Dynamic force control of cardiac ablation catheters

心脏消融导管的动态力控制

• 批准号: 8809654
• 负责人: Yong-Lae Park
• 金额: $ 22.68万
• 依托单位: CARNEGIE-MELLON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-12-01 至 2016-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8809654
• 关键词: 3-Dimensional; Ablation; Address; Affect; Algorithms; Alloys; American; Animal Testing; Animals; Arrhythmia; Atrial Fibrillation; Biocompatible Materials; Biological Models; Blood Vessels; Burn injury; Cardiac; Cardiac ablation; Cardiology; Catheters; Cause of Death; Clinical; Computers; Data; Development; Diagnosis; Disease; Fiber Optics; Frequencies; Future; Goals; Health; Heart; Heart Arrest; Heating; Hospitals; Human; Lesion; Life; Measurement; Mechanics; Medical emergency; Memory; Methods; Miniaturization; Modeling; Monitor; Motor; Operative Surgical Procedures; Pathway interactions; Patients; Perforation; Performance; Physicians; Procedures; Process; Radiofrequency Interstitial Ablation; Research; Research Support; Risk; Safety; Shapes; Site; Structure; Suction; System; Technology; Temperature Sense; Testing; Time; Tissues; Travel; Validation; Work; common treatment; cryogenics; design; dexterity; heart electrical activity; heart function; heart rhythm; improved; in vivo; innovation; minimally invasive; models and simulation; novel; prevent; prototype; public health relevance; research study; screening; sensor; titanium nickelide; tool

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.

描述（由申请人提供）：微创手术在筛查、诊断和手术中已变得越来越流行。最常用的手术之一是治疗心律失常的导管消融术。心律失常是一组心律异常的病症，其中心脏的电活动不规则或比正常快或慢。通过导管消融手术，可以破坏导致心律不齐的异常心脏组织。众所周知，消融尖端的接触力是能量输送的关键因素之一，决定手术过程中的病灶大小和消融时间。如果接触力太低，消融将花费太长时间来烧伤目标组织。如果力太大，就会产生穿孔的风险。为了解决这个问题，人们提出了各种尖端力传感技术，并且最近已投入商业应用。然而，这些技术仅提供消融期间的接触力测量，而不允许任何力控制的自动能力，导致操作员手动控制程序。因此，自动力控制的发展以及精确的尖端力传感将是一项可适用于所有领域的创新。 未来的导管消融手术。该项目的目标是开发用于心脏消融导管的自动力控制系统。所提出系统的创新包括一种新颖的设计，该设计结合了位于消融导管尖端的用于控制接触力的微致动器，并结合了多个嵌入式光纤应变传感器，可实时检测多轴尖端力。具体目标包括 i) 设计和制造带有嵌入式力控制单元的消融导管原型，通过精确测量尖端力向目标组织施加线性位移和力，ii) 机械地保持力的锚定机构的设计和原型制作控制单元到目标位置以提高控制性能，iii）开发具有建模和系统识别的接触力控制算法，以及iv）使用模拟动态心脏功能的幻心模型和离体动物心脏对导管原型进行验证实验测试。在整个项目期间，心脏病学专家将监控和指导设计和原型制作过程以及验证实验。这项研究的成功完成将证明这项研究的可行性，并支持后续R01应用，通过更多的临床测试开发进一步改进的系统。