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

这个小型企业创新研究(SBIR)第二阶段项目将最终敲定GRIP-ACT-REPORT(GAR)微型稳定工作平台，用于在活跃器官内进行微创手术-最初的重点是治疗心房颤动(AF)。治疗房颤的常用方法是心脏射频消融术。带电极的导管是用来向组织输送射频电流的？电隔离纤颤触发源的燃烧路径。对于现有的基于导管的设备，消融线必须由大量连续产生的离散病变形成。在心脏跳动中形成连续病变是具有挑战性的，导致某些形式的房颤手术时间长，首次成功率低至30%。GAR将彻底改变以导管为基础的微创手术。GAR将(I)提供进入体腔或器官的机制，包括那些不断运动的器官；(Ii)夹在组织壁上；以及(Iii)创建一个稳定的平台，从这个平台上操作和/或向组织输送各种局部治疗(能量、药物)。此外，旋转齿轮机构和简单的抓取和释放功能将允许在腔内以连续的直线或弧形重新定位，而不会失去与组织壁的接触。该项目的更广泛影响/商业潜力是a)改善美国和世界各地的医疗保健，b)在50亿美元的市场空间创造收入和美国制造业的就业机会。房颤(房颤)影响着200-300万美国人，全世界大约有2000万人。据估计，美国医疗体系每年在手术和更常见的维持药物方面的成本为66.5亿美元。现有导管消融手术的主要限制是成本(12,000美元以上)、时间(4小时以上)和成功率(30-80%)。房颤的典型解决方案通常是每年花费3000美元以上的药物治疗，而且有许多副作用。GAR将缩短手术时间--在射频消融的情况下为1小时--并提高成功率，减少重复导管消融程序的需要。对于服用维持性药物的患者来说，心脏消融术将成为一种更可行的治疗方法。此外，GAR还可用于其他医疗应用和条件，例如修复肠道难治性出血，需要在移动的器官、松散的组织或体腔内精确导航。该项目还将促进学术机构和商业机构之间的更多合作，将技术推向市场，并为高中和大学实习生提供培训机会。

This Small Business Innovation Research (SBIR) Phase II project will finalize the Grip-Act-Reposition (GAR) Miniaturized Stable Working Platform for Minimally Invasive Procedures Inside Active Organs - with initial focus on treating Atrial Fibrillation (AF). A common procedure for treating AF is Radiofrequency (RF) Catheter Ablation in the heart. A catheter with an electrode is used to deliver RF electrical current to tissue ? burning paths that electrically isolate the fibrillation trigger sources. With existing catheter-based devices, ablation lines must be formed from a high number of discrete lesions created sequentially. Forming contiguous lesions in the beating heart is challenging, resulting in long procedure times and first-time success rates as low as 30% for some forms of AF. GAR will revolutionize catheter-based minimally invasive procedures. GAR will (i) provide a mechanism to enter a body cavity or organ, including those such as the heart or lungs which move constantly; (ii) clamp to a tissue wall, and (iii) create a stable platform from which to operate and/or deliver various local treatments (energy, pharmaceuticals) to tissues. Additionally, the rotating gear mechanism and simple grasp-and-release function will allow repositioning within the cavity in a continuous line or arc without losing contact with the tissue wall.The broader impact/commercial potential of this project is to a) improve healthcare in both the U.S. and worldwide and b) generate revenue and US manufacturing jobs in a $5 billion market space. Atrial Fibrillation (AF) affects 2-3 million Americans, and approximately 20 million people worldwide. The cost to the U.S. healthcare system is an estimated $6.65 billion annually in procedures and, more commonly, maintenance medications. Major limitations to existing catheter ablation procedures are cost ($12,000+), time (4+ hours), and success rate (30-80%). Typical solutions to AF are often treatment with medications costing $3,000+ yearly with many side-effects. GAR will reduce procedure time - in the case of RF ablation to 1 hour- and improve success rates, reducing the need for repeat catheter ablation procedures. Cardiac ablation will become a more viable treatment for patients on maintenance medications. Additionally, GAR can be applied in other medical applications and conditions, such as repairing difficult bleeds in the intestines, where precise navigation within a moving organ, loose tissue, or a body cavity is desired. The project will also result in additional collaboration between academic and commercial institutions to take the technology to market, along with training opportunities for both high-school and college interns.