We evaluated the biocompatibility of a dimethylpolysiloxane-coated micro-device which had been designed for monitoring real-time bladder volume in previous studies. The extract assay with dimethylpolysiloxane which had been used for coating the micro-device to measure the bladder volume was performed as an

in vitro

cytotoxicity test. For

in vivo

biocompatibility testing

the inflammatory responses around the implantation site of the micro-device in subcutaneous tissue of rat were assessed by light microscope with H

&

E stain and fluorescence microscope with ED1 stain and von Willebrand factor stain. The averages of cell viability in dimethylpolysiloxane group were 84.6% and 82.3% at 24 h and 72 h incubation

respectively. The qualitative evaluations with light and fluorescence microscope revealed that the inflammatory changes peaked during 2 weeks but almost disappeared at 4 weeks after implantation of devices. The quantitative evaluations for granulation layer formation and neovascularization showed that the thickness of the layer in dimethylpolysiloxane group peaked during 2 weeks but it came to be stabilized at 4 weeks as thin as at 2 weeks in control group

and the frequency of neovascularization was higher in dimethylpolysiloxane group than in control group but it was not increased with time. The dimethylpolysiloxane-coated micro-device is thought be a reliable bio-medical device.