JP2017018209A - Treatment instrument for endoscope and production method thereof - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a treatment instrument for endoscopes facilitating work of inserting the treatment instrument for endoscopes from a proximal side of a guide wire and work of extracting the treatment instrument for endoscopes, having high handlability, and being easily replaceable by another treatment instrument for endoscopes.SOLUTION: The treatment instrument for endoscopes includes: a balloon 2 at a distal end of a catheter tube 5 constituting the treatment instrument for endoscopes; a distal-side wire insertion hole 10b communicated to a main lumen 10, formed at the distal end of the catheter tube 5; and a proximal-side wire insertion hole 10a communicated to the main lumen 10, formed at a proximal side of the balloon 2 on a halfway position along the longitudinal direction of the catheter tube 5. The main lumen 10 heading for the proximal end direction from the proximal-side wire insertion hole 10a is closed by a hardened filler 40. The filler 40 includes a slope face 42 formed for facilitating the guide of a guide wire 20 from the distal-side wire passage toward the proximal-side wire insertion hole 10a.SELECTED DRAWING: Figure 5E

Description

  The present invention relates to an endoscopic treatment tool such as a calculus removing balloon catheter used for removing a calculus generated in, for example, a bile duct, and a manufacturing method thereof.

  Several methods are known as a method for removing a stone generated in a bile duct, that is, a gallstone outside the body, and one of them is a method using a balloon catheter. When removing gallstones from the bile duct using a balloon catheter, first insert the balloon catheter with the balloon deflated through the endoscope into the bile duct, and then remove the balloon from the position of the gallstone to be removed. , To the back. Next, when the balloon is inflated and the balloon catheter is pulled back, the gallstone can be scraped out by the balloon and discharged out of the bile duct.

  As the calculus removing balloon catheter used for removing gallstones as described above, for example, those having structures described in Patent Document 1 and Patent Document 2 are known. In the balloon catheter described in these documents, a balloon made of a stretchable material is joined to the distal end portion (distal end portion) of the catheter tube, and by introducing a fluid into the balloon, the balloon is Can be inflated.

  A guide wire is used to move the distal end of a conventional calculus removing balloon catheter having such a balloon to a predetermined position in the bile duct. That is, the guide wire is inserted into the patient's body through the endoscope, the distal end portion of the guide wire is positioned at a predetermined position in the bile duct, and then the balloon catheter is moved along the guide wire. Move it. Therefore, the balloon catheter is formed with a wire lumen for passing the guide wire along the longitudinal direction of the catheter tube.

  However, in the conventional calculus removing balloon catheter, since the wire lumen is formed along the entire length of the catheter tube, the operation of inserting the balloon catheter from the proximal end side of the guide wire and the operation of extracting the balloon catheter However, it was not easy and the work was complicated. That is, in order to move the balloon catheter along the guide wire relative to the guide wire, it is necessary to grasp both the balloon catheter and the guide wire. The length of the catheter tube must be longer than the total length of the catheter tube and must be pulled out from the endoscope, which is complicated to manage.

  It is also conceivable that a hole leading to the wire lumen is provided in the middle of the entire length of the catheter tube, and a guide wire is taken in and out from there. However, such a structure has a problem that it is difficult to pull out the proximal end of the guide wire from the hole. Further, simply opening a hole in the catheter tube has a problem that the tube becomes weak and the catheter tube is easily kinked starting from the hole.

Japanese Utility Model Publication No. 5-63551 JP-A-6-210001

  The present invention has been made in view of such a situation, and its purpose is to easily insert an endoscope treatment tool from the proximal end side of the guide wire and to remove the endoscope treatment tool. It is an object of the present invention to provide an endoscopic treatment tool that has excellent handling properties and can be easily replaced with another endoscopic treatment tool.

In order to achieve the above object, an endoscope treatment tool according to the present invention includes:
A catheter tube having a lumen formed along the longitudinal direction;
A treatment portion provided at a distal end portion of the catheter tube,
A distal wire insertion hole leading to the lumen is formed at the distal end of the catheter tube,
A proximal wire insertion hole leading to the lumen is formed at a midway position along the longitudinal direction of the catheter tube on the proximal side of the treatment portion.
The lumen from the proximal wire insertion hole toward the proximal end is closed with a hardened filler;
The lumen from the proximal wire insertion hole toward the distal end is usable as a distal wire passage through which a wire can be inserted,
The filling is formed with a slope to facilitate guiding the wire from the distal wire passage toward the proximal wire insertion hole.

  In the endoscope treatment tool according to the present invention, a proximal wire insertion hole that communicates with the lumen is formed at a position midway along the longitudinal direction of the catheter tube, more proximally than the treatment portion. Therefore, on the proximal end side of the guide wire, the guide wire may be pulled out from the endoscope slightly longer than the length corresponding to the distance from the distal wire insertion hole to the proximal wire insertion hole of the catheter tube.

  As a result, the operation of inserting the treatment instrument for endoscope from the proximal end side of the guide wire and the operation of extracting the treatment instrument for endoscope are facilitated, the handling property is improved, and the treatment instrument for endoscope is improved. Exchange is also easy. Furthermore, since the length of the guide wire pulled out from the endoscope can be shortened, its hygiene management becomes easy.

  Further, in the endoscope treatment tool of the present invention, the hardened filler is provided with an inclination for facilitating the guide of the wire from the distal wire passage toward the proximal wire insertion hole. By simply pushing the proximal end of the wire through the distal wire insertion hole, the proximal end of the guide wire is guided through the distal wire passageway toward the proximal wire insertion hole, and the guide wire is drawn therefrom. Work becomes easy. In addition, since the cured filler is filled in the lumen located near the proximal wire insertion hole, the vicinity of the proximal wire insertion hole is reinforced to effectively prevent kinking at that portion. be able to.

  A stylet may be detachably inserted into the lumen located further proximal than the proximal end of the cured filler. By inserting the stylet, the rigidity of the proximal end portion of the catheter tube is increased, and the feeding characteristics of the endoscope treatment tool along the guide wire are improved.

  Preferably, on the outer peripheral surface of the catheter tube located on the proximal end side of the proximal wire insertion hole, a filling hole for filling the inside of the lumen with the filling material that flows before curing is provided. The filling hole is closed by the filled material after curing. With such a configuration, the operation of filling the inside of the lumen of the catheter tube near the proximal wire insertion hole is facilitated. Moreover, since the filling hole is closed by the filling material after curing, the filling hole does not communicate with the inside of the lumen.

  Further, the opening edge of the filling hole is reinforced by a part of the filling after being cured. Further, the opening edge of the proximal wire insertion hole is also reinforced by a part of the filling after being cured.

  In the treatment portion, a balloon is attached to the distal end portion of the catheter tube, and the inside of the balloon portion communicates with a balloon lumen different from the lumen of the catheter tube. According to the endoscope treatment tool having such a configuration, it becomes easy to quickly discharge stones such as gallstones outside the body using a balloon.

  It is not necessary to insert a tube into the lumen used as the distal wire passage. Therefore, the flexibility at the distal end portion of the catheter tube can be improved. Therefore, the insertion characteristics of the endoscope treatment tool into the body are improved.

The method for manufacturing an endoscope treatment tool of the present invention includes:
A catheter tube having a lumen formed along the longitudinal direction;
A treatment portion provided at a distal end portion of the catheter tube, and a method for manufacturing a treatment instrument for an endoscope,
Forming a proximal wire insertion hole leading to the lumen at a midpoint along the longitudinal direction of the catheter tube at a position proximal to the treatment portion;
Inserting a temporary core toward the lumen from the proximal wire insertion hole toward the distal end;
A flowable filler is poured into a part of the lumen that is near the proximal-side wire insertion hole and extends from the outer peripheral portion of the temporary core member toward the proximal end, and the filler is cured. Closing the lumen from the proximal wire insertion hole toward the proximal end with a hardened filling;
Leaving the cured filling, and removing the temporary core from the lumen.

  According to the method for manufacturing an endoscope treatment tool of the present invention, an endoscope treatment tool excellent in operability is manufactured without leaving a temporary core material in a lumen used as a distal wire passage. Can do.

FIG. 1 is an overall view of a calculus removing balloon catheter according to an embodiment of the present invention. FIG. 2 is an enlarged partial cross-sectional view showing a distal end portion of the catheter tube in the calculus removing balloon catheter shown in FIG. FIG. 3 is an enlarged sectional view taken along line III-III shown in FIG. 4 is an enlarged cross-sectional view taken along line IV-IV shown in FIG. FIG. 5A is a partial cross-sectional view showing how to make a proximal wire insertion hole in the catheter tube shown in FIG. 1. FIG. 5B is a partial cross-sectional view showing a step continued from FIG. 5A. FIG. 5C is a partial cross-sectional view showing a step continued from FIG. 5B. FIG. 5D is a partial cross-sectional view showing a step continued from FIG. 5C. FIG. 5E is a partial cross-sectional view showing a state where a guide wire is inserted into the lumen of the catheter tube.

  Hereinafter, the present invention will be described based on embodiments shown in the drawings.

  As shown in FIG. 1, a calculus removal balloon catheter 1 as an endoscope treatment tool according to an embodiment of the present invention includes a catheter tube 5, a balloon (treatment section) 2, a cover 13, and three It consists of branch pipes 14a-14c and three hubs 15a-15c.

  The catheter tube 5 of the balloon catheter 1 for calculus removal is a tube formed of a flexible material, and is a distal end portion 7 which is an end portion to be inserted into the body endoscopically, and others. And a proximal end 6 located on the end side. The outer diameter d2 of the proximal end portion 6 of the catheter tube 5 is usually 1.0 to 4.2 mm, and the total length is usually 500 to 2500 mm. The material of the catheter tube 5 is not particularly limited as long as it is a flexible material, but is preferably a polymer material, and particularly preferably a polyamide resin or a polyamide-based elastomer.

  As shown in FIG. 2, a balloon lumen 8, a contrast medium lumen 9, and a main lumen 10 are formed inside the catheter tube 5. That is, the catheter tube 5 is composed of a multi-lumen tube. The balloon lumen 8 is a lumen serving as a flow path for sending a fluid such as air used to inflate the balloon 2 to the inside of the balloon 2, and from the proximal end of the catheter tube 5 to the distal end portion of the catheter tube 5. 7 penetrates to the fluid outlet 11 which is an opening provided so as to be located inside the balloon 2.

  The contrast medium lumen 9 is a lumen used as a contrast medium channel when performing X-ray contrast in the body for the purpose of confirming the position of a calculus. The contrast medium lumen 9 penetrates from the proximal end of the catheter tube 5 to the spout 12 at the distal end 7 of the catheter tube 5. The spout 12 is an opening provided outside the balloon 2. In this embodiment, the spout 12 is provided so as to be located on the proximal side of the balloon 2.

  The main lumen 10 penetrates from the proximal end to the distal end of the catheter tube 5, and functions on the distal side and the proximal side with the proximal wire insertion hole 10 a shown in FIG. 1 as a boundary. Is different. That is, the distal end opening of the main lumen 10 is formed as a distal wire insertion hole 10b at the distal end of the tube 5 located on the distal side of the balloon 2, and the proximal wire insertion hole 10a and A distal main lumen 10c (see FIGS. 2 and 5E) of the main lumen 10 located between the distal wire insertion hole 10b functions as a wire lumen (distal wire passage). Further, the proximal main lumen 10d of the main lumen 10 located closer to the proximal side than the proximal wire insertion hole 10a shown in FIG. 5E functions as a lumen for inserting a stylet, for example. The stylet is used for the purpose of increasing the rigidity of the catheter tube 5 and improving the insertion of the calculus removal balloon catheter 1 into the endoscope or the body, and is made of, for example, a metal such as stainless steel. A linear body (such as a stranded wire or a straight line) or a rod-shaped body.

  As shown in FIG. 1, the proximal-side wire insertion hole 10 a is located on the proximal side of the balloon 2, at a midway position along the longitudinal direction of the catheter tube 5, and has a small diameter distal end. It is formed in the position which has the outer diameter d2 in the proximal side rather than the part 7. FIG. The length L2 between the proximal wire insertion hole 10a and the distal wire insertion hole 10b is larger than the longitudinal length L1 of the distal end portion 7 which is made thin, preferably 35 to 800 mm. It is. The length of L2−L1 = L3 is preferably 5 to 400 mm.

  As shown in FIG. 5E, the lumen 10 from the proximal wire insertion hole 10a toward the proximal end is closed by the hardened filler 40, and the filler 40 causes the main lumen 10 to move distally. The main lumen 10c and the proximal main lumen 10d are separated into two parts so as not to communicate with each other. A distal main lumen 10c extending from the proximal wire insertion hole 10a toward the distal end can be used as a distal wire passage through which the wire 20 can be inserted. The cured filling 40 is formed with an inclined surface 42 for facilitating guiding the wire 20 from the proximal wire insertion hole 10a toward the distal main lumen 10c. The inclined surface 42 facilitates guiding the wire 20 from the distal main lumen 10c toward the proximal wire insertion hole 10a.

  In order to realize the structure shown in FIG. 5E, for example, as shown in FIG. 5A, first, only the main lumen 10 communicates with a predetermined position in the longitudinal direction of the catheter tube 5 (position L2 shown in FIG. 1). The proximal wire insertion hole 10a is formed. The inner diameter of the insertion hole 10a is substantially the same as the outer diameter of the temporary tube 30 (temporary core material) shown in FIG. 5B, and has a size that allows the temporary tube 30 to be in close contact with the inside of the insertion hole 10a.

  At the same time, a filling hole 10e communicating only with the main lumen 10 is formed at a position away from the proximal wire insertion hole 10a by a predetermined distance L4 in the proximal end direction. The inner diameter of the filling hole 10e is not particularly limited, and may be any size as long as it can be filled with the pre-curing filling 40a (see FIG. 5C) in a fluid state. Further, the predetermined distance L4 is not particularly limited as long as it exceeds 0, but is preferably 2 to 20 mm in order to reduce the filling amount of the filling 40a.

  The pre-curing filler 40a is not particularly limited, and may be any filler that can be cured after injection. For example, an ultraviolet curable resin such as an acrylate ultraviolet curable resin or an epoxy ultraviolet curable resin, or an epoxy thermosetting resin. Thermosetting resin, phenolic thermosetting resin, thermosetting resin such as polyester thermosetting resin, two-component room temperature curable resin such as epoxy two-component room temperature curable resin, acrylic two-component room temperature curable resin, acetic acid Examples thereof include solvent volatile adhesives such as vinyl solvent volatile adhesives, and moisture curable adhesives such as cyanoacrylate moisture curable adhesives.

  As shown in FIG. 5B, the temporary tube 30 has the distal end 30b of the temporary tube 30 positioned at the distal main lumen 10c of the main lumen 10 and the proximal end 30a protruding from the proximal wire insertion hole 10a. Is inserted into the proximal wire insertion hole 10a. After that, as shown in FIG. 5C, the pre-curing filling 40a in a fluidized state is filled from the filling hole 10e closer to the proximal end side than the temporary tube 30 of the main lumen 10. In the embodiment shown in FIGS. 5B and 5C, the tubular temporary tube 30 is used as the temporary core material to be inserted into the main lumen 10, but the temporary core material may be solid.

  In the present embodiment, the temporary tube 30 used as a temporary core material is formed of a short tube having excellent outer and inner diameter flexibility along the longitudinal direction. For example, fluorine such as polytetrafluoroethylene is used. It is made of a material such as resin, polyamide resin, polyamide-based elastomer, polyolefin-based resin, or polyvinyl chloride resin. Preferably, unlike the catheter tube 5, the temporary core material is preferably made of a material that does not adhere to the unfilled filler 40a shown in FIG. 5C and the cured filling portion 40 shown in FIG. 5E. From such a viewpoint, the temporary core material is preferably composed of a fluororesin such as polytetrafluoroethylene, a polyolefin-based resin, or the like.

  The filling amount of the pre-curing filler 40a in a fluidized state is not particularly limited, but at least the main lumen 10 extending in the proximal direction from the outer peripheral surface of the temporary tube 30 inserted into the main lumen 10 toward the proximal end is completely removed. It is preferable that the amount is sufficient to block the membrane. Moreover, as shown to FIG. 5D, it is preferable that it is the filling amount of the grade which fills up the hole 10e for filling completely, and rises somewhat from there. Further, the filling amount may be such that it rises to the outside of the main lumen 10 from the gap between the proximal wire insertion hole 10 a and the temporary tube 30.

  Next, the filler 40a is cured by a curing method according to the type of the pre-curing filler 40a used, and the lumen 10 directed from the proximal wire insertion hole 10a toward the proximal end is replaced with the cured filler 40. It is blocked by. Next, as shown in FIG. 5D, the cured filling 40 is left, and the temporary tube 30 is pulled out from the proximal wire insertion hole 10 a and removed from the main lumen 10. As a result, on the distal end side of the filler 40, an inclined surface 42 that is inclined from the proximal wire insertion hole 10 a toward the distal end direction of the main lumen 10 is transferred along the outer peripheral surface shape of the temporary tube 30. Formed.

  The raised portion 44 of the filling 40 rising from the filling hole 10e may be removed or left as it is. Further, the raised portion 46 of the filling 40 adhering to the opening edge of the proximal wire insertion hole 10a may be left as it is in order to protect the opening edge of the filling hole 10e.

  According to the present embodiment, the calculus removing balloon catheter 1 having excellent operability is manufactured without providing the catheter tube 5 and a separate tube in the distal main lumen 10c used as the distal wire passage. Can do.

The cross-sectional shapes of the balloon lumen 8, the contrast medium lumen 9, and the main lumen 10 shown in FIGS. 3 and 4 are not limited, and may be shapes that can be efficiently arranged in the catheter tube 5. However, the main lumen 10 preferably has a circular cross-sectional shape in the same manner as a general guide wire 20. Further, the cross-sectional area of the balloon lumen 8, 0.03 to 0.5 mm ^2, the cross-sectional area of the contrast medium lumen 9, the cross-sectional area of the 0.08～1.0Mm ^2, the main lumen 10, 0.5-2 Each is preferably 0.0 mm ² .

  The balloon 2 of the calculus removing balloon catheter 1 is attached to the distal end portion of the catheter tube 5 so as to cover the fluid outlet 11. The balloon 2 is formed of a stretchable material, and is inflated by introducing a fluid into the inside through a balloon lumen 8 of the catheter tube 5. The inflated balloon 2 can scrape or extrude the calculus to remove the calculus in the body.

  The stretchable material forming the balloon 2 is preferably one having a 100% modulus (measured in accordance with JIS K 6251) of 0.1 to 10 Mpa, particularly preferably 1 to 5 Mpa. If the 100% modulus is too small, the strength of the balloon 2 may be insufficient. If it is too large, the balloon 2 may not be expanded to a sufficient size. Specific examples of the stretchable material suitable for forming the balloon 2 include natural rubber, silicone rubber, polyurethane elastomer, and the like.

  As shown in FIG. 2, the balloon 2 has a tubular shape as a whole, and joint portions 4 to be joined to the outer peripheral surface of the catheter tube 5 are formed at both ends thereof, and between the joint portions 4 at both ends. Is formed with an inflatable portion 3 that expands when a fluid is introduced therein (in FIG. 2, the inflatable portion 3 that is not subjected to external force is indicated by a solid line, and the inflated portion is inflated by introducing a fluid therein. The part 3a is indicated by a two-dot chain line).

  The inflatable portion 3 of the balloon 2 is formed in a rotating body shape in which a convex curve is rotated toward the outside of the catheter tube 5 around the central axis of the catheter tube 5 in a state where no external force is applied. Yes. That is, the inflating portion 3 of the balloon 2 attached to the catheter tube 5 is in a state where the pressure is balanced between the inside and the outside (the state in which the fluid for inflating the balloon 2 is not sent into the balloon 2). It has a rotating body shape as described above.

  By forming the inflating portion 3 of the balloon 2 in such a shape, it is possible to inflate the balloon 2 to a larger outer diameter as compared with a conventional balloon that is not cylindrical. . Note that the curved line that serves as the rotor-shaped generatrix is not particularly limited as long as it is a convex curve toward the outer side of the catheter tube 5, and may be any curve, but it may be the same plane as the central axis of the catheter tube 5. The upper curve is preferred.

  The inflatable portion 3 of the balloon 2 in a state where no external force is received preferably has a maximum outer diameter of 110 to 250% of the minimum outer diameter. Further, the length of the inflatable portion 3 of the balloon 2 (the length along the longitudinal direction of the catheter tube 5) is preferably 5 to 20 mm, and the wall thickness is preferably 0.10 to 0.50 mm.

  When the calculus removing balloon catheter 1 is provided with an ejection port for ejecting a contrast medium, the catheter tube 5 is located at a position within 10 mm (more preferably within 5 mm) from the proximal end of the balloon 2 toward the proximal side. It is preferable to provide on the surface. If the spout 12 is provided at this position, the body 2 is closed by inflating the balloon 2 and then the contrast medium is ejected from the spout 12 so that the body 2 located on the near side of the inflated balloon 2 is located. This is because the lumen can be efficiently imaged. However, the spout may be provided on the surface of the catheter tube 5 at a position within 10 mm (more preferably within 5 mm) from the distal end of the balloon 2 toward the distal side. In the case where the ejection port is provided on the distal side of the balloon 2, before the balloon 2 is inflated in the body lumen, the contrast medium is ejected from the ejection port, and the body lumen is imaged. By confirming the situation, it becomes easy to insert the balloon 2 at a more appropriate position.

  The shape of the joint portion 4 positioned on both end sides of the inflatable portion 3 of the balloon 2 is not particularly limited as long as it can be joined to the distal end portion 7 of the catheter tube 5, but is preferably cylindrical. When the joint 4 of the balloon 2 is cylindrical, the inner diameter is preferably substantially equal to the outer diameter of the catheter tube 5, and the length is preferably 0.5 to 5 mm. Further, the thickness of the joint portion 4 of the balloon 2 is not particularly limited, and may be substantially equal to the inflatable portion 3, for example. The method for joining the joint 4 of the balloon 2 and the distal end 7 of the catheter tube 5 is not particularly limited. For example, bonding with an adhesive, thermal fusion, welding with a solvent, ultrasonic welding, etc. Can be mentioned.

  A method for manufacturing the balloon 2 having the shape as described above is not particularly limited, and a known method may be used as a method for forming the stretchable material, but it is preferable to use a dipping method. In the dipping molding method, a stretchable material and various additives as necessary are dissolved in a solvent to form a solution or suspension, and a mold having an outer shape substantially equal to the desired balloon shape is formed in this solution (suspension). It is immersed and a solution (suspension) is applied to the surface of the mold, and the solvent is evaporated to form a film on the surface of the mold. By repeating this immersion and drying, a balloon having a desired thickness can be formed. Depending on the type of stretchable material, crosslinking is performed after film formation, if necessary.

  In the calculus removing balloon catheter 1, as in the embodiment shown in FIG. 1, the distal end portion 7 of the catheter tube 5 to which the balloon 2 is attached is more than the other portion (proximal end portion 6) of the catheter tube 5. It is preferable that the outer diameter is a small diameter portion. In the balloon catheter 1 for calculus removal, even if the catheter tube 5 (distal end portion 7) where the balloon 2 is attached has a small diameter, the balloon can be inflated sufficiently large. This is because the operability of the calculus removing balloon catheter 1 is improved by making the distal end portion 7 thin and flexible while maintaining the rigidity of the proximal end portion 6 to some extent. In this case, the outer diameter d1 of the distal end portion 7 of the catheter tube 5 is preferably 50 to 95%, particularly preferably 60 to 90%, of the outer diameter d2 of the proximal end portion 6.

  The method of making the distal end 7 of the catheter tube 5 smaller in diameter than the proximal end 6 is not particularly limited, but the catheter tube 5 at the boundary position between the distal end 7 and the proximal end 6 is moved distally. It is preferable to have a tapered shape that narrows toward the end. Another method for making the distal end portion 7 smaller in diameter than the proximal end portion 6 is to provide a step between the distal end portion 7 and the proximal end portion 6. The length L1 in the longitudinal direction of the distal end portion 7 having a small diameter is preferably 30 to 400 mm.

  The branch pipes 14 a to 14 c of the calculus removal balloon catheter 1 are operated to send a fluid to the balloon lumen 8 of the catheter tube 5, to inject a contrast medium into the contrast medium lumen 9, or to place a stylet near the main lumen 10. These tubes are connected to the respective lumens so as to facilitate the operation of inserting the distal end side.

  The material of the branch pipes 14a to 14c is not particularly limited, but a polymer material is preferably used. Moreover, the connection method of the branch pipes 14a to 14c and each lumen of the catheter tube 5 is not particularly limited. For example, the distal ends of the branch pipes 14a to 14c are formed into a taper shape, and an adhesive is formed on the outer peripheral surface thereof. Is applied, and the end thereof is inserted into the lumen of the catheter tube 5 to be adhered.

  The hubs 15a to 15c of the calculus removing balloon catheter 1 are members connected to the proximal ends of the branch pipes 14a to 14c. For example, the hub 15a and the branch pipe 14a communicate with the balloon lumen 8 shown in FIG. 2, and a balloon expansion fluid can be introduced or led out from the hub 15a thereto. Further, the hub 15c and the branch pipe 14c communicate with the contrast lumen 9 shown in FIG. 2, and a contrast fluid can be introduced or led out from the hub 15c thereto. The hub 15b and the branch pipe 14b communicate with the proximal main lumen 10d shown in FIG. 5E, and a stylet can be introduced or led out from the hub 15b thereto. The material of the hubs 15a to 15c is not particularly limited, but it is preferable to use a transparent polymer material.

  The cover 13 of the calculus removing balloon catheter 1 shown in FIG. 1 is provided so as to cover and protect the connection portion between the catheter tube 5 and the branch pipes 14a to 14c. The shape of the cover 13 is not particularly limited, but is usually a box shape or a cylindrical shape. The material of the cover 13 is not particularly limited, but a polymer material is preferably used. It is also possible to use a heat shrinkable tube as the cover 13.

  A tag 16 is attached to the outer periphery of the catheter tube 5 on the distal end side of the cover 13. The tag 16 displays information unique to the balloon catheter 1, such as how much air volume the balloon 2 is inflated to how much outside diameter.

  Next, an example of removing gallstones from the bile duct will be described as an example of use of the calculus removal balloon catheter 1 of the present embodiment.

  First, the endoscope is inserted into the body, and the distal end of the endoscope is positioned in the vicinity of the bile duct entrance (duodenal papilla). Next, using a cannulation catheter as necessary, the guide wire 20 is inserted into the patient's body through the endoscope channel, and the distal end of the guide wire 20 is guided into the bile duct. At this time, the proximal end portion of the guide wire 20 is slightly shorter than the length (distance L2) between the proximal wire insertion hole 10a and the distal wire insertion hole 10b in the calculus removal balloon catheter 1 to be used. A guide wire 20 having an appropriate length is used in advance so as to exit the endoscope with a long length. Next, a stylet is inserted into the proximal main lumen 10d through the hub 15b and the branch pipe 14b as necessary, and the distal end between the proximal wire insertion hole 10a and the distal wire insertion hole 10b is inserted. The guide wire 20 is passed through the side main lumen (wire lumen) 10c from the distal wire insertion hole 10b side. Thereafter, the balloon catheter 1 for calculus removal is inserted into the body along the guide wire 20 from the distal end side of the catheter tube 5 through the endoscope channel without inflating the balloon 2, and the catheter Lead the distal end of 1 into the bile duct.

  Next, the catheter 1 is pushed forward to the deep part of the bile duct, and then the balloon 2 is inflated by sending air into the balloon 2 via the hub 15a, the branch pipe 14a, and the balloon lumen 8 with a syringe or the like.

  Next, the contrast medium is sent to the spout 12 through the hub 15c, the branch pipe 14c, and the contrast medium lumen 9 by a syringe or the like, the contrast medium is ejected, and X-ray contrast in the bile duct is performed. Confirm. Subsequently, when the catheter 1 is pulled back while the balloon 2 is inflated, the gallstone can be scraped out of the bile duct from the duodenal papilla by the balloon 2.

  At this time, in the catheter 1 of the present embodiment, since the balloon 2 can be expanded to a sufficient size, a gap is hardly formed between the inner wall of the bile duct and the balloon 2, and the gallstone can be easily scraped out. In addition, the gallstones scraped out of the bile duct are normally discharged naturally outside the body. That is, according to the balloon catheter 1 of this embodiment, it becomes easy to quickly discharge stones such as gallstones outside the body using the balloon 2.

  When it is necessary to replace the balloon catheter 1 with another endoscopic treatment tool such as another balloon catheter, only the balloon catheter 1 is left with the distal end of the guide wire 20 left in the body. Is pulled out of the body along the guide wire 20. At this time, the guide wire 20 is passed through the distal main lumen 10 at a relatively short distance L2 from the proximal wire insertion hole 10a located in the middle of the catheter tube 5 to the distal wire insertion hole 10b. Therefore, the catheter 1 can be easily taken out.

  That is, at the proximal end side of the guide wire 20, it is necessary to pull out from the endoscope a little longer than the length corresponding to at least the distal wire insertion hole 10b to the proximal wire insertion hole 10a of the catheter tube 5. Get better. As a result, not only the operation of inserting the guide wire 20 into the distal main lumen 10c, but also the operation of extracting the balloon catheter 1 along the wire 20 is facilitated, and handling properties are improved. In addition, replacement of the balloon catheter 1 with another endoscopic treatment tool is facilitated. Furthermore, since the length of the guide wire 20 drawn out from the endoscope can be shortened, hygiene management thereof is facilitated.

  Furthermore, in the balloon catheter 1 of the present embodiment, an inclined surface 42 for facilitating guiding the wire 20 from the proximal wire insertion hole 10a toward the distal end of the main lumen 10 is formed in the cured filler 40. Therefore, the proximal end of the guide wire 20 is simply pushed into the proximal wire insertion hole 10a through the distal wire passage 10c only by pushing the proximal end of the guide wire 20 through the distal wire insertion hole 10c. The operation of drawing the guide wire 20 therefrom is facilitated.

  Further, since the hard filler 40a is filled in the main lumen 10 located near the proximal wire insertion hole 10a, the vicinity of the proximal wire insertion hole 10a is reinforced, and the kink at that portion is reinforced. Can be effectively prevented.

  Furthermore, in the present embodiment, since the stylet is detachably inserted into the proximal main lumen 10d located further proximal than the proximal end of the temporary tube 30, the proximal end portion of the catheter tube 5 is inserted. And the feeding characteristics of the balloon catheter 1 along the guide wire 20 are improved.

  Further, in the present embodiment, the outer circumferential surface of the catheter tube 5 located on the proximal side of the proximal wire insertion hole 10a is filled to fill the lumen 10 with the flowing filler 40a before hardening. A hole 10e is formed, and the filling hole 10e is closed by the filling 40 after curing. With such a configuration, the work of filling the pre-curing filling 40a into the main lumen 10 of the catheter tube 1 near the proximal wire insertion hole 10a is facilitated. Further, since the filling hole 10e is closed by the filling 40 after curing, the filling hole 10e and the inside of the main lumen 10 do not communicate with each other.

  Further, the opening edge of the filling hole 10e is reinforced by a part 44 of the filling 40 after being cured. Further, the opening edge of the proximal wire insertion hole 10a is also reinforced by a part of the filling 40 after being cured.

  In this embodiment, the balloon 2 is attached to the distal end portion of the catheter tube 5, and the inside of the balloon 2 communicates with a balloon lumen 8 different from the main lumen 10 of the catheter tube 5. According to the balloon catheter 1 having such a configuration, it becomes easy to quickly discharge stones such as gallstones from the body using the balloon 2.

  Furthermore, in this embodiment, it is not necessary to insert the catheter tube 5 and a separate tube into the distal main lumen 10c used as the distal wire passage. Therefore, the flexibility at the distal end portion of the balloon catheter 1 can be improved. Therefore, the insertion characteristics of the endoscope treatment tool into the body are improved.

  The present invention is not limited to the above-described embodiment, and can be variously modified within the scope of the present invention.

  For example, in the above-described embodiment, the calculus removing balloon catheter 1 includes one balloon, but may include a plurality of balloons. In the catheter tube 5, the contrast medium lumen 9 is not necessarily provided, and other lumens having functions other than those described above can be formed. Further, the contrast agent lumen 9 may perform a function other than feeding the contrast agent to the ejection port 12. For example, a fluid such as physiological saline may be vigorously fed into the contrast medium lumen 9, and the fluid may be ejected from the ejection port 12 so that a calculus or the like is swept away by the fluid. In this case, it is preferable to form the ejection port 12 obliquely with respect to the wall surface of the catheter tube 5 so that the fluid is ejected obliquely toward the proximal end side with respect to the central axis of the catheter.

  In the above-described embodiment, the catheter tube 5 is formed of a multi-lumen tube, but a single-lumen catheter tube may be used. Further, another tube may be inserted inside the single lumen catheter tube.

  Moreover, in embodiment mentioned above, although the outer diameter of the distal end part 7 of the catheter tube 5 was made thinner than the proximal end part, it is not necessarily limited to this, For example, a distal end part and a proximal end part The outer diameters may be substantially equal.

  In the above-described embodiment, the inflatable portion 3 of the balloon 2 is inflated in a substantially rotationally symmetric shape with the central axis of the catheter tube 5 as the axis of symmetry. However, as described in Japanese Patent Application Laid-Open No. 2008-194166. In addition, an eccentric expansion means may be provided on at least a part of the circumferential direction of the balloon 2 so that the expansion portion 3 expands eccentrically with respect to the axis of the catheter tube 5.

  Furthermore, the calculus removing balloon catheter 1 is not limited to the use for removing gallstones as long as it is used for removing calculus from the body. Further, the treatment section in the endoscope treatment tool of the present invention may be other than the balloon 2, or may be a balloon catheter other than the stone removal application, or an endoscope treatment tool other than the balloon catheter.

1 ... Balloon catheter for calculus removal (endoscopic instrument)
2 ... Balloon (treatment section)
DESCRIPTION OF SYMBOLS 3 ... Expansion part 4 ... Junction part 5 ... Catheter tube 6 ... Proximal end part 7 ... Distal end part 8 ... Balloon lumen 9 ... Contrast medium lumen 10 ... Main lumen 10a ... Proximal wire insertion hole 10b ... Distal side Wire insertion hole 10c ... Distal main lumen 10d ... Proximal main lumen 10e ... Filling hole 11 ... Fluid outlet 12 ... Jet port 13 ... Covers 14a-14c ... Branch pipes 15a-15c ... Hub 20 ... Guide wire 30 … Temporary tube (temporary core material)
30a ... Proximal end 30b ... Distal end 40 ... Filler 40a after curing ... Filler before curing

Claims (7)

A catheter tube having a lumen formed along the longitudinal direction;
A treatment portion provided at a distal end portion of the catheter tube,
A distal wire insertion hole leading to the lumen is formed at the distal end of the catheter tube,
A proximal wire insertion hole leading to the lumen is formed at a midway position along the longitudinal direction of the catheter tube on the proximal side of the treatment portion.
The lumen from the proximal wire insertion hole toward the proximal end is closed with a hardened filler;
The lumen from the proximal wire insertion hole toward the distal end is usable as a distal wire passage through which a wire can be inserted,
A treatment instrument for an endoscope, wherein the filling is formed with an inclination to facilitate guiding the wire from the distal wire passage toward the proximal wire insertion hole. On the outer peripheral surface of the catheter tube located on the proximal end side of the proximal side wire insertion hole, a filling hole for filling the inside of the lumen with the filling material that flows before being cured is formed. Yes,
The treatment instrument for an endoscope according to claim 1, wherein the filling hole is closed by the filling material after curing.   The treatment instrument for an endoscope according to claim 2, wherein an opening edge of the filling hole is reinforced by a part of the filling material after being hardened.   The treatment instrument for an endoscope according to any one of claims 1 to 3, wherein an opening edge of the proximal wire insertion hole is reinforced by a part of the filling after being cured. In the treatment section, a balloon is attached to the distal end of the catheter tube,
The treatment instrument for an endoscope according to any one of claims 1 to 4, wherein the inside of the balloon portion communicates with a balloon lumen different from the lumen of the catheter tube.   The treatment instrument for an endoscope according to any one of claims 1 to 5, wherein a tube is not inserted into the lumen used as the distal wire passage. A catheter tube having a lumen formed along the longitudinal direction;
A treatment portion provided at a distal end portion of the catheter tube, and a method for manufacturing a treatment instrument for an endoscope,
Forming a proximal wire insertion hole leading to the lumen at a midpoint along the longitudinal direction of the catheter tube at a position proximal to the treatment portion;
Inserting a temporary core toward the lumen from the proximal wire insertion hole toward the distal end;
A flowable filler is poured into a part of the lumen that is near the proximal-side wire insertion hole and extends from the outer peripheral portion of the temporary core member toward the proximal end, and the filler is cured. Closing the lumen from the proximal wire insertion hole toward the proximal end with a hardened filling;
Leaving the cured filling, and removing the temporary core from the lumen.

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