Abstract
Raynaud’s phenomenon (RP) is a condition that causes decreased blood flow to areas perfused by small blood vessels (e.g., fingers, toes). In severe cases, ulceration, gangrene, and loss of fingers may occur. Most treatments focus on inducing vasorelaxation in affected areas by the way of pharmaceuticals. Recently, animal studies have shown that vasorelaxation can be induced by non-coherent blue light (wavelength ~ 430–460 nm) through the actions of melanopsin, a photoreceptive opsin protein encoded by the OPN4 gene. To study this effect in humans, a reliable phototherapy device (PTD) is needed. We outline the construction of a PTD to be used in studying blue light effects on Raynaud’s patients. Our design addresses user safety, calibration, electromagnetic compatibility/interference (EMC/EMI), and techniques for measuring physiological responses (temperature sensors, laser Doppler flow sensors, infrared thermal imaging of the hands). We tested our device to ensure (1) safe operating conditions, (2) predictable, user-controlled irradiance output levels, (3) an ability for measuring physiological responses, and (4) features necessary to enable a double-blinded crossover study for a clinical trial. We also include in the Methods an approved research protocol utilizing our device that may serve as a starting point for clinical study. We introduced a reliable PTD for studying the effects of blue light therapy for patients suffering from Raynaud’s phenomenon and showed that our device is safe and reliable and includes the required measurement vectors for tracking treatment effects throughout the duration of a clinical study.
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Acknowledgments
The authors acknowledge the participation and invaluable contributions of Jennifer Chmura and Kushal Sehgal. We are also grateful for support from the University of Minnesota Institute for Engineering in Medicine (IEM).
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On January 9, 2024 the authors and the University of Minnesota received a patent (U.S. 11,865,357) for the PTD and various methods for translating the technology into useful solutions for patients (both stationary and wearable systems).
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Brett Levac: work was primarily done while a student at the University of Minnesota.
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Levac, B., Kerber, J., Wagner, E. et al. An Experimental Phototherapy Device for Studying the Effects of Blue Light on Patients with Raynaud’s Phenomenon. Ann Biomed Eng (2024). https://doi.org/10.1007/s10439-024-03487-z
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DOI: https://doi.org/10.1007/s10439-024-03487-z