The Bumps ad device for rapid non invasive quantification of touch sensation

描述（由申请人提供）：我们的提案描述了一种名为 Bumps 的优雅设备，它可以在低微米水平上量化手指上的触觉。目的是在周围神经病发作时诊断周围神经病，此时逆转的可能性最高，并在治疗期间监测神经病的进展或逆转。目标神经病变是与化疗和糖尿病相关的神经病变。如果及早诊断，这两种情况都有可能得到治疗。常见症状是麻木、疼痛、虚弱、出汗减少和血管功能受损。我们认为，与后来通过依赖神经变性影响进行诊断的测试发现相比，早期发现肿块接触功能受损提供了更好的机会来阻止或逆转神经病变。 Bumps 是一款看似简单、衣袋大小的设备，没有电源或移动部件，可以在几分钟内量化指腹的触摸。该设备是一个光滑的表面，被标记为几个正方形，很像棋盘。每个正方形包含五个彩色圆圈。每个正方形中的一个圆圈包含一个微小的颗粒（凹凸）。凸块的形状像薄薄的扁平圆柱体。受试者用指腹搜索正方形的 5 个圆圈，就像感觉皮肤或任何表面一样。任务是在正方形中找到一个包含凹凸的圆；依次探索每个方格。每个方块中的凹凸高度不同。当受试者找到肿块时，无需询问他们是否感觉到了。 定位凸块的要求使测试变得客观。当手指接触凸起时，指纹脊线会稍微扭曲，并激活沿着指纹脊线排列的底层迈斯纳小体 (MC) 触摸感受器。 MC 将感觉传递给大脑进行识别。由于没有时间限制，允许多次通过 5 个圆圈，从而提供了时间和空间求和的机会，而这是通过用冯弗雷单丝或探针接触皮肤来测量触觉的方法不可能实现的。在第一阶段，我们展示了该设备的可行性。第二阶段的目标是：1）测试健康受试者和神经病患者，并建立一个具有性别和年龄平均控制阈值的数据库。开发人员。以及供客户用作与患者结果进行比较的标准的截止值； 2) 在化疗期间经常对患者进行测试，以显示肿块的早期诊断能力和检测神经病变进展增量的能力； 3) 通过将 Bumps 结果与测试手指的反射共焦显微镜图像中计数的手指 MC 触摸受体的密度相关联来进一步验证； 4) 构建主模具来制造廉价的市场现成的凹凸器件。第二阶段的目标将通过与明尼苏达大学肯尼迪实验室 (KLAB) 签订合同来实现，并通过 KLAB 与其他三个主要机构的专家合作者将 Bumps 测试纳入其协议中，以扩大测试对象的数量。

DESCRIPTION (provided by applicant): Our proposal describes an elegant device called the Bumps that quantifies touch sensation on the fingers at low micron levels. The objectives are to diagnose peripheral neuropathy near its onset, when the possibility for reversal is highest, and to monitor either progression or reversal of neuropathy during treatment. Target neuropathies are those related to chemotherapy and diabetes. Both are potentially treatable if diagnosed early. Common symptoms are numbness, pain, weakness, decreased sweating and impaired vascular function. We propose that early discovery of functionally impaired touch with the Bumps provides a better chance to halt or reverse neuropathy than later discovery by tests that rely on the effects of nerve degeneration for diagnosis. The Bumps is a deceivingly simple, coat pocket size device without power or moving parts that quantifies touch of the fingerpad in a few minutes. The device is a smooth surface marked into several squares, much like a checkerboard. Each square contains five colored circles. One circle in each square contains a tiny particle (bump). Bumps are shaped like thin flattened cylinders. Subjects search the 5 circles of a square with the fingerpad much like feeling skin or any surface. The task is to find the one circle in the square that contains a bump; each square is explored in turn. Bump height is different in each square. When a subject locates a bump there is no need to ask if they felt it. This requirement to locate a bump makes the test objective. When the finger contacts a bump the fingerprint ridges become slightly distorted and activate underlying Meissner Corpuscles (MCs) touch receptors that are lined along the fingerprint ridges. The MCs relay sensation to the brain for recognition. The absence of a time restriction allows multiple passes over the 5 circles providing opportunity for temporal and spatial summation not possible with methods that measure tactile sense by touching skin with a von Frey monofilament or probe. In Phase I we demonstrated feasibility of the device. Phase II goals are: 1) to test healthy subjects and neuropathy patients and build a database with mean control thresholds for sex and age ¿ std. dev. and cutoff values for customers to use as standards to compare with results from their patients; 2) to test patients frequently during chemotherapy to show the Bumps ability for early diagnosis and for detecting increments of progression of neuropathy; 3) further validation by correlating Bumps results with the density of finger MCs touch receptors counted in reflectance confocal microscopy images of the tested finger; and 4) construction of a master mold to manufacture inexpensive market ready Bumps devices. Phase II goals will be accomplished by contract with the U of MN Kennedy laboratory (KLAB), and via KLAB with expert collaborators at three other major institutions to incorporate Bumps testing in their protocols to enlarge the number of subjects tested.