a resultant rapidly cross-linkable silicone foam composition has a viscosity of ≤150 cPs for ≥1 min. post-preparation and ≤300 cPs ≤5 min. post-preparation, at ambient temperature, and the resultant rapidly cross-linkable silicone foam composition has a platinium content of from about 1 ppm to about 16 ppm;
• mixing the catalyst fluid with the cross-linker suspension via the static mixer to produce an injectable composition having an initial viscosity of <150 cPs for at least about 1 min.;
• and
• within ≤5 min. of initiating mixing, and substantially simultaneous with mixing, injecting a predetermined volume of the injectable composition via the dual syringe hypodermic device, into the implanted medical device in situ, whereby the rapidly cross-linkable silicone foam composition substantially cross-links and gels in situ in an amount of time ≥5 min. to produce a filled implanted medical device comprising a silicone foam gel,
• wherein the rapidly cross-linkable silicone foam gel has a viscosity ≥50,000 cPs ≤24 hrs. post-injection at ambient temperature, and the volume of the implanted device has been adjusted.