This paper details the systematic approach used to develop a viable clinical prototype of a therapeutic ultrasound applicator and discusses the rationale and deliberations that led to the design strategy. The applicator was specifically devised to treat chronic wounds and - to the best of the author's knowledge - is the first truly wearable device with a proven record of reducing healing time, directly translating to a reduction of healthcare costs. The prototype operates in the kHz (20-100) range of frequencies and uses non-cavitational and non-thermal levels of ultrasound energy. Hence, in the absence of inertial cavitation and temperature elevation, the tissue-ultrasound interaction is considered to be dependent on stable cavitation (if any) and radiation force. The peak acoustic output pressure amplitude is limited to 55 kPa, corresponding to a spatial peak temporal peak intensity of 100 mW/cm2. This level of intensity is considered to be safe to apply for extended (up to four hours) periods of time. The patch-like applicator design is suitable to be embedded in wound dressing. With its light weight (<20g) and circular (40 mm dia) disk shape architecture, the applicator is well suited for chronic wound treatment. A small (n=8) pilot study on the effects of the applicator on diabetic ulcers healing time is presented. The average time to wound closure was 4.7 weeks for subjects treated with the active ultrasound applicator, compared to 12 weeks for subjects treated with a sham applicator, suggesting that patients with diabetic ulcers may benefit from the proposed treatment.
Chronic wounds, such as venous and diabetic ulcers, cost the U.S healthcare system alone, close to $25 billion annually. Hence, a reduction of healing time directly translates into savings of treatment related expenses. This work describes the implementation of patch-like, un-tethered and clinically viable therapeutic ultrasound applicator. The device uses well-defined non-cavitational and non-thermal levels of ultrasound energy; its peak acoustic output pressure amplitude was intentionally limited to 55 kPa, corresponding to a spatial peak temporal peak intensity of 100 mW/cm2. A small (n = 8) pilot study targeting diabetic ulcers treatment was performed and indicated that with its light weight (<20g), and circular (40 mm dia) disk shape architecture this applicator is suitable to be embedded in wound dressing. The average time to wound closure was 4.7 weeks for subjects treated with the active device, compared to 12 weeks for subjects treated with a sham applicator, suggesting that patients with diabetic ulcers may benefit from the proposed treatment. [Work supported by the NINR grant5R01NR015995. The contents of this presentation are solely the responsibility of the authors and do not necessarily represent the official views of the NIH.]
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