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，医生常规使用了触诊来诊断疾病。在临床乳房中 检查（CBE），可疑病变的医疗人员屏幕（比 周围的组织）通过触诊使用两个或三个手指，然后预防约1-2 in2接触 区域。避免不适并感觉到更深层的物体的典型压力范围为40-90 kPa。 但是，触诊是高度定性和主观的。而且不可能跟随 形态学变化。概念证明研究的目的是开发符合人体工程学的低成本（小于 $ 5）触诊期间捕获触觉图像的听诊器样探针。探针将按30-90 kPa按 压力和一系列图像将通过在固定的接触区域上旋转探针来实时记录 在类似于CBE的动力运动中约1-2 in2。这些研究将通过特征良好的 物理模型，人造乳房以及对人类的临床测试。触觉图像将是 〜100 µm至图像≥5毫米特征在20-30毫米深度，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力是：（i）数字化CBE将会 为40岁以下的女性和低收入的女性提供筛查记录 对乳房X光检查的可及性有限的国家； （ii）当前的数字CBE仪器（带有 与提议的100μm尺寸像素相比，1毫米尺寸传感器的阵列需要在皮肤上摩擦设备 在恒定的压力和速度下，通过将框架缝合在一起来创建图像，可能导致 由于明显特征的动力学而引起的扭曲/涂抹。提议的图像的灰度 设备将是线性的，使分析定量以检测局部硬度并进行评分并跟踪手掌 随着时间的推移。该设备的低功率将允许与USB端口的连接，以获取功率，信号和成像 笔记本电脑或智能手机。图像更复杂的身体形态，例如腋和颈椎 淋巴结，设计将允许具有不同尺寸的可互换设备头。核心 建议的设备是〜100 nm厚的纳米结构膜，将压力转换为电信号以形成 触觉图像。该膜是由〜5 nm厚的Au纳米颗粒的单层的分层结构 聚合物层。按下膜，颗粒之间的电子隧穿电流调节至 测量局部压力。有两个具体的目的：（i）开发一个未包装的设备来证明 关于分辨率，灵敏度，对USB连接性的功率要求以及图像10倍的能力的原理 使用物理模型在3-30毫米深度的3-10毫米的硬结构尺寸为3-10毫米； （ii）开发手持 对人造乳房模型进行测试的设备和有限的临床研究，约有50名被识别的乳房患者 疼痛投诉或计划进行乳房X线照片。初步和发布的结果（PI）指示 指定的分辨率，灵敏度和性能是可能的。 2010年发行了美国专利。