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.

项目总结 外周动脉疾病(PAD)是一种高度流行的疾病，由于移位而迅速增长。 全球有2.02亿人受到影响，美国有1800万人，年增长率为6.8%。 PAD的早期阶段会导致跛行，而PAD的晚期会导致静息痛、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。最新进展 以导管为基础的治疗，包括血管成形术、支架植入和药物涂层球囊，以及外科搭桥 治疗，在PAD中往往无效，并伴随着并发症和高达40%的长期发生率 血管再狭窄。 治疗超声(TUS)等声能疗法已被证明可以促进侧支循环。 在冠状动脉疾病和PAD动物模型中，为了改善血管生长、血管生成和改善血流灌注， 在这两种疾病过程中都有很有希望的早期人类数据。Vibrato医疗公司开发了一种新的治疗方法 使用第一个可穿戴治疗性超声波(TUS)设备进行非侵入性门诊治疗PAD 这将促进侧支血管的生长和血管生成，恢复灌流，降低截肢率。 我们已经证明了VibratoSleve在显著改善下肢血流灌注方面的有效性。 健康志愿者使用多项灌流措施，仅需30分钟的后部治疗 小牛。然而，这是用一个单一大小/频率的设备完成的，而不考虑患者的大小，并且患者在 极端的剂量可能不会有最佳的安全性和有效性。 这个第一阶段SBIR方案的目标是系统地测量皮下脂肪的深度， 小腿后入路的腓肠肌/比目鱼肌、胫后动脉和骨， 患者的体型也各不相同。这些解剖学测量将被用来告知声学 模拟，然后将预测所需换能器的大小和频率，以提供安全和有效的 胫后血管小体的治疗。候选换能器将基于模拟数据组装， 并以商业上可行的方式结合到16换能器振动休眠阵列中。