CFD Analysis of Aerosol Mask using a Breathing Model

CFD Analysis of Aerosol Mask using a Breathing Model

Sep 2, 2015

ARE Labs constructed and performed computational fluid dynamics modeling for the Rollins7 Aerosol Adult Oxygen Mask System.  The modeling was compared to test data and part of a FDA 510(k) submission package.   The 3D computation fluid dynamic model (CFD) incorporated custom code to allow the full 3D model to breath.  Individual tidal volume, frequency and I:E ratios are able to be set to explore the effects they have on total drug delivery, oxygen delivery and carbon dioxide re-breathing to a patient.  The model was confirmed via laboratory aerosol testing on a ventilated mannequin connected to a ventilator.  Both resting male and female respiratory patterns were investigated for the CFD model and the aerosol testing.  Testing confirmed the CFD computed aerosol drug delivery within 10% of modeling values.

Rollins Medical receives approval letter from FDA regarding the 510(k) application for the Rollins7 Adult Oxygen Mask.  ARE Labs was proud to provide FDA 510(k) testing and Computation Fluid Dynamics (CFD) Modeling support for Rollins Medical Solutions.  The Rollins7 Adult Oxygen mask is a combination device which allows oxygen therapy and delivery of aerosolized drug via either a nebulizer or MDI simultaneously.  The new innovative mask offers high delivery of aerosol medication while also allowing patient to imbibe drink and food through the open mouth port in the mask.  The open port mask design also greatly enhances removal of carbon dioxide thus reducing CO2 re-breathing compared to other masks on the market.

ARE labs was contracted with Rollins Medical Solutions to provide FDA 510(k) testing support for their new Rollins7 Adult Oxygen Mask.  The testing included cascade impactor studies to measure the total patient repairable dose received during a typical treatment time.  Particle size analysis, MMAD and GSD of the aerosols was measured for multiple respiratory drugs using a cascade impactor.   The mask was also evaluated under a variety of respiratory conditions using a piston type ventilator and a human model to accurately measure the total dosage received to a typical patient.   All drug analysis was performed using an HPLC system with UV detection.

ARE Labs provided computational fluid dynamics modeling (CFD) support for the Rollins7 Adult oxygen mask.  The model was constructed using a 3D human model (breathing parameters were custumizable in the model to control tidal volume, frequency and I:E ratios of the human model).  Aerosol and oxygen flows were controllable and set in the boundary condition of the model.  The CFD model provided key insights to the function of the mask.   The CFD model confirmed testing results for aerosol drug delivery and provide additional data which is not easily obtained through traditional test methods.  Primarily the model provided assessments of  patient oxygen enrichment, carbon dioxide elimination and temperature gradients of the mask under a variety of oxygen flows, aerosol mass rates and patient breathing conditions.     Several pictures and an animation of the CFD model are shown.

ARE Labs combines design, formulation, testing, rapid prototyping  and computation fluid dynamics modeling under one roof for our clients.  This set of in-house abilities allows ARE Labs to bring a complete respiratory drug delivery package to our clients with exceptional cost saving and speed to market.

The Rollins7 Oxygen Mask is a next-generation mask to deliver aerosolized medication via nebulizer and metered dose inhalers while providing oxygen therapy.  The mask provides very high oxygen delivery and carbon dioxide removal through it innovative open port design, which other oxygen masks lack.  The multi-function design and delivery performance is what makes the Rollins7 Oxygen mask a next-generation respiratory therapy device.  Please visit the Rollins Medical Solutions to learn more about their innovative solutions for the 21st century.

At ARE Labs, we pride ourselves on adhering to the highest standards of regulatory compliance. All our testing services are conducted in strict accordance with FDA guidelines and cGLP (current Good Laboratory Practice) regulations, ensuring our clients receive results that are both reliable and recognized by regulatory bodies.