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.

这项建议的目的是开发一种新的设备，以提供腿部热疗(HT)的患者 症状性外周动脉疾病(PAD)。目前PAD的非介入治疗标准为12级。 督导运动疗法周计划(SET)。对于病人来说，这通常是非常痛苦的，因为他们正在锻炼 到了跛行的地步，许多老年患者发现很难或不可能反复前往 治疗设施。因此，这些患者中的大多数仍然没有得到治疗。最近，HT被证明是一种 治疗PAD患者的前景看好。最近的一项研究表明，8周的家庭热疗疗程是 既安全又有效-步行能力的改善与SET相似。家庭HT也被发现 舒适度和依从性是治疗方案非常高的。目前，还没有一种制度 尽管羟色胺可能被证明是治疗PAD的最佳疗法，但它仍可用于商业治疗 因为它可以在家中舒适地交付给患者。Aquilo多学科开发团队已经 专业知识、经验和信心，以实现我们的临床翻译和商业化目标 一种具有竞争力的先进技术来安全有效地治疗PAD，这将导致改进的治疗 对于PAD患者。 专有的Aquilo HT系统(美国专利申请号63/215,129)由两个主要部件组成 组件。第一个部件是一种可穿戴的下身服装，它的外壳与 一条拉链和6个气动室。在衣服内部是一个循环水垫，以提供高温。 温度热敏电阻安装在小腿和大腿部位的水循环垫上。 腿。第二个组件是控制台。控制台内有一个加热器和两个泵--一个用于循环加热 一个是水，另一个是向气动室泵入空气，使垫子与腿部保持温和接触。 该游戏机具有触摸屏，可供老年PAD患者进行简单的一键全面治疗操作。许多 对重要的安全功能进行了编程，包括声音和视觉警报，以及在腿部发生故障时关闭系统 温度过高，检测到扭结和低水位警告。该控制台还将包括一个数据 收集系统。之前研究的严谨性通过开发原型设备和证明 概念测试以定义设计规范，评估功能和性能，并确定工程 为新的Aquilo HT系统提出挑战并制定解决方案。 在这个第一阶段项目中，我们将(1)完成Aquilo HT系统的制造，并确认取得的成就 设计规范(目标1)；(2)在一小群患者中演示系统的安全性和功能 12周为一个疗程(目标2)。成功演示Aquilo HT系统的可行性将包括： (1)达到设计规格、功能和性能指标(目标1)，以及(2)证明安全(否 在6名PAD患者(目标2)的12周治疗中，PAD患者的皮肤损伤或皮肤烧伤)和设备的可靠性。总而言之， 在成功示范达到设计基准和研究指标(第一阶段)后，我们将致力于 实现符合Good的设计冻结、完全验证和确认(V&V)测试 生产规范(GMP)，然后按照良好的实验室规范进行临床前测试 (GLP)。我们的工程控制文档和临床前测试数据和分析将用于支持 在PAD患者中进行临床试验的申请。我们的愿景是成功地将Aquilo HT系统转化为 临床实践，改善PAD患者的预后。