Intraoperative Stereovision for Surgical Guidance

项目摘要/摘要： Insight Surgical Technologies，LLC是一家由NIH长期资助的高级成员创立的初创企业 研究开发术中图像更新以保持准确的图像一致性 整个手术过程中的整个外科领域。这一努力导致了研究创新，产生了 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。第一阶段论证了新的 用于将多个术中立体视觉(ISV)采集装配到复合视野中的算法 完成ISV到MRI的配准/重配准以及现有的3D ISV算法的转换 图形处理器(GPU)加速形式的曲面重建和校准。另外， 在一个大型动物(猪)脑肿瘤切除过程中获得的I期结果表明，该模型是一个极好的模型。 用于测试和验证Insight的完整图像更新系统I2UpdateTM的系统处于第二阶段。 具体地说，我们将利用第一阶段的成果来完全自动化I2UpdateTM，并展示其技术 在质量体系下的性能和临床功能足以满足法规要求。特定的 AIMS将(I)开发一种全自动、支持图形处理器的处理系统，用于术中图像更新 (I2UpdateTM)，(Ii)I2UpdateTM的完整验证测试和临床前体内验证，Under Quality 系统控制足以支持第二阶段结束时的监管申报，以及(Iii)进行多站点 在接受脑瘤切除的患者中使用无显著风险的I2UpdateTM的临床应用研究。 成功完成第二阶段将产生I2UpdateTM产品平台作为最终的商业 支持GPU的软件系统，同时具有设计控制、软件验证、程序使用和质量 系统，伴随着活体动物验证和多部位、多外科医生使用的临床演示- 相关和可接受的图像更新性能，包括自动化、计算效率和 配准准确率。

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.