自控排尿器的研制与在体试验初步报告

The advanced development and in vivo test rudiment report of self-controlled urinary apparatus

目的针对脊髓损伤与截瘫患者的远期尿动力学特点，研制一种成本低廉、安全可靠、携带方便、操作简单、排控兼容的自控排尿器具。方法根据先期神经源性膀胱的远期尿流动力学参数与排尿要求设计制作原型机，该自控排尿器具安装微型压力感受器、电子时间控制器并设定生理接受阀值；参照Crede排尿原理内置滚动式气压囊作排尿动力，另配密封式集尿系统。在体外试验的基础上选择21例完全眭脊髓损伤与截瘫患者试用本自动排尿器，其中截瘫平面在颈椎5例、胸椎7例、腰椎9例，均采用个体化参数设置、压力与时间双重控制。观察压力感受器和时间控制器的敏感性；测定排尿压、尿流率、排尿时间及残余尿；比较试用前后尿液返流、尿路积水及肾功能指标变化。结果压力感受器、时间控制器和双重控制的可靠性分别为85．8％、94．5％和97．9％；排尿量（250±80）ml，排尿时膀胱充盈压（15±6．8）emH2O，最大尿流率（12±4．6）ml/s，最大尿道压（25±10．5）emil2O；排尿时间（1．0±0．5）min，残余尿35±10ml，不同截瘫平面应用自控排尿器的尿道动力学指标差异无显著性意义（P〉0．05）；试用前后尿液返流率、尿路积水率及肾功能指标均无明显变化（P〉0．05），全组无不良事件发生。结论自控排尿器通过压力与时间控制可有效监控患者的膀胱压力与排尿时间，实现无污染、无辅助、无损伤排尿。初步应用表明除外尿道明显梗阻者，该器具可安全、有效的替代人工辅助排尿。

Objective To develop a low-cost, safe, convenient and simple self-controlled urinary apparatus. Methods According to the long-term urodynamics parameters of neurogenic bladder and urination demand, design and make the self-controlled urinary apparatus. It assembled mini-pressoreceptor, electronic time controller and set the physiological acceptable thresholds. The effects of the self-controlled urinary apparatus on 21 complete paraplegic patients with spinal cord injury were observed. Results Reliabilities of pressoreceptor and time controller and double controling were 85.8%, 94.5%and97.9% respectively. The urine backstreaming, accumulate water rate of urinary tract and renal function were as same as those before using the apparatus （P〉0.05）. Conclusion The selfcontrolled urinary apparatus can monitored effectively the press of bladder and time of urination through the control of press and time. It proved that the instrument can substitute the artificial accessory urination safely and effectively, except obvious urinary tract obstruction.