CN111420243A - A Novel Esophageal Dilation Balloon Catheter - Google Patents
A Novel Esophageal Dilation Balloon Catheter Download PDFInfo
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- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1011—Multiple balloon catheters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J15/00—Feeding-tubes for therapeutic purposes
- A61J15/0003—Nasal or oral feeding-tubes, e.g. tube entering body through nose or mouth
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J15/00—Feeding-tubes for therapeutic purposes
- A61J15/0026—Parts, details or accessories for feeding-tubes
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/84—Drainage tubes; Aspiration tips
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1002—Balloon catheters characterised by balloon shape
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
- A61M29/02—Dilators made of swellable material
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M2025/0008—Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M2025/0063—Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
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- A—HUMAN NECESSITIES
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2210/00—Anatomical parts of the body
- A61M2210/10—Trunk
- A61M2210/1042—Alimentary tract
- A61M2210/105—Oesophagus
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Abstract
Description
技术领域technical field
本发明涉及一种新型食管扩张球囊导管,具体涉及一种新型新型扩张球囊的设计及使用方法,属于医用生物材料技术领域。The invention relates to a novel esophagus expansion balloon catheter, in particular to a design and use method of a novel novel expansion balloon, and belongs to the technical field of medical biological materials.
背景技术Background technique
食管闭锁是一种常见的先天性消化道畸形,活产新生儿中发病率约为1/3000-4000。随着外科手术技术、围术期重症监护技术、小儿腔镜技术以及围术期营养支持的进步,患儿的存活率有了显著提高。然而,吻合口狭窄、吻合口漏、胃食管反流等术后并发症仍影响患儿的生存质量。其中,吻合口狭窄是一种较常见的并发症,有文献报道其发病率高达18%-50%。此外,各种原因导致的食管狭窄包括先天性狭窄,后天性如腐蚀性食管炎、食管术后吻合口狭窄等均需对狭窄处进行反复多次扩张。Esophageal atresia is a common congenital malformation of the digestive tract, with an incidence of approximately 1/3000-4000 live births. With the advancement of surgical techniques, perioperative intensive care techniques, pediatric endoscopic techniques, and perioperative nutritional support, the survival rate of children has improved significantly. However, postoperative complications such as anastomotic stenosis, anastomotic leakage, and gastroesophageal reflux still affect the quality of life of children. Among them, anastomotic stenosis is a relatively common complication, and it has been reported in the literature that its incidence is as high as 18%-50%. In addition, esophageal stenosis caused by various reasons, including congenital stenosis, and acquired esophagitis such as erosive esophagitis, postoperative anastomotic stenosis, etc., require repeated expansion of the stenosis.
扩张方式主要有两种:硬质探条和软质球囊。硬质探条在胃镜下通过探条适度撕裂食管肌肉层而起到扩张作用。然而研究表明硬质探条在扩张食管时所产生的力仅为纵行的轴向剪切力,这可能造成食管内膜的损伤甚至穿孔。球囊扩张时所产生的力为环形辐射状扩张力,大大减少了力量过于集中而造成食管损伤的可能。球囊扩张导管选用可塑性较好的尼龙材料,具有良好的过弯性能,有效减轻通过时对对腔道的损伤,球囊段安装有显影标记,可精确的判断使用时导管所在的位置,球囊通透性好,可以清晰观察扩张、撕裂、出血情况,安全性良好。但不论是哪种扩张方式均需在内镜下或X线造影下完成,治疗程序繁琐,增加了医务工作者和患者的放射线暴露。部分或者需进行多次扩张导致他们需多次住院,增加治疗成本,因此,迫切的需要一种新的方案解决上述技术问题。There are two main ways of expansion: rigid probe and soft balloon. Rigid probes play a role in dilation by moderately tearing the esophageal muscle layer under gastroscopy. However, studies have shown that the force generated by the rigid probe when expanding the esophagus is only the longitudinal axial shear force, which may cause damage or even perforation of the esophageal intima. The force generated when the balloon is inflated is a ring-shaped radial expansion force, which greatly reduces the possibility of esophagus injury caused by excessive force concentration. The balloon dilatation catheter is made of nylon material with good plasticity, which has good bending performance and can effectively reduce the damage to the lumen when passing through. The capsule has good permeability, and can clearly observe the expansion, tearing, and bleeding, and the safety is good. However, no matter which expansion method is used, it needs to be completed under endoscopy or X-ray angiography, and the treatment procedures are cumbersome, which increases the radiation exposure of medical workers and patients. Partial or multiple expansions lead to multiple hospitalizations and increased treatment costs. Therefore, a new solution is urgently needed to solve the above-mentioned technical problems.
发明内容SUMMARY OF THE INVENTION
本发明正是针对现有技术中存在的问题,提供一种新型食管扩张球囊导管,该技术方案通过一特制的三腔二囊导管实现对狭窄食管进行多次间断扩张,避免多次内镜或造影操作。同时通过胃内抗返流囊减少患者进食后胃食管返流导致食管再狭窄。The present invention is aimed at the problems existing in the prior art, and provides a novel esophagus dilation balloon catheter. The technical scheme realizes multiple intermittent expansion of the narrow esophagus through a special three-lumen two-balloon catheter, avoiding multiple endoscopic procedures. or imaging operations. At the same time, the gastroesophageal reflux after eating is reduced by the intragastric anti-reflux balloon, which leads to esophageal restenosis.
为了实现上述目的,本发明的技术方案如下,一种新型食管扩张球囊导管,包括上端的食管扩张球囊、下端的抗返流球囊、中心鼻饲管、中心导管内导丝及尾端带阀注水接口,所述食管扩张球囊位于新型扩张球囊的上端,放置于食管内食管狭窄处,所述抗返流球囊位于新型扩张球囊下端,放置于胃内贲门处,所述中心鼻饲管位于新型食管扩张球囊中心部,中空,可以进行胃肠减压或鼻饲。所述尾端带阀注水接口位于新型食管扩张球囊导管尾端,通过控制注水量分别对食管扩张球囊、抗返流球囊进行扩张压力调节。中心鼻饲管可进行流质饮食鼻饲,实现早期肠内营养。本食管扩张导管,未充气时,主管道管身自端部三腔管以后平滑延伸,无明显凸起,降低了插管的难度,减轻了插管时的咽反应。所述主管道为高弹性管道,食管扩张囊及抗返流囊均为压缩态水(气)囊,经充水(气),食管扩张囊膨胀橄榄形,抗返流囊膨胀成蘑菇头形。抽水(气)后,在高弹性主管身弹性恢复力下,气囊再次压缩,拔管时减少医源性再出血风险。In order to achieve the above purpose, the technical scheme of the present invention is as follows, a novel esophageal dilation balloon catheter, comprising an esophageal dilation balloon at the upper end, an anti-reflux balloon at the lower end, a central nasogastric feeding tube, a guide wire in the central catheter and a tail end band Valve water injection interface, the esophagus dilation balloon is located at the upper end of the new type of expansion balloon, and is placed at the esophagus stenosis in the esophagus, the anti-reflux balloon is located at the lower end of the new type of expansion balloon, and is placed at the gastric cardia, the center The nasogastric feeding tube is located in the center of the new esophageal dilation balloon, which is hollow and can be used for gastrointestinal decompression or nasogastric feeding. The water injection port with valve at the tail end is located at the tail end of the new esophageal dilation balloon catheter, and the dilation pressure of the esophagus dilation balloon and the anti-reflux balloon is adjusted respectively by controlling the water injection volume. The central nasogastric tube can be used for liquid diet nasogastric feeding to achieve early enteral nutrition. When the esophageal dilation catheter is not inflated, the main pipe body extends smoothly from the three-lumen tube at the end without obvious bulge, which reduces the difficulty of intubation and reduces the pharyngeal reaction during intubation. The main pipeline is a high elastic pipeline, the esophagus dilatation bag and the anti-reflux sac are both compressed water (air) sacs, which are filled with water (air), the esophagus dilatation sac is inflated into an olive shape, and the anti-reflux sac is inflated into a mushroom head shape. . After pumping water (air), the balloon is compressed again under the elastic restoring force of the highly elastic main body, reducing the risk of iatrogenic rebleeding during extubation.
作为本发明的一种改进,所述新型食管扩张球囊导管为特制的三腔二囊导管,所述食管扩张球囊为橄榄形或囊柱状球囊,抗返流球囊为蘑菇头形球囊,该设计为蘑菇头形为临床常用防止管道脱落。As an improvement of the present invention, the novel esophageal dilation balloon catheter is a special three-cavity two-balloon catheter, the esophagus dilation balloon is an olive-shaped or balloon-columnar balloon, and the anti-reflux balloon is a mushroom head-shaped balloon The sac, which is designed as a mushroom head shape, is commonly used in clinics to prevent the duct from falling off.
作为本发明的一种改进,所述尾端带阀注水接口包括食管扩张囊注水管和抗返流囊注水管,所述食管扩张囊注水管、抗返流囊注水管分别与食管扩张球囊、抗返流球囊相连通。As an improvement of the present invention, the water injection port with valve at the tail end includes an esophagus dilatation balloon water injection pipe and an anti-reflux balloon water injection pipe, and the esophagus dilation balloon water injection pipe and the anti-reflux balloon water injection pipe are respectively connected with the esophagus dilation balloon. , The anti-reflux balloon is connected.
作为本发明的一种改进,所述食管扩张囊注水管、抗返流囊注水管尾端均设有带螺纹抗返流阀,在抗返流阀与注水管间设有指示球囊。所述指示球囊所用球囊质地硬于食管扩张球囊、抗返流球囊,可通过指示囊硬度判断食管扩张球囊、抗返流球囊是否处于注水状态或破裂漏水。As an improvement of the present invention, a threaded anti-reflux valve is provided at the end of the esophagus dilatation bag water injection pipe and the anti-reflux bag water injection pipe, and an indicator balloon is provided between the anti-reflux valve and the water injection pipe. The quality of the balloon used for the indicator balloon is harder than that of the esophagus dilation balloon and the anti-reflux balloon. Whether the esophagus dilatation balloon or the anti-reflux balloon is in a water-filled state or ruptured and leaked can be judged by the hardness of the indicator balloon.
作为本发明的一种改进,所述带螺纹抗返流阀为单向阀,包括注水漏斗、密封塞、支撑杆、弹簧、密封圈、挡板以及尾端螺纹接口,所述注水漏斗顶部直径大于注射器乳头,底部直径小于注射器乳头,漏斗底部带有孔隙,所述密封塞与所述支撑杆为一体成型结构,所述支撑杆滑动插接在所述挡板上,所述弹簧位于所述密封塞与所述挡板之间,所述密封圈的内径小于述密封塞的直径,所述密封圈 通过固定在所述抗返流阀尾端内侧壁上,所述支撑挡板带有孔隙固定在所述注抗返流阀的内侧壁上。单向阀可使医务人员或患者在注水(注气)后解放双手,避免应用止血钳钳夹注水口。传统止血钳钳夹可能造成管道损伤或止血钳松脱导致球囊萎陷。抗返流阀尾端设有螺纹,可与带螺纹设计的测压泵稳定连接,检测扩张球囊内压力。As an improvement of the present invention, the threaded anti-reflux valve is a one-way valve, including a water injection funnel, a sealing plug, a support rod, a spring, a sealing ring, a baffle and a threaded interface at the end. The diameter of the top of the water injection funnel is It is larger than the syringe nipple, the diameter of the bottom is smaller than that of the syringe nipple, the bottom of the funnel has a hole, the sealing plug and the support rod are integrally formed, the support rod is slidably inserted on the baffle, and the spring is located in the Between the sealing plug and the baffle, the inner diameter of the sealing ring is smaller than the diameter of the sealing plug, the sealing ring is fixed on the inner side wall of the tail end of the anti-reflux valve, and the supporting baffle has holes It is fixed on the inner wall of the anti-reflux valve. The one-way valve enables medical staff or patients to free their hands after water (gas) injection, avoiding the application of hemostatic forceps to clamp the water injection port. Traditional hemostatic clamps can cause damage to the tubing or loosen the hemostat leading to balloon collapse. The end of the anti-reflux valve is provided with a thread, which can be stably connected with a pressure measuring pump with a thread design to detect the pressure in the expansion balloon.
作为本发明的一种改进,所述在食管扩张球囊及抗返流球囊上下端均有金属标记物(16),可在X线下显影,便于定位。As an improvement of the present invention, the upper and lower ends of the esophagus dilation balloon and the anti-reflux balloon are provided with metal markers (16), which can be visualized under X-rays and facilitate positioning.
作为本发明的一种改进,所述扩张球囊导管表面带有长度刻度标记,便于置管过程中准确控制置管深度。As an improvement of the present invention, the surface of the dilation balloon catheter is marked with a length scale, which facilitates accurate control of the depth of catheter placement during catheter placement.
作为本发明的一种改进,所述中心鼻饲管的导管为中空结构,具有一定强度,不因球囊注水挤压而发生明显内径减小。其内径大于导引钢丝直径。在放置导管时导引钢丝起到导引支撑作用,便于置管操作。鼻饲管尾端带有螺纹接口,可通过连接肝素帽关闭鼻饲管或连接减压囊进行胃肠减压。As an improvement of the present invention, the catheter of the central nasogastric feeding tube has a hollow structure and has a certain strength, and the inner diameter is not significantly reduced due to the extrusion of water injection of the balloon. Its inner diameter is larger than the diameter of the guide wire. When placing the catheter, the guide wire plays a guiding and supporting role, which is convenient for the catheter placement operation. The end of the nasogastric feeding tube has a threaded interface, which can be used for gastrointestinal decompression by connecting a heparin cap to close the nasogastric feeding tube or connecting a decompression bag.
作为本发明的一种改进,食管扩张球囊可分别位于食管上段、中段及下段对不同部位的狭窄进行扩张,所述食管扩张囊与抗返流囊之间间距2cm-30cm,2cm为一个区间。所述扩张囊长度为4cm-8cm,2cm为一个区间。所述扩张囊直径为6mm-20mm,2mm为一个区间。直径长度系列化。所述抗返流球囊直径2-6cm,1cm为一个区间,长度1-2cm,1cm为一个区间。直径长度系列化。新型食管扩张球囊导管外管直径不注水状态下小于4mm。主管道为高弹性硅胶或橡胶管,球囊为聚氨酯及硅胶等高聚物,指示球囊为较扩张及抗返流囊顺应性小的PVC材料。此处压力指示囊为简易PVC塑料球囊,通过其充盈程度判断扩张球囊或抗返流囊是否处于注水状态或球囊破损,操作简单,成本较低,对于扩张球囊压力精确测量可通过注水尾端连接测压泵测量。As an improvement of the present invention, the esophageal dilation balloon can be respectively located in the upper, middle and lower segments of the esophagus to expand the stenosis in different parts, and the distance between the esophageal dilation balloon and the anti-reflux balloon is 2cm-30cm, and 2cm is an interval . The length of the expansion bag is 4cm-8cm, and 2cm is an interval. The diameter of the expansion balloon is 6mm-20mm, and 2mm is an interval. Diameter length serialization. The diameter of the anti-reflux balloon is 2-6 cm, 1 cm is an interval, and the length is 1-2 cm, and 1 cm is an interval. Diameter length serialization. The diameter of the outer tube of the new esophageal dilation balloon catheter is less than 4mm without water injection. The main pipe is a high elastic silicone or rubber tube, and the balloon is a high polymer such as polyurethane and silicone, indicating that the balloon is a PVC material with less compliance than the expansion and anti-reflux balloon. The pressure indicating bag here is a simple PVC plastic balloon, and it can be judged by its filling degree whether the expansion balloon or anti-reflux balloon is in a water-filled state or the balloon is damaged. The operation is simple and the cost is low. The water injection end is connected to the pressure measuring pump for measurement.
相对于现有技术,本发明具有如下优点,1)该技术方案提供一种食管扩张球囊导管,具有一次置管反复多次间断扩张作用;2)该技术方案中抗返流囊的设计能减少术后早期因胃食管返流而导致的食管再狭窄发生几率;3)该中心鼻饲管可以进行营养液鼻饲或进行胃肠减压操作;使用时由于鼻饲管内设有导丝,从而增加导管的硬度,能降低医护人员在操作的难度指标;4)该设计通过食管扩张球囊的间断扩张减少此类患者胃镜检查及造影检查的次数;下端抗返流球囊的扩张避免进食后胃食管反流导致的返流性食管炎、食管再狭窄;中心鼻饲管可进行流质饮食鼻饲,实现早期肠内营养。中心鼻饲管的设计可以在术后早期就实现肠内营养,结合抗返流囊的应用可以实现术后早期旷置食管的作用,从而起到避免胃食管返流对吻合口愈合的影响同时尽早恢复肠内营养改善和维持肠黏膜细胞结构和功能的完整性,维护肠道黏膜屏障,减少肠道细菌移位及肠源性感染发生。此外,在胃肠胀气时于中心鼻饲管尾端连接负压囊可以起到胃肠加压的作用,以改善胃肠壁血液循环,促进消化道功能恢复。Compared with the prior art, the present invention has the following advantages: 1) the technical solution provides an esophageal dilation balloon catheter, which has the effect of repeated intermittent expansion after one-time catheter placement; 2) the design of the anti-reflux balloon in this technical solution can Reduce the risk of esophageal restenosis caused by gastroesophageal reflux in the early postoperative period; 3) The central nasogastric feeding tube can be used for nutrient solution nasogastric feeding or gastrointestinal decompression operation; when used, there is a guide wire in the nasogastric feeding tube, thereby increasing the number of catheters 4) The design reduces the number of gastroscopy and angiography examinations for such patients through the intermittent expansion of the esophageal dilation balloon; the expansion of the anti-reflux balloon at the lower end prevents the gastroesophagus after eating Reflux esophagitis and esophageal restenosis caused by reflux; central nasogastric feeding tube can be used for liquid diet nasogastric feeding to achieve early enteral nutrition. The design of the central nasogastric feeding tube can realize enteral nutrition in the early postoperative period, and the application of the anti-reflux bag can realize the effect of emptying the esophagus in the early postoperative period, thus avoiding the effect of gastroesophageal reflux on the healing of the anastomosis and at the same time as soon as possible. Restoring enteral nutrition improves and maintains the integrity of the intestinal mucosal cell structure and function, maintains the intestinal mucosal barrier, and reduces the translocation of intestinal bacteria and the occurrence of intestinal infection. In addition, connecting a negative pressure bag to the end of the central nasogastric feeding tube during flatulence can play a role in gastrointestinal pressure, so as to improve the blood circulation of the gastrointestinal wall and promote the recovery of digestive tract function.
附图说明Description of drawings
图1本发明的结构示意图;Fig. 1 is the structural representation of the present invention;
图2本发明中单向阀示意图;Figure 2 is a schematic diagram of the one-way valve in the present invention;
图中:1新型食管扩张球囊导管,2抗反流阀,3指示球囊,11食管扩张球囊,12抗返流囊,13中心鼻饲导管,14导丝,151及152为注水接口,16金属标识,2抗返流阀,21注水漏斗,22密封塞,23支撑杆,24弹簧,25密封圈,26挡板,27螺纹接口。In the figure: 1 new esophageal dilation balloon catheter, 2 anti-reflux valve, 3 indicating balloon, 11 esophagus dilation balloon, 12 anti-reflux balloon, 13 central nasogastric feeding catheter, 14 guide wire, 151 and 152 are water injection ports, 16 metal signs, 2 anti-reflux valves, 21 water injection funnels, 22 sealing plugs, 23 supporting rods, 24 springs, 25 sealing rings, 26 baffles, 27 threaded ports.
具体实施方式:Detailed ways:
为了加深对本发明的理解,下面结合附图对本实施例做详细的说明。In order to deepen the understanding of the present invention, the present embodiment will be described in detail below with reference to the accompanying drawings.
实施例1:参见图1,一种新型食管扩张球囊导管,包括上端的食管扩张球囊11、下端的抗返流球囊12、中心鼻饲管13、中心导管内导丝14及尾端带阀注水接口15,所述食管扩张球囊11位于新型扩张球囊的上端,放置于食管内食管狭窄处,所述抗返流球囊12位于新型扩张球囊下端,放置于胃内贲门处,所述中心鼻饲管13位于新型食管扩张球囊1中心部,中空,可以进行胃肠减压或鼻饲。所述尾端带阀注水接口15位于新型食管扩张球囊导管1尾端,通过控制注水量分别对食管扩张球囊11、抗返流球囊12进行扩张压力调节。中心鼻饲管可进行流质饮食鼻饲,实现早期肠内营养。本食管扩张导管,未充气时,主管道管身自端部三腔管以后平滑延伸,无明显凸起,降低了插管的难度,减轻了插管时的咽反应。所述主管道为高弹性管道,食管扩张囊及抗返流囊均为压缩态水(气)囊,经充水(气),食管扩张囊膨胀橄榄形,抗返流囊膨胀成蘑菇头形。Embodiment 1: Referring to FIG. 1, a new type of esophageal dilation balloon catheter includes an
抽水(气)后,在高弹性主管身弹性恢复力下,气囊再次压缩,拔管时减少医源性再出血风险,所述新型食管扩张球囊导管1为特制的三腔二囊导管,所述食管扩张球囊11为橄榄形或囊柱状球囊,抗返流球囊12为蘑菇头形球囊,在正常使用中,具体形状也可以适当调整,所述尾端带阀注水接口15包括食管扩张囊注水管151和抗返流囊注水管152,所述食管扩张囊注水管151、抗返流囊注水管152分别与食管扩张球囊11、抗返流球囊12相连通,所述食管扩张囊注水管151、抗返流囊注水管152尾端均设有带螺纹抗返流阀2,在抗返流阀与注水管间设有指示球囊3。所述指示球囊3所用球囊质地硬于食管扩张球囊11、抗返流球囊12,可通过指示囊硬度判断食管扩张球囊11、抗返流球囊12是否处于注水状态或破裂漏水,所述带螺纹抗返流阀2为单向阀,包括注水漏斗21、密封塞22、支撑杆23、弹簧24、密封圈25、挡板26以及尾端螺纹接口27,所述注水漏斗21顶部直径大于注射器乳头,底部直径小于注射器乳头,漏斗底部带有孔隙,所述密封塞22与所述支撑杆23为一体成型结构,所述支撑杆23滑动插接在所述挡板26上,所述弹簧24位于所述密封塞22与所述挡板26之间,所述密封圈25的内径小于述密封塞22的直径,所述密封圈 25通过固定在所述抗返流阀尾端内侧壁上,所述支撑挡板26带有孔隙固定在所述注抗返流阀的内侧壁上,所述在食管扩张球囊11及抗返流球囊12上下端均有金属标记物16,可在X线下显影,便于定位,所述扩张球囊导管表面带有长度刻度标记,便于置管过程中准确控制置管深度,所述中心鼻饲管13的导管为中空结构,具有一定强度,不因球囊注水挤压而发生明显内径减小。其内径大于导引钢丝直径14。在放置导管时导引钢丝起到导引支撑作用,便于置管操作。鼻饲管尾端带有螺纹接口,可通过连接肝素帽关闭鼻饲管或连接减压囊进行胃肠减压,食管扩张球囊11可分别位于食管上段、中段及下段对不同部位的狭窄进行扩张,所述食管扩张囊11与抗返流囊12之间间距2cm-30cm,2cm为一个区间。所述扩张囊长度为4cm-8cm,2cm为一个区间。所述扩张囊直径为6mm-20mm,2mm为一个区间。直径长度系列化;所述抗返流球囊12直径2-6cm,1cm为一个区间,长度1-2cm,1cm为一个区间。直径长度系列化。新型食管扩张球囊导管1外管直径不注水状态下小于4mm。主管道为高弹性硅胶或橡胶管,球囊为聚氨酯及硅胶等高聚物,指示球囊为较扩张及抗返流囊顺应性小的PVC材料。After pumping water (air), the balloon is compressed again under the elastic restoring force of the highly elastic main body, which reduces the risk of iatrogenic rebleeding during extubation. The
应用实施例以及工作过程:一种特制的三腔二囊导管,如图1所示,包括上端食管扩张球囊11、下端抗返流球囊12、中心鼻饲管13、中心导管内导丝14及尾端带阀注水接口15。所述食管扩张球囊11位于新型扩张球囊的上端,放置于食管内食管狭窄处。所述抗返流球囊12位于新型扩张球囊下端,放置于胃内贲门处。所述中心鼻饲管13位于新型食管扩张球囊1中心部,中空,可以进行胃肠减压或鼻饲。所述尾端带阀注水接口15位于新型食管扩张球囊导管(1)尾端,通过控制注水量分别对食管扩张球囊11、抗返流球囊12进行扩张压力调节。Application example and working process: a special three-lumen two-balloon catheter, as shown in Figure 1, includes an upper end
医务工作者在操作前经消化道造影、内镜检查或术中测量结果,确定食管狭窄的部位及范围,选择适宜尺寸的食管扩张球囊导管(包括球囊直径、长度、扩张囊与抗返流囊间距等指标)。在导引钢丝14引导下放置食管扩张球囊。通过X线检查,依据金属标识16确定两个球囊的位置关系。术后早期通过对扩张囊间断多次注水扩张,预防疤痕增生引起的食管狭窄。在扩张过程中要注意扩张时长及球囊张力,避免过度压迫导致食管粘膜缺血。具体压力为0.5-3个大气压,扩张时间3-5分钟,每日扩张3-5次。在患者鼻饲后对抗返流囊进行注水,适度牵拉扩张导管使抗返流囊紧贴贲门口,预防术后早期胃食管返流导致返流物刺激吻合口而造成吻合口漏或狭窄。在胃排空后抽空抗返流囊避免球囊对胃底粘膜的压迫。所述中心鼻饲管13,导管为中空结构,具有一定强度,不因球囊注水挤压而发生明显内径减小。其内径大于导引钢丝直径14。尾端带有螺纹接口,可通过连接肝素帽关闭鼻饲管或连接减压囊进行胃肠减压。Before the operation, medical workers will determine the location and extent of esophageal stenosis through gastrointestinal angiography, endoscopy or intraoperative measurement results, and select an appropriate size of esophageal dilatation balloon catheter (including balloon diameter, length, dilation balloon and anti-return balloon). sac spacing and other indicators). The esophageal dilation balloon is placed under the guidance of the
依据图2所示在注水口151及152处设有单向抗返流阀2,包括注水漏斗21、密封塞22、支撑杆23、弹簧24、密封圈25、挡板26以及尾端螺纹接口27。所述注水漏斗21顶部直径大于注射器乳头,底部直径小于注射器乳头,漏斗底部带有孔隙。所述密封塞22与所述支撑杆23为一体成型结构,所述支撑杆23滑动插接在所述挡板26上,所述弹簧24位于所述密封塞22与所述挡板26之间。所述密封圈25的内径小于述密封塞22的直径,所述密封圈 25通过固定在所述抗返流阀尾端内侧壁上。所述支撑挡板26带有孔隙固定在所述注抗返流阀的内侧壁上。操作过程中将注射器或带有压力检测的注水泵与抗返流阀螺纹接口连接,通过注射器或压力泵乳头推动注水漏斗使密封塞、支撑杆复合体下移而使单向阀开放进行注水或抽水操作。操作结束后拔出注射器或压力泵,复合体在弹簧作用下回弹,使密封塞与密封圈紧密贴合关闭阀门,起到抗返流作用。According to FIG. 2, a one-way anti-reflux valve 2 is provided at the
依据图1所示,在抗返流阀下端设有指示球囊3,其特征在于:所用球囊质地硬于食管扩张球囊11、抗返流球囊12,可通过指示囊硬度判断食管扩张球囊11、抗返流球囊12是否处于注水状态或破裂漏水。As shown in FIG. 1, an
需要说明的是上述实施例,并非用来限定本发明的保护范围,在上述技术方案的基础上所作出的等同变换或替代均落入本发明权利要求所保护的范围。It should be noted that the above-mentioned embodiments are not intended to limit the protection scope of the present invention, and equivalent transformations or substitutions made on the basis of the above-mentioned technical solutions all fall into the protection scope of the present invention.
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| CN209377659U (en) * | 2018-09-06 | 2019-09-13 | 扬州大学附属医院 | A kind of Sengstaken-Blakemore tube |
| CN213048922U (en) * | 2020-03-29 | 2021-04-27 | 南京市儿童医院 | Novel esophagus dilating balloon catheter |
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| CN112932400A (en) * | 2021-01-27 | 2021-06-11 | 上海市第一人民医院 | Continuous expansion device for esophageal entrance stenosis |
| CN113456143A (en) * | 2021-08-10 | 2021-10-01 | 西安交通大学医学院第一附属医院 | Double-balloon anastomat for digestive tract reconstruction |
| CN113842154A (en) * | 2021-09-28 | 2021-12-28 | 山东大学齐鲁医院 | Esophageal upper sphincter achalasia segment positioning device and measuring method |
| CN113842154B (en) * | 2021-09-28 | 2024-03-05 | 山东大学齐鲁医院 | Esophageal upper sphincter achalasia section positioner |
| CN114504508A (en) * | 2022-01-14 | 2022-05-17 | 西安市儿童医院 | Composite nutrient canal supported by esophageal stenosis |
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