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

这个小企业创新研究第一阶段项目将开发？用于活动器官内微创手术的GAR微型稳定工作平台。 在运动器官内或运动器官上工作？比如心脏或者肺在微创手术中是非常具有挑战性的。 手术工具的工作端必须通过长（100 cm）、窄（3 mm）导管展开。 导管需要很大的灵活性来通过到达靶器官的路径-这固有地限制了对工作端的控制。 在用于治疗心房颤动（AF）的导管消融中，例如，射频消融导管产生疤痕组织线以将AF源与剩余心脏隔离。 心脏的跳动使其极难附着在心壁上，在正确的深度损伤中燃烧，然后转移到下一个期望的消融位置？GAR技术平台将能够紧紧抓住心壁，并由临床医生精确控制移动到下一个烧伤位置。并且可以集成到需要在运动器官或体腔内稳定定位和重新定位的广泛的医疗应用中。 该项目更广泛的影响/商业潜力有几个方面。 该项目将启动心脏外科医生和行业医疗器械开发专家之间的长期合作。 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个工作岗位。 当左心房射频消融术简化后，预期会有更大的潜在收入？使用GAR方法-并有效地交付给美国超过200万潜在的患者。在心脏手术中使用GAR系统只是第一个应用。 肺部和消化道的手术也会因手术过程中目标器官和组织的移动而变得复杂。 GAR方法将通过允许更有效地接触身体内的移动或松散组织来获得市场份额，其中临床医生通常受到传统系统无法准确确定和控制器械位置的限制。 该项目还将与附近的大学，技术学校和高中进行实习和长期合作。目标是培养未来的工程师，同时评估潜在的雇员。

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.