WO2019116935A1 - Medical balloon catheter - Google Patents

Medical balloon catheter Download PDF

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Publication number
WO2019116935A1
WO2019116935A1 PCT/JP2018/044263 JP2018044263W WO2019116935A1 WO 2019116935 A1 WO2019116935 A1 WO 2019116935A1 JP 2018044263 W JP2018044263 W JP 2018044263W WO 2019116935 A1 WO2019116935 A1 WO 2019116935A1
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WO
WIPO (PCT)
Prior art keywords
balloon
catheter tube
catheter
lumen
medical
Prior art date
Application number
PCT/JP2018/044263
Other languages
French (fr)
Japanese (ja)
Inventor
政明 北山
Original Assignee
日本ゼオン株式会社
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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 JP2019559553A priority Critical patent/JPWO2019116935A1/en
Publication of WO2019116935A1 publication Critical patent/WO2019116935A1/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
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • 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

Definitions

  • the present invention relates to a medical balloon catheter, and more particularly to a medical balloon catheter having at least two balloons.
  • a balloon catheter described in Patent Document 1 has been proposed as an endoscopic treatment tool for compressing and stopping bleeding from an incision after performing endoscopic duodenal papillary sphincterotomy (EST).
  • This treatment tool comprises a first balloon and two balloons of a second balloon near the proximal end side of the first balloon near the distal end of the catheter tube, and passes through the duodenal papilla to the common bile duct Position the second balloon inside so as to pass the first balloon inside and out of the nipple, inflate the first balloon to fix the position of the catheter (anchor), and in this state inflate the second balloon
  • the bleeding portion of the nipple is compressed radially outward to stop bleeding.
  • the cited reference 1 exemplifies a spherical shape, a wedge shape, a forceps shape, etc. It has the shape of a rotating body.
  • the balloon catheter when using the balloon catheter, for example, when the hemostasis at the incision of the papillary sphincter is performed, since the second balloon is expanded substantially uniformly in the radial direction and the incision is compressed, the position of the incision or Depending on the shape, etc., the incision may be pushed back and spread, and there may be a case where hemostasis can not be performed properly.
  • the present invention has been made in view of these points, and it is an object of the present invention to provide a medical balloon catheter capable of appropriately compressing the hemorrhage in the body and performing hemostasis and the like.
  • the medical balloon catheter is A catheter tube comprising a distal end and a proximal end; A first balloon disposed near the distal end of the catheter tube and inflated by the fluid being injected therein; And a second balloon provided near the proximal end side of the first balloon of the catheter tube and inflated by the fluid being injected therein.
  • At least one of the first balloon and the second balloon is a medical balloon catheter that is an eccentric balloon that expands eccentrically with respect to the axial center of the catheter tube.
  • both the first balloon and the second balloon are in the form of a rotor having a rotational axis with the axis of the catheter, such as a spherical shape, a wedge shape or a forceps shape.
  • at least one of the first balloon and the second balloon is an eccentric balloon that expands eccentrically with respect to the axial center of the catheter tube.
  • a rotor-shaped balloon having the axis of the catheter as the axis of rotation that is, a balloon that inflates approximately equally to the axis of the catheter tube
  • a balloon which is not eccentric with respect to there may be a case of a non-eccentric balloon.
  • the non-eccentric balloon expands mainly in the radial direction of the catheter and inflates only in the direction along the axial center of the catheter (hereinafter sometimes referred to simply as the axial direction), whereas the eccentric balloon It can be expanded relatively large in the axial direction. Therefore, when the eccentric balloon and another balloon (non-ecentric balloon or eccentric balloon) provided in the vicinity of the eccentric balloon are expanded, a part of the eccentric balloon in the axial direction and a corresponding one of the other balloons The parts can be brought close to, in contact with or in pressure contact with one another.
  • a treatment in the body for example, an incision in the papillary sphincter is pinched from both sides of the duodenum side and the common bile duct side by the first balloon and the second balloon to perform pressure hemostasis Treatment can be performed properly.
  • the first balloon may be a non-eccentric balloon which is uniformly inflated with respect to the axial center of the catheter tube
  • the second balloon may be the eccentric balloon.
  • the first balloon anchors the catheter tube inside the papilla (portion on the side of the common bile duct), and a part of the distal end side of the second balloon, the papillary sphincter muscle
  • the incision can be compressed from the duodenum side to stop bleeding.
  • the eccentric balloon is preferably transparent or translucent when inflated.
  • the proximal end side to the distal end side of the eccentric balloon can be visually recognized.
  • an incision (bleeding portion) of the duodenal papilla is visually recognized by the endoscopic camera via the eccentric balloon. While doing, it can do the treatment for the pressure hemostasis.
  • the catheter tube is a single balloon in communication with each of the first balloon and the second balloon in order to supply fluid to the first balloon and the second balloon.
  • a lumen can be provided.
  • the through hole for the first balloon of the balloon lumen and the through hole for the second balloon of the balloon lumen can have substantially the same diameter.
  • the first balloon located on the distal end side can be inflated first
  • the second balloon on the proximal end side can be inflated after being inflated to a certain extent.
  • the first balloon is inflated first and anchored, and then the second balloon is inflated to open the incision between the two balloons. Measures such as compression can be performed.
  • the catheter tube may include a first balloon lumen that supplies fluid to the first balloon, and a second balloon lumen that supplies fluid to the second balloon.
  • the foreign matter in the approximately straight trunk portion of the common bile duct is scratched out by the expanded non-eccentric balloon and has a bulge that becomes convex on the duodenum side of the common bile duct.
  • the foreign matter in the bag-like portion can be scraped off by the inflated eccentric balloon.
  • the medical balloon catheter according to the present invention in a state in which the first balloon and the second balloon are expanded, a part of the proximal end side of the first balloon and a distal end side of the second balloon Some parts can be brought close to, in contact with, or in pressure contact with each other.
  • the portion of the first balloon of the catheter tube is inserted from the duodenal papilla into the common bile duct side, and the portion of the second balloon is placed on the duodenal side.
  • the first balloon anchors the catheter tube inside the duodenal papilla (portion on the side of the common bile duct), and a part of the second balloon distal end and the first balloon
  • the papillary sphincter can be pinched from both sides to pressurize the hemostasis.
  • the catheter tube has a guide wire lumen provided eccentrically with respect to the axial center of the catheter tube, and the eccentric balloon is the shaft of the catheter tube. It can be provided to expand eccentrically on the side opposite to the side eccentric to the center.
  • the catheter tube can be used by passing through the treatment instrument guiding tube of the side-viewing endoscope (side endoscope).
  • side endoscope side endoscope
  • the catheter tube is relatively largely curved near the outlet of the treatment instrument guide tube, so that eccentricity occurs.
  • the balloon can be in a rotational orientation such that it expands in a direction generally approximately 11 to 12 o'clock in the papillary sphincter, which is the direction generally cut in endoscopic duodenal papillary sphincter dissection. Therefore, it becomes easy to adjust the rotational attitude of the eccentric balloon.
  • the medical balloon catheter according to the present invention when the first balloon and the second balloon are inflated, a part of the proximal end side of the first balloon and a distal end side of the second balloon In part, it can be suitably used to pressurize the hemostasis across the site to be hemostasis. Further, the medical balloon catheter according to the present invention is not only for such pressure-controlled hemostasis, but also for scraping foreign substances (such as calculus and sludge) in the body with the first balloon or the second balloon selectively expanded. Can also be suitably used.
  • FIG. 1 is a plan view showing the entire configuration of a medical balloon catheter according to an embodiment of the present invention.
  • FIG. 2 is a cross-sectional view taken along the line II-II of FIG.
  • FIG. 3 is an enlarged cross-sectional view of the main part of the medical balloon catheter shown in FIG.
  • FIG. 4 is a plan view showing the entire configuration of a medical balloon catheter according to another embodiment of the present invention.
  • FIG. 5 is a cross-sectional view taken along the line VV of FIG.
  • FIG. 6 is an enlarged cross-sectional view of the main part of the medical balloon catheter shown in FIG.
  • FIG. 7 is a view showing an example of treatment using the medical balloon catheter shown in FIG.
  • the medical balloon catheter according to the present invention can be suitably used to treat hemorrhage from the incision after the endoscopic duodenal papillary sphincterotomy (EST) is performed.
  • EST endoscopic duodenal papillary sphincterotomy
  • the present invention is not limited to this, and is widely applicable to a medical treatment instrument provided with a catheter tube for performing various treatments in a body cavity or a lumen in the body.
  • a medical treatment tool for removing foreign substances such as calculi (such as gallstones) and sludge (such as bile) existing in a body cavity or lumen (such as bile duct) in the body.
  • the present invention is not limited to a treatment tool for an endoscope which is inserted into the body using an endoscope and used, and the inside of the body percutaneously or from the natural mouth of the body without using the endoscope It is widely applicable to the medical treatment tool used by being inserted in a lumen.
  • the balloon catheter 1 includes a catheter tube 2, a first balloon 3, a second balloon 4, a cover 5, two branch pipes (branch pipes) 6a and 7a, and two ports 6b and 7b. It is configured to have an outline.
  • the catheter tube 2 is a tube formed of a flexible material, and is a distal end which is an end to be inserted into the body, and a proximal end which is located on the other end side and placed outside the body Have a department.
  • the outer diameter of the catheter tube 2 is about 1.0 to 3.0 mm, and the total length is about 500 to 2500 mm.
  • the material of the catheter tube 2 is not particularly limited as long as it is a flexible material, but is preferably a polymer material, and particularly preferably a polyamide resin or a polyamide-based elastomer.
  • a tube having a uniform diameter over the entire length is used as the catheter tube 2, but in consideration of insertability etc., a predetermined section on the distal end side is a proximal end The diameter may be smaller than that of the side.
  • the catheter tube 2 uses a two-lumen type having a main lumen (guide wire lumen) 21 and a balloon lumen 22 inside.
  • the main lumen 21 is used as a flow path for contrast medium when performing X-ray imaging in a body lumen, as a flow path for medical fluid for injecting saline and other drugs into the body lumen, It is a lumen that can be used to insert a guide wire.
  • the guide wire is previously inserted into the body lumen to secure the insertion path of the catheter tube 2, or to the main lumen 21 of the catheter tube 2 to secure rigidity when the catheter tube 2 is inserted into the body.
  • a wire made of metal strands such as stainless steel can be used.
  • the main lumen 21 is provided to penetrate from the proximal end of the catheter tube 2 to the opening 21 a of the distal end of the catheter tube 2. Further, in the present embodiment, the axis of the main lumen 21 is provided eccentrically with respect to the axis of the catheter tube 2.
  • the balloon lumen 22 is a lumen serving as a flow path for delivering (supplying) a fluid such as air used to inflate the first balloon 3 and the second balloon 4 into the interior of the first balloon 3 and the second balloon 4. is there.
  • the balloon lumen 22 is provided from the proximal end of the catheter tube 2 to the through hole 22 a communicating with the inside of the first balloon 3 inside the first balloon 3 at the distal end.
  • the balloon lumen 22 communicates with the inside of the second balloon 4 via a through hole 22 b communicating with the inside of the second balloon 4 inside the second balloon 4.
  • the through holes 22a for the first balloon 3 of the balloon lumen 22 and the through holes 22b for the second balloon 4 of the balloon lumen 22 are set to have substantially the same diameter. Assuming that the through holes 22a and the through holes 22b have the same diameter, when the first balloon 3 and the second balloon 4 have the same specifications, when air is supplied through the balloon lumen 22, the distal end side It is experimentally confirmed that the first balloon 3 of the first balloon 3 inflates first and the second balloon 4 on the proximal end side later inflates. Therefore, it is convenient, for example, in the case where the first balloon 3 is inflated first for anchoring and the second balloon 4 is later inflated to perform compression hemostasis. However, the through holes 22a and the through holes 22b may be set to diameters different from each other.
  • the number of lumens provided in the catheter tube 2 is not limited to two, and may be three or more.
  • lumens for contrast agent and medical fluid may be added separately from the main lumen 21.
  • the other lumens may extend to the distal end of the catheter tube 2 similarly to the main lumen 21, but the middle of the catheter tube 2 (for example, near the proximal end side than the second balloon 4)
  • An opening may be provided on the side or the side of the portion between the first balloon 3 and the second balloon 4 so as to reach the opening.
  • other lumens having functions other than those described above may be provided.
  • the main lumen 21 and the balloon lumen 22 are arranged side by side as substantially circular in FIG. 2 respectively, but the shape and arrangement are not limited to this, and the shape and arrangement so as to be efficient in the catheter tube 2 respectively It is preferable to
  • the cross-sectional area of the main lumen 21 is preferably as large as possible within the range that does not impair the strength of the catheter tube 2 and is preferably 0.08 to 0.8 mm 2 .
  • the cross-sectional area of the balloon lumen 22 is about 0.03 to 0.3 mm 2 .
  • the area ratio of the main lumen 21 to the balloon lumen 22 in the cross section of the catheter tube 2 can be set within the range of 5: 1 to 20: 1.
  • the first balloon 3 is expanded by supplying (injecting) a fluid (in the present embodiment, air) into the inside thereof, and is deflated by being discharged (suctioned) on the contrary, It is attached so as to cover the through hole 22a in the vicinity of the lateral end.
  • a fluid in the present embodiment, air
  • the first balloon 3 is a rotor-shaped balloon (a non-decentered balloon which is not eccentric to the axial center of the catheter) having the axis of the catheter tube 2 as the rotation axis.
  • the second balloon 4 is expanded by supplying (injecting) a fluid (in this embodiment, air) into the inside thereof, and contracting by being discharged (suctioned) on the contrary, It is attached near the proximal end side than 1 balloon 3 so that the through-hole 22b may be covered.
  • the second balloon 4 is an eccentric balloon that expands eccentrically with respect to the axial center of the catheter tube 2.
  • the eccentric balloon can be expanded relatively large in the axial direction of the catheter tube 2 as compared to the non-eccentric balloon.
  • the stretchable material for forming the balloons 3 and 4 one having a 100% modulus (value measured according to JIS K 6251) of 0.1 to 10 MPa is preferable, and one having 1 to 5 MPa is particularly preferable. . If the 100% modulus is too small, the strength of the balloons 3 and 4 may be insufficient, and if it is too large, the balloons 3 and 4 may not be able to expand to a sufficient size. Further, specific examples of stretchable materials suitable for forming the balloons 3 and 4 include natural rubber, silicone rubber, polyurethane elastomer and the like.
  • the balloons 3 and 4 basically have the same specifications (configurations and shapes), and they are generally cylindrical in a contracted state, and both ends of the catheter tube 2 are used.
  • a substantially cylindrical joint portion 3a, 3b, 4a, 4b joined to the outer peripheral surface is formed, and a fluid is introduced into the space between the joint portions 3a, 3b, 4a, 4b at both ends thereof.
  • expansion portions 3c and 4c are formed to expand.
  • the expanded portions 3c and 4c of the balloons 3 and 4 are rotating body shapes formed by rotating a convex curve outward of the catheter tube 2 with the axial center of the catheter tube 2 as a rotation axis without receiving external force. Is formed.
  • the method to join the junction parts 3a, 3b, 4a, 4b of the balloons 3 and 4 and the catheter tube 2 is not particularly limited. For example, adhesion by adhesive, heat fusion, welding by solvent, ultrasonic welding And the like.
  • the expanded portions 3c and 4c of the balloons 3 and 4 preferably have a maximum outer diameter in the inflated state of 110 to 200% of the minimum outer diameter in the deflated state. If this ratio is too small, the balloons 3 and 4 may not expand to a sufficient size, and if too large, the balloons 3 and 4 may be in the way when the balloon catheter 1 is inserted into the body. Further, the length (length along the axial direction of the catheter tube 2) of the expansion portions 3c and 4c in the balloons 3 and 4 is preferably 5 to 20 mm, and the thickness is 0.10 to 0.50 mm. Is preferred. The thickness of the balloons 3 and 4 is preferably uniform along the circumferential direction.
  • the method for producing the balloons 3 and 4 having the shape as described above is not particularly limited, and a known method may be used as a film forming method of the stretchable material, but it is preferable to use the dipping molding method.
  • the stretchable material and, if necessary, various additives are dissolved in a solvent to form a solution or a suspension, and the solution (suspension) has a mold having an outer shape substantially equal to the desired balloon shape.
  • a balloon having a desired thickness can be formed by repeating this immersion and drying.
  • crosslinking is carried out after film formation, if necessary.
  • a part of the second balloon 4 in the circumferential direction from above the second balloon 4 is fixed to the catheter tube 2 along the longitudinal direction thereof.
  • a fixing tape 41 for attaching is attached.
  • the fixing tape 41 is longer than the axial length of the balloon 4, and both ends of the tape 41 are fixed to the outer peripheral surface of the catheter tube 2.
  • the material of the fixing tape 41 is not particularly limited, and is made of the same resin as the resin constituting the catheter tube 2.
  • the fixing method of the both ends of the fixing tape 41 is not particularly limited, and adhesion, heat fusion, high frequency fusion and the like can be mentioned.
  • an adhesive adheresive
  • an adhesive is applied to the back surface of the tape 41 so as to adhere to a part of the balloon 4 in the circumferential direction and a part of the catheter tube 2.
  • the width of the fixing tape 41 is 1/2 or less of the circumferential length at the outer periphery of the catheter tube 2, and preferably 1/3 to 1/5. If this width is too small, the function of fixing a part of the balloon 4 in the circumferential direction from the top of the balloon 4 to the catheter tube 2 becomes small, and if the width is too large, the balloon 4 is eccentrically inflated and inflated. Will be difficult.
  • the fixing tape 41 for fixing a part of the balloon 4 in the circumferential direction to the catheter tube 5 is attached from above the balloon 4, as shown in FIG.
  • the inflating portion 4 c inflates eccentrically with respect to the axial center of the catheter tube 2.
  • the amount of eccentricity of the expansion center of the expansion portion with respect to the axial center of the catheter tube 2 is preferably 50 to 100%, more preferably 75 to 100% with respect to the expansion radius of the expansion portion.
  • the balloon 4 does not have to be completely circularly expanded in its cross section, and may be expanded in an elliptical or other shape.
  • the balloon 4 is attached to the catheter tube 2 such that the axial center of the guide wire lumen 21 is expanded eccentrically on the opposite side to the side eccentric to the axial center of the catheter tube 2. That is, the fixing tape 41 is attached to the same side as the side where the axial center of the guide wire lumen 21 is eccentric to the axial center of the catheter tube 2.
  • the first balloon 3 and the second balloon 4 in a state in which they are respectively inflated, a part of the proximal end side of the first balloon 3 and a distal end side of the second balloon 4
  • the parts are arranged to be close to each other.
  • a part on the proximal end side of the first balloon 3 and a part on the distal end side of the second balloon 4 mutually You may arrange
  • the second balloon 4 which is an eccentric balloon is preferably transparent or translucent at least at the time of inflation.
  • the second balloon 4 has transparency such that the distal end side of the second balloon 4 can be seen from the proximal end side of the second balloon 4 at least when inflated. preferable.
  • treatment for compression hemostasis can be performed, while confirming the state of bleeding. It can be treated.
  • a transparent or translucent balloon material a material that is transparent or translucent can be used both at the time of deflation and at the time of inflation. However, even if the material is not transparent or translucent at the time of contraction, since the film thickness of the balloon becomes thin at the time of inflation, any material may be used as long as it becomes transparent or translucent in the thin state.
  • branch pipes 6 a and 6 b are connected to the proximal end side of the catheter tube 2 at a portion of the cover 5.
  • the branch pipe 6 a is a tube whose distal end is connected to the main lumen 21, and the branch pipe 7 a is a tube whose distal end is connected to the balloon lumen 22.
  • the material of the branch pipes 6a and 7a is not particularly limited, but it is preferable to use a polymer material.
  • the port 6b is connected to the proximal end of the branch pipe 6a, and the port 7b is connected to the proximal end of the branch pipe 7a.
  • a syringe or the like is connected to the port 6 b so that a contrast agent or a drug solution can be sent to the main lumen 21.
  • a guide wire can be inserted from the opening of the port 6 b and inserted into the main lumen 21.
  • a syringe or the like is connected to the port 7 b so that fluid (in the present embodiment, air) for inflating the balloons 3 and 4 can be sent to the balloon lumen 22.
  • the material of the ports 6 b and 7 b is not particularly limited, but it is preferable to use a transparent polymer material.
  • the method of connecting the branch pipes 6a, 7a and the respective lumens 21, 22 of the catheter tube 2 is not particularly limited.
  • the distal end of the branch pipes 6a, 7a is formed into a tapered shape, and the outer peripheral surface thereof An adhesive may be applied to the tube and glued by inserting its end into the corresponding lumens 21 and 22 of the catheter tube 2.
  • the connection between the catheter tube 2 and the branch pipes 6a, 7a is reinforced by the cover 5 and protected.
  • the cover 5 is provided to cover the connection between the catheter tube 2 and the branch pipes 6a and 7a.
  • the shape of the cover 5 is not particularly limited, but is usually a box or a cylinder.
  • the material of the cover 5 is not particularly limited, but it is preferable to use a polymer material. It is also possible to use a heat shrinkable tube as the cover 5.
  • a procedure for hemostasis of hemorrhage from an incision after performing endoscopic duodenal papillary sphincterotomy is outlined with reference to FIG. Do.
  • an endoscope (a side endoscope) (not shown) is inserted to the vicinity of the papilla in the duodenum, and a guide wire is inserted into the main lumen 21 via the port 6b and the branch pipe 6a.
  • the catheter tube 2 of the balloon catheter 1 is inserted from the distal end side of the catheter tube 2 through the channel (treatment tool guide tube) of the endoscope.
  • the distal end of the catheter tube 2 is inserted into the bile duct through the nipple with the guide wire, and the first balloon 3 is on the inside of the nipple (in the common bile duct side) and the second balloon 4 is on the outside of the nipple Push the catheter tube 2 until it is placed in).
  • the guide wire may be inserted in advance, and the catheter tube 2 may be inserted along the guide wire.
  • the guide wire and the catheter tube 2 are greatly curved and inserted from the nipple into the common bile duct when pushed out from the opening of the channel of the endoscope.
  • the catheter tube 2 is disposed so that the side where the main lumen 21 is located is the outer side in the radial direction of the curved portion. 2 rotation posture is corrected.
  • the second balloon 4 is provided so that the main lumen 21 is eccentrically expanded on the opposite side to the side eccentric to the axial center of the catheter tube 2, the second balloon 4 is a part of the curved portion.
  • the rotational attitude is such that it expands radially inward.
  • the second balloon 4 is in a rotational posture in which the second balloon 4 expands in a direction of approximately 11 to 12 o'clock, which is a direction generally cut in endoscopic duodenal papillary sphincter incision.
  • the syringe connected to the port 7b is pressed to send air through the port 7b, the branch pipe 7a, and the balloon lumen 22.
  • the first balloon 3 is inflated first, and the catheter tube 2 is anchored on the inside of the papilla (the side of the common bile duct), and with a slight time difference, the second balloon 4 is then placed on the outside of the papilla (duodenal side). Expand with).
  • the second balloon 4 Since the second balloon 4 is an eccentric balloon, it expands relatively relatively not only in the radial direction but also in the axial direction with respect to the catheter tube 2, so the distal end side portion of the second balloon 4 An incision (approximately 11 to 12 o'clock direction) can be compressed from the outer side (duodenal side) to the inner side (general bile duct side) of the papilla.
  • the incision portion of the papillary sphincter is a portion at the distal end side of the second balloon 4 and the proximal end side of the first balloon 3 It is pinched by the part corresponding to, and it is compressed hemostasis.
  • the first balloon 3 on the distal end side is a non-eccentric balloon
  • the second balloon 4 on the proximal end side can be expanded relatively largely in the axial center direction of the catheter tube 2 It is a balloon.
  • a part of the distal end side of the second balloon is a part of the proximal end side of the first balloon 3 Since it is configured to be close to each other, when expanding both balloons, the papillary sphincter is formed on both sides by a part of the distal end side of the second balloon 4 and a corresponding part of the first balloon 3 It is possible to put pressure on it and press down on it to stop bleeding.
  • the degree of proximity of a portion on the distal end side of the second balloon 4 and a corresponding portion of the first balloon 3 at the time of inflation is the thickness of the site to be pinched and compressed (here, the thickness of the papillary sphincter muscle Is set to an extent that can be appropriately compressed.
  • a part of the distal end side of the second balloon 4 may be configured to abut or press against a part corresponding to the proximal end side of the first balloon 3.
  • a part of the distal end of the second balloon 4 and a corresponding part of the proximal end of the first balloon 3 may be configured to be separated to some extent.
  • a part of the distal end side of the second balloon 4 since the first balloon 3 is anchored in the common bile duct, a part of the distal end side of the second balloon 4 Then, it is possible to press against (pressure) the papillary sphincter from the outside (duodenal side) to stop bleeding.
  • the second balloon 4 which is transparent or translucent at the time of inflation is used, the second balloon 4 can be seen through the second balloon 4 from the proximal end side to the distal end side.
  • a treatment for pressing and stopping the hemostasis can be performed while visually recognizing the incision (bleeding portion) of the duodenal papilla from the duodenum side via an endoscopic camera or the like.
  • the single balloon lumen 22 can supply air for inflating both the first balloon and the second balloon, so that the configuration is simplified as compared with the case of supplying them separately.
  • the first balloon 3 located on the distal end side is inflated first, with the through hole 22a for the first balloon 3 of the balloon lumen 22 and the through hole 22b for the second balloon 4 of the balloon lumen 22 having substantially the same diameter.
  • the second balloon 4 on the proximal end side is inflated after being inflated to a certain extent.
  • the second balloon 4 which is an eccentric balloon is provided with the main lumen 21 which is provided eccentrically with respect to the axial center of the catheter tube 2 and can be used as a guide wire lumen.
  • the main lumen 21 is provided so as to expand eccentrically on the opposite side to the side eccentric to the axial center of the catheter tube 2.
  • the second balloon 4 is in a direction generally cut in the endoscopic duodenal papillary sphincter incision approximately 11 to 12 It is automatically corrected to become a rotational posture that expands in a time direction. For this reason, the treatment for pressing and stopping the incision of the papillary sphincter can be performed highly efficiently.
  • both the first balloon 3 and the second balloon 4 are inflated by the single balloon lumen 22.
  • the balloon lumen for inflating the first balloon 3 and the second balloon may be provided separately and independently of one another, as shown in FIGS. That is, in the configuration shown in FIGS. 4 to 6, the catheter tube 2 has a first balloon lumen 23 supplying fluid to the first balloon 3 and a second balloon lumen 24 supplying fluid to the second balloon 4. There is.
  • the first balloon lumen 23 is provided from the proximal end of the catheter tube 2 to a through hole 23a communicating with the inside of the first balloon 3 inside the first balloon 3 at the distal end.
  • the second balloon lumen 24 is provided from the proximal end of the catheter tube 2 to the through hole 24 a communicating with the inside of the second balloon 4 inside the second balloon 4 at the distal end. ing.
  • the branch pipe 8a and the port 8b consisting of a tube communicating with the first balloon lumen 23 and the branch pipe 9a and a port 9b consisting of a tube communicating with the second balloon lumen 24 Is provided.
  • the branch pipes 8a and 9a and the ports 8b and 9b have the same configuration as the above-described branch pipe 7a and port 7b shown in FIG.
  • a syringe or the like is connected to the port 8b, and a fluid (in the present embodiment, air) for inflating the balloon 3 is connected to the first balloon lumen 23, and a syringe or the like is connected to the port 9b to inflate the balloon 4 Fluid (in this embodiment, air) can be fed to the second balloon lumen 24.
  • a fluid in the present embodiment, air
  • a syringe or the like is connected to the port 9b to inflate the balloon 4
  • Fluid in this embodiment, air
  • the first balloon 3 and the second balloon 4 are arbitrarily selected and inflated. It is possible to freely adjust the timing of the expansion of the first balloon 3 and the expansion of the second balloon 4 and is not only convenient for pressing the hemostasis at the incision of the papillary sphincter but also various other types. It becomes possible to apply to treatment. For example, when applied to a process of scraping foreign matter such as gallstone and bile mud in the common bile duct, the foreign matter in a portion substantially straight of the common bile duct causes the first balloon 3 to expand while the second balloon 4 is contracted.
  • the foreign substance in the bag-like portion having a bulge which is scraped by the inflated first balloon 3 and which is convex toward the duodenum side of the common bile duct causes the second balloon 4 to be inflated while the first balloon 3 is contracted,
  • Various treatments can be flexibly coped with, such as being able to scrape with the expanded second balloon 4.
  • the balloon provided in the balloon catheter 1 is two, the first balloon 3 and the second balloon 4, and the second balloon 4 is an eccentric balloon, but three or more balloons are provided, At least one of the above may be an eccentric balloon.
  • first balloon catheter 2 ... catheter tube 21 ... main lumen (guide wire lumen) 22, 23, 24 ... balloon lumens (first balloon lumen, second balloon lumen) 22a, 22b, 23a, 24a: through holes 3: first balloon 4.

Abstract

[Problem] To provide a medical balloon catheter with which pressure hemostasis, for example, can be performed appropriately on a bleed site inside a body. [Solution] The present invention includes: a catheter tube 2; a first balloon 3 which is provided near the distal end of the catheter tube 2 and expands by having a fluid injected therein through a lumen 22; and a second balloon 4 which is provided near the proximal end of the first balloon 3 of the catheter tube 2 and expands by having a fluid injected therein through the lumen 22. The first balloon 3 is a concentric balloon that expands evenly relative to the axis of the shaft of the catheter tube 2 and the second balloon 4 is an eccentric balloon that expands eccentrically relative to the axis of the shaft of the catheter tube 2.

Description

医療用バルーンカテーテルMedical balloon catheter
　本発明は、医療用バルーンカテーテルに関し、特に、少なくとも２つのバルーンを有する医療用バルーンカテーテルに関する。 The present invention relates to a medical balloon catheter, and more particularly to a medical balloon catheter having at least two balloons.
　内視鏡的十二指腸乳頭括約筋切開術（ＥＳＴ）を実施した後の切開部からの出血を圧迫止血するための内視鏡用処置具として、特許文献１に記載のバルーンカテーテルが提案されている。この処置具は、カテーテルチューブの遠位端近傍に、第１バルーンおよび該第１バルーンの近位端側近傍に第２バルーンの２つのバルーンを備えており、十二指腸乳頭部を通過して総胆管内に第１バルーンを、乳頭部の内外に渡るように第２バルーンを配置して、第１バルーンを膨張させてカテーテルの位置を固定（アンカリング）し、この状態で第２バルーンを膨張させることにより、乳頭部の出血部を径方向外側に圧迫して止血するものである。 A balloon catheter described in Patent Document 1 has been proposed as an endoscopic treatment tool for compressing and stopping bleeding from an incision after performing endoscopic duodenal papillary sphincterotomy (EST). This treatment tool comprises a first balloon and two balloons of a second balloon near the proximal end side of the first balloon near the distal end of the catheter tube, and passes through the duodenal papilla to the common bile duct Position the second balloon inside so as to pass the first balloon inside and out of the nipple, inflate the first balloon to fix the position of the catheter (anchor), and in this state inflate the second balloon Thus, the bleeding portion of the nipple is compressed radially outward to stop bleeding.
　このバルーンカテーテルの第１バルーンおよび第２バルーンの膨張時のバルーン形状としては、引用文献１には、球形状、俵形状または茄子形状等が例示されており、カテーテルの軸心を回転軸とする回転体形状となっている。 As the balloon shape at the time of expansion of the first balloon and the second balloon of this balloon catheter, the cited reference 1 exemplifies a spherical shape, a wedge shape, a forceps shape, etc. It has the shape of a rotating body.
　しかしながら、このバルーンカテーテルを用いて、たとえば乳頭括約筋の切開部を止血する場合には、第２バルーンが半径方向に略均等に膨張して切開部を圧迫することになるため、切開部の位置や形状等によっては、切開部を却って押し広げてしまう場合があり、適正に止血できない場合があった。 However, when using the balloon catheter, for example, when the hemostasis at the incision of the papillary sphincter is performed, since the second balloon is expanded substantially uniformly in the radial direction and the incision is compressed, the position of the incision or Depending on the shape, etc., the incision may be pushed back and spread, and there may be a case where hemostasis can not be performed properly.
特開平９－１０２１９号公報Japanese Patent Laid-Open No. 9-10219
　本発明は、このような点に鑑みてなされたものであり、体内の出血部を適正に圧迫止血等することができる医療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 has been made in view of these points, and it is an object of the present invention to provide a medical balloon catheter capable of appropriately compressing the hemorrhage in the body and performing hemostasis and the like.
　上記目的を達成するために、本発明に係る医療用バルーンカテーテルは、
遠位端および近位端を備えるカテーテルチューブと、
前記カテーテルチューブの遠位端近傍に設けられ、その内部に流体が注入されることにより膨張する第１バルーンと、
前記カテーテルチューブの前記第１バルーンの近位端側近傍に設けられ、その内部に流体が注入されることにより膨張する第２バルーンとを有し、
前記第１バルーンおよび前記第２バルーンの少なくも一方は、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偏心バルーンである医療用バルーンカテーテルである。 In order to achieve the above object, the medical balloon catheter according to the present invention is
A catheter tube comprising a distal end and a proximal end;
A first balloon disposed near the distal end of the catheter tube and inflated by the fluid being injected therein;
And a second balloon provided near the proximal end side of the first balloon of the catheter tube and inflated by the fluid being injected therein.
At least one of the first balloon and the second balloon is a medical balloon catheter that is an eccentric balloon that expands eccentrically with respect to the axial center of the catheter tube.
　引用文献１に記載の従来技術では、第１バルーンおよび第２バルーンの双方が、球形状、俵形状または茄子形状等、カテーテルの軸心を回転軸とする回転体形状のバルーンとなっているのに対して、本発明に係る医療用バルーンカテーテルでは、第１バルーンおよび第２バルーンの少なくとも一方が、カテーテルチューブの軸心に対して偏心して膨張する偏心バルーンとなっている。なお、以下では、偏心バルーンと区別するため、カテーテルの軸心を回転軸とする回転体形状のバルーン（すなわち、カテーテルチューブの軸心に対して略均等に膨張するバルーン）を、カテーテルの軸心に対して偏心していないバルーンとして、非偏心バルーンという場合がある。 In the prior art described in the cited document 1, both the first balloon and the second balloon are in the form of a rotor having a rotational axis with the axis of the catheter, such as a spherical shape, a wedge shape or a forceps shape. On the other hand, in the medical balloon catheter according to the present invention, at least one of the first balloon and the second balloon is an eccentric balloon that expands eccentrically with respect to the axial center of the catheter tube. In the following, in order to distinguish from the eccentric balloon, a rotor-shaped balloon having the axis of the catheter as the axis of rotation (that is, a balloon that inflates approximately equally to the axis of the catheter tube) As a balloon which is not eccentric with respect to, there may be a case of a non-eccentric balloon.
　非偏心バルーンは、主としてカテーテルの径方向に膨張し、カテーテルの軸心に沿う方向（以下、単に軸心方向という場合がある）へは全くまたは僅かしか膨張しないのに対して、偏心バルーンは該軸心方向に比較的に大きく膨張させることができる。このため、偏心バルーンとこれの近傍に設けられた他のバルーン（非偏心バルーンまたは偏心バルーン）とが膨張されると、該偏心バルーンの該軸心方向の一部と他のバルーンの対応する一部とを互いに近接、当接または圧接させることができる。したがって、このバルーン同士の近接、当接または圧接を利用して、体内における処置（たとえば、乳頭括約筋の切開部を第１バルーンおよび第２バルーンで十二指腸側と総胆管側の両側から挟み込んで圧迫止血する処置）を適正に行うことができる。 The non-eccentric balloon expands mainly in the radial direction of the catheter and inflates only in the direction along the axial center of the catheter (hereinafter sometimes referred to simply as the axial direction), whereas the eccentric balloon It can be expanded relatively large in the axial direction. Therefore, when the eccentric balloon and another balloon (non-ecentric balloon or eccentric balloon) provided in the vicinity of the eccentric balloon are expanded, a part of the eccentric balloon in the axial direction and a corresponding one of the other balloons The parts can be brought close to, in contact with or in pressure contact with one another. Therefore, utilizing the proximity, contact or pressure contact between the balloons, a treatment in the body (for example, an incision in the papillary sphincter is pinched from both sides of the duodenum side and the common bile duct side by the first balloon and the second balloon to perform pressure hemostasis Treatment can be performed properly.
　本発明に係る医療用バルーンカテーテルにおいて、前記第１バルーンを前記カテーテルチューブの軸心に対して均等に膨張する非偏心バルーンとし、前記第２バルーンを前記偏心バルーンとすることができる。これにより、たとえば、十二指腸乳頭部の切開部を止血する場合に、カテーテルチューブの第１バルーンの部分を乳頭部から総胆管側に挿入し、第２バルーンの部分は十二指腸側に配置する。この状態で、両バルーンを膨張させると、第１バルーンによってカテーテルチューブが乳頭の内部で（総胆管側の部分）でアンカリングされ、第２バルーンの遠位端側の一部で、乳頭括約筋の切開部を十二指腸側から圧迫して止血することができる。 In the medical balloon catheter according to the present invention, the first balloon may be a non-eccentric balloon which is uniformly inflated with respect to the axial center of the catheter tube, and the second balloon may be the eccentric balloon. Thus, for example, in the case of stopping the incision of the duodenal papilla, the portion of the first balloon of the catheter tube is inserted from the papilla to the common bile duct side, and the portion of the second balloon is disposed on the duodenum side. In this state, when both balloons are inflated, the first balloon anchors the catheter tube inside the papilla (portion on the side of the common bile duct), and a part of the distal end side of the second balloon, the papillary sphincter muscle The incision can be compressed from the duodenum side to stop bleeding.
　本発明に係る医療用バルーンカテーテルにおいて、前記偏心バルーンは、膨張時に透明または半透明であることが好ましい。このように構成することにより、偏心バルーンの近位端側から遠位端側を視認し得るため、たとえば十二指腸乳頭の切開部（出血部）を該偏心バルーンを介して内視鏡カメラ等で視認しながら、圧迫止血するための処置を行うことができる。 In the medical balloon catheter according to the present invention, the eccentric balloon is preferably transparent or translucent when inflated. With this configuration, the proximal end side to the distal end side of the eccentric balloon can be visually recognized. For example, an incision (bleeding portion) of the duodenal papilla is visually recognized by the endoscopic camera via the eccentric balloon. While doing, it can do the treatment for the pressure hemostasis.
　本発明に係る医療用バルーンカテーテルにおいて、前記カテーテルチューブは、前記第１バルーンおよび前記第２バルーンに流体を供給するために、該第１バルーンおよび該第２バルーンのそれぞれに連通する単一のバルーンルーメンを備えることができる。このように構成することにより、単一のバルーンルーメンで第１バルーンおよび第２バルーンの両者に、これらを膨張させるための流体を供給することができるため、別々に供給する場合と比較して、構成を簡略にできる。 In the medical balloon catheter according to the present invention, the catheter tube is a single balloon in communication with each of the first balloon and the second balloon in order to supply fluid to the first balloon and the second balloon. A lumen can be provided. By configuring in this way, it is possible to supply both the first balloon and the second balloon with a fluid for inflating them with a single balloon lumen, compared to separately supplying Configuration can be simplified.
　この場合において、前記バルーンルーメンの前記第１バルーンに対する通孔と、該バルーンルーメンの前記第２バルーンに対する通孔とを略同径とすることができる。このように構成することにより、遠位端側に位置する第１バルーンが先に膨張し、ある程度膨張した後に近位端側の第２バルーンを膨張させることができる。したがって、たとえば上述したような乳頭括約筋の切開部を圧迫止血する場合に、第１バルーンが先に膨張してアンカリングを行い、次いで第２バルーンが膨張して、両バルーン間で該切開部を圧迫する等の処置を行うことができる。 In this case, the through hole for the first balloon of the balloon lumen and the through hole for the second balloon of the balloon lumen can have substantially the same diameter. With this configuration, the first balloon located on the distal end side can be inflated first, and the second balloon on the proximal end side can be inflated after being inflated to a certain extent. Thus, for example, when compressing the incision of the papillary sphincter muscle as described above, the first balloon is inflated first and anchored, and then the second balloon is inflated to open the incision between the two balloons. Measures such as compression can be performed.
　本発明に係る医療用バルーンカテーテルにおいて、前記カテーテルチューブは、前記第１バルーンに流体を供給する第１バルーンルーメン、および前記第２バルーンに流体を供給する第２バルーンルーメンを備えることができる。上述した単一のバルーンルーメンの場合と比較して、構成は複雑とはなるが、第１バルーンと第２バルーンとを任意に選択して膨張し得るため、乳頭括約筋の切開部の圧迫止血のような圧迫止血だけでなく、他の各種の処置に応用することが可能となる。たとえば、総胆管内の胆石や胆泥等の異物を掻き
出す場合に、総胆管の略直胴の部分の異物は膨張させた非偏心バルーンで掻き出し、総胆管の十二指腸側に凸となる膨らみをもった袋状の部分の異物は膨張させた偏心バルーンで掻き出すようにできる。 In the medical balloon catheter according to the present invention, the catheter tube may include a first balloon lumen that supplies fluid to the first balloon, and a second balloon lumen that supplies fluid to the second balloon. Although the configuration is complicated as compared with the case of the single balloon lumen described above, since the first balloon and the second balloon can be arbitrarily selected and inflated, the compression of the hemostasis at the papillary sphincter incision It becomes possible to apply to other various treatment as well as compression hemostasis. For example, when scraping foreign matter such as gallstone or bile in the common bile duct, the foreign matter in the approximately straight trunk portion of the common bile duct is scratched out by the expanded non-eccentric balloon and has a bulge that becomes convex on the duodenum side of the common bile duct. The foreign matter in the bag-like portion can be scraped off by the inflated eccentric balloon.
　本発明に係る医療用バルーンカテーテルにおいて、前記第１バルーンおよび前記第２バルーンを膨張させた状態で、該第１バルーンの近位端側の一部と、該第２バルーンの遠位端側の一部とが互いに近接、当接または圧接するようにできる。これにより、たとえば、十二指腸乳頭部の切開部を止血する場合に、カテーテルチューブの第１バルーンの部分を十二指腸乳頭から総胆管側に挿入し、第２バルーンの部分は十二指腸側に配置する。この状態で、両バルーンを膨張させると、第１バルーンによってカテーテルチューブが十二指腸乳頭の内部で（総胆管側の部分）でアンカリングされ、第２バルーンの遠位端側の一部と第１バルーンのこれに対応する一部とで、乳頭括約筋を両側から挟み込んで圧迫止血することができる。 In the medical balloon catheter according to the present invention, in a state in which the first balloon and the second balloon are expanded, a part of the proximal end side of the first balloon and a distal end side of the second balloon Some parts can be brought close to, in contact with, or in pressure contact with each other. Thus, for example, in the case of stopping the incision of the duodenal papilla, the portion of the first balloon of the catheter tube is inserted from the duodenal papilla into the common bile duct side, and the portion of the second balloon is placed on the duodenal side. In this state, when both balloons are inflated, the first balloon anchors the catheter tube inside the duodenal papilla (portion on the side of the common bile duct), and a part of the second balloon distal end and the first balloon The papillary sphincter can be pinched from both sides to pressurize the hemostasis.
　本発明に係る医療用バルーンカテーテルにおいて、前記カテーテルチューブは、該カテーテルチューブの軸心に対して偏心して設けられたガイドワイヤルーメンを備え、前記偏心バルーンを、前記ガイドワイヤルーメンが前記カテーテルチューブの軸心に対して偏心する側と反対側に偏心して膨張するように設けることができる。このように構成することにより、先行して体内管腔に挿入されたガイドワイヤに沿ってカテーテルチューブを挿入した際に、またはガイドワイヤをガイドワイヤルーメンに挿入した状態でカテーテルチューブを体内管腔に挿入した際に、カテーテルチューブの進行に伴い該カテーテルチューブが湾曲した状態になると、カテーテルチューブのガイドワイヤルーメンの在る側が該湾曲した部分の半径方向外側となるようにその回転姿勢が矯正される。このため、特に意図的に操作（カテーテルチューブを回転させる操作）を行わなくても、偏心バルーンを該湾曲した部分の内側を指向して膨張するような回転姿勢とすることができ、偏心バルーンの回転姿勢の把握、調整がし易くなる。 In the medical balloon catheter according to the present invention, the catheter tube has a guide wire lumen provided eccentrically with respect to the axial center of the catheter tube, and the eccentric balloon is the shaft of the catheter tube. It can be provided to expand eccentrically on the side opposite to the side eccentric to the center. By this configuration, when the catheter tube is inserted along the guide wire previously inserted into the body lumen, or with the guide wire inserted into the guide wire lumen, the catheter tube is inserted into the body lumen. When inserted, if the catheter tube is in a curved state as the catheter tube advances, its rotational posture is corrected so that the side where the guide wire lumen of the catheter tube is located is the radially outer side of the curved portion . For this reason, the eccentric balloon can be in a rotational posture in which the eccentric balloon is expanded toward the inside of the curved portion without intentionally operating (operation to rotate the catheter tube). It becomes easy to grasp and adjust the rotation attitude.
　この場合において、前記カテーテルチューブを側視型の内視鏡（側視鏡）の処置具案内管に挿通して用いることができる。側視鏡の処置具案内管を介して、ガイドワイヤの誘導の下にカテーテルチューブを十二指腸乳頭部に挿入すると、カテーテルチューブが処置具案内管の出口付近で比較的に大きく湾曲されるため、偏心バルーンが、内視鏡的十二指腸乳頭括約筋切開術で一般的に切開される方向である乳頭括約筋の略１１～１２時方向を指向して膨張するような回転姿勢とすることができる。したがって、偏心バルーンの回転姿勢の調整が容易となる。 In this case, the catheter tube can be used by passing through the treatment instrument guiding tube of the side-viewing endoscope (side endoscope). When the catheter tube is inserted into the duodenal papilla under guidance of a guide wire through the treatment instrument guide tube of the side endoscope, the catheter tube is relatively largely curved near the outlet of the treatment instrument guide tube, so that eccentricity occurs. The balloon can be in a rotational orientation such that it expands in a direction generally approximately 11 to 12 o'clock in the papillary sphincter, which is the direction generally cut in endoscopic duodenal papillary sphincter dissection. Therefore, it becomes easy to adjust the rotational attitude of the eccentric balloon.
　本発明に係る医療用バルーンカテーテルは、前記第１バルーンおよび前記第２バルーンを膨張させた状態で、該第１バルーンの近位端側の一部と、該第２バルーンの遠位端側の一部とで、止血すべき部位を挟んで圧迫止血するために好適に用いることができる。また、本発明に係る医療用バルーンカテーテルは、このような圧迫止血だけでなく、選択的に膨張された前記第１バルーンまたは前記第２バルーンで体内の異物（結石やスラッジ等）を掻き出すためにも好適に用いることができる。 In the medical balloon catheter according to the present invention, when the first balloon and the second balloon are inflated, a part of the proximal end side of the first balloon and a distal end side of the second balloon In part, it can be suitably used to pressurize the hemostasis across the site to be hemostasis. Further, the medical balloon catheter according to the present invention is not only for such pressure-controlled hemostasis, but also for scraping foreign substances (such as calculus and sludge) in the body with the first balloon or the second balloon selectively expanded. Can also be suitably used.
図１は、本発明の実施形態に係る医療用バルーンカテーテルの全体構成を示す平面図である。FIG. 1 is a plan view showing the entire configuration of a medical balloon catheter according to an embodiment of the present invention. 図２は、図１のＩＩ－ＩＩ線に沿った断面図である。FIG. 2 is a cross-sectional view taken along the line II-II of FIG. 図３は、図１に示す医療用バルーンカテーテルの要部を拡大して示す断面図である。FIG. 3 is an enlarged cross-sectional view of the main part of the medical balloon catheter shown in FIG. 図４は、本発明の他の実施形態に係る医療用バルーンカテーテルの全体構成を示す平面図である。FIG. 4 is a plan view showing the entire configuration of a medical balloon catheter according to another embodiment of the present invention. 図５は、図４のＶ－Ｖ線に沿った断面図である。FIG. 5 is a cross-sectional view taken along the line VV of FIG. 図６は、図４に示す医療用バルーンカテーテルの要部を拡大して示す断面図である。FIG. 6 is an enlarged cross-sectional view of the main part of the medical balloon catheter shown in FIG. 図７は、図１に示す医療用バルーンカテーテルを用いた処置の一例を示す図である。FIG. 7 is a view showing an example of treatment using the medical balloon catheter shown in FIG.
　以下、本発明の実施形態を図面に基づいて説明する。本発明に係る医療用バルーンカテーテルは、内視鏡的十二指腸乳頭括約筋切開術（ＥＳＴ）を実施した後の切開部からの出血を止血する処置に好適に用いることができるので、本実施形態では、内視鏡的止血用バルーンカテーテルに本発明を適用した場合を例にとり、説明する。 Hereinafter, embodiments of the present invention will be described based on the drawings. In the present embodiment, the medical balloon catheter according to the present invention can be suitably used to treat hemorrhage from the incision after the endoscopic duodenal papillary sphincterotomy (EST) is performed. The case where the present invention is applied to an endoscopic hemostasis balloon catheter will be described as an example.
　ただし、本発明は、これに限定されず、体内の体腔ないし管腔内で各種の処置を行うためのカテーテルチューブを備える医療用処置具に広く適用可能である。たとえば、体内の体腔ないし管腔（胆管等）内に存在する結石（胆石等）やスラッジ（胆泥等）等の異物を除去する医療用処置具として用いることも可能である。また、本発明は、内視鏡を利用して体内に挿入されて用いられる内視鏡用処置具にも限定されず、内視鏡を用いずに経皮的にあるいは身体の自然口から体内管腔内に挿入されて使用される医療用処置具に広く適用可能である。 However, the present invention is not limited to this, and is widely applicable to a medical treatment instrument provided with a catheter tube for performing various treatments in a body cavity or a lumen in the body. For example, it can be used as a medical treatment tool for removing foreign substances such as calculi (such as gallstones) and sludge (such as bile) existing in a body cavity or lumen (such as bile duct) in the body. Further, the present invention is not limited to a treatment tool for an endoscope which is inserted into the body using an endoscope and used, and the inside of the body percutaneously or from the natural mouth of the body without using the endoscope It is widely applicable to the medical treatment tool used by being inserted in a lumen.
　まず、図１～図３を参照する。本実施形態のバルーンカテーテル１は、カテーテルチューブ２と、第１バルーン３と、第２バルーン４と、カバー５と、２つの枝管（分岐管）６ａ，７ａと、２つのポート６ｂ，７ｂとを概略備えて構成されている。 First, FIG. 1 to FIG. 3 will be referred to. The balloon catheter 1 according to this embodiment includes a catheter tube 2, a first balloon 3, a second balloon 4, a cover 5, two branch pipes (branch pipes) 6a and 7a, and two ports 6b and 7b. It is configured to have an outline.
　カテーテルチューブ２は、可撓性材料によって形成されたチューブであって、体内に挿入される側の端部である遠位端部と、その他端側に位置し、体外に配置される近位端部とを有している。特に限定されないが、カテーテルチューブ２の外径は、１．０～３．０ｍｍ程度であり、全長は、５００～２５００ｍｍ程度である。また、カテーテルチューブ２の材料は、可撓性を有する材料であれば特に限定されないが、高分子材料であることが好ましく、なかでも、ポリアミド樹脂あるいはポリアミド系エラストマーであることが特に好ましい。 The catheter tube 2 is a tube formed of a flexible material, and is a distal end which is an end to be inserted into the body, and a proximal end which is located on the other end side and placed outside the body Have a department. Although not particularly limited, the outer diameter of the catheter tube 2 is about 1.0 to 3.0 mm, and the total length is about 500 to 2500 mm. The material of the catheter tube 2 is not particularly limited as long as it is a flexible material, but is preferably a polymer material, and particularly preferably a polyamide resin or a polyamide-based elastomer.
　カテーテルチューブ２としては、本実施形態では、全長に渡って一様な径を有するチューブを用いているが、挿入性等を考慮して、遠位端部側の所定の区間を近位端部側よりも細径としたものを用いてもよい。カテーテルチューブ２は、本実施形態では、図２および図３に示すように、その内部に、メインルーメン（ガイドワイヤルーメン）２１およびバルーンルーメン２２を有する２ルーメンタイプのものを用いている。 In this embodiment, a tube having a uniform diameter over the entire length is used as the catheter tube 2, but in consideration of insertability etc., a predetermined section on the distal end side is a proximal end The diameter may be smaller than that of the side. In this embodiment, as shown in FIG. 2 and FIG. 3, the catheter tube 2 uses a two-lumen type having a main lumen (guide wire lumen) 21 and a balloon lumen 22 inside.
　メインルーメン２１は、体内管腔内のＸ線造影を行う場合における造影剤用の流路として、体内管腔内に生理食塩水やその他の薬剤を注入するための薬液用の流路として、およびガイドワイヤの挿通に用いることができるルーメンである。ガイドワイヤは、カテーテルチューブ２の挿入経路を確保するために先行して体内管腔に挿入され、あるいはカテーテルチューブ２の体内への挿入時の剛性を確保するためにカテーテルチューブ２のメインルーメン２１に挿入して用いられるものであり、たとえばステンレス等の金属撚り線からなるワイヤを用いることができる。メインルーメン２１は、カテーテルチューブ２の近位端から、カテーテルチューブ２の遠位端の開口２１ａにまで貫通して設けられている。また、メインルーメン２１は、本実施形態では、その軸心がカテーテルチューブ２の軸心に対して偏心して設けられている。 The main lumen 21 is used as a flow path for contrast medium when performing X-ray imaging in a body lumen, as a flow path for medical fluid for injecting saline and other drugs into the body lumen, It is a lumen that can be used to insert a guide wire. The guide wire is previously inserted into the body lumen to secure the insertion path of the catheter tube 2, or to the main lumen 21 of the catheter tube 2 to secure rigidity when the catheter tube 2 is inserted into the body. For example, a wire made of metal strands such as stainless steel can be used. The main lumen 21 is provided to penetrate from the proximal end of the catheter tube 2 to the opening 21 a of the distal end of the catheter tube 2. Further, in the present embodiment, the axis of the main lumen 21 is provided eccentrically with respect to the axis of the catheter tube 2.
　バルーンルーメン２２は、第１バルーン３および第２バルーン４を膨張させるために用いる空気等の流体を第１バルーン３および第２バルーン４の内部に送る（供給する）ための流路となるルーメンである。バルーンルーメン２２は、カテーテルチューブ２の近位端から、遠位端部の第１バルーン３の内側で該第１バルーン３の内部に連通する通孔２２ａにまで至るように設けられている。また、バルーンルーメン２２は、第２バルーン４の内側で該第２バルーン４の内部に連通する通孔２２ｂを介して第２バルーン４の内部に連通している。 The balloon lumen 22 is a lumen serving as a flow path for delivering (supplying) a fluid such as air used to inflate the first balloon 3 and the second balloon 4 into the interior of the first balloon 3 and the second balloon 4. is there. The balloon lumen 22 is provided from the proximal end of the catheter tube 2 to the through hole 22 a communicating with the inside of the first balloon 3 inside the first balloon 3 at the distal end. The balloon lumen 22 communicates with the inside of the second balloon 4 via a through hole 22 b communicating with the inside of the second balloon 4 inside the second balloon 4.
　本実施形態では、バルーンルーメン２２の第１バルーン３に対する通孔２２ａと、バルーンルーメン２２の第２バルーン４に対する通孔２２ｂとは、略同径となるように設定している。通孔２２ａと通孔２２ｂとを同径とすると、第１バルーン３と第２バルーン４とが同一の仕様である場合に、バルーンルーメン２２を介して空気を供給した際に、遠位端側の第１バルーン３が先に膨張し、近位端側の第２バルーン４が後から膨張することが、実験的に確認されている。したがって、たとえばアンカリングのために第１バルーン３を先に膨張させ、第２バルーン４を後から膨張させて圧迫止血する場合等に、都合がよい。ただし、通孔２２ａと通孔２２ｂとを互いに異なる径に設定してもよい。 In the present embodiment, the through holes 22a for the first balloon 3 of the balloon lumen 22 and the through holes 22b for the second balloon 4 of the balloon lumen 22 are set to have substantially the same diameter. Assuming that the through holes 22a and the through holes 22b have the same diameter, when the first balloon 3 and the second balloon 4 have the same specifications, when air is supplied through the balloon lumen 22, the distal end side It is experimentally confirmed that the first balloon 3 of the first balloon 3 inflates first and the second balloon 4 on the proximal end side later inflates. Therefore, it is convenient, for example, in the case where the first balloon 3 is inflated first for anchoring and the second balloon 4 is later inflated to perform compression hemostasis. However, the through holes 22a and the through holes 22b may be set to diameters different from each other.
　なお、カテーテルチューブ２が備えるルーメンの数は、２つに限られず、３つ以上であってもよい。たとえば、造影剤用や薬液用のルーメンをメインルーメン２１とは別に追加してもよい。この場合に、他のルーメンは、メインルーメン２１と同様に、カテーテルチューブ２の遠位端にまで至らせてもよいが、カテーテルチューブ２の途中（たとえば第２バルーン４よりも近位端側近傍部分や第１バルーン３と第２バルーン４との間の部分）の側面に開口を設けて、該開口まで至るように設けられてもよい。また、上記した機能以外の機能を有する他のルーメンを設けてもよい。 The number of lumens provided in the catheter tube 2 is not limited to two, and may be three or more. For example, lumens for contrast agent and medical fluid may be added separately from the main lumen 21. In this case, the other lumens may extend to the distal end of the catheter tube 2 similarly to the main lumen 21, but the middle of the catheter tube 2 (for example, near the proximal end side than the second balloon 4) An opening may be provided on the side or the side of the portion between the first balloon 3 and the second balloon 4 so as to reach the opening. Also, other lumens having functions other than those described above may be provided.
　メインルーメン２１およびバルーンルーメン２２は、図２では、それぞれ略円形として並べて配置しているが、形状および配置はこれに限定されず、それぞれをカテーテルチューブ２内で効率的となるような形状および配置とすることが好ましい。なお、メインルーメン２１の断面積は、カテーテルチューブ２の強度を損なわない範囲でなるべく大きくすることが好ましく、０．０８～０．８ｍｍ２であることが好ましい。バルーンルーメン２２の断面積は、０．０３～０．３ｍｍ２程度である。また、カテーテルチューブ２の断面におけるメインルーメン２１とバルーンルーメン２２との面積比は、５対１～２０対１の範囲内で設定することができる。 The main lumen 21 and the balloon lumen 22 are arranged side by side as substantially circular in FIG. 2 respectively, but the shape and arrangement are not limited to this, and the shape and arrangement so as to be efficient in the catheter tube 2 respectively It is preferable to The cross-sectional area of the main lumen 21 is preferably as large as possible within the range that does not impair the strength of the catheter tube 2 and is preferably 0.08 to 0.8 mm 2 . The cross-sectional area of the balloon lumen 22 is about 0.03 to 0.3 mm 2 . The area ratio of the main lumen 21 to the balloon lumen 22 in the cross section of the catheter tube 2 can be set within the range of 5: 1 to 20: 1.
　第１バルーン３は、その内部に流体（本実施形態では空気）が供給（注入）されることにより膨張し、反対に排出（吸引）されることにより収縮するものであり、カテーテルチューブ２の遠位端近傍であって、通孔２２ａを覆うように取り付けられている。本実施形態では、第１バルーン３は、カテーテルチューブ２の軸心を回転軸とする回転体形状のバルーン（カテーテルの軸心に対して偏心していない非偏心バルーン）である。 The first balloon 3 is expanded by supplying (injecting) a fluid (in the present embodiment, air) into the inside thereof, and is deflated by being discharged (suctioned) on the contrary, It is attached so as to cover the through hole 22a in the vicinity of the lateral end. In the present embodiment, the first balloon 3 is a rotor-shaped balloon (a non-decentered balloon which is not eccentric to the axial center of the catheter) having the axis of the catheter tube 2 as the rotation axis.
　第２バルーン４は、その内部に流体（本実施形態では空気）が供給（注入）されることにより膨張し、反対に排出（吸引）されることにより収縮するものであり、カテーテルチューブ２の第１バルーン３よりも近位端側近傍であって、通孔２２ｂを覆うように取り付けられている。本実施形態では、第２バルーン４は、カテーテルチューブ２の軸心に対して偏心して膨張する偏心バルーンである。偏心バルーンは、非偏心バルーンと比較して、カテーテルチューブ２の軸心方向に比較的に大きく膨張させることができる。 The second balloon 4 is expanded by supplying (injecting) a fluid (in this embodiment, air) into the inside thereof, and contracting by being discharged (suctioned) on the contrary, It is attached near the proximal end side than 1 balloon 3 so that the through-hole 22b may be covered. In the present embodiment, the second balloon 4 is an eccentric balloon that expands eccentrically with respect to the axial center of the catheter tube 2. The eccentric balloon can be expanded relatively large in the axial direction of the catheter tube 2 as compared to the non-eccentric balloon.
　バルーン３，４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。１００％モジュラスが小さすぎると、バルーン３，４の強度が不足するおそれがあり、大きすぎると、バルーン３，４を十分な大きさに膨張できなくなるおそれがある。また、バルーン３，４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 stretchable material for forming the balloons 3 and 4, one having a 100% modulus (value measured according to JIS K 6251) of 0.1 to 10 MPa is preferable, and one having 1 to 5 MPa is particularly preferable. . If the 100% modulus is too small, the strength of the balloons 3 and 4 may be insufficient, and if it is too large, the balloons 3 and 4 may not be able to expand to a sufficient size. Further, specific examples of stretchable materials suitable for forming the balloons 3 and 4 include natural rubber, silicone rubber, polyurethane elastomer and the like.
　本実施形態では、バルーン３，４としては、基本的に同じ仕様（構成、形状）のものを用いており、これらは収縮した状態で全体として筒状であり、その両端部にカテーテルチューブ２の外周面と接合される略円筒状の接合部３ａ，３ｂ，４ａ，４ｂが形成されていて、その両端の接合部３ａ，３ｂ，４ａ，４ｂの間には、内部に流体が導入されることにより膨張する膨張部３ｃ，４ｃが形成されている。このバルーン３，４の膨張部３ｃ，４ｃは、外力を受けない状態において、カテーテルチューブ２の軸心を回転軸としてカテーテルチューブ２の外方に向かって凸の曲線を回転させてなる回転体形状に形成されている。なお、バルーン３，４の接合部３ａ，３ｂ，４ａ，４ｂとカテーテルチューブ２とを接合する手法は、特に限定されず、たとえば、接着剤による接着、熱融着、溶剤による溶着、超音波溶着などを挙げることができる。 In the present embodiment, the balloons 3 and 4 basically have the same specifications (configurations and shapes), and they are generally cylindrical in a contracted state, and both ends of the catheter tube 2 are used. A substantially cylindrical joint portion 3a, 3b, 4a, 4b joined to the outer peripheral surface is formed, and a fluid is introduced into the space between the joint portions 3a, 3b, 4a, 4b at both ends thereof. Thus, expansion portions 3c and 4c are formed to expand. The expanded portions 3c and 4c of the balloons 3 and 4 are rotating body shapes formed by rotating a convex curve outward of the catheter tube 2 with the axial center of the catheter tube 2 as a rotation axis without receiving external force. Is formed. In addition, the method to join the junction parts 3a, 3b, 4a, 4b of the balloons 3 and 4 and the catheter tube 2 is not particularly limited. For example, adhesion by adhesive, heat fusion, welding by solvent, ultrasonic welding And the like.
　バルーン３，４の膨張部３ｃ，４ｃは、膨らんだ状態での最大外径が、萎んだ状態での最小外径の１１０～２００％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３，４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、バルーンカテーテル１を体内に挿入する際にバルーン３，４が邪魔になるおそれがある。また、バルーン３，４における膨張部３ｃ，４ｃの長さ（カテーテルチューブ２の軸方向に沿った長さ）は、５～２０ｍｍが好ましく、肉厚は、０．１０～０．５０ｍｍであることが好ましい。バルーン３，４の肉厚は、周方向に沿って均一であることが好ましい。 The expanded portions 3c and 4c of the balloons 3 and 4 preferably have a maximum outer diameter in the inflated state of 110 to 200% of the minimum outer diameter in the deflated state. If this ratio is too small, the balloons 3 and 4 may not expand to a sufficient size, and if too large, the balloons 3 and 4 may be in the way when the balloon catheter 1 is inserted into the body. Further, the length (length along the axial direction of the catheter tube 2) of the expansion portions 3c and 4c in the balloons 3 and 4 is preferably 5 to 20 mm, and the thickness is 0.10 to 0.50 mm. Is preferred. The thickness of the balloons 3 and 4 is preferably uniform along the circumferential direction.
　上述したような形状を有するバルーン３，４を製造する方法は特に限定されず、伸縮性材料の製膜方法として公知の方法を用いればよいが、ディッピング成形法を用いることが好ましい。ディッピング成形法では、伸縮性材料と必要に応じて各種添加剤を溶剤に溶解して溶液あるいは懸濁液とし、この溶液（懸濁液）に所望するバルーンの形状と略等しい外形を有する型を浸漬させて型の表面に溶液（懸濁液）を塗布し、溶剤を蒸発させて型の表面に被膜を形成させる。この浸漬と乾燥を繰り返すことにより所望の肉厚を有するバルーンを製膜することができる。なお、伸縮性材料の種類により、必要に応じて、製膜後、架橋を行う。 The method for producing the balloons 3 and 4 having the shape as described above is not particularly limited, and a known method may be used as a film forming method of the stretchable material, but it is preferable to use the dipping molding method. In the dipping molding method, the stretchable material and, if necessary, various additives are dissolved in a solvent to form a solution or a suspension, and the solution (suspension) has a mold having an outer shape substantially equal to the desired balloon shape. Immerse and apply a solution (suspension) to the surface of the mold and evaporate the solvent to form a film on the surface of the mold. A balloon having a desired thickness can be formed by repeating this immersion and drying. In addition, depending on the type of stretchable material, crosslinking is carried out after film formation, if necessary.
　本実施形態では、第２バルーン４のみを偏心して膨張させるため、その長手方向に沿って、第２バルーン４の上から当該第２バルーン４の周方向の一部をカテーテルチューブ２に対して固定するための固定用テープ４１が貼り付けてある。固定用テープ４１は、バルーン４の軸方向長さよりも長く、テープ４１の両端がカテーテルチューブ２の外周面に固定してある。 In the present embodiment, in order to expand only the second balloon 4 eccentrically, a part of the second balloon 4 in the circumferential direction from above the second balloon 4 is fixed to the catheter tube 2 along the longitudinal direction thereof. A fixing tape 41 for attaching is attached. The fixing tape 41 is longer than the axial length of the balloon 4, and both ends of the tape 41 are fixed to the outer peripheral surface of the catheter tube 2.
　固定用テープ４１の材質としては、特に限定されず、カテーテルチューブ２を構成する樹脂と同様な樹脂で構成される。固定用テープ４１の両端の固定方法は、特に限定されず、接着、熱融着、高周波融着などを挙げることができる。たとえば接着方法の場合、テープ４１の裏面には、接着剤（粘着剤）が塗布してあり、バルーン４の周方向一部とカテーテルチューブ２の一部に接着するようになっている。 The material of the fixing tape 41 is not particularly limited, and is made of the same resin as the resin constituting the catheter tube 2. The fixing method of the both ends of the fixing tape 41 is not particularly limited, and adhesion, heat fusion, high frequency fusion and the like can be mentioned. For example, in the case of the bonding method, an adhesive (adhesive) is applied to the back surface of the tape 41 so as to adhere to a part of the balloon 4 in the circumferential direction and a part of the catheter tube 2.
　固定用テープ４１の幅は、カテーテルチューブ２の外周における円周方向長さの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４の上から当該バルーン４の周方向の一部をカテーテルチューブ２に対して固定する機能が小さくなり、幅が大きすぎると、バルーン４を偏心させて膨らませることが困難になる。 The width of the fixing tape 41 is 1/2 or less of the circumferential length at the outer periphery of the catheter tube 2, and preferably 1/3 to 1/5. If this width is too small, the function of fixing a part of the balloon 4 in the circumferential direction from the top of the balloon 4 to the catheter tube 2 becomes small, and if the width is too large, the balloon 4 is eccentrically inflated and inflated. Will be difficult.
　本実施形態では、バルーン４の上から当該バルーン４の周方向の一部をカテーテルチューブ５に対して固定するための固定用テープ４１が貼り付けてあるので、図３に示すように、バルーン４の膨張部４ｃがカテーテルチューブ２の軸心に対して偏心して膨張する。カテーテルチューブ２の軸心に対する膨張部の膨張中心の偏心量は、膨張部の膨張半径に対して、好ましくは５０～１００％、さらに好ましくは７５～１００％である。なお、バルーン４は、その横断面において、完全に円形に膨張する必要はなく、楕円形、その他の形状に膨張してもよい。 In this embodiment, since the fixing tape 41 for fixing a part of the balloon 4 in the circumferential direction to the catheter tube 5 is attached from above the balloon 4, as shown in FIG. The inflating portion 4 c inflates eccentrically with respect to the axial center of the catheter tube 2. The amount of eccentricity of the expansion center of the expansion portion with respect to the axial center of the catheter tube 2 is preferably 50 to 100%, more preferably 75 to 100% with respect to the expansion radius of the expansion portion. The balloon 4 does not have to be completely circularly expanded in its cross section, and may be expanded in an elliptical or other shape.
　また、バルーン４は、ガイドワイヤルーメン２１の軸心がカテーテルチューブ２の軸心に対して偏心する側と反対側に偏心して膨張するように、カテーテルチューブ２に取り付けられている。すなわち、固定用テープ４１は、ガイドワイヤルーメン２１の軸心がカテーテルチューブ２の軸心に対して偏心する側と同じ側に貼り付けられている。 Further, the balloon 4 is attached to the catheter tube 2 such that the axial center of the guide wire lumen 21 is expanded eccentrically on the opposite side to the side eccentric to the axial center of the catheter tube 2. That is, the fixing tape 41 is attached to the same side as the side where the axial center of the guide wire lumen 21 is eccentric to the axial center of the catheter tube 2.
　さらに、本実施形態では、第１バルーン３および第２バルーン４は、それぞれを膨張させた状態において、第１バルーン３の近位端側の一部と、第２バルーン４の遠位端側の一部とが互いに近接するように配置されている。ただし、第１バルーン３および第２バルーン４は、それぞれを膨張させた状態において、第１バルーン３の近位端側の一部と、第２バルーン４の遠位端側の一部とが互いに当接または圧接するように配置してもよい。これらは、圧迫止血する部位に応じて、適宜に設定することができる。 Furthermore, in the present embodiment, the first balloon 3 and the second balloon 4 in a state in which they are respectively inflated, a part of the proximal end side of the first balloon 3 and a distal end side of the second balloon 4 The parts are arranged to be close to each other. However, in the state where each of the first balloon 3 and the second balloon 4 is inflated, a part on the proximal end side of the first balloon 3 and a part on the distal end side of the second balloon 4 mutually You may arrange | position so that it may contact | abut or press-contact. These can be suitably set according to the area | region which carries out the pressure stop hemostasis.
　また、偏心バルーンである第２バルーン４は、少なくとも膨張時において、透明または半透明であることが好ましい。半透明の場合には、第２バルーン４は、少なくとも膨張時において、該第２バルーン４の近位端側から、該第２バルーン４の遠位端側が視認し得る程度の透明度とすることが好ましい。このようにすることで、第２バルーン４を介して、内視鏡のカメラで乳頭括約筋の切開部を視認しながら、圧迫止血のための処置を行うことができ、出血の状況を確認しながら処置することができる。このような透明または半透明なバルーンの材料としては、収縮時および膨張時の両方において、透明または半透明である素材を用いることができる。ただし、収縮時には透明または半透明でなくても、膨張時にはバルーンの膜厚が薄くなるので、その薄くなった状態で透明または半透明となるような素材であればよい。 The second balloon 4 which is an eccentric balloon is preferably transparent or translucent at least at the time of inflation. In the case of translucent, the second balloon 4 has transparency such that the distal end side of the second balloon 4 can be seen from the proximal end side of the second balloon 4 at least when inflated. preferable. In this way, while observing the incision of the papillary sphincter with the camera of the endoscope through the second balloon 4, treatment for compression hemostasis can be performed, while confirming the state of bleeding. It can be treated. As such a transparent or translucent balloon material, a material that is transparent or translucent can be used both at the time of deflation and at the time of inflation. However, even if the material is not transparent or translucent at the time of contraction, since the film thickness of the balloon becomes thin at the time of inflation, any material may be used as long as it becomes transparent or translucent in the thin state.
　図１において、カテーテルチューブ２の近位端側には、カバー５の部分において、枝管６ａ，６ｂが接続されている。枝管６ａは、その遠位端がメインルーメン２１に接続されたチューブであり、枝管７ａは、その遠位端がバルーンルーメン２２に接続されたチューブである。枝管６ａ，７ａの材質としては、特に限定されないが、高分子材料を用いることが好ましい。 In FIG. 1, branch pipes 6 a and 6 b are connected to the proximal end side of the catheter tube 2 at a portion of the cover 5. The branch pipe 6 a is a tube whose distal end is connected to the main lumen 21, and the branch pipe 7 a is a tube whose distal end is connected to the balloon lumen 22. The material of the branch pipes 6a and 7a is not particularly limited, but it is preferable to use a polymer material.
　枝管６ａの近位端にはポート６ｂが、枝管７ａの近位端には、ポート７ｂが接続されている。ポート６ｂにはシリンジ等を接続して、造影剤もしくは薬液等をメインルーメン２１に送り込めるようになっている。また、ポート６ｂの開口からガイドワイヤを挿入して、メインルーメン２１内に挿通することもできるようになっている。ポート７ｂにはシリンジ等を接続して、バルーン３，４を膨張させるための流体（本実施形態では、空気）をバルーンルーメン２２に送り込めるようになっている。 The port 6b is connected to the proximal end of the branch pipe 6a, and the port 7b is connected to the proximal end of the branch pipe 7a. A syringe or the like is connected to the port 6 b so that a contrast agent or a drug solution can be sent to the main lumen 21. In addition, a guide wire can be inserted from the opening of the port 6 b and inserted into the main lumen 21. A syringe or the like is connected to the port 7 b so that fluid (in the present embodiment, air) for inflating the balloons 3 and 4 can be sent to the balloon lumen 22.
　ポート６ｂ，７ｂの材質としては、特に限定されないが、透明な高分子材料を用いることが好ましい。なお、枝管６ａ，７ａとカテーテルチューブ２の各ルーメン２１，２２との接続方法は、特に限定されないが、たとえば、枝管６ａ，７ａの遠位端部をテーパー状に成形し、その外周面に接着剤を塗布して、その端部をカテーテルチューブ２の対応するルーメン２１，２２に挿入することにより、接着すればよい。 The material of the ports 6 b and 7 b is not particularly limited, but it is preferable to use a transparent polymer material. The method of connecting the branch pipes 6a, 7a and the respective lumens 21, 22 of the catheter tube 2 is not particularly limited. For example, the distal end of the branch pipes 6a, 7a is formed into a tapered shape, and the outer peripheral surface thereof An adhesive may be applied to the tube and glued by inserting its end into the corresponding lumens 21 and 22 of the catheter tube 2.
　カテーテルチューブ２と各枝管６ａ，７ａとの接続部は、カバー５で補強されるとともに、保護されている。カバー５は、カテーテルチューブ２と枝管６ａ，７ａとの接続部を覆うように設けられる。カバー５の形状は特に限定されないが、通常、箱型あるいは筒型である。カバー５の材質としては、特に限定されないが、高分子材料を用いることが好ましい。また、熱収縮チューブをカバー５として用いることも可能である。 The connection between the catheter tube 2 and the branch pipes 6a, 7a is reinforced by the cover 5 and protected. The cover 5 is provided to cover the connection between the catheter tube 2 and the branch pipes 6a and 7a. The shape of the cover 5 is not particularly limited, but is usually a box or a cylinder. The material of the cover 5 is not particularly limited, but it is preferable to use a polymer material. It is also possible to use a heat shrinkable tube as the cover 5.
　次に、本実施形態のバルーンカテーテル１の使用例として、内視鏡的十二指腸乳頭括約筋切開術（ＥＳＴ）を実施した後の切開部からの出血を止血する処置について、図７を参照して概説する。 Next, as an example of use of the balloon catheter 1 according to this embodiment, a procedure for hemostasis of hemorrhage from an incision after performing endoscopic duodenal papillary sphincterotomy (EST) is outlined with reference to FIG. Do.
　まず、不図示の内視鏡（側視鏡）を十二指腸内の乳頭付近まで挿入しておき、ポート６ｂおよび枝管６ａを介してメインルーメン２１にガイドワイヤを挿入するとともに、バルーン３，４を膨張させない状態で、カテーテルチューブ２の遠位端側から、内視鏡のチャネル（処置具案内管）を介して、バルーンカテーテル１のカテーテルチューブ２を挿入する。次いで、カテーテルチューブ２の遠位端をガイドワイヤと共に乳頭から胆管内に挿入し、第１バルーン３が乳頭部の内側（総胆管側）に、第２バルーン４が該乳頭部の外側（十二指腸側）に配置されるまで、カテーテルチューブ２を押し進める。なお、ガイドワイヤを先行して挿入しておき、これに沿わせてカテーテルチューブ２を挿入するようにしてもよい。 First, an endoscope (a side endoscope) (not shown) is inserted to the vicinity of the papilla in the duodenum, and a guide wire is inserted into the main lumen 21 via the port 6b and the branch pipe 6a. In the non-inflated state, the catheter tube 2 of the balloon catheter 1 is inserted from the distal end side of the catheter tube 2 through the channel (treatment tool guide tube) of the endoscope. Then, the distal end of the catheter tube 2 is inserted into the bile duct through the nipple with the guide wire, and the first balloon 3 is on the inside of the nipple (in the common bile duct side) and the second balloon 4 is on the outside of the nipple Push the catheter tube 2 until it is placed in). The guide wire may be inserted in advance, and the catheter tube 2 may be inserted along the guide wire.
　ガイドワイヤおよびカテーテルチューブ２は、内視鏡のチャネルの開口から押し出される際に大きく湾曲して乳頭から総胆管内に挿入される。このとき、メインルーメン２１はカテーテルチューブ２の軸心に対して偏心して設けられているため、カテーテルチューブ２のメインルーメン２１の在る側が当該湾曲部の半径方向外側となるように、該カテーテルチューブ２の回転姿勢が矯正される。そして、第２バルーン４は、メインルーメン２１がカテーテルチューブ２の軸心に対して偏心する側と反対側に偏心して膨張するように設けられているため、第２バルーン４は、当該湾曲部の半径方向内側を指向して膨張するような回転姿勢となる。その結果、第２バルーン４は、内視鏡的十二指腸乳頭括約筋切開術で一般的に切開される方向である略１１～１２時方向を指向して膨張するような回転姿勢となる。 The guide wire and the catheter tube 2 are greatly curved and inserted from the nipple into the common bile duct when pushed out from the opening of the channel of the endoscope. At this time, since the main lumen 21 is provided eccentrically with respect to the axial center of the catheter tube 2, the catheter tube 2 is disposed so that the side where the main lumen 21 is located is the outer side in the radial direction of the curved portion. 2 rotation posture is corrected. And since the second balloon 4 is provided so that the main lumen 21 is eccentrically expanded on the opposite side to the side eccentric to the axial center of the catheter tube 2, the second balloon 4 is a part of the curved portion. The rotational attitude is such that it expands radially inward. As a result, the second balloon 4 is in a rotational posture in which the second balloon 4 expands in a direction of approximately 11 to 12 o'clock, which is a direction generally cut in endoscopic duodenal papillary sphincter incision.
　次いで、ポート７ｂに接続したシリンジを押圧して、ポート７ｂ、枝管７ａ、バルーンルーメン２２を介して、空気を送り込む。これにより、第１バルーン３が先に膨張し、乳頭部の内側（総胆管側）でカテーテルチューブ２がアンカリングされ、僅かな時間差をもって、その後に第２バルーン４が乳頭部の外側（十二指腸側）で膨張する。第２バルーン４は偏心バルーンであるため、カテーテルチューブ２に対して径方向のみならず、軸心方向にも比較的に大きく膨張するため、第２バルーン４の遠位端側の部分により乳頭括約筋の切開部（略１１～１２時方向の部分）を乳頭部の外側（十二指腸側）から内側（総胆管側）に圧迫することができる。このとき、乳頭部の内側に第１バルーン３がアンカリングされているため、乳頭括約筋の切開部は、第２バルーン４の遠位端側の部分と第１バルーン３の近位端側のこれに対応する部分とで挟み込まれて圧迫止血される。 Then, the syringe connected to the port 7b is pressed to send air through the port 7b, the branch pipe 7a, and the balloon lumen 22. As a result, the first balloon 3 is inflated first, and the catheter tube 2 is anchored on the inside of the papilla (the side of the common bile duct), and with a slight time difference, the second balloon 4 is then placed on the outside of the papilla (duodenal side). Expand with). Since the second balloon 4 is an eccentric balloon, it expands relatively relatively not only in the radial direction but also in the axial direction with respect to the catheter tube 2, so the distal end side portion of the second balloon 4 An incision (approximately 11 to 12 o'clock direction) can be compressed from the outer side (duodenal side) to the inner side (general bile duct side) of the papilla. At this time, since the first balloon 3 is anchored to the inside of the papilla, the incision portion of the papillary sphincter is a portion at the distal end side of the second balloon 4 and the proximal end side of the first balloon 3 It is pinched by the part corresponding to, and it is compressed hemostasis.
　上述した実施形態では、遠位端側の第１バルーン３を非偏心バルーンとし、近位端側の第２バルーン４を、カテーテルチューブ２の軸心方向に比較的に大きく膨張させることができる偏心バルーンとしている。これにより、カテーテルチューブ２の第１バルーン３の部分を十二指腸乳頭から総胆管側に挿入し、第２バルーン４の部分は十二指腸側に配置して、両バルーン３，４を膨張させると、第１バルーン３によってカテーテルチューブ２が十二指腸乳頭の内部（総胆管側の部分）でアンカリング（位置が固定）され、第２バルーン４の遠位端側の一部で、乳頭括約筋を十二指腸側から圧迫して止血することができる。ただし、本発明はこれに限定されず、第１バルーン３を偏心バルーンとし、第２バルーン４を非偏心バルーンとしてもよいし、第１バルーン３および第２バルーン４の両者を偏心バルーンとしてもよい。 In the embodiment described above, the first balloon 3 on the distal end side is a non-eccentric balloon, and the second balloon 4 on the proximal end side can be expanded relatively largely in the axial center direction of the catheter tube 2 It is a balloon. Thereby, when the portion of the first balloon 3 of the catheter tube 2 is inserted from the duodenal papilla into the common bile duct side, the portion of the second balloon 4 is disposed on the duodenum side, and both balloons 3 and 4 are expanded, the first The catheter tube 2 is anchored (the position is fixed) inside the duodenal papilla (portion fixed to the common bile duct) by the balloon 3 and the papillary sphincter is compressed from the duodenum side by a part of the distal end side of the second balloon 4 Can stop bleeding. However, the present invention is not limited to this, the first balloon 3 may be an eccentric balloon, the second balloon 4 may be a non-eccentric balloon, or both the first balloon 3 and the second balloon 4 may be eccentric balloons. .
　また、上述した実施形態では、第１バルーン３および第２バルーン４を膨張させた状態で、第２バルーンの遠位端側の一部が、第１バルーン３の近位端側の一部に近接するように構成しているので、両バルーンを膨張させた際に、第２バルーン４の遠位端側の一部と第１バルーン３のこれに対応する一部とで、乳頭括約筋を両側から挟み込んで圧迫止血することができる。膨張時における第２バルーン４の遠位端側の一部と第１バルーン３のこれに対応する一部との近接の程度は、挟み込んで圧迫する部位の厚さ（ここでは、乳頭括約筋の厚さ）に応じて、適切に圧迫し得る程度に設定される。なお、第２バルーン４の遠位端側の一部が、第１バルーン３の近位端側のこれに対応する一部に、当接または圧接するように構成してもよい。 Further, in the embodiment described above, when the first balloon 3 and the second balloon 4 are inflated, a part of the distal end side of the second balloon is a part of the proximal end side of the first balloon 3 Since it is configured to be close to each other, when expanding both balloons, the papillary sphincter is formed on both sides by a part of the distal end side of the second balloon 4 and a corresponding part of the first balloon 3 It is possible to put pressure on it and press down on it to stop bleeding. The degree of proximity of a portion on the distal end side of the second balloon 4 and a corresponding portion of the first balloon 3 at the time of inflation is the thickness of the site to be pinched and compressed (here, the thickness of the papillary sphincter muscle Is set to an extent that can be appropriately compressed. A part of the distal end side of the second balloon 4 may be configured to abut or press against a part corresponding to the proximal end side of the first balloon 3.
　これとは逆に、第２バルーン４の遠位端側の一部と、第１バルーン３の近位端側のこれに対応する一部とが、ある程度離間するように構成してもよい。この場合には、両バルーン３，４で乳頭括約筋を挟み込んで圧迫することはできないが、第１バルーン３が総胆管内でアンカリングされるため、第２バルーン４の遠位端側の一部で、該乳頭括約筋を外側（十二指腸側）から押圧（圧迫）して止血することは可能である。 Conversely, a part of the distal end of the second balloon 4 and a corresponding part of the proximal end of the first balloon 3 may be configured to be separated to some extent. In this case, although it is not possible to sandwich and compress the papillary sphincter with both balloons 3 and 4, since the first balloon 3 is anchored in the common bile duct, a part of the distal end side of the second balloon 4 Then, it is possible to press against (pressure) the papillary sphincter from the outside (duodenal side) to stop bleeding.
　また、上述した実施形態では、第２バルーン４として、膨張時に透明または半透明であるものを用いているので、第２バルーン４を通して、その近位端側から遠位端側を視認し得るため、十二指腸乳頭の切開部（出血部）を、十二指腸側から内視鏡カメラ等を介して視認しながら、圧迫止血するための処置を行うことができる。 Moreover, in the embodiment described above, since the second balloon 4 which is transparent or translucent at the time of inflation is used, the second balloon 4 can be seen through the second balloon 4 from the proximal end side to the distal end side. A treatment for pressing and stopping the hemostasis can be performed while visually recognizing the incision (bleeding portion) of the duodenal papilla from the duodenum side via an endoscopic camera or the like.
　さらに、上述した実施形態では、カテーテルチューブ２として、第１バルーン３および第２バルーン４に流体を供給するために、これらのそれぞれに連通する単一のバルーンルーメン２２を備えるものを用いている。単一のバルーンルーメン２２で第１バルーンおよび第２バルーンの両者に、これらを膨張させるための空気を供給することができるため、別々に供給する場合と比較して、構成が簡略である。 Furthermore, in the embodiment described above, in order to supply fluid to the first balloon 3 and the second balloon 4 as the catheter tube 2, one having a single balloon lumen 22 in communication with each of these is used. The single balloon lumen 22 can supply air for inflating both the first balloon and the second balloon, so that the configuration is simplified as compared with the case of supplying them separately.
　また、バルーンルーメン２２の第１バルーン３に対する通孔２２ａと、バルーンルーメン２２の第２バルーン４に対する通孔２２ｂとを略同径として、遠位端側に位置する第１バルーン３を先に膨張させ、ある程度膨張した後に近位端側の第２バルーン４を膨張させるようにしている。これにより、乳頭括約筋の切開部を圧迫止血する場合に、第１バルーン３が先に膨張してアンカリングを行い、次いで第２バルーン４が膨張して、両バルーン３，４間で該切開部を圧迫する等の処置を行うことができる。単一のバルーンルーメン２２で、このような時間差によるバルーンの膨張を実現している。 Further, the first balloon 3 located on the distal end side is inflated first, with the through hole 22a for the first balloon 3 of the balloon lumen 22 and the through hole 22b for the second balloon 4 of the balloon lumen 22 having substantially the same diameter. And the second balloon 4 on the proximal end side is inflated after being inflated to a certain extent. As a result, in the case where the incision of the papillary sphincter is compressed and hemostasis is performed, the first balloon 3 is first inflated and anchored, and then the second balloon 4 is inflated, and the incision is made between the two balloons 3 and 4. Treatment such as squeezing A single balloon lumen 22 achieves such time difference balloon inflation.
　また、上述した実施形態では、カテーテルチューブ２として、カテーテルチューブ２の軸心に対して偏心して設けられ、ガイドワイヤルーメンとして用いることができるメインルーメン２１を備え、偏心バルーンである第２バルーン４を、メインルーメン２１がカテーテルチューブ２の軸心に対して偏心する側と反対側に偏心して膨張するように設けている。側視鏡の処置具案内管を介して、ガイドワイヤの誘導の下にカテーテルチューブ２を十二指腸乳頭部に挿入すると、カテーテルチューブ２が処置具案内管の出口付近で比較的に大きく湾曲されるため、カテーテルチューブ２のメインルーメン２１の在る側が該湾曲した部分の半径方向外側となるようにその回転姿勢が矯正される。すなわち、特に意図的に操作（カテーテルチューブを回転させる操作）を行わなくても、第２バルーン４が、内視鏡的十二指腸乳頭括約筋切開術で一般的に切開される方向である略１１～１２時方向を指向して膨張するような回転姿勢となるように自動的に矯正される。このため、乳頭括約筋の切開部の圧迫止血のための処置を高効率的に行うことができる。 Further, in the embodiment described above, the second balloon 4 which is an eccentric balloon is provided with the main lumen 21 which is provided eccentrically with respect to the axial center of the catheter tube 2 and can be used as a guide wire lumen. The main lumen 21 is provided so as to expand eccentrically on the opposite side to the side eccentric to the axial center of the catheter tube 2. When the catheter tube 2 is inserted into the duodenal papilla under guidance of a guide wire through the treatment instrument guide tube of the side endoscope, the catheter tube 2 is relatively largely curved near the outlet of the treatment instrument guide tube. The rotational posture is corrected such that the main lumen 21 side of the catheter tube 2 is radially outside of the curved portion. That is, even if the operation (operation to rotate the catheter tube) is not particularly performed intentionally, the second balloon 4 is in a direction generally cut in the endoscopic duodenal papillary sphincter incision approximately 11 to 12 It is automatically corrected to become a rotational posture that expands in a time direction. For this reason, the treatment for pressing and stopping the incision of the papillary sphincter can be performed highly efficiently.
　なお、上述した実施形態では、単一のバルーンルーメン２２により、第１バルーン３および第２バルーン４の両者を膨張させるようにしているが、第１バルーン３を膨張させるバルーンルーメンと、第２バルーン４を膨張させるバルーンルーメンとを、図４～図６に示すように、互いに独立して別々に設けてもよい。すなわち、図４～図６に示す構成では、カテーテルチューブ２は、第１バルーン３に流体を供給する第１バルーンルーメン２３、および第２バルーン４に流体を供給する第２バルーンルーメン２４を備えている。 In the embodiment described above, both the first balloon 3 and the second balloon 4 are inflated by the single balloon lumen 22. However, the balloon lumen for inflating the first balloon 3 and the second balloon The balloon lumens that inflate 4 may be provided separately and independently of one another, as shown in FIGS. That is, in the configuration shown in FIGS. 4 to 6, the catheter tube 2 has a first balloon lumen 23 supplying fluid to the first balloon 3 and a second balloon lumen 24 supplying fluid to the second balloon 4. There is.
　第１バルーンルーメン２３は、カテーテルチューブ２の近位端から、遠位端部の第１バルーン３の内側で該第１バルーン３の内部に連通する通孔２３ａにまで至るように設けられている。また、第２バルーンルーメン２４は、カテーテルチューブ２の近位端から、遠位端部の第２バルーン４の内側で該第２バルーン４の内部に連通する通孔２４ａにまで至るように設けられている。 The first balloon lumen 23 is provided from the proximal end of the catheter tube 2 to a through hole 23a communicating with the inside of the first balloon 3 inside the first balloon 3 at the distal end. . Also, the second balloon lumen 24 is provided from the proximal end of the catheter tube 2 to the through hole 24 a communicating with the inside of the second balloon 4 inside the second balloon 4 at the distal end. ing.
　これに伴い、カテーテルチューブ２の近位端側において、第１バルーンルーメン２３に連通するチューブからなる枝管８ａおよびポート８ｂを、第２バルーンルーメン２４に連通するチューブからなる枝管９ａおよびポート９ｂを設けている。これらの枝管８ａ，９ａおよびポート８ｂ，９ｂは、図１に示した上述の枝管７ａおよびポート７ｂと同様の構成である。ポート８ｂにシリンジ等を接続して、バルーン３を膨張させるための流体（本実施形態では、空気）を第１バルーンルーメン２３に、ポート９ｂにシリンジ等を接続して、バルーン４を膨張させるための流体（本実施形態では、空気）を第２バルーンルーメン２４に送り込めるようになっている。 Along with this, on the proximal end side of the catheter tube 2, the branch pipe 8a and the port 8b consisting of a tube communicating with the first balloon lumen 23 and the branch pipe 9a and a port 9b consisting of a tube communicating with the second balloon lumen 24 Is provided. The branch pipes 8a and 9a and the ports 8b and 9b have the same configuration as the above-described branch pipe 7a and port 7b shown in FIG. A syringe or the like is connected to the port 8b, and a fluid (in the present embodiment, air) for inflating the balloon 3 is connected to the first balloon lumen 23, and a syringe or the like is connected to the port 9b to inflate the balloon 4 Fluid (in this embodiment, air) can be fed to the second balloon lumen 24.
　図１～図３に示した上述の単一のバルーンルーメン２２を設けた場合と比較して、構成は複雑とはなるが、第１バルーン３と第２バルーン４とを任意に選択して膨張し得るため、第１バルーン３の膨張と第２バルーン４の膨張のタイミングを自在に調整することができ、乳頭括約筋の切開部を圧迫止血する場合に便宜であるだけでなく、他の各種の処置に応用することが可能となる。たとえば、総胆管内の胆石や胆泥等の異物を掻き出す処置に応用した場合に、総胆管の略直胴の部分の異物は、第２バルーン４を収縮させたまま第１バルーン３を膨張させて、膨張した第１バルーン３で掻き出し、総胆管の十二指腸側に凸となる膨らみをもった袋状の部分の異物は、第１バルーン３を収縮させたまま第２バルーン４を膨張させて、膨張した第２バルーン４で掻き出すことができる等、各種の処置に柔軟に対応することができる。 Although the structure becomes complicated as compared with the case where the above-described single balloon lumen 22 shown in FIGS. 1 to 3 is provided, the first balloon 3 and the second balloon 4 are arbitrarily selected and inflated. It is possible to freely adjust the timing of the expansion of the first balloon 3 and the expansion of the second balloon 4 and is not only convenient for pressing the hemostasis at the incision of the papillary sphincter but also various other types. It becomes possible to apply to treatment. For example, when applied to a process of scraping foreign matter such as gallstone and bile mud in the common bile duct, the foreign matter in a portion substantially straight of the common bile duct causes the first balloon 3 to expand while the second balloon 4 is contracted. The foreign substance in the bag-like portion having a bulge which is scraped by the inflated first balloon 3 and which is convex toward the duodenum side of the common bile duct causes the second balloon 4 to be inflated while the first balloon 3 is contracted, Various treatments can be flexibly coped with, such as being able to scrape with the expanded second balloon 4.
　以上説明した実施形態は、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 to facilitate the understanding of the present invention, and are not described to limit the present invention. Therefore, each element disclosed in the embodiment described above is intended to include all design changes and equivalents that fall within the technical scope of the present invention.
　たとえば、上述した実施形態では、バルーンカテーテル１が備えるバルーンは、第１バルーン３と第２バルーン４の２つとし、第２バルーン４を偏心バルーンとしたが、３つ以上のバルーンを設け、そのうちの少なくとも１つを偏心バルーンとしてもよい。 For example, in the embodiment described above, the balloon provided in the balloon catheter 1 is two, the first balloon 3 and the second balloon 4, and the second balloon 4 is an eccentric balloon, but three or more balloons are provided, At least one of the above may be an eccentric balloon.
　１…バルーンカテーテル
　２…カテーテルチューブ
　　２１…メインルーメン（ガイドワイヤルーメン）
　　２２，２３，２４…バルーンルーメン（第１バルーンルーメン、第２バルーンルーメン）
　　　２２ａ，２２ｂ，２３ａ，２４ａ…通孔
　３…第１バルーン
　４…第２バルーン
　　４１…固定用テープ
　５…カバー
　６ａ，７ａ，８ａ，９ａ…枝管
　６ｂ，７ｂ，８ｂ，９ｂ…ポート 1 ... balloon catheter 2 ... catheter tube 21 ... main lumen (guide wire lumen)
22, 23, 24 ... balloon lumens (first balloon lumen, second balloon lumen)
22a, 22b, 23a, 24a: through holes 3: first balloon 4. second balloon 41: fixing tape 5: cover 6a, 7a, 8a, 9a: branch pipe 6b, 7b, 8b, 9b: port

Claims (11)

  1. 　遠位端および近位端を備えるカテーテルチューブと、
    前記カテーテルチューブの遠位端近傍に設けられ、その内部に流体が注入されることにより膨張する第１バルーンと、
    前記カテーテルチューブの前記第１バルーンの近位端側近傍に設けられ、その内部に流体が注入されることにより膨張する第２バルーンとを有し、
    前記第１バルーンおよび前記第２バルーンの少なくも一方は、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偏心バルーンである医療用バルーンカテーテル。     A catheter tube comprising a distal end and a proximal end;
    A first balloon disposed near the distal end of the catheter tube and inflated by the fluid being injected therein;
    And a second balloon provided near the proximal end side of the first balloon of the catheter tube and inflated by the fluid being injected therein.
    The medical balloon catheter, wherein at least one of the first balloon and the second balloon is an eccentric balloon that inflates eccentrically with respect to the axial center of the catheter tube.
  2. 　前記第１バルーンを前記カテーテルチューブの軸心に対して均等に膨張する非偏心バルーンとし、前記第２バルーンを前記偏心バルーンとした請求項１に記載の医療用バルーンカテーテル。 The medical balloon catheter according to claim 1, wherein the first balloon is a non-eccentric balloon that inflates uniformly with respect to the axial center of the catheter tube, and the second balloon is the eccentric balloon.
  3. 　前記偏心バルーンは、膨張時に透明または半透明である請求項１または２に記載の医療用バルーンカテーテル。 The medical balloon catheter according to claim 1, wherein the eccentric balloon is transparent or translucent when inflated.
  4. 　前記カテーテルチューブは、前記第１バルーンおよび前記第２バルーンに流体を供給するために、該第１バルーンおよび該第２バルーンのそれぞれに連通する単一のバルーンルーメンを備える請求項１～３のいずれかに記載の医療用バルーンカテーテル。 The catheter tube according to any one of claims 1 to 3, wherein the catheter tube comprises a single balloon lumen in communication with each of the first balloon and the second balloon to supply fluid to the first balloon and the second balloon. Medical balloon catheter as described in.
  5. 　前記バルーンルーメンの前記第１バルーンに対する通孔と、該バルーンルーメンの前記第２バルーンに対する通孔とが略同径である請求項４に記載の医療用バルーンカテーテル。 The medical balloon catheter according to claim 4, wherein the through hole of the balloon lumen for the first balloon and the through hole of the balloon lumen for the second balloon have substantially the same diameter.
  6. 　前記カテーテルチューブは、前記第１バルーンに流体を供給する第１バルーンルーメン、および前記第２バルーンに流体を供給する第２バルーンルーメンを備える請求項１～３のいずれかに記載の医療用バルーンカテーテル。 The medical balloon catheter according to any one of claims 1 to 3, wherein the catheter tube comprises a first balloon lumen for supplying fluid to the first balloon and a second balloon lumen for supplying fluid to the second balloon. .
  7. 　前記第１バルーンおよび前記第２バルーンを膨張させた状態で、該第１バルーンの近位端側の一部と、該第２バルーンの遠位端側の一部とが互いに近接、当接または圧接する請求項１～６のいずれかに記載の医療用バルーンカテーテル。 When the first balloon and the second balloon are inflated, a part on the proximal end side of the first balloon and a part on the distal end side of the second balloon are close to each other, in contact with each other, or The medical balloon catheter according to any one of claims 1 to 6, which is pressure-welded.
  8. 　前記カテーテルチューブは、該カテーテルチューブの軸心に対して偏心して設けられたガイドワイヤルーメンを備え、
    前記偏心バルーンを、前記ガイドワイヤルーメンが前記カテーテルチューブの軸心に対して偏心する側と反対側に偏心して膨張するように設けた請求項１～７のいずれかに記載の医療用バルーンカテーテル。     The catheter tube comprises a guidewire lumen provided eccentrically to the axial center of the catheter tube,
    The medical balloon catheter according to any one of claims 1 to 7, wherein the eccentric balloon is provided so as to eccentrically expand on the opposite side of the side where the guide wire lumen is eccentric to the axial center of the catheter tube.
  9. 　前記カテーテルチューブを側視型の内視鏡の処置具案内管に挿通して用いる請求項１～８のいずれかに記載の医療用バルーンカテーテル。 The medical balloon catheter according to any one of claims 1 to 8, wherein the catheter tube is inserted into a treatment instrument guiding tube of a side-viewing type endoscope.
  10. 　前記第１バルーンおよび前記第２バルーンを膨張させた状態で、該第１バルーンの近位端側の一部と、該第２バルーンの遠位端側の一部とで、止血すべき部位を挟んで圧迫止血するために用いる請求項１～９のいずれかに記載の医療用バルーンカテーテル。 When the first balloon and the second balloon are inflated, a portion to be hemostasis is required to be a part of the proximal end side of the first balloon and a part of the distal end side of the second balloon. The medical balloon catheter according to any one of claims 1 to 9, which is used to clamp and stop the bleeding.
  11. 　選択的に膨張された前記第１バルーンまたは前記第２バルーンで体内の異物を掻き出すために用いる請求項１～９のいずれかに記載の医療用バルーンカテーテル。 The medical balloon catheter according to any one of claims 1 to 9, which is used to scrape foreign substances in the body by the first balloon or the second balloon which is selectively inflated.
PCT/JP2018/044263 2017-12-12 2018-11-30 Medical balloon catheter WO2019116935A1 (en)

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WO2022172321A1 (en) * 2021-02-09 2022-08-18 日本ライフライン株式会社 Endoscope

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JPH063353U (en) * 1992-06-22 1994-01-18 クリエートメディック株式会社 Hemostasis catheter
JPH0910219A (en) * 1995-06-30 1997-01-14 Nippon Zeon Co Ltd Balloon catheter for endoscopic hemostasis
JP2003500121A (en) * 1998-09-10 2003-01-07 パーカーディア，インコーポレイティド Ventricular wall conduction catheter for artificial conduit
JP2003250896A (en) * 2002-02-28 2003-09-09 Terumo Corp Balloon catheter for aneurysmal embolic treatment
JP2014140465A (en) * 2013-01-23 2014-08-07 Terumo Corp Balloon catheter for removing solid matter

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH063353U (en) * 1992-06-22 1994-01-18 クリエートメディック株式会社 Hemostasis catheter
JPH0910219A (en) * 1995-06-30 1997-01-14 Nippon Zeon Co Ltd Balloon catheter for endoscopic hemostasis
JP2003500121A (en) * 1998-09-10 2003-01-07 パーカーディア，インコーポレイティド Ventricular wall conduction catheter for artificial conduit
JP2003250896A (en) * 2002-02-28 2003-09-09 Terumo Corp Balloon catheter for aneurysmal embolic treatment
JP2014140465A (en) * 2013-01-23 2014-08-07 Terumo Corp Balloon catheter for removing solid matter

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022172321A1 (en) * 2021-02-09 2022-08-18 日本ライフライン株式会社 Endoscope

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