肝胆胰外科杂志2026，Vol.38Issue(10)：685-698,705,15.DOI:10.11952/j.issn.1007-1954.2026.10.001
浅谈ERCP取石操作中一次性耗材的设计缺陷及改进创新
Brief discussion on the design defects and improvement innovations of disposable consumables in ERCP stone extraction
摘要
Abstract
Endoscopic retrograde cholangiopancreatography(ERCP)is one of the most preferred treatment options for common bile duct stones,with advantages of minimally invasive,fast recovery,and strong reproducibility.After more than 50 years of development,ERCP technology has become increasingly mature,the success rate of stone extraction has significantly increased,and the incidence rate of complications has significantly decreased.However,ERCP-related events such as selective biliary catheterization failure,stone extraction failure,guidewire perforation,and stent displacement still occur occasionally.In addition to the proficiency of physicians,the design defects of disposable consumables and slow product updates during ERCP procedures are also related to certain factors.This article summarizes our team's clinical experience of using ERCP technology to treat common bile duct stones for more than 20 years.Based on relevant literature at home and abroad,this article discusses the design defects of imported and domestic disposable consumables.For example,nasal oxygen tubes can only provide oxygen to nasal cavity,but patients with nasopharyngeal stenosis or blockage who wear nasal oxygen tubes for oxygen supply are prone to hypoxemia.The lack of insulation protection for guidewire of arciform sphincterotome can cause secondary damage to duodenal folds.The sphincterotome has only one guidewire channel,and double-guidewire method is used for difficult biliary cannulation,which requiring withdrawal of sphincterotome.Balloon dilation catheters need to pass through guidewire throughout the entire process and cannot be exchanged quickly.The guidewire has only one soft tip,and difficult biliary cannulation may require multiple guidewires.The zebra stripes on surface of guidewire help to indicate its movement,but cannot determine its insertion depth.Contrast agent can be injected into the distal bile duct of balloon through a stone extraction balloon catheter,but the proximal bile duct stones are often not clearly visible.The sheath tube of stone extraction basket is relatively thick,and stones in small diameter common bile duct are easily pushed into intrahepatic bile duct.The stone extraction basket sheath without a guiding head is prone to accidentally entering pancreatic duct and is difficult to insert into cystic duct or target intrahepatic bile duct.The gravel basket is difficult to pass through duodenal papilla,the efficiency of crushing hard small stones is low,and the steel wire of basket is prone to deformation.Laser or liquid electric lithotripsy can only be performed under direct view of a microscope and cannot be completed under X-ray.When the linear bile duct stent is removed,the distal flank is prone to scratching duodenal papilla.The difficulty of releasing a single-pigtail pancreatic duct stent is high,and the difficulty of removing a single-pigtail pancreatic duct stent with proximal displacement is even greater.The placement of a fully covered biliary metal stent can damage airtightness of bile duct and easily lead to intestinal bile reflux.The single-pigtail loop of nasobiliary drainage tube can only form a loop within dilated bile duct.During the process of removing nasobiliary drainage tube,the single-pigtail loop or straight head is prone to scratching duodenal papilla.We have made many improvements and designed many innovative disposable products,such as integrated oxygen supply mouth guard,multi-mode oral-nasal oxygen supply mouth guard;double-guidewire sphincterotome,rapid exchange sphincterotome;double-headed zebra guidewire,zebra marker positioning guidewire;rapid exchange balloon dilation catheter;rapid exchange bidirectional injection stone extraction balloon;sphincterotome-assisted stone extraction basket,endoscopic guidewire stone extraction basket;multi-function stone gravel and extraction basket;lantern-shaped bile duct stent,rapid exchange bile duct stent;single-pigtail with side wing pancreatic duct stent;fully covered metal stent with long recycling line;double-pigtail gallbladder stent;lantern-shaped alpha-shaped nasobiliary drainage tube,and series of transparent caps for cholangioscopy.The innovative design of above-mentioned consumables can not only improve the success rate of ERCP stone extraction and reduce the incidence rate of complications,but also increase the competitiveness of domestic consumables.关键词
内镜逆行胰胆管造影/胆总管结石/一次性耗材/设计缺陷/改进和创新/专利成果转化Key words
endoscopic retrograde cholangiopancreatography/common bile duct stones/disposable consumables/design defect/improvement and innovation/patents transformation分类
医药卫生引用本文复制引用
张诚,张桂信,杨玉龙..浅谈ERCP取石操作中一次性耗材的设计缺陷及改进创新[J].肝胆胰外科杂志,2026,38(10):685-698,705,15.基金项目
上海市浦东新区卫生系统重点专科项目(PWZzk2022-17). （PWZzk2022-17）
