WO2021085537A1 - 異物除去用バルーンカテーテル - Google Patents

異物除去用バルーンカテーテル 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
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2020/040653
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English (en)
French (fr)
Japanese (ja)
Inventor
泊　晃平
恭代 冨永
正権 李
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Zeon Corp
Original Assignee
Zeon Corp
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 Zeon Corp filed Critical Zeon Corp
Priority to JP2021553685A priority Critical patent/JP7616062B2/ja
Priority to CN202080073921.4A priority patent/CN114599297B/zh
Publication of WO2021085537A1 publication Critical patent/WO2021085537A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; 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
    • 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
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; 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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CN114469291A (zh) * 2022-02-14 2022-05-13 郑州大学 一种负压气管异物取出钳及其使用方法
US20220362511A1 (en) * 2021-05-17 2022-11-17 Boston Scientific Scimed, Inc. Medical systems, devices, and related methods

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CN117258118A (zh) * 2023-10-12 2023-12-22 中国人民解放军总医院第五医学中心 一种球囊阻断装置

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US4775371A (en) * 1986-09-02 1988-10-04 Advanced Cardiovascular Systems, Inc. Stiffened dilatation catheter and method of manufacture
US20050090853A1 (en) * 2002-07-23 2005-04-28 Duchamp Jacky G. Catheter having a multilayered shaft section with a reinforcing mandrel
US20070260177A1 (en) * 2006-05-05 2007-11-08 Boris Warnack Balloon having a double compliance
JP2009537222A (ja) * 2006-05-16 2009-10-29 ウィルソン−クック・メディカル・インコーポレーテッド バルーンカフ
JP2014511233A (ja) * 2011-02-19 2014-05-15 ホットスパー テクノロジーズ，インコーポレイテッド 身体管腔内の閉塞を処置するための装置および方法
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US20220362511A1 (en) * 2021-05-17 2022-11-17 Boston Scientific Scimed, Inc. Medical systems, devices, and related methods
WO2022246386A1 (en) * 2021-05-17 2022-11-24 Boston Scientific Scimed, Inc. Medical systems, devices, and related methods
JP2024519021A (ja) * 2021-05-17 2024-05-08 ボストン サイエンティフィック サイムド，インコーポレイテッド 医療システム、デバイス、および関連する方法
CN114469291A (zh) * 2022-02-14 2022-05-13 郑州大学 一种负压气管异物取出钳及其使用方法
CN114469291B (zh) * 2022-02-14 2023-08-08 郑州大学 一种负压气管异物取出钳及其使用方法

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