Assessment of telemetry and fluidic control system used in the Medstream programmable infusion system: an in vivo and in vitro study.

Abstract

The MedStream Programmable Infusion Pump, an intrathecal pump indicated for the treatment of chronic intractable pain and severe spasticity (CE-mark) or severe spasticity (US), has a highly accurate medication delivery (within 10% of the programmed flow rate) and is certified for use in 3-Tesla magnetic resonance imaging systems (conditional). Performance of the telemetric link between external control-unit and implanted pump was assessed in sheep (in vivo) up to 26 weeks, resulting in 1040 communication sessions. The telemetric communication envelope (communication distance and maximum antenna tilt angles) and communication duration were characterized in an in vitro test. Capacitance measurements of the piezoelectric actuator of the valve, valve flow rates, and leak rates were measured in an in vitro cyclic accelerated aging test to assess reliability of the valve over 6,200 k cycles. The pump was well tolerated in vivo; all communication sessions between control-unit and pump were successful (P = 6.889 × 10(-14)). Mean communication distance between pump and control-unit was 3.8 cm, with the maximum antenna tilt angles being 40° (θy) and 50° (θx) for all test cases; the maximum communication duration was 5.5 s. Capacitance measurements, flow rates, and leak rates were within ±10 % range up to 6,200 k cycles corresponding to approximately 10 times the valve cycles over the specified service life of the pump (8 years), except for one flow-rate value, which can be explained by the measurement setup. These results demonstrate the reliability of the telemetry link and piezoelectric valve system of the MedStream Programmable Infusion Pump.