心内导管三维定位装置的信号源系统关键技术研究与开发
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摘要
心房纤颤(简称房颤)是临床上最常见的复杂性心律失常,房颤本身及其所引起的并发症严重威胁着人类健康。目前在针对房颤的临床防治技术中,射频消融手术治疗一直备受重视,其原因主要是由于手术中所采用的心内导管三维定位装置能够快速准确地完成心脏待消融靶点的精确定位,因此在介入治疗中得到了广泛的应用。近年来,导管定位已从传统的二维定位方式发展为空间三维定位技术,更进一步地实现了导管快速定位,并提高了消融成功率。
     心内导管的位置探测必须借助于专用装置来进行。目前与电生理诊疗技术相关的生物电场定位装置的开发,已成为心脏电生理工程领域的研究热点。
     本文在生物电场定位技术的基础上,对心内导管三维定位装置中的信号源系统进行了研究。同时,针对射频消融手术中对信号源系统各项性能指标的要求,开发出一套高集成度、稳定性强的专用信号源系统,并通过实验测试和验证了该系统各项性能指标。
     本研究主要完成了以下内容:
     1)分析了生物电场定位技术原理,探讨了整个定位装置对信号源系统的功能要求,拟定了系统输出信号的电流和频率等指标范围,并在此基础上完成了信号源系统的总体方案设计。
     2)完成了系统中信号发生模块、信号调理模块、压控恒流源(VCCS)模块及稳压电源模块的硬件电路原理设计,并编写了软件控制程序。
     3)对压控恒流源模块进行仿真以验证其恒流效果;搭建系统硬件平台,验证电路的可行性和可靠性;分阶段制作了PCB电路板并进行了系统性能测试。
     4)设计了一个模拟心内导管在人体胸腔中进行定位的装置,将信号源系统连入该装置进行测试,以检验系统对本实验中的动态生物电场、在呼吸、心跳条件下所引起波动的敏感性;通过动物实验进一步对系统进行验证,并将信号源系统与数据采集和信号处理装置进行连接,探索临床手术中系统输出信号的频率和电流特性及安全性。
Atrial fibrillation (AF) is a familiar complex arrhythmia disease in clinic. AF and its complications are serious harm to people's health. At present, radio-frequency (RF) ablation operation is widely used to cure AF due to its three dimension (3D) positioning system. Through this system, the ablation catheter can detect endocardial target easily. In recent years, detect technology in catheter positioning is developed from two-dimensions (2D) to 3D, therefore, catheter can located the pathologic focus in human heart effectively, and operative success rate is raised greatly.
     Based on positioning technology in bioelectric field, a signal source system is researched in this dissertation according to endocardial catheter 3D positioning. At the same time, considering RF ablation operation, various performance indexes of the system are introduced. Subsequently, a special signal source system is developed with high integration and stability; experiments are performed to test its various indexes.
     The main researches are described as follows:
     1) Principle of positioning technology based on the bioelectric field is analyzed. Functional requirements in the whole positioning device are discussed. Moreover, indexes range of current and frequency in the output signal are specified. Based on these results, schematic design of the whole signal source is completed.
     2) Signal generating module, signal conditioning module, voltage controlled current source (VCCS) module and regulated power supply module are designed, furthermore, software control program are compiled for debugging.
     3) Constant current effect in VCCS module is verified through simulation methods; hardware circuit of the whole system is built up for proving feasibility and reliability; printed circuit boards (PCB) are produced in each step in order to test the system performance.
     4) A kind of positioning device is designed to simulate the process of endocardial catheter inserting human thorax. Because signal source system is connected to the positioning device, within breath and heartbeat effects, the sensibility of biological electric field must be considered. Through animal experiments, system performances are analyzed for further research. By linking the signal source system with data acquisition and signal process device, current and frequency characteristics in the output signal are explored for clinical medicine research.
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