Vascular capsule for telemetric monitoring of blood pressure.

Purpose: Development and experimental evaluation of an intravascular monitoring system for telemetric measurement of blood pressure and heart rate.

Materials And Methods: The monitoring system consists of an implantable silicone capsule (diameter 2.3 mm), containing a dedicated microchip with pressure sensors and signal-processing circuits as well as an antenna for wireless data and energy transfer using 6.78 MHz transponder technology. Three self-expanding legs at one end of the capsule served as a mechanism to lock the capsule at an arterial branch. A flow model, driven by a ventricular assist system, was used for testing and optimizing the implantation equipment, for checking the anchoring mechanism and for ensuring transmission of the measured pressure to the readout unit. In-vivo experiments were performed in 8 minipigs (weight 25 to 30 kg), with three capsules placed in each minipig via the femoral artery using a dedicated 8-F sheath/pusher system. Follow-up was by CT angiography for up to 6 months after implantation.

Results: Flow model tests revealed a maximum deviation of pressure and heart rate measurements of 5% from the reference measurements. Signal transmission was reliable over a distance of 3 to 4 cm. Fluoroscopically guided in-vivo implantation of the capsules was simple and straightforward. In arteries with a diameter of 5 to 6 mm, the capsules were permanently fixed with one or two legs interlocked in side branches and without occlusion within 6 months. Three capsules developed a small non-occlusive appositional thrombus attached to the downstream (leg) part of the capsule.

Conclusion: Our in-vitro and in-vivo experiments demonstrate the feasibility of wireless transmission from a capsule with a sufficient resolution of the sensor output signals to determine blood pressure and pulse rate. As long as the vessel diameter is wide enough, arterial fixation of the capsule does not induce thrombotic occlusion of the parent artery. With respect to future clinical applications, further refinements of the transmission technology are needed to extend the transmission distance between capsule and reader antenna. The technology of intelligent implants has further implications, such as monitoring of other physiological parameters, and the design of a control loop, which may be used for therapeutic feedback.