The Bumps: A Device for Rapid, Non-Invasive Quantification of Touch Sensation

The Bumps：一种快速、非侵入性量化触觉的设备

• 批准号: 9913601
• 负责人: WILLIAM R KENNEDY
• 金额: $ 84.68万
• 依托单位: NEURO DEVICES, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9913601
• 关键词: Address; Adult; Age; Auditory; Biopsy; Boston; Caliber; Cancer Center; Chemotherapy-induced peripheral neuropathy; Clinics and Hospitals; Coin; Color; Data; Databases; Deposition; Detection; Devices; Diabetes Mellitus; Diabetic Neuropathies; Diagnosis; Dimensions; Disease; Early Diagnosis; Fingers; General Hospitals; Generations; Glass; Goals; Grant; Hand; Height; Human; Illinois; Institution; Instruction; Location; Marketing; Massachusetts; Measures; Medical Device; Meissners Corpuscle; Methods; Minnesota; Molds; Monitor; Motor; Nerve Degeneration; Neuropathy; Patients; Peripheral Nervous System Diseases; Persons; Pharmacologic Substance; Phase; Price; Provider; Secondary to; Sensitivity and Specificity; Sensory; Severities; Skin; Standardization; Stimulus; Structure; Stuttering; Surface; Tactile; Techniques; Technology; Testing; Thick; Touch sensation; Universities; Validation; Visual; Work; afferent nerve; chemotherapy; cohort; commercialization; density; design; distraction; effectiveness evaluation; functional disability; health care settings; improved; indexing; member; nano; nanometer; nervous system disorder; novel; particle; phase 2 testing; prototype; receptor; reflectance confocal microscopy; response; sensory input; sex; touchpad

The Bumps: A Device for Rapid, Non-Invasive Quantification of Touch Sensation Abstract ! Our proposal describes an elegant device called the Bumps that quantifies finger pad touch sensation 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. Early discovery of functionally impaired touch 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 finger pad touch in 5-7 minutes. The device is a smooth surface marked into checkerboard-like squares. Each square contains five colored circles. One circle in each square contains a tiny coin-shaped particle (a bump). Subjects search the circles of each square with the finger pad in search of the one circle that contains a bump. Bump height is different in each square. The test is objective because the subject must locate a bump from among several possible locations. The unique feature of the Bumps is that the subject continuously uses the very motor and sensory nerves suspected of being neuropathic to control the search with the finger pad and monitor the sensory input. Other tests of touch sensation are subjective. For example, an examiner touches the skin with a von Frey monofilament or probe, then asks the subject if they felt the probe, yes or no, felt or not felt. In Phase I, we demonstrated feasibility of the device. In Phase II, we tested healthy control subjects and subjects with peripheral neuropathy with the original device to start 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. At the onset of Phase II, we worked with four different companies each using their special techniques as they attempted (unsuccessfully) to construct a Bumps device with the precision required at nanometer levels. After an extensive search, we found 10X Technology LLC, an Illinois company that is capable of constructing a master mold that will be used in Phase IIB to produce the final Bumps product in larger quantities at a reasonable price for providers in clinics, hospitals and other health care settings. Phase IIB goals are: 1) Construct a market-ready Bumps device. 2) Compare the results obtained from the new Bumps device with results from the original ground-glass prototype #1 in a large cohort, 3) determine the sensitivity and specificity of the new Bumps device to discriminate between healthy and neuropathic subjects; 4) continue to develop a normative database of test values and “cut off” values for diagnosis of neuropathy; and 5) Work with a marketing partner to commercialize the device. The grant period is 24 months.

Bumps：一种快速、无创量化触觉的设备 摘要 ! 我们的提案描述了一种名为Bumps的优雅设备，它可以量化手指垫的触摸感觉， 低微米级。其目的是诊断周围神经病变的发病，当有可能为 逆转是最高的，并监测治疗期间神经病变的进展或逆转。早期 发现功能受损的触摸提供了更好的机会，停止或逆转神经病变比后来 通过依赖神经变性的影响进行诊断的测试发现。 Bumps是一个简单得令人难以置信的外套口袋大小的设备，没有电源或移动部件， 在5 - 7分钟内量化指垫触摸。该装置是一个光滑的表面标记成棋盘状 广场。每个正方形包含五个彩色圆圈。每个正方形中的一个圆包含一个微小的硬币形状的粒子 （一个肿块）。受试者用指腹搜索每个正方形的圆圈，以寻找包含以下内容的一个圆圈： 一个肿块每个方块的凹凸高度不同。测试是客观的，因为受试者必须找到一个肿块 从几个可能的地点中选出颠簸的独特之处在于，受试者不断使用 怀疑是神经病的运动和感觉神经控制用指垫的搜索， 监控感官输入触觉的其他测试是主观的。例如，检查员触摸 用von Frey单丝或探针对皮肤进行检查，然后询问受试者是否感觉到探针，是或否，感觉到或没有 感觉。 在第一阶段，我们证明了该设备的可行性。在第二阶段，我们测试了健康对照组， 使用原始器械的周围神经病变受试者开始使用平均对照阈值的数据库， 性别和年龄±标准dev.和截止值，供客户用作标准，与 患者在第二阶段开始时，我们与四家不同的公司合作，每家公司都使用他们的特殊技术 因为他们试图（不成功地）构建具有纳米级所需精度的凸点设备。 经过广泛的搜索，我们找到了10X技术有限责任公司，一家伊利诺伊州的公司，有能力建造一个 主模具，将用于第二阶段B，以生产最终的凸点产品在更大的数量， 为诊所、医院和其他卫生保健机构提供合理的价格。 IIB阶段的目标是：1）构建市场就绪的Bumps设备。2)比较从以下获得的结果： 新的Bumps设备与大型队列中原始毛玻璃原型#1的结果，3）确定 新Bumps设备区分健康和神经病变的灵敏度和特异性 4）继续开发用于诊断的测试值和"截止"值的规范数据库， 神经病变;和5）与营销合作伙伴合作，将该设备商业化。补助期为24个月。