Precise Micro-Steerable Mapping and Ablation Catheters for Treatment of Atrial Fi

描述（由申请人提供）：心律失常是最常见的心脏疾病之一。心房颤动（AFib）是一种常见的心律失常，发病率高。目前有超过250万美国人患有AFib，每年诊断出约16万例新病例。对于40岁以上的美国人，AFib发展的终身风险估计为25%。房颤可导致心绞痛、心力衰竭和中风。房颤的治疗对于患有严重和频繁发作的心律失常的患者至关重要。消融导管用于治疗室性和室上性心律失常。有新的证据表明，与药物治疗和植入治疗相比，消融导管治疗心律失常具有治愈性，但由于治疗的成本和复杂性，只有不到1%的患者得到治疗。这是由于在当前导管中通过推/拉电缆控制导管头端位置时缺乏再现性和精确度，导致手术时间较长（2至9小时），这会使医生和工作人员暴露于长时间X射线辐射以及手术期间站立的人体工程学挑战。所提出的基于电活性聚合物（EAP）的电动微型可操纵致动器利用了SPS创始人之一发明的突破性固态致动器技术，以操纵导管尖端位置并实现先进的基于导管的手术。所施加的电压与EAP致动器中的尺寸变化之间的线性对应关系使得能够精确控制导管头端及其力水平，从而显著缩短手术时间，并受益于可编程操作能力，以减少医生暴露于辐射。所提出的致动技术与当前导管的易于集成导致了较低的总系统成本以及减少手术和培训时间的额外益处。这项技术的商业化并不简单。SPS将在EAP材料的纯化和处理非常软的EAP材料以形成多层结构的工艺的开发方面面临挑战。然而，之前与包括美敦力和圣犹达医疗用品有限公司在内的大型医疗器械公司的讨论非常积极。所有这些公司都表现出很高的兴趣，但表示SPS需要展示一个工作原型，然后才有兴趣进一步投资。有了这个潜在的BRDG-SPAN计划的资金，SPS预计将设计和生产原型微型可操纵致动器，可用于概念演示。SPS预计，这一演示将导致额外的资金和联合开发计划所需的充分商业化的技术。此外，导管应用致动器开发的成功将推动其他新的医疗器械应用。 公共卫生相关性：标测/消融导管用于治疗房颤。目前的机械导管操作困难且耗时，无法提供可再现和一致的消融，而拟议的BRDG-SPAN项目将开发电控致动器，以实现先进的微操纵性、缩短手术时间和先进的自动化功能。创新的电导管将使数百万患有房颤的美国人受益。

DESCRIPTION (provided by applicant): Arrhythmias are among the most common disorders of the heart. Atrial fibrillation (AFib) is a common arrhythmia associated with significant morbidity. There are currently more than 2.5 million Americans suffering from AFib and there are about 160,000 new cases diagnosed each year. The lifetime risk for the development of AFib is estimated at 25% for Americans older than 40. AFib can lead to angina, heart failure, and stroke. Treatment of AFib is essential for the patient suffering from severe and frequent episodes of these arrhythmias. Ablation catheters are used to treat both ventricular and supraventricular arrhythmia. There is emerging evidence that the ablation catheter treatment of arrhythmias is curative compared with drug therapy and implant treatments, which are not curative, however less than 1% is treated due to the cost and complexity of the treatment. This is due to the lack of reproducibility and precision in controlling the catheter tip position by the push/pull cable in current catheters resulting in long procedure times (2 to 9 hrs), which risks exposure of physicians and staff to prolonged X-Ray radiation as well as the ergonomic challenge of standing for the duration of the procedure. The proposed electroactive polymer (EAP)-based electrical micro-steerable actuator utilizes a breakthrough solid-state actuator technology, invented by one of the founders of SPS, to manipulate the catheter tip position and enable advanced catheter based procedures. The linear correspondence between the applied voltage and the dimension change in the EAP actuator enables precise control of the catheter tip and its force level, resulting in a significantly reduced procedure time with the benefit of a programmable operation capability to reduce the physician exposure to radiation. The ease of integration of the proposed actuation technology with the current catheter results in a lower total system cost with the added benefit of reduced procedure and training time. Commercialization of this technology is not trivial. SPS will face challenges in the purification of the EAP materials and the development of processes to handle the very soft EAP materials to form multilayer structures. However, previous discussions with large medical device companies, including Medtronic and St. Jude Medical, have been very positive. All of these companies showed a high level of interest but indicated that SPS needed to demonstrate a working prototype before they would be interested in further investment. With the funding from this potential BRDG-SPAN program, SPS expects to design and produce prototype micro-steerable actuators, which can be used for concept demonstration. SPS expects that this demonstration will lead to the additional funding and the joint development programs required to fully commercialize the technology. In addition, success on actuator development for catheter applications will drive other new medical device applications.) PUBLIC HEALTH RELEVANCE: Mapping/ablation catheters are used to treat atrial fibrillation. Current mechanical catheters are difficult and time consuming to operate and cannot provide reproducible and consistent ablation, whereas the proposed BRDG-SPAN project will develop electronically controlled actuators that will enable advanced micro- steerability, reduced procedure times and advanced automation capabilities. The innovative electrical catheters will benefit millions of Americans who are suffering from atrial fibrillation.