Development of novel Aquilo Heat Therapy Device to treat patients with PeripheralArtery Disease

开发新型 Aquilo 热疗装置来治疗外周动脉疾病患者

• 批准号: 10483885
• 负责人: Paul Spence
• 金额: $ 35.07万
• 依托单位: AQUILO SPORTS, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10483885
• 关键词: Achievement; Address; Adopted; Adverse event; Age-Years; Air; Ankle; Atherosclerosis; Benchmarking; Blood flow; Burn injury; Clinical; Clinical Trials; Commuting; Data Analyses; Data Collection; Detection; Development; Devices; Disease; Effectiveness; Elderly; Electronics; Engineering; Ensure; Exercise; Exercise Therapy; Freezing; Goals; Heating; Home; Impairment; Individual; Interruption; Leg; Legal patent; Lower Extremity; Medical Device; Modification; Monitor; Morbidity - disease rate; Outcome; Outcome Study; Pain; Patients; Performance; Peripheral arterial disease; Persons; Phase; Physical Function; Polyurethanes; Preclinical Testing; Pump; Quality of life; Questionnaires; Randomized; Randomized Clinical Trials; Recovery; Regimen; Research; Research Personnel; Safety; Scientist; Skin Temperature; Skin injury; Sports; Supervision; System; Technology; Temperature; Testing; Therapeutic heat application; Thigh structure; Touch sensation; Training Programs; Translating; Travel; United States National Institutes of Health; Validation; Vision; Visual; Walking; Water; Well in self; Work; base; cardiovascular risk factor; claudication; clinical practice; clinical translation; cohort; commercialization; comorbidity; compliance behavior; design; effective therapy; engineering design; exercise training; experience; good laboratory practice; improved; improved outcome; indexing; innovation; meetings; meter; mortality; multidisciplinary; novel; older patient; operation; optimal treatments; phase 1 study; phase 2 study; pressure; prevent; programs; prototype; secondary outcome; skin burn; standard of care; touchscreen; treadmill; treatment duration; treatment program; usability; verification and validation; water testing

The objective of this proposal is to develop a novel device to provide leg heat therapy (HT) for patients with symptomatic peripheral arterial disease (PAD). The current non-interventional standard of care for PAD is a 12 week program of supervised exercise therapy (SET). For patients this is often very painful as they are exercised to the point of claudication and many elderly patients find it difficult or impossible to repeatedly travel to a treatment facility. Thus the majority of these patients remain untreated. Recently HT has been shown to be a promising therapy to treat PAD patients. A recent study demonstrated that an 8 week course of home HT was both safe and effective - with improvement in walking performance similar to SET. Home HT was also found to be comfortable and compliance was the treatment program was very high. Presently, there is no system commercially available for HT therapy despite the fact that HT may prove to be an optimal therapy for PAD patients since it can be delivered comfortably and at home. The Aquilo multi-disciplinary development team has the expertise, experience, and confidence to achieve our objective of clinical translation and commercialization of a competitive advanced technology to safely and effectively treat PAD, which will lead to an improved therapy for PAD patients. The proprietary Aquilo HT system (U.S. Patent Application No. 63/215,129) consists of two principal components. The first component is a wearable lower body garment that has an outer shell that is closed with a zipper and houses 6 pneumatic chambers. Inside the garment is a water circulating pad to provide HT. Temperature thermistors are attached to the water circulating pad in the region of the calf and the thigh of each leg. The second component is a console. The console houses a heater and two pumps – one to circulate heated water and a second that pumps air into the pneumatic chambers to keep the pads in gentle contact with the leg. The console has a touch screen for simple one-touch full treatment operation by elderly PAD patients. Many important safety features are programmed including audible and visual alarms and system shut off if leg temperature is excessive, kink detection and a low water level warning. The console will also include a data collection system. Rigor of prior research was demonstrated by development of prototype devices and proof-of- concept testing to define design specifications, evaluate function and performance, and identify engineering challenges and formulate solutions for new the Aquilo HT system. In this phase I project, we will (1) complete fabrication of the Aquilo HT system and confirm achievement of the design specifications (Aim 1); (2) demonstrate system safety and function in a small cohort of patients over a 12 week treatment period (Aim 2). Successful demonstration of feasibility of the Aquilo HT system will include: (1) achieve design specifications, function, and performance metrics (Aim 1), and (2) demonstrate safety (no skin injury or skin burn) and device reliability over 12 weeks of therapy in 6 PAD patients (Aim 2). Collectively, upon successful demonstration of meeting design benchmarks and study metrics (phase I), we will work to achieve a design freeze, complete verification and validation (V&V) testing in compliance with Good Manufacturing Practices (GMP), then conduct pre-clinical testing in compliance with Good Laboratory Practices (GLP). Our engineering control documents and pre-clinical test data and analyses will be then used to support an application for a clinical trial in PAD patients. Our vision is to successfully translate the Aquilo HT system into clinical practice and improve the outcome of PAD patients.

该提案的目的是开发一种新型设备，为患有以下疾病的患者提供腿部热疗（HT）： 有症状的外周动脉疾病（PAD）。目前 PAD 的非介入治疗标准是 12 监督运动治疗（SET）周计划。对于患者来说，这通常是非常痛苦的，因为他们在锻炼 以至于跛行，许多老年患者发现很难或不可能反复前往医院 治疗设施。因此，大多数患者仍未得到治疗。最近 HT 已被证明是 治疗 PAD 患者的有希望的疗法。最近的一项研究表明，为期 8 周的家庭 HT 课程对 既安全又有效——与 SET 类似，步行性能得到改善。 Home HT 还被发现 舒适且依从性很高，治疗方案非常高。目前还没有系统 尽管 HT 可能被证明是 PAD 的最佳疗法，但 HT 疗法已在商业上可用 患者可以在家中舒适地分娩。 Aquilo 多学科开发团队拥有 实现临床转化和商业化目标的专业知识、经验和信心 安全有效治疗 PAD 的具有竞争力的先进技术，这将导致治疗方法的改进 对于 PAD 患者。 专有的 Aquilo HT 系统（美国专利申请号 63/215,129）由两个主要部分组成： 成分。第一个组件是可穿戴的下半身衣服，其外壳由密封件封闭 一个拉链并容纳 6 个气压室。衣服内部有一个水循环垫，可提供 HT。 温度热敏电阻安装在每个人的小腿和大腿区域的水循环垫上 腿。第二个组件是控制台。控制台装有一个加热器和两个泵——一个用于循环加热 水和第二个将空气泵入气动室，以保持护垫与腿部的温和接触。 控制台设有触摸屏，方便老年PAD患者进行简单的一键式全程治疗操作。许多 对重要的安全功能进行了编程，包括声音和视觉警报以及如果腿部发生危险则系统关闭 温度过高、扭结检测和低水位警告。控制台还将包含一个数据 收集系统。原型设备的开发和证明证明了先前研究的严谨性 概念测试，用于定义设计规范、评估功能和性能以及确定工程 为新的 Aquilo HT 系统面临挑战并制定解决方案。 在这一阶段的项目中，我们将（1）完成 Aquilo HT 系统的制造并确认实现 设计规范（目标 1）； (2) 在一小群患者中展示系统的安全性和功能 12 周治疗期（目标 2）。 Aquilo HT 系统可行性的成功论证将包括： (1) 实现设计规范、功能和性能指标（目标 1），以及 (2) 证明安全性（无 6 名 PAD 患者在 12 周治疗期间的皮肤损伤或皮肤烧伤）和设备可靠性（目标 2）。总的来说， 在成功演示满足设计基准和研究指标（第一阶段）后，我们将努力 实现设计冻结、完整的验证和确认 (V&V) 测试，符合 Good 生产规范 (GMP)，然后根据良好实验室规范进行临床前测试 （良好实验室规范）。我们的工程控制文件以及临床前测试数据和分析将用于支持 PAD 患者临床试验申请。我们的愿景是将 Aquilo HT 系统成功转化为 临床实践并改善 PAD 患者的预后。