Use of a piezoelectric film sensor for monitoring vascular grafts

Detection of failing arterial reconstructions requires intensive surveillance by frequent physical examination and noninvasive laboratory testing. However, many grafts fail during the intervals between these examinations. For this reason, we have developed an implantable miniaturized piezoelectric flow detection device whose function can be monitored externally by radiotransmission across the skin. Sensors were constructed from ultrathin polyvinylidene fluoride (PVF2) with piezoelectric activity and attached with silicone fixative to 6-mm polytetrafluoroethylene grafts. Ten of these grafts were placed in mongrel dogs as iliofemoral bypasses. Real time data were acquired from the sensors at a rate of 200 Hz, using a DATAQ A/D data acquisition board and CODAS data acquisition software, while simultaneous blood flow (using an electromagnetic flowmeter) and intraluminal pressure were processed by using separate channels of the same data acquisition board. The data were stored on computer storage media and analyzed by the ASYST software, which allows simultaneous signal curves to be compared using regression analysis. In the resting state, the mean blood flow was 123 +/- 16 mL and the mean intraluminal pressure was 124/78 mm Hg, and there was perfect correlation between the PVF2 sensor and the flowmeter and between the sensor and the intraluminal pressure (correlation coefficient, r greater than or equal to 0.99 and r greater than or equal to 0.93, respectively). A tourniquet was applied to the iliac artery proximal to the graft to reduce the flow to approximately half of the resting state (mean flow after tourniquet: 66 +/- 6 mL/minute). Signal tracings from the three sources showed a remarkable similarity with a very high correlation coefficient (r greater than or equal to 0.99 between sensor and flowmeter and r greater than or equal to 0.92 between sensor and the pressure signal). These preliminary results show that the sensors made from low-profile and low-mass PVF2 material have the potential of being implanted around grafts for long-term, continuous monitoring of graft function. Further studies involving long-term implantation to assess the effect of tissue ingrowth and loss of compliance are necessary before this device can be used clinically.