Low-Cost, Handheld Tactile Imaging Device for Breast Cancer Screening

用于乳腺癌筛查的低成本手持式触觉成像设备

• 批准号: 9465604
• 负责人: Ravi Saraf
• 金额: $ 29.97万
• 依托单位: VAJRA INSTRUMENTS, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-20 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9465604
• 关键词: American Cancer Society; Area; Axilla; Breast; Breast Cancer Detection; Cancerous; Cellular Phone; Cervical lymph node group; Clinical; Clinical Research; Complex; Computers; Detection; Developing Countries; Devices; Electronics; Electrons; Filler; Film; Fingers; Goals; Guidelines; Hardness; Head; Health Personnel; Heart; Heterogeneity; Human; Image; Imaging Device; Industry; Legal patent; Lesion; Light; Mammography; Manuals; Manufactured Materials; Measures; Methods; Modality; Modeling; Morphology; Motion; Nanostructures; Outcome; Pain; Palpable; Palpation; Patients; Performance; Phase; Physical Examination; Physicians; Polymers; Procedures; Process; Production; Publishing; Research; Resolution; Sampling; Schedule; Series; Signal Transduction; Skin; Specific qualifier value; Speed; Stethoscopes; Structure; Surface; Tactile; Techniques; Technology; Testing; Thick; Thinness; Time; Tissues; Touch sensation; Transducers; Translations; Variant; Woman; base; cost; data acquisition; design; device physics; digital; disease diagnosis; experience; grasp; handheld equipment; high resolution imaging; instrument; invention; laptop; light intensity; low income country; manufacturing process; millimeter; monolayer; nanodevice; nanoparticle; nanostructured; operation; particle; physical model; portability; pressure; research clinical testing; response; screening; sensor; tool

Palpation has been routinely used by physicians to diagnose diseases for centuries. In Clinical Breast Examination (CBE), medical personnel screen for suspect lesions (that are 10- to 20-fold stiffer than surrounding tissue) by palpation using two or three fingers followed by precession about a fixed 1-2 in2 contact area. Typical pressure to avoid discomfort and also feel deeper palpable objects ranges from 40-90 KPa. However, palpation is highly qualitative and subjective; and it is not possible to follow progression in the morphological changes. The goal of the proof-of-concept study is to develop an ergonomic, low cost (less than $5) stethoscope-like probe to capture tactile images during palpation. The probe will be pressed at 30-90 KPa pressure and a series of images will be recorded in real time by pivoting the probe over a fixed contact area of about 1-2 in2 in a precession motion similar to CBE. The studies will be performed over a well-characterized physical model, an artificial breast, and a clinical test on humans. The tactile image would be at a resolution of ~100 µm to image ≥5 mm features at 20-30 mm depth from the surface with relative hardness of ≥10-fold compared to the surrounding matrix. Two key drivers for developing the technology are: (i) digitizing CBE will offer a screening record between biannual mammogram exams, for women below 40, and in low-income countries where accessibility to a mammogram is limited; and (ii) the current digital CBE instruments (with array of 1 mm size sensors compared to proposed 100 μm size pixels) require rubbing the device on the skin at constant pressure and speed to create an image by stitching together the frames, potentially causing distortions/smearing due to dynamics of the palpable features. The grayscale of the image for the proposed device will be linear making the analysis quantitative to detect local hardness and score and track the palpation over time. The low power of the device will allow connectivity to a USB port for power, signal, and imaging on a laptop computer or smart phone. To image more complex body topography, such as axillary and cervical lymph nodes, the design will allow for interchangeable device heads of different sizes. At the heart of the proposed device is a ~100 nm thick nanostructured film that converts pressure to electrical signal to form the tactile image. The film is a stratified structure of a monolayer of Au nanoparticles interposed by ~5 nm thick polymer layers. On pressing the film, the electron tunneling current between the particles modulates to measure the local pressure. There are two specific aims: (i) develop an unpackaged device to prove the principle in terms of resolution, sensitivity, power requirement for USB connectivity, and ability to image 10-fold harder structures 3-10 mm in size at depths of 3-30 mm using a physical model; and (ii) develop a handheld device for testing on artificial breast model and limited clinical study with ~50 de-identified patients with breast- pain complaints or who are scheduled for mammograms. The preliminary and published results (by PI) indicate that the specified resolution, sensitivity, and performance are possible. A US Patent was issued in 2010.

几个世纪以来，触诊一直被医生用来诊断临床乳腺疾病。 检查 (CBE)，医务人员筛查可疑病变（其硬度是其 10 至 20 倍） 周围组织）通过使用两个或三个手指触诊，然后围绕固定的 1-2 in2 接触进动 避免不适并感觉到更深的可触及物体的典型压力范围为 40-90 KPa。 然而，触诊是高度定性和主观的，不可能跟踪病情的进展。 概念验证研究的目标是开发一种符合人体工程学的、低成本的（低于 5 美元）类似听诊器的探头，用于在触诊过程中捕捉触觉图像 探头将以 30-90 KPa 的压力按压。 通过在固定接触区域上旋转探头，可以实时记录压力和一系列图像。 与 CBE 类似的进动运动约为 1-2 in2 这些研究将在充分表征的基础上进行。 物理模型、人造乳房和人体临床测试触觉图像的分辨率为 ~100 µm，在距表面 20-30 mm 深度处对 ≥5 mm 特征进行成像，相对硬度≥10 倍 与周围的矩阵相比，开发该技术的两个关键驱动因素是：(i) 数字化 CBE 将 为 40 岁以下的女性和低收入人群提供每年两次乳房 X 光检查之间的筛查记录 乳房 X 光检查的可获得性有限的国家；以及 (ii) 当前的数字 CBE 仪器（带有 与建议的 100 μm 大小的像素相比，1 毫米大小的传感器阵列）需要在皮肤上摩擦设备 以恒定的压力和速度通过将帧缝合在一起来创建图像，可能会导致 由于可感知特征的动态而导致的失真/拖尾 所提议的图像的灰度。 设备将是线性的，进行定量分析以检测局部硬度并评分并跟踪触诊 随着时间的推移，设备的低功耗将允许连接到 USB 端口以获取电源、信号和成像。 笔记本电脑或智能手机对更复杂的身体地形进行成像，例如腋窝和颈部。 淋巴结，该设计将允许不同尺寸的可互换设备头。 所提出的装置是约 100 nm 厚的纳米结构薄膜，可将压力转换为电信号以形成 该薄膜是由约 5 nm 厚的单层金纳米粒子组成的分层结构。 在按压薄膜时，颗粒之间的电子隧道电流调节为 测量局部压力有两个具体目标：（i）开发一种未封装的设备来证明 在分辨率、灵敏度、USB 连接的电源原理要求以及 10 倍成像能力方面 使用物理模型开发尺寸为 3-10 毫米、深度为 3-30 毫米的较硬结构；以及 (ii) 开发手持式设备 用于测试人造乳房模型的设备以及对约 50 名身份不明的乳腺患者进行的有限临床研究 疼痛主诉或计划进行乳房 X 光检查的人 初步和公布的结果（由 PI 提供）表明。 指定的分辨率、灵敏度和性能已于 2010 年获得美国专利。