一种多参数可控自动化火针的设计、制造和评价

Design,manufacture and evaluation of a multi-parameter controllable automatic fire-acupuncture instrument

将传统火针与现代医疗器械相结合,研制出一种多参数可控的自动化火针医疗器械。采用枪式外形便于手持操作;采用电磁感应加热针体;通过刻度旋钮控制针刺深度;采用电磁弹射结合弹簧复位,精确控制留针时间;使用可更换的一次性无菌单针或多针针头,达到适形、高效、防止感染的目的。以上设计与整体流程控制系统相结合,实现针体温度、针刺密度、进针深度、留针时间精确可控,同时兼具操作简便、快速、无菌、效率高、适形性、可视化等优点。本研究进一步在大鼠上测试了自动化火针对皮肤损伤和毛发生长的影响,结果显示各参数的精确可控对治疗的安全性控制和有效性提高都具有明显的优势,为下一步系统评价其安全性和有效性打下了坚实的工作基础。

A multi-parameter controllable automatic fire-acupuncture instrument was developed by integrating traditional fire needling with modern medical device technology.A gun-like appearance was designed for easy hand-held operation,the electromagnetic induction was for heating needle body,a scale knob was for controlling the needle insertion depth,the combination of electromagnetic ejection and spring return was for the precise control of the needle retention time;and the changeable single sterile needle or multiple needles were adopted to meet individual demand,obtain high efficiency and prevent infection.All of these designs are associated with the overall process control system to ensure the exact controllability of needle body temperature,needling density,insertion depth and needle retention time.Besides,this device is advantageous at handy and aseptic operation with high efficiency,conformability and visualization.In this research,this instrument was tested in animals for the impacts of automatic fire needling on skin damage and fur growth.It is found that the accurate control of each parameter is of the significant advantage in the safety and effectiveness of treatment,which lays a solid foundation for the subsequent systematic review on safety and effectiveness.