WO2022174693A1 - 一种可视化导管及带有该可视化导管的切开刀 - Google Patents

一种可视化导管及带有该可视化导管的切开刀 Download PDF

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Publication number
WO2022174693A1
WO2022174693A1 PCT/CN2022/071330 CN2022071330W WO2022174693A1 WO 2022174693 A1 WO2022174693 A1 WO 2022174693A1 CN 2022071330 W CN2022071330 W CN 2022071330W WO 2022174693 A1 WO2022174693 A1 WO 2022174693A1
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catheter
catheter body
visual
distal end
lumen
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PCT/CN2022/071330
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English (en)
French (fr)
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石益海
石天琦
侯丽英
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石益海
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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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • 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
    • 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
    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/0034—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means adapted to be inserted through a working channel of an endoscope
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/587—Lighting arrangements

Definitions

  • the invention relates to the technical field of medical devices, in particular to a visualization catheter and a cutting knife with a transparent cap that ensures a visual field and can adjust the direction of the visualization catheter.
  • Endoscopic retrograde cholangiopancreatography refers to inserting a duodenoscope into the descending part of the duodenum, finding the duodenal papilla, inserting an angiographic catheter into the opening of the nipple, and injecting angiography.
  • Post-dose radiographs to show the technique of the pancreaticobiliary duct.
  • sphincterotomy of the duodenal papilla endoscopic nasobiliary drainage, endoscopic intrabiliary drainage, common bile duct lithotomy, stent drainage of bile and pancreatic duct tumors, biopsy, local Interventional treatments such as radiotherapy and radiofrequency therapy.
  • MRCP has gradually replaced diagnostic ERCP due to its advantages of non-invasiveness, no X-ray irradiation, and no need for contrast agents, and has become the preferred diagnostic method for pancreatic and biliary diseases. Because ERCP does not require laparotomy, the trauma is small, and the operation time is short, which can greatly reduce the pain of patients, have fewer complications than surgical operations, and greatly shorten the hospitalization time. In just a few decades, ERCP has made great clinical achievements and has become an important treatment method for pancreatic and biliary diseases.
  • the most critical and difficult technique in the procedure is the selective cannulation of the bile duct or pancreatic duct, because if the cannulation is unsuccessful, subsequent diagnosis and treatment cannot be performed.
  • the success rate of selective cholangiopancreatic duct insertion has been significantly improved through the improvement of manipulation and the advancement of equipment, but the success rate after the improvement is still unsatisfactory, and it needs to be carried out under the guidance of X-ray, and the incidence of complications is higher than high.
  • the mucosa of the digestive tract will be blocked at the front of the lens and affect the observation. It is impossible to accurately find the lumen or observe the mucosa of the lesion, thus affecting the endoscopy and diagnosis, and even unable to enter the endoscope to the ideal position. Affect the diagnosis and treatment of diseases.
  • the purpose of the present invention is to provide a visual catheter in order to solve the problem that the digestive tract mucosa blocks the lens, which affects the entering of the lens, diagnosis and treatment, and realizes intubation and related diagnosis and treatment operations under direct vision.
  • Intubation is performed under direct vision, and the pancreatic duct and bile duct can be distinguished by observing the image, so the exposure time of the operator and the patient to the radiation can be reduced or avoided, and the success rate of selective intubation can be improved, while reducing some the occurrence of complications.
  • other related diagnosis and treatment can be carried out under direct vision.
  • a visualized catheter used for minimally invasive interventional surgery of the pancreaticobiliary duct, comprises a catheter body and a traction wire with the functions of adjusting direction and cutting knife, the insertion end of the catheter body is a distal end, and the other end is a proximal end, and the The distal end of the catheter body can bend and turn under the action of the pulling wire;
  • the catheter body is provided with at least one visual lumen for accommodating the optical imaging system and a working lumen for auxiliary instruments to pass through, and both the visual lumen and the working lumen pass through from the proximal end of the catheter body to the
  • the distal end, the visible cavity is provided with a miniature video image sensor and an illumination element at the end of the distal end of the catheter body, and the end of the distal end of the catheter body is also provided with a camera module for ensuring the field of view and increasing Transparent cap for viewing angle.
  • the invention utilizes the support function of the miniature video image sensor and the front-end conical transparent cap to open the front-end tube mucosa of the lens, ensure and widen the field of vision, and is helpful for finding the lumen and judging its running direction to guide intubation.
  • the video image sensor in the transparent part of the front end can be used to ensure the field of view, so as to guide the nipple intubation under direct vision, and guide further selective bile duct or pancreatic duct intubation under direct vision, and select common bile duct or common hepatic duct intubation under further direct vision, And further choose left and right hepatic duct and intrahepatic bile duct intubation under direct vision to avoid difficulties and possible complications caused by blind intubation.
  • the transparent cap is a conical transparent cap, or a circular tube with a tapered front end, made of a fully transparent material, with a length of 0.1cm-5cm, preferably 0.2cm-2cm, gradually tapering, and an outer diameter of the front end of 0.1 cm. mm-4mm.
  • the distance between the miniature video image sensor and the lighting element is 0.1cm-5cm, preferably 0.2cm-2cm from the terminal, the miniature video image sensor and the lighting element can be in one plane or not in the same plane, so as to reduce the occupied cross-sectional area, and at the same time. The two will not interfere with each other, resulting in obstructed viewing angles or unclear imaging (such as shadow areas), which can effectively increase the viewing angle of the camera module.
  • a plurality of cavities are arranged in the transparent cap, which can be repeatedly washed and suctioned to wash out the stones, pus, parasites, etc. in the biliopancreatic duct, so as to ensure the visual field, and guide the diagnosis and treatment under direct vision.
  • the length of the catheter is 180cm-260cm, and the surface of the front 160cm is coated with a super-smooth coating, which makes the catheter have good synchronous rotation, so that the catheter has good synchronous rotation.
  • the cannula direction can be flexibly adjusted to facilitate insertion and Super-selected common bile duct, pancreatic duct, cystic duct, common hepatic duct, left and right hepatic duct, and intrahepatic bile duct.
  • the miniature video image sensor is a miniature endoscope with a size of 0.1-4.0 mm.
  • an illumination element is provided on the side of the video image sensor, and the illumination element may adopt a small LED light group or other light sources.
  • the transparent cap is integrally formed with the catheter body, or is detachably provided on the catheter body.
  • the working cavity includes an injection cavity and/or a liquid suction cavity, and an electric suction and water injection device can be externally connected.
  • the catheter can be used to deliver accessories from an approach to a target location in the pancreaticobiliary anatomy and display live video when connected to a digital imaging controller.
  • the catheter is used in conjunction with a digital controller, the controller can provide light source and image processing functions for the catheter, and the doctor sends the catheter to the diagnosis and treatment site through the working channel of the duodenoscope.
  • the miniature video image sensor transmits light from the controller to the distal end of the catheter through the catheter cable, and transmits the video signal captured by the video sensor to the controller to realize image processing and display;
  • the working channel port is where the accessories are inserted.
  • a Y-port connector (packaging accessory) can be connected here to provide a sealing mechanism for accessories inserted in the working channel without removing the Liquid can be injected with the lower attachment.
  • the visualized catheter device reaches the nipple area of the descending duodenum through the biopsy hole of the duodenoscope, and the nipple is observed from the video image sensor.
  • the pancreatic duct and the bile duct can be distinguished, thus reducing or avoiding the exposure time of the operating physician and the patient to the radiation, while improving the success rate of selective intubation and avoiding some complications.
  • the transparent cap with the tapered structure of the transparent part at the front end is used as a support to open the mucosa of the front end of the lens to ensure and widen the field of vision, which is helpful for finding the lumen and judging its running direction to guide the intubation.
  • the video image sensor in the transparent part of the front end can be used to ensure the field of view, so as to guide the nipple intubation under direct vision, and guide further selective bile duct or pancreatic duct intubation under direct vision, and select common bile duct or common hepatic duct intubation under further direct vision,
  • the left and right hepatic ducts and intrahepatic bile ducts can be selected for intubation under direct vision to avoid the difficulties and possible complications caused by blind intubation. Ensure a clear vision, and guide diagnosis and treatment under direct vision.
  • Fig. 1 is the schematic diagram of the concrete application of the visualization catheter of the present invention
  • Fig. 2 is the partial structure schematic diagram of the visualization catheter of the present invention.
  • Fig. 3 is the cross-sectional schematic diagram at A place in Fig. 2;
  • Figure 4 is a schematic cross-sectional view at B in Figure 2;
  • Figure 5 is a schematic cross-sectional view at C in Figure 2;
  • Figure 6 is a schematic cross-sectional view at D or E in Figure 2;
  • a scalpel is used for minimally invasive interventional surgery of the pancreaticobiliary duct with a visualization catheter.
  • the visualization catheter includes a catheter body 1 and a traction wire 2 as an incision knife.
  • the insertion end of the catheter body 1 is the distal end, and the other end is the proximal end.
  • the distal end of the catheter body 1 acts on the traction wire 2. Bending and steering can be achieved by controlling the operating handle 3.
  • the catheter body 1 is provided with a visual lumen 105 for accommodating an optical imaging system and a working lumen 104 through which auxiliary instruments can pass.
  • the visible cavity 104 is provided with a miniature video image sensor 101 at the end of the distal end of the catheter body 1, and the end of the distal end of the catheter body 1 is also provided with a transparent cap 9 for ensuring the field of view of the camera module.
  • the miniature video image sensor 101 is a miniature endoscope with a size of 0.1-4 mm.
  • the side of the video image sensor 101 is provided with an illumination element 102, and the illumination element 102 can be a miniature LED light group or other light sources.
  • 101 and the lighting element 102 are both connected to the proximal cable connector 7 through a data line passing through the visual channel 105 .
  • This setting can perform intubation under direct vision, and the pancreatic duct and bile duct can be distinguished by observing the image, which can reduce the time that the operator and the patient are exposed to X-rays, and at the same time can improve the success rate of selective intubation. Some complications occur, and other related diagnosis and treatment can be performed under direct vision.
  • the distance between the miniature video image sensor and the lighting element is 0.1cm-5cm, preferably 0.2cm-2cm from the terminal.
  • the miniature video image sensor 101 and the lighting element 102 can be on the same plane or not in the same plane to reduce the occupied cross-sectional area, and the two do not They will affect each other and cause the viewing angle to be obstructed or the imaging to be unclear (such as shadow areas), which can effectively increase the viewing angle of the camera module.
  • the transparent cap 9 is a tubular transparent cap with a tapered front end, made of fully transparent material, the outer diameter of the front end is 0.1mm-4mm, the transparent cap is integrally formed with the catheter body, or can be detachably arranged on the catheter body, using the transparent part of the front end.
  • the transparent cap of the conical structure plays a supporting role, spreads the mucosa of the front end of the lens, ensures and widens the field of vision, and helps to find the lumen and determine its running direction to guide the intubation.
  • the video image sensor in the transparent part of the front end can be used to ensure the field of view, so as to guide the nipple intubation under direct vision, and guide further selective bile duct or pancreatic duct intubation under direct vision, and select common bile duct or common hepatic duct intubation under further direct vision, And further choose left and right hepatic duct and intrahepatic bile duct intubation under direct vision to avoid difficulties and possible complications caused by blind intubation.
  • FIG. 1 is a schematic diagram of the visualization catheter of the present invention being specifically used for a disposable cholangiopancreatography imaging catheter.
  • the imaging catheter is provided with an operating handle 3 , which can control the pulling wire 2 and realize the bending and steering of the distal end of the catheter body 1 .
  • the imaging catheter is sequentially provided with a suction port 5 or an irrigation port 6 communicated with a suction tube or an irrigation tube 103, and a working channel connector 4 connected with the working lumen 104, which can be respectively connected to external equipment.
  • a Y-port connector (packaging accessory) can optionally be attached to the working channel port accessory insert to provide a sealing mechanism for accessories inserted in the working channel while allowing fluid injection without removing the accessory.
  • the suction tube and the flushing tube 103 can be set independently as shown in FIG. 3 , or can share a channel.
  • the catheter is used to deliver the accessory from the approach to the target site in the pancreaticobiliary anatomy and can display live video when connected to a digital imaging controller.
  • the tiny endoscope and LED light group or other light sources in the visual channel transmit light from the controller to the distal end of the catheter through the catheter cable, and transmit the video signal captured by the video sensor to the controller to realize image processing and display.
  • the catheter is used in conjunction with a digital controller that provides light and image processing to the catheter. The doctor sends the catheter to the diagnosis and treatment site through the working channel of the duodenoscope.
  • the catheter is inserted into the duodenal papilla through a duodenoscope or other endoscope, so that the catheter contacts the papilla.
  • a part of the transparent cap at the distal end of the catheter enters the papilla, and the transparent cap is used to support it.
  • Open the nipple opening observe the duct in the nipple, judge the running direction of the bile duct and the pancreatic duct, insert the catheter along the direction of the bile duct or the pancreatic duct, and further selectively intubate.
  • the incision knife can be used to tighten or loosen or rotate the catheter to adjust the insertion direction, and the adjustment of the duodenoscope or other endoscopes can make the insertion easier.
  • a nipple incision can be performed with a scalpel to facilitate the entry of the catheter into the duct.
  • Other instruments such as sampling forceps, can be inserted into the working channel of the catheter.
  • the lesion can be directly extracted for stone extraction or tissue grabbing.
  • the end of the tapered transparent cap is provided with an injection or suction pipe, which improves flushing efficiency.
  • a syringe or aspirator can be connected separately at the same time, and the injection water is convenient for flushing the human body cavity for easy observation.

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Abstract

本发明涉及一种可视化导管，用于胰胆管微创介入性手术，包括导管本体和作为切开刀的牵引丝，所述导管本体的远端在所述牵引丝的作用下能够弯曲转向及旋转以改变***方向及角度，所述导管本体设有可视腔道和工作腔道，所述可视腔道在所述导管本体的远端的端部设置微型视频图像传感器及照明元件，所述导管本体远端的端部还设置有用于保证视野和增大摄像模组视野角度的透明帽。本发明通过微型视频图像传感器及透明帽的支撑作用，有助于寻找管腔及判断其走行方向，准确指导插管及相关诊疗，能在直视状态下进行插管，通过观察图像可对胰管和胆管进行分辨，减少或避免操作医师和病人暴露在射线下的时间，可提高选择性插管的成功率，减少并发症的产生。

Description

一种可视化导管及带有该可视化导管的切开刀 技术领域
本发明涉及医疗器械技术领域，具体涉及一种可视化导管及带有保证视野的透明帽、可以调节该可视化导管方向的切开刀。
背景技术
经内镜逆行性胰胆管造影术(ERCP)是指将十二指肠镜插至十二指肠降部，找到十二指肠***，由活检管道内***造影导管至***开口部，注入造影剂后X线摄片，以显示胰胆管的技术。在此基础上，可以进行十二指肠******切开术、内镜下鼻胆汁引流术、内镜下胆汁内引流术、胆总管取石术、胆胰管肿瘤支架引流术、活检术、局部放疗、射频治疗等介入治疗。
随着影像技术的进步，MRCP因其无创、无X线照射、不需造影剂等优点己逐步取代诊断性ERCP，成为胰胆疾病首选的诊断方法，ERCP逐渐转向胰胆疾病的治疗。由于ERCP不用开腹，创伤小，手术时间短，可以极大地减轻病人痛苦，并发症较外科手术少，住院时间也大大缩短，深受患者欢迎。在短短几十年中ERCP在临床上取得了巨大的成绩，已经成为当今胰胆疾病重要的治疗手段。
在操作中最关键也是最难的技术是选择性胆管或胰管的插管，因为如果插管不成功，后续的诊断和治疗也就无法进行。通过手法的改良和器械的进步，选择性胆胰管插的成功率已得到了显著提高，但经过改良后的成功率仍不满意，且需在X线引导下进行，并发症的发生率较高。
特别是选择性胆管或胰管插管时，消化道粘膜会阻挡在镜头前端影响观察，不能准确地寻找到腔道或观察病变粘膜，从而影响进镜及诊断，甚至无法进镜到理想部位而影响疾病的诊断及治疗。目前尚未直视下无需借助X线或腔内超声直接进行胆胰管选择性插管的简单 安全的方法。
发明内容
本发明的目的就是为了解决消化道粘膜阻挡镜头，影响进镜及诊断、治疗的问题而提供一种可视化导管，实现直视下插管及相关诊疗操作，同时不需要X线的引导，能在直视状态下进行插管，通过观察图像可对胰管和胆管进行分辨，因此可减少或避免操作医师和病人暴露在射线下的时间，同时可提高选择性插管的成功率，同时减少一些并发症的产生。同时可以在直视下进行其它相关诊疗。
本发明的目的通过以下技术方案实现：
一种可视化导管，用于胰胆管微创介入性手术，包括导管本体和具有调整方向、切开刀功能的牵引丝，所述导管本体的***端为远端，另一端为近端，所述导管本体的远端在所述牵引丝的作用下能够弯曲转向；
所述导管本体至少设有一个容纳光学成像***的可视腔道和一个可供辅助器械通过的工作腔道，所述可视腔道和工作腔道均自所述导管本体的近端贯通至远端，所述可视腔道在所述导管本体的远端的端部设置微型视频图像传感器及照明元件，所述导管本体远端的端部还设置有用于保证视野和增大摄像模组视野角度的透明帽。
本发明利用微型视频图像传感器外加前端锥形透明帽支撑作用，撑开镜头前端管道粘膜，保证和拓宽视野，有助于寻找管腔及判断其走行方向指导插管。前端透明部的视频图像传感器可用于保证视野，从而直视下指导***插管，并直视下指导进一步选择性胆管或胰管插管，及进一步直视下选择胆总管或肝总管插管，及进一步直视下选择左右肝管及肝内胆管插管，避免盲目插管所造成的困难和可能的并发症。
进一步地，所述透明帽为圆锥形透明帽，或前端呈锥形的圆管，采用全透明材质制得，长度0.1cm-5cm，优选为0.2cm-2cm，逐渐变细，前端外径0.1mm-4mm。
进一步地，所述微型视频图像传感器及照明元件距离终端0.1cm-5cm，优选为0.2cm-2cm，微型视频图像传感器及照明元件可以在一个平面或不在一个平面，以减少所占截面积，同时二者不会相互影响造成视角阻碍或成像不清(如阴影区域)，能够有效地增大摄像模组的视野角度。
进一步地，在透明帽内设有多个腔道，可反复冲洗和吸引将胆胰管内结石、脓液、寄生虫等洗出以保证视野，且直视下指导诊断及治疗。
进一步地，导管长度180cm-260cm，前部160cm表面涂超滑涂层使导管具有良好的同步旋转性，使导管具有良好的同步旋转性，结合牵引丝可以灵活调整插管方向，以方便***和超选胆总管、胰管、胆囊管、肝总管、左右肝管、肝内胆管。
进一步地，所述微型视频图像传感器为微小内窥镜，尺寸大小在0.1～4.0mm。
进一步地，所述视频图像传感器的侧部设有照明元件，所述照明元件可采用微小LED灯组或其它光源。
进一步地，所述透明帽与所述导管本体一体成型，或者可拆卸的设置在所述导管本体上。
进一步地，所述工作腔道包括注射腔和/或吸液腔，可以外接电动吸引及注水装置。
该导管可用于将附件从入路递送至胰胆管解剖部位的目标位置，并连接数字成像控制器时显示实时视频。
该导管与数字控制器配合使用，控制器可为导管提供光源和图像处理功能，医生通过十二指肠内镜的工作通道将导管送入到诊疗部位。
微型视频图像传感器通过导管缆线将光从控制器传输至导管的远端终端，并将视频传感器捕获的视频信号传输至控制器，以实现图像处理和显示；
工作腔道的近端设有端口，工作通道端口是附件***处，也可选 择将Y型端口连接器(包装配件)连接于此，以便为工作通道中***的附件提供密封机制，同时无需取下附件即可注入液体。
本发明将可视化导管装置通过十二指肠镜活检孔到达十二指肠降段***区域，从视频图像传感器观察***，可视化导管装置的优点是能在直视状态下进行插管，通过观察图像可对胰管和胆管进行分辨，因此可减少或避免操作医师和病人暴露在射线下的时间，同时可提高选择性插管的成功率，同时避免一些并发症的产生。
利用前端透明部锥形结构的透明帽起到支撑作用，撑开镜头前端管道粘膜，保证和拓宽视野，有助于寻找管腔及判断其走行方向指导插管。前端透明部的视频图像传感器可用于保证视野，从而直视下指导***插管，并直视下指导进一步选择性胆管或胰管插管，及进一步直视下选择胆总管或肝总管插管，及进一步直视下选择左右肝管及肝内胆管插管，避免盲目插管所造成的困难和可能的并发症，可反复冲洗和吸引将胆胰管内结石、脓液、寄生虫等洗出以保证视野清晰，且直视下指导诊断及治疗。
附图说明
图1为本发明可视化导管具体应用的示意图；
图2为本发明可视化导管的局部结构示意图；
图3为图2中A处的截面示意图；
图4为图2中B处的截面示意图；
图5为图2中C处的截面示意图；
图6为图2中D或E处的截面示意图；
图中：1-导管本体；2-牵引丝；3-操作手柄；4-工作通道接头；5-吸引端口；6-冲洗端口；7-电缆接头；8-外管；9-透明帽；101-微型视频图像传感器；102-照明元件；103-吸引管或冲洗管；104-工作腔道；105-可视腔道。
具体实施方式
下面结合附图和具体实施例对本发明进行详细说明。
如图1，一种切开刀，用于胰胆管微创介入性手术，该切开刀带有可视化导管。
参照图2-6，可视化导管包括导管本体1和作为切开刀的牵引丝2，导管本体1的***端为远端，另一端为近端，导管本体1的远端在牵引丝2的作用下能够弯曲转向，通过控制操作手柄3来实现。导管本体1设有容纳光学成像***的可视腔道105和可供辅助器械通过的工作腔道104，可视腔道105和工作腔道104均自导管本体1的近端贯通至远端，可视腔道104在导管本体1的远端的端部设置微型视频图像传感器101，导管本体1远端的端部还设置有用于保证摄像模组视野的透明帽9。
其中，微型视频图像传感器101为微小内窥镜，尺寸大小在0.1～4mm，视频图像传感器101的侧部设有照明元件102，照明元件102可采用微小LED灯组或其它光源，微型视频图像传感器101及照明元件102均通过穿过可视腔道105的数据线与近端的电缆接头7连接。该设置能在直视状态下进行插管，通过观察图像可对胰管和胆管进行分辨，可减少操作医师和病人暴露在X射线下的时间，同时可提高选择性插管的成功率，减少一些并发症的产生，同时可以在直视下进行其它相关诊疗。
微型视频图像传感器及照明元件距离终端0.1cm-5cm，优选为0.2cm-2cm，微型视频图像传感器101及照明元件102可以在一个平面或不在一个平面，以减少所占截面积，同时二者不会相互影响造成视角阻碍或成像不清(如阴影区域)，能够有效地增大摄像模组的视野角度。
透明帽9为前端呈锥形的管状透明帽，为全透明材质制得，前端外径0.1mm-4mm，透明帽与导管本体一体成型，或者可拆卸的设置在导管本体上，利用前端透明部锥形结构的透明帽起到支撑作用，撑开镜头前端管道粘膜，保证和拓宽视野，有助于寻找管腔及判断其走 行方向指导插管。前端透明部的视频图像传感器可用于保证视野，从而直视下指导***插管，并直视下指导进一步选择性胆管或胰管插管，及进一步直视下选择胆总管或肝总管插管，及进一步直视下选择左右肝管及肝内胆管插管，避免盲目插管所造成的困难和可能的并发症。
图1为将本发明可视化导管具体用于一次性使用胆胰管成像导管的示意图。
该成像导管设有操作手柄3，可以控制牵引丝2，实现导管本体1的远端的弯曲转向。该成像导管依次设有与吸引管或冲洗管103相通的吸引端口5或冲洗端口6，以及与工作腔道104相连的工作通道接头4，能够分别与外部设备相连。工作腔道端口附件***处可选择将Y型端口连接器(包装配件)连接于此，以便为工作通道中***的附件提供密封机制，同时无需取下附件即可注入液体。吸引管与冲洗管103可以如图3单独设置，也可以共用设置一个通道。
该导管用于将附件从入路递送至胰胆管解剖部位的目标位置，并可在连接数字成像控制器时显示实时视频。可视腔道内的微小内窥镜及LED灯组或其它光源通过导管缆线将光从控制器传输至导管的远端终端，并将视频传感器捕获的视频信号传输至控制器，以实现图像处理和显示。该导管与数字控制器配合使用，控制器可为导管提供光源和图像处理功能。医生通过十二指肠内镜的工作通道将导管送入到诊疗部位。
手术开始时，将导管通过十二指肠镜或其他内镜进入到如十二指肠***处，使导管接触***，此时导管远端的透明帽部分的一部分进入***内，利用透明帽撑开***开口，观察***内管道，判断胆管和胰管的走行方向，沿胆管或者胰管方向***导管，同时还可以进一步选择性的深入插管。若***困难可以利用切开刀拉紧或放松或旋转导管来调节***方向，结合十二指肠镜或其他内镜的调节从而使***变得容易。若***较小导致深***困难可以利用切开刀进行***切开从而使导管进入管道变得容易。从导管的工作通道可***其他器械，如 取样钳等，在可视支持下，直接对病变部位进行取石或组织抓取，锥形透明帽末端别设有注射或吸引管道，冲洗效率更高，可同时分别连接注射器或吸引器，注射水便于冲洗人体腔道以方便观察。
上述的对实施例的描述是为便于该技术领域的普通技术人员能理解和使用发明。熟悉本领域技术的人员显然可以容易地对这些实施例做出各种修改，并把在此说明的一般原理应用到其他实施例中而不必经过创造性的劳动。因此，本发明不限于上述实施例，本领域技术人员根据本发明的揭示，不脱离本发明范畴所做出的改进和修改都应该在本发明的保护范围之内。

Claims (10)

  1. 一种可视化导管，用于胰胆管微创介入性手术，包括导管本体和具有调整方向、切开刀功能的牵引丝，所述导管本体的***端为远端，另一端为近端，所述导管本体的远端在所述牵引丝的作用下能够弯曲转向；
    其特征在于，所述导管本体至少设有一个容纳光学成像***的可视腔道和一个可供辅助器械通过的工作腔道，所述可视腔道和工作腔道均自所述导管本体的近端贯通至远端，
    所述可视腔道在所述导管本体的远端的端部设置微型视频图像传感器及照明元件，所述导管本体远端的端部还设置有用于保证视野和增大摄像模组视野角度的透明帽。
  2. 根据权利要求1所述的一种可视化导管，其特征在于，所述透明帽为圆锥形透明帽，或前端呈锥形的圆管，采用全透明材质制得，长度0.1cm-5cm，逐渐变细，末端外径为0.1mm-4mm。
  3. 根据权利要求2所述的一种可视化导管，其特征在于，所述透明帽与所述导管本体一体成型，或者可拆卸的设置在所述导管本体上。
  4. 根据权利要求1所述的一种可视化导管，其特征在于，所述微型视频图像传感器为微小内窥镜，尺寸大小在0.2～4.0mm。
  5. 根据权利要求4所述的一种可视化导管，其特征在于，所述微型视频图像传感器及照明元件距离终端距离为0.1cm-5cm。
  6. 根据权利要求1所述的一种可视化导管，其特征在于，所述工作腔道包括注射腔和/或吸液腔，能够外接电动吸引或注水装置。
  7. 根据权利要求1所述的一种可视化导管，其特征在于，所述导管本体表面涂有超滑涂层。
  8. 根据权利要求1所述的一种可视化导管，其特征在于，该导管工作长度为150cm-350cm，在末端直径由1.7mm-3.6mm逐渐缩为 0.5mm-3mm。
  9. 根据权利要求8所述的一种可视化导管，其特征在于，该导管带有独立的2-5个腔道，腔道内径在1-2.5mm。
  10. 一种切开刀，其特征在于，该切开刀带有如权利要求1-9任意一项所述的可视化导管。
PCT/CN2022/071330 2021-02-22 2022-01-11 一种可视化导管及带有该可视化导管的切开刀 WO2022174693A1 (zh)

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