A novel low temperature transcutaneous energy transfer system suitable for high power implantable medical devices: performance and validation in sheep.

Abstract

Transcutaneous energy transfer (TET) systems use magnetic fields to transfer power across the skin without direct electrical connectivity. This offers the prospect of lifetime operation and overcomes risk of infection associated with wires passing through the skin. Previous attempts at this technology have not proved suitable due to poor efficiency, large size, or tissue damage. We have developed a novel approach utilizing frequency control that allows for wide tolerance in the alignment between internal and external coils for coupling variations of 10 to 20 mm, and relatively small size (50 mm diameter, 5 mm thickness). Using a sheep experimental model, the secondary coil was implanted under the skin in six sheep, and the system was operated to deliver a stable power output to a 15 W load continuously over 4 weeks. The maximum surface temperature of the secondary coil increased by a mean value of 3.4 +/- 0.4 degrees C (+/-SEM). The highest absolute mean temperature was 38.3 degrees C. The mean temperature rise 20 mm from the secondary coil was 0.8 +/- 0.1 degrees C. The efficiency of the system exceeded 80% across a wide range of coil orientations. Histological analysis revealed no evidence of tissue necrosis or damage after four weeks of operation. We conclude that this technology is able to offer robust transfer of power to implantable devices without excess heating causing tissue damage.