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

1. A method of filling an implanted medical device in situ, comprising:

providing a two-part rapidly cross-linkable silicone composition, comprising:

a 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 platinum 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

a cross-linker fluid 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, and

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,

wherein the cross-linker fluid has a viscosity of from about 1 to about 150 cPs, and

wherein post-preparation or post-mixing of the catalyst fluid and the cross-linker fluid, the resultant rapidly cross-linkable silicone 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 composition has a platinum content of from about 1 ppm to about 16 ppm;

mixing the catalyst fluid with the cross-linker fluid 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, injecting a predetermined volume of the injectable composition into the implanted medical device in situ, whereby the rapidly cross-linkable silicone composition substantially cross-links and gels in situ in an amount of time ≥5 min. to produce a filled implant comprising a homogeneous rapidly cross-linkable silicone gel,

wherein the rapidly cross-linkable silicone gel has a viscosity ≥50,000 cPs≤24 hrs. post-injection at ambient temperature.

2. The method of claim 1 , wherein the implanted medical device comprises silicone.

3. The method of claim 1 , wherein the filled implant is free from any physical defect.

4. The method of claim 1 , wherein post-injection, there is no leakage of the silicone gel from the filled implant at the injection site.

5. The method of claim 1 , wherein the implanted medical device comprises a breast implant, an adjustable breast implant, a calf implant, a tissue expander, or a lumpectomy implant.

6. The method of claim 5 , wherein the implanted medical device comprises:

at least one empty envelope, and injecting comprises injecting into the empty envelope; and/or

at least one silicone containing envelope, and injecting comprises injecting into the silicone containing envelope.

7. The method of claim 6 , wherein the implanted medical device comprises an implanted silicone breast implant comprising the at least one silicone containing envelope, and the predetermined volume of the injectable composition comprises a volume of from about 50 ml to about 800 ml.

8. The method of claim 5 , wherein the implanted medical device comprises an unfilled or partially filled tissue expander or an unfilled or partially filled lumpectomy implant.

9. The method of claim 5 , wherein the implanted medical device comprises an adjustable breast implant comprising an unfilled first envelope and a second envelope comprising a silicone gel.

10. The method of claim 9 , wherein injecting comprises injecting the volume into the first unfilled envelope and/or the second envelope.

11. The method of claim 5 , wherein the implanted medical device comprises a silicone filled breast implant comprising a shell having an upper pole wrinkling defect and/or lower pole wrinkling defect.

12. The method of claim 11 , wherein injecting comprises injecting a volume of the rapidly cross-linkable silicone composition into the upper pole and/or the lower pole of the shell at a site of wrinkling, wherein the volume is sufficient to fill the shell to capacity, whereby the wrinkling defect is ameliorated or eliminated.

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

providing a dual syringe hypodermic device comprising:

a static mixer including a first syringe containing a catalyst fluid, a second syringe containing a cross-linker fluid, and an 18 to 21 gauge hypodermic needle, the static mixer configured to mix and inject the catalyst fluid and the cross-linker fluid 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 platinum 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 fluid 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, and

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,

wherein the cross-linker fluid has a viscosity of from about 1 to about 150 cPs, and

wherein post-preparation or post-mixing of the catalyst fluid and the cross-linker fluid, a resultant rapidly cross-linkable silicone 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 composition has a platinum content of from about 1 ppm to about 16 ppm;

mixing the catalyst fluid with the cross-linker fluid 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 composition substantially cross-links and gels in situ in an amount of time ≥5 min. to produce a filled implant comprising a homogeneous silicone gel,

wherein the rapidly cross-linkable silicone gel has a viscosity ≥50,000 cPs≤24 hrs. post-injection at ambient temperature, and the volume of the implanted device has been adjusted.

14. The method of claim 13 , wherein the implanted device comprises an adjustable breast implant comprising an unfilled first envelope and a second envelope comprising a silicone gel, and injecting comprises injecting the volume into the first unfilled envelope and/or the second envelope.

15. The method of claim 1 , wherein initiating mixing and injecting are carried out substantially simultaneously.