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

描述（由申请人提供）：本申请描述了一种优雅简单的口袋大小的装置，称为“Bumps”，其以微米（μ m）为单位快速量化手指上的触摸的重要感觉。这种高灵敏度区分了健康受试者之间存在的触觉的小变化，并且可以检测到患有周围神经病变的人的手指中触觉的轻微降低。Bumps的目的是在逆转的可能性最高的情况下，尽早诊断神经病;并监测分子遗传学和其他令人兴奋的领域研究中出现的新疗法的有效性，这在一定程度上是现在不可能的。Bumps测量指纹脊上的触觉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颗粒中的最小颗粒（凸起）。当受试者从几个可能的位置中找到一个肿块时，我们假设他们感觉到了。肿块消除了耗时的强迫选择，是或否，方法。正常人在不到10分钟内找到< 5 m高度的肿块;儿童在不到3分钟内。这种灵敏度超过了目前的测试，并允许早期检测神经损伤。在第一阶段，我们将建立一个新的原型Bumps设备，并通过测量糖尿病患者（因为神经病变的高患病率）以及儿童和成人癌症患者的小队列的触觉阈值来检测化疗引起的周围神经病变（CIPN）来显示可行性。CIPN对于测试这种新设备特别有用，因为从化疗前假定感觉正常到出现严重麻木之间的时间只有几个月。在此期间，可以以短的、成本有效的方式评估用于神经病变的早期检测和用于跟随触摸灵敏度下降的装置的效用。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和神经毒性脑并发症出现之前修改治疗。该STTR回应了2009年3月NCI的一份报告，该报告引用了对快速、灵敏、节省成本的方法的需求，以在当地家庭环境中检测CIPN患者。 公共卫生相关性：Bumps设备快速，廉价，客观地测量手指的触觉，具有千分尺灵敏度。它将有助于识别周围神经病变，从许多原因，特别是糖尿病，癌症化疗和艾滋病毒，早期时，治疗成功的潜力是最高的。这将是新一代更敏感的诊断测试之一，需要衡量新兴疗法的有效性。该STTR I期将用于制造新的原型器械，并由专家在选定的高知名度研究中证明其在周围神经病变中的实用性。

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.