Research Project
7926729
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.
