WO2016115799A1 - 胆道用取石球囊 - Google Patents

胆道用取石球囊 Download PDF

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Publication number
WO2016115799A1
WO2016115799A1 PCT/CN2015/080549 CN2015080549W WO2016115799A1 WO 2016115799 A1 WO2016115799 A1 WO 2016115799A1 CN 2015080549 W CN2015080549 W CN 2015080549W WO 2016115799 A1 WO2016115799 A1 WO 2016115799A1
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WO
WIPO (PCT)
Prior art keywords
balloon
biliary tract
sheath
filling
valve
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PCT/CN2015/080549
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English (en)
French (fr)
Inventor
叶丽萍
李丽清
Original Assignee
杭州安杰思医学科技有限公司
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Application filed by 杭州安杰思医学科技有限公司 filed Critical 杭州安杰思医学科技有限公司
Priority to CN201580050114.XA priority Critical patent/CN106804102A/zh
Publication of WO2016115799A1 publication Critical patent/WO2016115799A1/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
    • 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
    • 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
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves

Definitions

  • the invention belongs to the field of stone removing medical instruments, in particular to a biliary stone removing balloon used in combination with endoscope.
  • the stone balloon is a commonly used medical device for ERCP (endoscopic retrograde cholangiopancreatography) surgery for biliary stone removal, and is mainly used for the removal of sediment-like stones.
  • the stone balloon is usually composed of a catheter, a balloon body and an inflating mechanism.
  • the balloon body is an elastic thin-walled structure, and the balloon can be kept in a small diameter before filling; in use, pre-inserted Guided by the guide wire in the biliary tract, the duodenoscopic forceps enter the biliary tract of the human body.
  • the balloon is inflated by the inflation mechanism to expand the balloon.
  • the sediment-like stones can easily slide out from the lower end surface of the balloon, resulting in multiple cleanings, increasing the operation time and difficulty of operation.
  • the present invention provides a biliary stone-removing balloon which can reduce the frictional resistance and is more easy to take stone.
  • a stone bag for biliary tract includes a balloon interface, a sheath tube and a balloon, the proximal end of the sheath tube is connected to the balloon interface, and the distal end of the sheath tube is sleeved with the ball a capsule, wherein the sheath is provided with an orifice at the sleeve; the two ends of the balloon are fixed on the outer side wall of the sheath, between the two ends of the balloon An effective storable portion of the balloon, the effective storable portion of the balloon being radially expandable, and the balloon having a flattened radial dimension greater than the axial dimension after filling.
  • the balloon is sufficiently filled with a radial dimension that is more than 1.3 times the axial dimension.
  • the balloon is sufficiently filled with a radial dimension that is more than twice the length of the effective fillable portion.
  • the balloon is flattened as a chess piece after filling.
  • the balloon is provided with a balloon filling recovery structure for filling and contracting the balloon, the balloon filling recovery structure comprising a syringe, a two-way valve, the syringe being connected to one end of the two-way valve The other end of the two-way valve is connected to the balloon.
  • a balloon filling recovery structure for filling and contracting the balloon, the balloon filling recovery structure comprising a syringe, a two-way valve, the syringe being connected to one end of the two-way valve The other end of the two-way valve is connected to the balloon.
  • the balloon filling recovery structure is provided with a unidirectional current limiting structure connected between the syringe and the two-way valve,
  • the unidirectional current limiting structure includes:
  • An outer locking joint disposed on one end side of the main body portion and connected to the two-way valve;
  • An adjusting knob comprising an adjusting handle and a rod body connected to the adjusting handle, the adjusting handle is located above the outer portion of the main body, and the rod body is disposed in the main body portion;
  • the syringe includes a syringe barrel, a push rod, and a sealing piston, the sealing piston is mounted on the push rod, the push rod is installed in the syringe barrel, and the sealing piston is friction when unidirectionally moving The increased barb structure or the structure with increased friction when moving in both directions.
  • the two-way valve comprises: a rotary valve, a valve body, a joint, a one-way current limiting baffle, wherein the rotary valve is located above the valve body, and the joint is located on a side of the valve body, wherein The handle portion of the rotary valve is located above the valve body, the plug body of the rotary valve is disposed in the valve body, the joint is located on one side of the valve body, and the upper end of the unidirectional current limiting block
  • the unidirectional current limiting baffle is integrally disposed in the valve body of the rotary valve handle portion.
  • the injector is provided with a variable speed filling adjustment structure, which includes an adjusting rod, a sealing piston, a limiting slider and an adjusting valve body;
  • the limiting slider comprises a left limiting slider and a right limit sliding a sealing piston fixed to the adjusting rod, the adjusting rod can drive the sealing piston to reciprocate in the regulating valve body;
  • the left limiting slider and the right limiting slider sleeve Adjusting the adjustment valve body relative to the adjustment valve body; adjusting the speed of the variable speed filling adjustment structure by adjusting the limit slider.
  • the sheath tube has a double lumen structure, wherein one lumen is a balloon lumen channel and the other lumen is a guide wire channel or an injection channel; a balloon interface and the sheath tube Balloon cavity The proximal end of the channel is connected.
  • the sheath tube has a three-lumen structure, which are respectively a balloon lumen channel, a guide wire channel and an injection channel; and a proximal communication end of the balloon lumen channel
  • the balloon interface is connected to the proximal end of the guidewire channel, and the proximal end of the injection channel is connected to the injection interface.
  • the stone bag for biliary tract of the present invention may further comprise a developing assembly, the developing assembly comprising at least two developing parts, at least one of the developing parts being located on one side of the balloon, and the remaining developing parts being located in the balloon The other side is located on the other side of the balloon near the balloon and is connected to the sheath.
  • the effective contact area between the balloon and the biliary wall is made by making the storable portion of the balloon radially expandable and the balloon has a radial shape larger than the axial dimension after filling.
  • the reduction thereby reducing the friction between the balloon and the biliary wall, thereby solving the problem of large frictional resistance occurring in the clinical process of removing the stone balloon on the market, making the operation easier, labor-saving and reducing the pain of the patient;
  • the flat shape with the radial dimension larger than the axial dimension makes the transition gap between the axial side wall of the balloon and the upper and lower ends of the radial direction smaller, thereby solving the problem that the sediment-like stone is easy to slide from the side of the balloon during the stone taking process.
  • FIG. 1 is a schematic view showing the structure of a stone bag for biliary tract according to the present invention
  • FIG. 2 is a schematic view showing the initial structure of a stone bag for biliary tract according to the present invention
  • Figure 3 is a schematic view showing the shape of a sheath tube
  • FIG. 4 is a schematic structural view of a stone bag for biliary tract according to another embodiment of the present invention.
  • Figure 5 is a cross-sectional view of the unidirectional current limiting structure in the balloon for biliary tract of Figure 4;
  • FIG. 6 is a schematic structural view of a modified example of a stone balloon for biliary tract
  • Figure 7 is a schematic view showing the structure of the two-way valve of the stone bag for biliary tract of Figure 6;
  • Figure 8 is a schematic view showing the structure of a syringe for removing a stone balloon for biliary tract
  • Figure 9 is a cross-sectional view showing a structure of a two-way valve including a flow restricting flap for a stone balloon for biliary tract;
  • Figure 10 is a schematic structural view showing another modification of the stone bag for biliary tract
  • Figure 11 is a perspective view of the variable speed filling and returning adjustment structure of the stone bag for biliary tract of Figure 10;
  • Figure 12 is a schematic view showing the structure of the variable speed filling and returning adjustment structure of the stone bag for biliary tract of Figure 11;
  • Figure 13 is a cross-sectional view taken along line A-A of Figure 12;
  • FIG. 14 is a schematic structural view of a left limit slider of the variable speed filling recovery adjustment structure of FIG. 11;
  • FIG. 15 is a schematic structural view of a right limit slider of the variable speed filling recovery adjustment structure of FIG. 11;
  • Figure 16 is a partial structural schematic view showing still another modification of the stone bag for biliary tract
  • Figure 17 is a schematic structural view showing still another modification of the stone bag for biliary tract
  • Fig. 18 is a cross-sectional view of the sheath tube of the biliary stone bag of Fig. 17 taken along line A-A.
  • a stone bag for biliary tract includes a balloon interface 1, a sheath 2 and a balloon 3.
  • the proximal end of the sheath 2 is connected to the balloon interface 1, and the distal end of the sheath 2
  • the outer side is sleeved with a balloon 3, and the sheath tube 2 is provided with an orifice (not shown) at the sleeved balloon 3; both ends of the balloon 3 are fixed on the outer side wall of the sheath tube 2, in the balloon
  • L is the length of the effective fillable portion
  • the effective fillable portion of the balloon 3 is radially retractable, and the ball
  • the capsule 3 has a flat shape in which the radial dimension D is larger than the axial dimension H after filling.
  • the balloon interface 1 is connected to the proximal end of the sheath by injection molding or other connection to form an air flow passage, and the balloon interface 1 is connected to the syringe by a detachable connection such as a thread for an effective filling portion of the balloon
  • the inflation is performed such that the radial direction of the effective fillable portion of the balloon contracts after filling and deflation.
  • the balloon 3 is made of a compliant polymer material, which is itself in a straight cylindrical shape (as shown in Fig. 3(a)) or a slightly smaller waist-like shape at both ends (as shown in Fig. 3(b)). It is to be noted that the balloon 3 itself is not limited to the several shapes shown.
  • the balloon 3 is sleeved at the distal end of the sheath 2, preferably near the distal end of the sheath, and the ends of the balloon 3 are fixed to the outer side wall of the sheath 2 by bonding or other means.
  • the operation method of the stone bag for biliary tract of the present invention is: in the initial state, the effective storable portion of the balloon is contracted; when the stone is taken, the balloon 3 and the sheath 2 enter the biliary tract of the patient, and the balloon is placed At the upper end of the stone, the airflow generated by the syringe is then inflated through the balloon interface and the sheath tube. After the balloon is fully filled, the balloon has a radial dimension D greater than the axial dimension H, and the ball is pulled through the sheath. The sac removes the stones from the biliary tract.
  • the balloon 3 has a radial dimension that is more than 1.3 times the axial dimension after sufficient filling; or preferably Ground, the balloon is fully filled and the radial dimension is more than twice the length of the effective fillable portion, so that the balloon is flatter after full filling, the contact area between the side of the balloon and the biliary wall is smaller, and thus the friction with the biliary wall The force is even smaller.
  • the balloon is flattened as a chess piece after being fully filled, so that the balloon is flattened after being fully filled, the contact area of the side of the balloon with the biliary wall is smaller, and the upper and lower end faces of the balloon are flatter and cut. The area is larger.
  • the invention is radially retractable by the effective storable portion of the balloon and the balloon has a flat shape with a radial dimension larger than the axial dimension after filling, reducing the effective length dimension after the balloon is filled, so that the balloon is substantially filled after being filled.
  • the flat chess piece shape reduces the effective contact area between the balloon and the biliary wall, thereby reducing the friction between the balloon and the biliary wall, thereby solving the frictional resistance occurring in the clinical process of removing the stone balloon on the market.
  • the problem furthermore, it is more effective to avoid damage to the bile duct wall; and the operation is simpler, labor-saving and reliable;
  • the radial dimension is larger than the axial dimension, so that the axial side wall and the radial direction of the balloon
  • the transition gap of the lower end faces becomes smaller, thereby solving the problem that the sediment-like stones are easy to slide from the side of the balloon during the stone removal process, effectively reducing the damage caused by repeated stone removal, shortening the operation time and reducing the patient's pain.
  • the stone removing balloon of the present invention may further comprise a balloon filling recovery structure 4 for filling and contracting the balloon.
  • the balloon filling recovery structure 4 includes: a syringe 4-1, a unidirectional current limiting structure 4-3, and a two-way valve 4-2, wherein the two-way valve 4-2 One end of the two-way valve 4-2 is connected to one end of the one-way current limiting structure 4-3, and the other end of the one-way current limiting structure 4-3 is connected to the syringe 4-1.
  • the unidirectional current limiting structure includes: a main body portion 4-3-1, a spring 4-3-2, an outer locking joint 4-3-3, an adjusting button 4-3-4, and a sealing ring 4-3. -5.
  • the outer locking joint 4-3-3 is disposed on one end side of the one-way current limiting structure 4-3 for connecting the two-way valve
  • the adjusting button 4-3-4 comprises an adjusting handle and a rod body connected with the adjusting handle, the adjusting handle Located above the outer portion of the main body portion 4-3-1, the rod body is disposed in the main body portion 4-3-1, and the spring is fixedly mounted on the inner portion of the main body portion 4-3-1 and sleeved on the rod body, and is fixed to the rod body.
  • the lower end of the seal ring 4-3-5 contacts.
  • the biliary balloon in this embodiment is operated in the initial state, the balloon 3 is in the return state, the two-way valve 4-2 of the balloon filling recovery structure 4 is in the closed state, and the syringe 4-1 is provided with a limit. Position to limit the filling volume of the balloon 3, the syringe 4-1 is at the maximum limit; when the stone balloon is filled, The two-way valve 4-2 of the balloon filling recovery structure 4 is in an open state, the syringe 4-1 is pushed to the bottom end, and the balloon 3 is filled to a prescribed maximum diameter size; the above process is the same as that of a normal stone removing balloon, except that The radial dimension and the axial dimension ratio of the balloon 3 after filling become larger, and the balloon 3 is shaped like a flat chess piece.
  • the axial dimension of the balloon 3 becomes smaller, the contact area between the balloon 3 and the biliary wall is reduced, and the balloon 3 is dragged when the stone is taken, and the friction with the biliary wall becomes smaller. It is easier to take stones and take more stone, which can shorten the operation time and alleviate the suffering of patients.
  • the unidirectional current limiting structure 4-3 of the balloon filling recovery structure 4 acts as a current limiting function, and simultaneously adjusts the unidirectional current limiting structure 4-
  • the adjustment button 4-3-4 of 3 can adjust the current limiting speed, slow down the recovery speed of the balloon 3, and solve the internal pressure increase caused by the shape change of the stone balloon 3 after filling, and the recovery speed of the balloon is higher than that of the ordinary stone balloon. Quick question.
  • the balloon filling recovery structure 4 includes a syringe 4-1 and a two-way valve 4-2, and one end of the two-way valve 4-2 is connected to one end of the balloon port 1.
  • the two-way valve 4-2 includes: a rotary valve 4-2-1, a valve body 4-2-2, a joint 4-2-3, and a rotary valve 4-2-1 including a handle and a handle
  • the connected plug body is located above the valve body 4-2-2, the plug body is placed in the valve body 4-2-2, and the joint 4-2-3 is located on the valve body 4-2-2 side.
  • the syringe 4-1 includes a pusher 4-1-1, a sealing piston 4-1-2, and a cylinder 4-1-3.
  • the sealing piston 4-1-2 is fixed on the push rod 4-1-1, and the push rod 4-1-1 can drive the sealing piston 4-1-2 to reciprocate in the cylinder 4-1-3.
  • the stone balloon can directly realize the current limiting function by using the syringe 4-1 itself, and the operation is as follows: when filling, push the push rod 4-1-1 of the syringe 4-1 to drive the sealing piston 4-1-2 forward movement, the balloon 3 gradually becomes larger and larger with the movement of the push rod 4-1-1 until the maximum filling size is reached, and the two-way valve 4-2 is closed; at this time, the push rod 4 1-1 drives the sealing piston 4-1-2 forward, and its friction with the cylinder is no significant difference compared with the standard syringe.
  • the two-way valve 4-2 is opened, and the filled balloon 3 automatically recovers, pushing the push rod 4-1-1 in the syringe 4-1 to drive the sealing piston 4-1-2 relative to the cylinder 4- 1-3 moves backward; at this time, the friction between the sealing piston 4-1-2 and the cylinder 4-1-3 is significantly increased to slow the recovery speed of the balloon 3.
  • the sealing piston 4-1-2 may be a structure that increases the unidirectional motion friction, such as a barbed structure; that is, when the push rod 4-1-1 drives the sealing piston 4-1-2 to move forward, When the balloon 3 is filled, its frictional resistance with the cylinder 4-1-3 is no different from that of the standard syringe; when the push rod 4-1-1 drives the sealing piston 4-1-2 to move backward, the sealing piston The frictional resistance between 4-1-2 and the cylinder 4-1-3 becomes large.
  • sealing live The plug 4-1-2 can be made of an elastic polymer material.
  • the operation of the stone removing balloon in this example is as follows: in the initial state, the balloon 3 is fixed at the distal end of the sheath 2, the proximal end of the sheath 2 is connected to the balloon interface 1, and the balloon filling and returning structure is in a closed state.
  • the balloon filling recovery structure 4 is opened, that is, the two-way valve 4-2 is opened, the balloon 3 is filled with the syringe 4-1, and the balloon 3 is filled to the prescribed size.
  • the balloon 3 has a flat chess piece shape, and the radial dimension is more than 1.3 times the axial dimension.
  • the push rod 4-1-1 drives the sealing piston 4-1-2 to move forward, and
  • the friction with the cylinder 4-1-3 is not significantly different or slightly larger than that of the standard syringe; close the two-way valve 4-2, drag the balloon 3 down, observe under X-ray until the stone is dragged
  • the friction between the balloon 3 and the biliary wall is significantly reduced, and the stone is not easily slipped off the end surface of the balloon; after completing the above operation, the two-way valve 4-2 is opened, and the balloon 3 will return to the initial state.
  • the push rod 4-1-1 in the syringe 4-1 drives the sealing piston 4-1-2 to move, and the friction with the cylinder 4-1-3 is significantly larger than that of the standard syringe, which can control the recovery of the balloon 3.
  • Speed solve the problem of internal pressure increase due to the change of balloon shape and the recovery speed of the balloon after it is filled Problem. After the balloon returns to the initial state, repeat the above operation until the stone is completely removed.
  • the two-way valve 4-2 may further include a one-way current limiting baffle 4-2-4, the one-way current limiting baffle 4-2-
  • the upper end of 4 is fixed in the slot of the handle of the rotary valve 4-2-1, and the whole block is placed in the plug body of the rotary valve 4-2-1.
  • the restrictor opening does not have a current limiting function.
  • the restrictor can not be opened to limit the flow.
  • the syringe 4-1 in the balloon filling and recovery structure 4 is a variable-speed filling and returning adjustment structure
  • the variable-speed filling and returning adjustment structure comprises: an adjusting rod 4-1-4, Sealing piston 4-1-2, left limit slider 4-1-6, right limit slider 4-1-7, regulating valve body 4-1-5.
  • the sealing piston 4-1-2 is fixed on the adjusting rod 4-1-4, and the adjusting rod 4-1-4 can drive the sealing piston 4-1-2 to reciprocate in the regulating valve body 4-1-5, left
  • the limit slider 4-1-6 is fixed relative to the right limit slider 4-1-7 and the regulating valve body 4-1-5, respectively, and the right limit slider 4-1-7 is also adjusted with the valve body 4- 1-5 is relatively fixed; the left limit slider 4-1-6 and the right limit slider 4-1-7 are set on the adjusting rod 4-1-4, and the left limit slider 4-1-6
  • the right limit slider 4-1-7 There are 2 bosses 4-1-7-1, 4-1-7-2, the right limit slider 4-1-7 is also provided with thread, and the thread on the adjusting rod 4-1-4 can be Engage each other.
  • the operation procedure of the stone removing balloon in the embodiment is as follows: in the initial state, the two bosses provided on the right limit slider 4-1-7 are respectively fixed to the card slots of the left limit slider 4-1-6.
  • 4-1-6-1,4-1-6-2 the thread on the right limit slider 4-1-7 is engaged with the thread on the adjustment lever 4-1-4; when the balloon is filled, Pull the right limit slider 4-1-7 so that the bosses 4-1-7-1 and 4-1-7-2 are respectively fixed to the card slot 4-1- of the left limit slider 4-1-6.
  • 6-3, 4-1-6-4 at this time, the thread on the right limit slider 4-1-7 is separated from the thread of the adjustment lever 4-1-4, and the adjustment lever 4-1-4 is pushed.
  • the stone removing balloon of the present invention further comprises a developing assembly 5 comprising at least two developing parts which can be made of X-ray radiopaque metal parts. to make.
  • the developing member is fixed to the outside of both end faces of the balloon 3 or one of the developing members may be disposed in the balloon near the other end.
  • the developing part and the balloon can be connected by a binding line.
  • the developing member is annular in this embodiment and is fixedly sleeved at the end of the balloon, although the developing member is not limited to the shape of the embodiment.
  • the stone balloon When working, the stone balloon enters the biliary tract of the patient along the guide wire, and the desired stone removal position of the balloon can be observed through the developing member under X-ray, which is convenient for the operator to quickly find a suitable stone removal position. Make the stone removal effect better.
  • the sheath tube 2 may further comprise two independent channels.
  • one of the inner cavities is a balloon lumen channel, and the other lumen is a guide wire channel or an injection channel;
  • the balloon interface 1 is in communication with the proximal end of the balloon lumen of the sheath 2.
  • the proximal end of the guide wire channel is connected to the guide wire interface through injection molding or other linking means for the guide wire to pass.
  • the end of the guide wire is inserted into the biliary tract of the patient, and the other end of the guide wire extends through the guide wire passage from the guide wire interface, and then the sheath 2 and the balloon 3 enter the biliary tract of the patient along the guide wire, and The balloon is placed at the upper end of the stone, and then the airflow generated by the syringe is inflated through the balloon interface and the sheath tube. After the balloon is fully filled, the radial dimension D is larger than the axial dimension H. The sheath pulls the balloon to remove the stones from the biliary tract.
  • the stone balloon enters the narrow and slender biliary tract more smoothly. In turn, the surgical efficiency is improved and the patient's pain is reduced.
  • the sheath tube 2 may further comprise three independent channels, respectively, a balloon lumen channel 2-1, a guidewire channel 2-2, and Injection channel 2-3; the proximal end of the balloon lumen channel 2-1 communicates with the balloon interface 1; the proximal end of the guidewire channel 2-2 is connected to the guidewire interface 6 by injection molding or other linking means for the guide wire to pass The proximal end of the injection channel 2-3 is connected to the injection port 7 by injection molding or other linking means, and can be used for injecting contrast medium or water.
  • the first end of the guide wire is inserted into the biliary tract of the patient, and the other end of the guide wire extends through the guide wire passage from the guide wire interface, and then the sheath 2 and the balloon 3 enter the patient biliary tract along the guide wire.
  • the balloon is placed at the upper end of the stone, and the balloon is observed by X-ray to enter the position of the patient's biliary tract.
  • the airflow generated by the syringe is inflated through the balloon interface and the sheath to the balloon.
  • the flat dimension of the radial dimension D is greater than the axial dimension H, and the balloon is pulled through the sheath to remove the stone from the biliary tract.
  • the stone removal is smoother and more convenient; thereby improving the operation efficiency, shortening the operation time and reducing the patient's pain.

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Abstract

一种胆道用取石球囊，包括球囊接口(1)、鞘管(2)和球囊(3)，所述鞘管(2)的近端连接所述球囊接口(1)，所述鞘管(2)的远端外侧套设所述球囊(3)，所述鞘管(2)在套设所述球囊(3)处设有孔口；所述球囊(3)的两端部固定在所述鞘管(2)的外侧壁上，在所述球囊(3)的两端部之间是球囊(3)的有效可充盈部分，所述球囊(3)的有效可充盈部分为径向可伸缩的，且所述球囊(3)在充盈后呈径向尺寸(D)大于轴向尺寸(H)的扁平状。所述胆道用取石球囊在使用时能够减小摩擦阻力，同时更易取出泥沙状结石，进而可以缩短手术时间，减少患者痛苦；通过设置球囊充盈回复结构(4)，可以调节球囊(3)在收缩回复时的回复速度，解决了球囊(3)充盈后回复速度过快的问题。

Description

胆道用取石球囊 技术领域
本发明属于取石医疗器械领域，尤其是一种配合内镜使用的胆道内取石球囊。
背景技术
取石球囊是进行胆道取石等ERCP(内镜下逆行胰胆管造影术)手术的常用医疗器械，主要用于泥沙样结石的取出。
在现有技术中，取石球囊通常由导管、球囊本体以及充气机构构成，球囊本体为一弹性薄壁结构，在充盈前球囊可以保持很小的直径；使用时，经由预先置入胆道内的导丝引导下，经十二指肠镜钳道进入人体胆道内，待球囊到达指定位置时，通过充气机构对球囊进行充气从而使球囊膨胀。
而现有常规取石球囊在进行胆道取石过程中，存在几个问题：
1、球囊与胆道壁的摩擦阻力大，操作费力难以拖动充盈后的球囊；
2、泥沙样结石很容易从球囊的下端面滑出，导致需要多次清理，增加手术时间和操作难度。
发明内容
为了克服现有的取石球囊在临床使用时摩擦阻力大，同时结石不易取出的缺点，本发明提供了一种使用时能减小摩擦阻力，同时更易取石的一种胆道用取石球囊。
本发明的一种胆道用取石球囊，其包括球囊接口、鞘管和球囊，所述鞘管的近端连接所述球囊接口，所述鞘管的远端外侧套设所述球囊，所述鞘管在套设所述球囊处设有孔口；所述球囊的两端部固定在所述鞘管的外侧壁上，在所述球囊的两端部之间是球囊的有效可充盈部分，所述球囊的有效可充盈部分为径向可伸缩的，且所述球囊在充盈后呈径向尺寸大于轴向尺寸的扁平状。
优选地，所述球囊充分充盈后径向尺寸为轴向尺寸的1.3倍以上。
优选地，所述球囊充分充盈后径向尺寸为有效可充盈部分长度的2倍以上。
优选地，所述球囊在充盈后呈扁平的象棋棋子状。
优选地，所述球囊设有用于对球囊进行充盈以及收缩回复的球囊充盈回复结构，该球囊充盈回复结构包括注射器、两通阀，所述注射器连接于所述两通阀的一端，所述两通阀的另一端与所述球囊接口连接。
优选地，所述球囊充盈回复结构设有单向限流结构，所述单向限流结构连接在所述注射器和所述两通阀之间，
其中，所述单向限流结构包括：
主体部；
设置于所述主体部的一端侧并连接所述两通阀的外锁定接头；
调节钮，其包含调节柄和与所述调节柄连接的杆体，所述调节柄位于所述主体部外的上方，所述杆体置于所述主体部内；
密封圈，其固定于所述杆体的下端；
弹簧，其固定安装于所述主体部的内部上方并套设于所述杆体上，同时与固定于所述杆体下端的所述密封圈接触。
进一步，所述注射器包括注射筒体、推杆以及密封活塞，所述密封活塞安装在所述推杆上，所述推杆安装于所述注射筒体内，所述密封活塞为单向运动时摩擦增大的倒刺结构或者为双向运动时摩擦增大的结构。
优选地，所述两通阀包括：旋阀、阀体、接头、单向限流挡片，其中，所述旋阀位于所述阀体上方，所述接头位于所述阀体一侧，其中，所述旋阀的手柄部位于所述阀体上方，所述旋阀的塞体置于所述阀体内，所述接头位于所述阀体一侧，所述单向限流挡片的上端固定在所述旋阀手柄部的卡槽内，所述单向限流挡片整体置于所述旋阀塞体内。
进一步，所述注射器设有变速充盈调节结构，该变速充盈调节结构包含调节杆、密封活塞、限位滑块及调节阀体；所述限位滑块包含左限位滑块以及右限位滑块；所述密封活塞固定于所述调节杆上，所述调节杆可带动所述密封活塞在所述调节阀体内往复运动；所述左限位滑块和所述右限位滑块套设于所述调节杆上与所述调节阀体相对固定；通过调节所述限位滑块来调整所述变速充盈调节结构的速度。
作为本发明中的一种优选结构，所述鞘管为双内腔结构，其中一个内腔为球囊腔通道，另一个内腔为导丝通道或注射通道；球囊接口与所述鞘管的球囊腔 通道的近端连通。
作为本发明中的一种优选结构，所述鞘管为三内腔结构，该三个内腔分别为球囊腔通道、导丝通道及注射通道；所述球囊腔通道的近端连通所述球囊接口；所述导丝通道的近端连通有导丝接口，所述注射通道的近端连通有注射接口。
进一步，本发明的胆道用取石球囊还可包括显影组件，所述显影组件至少包括两个显影零件，所述显影零件至少有一个位于所述球囊的一侧，其余的显影零件位于球囊另外一侧或位于球囊内部靠近球囊的另外一侧，并与鞘管连接。
采用本发明的胆道用取石球囊，通过使球囊的可充盈部分径向可伸缩且球囊在充盈后呈径向尺寸大于轴向尺寸的扁平状，使得球囊与胆道壁的有效接触面积减小，进而减小了球囊与胆道壁的摩擦力，从而解决了目前市场上取石球囊临床过程中出现的摩擦阻力大的问题，使操作更简便、省力并减轻了患者痛苦；球囊有效充盈后，呈径向尺寸大于轴向尺寸的扁平状使得球囊轴向侧壁与径向上下两端面的过渡间隙变小，从而解决了取石过程中泥沙样结石易从球囊旁边滑过的问题，缩短了手术时间，减轻了患者的痛苦；同时，通过设置球囊充盈回复结构，可以调节球囊在收缩回复时的回复速度，解决了球囊充盈后回复速度过快的问题。
附图说明
图1是本发明一种胆道用取石球囊结构示意图；
图2是本发明一种胆道用取石球囊初始结构示意图；
图3是表示鞘管形状的示意图；
图4是按照本发明的另一种实施方式中的胆道用取石球囊的结构示意图；
图5为图4的胆道用球囊中的单向限流结构的剖面图；
图6是胆道用取石球囊的一种变形例的结构示意图；
图7为图6中的胆道用取石球囊的两通阀的结构示意图；
图8是胆道用取石球囊的一种注射器的结构示意图；
图9是表示胆道用取石球囊的一种包含限流挡片的两通阀结构的剖面图；
图10是胆道用取石球囊的另一种变形例的结构示意图；
图11是图10的胆道用取石球囊的变速充盈回复调节结构的立体图；
图12是图11的胆道用取石球囊的变速充盈回复调节结构的结构示意图；
图13是按照图12的A-A线截开的剖面图；
图14是图11的变速充盈回复调节结构的左限位滑块的结构示意图；
图15是图11的变速充盈回复调节结构的右限位滑块的结构示意图；
图16是胆道用取石球囊的又一种变形例的局部结构示意图；
图17是胆道用取石球囊的再一种变形例的结构示意图；
图18是图17的胆道用取石球囊的鞘管沿A-A线的截面图。
具体实施方式
下面将结合附图详细描述本发明的胆道用球囊的具体实施方式，但本发明并不局限于这些具体实施方式。
实施例1
如图1至图3所示，本发明一种胆道用取石球囊包括球囊接口1、鞘管2和球囊3，鞘管2的近端连接球囊接口1，鞘管2的远端外侧套设球囊3，鞘管2在套设球囊3处设有孔口(图中未示出、)；球囊3的两端部固定在鞘管2的外侧壁上，在球囊3的两端部之间是球囊3的有效可充盈部分(见图2所示，L为有效可充盈部分的长度)，球囊3的有效可充盈部分为径向可伸缩的，且球囊3在充盈后呈径向尺寸D大于轴向尺寸H的扁平状。
其中，球囊接口1通过注塑或其他连接方式与鞘管的近端连通形成气流通道，而且球囊接口1通过可拆卸的连接方式例如螺纹与注射器连接，用于对球囊的有效可充盈部分进行充气，使得球囊的有效可充盈部分的径向在充盈后伸长及放气后收缩。
球囊3用顺应性高分子材料制成，其本身为直筒状(如图3(a)所示)或两端部略小的类似腰鼓状(如图3(b)所示)，此在予以说明球囊3本身并不限于图示的几种形状。球囊3套设在鞘管2的远端，最好接近鞘管的远端部，且球囊3的两端部通过粘接或者其他方式固定在鞘管2的外侧壁上。
本发明一种胆道用取石球囊的操作方法是：初始状态时，球囊的有效可充盈部分是收缩的；当取石时，球囊3和鞘管2进入患者胆道内，并将球囊置于结石上端，然后用注射器产生的气流通过球囊接口和鞘管对球囊进行充气，待球囊被充分充盈后即呈径向尺寸D大于轴向尺寸H的扁平状，通过鞘管拉动球囊将结石清除出胆道。
较佳地，球囊3在充分充盈后径向尺寸为轴向尺寸的1.3倍以上；或者较佳 地，球囊充分充盈后径向尺寸为有效可充盈部分长度的2倍以上，使得球囊在充分充盈后更扁平，球囊的侧面与胆道壁的接触面积更小，进而与胆道壁的摩擦力更小。
更佳地，球囊在充分充盈后呈扁平的象棋棋子状，使得球囊在充分充盈后更扁平，球囊的侧面与胆道壁的接触面积更小的同时球囊的上下端面更平坦、截面积更大。
本发明通过球囊的有效可充盈部分径向可伸缩且球囊在充盈后呈径向尺寸大于轴向尺寸的扁平状，减小球囊充盈后的有效长度尺寸，使球囊充盈后大致呈扁平的象棋棋子状，使得球囊与胆道壁的有效接触面积减小，进而减小了球囊与胆道壁的摩擦力，从而解决了目前市场上取石球囊临床过程中出现的摩擦阻力大的问题；进而更有效的避免损伤胆管壁；而且使操作更简便、省力、可靠；其次，球囊有效充盈后，呈径向尺寸大于轴向尺寸的扁平状使得球囊轴向侧壁与径向上下两端面的过渡间隙变小，从而解决了取石过程中泥沙样结石易从球囊旁边滑过的问题，有效的减少反复取石的对患者带来的损伤，缩短了手术时间，减少患者痛苦。
实施例2
进一步，在实施例1的基础上，本发明的取石球囊还可以包括球囊充盈回复结构4，用于对球囊进行充盈和收缩回复。
如图4所示，在实施例2中，球囊充盈回复结构4包含有：注射器4-1、单向限流结构4-3、两通阀4-2，其中，两通阀4-2的一端与球囊接口1的一端连接，两通阀4-2的另一端与单向限流结构4-3的一端连接，单向限流结构4-3的另一端与注射器4-1连接。如图5所示，单向限流结构包含：主体部4-3-1、弹簧4-3-2、外锁定接头4-3-3、调节钮4-3-4、密封圈4-3-5。其中，外锁定接头4-3-3设置于单向限流结构4-3的一端侧用于连接两通阀，调节钮4-3-4包含调节柄和与调节柄连接的杆体，调节柄位于主体部4-3-1外的上方，杆体置于主体部4-3-1内，弹簧固定安装于主体部4-3-1的内部上方并套设于杆体上，同时与固定于杆体下端的密封圈4-3-5接触。
在该实施例中的胆道用球囊的操作方式是：初始状态时，球囊3处于回复状态，球囊充盈回复结构4的两通阀4-2处于关闭状态，注射器4-1上设有限位以限定对球囊3的充盈体积数，注射器4-1处于最大限位处；取石球囊充盈时， 球囊充盈回复结构4的两通阀4-2处于打开状态，注射器4-1推到最底端，球囊3充盈到规定最大直径尺寸；上述过程与正常取石球囊相同，不同之处在于球囊3充盈后的径向尺寸和轴向尺寸比变大，球囊3形状为扁平的象棋子状。在取石过程中，相较与普通球囊，球囊3充盈后轴向尺寸变小，球囊3与胆道壁的接触面积减小，取石时拖拉球囊3，其与胆道壁的摩擦变小，更易取石，取石量更大，从而可缩短手术时间，减轻患者痛苦。当充盈后的球囊3回复到初始状态时，相较于普通取石球囊，球囊充盈回复结构4的单向限流结构4-3起限流作用，同时调节单向限流结构4-3的调节钮4-3-4可调节限流速度，减慢球囊3的的回复速度，解决取石球囊3充盈后形状变化导致的内部压力增大，球囊回复速度较普通取石球囊快的问题。
实施例3
如图6所示，在实施例3中，球囊充盈回复结构4包含注射器4-1、两通阀4-2，两通阀4-2的一端与球囊接口1的一端连接。如图7所示，两通阀4-2包含：旋阀4-2-1，阀体4-2-2，接头4-2-3，旋阀4-2-1包括手柄和与手柄相连接的塞体，手柄位于阀体4-2-2上方，塞体置于阀体4-2-2内，接头4-2-3位于阀体4-2-2一侧。如图8所示，注射器4-1包含：推杆4-1-1，密封活塞4-1-2，筒体4-1-3。密封活塞4-1-2固定在推杆4-1-1上，推杆4-1-1可以带动密封活塞4-1-2在筒体4-1-3内往复运动。
如图8所示，在一个例子中，取石球囊可以直接利用注射器4-1自身实现限流功能，其操作如下：充盈时，推动注射器4-1的推杆4-1-1带动密封活塞4-1-2向前运动，球囊3随着推杆4-1-1的运动，逐渐充盈变大，直至到达最大充盈尺寸，关闭两通阀4-2；此时，推杆4-1-1带动密封活塞4-1-2向前，其与筒体的摩擦力同标准注射器相比较无明显差异。球囊3回复时，打开两通阀4-2，充盈后的球囊3自动回复，推动注射器4-1内的推杆4-1-1带动密封活塞4-1-2相对筒体4-1-3向后运动；此时密封活塞4-1-2与筒体4-1-3的摩擦明显增大，用以减慢球囊3的回复速度。
优选地，密封活塞4-1-2可以为使单向运动摩擦增大的结构，例如倒刺形结构；即当推杆4-1-1带动密封活塞4-1-2向前运动，对球囊3进行充盈时，其与筒体4-1-3的摩擦阻力同标准注射器相比无差异；当推杆4-1-1带动密封活塞4-1-2向后运动时，密封活塞4-1-2与筒体4-1-3的摩擦阻力变大。此外，密封活 塞4-1-2可以采用弹性高分子材料制得。
采用该例中的取石球囊的操作方式如下：初始状态时，球囊3固定在鞘管2的远端，鞘管2的近端连接球囊接口1，球囊充盈回复结构处于关闭状态。工作时，观察取石球囊到达预期取石位置后，打开球囊充盈回复结构4，即两通阀4-2打开，用注射器4-1对球囊3进行充盈，将球囊3充盈到规定尺寸，球囊3呈扁平的象棋子状，径向尺寸大于轴向尺寸1.3倍以上，此时注射器4-1内，推杆4-1-1带动密封活塞4-1-2向前运动，其与筒体4-1-3的摩擦力同标准注射器相比无明显差异或略大于标准注射器；关闭两通阀4-2，向下拖动球囊3，在X光下观察直至将结石拖出胆道，运动过程中，球囊3与胆道壁的摩擦明显减小，同时结石不易从球囊端面滑脱；完成上述操作后，打开两通阀4-2，球囊3将回复到初始状态，此时，注射器4-1内的推杆4-1-1带动密封活塞4-1-2运动，其与筒体4-1-3的摩擦明显大于标准注射器，这可以控制球囊3的回复速度，解决由于球囊形状的改变导致的内部压力增大问题以及由其引起的球囊充盈后回复速度过快的问题。待球囊回复到初始状态后，重复上述操作，直至结石完全取出。
此外，作为本实施例的另一个例子，如图9所示，两通阀4-2进一步可以包含一个单向限流挡片4-2-4，该单向限流挡片4-2-4的上端固定在旋阀4-2-1手柄部的卡槽内，挡片整体置于旋阀4-2-1的塞体内，当对球囊充盈时，限流片打开不具有限流作用，当球囊回复时，限流片无法打开起到限流作用。
实施例4
在实施例4中，如图10-15所示，球囊充盈回复结构4中的注射器4-1为一变速充盈回复调节结构，该变速充盈回复调节结构包含：调节杆4-1-4，密封活塞4-1-2，左限位滑块4-1-6，右限位滑块4-1-7，调节阀体4-1-5。
其中，密封活塞4-1-2固定在调节杆4-1-4上，调节杆4-1-4可以带动密封活塞4-1-2在调节阀体4-1-5内往复运动，左限位滑块4-1-6分别与右限位滑块4-1-7和调节阀体4-1-5相对固定，右限位滑块4-1-7也与调节阀体4-1-5相对固定；左限位滑块4-1-6和右限位滑块4-1-7套设在调节杆4-1-4上，同时左限位滑块4-1-6上设有四个卡槽4-1-6-1、4-1-6-2、4-1-6-3、4-1-6-4，右限位滑块4-1-7上设有2个凸台4-1-7-1、4-1-7-2，右限位滑块4-1-7上还设有螺纹，与调节杆4-1-4上的螺纹可相互啮合。
本实施例中的取石球囊操作过程如下：初始状态时，右限位滑块4-1-7上设有的2个凸台分别固定在左限位滑块4-1-6的卡槽4-1-6-1，4-1-6-2内，右限位滑块4-1-7上的螺纹与调节杆4-1-4上螺纹处于啮合状态；对球囊充盈时，拉动右限位滑块4-1-7，使凸台4-1-7-1和4-1-7-2分别固定在左限位滑块4-1-6的卡槽4-1-6-3，4-1-6-4内，此时右限位滑块4-1-7上的螺纹与调节杆4-1-4的螺纹处于分离状态，推动调节杆4-1-4对球囊3进行充盈；球囊3随着调节杆4-1-4的运动，逐渐充盈变大，直至到达最大充盈尺寸，关闭两通阀4-2；球囊3回复时，打开两通阀4-2，推动右限位滑块4-1-7至初始状态，即右限位滑块4-1-7上的螺纹与调节杆4-1-4上螺纹啮合，慢慢反向转动调节杆4-1-4，球囊3慢慢恢复到初始状态；采用这种方式可以人为控制球囊3的回复速度，解决由于球囊形状发生改变而引起的球囊内压增加和球囊快速收缩回复的问题。
此外，如图15所示，在以上任何一个实施例的基础上，本发明的取石球囊还包括显影组件5，显影组件5至少包括两个显影零件，其可以由X光不透射金属零件制成。显影零件固定在球囊3两端面的外侧或者其中一个显影零件还可设置在球囊内靠近另一端部处。显影零件与球囊之间可以通过绑缚线来连接。该显影零件在该具体实施例中为环状，固定套设在球囊的端部，当然显影零件并不局限于该具体实施例的形状。通过设置该结构，工作时，取石球囊沿导丝进入到患者胆道内，能够在X光下通过显影件观察球囊预期合适的取石位置，这样有利于使操作者快速找到合适的取石位置，使得取石效果更好。
优选地，本实施例的取石球囊中，鞘管2还可以包含有两个独立通道，此时，其中一个内腔为球囊腔通道，另一个内腔为导丝通道或注射通道；球囊接口1与鞘管2的球囊腔通道的近端连通。以导丝通道为例，导丝通道的近端通过注塑或其他链接方式连通有导丝接口，供导丝通过。
在工作时，首先导丝一端头插入患者胆道内，导丝另一端头穿过导丝通道从导丝接口伸出，接下来鞘管2和球囊3沿着导丝进入患者胆道内，并将球囊置于结石上端，然后用注射器产生的气流通过球囊接口和鞘管对球囊进行充气，待球囊被充分充盈后即呈径向尺寸D大于轴向尺寸H的扁平状，通过鞘管拉动球囊将结石清除出胆道。
通过导丝的引导，取石球囊进入狭窄细长的胆道更顺畅。进而提高手术效率，减少患者痛苦。
参照图17和图18，在前述任何一个实施例的基础上，鞘管2还可以包含三个独立通道，该三个独立通道分别为球囊腔通道2-1、导丝通道2-2及注射通道2-3；所述球囊腔通道2-1的近端连通球囊接口1；导丝通道2-2的近端通过注塑或其他链接方式连通有导丝接口6，供导丝通过；注射通道2-3的近端通过注塑或其他链接方式连通有注射接口7，可用于注射造影剂或者水。
本实施例在工作时，首先导丝一端头插入患者胆道内，导丝另一端头穿过导丝通道从导丝接口伸出，接下来鞘管2和球囊3沿着导丝进入患者胆道内，并将球囊置于结石上端，在X光下通过造影剂观察球囊进入患者胆道的位置，然后用注射器产生的气流通过球囊接口和鞘管对球囊进行充气，待球囊被充分充盈后即呈径向尺寸D大于轴向尺寸H的扁平状，通过鞘管拉动球囊将结石清除出胆道。
还可以在手术后，通过注射通道注入水或其他流体清理患者胆道。
通过设置导丝通道和注射通道，使得取石更顺畅、便捷；进而提高了手术效率，缩短了手术时间，减少了患者痛苦。
本说明书实施例所述的内容仅仅是对发明构思的实现形式的列举，本发明的保护范围不应当被视为仅限于实施例所陈述的具体形式，本发明的保护范围也基于本领域技术人员根据本发明构思所能够想到的等同技术手段。

Claims (12)

  1. 一种胆道用取石球囊，其特征在于：包括球囊接口、鞘管和球囊，所述鞘管的近端连接所述球囊接口，所述鞘管的远端外侧套设所述球囊，所述鞘管在套设所述球囊处设有孔口；所述球囊的两端部固定在所述鞘管的外侧壁上，在所述球囊的两端部之间是球囊的有效可充盈部分，所述球囊的有效可充盈部分为径向可伸缩的，且所述球囊在充盈后呈径向尺寸大于轴向尺寸的扁平状。
  2. 如权利要求1所述的胆道用取石球囊，其特征在于：所述球囊充分充盈后径向尺寸为轴向尺寸的1.3倍以上。
  3. 如权利要求1所述的胆道用取石球囊，其特征在于：所述球囊充分充盈后径向尺寸为有效可充盈部分长度的2倍以上。
  4. 如权利要求1所述的胆道用取石球囊，其特征在于：所述球囊在充盈后呈扁平的象棋棋子状。
  5. 如权利要求1所述的胆道用取石球囊，其特征在于：所述球囊设有用于对球囊进行充盈以及收缩回复的球囊充盈回复结构，该球囊充盈回复结构包括注射器、两通阀，所述注射器连接于所述两通阀的一端，所述两通阀的另一端与所述球囊接口连接。
  6. 如权利要求5所述的胆道用取石球囊，其特征在于：所述球囊充盈回复结构设有单向限流结构，所述单向限流结构连接在所述注射器和所述两通阀之间，
    其中，所述单向限流结构包括：
    主体部；
    设置于所述主体部的一端侧并连接所述两通阀的外锁定接头；
    调节钮，其包含调节柄和与所述调节柄连接的杆体，所述调节柄位于所述主体部外的上方，所述杆体置于所述主体部内；
    密封圈，其固定于所述杆体的下端；
    弹簧，其固定安装于所述主体部的内部上方并套设于所述杆体上，同时与固定于所述杆体下端的所述密封圈接触。
  7. 如权利要求5所述的胆道用取石球囊，其特征在于：所述注射器包括注射筒体、推杆以及密封活塞，所述密封活塞安装在所述推杆上，所述推杆安装于所述注射筒体内，所述密封活塞为单向运动时摩擦增大的倒刺结构或者为双 向运动时摩擦增大的结构。
  8. 如权利要求5所述的胆道用取石球囊，其特征在于：
    所述两通阀包括：旋阀、阀体、接头、单向限流挡片，其中，所述旋阀的手柄部位于所述阀体上方，所述旋阀的塞体置于所述阀体内，所述接头位于所述阀体一侧，所述单向限流挡片的上端固定在所述旋阀手柄部的卡槽内，所述单向限流挡片整体置于所述旋阀塞体内。
  9. 如权利要求5所述的胆道用取石球囊，其特征在于：所述注射器设有变速充盈调节结构，该变速充盈调节结构包含调节杆、密封活塞、限位滑块及调节阀体；所述限位滑块包含左限位滑块以及右限位滑块；所述密封活塞固定于所述调节杆上，所述调节杆可带动所述密封活塞在所述调节阀体内往复运动；所述左限位滑块和所述右限位滑块套设于所述调节杆上与所述调节阀体相对固定；通过调节所述限位滑块来调整所述变速充盈调节结构的速度。
  10. 如权利要求1-9中任一项所述的胆道用取石球囊，其特征在于：所述鞘管为双内腔结构，其中一个内腔为球囊腔通道，另一个内腔为导丝通道或注射通道；球囊接口与所述鞘管的球囊腔通道的近端连通。
  11. 如权利要求1-9中任一项所述的胆道用取石球囊，其特征在于：所述鞘管为三内腔结构，该三个内腔分别为球囊腔通道、导丝通道及注射通道；所述球囊腔通道的近端连通所述球囊接口；所述导丝通道的近端连通有导丝接口，所述注射通道的近端连通有注射接口。
  12. 如权利要求1-9中任一项所述的胆道用取石球囊，其特征在于：还可包括显影组件，所述显影组件至少包括两个显影零件，所述显影零件至少有一个位于所述球囊的一侧，其余的显影零件位于球囊另外一侧或位于球囊内部靠近球囊的另外一侧，并与鞘管连接。
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