In vitro and in vivo testing of an electrocatalytic glucose sensor.

A prerequisite for the development of an implantable artificial pancreas is the availability of a stable, long-life glucose sensor. Platinum (Pt) catalyzed electrodes have been demonstrated in vitro to show high sensitivity to glucose and long cycle life but are more sensitive to co-reactants compared with enzymatic methods. The authors developed a special data processing method (compensated net charge ratio, or CNCR) in which the measured electrode response is very sensitive to glucose, completely insensitive to urea, and only moderately sensitive to amino acids. Other endogenous and exogenous co-reactants show only minor interferences. The CNCR method involves the determination of the ratio of net oxidation charge to total charge during one complete cycle of a cyclic voltammogram. Prototype electrodes tested in vitro in spiked plasma have shown typical sensitivities of greater than 2 x 10(-4) CNCR units per 1 mg/dl change in glucose concentration, with linear response up to 400 mg/dl. For in vivo testing, a modified 5 F vascular catheter with membrane covered surface mounted electrodes was used at a vena cava site in swine. Several sensor designs were tested in vivo, with sensitivities of 1-5 x 10(-4) CNCR units (mg/dl).

Electrocatalytic glucose sensor.

High surface area platinum subjected to the appropriate electrical potential cycling regimes exhibits considerable electrocatalytic activity towards glucose oxidation. We have developed a special data processing method, the compensated net charge (CNC) method, to take advantage of the electrocatalytic activity of platinum. This method involves the determination of the net oxidation charge during one complete cycle of a cyclic voltammogram applied to the platinum electrode in a potentiodynamic mode. Under these conditions, the electrode response is very sensitive to glucose, completely insensitive to urea, and only moderately sensitive to amino acid concentration changes. Earlier work with other endogenous and exogenous potential co-reactants shows little interference. Data obtained in vitro and in vivo will be presented and discussed.

Bioevaluation of plasma polymerized films in skeletal muscle.

Plasma polymerized ethylene (PPE), styrene (PPS), and chlorotrifluoroethylene (PPCTFE) were synthesized by exposing the monomeric gases to an inductively coupled radio frequency "glow-discharge" field. The polymer films were deposited on poly(dimethyl) siloxane (medical grade Silastic), which was then surgically implanted in rat paravertebral muscle for periods up to 84 weeks. The biocompatibility of the plasma deposited films and uncoated Silastic was evaluated by qualitative (graded inflammatory cell response) and quantitative (connnective tissue capsule thickness) techniques as a function of time. The morphological features of the connective tissue capsule and the plasma polymerized films were examined by SEM after 75 weeks of implantation. Results showed that the acute inflammatory cell migration around PPS and PPCTFE was at a maximum in 2 weeks, decaying to control levels in 4 to 8 weeks. The PPE response was judged as less than the control response up to 4 weeks. After 8 weeks no qualitative difference could be detected between the plasma polymerized films and Silastic. On the other hand, a quantifiable change in fibrous capsule response as a function of time and material was noted until 24 weeks. From these data we conclude that these types of films do not elicit an untoward foreign body reaction at a skeletal muscle implant site in rats.