A Device to Quantify Sweat of Single Sweat Glands to Diagnose Neuropathy

一种量化单个汗腺汗液以诊断神经病变的装置

基本信息

批准号：
8922071
负责人：
WILLIAM R KENNEDY
金额：
$ 84.73万
依托单位：
NEURO DEVICES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-04-01 至 2018-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8922071
关键词：
Area Biopsy Blood Circulation Breast Characteristics Chemotherapy-Oncologic Procedure Chemotherapy-induced peripheral neuropathy Clinic Clinical Colon Computer software Computers Contracts Databases Denervation Detection Devices Diabetes Mellitus Diabetic Neuropathies Diagnosis Drops Early Diagnosis Etiology Evaluation Evolution Feasibility Studies Functional disorder Generations Gland Goals Hand Health Home environment Image Individual Institution Iodine Iontophoresis Laboratory Research Lead Learning Marketing Measurement Measures Medical Medical Device Methods Mus Nerve Nerve Degeneration Neuropathy Normal Range Numbness Pain Patients Pattern Peripheral Peripheral Nervous System Diseases Persons Phase Physicians Probability Protective Agents Reaction Recovery Running Sensory Severities Signal Transduction Skin Spottings Staging Starch Sweat Sweat Glands Sweat test Sweating Symptoms Testing Time Translating Water chemotherapeutic agent chemotherapy commercialization cost effective density diabetic diagnosis evaluation experience expiration foot healthy volunteer improved innovation instrument miniaturize nanolitre novel prototype rectal response success

项目摘要

DESCRIPTION (provided by applicant): We devised a new generation, highly sensitivity method to diagnosis peripheral neuropathy early, when the probability for reversal is greatest. Cancer chemotherapy and diabetes are the most common causes of neuropathy in the USA. Both cause decreased sweating, abnormal circulation, peripheral numbness, pain and weakness. If diagnosed early, both are potentially treatable. Unfortunately, the minimal changes in function, that first signal impending neuropathy or response to treatment, escape detection by current tests. Early recognition would provide a better opportunity to treat, halt or reverse neuropathy than later discovery after significant nerve degeneration. Our sensitive sweat test (SST) detects early dysfunction of sudomotor nerves that activate sweat glands (SGs) by measuring the rate and volume of water secreted from each of > 200 individual SGs per image. The innovative feature of the SST was placement of starch-coated Scotch(R) tape on the iodine-coated skin. Tape forces the sweat droplets to flow centrifugally in a flat expanding spot made densely black by reaction of the sweat-wetted starch and iodine. The rate of expansion of the black spot is proportional to the sweat rate of that SG. Spot area is proportional to volume from the same SG. The sweat spots are imaged by miniature device at 1 image/sec for 90 seconds, counted and rates and volumes calculated. Each SG appears to have its own characteristic secretion rate. Dysfunction of secretion at the level of the single gland is an earler indicator of beginning neuropathy than the current QSART measure of total water/skin area. The SST appears capable of measuring progression of neuropathy and potential to record degrees of recovery by recording small incremental changes of sweat rate and volume from single SGs. The SST can make diagnosis and evaluation of neuropathy faster, more convenient and less expensive. Phase I has been highly successful. We constructed a compact, computer mouse size, sensitive device that we used to test controls and patients with diabetic and chemotherapy neuropathy. Sweat spot counts, their distribution, and individual SG rate and volume of water secreted correlated with severe neuropathy on the foot and calf. In Phase II we will construct a market-ready device that is convenient, affordable, hand held and easily used in medical clinics, at the bedside or in the home. We will obtain control values from large numbers of healthy persons and test patients with CIPN, diabetic neuropathy and other neuropathies in MN and from three collaborating institutions. Commercialization will be in partnership with the WR Co Inc. a MN medical device company that markets other medical devices.

描述（由申请人提供）：当逆转的可能性最大时，我们设计了一种新一代，高度敏感的方法来诊断周围神经病。癌症化学疗法和糖尿病是美国神经病最常见的原因。两者都会导致出汗，循环异常，周围麻木，疼痛和无力减少。如果早点诊断，两者都是可以治疗的。不幸的是，功能的最小变化，第一个信号即将来临的神经病或对治疗的反应，通过当前测试逃脱检测。早期识别将为治疗，停止或反向神经病提供更好的机会，而神经变性后后来的发现。我们的敏感汗液测试（SST）通过测量每个图像中> 200个单独的SGS中分泌的水的速率和水量，检测出激活汗腺（SGS）的Sudomotor神经的早期功能障碍。 SST的创新特征是将淀粉涂层的苏格兰胶带放置在碘涂层的皮肤上。胶带迫使汗液在平坦的膨胀点中以汗水润湿的淀粉和碘反应而浓密地离心。黑点的膨胀率与该SG的汗水速率成正比。现场区域与同一SG的体积成正比。通过微型设备在1图像/秒内将汗水斑点成像，持续90秒，计算速率和体积。每个SG似乎都有其自身的特征分泌率。与当前的总水/皮肤面积的QSART度量相比，单腺水平的分泌功能障碍是开始神经病的核心指标。 SST似乎能够测量神经病的进展，并通过记录单个SGS的汗液率和体积的微小变化来记录恢复度的潜力。 SST可以使神经病的诊断和评估更快，更方便，更便宜。第一阶段一直很成功。我们构建了一种紧凑的计算机小鼠大小，敏感的装置，用于测试对照和糖尿病和化学疗法神经病的患者。汗水点数，它们的分布以及单个SG率和分泌的水量与脚和小腿上的严重神经病相关。在第二阶段，我们将构建一种可提供市场就绪的设备，该设备在医疗诊所，床边或家中易于使用，可轻松使用并易于使用。我们将从大量健康的人中获得控制值，并测试MN中有CIPN，糖尿病神经病和其他神经病的患者以及三个合作机构。商业化将与WR Co Inc.合作，一家MN医疗设备公司，该公司销售其他医疗设备。