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

针对外周动脉疾病的患者专用可穿戴超声治疗设备的声学解剖建模和开发

• 批准号: 10603253
• 负责人: Juliana Elstad
• 金额: $ 30万
• 依托单位: VIBRATO MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10603253
• 关键词: Acoustics; Address; Adoption; Affect; Air; Ambulatory Care; Amputation; Anatomic Models; Anatomy; Angioplasty; Animal Model; Ankle; Arteries; Bathing; Blood Vessels; Body mass index; Bypass; Calibration; Catheters; Ceramics; Clinical; Coronary Arteriosclerosis; Coupled; Coupling; Custom; Data; Development; Devices; Diagnosis; Dimensions; Disease; Elements; Engineering; Exclusion; Fatty acid glycerol esters; Frequencies; Gangrene; Gastrocnemius Muscle; Generations; Goals; Growth; Health Personnel; Hemoglobin; Home; Hospitalization; Housing; Immobilization; Individual; Intervention; Knee; Lateral; Lower Extremity; MRI Scans; Marketing; Measurement; Measures; Medial; Medical; Modality; Modeling; Muscle; Needles; Operative Surgical Procedures; Pain; Patient Isolation; Patients; Perfusion; Peripheral arterial disease; Persons; Pharmaceutical Preparations; Phase; Pilot Projects; Process; Rest; Safety; Shapes; Skin; Small Business Innovation Research Grant; Soleus Muscle; Source; Stenosis; Stents; Surface; Therapeutic; Thinness; Tibial Arteries; Tissues; Transducers; Vasodilation; Water; X-Ray Computed Tomography; angiogenesis; bone; claudication; clinical effect; clinical efficacy; critical limb Ischemia; demographics; design; effective therapy; electric impedance; fabrication; fibula; first-in-human; handheld equipment; healthy volunteer; human data; improved; novel; preference; pressure; prevent; prototype; restenosis; seal; simulation; skin ulcer; subcutaneous; therapy duration; tibia; tissue oxygenation; ultrasound

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.

项目摘要 外围动脉疾病（PAD）是一种高度普遍的疾病，由于变化而迅速增长 人口统计，在美国影响全球2.02亿人口，在美国有1800万人口，年增长率为6.8％。 PAD的早期阶段会导致lau不平 坏疽和截肢，所有这些都降低了老年人的流动性，功能和独立性。进步 基于导管的疗法，包括血管成形术，支架和涂有药物的气球，以及手术旁路 治疗通常在PAD上无效，并且与并发症相关，并且长期最高40％ 再狭窄。 声学能量模态（例如治疗超声（TUS））已被证明可以促进抵押品 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， 在两个疾病过程中，人类的早期数据都有承诺。颤音医学已经开发了一种新颖的治疗方法 使用第一个可穿戴热超声（TUS）设备，用于对PAD的非侵入性门诊治疗 这将促进附带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在明显改善下肢灌注方面的效率 使用多种灌注措施的健康志愿者，后部治疗只有30分钟 小牛。但是，这是使用单个尺寸/频率的设备进行的，无论患者的大小如何 尺寸的极端可能没有最佳的安全性和易感性。 该阶段1 SBIR建议的目标是系统地测量皮下脂肪的深度， 腹膜/比目鱼肌，胫骨后动脉和颤音的骨骼骨，颤音的后小腿方法， 并超过各种患者大小。这些解剖测量将用于告知声学 模拟，这将预测提供安全有效的传感器的大小和频率 对胫骨后部血管组的治疗。候选传感器将根据仿真数据组装而组装 并以商业上可行的方式掺入16个Transducer Vibratosleeve阵列中。