Assessment of Flow through Microchannels for Inertia-Based Sorting: Steps toward Microfluidic Medical Devices

The development of new standardized test methods would allow for the consistent evaluation of microfluidic medical devices and enable high-quality products to reach the market faster. A comprehensive flow characterization study was conducted to identify regulatory knowledge gaps using a generic iner...

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Main Authors: Rucha Natu, Suvajyoti Guha, Seyed Ahmad Reza Dibaji, Luke Herbertson
Format: Article
Language:English
Published: MDPI AG 2020-09-01
Series:Micromachines
Subjects:
Online Access:https://www.mdpi.com/2072-666X/11/10/886
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spelling doaj-9a6786b56219480b8401e09e040576782020-11-25T03:30:22ZengMDPI AGMicromachines2072-666X2020-09-011188688610.3390/mi11100886Assessment of Flow through Microchannels for Inertia-Based Sorting: Steps toward Microfluidic Medical DevicesRucha Natu0Suvajyoti Guha1Seyed Ahmad Reza Dibaji2Luke Herbertson3Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993, USADivision of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993, USADivision of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993, USADivision of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD 20993, USAThe development of new standardized test methods would allow for the consistent evaluation of microfluidic medical devices and enable high-quality products to reach the market faster. A comprehensive flow characterization study was conducted to identify regulatory knowledge gaps using a generic inertia-based spiral channel model for particle sorting and facilitate standards development in the microfluidics community. Testing was performed using 2–20 µm rigid particles to represent blood elements and flow rates of 200–5000 µL/min to assess the effects of flow-related factors on overall system performance. Two channel designs were studied to determine the variability associated with using the same microchannel multiple times (coefficient of variation (CV) of 27% for Design 1 and 18% for Design 2, respectively). The impact of commonly occurring failure modes on device performance was also investigated by simulating progressive and complete channel outlet blockages. The pressure increased by 10–250% of the normal channel pressure depending on the extent of the blockage. Lastly, two common data analysis approaches were compared—imaging and particle counting. Both approaches were similar in terms of their sensitivity and consistency. Continued research is needed to develop standardized test methods for microfluidic systems, which will improve medical device performance testing and drive innovation in the biomedical field.https://www.mdpi.com/2072-666X/11/10/886microfluidicsspiral channelinertial separationparticle focusingsortingflow performance testing
collection DOAJ
language English
format Article
sources DOAJ
author Rucha Natu
Suvajyoti Guha
Seyed Ahmad Reza Dibaji
Luke Herbertson
spellingShingle Rucha Natu
Suvajyoti Guha
Seyed Ahmad Reza Dibaji
Luke Herbertson
Assessment of Flow through Microchannels for Inertia-Based Sorting: Steps toward Microfluidic Medical Devices
Micromachines
microfluidics
spiral channel
inertial separation
particle focusing
sorting
flow performance testing
author_facet Rucha Natu
Suvajyoti Guha
Seyed Ahmad Reza Dibaji
Luke Herbertson
author_sort Rucha Natu
title Assessment of Flow through Microchannels for Inertia-Based Sorting: Steps toward Microfluidic Medical Devices
title_short Assessment of Flow through Microchannels for Inertia-Based Sorting: Steps toward Microfluidic Medical Devices
title_full Assessment of Flow through Microchannels for Inertia-Based Sorting: Steps toward Microfluidic Medical Devices
title_fullStr Assessment of Flow through Microchannels for Inertia-Based Sorting: Steps toward Microfluidic Medical Devices
title_full_unstemmed Assessment of Flow through Microchannels for Inertia-Based Sorting: Steps toward Microfluidic Medical Devices
title_sort assessment of flow through microchannels for inertia-based sorting: steps toward microfluidic medical devices
publisher MDPI AG
series Micromachines
issn 2072-666X
publishDate 2020-09-01
description The development of new standardized test methods would allow for the consistent evaluation of microfluidic medical devices and enable high-quality products to reach the market faster. A comprehensive flow characterization study was conducted to identify regulatory knowledge gaps using a generic inertia-based spiral channel model for particle sorting and facilitate standards development in the microfluidics community. Testing was performed using 2–20 µm rigid particles to represent blood elements and flow rates of 200–5000 µL/min to assess the effects of flow-related factors on overall system performance. Two channel designs were studied to determine the variability associated with using the same microchannel multiple times (coefficient of variation (CV) of 27% for Design 1 and 18% for Design 2, respectively). The impact of commonly occurring failure modes on device performance was also investigated by simulating progressive and complete channel outlet blockages. The pressure increased by 10–250% of the normal channel pressure depending on the extent of the blockage. Lastly, two common data analysis approaches were compared—imaging and particle counting. Both approaches were similar in terms of their sensitivity and consistency. Continued research is needed to develop standardized test methods for microfluidic systems, which will improve medical device performance testing and drive innovation in the biomedical field.
topic microfluidics
spiral channel
inertial separation
particle focusing
sorting
flow performance testing
url https://www.mdpi.com/2072-666X/11/10/886
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AT seyedahmadrezadibaji assessmentofflowthroughmicrochannelsforinertiabasedsortingstepstowardmicrofluidicmedicaldevices
AT lukeherbertson assessmentofflowthroughmicrochannelsforinertiabasedsortingstepstowardmicrofluidicmedicaldevices
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