MRI-enhanced Endoscopy with tracking-imaging probes

描述（由申请人提供）： II期项目旨在开发用于MR增强内窥镜检查的跟踪和成像探头（TIP）。与传统的光学和超声内窥镜相比，MRI具有许多优势，例如出色的软组织对比度和温度敏感成像。Robin Medical专有的跟踪技术与局部成像的结合使用将能够在内窥镜检查期间进行高分辨率MR成像，并有望提高内窥镜干预的效果，例如通过用图像引导的微创内窥镜检查取代开放手术。 II期的具体目标是：开发TIP的最终配置;将TIP集成到MR兼容内窥镜中;进行动物研究以进行安全性评估并评价系统的体内性能;进行初步人体研究以证明MR辅助内窥镜的临床有效性。 TIP是一种创新的中空探头，可实现跟踪和成像，将集成到MR兼容内窥镜的尖端。将开发匹配和调谐电路，以将TIP连接到标准MR扫描仪。动物研究将包括MRI期间内窥镜的温度监测、正常壁成像、病变诱导后壁结构成像以及冷冻治疗的成像效果。有限系列的人类内窥镜检查程序将通过MR内窥镜检查对息肉结构与组织学切片进行比较。

DESCRIPTION (provided by applicant): The Phase-II project aims to develop tracking and imaging probe (TIP) for MR-enhanced endoscopy. MRI has many advantages over traditional optical and ultrasound endoscopy, such as excellent soft tissue contrast and temperature-sensitive imaging. The use of Robin Medical's proprietary tracking technology with local imaging will enable high-resolution MR imaging during endoscopy and is expected to improve the yield of endoscopic interventions, for example by replacing open surgery with image-guided, minimally-invasive endoscopy. The specific aims of Phase-2 are: To develop the final configuration of the TIP; To integrate the TIP into MR-compatible endoscopes; To conduct animal studies for safety assessment and to evaluate the performance of the system in-vivo; To conduct pilot human studies to demonstrate the clinical efficacy of MR-aided endoscopy. The TIP, an innovative hollow probe that enables tracking and imaging, will be integrated into the tip of MR-compatible endoscope. Matching and tuning circuitry will be developed to interface the TIP to standard MR scanners. The animal studies will include temperature monitoring of the endoscope during MRI, imaging normal wall, imaging wall structure following induction of lesions, and imaging effect of cryotherapy. Limited series of human endoscopy procedures will compare polyp structure by MR-endoscopy to histology sections.