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

将开发一种低成本的一次性设备和一种手持电池供电的仪器。该设备可以插入活检针，并将通过检测包括组织结构和电化学变化在内的多个组织参数来识别针尖是否在活组织检查之前的最佳肿瘤区域。肿瘤组织中的这些参数已被证明与正常组织中的参数显著不同。该仪器将显示参数的实时曲线，并在超过预设阈值时给出音频提示。 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进行创新地检测。该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。安装在装置顶端的两个生物兼容的针状电极共用一个参比电极，用于检测电化学参数。 由于有多个参数，该设备将通过对高肿瘤含量区域进行采样来提高活检成功率。收集高质量的肿瘤活检组织，为生物标志物分析提供足够的材料，是全面实施癌症患者精准医学的关键。

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.