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

SBIR 第二阶段：用于活动器官内微创手术的 Grip-Act-Reposition 小型稳定工作平台

• 批准号: 1353176
• 负责人: Roger Bagwell
• 金额: $ 75万
• 依托单位: Actuated Medical, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-15 至 2017-01-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1353176&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Grip; Act

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.

这个小企业创新研究（SBIR）二期项目将完成用于主动器官内微创手术的Grip-Act-Reposition （GAR）小型化稳定工作平台，最初的重点是治疗心房颤动（AF）。治疗房颤的一种常用方法是心脏射频导管消融。带电极的导管用于向组织输送射频电流。燃烧路径，电隔离纤颤触发源。对于现有的导管设备，消融线必须由大量连续形成的离散病灶形成。在跳动的心脏中形成连续病变是具有挑战性的，导致手术时间长，对于某些形式的房颤，首次成功率低至30%。GAR将彻底改变基于导管的微创手术。GAR将(i)提供一种进入体腔或器官的机制，包括心脏或肺等不断运动的器官；（ii）夹在组织壁上，（iii）创建一个稳定的平台，从这个平台上操作和/或向组织提供各种局部治疗（能量，药物）。此外，旋转齿轮机构和简单的抓放功能将允许在腔内以连续的线或弧重新定位，而不会失去与组织壁的接触。该项目的更广泛的影响/商业潜力是：a)改善美国和全球的医疗保健；b)在50亿美元的市场空间中创造收入和美国制造业就业机会。心房颤动（AF）影响着2-3百万美国人，全世界大约有2000万人。据估计，美国医疗保健系统每年在手术和更常见的维持性药物方面的成本为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，而且有很多副作用。GAR将缩短手术时间——射频消融为1小时——并提高成功率，减少重复导管消融手术的需要。心脏消融将成为一种更可行的治疗病人维持药物。此外，GAR还可以应用于其他医疗应用和条件，例如修复肠内难治性出血，其中需要在移动器官、松散组织或体腔内进行精确导航。该项目还将导致学术和商业机构之间的额外合作，将技术推向市场，并为高中和大学实习生提供培训机会。