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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要外周动脉疾病 (PAD) 是一种非常普遍的疾病，由于转移而迅速增长。人口统计，影响全球 2.02 亿人，影响美国 1800 万人，年增长率为 6.8%。 PAD 的早期阶段会导致跛行，而 PAD 的晚期阶段会导致静息痛、皮肤溃疡、坏疽和截肢，所有这些都会降低老年人的活动能力、功能和独立性。基于导管的治疗，包括血管成形术、支架置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，长期复发率高达 40% 再狭窄。超声治疗 (TUS) 等声能模式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，凭借这两种疾病过程的早期人类数据，Vibrato Medical 开发出了一种新的治疗方法。推出首款可穿戴式超声治疗 (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 在显着改善下肢灌注方面的功效健康志愿者使用多种灌注措施，在后路进行短短 30 分钟的治疗然而，这是使用单一尺寸/频率的设备来完成的，无论患者的体型大小和患者的年龄。极端的尺寸可能不具有最佳的安全性和有效性。第一阶段 SBIR 提案的目标是系统测量皮下脂肪的深度，来自 VibratoSleeve 后小腿入路的腓肠肌/比目鱼肌、胫后动脉和骨骼，这些解剖测量将用于为声学提供信息。模拟，然后预测提供安全有效的传感器所需的尺寸和频率将根据模拟数据组装候选换能器，并以商业上可行的方式整合到 16 传感器 VibratoSleeve 阵列中。