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

摘要 医疗需求：肺动脉高压伴间质性肺病（PH-ILD）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--但器官供应短缺。涉及吸入 选择性肺血管扩张剂一氧化氮可以治疗这样的患者，但不幸的是，目前NO是由大的、笨重的、加压的气瓶提供的，限制了对这种挽救生命的治疗的主要使用。 医疗中心。 建议的解决方案：Third Pole的价值主张是提供一种轻便、紧凑、电池供电的 便携式，无罐电动NO发生器（3P-100），以开辟治疗PH的可能性， 通过提供来自电力和空气的基本上无限量的iNO供应，实现全球接入，包括资源贫乏地区。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装置将在鼻通道中递送NO脉冲， 早期吸气以优化氧合。 具体目标：要求提供资金以支持1）小型化和2）创建连接的医疗保健 3P-100的解决方案，患者易于使用和吸引潜在投资者所需的关键要素。 目标1：最大限度减小便携式3P-100的尺寸和重量：用户研究得出结论，3P-100器械 原型，由现成的组件组成，体积为160英寸，重量为3.5磅，3小时的电池 寿命和有限的携带附件对于24小时的家庭使用是不可接受的，因为用户认为这是身体上的挑战、笨重并且限制了他们的移动性。将体积和重量减少到最大75英寸 至最大2磅，将电池寿命延长至最少4小时，最好是8小时，并提供各种配件，包括AC/DC电源适配器，用于在以下情况下保持设备供电 在家里或办公室插入将使用户能够保持独立的日常生活活动， 外出旅行而不用担心电池电量耗尽。 目标2：为临床和研究信息学开发一个平台：该目标将启用iNO使用模式 来自3P-100设备的数据与通过市售可穿戴设备收集的患者相关数据相结合 产品，包括身体活动，氧饱和度，心率和呼吸率上传到一个 Third Pole基于云的存储库。这将允许临床医生，临床试验工作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指标以及3P-100器械性能。三 Pole将在3P-100设备中设计足够的硬件"数字骨干"元件，以允许无线通信，并提供管理数据并将其传输到中央处理器所需的应用软件。 基于云的存储库。

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.