MRI interactions of a fully implantable pressure monitoring device.

PURPOSE: To investigate the potential patient risk and interactions between a prototype implantable pressure monitoring device and a 3T clinical magnetic resonance imaging (MRI) machine to guide device design towards MR Conditional safety approval. MATERIALS AND METHODS: The pressure monitor device contained a catheter-mounted piezo-resistive pressure sensor, rechargeable battery, wireless communication system, and inductive pickup coil. Standard testing methods were used to guide experiments to investigate static field induced force and torque, radiofrequency (RF)-induced heating, image artifacts, and the MR's effect on device function. The specific clinical application of intracranial pressure monitoring was considered. RF-induced heating experiments were supported by numerical modeling of the RF body coil, the device, and experimental phantom. RESULTS: Sensing catheter lead length and configuration was an important component of the device design. A short 150 mm length catheter produced a heating effect of less than 2°C and a long 420 mm length catheter caused heating of 7.2°C. Static magnetic field interactions were below standard safety risk levels and the MR did not interfere with device function; however, artifacts have the potential to interfere with image quality. CONCLUSION: Investigation of MR interactions at the prototype stage provides useful implantable device design guidance and confidence that an implantable pressure monitor may be able to achieve MR Conditional safety approval.

Chronic measurement of left ventricular pressure in freely moving rats.

Measurements of left ventricular pressure (LVP) in conscious freely moving animals are uncommon, yet could offer considerable opportunity for understanding cardiovascular disease progression and treatment. The aim of this study was to develop surgical methods and validate the measurements of a new high-fidelity, solid-state pressure-sensor telemetry device for chronically measuring LVP and dP/dt in rats. The pressure-sensor catheter tip (2-Fr) was inserted into the left ventricular chamber through the apex of the heart, and the telemeter body was implanted in the abdomen. Data were measured up to 85 days after implant. The average daytime dP/dt max was 9,444 ± 363 mmHg/s, ranging from 7,870 to 10,558 mmHg/s (n = 7). A circadian variation in dP/dt max and heart rate (HR) was observed with an average increase during the night phase in dP/dt max of 918 ± 84 mmHg/s, and in HR of 38 ± 3 bpm. The ß-adrenergic-agonist isoproterenol, ß1-adrenergic agonist dobutamine, Ca(2+) channel blocker verapamil, and the calcium sensitizer levosimendan were administered throughout the implant period, inducing dose-dependent time course changes and absolute changes in dP/dt max of -6,000 to +13,000 mmHg/s. The surgical methods and new technologies demonstrated long-term stability, sensitivity to circadian variation, and the ability to measure large drug-induced changes, validating this new solution for chronic measurement of LVP in conscious rats.

Implantable ICP monitor for improved hydrocephalus management.

BACKGROUND: Hydrocephalus patients are commonly treated by insertion of ventriculoperitoneal shunts, but these have high complication rates. Monitoring of shunt and patient condition can be achieved through measuring intracranial pressure (ICP). Significant zero drift has limited previous developments towards a long-term implantable ICP monitor. We present a new implantable solid-state pressure sensor system appropriate for chronic (lifetime) monitoring of ICP. MATERIALS AND METHODS: Initial designs of the proposed ICP system were realised and the pressure sensor catheter underwent bench-top tests to analyse its characteristics. A drift rig was constructed for the long-term analysis of the sensor's zero drift. The pressure sensor catheter was used to continuously monitor blood pressure in rats. RESULTS: Three potential design solutions were realised: a standalone sensor, the sensor unit in line with a shunt system, and the sensor unit fully integrated into the shunt valve housing. Initial stability results across 46 days show a maximum drift of less than 2 mmHg and a minimum drift of less than 0.2 mmHg. CONCLUSION: Initial experience with the new implantable solid-state pressure sensor system confirms its suitability for chronic pressure monitoring. The device is promising for providing vital information on shunt and patient condition.