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.

本提案的目的是开发一种新型器械，为以下患者提供腿部热疗（HT）： 症状性外周动脉疾病（PAD）。目前PAD的非干预性标准治疗是12 监督运动疗法（SET）。对于病人来说，这往往是非常痛苦的，因为他们行使 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未经治疗。最近HT被证明是一种 有希望的治疗PAD患者的疗法。最近的一项研究表明，8周的家庭HT疗程 既安全又有效-步行性能的改善与SET相似。家庭HT也被发现， 舒适性和依从性是治疗方案非常高。目前，没有一个系统 尽管HT可能被证明是PAD的最佳治疗方法， 患者，因为它可以舒适地在家中进行。Aquilo多学科开发团队 实现临床翻译和商业化目标的专业知识、经验和信心 具有竞争力的先进技术，安全有效地治疗PAD，这将导致治疗的改进 对于PAD患者。 专有的Aquilo HT系统（美国专利申请号63/215，129）由两个主要部件组成， 件.第一部件是可穿戴的下身服装，其具有外壳，该外壳通过与第一部件的第二部件的第一部件的第二部件的第三部件的第四部件的第四部件的第五部件的第六部件的第七部件的第七部件的 一个拉链和房屋6气动室。衣服里面是一个水循环垫，以提供HT。 温度调节器被附接到每个人的小腿和大腿区域中的水循环垫。 法例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 第一个是水，第二个是将空气泵入气动室，以保持垫与腿温和接触。 控制台配有触摸屏，老年PAD患者可进行简单的一键式全方位治疗操作。许多 重要的安全特性被编程，包括声音和视觉警报以及系统关闭，如果腿 温度过高、扭结检测和低水位警告。控制台还将包括一个数据 收集系统先前研究的严谨性通过原型设备的开发和 概念测试，以确定设计规范，评估功能和性能，并确定工程 挑战并制定新的Aquilo HT系统的解决方案。 在第一阶段项目中，我们将（1）完成Aquilo HT系统的制造，并确认 设计规范（目标1）;（2）在一个小的患者队列中证明系统的安全性和功能， 12周治疗期（目标2）。Aquilo HT系统可行性的成功演示将包括： (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（不 皮肤损伤或皮肤烧伤）和器械可靠性（目的2）。总的来说， 在成功证明符合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，完成验证和确认（V&V）测试， 生产规范（GMP），然后按照药物非临床研究质量管理规范进行临床前试验 （GLP）。我们的工程控制文件和临床前试验数据和分析将用于支持 PAD患者临床试验的申请。我们的愿景是成功地将Aquilo HT系统转化为 临床实践和改善PAD患者的结局。