Dynamic force control of cardiac ablation catheters

描述（由申请人提供）：微创手术在筛查、诊断和手术中越来越受欢迎。心律失常的导管消融是最常用的治疗方法之一。心律失常是心律失常的一组情况，其中心脏的电活动不规则或比正常更快或更慢。通过导管消融手术，可以破坏引起不规则心跳的异常心脏组织。众所周知，消融尖端的接触力是决定消融过程中病灶大小和消融时间的能量传递的关键因素之一。如果接触力过低，消融将花费太长时间来燃烧目标组织。如果力过大，则有穿孔的危险。为了解决这个问题，已经提出了各种尖端力传感技术，并且最近已经商业化。然而，这些技术仅在烧蚀过程中提供接触力测量，而不允许任何自动力控制能力，导致操作员手动控制程序。因此，发展自动力控制以及精确的尖端力传感将是一项适用于所有人的创新

DESCRIPTION (provided by applicant): Minimally-invasive procedures have become increasingly popular for screening, diagnosis and surgery. One of the most commonly performed procedures is catheter ablation for cardiac arrhythmia. Cardiac arrhythmia is a group of conditions abnormal heart rhythm in which the electrical activity of the heart is irregular or i faster or slower than normal. Through catheterized ablation procedures, abnormal cardiac tissues that cause irregular heartbeats can be destroyed. It is well known that contact force of the ablation tip is one of the critical factors of energy delivery that determine the lesion size ad ablation time during the procedure. If the contact force is too low, the ablation will take too lon to burn the target tissue. If the force is too high, a risk of perforation is introduced. To addres this issue, various tip force-sensing technologies have been proposed and have recently become commercially available. However, these technologies provide only contact force measurement during ablation but do not allow any automatic capability of force control, resulting in manually controlled procedure by the operator. Therefore, development of automatic force control along with accurate tip force sensing will be an innovation that could be applicable to all catheter ablation procedures in the future. The goal of this project is to develop an automatic force control system for cardiac ablation catheters. The innovation in the proposed system consists of a novel design incorporating a micro-actuator located at the tip of an ablation catheter for contact force control, combined with multiple embedded fiber-optic strain sensors that detect a multi-axis tip force in real-time. Specific aims include i) design and fabrication ofa ablation catheter prototype with an embedded force control unit that applies linear displacement and force to the target tissue with an accurate measurement of tip force, ii) design and prototyping of an anchor mechanism that mechanically holds the force control unit to the target site for increased control performance, iii) development of contact force control algorithms with modeling and system identification, and iv) validation experiments of the catheter prototype using phantom heart models that simulate dynamic heart function, and ex-vivo animal heart tests. The design and prototyping process as well as validation experiments will be monitored and guided by a cardiology expert through the entire project period. Successful completion of this research will demonstrate the feasibility of this research and support follow-on R01 application for developing a further improved system with more clinical tests.