IGF::OT::IGF SBIR PHASE I TOPIC 331: DEVELOPMENT OF A BIOSENSOR-BASED CORE NEEDLE TUMOR BIOPSY DEVICE

IGF::OT::IGF SBIR 第一阶段主题 331：开发基于生物传感器的核心针肿瘤活检装置

• 批准号: 8945645
• 负责人: PEIJIE CAO
• 金额: $ 22.5万
• 依托单位: BIOSONO, INC.
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-22 至 2015-06-21
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8945645
• 关键词: Animals; Area; Biocompatible; Biological Markers; Biopsy; Biosensor; Cancer Patient; Collection; Computer software; Computers; Detection; Development; Devices; Distal; Elasticity; Electrochemistry; Electrodes; Medicine; Needle biopsy procedure; Needles; Normal tissue morphology; Phase; Polychlorinated Biphenyls; Sampling; Shapes; Small Business Innovation Research Grant; Testing; Time; Tissues; Transducers; Tumor Tissue; Ultrasonic Transducer; base; cost; design; in vivo; instrument; pressure; success; tumor

A low-cost disposable device and a handheld battery-powered instrument will be developed. The device can be inserted into a biopsy needle and will identify whether the needle tip is in an optimal tumor area prior to biopsy by sensing multiple tissue parameters including tissue structural and electrochemical changes. These parameters in tumor tissue have been proven to be significantly different from those in normal tissue. The instrument will display real time curves of the parameters, and give audio indications when they exceed the preset thresholds. Tissue flow, elasticity, and pressure information will be innovatively detected by a single ultrasound transducer mounted at the tip of the device. The transducer will be composed of the advanced single crystal composite and will have high sensitivity and wide bandwidth. It will be used for Doppler flow detection for the first time. Two biocompatible needle shape electrodes mounted at the device tip, sharing a common reference electrode, will be used to detect the electrochemistry parameters. With multiple parameters, the device will enhance the biopsy success by sampling high tumor content areas. Collection of high quality tumor biopsies with sufficient material for biomarker profiling is essential for full implementation of precision medicine for cancer patients.

将开发一种低成本的一次性装置和一种手持式电池供电仪器。该装置可以插入活检针中，并且将通过感测包括组织结构和电化学变化的多个组织参数来在活检之前识别针尖是否处于最佳肿瘤区域中。肿瘤组织中的这些参数已被证明与正常组织中的这些参数显著不同。仪器将显示各参数的真实的时间曲线，并在超过预设阈值时给出音频指示。 组织流动、弹性和压力信息将通过安装在设备尖端的单个超声换能器创新地检测。传感器将由先进的单晶复合材料组成，具有高灵敏度和宽带宽。它将首次用于多普勒血流检测。将使用安装在器械头端的两个生物相容性针形电极（共用一个参比电极）检测电化学参数。 通过多个参数，该设备将通过采样高肿瘤含量区域来提高活检成功率。收集高质量的肿瘤活检标本，并提供足够的生物标志物分析材料，对于全面实施癌症患者的精准医疗至关重要。