A point-of-care device for generating nitric oxide for inhalation

一种用于产生吸入一氧化氮的护理点设备

• 批准号: 8124256
• 负责人: Robert L. Whalen
• 金额: $ 15.24万
• 依托单位: WHALEN BIOMEDICAL, INC
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-03-15 至 2012-03-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8124256
• 关键词: Africa South of the Sahara; Age; Air; Anesthesia procedures; Animal Testing; Animals; Boston; Breathing; Cessation of life; Chemicals; Child; Clinical; Clinical Trials; Country; Critical Care; Developed Countries; Developing Countries; Development; Device Designs; Devices; Disease; Electrodes; Energy-Generating Resources; Environmental Risk Factor; Equipment; Evaluation; Extracorporeal Membrane Oxygenation; Gases; General Hospitals; Goals; Hypoxia; Inhalation Therapy; International; Laboratories; Lead; Life; Malaria; Mass Spectrum Analysis; Massachusetts; Measurement; Mechanics; Medical; Methods; Modeling; Mus; Newborn Infant; Nitric Oxide; Nitrogen; Output; Oxygen; Patients; Performance; Pharmaceutical Preparations; Pharmacotherapy; Physiology; Plasmodium berghei; Power Sources; Publishing; Pulmonary Hypertension; Pump; Research; Residual state; Resources; Safety; Series; Staging; System; Testing; Time; Universities; World Health; base; commercialization; cost; cost effective; design; experience; inhaled nitric oxide; instrumentation; meetings; performance tests; point of care; pollutant; prevent; programs; prototype; research study; tool; voltage

DESCRIPTION (provided by applicant): Nitric oxide (NO) gas was considered to be a highly toxic pollutant as recently as the 1980s. It is now recognized to be an important messenger molecule in mammalian physiology. Inhaled NO is currently used to treat approximately 25,000 patients per year in this country with pulmonary hypertension. It is safe, effective, but costly. Published studies in which the per patient acquisition cost for bottled NO gas was over $5,000 suggest that even at that cost level, inhaled NO remains cost-effective compared with alternative, more invasive therapies such as extracorporeal membrane oxygenation. We are proposing to develop and test a compact point-of-care device that will generate unlimited quantities of NO gas at clinically useful concentrations from room air using a low-power electrical energy source. The device has the potential to eliminate cost as a factor in the utilization of NO inhalation therapy. In the proposed program, mass spectroscopy will be employed to characterize and optimize the output of the device. Its performance, mechanical endurance, and electrical safety also will be examined. We will then test its efficacy experimentally for a new and emerging application of NO for inhalation that we believe represents a rapid path to commercialization. As an adjunct in the treatment of malaria, NO inhalation appears to significantly prolong survival in experimental studies of severe malaria. While effective drug therapy for malaria exists, the disease is often in an advanced stage before therapy is begun, and many patients die before the drugs can take effect. Extending their survival with NO inhalation has the potential to be a means for salvaging a significant number of those patients. We will demonstrate that electrically-generated NO from the device is able to similarly prolong survival using a well-established murine model of severe malaria. Almost a million children under the age of 5 die each year from malaria in sub-Saharan Africa alone. In those regions where malaria is endemic, the limited available resources make it unlikely that NO inhalation using bottled gas is feasible. The proposed device may offer clinicians in under-developed countries a new tool for dealing with this major world health problem. Ultimately, we believe the device will also be employed for NO inhalation therapy for pulmonary hypertension in developed countries by virtue of the cost reduction it offers compared with using bottled gas. PUBLIC HEALTH RELEVANCE: The objective of this program is the development and evaluation of a point-of-care device to produce nitric oxide (NO) for inhalation from atmospheric nitrogen and oxygen. Presently used primarily as a life-saving therapy for treating newborns with hypoxia, NO inhalation also has the potential to be an important adjunct in the treatment of severe malaria, a disease that results in the death of an estimated 700,000 to 900,000 children under the age of five annually in sub-Saharan Africa alone.

描述（由申请人提供）：一氧化氮（NO）气体在20世纪80年代被认为是一种剧毒污染物。现在被认为是哺乳动物生理学中重要的信使分子。吸入NO目前在这个国家每年用于治疗约25，000名患有肺动脉高压的患者。它是安全的，有效的，但昂贵的。已发表的研究表明，瓶装NO气体的每位患者购买成本超过5，000美元，即使在该成本水平下，与替代的更具侵入性的治疗（如体外膜氧合）相比，吸入NO仍然具有成本效益。我们建议开发和测试一种紧凑的床旁设备，该设备将使用低功率电源从室内空气中产生无限量的临床有用浓度的NO气体。该装置有可能消除作为NO吸入治疗利用的一个因素的成本。在拟议的计划中，质谱将被用来表征和优化设备的输出。它的性能，机械耐久性和电气安全性也将被检查。然后，我们将通过实验测试其有效性，用于一种新的和新兴的NO吸入应用，我们认为这是一条快速商业化的道路。作为疟疾治疗的辅助手段，在重症疟疾的实验研究中，吸入NO似乎可显著延长存活期。虽然存在有效的疟疾药物疗法，但在开始治疗之前，这种疾病往往已处于晚期，许多患者在药物发挥作用之前死亡。用NO吸入延长他们的生存期有可能成为挽救大量这些患者的一种手段。我们将证明，从该设备的电产生的NO是能够类似地延长生存使用一个完善的严重疟疾小鼠模型。仅在撒哈拉以南非洲，每年就有近100万5岁以下儿童死于疟疾。在疟疾流行的地区，有限的可用资源使得使用瓶装气体吸入NO不太可行。拟议中的设备可能为欠发达国家的临床医生提供一种新的工具来处理这一重大的世界健康问题。最终，我们相信该装置也将用于发达国家肺动脉高压的NO吸入治疗，因为与使用瓶装气体相比，它提供了成本降低。 公共卫生相关性：该项目的目的是开发和评价一种即时装置，用于从大气中的氮气和氧气中产生一氧化氮（NO）用于吸入。目前主要用作治疗新生儿缺氧的救生疗法，吸入NO也有可能成为治疗严重疟疾的重要辅助手段，仅在撒哈拉以南非洲，这种疾病每年就导致约70万至90万名五岁以下儿童死亡。