SBIR Phase I: Handheld Portable Impulse Oscillometer

SBIR 第一阶段：手持式便携式脉冲示波器

• 批准号: 1913507
• 负责人: Michael Wolfe
• 金额: $ 22.29万
• 依托单位: Medical Innovation Through Technology, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-01 至 2020-02-29
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1913507&HistoricalAwards=false
• 关键词: SBIR; Phase; Handheld; Portable; Impulse

The broader impact/commercial of this Small Business Innovation Research (SBIR)Phase I project directly addresses the scope of Asthma in the United States. Respiratory specialists say they are in a quandary in their attempts to obtain definitive diagnoses of lung diseases because they lack a reliable pulmonary functions test device that can be used on all patients and have a high degree of accuracy. Spirometry has a long list of shortcomings that are well known, and the specialists are asking for a better device. A growing body of international research, that includes ten plus years of NIH studies, is showing that impulse oscillometry is the most accurate PFT for respiratory diseases and that it can often worsening lung status several days before symptoms appear. The overall costs of asthma alone in the U.S. are estimated to be approximately $56 billion a year. Much of this is attributed to the fact that maintaining asthma control in a patient is difficult to do without frequent objective measurement. Losing control leads to increased asthma exacerbations, ER visits, hospitalizations, lost work and school days, and higher medical costs. Having an easy to use and clinically accurate pulmonary functions test device is the key element in this process. This Small Business Innovation Research (SBIR) Phase I project has a revolutionary design that incorporates the advanced technology of impulse oscillometry into a handheld and cost effective medical device that fulfills the lung measurement requirements requested by respiratory specialists during our customer discovery process. The core of IOS methodology is that gentle impulses of air are pulsed into the lungs of a patient via their normal tidal breathing. The low frequency impulses pass through the central lungs, travel throughout the peripheral lungs (resistance) and rebound back to the IOS device (reactance). The differences between the resistance and reactance pressures are then measured and analyzed, revealing the extent of the obstruction in the peripheral airways. Test data from each device is automatically sent to a secure cloud server where it is analyzed and compared to other demographically similar patients. The analyzed results are then transmitted to a proprietary application on the patient's smartphone, the caregiver's smartphone, and to the patient's primary care manager electronic medical record. The home version of the device will allow objectively measured pulmonary status to be remotely and frequently measured, and automatically sent to the provider. This is the breakthrough that the Asthma community has long needed.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业直接解决了哮喘在美国的范围。呼吸专家表示，他们在试图获得肺部疾病的明确诊断方面陷入了两难境地，因为他们缺乏可靠的肺功能测试设备，可以用于所有患者，并且具有高度的准确性。肺活量测定仪有一长串众所周知的缺点，专家们正在要求一种更好的设备。越来越多的国际研究，包括美国国立卫生研究院十多年的研究，表明脉冲振荡法是呼吸系统疾病最准确的PFT，而且它通常会在症状出现前几天恶化肺部状况。据估计，仅在美国，哮喘每年的总成本就约为560亿美元。这在很大程度上归因于这样一个事实，即如果没有频繁的客观测量，很难维持患者的哮喘控制。失去控制会导致哮喘加重、急诊室就诊、住院、失去工作和上学天数以及更高的医疗费用。在这一过程中，拥有一台使用方便、临床准确的肺功能测试设备是关键。这个小型企业创新研究(SBIR)第一阶段项目具有革命性的设计，将先进的脉冲振荡器技术整合到一种具有成本效益的手持医疗设备中，满足了呼吸专家在客户发现过程中要求的肺部测量要求。IOS方法的核心是，通过患者正常的潮气呼吸，温和的空气脉冲进入患者的肺部。低频脉冲通过中央肺，穿过外围肺(阻力)，然后反弹回iOS设备(电抗)。然后测量和分析阻力和电抗压力之间的差异，揭示周围呼吸道的阻塞程度。来自每台设备的测试数据将自动发送到安全的云服务器，在那里进行分析并与其他人口统计相似的患者进行比较。然后，分析结果被传输到患者智能手机上的专有应用程序，护理者的智能手机，以及患者的初级保健经理的电子医疗记录。该设备的家庭版本将允许远程和频繁地测量客观测量的肺状态，并自动发送到提供商。这是哮喘界长期以来一直需要的突破。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。