WO2022127537A1 - 一种专用于ercp术后残余胆管结石、粘液和絮状物的清理装置 - Google Patents

一种专用于ercp术后残余胆管结石、粘液和絮状物的清理装置 Download PDF

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WO2022127537A1
WO2022127537A1 PCT/CN2021/132660 CN2021132660W WO2022127537A1 WO 2022127537 A1 WO2022127537 A1 WO 2022127537A1 CN 2021132660 W CN2021132660 W CN 2021132660W WO 2022127537 A1 WO2022127537 A1 WO 2022127537A1
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bile duct
rod
cleaning
stones
transmission rod
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PCT/CN2021/132660
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English (en)
French (fr)
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孟文勃
林延延
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兰州大学第一医院
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Publication of WO2022127537A1 publication Critical patent/WO2022127537A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for

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  • the invention relates to the technical field of medical devices, in particular to a cleaning device specially used for residual bile duct stones, mucus and flocs after ERCP.
  • Bile duct stones are a common disease in surgery. Stones in the common bile duct can cause bile duct obstruction secondary to jaundice, cholangitis and even pancreatitis. Bile duct stones may also be complicated by biliary cirrhosis, liver atrophy, liver abscess and other diseases. The clinical symptoms of bile duct stones are mainly epigastric pain.
  • the only treatment for bile duct stones is surgery, in which the stones in the bile duct are removed or broken up by surgery. Commonly used treatment methods include: 1 using metal hard stone forceps to explore and extract the stone along the direction of the bile duct; 2 inserting each bile duct with a rubber catheter for flushing; 3 using choledochoscope to extract the stone.
  • choledochoscopy is the most commonly used treatment for biliary calculi.
  • a fiberoptic choledochoscope is placed along the incision of the biliary duct, and after stones are found, the stones are removed with a stone mesh.
  • the utility model patent is a bile duct stone removal system and its use method (CN202010007836.X), which discloses that small bile duct stones can be washed with water, and the flushing fluid and small bile duct stones can also be sucked out with a negative pressure suction tube, but larger bile duct stones can be sucked out.
  • the stone is blocked in the outer water pipe by the permeable reticular membrane and needs to be clamped out with a clip; the operation steps of this technical solution are complicated, and multiple operations will cause certain damage to the bile duct, and the mucus in the bile duct wall cannot be completely cleared out of the bile duct.
  • the utility model patented fishing method with two mirrors and one thread combined with minimally invasive hepatoprotection for intrahepatic and extrahepatic bile duct stones with lithotripsy and lithotripsy discloses the design of a retractable mesh basket, which avoids the stone extraction basket from touching the inner wall of the bile duct, and the operation is free of pain, trauma, and bleeding. It can integrate biliary stone extraction, flushing, angiography and expansion.
  • A shows 4 mm stones remain in the common bile duct; B shows a large amount of gravel, bile sludge and/or floc in the common bile duct; C shows a small amount of gravel in the common bile duct , bile sludge and flocs; D shows flocs in the common bile duct; E shows cleanness in the common bile duct.
  • Residual bile duct stones and inflammatory flocs on the bile duct wall will be gradually wrapped by crystalline metabolites such as bile pigments and gradually form stones, which require a second operation to remove them, causing damage to both the patient's body and mind.
  • the inventor applied for a stone extraction device (CN201921922709.1) dedicated to residual bile duct stones after ERCP on November 8, 2019.
  • the stone extraction device is provided with a sponge-made stone extraction part 8, which can Take out the gravel, mucus and flocs in the bile duct; however, the inventor applied the above-mentioned device to clinical operations and found that the above-mentioned device could take out the gravel that was not adsorbed by mucus in the bile duct, but was adsorbed on the wall of the bile duct by the mucus. Due to the viscous force of the mucus, the sponge cannot completely remove the mucus and flocs of the bile duct wall.
  • the inventor improved the original device and set up a special device for ERCP. Cleaning device for residual bile duct stones, mucus and flocs after operation, especially suitable for sediment-like stones, mucus or flocs.
  • the present invention provides a cleaning device specially used for residual bile duct stones, mucus and floc after ERCP, including an operating handle, a Luer connector 6, an outer tube 7 and a transmission rod 8.
  • the outer tube 7 is hollow inside, one end is connected with the operating handle, and the transmission rod 8 is placed in the outer tube 7 and the operating handle;
  • the Luer connector 6 is arranged on one end of the side wall of the outer tube 7 close to the operating handle;
  • the operating handle It is composed of a core rod 1, a slider 2 and a booster rod 3.
  • the core rod 1 is in the shape of a hollow rod, one end is provided with an internal thread, the other end is provided with a handle ring, and the side wall is provided with an opening;
  • the booster rod 3 is provided with Inside the core rod 1, the slider 2 is nested on the core rod 1, and can slide relative to the core rod 1; one end of the booster rod 3 is connected to the slide block 2, and the other end of the booster rod 3 is connected to the transmission rod 8;
  • the outer tube 7 is provided with a connecting portion 4, and the outer tube 7 and the core rod 1 are connected through the connecting portion 4;
  • the slider 2 is provided with a water inlet 14, and the water inlet 14 is sealed with the transmission rod 8 , the transmission rod 8 is hollow, can be passed through by water, and the end is closed;
  • the cleaning device also includes a first cleaning part 9, a second cleaning part 11 and a flushing part 10, the first cleaning part 9 and the first cleaning part 9 and the first cleaning part 10.
  • the second cleaning part 11 is made of expanded material, the first cleaning part 9 is nested on the end surface of the transmission rod 8, and is used for cleaning large pieces of gravel in the bile duct.
  • the diameter of the flushing part 10 is the same as that of the transmission rod. 8 is equal, and is connected to the end of the transmission rod 8, and its surface is provided with a water outlet 101 for flushing the bile duct wall, and flushing the mucus and floc on the bile duct wall into the bile duct; the second cleaning part 11 is in turn Connected to the end of the flushing part 10, it is used to clean up small gravel in the bile duct, mucus and floc on the bile duct wall.
  • the expansion/compression ratio of the first cleaning part 9 and the second cleaning part 11 is 10:1.
  • the first cleaning part 9 and the second cleaning part 11 are made of sponge.
  • the first cleaning part 9 and the second cleaning part 11 are cylindrical or conical or other shapes that can realize the technical solution.
  • the cross-sectional diameter is 1-3cm, and the length is 1-2cm, and the side walls of the first cleaning portion 9 and the second cleaning portion 11 are integrally contacted with the bile duct wall; when the first cleaning portion 9 and the second cleaning portion 11 are conical, The diameter of the section near the operating handle is the smallest, and gradually expands to the distance.
  • the diameter of the largest section is 1-3cm and the length is 1-2cm. It is in contact with the bile duct wall and fills the bile duct. Pull the first cleaning section 9 and the second cleaning section. 11. All the gravel, mucus and floc in the bile duct and the bile duct wall are cleaned out of the bile duct by the first cleaning part 9 and the second cleaning part 11 .
  • the length of the core rod 1 is 2-10 cm, and each cm is provided with a scale, and the medical staff can push and pull the transmission wire 9 according to the scale, which is convenient and accurate for positioning.
  • the outer tube 7 is provided with two cavities, which are the first cavity 12 and the second cavity 13 respectively.
  • the transmission rod 8 is arranged in the second cavity 13 to push the slider 2 and drive the booster rod 3 and the second cavity 13 .
  • the transmission rod 8 slides in the second cavity 13 .
  • the booster rod 3 and the transmission rod 8 are connected in a spiral or inlaid form, and the connected booster rod 3 and the transmission rod 8 pass through.
  • the end of the outer tube 7 close to the operating handle is provided with a sheath tube 5 , and the sheath tube 5 is sleeved outside the outer tube 7 to prevent the outer tube 7 from falling off the core rod 1 .
  • the cross section of the outer tube 7 is circular, oval or any other shape that can realize the technical solution.
  • the beneficial effects of the present invention are: using the cleaning device for residual bile duct stones, mucus and flocs after ERCP operation disclosed in the present invention, 1 there are three independent cleaning devices, the first cleaning part 9, the second cleaning part 11 and the The flushing part 10, the first cleaning part 9 can non-invasively take out the small block stones or quicksand-shaped gravel in the bile duct of the patient, without causing damage to the bile duct wall of the patient, and the surface of the first cleaning part 9 can be Adsorb part of mucus and flocs; 2. the flushing part 10 can flush the sand-like or flocculent stones, mucus and flocs adhering to the bile duct wall into the bile duct; 3.
  • the second cleaning part 11 will The washed sand, mucus and flocs clear the bile duct, prevent the small sand and stones from remaining in the bile duct and continue to grow up, causing the recurrence of the calculus and affecting the health of the patient; 4 booster rod 3, transmission rod 8 of the present invention It is sealed with the flushing part 10, and the water inlet 14 is connected to a water pump or other pressure device with pressure, and the water or cleaning liquid enters from the water inlet 14, and enters the flushing part 10 along the booster rod 3 and the transmission rod 8, and passes through the outlet.
  • the nozzle 101 is sprayed out, thereby flushing the mucus and flocs adhered to the bile duct wall; the present invention can simultaneously take out the gravel, mucus and flocs in the bile duct at one time, the technical scheme is novel, the operation mode is simple, the effect is remarkable, and the application in clinical practice.
  • FIG. 1 Schematic diagram of a cleaning device dedicated to residual bile duct stones, mucus and flocs after ERCP
  • FIG. 2 Schematic diagram of the use state of a cleaning device dedicated to residual bile duct stones, mucus and flocs after ERCP
  • FIG. 3 is a schematic diagram of the connection of the flushing part 10
  • ERCP Endoscopic retrograde cholangiopancreatography is one of the main methods for minimally invasive treatment of biliopancreatic diseases at present.
  • the endoscope is inserted into the descending part of the duodenum through the mouth, and a special instrument is introduced into the duodenal papilla.
  • the SpyGlass system also known as the SpyGlass aperture choledochoscopy system (SpyGlass direct visualization system, SDVS), consists of a host system and related consumable accessories.
  • the host system is similar to our commonly used endoscopy system, including the host, water injection pump, camera, light source and display and other components.
  • Consumable accessories include delivery catheters, fiber optic cameras, biopsy forceps, electro-hydraulic lithotripsy probes, and photodynamic therapy components.
  • Bile duct stones refer to the formation of stones in the intrahepatic bile duct system, so it is also called intrahepatic bile duct stones. Often combined with extrahepatic bile duct stones, but there are also simple intrahepatic bile duct stones, also known as true intrahepatic stones. In recent years, there have been more and more cases of intrahepatic bile duct stones, and the classification of stones is mostly bilirubin stones. Hepatobiliary stones are mostly yellow-green lumps or "silt-like" stones, mostly calcium bilirubin. Ascaris eggs can often be found in the stone center, so some people think that hepatolithiasis is caused by bile duct obstruction caused by bile duct ascaris and bacterial infection.
  • Choledochoscope is a medical optical endoscope designed for endoscopy and endoscopic surgery of the pancreatic and bile ducts.
  • a choledochoscope usually consists of an objective lens system, an optical imaging system, and an eyepiece system. It enters the body through natural orifices for imaging and diagnostics.
  • the fiberoptic choledochoscope is mainly composed of a fiberoptic choledochoscope body and a cold light source.
  • the lens body is connected to the light source by means of a connector to form a fully functional fiberoptic choledochoscopy and treatment system.
  • it is usually equipped with a variety of accessories, mainly including stone extraction nets, biopsy forceps, cytobrushes, irrigation catheters, cameras, TV video observation systems, etc.
  • Sponge It is a porous material with good water absorption and can be used for cleaning items. Commonly used sponges are made of wood cellulose fibers or foamed plastic polymers.
  • Intumescent material a material that can undergo volume expansion through different reactions
  • Mosaic refers to embedding an object into another object, so that the two are fixed; also refers to embedding objects as decoration.
  • Inlay refers to inserting objects, and inlay refers to clamping small objects in the gaps of large objects.
  • Example 1 A special cleaning device for residual bile duct stones, mucus and flocs after ERCP
  • the present invention provides a cleaning device specially used for residual bile duct stones, mucus and floc after ERCP, including an operating handle, a luer connector 6, an outer tube 7 and a transmission rod 8.
  • the outer tube 7 is empty inside, one end is connected with the operating handle, and the transmission rod 8 is placed in the outer tube 7 and the operating handle; the Luer connector 6 is arranged on one end of the side wall of the outer tube 7 close to the operating handle; the operating handle is formed by the core
  • the rod 1, the slider 2 and the booster rod 3 are composed.
  • the core rod 1 is in the shape of a hollow rod, one end is provided with an internal thread, the other end is provided with a handle ring, and the side wall is provided with an opening;
  • the booster rod 3 is arranged on the core Inside the rod 1, the slider 2 is nested on the core rod 1 and can slide relative to the core rod 1; one end of the booster rod 3 is connected to the slider 2, and the other end of the booster rod 3 is connected to the transmission rod 8;
  • the said The outer tube 7 is provided with a connecting portion 4, and the outer tube 7 and the core rod 1 are connected through the connecting portion 4;
  • the slider 2 is provided with a water inlet 14, and the water inlet 14 is sealed with the transmission rod 8, so
  • the transmission rod 8 is hollow, can be passed through by water, and the end is closed;
  • the cleaning device also includes a first cleaning part 9, a second cleaning part 11 and a flushing part 10, the first cleaning part 9 and the second cleaning part 9.
  • the portion 11 is made of expanded material, the first cleaning portion 9 is nested on the end surface of the transmission rod 8, and is used for cleaning larger pieces of gravel in the bile duct.
  • the diameter of the flushing portion 10 is equal to that of the transmission rod 8. , which is connected to the end of the transmission rod 8, and its surface is provided with a water outlet 101 for flushing the bile duct wall, and flushing the mucus and floc on the bile duct wall into the bile duct; the second cleaning part 11 is connected to the bile duct.
  • the end of the irrigating part 10 is used to clean the small gravel in the bile duct, mucus and flocs on the bile duct wall.
  • the length of the core rod 1 is 10 cm, and every cm is provided with a scale, and the medical staff can push and pull the transmission wire 9 according to the scale, which is convenient and accurate for positioning.
  • the outer tube 7 is provided with two cavities, which are the first cavity 12 and the second cavity 13 respectively.
  • the transmission rod 8 is arranged in the second cavity 13 to push the slider 2 and drive the boost rod 3 and the transmission rod 8 Slide in the second cavity 13 .
  • One end of the outer tube 7 close to the operating handle is provided with a sheath tube 5, and the sheath tube 5 is sleeved outside the outer tube 7 to prevent the outer tube 7 and the core rod 1 from falling off. round.
  • Example 2 A method of using a cleaning device dedicated to residual bile duct stones, mucus and flocs after ERCP

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Abstract

一种专用于ERCP术后残余胆管结石、粘液和絮状物的清理装置。清理装置设置有三个独立的清理装置第一清理部(9)、第二清理部(11)和冲洗部(10)，第一清理部(9)能够无创地将患者胆管内小块状结石或流沙状的碎石取出，不会对患者的胆管壁造成损伤；冲洗部(10)能够将黏附在胆管上的泥沙状或絮状结石、粘液以及絮状物冲洗下来；第二清理部(11)将冲洗下来的沙石、粘液和絮状物清出胆管，防止细小沙石留存在胆管内继续长大，导致结石的复发，影响患者健康。

Description

一种专用于ERCP术后残余胆管结石、粘液和絮状物的清理装置 技术领域
本发明涉及医疗器械技术领域，具体涉及一种专用于ERCP术后残余胆管结石、粘液和絮状物的清理装置。
背景技术
胆道结石是外科中的常见疾病，胆总管内的结石可以引起胆道梗阻继发黄疸、胆管炎甚至胰腺炎危及生命。胆管结石还可能并发胆汁性肝硬化、肝萎缩、肝脓肿等疾病。胆管结石的临床症状主要表现为上腹部疼痛。胆管结石的唯一治疗方法是手术治疗，即通过手术的方式将胆管内的结石取出或者打碎取出。常用的治疗方法有：①用金属硬质取石钳顺着胆管方向探查取石；②用橡胶导尿管插入各支胆管后进行冲洗；③用胆道镜取石。
微创手术具有创口小、疼痛轻、恢复快、住院时间短以及出血少等优点，由于以上特点，使得其成为目前临床大力推广的手术方法。利用胆道镜取石是治疗胆道结石最常用的一种治疗手段。通常沿胆道切开处放置纤维胆道镜，发现结石后，用取石网套取结石。
实用新型专利一种胆管结石取出系统及使用方法(CN202010007836.X)公开了可以用水冲洗细小胆道碎石，也可以用负压吸引管将冲洗液及细小胆道碎石吸引出，但是较大胆道碎石被透水网状膜阻挡在外水管，需要用夹子夹出；该技术方案操作步骤复杂，多次操作对胆管造成一定的损伤，也不能将胆管壁的粘液完全清理出胆管。实用新型专利钓鱼法两镜一丝联合微创保肝肝内外胆管结石碎石取石术(201610574783.3)公开了收拢式网篮设计，避免取石网篮碰触胆管内壁，手术过程无疼痛、创伤、出血，能够集胆道取石、冲洗、造影和扩张于一体。但是上述技术方案不能够将胆管壁的粘液和吸附在粘液上的碎石 以及絮状物完全清理出胆道，且网篮只能清理较大的碎石，细小的碎石无法清除。临床数据统计结果显示，胆总管结石患者ERCP术后结石复发率为4％-24％。现有研究者认为胆结石复发与胆总管直径、胆总管扩张、胆囊管扩张、合并胆管或胰腺炎症等因素有关，认为胆管正常运动功能受限、胆汁流速缓慢或引流不畅可能沉积胆汁中的有形成分引起结石。
发明人在临床中发现，患者经过ERCP取结石后，球囊加压造影提示患者胆管结石清除干净，但是采用胆管内置入SpyGlass方式观测，直视下仍可以观察到大量残余泥沙样结石或絮状物，具体图片如说明书附图5所示，A显示胆总管中残留4毫米结石；B显示胆总管中有大量碎石，胆汁淤泥和/或絮凝物；C显示胆总管中有少量碎石，胆汁淤泥和絮状物；D显示胆总管中有絮凝物；E显示胆总管中清洁。残余胆管结石及胆管壁炎症絮状物会逐渐被胆色素等结晶代谢物包裹逐渐形成结石，需要二次手术清除，对患者的身心均造成伤害。基于以上背景，发明人于2019年11月8日申请了一种专用于ERCP术后残余胆管结石的取石装置(CN201921922709.1)，所述的取石装置中设置了海绵制备的取石部8，可以将胆管内的碎石、粘液和絮状物取出；但是，发明人将上述装置应用于临床手术中，发现上述装置能够将胆管内没有被粘液吸附的碎石取出，但是被粘液吸附在胆管壁的碎石，由于粘液的粘力使得海绵不能够将胆管壁的粘液和絮状物完全取干净，同时，海绵制备的取石部8的表面吸附粘液后，表面的粘液与胆管壁的粘液之间相互无阻力，导致胆管壁的粘液无法被完全取出，多次也无法取干净，且对胆管壁造成了一定的损伤，所以发明人在原装置的基础上进行了改进，设置了一种专用于ERCP术后残余胆管结石、粘液和絮状物的清理装置，尤其适用于泥沙样结石、粘液或絮状物。
发明内容
为了解决上述技术问题，本发明提供了一种专用于ERCP术后残余胆管结石、粘液和絮状物的清理装置，包括操作手柄、鲁尔接头6、外管7和传动杆8，所述的外管7内空，一端与操作手柄连接，传动杆8置于外管7和操作手柄内；所述的鲁尔接头6设置于外管7侧壁靠近操作手柄的一端；所述的操作手柄由芯杆1、滑块2和助推杆3组成，所述的芯杆1呈中空杆状，一端设有内螺纹，另一端设有手柄环，侧壁设有开口；助推杆3设置于芯杆1内部，滑块2嵌套在芯杆1上，与芯杆1可相对滑动；助推杆3一端连接在滑块2上，助推杆3的另一端连接传动杆8；所述的外管7上设有连接部4，外管7和芯杆1通过连接部4连接；所述的滑块2上设置有进水口14，所述的进水口14与传动杆8密封连接，所述的传动杆8中空，可经水流通过，末端封闭；所述的清理装置还包括第一清理部9、第二清理部11和冲洗部10，所述的第一清理部9和第二清理部11由膨胀材料制备而成，所述的第一清理部9嵌套在传动杆8末端表面，用于清理胆道中较大块的碎石，所述的冲洗部10直径与传动杆8相等，贯通连接于传动杆8的末端，其表面设置有出水口101，用于冲洗胆管壁，将胆管壁上的粘液、絮状物冲洗到胆管中；所述的第二清理部11依次连接在冲洗部10末端，用于清理胆管中较小的碎石、胆管璧上的粘液以及絮状物。
优选地，所述的第一清理部9和第二清理部11的膨胀/压缩比为10：1。
优选地，所述的第一清理部9和第二清理部11由海绵制成。
优选地，所述的第一清理部9和第二清理部11呈圆柱状或圆锥状或者其他能够实现本技术方案的形状，当第一清理部9和第二清理部11呈圆柱状时，横截面直径为1-3cm，长为1-2cm，第一清理部9和第二清理部11侧壁整体与胆管壁接触；当第一清理部9和第二清理部11呈圆锥状时，靠近操作手柄的一端截面直径最小，向远处逐渐扩大，最大截面的直径为1-3cm，长为1-2cm，与胆 管壁接触并填满胆管，拉动第一清理部9和第二清理部11，胆管内和胆管壁的所有碎石、粘液以及絮状物被第一清理部9和第二清理部11清扫出胆管。
优选地，所述的芯杆1长为2-10cm，每cm处设有刻度，医护人员可根据刻度推拉传动丝9，方便准确定位。
优选地，所述的外管7内部设有两个腔，分别为第一腔12和第二腔13，传动杆8设置于第二腔13中，推动滑块2，带动助推杆3和传动杆8在第二腔13内滑动。
优选地，所述的助推杆3和传动杆8通过螺旋或者镶嵌的形式连接，连接后的助推杆3和传动杆8贯通。
优选地，所述的外管7靠近操作手柄的一端设置有护套管5，护套管5套在外管7的外部，防止外管7从芯杆1上脱落。
优选地，所述的外管7的横截面呈圆形、椭圆形或者其他任何能够实现本技术方案的形状。
本发明的有益效果是：采用本发明公开的专用于ERCP术后残余胆管结石、粘液和絮状物的清理装置，①设置有三个独立的清理装置第一清理部9、第二清理部11和冲洗部10，所述的第一清理部9能够无创的将患者胆管内小块状结石或流沙状的碎石取出，不会对患者的胆管壁造成损伤，且第一清理部9的表面能够吸附部分粘液和絮状物；②所述的冲洗部10能够将黏附在胆管壁的泥沙状或絮状结石、粘液以及絮状物冲洗到胆管内；③所述的第二清理部11将冲洗下来的沙石、粘液和絮状物清出胆管，防止细小沙石留存在胆管内继续长大，导致结石的复发，影响患者健康；④本发明所述的助推杆3、传动杆8和冲洗部10密封连接，进水口14连接有压力的水泵或其他压力器，将水或者清洗液从进水口14进入，顺着助推杆3和传动杆8进入到冲洗部10中，通过出水口101 喷出，从而冲洗胆管壁黏附的粘液和絮状物；本发明可以一次性地将胆管内的碎石、粘液和絮状物同时取出，技术方案新颖，操作方式简单，效果显著，可在临床上推广应用。
附图说明
图1一种专用于ERCP术后残余胆管结石、粘液和絮状物的清理装置的示意图
1.芯杆；2.滑块；3.助推杆；4.连接部；5.护套管；6.鲁尔接头；7.外管；8.传动杆；14.进水口；
图2一种专用于ERCP术后残余胆管结石、粘液和絮状物的清理装置使用状态的示意图
1.芯杆；2.滑块；3.助推杆；4.连接部；5.护套管；6.鲁尔接头；7.外管；8.传动杆；9.第一清理部；10.冲洗部；101.出水口；11.第二清理部；12.第一腔；13.第二腔；14.进水口；
图3冲洗部10连接示意图
8.传动杆；9.第一清理部；10.冲洗部；101.出水口；11.第二清理部；12.第一腔；13.第二腔；14.进水口；
图4外管7中传动杆8与第一清理部9、清洗部10和第二清理部11的剖面图
8.传动杆；9.第一清理部；10.冲洗部；101.出水口；11.第二清理部；12.第一腔；13.第二腔；
图5 ERCP取结石后球囊加压造影结果图
具体实施方式
下面结合具体实施例对本发明的技术方案进行说明，但是本发明技术方案的保护范围并不限定于以下实施例，任何本领域技术人员在不改变本发明技术 方案宗旨的前提下，对技术方案进行简单的修改、替换或者变形，均属于本发明技术方案的保护范围。
名词解释：
1.ERCP：经内镜逆行胰胆管造影术，是目前微创治疗胆胰疾病的主要手段之一，将内镜经口插入十二指肠降部，经十二指肠乳头导入专用器械进入胆管或者胰管内在X线透视下注射造影剂造影、导入子内镜/超声探头观察，完成对胆、胰疾病的诊断，并在诊断基础之上实施相应介入治疗的技术的总称。
2.SpyGlass系统也称SpyGlass径口胆道镜直视系统(SpyGlass directvisualization system，SDVS)，由主机系统和相关消耗性附件组成。主机系统类似于我们常用的内镜系统，包括主机、注水泵、摄像机、光源及显示器等组件。消耗性附件包括传送导管、光纤摄像头、活检钳、液电碎石探头和光动力治疗组件等。
3.胆管结石：胆管结石是指肝内胆管系统产生结石，所以，又称肝内胆管结石。常与肝外胆管结石合并存在，但也有单纯的肝内胆管结石，又称真性肝内结石症。近年来，肝内胆管结石的病例越来越多，结石的分类多属胆红素结石。肝胆管结石多有黄绿色块状或“泥沙样”结石的成分，多为胆红素钙。结石中心常可找到蛔虫卵，所以有人认为肝胆管结石系由胆道蛔虫、细菌感染致胆管阻塞所致。
4.胆道镜是为胰胆管的内窥镜检查和内窥镜手术设计的一种医用光学内窥镜。胆道镜通常由物镜系统、光学传像系统、目镜系统构成。它通过自然孔道进入人体内，用于成像和诊断。纤维胆道镜主要由纤维胆道镜镜身和冷光源组成，借助连接器将镜身连接到光源上，构成一套功能齐全的纤维胆道镜检査和治疗系统。为了满足各种检查和治疗的需要，通常配有多种附件，主要有 取石网、活检钳、细胞刷、冲洗导管、照相机、电视录像观察系统等
5.海绵：是一种多孔材料，具有良好的吸水性，能够用于清洁物品。人们常用的海绵由木纤维素纤维或发泡塑料聚合物制成。
6.膨胀材料：一种可通过不同的反应发生体积膨胀的材料；
7.螺旋：圆柱体表面有像螺蛳壳上的螺纹叫做阳螺旋，在物体孔眼里的螺纹叫做阴螺旋。阴阳两组螺旋配合起来，旋转其中一个就可以使两者沿螺旋移动，螺纹愈密，螺旋直径愈大愈省力。
8.镶嵌：指将一个物体嵌入另一个物体中，使二者固定；也指以物嵌入，作为装饰。镶是指把物体嵌入，嵌是指把小物体卡紧在大物体的空隙里。
实施例1 一种专用于ERCP术后残余胆管结石、粘液和絮状物的清理装置
本发明提供了本发明提供了一种专用于ERCP术后残余胆管结石、粘液和絮状物的清理装置，包括操作手柄、鲁尔接头6、外管7和传动杆8，所述的外管7内空，一端与操作手柄连接，传动杆8置于外管7和操作手柄内；所述的鲁尔接头6设置于外管7侧壁靠近操作手柄的一端；所述的操作手柄由芯杆1、滑块2和助推杆3组成，所述的芯杆1呈中空杆状，一端设有内螺纹，另一端设有手柄环，侧壁设有开口；助推杆3设置于芯杆1内部，滑块2嵌套在芯杆1上，与芯杆1可相对滑动；助推杆3一端连接在滑块2上，助推杆3的另一端连接传动杆8；所述的外管7上设有连接部4，外管7和芯杆1通过连接部4连接；所述的滑块2上设置有进水口14，所述的进水口14与传动杆8密封连接，所述的传动杆8中空，可经水流通过，末端封闭；所述的清理装置还包括第一清理部9、第二清理部11和冲洗部10，所述的第一清理部9和第二清理部11由膨胀材料制备而成，所述的第一清理部9嵌套在传动杆8末端表面，用于清 理胆道中较大块的碎石，所述的冲洗部10直径与传动杆8相等，贯通连接于传动杆8的末端，其表面设置有出水口101，用于冲洗胆管壁，将胆管壁上的粘液、絮状物冲洗到胆管中；所述的第二清理部11依次连接在冲洗部10末端，用于清理胆管中较小的碎石、胆管璧上的粘液以及絮状物。所述的芯杆1长为10cm，每cm处设有刻度，医护人员可根据刻度推拉传动丝9，方便准确定位。所述的外管7内部设有两个腔，分别为第一腔12和第二腔13，传动杆8设置于第二腔13中，推动滑块2，带动助推杆3和传动杆8在第二腔13内滑动。所述的外管7靠近操作手柄的一端设置有护套管5，护套管5套在外管7的外部，防止外管7与芯杆1的脱落，所述的外管7的横截面呈圆形。
实施例2 一种专用于ERCP术后残余胆管结石、粘液和絮状物的清理装置的使用方法
以下操作均是在无菌环境或者符合手术条件下完成的。
(1)根据手术部位和患者胆管的直径大小，取不同型号的由海绵块制成的第一清理部9和第二清理部11，将第一清理部9嵌套于传动杆8上，将第二清理部11连接在清洗部10末端，连接好后拉动滑块2，将第一清理部9、清洗部10和第二清理部11收缩于第二腔13中，备用；
(2)医护人员将导丝放入结石患者胆管内；
(3)将导丝后端沿着外管7的第一腔12穿入，通过鲁尔接头6穿出，则外管7沿导丝进入并到达胆管的有流沙状结石、絮状物和粘液处，外管7末端越过流沙状结石、絮状物和粘液，到达更远处，推动滑块2，将与滑块2连接的传动杆8推出第二腔13，则第一清理部9和第二清理部11暴露在胆管内，并迅速膨胀变大，将整个胆管填满，则流沙状结石在第一清理部9靠近传动杆8的一端，进水口14连接水泵或者增压装置，将水或者清洗液打入，水或者清洗液从出水 口101以一定的压力喷出，将胆管壁的粘液、絮状物冲洗下来，拉到滑块2，所述的第一清理部9将患者胆管内小块状结石或流沙状的碎石清扫，所述的冲洗部10将第一清理部9清扫过的胆管壁进行冲洗，将第一清理部9未清理掉的粘液、絮状物以及包裹在粘液中的碎石进行冲洗，所述的第二清理部11将冲洗下来的沙石、粘液和絮状物清出胆管，完成清理，缓慢取出清理装置。

Claims (8)

  1. 一种专用于ERCP术后残余胆管结石、粘液和絮状物的清理装置，包括操作手柄、鲁尔接头(6)、外管(7)和传动杆(8)，所述的外管(7)内空，一端与操作手柄连接，传动杆(8)置于外管(7)和操作手柄内；所述的鲁尔接头(6)设置于外管(7)侧壁靠近操作手柄的一端；所述的操作手柄由芯杆(1)、滑块(2)和助推杆(3)组成，所述的芯杆(1)呈中空杆状，一端设有内螺纹，另一端设有手柄环，侧壁设有开口；助推杆(3)设置于芯杆(1)内部，滑块(2)嵌套在芯杆(1)上，与芯杆(1)可相对滑动；助推杆(3)一端连接在滑块(2)上，助推杆(3)的另一端连接传动杆(8)；所述的外管(7)上设有连接部(4)，外管(7)和芯杆(1)通过连接部(4)连接；其特征在于：
    所述的滑块(2)上设置有进水口(14)，所述的进水口(14)与传动杆(8)密封连接，所述的传动杆(8)中空，可经清洗液通过，末端封闭；所述的清理装置还包括第一清理部(9)、第二清理部(11)和冲洗部(10)，所述的第一清理部(9)和第二清理部(11)由海绵制备而成，所述的第一清理部(9)嵌套在传动杆(8)末端表面，所述的冲洗部(10)直径与传动杆(8)相等，贯通连接于传动杆(8)的末端，其表面设置有出水口(101)；所述的第二清理部(11)依次连接在冲洗部(10)末端。
  2. 如权利要求1所述的清理装置，其特征在于，所述的第一清理部(9)和第二清理部(11)的膨胀/压缩比为10：1。
  3. 如权利要求1所述的清理装置，其特征在于，所述的第一清理部(9)和第二清理部(11)呈圆柱状或圆锥状，膨胀后得最大横截面直径为1-3cm，长为：1-2cm。
  4. 如权利要求1所述的清理装置，其特征在于，所述的芯杆(1)上设有刻度。
  5. 如权利要求1所述的清理装置，其特征在于，所述的外管(7)内部设有两个腔，分别为第一腔(12)和第二腔(13)，传动杆(8)设置于第二腔(13)中， 推动滑块(2)，带动助推杆(3)和传动杆(8)在第二腔(13)内滑动。
  6. 如权利要求1所述的清理装置，其特征在于，所述的助推杆(3)和传动杆(8)通过螺旋或者镶嵌的形式连接。
  7. 如权利要求6所述的清理装置，其特征在于，所述的外管(7)靠近操作手柄的一端设置有护套管(5)，护套管(5)套在外管(7)的外部。
  8. 如权利要求7所述的清理装置，其特征在于，所述的外管(7)的横截面呈圆形、椭圆形。
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