SOFT TISSUE IMPLANT

1 . A soft tissue implant comprising a shell filled with a fluid biomaterial that is capable of curing in situ.

2 . The soft tissue implant claimed in claim 1 wherein the biomaterial is biostable.

3 . The soft tissue implant claimed in claim 1 wherein the biomaterial is silicon-containing.

4 . The soft tissue implant claimed in claim 3 wherein the biomaterial is a silicon-containing gel.

5 . The soft tissue implant claimed in claim 4 wherein the exothermic properties of the gel are limited to a maximum temperature difference of +4° C.

6 . The soft tissue implant claimed in claim 4 wherein the gel contains extractables of less than 35%.

7 . The soft tissue implant claimed in claim 1 wherein the shell contains an aperture through which biomaterial is filled.

8 . The soft tissue implant claimed in claim 7 wherein the aperture is defined by a check valve.

9 . The soft tissue implant claimed in claim 8 wherein the valve is a diaphragm valve, a duckbill valve, a reed valve, a leaf valve, a cross slit valve or a plug valve.

10 . The soft tissue implant claimed in claim 1 wherein the shell is made of an elastomeric material.

11 . The soft tissue implant claimed in claim 10 wherein the elastomeric material is a polyurethane, polyurethane urea, polycarbonate and/or silicon.

12 . The soft tissue implant claimed in claim 10 wherein the material is an ElastEon® polymer.

13 . The soft tissue implant claimed in claim 1 wherein the shell contains radio-opaque markings for verification of location.

14 . The soft tissue implant claimed in claim 10 wherein the elastomeric shell has a modulus of elongation such that the shell expands without distorting upon filling with biomaterial.

15 . A method of implanting a soft tissue implant including:

creating a pocket in soft tissue thereby defining the location of the implant;

inserting an unfilled shell into the pocket;

filling the shell with a biomaterial to a predetermined volume; and

curing the biomaterial in situ.

16 . The method claimed in claim 15 including closing the pocket before or after curing.

17 . The method claimed in claim 15 including initiating curing of the biomaterial during filling such that curing is completed in situ.

18 . The method claimed in claim 15 including curing the biomaterial after filling the shell.

19 . The method claimed in claim 15 including curing the biomaterial externally.

20 . The method claimed in claim 19 including using infra-red radiation, ultraviolet radiation or ultrasonic energy to externally cure the biomaterial.

21 . The method claimed in claim 15 including curing the biomaterial chemically.

22 . The method claimed in claim 21 including mixing the constituent monomers or a pre-polymer of the biomaterial and a curative cross linking agent and filling the shell with the biomaterial.

23 . The method claimed in claim 22 including adding a catalyst and/or initiator to the biomaterial mixture.

24 . The method claimed in claim 15 including supporting the implant during curing to define the shape of the implant.

25 . The method claimed in claim 24 including supporting the implant with a brassiere.

26 . The method claimed in claim 15 including filling the shell through a hole located on the shell.

27 . The method claimed in claim 26 including filling the shell through a valve provided at the hole.

28 . The method claimed in claim 15 wherein the empty shell is provided rolled onto an end of a stylet, inserting the stylet into the pocket and unrolling the empty shell off the stylet and into position.

29 . The method claimed in claim 15 including delivering fluid biomaterial to the empty shell through a tube under pressure.

30 . The method claimed in claim 29 including delivering the biomaterial to the empty shell under gravity.

31 . The method claimed in claim 29 including injecting the biomaterial into the empty shell using a syringe.

32 . The method claimed in claim 29 including pumping the biomaterial into the empty shell using a pump.

33 . The method claimed in claim 15 including creating a pocket by first making an incision through the soft tissue and then clearing an area in the soft tissue to form a pocket.

34 . The method claimed in claim 33 including making an incision between 0.5 cm and 5 cm in length.

35 . The method claimed in claim 15 including confirming pocket size before shell insertion by measurement, visual means and/or trialing a sizer.