WO2020052331A1 - 一种导丝接头 - Google Patents

一种导丝接头 Download PDF

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Publication number
WO2020052331A1
WO2020052331A1 PCT/CN2019/094692 CN2019094692W WO2020052331A1 WO 2020052331 A1 WO2020052331 A1 WO 2020052331A1 CN 2019094692 W CN2019094692 W CN 2019094692W WO 2020052331 A1 WO2020052331 A1 WO 2020052331A1
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WO
WIPO (PCT)
Prior art keywords
guide wire
cover plate
wire joint
guidewire
joint
Prior art date
Application number
PCT/CN2019/094692
Other languages
English (en)
French (fr)
Inventor
李晓春
徐潮伟
李常青
冷德嵘
刘春俊
Original Assignee
南微医学科技股份有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 南微医学科技股份有限公司 filed Critical 南微医学科技股份有限公司
Priority to AU2019339565A priority Critical patent/AU2019339565B2/en
Priority to US17/270,993 priority patent/US20210186589A1/en
Priority to EP19860360.7A priority patent/EP3821935A4/en
Priority to CA3111036A priority patent/CA3111036C/en
Priority to JP2020571789A priority patent/JP7257426B2/ja
Publication of WO2020052331A1 publication Critical patent/WO2020052331A1/zh

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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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00482—Digestive system
    • A61B2018/00494—Stomach, intestines or bowel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00553—Sphincter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00601—Cutting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00702—Power or energy
    • A61B2018/00708—Power or energy switching the power on or off
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09116—Design of handles or shafts or gripping surfaces thereof for manipulating guide wires

Definitions

  • the invention relates to the field of medical equipment, in particular to a guide wire joint.
  • Endoscopic sphincteropapillotomy is a further development based on the diagnostic technique of endoscopic retrograde cholangiopancreatography (ERCP), which uses high-frequency electrosurgical incision under endoscope A technique for cutting the duodenal papillary sphincter and the end of the common bile duct.
  • ERCP endoscopic retrograde cholangiopancreatography
  • EST is widely used in the treatment of common bile duct stones, biliary pancreatitis, acute obstructive suppurative cholangitis, periampullary tumors, biliary ascaris, benign stricture of common bile duct end, Oddi sphincter dysfunction and other diseases.
  • endoscopic papillary sphincterotomy combined with lithotripsy, lithotripsy, tapeworm removal, nasal bile duct drainage, internal stent drainage, etc., the disease can be partially or completely treated.
  • the negative plate of the high-frequency power generator is affixed to the patient's hip skin.
  • the connection connector of the incision control handle is connected to the corresponding electrode connector of the high-frequency power generator. Incision was performed with coagulation power and its mixing ratio. It is also possible to use a simple resection current for EST, which can reduce the coagulation of nearby tissues during the incision and thus help maintain a clear endoscopic field of view.
  • the purpose of the present invention is to design a guide wire joint, so that the guide wire has better guideability when it is inserted into the guide wire cavity, and the guide wire penetration efficiency is improved; secondly, the doctor can achieve a single person when performing ERCP Operation; finally shortening the exchange distance of the quick-exchange device guidewire withdrawal from the endoscope effectively shortens the operation time and relieves the patient's pain.
  • the invention provides a guide wire joint, which includes a first cover plate, a second cover plate, a connecting portion connecting the first cover plate and the second cover plate, and a connecting piece; the connecting piece can connect the guide wire.
  • the wire joint and the medical device, and the side of the first cover plate and the second cover plate that is far from the connecting portion may be in a contact or separation state, so that the guide wire joint is closed and opened;
  • a guide wire cavity is provided between the first cover plate and the second cover plate to allow a guide wire to pass therethrough. In the separated state, the guide wire can be detached from the guide wire joint.
  • the medical device is a rapid exchange device
  • the guide wire joint can be used in conjunction with the rapid exchange device to achieve rapid separation of the guide wire from the rapid exchange device.
  • a side of the first cover plate and the second cover plate facing away from the connection portion forms a cylindrical structure, and a distal diameter of the cylindrical structure is smaller than a proximal diameter.
  • the guidewire joint of the present invention wherein the guidewire joint further includes a switch, and the guidewire joint can be opened by pushing or pressing the switch to realize separation of the guidewire.
  • the switch is located on a side of the first cover plate away from the connection portion and has an arched structure.
  • the switch is located between the first cover plate and the second cover plate, and includes a pressure spring.
  • the first cover plate and the second cover plate are injection molded from plastic.
  • connection portion is a hinge structure.
  • the outer surface of the second cover plate has a rough surface.
  • the guide wire joint of the present invention wherein the quick exchange device used in conjunction with the guide wire joint includes an outer sheath tube.
  • the outer sheath tube includes a guide wire cavity with a C-shaped groove on one side.
  • FIG. 1 is a schematic diagram when the right-side open type guide wire joint is closed.
  • FIG. 2 is a schematic view of the right opening and closing type guide wire joint shown in FIG. 1 after being opened.
  • FIG. 2 is a schematic view of the right opening and closing type guide wire joint shown in FIG. 1 after being opened.
  • FIG. 3 is an enlarged view of a schematic view of a right-side opening type guide wire joint shown in FIG. 2 after being opened.
  • FIG. 4 is a cross-sectional view of the right-side open type guide wire joint shown in FIG. 1.
  • FIG. 5 is a schematic diagram when the upper open-close type guide wire joint is closed.
  • FIG. 6 is a schematic view of an opened state of the upper opening and closing type guide wire joint shown in FIG. 5.
  • FIG. 7 is an enlarged view of a schematic view of the upper openable type guide wire joint shown in FIG. 6 after it is opened.
  • FIG. 8 is a schematic view of the upper side open type guide wire joint shown in FIG. 5 with the second cover plate and the connecting portion removed.
  • FIG. 9 is a cross-sectional view of the upper openable type guide wire joint shown in FIG. 5.
  • FIG. 10 is a front view of an outer sheath used with a guide wire joint.
  • FIG. 11 is a cross-sectional view of an outer sheath tube used in conjunction with a guide wire joint shown in FIG. 10.
  • the invention provides a guide wire joint, which includes a first cover plate, a second cover plate, a connection portion connecting the first and second cover plates, and a connection piece; the connection piece can connect the guide wire connection piece.
  • the side of the first cover plate and the second cover plate remote from the connection portion may be in a contact or separated state, thereby closing and opening the guide wire joint; in the contact state, the A guide wire cavity is provided between the first cover plate and the second cover plate to allow the guide wire to pass through.
  • the guide wire joint is in a closed state; in the separated state, the guide wire can be removed from the guide wire.
  • the wire connector is detached, and the guide wire connector is open at this time.
  • the medical device is a rapid exchange device
  • the guide wire joint can be used in conjunction with the rapid exchange device to achieve rapid separation of the guide wire and the rapid exchange device.
  • the specific rapid exchange device may be a nipple incision. Knife, stone extraction balloon, angiography catheter, stone extraction basket, dilation balloon, etc.
  • the first cover plate and the second cover plate are in contact with each other on a side remote from the connecting portion to form a tubular structure, and the distal diameter of the tubular structure is smaller than the proximal diameter.
  • the guidewire joint further includes a switch, and the guidewire joint can be opened by pushing or pressing the switch to realize separation of the guidewire.
  • the switch is located on a side of the first cover plate away from the connecting portion, and has an arched structure.
  • the switch may also be located between the first cover plate and the second cover plate and includes at least one pressure spring.
  • the first cover plate and the second cover plate are injection molded from plastic.
  • connection portion is a hinge structure.
  • the outer surface of the second cover plate has a rough surface.
  • the rough surface is a finger clamping position during use, which increases frictional resistance and can also prevent the guidewire joint from being opened or the guidewire clamp being separated Holding off.
  • the rapid exchange device used in conjunction with the guide wire joint includes an outer sheath tube.
  • the outer sheath tube includes a guide wire cavity with a C-shaped groove on one side, so that the guide wire can pass through the guide wire cavity of the guide wire connector into the guide wire cavity of the outer sheath.
  • FIG. 1 to FIG. 9 it illustrates a guide wire joint according to an embodiment of the present invention
  • FIGS. 10 to 11 illustrate a sheath structure of the present invention.
  • a guide wire connector in a non-limiting embodiment of the present invention, as shown in FIG. 1-9, includes a first cover plate 1, a second cover plate 2, and a connector connecting the first cover plate 1 and the second cover plate 2. Connection portion 3, and connection member 4.
  • the first cover plate 1 and the second cover plate 2 can be contacted to form a tube-like structure on the side away from the connecting portion 3.
  • the guide wire joint is closed, and the first cover plate 1 and the second cover plate of the guide wire joint are closed.
  • a guidewire lumen 10 is formed between 2 and a guidewire 8 enters the guidewire joint from the proximal end of the guidewire joint through the guidewire lumen 10; the distal diameter of the tubular structure is smaller than the proximal diameter, and the first cover plate 1.
  • the side of the second cover plate 2 away from the shaft tube 3 can be separated to form an opening. At this time, the guide wire joint is open, and the guide wire 8 is detached from the guide wire joint.
  • the connecting piece 4 is arranged on the second cover plate 2 and is fixedly connected to the second cover plate 2; the connecting piece 4 may also be formed by protruding the inside of the first cover plate 1 and the second cover plate 2 so that the guide wire joint is closed. When the protrusions located on the inside of the two cover plates are in contact, a complete connecting piece 4 can be connected.
  • the connecting piece 4 can be connected to the rapid exchange device. The thickness from the proximal end of the guide wire joint to the distal end becomes gradually smaller. At the same time, a guide channel is formed with the first cover plate 1 to guide the guide wire 8.
  • the outer surface of the second cover plate 2 has a rough surface 5.
  • the rough surface 5 may be a dot-like protrusion, a stripe-like indentation, or the like.
  • the rough surface is the finger clamping position during use, which can increase the friction resistance and also prevent the clamping and falling off when the guide wire joint is opened or the guide wire 8 is separated.
  • the guidewire connector can be connected to the outer tube 16 of the quick-exchange device through the connector 4 so that the guidewire 8 penetrates through the guidewire lumen 10 of the guidewire connector and extends to the distal end, and finally extends from the distal end of the outer tube 16
  • the distal end of the outer tube 16 is provided with an opening to facilitate the rapid separation of the guide wire 8 from the guide wire joint when it is separated from the rapid exchange device.
  • the opening provided at the distal end of the outer tube 16 is a triangular opening 17;
  • the guidewire 8 When the guidewire lumen 10 enters the guidewire joint, the guidewire 8 is quickly entered into the lumen of the rapid exchange device and protrudes from the distal exit of the rapid exchange device to play a guiding role; the guidewire 8 is held in the guidewire lumen 11 When inside, the distal end of the triangular opening 17 makes the guide wire 8 stay in the guide wire cavity 11.
  • the guide wire 8 can be pulled through with a certain force The distal end of the triangular opening 17 is passed so that the guide wire 8 is separated from the guide wire joint.
  • the outer tube 16 can be designed to be connected with the outer sheath tube 9, wherein the outer sheath tube 9 is provided with a C-shaped groove 12 on one side, so that the guide wire 8 can pass through the guide wire lumen 10 of the guide wire joint to the outside
  • the outer diameter of the outer sheath tube 9 can be designed to be equal to or slightly smaller than the inner diameter of the distal end of the guidewire connector. Therefore, when the guidewire connector is closed, the guidewire 8 can be smoother from the guidewire lumen 10 of the guidewire connector.
  • the guidewire lumen 11 inserted into the outer sheath tube 9 reaches the distal end of the rapid exchange device along the guidewire lumen 11 and protrudes from the distal exit of the rapid exchange device, so as to accurately guide the forward direction of the guidewire 8 and is effective.
  • the penetration efficiency of the guide wire 8 is improved.
  • connection part 3 in the guide wire joint may be a hinge structure, and the first cover plate 1 and the second cover plate 2 are fixedly connected.
  • the guidewire connector further includes a switch 6, which can be opened through the guidewire lumen 10 by a push or press.
  • a switch 6 which can be opened through the guidewire lumen 10 by a push or press.
  • the switch 6 may be located on the side 7 of the first cover plate 1 away from the connection portion 3, and has an arcuate structure. Specifically, the outer side of the guide wire joint is arc-shaped. When the guide wire joint is opened, the switch 6 is used to gradually open the first cover side 7 away from the second cover 2 to form an opening, and the guide wire 8 provided inside the guide wire joint is detached from the guide wire joint.
  • the switch 6 may also be located between the first cover plate 1 and the second cover plate 2 and includes at least one pressure spring 15.
  • the first cover plate 1 of the guide wire connector can be opened by pressing the second cover plate 2 of the guide wire connector. Opening, the guide wire 8 provided inside the guide wire joint is released from the opening.
  • the guide wire joint of the present invention is easy to operate.
  • the guide wire joint can be opened only by opening or pressing the switch 6, so that the guide wire 8 is separated from the guide wire joint, and is thus quickly separated from the rapid exchange device to the distance of the rapid exchange device.
  • the end part is suitable for the rapid exchange process of the quick exchange device, including a nipple incision, a stone extraction balloon, an imaging catheter, a stone extraction basket, an expansion balloon, and the like.
  • the guide wire joint of the present invention effectively shortens the exchange distance of the rapid exchange device withdrawing the endoscope along the guide wire 8, realizes the rapid withdrawal of the rapid exchange device, and effectively shortens the operation time.
  • the guide wire joint is closed.
  • the first cover plate 1 and the second cover plate 2 are far away from the connecting portion 3.
  • the first cover plate 1 is an arched structure with a larger proximal diameter and a smaller distal diameter. As shown in FIG. 3, the first cover plate 1 has a diameter from the proximal end to the distal end. Reduce first, then change, and then decrease again; the connection between the proximal end surface of the second cover plate 2 and its side wall forms a curved structure with a certain arc. The second cover plate 2 has a constant diameter from the proximal end to the distal end. After the reduction; the starting positions of the diameter reduction of the first cover plate 1 and the second cover plate 2 are consistent.
  • the guide wire 8 can pass from the guide wire lumen 10 into the guide wire joint and can be more conveniently transmitted to the distal end of the rapid exchange device.
  • the guide wire 8 With the structure of a C-shaped groove on the outer sheath tube 9 side of the rapid exchange device, the guide wire 8 can not only better and smoothly insert the guide wire cavity 10 from the guide wire joint into the guide of the outer sheath tube 9 smoothly. The inside of the wire cavity 11 thus enters the distal end of the rapid exchange device, and the exchange distance between the guide wire 8 and the rapid exchange device can be shortened.
  • a switch 6 is provided on the side 7 of the first cover 1 of the guide wire joint remote from the connecting portion 3.
  • the switch 6 is located on the side 7 of the first cover, and the outer side of the guide wire joint is arched in a curved shape.
  • the first cover side 7 is gradually separated from the second cover 2 by opening the switch 6 by turning the switch 6, and the guide wire 8 provided inside the guide wire joint is released from the opening.
  • the first cover plate 1 and the second cover plate 2 are symmetrical structures.
  • the connecting portion 3 is located at the first portion.
  • the middle of a cover plate 1 divides the first cover plate 1 into a curved upper half 13 and a planar lower half 14.
  • the upper half 13 is an arched structure with a larger diameter at the proximal end and a smaller diameter at the distal end; the diameter of the upper half 13 decreases from the proximal end to the distal end, and then decreases.
  • the lower half 14 is a planar structure with two grooves symmetrically distributed on the lower half 14 for setting the pressure spring 15.
  • the switch 6 in the guide wire joint is located between the first cover plate 1 and the second cover plate 2 and includes at least one pressure spring 15.
  • the connecting piece 4 in the guide wire joint may be as shown in FIG. 7, and the proximal ends terminate at the proximal ends of the first cover plate 1 and the second cover plate 2. At this time, the guide wire connection is buckled on the outer sheath 9 or On the outer tube 16.
  • the connecting piece 4 can also be as shown in FIG. 8 and FIG. 9, the proximal ends of which are located outside the proximal ends of the first cover plate 1 and the second cover plate 2, and the outward extension portion is fixed with the outer sheath tube 9 or the outer tube 16. connection.

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Abstract

一种导丝接头，包括第一盖板（1）、第二盖板（2）、连接第一和第二盖板的连接部（3）以及连接件（4）；连接件（4）可连接导丝接头与医疗器械；第一盖板（1）和第二盖板（2）通过远离连接部（3）的一侧接触或分开来调节导丝接头的闭合和打开。导丝接头闭合时第一盖板（1）和第二盖板（2）之间具有过导丝腔道（10），可允许导丝通过并穿入含有C型槽的医疗器械的导丝腔中；导丝接头打开时导丝可以从导丝接头中快速脱离，并快速与医疗器械分离。

Description

一种导丝接头 技术领域
本发明涉及一种医疗器械领域，特别是一种导丝接头。
背景技术
括约肌切开术(Endoscopic sphincteropapillotomy,EST)是在经内镜逆行性胰胆管造影术(Endoscopic retrograde cholangiopancreatography,ERCP)的诊断性技术基础上进一步发展起来的、于内镜下利用高频电切开刀将十二指肠乳头括约肌及胆总管末端部分切开的一种治疗技术。
临床上EST广泛应用于胆总管结石、胆源性胰腺炎、急性梗阻性化脓性胆管炎、壶腹部周围肿瘤、胆道蛔虫、胆总管末端良性狭窄、Oddi括约肌功能障碍等疾病的治疗。于实施内镜下乳头括约肌切开术后配合碎石、取石、蛔虫取出、鼻胆管引流、内支架引流等，可使疾病得到部分或彻底的治疗。
主要是通过绝缘导丝插入胆总管，高频电发生器的负极板粘贴于患者臀部皮肤上，切开刀控制把手的连接接头与高频电发生器的对应电极接头相连接，调整电切、电凝功率及其混合比例而进行切开术。也可使用单纯的电切电流进行EST，其可减少切开过程中对附近组织的凝固作用，从而有利于保持清晰的内镜视野。
传统的ERCP手术中一般乳头切开刀在做完胰胆管系统插管及括约肌切开术之后，一般需要保留导丝(4.5m)位置同时慢慢从内窥镜中撤出乳头切开刀，这个需要医生和护士配合进行，交换距离约为1.6～2m。乳头切开刀从内窥镜撤出后,在体外还需要与导丝有2m以上的撤出距离。此过程切开刀的撤出距离长，导致手术耗时较长；对医生和护士操作的配合的熟练程度有较高要求。
目前市场上大多数的快速交换切开刀产品是在切开刀外管导丝腔侧壁开导丝插入孔或者是在开孔后增加一个开槽式的导丝接头作为导丝预装入口。外管导丝侧壁开口结构由于受到导管尺寸的限制，开口尺寸较小，对于导丝的穿入预装操作不便。开槽式的导丝接头，因为是不封闭的，虽有一定的导向作用，但是碰到预装使用J型导丝时，有一定的几率导丝会从开槽位置伸出。
因此为了节省手术时间并实现医生单人操作，同时保证导丝穿入切开刀导 丝腔有较好的导向性，一种通过导丝腔侧壁开槽和在导丝接头上增加导丝通道的开合功能，配合导丝锁定快速交换装置实现导丝从切开刀的导丝腔侧壁快速分离到乳头切开刀远端，缩短乳头切开刀沿导丝撤出内窥镜的交换距离的导丝接头是迫切需要的。
实用新型内容
本发明的目的，是设计一种导丝接头，使得导丝在穿入导丝腔时有较好的导向性，提高导丝的穿入效率；其次令医生在进行ERCP手术时能实现单人操作；最后缩短快速交换装置延导丝撤出内窥镜的交换距离有效的减短手术时间，减轻患者的痛苦。
本发明提供了一种导丝接头，包括第一盖板、第二盖板、连接所述第一盖板和第二盖板的连接部，以及连接件；所述连接件可连接所述导丝接头与医疗器械，所述第一盖板和所述第二盖板远离所述连接部的一侧可以呈接触或分开状态，从而实现导丝接头的闭合和打开；所述接触状态时，所述第一盖板和所述第二盖板之间具有过导丝腔道，可允许导丝通过，所述分开状态时，所述导丝可以从所述导丝接头中脱离。
本发明的导丝接头，其中，所述医疗器械为快速交换装置，所述导丝接头可以和快速交换装置配合使用，实现导丝与快速交换装置的快速分离。
本发明的导丝接头，其中，所述第一盖板和所述第二盖板远离所述连接部的一侧接触形成类筒状结构，所述类筒状结构远端直径小于近端直径。
本发明的导丝接头，其中，所述导丝接头还包括开关，通过掰动或按压所述开关的方式可打开导丝接头，实现导丝分离。
本发明的导丝接头，其中，所述开关位于所述第一盖板远离所述连接部的一侧，为拱形结构。
本发明的导丝接头，其中，所述开关位于所述第一盖板和所述第二盖板之间，包括压力弹簧。
本发明的导丝接头，其中，第一盖板和第二盖板由塑料注塑成型。
本发明的导丝接头，其中，所述连接部为铰链结构。
本发明导丝接头，其中，所述第二盖板外表面上有粗糙面。
本发明的导丝接头，其中，与导丝接头配合使用的快速交换装置包括外鞘管。
本发明的导丝接头，其中，所述外鞘管包括一侧开有C型槽的导丝腔。
附图说明
图1是右侧开合型导丝接头闭合时的示意图。
图2是图1所示的右侧开合型导丝接头打开后的示意图。
图3是图2所示的右侧开合型导丝接头打开后的示意图的放大图。
图4是图1所示的右侧开合型导丝接头的剖视图。
图5是上侧开合型导丝接头闭合时的示意图。
图6是图5所示的上侧开合型导丝接头打开状态示意图。
图7是图6所示的上侧开合型导丝接头打开后的示意图的放大图。
图8是图5所示的上侧开合型导丝接头去除第二盖板和连接部的示意图。
图9是图5所示的上侧开合型导丝接头的剖视图。
图10是配合导丝接头使用的外鞘管的主视图。
图11是图10所示的配合导丝接头使用的外鞘管的截面图。
主要组件符号说明：
1第一盖板                    2第二盖板
3连接部                      4连接件
5粗糙面                      6开关
7第一盖板侧边                8导丝
9外鞘管                      10过导丝腔道
11导丝腔道                   12C型槽
13上半部                     14下半部
15压力弹簧                   16外管
17三角开口
具体实施方式
以下配合图式及本实用新型的较佳实施例，进一步阐述本实用新型为达成预定实用新型目的所采取的技术手段。
本发明提供了一种导丝接头，包括第一盖板、第二盖板、连接所述第一和第二盖板的连接部，以及连接件；所述连接件可连接所述导丝接头与医疗器械，所述第一盖板和所述第二盖板远离所述连接部的一侧可以呈接触或分开状态，从而实现导丝接头的闭合和打开；所述接触状态时，所述第一盖板和所述第二 盖板之间具有过导丝腔道，可允许导丝通过，此时导丝接头为闭合状态；所述分开状态时，所述导丝可以从所述导丝接头中脱离，此时导丝接头为打开状态。
本发明的导丝接头，所述医疗器械为快速交换装置，所述导丝接头可以和快速交换装置配合使用，实现导丝与快速交换装置的快速分离，具体的快速交换装置可以是乳头切开刀、取石球囊、造影导管、取石网篮、扩张球囊等。
本发明的导丝接头，所述第一盖板和所述第二盖板远离所述连接部的一侧接触形成类筒状结构，所述类筒状结构远端直径小于近端直径。
本发明的导丝接头，所述导丝接头还包括开关，通过掰动或按压所述开关的方式可打开导丝接头，实现导丝分离。
优选的，所述开关位于所述第一盖板远离所述连接部的一侧，为拱形结构。所述开关也可以是位于所述第一盖板和所述第二盖板之间，包括至少一个压力弹簧。
本发明的导丝接头，第一盖板和第二盖板由塑料注塑成型。
本发明的导丝接头，所述连接部为铰链结构。
本发明导丝接头，所述第二盖板外表面上有粗糙面，所述粗糙面是使用时的手指夹持位置，增加摩擦阻力的同时还可以防止打开导丝接头或分离导丝时夹持脱落。
本发明的导丝接头，与导丝接头配合使用的快速交换装置包括外鞘管。
优选的，所述外鞘管包括一侧开有C型槽的导丝腔，使得导丝可以从导丝接头的过导丝腔道穿入外鞘管的导丝腔道。
如图1至图9所示，其示意了本发明实施方式的导丝接头，图10至图11示意了一种本发明的外鞘管结构。
在本发明的非限制性实施例中，一种导丝接头如图1-9所示，包括第一盖板1、第二盖板2、连接第一盖板1和第二盖板2的连接部3，以及连接件4。其中第一盖板1、第二盖板2远离连接部3的一侧可以接触形成类筒状结构，此时导丝接头为关闭状态，导丝接头的第一盖板1与第二盖板2之间形成过导丝腔道10，导丝8从导丝接头近端通过过导丝腔道10进入导丝接头；所述类筒状结构远端直径小于近端直径，第一盖板1、第二盖板2远离轴管3的一侧可以分开形成一个开口，此时导丝接头为打开状态，导丝8从开口中脱离导丝接头。
连接件4设置在第二盖板2上，与第二盖板2固定连接；连接件4还可以 是第一盖板1和第二盖板2内侧向外凸出形成，使得导丝接头闭合时位于两个盖板内侧的凸起相接触形成完整的连接件4,连接件4可以与快速交换装置相连接，从导丝接头近端至其远端厚度逐渐变小，可以在快速交换装置相连接的同时与第一盖板1形成一个导向通道，引导导丝8。
第二盖板2外表面上有粗糙面5，粗糙面5可以是点状凸起、条纹状内凹等。粗糙面是使用时的手指夹持位置，增加摩擦阻力的同时还可以防止打开导丝接头或分离导丝8时夹持脱落。
导丝接头可以通过连接件4与快速交换装置的外管16连接，使得导丝8从导丝接头的过导丝腔道10穿入并向远端延伸，最后从外管16的远端伸出；外管16的远端设置有开口，方便导丝8与快速交换装置分离时从导丝接头快速分离，优选的，设置在外管16远端的开口为三角开口17；导丝8从过导丝腔道10进入导丝接头时，引导导丝8快速进入快速交换装置的腔道内并从快速交换装置的远端出口伸出，起到引导作用；导丝8保持在导丝腔道11里时，三角开口17的远端接触使得导丝8保持在导丝腔道11内，当导丝8从快速交换装置脱离时，使用一定的力扯动导丝8就可以使得导丝8穿过三角开口17的远端，从而导丝8从导丝接头中分离出来。
具体地，外管16可以设计为与外鞘管9相连接，其中外鞘管9一侧开有C型槽12，使得导丝8可以从导丝接头的过导丝腔道10穿入外鞘管9的导丝腔道11。外鞘管9的外径可以设计为等于或略小于导丝接头远端的内径，因此当导丝接头闭合时，导丝8可以更好的从导丝接头的过导丝腔道10平滑的插入外鞘管9的导丝腔道11，沿着导丝腔道11达到快速交换装置的远端并从快速交换装置的远端出口伸出，达到准确引导导丝8前进方向的效果，有效提高导丝8的穿入效率。
导丝接头中的连接部3可以为铰链结构，将第一盖板1和第二盖板2固定连接。
导丝接头上还包括开关6，可以通过掰动或按压的方式打开过导丝腔道10形成一个开口。当导丝接头打开后，导丝8从导丝接头的开口和快速交换装置分离出，从而实现快速交换。
开关6可以位于第一盖板1远离连接部3的一侧侧边7上，为拱形结构，具体的，是向导丝接头的外侧拱出呈弧面型。打开导丝接头时通过掰动开关6 使得第一盖板侧边7逐渐远离第二盖板2形成开口，设置在导丝接头内部的导丝8从开口处脱离导丝接头。
开关6还可以是位于第一盖板1和第二盖板2之间，包括至少一个压力弹簧15，通过按压导丝接头的第二盖板2可以打开导丝接头的第一盖板1形成开口，设置在导丝接头内部的导丝8从开口处释放。
因此，本发明的导丝接头操作简便，只需要通过掰开或者按压开关6就可以打开导丝接头，使得导丝8与导丝接头分离，从而与快速交换装置快速分离至快速交换装置的远端部分，适用于快速交换装置的快速交换过程中，包括乳头切开刀、取石球囊、造影导管、取石网篮、扩张球囊等。并且本发明的导丝接头有效的缩短了快速交换装置沿导丝8撤出内窥镜的交换距离，实现快速交换装置的快速撤离，有效缩短手术时间。
在本发明的非限制性实施方式中，如图1和图5所示为导丝接头闭合时的示意图，导丝接头闭合时，第一盖板1和第二盖板2远离连接部3的一侧接触形成类筒状结构；导丝8穿过类筒状结构的内部；第一盖板1、第二盖板2的远端逐渐向连接部3靠拢，使得类筒状结构的远端直径小于近端直径。
如图1至图4所示，第一盖板1为近端直径较大、远端直径较小的拱形结构；如图3所示，第一盖板1由近端至远端，直径先减小后不变最后再减小；第二盖板2的近端端面与其侧壁连接处形成具有一定弧度的弯角结构，第二盖板2由近端至远端，直径先不变后减小；第一盖板1和第二盖板2直径减小的起始位置一致。又因为类筒状结构的远端直径小于近端直径，所以导丝接头闭合时，导丝8从过导丝腔道10进入导丝接头后可以更方便的传递到快速交换装置的远端，而快速交换装置的外鞘管9一侧开有C型槽的结构，导丝8不仅可以更好的更顺利的从导丝接头的过导丝腔道10平滑的插入外鞘管9的导丝腔内11从而进入快速交换装置的远端，还可以减短导丝8与快速交换装置的交换距离。
导丝接头第一盖板1远离连接部3的一侧7上有开关6，开关6位于第一盖板侧边7上，向导丝接头的外侧拱出呈弧面型。打开导丝接头时通过掰动开关6使得第一盖板侧边7逐渐远离第二盖板2形成开口，设置在导丝接头内部的导丝8从开口处释放。
在本发明的另一种实施例中，如图5至图9所示，第一盖板1和第二盖板2 为对称的结构，如图8至图9所示，连接部3位于第一盖板1的中间将第一盖板1划分成曲面状的上半部13和平面状的下半部14。上半部13为近端直径较大、远端直径较小的拱形结构；上半部13由近端至远端，直径先减小后不变最后再减小。下半部14为一个平面状结构，其上有对称分布两个凹槽，用于设置压力弹簧15。导丝接头中与第一盖板1对称的第二盖板2和第一盖板1合并时形成类筒状结构，此时的导丝接头为关闭状态。
如图5至图9所示，导丝接头中的开关6是位于第一盖板1和第二盖板2之间，包括至少一个压力弹簧15，优选的，是对称分布在导丝第一盖板1和第二盖板2下半部14之间的两个压力弹簧15。通过按压导丝接头的第二盖板2，使得两个盖板的下半部14之间距离减小，因为第一盖板1和第二盖板2之间由设置在上半部13和下半部14中间的连接部3连接，因此两个下半部14之间距离减小时，上半部13之间趋于彼此远离，从而导丝接头打开形成开口，设置在导丝接头内部的导丝8从开口处释放。
导丝接头中的连接件4可以是如图7所示，其近端末端终止于第一盖板1和第二盖板2的近端末端，此时导丝接头是扣在外鞘管9或外管16上。连接件4还可以是如图8和图9所示，其近端末端位于第一盖板1和第二盖板2的近端外侧，向外延伸部分与外鞘管9或外管16固定连接。
以上所述仅是本实用新型的优选实施例而已，并非对本实用新型做任何形式上的限制，虽然本实用新型已以优选实施例揭露如上，然而并非用以限定本实用新型，任何熟悉本专业的技术人员，在不脱离本实用新型技术方案的范围内，当可利用上述揭示的技术内容作出些许更动或修饰为等同变化的等效实施例，但凡是未脱离本实用新型技术方案的内容，依据本实用新型的技术实质对以上实施例所作的任何简单修改、等同变化与修饰，均仍属于本实用新型技术方案的范围内。

Claims (11)

  1. 一种导丝接头，其特征在于，包括第一盖板、第二盖板、连接所述第一和第二盖板的连接部，以及连接件；所述连接件可连接所述导丝接头与医疗器械，所述第一盖板和所述第二盖板远离所述连接部的一侧可以呈接触或分开状态，从而实现导丝接头的闭合和打开；所述接触状态时，所述第一盖板和所述第二盖板之间具有过导丝腔道，可允许导丝通过，所述分开状态时，所述导丝可以从所述导丝接头中脱离。
  2. 根据权利要求1所述的导丝接头，其特征在于，所述医疗器械为快速交换装置，所述导丝接头可以和快速交换装置配合使用，实现导丝与快速交换装置的快速分离。
  3. 根据权利要求1所述的导丝接头，其特征在于，所述第一盖板和所述第二盖板远离所述连接部的一侧接触形成的结构的远端直径小于近端直径。
  4. 根据权利要求1所述的导丝接头，其特征在于，所述导丝接头还包括开关，通过掰动或按压所述开关的方式可打开导丝接头，实现导丝分离。
  5. 根据权利要求4所述的导丝接头，其特征在于，所述开关位于所述第一盖板远离所述连接部的一侧，为拱形结构。
  6. 根据权利要求4所述的导丝接头，其特征在于，所述开关位于所述第一盖板和所述第二盖板之间，包括压力弹簧。
  7. 根据权利要求1所述的导丝接头，其特征在于，第一盖板和第二盖板由塑料注塑成型。
  8. 根据权利要求1所述的导丝接头，其特征在于，所述连接部为铰链结构。
  9. 根据权利要求1所述的导丝接头，其特征在于，所述第二盖板外表面上有粗糙面。
  10. 根据权利要求2所述的导丝接头，其特征在于，与导丝接头配合使用的快速交换装置包括外鞘管。
  11. 根据权利要求10所述的导丝接头，其特征在于，所述外鞘管包括一侧开有C型槽的导丝腔。
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EP3821935A4 (en) 2022-04-20
JP7257426B2 (ja) 2023-04-13
EP3821935A1 (en) 2021-05-19
US20210186589A1 (en) 2021-06-24
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