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

描述（由申请人提供）：我们设计了一种新一代的高灵敏度方法来早期诊断周围神经病变，此时逆转的可能性最大。癌症化疗和糖尿病是美国神经病变的最常见原因。两者都会导致出汗减少、循环异常、外周麻木、疼痛和虚弱。如果早期诊断，两者都有可能治愈。不幸的是，功能的最小变化，即第一个信号即将发生的神经病变或对治疗的反应，逃脱了当前测试的检测。早期识别将提供一个更好的机会来治疗，停止或逆转神经病变比后发现显着的神经变性。我们的敏感汗液测试（SST）通过测量每个图像从> 200个个体SG中的每一个分泌的水的速率和体积来检测激活汗腺（SG）的催汗神经的早期功能障碍。SST的创新特点是在涂有碘的皮肤上放置涂有淀粉的Scotch（R）胶带。胶带迫使汗滴在一个扁平的扩展点中离心流动，通过汗液润湿的淀粉和碘的反应而形成浓密的黑色。黑点的扩张速率与SG的出汗速率成正比。斑点面积与来自相同SG的体积成比例。通过微型装置以1图像/秒对汗点成像90秒，计数并计算速率和体积。每个SG似乎都有自己的特征性分泌速率。在单个腺体水平的分泌功能障碍是比总水/皮肤面积的当前QSART测量更早的开始神经病变的指标。SST似乎能够测量神经病变的进展，并通过记录单个SG的出汗率和出汗量的微小增量变化来记录恢复程度。SST可以使神经病变的诊断和评估更快，更方便，更便宜。第一阶段非常成功。我们构建了一个紧凑的，计算机鼠标大小的，敏感的设备，我们用来测试控制和糖尿病和化疗神经病变的患者。汗点计数、分布、个体SG率和水分泌量与足和小腿严重神经病变相关。在第二阶段，我们将构建一个市场上准备好的设备，它是方便的，负担得起的，手持的，易于在医疗诊所，床边或在家里使用。我们将从大量的健康人和测试患者CIPN，糖尿病神经病变和其他神经病变的MN和三个合作机构的控制值。商业化将与WR Co Inc.合作。一家销售其他医疗器械的MN医疗器械公司。

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.