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

描述(申请人提供)：心律失常是最常见的心脏疾病之一。房颤(AFib)是一种常见的心律失常，发病率很高。目前有超过250万美国人患有房颤，每年约有16万新诊断病例。据估计，40岁以上的美国人患房颤的终生风险为25%。纤维蛋白原可导致心绞痛、心力衰竭和中风。对于患有严重和频繁发作的这些心律失常的患者，房颤的治疗是必不可少的。消融导管用于治疗室性和室上性心律失常。越来越多的证据表明，与药物治疗和植入治疗相比，消融导管治疗心律失常是有效的，但由于治疗的成本和复杂性，只有不到1%的人得到了治疗。这是由于当前导管中的推/拉电缆在控制导管尖端位置方面缺乏重复性和精确性，导致手术时间较长(2至9小时)，这可能会使医生和工作人员暴露在长时间的X射线辐射下，并面临在手术过程中站立的人体工程学挑战。提出的基于电活性聚合物(EAP)的电动微转向执行器利用由SPS创始人之一发明的突破性固态执行器技术来操纵导管尖端位置，并实现基于导管的先进程序。所施加的电压与EAP致动器中的尺寸变化之间的线性对应使得能够精确地控制导管尖端及其力水平，从而大大缩短了手术时间，同时得益于可编程的操作能力，以减少医生暴露在辐射中。建议的驱动技术易于与当前的导管集成，从而降低了系统总成本，同时减少了程序和培训时间。这项技术的商业化并不是微不足道的。SPS将在提纯EAP材料和开发工艺以处理非常软的EAP材料以形成多层结构方面面临挑战。然而，之前与包括美敦力和圣裘德医疗在内的大型医疗器械公司的讨论一直非常积极。所有这些公司都表现出了高度的兴趣，但他们表示，在对进一步投资感兴趣之前，SP需要展示一个工作样机。在这个潜在的BRDG-SPAN计划的资助下，SPS希望设计和生产可用于概念演示的微型可操纵执行器的原型。SPS预计，这一演示将带来完全商业化该技术所需的额外资金和联合开发计划。此外，用于导管应用的致动器开发的成功将推动其他新的医疗设备的应用。) 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，耗时长，不能提供可重复和一致的消融，而拟议的BRDG-SPAN项目将开发电子控制执行器，使其能够实现先进的微操纵性、减少的程序时间和先进的自动化能力。这种创新的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.