新型抗返流输尿管支架管的制作

Fabrication of newly designed ureteral stent with antireflux device

目的制备两款具有抗返流设计的新型输尿管支架管并通过体外实验验证其有效性。方法设计并制备两款新型抗返流输尿管支架管（Q-1型、Q-2型）。将60根普通输尿管支架管随机分为3组（A、B、C组），每组各20根。A组改造成Q-1型抗返流输尿管支架管，B组改造成Q-2型抗返流输尿管支架管。通过体外实验检测3组输尿管支架管的引流通畅性与抗返流性能。并通过体外模拟输尿管支架管置管过程，测定并比较3组支架管在置管过程的阻力。结果成功制作两款新型抗返流输尿管支架管（Q-1型和Q-2型）。在体外实验中，A组和B组输尿管支架管中均有20根支架管具有抗返流性能（100％），而C组输尿管支架管。根支架管具有抗返流性能（0％）。3组支架管在抗返流性能差异有统计学意义（P〈0．01）。在3种不同压力下[30、20、12cmH2O（1cmH2O=0．098kPa）]3组输尿管支架管引流速度分别为（23．25±1．80）、（15．92±1．42）、（10．11±1．23）ml／min，（25．18±2．16）、（18．15±1．58）、（12．46±2．01）ml／min，（51．38±1．78）、（39．31±2．23）、（27．09±1．46）ml／min，引流通畅性能差异有统计学意义（P〈0．01）。3组支架管在体外模拟两种不同方式置管过程测得的阻力分别是（0．797±0．093）、（0．997±0．122）N，（0．746±0．043）、（0．786±0．076）N，（0．683±0．094）、（0．654±0．087）N（P〈0．05）。结论Q-1型和Q-2型抗返流输尿管支架管具备极佳的抗返流性能和足够良好的引流通畅性，在置管方面也易于操作。

Objective To develop two advanced double J stents with anti - reflux device and eval- uate the effectiveness of these new double J stents by in vitro studies. Methods We manufactured two newly designed double J stents with anti - reflux device （ Model Q - 1, and Model Q - 2）. Sixty pieces of standard double J stents were randomly divided into three groups： A, B and C （n =20 each）. Group A was given Model Q - 1, and group B Model Q - 2. In vitro testing was conducted to evaluate the drainage and antireflux characteristics of Model Q -1 （group A）, Model Q -2 （group B） and standard double J stent （group C）. In an in vitro experimental model, we compared the resistance of ureteral placement among the three groups and the force of stent insertion was measured. Results Two newly designed double J stents with anti - reflux device （ Model Q - 1, and Model Q - 2） were manufactured. In the in vitro tes- ting, there was significant difference among the three groups in anti - reflux properties （ P 〈 0.01 ）. Twenty cases in both group A and group B had positive results of anti - reflux （ 100% , 20/20）, while 0 case in group C （0%, 0/20）. In terms of drainage properties, the flow rate [under different pressues of 30, 20 and 12cmH2O （l cmH2O =0.098 kPa）] was （23.25± 1.80）, （15.92 ± 1.42） and （10.11 ±1. 23 ） ml/min in group A, （25. 18 ± 2. 16）, （ 18. 15 ± 1.58） and （ 12.46 ± 2. 01 ） ml/min in group B, and （51.38 ± 1.78） , （39. 31 ±2. 23） and （27.09 ± 1.46） ml/min in group C, respectively. There were notable differences among three groups （P 〈 0. 01 ）. The force of stent insertion in two different ways was （0.797±0.093） and （0.997 ±0.122） N in group A, （0.746 ±0.043） and （0.786 ±0.076） N in group B, and （0.683 ±0.094） and （0.654 ±0.087） N in group C （P〈0.05）. Conclusion The two newly designed double J stents with anti - reflux device （ Model Q - 1, and Model Q - 2） had favorable drainage and perfect anti - reflux properties, and were easily placed over a gnidwire.