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

描述(申请人提供)：我们设计了一种新一代的、高灵敏度的方法来早期诊断周围神经病，当逆转的可能性最大时。癌症化疗和糖尿病是美国最常见的神经病原因。两者都会导致出汗减少、血液循环异常、外周麻木、疼痛和虚弱。如果及早诊断，这两种疾病都有可能治愈。不幸的是，功能上的最小变化，即第一个发出即将到来的神经病变或治疗反应的信号，没有被目前的测试检测到。与在重大神经变性后发现早期发现相比，及早发现将为治疗、阻止或逆转神经病提供更好的机会。我们的敏感汗液测试(SST)通过测量每个图像200个汗腺(SGS)分泌的水分的速率和体积，检测激活汗腺(SGS)的运动神经早期功能障碍。SST的创新特征是在涂有碘的皮肤上放置了涂有淀粉的苏格兰威士忌(R)胶带。胶带迫使汗滴在一个扁平的膨胀点上离心式流动，由于汗水浸湿的淀粉和碘的反应，这个点变成了浓密的黑色。黑点的扩张率与该SG的出汗率成正比。光斑面积与同一SG的体积成正比。用微型设备以每秒1张图像的速度对汗点进行成像，持续90秒，计数并计算出血率和出血量。每个SG似乎都有其特有的分泌率。与目前QSART测量总水/皮肤面积相比，单腺体水平的分泌功能障碍是开始神经病变的更早的指标。SST似乎能够测量神经病变的进展，并通过记录单个SGS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、计算机鼠标大小的灵敏设备，用于测试对照组和患有糖尿病和化疗的神经病变患者。汗斑的数量、分布、个体SG率和分泌量与足部和小腿的严重神经病变相关。在第二阶段，我们将建造一种方便、负担得起的、手持的、易于在医疗诊所、床边或家中使用的设备。我们将从大量健康人和MN的CIPN、糖尿病神经病变和其他神经病变患者以及三家合作机构获得控制值。商业化将与WR公司合作，该公司是一家销售其他医疗设备的MN医疗设备公司。

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.