WO2021085537A1 - Balloon catheter for foreign matter removal - Google Patents

Balloon catheter for foreign matter removal Download PDF

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Publication number
WO2021085537A1
WO2021085537A1 PCT/JP2020/040653 JP2020040653W WO2021085537A1 WO 2021085537 A1 WO2021085537 A1 WO 2021085537A1 JP 2020040653 W JP2020040653 W JP 2020040653W WO 2021085537 A1 WO2021085537 A1 WO 2021085537A1
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WO
WIPO (PCT)
Prior art keywords
balloon
catheter
distal end
catheter tube
tube
Prior art date
Application number
PCT/JP2020/040653
Other languages
French (fr)
Japanese (ja)
Inventor
泊　晃平
恭代 冨永
正権 李
Original Assignee
日本ゼオン株式会社
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 日本ゼオン株式会社 filed Critical 日本ゼオン株式会社
Priority to CN202080073921.4A priority Critical patent/CN114599297A/en
Priority to JP2021553685A priority patent/JPWO2021085537A1/ja
Publication of WO2021085537A1 publication Critical patent/WO2021085537A1/en

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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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/50—Instruments, other than pincettes or toothpicks, for removing foreign bodies from the human body
    • 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
    • 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
    • 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
    • A61B2017/22051—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 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1079—Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon

Definitions

  • the present invention relates to a foreign matter removing balloon catheter used for removing foreign matter in the body such as gallstones generated in the bile duct.
  • Patent Document 1 discloses a method in which a balloon catheter for removing foreign substances is inserted into the bile duct from the papilla of Vater and gallstones are scraped out of the papilla of Vater by a balloon provided at the distal end of the catheter tube. ing.
  • the method of inserting a balloon catheter for removing a foreign body into the bile duct from the papilla of Vater is called an ERCP (endoscopic retrograde cholangiopancreatography) approach.
  • the tip of the endoscope 900 is placed near the duodenal papilla 940, which is the entrance of the bile duct 930, and foreign matter is removed via the endoscope 900.
  • the balloon 903 is positioned at the back of the bile duct 930, the balloon 903 is inflated, and the catheter tube 902 is moved from the inside of the bile duct 930 toward the duodenal papilla 940 (in the direction of the arrow in FIG. 9).
  • the gallstone 950 existing on the proximal end side of the balloon 903 can be scraped out of the bile duct 930 from the duodenal papilla 940.
  • the balloon catheter could not be inserted into the bile duct from the papilla of Vater, making the ERCP approach difficult in some cases.
  • the present invention is a simple method capable of satisfactorily discharging foreign substances in the body such as gallstones generated in the bile duct to the outside of the body even when an approach by a commonly used route such as an ERCP approach is difficult.
  • An object of the present invention is to provide a balloon catheter for removing foreign substances, which is excellent in configuration and convenience.
  • the foreign matter removing balloon catheter according to the present invention is a foreign matter removing balloon catheter used for removing foreign matter in the body.
  • the axis is a balloon lumen that circulates the fluid led out from the fluid outlet provided near the distal end and a guide wire lumen through which the guide wire led out from the guide wire insertion hole provided at the distal end is inserted.
  • a catheter tube made of a flexible material formed inside along the direction, and It has a balloon that is located near the distal end of the catheter tube and is inflated by the fluid that is led out of the fluid outlet.
  • the distal end of the catheter tube is formed in a tapered shape.
  • a reinforcing tube for improving the rigidity of the catheter tube is inserted in the guide wire lumen.
  • the balloon is eccentrically inflated with respect to the axial center of the catheter tube.
  • the distal end of the catheter tube is formed in a tapered shape, and the guide wire followability and the dilation (expansion) performance of the body tissue that proceed along the guide wire are formed.
  • the distal end of the balloon catheter for removing foreign matter can easily and quickly place the balloon at the target site through a puncture hole provided in a body tissue such as a stomach wall or a bile duct wall.
  • a reinforcing tube for improving the rigidity of the catheter tube is inserted in the guide wire lumen, and a configuration in which the pushability of the catheter tube is improved is realized.
  • the pushability of the catheter tube is the pushing ability to transmit the pushing force acting at the proximal end to the distal end when the catheter tube is pushed axially from the proximal end to the distal end. Means. As a result, the pushing force applied to the proximal end is reliably transmitted to the distal end, and the balloon can be moved toward the distal end with a desired force.
  • the balloon eccentrically inflates with respect to the axial center of the catheter tube, so that the most distal end of the catheter tube can be arranged at a position deviated from the center of the balloon. There is. This makes it difficult for the most distal end of the catheter tube to hit the foreign body, while ensuring that the balloon hits the foreign body and is pushed out.
  • the catheter tube is composed of a small diameter portion on the distal end side and a large diameter portion on the proximal end side having a larger outer diameter than the small diameter portion.
  • the reinforcing tube is inserted into the large diameter portion.
  • the balloon catheter for removing foreign matter according to the present invention is characterized in that the reinforcing tube is made of polyetheretherketone.
  • the rigidity of the catheter tube can be improved with a simple configuration in which a reinforcing tube made of polyetheretherketone is inserted into the guide wire lumen.
  • the catheter tube is pushed from the proximal end side to the distal end side in a state where the balloon is inflated, and the balloon moves in the bile duct toward the duodenal papilla.
  • the catheter tube is pushed from the proximal end side to the distal end side in a state where the balloon is inflated, and the balloon moves in the bile duct toward the duodenal papilla.
  • it is characterized in that it is used to push a foreign substance in the bile duct out of the bile duct on the distal end side of the balloon.
  • a balloon is placed in the bile duct through a puncture hole provided in a body tissue such as the stomach wall or the bile duct wall, and foreign substances such as gallstones generated in the bile duct are transferred to the duodenal papilla. It is possible to realize a highly convenient balloon catheter for removing foreign substances with a simple structure that can be satisfactorily discharged to the outside of the bile duct by pushing it toward the distal end side of the balloon.
  • FIG. 1 It is a top view which shows an example of the structure of the balloon catheter for foreign matter removal in embodiment of this invention. It is an enlarged side view of the vicinity of region X of FIG. It is sectional drawing which showed the AA cross section of FIG. It is a schematic axial sectional view in the vicinity of region Y of FIG. It is a schematic axial sectional view in the vicinity of region Z of FIG. It is a schematic diagram for demonstrating the use example of removing a gallstone from a bile duct by using the balloon catheter for removing a foreign substance in embodiment of this invention.
  • FIG. 1 is a plan view showing an example of the configuration of a balloon catheter for removing foreign matter according to the embodiment of the present invention.
  • the balloon catheter 100 for removing foreign matter shown in FIG. 1 is used, for example, via an endoscope, and includes a catheter tube 200, a balloon 300, a branch portion 400, and three branch tubes 500a to 500c. There is.
  • the extending direction of the foreign matter removing balloon catheter 100 is the axial direction
  • the balloon 300 side of the foreign matter removing balloon catheter 100 is the distal end side
  • the three branch tubes 500a to 500c side of the foreign matter removing balloon catheter 100 Will be described as the proximal end side.
  • the catheter tube 200 is a tube formed of a flexible material. Although not shown in the middle of the catheter tube 200 in FIG. 1, the catheter tube 200 is actually connected and has a long shape in the axial direction.
  • the catheter tube 200 has a small diameter portion 210 on the distal end side inserted into the body via an endoscope, and a large diameter portion 215 on the proximal end side with respect to the small diameter portion 210.
  • the total length of the catheter tube 200 is, for example, 500 to 2500 mm, and the axial dimension of the small diameter portion 210 is 30 to 800 mm.
  • the outer diameter of the small diameter portion 210 is 50 to 95% of the outer diameter of the large diameter portion 215, for example, 1.0 to 4.2 mm.
  • the material of the catheter tube 200 is not particularly limited as long as it has flexibility, but a thermoplastic resin or a thermoplastic elastomer is preferable from the viewpoint of moldability, and for example, a polyamide resin or a polyamide-based elastomer can be used. ..
  • One or more contrast rings 250 are attached to the small diameter portion 210 of the catheter tube 200.
  • Two contrast ring 250s are attached to the catheter tube 200 shown in FIG. 1, for example, in the vicinity of the attachment position of the balloon 300, but the shape of the contrast ring 250, the position where the contrast ring 250 is attached, the number, and the like are not particularly limited. ..
  • the contrast ring 250 is for confirming the position of the balloon 300 by X-ray imaging when the distal end of the catheter tube 200 is inserted into the body, so that the position of the balloon 300 can be confirmed. It has become.
  • a metal such as gold, platinum, or tungsten can be used as the material of the contrast ring 250.
  • a tapered portion 211 formed in a tapered shape is provided at the most distal end of the narrow diameter portion 210 of the catheter tube 200.
  • the tapered portion 211 is provided to improve dilation performance when passing through a puncture hole provided in an internal tissue such as a stomach wall or an internal lumen.
  • FIG. 2 is an enlarged side view of the vicinity of region X in FIG.
  • the tapered portion 211 has an inclination such that the tapered portion 211 has a tapered shape from the most distal end to the axial dimension L1, and the outer diameter of the straight body portion of the tapered portion 210. It is molded so that the outer diameter of the most distal end is smaller than that of the other.
  • the axial dimension L1 of the tapered portion 211 is not particularly limited, but is, for example, 0.5 to 20 mm.
  • the tapered portion 211 may have a tapered shape, and the inclination angle of the tapered portion 211, the size of the outer diameter at the most distal end, and the like are not particularly limited.
  • the method of providing the tapered portion 211 formed in a tapered shape is not particularly limited, but for example, by processing the most distal end of the catheter tube 200 using a molding die or the like, the taper becomes tapered.
  • the portion 211 can be molded. Further, a member including the tapered portion 211 is molded and manufactured, and the manufactured member is joined to the distal end of the catheter tube 200 so that the distal end of the catheter tube 200 has a tapered shape. May be good.
  • the catheter tube 200 is a multi-lumen tube. As shown in FIG. 3, for example, a balloon lumen 220, a guide wire lumen 230, and a contrast agent lumen 240 are formed inside the catheter tube 200, and the lumens 220 to 240 described above are isolated from each other.
  • the balloon lumen 220 is a lumen used as a flow path for sending a fluid such as air inside the balloon 300 in order to expand and contract the balloon 300.
  • the balloon lumen 220 penetrates from the proximal end of the catheter tube 200 to a fluid flow port (not shown).
  • the fluid flow port is an opening that opens inside the balloon 300 provided in the small diameter portion 210 of the catheter tube 200. Further, as will be described later, the balloon lumen 220 communicates with the branch pipe 500a at the branch portion 400.
  • the guide wire lumen 230 is a lumen used as a path through which the guide wire 235 is inserted.
  • the guide wire lumen 230 penetrates from the proximal end of the catheter tube 200 to the guide wire insertion hole 231 at the distal end.
  • the guide wire insertion hole 231 is an opening that opens at the most distal end of the catheter tube 200. Further, as will be described later, the guide wire lumen 230 communicates with the branch pipe 500b at the branch portion 400.
  • the contrast medium lumen 240 is a lumen used as a flow path for the contrast medium in X-ray imaging.
  • the contrast agent lumen 240 penetrates from the proximal end of the catheter tube 200 to the contrast agent outlet (not shown).
  • the contrast medium outlet is an opening provided in the small diameter portion 210 of the catheter tube 200.
  • the balloon catheter 100 for removing foreign matter in the embodiment of the present invention is particularly preferably used for pushing out gallstones in the bile duct existing in front with the balloon 300, and for example, contrasting the image on the distal end side of the balloon 300.
  • the contrast medium can be ejected toward the gallstone in the bile duct.
  • the contrast agent lumen 240 communicates with the branch tube 500c at the branch portion 400.
  • the cross-sectional shape of the balloon lumen 220, the guide wire lumen 230, and the contrast agent lumen 240 may be any shape that can be efficiently arranged in the catheter tube 200, but the guide wire lumen 230 has a reinforcing tube 216 inserted therein. Since the guide wire 235 inserted through the reinforcing tube 216 generally has a circular cross-sectional shape, the cross-sectional shape of the guide wire lumen 230 is preferably substantially circular.
  • the cross-sectional areas of the balloon lumen 220, the guide wire lumen 230, and the contrast agent lumen 240 are not particularly limited, but the cross-sectional area of the guide wire lumen 230 is relatively large with respect to the cross-sectional areas of the balloon lumen 220 and the contrast agent lumen 240. It is preferably set, for example, the cross-sectional area of the balloon lumen 220 is 0.03 to 1.0 mm 2 , the cross-sectional area of the guide wire lumen 230 is 0.5 to 6.0 mm 2 , and the cross-sectional area of the contrast agent lumen 240 is. It is 0.08 to 4.0 mm 2 .
  • the guide wire lumen 230 is interpolated with a reinforcing tube 216 that improves the pushability of the catheter tube 200 over the entire large diameter portion 215, that is, the range from the proximal end to the distal end of the large diameter portion 215.
  • a reinforcing tube 216 that improves the pushability of the catheter tube 200 over the entire large diameter portion 215, that is, the range from the proximal end to the distal end of the large diameter portion 215.
  • the reinforcing tube 216 By inserting the reinforcing tube 216 into the guide wire lumen 230 so as to extend in the axial direction, the rigidity of the catheter tube 200, particularly the axial rigidity and the bending rigidity of the catheter tube 200, is increased, and the pushability of the catheter tube 200 is increased. Can be improved.
  • the reinforcing tube 216 is preferably a tube having a circular cross-sectional shape because the guide wire 235 inserted through the reinforcing tube 216 generally has a circular cross-sectional shape.
  • the outer diameter of the reinforcing tube 216 is substantially the same as the inner diameter of the guide wire lumen 230, and is such that the reinforcing tube 216 is inserted in close contact with the inner peripheral surface of the guide wire lumen 230.
  • the inner diameter of the reinforcing tube 216 is larger than the outer diameter of the guide wire 235, and is a dimension through which the guide wire 235 can be inserted.
  • the material of the reinforcing tube 216 is not particularly limited, but a thermoplastic resin is preferable from the viewpoint of moldability and rigidity, and among them, polyetheretherketone (PEEK) having high rigidity is particularly preferable.
  • the reinforcing tube 216 inserted in the guide wire lumen 230 will be described with reference to FIGS. 3 to 5.
  • FIG. 3 is a cross-sectional view showing the AA cross section of FIG.
  • a balloon lumen 220, a guide wire lumen 230, and a contrast agent lumen 240 are formed in the large diameter portion 215 of the catheter tube 200, and a reinforcing tube 216 is inserted into the guide wire lumen 230. ing.
  • the cross-sectional view of the catheter tube 200 in FIG. 3 is an example, and the cross-sectional shape of each lumen 220 to 240 is not limited to the shape shown in FIG.
  • a 3-lumen type catheter tube is illustrated in FIG. 3 as an example, a 2-lumen type catheter tube having two lumens used as, for example, a balloon lumen 220 and a guide wire lumen 230 may be used. ..
  • the reinforcing tube 216 is interpolated only in the guide wire lumen 230 here, the reinforcing tube 216 may be further interpolated in one or both of the balloon lumen 220 and the contrast agent lumen 240.
  • FIG. 4 is a schematic axial sectional view in the vicinity of the region Y in FIG.
  • FIG. 4 shows the vicinity of the boundary between the small diameter portion 210 and the large diameter portion 215 of the catheter tube 200, and the three lumens of the balloon lumen 220, the guide wire lumen 230, and the contrast agent lumen 240 are the catheter tube 200.
  • the state provided inside is schematically shown.
  • three lumens, a balloon lumen 220, a guide wire lumen 230, and a contrast agent lumen 240, are formed in the small diameter portion 210 and the large diameter portion 215, respectively, and the small diameter portion 210 is formed.
  • the internal lumens 220 to 240 and the internal lumens 220 to 240 of the large diameter portion 215 communicate with each other.
  • the outer diameter of the small diameter portion 210 is smaller than the outer diameter of the large diameter portion 215, and the cross-sectional area of each lumen 220 to 240 inside the small diameter portion 210 is also smaller than the cross-sectional area of each lumen 220 to 240 inside the large diameter portion 215. ing.
  • the reinforcing tube 216 is inserted into the guide wire lumen 230 inside the large diameter portion 215, and the distal end of the reinforcing tube 216 is near the distal end of the large diameter portion 215 and is connected to the small diameter portion 210. It is located near the boundary with the large diameter portion 215.
  • the reinforcing tube 216 has an outer diameter that is substantially the same as or slightly smaller than the inner diameter of the large diameter portion 215 and is larger than the inner diameter of the small diameter portion 210, and can be interpolated into the large diameter portion 215. However, it cannot be inserted into the small diameter portion 210.
  • FIG. 5 is a schematic axial cross-sectional view in the vicinity of region Z in FIG.
  • FIG. 5 shows a connection portion between the large diameter portion 215 of the catheter tube 200 and each branch tube 500a to 500c, that is, the vicinity of the branch portion 400, and the balloon lumen 220, the guide wire lumen 230, and the contrast agent lumen 240.
  • a state in which three lumens are provided inside the catheter tube 200 is schematically shown.
  • the capacity tag 700 shown in FIG. 1 is not shown.
  • each lumen 220 to 240 inside the large diameter portion 215 is formed inside the large diameter portion 215, and each lumen 220 to 240 inside the large diameter portion 215 is formed.
  • each branch pipe 500a to 500c are in communication with each other.
  • the reinforcing tube 216 is inserted into the guide wire lumen 230 inside the large diameter portion 215, and the proximal end of the reinforcing tube 216 is near the proximal end of the large diameter portion 215 and is connected to the large diameter portion 215. It is located near the boundary with the branch pipe 500b.
  • the method of communicating each lumen 220 to 240 with each branch pipe 500a to 500c is not particularly limited, but in FIG. 5, the distal end of each branch pipe 500a to 500c is inserted into each lumen 220 to 240 as an example. The state of communication is schematically illustrated.
  • the reinforcing tube 216 extends from the vicinity of the boundary between the small diameter portion 210 and the large diameter portion 215 to the vicinity of the boundary between the large diameter portion 215 and the branch pipe 500b, that is, the entire large diameter portion 215. It is interpolated in the guide wire lumen 230.
  • the method of interpolating the reinforcing tube 216 into the large diameter portion 215 of the catheter tube 200 is not particularly limited.
  • the large diameter portion 215 is reinforced before the guide wire lumen 230 of the catheter tube 200 and the branch pipe 500c are communicated with each other.
  • the tube 216 can be inserted.
  • a catheter tube 200 having a small diameter portion 210 on the distal end side and a large diameter portion 215 on the proximal end side is prepared, and an opening is made in the proximal end face of the large diameter portion 215 on the proximal end side.
  • the reinforcing tube 216 is inserted into the guide wire lumen 230, and the reinforcing tube 216 is pushed toward the distal end side.
  • the distal end of the pushed-in reinforcing tube 216 reaches the vicinity of the boundary between the small diameter portion 210 and the large diameter portion 215, the pushed reinforcing tube 216 cannot enter the inside of the small diameter portion 210 having a small cross-sectional area, and the small diameter portion 210 cannot enter.
  • the reinforcing tube 216 protruding from the proximal end face of the large diameter portion 215 is cut in accordance with the proximal end face of the large diameter portion 215, so that the reinforcing tube 216 is a guide wire over the entire large diameter portion 215.
  • the state of being interpolated in the lumen 230 is realized.
  • the reinforcing tube 216 is prevented from coming out of the guide wire lumen 230 by connecting the branch pipe 500b to the reinforcing tube 216 as described later, the reinforcing tube 216 is prevented from coming off.
  • it is not directly fixed between the 216 and the guide wire lumen 230 it is fixed between the reinforcing tube 216 and the guide wire lumen 230 by means such as adhesion using an adhesive if necessary. You may.
  • the balloon 300 is a tubular thin film that can be expanded by introducing a fluid inside, and is attached to a small diameter portion 210 of the catheter tube 200 so as to cover a fluid outlet (not shown).
  • the balloon 300 is made of an elastic material and is inflated by introducing a fluid inside through the balloon lumen 220 and the fluid outlet of the catheter tube 200. In the embodiment of the present invention, it is possible to remove the foreign matter in the body by pushing out the foreign matter such as gallstones on the distal end side of the inflated balloon 300.
  • the elastic material forming the balloon 300 a material having a 100% modulus (value measured in accordance with JIS K6251) of 0.1 to 10 MPa is preferable, and a material having a 100% modulus of 1 to 5 MPa is particularly preferable.
  • specific examples of the elastic material suitable for forming the balloon 300 include natural rubber, silicone rubber, polyurethane elastomer and the like.
  • the balloon 300 has a tubular shape as a whole, and joint portions 310 and 320 that are joined to the outer peripheral surface of the catheter tube 200 are formed on the distal end side and the proximal end side.
  • the joint portions 310 and 320 refer to a portion where the balloon 300 is cylindrically joined to the outer peripheral surface of the catheter tube 200, and the axial dimensions of the joint portions 310 and 320 are, for example, 0.5 to 5.0 mm.
  • the method of joining the joining portions 310 and 320 of the balloon 300 to the outer peripheral surface of the catheter tube 200 is not particularly limited, and for example, bonding using an adhesive, heat welding, welding with a solvent, ultrasonic welding and the like are possible. is there.
  • An expansion portion 330 that is not bonded to the outer peripheral surface of the catheter tube 200 and expands when a fluid is introduced into the balloon 300 is formed between the joint portions 310 and 320 of the balloon 300.
  • the maximum outer diameter of the inflated portion 330 of the balloon 300 in the inflated state is preferably 200 to 1500% of the outer diameter in the inflated state. If this ratio is too small, the balloon 300 may not expand to a sufficient size, and if it is too large, the balloon 300 may interfere with the insertion of the catheter tube 200 into the body.
  • the axial dimension of the expansion portion 330 is, for example, 5 to 20 mm, and the film thickness is, for example, 0.10 to 0.50 mm.
  • an offset sheet 340 is attached to a part of the inflatable portion 330 so that the inflatable portion 330 eccentrically inflates with respect to the axial center of the catheter tube 200.
  • the offset sheet 340 has, for example, an elongated shape in which the axial dimension of the offset sheet 340 is set longer than the axial dimension of the expansion portion 330.
  • the offset sheet 340 is attached to a part of the expansion portion 330 along the axial direction, and both ends thereof are fixed to the joint portions 310, 320 or the outer peripheral surface of the catheter tube 200.
  • the inflatable portion 330 on the side to which the offset sheet 340 is attached is in a state where it is difficult to inflate or cannot be inflated. ..
  • the inflated portion 330 on the side to which the offset sheet 340 is not attached expands in an eccentric shape with respect to the axial center of the catheter tube 200.
  • the material of the offset sheet 340 is not particularly limited, and for example, the same resin as the catheter tube 200 can be used.
  • the method of fixing the offset sheet 340 is not particularly limited, and for example, adhesion, heat fusion, high frequency fusion and the like are possible.
  • an offset sheet 340 having an adhesive coated on the back surface is used, and the offset sheet 340 is adhered to a part of the balloon 300 including the inflatable portion 330 in the circumferential direction and a part of the catheter tube 200.
  • the width of the offset sheet 340 is, for example, a width of 1/2 or less, preferably 1/3 to 1/5 of the circumferential length of the outer peripheral surface of the catheter tube 200. If this width is too small, it becomes difficult to inflate the balloon 300 in an eccentric state, and if this width is too large, it becomes difficult for the balloon 300 to inflate itself.
  • the balloon 300 is inflated in a shape eccentric to the axial center of the catheter tube 200 by attaching the offset sheet 340.
  • the inflated portion 330 is formed on the outer peripheral surface of the catheter tube 200.
  • a configuration other than the above, such as providing the balloon 300 so as to be biased to a part, may allow the balloon 300 to expand in an eccentric state with respect to the axial center of the catheter tube 200.
  • the branch portion 400 is a member provided at the connection portion that connects the catheter tube 200 and the branch tubes 500a to 500c.
  • the balloon lumen 220 and the branch pipe 500a communicate with each other
  • the lumen of the reinforcing tube 216 inserted in the guide wire lumen 230 and the branch pipe 500b communicate with each other
  • the contrast agent lumen 240 and the branch pipe 500c communicate with each other. Is configured to communicate with.
  • the method of communicating the lumens 220 to 240 of each lumen 220 to 240 in the catheter tube 200 or the lumen of the reinforcing tube 216 with each branch tube 500a to 500c is not particularly limited, and for example, the distal end of each branch tube 500a to 500c.
  • the tapered portion is inserted into the corresponding lumens 220 to 240 and fixed with an adhesive.
  • the branch portion 400 which is a tubular cover member made of a polymer material such as synthetic resin, covers and protects the connection portion connecting the catheter tube 200 and the branch tubes 500a to 500c.
  • the material of the branch pipes 500a to 500c is not particularly limited, and a polymer material such as a synthetic resin can be used.
  • the branch pipe 500a is a branch pipe for a balloon, and a hub 600a for a balloon equipped with, for example, a two-way stopcock is connected to the proximal end of the branch pipe 500a.
  • the balloon hub 600a and the branch pipe 500a communicate with the balloon lumen 220 at the branch portion 400 so that the fluid can be introduced into the balloon 300 from the balloon hub 600a through the branch pipe 500a, the balloon lumen 220 and the fluid flow port. It has become.
  • the branch pipe 500b is a branch pipe for a guide wire, and for example, a luer lock type guide wire hub 600b is connected to the proximal end of the branch pipe 500b.
  • the guide wire hub 600b and the branch pipe 500b communicate with the lumen of the reinforcing tube 216 inserted in the guide wire lumen 230 at the branch portion 400, and the guide wire hub 600b to the branch pipe 500b and the reinforcing tube are communicated with each other.
  • the guide wire 235 can be projected to the outside through the guide wire lumen 230 and the guide wire insertion hole 231 provided at the most distal end of the catheter tube 200.
  • the branch tube 500c is a contrast-enhancing branch tube, and for example, a luer lock type contrast-enhancing hub 600c is connected to the proximal end of the branch tube 500c.
  • the contrast medium hub 600c and the branch tube 500c communicate with the contrast medium lumen 240 at the branch portion 400, and the contrast medium is ejected from the contrast medium hub 600c through the branch tube 500c, the contrast medium lumen 240, and the contrast medium outlet. You can do it.
  • a capacitance tag 700 is attached to the outer circumference of the catheter tube 200 on the distal end side of the branch portion 400.
  • the capacity tag 700 contains information specific to the balloon catheter 100 for removing foreign matter, such as the relationship between the outer diameter of the balloon 300 and the internal pressure or gas capacity of the balloon 300.
  • the balloon catheter 100 for removing foreign matter has a tapered tapered portion 211 formed at the most distal end of the catheter tube 200 as a first feature.
  • a reinforcing tube 216 for improving the rigidity of the catheter tube 200 is inserted, and as a third feature, the balloon 300 is eccentrically expanded with respect to the axial center of the catheter tube 200. It is configured.
  • the balloon catheter 100 for removing foreign matter in the embodiment of the present invention will be described with reference to FIG.
  • the patient's gastric wall and intrahepatic bile duct wall (liver) are used when it is confirmed that the ERCP approach is difficult due to circumstances such as stenosis in the duodenum of the patient. ), And the balloon catheter 100 for removing foreign matter is inserted into the bile duct through the puncture hole.
  • the tip of the endoscope 800 which is an ultrasonic endoscope, is used. It is inserted into the body, and the intrahepatic bile duct 820 is visualized from the stomach 810 as an ultrasonic image to confirm the position of the intrahepatic bile duct 820.
  • a puncture needle was punctured from the gastrointestinal wall such as the stomach wall into the intrahepatic bile duct 820, and a guide wire was inserted into the balloon catheter 100 for removing foreign substances via the endoscope 800 (FIG.
  • the contrast medium is ejected with the balloon 300 placed in the bile duct 830, and the inside of the bile duct 830 and the state of the gallstone 850 are confirmed by an X-ray contrast image, and then the balloon 300 is inflated. Then, with the balloon 300 inflated, the proximal end of the catheter tube 200 is pushed toward the distal end (direction of the arrow in FIG. 6), so that the balloon 300 moves through the bile duct 830 and the duodenal papilla 840.
  • the gallstone 850 can be removed by pushing it out of the bile duct 830 from the duodenal papilla 840 at the distal end side of the inflated balloon 300, moving to the side (in the direction of the arrow in FIG. 6).
  • the balloon catheter 100 for removing foreign substances is preferably used when the ERCP approach is difficult, and for example, the distal end of the catheter tube 200 is placed in the stomach wall and intrahepatic. It is used by inserting it from the intrahepatic bile duct into the bile duct through a puncture hole provided in the bile duct wall.
  • internal lumens such as puncture holes and intrahepatic bile ducts are very narrow, and it is not easy to insert the distal end of the catheter tube of a conventional balloon catheter into the puncture hole or advance the internal lumen.
  • the distal end of the catheter tube 200 is formed in a tapered shape, and the distal end of the catheter tube 200 is a puncture hole. It is possible to proceed while expanding the pathway without damaging the internal tissues such as the peripheral wall of the catheter. That is, the foreign matter removing balloon catheter 100 according to the embodiment of the present invention proceeds along the guide wire 235 due to the first feature that the distal end end of the catheter tube 200 is formed in a tapered shape. A configuration with improved guide wire followability and dilation performance has been realized.
  • the order is different.
  • the balloon catheter 100 for removing foreign matter into the bile duct and pushing the proximal end of the catheter tube 200 toward the distal end while the balloon 300 is inflated, the balloon 300 is pushed toward the distal end. It is moved to push gallstones out of the bile duct from the papilla of Vater at the distal end of the balloon 300.
  • the pushing force applied to the proximal end of the catheter tube may not be reliably transmitted to the distal end of the catheter tube.
  • the balloon may not be able to move toward the distal end with the desired force, and the gallstone may not be pushed out of the bile duct on the distal end side of the balloon.
  • the reinforcing tube 216 for improving the rigidity of the catheter tube 200 is inserted in the guide wire lumen 230, and is proximal to the catheter tube 200.
  • the pushing force applied to the end is reliably transmitted to the distal end of the catheter tube 200, allowing the balloon 300 to move toward the distal end with a desired force. That is, the foreign matter removing balloon catheter 100 according to the embodiment of the present invention has the catheter tube 200 due to the second feature that the reinforcing tube 216 for improving the rigidity of the catheter tube 200 is inserted in the guide wire lumen 230.
  • a configuration has been realized in which the pushing force applied to the proximal end of the catheter tube 200 is transmitted to the distal end of the catheter tube 200 to improve the pushability (pushing ability).
  • the gallstones are expanded.
  • the gallstone will be pushed out on the distal end side of the balloon 300.
  • the bile stone existing on the distal end side of the balloon is pushed out by the balloon, when a conventional balloon catheter is used, the most distal end of the catheter tube hits the bile stone when moving the balloon toward the distal end, and the catheter tube May interfere with the movement of the balloon toward the distal end.
  • the balloon may not be able to move toward the distal end, and gallstones may not be pushed out of the bile duct on the distal end side of the balloon.
  • the balloon 300 expands eccentrically with respect to the axial center of the catheter tube 200, so that the most distal end of the catheter tube 200 is balloon 300. It can be placed at a position deviated from the center of. That is, the balloon catheter 100 for removing foreign matter according to the embodiment of the present invention has a third feature that the balloon 300 expands eccentrically with respect to the axial center of the catheter tube 200, so that the most distal end of the catheter tube 200 is ballooned.
  • the balloon 300 can be placed in a position where it does not get in the way when it hits the gallstone, and the balloon 300 can be reliably hit against the gallstone and pushed out.
  • FIG. 7A is a diagram according to a comparative example with respect to the embodiment of the present invention, and is a schematic view showing a case where the center of the balloon 300 is arranged at a position coincided with the axial center of the catheter tube 200.
  • FIG. 7B is a diagram according to an embodiment of the present invention, and is a schematic view showing a case where the center of the balloon 300 is arranged at a position deviated from the axial center of the catheter tube 200.
  • the most distal end of the catheter tube 200 in which the tapered portion 211 is formed is approximately the center of the balloon 300.
  • the balloon 300 moves in the direction of the distal end (direction of the arrow in FIG. 7A).
  • the most distal end of the catheter tube 200 hits the gallstone 850 and the movement of the catheter tube 200 to the distal end side is hindered, the balloon 300 cannot be moved to the distal end side, and the balloon The gallstone 850 cannot be extruded on the distal end side of the 300.
  • the most distal end of the catheter tube 200 in which the tapered portion 211 is formed is formed.
  • the balloon 300 moves in the distal end direction (direction of the arrow in FIG. 7B) while being positioned laterally with respect to the moving direction of the balloon 300.
  • the distal end of the catheter tube 200 can be successfully pressed against the gallstone 850 without hitting the gallstone 850, at the distal end of the balloon 300.
  • the gallstone 850 can be pushed out reliably.
  • a foreign matter removing balloon catheter 100 is provided with a puncture hole in the patient's stomach wall and intrahepatic bile duct wall (liver), and the gallstone is inserted from the intrahepatic bile duct into the bile duct through the puncture hole.
  • the balloon catheter for removing foreign matter according to the present invention is not limited to this, and is used as a balloon catheter for removing foreign matter in other cases. Can also be used for.
  • the balloon catheter for removing foreign substances according to the present invention is particularly suitable for an approach through a puncture hole provided in a body tissue when it is difficult to approach by a commonly used route such as an ERCP approach. Can be used.
  • Balloon catheter for removing foreign matter 100 Balloon catheter for removing foreign matter 200, 902 Catheter tube 210 Small diameter part 211 Tapered part 215 Large diameter part 216 Reinforcing tube 220 Balloon lumen 230 Guide wire lumen 231 Guide wire insertion hole 235 Guide wire 240 Contrast agent lumen 250 Contrast ring 300 Balloon 310, 320 Joint 330 Expansion 340 Offset sheet 400 Branch 500a-500c Branch tube 600a Balloon hub 600b Guide wire hub 600c Contrast hub 700 Capacity tag 800, 900 Endoscope 810 Gastric 820 Intrahepatic bile duct 830, 930 Bile duct 840, 940 Duodenal papilla 850, 950 Gallstone

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Abstract

In order to provide a balloon catheter for foreign matter removal which is capable of successfully removing foreign matter in the body to the outside even when an approach along a generally used route is difficult, and has a simple structure and good usability, this balloon catheter 100 for foreign matter removal has: a catheter tube 200 which is made of a flexible material and in which a balloon lumen 220 and a guide wire lumen 230 are formed in the axial direction; and a balloon 300 which is disposed near the distal end of the catheter tube 200 and is expanded with a fluid delivered from a fluid outlet. The most distal end of the catheter tube 200 has a tapered shape. A reinforcement tube 216 for improving the rigidity of the catheter tube 200 is inserted in the guide wire lumen 230. The balloon 300 expands eccentrically to the axial center of the catheter tube 200.

Description

異物除去用バルーンカテーテルBalloon catheter for removing foreign matter
　本発明は、例えば胆管に生じた胆石等の体内の異物を除去するために用いられる異物除去用バルーンカテーテルに関する。 The present invention relates to a foreign matter removing balloon catheter used for removing foreign matter in the body such as gallstones generated in the bile duct.
　例えば胆管に生じた胆石を除去する方法として、異物除去用バルーンカテーテルを用いる方法が知られている。例えば、下記の特許文献１には、異物除去用バルーンカテーテルを十二指腸乳頭から胆管内に挿入し、カテーテルチューブの遠位端に設けられたバルーンにより胆石を十二指腸乳頭から胆管外へ掻き出す方法が開示されている。本明細書では、異物除去用バルーンカテーテルを十二指腸乳頭から胆管内に挿入する方法をＥＲＣＰ（内視鏡的逆行性胆管膵管造影）アプローチと呼ぶ。 For example, as a method for removing gallstones generated in the bile duct, a method using a balloon catheter for removing foreign matter is known. For example, Patent Document 1 below discloses a method in which a balloon catheter for removing foreign substances is inserted into the bile duct from the papilla of Vater and gallstones are scraped out of the papilla of Vater by a balloon provided at the distal end of the catheter tube. ing. In the present specification, the method of inserting a balloon catheter for removing a foreign body into the bile duct from the papilla of Vater is called an ERCP (endoscopic retrograde cholangiopancreatography) approach.
　ＥＲＣＰアプローチによる内視鏡的胆石除去術では、図８に示すように、内視鏡９００の先端を胆管９３０の入り口である十二指腸乳頭９４０の近傍に配置し、内視鏡９００を介して異物除去用バルーンカテーテルのカテーテルチューブ９０２を十二指腸乳頭９４０から胆管９３０内に挿入する。そして、図９に示すように、バルーン９０３を胆管９３０の奥に位置させてからバルーン９０３を膨張させ、カテーテルチューブ９０２を胆管９３０内から十二指腸乳頭９４０の方向（図９内の矢印の方向）へ引き戻すことで、バルーン９０３の近位端側に存在する胆石９５０を十二指腸乳頭９４０から胆管９３０外へ掻き出すことができるようになっている。 In endoscopic gallstone removal by the ERCP approach, as shown in FIG. 8, the tip of the endoscope 900 is placed near the duodenal papilla 940, which is the entrance of the bile duct 930, and foreign matter is removed via the endoscope 900. Insert the catheter tube 902 of the balloon catheter into the bile duct 930 from the duodenal papilla 940. Then, as shown in FIG. 9, the balloon 903 is positioned at the back of the bile duct 930, the balloon 903 is inflated, and the catheter tube 902 is moved from the inside of the bile duct 930 toward the duodenal papilla 940 (in the direction of the arrow in FIG. 9). By pulling it back, the gallstone 950 existing on the proximal end side of the balloon 903 can be scraped out of the bile duct 930 from the duodenal papilla 940.
特開２０１９－１０２９７号公報Japanese Unexamined Patent Publication No. 2019-10297
　しかしながら、例えば十二指腸狭窄等の場合には、バルーンカテーテルを十二指腸乳頭から胆管内に挿入することができず、ＥＲＣＰアプローチが困難な場合があった。 However, in the case of duodenal stenosis, for example, the balloon catheter could not be inserted into the bile duct from the papilla of Vater, making the ERCP approach difficult in some cases.
　本発明は、ＥＲＣＰアプローチ等の一般的に用いられるルートでのアプローチが困難な場合であっても、胆管に生じた胆石等の体内の異物を体外へ良好に排出することが可能な、簡易な構成で利便性に優れた異物除去用バルーンカテーテルを提供することを目的とする。 The present invention is a simple method capable of satisfactorily discharging foreign substances in the body such as gallstones generated in the bile duct to the outside of the body even when an approach by a commonly used route such as an ERCP approach is difficult. An object of the present invention is to provide a balloon catheter for removing foreign substances, which is excellent in configuration and convenience.
　上記目的を達成するため、本発明に係る異物除去用バルーンカテーテルは、体内の異物を除去するために用いられる異物除去用バルーンカテーテルであって、
　遠位端近傍に設けられた流体導出口から導出される流体を流通するバルーンルーメンと、最遠位端に設けられたガイドワイヤ挿通孔から導出されるガイドワイヤを挿通するガイドワイヤルーメンとが軸方向に沿って内部に形成された、可撓性の材料からなるカテーテルチューブと、
　前記カテーテルチューブの前記遠位端近傍に配置されており、前記流体導出口から導出される前記流体によって膨張するバルーンと、を有し、
　前記カテーテルチューブの前記最遠位端が先細のテーパ状に形成されており、
　前記カテーテルチューブの剛性を向上させる補強用チューブが前記ガイドワイヤルーメンに内挿されており、
　前記バルーンが前記カテーテルチューブの軸心に対して偏心して膨張することを特徴とする。これにより、ＥＲＣＰアプローチ等の一般的に用いられるルートでのアプローチが困難な場合であっても、胃壁や胆管壁等の体内組織に設けた穿刺孔を経るアプローチで胆石等の体内の異物を体外へ良好に排出することが可能な、簡易な構成で利便性に優れた異物除去用バルーンカテーテルを実現することができる。 In order to achieve the above object, the foreign matter removing balloon catheter according to the present invention is a foreign matter removing balloon catheter used for removing foreign matter in the body.
The axis is a balloon lumen that circulates the fluid led out from the fluid outlet provided near the distal end and a guide wire lumen through which the guide wire led out from the guide wire insertion hole provided at the distal end is inserted. A catheter tube made of a flexible material formed inside along the direction, and
It has a balloon that is located near the distal end of the catheter tube and is inflated by the fluid that is led out of the fluid outlet.
The distal end of the catheter tube is formed in a tapered shape.
A reinforcing tube for improving the rigidity of the catheter tube is inserted in the guide wire lumen.
The balloon is eccentrically inflated with respect to the axial center of the catheter tube. As a result, even when it is difficult to approach by a commonly used route such as the ERCP approach, foreign substances in the body such as gallstones can be removed from the body by an approach through a puncture hole provided in a body tissue such as a stomach wall or a bile duct wall. It is possible to realize a highly convenient balloon catheter for removing foreign matter with a simple structure that can be discharged well.
　本発明に係る異物除去用バルーンカテーテルは、カテーテルチューブの最遠位端が先細のテーパ状に形成されており、ガイドワイヤに沿って進行するガイドワイヤ追従性および体内組織のダイレーション（拡張）性能を向上させた構成が実現されている。これにより、異物除去用バルーンカテーテルの遠位端が、胃壁や胆管壁等の体内組織に設けられた穿刺孔を通じて、容易かつ迅速に目的部位にバルーンを配置できるようになる。 In the balloon catheter for removing foreign matter according to the present invention, the distal end of the catheter tube is formed in a tapered shape, and the guide wire followability and the dilation (expansion) performance of the body tissue that proceed along the guide wire are formed. Has been realized. As a result, the distal end of the balloon catheter for removing foreign matter can easily and quickly place the balloon at the target site through a puncture hole provided in a body tissue such as a stomach wall or a bile duct wall.
　本発明に係る異物除去用バルーンカテーテルは、カテーテルチューブの剛性を向上させる補強用チューブがガイドワイヤルーメンに内挿されており、カテーテルチューブのプッシャビリティを向上させた構成が実現されている。なお、カテーテルチューブのプッシャビリティとは、カテーテルチューブが近位端から遠位端に向けて軸方向に押し込まれた際に、近位端において作用した押し込み力を遠位端に伝達する押し込み能力を意味している。これにより、近位端に作用させた押し込み力が遠位端にまで確実に伝達されて、バルーンを所望の力で遠位端方向へ移動できるようになる。 In the balloon catheter for removing foreign matter according to the present invention, a reinforcing tube for improving the rigidity of the catheter tube is inserted in the guide wire lumen, and a configuration in which the pushability of the catheter tube is improved is realized. The pushability of the catheter tube is the pushing ability to transmit the pushing force acting at the proximal end to the distal end when the catheter tube is pushed axially from the proximal end to the distal end. Means. As a result, the pushing force applied to the proximal end is reliably transmitted to the distal end, and the balloon can be moved toward the distal end with a desired force.
　本発明に係る異物除去用バルーンカテーテルは、バルーンがカテーテルチューブの軸心に対して偏心して膨張することによって、カテーテルチューブの最遠位端をバルーンの中心から偏った位置に配置できるようになっている。これにより、カテーテルチューブの最遠位端が異物に当たりにくくなる一方、バルーンを確実に異物に当てて押し出すことができるようになる。 In the balloon catheter for removing foreign matter according to the present invention, the balloon eccentrically inflates with respect to the axial center of the catheter tube, so that the most distal end of the catheter tube can be arranged at a position deviated from the center of the balloon. There is. This makes it difficult for the most distal end of the catheter tube to hit the foreign body, while ensuring that the balloon hits the foreign body and is pushed out.
　また、本発明に係る異物除去用バルーンカテーテルは、前記カテーテルチューブが、遠位端側の細径部と前記細径部より外径の大きい近位端側の太径部とにより構成されており、前記補強用チューブが前記太径部に内挿されていることを特徴とする。これにより、カテーテルチューブの遠位端側の細径部における柔軟性を維持したまま、カテーテルチューブの遠位端側の太径部の剛性を向上させることができる。 Further, in the balloon catheter for removing foreign substances according to the present invention, the catheter tube is composed of a small diameter portion on the distal end side and a large diameter portion on the proximal end side having a larger outer diameter than the small diameter portion. The reinforcing tube is inserted into the large diameter portion. As a result, the rigidity of the large diameter portion on the distal end side of the catheter tube can be improved while maintaining the flexibility of the small diameter portion on the distal end side of the catheter tube.
　また、本発明に係る異物除去用バルーンカテーテルは、前記補強用チューブがポリエーテルエーテルケトンからなることを特徴とする。これにより、ポリエーテルエーテルケトンからなる補強用チューブをガイドワイヤルーメンに内挿させた簡易な構成で、カテーテルチューブの剛性を向上させることができる。 Further, the balloon catheter for removing foreign matter according to the present invention is characterized in that the reinforcing tube is made of polyetheretherketone. As a result, the rigidity of the catheter tube can be improved with a simple configuration in which a reinforcing tube made of polyetheretherketone is inserted into the guide wire lumen.
　また、本発明に係る異物除去用バルーンカテーテルは、前記バルーンが膨張した状態で前記カテーテルチューブが近位端側から遠位端側へ押し込まれて前記バルーンが胆管内を十二指腸乳頭に向かって移動することにより、前記バルーンの遠位端側で前記胆管内の異物を前記胆管外へ押し出すために用いられることを特徴とする。これにより、ＥＲＣＰアプローチが困難な場合であっても、例えば胃壁や胆管壁等の体内組織に設けられた穿刺孔を通じて胆管内にバルーンを配置し、胆管に生じた胆石等の異物を十二指腸乳頭に向かってバルーンの遠位端側で押し出すことにより胆管外へ良好に排出することが可能な、簡易な構成で利便性に優れた異物除去用バルーンカテーテルを実現することができる。 Further, in the balloon catheter for removing foreign substances according to the present invention, the catheter tube is pushed from the proximal end side to the distal end side in a state where the balloon is inflated, and the balloon moves in the bile duct toward the duodenal papilla. Thereby, it is characterized in that it is used to push a foreign substance in the bile duct out of the bile duct on the distal end side of the balloon. As a result, even when the ERCP approach is difficult, a balloon is placed in the bile duct through a puncture hole provided in a body tissue such as the stomach wall or the bile duct wall, and foreign substances such as gallstones generated in the bile duct are transferred to the duodenal papilla. It is possible to realize a highly convenient balloon catheter for removing foreign substances with a simple structure that can be satisfactorily discharged to the outside of the bile duct by pushing it toward the distal end side of the balloon.
本発明の実施の形態における異物除去用バルーンカテーテルの構成の一例を示す平面図である。It is a top view which shows an example of the structure of the balloon catheter for foreign matter removal in embodiment of this invention. 図１の領域Ｘ近傍の拡大側面図である。It is an enlarged side view of the vicinity of region X of FIG. 図１のＡ－Ａ断面を表した断面図である。It is sectional drawing which showed the AA cross section of FIG. 図１の領域Ｙ近傍の模式的な軸方向断面図であるIt is a schematic axial sectional view in the vicinity of region Y of FIG. 図１の領域Ｚ近傍の模式的な軸方向断面図である。It is a schematic axial sectional view in the vicinity of region Z of FIG. 本発明の実施の形態における異物除去用バルーンカテーテルを用いて胆管から胆石を除去する使用例について説明するための模式図である。It is a schematic diagram for demonstrating the use example of removing a gallstone from a bile duct by using the balloon catheter for removing a foreign substance in embodiment of this invention. 本発明の実施の形態に対する比較例に係る図であって、バルーンの中心がカテーテルチューブの軸心と一致した位置に配置された場合を示す模式図である。It is a figure which concerns on the comparative example with respect to the Embodiment of this invention, and is the schematic diagram which shows the case where the center of a balloon is arranged at the position which coincides with the axis of the catheter tube. 本発明の実施の形態に係る図であって、バルーンの中心がカテーテルチューブの軸心から偏った位置に配置された場合を示す模式図である。It is a figure which concerns on embodiment of this invention, and is the schematic diagram which shows the case where the center of a balloon is arranged at the position deviated from the axis of the catheter tube. 従来の技術における異物除去用バルーンカテーテルを用いて胆管から胆石を除去する使用例について説明するための模式図である。It is a schematic diagram for demonstrating the use example of removing a gallstone from a bile duct by using a balloon catheter for removing a foreign substance in the prior art. 図８の十二指腸乳頭および胆管近傍の拡大図である。It is an enlarged view of the duodenal papilla and the vicinity of the bile duct of FIG.
　以下、図面を参照しながら、本発明の実施の形態について説明する。 Hereinafter, embodiments of the present invention will be described with reference to the drawings.
　図１は、本発明の実施の形態における異物除去用バルーンカテーテルの構成の一例を示す平面図である。図１に示す異物除去用バルーンカテーテル１００は、例えば内視鏡を介して用いられ、カテーテルチューブ２００と、バルーン３００と、分岐部４００と、３つの枝管５００ａ～５００ｃとを含んで構成されている。 FIG. 1 is a plan view showing an example of the configuration of a balloon catheter for removing foreign matter according to the embodiment of the present invention. The balloon catheter 100 for removing foreign matter shown in FIG. 1 is used, for example, via an endoscope, and includes a catheter tube 200, a balloon 300, a branch portion 400, and three branch tubes 500a to 500c. There is.
　以下では、異物除去用バルーンカテーテル１００の延在方向を軸方向とし、異物除去用バルーンカテーテル１００のバルーン３００側を遠位端側とし、異物除去用バルーンカテーテル１００の３つの枝管５００ａ～５００ｃ側を近位端側として説明を行う。 In the following, the extending direction of the foreign matter removing balloon catheter 100 is the axial direction, the balloon 300 side of the foreign matter removing balloon catheter 100 is the distal end side, and the three branch tubes 500a to 500c side of the foreign matter removing balloon catheter 100. Will be described as the proximal end side.
　カテーテルチューブ２００は、可撓性材料によって形成されたチューブである。図１では、カテーテルチューブ２００の途中は図示省略されているが、実際にはカテーテルチューブ２００は繋がっており軸方向に長尺な形状を有している。 The catheter tube 200 is a tube formed of a flexible material. Although not shown in the middle of the catheter tube 200 in FIG. 1, the catheter tube 200 is actually connected and has a long shape in the axial direction.
　カテーテルチューブ２００は、内視鏡を介して体内に挿入される遠位端側に細径部２１０を有し、細径部２１０よりも近位端側に太径部２１５を有している。カテーテルチューブ２００の全長は、例えば５００～２５００ｍｍであり、細径部２１０の軸方向の寸法は３０～８００ｍｍである。細径部２１０の外径は太径部２１５の外径の５０～９５％であり、例えば１．０～４．２ｍｍである。カテーテルチューブ２００の材質は可撓性を有するものであれば特に限定されないが、成形性の観点から熱可塑性樹脂または熱可塑性エラストマーが好適であり、例えば、ポリアミド樹脂あるいはポリアミド系エラストマーを用いることができる。 The catheter tube 200 has a small diameter portion 210 on the distal end side inserted into the body via an endoscope, and a large diameter portion 215 on the proximal end side with respect to the small diameter portion 210. The total length of the catheter tube 200 is, for example, 500 to 2500 mm, and the axial dimension of the small diameter portion 210 is 30 to 800 mm. The outer diameter of the small diameter portion 210 is 50 to 95% of the outer diameter of the large diameter portion 215, for example, 1.0 to 4.2 mm. The material of the catheter tube 200 is not particularly limited as long as it has flexibility, but a thermoplastic resin or a thermoplastic elastomer is preferable from the viewpoint of moldability, and for example, a polyamide resin or a polyamide-based elastomer can be used. ..
　カテーテルチューブ２００の細径部２１０には、１つ以上の造影リング２５０が装着されている。図１に示すカテーテルチューブ２００には、例えばバルーン３００の取付位置近傍に２つの造影リング２５０が装着されているが、造影リング２５０の形状や造影リング２５０を装着する位置、個数等は特に限定されない。造影リング２５０は、カテーテルチューブ２００の遠位端を体内に挿入した際に、Ｘ線造影でその位置を確認するためのものであり、これにより、バルーン３００の位置を確認することができるようになっている。造影リング２５０の材質としては、金、白金、タングステン等の金属を用いることができる。 One or more contrast rings 250 are attached to the small diameter portion 210 of the catheter tube 200. Two contrast ring 250s are attached to the catheter tube 200 shown in FIG. 1, for example, in the vicinity of the attachment position of the balloon 300, but the shape of the contrast ring 250, the position where the contrast ring 250 is attached, the number, and the like are not particularly limited. .. The contrast ring 250 is for confirming the position of the balloon 300 by X-ray imaging when the distal end of the catheter tube 200 is inserted into the body, so that the position of the balloon 300 can be confirmed. It has become. As the material of the contrast ring 250, a metal such as gold, platinum, or tungsten can be used.
　カテーテルチューブ２００の細径部２１０の最遠位端には、先細のテーパ状に形成されたテーパ部２１１が設けられている。テーパ部２１１は、胃壁等の体内組織に設けられた穿刺孔や体内管腔を通過する際のダイレーション性能を向上させるために設けられている。 A tapered portion 211 formed in a tapered shape is provided at the most distal end of the narrow diameter portion 210 of the catheter tube 200. The tapered portion 211 is provided to improve dilation performance when passing through a puncture hole provided in an internal tissue such as a stomach wall or an internal lumen.
　図２は、図１の領域Ｘ近傍の拡大側面図である。図２に示すように、テーパ部２１１は、例えば最遠位端から軸方向の寸法Ｌ１にわたって先細のテーパ状となるような傾斜を有しており、細径部２１０の直胴部の外径に対して最遠位端の外径が小さくなるように成形されている。テーパ部２１１の軸方向の寸法Ｌ１は特に限定されないが、例えば０．５～２０ｍｍである。また、テーパ部２１１は先細のテーパ状であればよく、テーパ部２１１の傾斜角度や最遠位端の外径の寸法等は特に限定されない。 FIG. 2 is an enlarged side view of the vicinity of region X in FIG. As shown in FIG. 2, the tapered portion 211 has an inclination such that the tapered portion 211 has a tapered shape from the most distal end to the axial dimension L1, and the outer diameter of the straight body portion of the tapered portion 210. It is molded so that the outer diameter of the most distal end is smaller than that of the other. The axial dimension L1 of the tapered portion 211 is not particularly limited, but is, for example, 0.5 to 20 mm. Further, the tapered portion 211 may have a tapered shape, and the inclination angle of the tapered portion 211, the size of the outer diameter at the most distal end, and the like are not particularly limited.
　先細のテーパ状に形成されたテーパ部２１１を設ける方法は特に限定されないが、例えば、成形金型等を用いてカテーテルチューブ２００の最遠位端を加工することで、先細のテーパ状となるテーパ部２１１を成形することができる。また、テーパ部２１１を含む部材を成形して作製し、作製した部材をカテーテルチューブ２００の遠位端に接合することによって、カテーテルチューブ２００の最遠位端が先細のテーパ状となるようにしてもよい。 The method of providing the tapered portion 211 formed in a tapered shape is not particularly limited, but for example, by processing the most distal end of the catheter tube 200 using a molding die or the like, the taper becomes tapered. The portion 211 can be molded. Further, a member including the tapered portion 211 is molded and manufactured, and the manufactured member is joined to the distal end of the catheter tube 200 so that the distal end of the catheter tube 200 has a tapered shape. May be good.
　カテーテルチューブ２００はマルチルーメンチューブである。カテーテルチューブ２００の内部には、例えば図３に示すように、バルーンルーメン２２０、ガイドワイヤルーメン２３０、造影剤ルーメン２４０が形成されており、上記の各ルーメン２２０～２４０は互いに隔離されている。 The catheter tube 200 is a multi-lumen tube. As shown in FIG. 3, for example, a balloon lumen 220, a guide wire lumen 230, and a contrast agent lumen 240 are formed inside the catheter tube 200, and the lumens 220 to 240 described above are isolated from each other.
　バルーンルーメン２２０は、バルーン３００を拡張および収縮させるために、バルーン３００の内部に空気などの流体を送る流路として用いられるルーメンである。バルーンルーメン２２０は、カテーテルチューブ２００の近位端から不図示の流体流通口まで貫通している。流体流通口は、カテーテルチューブ２００の細径部２１０に設けられたバルーン３００の内部に開口している開口部である。また、後述するように、バルーンルーメン２２０は、分岐部４００において枝管５００ａと連通している。 The balloon lumen 220 is a lumen used as a flow path for sending a fluid such as air inside the balloon 300 in order to expand and contract the balloon 300. The balloon lumen 220 penetrates from the proximal end of the catheter tube 200 to a fluid flow port (not shown). The fluid flow port is an opening that opens inside the balloon 300 provided in the small diameter portion 210 of the catheter tube 200. Further, as will be described later, the balloon lumen 220 communicates with the branch pipe 500a at the branch portion 400.
　ガイドワイヤルーメン２３０は、ガイドワイヤ２３５を挿通する経路として用いられるルーメンである。ガイドワイヤルーメン２３０は、カテーテルチューブ２００の近位端から遠位端のガイドワイヤ挿通孔２３１まで貫通している。ガイドワイヤ挿通孔２３１は、カテーテルチューブ２００の最遠位端で開口する開口部である。また、後述するように、ガイドワイヤルーメン２３０は、分岐部４００において枝管５００ｂと連通している。 The guide wire lumen 230 is a lumen used as a path through which the guide wire 235 is inserted. The guide wire lumen 230 penetrates from the proximal end of the catheter tube 200 to the guide wire insertion hole 231 at the distal end. The guide wire insertion hole 231 is an opening that opens at the most distal end of the catheter tube 200. Further, as will be described later, the guide wire lumen 230 communicates with the branch pipe 500b at the branch portion 400.
　造影剤ルーメン２４０は、Ｘ線造影における造影剤の流路として用いられるルーメンである。造影剤ルーメン２４０は、カテーテルチューブ２００の近位端から不図示の造影剤流出口まで貫通している。造影剤流出口は、カテーテルチューブ２００の細径部２１０に設けられた開口部である。本発明の実施の形態における異物除去用バルーンカテーテル１００は、前方に存在する胆管内の胆石をバルーン３００で押し出す用途に特に好適に用いられるものであり、例えば、バルーン３００より遠位端側に造影剤流出口を設けることで胆管内の胆石に向けて造影剤を噴出することができるようになる。また、後述するように、造影剤ルーメン２４０は、分岐部４００において枝管５００ｃと連通している。 The contrast medium lumen 240 is a lumen used as a flow path for the contrast medium in X-ray imaging. The contrast agent lumen 240 penetrates from the proximal end of the catheter tube 200 to the contrast agent outlet (not shown). The contrast medium outlet is an opening provided in the small diameter portion 210 of the catheter tube 200. The balloon catheter 100 for removing foreign matter in the embodiment of the present invention is particularly preferably used for pushing out gallstones in the bile duct existing in front with the balloon 300, and for example, contrasting the image on the distal end side of the balloon 300. By providing the agent outlet, the contrast medium can be ejected toward the gallstone in the bile duct. Further, as will be described later, the contrast agent lumen 240 communicates with the branch tube 500c at the branch portion 400.
　バルーンルーメン２２０、ガイドワイヤルーメン２３０、造影剤ルーメン２４０の断面形状は、カテーテルチューブ２００内に効率的に配置できる任意の形状であればよいが、ガイドワイヤルーメン２３０には補強用チューブ２１６が内挿され、その補強用チューブ２１６に挿通されるガイドワイヤ２３５は一般的には断面形状が円形であることから、ガイドワイヤルーメン２３０の断面形状は略円形であることが好ましい。また、バルーンルーメン２２０、ガイドワイヤルーメン２３０、造影剤ルーメン２４０の断面積は特に限定されないが、バルーンルーメン２２０および造影剤ルーメン２４０の断面積に対してガイドワイヤルーメン２３０の断面積が相対的に大きく設定されることが好ましく、例えば、バルーンルーメン２２０の断面積は０．０３～１．０ｍｍ２、ガイドワイヤルーメン２３０の断面積は０．５～６．０ｍｍ２、造影剤ルーメン２４０の断面積は０．０８～４．０ｍｍ２である。 The cross-sectional shape of the balloon lumen 220, the guide wire lumen 230, and the contrast agent lumen 240 may be any shape that can be efficiently arranged in the catheter tube 200, but the guide wire lumen 230 has a reinforcing tube 216 inserted therein. Since the guide wire 235 inserted through the reinforcing tube 216 generally has a circular cross-sectional shape, the cross-sectional shape of the guide wire lumen 230 is preferably substantially circular. The cross-sectional areas of the balloon lumen 220, the guide wire lumen 230, and the contrast agent lumen 240 are not particularly limited, but the cross-sectional area of the guide wire lumen 230 is relatively large with respect to the cross-sectional areas of the balloon lumen 220 and the contrast agent lumen 240. It is preferably set, for example, the cross-sectional area of the balloon lumen 220 is 0.03 to 1.0 mm 2 , the cross-sectional area of the guide wire lumen 230 is 0.5 to 6.0 mm 2 , and the cross-sectional area of the contrast agent lumen 240 is. It is 0.08 to 4.0 mm 2 .
　また、ガイドワイヤルーメン２３０には、太径部２１５全体、すなわち太径部２１５の近位端から遠位端の範囲にわたって、カテーテルチューブ２００のプッシャビリティを向上させる補強用チューブ２１６が内挿されている。補強用チューブ２１６が軸方向に延在するようにガイドワイヤルーメン２３０に挿入されることで、カテーテルチューブ２００の剛性、特にカテーテルチューブ２００の軸剛性および曲げ剛性が大きくなり、カテーテルチューブ２００のプッシャビリティを向上させることができる。 Further, the guide wire lumen 230 is interpolated with a reinforcing tube 216 that improves the pushability of the catheter tube 200 over the entire large diameter portion 215, that is, the range from the proximal end to the distal end of the large diameter portion 215. There is. By inserting the reinforcing tube 216 into the guide wire lumen 230 so as to extend in the axial direction, the rigidity of the catheter tube 200, particularly the axial rigidity and the bending rigidity of the catheter tube 200, is increased, and the pushability of the catheter tube 200 is increased. Can be improved.
　補強用チューブ２１６は、補強用チューブ２１６に挿通されるガイドワイヤ２３５が一般的には断面形状が円形であることから、断面形状が円形のチューブであることが好ましい。また、補強用チューブ２１６の外径は、ガイドワイヤルーメン２３０の内径と略同一であってガイドワイヤルーメン２３０の内周面に密着して挿入される程度の寸法である。補強用チューブ２１６の内径は、ガイドワイヤ２３５の外径より大きく、ガイドワイヤ２３５が挿通可能な寸法である。補強用チューブ２１６の材質は特に限定されないが、成形性および剛性の観点から熱可塑性樹脂が好適であり、そのなかでも高い剛性を有するポリエーテルエーテルケトン（ＰＥＥＫ）を用いることが特に好ましい。 The reinforcing tube 216 is preferably a tube having a circular cross-sectional shape because the guide wire 235 inserted through the reinforcing tube 216 generally has a circular cross-sectional shape. The outer diameter of the reinforcing tube 216 is substantially the same as the inner diameter of the guide wire lumen 230, and is such that the reinforcing tube 216 is inserted in close contact with the inner peripheral surface of the guide wire lumen 230. The inner diameter of the reinforcing tube 216 is larger than the outer diameter of the guide wire 235, and is a dimension through which the guide wire 235 can be inserted. The material of the reinforcing tube 216 is not particularly limited, but a thermoplastic resin is preferable from the viewpoint of moldability and rigidity, and among them, polyetheretherketone (PEEK) having high rigidity is particularly preferable.
　図３～図５を参照しながら、ガイドワイヤルーメン２３０に内挿された補強用チューブ２１６について説明する。 The reinforcing tube 216 inserted in the guide wire lumen 230 will be described with reference to FIGS. 3 to 5.
　図３は、図１のＡ－Ａ断面を表した断面図である。図３に示すように、カテーテルチューブ２００の太径部２１５には、バルーンルーメン２２０、ガイドワイヤルーメン２３０、造影剤ルーメン２４０が形成されており、ガイドワイヤルーメン２３０に補強用チューブ２１６が内挿されている。 FIG. 3 is a cross-sectional view showing the AA cross section of FIG. As shown in FIG. 3, a balloon lumen 220, a guide wire lumen 230, and a contrast agent lumen 240 are formed in the large diameter portion 215 of the catheter tube 200, and a reinforcing tube 216 is inserted into the guide wire lumen 230. ing.
　なお、図３のカテーテルチューブ２００の断面図は一例であり、各ルーメン２２０～２４０の断面形状は図３に示す形状に限定されない。図３には、３ルーメンタイプのカテーテルチューブが一例として図示されているが、例えばバルーンルーメン２２０およびガイドワイヤルーメン２３０として使用される２つのルーメンを有する２ルーメンタイプのカテーテルチューブが用いられてもよい。また、ここではガイドワイヤルーメン２３０にのみ補強用チューブ２１６が内挿されているが、さらに、バルーンルーメン２２０および造影剤ルーメン２４０の一方または両方に補強用チューブ２１６が内挿されてもよい。 The cross-sectional view of the catheter tube 200 in FIG. 3 is an example, and the cross-sectional shape of each lumen 220 to 240 is not limited to the shape shown in FIG. Although a 3-lumen type catheter tube is illustrated in FIG. 3 as an example, a 2-lumen type catheter tube having two lumens used as, for example, a balloon lumen 220 and a guide wire lumen 230 may be used. .. Further, although the reinforcing tube 216 is interpolated only in the guide wire lumen 230 here, the reinforcing tube 216 may be further interpolated in one or both of the balloon lumen 220 and the contrast agent lumen 240.
　図４は、図１の領域Ｙ近傍の模式的な軸方向断面図である。図４には、カテーテルチューブ２００の細径部２１０と太径部２１５との境界近傍が図示されており、バルーンルーメン２２０、ガイドワイヤルーメン２３０、造影剤ルーメン２４０の３つのルーメンがカテーテルチューブ２００の内部に設けられている状態が模式的に示されている。 FIG. 4 is a schematic axial sectional view in the vicinity of the region Y in FIG. FIG. 4 shows the vicinity of the boundary between the small diameter portion 210 and the large diameter portion 215 of the catheter tube 200, and the three lumens of the balloon lumen 220, the guide wire lumen 230, and the contrast agent lumen 240 are the catheter tube 200. The state provided inside is schematically shown.
　図４に示すように、細径部２１０および太径部２１５には、それぞれの内部にバルーンルーメン２２０、ガイドワイヤルーメン２３０、造影剤ルーメン２４０の３つのルーメンが形成されており、細径部２１０内部の各ルーメン２２０～２４０と太径部２１５内部の各ルーメン２２０～２４０とは連通している。細径部２１０の外径は太径部２１５の外径より小さく、細径部２１０内部の各ルーメン２２０～２４０の断面積も太径部２１５内部の各ルーメン２２０～２４０の断面積より小さくなっている。補強用チューブ２１６は、太径部２１５内部のガイドワイヤルーメン２３０に内挿されており、補強用チューブ２１６の遠位端は、太径部２１５の遠位端近傍であって細径部２１０と太径部２１５との境界近傍に位置している。補強用チューブ２１６は、例えば太径部２１５の内径と略同一または僅かに小さく、かつ細径部２１０の内径よりも大きい外径を有しており、太径部２１５には内挿可能であるが細径部２１０には内挿不可能となっている。 As shown in FIG. 4, three lumens, a balloon lumen 220, a guide wire lumen 230, and a contrast agent lumen 240, are formed in the small diameter portion 210 and the large diameter portion 215, respectively, and the small diameter portion 210 is formed. The internal lumens 220 to 240 and the internal lumens 220 to 240 of the large diameter portion 215 communicate with each other. The outer diameter of the small diameter portion 210 is smaller than the outer diameter of the large diameter portion 215, and the cross-sectional area of each lumen 220 to 240 inside the small diameter portion 210 is also smaller than the cross-sectional area of each lumen 220 to 240 inside the large diameter portion 215. ing. The reinforcing tube 216 is inserted into the guide wire lumen 230 inside the large diameter portion 215, and the distal end of the reinforcing tube 216 is near the distal end of the large diameter portion 215 and is connected to the small diameter portion 210. It is located near the boundary with the large diameter portion 215. The reinforcing tube 216 has an outer diameter that is substantially the same as or slightly smaller than the inner diameter of the large diameter portion 215 and is larger than the inner diameter of the small diameter portion 210, and can be interpolated into the large diameter portion 215. However, it cannot be inserted into the small diameter portion 210.
　図５は、図１の領域Ｚ近傍の模式的な軸方向断面図である。図５には、カテーテルチューブ２００の太径部２１５と各枝管５００ａ～５００ｃとの接続部、すなわち分岐部４００近傍が図示されており、バルーンルーメン２２０、ガイドワイヤルーメン２３０、造影剤ルーメン２４０の３つのルーメンがカテーテルチューブ２００の内部に設けられている状態が模式的に示されている。なお、図５では、図１に図示されている容量タグ７００は図示省略されている。 FIG. 5 is a schematic axial cross-sectional view in the vicinity of region Z in FIG. FIG. 5 shows a connection portion between the large diameter portion 215 of the catheter tube 200 and each branch tube 500a to 500c, that is, the vicinity of the branch portion 400, and the balloon lumen 220, the guide wire lumen 230, and the contrast agent lumen 240. A state in which three lumens are provided inside the catheter tube 200 is schematically shown. In FIG. 5, the capacity tag 700 shown in FIG. 1 is not shown.
　図５に示すように、太径部２１５の内部には、バルーンルーメン２２０、ガイドワイヤルーメン２３０、造影剤ルーメン２４０の３つのルーメンが形成されており、太径部２１５内部の各ルーメン２２０～２４０と各枝管５００ａ～５００ｃとは連通している。補強用チューブ２１６は、太径部２１５内部のガイドワイヤルーメン２３０に内挿されており、補強用チューブ２１６の近位端は、太径部２１５の近位端近傍であって太径部２１５と枝管５００ｂとの境界近傍に位置している。なお、各ルーメン２２０～２４０と各枝管５００ａ～５００ｃとを連通する方法は特に限定されないが、図５では一例として、各枝管５００ａ～５００ｃの遠位端が各ルーメン２２０～２４０に挿入されることにより連通している状態が模式的に図示されている。 As shown in FIG. 5, three lumens of a balloon lumen 220, a guide wire lumen 230, and a contrast agent lumen 240 are formed inside the large diameter portion 215, and each lumen 220 to 240 inside the large diameter portion 215 is formed. And each branch pipe 500a to 500c are in communication with each other. The reinforcing tube 216 is inserted into the guide wire lumen 230 inside the large diameter portion 215, and the proximal end of the reinforcing tube 216 is near the proximal end of the large diameter portion 215 and is connected to the large diameter portion 215. It is located near the boundary with the branch pipe 500b. The method of communicating each lumen 220 to 240 with each branch pipe 500a to 500c is not particularly limited, but in FIG. 5, the distal end of each branch pipe 500a to 500c is inserted into each lumen 220 to 240 as an example. The state of communication is schematically illustrated.
　図４および図５に示すように、補強用チューブ２１６は、細径部２１０と太径部２１５との境界近傍から太径部２１５と枝管５００ｂとの境界近傍まで、すなわち太径部２１５全体にわたってガイドワイヤルーメン２３０に内挿されている。カテーテルチューブ２００の太径部２１５に補強用チューブ２１６を内挿する方法は特に限定されないが、例えばカテーテルチューブ２００のガイドワイヤルーメン２３０と枝管５００ｃとを連通させる前に、太径部２１５に補強用チューブ２１６を内挿することが可能である。 As shown in FIGS. 4 and 5, the reinforcing tube 216 extends from the vicinity of the boundary between the small diameter portion 210 and the large diameter portion 215 to the vicinity of the boundary between the large diameter portion 215 and the branch pipe 500b, that is, the entire large diameter portion 215. It is interpolated in the guide wire lumen 230. The method of interpolating the reinforcing tube 216 into the large diameter portion 215 of the catheter tube 200 is not particularly limited. For example, the large diameter portion 215 is reinforced before the guide wire lumen 230 of the catheter tube 200 and the branch pipe 500c are communicated with each other. The tube 216 can be inserted.
　具体的には、遠位端側に細径部２１０を有し近位端側に太径部２１５を有するカテーテルチューブ２００を用意し、近位端側の太径部２１５の近位端面に開口しているガイドワイヤルーメン２３０に補強用チューブ２１６を挿入して、補強用チューブ２１６を遠位端側へ押し込んでいく。押し込まれた補強用チューブ２１６は、その遠位端が細径部２１０と太径部２１５との境界近傍に到達すると、断面積の小さい細径部２１０内部に進入できず、細径部２１０の遠位端に突き当たった状態となる。この状態で、太径部２１５の近位端面から突出している補強用チューブ２１６を太径部２１５の近位端面に合わせて切断することで、補強用チューブ２１６が太径部２１５全体にわたってガイドワイヤルーメン２３０に内挿された状態が実現される。なお、本発明の実施の形態では、後述するように補強用チューブ２１６に枝管５００ｂを接続することにより、補強用チューブ２１６がガイドワイヤルーメン２３０から抜け出すことが防止されているため、補強用チューブ２１６とガイドワイヤルーメン２３０との間での直接的な固定を行っていないが、必要に応じて補強用チューブ２１６とガイドワイヤルーメン２３０との間で接着剤を用いる接着等の手段によって固定を行ってもよい。 Specifically, a catheter tube 200 having a small diameter portion 210 on the distal end side and a large diameter portion 215 on the proximal end side is prepared, and an opening is made in the proximal end face of the large diameter portion 215 on the proximal end side. The reinforcing tube 216 is inserted into the guide wire lumen 230, and the reinforcing tube 216 is pushed toward the distal end side. When the distal end of the pushed-in reinforcing tube 216 reaches the vicinity of the boundary between the small diameter portion 210 and the large diameter portion 215, the pushed reinforcing tube 216 cannot enter the inside of the small diameter portion 210 having a small cross-sectional area, and the small diameter portion 210 cannot enter. It will be in a state of hitting the distal end. In this state, the reinforcing tube 216 protruding from the proximal end face of the large diameter portion 215 is cut in accordance with the proximal end face of the large diameter portion 215, so that the reinforcing tube 216 is a guide wire over the entire large diameter portion 215. The state of being interpolated in the lumen 230 is realized. In the embodiment of the present invention, since the reinforcing tube 216 is prevented from coming out of the guide wire lumen 230 by connecting the branch pipe 500b to the reinforcing tube 216 as described later, the reinforcing tube 216 is prevented from coming off. Although it is not directly fixed between the 216 and the guide wire lumen 230, it is fixed between the reinforcing tube 216 and the guide wire lumen 230 by means such as adhesion using an adhesive if necessary. You may.
　バルーン３００は、内部に流体が導入されることによって膨張可能な筒状の薄膜であり、カテーテルチューブ２００の細径部２１０に不図示の流体導出口を覆うように取り付けられている。バルーン３００は伸縮性材料により形成されており、カテーテルチューブ２００のバルーンルーメン２２０および流体導出口を介して、内部に流体が導入されることにより膨張されるようになっている。本発明の実施の形態では、膨張したバルーン３００の遠位端側で胆石等の異物を押し出すことで、体内の異物を除去することが可能である。 The balloon 300 is a tubular thin film that can be expanded by introducing a fluid inside, and is attached to a small diameter portion 210 of the catheter tube 200 so as to cover a fluid outlet (not shown). The balloon 300 is made of an elastic material and is inflated by introducing a fluid inside through the balloon lumen 220 and the fluid outlet of the catheter tube 200. In the embodiment of the present invention, it is possible to remove the foreign matter in the body by pushing out the foreign matter such as gallstones on the distal end side of the inflated balloon 300.
　バルーン３００を形成する伸縮性材料としては、１００％モジュラス（ＪＩＳ　Ｋ　６２５１に準拠して測定した値）が、０．１～１０ＭＰａであるものが好ましく、１～５ＭＰａであるものが特に好ましい。また、バルーン３００を形成するために好適な伸縮性材料の具体例としては、天然ゴム、シリコーンゴム、ポリウレタンエラストマー等が挙げられる。 As the elastic material forming the balloon 300, a material having a 100% modulus (value measured in accordance with JIS K6251) of 0.1 to 10 MPa is preferable, and a material having a 100% modulus of 1 to 5 MPa is particularly preferable. Further, specific examples of the elastic material suitable for forming the balloon 300 include natural rubber, silicone rubber, polyurethane elastomer and the like.
　バルーン３００は全体として筒状であり、カテーテルチューブ２００の外周面と接合される接合部３１０、３２０が遠位端側および近位端側に形成されている。接合部３１０、３２０は、カテーテルチューブ２００の外周面にバルーン３００を円筒状に接合する部位を指しており、接合部３１０、３２０の軸方向の寸法は例えば０．５～５．０ｍｍである。なお、バルーン３００の接合部３１０、３２０をカテーテルチューブ２００の外周面に接合する方法は特に限定されず、例えば、接着剤を用いる接着、熱融着、溶剤による溶着、超音波溶着等が可能である。 The balloon 300 has a tubular shape as a whole, and joint portions 310 and 320 that are joined to the outer peripheral surface of the catheter tube 200 are formed on the distal end side and the proximal end side. The joint portions 310 and 320 refer to a portion where the balloon 300 is cylindrically joined to the outer peripheral surface of the catheter tube 200, and the axial dimensions of the joint portions 310 and 320 are, for example, 0.5 to 5.0 mm. The method of joining the joining portions 310 and 320 of the balloon 300 to the outer peripheral surface of the catheter tube 200 is not particularly limited, and for example, bonding using an adhesive, heat welding, welding with a solvent, ultrasonic welding and the like are possible. is there.
　バルーン３００の接合部３１０、３２０の間には、カテーテルチューブ２００の外周面と接合されておらず、内部に流体が導入されることにより膨張する膨張部３３０が形成されている。バルーン３００の膨張部３３０は、膨らんだ状態での最大外径が、萎んだ状態での外径の２００～１５００％であることが好ましい。この比率が小さすぎるとバルーン３００が十分な大きさに膨張しないおそれがあり、大きすぎるとカテーテルチューブ２００を体内に挿入する際にバルーン３００が邪魔になるおそれがある。膨張部３３０の軸方向の寸法は例えば５～２０ｍｍであり、膜厚は例えば０．１０～０．５０ｍｍである。 An expansion portion 330 that is not bonded to the outer peripheral surface of the catheter tube 200 and expands when a fluid is introduced into the balloon 300 is formed between the joint portions 310 and 320 of the balloon 300. The maximum outer diameter of the inflated portion 330 of the balloon 300 in the inflated state is preferably 200 to 1500% of the outer diameter in the inflated state. If this ratio is too small, the balloon 300 may not expand to a sufficient size, and if it is too large, the balloon 300 may interfere with the insertion of the catheter tube 200 into the body. The axial dimension of the expansion portion 330 is, for example, 5 to 20 mm, and the film thickness is, for example, 0.10 to 0.50 mm.
　また、膨張部３３０がカテーテルチューブ２００の軸心に対して偏心して膨らむようにするため、膨張部３３０の一部にオフセットシート３４０が貼付されている。オフセットシート３４０は、例えば、オフセットシート３４０の軸方向の寸法が膨張部３３０の軸方向の寸法よりも長く設定された細長い形状を有している。オフセットシート３４０は、軸方向に沿って膨張部３３０の一部に貼付されるとともに、その両端が接合部３１０、３２０あるいはカテーテルチューブ２００の外周面に固定される。 Further, an offset sheet 340 is attached to a part of the inflatable portion 330 so that the inflatable portion 330 eccentrically inflates with respect to the axial center of the catheter tube 200. The offset sheet 340 has, for example, an elongated shape in which the axial dimension of the offset sheet 340 is set longer than the axial dimension of the expansion portion 330. The offset sheet 340 is attached to a part of the expansion portion 330 along the axial direction, and both ends thereof are fixed to the joint portions 310, 320 or the outer peripheral surface of the catheter tube 200.
　オフセットシート３４０が貼付された膨張部３３０の一部はカテーテルチューブ２００に対して固定されているため、オフセットシート３４０が貼付されている側の膨張部３３０が膨張しにくい状態または膨張できない状態となる。その結果、オフセットシート３４０が貼付されていない側の膨張部３３０が偏って膨張することで、カテーテルチューブ２００の軸心に対して偏心した形状に膨張する。 Since a part of the inflatable portion 330 to which the offset sheet 340 is attached is fixed to the catheter tube 200, the inflatable portion 330 on the side to which the offset sheet 340 is attached is in a state where it is difficult to inflate or cannot be inflated. .. As a result, the inflated portion 330 on the side to which the offset sheet 340 is not attached expands in an eccentric shape with respect to the axial center of the catheter tube 200.
　オフセットシート３４０の材質は特に限定されず、例えばカテーテルチューブ２００と同一の樹脂等を用いることができる。オフセットシート３４０の固定方法は特に限定されず、例えば、接着、熱融着、高周波融着等が可能である。一例として、裏面に接着剤が塗布してあるオフセットシート３４０を使用し、オフセットシート３４０が、膨張部３３０を含むバルーン３００の周方向の一部およびカテーテルチューブ２００の一部に接着される。また、オフセットシート３４０の幅は、例えばカテーテルチューブ２００の外周面の円周方向長さの１／２以下の幅であり、好ましくは１／３～１／５の幅である。この幅が小さすぎるとバルーン３００を偏心した状態で膨らませることが困難となり、この幅が大きすぎるとバルーン３００が膨らむこと自体困難となる。 The material of the offset sheet 340 is not particularly limited, and for example, the same resin as the catheter tube 200 can be used. The method of fixing the offset sheet 340 is not particularly limited, and for example, adhesion, heat fusion, high frequency fusion and the like are possible. As an example, an offset sheet 340 having an adhesive coated on the back surface is used, and the offset sheet 340 is adhered to a part of the balloon 300 including the inflatable portion 330 in the circumferential direction and a part of the catheter tube 200. The width of the offset sheet 340 is, for example, a width of 1/2 or less, preferably 1/3 to 1/5 of the circumferential length of the outer peripheral surface of the catheter tube 200. If this width is too small, it becomes difficult to inflate the balloon 300 in an eccentric state, and if this width is too large, it becomes difficult for the balloon 300 to inflate itself.
　なお、本発明の実施の形態では、オフセットシート３４０の貼付によりカテーテルチューブ２００の軸心に対して偏心した形状にバルーン３００を膨張させているが、例えば膨張部３３０をカテーテルチューブ２００の外周面の一部に偏るように設ける等、上記以外の構成によって、バルーン３００がカテーテルチューブ２００の軸心に対して偏心した状態で膨張できるようにしてもよい。 In the embodiment of the present invention, the balloon 300 is inflated in a shape eccentric to the axial center of the catheter tube 200 by attaching the offset sheet 340. For example, the inflated portion 330 is formed on the outer peripheral surface of the catheter tube 200. A configuration other than the above, such as providing the balloon 300 so as to be biased to a part, may allow the balloon 300 to expand in an eccentric state with respect to the axial center of the catheter tube 200.
　分岐部４００は、カテーテルチューブ２００と枝管５００ａ～５００ｃとを接続する接続部に設けられた部材である。分岐部４００では、バルーンルーメン２２０と枝管５００ａとが連通し、ガイドワイヤルーメン２３０に内挿された補強用チューブ２１６の内腔と枝管５００ｂとが連通し、造影剤ルーメン２４０と枝管５００ｃとが連通するように構成されている。なお、カテーテルチューブ２００内の各ルーメン２２０～２４０あるいは補強用チューブ２１６の内腔と各枝管５００ａ～５００ｃとを連通する方法は特に限定されず、例えば、各枝管５００ａ～５００ｃの遠位端を先細に成形し、その先細に成形した部分を対応する各ルーメン２２０～２４０に挿入して接着剤で固定する等の方法を採用することができる。このとき、合成樹脂等の高分子材料からなる筒型形状のカバー部材である分岐部４００により、カテーテルチューブ２００と枝管５００ａ～５００ｃとを接続する接続部を覆って保護することが好ましい。また、枝管５００ａ～５００ｃの材質も特に限定されず、例えば合成樹脂等の高分子材料を用いることができる。 The branch portion 400 is a member provided at the connection portion that connects the catheter tube 200 and the branch tubes 500a to 500c. At the branch portion 400, the balloon lumen 220 and the branch pipe 500a communicate with each other, the lumen of the reinforcing tube 216 inserted in the guide wire lumen 230 and the branch pipe 500b communicate with each other, and the contrast agent lumen 240 and the branch pipe 500c communicate with each other. Is configured to communicate with. The method of communicating the lumens 220 to 240 of each lumen 220 to 240 in the catheter tube 200 or the lumen of the reinforcing tube 216 with each branch tube 500a to 500c is not particularly limited, and for example, the distal end of each branch tube 500a to 500c. Can be tapered, and the tapered portion is inserted into the corresponding lumens 220 to 240 and fixed with an adhesive. At this time, it is preferable that the branch portion 400, which is a tubular cover member made of a polymer material such as synthetic resin, covers and protects the connection portion connecting the catheter tube 200 and the branch tubes 500a to 500c. Further, the material of the branch pipes 500a to 500c is not particularly limited, and a polymer material such as a synthetic resin can be used.
　枝管５００ａはバルーン用枝管であり、枝管５００ａの近位端には、例えば二方活栓を備えたバルーン用ハブ６００ａが接続されている。バルーン用ハブ６００ａおよび枝管５００ａは、分岐部４００においてバルーンルーメン２２０と連通しており、バルーン用ハブ６００ａから枝管５００ａ、バルーンルーメン２２０および流体流通口を通じて、バルーン３００内部へ流体を導入できるようになっている。 The branch pipe 500a is a branch pipe for a balloon, and a hub 600a for a balloon equipped with, for example, a two-way stopcock is connected to the proximal end of the branch pipe 500a. The balloon hub 600a and the branch pipe 500a communicate with the balloon lumen 220 at the branch portion 400 so that the fluid can be introduced into the balloon 300 from the balloon hub 600a through the branch pipe 500a, the balloon lumen 220 and the fluid flow port. It has become.
　枝管５００ｂはガイドワイヤ用枝管であり、枝管５００ｂの近位端には、例えばルアーロックタイプのガイドワイヤ用ハブ６００ｂが接続されている。ガイドワイヤ用ハブ６００ｂおよび枝管５００ｂは、分岐部４００においてガイドワイヤルーメン２３０に内挿された補強用チューブ２１６の内腔と連通しており、ガイドワイヤ用ハブ６００ｂから枝管５００ｂ、補強用チューブ２１６、ガイドワイヤルーメン２３０およびカテーテルチューブ２００の最遠位端に設けられたガイドワイヤ挿通孔２３１を通じて、外部へガイドワイヤ２３５を突出できるようになっている。 The branch pipe 500b is a branch pipe for a guide wire, and for example, a luer lock type guide wire hub 600b is connected to the proximal end of the branch pipe 500b. The guide wire hub 600b and the branch pipe 500b communicate with the lumen of the reinforcing tube 216 inserted in the guide wire lumen 230 at the branch portion 400, and the guide wire hub 600b to the branch pipe 500b and the reinforcing tube are communicated with each other. The guide wire 235 can be projected to the outside through the guide wire lumen 230 and the guide wire insertion hole 231 provided at the most distal end of the catheter tube 200.
　枝管５００ｃは造影用枝管であり、枝管５００ｃの近位端には、例えばルアーロックタイプの造影用ハブ６００ｃが接続されている。造影用ハブ６００ｃおよび枝管５００ｃは、分岐部４００において造影剤ルーメン２４０と連通しており、造影用ハブ６００ｃから枝管５００ｃ、造影剤ルーメン２４０および造影剤流出口を通じて、外部へ造影剤を噴出できるようになっている。 The branch tube 500c is a contrast-enhancing branch tube, and for example, a luer lock type contrast-enhancing hub 600c is connected to the proximal end of the branch tube 500c. The contrast medium hub 600c and the branch tube 500c communicate with the contrast medium lumen 240 at the branch portion 400, and the contrast medium is ejected from the contrast medium hub 600c through the branch tube 500c, the contrast medium lumen 240, and the contrast medium outlet. You can do it.
　分岐部４００の遠位端側のカテーテルチューブ２００の外周には、容量タグ７００が取り付けられている。容量タグ７００には、例えばバルーン３００の外径とバルーン３００の内圧または気体容量との関係等、異物除去用バルーンカテーテル１００に特有の情報が記載されている。 A capacitance tag 700 is attached to the outer circumference of the catheter tube 200 on the distal end side of the branch portion 400. The capacity tag 700 contains information specific to the balloon catheter 100 for removing foreign matter, such as the relationship between the outer diameter of the balloon 300 and the internal pressure or gas capacity of the balloon 300.
　本発明の実施の形態における異物除去用バルーンカテーテル１００は、上述したように、第１の特徴としてカテーテルチューブ２００の最遠位端に先細のテーパ状のテーパ部２１１が形成されており、第２の特徴としてガイドワイヤルーメン２３０にカテーテルチューブ２００の剛性を向上させる補強用チューブ２１６が内挿されており、第３の特徴としてバルーン３００がカテーテルチューブ２００の軸心に対して偏心して膨張するように構成されている。 As described above, the balloon catheter 100 for removing foreign matter according to the embodiment of the present invention has a tapered tapered portion 211 formed at the most distal end of the catheter tube 200 as a first feature. As a feature of the guide wire lumen 230, a reinforcing tube 216 for improving the rigidity of the catheter tube 200 is inserted, and as a third feature, the balloon 300 is eccentrically expanded with respect to the axial center of the catheter tube 200. It is configured.
　以下、上記の第１～第３の特徴に着目し、本発明の実施の形態における異物除去用バルーンカテーテル１００の使用例について、図６を参照しながら説明する。なお、以下に説明する使用例は、患者の十二指腸に狭窄が生じている等の事情によって、ＥＲＣＰアプローチが困難であることが確認されている場合において、患者の胃壁および肝内胆管壁（肝臓）に穿刺孔を設け、その穿刺孔を経て、異物除去用バルーンカテーテル１００を胆管内に挿入する例である。 Hereinafter, focusing on the first to third features described above, an example of using the balloon catheter 100 for removing foreign matter in the embodiment of the present invention will be described with reference to FIG. In the use cases described below, the patient's gastric wall and intrahepatic bile duct wall (liver) are used when it is confirmed that the ERCP approach is difficult due to circumstances such as stenosis in the duodenum of the patient. ), And the balloon catheter 100 for removing foreign matter is inserted into the bile duct through the puncture hole.
　図６に示すように本発明の実施の形態における異物除去用バルーンカテーテル１００を用いて胆管８３０から胆石８５０を除去する場合には、まず、超音波内視鏡である内視鏡８００の先端を体内に挿入し、超音波画像として胃８１０から肝内胆管８２０を描出して肝内胆管８２０の位置を確認する。次いで、超音波画像で観察しながら、胃壁等の消化管壁から肝内胆管８２０へ穿刺針を穿刺し、内視鏡８００を介して異物除去用バルーンカテーテル１００に挿通されたガイドワイヤ（図６では不図示）を、穿刺孔を通じて肝内胆管８２０から胆管８３０へ挿入する。その後、バルーン３００を収縮させた状態で異物除去用バルーンカテーテル１００を体内に挿入し、カテーテルチューブ２００の遠位端をガイドワイヤ（図６では不図示）に沿わせながら穿刺孔を通じて肝内胆管８２０から胆管８３０へ挿入する。 As shown in FIG. 6, when removing the gallstone 850 from the bile duct 830 using the foreign matter removing balloon catheter 100 according to the embodiment of the present invention, first, the tip of the endoscope 800, which is an ultrasonic endoscope, is used. It is inserted into the body, and the intrahepatic bile duct 820 is visualized from the stomach 810 as an ultrasonic image to confirm the position of the intrahepatic bile duct 820. Next, while observing with an ultrasonic image, a puncture needle was punctured from the gastrointestinal wall such as the stomach wall into the intrahepatic bile duct 820, and a guide wire was inserted into the balloon catheter 100 for removing foreign substances via the endoscope 800 (FIG. 6). (Not shown) is inserted from the intrahepatic bile duct 820 into the bile duct 830 through the puncture hole. Then, the balloon catheter 100 for removing foreign matter is inserted into the body with the balloon 300 contracted, and the intrahepatic bile duct 820 is passed through the puncture hole while the distal end of the catheter tube 200 is along a guide wire (not shown in FIG. 6). Is inserted into the bile duct 830.
　次いで、バルーン３００が胆管８３０に配置された状態で造影剤を噴出して、胆管８３０内や胆石８５０の様子をＸ線造影画像で確認した後、バルーン３００を膨張させる。そして、バルーン３００を膨張させたままの状態でカテーテルチューブ２００の近位端を遠位端方向（図６内の矢印の方向）へ向かって押し込むことで、バルーン３００が胆管８３０内を十二指腸乳頭８４０側（図６内の矢印の方向）へ移動し、膨張させたバルーン３００の遠位端側で胆石８５０を十二指腸乳頭８４０から胆管８３０外へ押し出して除去することができる。 Next, the contrast medium is ejected with the balloon 300 placed in the bile duct 830, and the inside of the bile duct 830 and the state of the gallstone 850 are confirmed by an X-ray contrast image, and then the balloon 300 is inflated. Then, with the balloon 300 inflated, the proximal end of the catheter tube 200 is pushed toward the distal end (direction of the arrow in FIG. 6), so that the balloon 300 moves through the bile duct 830 and the duodenal papilla 840. The gallstone 850 can be removed by pushing it out of the bile duct 830 from the duodenal papilla 840 at the distal end side of the inflated balloon 300, moving to the side (in the direction of the arrow in FIG. 6).
　上述したように、本発明の実施の形態における異物除去用バルーンカテーテル１００は、ＥＲＣＰアプローチが困難な場合に好適に用いられるものであって、例えば、カテーテルチューブ２００の遠位端を胃壁および肝内胆管壁に設けられた穿刺孔を通じて肝内胆管から胆管へ挿入して用いられる。しかしながら、穿刺孔や肝内胆管等の体内管腔は非常に狭く、従来のバルーンカテーテルのカテーテルチューブの遠位端を穿刺孔に挿入したり体内管腔を進行させたりすることは容易ではない。 As described above, the balloon catheter 100 for removing foreign substances according to the embodiment of the present invention is preferably used when the ERCP approach is difficult, and for example, the distal end of the catheter tube 200 is placed in the stomach wall and intrahepatic. It is used by inserting it from the intrahepatic bile duct into the bile duct through a puncture hole provided in the bile duct wall. However, internal lumens such as puncture holes and intrahepatic bile ducts are very narrow, and it is not easy to insert the distal end of the catheter tube of a conventional balloon catheter into the puncture hole or advance the internal lumen.
　これに対して、本発明の実施の形態における異物除去用バルーンカテーテル１００は、カテーテルチューブ２００の最遠位端が先細のテーパ状に形成されており、カテーテルチューブ２００の最遠位端が穿刺孔の周壁等の体内組織を傷つけることなく経路を拡張しながら進行できるようになっている。すなわち、本発明の実施の形態における異物除去用バルーンカテーテル１００は、カテーテルチューブ２００の最遠位端が先細のテーパ状に形成されているという第１の特徴により、ガイドワイヤ２３５に沿って進行するガイドワイヤ追従性およびダイレーション性能を向上させた構成が実現されている。 On the other hand, in the balloon catheter 100 for removing foreign matter according to the embodiment of the present invention, the distal end of the catheter tube 200 is formed in a tapered shape, and the distal end of the catheter tube 200 is a puncture hole. It is possible to proceed while expanding the pathway without damaging the internal tissues such as the peripheral wall of the catheter. That is, the foreign matter removing balloon catheter 100 according to the embodiment of the present invention proceeds along the guide wire 235 due to the first feature that the distal end end of the catheter tube 200 is formed in a tapered shape. A configuration with improved guide wire followability and dilation performance has been realized.
　また、上述したように、本発明の実施の形態における異物除去用バルーンカテーテル１００を用いて胆石を除去する場合には、従来の逆行性に胆管にバルーンカテーテルを挿入するＥＲＣＰアプローチとは異なり、順行性に胆管に異物除去用バルーンカテーテル１００を挿入して、バルーン３００を膨張させた状態でカテーテルチューブ２００の近位端を遠位端方向へ向かって押し込むことでバルーン３００を遠位端方向へ移動させて、バルーン３００の遠位端側で胆石を十二指腸乳頭から胆管外へ押し出すことが行われる。しかしながら、従来のバルーンカテーテルでは、カテーテルチューブの近位端に作用させた押し込み力がカテーテルチューブの遠位端にまで確実に伝達されないことがある。その結果、バルーンを所望の力で遠位端方向へ移動させることができず、バルーンの遠位端側で胆石を胆管外へ押し出すことができない場合がある。 Further, as described above, when removing gallstones using the balloon catheter 100 for removing foreign substances in the embodiment of the present invention, unlike the conventional ERCP approach in which the balloon catheter is retrogradely inserted into the bile duct, the order is different. By inserting the balloon catheter 100 for removing foreign matter into the bile duct and pushing the proximal end of the catheter tube 200 toward the distal end while the balloon 300 is inflated, the balloon 300 is pushed toward the distal end. It is moved to push gallstones out of the bile duct from the papilla of Vater at the distal end of the balloon 300. However, in a conventional balloon catheter, the pushing force applied to the proximal end of the catheter tube may not be reliably transmitted to the distal end of the catheter tube. As a result, the balloon may not be able to move toward the distal end with the desired force, and the gallstone may not be pushed out of the bile duct on the distal end side of the balloon.
　これに対して、本発明の実施の形態における異物除去用バルーンカテーテル１００は、カテーテルチューブ２００の剛性を向上させる補強用チューブ２１６がガイドワイヤルーメン２３０に内挿されており、カテーテルチューブ２００の近位端に作用させた押し込み力がカテーテルチューブ２００の遠位端にまで確実に伝達されて、バルーン３００を所望の力で遠位端方向へ移動できるようになっている。すなわち、本発明の実施の形態における異物除去用バルーンカテーテル１００は、カテーテルチューブ２００の剛性を向上させる補強用チューブ２１６がガイドワイヤルーメン２３０に内挿されているという第２の特徴により、カテーテルチューブ２００の近位端に作用させた押し込み力がカテーテルチューブ２００の遠位端にまで伝達されるプッシャビリティ（押し込み能力）を向上させた構成が実現されている。 On the other hand, in the balloon catheter 100 for removing foreign matter according to the embodiment of the present invention, the reinforcing tube 216 for improving the rigidity of the catheter tube 200 is inserted in the guide wire lumen 230, and is proximal to the catheter tube 200. The pushing force applied to the end is reliably transmitted to the distal end of the catheter tube 200, allowing the balloon 300 to move toward the distal end with a desired force. That is, the foreign matter removing balloon catheter 100 according to the embodiment of the present invention has the catheter tube 200 due to the second feature that the reinforcing tube 216 for improving the rigidity of the catheter tube 200 is inserted in the guide wire lumen 230. A configuration has been realized in which the pushing force applied to the proximal end of the catheter tube 200 is transmitted to the distal end of the catheter tube 200 to improve the pushability (pushing ability).
　また、上述したように、本発明の実施の形態における異物除去用バルーンカテーテル１００を用いて胆石を除去する場合には、従来のバルーンの近位端側で胆石を掻き出すＥＲＣＰアプローチとは異なり、膨張させたバルーン３００の遠位端側で胆石を押し出すこととなる。しかしながら、バルーンの遠位端側に存在する胆石をバルーンによって押し出すため、従来のバルーンカテーテルを用いると、バルーンを遠位端方向へ移動させる際にカテーテルチューブの最遠位端が胆石に当たって、カテーテルチューブの遠位端方向への移動を邪魔することがある。その結果、バルーンを遠位端方向へ移動させることができず、バルーンの遠位端側で胆石を胆管外へ押し出すことができない場合がある。 Further, as described above, when removing gallstones using the balloon catheter 100 for removing foreign substances in the embodiment of the present invention, unlike the conventional ERCP approach of scraping gallstones on the proximal end side of the balloon, the gallstones are expanded. The gallstone will be pushed out on the distal end side of the balloon 300. However, since the bile stone existing on the distal end side of the balloon is pushed out by the balloon, when a conventional balloon catheter is used, the most distal end of the catheter tube hits the bile stone when moving the balloon toward the distal end, and the catheter tube May interfere with the movement of the balloon toward the distal end. As a result, the balloon may not be able to move toward the distal end, and gallstones may not be pushed out of the bile duct on the distal end side of the balloon.
　これに対して、本発明の実施の形態における異物除去用バルーンカテーテル１００は、バルーン３００がカテーテルチューブ２００の軸心に対して偏心して膨張することによって、カテーテルチューブ２００の最遠位端をバルーン３００の中心から偏った位置に配置できるようになっている。すなわち、本発明の実施の形態における異物除去用バルーンカテーテル１００は、バルーン３００がカテーテルチューブ２００の軸心に対して偏心して膨張するという第３の特徴により、カテーテルチューブ２００の最遠位端をバルーン３００が胆石に当たる際に邪魔にならない位置に配置できるようになり、バルーン３００を胆石に確実に当てて押し出すことが可能な構成が実現されている。 On the other hand, in the balloon catheter 100 for removing foreign matter according to the embodiment of the present invention, the balloon 300 expands eccentrically with respect to the axial center of the catheter tube 200, so that the most distal end of the catheter tube 200 is balloon 300. It can be placed at a position deviated from the center of. That is, the balloon catheter 100 for removing foreign matter according to the embodiment of the present invention has a third feature that the balloon 300 expands eccentrically with respect to the axial center of the catheter tube 200, so that the most distal end of the catheter tube 200 is ballooned. The balloon 300 can be placed in a position where it does not get in the way when it hits the gallstone, and the balloon 300 can be reliably hit against the gallstone and pushed out.
　図７Ａおよび図７Ｂを参照しながら、上記の第３の特徴についてより詳細に説明する。図７Ａは、本発明の実施の形態に対する比較例に係る図であって、バルーン３００の中心がカテーテルチューブ２００の軸心と一致した位置に配置されている場合を示す模式図である。一方、図７Ｂは、本発明の実施の形態に係る図であって、バルーン３００の中心がカテーテルチューブ２００の軸心から偏った位置に配置されている場合を示す模式図である。 The above-mentioned third feature will be described in more detail with reference to FIGS. 7A and 7B. FIG. 7A is a diagram according to a comparative example with respect to the embodiment of the present invention, and is a schematic view showing a case where the center of the balloon 300 is arranged at a position coincided with the axial center of the catheter tube 200. On the other hand, FIG. 7B is a diagram according to an embodiment of the present invention, and is a schematic view showing a case where the center of the balloon 300 is arranged at a position deviated from the axial center of the catheter tube 200.
　図７Ａに示すように、バルーン３００の中心がカテーテルチューブ２００の軸心と一致している場合には、テーパ部２１１が形成されているカテーテルチューブ２００の最遠位端がバルーン３００の略中心に配置された状態でバルーン３００が遠位端方向（図７Ａの矢印の方向）に移動することになる。この場合には、カテーテルチューブ２００の最遠位端が胆石８５０に当たってカテーテルチューブ２００の遠位端側への移動が妨げられてしまい、バルーン３００を遠位端側へ移動させることができず、バルーン３００の遠位端側で胆石８５０を押し出すことができなくなる。 As shown in FIG. 7A, when the center of the balloon 300 coincides with the axis of the catheter tube 200, the most distal end of the catheter tube 200 in which the tapered portion 211 is formed is approximately the center of the balloon 300. In the arranged state, the balloon 300 moves in the direction of the distal end (direction of the arrow in FIG. 7A). In this case, the most distal end of the catheter tube 200 hits the gallstone 850 and the movement of the catheter tube 200 to the distal end side is hindered, the balloon 300 cannot be moved to the distal end side, and the balloon The gallstone 850 cannot be extruded on the distal end side of the 300.
　一方、図７Ｂに示すように、バルーン３００の中心がカテーテルチューブ２００の軸心から偏った位置に配置されている場合には、テーパ部２１１が形成されているカテーテルチューブ２００の最遠位端がバルーン３００の移動方向に対して側方に位置した状態でバルーン３００が遠位端方向（図７Ｂの矢印の方向）に移動することになる。この場合には、カテーテルチューブ２００の最遠位端が胆石８５０に当たらずにバルーン３００の遠位端側を胆石８５０に首尾よく押し当てることができるようになり、バルーン３００の遠位端側で胆石８５０を確実に押し出すことができるようになる。 On the other hand, as shown in FIG. 7B, when the center of the balloon 300 is arranged at a position deviated from the axial center of the catheter tube 200, the most distal end of the catheter tube 200 in which the tapered portion 211 is formed is formed. The balloon 300 moves in the distal end direction (direction of the arrow in FIG. 7B) while being positioned laterally with respect to the moving direction of the balloon 300. In this case, the distal end of the catheter tube 200 can be successfully pressed against the gallstone 850 without hitting the gallstone 850, at the distal end of the balloon 300. The gallstone 850 can be pushed out reliably.
　以上説明した実施の形態は、本発明の理解を容易にするために記載されたものであって、本発明を限定するために記載されたものではない。したがって、上述した実施の形態に開示された各要素は、本発明の技術的範囲に属する全ての設計変更や均等物をも含む趣旨である。 The embodiments described above are described for facilitating the understanding of the present invention, not for limiting the present invention. Therefore, each element disclosed in the above-described embodiment is intended to include all design changes and equivalents belonging to the technical scope of the present invention.
　例えば、上述した実施の形態では、異物除去用バルーンカテーテル１００を、患者の胃壁および肝内胆管壁（肝臓）に穿刺孔を設け、その穿刺孔を通じて肝内胆管から胆管へ挿入して、胆石等の異物を胆管から排出する（除去する）ために用いる場合について述べたが、本発明に係る異物除去用バルーンカテーテルはこれに限定されるものではなく、異物除去用バルーンカテーテルとして、他の場合にも用いることができる。ただし、本発明に係る異物除去用バルーンカテーテルは、ＥＲＣＰアプローチ等の一般的に用いられるルートでのアプローチが困難な場合等において、体内組織に設けた穿刺孔を経るアプローチを行う場合に特に好適に用いることができる。 For example, in the above-described embodiment, a foreign matter removing balloon catheter 100 is provided with a puncture hole in the patient's stomach wall and intrahepatic bile duct wall (liver), and the gallstone is inserted from the intrahepatic bile duct into the bile duct through the puncture hole. Although the case of using for discharging (removing) foreign matter from the bile duct is described, the balloon catheter for removing foreign matter according to the present invention is not limited to this, and is used as a balloon catheter for removing foreign matter in other cases. Can also be used for. However, the balloon catheter for removing foreign substances according to the present invention is particularly suitable for an approach through a puncture hole provided in a body tissue when it is difficult to approach by a commonly used route such as an ERCP approach. Can be used.
　１００　異物除去用バルーンカテーテル
　２００、９０２　カテーテルチューブ
　２１０　細径部
　２１１　テーパ部
　２１５　太径部
　２１６　補強用チューブ
　２２０　バルーンルーメン
　２３０　ガイドワイヤルーメン
　２３１　ガイドワイヤ挿通孔
　２３５　ガイドワイヤ
　２４０　造影剤ルーメン
　２５０　造影リング
　３００　バルーン
　３１０、３２０　接合部
　３３０　膨張部
　３４０　オフセットシート
　４００　分岐部
　５００ａ～５００ｃ　枝管
　６００ａ　バルーン用ハブ
　６００ｂ　ガイドワイヤ用ハブ
　６００ｃ　造影用ハブ
　７００　容量タグ
　８００、９００　内視鏡
　８１０　胃
　８２０　肝内胆管
　８３０、９３０　胆管
　８４０、９４０　十二指腸乳頭
　８５０、９５０　胆石
  100 Balloon catheter for removing foreign matter 200, 902 Catheter tube 210 Small diameter part 211 Tapered part 215 Large diameter part 216 Reinforcing tube 220 Balloon lumen 230 Guide wire lumen 231 Guide wire insertion hole 235 Guide wire 240 Contrast agent lumen 250 Contrast ring 300 Balloon 310, 320 Joint 330 Expansion 340 Offset sheet 400 Branch 500a-500c Branch tube 600a Balloon hub 600b Guide wire hub 600c Contrast hub 700 Capacity tag 800, 900 Endoscope 810 Gastric 820 Intrahepatic bile duct 830, 930 Bile duct 840, 940 Duodenal papilla 850, 950 Gallstone

Claims (4)

  1. 　体内の異物を除去するために用いられる異物除去用バルーンカテーテルであって、
    　遠位端近傍に設けられた流体導出口から導出される流体を流通するバルーンルーメンと、最遠位端に設けられたガイドワイヤ挿通孔から導出されるガイドワイヤを挿通するガイドワイヤルーメンとが軸方向に沿って内部に形成された、可撓性の材料からなるカテーテルチューブと、
    　前記カテーテルチューブの前記遠位端近傍に配置されており、前記流体導出口から導出される前記流体によって膨張するバルーンと、を有し、
    　前記カテーテルチューブの前記最遠位端が先細のテーパ状に形成されており、
    　前記カテーテルチューブの剛性を向上させる補強用チューブが前記ガイドワイヤルーメンに内挿されており、
    　前記バルーンが前記カテーテルチューブの軸心に対して偏心して膨張することを特徴とする異物除去用バルーンカテーテル。     A balloon catheter for removing foreign substances used to remove foreign substances in the body.
    The axis is a balloon lumen that circulates the fluid led out from the fluid outlet provided near the distal end and a guide wire lumen through which the guide wire led out from the guide wire insertion hole provided at the distal end is inserted. A catheter tube made of a flexible material formed inside along the direction, and
    It has a balloon that is located near the distal end of the catheter tube and is inflated by the fluid that is led out of the fluid outlet.
    The distal end of the catheter tube is formed in a tapered shape.
    A reinforcing tube for improving the rigidity of the catheter tube is inserted in the guide wire lumen.
    A balloon catheter for removing foreign matter, wherein the balloon expands eccentrically with respect to the axial center of the catheter tube.
  2. 　前記カテーテルチューブが、遠位端側の細径部と前記細径部より外径の大きい近位端側の太径部とにより構成されており、前記補強用チューブが前記太径部に内挿されていることを特徴とする請求項１に記載の異物除去用バルーンカテーテル。 The catheter tube is composed of a small diameter portion on the distal end side and a large diameter portion on the proximal end side having a larger outer diameter than the small diameter portion, and the reinforcing tube is inserted into the large diameter portion. The balloon catheter for removing foreign matter according to claim 1, wherein the balloon catheter is provided.
  3. 　前記補強用チューブがポリエーテルエーテルケトンからなることを特徴とする請求項１または２に記載の異物除去用バルーンカテーテル。 The balloon catheter for removing foreign matter according to claim 1 or 2, wherein the reinforcing tube is made of polyetheretherketone.
  4. 　前記バルーンが膨張した状態で前記カテーテルチューブが近位端側から遠位端側へ押し込まれて前記バルーンが胆管内を十二指腸乳頭に向かって移動することにより、前記バルーンの遠位端側で前記胆管内の異物を前記胆管外へ押し出すために用いられることを特徴とする請求項１から３のいずれか１つに記載の異物除去用バルーンカテーテル。
          With the balloon inflated, the catheter tube is pushed from the proximal end side to the distal end side, and the balloon moves in the bile duct toward the duodenal papilla, so that the bile duct is located on the distal end side of the balloon. The balloon catheter for removing foreign matter according to any one of claims 1 to 3, wherein the foreign matter in the catheter is used to push the foreign matter out of the bile duct.
PCT/JP2020/040653 2019-10-31 2020-10-29 Balloon catheter for foreign matter removal WO2021085537A1 (en)

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