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

摘要 医疗需求：患有肺动脉高压并间质性肺疾病(PH-ILD)的患者 运动能力和生活质量明显受限，寿命严重缩短(2-5年) 除非他们能接受肺移植，但器官供不应求。涉及吸入的治疗 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NO是由大型、笨重的加压气瓶提供的，限制了这种救命疗法的使用。 医疗中心。 建议的解决方案：Third Pole的价值主张是提供轻便、紧凑、电池供电的 便携式、无罐电动NO发生器(3P-100)为在门诊治疗PH开辟了可能性 通过提供来自电力和空气的基本上无限的iNO供应，使包括资源匮乏地区在内的全球各地都能获得iNO。从空气中产生治疗浓度的NO的核心技术已经开发出来。3P-100设备将NO脉冲输送到鼻腔通道 早期灵感，以优化氧合。 具体目标：要求提供资金，以支持1)小型化和2)建立互联医疗保健 3P-100解决方案是患者易用性和吸引潜在投资者所需的关键要素。 目标1：将便携式3P-100的尺寸和重量降至最低：用户研究得出结论，3P-100设备 样机由现成组件组成，体积160英寸，重量3.5磅，电池3小时 对于24小时的家庭使用来说，生活和有限的携带配件是不可接受的，因为用户认为这是体力上的挑战，繁琐，并限制了他们的移动性。将体积减小到最大75英寸和重量 最大为2磅，将电池寿命提高到最少4小时，最好是8小时，并提供各种附件，包括AC/DC电源适配器，用于在设备 在家里或办公室插上电源将使用户能够保持独立于日常生活活动，并方便 出门远足，不用担心电池电量耗尽。 目标2：开发临床和研究信息学平台：这一目标将使iNO的使用模式成为可能 从3P-100设备结合商业化可穿戴设备收集的患者相关数据 产品，包括体力活动、血氧饱和度、心率和呼吸频率，将上载到 第三极基于云的存储库。这将允许临床医生、临床试验人员和第三极远程和 主动管理疾病，监测患者对iNO治疗的依从性，氧气使用情况，并分析 PH-ILD临床研究期间的安全性和有效性措施以及3P-100装置的性能。第三 POL将在3P-100设备中设计足够的硬件“数字主干”元件，以允许无线通信，以及管理数据并将其传输到中央-100设备所需的应用软件 基于云的资源库。

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.