Portable electrical nitric oxide generator for treatment of pulmonary hypertension accompanying interstitial lung disease

便携式电动一氧化氮发生器治疗肺动脉高压伴间质性肺疾病

基本信息

批准号：
10491114
负责人：
Greg Hall
金额：
$ 79.23万
依托单位：
THIRD POLE, INC.
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-08-15 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10491114
关键词：
Activities of Daily Living Air Breathing Cessation of life Charge Clinic Visits Clinical Data Clinical Research Clinical Trials Communities Computer software Cost of Illness Data Detection Development Device or Instrument Development Devices Diagnosis Disease Disease Management Dose Electricity Elements Environment Funding Gases Health Care Costs Healthcare Heart Rate Home Hospitalization Hospitals Hour Human Resources Impairment Individual Informatics Inhalation Interstitial Lung Diseases Libraries Life Longevity Lung Lung Transplantation Measures Medical Medical Device Medical center Miniaturization Nitric Oxide Nose Organ Donor Organ Transplantation Oxygen Partner in relationship Patient Care Patient Monitoring Patient-Focused Outcomes Patients Pattern Performance Physical activity Physiologic pulse Physiological Plug-in Procedures Progressive Disease Pulmonary Hypertension Quality of life Recurrence Research Resource-limited setting Running Safety Savings Serious Adverse Event Shortness of Breath Source Survival Rate System Technology Testing Therapeutic United States Vasodilation Vasodilator Agents Vertebral column Weight cloud based compliance behavior connected care data exchange data management design digital effective therapy exercise capacity health related quality of life improved inhaled nitric oxide light weight patient prognosis portability pressure prevent product development prototype pulmonary arterial hypertension pulmonary function remote monitoring repository respiratory right ventricular failure therapy duration usability web portal wireless communication

项目摘要

ABSTRACT Medical Need: Patients with pulmonary hypertension accompanying interstitial lung disease (PH-ILD) are markedly limited in their exercise capacity and quality of life and have a severely reduced lifespan (2-5 years) unless they can receive a lung transplant - but organs are in short supply. Treatment involving inhalation of the selective pulmonary vasodilator nitric oxide could treat such patients but, unfortunately, NO is currently provided from large, cumbersome, pressurized gas cylinders, restricting access to this life saving therapy to major medical centers. Proposed Solution: Third Pole’s value proposition is provision of a lightweight, compact, battery-powered portable, tank-less electrical NO generator (3P-100) to open up the possibility of treating PH in ambulatory settings by providing an essentially unlimited supply of iNO sourced from electricity and air enabling global access including resource-poor areas. The core technology for generating NO from air at therapeutic concentrations has been developed. The 3P-100 device will deliver pulses of NO into the nasal passages timed with early inspiration to optimize oxygenation. Specific Aims: Funding is requested to support 1) miniaturization and 2) creation of a connected healthcare solution of 3P-100, critical elements needed for ease of use by the patient and to attract potential investors. Aim 1: Minimize size and weight of the portable 3P-100: User research concluded that the 3P-100 device prototype, comprised of off-the-shelf components, with volume of 160 in, weight of 3.5 lbs., 3 hours of battery life, and limited carrying accessories is unacceptable for 24 hour home use, as users perceived it to be physically challenging, cumbersome, and limiting their mobility. Reducing volume to a maximum of 75 in and weight to maximum of 2 lbs., increasing battery life to a minimum of 4 hours, preferably to 8 hours, and offering a diverse range of accessories including an AC/DC power adapter with which to keep the device powered when plugged in at home or office will enable users to remain independent with activities of daily living and facilitate excursions outside of the home without concerns of running out of battery charge. Aim 2: Develop a platform for clinical and research informatics: This aim will enable iNO usage patterns from the 3P-100 device combined with patient-related data to be collected by commercially available wearable products, including physical activity, Oxygen saturation, heart rate and respiratory rate to be uploaded into a Third Pole cloud based repository. This will allow clinicians, clinical trial staff, and Third Pole to remotely and proactively manage the disease, monitor patient’s adherence to iNO therapy, oxygen usage, and analyze safety and efficacy measures as well as 3P-100 device performance during the PH-ILD clinical study. Third Pole will design sufficient hardware “digital backbone” elements into the 3P-100 device to allow wireless communication, with the required application software needed to manage the data and transfer it into the central- ized cloud-based repository.

抽象的医疗需求：患有肺动脉高压的患者涉及间质肺疾病（pH-dild）是其运动能力和生活质量明显限制，其寿命严重降低（2 - 5年）除非他们可以接受肺移植 - 但器官供应不足。处理涉及吸入选择性肺血管扩张剂一氧化氮可以治疗此类患者，但不幸的是，目前没有来自大型，繁琐的加压气缸，从而限制了对这种挽救生命的疗法的机会医疗中心。建议的解决方案：第三极的价值提议是提供轻巧，紧凑，电池供电的便携式，无罐电气无发电机（3P-100），以打开卧床治疗pH的可能性通过提供从电力和空气中提供的INO的基本无限供应，从而使全球访问包括资源贫乏地区。已经开发了用于治疗浓度的空气NO的核心技术。 3P-100设备将输送NO的脉冲到定时的鼻腔通道优化氧合的早期灵感。具体目的：要求资金支持1）小型化和2）创建互联医疗保健解决3P-100的解决方案，即易于使用并吸引潜在投资者所需的关键要素。目标1：最小化便携式3P-100的尺寸和重量：用户研究得出的结论是3P-100设备原型，由现成的组件组成，体积为160英寸，重量为3.5磅，电池3小时对于24小时的家庭使用，生活和有限的携带配件是不可接受的，因为用户认为它在身体上具有挑战性，繁琐和限制其移动性。将体积最多减少到75英寸和重量最大至2磅，将电池寿命提高到至少4小时，最好是8小时，并提供潜水员的配件范围，包括AC/DC功率适配器插入家中或办公室将使用户能够独立于日常生活的活动并促进不用担心电池充电的地方在房屋外面进行游览。目标2：为临床和研究信息开发一个平台：此目标将启用INO使用模式从3P-100设备以及与患者相关的数据结合使用，可通过市售可穿戴产品，包括体育锻炼，氧气满意度，心率和呼吸速度基于第三极云的存储库。这将允许临床医生，临床试验人员和第三杆远程主动管理该疾病，监测患者对INO治疗，用氧的遵守和分析在pH值临床研究中，安全性和有效性措施以及3P-100的设备性能。第三 POL将在3P-100设备中设计足够的硬件“数字骨干”元素，以允许无线通信，并需要使用所需的应用程序软件来管理数据并将其传输到中央基于云的存储库。