Transdermal H2S Sensing Device for Monitoring Peripheral Artery Disease

用于监测外周动脉疾病的透皮 H2S 传感装置

• 批准号: 8643372
• 负责人: Nancy L Kanagy
• 金额: $ 21.57万
• 依托单位: EXHALIX, LLC
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-06 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8643372
• 关键词: Acute; Address; Advanced Development; Affect; Affinity; Age; Air; American; Animals; Arteriographies; Atherosclerosis; Bacteria; Biological Assay; Blood; Blood Circulation; Blood Vessels; Blood gas; Carbon Dioxide; Cardiovascular Physiology; Characteristics; Cholesterol; Chronic; Clinical Research; Collaborations; Color; Complication; Coronary; Dermal; Dermis; Detection; Development; Devices; Diabetes Mellitus; Diagnosis; Diagnostic; Diffusion; Disease; Doppler Ultrasound; Early Diagnosis; Early treatment; Electrodes; Engineering; Environment; Equipment; Evaluation; Exercise; Exhalation; Feasibility Studies; Gases; Goals; Gold; Government; Heating; High Pressure Liquid Chromatography; Human; Hydrogen Peroxide; Hydrogen Sulfide; Inflammation; Infusion procedures; Injury; Ischemia; Kidney; Kidney Diseases; Laboratory Animals; Laboratory Research; Lead; Limb structure; Location; Lower Extremity; Marketing; Mass Spectrum Analysis; Measurement; Measures; Metabolic syndrome; Metabolism; Methodology; Methods; Monitor; Mucous body substance; Muscle; Myocardial Infarction; Nephrology; New Mexico; Non-Invasive Cancer Detection; Paper; Patients; Performance; Peripheral arterial disease; Phase; Phase I Clinical Trials; Plasma; Price; Production; Protocols documentation; Reading; Recovery; Reporting; Research; Research Personnel; Resolution; Resources; Respiration; Respiratory System; Risk; Saliva; Sampling; Side; Simulate; Skin; Sleep Apnea Syndromes; Small Business Technology Transfer Research; Smoker; Sprague-Dawley Rats; Staging; Stenosis; Stroke; System; Techniques; Technology; Testing; Time; Tissues; Training; Universities; Validation; Vascular Diseases; Venous; artery occlusion; base; calcification; commercialization; diabetic; diabetic patient; disease diagnosis; experience; improved; innovation; instrument; interest; male; medical schools; meetings; monitoring device; phase 1 study; phase 2 study; prevent; product development; prototype; public health relevance; screening; sensor; success; user-friendly; vapor

Project Summary/Abstract The proposed effort addresses an unmet need for early diagnosis of peripheral artery disease (PAD). PAD is a disorder of vascular circulation that affects more than 8 million Americans, most of whom are unaware of its existence, risks, and threats. PAD is caused primarily by plaque-induced atherosclerosis and in some instances by blood vessel inflammation, stenosis, and injury to the limbs. It is a debilitating, underdiagnosed, undertreated, and poorly understood complication in many diseases including diabetes, sleep apnea and metabolic syndrome. Patients with PAD are 3 to 6 times more likely to have a heart attack or stroke than are patients without PAD. People with PAD have impaired function, including those who are asymptomatic, and experience a significant decline in lower-extremity functioning over time, often leading to critical limb ischemia (CLI), heart attack, and stroke. PAD is difficult to detect in the early stages, requires expensive equipment and trained technicians to diagnose and frequently goes undetected until irreversible tissue damage has occurred. This highlights the need for a simple, inexpensive screening method that can be used to routinely screen those at risk for PAD, including smokers, diabetics and patients with elevated plasma cholesterol. Recent observations indicate that plasma H2S levels are lowered by arterial occlusions and maintaining an adequate level of H2S can be beneficial for preventing atherosclerosis, improving recovery from muscle ischemia and in mitigating damage from myocardial infarction. There are currently few methods to accurately measure plasma H2S and all require specialized equipment, trained technicians and none is non-invasive. In, the proposed study, we intend to demonstrate the feasibility in development of an innovative non-invasive blood H2S measurement device and protocols based on gas-phase electrocatalysis of H2S molecules. In this STTR Phase I study, Exhalix will collaborate with the University of New Mexico, School of Medicine, to perform laboratory animal studies in which the plasma levels of intravenously administered H2S in male Sprague-Dawley rats will be compared to the readings from this diagnostic approach for validation. Plasma samples will be collected from venous lines for analysis in the HPLC-based assays, to determine the threshold, sensitivity and reproducability of the instrument readings. We anticipate that these studies will last approximately 12 months, and success in feasibility demonstration is expected to lead to a Phase II effort for development of an advanced prototype and human studies.

项目总结/摘要 这项提议的努力解决了外周动脉疾病（PAD）早期诊断的未满足需求。垫是一个 血管循环障碍，影响超过800万美国人，其中大多数人不知道其 存在、风险和威胁。PAD主要由斑块诱导的动脉粥样硬化引起，在某些情况下， 血管发炎、狭窄、四肢受伤。这是一种令人虚弱的，诊断不足的， 治疗不足，以及对许多疾病的并发症知之甚少，包括糖尿病，睡眠呼吸暂停和 代谢综合征PAD患者发生心脏病发作或中风的可能性是正常人的3至6倍。 无PAD的患者。PAD患者功能受损，包括无症状患者， 随着时间的推移，下肢功能显著下降，通常导致严重的肢体缺血 (CLI)心脏病和中风。PAD在早期阶段难以检测，需要昂贵的设备， 经过专业培训的技术人员进行诊断，但在发生不可逆转的组织损伤之前，往往无法检测到。 这突出了需要一种简单，廉价的筛选方法，可用于常规筛选那些 有PAD风险的患者，包括吸烟者、糖尿病患者和血浆胆固醇升高患者。最近的观察 表明血浆H2S水平因动脉闭塞而降低， 有益于预防动脉粥样硬化、改善肌肉缺血的恢复和减轻损伤 心肌梗塞的原因。目前，精确测量血浆H2S的方法很少，并且都需要 专业设备，训练有素的技术人员，没有一个是非侵入性的。在拟议的研究中，我们打算 证明开发创新的非侵入性血液H2S测量设备的可行性， 基于H2S分子的气相电催化的方案。在这项STTR I期研究中，Exhalix将 与新墨西哥州大学医学院合作，在以下地区进行实验室动物研究： 其中将雄性Sprague-Dawley大鼠中静脉内施用的H2S的血浆水平与 从这种诊断方法中读取数据进行验证。将从静脉管路中采集血浆样本， 在基于HPLC的分析中进行分析，以确定仪器的阈值、灵敏度和重现性 读数。我们预计这些研究将持续约12个月，并在可行性方面取得成功 预计演示将导致第二阶段的努力，发展先进的原型和人类 问题研究