Biocompatibility of a physiological pressure sensor.

A newly developed fiber optic micropressure sensor was evaluated for biocompatibility using the International Organization for Standardization (ISO) test standard 10993-6. The test material and an inert control (fused silica glass) were tested in New Zealand white rabbits. Four test specimens were implanted in the paravertebral muscles on one side of the spine about 2-5 cm from the mid-line and parallel to the spinal column. Similarly, four control specimens were implanted on the opposite side. The implantation periods were 1, 4, and 12 weeks to ensure a steady state biological tissue response. Four animals were tested at each time period. Macroscopic and microscopic observations were performed to compare the biological reactions between the test and control materials. There was an inflammatory reaction at 1 week which subsided at 4 weeks. There was fibrous tissue growth near the implant that also decreased over time. Most importantly, there was no significant difference in the biological response between the test and control materials. Therefore, we conclude that the pressure microsensor is biocompatible.