Inhalation

INH0226

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Inhalation February 2026 33 flow, which may not fully capture real-world vari- ability such as turbulent fluctuations or anatomical complexity or humidity. erefore, future validation using in vitro models, such as cascade impactor test- ing, and in vivo data will be essential to confirm the accuracy of these simulations and refine the design. Although FlowMate was developed with pediat- ric asthma patients in mind, its delay-and-release mechanism could also benefit other populations. For example, elderly patients may suffer from age-related declines in inspiratory muscle strength or cogni- tive limitations that impair inhaler technique. Sim- ilarly, patients with chronic obstructive pulmonary disease (COPD) may struggle to generate sufficient inspiratory flow, especially during exacerbations. For both populations, FlowMate could provide a low- cost solution that may potentially lead to significant improvements in medication delivery outcomes. In addition, the key design principle of FlowMate— its delay-and-release mechanism—may help inform future redesigns of a more user-friendly DPIs. Conclusions Our FlowMate adaptor device can offer a novel, cost-effective solution for improving DPI functional- ity, particularly for pediatric patients and those with limited inspiratory capacity. Preliminary testing sup- ports its feasibility and potential to enhance medica- tion deposition. However, further studies are needed to validate its clinical efficacy, refine design features and optimize performance under real-world conditions. Future work includes particle size testing using cascade impactor studies to assess the impact of the adaptor on medication particle size and distribution. Should the results of these studies yield positive results, this device design could be incorporated into the refinement of the next generation of DPI delivery devices. Acknowledgement We would like to thank Beth Laube, PhD, Professor Emerita of Pediatrics at Johns Hopkins University, for her invaluable guidance and expertise. References 1. US Centers for Disease Control and Prevention. Most recent national asthma data. June 23, 2023. https://www.cdc.gov/asthma/most_recent_national_ asthma_data.htm 2. American Lung Association. How to use a metered-dose inhaler without a valved hold- ing chamber. https://www.lung.org/lung-health- diseases/lung-disease-lookup/asthma/treatment/ devices/metered-dose-inhaler 3. American Lung Association. How to use a metered-dose inhaler with a valved holding chamber (spacer). https://www.lung.org/lung-health-diseases/ lung-disease-lookup/asthma/treatment/devices/ metered-dose-inhaler-chamber-spacer devices have proven highly effective for MDIs, how- ever, no comparable passive solution exists for DPIs. Our device, the FlowMate, seeks to overcome these challenges in medication delivery by offering a pas- sive, mechanical solution that enhances inspiratory flow without the need for external power sources. e FlowMate is a detachable adaptor that attaches to existing DPIs and utilizes a delay-and-release mechanism to allow users to build sufficient inspira- tory pressure before medication is released. is can enable patients with low inspiratory capacity, such as children, to generate the flow rates required to actu- ate DPIs like the Ellipta. Because our device is an external attachment, it remains low-cost compared to active DPIs and can be modified for use with multiple other DPIs in the future. e FlowMate also retains the portability of the DPI since it is a separate attach- ment. Because our device is actuated by inhalation, it may be easier to use, lower-cost to manufacture and less vulnerable to failure due to its innovative design. Feedback from caregivers and patients played a cen- tral role in guiding the design of our device. Across two survey cohorts, participants consistently empha- sized the importance of feedback mechanisms and ease of use [16]. In response to this feedback, our current prototype includes a snapping magnetic gate that provides both tactile and auditory confirmation when the device actuates. Moreover, when the gate opens in our device, it triggers a visible indicator but- ton that signals to both patient and caregiver that the necessary inspiratory force has been achieved. e internal delay mechanism can ensure more consistent delivery by only initiating medication release once a predefined pressure threshold is reached. Our proposed device has demonstrated promising results in enhancing inspiratory flow rates and improv- ing medication delivery for patients with suboptimal inspiratory capabilities. When tested with an applied inspiratory force, the device consistently established a vacuum and pressure gradient, followed by the opening of the gate. ese results confirm that the delay-and- release mechanism can effectively delay medication delivery until sufficient pressure buildup is achieved, resulting in increased flow rates that can exceed the 60 L/min threshold required to activate the Ellipta DPI. To further assess the device's function, we conducted computational fluid dynamics simulations using COMSOL. ese simulations demonstrated the formation of a stable pressure gradient within the adaptor, facilitating the delay-and-release mecha- nism. Moreover, the simulations indicated minimal turbulence with particles following streamlined paths through the device. Particle trajectory analyses also revealed minimal impaction on the adaptor walls, which could help ensure efficient medication deliv- ery through the device and mouthpiece. However, these CFD simulations assumed idealized conditions, including smooth, rigid surfaces and steady-state

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