Intraoperative Stereovision for Surgical Guidance

项目总结/摘要： InSight Surgical Technologies，LLC是一家由NIH长期资助的 研究努力开发术中图像更新，以保持与 整个手术过程中的手术区域。这一努力导致了研究创新， 知识产权（IP）组合，包括13项已发布专利和8项正在申请的专利。第一阶段证明了新的 用于将多个术中立体视觉（iSV）采集组装成复合视场的算法 完成iSV到MRI的配准/再配准，以及现有iSV算法的3D转换 以图形处理单元（GPU）加速的形式进行表面重建和校准。此外，本发明还 在切除大型动物（猪）脑肿瘤期间获得的I期结果表明，该模型是极好的 用于在第二阶段体内测试和验证InSight完整图像更新系统I2 UpdateTM的系统。 具体来说，我们将利用第一阶段的结果，完全自动化I2 UpdateTM，并展示其技术 质量体系下的性能和临床功能足以满足监管要求。具体 aims将（i）开发一个全自动的、支持GPU的处理系统，用于术中图像更新 （I2 UpdateTM），（ii）完成I2 UpdateTM的验证测试和临床前体内确认，根据质量 系统控制足以支持在第二阶段结束时的监管备案，以及（iii）进行多站点 I2 UpdateTM在接受脑肿瘤切除术的患者中进行的非显著风险的临床使用研究。 第二阶段的成功完成将产生I2 UpdateTM产品平台作为最终的商业 支持GPU的软件系统，伴随设计控制、软件确认、程序使用和质量 系统，伴随着体内动物验证和多中心，多外科医生使用，证明临床- 在自动化、计算效率和 配准精度

PROJECT SUMMARY/ABSTRACT: InSight Surgical Technologies, LLC, is a start-up founded by senior members of a long-standing NIH-funded research effort to develop intraoperative image updating that maintains accurate image correspondence with the surgical field throughout a procedure. The effort has led to research innovations that have generated an intellectual property (IP) portfolio of 13 issued and 8 pending patents. Phase I demonstrated feasibility of new algorithms for assembling multiple intraoperative stereovision (iSV) acquisitions into a composite field-of-view and accomplishing iSV-to-MRI registration/re-registration, and conversion of existing iSV algorithms for 3D surface reconstruction and calibration in graphics processing unit (GPU) accelerated forms. Additionally, Phase I results obtained during resection of a large animal (swine) brain tumor indicate this model is a superb system for testing and validating InSight’s complete image updating system, I2UpdateTM, in vivo in Phase II. Specifically, we will leverage Phase I results to automate I2UpdateTM fully, and demonstrate its technical performance and clinical functionality under quality systems sufficient to meet regulatory requirements. Specific aims will (i) develop a fully-automated, GPU-enabled processing system for intraoperative image-updating (I2UpdateTM), (ii) complete verification testing and pre-clinical in vivo validation of I2UpdateTM, under quality system controls sufficient for supporting regulatory filings at the end of Phase II, and (iii) conduct a multi-site clinical-use study with I2UpdateTM under non-significant risk in patients undergoing brain tumor resection. Successful completion of Phase II will produce the I2UpdateTM product platform as a finalized commercial GPU-enabled software system with concomitant design control, software validation, procedural use and quality systems, accompanied by in vivo animal validation and multi-site, multi-surgeon use demonstrating clinically- relevant and acceptable image-updating performance in terms of automation, computational efficiency and registration accuracy.