The Bumps, a device for rapid, non invasive quantification of touch sensation

描述(申请人提供)：这份申请描述了一种非常简单的口袋大小的设备，称为“凸起”，它以微米为单位快速量化手指上的重要触摸感觉。这种高灵敏度区分了健康受试者之间存在的触觉的微小差异，并可以检测到周围神经病患者手指触觉的轻微下降。这些颠簸的目的是非常早地诊断神经疾病，而逆转的可能性最高；并监测分子遗传学和其他令人兴奋的领域研究出现的新疗法的有效性，达到现在不可能达到的程度。这些凸起测量了指纹脊上迈斯纳小体受体器官的触摸阈值。我们将触摸阈值定义为受试者可以用指垫检测到的一系列分级粒子中最小的粒子(凹凸)。当受试者从几个可能的位置中找到一个凸起时，我们假设他们感觉到了。这些颠簸消除了耗时的强制选择方法，是或不是。正常受试者在不到10分钟内找到5米高的肿块；儿童在不到3分钟内找到肿块。这种敏感性超过了目前的测试，可以及早发现神经损伤。在第一阶段，我们将构建一个新的BUPS设备原型，并通过测量小群糖尿病患者(因为神经病变的高患病率)以及儿童和成人癌症患者的触觉阈值来检测化疗引起的周围神经病变(CIPN)来展示其可行性。CIPN对于测试这种新设备特别有用，因为患者从化疗前假定的正常感觉到出现严重麻木只需要几个月的时间。在这段时间内，可以以短的、经济高效的方式评估该设备用于神经病变的早期检测和用于跟踪触摸敏感性下降的效用。早期诊断对CIPN患者是有益的，因为它为治疗医生提供了一个早期机会，在恢复潜力最大的时候修改治疗方案，并在出现神经毒性脑部并发症之前。2009年3月NCI的一份报告指出，需要快速、灵敏、节省成本的方法在当地家庭环境中测试CIPN患者。 与公共健康相关：该凹凸设备以微米灵敏度快速、廉价、客观地测量手指的触觉。这将有助于在治疗成功的可能性最高的时候，及早识别由多种原因引起的周围神经病变，特别是糖尿病、癌症化疗和艾滋病毒。这将是新一代更敏感的诊断测试之一，需要用来衡量新出现的疗法的有效性。STTRI期将被用于制造新的原型设备，并由选定的高知名度研究所的专家展示其在周围神经病中的应用的可行性。

DESCRIPTION (provided by applicant): This application describes an elegantly simple, pocket size device, called "the Bumps" that rapidly quantifies the important sensation of touch on the fingers in micrometer (¿m) units. This high sensitivity differentiates the small variations f touch sensation that exist between healthy subjects and can detect minor reduction of touch sensation in fingers of persons with peripheral neuropathy. The purposes of the Bumps are to diagnose neuropathy very early, while the potential for reversal is highest; and to monitor the effectiveness of new therapies appearing from research in molecular genetics and other exciting fields, to a degree not now possible. The Bumps measure the touch threshold of Meissner corpuscle receptor organs on the fingerprint ridges. We define touch threshold as the smallest particle (bump) in a graduated series of particles that subjects can detect with the finger pad. When subjects locate a bump from among several possible locations we assume they felt it. The Bumps eliminates the time consuming forced choice, yes or no, method. Normal subjects locate bumps of < 5 ¿m height in less than 10 minutes; children in less than 3 minutes. This sensitivity exceeds that of current tests and allows early detection of nerve damage. In Phase I we will build a new prototype Bumps device and show feasibility by measuring tactile thresholds of small cohorts of patients with diabetes (because of the high prevalence of neuropathy) and of children and adults with cancer to detect chemotherapy induced peripheral neuropathy (CIPN). CIPN is especially useful for testing this new device because the time elapsed between the patient having presumed normal sensation before chemotherapy to developing severe numbness is only a few months. During this time the utility of the device for early detection of neuropathy and for following the decline of touch sensitivity can be evaluated in a short, cost efficient, manner. Early diagnosis is beneficial for CIPN patients because it gives treating physicians an early opportunity to modify treatment at a time when the potential for recovery is greatest and before neurotoxic cerebral complications appear. This STTR responds to a March 2009 NCI report that cites a need for rapid, sensitive, cost saving methods to test patients with CIPN in their local home environment. PUBLIC HEALTH RELEVANCE: The Bumps device quickly, inexpensively and objectively measures touch sensation of fingers with micrometer sensitivity. It will be useful for recognition of peripheral neuropathy, from many causes, especially diabetes, cancer chemotherapy and HIV, early when the potential for therapeutic success is highest. It will be one of a new generation of more sensitive diagnostic tests needed to measure effectiveness of new emerging therapies. This STTR Phase I will be used to manufacture a new prototype device and to show feasibility for its utility in peripheral neuropathy by specialists at selected high profile instittions.