Acoustic-anatomic modeling and development of a patient-specific wearable therapeutic ultrasound device for peripheral arterial disease

项目摘要 外周动脉疾病（PAD）是一种高度流行的疾病，由于转变而迅速增长 人口统计数据，影响全球2.02亿人，美国1800万人，年增长率为6.8%。 PAD的早期阶段导致跛行，而PAD的晚期阶段导致静息痛、皮肤溃疡， 坏疽和截肢，所有这些都降低了老年人的行动能力、功能和独立性。进展 基于导管的治疗，包括血管成形术、支架植入术和药物涂层球囊，以及外科搭桥术 治疗通常对PAD无效，并伴有并发症，长期并发症率高达40% 再狭窄 声学能量模态，如治疗性超声（TUS），已被证明可以促进侧支循环 血管生长、血管生成，并改善冠状动脉疾病和PAD动物模型的灌注， 在这两种疾病的早期人类数据中，Vibrato Medical开发了一种新的治疗方法 第一个可穿戴式治疗超声（TUS）设备，用于PAD的非侵入性门诊治疗 这将促进侧支血管生长和血管生成，恢复灌注并降低截肢率。 我们已经证明了VibratoSleeve在显著改善下肢灌注方面的有效性， 健康志愿者使用多个灌注测量，在后部进行短至30分钟的治疗 小腿然而，这是使用单一尺寸/频率的器械完成的，与患者体型无关， 尺寸的极限可能不具有最佳的安全性和有效性。 第一阶段SBIR提案的目标是系统地测量皮下脂肪的深度， 腓肠肌/比目鱼肌、胫后动脉和来自VibratoSleeve小腿后侧入路的骨， 并且在宽范围的患者尺寸上。这些解剖测量将用于告知声学 模拟，然后将预测所需的传感器的大小和频率，以提供安全有效的 胫后血管小体治疗。候选传感器将根据模拟数据进行组装， 并以商业上可行的方式并入16换能器VibratoSleeve阵列中。

PROJECT SUMMARY Peripheral arterial disease (PAD) is a highly prevalent condition that is growing rapidly due to shifting demographics, affecting 202M people worldwide and 18M in the USA, with an annual growth rate of 6.8%. Early stages of PAD result in claudication, while the advanced stage of PAD results in resting pain, skin ulcers, gangrene and amputation, all of which reduce mobility, function and independence of seniors. Advances in catheter-based therapies including angioplasty, stenting, and drug-coated balloons, as well as surgical bypass treatments, are often ineffective in PAD and associated with complications and up to 40% rate of long-term restenosis. Acoustic energy modalities such as therapeutic ultrasound (TUS) have been shown to promote collateral vessel growth, angiogenesis, and to improve perfusion in animal models of coronary artery disease and PAD, with promising early human data in both disease processes. Vibrato Medical has developed a novel treatment with the first wearable therapeutic ultrasound (TUS) device for the non-invasive, outpatient treatment of PAD that will promote collateral vessel growth and angiogenesis, restore perfusion and reduce amputation rates. We have already demonstrated VibratoSleeve’s efficacy in markedly improving lower extremity perfusion in healthy volunteers using multiple perfusion measures with as little as 30 minutes of therapy over the posterior calf. However, this was done with a device of a single size/frequency regardless of patient size, and patients at the extremes of size may not have optimal safety and efficacy. The goal of this Phase 1 SBIR proposal is to systematically measure depths of subcutaneous fat, gastrocnemius/soleus muscle, posterior tibial artery and bone from the VibratoSleeve’s posterior calf approach, and over a wide range of patient sizes. These anatomic measurements will be used to inform acoustic simulations, that will then predict the size and frequency of transducers needed to provide safe and effective therapy to the posterior tibial angiosome. Candidate transducers will be assembled based on simulation data, and incorporated into 16-transducer VibratoSleeve arrays in a commercially viable manner.