SBIR Phase I: Grip-Act-Reposition Miniaturized Stable Working Platform for Minimally Invasive Procedures Inside Active Organs

这个小型企业创新研究第一阶段项目将开发GRIP-ACT-REPOSITION(GAR)微型稳定工作平台，用于在活跃器官内进行微创手术。在移动的器官内还是在移动的器官上工作？比如心脏或肺？在微创手术中极具挑战性。手术工具的工作端必须通过长(100厘米)、窄(3毫米)的导管展开。导管需要极大的灵活性来协商到达目标器官的路径--这固有地限制了对工作端的控制。例如，在用于治疗房颤(AF)的导管消融中，射频消融导管会产生疤痕组织线，将房颤来源与剩余心脏隔离。心脏的跳动使得连接到心壁，在正确的深度病变中烧伤，然后转移到下一个所需的消融位置变得极其困难？导致某些形式的房颤的首次成功率低至30%。GAR技术平台将能够紧紧抓住心壁，并精确地由临床医生控制运动到下一个烧伤位置？并且可以集成在需要在移动的器官或体腔内稳定定位和重新定位的广泛医疗应用中。这个项目的更广泛的影响/商业潜力有几个方面。该项目将启动心脏外科医生和业界医疗器械开发专家之间的长期合作。GRIP-ACT-REPOSITION(GAR)系统最终将在美国为一家分销心脏消融导管系统的大型商业实体制造，到2017年将创造720万美元的收入和20-30个就业机会。当左心房的射频消融被简化时，预计会有更大的潜在收入？使用GAR方法-并有效地提供给美国200多万潜在患者。在心脏手术中使用GAR系统只是第一次应用。肺部和消化道的手术也因手术过程中目标器官和组织的移动而变得复杂。GAR方法将允许更有效地接触体内移动或疏松的组织，从而获得市场份额。临床医生通常受到传统系统无法准确确定和控制设备位置的限制。该项目还将吸引实习生，并与附近的大学、技术学校和高中提供长期合作机会？目标是培训未来的工程师，并评估潜在的招聘人员。

This Small Business Innovation Research Phase I project will develop the ?Grip-Act-Reposition (GAR) Miniaturized Stable Working Platform for Minimally Invasive Procedures Inside Active Organs.? Working within or on moving organs ? like the heart or lungs ? is extremely challenging during minimally invasive procedures. The working end of the surgical tool must be deployed through a long (100 cm), narrow (3mm) catheter. The catheter needs significant flexibility to negotiate the path to the target organ - which inherently limits control of the working end. In catheter ablation for treating atrial fibrillation (AF), for example, a radiofrequency ablation catheter creates scar tissue lines to isolate AF sources from the remaining heart. The beating of the heart makes it extremely difficult to attach to the heart wall, burn in the correct depth lesion, and then shift to the next desired ablation position ? resulting in first-time success rates as low as 30% for some forms of AF. The GAR technology platform will enable a tight grip on the heart wall and precision clinician-controlled motion to the next burn location ? and can be integrated in a wide range of medical applications where stable positioning and relocation within a moving organ or body cavity is desired. The broader impact/commercial potential of this project has several aspects. This project will initiate long-term collaboration between cardiac surgeons and medical device development experts in industry. The Grip-Act-Reposition (GAR) system will ultimately be manufactured in the United States for a large commercial entity that distributes cardiac ablation catheter systems, generating $7.2 million in revenue and 20-30 jobs by 2017. Even greater potential revenue is anticipated when radiofrequency ablation in the left atrium is simplified ? using the GAR approach - and delivered effectively to the more than 2 million potential patients in the United States.Using the GAR system in cardiac surgery is only the first application. Surgery in the lungs and digestive tract are also complicated by the target organs and tissues moving during the procedure. The GAR approach will gain market share by allowing more effective contact with moving or loose tissues within the body where clinicians are normally limited by the inability of conventional systems to accurately determine and control the position of devices. This project will also engage interns and long term collaboration opportunities with nearby universities, tech schools, and high schools ? with a goal of training future engineers, and also evaluating potential hires.