CAJ | 학술논문

目的介绍一种高血压射频消融治疗导管系统的总体设计原理及系统的总体构成,检验肾交感神经射频消融(RFA)导管的性能、射频消融的可行性.方法设计一种高血压射频消融治疗导管系统,通过实际射频输出、实时温度测试、实时阻抗检测性能,检验该导管的不同射频输出条件对组织消融的影响.应用高血压射频消融治疗导管系统对8只成年猪行双侧肾动脉射频消融治疗,测量消融术前、手术后3及9个月的血压变化情况,切取消融区术后病理组织,了解消融术后肾交感神经变化情况.结果高血压射频消融治疗导管系统可实时测定温度、阻抗、射频输出性能良好,可顺利实施组织消融.具有专用计算机射频软件,治疗全程动态控制,可实现治疗参数设置、自动温度控制、治疗数据显示、自动存储、报警等功能.一次性射频输出,免除了旋转等不必要的操作,测温精度达±0.1℃,控温精度±0.15℃,各项性能完全达到临床设计要求.8只成年猪治疗后3个月、9个月的血压较治疗前均下降[(10.6±4.4) mmHg(1 mmHg=0.133 kPa)比(14.8±6.2) mmHg,(10.4±6.4)mmHg比(21.2±10.2) mmHg,均P＜0.05],无相关消融处肾动脉受损狭窄及肾功能损害情况发生.消融术前与术后消融区病理对比显示消融术后神经纤维组织呈坏死改变.结论可控肾交感神经射频消融导管从设计原理、操作和射频输出性能上优于国外同类产品,如能通过临床,则有望成为治疗高血压的国产医疗器械.
목적 개소일충고혈압사빈소융치료도관계통적총체설계원리급계통적총체구성,검험신교감신경사빈소융(RFA)도관적성능、사빈소융적가행성.방법 설계일충고혈압사빈소융치료도관계통,통과실제사빈수출、실시온도측시、실시조항검측성능,검험해도관적불동사빈수출조건대조직소융적영향.응용고혈압사빈소융치료도관계통대8지성년저행쌍측신동맥사빈소융치료,측량소융술전、수술후3급9개월적혈압변화정황,절취소융구술후병리조직,료해소융술후신교감신경변화정황.결과 고혈압사빈소융치료도관계통가실시측정온도、조항、사빈수출성능량호,가순리실시조직소융.구유전용계산궤사빈연건,치료전정동태공제,가실현치료삼수설치、자동온도공제、치료수거현시、자동존저、보경등공능.일차성사빈수출,면제료선전등불필요적조작,측온정도체±0.1℃,공온정도±0.15℃,각항성능완전체도림상설계요구.8지성년저치료후3개월、9개월적혈압교치료전균하강[(10.6±4.4) mmHg(1 mmHg=0.133 kPa)비(14.8±6.2) mmHg,(10.4±6.4)mmHg비(21.2±10.2) mmHg,균P＜0.05],무상관소융처신동맥수손협착급신공능손해정황발생.소융술전여술후소융구병리대비현시소융술후신경섬유조직정배사개변.결론 가공신교감신경사빈소융도관종설계원리、조작화사빈수출성능상우우국외동류산품,여능통과림상,칙유망성위치료고혈압적국산의료기계.
Objective To introduce the overall design principles and structure of a radiofrequency ablation catheter for treatment of hypertension,and to validate the performance and practicability of this catheter in renal sympathetic radiofrequency ablation (RFA) performance.Methods The designed RFA catheter was tested for its different output setups in tissue ablation by measuring the actual radiofrequency output,real-time temperature and real-time impedance.Then,the RFA system was used in 8 adult pigs for radiofrequency ablation of bilateral renal arteries.The blood pressures at baseline,3 and 9 months postablation were measured.The tissues at the operative region were harvested and examined for the change in renal sympathetic nervation after the procedure.Results The RFA system was with good performance in real-time temperature and impedance measurement as well as radiofrequency (RF) output.The tissue ablation was completed as desired.The built-in RF software application of the system allowed for full-length dynamic control of the treatment,with functions of setting treatment parameters,automatic temperature control,data display,automatic storage,and alarming.The one-shot RF output dismissed the need for unnecessary operations such as rotation.The temperature measurement accuracy of the device was ± 0.1 ℃,and the temperature control accuracy ±0.15 ℃.All the performance fulfilled the clinical requirements of design.At 3 and 9 months after radiofrequency ablation,the blood pressure of the 8 adult pigs was reduced as compared with baseline[(10.6±4.4) mmHg(1 mmHg=0.133 kPa) vs (14.8±6.2) mmHg,(10.4±6.4) mmHg vs (21.2± 10.2) mmHg,all P＜0.05].There were no findings for RF-related traumatic constricture of renal arteries or renal impairment.The peripheral sympathetic nerve fiber cells were complete degeneration and necrosis after the procedure compared with baseline.Conclusion The controllable renal sympathetic radiofrequency ablation catheter may be advantageous over international products of the same type in design principles,operation and RF output performance.If validated in clinical practicing,this device is expected to become the domestic medical equipment for treatment of high blood pressure.