CN111801132A - Balloon catheter for removing calculus - Google Patents

Balloon catheter for removing calculus Download PDF

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Publication number
CN111801132A
CN111801132A CN201980015729.7A CN201980015729A CN111801132A CN 111801132 A CN111801132 A CN 111801132A CN 201980015729 A CN201980015729 A CN 201980015729A CN 111801132 A CN111801132 A CN 111801132A
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China
Prior art keywords
tube
distal end
inner tube
balloon
catheter
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CN201980015729.7A
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Chinese (zh)
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河尻幸治
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Zeon Corp
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Zeon Corp
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The invention provides a balloon catheter for removing calculi, which can be applied to an endoscope with small inner diameter of a treatment instrument guide tube. Comprising: a catheter (2) of a double tube structure having an outer tube (outer tube) (21), an inner tube (inner tube) (22) inserted into the outer tube (21), and a balloon (3), which is provided in the vicinity of the distal end of the outer tube (21) and expands or contracts by supplying and discharging fluid to the inside through a supply and discharge air passage (21a) defined between the outer tube (21) and the inner tube (22), and a substantially cylindrical tip (4), the inner tube attachment hole (42) has an inner tube contact surface (42a) with which the distal end surface of the inner tube (22) is in contact in a state in which the distal end portion of the inner tube (22) is inserted, and the lumen (41) is continuous with the lumen (22a) of the inner tube (22) attached to the inner tube attachment hole (42) and is open at the distal end.

Description

Balloon catheter for removing calculus
Technical Field
The present invention relates to a balloon catheter for removing calculi generated in a body lumen such as a bile duct.
Background
A balloon catheter for removing gallstones (stones) generated in a bile duct is known (see, for example, patent document 1). When removing a biliary calculus from a bile duct, first, an endoscope is inserted transorally to the vicinity of the duodenal papilla, a balloon catheter in a balloon-contracted state is inserted into the bile duct via a treatment instrument guide tube of the endoscope, and the balloon is positioned at a position further inside than the position of the biliary calculus to be removed while observing an X-ray fluoroscopic image. When the balloon catheter is pulled back after the balloon is inflated, the gallstone can be discharged to the outside of the bile duct so as to be scooped out by the balloon.
As a catheter used for such a balloon catheter for removing a calculus, the following catheters can be used: using a catheter of a single-tube configuration having a guide wire lumen for inserting a guide wire and a balloon lumen for supplying a fluid to the balloon, the distal end portion thereof is heated and compressed using a mold, thereby occluding the balloon lumen and imparting a tip shape with a tapered tip. Here, the catheter is required to have flexibility to such an extent that the catheter can sufficiently follow the bending of the endoscope, and to have rigidity to such an extent that the catheter can travel without bending in the treatment instrument guide tube and the body lumen.
Recently, small-diameter endoscopes, such as a nasal endoscope, have been developed, and by using such small-diameter endoscopes, the distal end portion of the endoscope can be inserted into the biliary tract via the duodenal papilla, and the biliary tract can be directly observed by a camera provided in the endoscope. Since the inner diameter of the treatment instrument guide tube is also small in such a small-diameter endoscope, the balloon catheter for removing calculi inserted therethrough needs to be made thin correspondingly to the small-diameter endoscope. Further, the small diameter endoscope tends to have a larger curvature of bending than a general oral endoscope, and therefore, is required to have higher flexibility than a catheter.
However, in the conventional catheter having a single-tube structure, it is difficult to achieve both flexibility and rigidity, and since the catheter is applied to a small-diameter endoscope that can be inserted into a bile duct, the catheter is made thin, and there is a problem that when the flexibility is increased to sufficiently follow the bending of the small-diameter endoscope, the necessary rigidity cannot be secured. Further, since the distal end (distal end) portion of the catheter is hardened by heat and compression with respect to the rest, the insertion may be hindered when inserting a treatment instrument guide tube of a small-diameter endoscope having a relatively large curvature, which may be bent.
Documents of the prior art
Patent document
Patent document 1: japanese patent laid-open publication No. 2012-143377.
Disclosure of Invention
Problems to be solved by the invention
The present invention has been made in view of the above circumstances, and an object thereof is to provide a balloon catheter for removing calculi which can be applied to an endoscope having a small inner diameter of a treatment instrument guide tube.
Means for solving the problems
In order to achieve the above object, a balloon catheter for removing calculi according to the present invention includes:
a catheter of a double tube construction having an outer tube having a supply discharge hole penetrating inside and outside near a distal end, and an inner tube inserted inside the outer tube with a clearance,
a balloon provided so as to surround the supply discharge hole at an outer periphery near a distal end of the outer tube, performing inflation or deflation by supplying a discharge fluid to the inside via a supply and discharge passage partitioned between an inner surface of the outer tube and an outer surface of the inner tube and the supply and discharge hole, and
a substantially cylindrical distal tip having an inner tube attachment hole having an inner tube contact surface against which a distal end surface of the inner tube contacts in a state in which a distal end portion of the inner tube is inserted, an inner lumen that is continuous with and open at a distal end of the inner tube attached to the inner tube attachment hole, and an outer tube contact surface against which a distal end surface of the outer tube contacts.
Since the balloon catheter for removing calculi according to the present invention has a double tube structure in which the inner tube is inserted into the outer tube, one of the double tubes can be made of a material in which flexibility is important and the other can be made of a material in which rigidity is important. Therefore, even when the catheter is made thin, the necessary rigidity and flexibility can be achieved at the same time. Further, since the distal end portion is different from the catheter, the distal end portion (distal end portion) can be made flexible as compared with a case where the distal end shape is given by heating and compressing as in the conventional art, and even in a case where a treatment instrument guide tube of a small-diameter endoscope having a relatively large curvature which is sometimes bent is inserted, the insertion obstruction can be reduced.
In the balloon catheter for removing calculi according to the present invention, the inner tube may be made of a material harder than the outer tube. By making the inner tube hard, the deformation of the inner lumen of the inner tube accompanying bending can be made small, and when a guide wire is inserted into the inner lumen of the inner tube, the obstruction of the insertion of the guide wire can be suppressed.
In the balloon catheter for removing calculi according to the present invention, the outer diameter of the outer tube can be set within a range of 0.6 to 2.5 mm. The present invention is particularly effective when applied to such a balloon catheter of a small diameter.
Drawings
Fig. 1 is a general view showing an outline of a balloon catheter for removing calculi according to an embodiment of the present invention.
Fig. 2 is a sectional view taken along line II-II of fig. 1.
Fig. 3 is an enlarged cross-sectional view of the vicinity of the distal end portion of the balloon catheter for removing calculi of fig. 1 cut along a plane including the axis.
Fig. 4 is a sectional view showing the structure of the tip of the balloon catheter for removing calculus of fig. 1.
Fig. 5 is a sectional view showing another structure of the tip of the balloon catheter for removing calculi of fig. 1.
Fig. 6 is a sectional view showing another structure of the tip of the balloon catheter for removing calculi of fig. 1.
Fig. 7 is a general view of a balloon catheter for removing calculi according to another embodiment of the present invention.
Fig. 8 is an enlarged cross-sectional view of the balloon catheter for removing calculi of fig. 7 cut near the distal end portion thereof on a plane including the axis.
Detailed Description
Hereinafter, embodiments of the present invention will be described with reference to the drawings. The balloon catheter for removing calculi according to the present embodiment is a treatment instrument for endoscope which is inserted into an intra-body lumen via a treatment instrument guide tube of an endoscope to scrape out calculi and the like generated in the intra-body lumen. In the following, a description will be given, as an example, of a case where the calculus removal balloon catheter of the present embodiment is inserted into the body of a patient via a small-diameter endoscope sold as a transnasal endoscope to remove gallstones or the like in the biliary tract.
Here, a specific example of the small-diameter endoscope that can be preferably used for inserting the balloon catheter for removing calculi of the present embodiment includes a small-diameter endoscope sold as a nasal endoscope. While the outer diameter (axial diameter) of a general oral endoscope is 10 to 14mm, the outer diameter (axial diameter) of a small-diameter endoscope sold as a nasal endoscope is 4.9 to 5.9 mm. In addition, the inner diameter (channel diameter) of the treatment instrument guide tube of a general oral endoscope is about 3.7mm, whereas the inner diameter (channel diameter) of the treatment instrument guide tube of a small-diameter endoscope sold as a transnasal endoscope is about 2.0 to 2.5 mm.
The balloon catheter for removing calculi according to the present embodiment is optimized so as to be able to be inserted into a treatment instrument guide tube of a small-diameter endoscope sold as a transnasal endoscope, for example, and can of course be used by being inserted into a treatment instrument guide tube of a peroral endoscope.
First, fig. 1 to 3 are referred to. The balloon catheter 1 of the present embodiment is configured to substantially include: catheter 2, balloon 3, tip 4, cover 5, two branch tubes (branch tubes) 6a, 7a, two ports 6b, 7 b.
The catheter 2 has a distal end portion to be inserted into the body and a proximal end portion to be disposed outside the body, and is an elongated member having a double tube structure including an outer tube 21 and an inner tube 22 inserted with a gap in the inner cavity of the outer tube 21.
The outer diameter of the outer tube 21 can be set within a range of 0.6 to 2.5mm, and preferably within a range of 1.0 to 2.5 mm. The inner diameter of the outer tube 21 can be set within the range of 0.5 to 2.0 mm.
The outer diameter of the inner layer tube 22 is set within the range of 0.4 to 1.8mm so as to have a gap with the inner surface of the outer layer tube 21 to such an extent that a supply/discharge gas passage (supply/discharge passage) 21a (described later) is formed. The inner diameter of the inner tube 22 is set to a value that allows a guide wire to be slidably inserted, and in the present embodiment, the inner diameter of the inner tube 22 that uses a guide wire having an outer diameter of 0.025 inches (0.635 mm) is set within a range of 0.64 to 1.00 mm.
The total length of the conduit 2 (outer layer tube 21, inner layer tube 22) is about 500 to 3000 mm.
The material of the outer tube 21 is a flexible material, and a polymer material softer than the inner tube 22 is preferably used, and examples thereof include a polyether block amide copolymer, polyethylene terephthalate, polypropylene, an ethylene-propylene copolymer, an ethylene-vinyl acetate copolymer, polyvinyl chloride (PVC), a cross-linked ethylene-vinyl acetate copolymer, polyurethane, polyamide, a polyamide elastomer, polyimide, a polyimide elastomer, and silicone rubber. The material of the inner layer tube 22 is a flexible material, and a polymer material harder than the outer layer tube 21 is preferably used, and for example, polyetheretherketone, polysulfone, polyethersulfone, polyetherimide, or the like can be used.
A space defined between the inner surface of the outer tube 21 and the outer surface of the inner tube 22 serves as a supply/discharge passage 21a, and the supply/discharge passage 21a is a flow path for supplying or discharging a fluid (air in the present embodiment) used for inflating or deflating the balloon 3 to or from the inside of the balloon 3. Therefore, a supply/discharge hole (supply/discharge hole) 21b is formed so as to penetrate the inside and outside, that is, so as to communicate between the supply/discharge air passage 21a and the inside of the balloon 3, so as to be positioned inside the balloon 3 disposed in the vicinity of the distal end of the outer tube 21.
The lumen 22a of the inner tube 22 is used for insertion of a guide wire and, if necessary, as a flow path for a contrast medium for X-ray contrast in the bile duct or as a flow path for supplying a physiological saline solution or the like into the bile duct.
The balloon 3 is inflated by supplying (injecting) air into the interior thereof, and is contracted by discharging (sucking) air, and is attached to the vicinity of the distal end of the catheter 2 so as to surround and cover the supply/discharge holes 21 b. In the present embodiment, the balloon 3 is a balloon in a shape of a rotor having the axial center of the catheter 2 as a rotation axis (a non-eccentric balloon that is not eccentric with respect to the axial center of the catheter 2). The gallstone in the bile duct can be removed by scooping out or pushing out the gallstone with the inflated balloon 3.
The 100% modulus (value measured according to JIS K6251) of the stretchable material forming the balloon 3 is preferably 0.1 to 10MPa, and particularly preferably 1 to 5 MPa. When the 100% modulus is too small, the strength of the balloon 3 may be insufficient, and when too large, the balloon 3 may not be inflated to a sufficient size. Specific examples of preferable stretchable materials for forming the balloon 3 include natural rubber, silicone rubber, and urethane elastomer.
In the present embodiment, the balloon 3 is cylindrical as a whole in a deflated state, and substantially cylindrical joining portions 3a and 3b that join the outer peripheral surface of the catheter 2 are formed at both ends thereof, and an inflated portion 3c that inflates when a fluid is supplied to the inside is formed between the joining portions 3a and 3b at both ends thereof. The inflatable portion 3c of the balloon 3 is formed into a shape of a revolution body in which a convex curve is rotated toward the outside of the catheter 2 with the axial center of the catheter 2 as a rotation axis in a state where the balloon 3 is not subjected to an external force (a state where the fluid is not supplied to the inside and the internal pressure and the external air pressure are balanced and the balloon 3 is contracted). The method of joining the joining portions 3a and 3b of the balloon 3 and the catheter 2 is not particularly limited, and examples thereof include bonding with an adhesive, thermal welding, welding with a solvent, ultrasonic welding, and high-frequency welding.
The maximum outer diameter of the inflated portion 3c of the balloon 3 in a state where no external force is applied (a state where no fluid is supplied to the inside and the pressure inside and the external air pressure are balanced and the balloon 3 is deflated) is preferably 110 to 200% of the outer diameter of the joined portion 3 b. If the ratio is too small, the balloon 3 may not be inflated to a sufficient size, and if it is too large, the balloon 3 may become an obstacle even in a deflated state when the balloon catheter 1 is inserted into the body. The outer diameter of the balloon 3 (the inflatable portion 3c) when inflated can vary according to the pressure of the fluid supplied to the inside, and is preferably expandable to an outer diameter of at least 10mm, more preferably at least 15mm, in order to cause gallstones to be taken out of the bile duct. The length (length along the axial direction of the catheter 2) of the balloon 3 at the inflation portion 3c is preferably 2 to 20mm, more preferably 3 to 20mm, and the wall thickness is preferably 0.10 to 0.50 mm. The wall thickness of the balloon 3 is preferably uniform in the circumferential direction.
The method for producing the balloon 3 is not particularly limited, and a known method for forming a film of a stretchable material may be used, and a dip molding method or a melt molding method is preferably used, and a dip molding method is particularly preferably used. In the dip molding method, various additives and a stretchable material are dissolved in a solvent as necessary to prepare a solution or a suspension, the solution (suspension) is dipped in a mold having an outer shape substantially the same as the shape of a desired balloon to apply the solution (suspension) to the surface of the mold, and the solvent is evaporated to form a coating film on the surface of the mold. By repeating the dipping and drying, a balloon having a desired wall thickness can be formed into a film. Further, depending on the kind of the elastic material, crosslinking is performed after film formation as necessary.
The distal end of the catheter 2 is attached with a distal tip 4, and as shown in fig. 4, the distal tip 4 is a substantially cylindrical member having an inner cavity 41, an inner tube attachment hole (inner tube attachment hole) 42, and an outer tube attachment portion 43.
The outer periphery of the distal end 4 has a straight cylindrical shape (straight cylindrical portion 4a) whose diameter is not substantially changed on the proximal end (proximal end) side in the axial direction, and a tapered shape (tapered portion 4b) whose distal end is tapered on the distal end (distal end) side. The shape of the outer periphery of the tip head 4 is not limited to this, and may be a single taper tapered in the entire axial direction, or may be a combination of a plurality of tapers having different inclination angles. A single or multiple tapering cones and a single or multiple thickening cones and/or straight cylinders may also be present in combination. The distal end (distal end) of the distal tip 4 is preferably chamfered smoothly so as not to be caught by the inner wall of the treatment instrument guide tube or the body lumen and obstruct the insertion.
The lumen 41 of the distal end 4 has a distal end opening 41a that is open at the distal end thereof, and is formed so that the proximal end side thereof is continuous with the lumen 22a of the inner tube 22 fitted to the inner tube fitting hole 42. The inner diameter of the lumen 41 is set to be substantially the same as the inner diameter of the inner tube 22.
The inner tube attachment hole 42 is a portion to which the distal end portion of the inner tube 22 is attached, and is a substantially cylindrical hole formed substantially coaxially with the lumen 41 on the proximal end side of the lumen 41. The inner diameter of the inner pipe attachment hole 42 is set to be substantially the same as the outer diameter of the inner pipe 22. The inner tube attachment hole 42 has an inner tube abutment surface (inner tube abutment surface) 42a with which the distal end surface of the inner tube 22 abuts in a state where the distal end portion of the inner tube 22 is inserted.
The distal end portion of the inner tube 22 is adhesively fixed to the distal end head 4 in a state where the lumen 22a of the inner tube 22 is continuous with the lumen 41 of the distal end head 4 by applying an adhesive to one or both of the inner peripheral surface of the inner tube attachment hole 42 and the outer peripheral surface of the distal end portion of the inner tube 22 and inserting or press-fitting the distal end portion of the inner tube 22 into the inner tube attachment hole 42.
The outer layer tube mounting portion 43 is a portion to which the distal end portion of the outer layer tube 21 is mounted, and has an outer layer tube contact surface (outer tube contact surface) 43a with which the distal end surface of the outer layer tube 21 contacts. In the present embodiment, the proximal end surface (proximal end surface) of the distal end head 4 serves as the outer-layer-tube contact surface 43 a. The adhesive is applied to one or both of the outer layer tube contact surface 43a and the distal end surface of the outer layer tube 21, and the distal end portion of the outer layer tube 21 is brought into contact with or pressure-contacted with the outer layer tube contact surface 43a, whereby the distal end portion of the outer layer tube 21 and the tip 4 are fixed to each other in a state where the distal end portion of the supply/discharge air passage 21a is hermetically sealed (blocked) by the tip 4.
As the adhesive for bonding and fixing the inner layer tube 22 and the outer layer tube 21 to the top end 4, a cyanoacrylate adhesive, an epoxy resin adhesive, a silicone rubber adhesive, or the like can be used. The inner layer tube 22 and the outer layer tube 21 may be fixed to the top end 4 by thermal welding, solvent welding, ultrasonic welding, or the like.
In fig. 1, branch tubes 6a, 7a are connected to a portion of the cover 5 on the proximal side of the catheter 2. The branch tube 6a is a tube having a distal end connected to the proximal end of the lumen 22a of the inner tube 22, and the branch tube 7a is a tube having a distal end connected to the proximal end of the lumen (supply/discharge air passage 21a defined by the inner surface of the outer tube 21 and the outer surface of the inner tube 22) of the outer tube 21. The material of the branch pipes 6a and 7a is not particularly limited, and a polymer material is preferably used.
A port 6b is connected to the proximal end of the branch tube 6a, and a port 7b is connected to the proximal end of the branch tube 7 a. A syringe or the like is connected to the port 6b, and a contrast medium, a drug solution, or the like is fed into the lumen 22a of the inner tube 22. A guide wire may be inserted through the opening of the port 6b and inserted into the lumen 22a of the inner tube 22. A syringe or the like is connected to the port 7b, and a fluid (air in the present embodiment) for inflating the balloon 3 is sent to the supply/discharge air passage 21 a.
The material of the ports 6b and 7b is not particularly limited, and a transparent polymer material is preferably used. The connection method between the branch tube 6a and the inner cavity 22a of the inner tube 22 and between the branch tube 7a and the supply/discharge air passage 21a is not particularly limited, and for example, the proximal end portion of the inner tube 22 is led to the outside so as to airtightly penetrate the side wall of the outer tube 21, the distal end portions of the branch tubes 6a and 7a are molded into a tapered shape, an adhesive is applied to the outer peripheral surface thereof, and the end portions thereof are inserted into the corresponding tubes 21 and 22 of the catheter 2, whereby adhesion is achieved.
The connection of the pipe 2 and the respective branch pipes 6a, 7a is reinforced and protected by the cover 5. The hood 5 is provided to cover the connection of the pipe 2 and the branch pipes 6a, 7 a. The shape of the cover 5 is not particularly limited, and is generally a box-type or a cylindrical-type. The material of the cover 5 is not particularly limited, and a polymer material is preferably used. Further, a heat shrinkable tube can also be used as the cover 5.
When removing a biliary calculus in a biliary tract using the balloon catheter 1, first, an endoscope is inserted into a patient's body, and the distal end portion of the endoscope is inserted into the biliary tract via a duodenal papilla. Next, without inflating the balloon 3, a guide wire is inserted into the lumen 22a of the inner tube 22, and the balloon catheter 1 is inserted into the body from the distal end side of the catheter 2 through a treatment instrument guide tube (channel) of the endoscope.
Next, the distal end of the catheter 2 is advanced to a desired position in the deep part of the bile duct while visually confirming the distal end portion of the balloon catheter 1 protruding from the outlet of the treatment instrument guide tube at the distal end (distal end) of the endoscope by an image of the endoscope camera. Next, air is supplied into the balloon 3 through the port 7b, the branch tube 7a, the supply/discharge air passage 21a, and the supply/discharge air hole 21b by a syringe or the like to inflate the balloon 3, and when the catheter 2 is pulled back together with the endoscope, the gall stone can be pulled out of the bile duct from the duodenal papilla by the balloon 3. It should be noted that gallstones drawn out of the bile duct are naturally discharged from the body.
In the balloon catheter 1 for removing concretion of the above embodiment, as the catheter 2, a double tube structure in which the inner tube 22 is inserted into the outer tube 21, a tube made of a relatively hard material in which rigidity is important is used as the inner tube 22, and a tube made of a relatively soft material in which flexibility is important is used as the outer tube 21. Therefore, as compared with a catheter having a single-tube structure as in the related art, it is possible to achieve both necessary rigidity and flexibility even when the catheter is made thin.
In contrast to the above, even when a tube made of a relatively soft material, in which flexibility is important, is used as the inner layer tube 22 and a tube made of a relatively hard material, in which rigidity is important, is used as the outer layer tube 21, both necessary rigidity and flexibility can be achieved. However, when the inner tube 22 is made of a soft material, the lumen 22a of the inner tube 22 is deformed during bending, and when a guide wire is inserted into the lumen 22a of the inner tube 22, the insertion of the guide wire may be hindered. Therefore, as in the above-described embodiment, it is preferable to use a tube made of a relatively hard material, in which rigidity is important, as the inner layer tube 22, and a tube made of a relatively soft material, in which flexibility is important, as the outer layer tube 21.
Further, since the distal end head 4 is provided as a member different from the catheter 2, by using a tip head 4 formed of a relatively soft material, the distal end portion (distal end portion) can be made flexible as compared with a case where a tip shape is imparted by heating and compressing as in the related art, and even in a case where a treatment instrument guide tube of a small-diameter endoscope having a relatively large curvature which is sometimes bent is inserted, the insertion obstruction can be reduced.
Further, since the distal end portion of the supply/discharge air passage 21a is hermetically closed by adhesively fixing the inner tube 22 to the inner tube attachment hole 42 and adhesively fixing the outer tube 21 to the outer tube abutment surface 43a, it is not necessary to provide an additional member or process for closing, which is convenient.
In the above-described embodiment, as the distal end 4, as shown in fig. 4, since the distal end of the outer layer tube 21 is bonded and fixed, the distal end surface of the outer layer tube 21 is bonded and fixed to the outer layer tube abutment surface 43a which is the end surface on the proximal end (proximal end) side of the distal end 4, but a distal end 4' having the configuration shown in fig. 5 may be used. That is, the outer periphery of the proximal end (proximal end) of the straight tube portion 4a may be cut into a substantially annular shape to form an outer tube attachment portion 43' having an outer tube abutment surface 43a ', and the outer tube attachment portion 43' may be inserted or press-fitted into the distal end portion of the inner cavity of the outer tube 21 and bonded and fixed to each other. In fig. 5, the same reference numerals are given to the components substantially the same as those shown in fig. 4, and the description thereof will be omitted.
Further, the structure shown in fig. 6 can be used as the tip 4. That is, the outer layer tube mounting hole 43 "having the outer layer tube abutment surface 43a" may be provided on the base end (proximal end) side of the inner layer tube mounting hole 42, and the distal end portions of the outer layer tube 21 may be inserted or press-fitted into the outer layer tube mounting hole 43 "and fixed to each other by adhesion. If there is a step at the joint between the distal end of the outer tube 21 and the proximal end of the distal end head 4, the catheter 2 may get stuck when being pulled out from the treatment instrument guide tube of the endoscope, and therefore, it is preferable that the portion corresponding to the straight tube portion 4a in fig. 4 is not stepped, and is a tapered, thickened and tapered portion 4c having a thickened distal end. In fig. 6, the same reference numerals are given to the components substantially the same as those shown in fig. 4, and the description thereof will be omitted.
In the above-described embodiment, the case where a non-eccentric balloon inflated in a rotating body shape in which a convex curve is rotated toward the outside of the catheter 2 with the axial center of the catheter 2 as a rotation axis is used as the balloon 3 has been described as an example, an eccentric balloon inflated eccentrically with respect to the axial center of the catheter 2 may be provided as the balloon 3' instead of the balloon 3 shown in fig. 1 and 3 as shown in fig. 7 and 8. In fig. 7 and 8, the same reference numerals are given to substantially the same components as those shown in fig. 1 and 3, and the description thereof will be omitted.
The eccentric balloon 3' of the balloon catheter 1' of fig. 7 and 8 has the same basic structure as the non-eccentric balloon 3 of the balloon catheter 1 of fig. 1 and 3, and differs therefrom in that the inflatable portion 3c ' is inflated eccentrically with respect to the axial center of the catheter 2, and therefore a fixing tape 3d for fixing a part of the balloon 3' in the circumferential direction with respect to the catheter 2 from above the balloon 3' is bonded in the longitudinal direction thereof. The fixing band 3d is longer than the axial length of the balloon 3', and both ends of the band 3d are fixed to the outer peripheral surface of the catheter 2.
The material of the fixing band 3d is not particularly limited, and is made of the same resin as the resin constituting the catheter 2. The fixing method of both ends of the fixing tape 3d is not particularly limited, and examples thereof include adhesion, thermal welding, and high-frequency welding. For example, in the case of the adhesion method, an adhesive (bonding agent) is applied to the back surface of the tape 3d, and the tape is adhered to a part of the balloon 3' and a part of the catheter 2 in the circumferential direction.
The width of the fixing band 3d is equal to or less than 1/2 of the circumferential length of the outer periphery of the catheter 2, and preferably 1/3 to 1/5. If the width is too small, the function of fixing a part of the balloon 3' in the circumferential direction to the catheter 2 from above the balloon 3' becomes small, and if the width is too large, it becomes difficult to eccentrically inflate the balloon 3 '.
Since such a fixing tape 3d is attached, as shown in fig. 8, the inflation portion 3c 'of the balloon 3' is eccentrically inflated with respect to the axial center of the catheter 2. The eccentric amount of the expansion center of the expansion part with respect to the axial center of the conduit 2 is preferably 50 to 100%, more preferably 75 to 100%, with respect to the expansion radius of the expansion part. It should be noted that the balloon 3' does not need to be completely inflated in its cross section to a circular shape, but may be inflated to an elliptical shape or other shapes.
In the above-described embodiment, the balloon catheter 1 has one balloon 3 or 3', but may have a plurality of balloons.
The embodiments described above are described for easy understanding of the present invention, and are not described for limiting the present invention. Therefore, each element disclosed in the above embodiments is intended to include all design modifications and equivalents that fall within the technical scope of the present invention.
Description of the reference numerals
1. 1': balloon catheter for removing calculus
2: catheter tube
21: outer pipe (outer pipe)
21 a: supply/discharge gas circuit (supply/discharge circuit)
21 b: supply and discharge holes (supply and discharge holes)
22: inner pipe (inner pipe)
22 a: inner cavity
3. 3': balloon
3a, 3 b: joint part
3c, 3 c': expansion part
4. 4', 4 ": top end head
4 a: straight cylinder part
4 b: cone part
4 c: tapered part with thickened top end
41: inner cavity
41 a: open at the top
42: inner tube mounting hole (inner tube mounting hole)
42 a: inner layer pipe butt joint surface (inner pipe butt joint surface)
43. 43', 43 ": outer pipe mounting part
43a, 43a', 43a ": outer pipe butt joint face (outer pipe butt joint face)
5: cover
6a, 7 a: branch pipe
6b, 7 b: port(s)

Claims (3)

1. A balloon catheter for removing calculi, comprising:
a catheter of a double tube construction having an outer tube having a supply discharge hole penetrating inside and outside near a distal end, and an inner tube inserted inside the outer tube with a clearance,
a balloon provided so as to surround the supply discharge hole at an outer periphery near a distal end of the outer tube, performing inflation or deflation by supplying a discharge fluid to the inside via a supply and discharge passage partitioned between an inner surface of the outer tube and an outer surface of the inner tube and the supply and discharge hole, and
a substantially cylindrical distal tip having an inner tube attachment hole having an inner tube contact surface against which a distal end surface of the inner tube contacts in a state in which a distal end portion of the inner tube is inserted, an inner lumen that is continuous with and open at a distal end of the inner tube attached to the inner tube attachment hole, and an outer tube contact surface against which a distal end surface of the outer tube contacts.
2. The balloon catheter for removing calculi according to claim 1, wherein,
the inner tube is constructed of a harder material than the outer tube.
3. The balloon catheter for removing calculi according to claim 1 or 2, wherein,
the outer diameter of the outer pipe is set within the range of 0.6-2.5 mm.
CN201980015729.7A 2018-03-19 2019-03-18 Balloon catheter for removing calculus Pending CN111801132A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2018-051598 2018-03-19
JP2018051598 2018-03-19
PCT/JP2019/011132 WO2019181837A1 (en) 2018-03-19 2019-03-18 Balloon catheter for calculus removal

Publications (1)

Publication Number Publication Date
CN111801132A true CN111801132A (en) 2020-10-20

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CN201980015729.7A Pending CN111801132A (en) 2018-03-19 2019-03-18 Balloon catheter for removing calculus

Country Status (3)

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JP (1) JP7306376B2 (en)
CN (1) CN111801132A (en)
WO (1) WO2019181837A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021085537A1 (en) * 2019-10-31 2021-05-06 日本ゼオン株式会社 Balloon catheter for foreign matter removal

Citations (3)

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JPS63252166A (en) * 1987-04-08 1988-10-19 オリンパス光学工業株式会社 Balloon catheter
JP2011245114A (en) * 2010-05-28 2011-12-08 Nipro Corp Balloon catheter
JP2014200272A (en) * 2013-04-01 2014-10-27 テルモ株式会社 Balloon catheter

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US4921483A (en) * 1985-12-19 1990-05-01 Leocor, Inc. Angioplasty catheter
JP4103567B2 (en) * 2002-12-06 2008-06-18 ニプロ株式会社 Multi-lumen catheter
JP6625992B2 (en) * 2014-09-04 2019-12-25 テルモ株式会社 Catheter and manufacturing method thereof

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Publication number Priority date Publication date Assignee Title
JPS63252166A (en) * 1987-04-08 1988-10-19 オリンパス光学工業株式会社 Balloon catheter
JP2011245114A (en) * 2010-05-28 2011-12-08 Nipro Corp Balloon catheter
JP2014200272A (en) * 2013-04-01 2014-10-27 テルモ株式会社 Balloon catheter

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WO2019181837A1 (en) 2019-09-26
JP7306376B2 (en) 2023-07-11

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Application publication date: 20201020