WO2015198735A1 - カテーテル、カテーテル製造用金型、カテーテルの製造方法 - Google Patents
カテーテル、カテーテル製造用金型、カテーテルの製造方法 Download PDFInfo
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- WO2015198735A1 WO2015198735A1 PCT/JP2015/063808 JP2015063808W WO2015198735A1 WO 2015198735 A1 WO2015198735 A1 WO 2015198735A1 JP 2015063808 W JP2015063808 W JP 2015063808W WO 2015198735 A1 WO2015198735 A1 WO 2015198735A1
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- tube
- inner tube
- catheter
- cross
- outer tube
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M25/0028—Multi-lumen catheters with stationary elements characterized by features relating to at least one lumen located at the proximal part of the catheter, e.g. alterations in lumen shape or valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0097—Catheters; Hollow probes characterised by the hub
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/14—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
- B29C45/14336—Coating a portion of the article, e.g. the edge of the article
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/14—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
- B29C45/14467—Joining articles or parts of a single article
- B29C45/14491—Injecting material between coaxial articles, e.g. between a core and an outside sleeve for making a roll
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
- A61M25/0026—Multi-lumen catheters with stationary elements
- A61M2025/0039—Multi-lumen catheters with stationary elements characterized by lumina being arranged coaxially
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2207/00—Methods of manufacture, assembly or production
- A61M2207/10—Device therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
- A61M25/0014—Connecting a tube to a hub
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1036—Making parts for balloon catheter systems, e.g. shafts or distal ends
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2023/00—Use of polyalkenes or derivatives thereof as moulding material
- B29K2023/04—Polymers of ethylene
- B29K2023/06—PE, i.e. polyethylene
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
- B29L2031/7542—Catheters
- B29L2031/7543—Balloon catheters
Definitions
- the present invention relates to a catheter, a catheter manufacturing die, and a catheter manufacturing method.
- This application claims priority based on Japanese Patent Application No. 2014-133186 for which it applied to Japan on June 27, 2014, and uses the content here.
- Examples of treatment tools for treating a living body include catheters used in endoscopes and the like (see, for example, Patent Documents 1 to 3).
- the catheter has, for example, a plurality of lumens, and a plurality of ducts over almost the entire length.
- a balloon catheter or the like at least a part of a plurality of conduits is closed or sealed at one end.
- a catheter in which both ends of the conduit are open is also used.
- the medical balloon catheter described in Patent Document 3 has a balloon attached to the distal end of a flexible tube, and a main passage for feeding a drug such as a contrast medium to the flexible tube, and the balloon A passage for supplying a fluid for inflating the liquid is integrally formed.
- the flexible tube is branched into two tubes individually connected to the main passage and the passage by a branch portion provided on the base end side. Separate bases are attached to the extended ends of the two tubes.
- the main passage and the passage are branched at an appropriate angle with respect to the tube axis direction at the branch portion, and the periphery thereof is covered with a resin such as an adhesive, and the resin is formed into an appropriate shape. Solidified and solidified to form a branched portion.
- the present invention has been made in view of the above circumstances, and aims to achieve the following objects. 1. It is possible to provide a catheter having multiple lumens that can minimize line resistance and maximize internal fluid flow. 2. To prevent the sheath from collapsing due to the injection pressure when the branch part is outserted.
- the catheter according to the first aspect of the present invention includes an outer tube, an inner tube provided inside the outer tube, and a branch portion that separates the outer tube and the inner tube on the first end side.
- the ratio of the cross-sectional area of the second lumen formed in the inner tube to the cross-sectional area of the first lumen formed at least inside the outer tube and outside the inner tube is a length direction in which the outer tube and the inner tube extend, and the branch portion is equal to the value of the cross-sectional area ratio when the inner tube is disposed in the outer tube.
- the cross-sectional area ratio between the outer tube and the inner tube is set to the same value or more.
- the lengthwise central axis of the outer tube from the second end side of the branching portion toward the first end portion side and the The outer tube and the inner tube may be separated so that the central axis of the inner tube in the length direction is separated.
- the outer tube, the inner tube provided inside the outer tube, and the outer tube and the inner tube are separated on the first end side.
- the ratio (the cross-sectional area of the first lumen / the cross-sectional area of the second lumen) is the length direction in which the outer tube and the inner tube extend, and the cross-sectional area in the state where the inner tube is disposed in the outer tube.
- the cross-sectional area ratio between the front outer tube and the inner tube at the branch portion is set to be equal to or greater than the ratio value, and the first end from the second end side of the branch portion.
- a central axis in the length direction of the outer tube toward the end side A mold for manufacturing the catheter in which the outer tube and the inner tube are separated so that the central axis in the length direction of the inner tube is separated from the inner tube, and the mold is located in the outer tube and the outer tube.
- An outer shape of the branch portion is formed to cover the first cored bar inserted into the gap with the inner tube, the second cored bar inserted into the inner tube, the first cored bar, and the second cored bar.
- An outer mold, and in the first core bar, an insertion portion to be inserted into the outer tube has an outer surface portion along the inside of the outer tube and an inner surface portion along the outside of the inner tube.
- the inner surface portion is a groove corresponding to the outer shape of the inner tube, and the groove of the insertion portion is provided with a terminal end in the length direction, and the first cored bar extends from the terminal end to the base of the branch portion.
- the diameter of the outer mold is increased toward the end side, and the outer mold, the inner pipe, and the inserted into the outer mold And 1 and groove which branches the second metal core with a possible Y-shaped arrangement, wherein and the formation capable space bifurcations are arranged with these grooves.
- the cross-sectional shape of the insertion portion of the first core metal in a direction intersecting the axis is substantially crescent. Also good. Further, the second cored bar may have a substantially circular cross-sectional shape in a direction intersecting the axis.
- a method for manufacturing a catheter according to a fifth aspect of the present invention is a method for manufacturing a catheter using the mold described above, the step of inserting the second core bar into the inner tube, and the second core bar. Disposing the inserted inner tube in the groove of the first core, Inserting the second cored bar, the inner pipe and the first cored bar into the outer pipe; The step of disposing the second core bar, the inner tube, the first core bar, and the outer tube in the corresponding groove portion of the outer mold, and injecting resin into the space portion to form the branch portion And a step of releasing the metal mold and removing the core metal.
- the outer tube and the outer tube are arranged so that the cross-sectional area ratio between the first lumen and the second lumen is not reduced compared to the cross-sectional area ratio when the inner tube is arranged in the outer tube.
- An inner tube is arranged. Therefore, it is possible to provide a catheter having a plurality of lumens capable of minimizing the duct resistance of the fluid flowing in the first lumen and the second lumen and maximizing the flow rate of the fluid flowing in the interior. Further, it is possible to improve the sealing performance at the branch portion, and to reduce the cost in manufacturing the catheter.
- 1 is a perspective view showing a first embodiment of a catheter according to the present invention. It is an expansion perspective view which shows the branch part vicinity in 1st Embodiment of the catheter which concerns on this invention. It is sectional drawing which shows 1st Embodiment of the catheter which concerns on this invention. It is sectional drawing which shows 1st Embodiment of the catheter which concerns on this invention. It is sectional drawing which shows 1st Embodiment of the catheter which concerns on this invention. It is sectional drawing which shows 1st Embodiment of the catheter which concerns on this invention. It is sectional drawing which shows 1st Embodiment of the catheter which concerns on this invention. It is sectional drawing which shows 1st Embodiment of the catheter which concerns on this invention. It is sectional drawing which shows 1st Embodiment of the catheter which concerns on this invention.
- FIG. 1 is a perspective view showing a catheter in the present embodiment
- FIG. 2 is an enlarged perspective view of FIG. 1
- reference numeral 1 in the figure is a catheter.
- the catheter 1 in this embodiment is a balloon catheter. Note that the present invention is not limited to balloon catheters, and can be applied to other types of catheters. As shown in FIG. 1, the catheter 1 in this embodiment is provided inside a cylindrical outer tube 2 having flexibility, a balloon 3 attached to the tip of the outer tube 2, and the outer tube 2. A cylindrical inner tube 4 and a branch portion 6 that separates the outer tube 2 and the inner tube 4 on the base end (first end) side.
- a first lumen 5 is formed on the inner side of the outer tube 2 and an outer side of the inner tube 4 on the tip side of the branch portion 6, and similarly, a second lumen 7 is formed in the inner tube 4.
- the outer tube 2 branches from a branch portion 6 provided on the base end side into a tube 8 individually connected to the first lumen 5 and a tube 9 communicating with the second lumen 7.
- Separate bases 4a and 8b are attached to the extended tips of the two tubes 8 and 9, respectively.
- polyethylene resin or the like can be used in consideration of adhesiveness and processability with the balloon 3.
- materials constituting the outer tube 2 and the inner tube 4 include polyethylene resin, vinyl chloride resin (particularly soft vinyl chloride resin), silicone rubber, polyurethane resin, and the like.
- the material constituting the outer tube 2 and the inner tube 4 it is preferable to use the same material as that of the balloon 3.
- the outer tube 2 and the inner tube 4 may be made of different materials, but are preferably made of the same material. Thereby, since the material of the catheter 1 for medical use can be made common, productivity can be improved.
- the inner diameter of the outer tube 2 is not particularly limited, but is preferably 1 to 9 mm, and particularly preferably 2 to 4 mm.
- the outer diameter is not particularly limited, but is preferably 2 to 10 mm, and particularly preferably 3 to 5 mm. When the inner and outer diameters are within the above range, the outer tube 2 that is not bulky and has a low flow resistance when the branch portions are bundled can be configured.
- the inner diameter of the inner tube 4 is not particularly limited, but is preferably 1 to 9 mm, particularly preferably 0.3 to 3 mm.
- the outer diameter is not particularly limited, but is preferably 1 to 5 mm, particularly preferably 1 to 3 mm. When the inner and outer diameters are within the above range, the inner tube 4 that is not bulky when bundled and has low flow resistance can be configured.
- the balloon 3 is a tube manufactured from, for example, polyethylene or nylon, and is provided at the distal end of the catheter 1.
- the first lumen 5 communicates with the balloon 3 and is configured to supply a fluid for inflating the balloon 3.
- the second lumen 7 is open to communicate with the distal end side of the catheter 1.
- the second lumen 7 can be inserted with a guide wire or a stylet, or a contrast medium can be injected into the lumen.
- the first lumen 5 that supplies fluid to the balloon 3 does not reach the distal end portion of the inner tube 4 in the catheter 1.
- the second lumen 7 is positioned in the center.
- the distal end portion of the inner tube 4 is configured to be tapered toward the distal end, and to maintain the thickness of the peripheral edge of the distal end.
- the outer tube 2 and the inner tube 4 are separated so that the shaft is separated.
- the outer tube 2 is fitted into the branch portion 6 as a tube 8 that is a separate member having the same outer diameter as the outer diameter of the outer tube 2 on the proximal side of the branch portion 6.
- the inner tube 4 is fitted into the branch portion 6 as a tube 9 that is a tube material having the same outer diameter as the outer diameter of the inner tube 4 on the proximal end side with respect to the branch portion 6.
- the inner tube 4 may be a tube material that is continuous on the proximal end side and the distal end side of the branch portion 6.
- the inner tube 4 in the cross-sectional area SA of the first lumen 5 formed at least inside the outer tube 2 and outside the inner tube 4 over the entire length thereof.
- the ratio of the cross-sectional area SB of the second lumen 7 formed by is set to be a certain value or more.
- 3A to 3E are cross-sectional views taken along the arrow in the catheter of the present embodiment. Specifically, at the position indicated by arrows AA in FIG. 1, the longitudinal center axis of the outer tube 2 and the longitudinal center axis of the inner tube 4 are coaxial as shown in FIG. 3A. (The state in which the central axis of the outer tube 2 and the central axis of the inner tube 4 coincide).
- the central axis of the outer tube 2 and the central axis of the inner tube 4 are decentered from the coaxial state, as shown in FIG. 3B. (The center axis of the outer tube 2 and the center axis of the inner tube 4 are shifted).
- the outer tube 2 and the inner tube 4 are branched from the branch portion 6 indicated by arrow DD in FIG. Is provided with a tube 8 instead of the outer tube 2.
- the inner diameter of the tube 8 is set to be equal to the inner diameter of the outer tube 2 and the sectional area SA of the first lumen is larger than the reference position, the sectional area of the first lumen / second.
- the lumen cross-sectional area SA / SB is a value larger than the previous reference value and not smaller than the reference value.
- the length in which the catheter 1 extends is larger than the cross-sectional ratio at the position where the inner tube 4 is disposed in the outer tube 2 serving as a reference, in the sectional ratio SA / SB in the branch portion 6 in the present embodiment. It is set to maintain a large state over the entire length in the direction.
- a fluid such as water or air flows as much as possible with a low load. be able to. For example, as shown in FIG.
- the first lumen, the central axis of 5a and the central axis of the second lumen 7a are not coaxial. Even if the second lumen 7a having the same diameter as the second lumen 7 can be provided, the first lumen 5a does not have the same cross-sectional dimension as the first lumen 5, and the SA / SB becomes smaller. For this reason, duct resistance becomes large and flow volume will decrease rather than the catheter 1 of this embodiment.
- the mold 10 in the method for manufacturing the catheter 1 of the present embodiment, a mold 10 as shown in FIG. 4 is used.
- the mold 10 includes an upper mold (outer mold) 11, a lower mold (outer mold) 12, a thick core metal (first core metal) 13, and a core metal (second core metal) 14. It consists of.
- the inner surface (mating surface) of the upper mold 11 includes a space portion (cavity) 11 a that forms a resin molding space serving as the branch portion 6, a first groove 11 b in which the distal end side of the outer tube 2 can be disposed, and an outer tube 2.
- the first to fifth grooves (groove parts) 11b to 11f are provided on a reference surface that is substantially in the same plane at a position facing the space part 11a where the branch part 6 can be formed.
- a gate (not shown) for filling the resin constituting the branch portion 6 is provided so as to communicate with the space portion 11a from the side surface portion of the upper mold 11.
- the space portion 11a has a rectangular shape as the branching portion 6, for example, but may have a predetermined shape.
- the inner surface (matching surface) of the lower mold 12 includes a space portion (cavity) 12a constituting a resin molding space serving as the branch portion 6, a first groove 12b in which the distal end side of the outer tube 2 can be disposed, and an outer tube.
- the first to fifth grooves (groove parts) 12b to 12f are provided on a reference surface that is substantially in the same plane at a position facing the space part 12a where the branch part 6 can be formed.
- the first grooves 11 b and 12 b communicate the cavities 11 a and 12 a with the outside of the molds 11 and 12, and the outer pipe 2 is sandwiched between the molds 11 and 12 in a shape corresponding to the outer diameter of the outer pipe 2.
- the inside of the first grooves 11b and 12b is set to be sealed by the outer tube 2.
- the second grooves 11c and 12c extend from the cavities 11a and 12a to the outside of the molds 11 and 12, and are set to have a shape corresponding to the outer diameter of the outer tube 2 or the tube 8,
- the grooves 11b and 12b are formed at extended positions.
- the second grooves 11c and 12c have a shape corresponding to the outer diameter of the outer tube 2, and when the outer tube 2 is sandwiched between the molds 11 and 12, the inside of the second grooves 11c and 12c is the outer tube 2. It is set to be sealed.
- the third grooves 11d and 12d are set to be concentric with the second grooves 11c and 12c, and communicate with the second grooves 11c and 12c and the outside of the molds 11 and 12, and the thick metal core 13 As the shape corresponding to the outer diameter, when the thick cored bar 13 is sandwiched between the molds 11 and 12, the inside of the third grooves 11 d and 12 d is set to be sealed with the thick cored bar 13.
- the fourth grooves 11e and 12e extend from the cavities 11a and 12a to the outside of the molds 11 and 12, and are separated from the line connecting the first grooves 11b and 12b and the second grooves 11c and 12c.
- the fourth grooves 11e and 12e are set to have an angle from the first grooves 11b and 12b and have a shape corresponding to the outer diameter of the inner tube 4.
- the interior is set to be sealed with the inner tube 4.
- the fifth grooves 11f and 12f are set to be concentric with the fourth grooves 11e and 12e, and communicate with the fourth grooves 11e and 12e and the outside of the molds 11 and 12, and the outer diameter of the cored bar 14
- the first grooves 11b and 12b, the second grooves 11c and 12c, and the fourth grooves 11e and 12e are arranged so as to be branched in a Y shape.
- the second grooves 11c and 12c and the fourth grooves 11e and 12e can be extended to the outside of the molds 11 and 12, and the third grooves 11d and 12d and the fifth grooves 11f and 12f can be omitted.
- the thick cored bar (first cored bar) 13 is positioned in the outer tube 2 and the outer tube 2 so as to form the first lumen 5 at the branching portion 6 as shown in FIGS. 5A to 5C and FIG.
- An insertion portion 13 a that can be inserted into a gap with the inner tube 4 is provided.
- the insertion portion 13 a has an outer surface portion 13 b having an outer diameter equal to the inner diameter of the outer tube 2 and a substantially cylindrical shape, and an inner surface portion 13 c along the outside of the inner tube 4.
- the inner surface portion 13 c of the insertion portion 13 a is a groove 13 c corresponding to the outer shape of the inner tube 4.
- a terminal end 13 d is provided in the length direction of the groove 13 c of the insertion portion 13 a, and the thick metal core 13 is expanded from the terminal end 13 d toward the base end side of the branching portion 6. It has a diameter. That is, the terminal end 13d is provided in the groove 13c so that the diameter of the first lumen 5 is increased. That is, the distal end side of the thick metal core 13 from the terminal end 13d is the insertion portion 13a, and the groove 13c is provided in the entire length of the insertion portion 13a.
- the cross-sectional shape of the insertion portion 13a in the direction intersecting the axis is formed in a substantially crescent shape.
- the cored bar (second cored bar) 14 can be inserted into the inner tube 4, has a cylindrical shape having the same outer dimensions as the inner diameter of the inner tube 4, and is inserted into the inner tube 4, 14 is set so that the inner tube 4 can be positioned inside the outer tube 2 when disposed in the groove 13c.
- the cross-sectional shape of the metal core (second metal core) 14 in the direction intersecting the axis is substantially circular.
- the material constituting the core bars 13 and 14 is not particularly limited as long as the core bars 13 and 14 are not melted or deformed, but metals are preferable, and examples thereof include stainless steel and iron.
- the manufacturing method of the catheter 1 in the present embodiment includes the second core metal insertion step S1, the inner tube groove arrangement step S2, the first core metal insertion step S3, and the outer die arrangement step S4. And a resin injection step S5 and a mold release and core metal removal step S6.
- the second core metal 14 is inserted into the proximal end side of the inner tube 4.
- the insertion position of the second cored bar 14 to the distal end side with respect to the inner tube 4 is set as the outer position of the branch portion 6 or the outer position of the molds 11 and 12.
- the second cored bar 14 serving as the proximal end side of the branching portion 6 is provided with a separate tube. 9 is inserted at a predetermined position.
- the first core bar 13 is set in a state where the inner tube 4 into which the second core bar 14 has been inserted in the second core bar insertion step S1 is bent corresponding to the end 13d of the groove 13c. Arranged in the groove 13c. At this time, if it is located inside the branching portion 6, the position where the inner tube 4 into which the second metal core 14 is inserted is separated from the groove 13c of the first metal core 13 is strictly coincident with the terminal end 13d. do not have to.
- the distal end side of the second core metal 14 the inner tube 4 into which the second core metal 14 was inserted, and the proximal end side of the inner tube 4 were disposed in the groove 13c.
- the insertion portion 13 a of the first core bar 13 is inserted from the end side of the outer tube 2. Or as a process so far, while inserting the 2nd metal core 14 in the inner tube 4 previously inserted in the outer tube 2, between the outer tube 2 and the inner tube 4, the insertion part 13a of the 1st metal core 13 is inserted. May be inserted.
- the second core metal 14, the inner pipe 4, the first core metal 13, and the outer pipe 2 are arranged in the corresponding grooves 11b to 12f of the outer molds 11, 12.
- the position of the outer tube 2 is regulated by the first grooves 11b and 12b
- the position of the tube 8 is regulated by the second grooves 11c and 12c
- the position of the thick metal bar 13 is the third.
- the position of the inner tube 4 or the position of the tube 9 is restricted by the fourth grooves 11e and 12e
- the position of the cored bar 14 is restricted by the fifth grooves 11f and 12f.
- tube 2 are controlled by the 1st groove
- the position of the second core bar 14, the position of the inner tube 4, the position of the first core bar 13, and the outer tube 2 in the inserted state are branched into a Y shape by the first grooves 11 b to 12 f. It will be in the state regulated so that it may become a shape.
- the branch portion 6 is formed by injecting molten resin from the gate.
- the temperature of the cylinder in the resin extrusion part at the time of molding is not particularly limited because it depends on the resin to be extruded, but it is preferably 190 to 230 ° C, particularly preferably 200 to 220 ° C.
- the mold temperature is preferably 10 to 50 ° C., more preferably 15 to 20 ° C., depending on the shape of the branch part 6.
- the injected resin forms the branch portion 6 by the cavities 11a and 12a.
- the branch portion 6 is provided with a coaxial outer tube 2 and an inner tube 4 on the distal end side, and a tube 8 and a tube 9 serving as lumens branched to the proximal end side.
- the tube 8 and the tube 9 are provided with an axial angle between each other in the plane of substantially the same plane formed by each lumen.
- the mold release and core metal removal step S6 first, the molds 11 and 12 are released as shown in FIG. Then, the core bars 13 and 14 are removed to form the branch portion 6. Further, if necessary, adhesion or welding is performed outside the branching portion 6. Thereby, the catheter 1 can be finally obtained.
- the catheter of this invention the metal mold
- the structure of each part can exhibit the same function. Any configuration can be substituted.
- the outer metal mold arranging step S4 is such that the thick metal core 13 is substantially linear and the metal core 14 is curved near the end 13d of the groove 13c, as shown in FIG.
- the cored bar 14 may be substantially linear and the thick cored bar 13 may be curved near the end 13d of the groove 13c.
- the catheter 1 in the present embodiment has a cross-sectional area ratio SA / SB between the first lumen 5 and the second lumen 7 at the branching portion 6 to a cross-sectional area ratio when the inner tube 4 is disposed in the outer tube 2.
- the outer tube 2 and the inner tube 4 are arranged so as not to decrease. Therefore, it is possible to provide a catheter having a plurality of lumens capable of minimizing the duct resistance of the fluid flowing in the first lumen 5 and the second lumen 7 and maximizing the flow rate of the fluid flowing in the interior. Furthermore, it is possible to improve the sealing performance at the branch portion, reduce the number of manufacturing steps, and easily form an angled branch tube, thereby reducing the cost in manufacturing the catheter.
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Abstract
Description
本願は、2014年06月27日に、日本に出願された特願2014-133186号に基づき優先権を主張し、その内容をここに援用する。
1.管路抵抗を最小化し、内部流体流量を最大化できる複数ルーメンを有するカテーテルを提供可能とすること。
2.分岐部のアウトサート時に射出圧でシースがつぶれてしまうことを防止すること。
前記第2芯金と前記内側管と前記第1芯金とを前記外側管に挿入する工程と、
前記第2芯金と前記内側管と前記第1芯金と前記外側管とを前記外金型の対応する前記溝部に配置する工程と、前記空間部に樹脂を注入して前記分岐部を形成する工程と、前記金型を離型すると共に前記芯金を除去する工程とを有している。
図1は、本実施形態におけるカテーテルを示す斜視図であり、図2は、図1の拡大斜視図であり、図において、符号1は、カテーテルである。
本実施形態におけるカテーテル1は、図1に示すように、可撓性を有する円筒状の外側管2と、外側管2の先端に取り着けられたバルーン3と、外側管2の内側に設けられた円筒状の内側管4と、基端部(第一端部)側において外側管2と内側管4とを分離する分岐部6と、を有する。
また、外側管2は基端側に設けた分岐部6より第1ルーメン5に個別的に接続したチューブ8と第2ルーメン7に連通するチューブ9とに分岐している。2つのチューブ8,9の延出先端のそれぞれには別々の口金4a,8bが取り付けられている。
外側管2および内側管4は、異なる材料で構成されていても良いが、同じ材料で構成されていることが好ましい。これにより、医療用でのカテーテル1の材料を共通化できるため生産性を向上することができる。
第1ルーメン5は、たとえば、バルーン3まで連通するとともに、バルーン3を膨らませるための流体を供給するように構成されている。
カテーテル1における内側管4の先端部分までは、バルーン3に流体を供給する第1ルーメン5が達していない。また、この先端部分の機械的な強度を保つために、第2ルーメン7が中央に位置される。内側管4の先端部は挿入性を向上させるために、先端に向かってテーパ状に縮径されかつ先端周縁の厚みを全周的に維持するように構成されている。
具体的には、図1に矢視A-Aで示す位置においては、図3Aに示すように、外側管2の長手方向の中心軸と内側管4の長手方向の中心軸とは、同軸状態(外側管2の中心軸と内側管4の中心軸とが一致している状態)である。ここでの第1ルーメンの断面積/第2ルーメンの断面積=SA/SBを基準として、ルーメンの全長でこの比の値が基準値よりも小さくならないように設定されている。
例えば、図3Eに示すように、外側管2と同じ外径を有する外側管2aのカテーテルで、第1ルーメンと5aの中心軸と第2ルーメン7aの中心軸とが同軸ではない場合には、たとえ、第2ルーメン7と同じ径の第2ルーメン7aを設けることができても、第1ルーメン5aは第1ルーメン5と同じ断面寸法とはならず、SA/SBはより小さくなる。このため管路抵抗が大きくなり、流量が本実施形態のカテーテル1よりも減少してしまう。
金型10は、図4に示すように、上型(外金型)11と下型(外金型)12と太芯金(第1芯金)13と芯金(第2芯金)14とから構成される。
上型11の内面(合わせ面)は、分岐部6となる樹脂成形空間を構成する空間部(キャビティ)11aと、外側管2の先端側を配置可能な第1溝11bと、外側管2の基端部側を載置可能な第2溝11cと、第2溝11cに連続して太芯金13を載置可能な第3溝11dと、内側管4の基端側を配置可能な第4溝11eと、第4溝11eに連続して芯金14を載置可能な第5溝11fと、を有している。
第1~第5溝(溝部)11b~11fとは、分岐部6を形成可能な空間部11aを介して対向する位置に略同一平面である基準面上に設けられている。
空間部11aは、分岐部6として、例えば矩形を為しているが、所定の形状を有すればよい。
下型12の内面(合わせ面)は、同様に、分岐部6となる樹脂成形空間を構成する空間部(キャビティ)12aと、外側管2の先端側を配置可能な第1溝12bと外側管2の基端部側を載置可能な第2溝12cと、第2溝12cに連続して太芯金13を載置可能な第3溝12dと、内側管4の基端側を配置可能な第4溝12eと、第4溝12eに連続して芯金14を載置可能な第5溝12fと、を有している。
第1~第5溝(溝部)12b~12fとは、分岐部6を形成可能な空間部12aを介して対向する位置に略同一平面である基準面上に設けられている。
第2溝11c,12cは、キャビティ11a,12aから、金型11,12の外部側へと延在し、外側管2またはチューブ8の外径に対応した形状となるよう設定されて、第1溝11b,12bを延長した位置に形成されている。第2溝11c,12cも、同様に、外側管2の外径に対応した形状として、外側管2を金型11,12で挟んだ際に、第2溝11c,12c内部が外側管2で密閉されるように設定されている。
第4溝11e,12eは、キャビティ11a,12aから、金型11,12の外部側へと延在し、第1溝11b,12bと第2溝11c,12cとを結んだ線から、離心するように第1溝11b,12bから角度を有して設定され、内側管4の外径に対応した形状として、内側管4を金型11,12で挟んだ際に、第4溝11e,12e内部が内側管4で密閉されるように設定されている。
これらの第1溝11b,12bと第2溝11c,12cと第4溝11e,12eとは、Y字状に分岐した形状となるように配置されている。
なお、第2溝11c,12cおよび第4溝11e,12eを金型11,12の外部側へと延在させ、第3溝11d,12dと第5溝11f,12fを設けないこともできる。
挿入部13aの、軸線と交差する方向における断面形状が略三日月状に形成されている。
芯金(第2芯金)14の、軸線と交差する方向での断面形状は略円形である。
これら芯金13,14を構成する材料としては、芯金13,14が溶融または変形しない材料であれば特に限定されないが、金属類が好ましく、例えばステンレス鋼、鉄等が挙げられる。
なお、内側管4が分岐部6の基端側において別体とされるチューブ9等が用いられる場合には、分岐部6の基端側となる第2芯金14には、別体のチューブ9を所定位置に挿入しておく。
あるいは、ここまでの工程として、あらかじめ外側管2に挿入された内側管4に第2芯金14を挿入するとともに、外側管2と内側管4との間に第1芯金13の挿入部13aを挿入してもよい。
これにより、第1溝11b~12fによって、挿入された状態である第2芯金14の位置と内側管4の位置と第1芯金13の位置と外側管2とがY字状に分岐した形状となるように規制された状態となる。
成形する際の樹脂押出部におけるシリンダーの温度は、押し出す樹脂に依存するため特に限定されないが、190~230℃が好ましく、特に200~220℃が好ましい。また、金型温度は、分岐部6の形状によるが、10~50℃が好ましく、特に15~20℃が好ましい。
さらに、必要であれば分岐部6外側において接着あるいは溶着等を行う。これにより、最終的にカテーテル1を得ることができる。
例えば、本実施の形態では、内側管4が1本の場合について説明したが、2本等、複数本の場合でも用いることができる。
また、外金型配置工程S4として、図5Bに示すように、太芯金13がほぼ直線状で、芯金14が溝13cの終端13d付近で湾曲するようにしたが、図6に示すように、芯金14がほぼ直線状で、太芯金13が溝13cの終端13d付近で湾曲するようにしてもよい。
2…外側管
3…バルーン
4…内側管
5…第1ルーメン
6…分岐部
7…第2ルーメン
8…チューブ
10…金型
11…上型
11a…空間部
11b~11f…溝(溝部)
12…下型
12b~12f…溝(溝部)
13…第1芯金
13a…挿入部
13b…外面部
13c…内面部(溝)
13d…終端
14…第2芯金
Claims (5)
- 外側管と、前記外側管の内側に設けられた内側管と、第一端部側において前記外側管と前記内側管とを分離する分岐部と、を備え、
少なくとも前記外側管の内側と前記内側管の外側とで形成される第1ルーメンの断面積に対する前記内側管内で形成される第2ルーメンの断面積の比(第1ルーメンの断面積/第2ルーメンの断面積)が、
前記外側管と前記内側管とが延在する長さ方向で、前記外側管内に前記内側管が配置された状態における断面積比の値に対して、前記分岐部における前前記外側管と前記内側管との断面積比が同じかそれ以上の値として設定されるカテーテル。 - 前記分岐部の第二端部側から前記第一端部側に向けて前記外側管の前記長さ方向の中心軸と前記内側管の前記長さ方向の中心軸とが離れるように、前記外側管と前記内側管とが分離する
請求項1記載のカテーテル。 - 外側管と、前記外側管の内側に設けられた内側管と、第一端部側において前記外側管と前記内側管とを分離する分岐部と、を有するカテーテルであって、
少なくとも前記外側管の内側と前記内側管の外側とで形成される第1ルーメンの断面積に対する前記内側管内で形成される第2ルーメンの断面積の比(第1ルーメンの断面積/第2ルーメンの断面積)が、
前記外側管と前記内側管とが延在する長さ方向で、前記外側管内に前記内側管が配置された状態における断面積比の値に対して、前記分岐部における前前記外側管と前記内側管との断面積比が同じかそれ以上の値として設定され、かつ、前記分岐部の第二端部側から前記第一端部側に向けて前記外側管の前記長さ方向の中心軸と前記内側管の前記長さ方向の中心軸とが離れるように、前記外側管と前記内側管とが分離する前記カテーテルを製造する金型であって、
前記外側管と前記外側管内に位置する前記内側管との隙間に挿入される第1芯金と、前記内側管内に挿入される第2芯金と、前記第1芯金及び前記第2芯金を覆って前記分岐部の外形を形成する外金型と、を備え、
前記第1芯金において、前記外側管に挿入する挿入部が、前記外側管の内部に沿った外面部と前記内側管の外部に沿った内面部とを有し、
前記内面部が前記内部管の外形に対応した溝であり、前記挿入部の前記溝にはその長さ方向に終端が設けられ、
前記第1芯金は、前記終端から前記分岐部の基端側に向かって拡径し、
前記外金型には、前記外側管と前記内側管とこれらに挿入された前記第1及び第2芯金を配置可能なY字状に分岐した溝部と、これら溝部とともに前記分岐部を形成可能な空間部とが配置される
カテーテル製造用金型。 - 前記第1芯金の前記挿入部の、軸線と交差する方向における断面形状が略三日月状であり、
前記第2芯金の、軸線と交差する方向における断面形状が略円形である
請求項3記載のカテーテル製造用金型。 - 請求項3または請求項4に記載の金型を用いてカテーテルを製造する方法であって、
前記第2芯金を前記内側管に挿入する工程と、
前記第2芯金の挿入された前記内側管を前記第1芯金の前記溝に配置する工程と、
前記第2芯金と前記内側管と前記第1芯金とを前記外側管に挿入する工程と、
前記第2芯金と前記内側管と前記第1芯金と前記外側管とを前記外金型の対応する前記溝部に配置する工程と、
前記空間部に樹脂を注入して前記分岐部を形成する工程と、
前記金型を離型すると共に前記芯金を除去する工程とを備える
カテーテルの製造方法。
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DE112015002454.9T DE112015002454T5 (de) | 2014-06-27 | 2015-05-13 | Katheter, Katheterherstellungsform, und Katheterherstellungsverfahren |
CN201580027298.8A CN106413795A (zh) | 2014-06-27 | 2015-05-13 | 导管、导管制造用模具、导管的制造方法 |
US15/368,742 US20170136207A1 (en) | 2014-06-27 | 2016-12-05 | Catheter, catheter production mold, catheter production method |
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US11285299B2 (en) * | 2019-10-31 | 2022-03-29 | Abbott Cardiovascular Systems Inc. | Mold for forming solder distal tip for guidewire |
US11759611B2 (en) | 2021-08-09 | 2023-09-19 | Evolve Medicus, Inc. | Integrated catheter assembly |
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