膀胱功能电刺激器信号标准的研究

The standardization of electric stimulation signal on bladder function test

目的:膀胱功能电刺激器是应用于截瘫患者控制其排尿的医疗装置,为实现产业化目前尚无相关的国际和国家标准可借鉴,必须进行企业标准的研究。方法:根据现有临床患者使用国外产品的实际情况,参照相关的国家电器标准,分析和研究骶神经前根电刺激控制排尿所需信号的主要特征,包括幅值、脉宽、频率以及信号时间与空号时间等技术要求,并建立相应的试验方法。所确定的电刺激信号范围既能涵盖患者使用的参数值,又不因范围过宽造成不必要的浪费。结论:研究工作为PDC-1型膀胱功能电刺激器企业标准的制订提供了有力的依据,也为今后的试生产提供了具体的实施手段。

Objective:Bladder functional electrical Stimulator is a medical device applied in paraplegic patients with bladder dysfunction. Since there are no relative international and national standards for reference, it is an important step for industrialization to formulate a reasonable enterprise standard. Method && Result: According to the parameters applied by the paraplegic patients and considering the relative national electrical standard, the main characters of the signal for controlling the micturition had been analyzed, which included amplitude, pulse width, frequency, mark time, space time and so on. The ranges of these parameters were determined and the test methods for these parameters were set up. Conclusion:The results will be in accordance with formulating the enterprise standard of the PDC-1 bladder functional electrical stimulator and the test methods can be used to examine the quality of the products.Author′s address College of Life Science and Technology, Tongji University, Shanghai, 200092