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

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.

In vivo study of flow-rate accuracy of the MedStream Programmable Infusion System.

OBJECTIVE: Flow-rate accuracy and precision are important parameters to optimizing the efficacy of programmable intrathecal (IT) infusion pump delivery systems. Current programmable IT pumps are accurate within ±14.5% of their programmed infusion rate when assessed under ideal environmental conditions and specific flow-rate settings in vitro. We assessed the flow-rate accuracy of a novel programmable pump system across its entire flow-rate range under typical conditions in sheep (in vivo) and nominal conditions in vitro. MATERIALS AND METHODS: The flow-rate accuracy of the MedStream Programmable Pump was assessed in both the in vivo and in vitro settings. In vivo flow-rate accuracy was assessed in 16 sheep at various flow-rates (producing 90 flow intervals) more than 90 ± 3 days. Pumps were then explanted, re-sterilized and in vitro flow-rate accuracy was assessed at 37°C and 1013 mBar (80 flow intervals). RESULTS: In vivo (sheep body temperatures 38.1°C-39.8°C), mean ± SD flow-rate error was 9.32% ± 9.27% and mean ± SD leak-rate was 0.028 ± 0.08 mL/day. Following explantation, mean in vitro flow-rate error and leak-rate were -1.05% ± 2.55% and 0.003 ± 0.004 mL/day (37°C, 1013 mBar), respectively. CONCLUSIONS: The MedStream Programmable Pump demonstrated high flow-rate accuracy when tested in vivo and in vitro at normal body temperature and environmental pressure as well as when tested in vivo at variable sheep body temperature. The flow-rate accuracy of the MedStream Programmable Pump across its flow-rate range, compares favorably to the accuracy of current clinically utilized programmable IT infusion pumps reported at specific flow-rate settings and conditions.

Development and in-vitro characterization of an implantable flow sensing transducer for hydrocephalus.

An implantable transducer for monitoring the flow of Cerebrospinal fluid (CSF) for the treatment of hydrocephalus has been developed which is based on measuring the heat dissipation of a local thermal source. The transducer uses passive telemetry at 13.56 MHz for power supply and read out of the measured flow rate. The in vitro performance of the transducer has been characterized using artificial Cerebrospinal Fluid (CSF) with increased protein concentration and artificial CSF with 10% fresh blood. After fresh blood was added to the artificial CSF a reduction of flow rate has been observed in case that the sensitive surface of the flow sensor is close to the sedimented erythrocytes. An increase of flow rate has been observed in case that the sensitive surface is in contact with the remaining plasma/artificial CSF mix above the sediment which can be explained by an asymmetric flow profile caused by the sedimentation of erythrocytes having increased viscosity compared to artificial CSF. After removal of blood from artificial CSF, no drift could be observed in the transducer measurement which could be associated to a deposition of proteins at the sensitive surface walls of the packaged flow transducer. The flow sensor specification requirement of +-10% for a flow range between 2 ml/h and 40 ml/h. could be confirmed at test conditions of 37 degrees C.

A telemetric pressure sensor system for biomedical applications.

A new implantable pressure sensor for long-term monitoring of intracranial pressure is presented. The sensor is powered by telemetry and can be interrogated wirelessly. A capacitive pressure transducer, whose capacitance is converted to a frequency-encoded signal by an application-specific integrated circuit (ASIC), senses the absolute pressure. The pressure-encoded signal, the ASIC input voltage, and onboard calibration parameters are transmitted to an external reading unit. The proposed novel packaging solution is designed for long-term stability and reliability of the sensor. The accuracy of sensor at body temperature is better than 2 mbar across a pressure range of 600-1200 mbar. The sensor is 13 mm in diameter and 4.5 mm in height.