Safety of acoustic separation in plastic devices for extracorporeal blood processing

Abstract

BACKGROUND Acoustic cell separation uses ultrasound waves to separate cells from plasma to perform plasmapheresis. Although the fundamental process has been studied for decades, no acoustic cell separation has been studied in a disposable plastic format suitable for clinical applications. STUDY DESIGN AND METHODS We developed a disposable, rectangular polystyrene microchannel acoustic cell separation system and applied acoustic energy relevant for plasmapheresis. Fresh blood from healthy volunteers was exposed in vitro to acoustic energy in an open microfluidic circuit with and without ultrasound applied. Blood was tested for perturbations in red blood cells, platelets, and coagulation using clinical assays. RESULTS Red cell and platelet size parameters, and coagulation activation were all within 3% of baseline values. P-selectin expression on platelets increased by an average of 10.9% relative to baseline. Hemolysis increased with flow through the microfluidic channel, but percent hemolysis remained <0.3%. DISCUSSION Blood parameters in a single-pass, microfluidic acoustic cell separation apparatus remained within normal limits. In vivo animal studies that model continuous separation in a physiologic environment are warranted.

Acoustofluidic separation of cells and particles

“…Acoustofluidic separation techniques have been demonstrated for a variety of blood component separation applications. The biocompatibility of these techniques has also been shown by some studies in terms of achieving low levels of platelet activation and preserving cell functions 108–110 . Although many advancements have been made over the past decade, there are still limitations of acoustofluidic-based blood component separation.…”

Purification of Lymphocytes by Acoustic Separation in Plastic Microchannels

“…Despite the potential advantages of acoustic separation for cell therapy, a number of hurdles and questions remain. Although we and others have shown that acoustophoresis has no ill effects on various cells by many measures, 37,38 downstream steps of transduction and expansion of T cells or HSCs following acoustic separation have to our knowledge not yet been attempted. Additionally, blood samples representing the wide range in cell counts resulting from differing disease states, chemotherapy, and natural patient variation have yet to be tested for comparison with our current results from normal blood, and processing of clinical volumes awaits device scale-up.…”

Focalization Performance Study of a Novel Bulk Acoustic Wave Device

“…By this approach, particles subjected to an ultrasonic field, generated via bulk acoustic waves (BAW) or surface acoustic waves (SAW), are scattered or impinged by field waves, allowing the creation of an acoustic radiation force able to move particles towards the surrounding medium. In previous works, BAW devices were employed to separate blood components throughout a continuous and a biocompatible approach [26][27][28][29][30][31][32], thus validating a label-free approach [17] for biomarker detection.…”