JP2017113271A - Endoscopic treatment instrument - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an endoscopic treatment instrument with a balloon part which is inflated with less operation load and with which an object such as gallstones is easily removed.SOLUTION: An endoscopic treatment instrument includes a balloon part 2 at a distal end of a catheter tube 5 constituting the endoscopic treatment instrument. A first joining part 4a at which the distal end of the balloon film 3 constituting the balloon part 2 is joined with a distal-side first outer peripheral surface 5a is formed on the balloon film 3. A second joining part 4b at which a proximal end of the balloon film 3 is joined with a distal-side second outer peripheral surface 5b of the catheter tube 5 that is located at a proximal side with respect to the distal-side first outer peripheral surface 5a is formed on the balloon film 3. A second cap member 60b is attached to the catheter tube 5 so as to cover the second joining part 4b of the balloon film 3.SELECTED DRAWING: Figure 2A

Description

  The present invention relates to an endoscopic treatment instrument having a balloon portion such as a calculus removing balloon catheter used for removing calculi generated in, for example, a bile duct.

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

  As a calculus removing balloon catheter used for removing gallstones as described above, for example, one having a structure described in Patent Document 1 is known. In the balloon catheter described in Patent Document 1, a balloon membrane made of a stretchable material is joined to the distal end portion (distal end portion) of the catheter tube to form a balloon portion. The balloon membrane can be inflated by introducing a fluid such as air into the tube using a syringe or the like.

  In order to scrape the gallstones out of the bile duct efficiently with the balloon catheter for stone removal, the balloon part should be large enough for the bile duct lumen so that there is no gap between the inflated balloon part and the bile duct. Need to be inflated. Therefore, when treating a patient with a large bile duct, it is necessary to inflate the balloon portion to a large diameter. In this case, the amount of fluid to be introduced into the balloon portion increases. When the amount of fluid to be introduced into the balloon portion increases, the number of operations for introducing the fluid into the balloon portion increases, and there is a problem that the operation burden increases for the surgeon.

  Further, in the conventional balloon catheter for removing calculus, the outer shape of the inflated balloon part is substantially spherical. However, when the gallstone in the bile duct is scraped out with the substantially spherical balloon part, the gallstone follows the inclination of the balloon part. There is also a problem that the gallstones may not be scraped well because they tend to be guided into a narrow gap between the balloon portion and the bile duct wall.

Japanese Utility Model Publication No. 5-63551

   The present invention has been made in view of such a situation, and an object of the present invention is to provide an endoscopic treatment instrument having a balloon portion that has a small operation burden for inflating the balloon portion and that can easily scrape an object such as a gallstone. Is to provide.

In order to achieve the above object, an endoscopic treatment tool according to a first aspect of the present invention includes:
A catheter tube having a lumen formed along the longitudinal direction;
A balloon portion provided at a distal end portion of the catheter tube, and a treatment instrument for an endoscope,
The balloon membrane constituting the balloon portion has a distal end formed on the balloon membrane, the first joint portion joining the distal end side first outer peripheral surface of the catheter tube.
The balloon membrane has a second joint where a proximal end of the balloon membrane is joined to a distal end side second outer peripheral surface of the catheter tube located closer to the proximal end side than the distal end side first outer peripheral surface. Formed
A second cap member is attached to the catheter tube so as to cover the second joint portion of the balloon membrane.

  In the endoscope treatment tool according to the first aspect of the present invention, the second cap member is attached to the catheter tube so as to cover the second joint portion on the proximal end side of the balloon membrane. Is suppressed by the second cap member from expanding toward the proximal end side in the axial direction. Therefore, in the portion on the proximal end side of the balloon membrane, the balloon membrane expands in the radial direction of the balloon portion, and the proximal end side of the inflated balloon portion forms a substantially flat surface that is nearly perpendicular to the catheter tube. To do. According to the balloon portion having such a shape, gallstones and the like can be scraped out satisfactorily.

  In addition, since the second cap member prevents the balloon membrane from expanding to the proximal end side in the axial direction, the fluid introduced into the balloon portion is preferentially spent inflating the balloon membrane in the radial direction. Become. Therefore, even if the amount of fluid introduced into the balloon portion is small, the balloon portion can be greatly expanded in the radial direction. That is, since the amount of fluid required to inflate the balloon portion to a specific diameter is reduced, the number of operations for introducing the fluid is reduced, and the operation burden on the operator can be reduced.

  Preferably, the second cap is disposed so as to cover the second non-joined portion of the balloon membrane that is disposed adjacent to the second joint and is not joined to the catheter tube together with the second joint. A member is attached to the catheter tube. With this configuration, the amount of fluid necessary for inflating the balloon portion can be further reduced, and the shape of the inflated balloon portion can be made into a shape that facilitates scraping gallstones and the like better.

  Preferably, a first cap member is attached to the catheter tube so as to cover the first joint portion of the balloon membrane. By comprising in this way, since a 1st cap member suppresses that a balloon film expand | swells to the distal end side of an axial direction, the quantity of the fluid required in order to expand a balloon part becomes smaller.

  Preferably, the first cap is disposed so as to cover the first non-joining portion of the balloon membrane, which is disposed adjacent to the first joining portion and is not joined to the catheter tube, together with the first joining portion. A member is attached to the catheter tube. With this configuration, the amount of fluid necessary for inflating the balloon portion can be further reduced, and the shape of the inflated balloon portion can be made into a shape that facilitates scraping gallstones and the like better.

  Preferably, in the first cap member, a first non-bonded covering portion that covers the first non-bonded portion can be elastically deformed with the expansion of the balloon membrane. By comprising in this way, when a balloon film | membrane expand | swells, it becomes possible to suppress that an excessive stress acts on a balloon film | membrane in a contact part with a 1st cap member.

  Preferably, a second non-bonded covering portion that covers the second non-bonded portion of the second cap member is elastically deformable with the expansion of the balloon membrane. By comprising in this way, when a balloon film | membrane expand | swells, it becomes possible to suppress that an excessive stress acts on a balloon film | membrane in a contact part with a 2nd cap member.

In order to achieve the above object, an endoscopic treatment tool according to a second aspect of the present invention includes:
A catheter tube having a lumen formed along the longitudinal direction;
A balloon portion provided at a distal end portion of the catheter tube, and a treatment instrument for an endoscope,
The balloon membrane constituting the balloon portion has a distal end formed on the balloon membrane, the first joint portion joining the distal end side first outer peripheral surface of the catheter tube.
The balloon membrane has a second joint where a proximal end of the balloon membrane is joined to a distal end side second outer peripheral surface of the catheter tube located closer to the proximal end side than the distal end side first outer peripheral surface. Formed
A first cap member is attached to the catheter tube so as to cover the first joint portion of the balloon membrane.

  In the endoscope treatment tool according to the second aspect of the present invention, since the first cap member is attached to the catheter tube so as to cover the first joint portion on the distal end side of the balloon membrane, the balloon membrane The first cap member prevents the first cap member from expanding toward the distal end side in the axial direction. For this reason, the fluid introduced into the balloon portion is preferentially expended in expanding the balloon membrane in the radial direction, and the balloon portion is greatly expanded in the radial direction even if the amount of fluid introduced into the balloon portion is small. Is possible. That is, since the amount of fluid required to inflate the balloon portion to a specific diameter is reduced, the number of operations for introducing the fluid is reduced, and the operation burden on the operator can be reduced.

FIG. 1 is an overall view of a calculus removing balloon catheter according to an embodiment of the present invention. 2A is an enlarged partial cross-sectional view showing a distal end portion of a catheter tube in the calculus removing balloon catheter shown in FIG. FIG. 2B is a partially enlarged cross-sectional view showing a distal end portion of a catheter tube in a calculus removing balloon catheter according to another embodiment of the present invention. FIG. 3 is an enlarged sectional view taken along line III-III shown in FIG. 4 is an enlarged cross-sectional view taken along line IV-IV shown in FIG. FIG. 5 is a partial cross-sectional view of the proximal end side wire insertion hole in the catheter tube shown in FIG. 1.

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

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

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

  As shown in FIG. 2A, a balloon lumen 8, a contrast medium lumen 9, and a main lumen 10 are formed inside the catheter tube 5. That is, the catheter tube 5 is composed of a multi-lumen tube. The balloon lumen 8 is a lumen serving as a flow path for sending a fluid such as air used to inflate the balloon part 2 to the inside of the balloon membrane 3 constituting the balloon part 2, and from the proximal end of the catheter tube 5. , Penetrating to the fluid outlet 11. The fluid outlet 11 is an opening provided at the distal end portion 7 of the catheter tube 5 so as to be positioned inside the balloon membrane 3.

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

  The main lumen 10 penetrates from the proximal end to the distal end of the catheter tube 5, but at the distal end side and the proximal end side with the proximal end side wire insertion hole 10a shown in FIG. The function is different. That is, the distal end opening of the main lumen 10 is formed as a distal end side wire insertion hole 10b at the distal end of the tube 5 located on the distal end side of the balloon portion 2, and the proximal end side wire The distal end main lumen 10c (see FIGS. 2A and 5) of the main lumen 10 located between the insertion hole 10a and the distal end side wire insertion hole 10b functions as a wire lumen (distal end side wire passage). To do.

  Further, the proximal end main lumen 10d of the main lumen 10 located closer to the proximal end side than the proximal end side wire insertion hole 10a shown in FIG. 5 functions as a lumen for inserting a stylet, for example. . The stylet is used for the purpose of increasing the rigidity of the catheter tube 5 and improving the insertion of the calculus removal balloon catheter 1 into the endoscope or the body, and is made of, for example, a metal such as stainless steel. A linear body (such as a stranded wire or a straight line) or a rod-shaped body.

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

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

  In order to realize the structure shown in FIG. 5, for example, first, a proximal end side wire that communicates only with the main lumen 10 at a predetermined position in the longitudinal direction of the catheter tube 5 (position L <b> 2 shown in FIG. 1). The insertion hole 10a is formed. The inner diameter of the insertion hole 10a is substantially the same as the outer diameter of a temporary tube (temporary core material) (not shown), and has a size that allows the temporary tube to be intimately inserted into the insertion hole 10a.

  At the same time, a filling hole 10e communicating only with the main lumen 10 is formed at a position away from the proximal end side wire insertion hole 10a by a predetermined distance in the proximal end direction. The inner diameter of the filling hole 10e is not particularly limited, and may be any size as long as it can be filled with the pre-curing filler (filler 40 in FIG. 5) in a fluid state.

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

  The temporary tube is moved to the proximal end so that the distal end of the temporary tube (not shown) is located at the distal main lumen 10c of the main lumen 10 and the proximal end protrudes from the proximal wire insertion hole 10a. The wire is inserted into the side wire insertion hole 10a. Thereafter, the pre-curing filler in a fluid state is filled to the proximal end side of the temporary lumen 10 through the filling hole 10e. In addition, although the tube-shaped temporary tube is used as the temporary core material inserted in the main lumen 10, the temporary core material may be solid.

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

  The filling amount of the pre-curing filling material in a fluidized state is not particularly limited, but at least the main lumen 10 directed toward the proximal end from the proximal end side outer peripheral surface of the temporary tube inserted inside the main lumen 10 is completely blocked. It is preferable that the amount be sufficient. Moreover, as shown in FIG. 5, it is preferable that the filling amount is such that the filling hole 10e is completely blocked and is slightly raised from there. Further, the filling amount may be such that it rises to the outside of the main lumen 10 from the gap between the proximal end side wire insertion hole 10a and the temporary tube.

  Next, the filler 40 is cured by a curing method according to the type of the pre-curing filler used, and the lumen 10 extending from the proximal end side wire insertion hole 10a toward the proximal end is cured. It is blocked by. Next, the hardened filling 40 is left, and the temporary tube is pulled out from the proximal end side wire insertion hole 10 a and removed from the main lumen 10. As a result, on the distal end side of the filler 40, an inclined surface 42 inclined from the proximal end side wire insertion hole 10a toward the distal end of the main lumen 10 is transferred along the outer peripheral surface shape of the temporary tube. Formed.

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

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

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

  As shown in FIG. 2, the balloon membrane 3 constituting the balloon portion 2 of the calculus removing balloon catheter 1 is attached to the distal end portion of the catheter tube 5 so as to cover the fluid outlet 11. The balloon membrane 3 is formed of a stretchable material, and is inflated by introducing a fluid into the inside through the balloon lumen 8 of the catheter tube 5. The inflated balloon membrane 3 can scrape or extrude the calculus to remove the calculus in the body.

  The stretchable material forming the balloon membrane 3 preferably has a 100% modulus (measured in accordance with JIS K 6251) of 0.1 to 10 Mpa, and particularly preferably 1 to 5 Mpa. Specific examples of the stretchable material suitable for forming the balloon membrane 3 include natural rubber, silicone rubber, polyurethane elastomer and the like.

  As shown in FIG. 2A, the balloon membrane 3 constituting the balloon portion 2 has a tubular shape as a whole, and the first joint portion 4a and the second joint portion 4b joined to the outer peripheral surface of the catheter tube 5 at both ends thereof. The balloon membrane 3 that is not joined to the outer peripheral surface of the catheter tube 5 and expands when fluid is introduced therein is formed between the joint portions 4a and 4b. . In the present embodiment, the inflated portion of the balloon membrane 3 has a substantially circular longitudinal section in a state where substantially no fluid is introduced into the balloon membrane 3 (the state of the balloon portion 2 shown by a solid line in FIG. 1). It is formed as follows. Since the inflated portion of the balloon membrane 3 has such a shape, the balloon portion 2 can be greatly inflated as compared with the case where the balloon membrane uses a cylindrical balloon portion as a whole. The removal performance such as calculus of 2 becomes better.

  In the present embodiment, at the first joint 4 a located at the distal end of the balloon membrane 3, the distal end of the balloon membrane 3 is joined to the distal end side first outer peripheral surface 5 a of the catheter tube 5. Further, in the second joint portion 4 b located at the proximal end of the balloon membrane 3, the proximal end of the balloon membrane 3 is located closer to the proximal end side than the distal end side first outer peripheral surface 5 a of the catheter tube 5. The distal end side second outer peripheral surface 5b of the catheter tube 5 is joined.

  The method for joining at the first joint 4a and the second joint 4b is not particularly limited, and examples thereof include adhesion using an adhesive, thermal fusion, welding with a solvent, and ultrasonic welding. The axial lengths L4a and L4b of the joints 4a and 4b may be the same or different, but are preferably in the range of 0.2 to 5 mm.

  In the present embodiment, a cylindrical first cap member 60a is provided so as to cover at least the distal end side first joint portion 4a of the balloon membrane 3 joined to the distal end side first outer peripheral surface 5a of the catheter tube 5. Is attached to the catheter tube 5. Further, the cylindrical second cap member 60b is formed so as to cover the proximal end side second joint portion 4b of the balloon membrane 3 joined to the distal end side second outer peripheral surface 5b of the catheter tube 5. 5 is attached. The method for joining the cap members 60a and 60b on the outer peripheral surfaces 5a and 5b of the catheter tube 5 is not particularly limited, and examples thereof include adhesion using an adhesive, thermal fusion, welding with a solvent, and ultrasonic welding. The

  The first cap member 60a is arranged so as to be adjacent to the proximal end side of the first joint portion 4a, and the first non-joint portion 4c of the balloon membrane 3 that is not joined to the catheter tube 5 is replaced with the first joint portion. It is preferable that it is attached to the catheter tube 5 so as to cover it together with 4a. Similarly, the second cap member 60b is disposed so as to be adjacent to the distal end side of the second joint portion 4b, and the second non-joint portion 4d of the balloon membrane 3 that is not joined to the catheter tube 5 is provided. It is preferable to attach to the catheter tube 5 so as to cover the second joint 4b.

  The axial lengths of the first non-joining portion 4c and the second non-joining portion 4d may be the same or different, but are preferably 0 to 10 mm, and more preferably 0.5 to 5 mm. The axial lengths L6a and L6b of the cap members 60a and 60b may be the same or different, but are preferably equal to or greater than L4a + L5a and L4b + L5b, respectively.

  In the present embodiment, the first inner peripheral surface 62a of the first cap member 60a is the same along the axial direction. When the axial length L6a of the first cap member 60a is longer than L4a + L5a, a first inner peripheral gap 64a is formed between the first cap member 60a and the outer peripheral surface of the catheter tube 5 on the distal end side. . The first inner circumferential gap 64a may be filled with an adhesive. The second inner peripheral surface 62b of the second cap member 60b is the same along the axial direction. When the axial length L6b of the second cap member 60b is longer than L4b + L5b, a second inner peripheral gap 64b is formed between the second cap member 60b and the outer peripheral surface of the catheter tube 5 on the proximal end side. . The inside of the second inner peripheral gap 64b may be filled with an adhesive.

  In the present embodiment, the proximal end surface 68a of the first cap member 60a is formed as a hollow circular surface substantially perpendicular to the axis of the catheter tube 5. When fluid is introduced into the balloon membrane 3 and the balloon membrane 3 is inflated, on the distal end side of the balloon portion 2, the inflated balloon membrane 3 comes into contact with the proximal end surface 68a of the first cap member 60a. Inflation of the balloon membrane 3 toward the distal end side in the axial direction is suppressed. The distal end surface 68b of the second cap member 60b is also formed as a hollow circular surface substantially perpendicular to the axis of the catheter tube 5. When fluid is introduced into the balloon membrane 3 and the balloon membrane 3 is inflated, the balloon membrane 3 inflated comes into contact with the distal end surface 68b of the second cap member 60b on the proximal end side of the balloon portion 2, Inflation of the balloon membrane 3 to the proximal end side in the axial direction is suppressed. The width of the proximal end surface 68a of the first cap member 60a (the thickness at the proximal end of the first cap member 60a) and the width of the distal end surface 68b of the second cap member 60b (at the distal end of the second cap member 60b) The thickness) may be any thickness as long as it can sufficiently suppress the expansion of the balloon membrane 3 in the axial direction and does not interfere with the insertion into the endoscope. Preferably it is 0.2-2 mm, More preferably, it exists in the range of 0.3-1 mm.

  It is preferable that a tapered portion whose outer diameter becomes narrower toward the distal end side is formed on the outer peripheral surface of the first cap member 60a on the distal end side. This is to reduce the resistance when the balloon catheter 1 is inserted. Moreover, it is preferable that the outer peripheral surface at the proximal end side of the 2nd cap member 60b is formed with the taper part which an outer diameter becomes thin toward the proximal end side. This is to reduce the resistance when the balloon catheter 1 is pulled out.

  At the distal end of the catheter tube 5, the first cap member 60 a is attached to the catheter tube 5 so that the distal end tip 5 c located on the distal end side of the distal end of the first cap member 60 a remains. It is preferable to be joined to the outer periphery. The axial length L7 of the distal end tip 5c is preferably 0.5 to 20 mm.

  In the balloon part 2, the axial length (length along the longitudinal direction of the catheter tube 5) L8 of the balloon membrane 3 not covered with the cap members 60a and 60b is preferably 5 to 20 mm. The thickness is preferably 0.10 to 0.50 mm.

  When the calculus removing balloon catheter 1 is provided with an ejection port for ejecting a contrast medium, the position is within 10 mm (more preferably within 5 mm) from the proximal end of the second cap member 60b toward the proximal end. It is preferable to provide on the surface of the catheter tube 5. If the spout 12 is provided at this position, the balloon membrane 3 is inflated to block the body lumen, and then the contrast medium is spouted from the spout 12 to be positioned on the near side of the inflated balloon 2. This is because the body lumen can be efficiently imaged.

  However, the spout is located on the surface of the catheter tube 5 at a position within 10 mm (more preferably within 5 mm) from the distal end of the balloon portion 2 (first cap member 60a in this embodiment) toward the distal end. May be provided. In the case where the ejection port is provided on the distal end side of the balloon part 2, before the balloon part 2 is inflated in the body lumen, the contrast medium is ejected from the ejection port, and the body lumen is imaged by imaging. By confirming the situation in the lumen, the balloon part 2 can be easily inserted at a more appropriate position.

  The shape of the joint portions 4a and 4b located at both axial ends of the balloon membrane 3 of the balloon portion 2 is not particularly limited as long as it can be joined to the distal end portion 7 of the catheter tube 5, but is cylindrical. It is preferable. When the joint portions 4 a and 4 b of the balloon portion 2 are cylindrical, the inner diameter is preferably substantially equal to the outer diameter of the catheter tube 5. Moreover, the thickness of the joint portions 4a and 4b of the balloon portion 2 is not particularly limited, and may be substantially equal to the thickness of the inflated portion of the balloon membrane 3, for example.

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

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

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

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

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

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

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

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

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

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

  Next, after pushing the catheter 1 to the deep part of the bile duct, air is sent into the balloon membrane 3 of the balloon part 2 via the hub 15a, the branch pipe 14a and the balloon lumen 8 by a syringe or the like. Inflates. At this time, in the catheter 1 of the present embodiment, since the amount of fluid necessary for inflating the balloon portion 2 to a necessary diameter is small, the number of operations of a syringe or the like for introducing the fluid into the balloon portion 2 is small. Therefore, the burden on the operator's operation is small.

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

  At this time, in the catheter 1 of the present embodiment, since the balloon portion 2 can be inflated to a sufficient size in the radial direction, a gap is hardly formed between the inner wall of the bile duct and the balloon portion 2, and in FIG. Like the shape of the balloon part 2 shown by the dotted line, the proximal end side of the inflated balloon part 2 forms a substantially flat surface that is nearly perpendicular to the catheter tube 5, so that by capturing gallstones in this plane, Gallstones can be scraped easily. In addition, the gallstones scraped out of the bile duct are normally discharged naturally outside the body. That is, according to the balloon catheter 1 of this embodiment, it becomes easy to quickly discharge stones such as gallstones from the body using the balloon unit 2.

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

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

  Furthermore, in the balloon catheter 1 of the present embodiment, an inclined surface 42 for easily guiding the wire 20 from the proximal end side wire insertion hole 10a toward the distal end of the main lumen 10 is formed in the cured filler 40. Therefore, the proximal end of the guide wire 20 is pushed through the distal end side wire passage 10c only by pushing the proximal end of the guide wire 20 through the distal end side wire insertion hole 10c. It is guided toward the insertion hole 10a, and the work of pulling out the guide wire 20 therefrom becomes easy.

  Further, since the filler 40 is filled in the main lumen 10 located near the proximal end side wire insertion hole 10a, the vicinity of the proximal end side wire insertion hole 10a is reinforced, Kink can be effectively prevented.

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

  In the present embodiment, the outer peripheral surface of the catheter tube 5 located on the proximal end side of the proximal end side wire insertion hole 10a is filled with a filling material that flows before being hardened into the lumen 10. A filling hole 10e is formed, and the filling hole 10e is closed by the filling 40 after curing. With such a configuration, the operation of filling the pre-curing filling into the main lumen 10 of the catheter tube 1 near the proximal end side wire insertion hole 10a is facilitated. Further, since the filling hole 10e is closed by the filling 40 after curing, the filling hole 10e and the inside of the main lumen 10 do not communicate with each other.

  Moreover, as shown in FIG. 5, the opening edge of the hole 10e for filling will be reinforced with a part of the filling 40 after hardening. Furthermore, the opening edge of the proximal end side wire insertion hole 10a is also reinforced by a part of the filling 40 after being cured.

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

  In particular, in this embodiment, since the second cap member 60b is attached to the catheter tube 5 so as to cover the second joint 4b on the proximal end side of the balloon membrane, the balloon membrane 3 is proximal in the axial direction. The second cap member 60b suppresses expansion to the end side. Therefore, in the portion on the proximal end side of the balloon membrane 3, the balloon membrane 3 is expanded in the radial direction of the balloon portion 2, and the proximal end side of the expanded balloon portion 2 is perpendicular to the catheter tube 5. Forms a nearly flat surface. According to the balloon portion 2 having such a shape, gallstones and the like can be scraped out satisfactorily.

  In addition, since the second cap member 60b prevents the balloon membrane 3 from expanding toward the proximal end in the axial direction, the fluid introduced into the balloon portion 2 preferentially expands the balloon membrane 3 in the radial direction. Will be spent. Therefore, even if the amount of fluid introduced into the balloon part 2 is small, the balloon part 2 can be greatly expanded in the radial direction. That is, since the amount of fluid required for inflating the balloon portion 2 to a specific diameter is reduced, the number of operations for introducing the fluid is reduced, and the operation burden on the operator can be reduced.

  Furthermore, since the second cap member 60b is attached to the catheter tube 5 so as to cover the second non-joining portion 4d of the balloon membrane 3 together with the second joining portion 4b, it is necessary for further inflating the balloon portion 2. In addition, the amount of fluid can be reduced, and the shape of the inflated balloon portion 2 can be made into a shape that facilitates scraping gallstones and the like better.

  Further, since the first cap member 60a is attached to the catheter tube so as to cover the first joint portion 4a of the balloon membrane 3, it is possible to prevent the balloon membrane 3 from expanding toward the distal end side in the axial direction. The member 60a suppresses. For this reason, the amount of fluid required to inflate the balloon portion 2 is reduced.

  Further, the first cap member is disposed so as to cover the first non-joining portion 4c of the balloon membrane 3 which is disposed adjacent to the first joint portion 4a and is not joined to the catheter tube 5 together with the first joint portion 4a. 60 a is attached to the catheter tube 5. By configuring in this way, the amount of fluid required for inflating the balloon part 2 is further reduced, and the shape of the inflated balloon part 2 can be made easier to scrape gallstones and the like. it can.

  In the present embodiment, the first non-bonded covering portion 66 a that covers the first non-bonded portion 4 c in the first cap member 60 a can be elastically deformed with the expansion of the balloon membrane 3. With this configuration, when the balloon membrane 3 is inflated, it is possible to suppress an excessive stress from acting on the balloon membrane 3 at the contact portion with the first cap member 60a.

  Similarly, the second non-bonded covering portion 66b that covers the second non-bonded portion 4d in the second cap member 60b can be elastically deformed as the balloon membrane 3 expands. With this configuration, when the balloon membrane 3 is inflated, it is possible to suppress an excessive stress from acting on the balloon membrane 3 at the contact portion with the second cap member 60b. From such a viewpoint, it is preferable that the cap members 60a and 60b as a whole, or in particular, the non-bonded covering portions 66a and 66b are made of an elastically deformable synthetic resin.

Second Embodiment The balloon catheter 1a of the present embodiment shown in FIG. 2B has the same configuration and operational effects as those of the first embodiment described above, except for the following, and description of common parts is omitted. Then, the common member code | symbol is attached | subjected to the common member. As shown in FIG. 2B, the first cap member 60 a 1 covering the distal end side first joint portion 4 a of the balloon membrane 3 joined to the distal end side first outer peripheral surface 5 a of the catheter tube 5 includes the catheter tube 5. It is joined near the distal end tip 5c.

  In the present embodiment, the first cap member 60a1 does not have the first inner peripheral surface 62a1 having the same inner diameter along the axial direction, but on the outer periphery of the first joint portion 4a and the first non-joint portion 4c. It has an inner diameter substantially equal to these outer diameters, and has an inner diameter substantially equal to the outer diameter of the catheter tube 5 on the distal end side of the first joint 4a. That is, on the distal end side of the first cap member 60a1, a first inward convex portion 64a1 having an inner diameter substantially equal to the outer diameter of the catheter tube 5 is formed.

  Similarly, the second cap member 60b1 does not have the first inner peripheral surface 62b1 having the same inner diameter along the axial direction, but on the outer periphery of the second joint portion 4b and the second non-joint portion 4d. And has an inner diameter substantially equal to the outer diameter of the catheter tube 5 on the proximal end side of the second joint 4b. That is, on the proximal end side of the second cap member 60b1, a second inward convex portion 64b1 having an inner diameter substantially equal to the outer diameter of the catheter tube 5 is formed.

  In the present embodiment, at least one of the first cap member 60a1 or the second cap member 60b1 may be mounted so as to be movable and adjustable along the axial direction of the catheter tube 5. Alternatively, at least one of them may be fixed to the catheter tube 5 by a bonding method such as an adhesive. By attaching these cap members 60a1 or 60b1 along the axial direction of the catheter tube 5 so that the movement can be adjusted, the axial length L5a or L5b of the non-joint portion 4c or 4d can be adjusted, and the balloon membrane 3 expansion shapes can be controlled. Alternatively, both the first cap member 60a1 and the second cap member 60b1 may be fixed to the catheter tube 5 after controlling the expansion shape of the balloon membrane 3.

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

  For example, in the above-described embodiment, both the first cap members 60a and 60a1 and the second cap members 60b and 60b1 are used, but only the second cap members 60b and 60b1 may be attached to the catheter tube 5. Alternatively, only the first cap members 60 a and 60 a 1 may be attached to the catheter tube 5.

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

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

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

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

  Furthermore, in the above-described embodiment, the endoscope treatment tool is a calculus removal balloon catheter used for gallstone removal, but is not necessarily limited thereto, and can be any one that is used via an endoscope. It may be a balloon catheter used for other purposes.

1 ... Balloon catheter for calculus removal (endoscopic instrument)
2 ... Balloon part (treatment part)
DESCRIPTION OF SYMBOLS 3 ... Balloon membrane 4a ... 1st junction part 4b ... 2nd junction part 4c ... 1st non-joint part 4d ... 2nd non-joint part 5 ... Catheter tube 5a ... Distal end side 1st outer peripheral surface 5b ... Distal end side 2nd outer peripheral surface 5c ... Distal end tip 6 ... Proximal end 7 ... Distal end 8 ... Balloon lumen 9 ... Contrast medium lumen 10 ... Main lumen 10a ... Proximal end side wire insertion hole 10b ... Distal end Side wire insertion hole 10c ... Distal end side main lumen 10d ... Proximal end side main lumen 10e ... Filling hole 11 ... Fluid outlet 12 ... Jet port 13 ... Covers 14a-14c ... Branch pipes 15a-15c ... Hub 20 ... Guide wire 40 ... Filler 50 ... Endoscope channels 60a, 60a1 ... First cap members 60b, 60b1 ... Second cap members 62a, 62a1 ... First inner peripheral surfaces 62b, 62b1 ... Second inner peripheral surfaces 64a ... First Within 1 Gaps 64b ... second inner peripheral clearance 64a1 ... first inner protrusion 64b1 ... second inner protrusion

Claims (7)

A catheter tube having a lumen formed along the longitudinal direction;
A balloon portion provided at a distal end portion of the catheter tube, and a treatment instrument for an endoscope,
The balloon membrane constituting the balloon portion has a distal end formed on the balloon membrane, the first joint portion joining the distal end side first outer peripheral surface of the catheter tube.
The balloon membrane has a second joint where a proximal end of the balloon membrane is joined to a distal end side second outer peripheral surface of the catheter tube located closer to the proximal end side than the distal end side first outer peripheral surface. Formed
A treatment instrument for an endoscope, wherein a second cap member is attached to the catheter tube so as to cover the second joint portion of the balloon membrane.   The second cap member is disposed so as to be adjacent to the second joint part and covers the second non-joint part of the balloon membrane that is not joined to the catheter tube together with the second joint part. 2. The endoscope treatment tool according to claim 1, wherein the treatment tool is attached to a catheter tube.   The treatment instrument for endoscope according to claim 1 or 2, wherein a first cap member is attached to the catheter tube so as to cover the first joint portion of the balloon membrane.   The first cap member is disposed so as to be adjacent to the first joint part and covers the first non-joint part of the balloon membrane that is not joined to the catheter tube together with the first joint part. The endoscopic treatment tool according to claim 3, which is attached to a catheter tube.   The treatment instrument for an endoscope according to claim 4, wherein a first non-bonded covering portion that covers the first non-bonded portion in the first cap member is elastically deformable along with the expansion of the balloon membrane.   6. The endoscope according to claim 2, wherein a second non-bonded covering portion that covers the second non-bonded portion of the second cap member is elastically deformable with expansion of the balloon membrane. Treatment tool. A catheter tube having a lumen formed along the longitudinal direction;
A balloon portion provided at a distal end portion of the catheter tube, and a treatment instrument for an endoscope,
The balloon membrane constituting the balloon portion has a distal end formed on the balloon membrane, the first joint portion joining the distal end side first outer peripheral surface of the catheter tube.
The balloon membrane has a second joint where a proximal end of the balloon membrane is joined to a distal end side second outer peripheral surface of the catheter tube located closer to the proximal end side than the distal end side first outer peripheral surface. Formed
A treatment instrument for an endoscope, wherein a first cap member is attached to the catheter tube so as to cover the first joint portion of the balloon membrane.

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