Long-term in vivo experience of an electrochemical sensor using the potential step technique for measurement of mixed venous oxygen pressure

Abstract

An implantable amperometric blood oxygen sensor was developed to improve rate adaptation of heart pacemakers. Two different working electrode materials in direct contact with the blood were tested, smooth glassy carbon and gold. Reference electrodes of Ag/AgCl and porous pyrolytic carbon were evaluated. A counter electrode being the titanium housing of the pulse generator was partly coated with carbon. An implantable pacemaker system with chronocoulometric oxygen detection was developed. Heart synchronous potential steps were periodically applied to the 7.5 mm 2 working electrode in the atrium. Both single and double potential step techniques were evaluated. The oxygen diffusion limited current was used to calculate the stimulation rate. Bench tests and studies on 31 animals were performed to evaluate long-term stability and biocompatibility. In five dogs, the AV node was destroyed by RF ablation to create a realistic animal model of a pacemaker patient. Sensor stability and response to exercise was followed up to a maximum implantation time of 4 years. Post-mortem examinations of the electrode surfaces and tissue response were performed. The results show that a gold electrode is more stable than glassy carbon. The Ag/AgCl reference was found not to be biocompatible, but activated carbon was stable enough for use as reference for the potentiostat. Double potential steps stabilize the sensor response in comparison to single steps. Blood protein adsorption on the gold surface decreased the oxygen transport but not the reaction efficacy. No adverse tissue reactions were observed.