New method for the detection of thrombus formation in cardiovascular devices: optical sensor evaluation in a flow chamber model.

We proposed a new method of detecting the onset of thrombus formation based upon the backscattered light intensity changes caused by the alteration of blood flow behavior in the cardiopulmonary devices. In an optical senor based upon the First Order Scattering theory, the relationship between the backscattered light intensity and hematocrit exhibited a monotonically decaying curve for the hematocrit level greater than 45%. To distinguish the effect either by thrombus formation or erythrocyte aggregation on the back-scattered light intensity with a flow chamber connected to a rabbit arterial-venous bypass model, we generated an oscillatory flow using a roller pump and analyzed the results using a Fast Fourier Transform (FFT) method. Our hypothesis was that the nonclotting blood flow would yield an unchanged fundamental spectral power density of the oscillation frequency generated by a roller pump, whereas the thrombus formation would attenuate its power. We measured the back-scattered light intensity in the flow chamber of high shear region and low shear region (n = 5). The blood flow rate was 40 ml/min with the roller pump. The activated clotting time and the hematocrit level were adjusted to 170 +/- 10 s with heparin and 35 +/- 5% with a phosphate buffered sulfate solution, respectively. As a result, the backscattered light intensity from the low shear rate region gradually diminished with time (p < 0.05; 0-5 minutes vs. more than 10-15 minutes), whereas that from the high shear rate region remained fairly constant. The experimental finding supported the hypothesis that the decrease of the backscattered light intensity and diminished spectral power density were caused by the aggregation or clotting erythrocytes. In conclusion, we found that the measurement of the average backscattered light intensity level together with FFT analysis of the backscattered light from the flowing blood is a valuable approach in detecting the onset of thrombus formation.