Development of Low Frequency (20-100 kHz) Clinically Viable Ultrasound Applicator for Chronic Wound Treatment.
Development of Low Frequency (20-100 kHz) Clinically Viable Ultrasound Applicator for Chronic Wound Treatment.
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DOI：
10.1109/tuffc.2018.2836311
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发表时间：
2019-03
期刊：
影响因子：
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通讯作者：
Lewin PA
中科院分区：
文献类型：
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作者：
Ngo O;Niemann E;Gunasekaran V;Sankar P;Putterman M;Lafontant A;Nadkarni S;DiMaria-Ghalili RA;Neidrauer M;Zubkov L;Weingarten M;Margolis DJ;Lewin PA
本文详细介绍了系统的方法，用于开发一个可行的临床原型的治疗性超声施源器，并讨论了基本原理和审议，导致的设计策略。该涂抹器专门设计用于治疗慢性伤口，据作者所知，它是第一款真正的可穿戴设备，具有缩短愈合时间的可靠记录，直接转化为降低医疗成本。该原型在kHz（20-100）频率范围内工作，并使用非空化和非热水平的超声能量。因此，在没有惯性空化和温度升高的情况下，组织-超声相互作用被认为取决于稳定的空化（如果有的话）和辐射力。峰值声输出压力幅度被限制为55 kPa，对应于100 mW/cm 2的空间峰值时间峰值强度。这种强度被认为是安全的，可以延长（最多4小时）。贴片式涂药器设计适合嵌入伤口敷料中。由于其重量轻（<20 g）和圆形（直径40 mm）盘状结构，该涂抹器非常适合慢性伤口治疗。介绍了一项关于施用器对糖尿病溃疡愈合时间影响的小型（n=8）初步研究。使用有源超声施源器治疗的受试者的伤口闭合平均时间为4.7周，而使用假施源器治疗的受试者为12周，表明糖尿病溃疡患者可能从拟定治疗中获益。
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.