Davis Niall F, Cunnane Eoghan M, Mooney Rory C, Manecksha Rustom P, Thornhill John A, Walsh Michael T
Department of Urology, Tallaght Hospital, Dublin, Ireland; Centre for Applied Biomedical Engineering and Research, School of Engineering, Bernal Institute and the Health Research Institute, University of Limerick, Castletroy, Limerick, Ireland.
Centre for Applied Biomedical Engineering and Research, School of Engineering, Bernal Institute and the Health Research Institute, University of Limerick, Castletroy, Limerick, Ireland.
Urology. 2017 Apr;102:258-263. doi: 10.1016/j.urology.2016.11.037. Epub 2017 Jan 13.
To quantify user variability and manufacturer variability in urinary catheter anchoring balloon inflation pressure and to mitigate any significant variance by incorporating flow resistance into the anchoring balloon inflation process.
Inflation of a urinary catheter anchoring balloon was performed at atmospheric pressure by different users (n = 8) to investigate user variability. A calibrated pressure transducer measured inflation pressures, and a video extensometer measured balloon inflation profiles. Manufacturer variability was investigated by applying constant forces to the plunger of conventional syringes to mimic "heavy-," "intermediate-," and "light"-handed users for 3 brands of catheter. Flow restrictors of variable reduced cross-sectional areas were introduced to the outflow of the inflation syringes to investigate the effect of flow resistance on anchoring balloon inflation profiles.
Variations in maximum inflation pressures (range: 75-355 kPa) were observed among the different users. There were no significant differences in maximum inflation pressure between brands at any of the 3 simulated hand forces (P = .97). Increasing the flow resistance significantly reduces the applicable inflation pressure of all hand forces (P < .001). Specifically, the difference in inflation pressure between heavy- and light-handed forces is reduced from over 405 kPa to under 65 kPa. Introducing flow resistance does not result in a significant difference in inflation pressure between brands (P = .254).
There is significant user variability in urinary catheter balloon inflation pressure. This variation can be significantly reduced by introducing flow resistance to the inflation technique.
量化导尿管固定球囊充气压力中的用户变异性和制造商变异性，并通过在固定球囊充气过程中纳入流动阻力来减轻任何显著差异。
8名不同用户在大气压下对导尿管固定球囊进行充气，以研究用户变异性。校准后的压力传感器测量充气压力，视频引伸计测量球囊充气曲线。通过对传统注射器的柱塞施加恒定力来模拟“用力”“中等用力”和“轻轻用力”的用户，对3个品牌的导尿管进行制造商变异性研究。在充气注射器的流出端引入可变横截面积的限流装置，以研究流动阻力对固定球囊充气曲线的影响。
不同用户之间观察到最大充气压力存在差异（范围：75 - 355kPa）。在3种模拟用力情况下，各品牌之间的最大充气压力无显著差异（P = 0.97）。增加流动阻力显著降低了所有用力情况下的适用充气压力（P < 0.001）。具体而言，用力和轻轻用力之间的充气压力差异从超过405kPa降至65kPa以下。引入流动阻力后，各品牌之间的充气压力无显著差异（P = 0.254）。
导尿管球囊充气压力存在显著的用户变异性。通过在充气技术中引入流动阻力，这种变异性可显著降低。
