WO2019049954A1 - Urinary catheter - Google Patents

Urinary catheter Download PDF

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Publication number
WO2019049954A1
WO2019049954A1 PCT/JP2018/033106 JP2018033106W WO2019049954A1 WO 2019049954 A1 WO2019049954 A1 WO 2019049954A1 JP 2018033106 W JP2018033106 W JP 2018033106W WO 2019049954 A1 WO2019049954 A1 WO 2019049954A1
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WO
WIPO (PCT)
Prior art keywords
lumen
deformation
catheter body
catheter
urine
Prior art date
Application number
PCT/JP2018/033106
Other languages
French (fr)
Japanese (ja)
Inventor
慎一郎 井上
増田 哲也
信夫 津久井
Original Assignee
大塚テクノ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by 大塚テクノ株式会社 filed Critical 大塚テクノ株式会社
Priority to JP2019541007A priority Critical patent/JPWO2019049954A1/en
Publication of WO2019049954A1 publication Critical patent/WO2019049954A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters

Definitions

  • the present invention relates to a urethral catheter.
  • a urinary catheter is known as a medical device for assisting the urine extraction of a patient who has difficulty in urination.
  • Patent Document 1 discloses a urethral catheter including a rod-shaped catheter body, a balloon portion formed at one end of the catheter body, and an operating portion formed at the other end of the catheter body.
  • the urinary catheter of Patent Document 1 is used, for example, by performing the following processes (1) to (4) in this order.
  • (1) Disinfect the area around the external urethral opening of the penis with a cotton ball soaked with a disinfectant such as povidone iodine.
  • (2) Open the package of the urinary catheter and apply a water-soluble lubricant to the urinary catheter.
  • (3) Carefully insert the urethral catheter from the external urethral opening. After the balloon reaches the bladder, a defined volume of sterile water is slowly infused into the balloon. (4) The urinary catheter is pulled slightly and indwelled until the balloon portion contacts the bladder neck.
  • Patent No. 5318925 gazette
  • the catheter may travel through a very narrow urethra, which may cause the patient to feel a great deal of pain.
  • An object of the present invention is to provide a urethral catheter that can reduce the pain felt by the patient during insertion and removal.
  • the urethral catheter of the present invention is formed in a catheter body consisting of a flexible tube having a tip placed in the patient's bladder and a base opposite to the tip, and the catheter body is formed of urine in the patient's bladder.
  • the deformation lumen may be formed into a flat shape that is curved along the circumferential surface of the catheter body in a radial sectional view of the catheter body.
  • the deformation lumen has an outer surface close to the circumferential surface of the catheter body and an inner surface opposite to the outer surface, and the length L 2 of the inner surface of the deformation lumen However, it may be longer than the length L 1 of the outer side surface.
  • the urine drainage lumen may be formed in an elliptical shape whose major axis is a direction along the longitudinal direction of the deformation lumen in a radial cross-sectional view of the catheter body.
  • the deformation lumen is an end of a radius line segment of a fan-shaped area having a central angle of 90 ° or less extending from the center of the urine drainage lumen in the radial cross section of the catheter body. And the other end.
  • the catheter body may have a constant outer diameter from the base to the tip.
  • the outer diameter of the catheter body may be 2 mm to 10 mm.
  • the urethral catheter according to the present invention is provided on the distal end side of the catheter body, and extends along the urine drainage lumen in the catheter body so as to communicate with the balloon portion expanding in the patient's bladder and the balloon portion.
  • the balloon may further include a liquid introducing lumen for introducing an inflating liquid into the balloon portion.
  • the deformation lumen may be disposed to face the fluid introduction lumen with the urine drainage lumen interposed therebetween.
  • the urethral catheter according to the present invention further includes a balloon portion provided on the distal end side of the catheter body and inflated in a patient's bladder, and the deformation lumen communicates with the balloon portion in the catheter body.
  • the balloon may be formed to extend along the urine drainage lumen and also serve as a fluid introduction lumen for introducing an inflation fluid into the balloon portion.
  • the first and second deformation lumens which also serve as the liquid introduction lumens, and the first deformation lumen, close the distal end portion of the catheter body. And a second deformation lumen.
  • the first deformation lumen and the second deformation lumen may be disposed to face each other across the urine discharge lumen.
  • the inner surfaces of the deformation lumens can be brought into close contact with each other by drawing air in the deformation lumen to obtain a negative pressure. .
  • the outer diameter of a catheter body can be made small. As a result, the pain felt by the patient at the time of insertion of the urethral catheter can be reduced.
  • FIG. 1 is a view showing a usage state of a urinary catheter according to an embodiment of the present invention, showing a balloon in an uninflated state in a bladder.
  • FIG. 2 is a view showing a usage state of the urinary catheter according to an embodiment of the present invention, showing a balloon inflated in a bladder.
  • FIG. 3 is a plan view of a urinary catheter according to an embodiment of the present invention.
  • FIG. 4 is a side view of a urinary catheter according to an embodiment of the present invention.
  • FIG. 5 is a cross-sectional view taken along the line VV of FIG.
  • FIG. 6 is an enlarged view of a portion surrounded by a two-dot chain line VI in FIG. 5 and showing a balloon unused state.
  • FIG. 5 is a cross-sectional view taken along the line VV of FIG.
  • FIG. 6 is an enlarged view of a portion surrounded by a two-dot chain line VI in FIG. 5 and showing a balloon unused state.
  • FIG. 7 is an enlarged view of a portion surrounded by a two-dot chain line VI in FIG. 5 and showing a balloon used state.
  • FIG. 8 is an enlarged view of a portion surrounded by a two-dot chain line VIII in FIG.
  • FIG. 9 is an enlarged view of a portion surrounded by a two-dot chain line IX in FIG.
  • FIG. 10 is a diagram showing the positional relationship between the first urine outlet and the second urine outlet.
  • FIG. 11 is a cross-sectional view taken along the line XI-XI in FIG. 3 and showing the catheter body in an uncompressed state.
  • FIG. 12 is a cross-sectional view taken along the line XI-XI in FIG.
  • FIG. 13 is a view showing a modified example of the catheter body, and shows a state in which the shape of the catheter body is not compressed.
  • FIG. 14 is a view showing a modified example of the catheter main body, in which the shape of the catheter main body is compressed.
  • FIG. 15 is a view showing a modified example of the catheter main body, and shows a state in which the shape of the catheter main body is not compressed.
  • FIG. 16 is a view showing a modified example of the catheter main body, in which the shape of the catheter main body is compressed.
  • FIG. 17 is a view showing a modified example of the catheter body, and shows a state in which the shape of the catheter body is not compressed.
  • FIG. 18 is a perspective view for explaining the shape feature of the balloon of the urinary catheter according to the embodiment of the present invention.
  • FIG. 19 is a perspective view for explaining the feature of the shape of the balloon of the urinary catheter according to one embodiment of the present invention.
  • FIG. 20 is a cross-sectional view for describing features of the shape of the balloon of the urinary catheter according to one embodiment of the present invention.
  • FIG. 21 is a view for explaining the effect of the urinary catheter according to the embodiment of the present invention.
  • FIG. 1 is a view showing a usage state of a urethral catheter 1 according to an embodiment of the present invention, showing a balloon 4 in a non-inflated state in a bladder.
  • FIG. 2 is a view showing a usage state of the urethral catheter 1 according to an embodiment of the present invention, and shows a state in which the balloon 4 is expanded in the bladder.
  • the urinary catheter 1 is an instrument for assisting in the urine conversion of a patient who has difficulty in urination, and includes a catheter body 2, an operation unit 3 and a balloon 4. As shown in FIG. 1, the catheter body 2 is used by inserting it into the urethra 8 of the human body 6 until the tip 5 reaches the bladder 7 of the human body 6 with the balloon 4 uninflated. After insertion, the balloon 4 is expanded and fixed to prevent the catheter body 2 from falling off, and the catheter body 2 is indwelled in the bladder 7.
  • the urine 10 accumulated in the bladder 7 is discharged from the operation unit 3 through the inside of the catheter main body 2 from the first urine outlet 9 formed in the distal end portion 5 of the catheter main body 2.
  • FIG. 3 is a plan view of a urinary catheter 1 according to an embodiment of the present invention.
  • FIG. 4 is a side view of a urinary catheter 1 according to an embodiment of the present invention.
  • FIG. 5 is a cross-sectional view taken along the line VV of FIG.
  • FIG. 6 is an enlarged view of a portion surrounded by a two-dot chain line VI in FIG. 5 and showing the balloon 4 in an unused state.
  • FIG. 7 is an enlarged view of a portion surrounded by a two-dot chain line VI in FIG. 5 and showing a state in which the balloon 4 is used.
  • FIG. 8 is an enlarged view of a portion surrounded by a two-dot chain line VIII in FIG. 5, but the catheter main body 2 is hidden.
  • FIG. 9 is an enlarged view of a portion surrounded by a two-dot chain line IX in FIG.
  • the urinary catheter 1 includes a catheter body 2, an operation unit 3 and a balloon 4.
  • the catheter body 2 is made of a flexible tube, and a hard tip 5 is attached to the tip thereof.
  • the catheter body 2 is inserted into the cap-like distal end portion 5 to form an inlay structure, and the mating surfaces of the inlay structures are fixed to each other by welding, bonding or the like.
  • the catheter main body 2 and the distal end portion 5 may be made of, for example, a rubber latex base such as natural rubber latex or synthetic rubber latex, a silicone base, or a base member such as a thermoplastic elastomer and subjected to surface treatment.
  • a rubber latex base such as natural rubber latex or synthetic rubber latex
  • a silicone base such as a silicone base
  • a base member such as a thermoplastic elastomer and subjected to surface treatment.
  • the surface treatment include a hydrophilic coating that imparts lubricity to the base member, a urethane coating / fluorine coating that imparts smoothness to the base member, and a silver coating that imparts antimicrobial properties to the base member. Two or more of these surface treatments may be used in combination.
  • the catheter body 2 is formed so as to extend along the longitudinal direction of the catheter body 2 such as a urine discharge lumen 11, a fluid introduction lumen 12 and a deformation lumen 13. It is done.
  • the urine drainage lumen 11 is a passage for guiding the urine 10 in the patient's bladder 7 to the outside of the patient, and is a tip from the base 14 (see FIG. 5) which is one longitudinal end of the catheter body 2 It penetrates to the portion 15 and is formed substantially at the center of the catheter body 2.
  • the urine discharge lumen 11 is in communication with a first urine discharge port 9 formed in the cylindrical distal end portion 5, and through the first urine discharge port 9, urine passes through the urine discharge lumen 11. It will enter.
  • the first urine outlet 9 is formed in an elliptical shape slightly elongated in the longitudinal direction of the catheter body 2 (see FIG. 9), and for example, a pair is provided to face in the radial direction of the catheter body 2 (See FIGS. 6 and 7).
  • the catheter body 2 communicates with the urine discharge lumen 11 on the opposite side of the first urine discharge port 9 with the balloon 4 in the longitudinal direction of the catheter body 2.
  • the urine outlet 37 is formed. More specifically, a second urine outlet 37 is formed to penetrate a first end 25 of the balloon 4 described later.
  • the second urine outlet 37 is formed in an oval shape slightly longer in the longitudinal direction of the catheter body 2, and, for example, opposed in the radial direction of the catheter body 2 A pair may be provided. Further, as shown in FIG. 10, the second urine outlet 37 is located at a position avoiding the fluid introducing lumen 12 and the deforming lumen 13 in the radial sectional view of the catheter body 2, and in this embodiment, the first urine outlet 37.
  • the urine outlet 9 is disposed at a position rotated by 90 °. Thereby, the second urine outlet 37 is prevented from interfering with the fluid introducing lumen 12 and the deforming lumen 13.
  • the fluid introducing lumen 12 is a passage for introducing an inflation fluid to the balloon 4 and is formed extending along the urine drainage lumen 11.
  • the fluid introducing lumen 12 is formed from the base 14 to a midway in the longitudinal direction of the catheter body 2 with the base 14 of the catheter body 2 as an open end, and the end is a dead end 16.
  • the dead end portion 16 is disposed between the first urine outlet 9 and the balloon circulation port 17 (described later). Further, in the circumferential surface 31 of the catheter main body 2, a balloon circulation port 17 communicating with the liquid introduction lumen 12 is formed.
  • the deformation lumen 13 is a passage for deforming the catheter body 2 to facilitate insertion and removal of the urinary catheter 1, and is formed extending along the urine drainage lumen 11.
  • the deformation lumen 13 is formed from the base 14 to a midway in the longitudinal direction of the catheter body 2 with the base 14 of the catheter body 2 as an open end, and the end is a dead end 18.
  • the dead end portion 18 is disposed between the first urine outlet 9 and the balloon communication port 17 and at the same longitudinal position as the dead end portion 16 of the fluid introducing lumen 12 in the longitudinal direction of the catheter body 2. ing.
  • the deformation lumen 13 does not circulate with the outside through an opening or the like such as the balloon circulation port 17, and circulates with the outside only at the open end thereof.
  • the operation unit 3 is a portion handled by an assistant such as a doctor or a nurse, and integrally includes a urine discharge port 19, a liquid introduction port 20, and a deformation port 21. As shown in FIGS. 3 to 5, in the operation unit 3, the liquid introduction port 20 and the deformation port 21 are symmetrical to each other from the peripheral surface of the funnel-shaped urine discharge port 19 extending along the extension of the catheter body 2. It may be formed in the shape of a fork that branches into.
  • the operation unit 3 may be made of, for example, the same material as the catheter body 2 and may be fixed to the catheter body 2 by insert molding on the catheter body 2.
  • the operation unit 3 may be made of a material different from that of the catheter body 2, and in this case, it may be fixed to the catheter body 2 by insert molding, welding, adhesion or the like.
  • the liquid introduction port 20 and the deformation port 21 are mutually independent. It is formed.
  • the urine discharge passage 22 communicates with the urine discharge lumen 11
  • the fluid introduction passage 23 communicates with the fluid introduction lumen 12
  • the deformation passage 24 communicates with the deformation lumen 13.
  • the urine discharge port 19 is connected to a container such as a urine collection bag for storing the discharged urine.
  • a container such as a urine collection bag for storing the discharged urine.
  • valves 39 and 40 for connecting a syringe are provided at the tips of the liquid introduction port 20 and the deformation port 21.
  • An assistant such as a doctor or a nurse connects the syringe filled with the liquid for balloon inflation to the valve 39 and pushes the plunger of the syringe to pass the liquid introduction passage 23 and the liquid introduction lumen 12 Liquid can be injected into the balloon 4.
  • an assistant such as a doctor or a nurse connects an empty syringe to the valve 40 and pulls the plunger of the syringe to store the air in the deformation passage 24 and the deformation lumen 13 in the syringe,
  • the pressure in the deformation lumen 13 can be negative.
  • the balloon 4 has a first end 25 fixed so as to surround the catheter body 2 and a second end 26 closer to the distal end 15 than the first end 25, and the first end 25 and the second end
  • An inflatable portion 27 is provided between the portion 26 and is a membrane that spherically inflates in the bladder 7 of the patient.
  • the balloon 4 is connected to the balloon communication port 17 inside the inflation portion 27.
  • the first end 25 and the second end 26 of the balloon 4 may be fixed to the catheter body 2 by welding, adhesion or the like, for example.
  • rubber latex, silicone, a thermoplastic elastomer etc. are mentioned, for example.
  • a plurality of ribs 28 may be provided on the inner surface of the inflating portion 27 along the circumferential direction of the catheter body 2.
  • the plurality of ribs 28 are each formed in an annular shape so as to surround the catheter body 2 and are spaced along the longitudinal direction of the catheter body 2.
  • an assistant such as a doctor or a nurse injects a dilation fluid such as sterile distilled water into the fluid introduction passage 23 with a syringe, whereby the dilation fluid is introduced into the liquid introduction lumen 12 and the balloon flow port 17.
  • a dilation fluid such as sterile distilled water
  • the balloon 4 expands spherically as shown in FIG.
  • FIG. 11 is a cross-sectional view taken along the line XI-XI in FIG. 3, and shows the catheter body 2 in an uncompressed state.
  • FIG. 12 is a cross-sectional view taken along the line XI-XI in FIG. 3, and shows a state in which the shape of the catheter body 2 is compressed.
  • FIG. 13 is a view showing a modified example of the catheter body 2 and shows a state in which the shape of the catheter body 2 is not compressed.
  • FIG. 14 is a view showing a modified example of the catheter main body 2 and shows a state in which the shape of the catheter main body 2 is compressed.
  • the catheter body 2 may be entirely constituted by a flexible soft member such as a rubber latex base or a silicone base,
  • the outer layer 29 may be in contact with the inner wall (mucosal portion) of the urethra 8 and the inner layer 30 formed on the inner side of the outer layer 29 and forming the inner wall of the urine drainage lumen 11.
  • the inner layer 30 is preferably made of a member harder than the outer layer 29.
  • the catheter main body 2 has a configuration in which a tube-shaped core material composed of the inner layer 30 having relatively rigidity (stiffness) is coated with the outer layer 29 which is softer and more deformable than the core material.
  • the rigidity of the inner layer 30 makes it easy for an assistant such as a doctor or nurse who is inserting the urinary catheter 1 to insert the urinary catheter 1 due to the rigidity of the inner layer 30.
  • the softness of the portion in contact with the inner wall of the urethra 8 has the advantage of reducing pain.
  • the outer layer 29 may be made of, for example, a rubber latex base such as the above-mentioned natural rubber latex or synthetic rubber latex, or a base member such as silicone base.
  • the inner layer 30 may be made of, for example, hard silicone, thermoplastic elastomer or the like.
  • the inner layer 30 may be subjected to the above-described surface treatment, similarly to the outer layer 29.
  • the catheter body 2 has a constant outer diameter from the base 14 to the distal end portion 15 (see FIG. 5), for example, an outer diameter of 2 mm to 10 mm.
  • the urine drainage lumen 11 is formed in a circular shape at the center of the catheter main body 2 in a radial cross-sectional view.
  • the inner diameter of the urine drainage lumen 11 may be, for example, about 2 mm to 5 mm.
  • the fluid introducing lumen 12 is formed in a circular shape having a diameter smaller than that of the urine discharging lumen 11 around the urine discharging lumen 11.
  • the inner diameter of the liquid introducing lumen 12 may be, for example, about 0.1 mm to 0.8 mm.
  • the deformation lumen 13 is disposed around the urine discharge lumen 11 so as to face the liquid introduction lumen 12 across the urine discharge lumen 11.
  • the deformation lumen 13 is formed in a flat shape that is curved along the circumferential surface 31 of the catheter body 2 in this embodiment. More specifically, in the radial direction cross-sectional view of the catheter main body 2, the deformation lumen 13 is a radial line segment R 1 of the fan-shaped region 32 whose central angle ⁇ spreads from the center C of the urine drainage lumen 11 is 90 ° or less on R 2, it is formed in a flat shape having one end portion 33 and the other end portion 34.
  • an assistant such as a doctor or a nurse pulls the air in the deformation lumen 13 with a syringe to make it negative pressure, whereby the outer surface of the deformation lumen 13 is obtained. 35 and the inner surface 36 can be in close contact. Thereby, since a part of catheter body 2 can be compressed, the outside diameter of catheter body 2 can be made small. As a result, the pain felt by the patient when the urinary catheter 1 is inserted can be reduced.
  • the deformation lumen 13 is preferably formed in the relatively soft outer layer 29. Thereby, the catheter body 2 can be easily compressed.
  • deformation lumen 13 may be formed in the catheter body 2 as shown in FIGS. 11 and 12, but a plurality of deformation lumens 13 may be formed as shown in FIGS. 13 and 14. .
  • one end of the deformation lumen 13 (second deformation lumen) may be blocked by the dead end 18 as described above, and the other deformation lumen 13 (first deformation lumen) may be closed.
  • the lumen) may be formed to communicate with the balloon 4 through the balloon communication port 17 and may also serve as the fluid introduction lumen 12. Even when the fluid introduction lumen 12 is also used, the balloon 4 is occluded so that the fluid is communicated with the outside only at the open end of the fluid introduction lumen 12, so that the inside of the lumen can be made negative pressure.
  • the plurality of deformation lumens 13 may be disposed to face each other with the urine discharge lumen 11 interposed therebetween. If a plurality of deformation lumens 13 are formed, the catheter body 2 can be compressed to a smaller diameter.
  • the deformation lumen 13 may be configured as shown in FIG. 15 and FIG. Specifically, in the radial cross section of the catheter body 2, the length L 2 of the inner side surface 36 of the deformation lumen 13 may be longer than the length L 1 of the outer side surface 35 (L 2 > L 1 ).
  • the length L- 1 of the outer surface 35 of the deformation lumen 13 having such a shape (an upper line segment connecting one end 33 and the other end 34 of the deformation lumen 13 in the deformation lumen 13 on the upper side of FIG. ) May be, for example, 2 mm to 4 mm.
  • the inner surface 36 of the deformation lumen 13 defines a flat deformation lumen 13 along the circumferential surface 31 of the catheter body 2 in cooperation with the outer surface 35, but the shape is similar to the outer surface 35.
  • the arc is different from the arc 31 along which the peripheral surface 31 is kept at a constant distance.
  • the inner side surface 36 of the deformation lumen 13 is recessed such that a portion thereof is separated from the circumferential surface 31 toward the inward region of the catheter 2.
  • the inner side surface 36 of the deformation lumen 13 is arranged along the outer side surface 35 from each of the one end 33 and the other end 34 of the deformation lumen 13 (with a constant distance from the circumferential surface 31).
  • a pair of arcuate projection 46 toward the one direction D 1, (in this modification, the direction of the center C) inner region of the catheter 2 in the vicinity of the first direction D 1 recess away from the peripheral surface 31 toward the It is formed in the shape of a wave which has a concave portion 45 integrally.
  • the length L- 2 of the wavy inner surface 36 is longer than the length L- 1 of the arc-shaped outer surface 35.
  • the length L- 2 of the wavy inner surface 36 (the length of the lower segment connecting the one end 33 and the other end 34 of the deformation lumen 13 in the upper deformation lumen 13 in FIG. 15) is, for example, , 2.5 mm to 4.5 mm.
  • the distance (thickness T 1 ) between the recess 45 of the inner side surface 36 of the deformation lumen 13 and the inner peripheral surface 47 of the urine discharge lumen may be, for example, 0.4 mm to 0.6 mm.
  • the distance (thickness T 2 ) between the convex portion 46 of the inner side surface 36 of the deformation lumen 13 and the inner circumferential surface 47 of the urine discharge lumen may be, for example, 0.7 mm to 0.9 mm.
  • the urine discharge lumen 11 is formed in an elliptical shape whose major axis is a direction along the longitudinal direction of the deformation lumen 13 in the radial cross section of the catheter body 2. More specifically, the direction along the second direction D 2 may be an oval shape with the major axis direction. In this modification, the urine discharge lumen 11 is formed into an elliptical shape having the ends 48 and 49 of the major axis on the side away from the outside (center C) from the one end 33 and the other end 34 of the deformation lumen 13. It is formed.
  • the length L 2 of the inner side surface 36 of the deformation lumen 13 is longer than the length L 1 of the outer side surface 35. Therefore, when a negative pressure by pulling air deforming lumen 13 as shown in FIG. 16, flexures peripheral surface 31 of the catheter body 2 is a 1 direction, a 2 direction, b in the first direction and b 2 directions It is compressed too much. As a result, it is possible to suppress the occurrence of a so-called excess of meat in which a part of the circumferential surface 31 of the catheter body 2 is angular.
  • the outer surface 35 approaching the inner surface 36 due to compression is selected as the pair of convex portions 46 of the inner surface 36 Contact (not in contact with the recess 45).
  • selectively applying a load to the end portion 50 and 51 of the minor axis of the inner circumferential surface 47 of the urinary drainage lumen 11 Can.
  • the urine discharge lumen 11 is deformed in the c 1 direction, c 2 direction, d 1 direction and d 2 direction, and the end portions 50 and 51 are protruded into the urine discharge lumen 11.
  • This enables further cross-sectional compression of the catheter body 2.
  • the diameter of the catheter body 2 before compression is D c1
  • the diameter D c2 of the catheter body 2 after compression can be about 70 to 80%.
  • the deformation lumen 13 has a flat shape along the circumferential surface 31 of the catheter main body 2 as shown in FIG. 17, it may not be curved along the circumferential surface 31.
  • FIG. 18 and FIG. 19 are perspective views for explaining the characteristics of the shape of the balloon 4 of the urinary catheter 1, and show a state in which the balloon 4 is expanded.
  • FIG. 18 is a view of the balloon 4 viewed from the side of the tip 15 of the catheter body 2
  • FIG. 19 is a view of the balloon 4 viewed from the opposite side of the tip 15 of the catheter body 2.
  • FIG. 20 is a cross-sectional view for describing the feature of the shape of the balloon of the urinary catheter 1.
  • FIG. 21 is a view for explaining the effect of the urinary catheter 1.
  • the balloon 4 has linear recesses 38 (concave lines) extending along the circumferential surface from the first end 25 to the second end 26.
  • the recess 38 is formed to start at the first end 25 and end at the second end 26.
  • a constant space 41 is formed in a state where the expanded portion 27 of the expanded balloon 4 is in contact with the inner wall (for example, the bladder neck) of the bladder 7, between the expanded portion 27 and the inner wall of the bladder 7
  • a constant space 41 is formed.
  • the second urine outlet 37 is formed at a predetermined position of the first end 25 of the balloon 4 so as to be exposed to the space 41.
  • the recesses 38 are formed at equal intervals in the annular direction along the circumferential surface 31 of the catheter body 2 as shown in FIG. For example, in this embodiment, a total of three are formed at intervals of 120 ° around the center C (the center of the urine drainage lumen 11) in the radial cross section of the catheter body 2.
  • the number of recesses 38 is not limited to three, and may be four or more.
  • the inner wall of the balloon 4 in the expanded state projects inward with respect to the flat region 42 other than the portion where the recess 38 is formed. It is formed as a convex portion 43.
  • "balloon 4 '" of FIG. 20 shows a state in which the balloon 4 is not inflated. In this state, the convex portion 44 is formed at a position corresponding to the concave portion 38 on the outer peripheral surface of the balloon 4'. There is.
  • the film thickness T 1 (height of the convex portions 43 and 44) of the portion where the concave portion 38 is formed is formed thicker than the film thickness T 2 of the other portion (planar region 42).
  • the thickness T 1 is a 0.3 mm ⁇ 1.5 mm
  • thickness T 2 is 0.05 mm ⁇ 0.7 mm. That is, when the balloon 4 is inflated, the convexity 44 is formed when the balloon 4 is not inflated, so that there is a difference in the degree of expansion between the convexity 44 and the other parts. A recess 38 is formed at the formation site.
  • Liquid level of the urine 10 in the bladder 7 is, as the liquid surface S 1 in FIG. 21, if a position higher than the first urine output port 9, the urine 10 via the first urine output port 9 It can be discharged.
  • the liquid surface S 2 in FIG. 21 if a position lower than the liquid level first urine outlet 9 of urine 10, it is discharged through the first urine output port 9 is difficult is there.
  • the urethral catheter 1 provided with the balloon 4 is taken as an example, but the balloon 4 is provided from the viewpoint of "reducing pain felt by the patient at the time of insertion and removal" of the present invention. You do not have to.

Abstract

Provided is a urinary catheter with which it is possible to mitigate pain felt by a patient during insertion and removal of the urinary catheter. Provided is a urinary catheter including: a catheter body 2 comprising a flexible tube that has a distal-end part to be placed inside the urinary bladder of a patient and a base part that is on the opposite side from the distal-end part; a urine output lumen 11 for guiding urine within the urinary bladder of the patient to outside of the body of the patient, the urine output lumen 11 being formed within the catheter body 2; and a flat deformation lumen 13 formed within the catheter body 2 so as to extend along the urine output lumen 11 such that the distal-end part side is blocked off, the deformation lumen 13 following a peripheral surface 31 of the catheter body 2 in a radial-direction cross-sectional view of the catheter body 2.

Description

尿道カテーテルUrethral catheter
 本発明は、尿道カテーテルに関する。 The present invention relates to a urethral catheter.
 従来、排尿が困難な患者の導尿を助けるための医療器具として、尿道カテーテルが知られている。 Conventionally, a urinary catheter is known as a medical device for assisting the urine extraction of a patient who has difficulty in urination.
 例えば、特許文献1は、棒形状のカテーテル本体と、カテーテル本体の一端部に形成されたバルーン部と、カテーテル本体の他端部に形成された操作部とを備える尿道カテーテルを開示している。 For example, Patent Document 1 discloses a urethral catheter including a rod-shaped catheter body, a balloon portion formed at one end of the catheter body, and an operating portion formed at the other end of the catheter body.
 特許文献1の尿道カテーテルは、例えば、下記(1)~(4)の処理をこの順で行うことによって使用される。
(1)ポビドンヨード等の消毒液を浸した綿球等でペニスの外尿道口周辺を消毒する。
(2)尿道カテーテルの包装を開封し、尿道カテーテルに水溶性潤滑剤を塗布する。
(3)尿道カテーテルを外尿道口より注意深く挿入する。バルーン部が膀胱内に達した後、規定容量の滅菌水をバルーン部にゆっくりと注入する。
(4)バルーン部が膀胱頸部に接触するまで尿道カテーテルを少し引いて留置する。
The urinary catheter of Patent Document 1 is used, for example, by performing the following processes (1) to (4) in this order.
(1) Disinfect the area around the external urethral opening of the penis with a cotton ball soaked with a disinfectant such as povidone iodine.
(2) Open the package of the urinary catheter and apply a water-soluble lubricant to the urinary catheter.
(3) Carefully insert the urethral catheter from the external urethral opening. After the balloon reaches the bladder, a defined volume of sterile water is slowly infused into the balloon.
(4) The urinary catheter is pulled slightly and indwelled until the balloon portion contacts the bladder neck.
特許第5318925号公報Patent No. 5318925 gazette
 尿道カテーテルの挿入および抜去の際には、非常に狭い尿道内をカテーテルが移動するため、患者が相当な痛みを感じることがある。 During insertion and removal of the urethral catheter, the catheter may travel through a very narrow urethra, which may cause the patient to feel a great deal of pain.
 本発明の目的は、挿入および抜去時に患者が感じる痛みを軽減することができる尿道カテーテルを提供することである。 An object of the present invention is to provide a urethral catheter that can reduce the pain felt by the patient during insertion and removal.
 本発明の尿道カテーテルは、患者の膀胱内に留置される先端部およびその反対側の基部を有する可撓性チューブからなるカテーテル本体と、前記カテーテル本体内に形成され、患者の膀胱内の尿を体外に導くための尿排出用ルーメンと、前記カテーテル本体内において前記尿排出用ルーメンに沿って延びて形成され、前記カテーテル本体の径方向断面視において、前記カテーテル本体の周面に沿う扁平形状の変形用ルーメンとを含む。 The urethral catheter of the present invention is formed in a catheter body consisting of a flexible tube having a tip placed in the patient's bladder and a base opposite to the tip, and the catheter body is formed of urine in the patient's bladder. A lumen for draining urine for guiding the body and a lumen extending along the lumen for draining urine in the catheter body, and has a flat shape along the circumferential surface of the catheter body in a radial sectional view of the catheter body And a lumen for deformation.
 本発明の尿道カテーテルでは、前記変形用ルーメンは、前記カテーテル本体の径方向断面視において、前記カテーテル本体の周面に沿って湾曲した扁平形状に形成されていてもよい。 In the urinary catheter of the present invention, the deformation lumen may be formed into a flat shape that is curved along the circumferential surface of the catheter body in a radial sectional view of the catheter body.
 本発明の尿道カテーテルでは、前記変形用ルーメンは、前記カテーテル本体の周面に近い外側面と、前記外側面に対向する内側面とを有し、前記変形用ルーメンの内側面の長さLが、前記外側面の長さLよりも長くてもよい。 In the urinary catheter of the present invention, the deformation lumen has an outer surface close to the circumferential surface of the catheter body and an inner surface opposite to the outer surface, and the length L 2 of the inner surface of the deformation lumen However, it may be longer than the length L 1 of the outer side surface.
 本発明の尿道カテーテルでは、前記尿排出用ルーメンは、前記カテーテル本体の径方向断面視において、前記変形用ルーメンの長手方向に沿う方向を長軸方向とする楕円形状に形成されていてもよい。 In the urinary catheter of the present invention, the urine drainage lumen may be formed in an elliptical shape whose major axis is a direction along the longitudinal direction of the deformation lumen in a radial cross-sectional view of the catheter body.
 本発明の尿道カテーテルでは、前記変形用ルーメンは、前記カテーテル本体の径方向断面視において、前記尿排出用ルーメンの中心から広がる中心角90°以下の扇形領域の半径線分上に、その一端部および他端部を有していてもよい。 In the urethral catheter according to the present invention, the deformation lumen is an end of a radius line segment of a fan-shaped area having a central angle of 90 ° or less extending from the center of the urine drainage lumen in the radial cross section of the catheter body. And the other end.
 本発明の尿道カテーテルでは、前記カテーテル本体は、前記基部から前記先端部まで一定の外径を有していてもよい。 In the urinary catheter of the present invention, the catheter body may have a constant outer diameter from the base to the tip.
 本発明の尿道カテーテルでは、前記カテーテル本体の外径が、2mm~10mmであってもよい。 In the urinary catheter of the present invention, the outer diameter of the catheter body may be 2 mm to 10 mm.
 本発明の尿道カテーテルは、前記カテーテル本体の前記先端部側に設けられ、患者の膀胱内で膨張するバルーン部と、前記バルーン部と連通するように前記カテーテル本体内において前記尿排出用ルーメンに沿って延びて形成され、前記バルーン部に膨張用の液体を導入するための液体導入用ルーメンとをさらに含んでいてもよい。 The urethral catheter according to the present invention is provided on the distal end side of the catheter body, and extends along the urine drainage lumen in the catheter body so as to communicate with the balloon portion expanding in the patient's bladder and the balloon portion. The balloon may further include a liquid introducing lumen for introducing an inflating liquid into the balloon portion.
 本発明の尿道カテーテルでは、前記変形用ルーメンは、前記尿排出用ルーメンを挟んで前記液体導入用ルーメンと対向するように配置されていてもよい。 In the urinary catheter of the present invention, the deformation lumen may be disposed to face the fluid introduction lumen with the urine drainage lumen interposed therebetween.
 本発明の尿道カテーテルは、前記カテーテル本体の前記先端部側に設けられ、患者の膀胱内で膨張するバルーン部をさらに含み、前記変形用ルーメンは、前記バルーン部と連通するように前記カテーテル本体内において前記尿排出用ルーメンに沿って延びて形成され、前記バルーン部に膨張用の液体を導入するための液体導入用ルーメンを兼ねていてもよい。 The urethral catheter according to the present invention further includes a balloon portion provided on the distal end side of the catheter body and inflated in a patient's bladder, and the deformation lumen communicates with the balloon portion in the catheter body. The balloon may be formed to extend along the urine drainage lumen and also serve as a fluid introduction lumen for introducing an inflation fluid into the balloon portion.
 本発明の尿道カテーテルでは、前記変形用ルーメンは、前記液体導入用ルーメンを兼ねる第1の変形用ルーメンと、前記第1の変形用ルーメンとは異なり、前記カテーテル本体の前記先端部側が塞がれた第2の変形用ルーメンとを含んでいてもよい。 In the urethral catheter according to the present invention, the first and second deformation lumens, which also serve as the liquid introduction lumens, and the first deformation lumen, close the distal end portion of the catheter body. And a second deformation lumen.
 本発明の尿道カテーテルでは、前記第1の変形用ルーメンと前記第2の変形用ルーメンとが、前記尿排出用ルーメンを挟んで互いに対向するように配置されていてもよい。 In the urinary catheter of the present invention, the first deformation lumen and the second deformation lumen may be disposed to face each other across the urine discharge lumen.
 本発明の尿道カテーテルによれば、扁平形状の変形用ルーメンが形成されているので、変形用ルーメン内の空気を引いて陰圧にすることによって、変形用ルーメンの内面同士を密着させることができる。これにより、カテーテル本体の一部を圧縮することができるので、カテーテル本体の外径を小さくすることができる。その結果、尿道カテーテルの挿入時に患者が感じる痛みを軽減することができる。 According to the urethral catheter of the present invention, since the flat-shaped deformation lumen is formed, the inner surfaces of the deformation lumens can be brought into close contact with each other by drawing air in the deformation lumen to obtain a negative pressure. . Thereby, since a part of catheter body can be compressed, the outer diameter of a catheter body can be made small. As a result, the pain felt by the patient at the time of insertion of the urethral catheter can be reduced.
図1は、本発明の一実施形態に係る尿道カテーテルの使用状態を示す図であって、膀胱内でバルーンが未膨張の状態を示している。FIG. 1 is a view showing a usage state of a urinary catheter according to an embodiment of the present invention, showing a balloon in an uninflated state in a bladder. 図2は、本発明の一実施形態に係る尿道カテーテルの使用状態を示す図であって、膀胱内でバルーンが膨張した状態を示している。FIG. 2 is a view showing a usage state of the urinary catheter according to an embodiment of the present invention, showing a balloon inflated in a bladder. 図3は、本発明の一実施形態に係る尿道カテーテルの平面図である。FIG. 3 is a plan view of a urinary catheter according to an embodiment of the present invention. 図4は、本発明の一実施形態に係る尿道カテーテルの側面図である。FIG. 4 is a side view of a urinary catheter according to an embodiment of the present invention. 図5は、図4のV-V切断線における断面図である。FIG. 5 is a cross-sectional view taken along the line VV of FIG. 図6は、図5の二点鎖線VIで囲まれた部分の拡大図であって、バルーン未使用状態を示す図である。FIG. 6 is an enlarged view of a portion surrounded by a two-dot chain line VI in FIG. 5 and showing a balloon unused state. 図7は、図5の二点鎖線VIで囲まれた部分の拡大図であって、バルーン使用状態を示す図である。FIG. 7 is an enlarged view of a portion surrounded by a two-dot chain line VI in FIG. 5 and showing a balloon used state. 図8は、図5の二点鎖線VIIIで囲まれた部分の拡大図である。FIG. 8 is an enlarged view of a portion surrounded by a two-dot chain line VIII in FIG. 図9は、図4の二点鎖線IXで囲まれた部分の拡大図である。FIG. 9 is an enlarged view of a portion surrounded by a two-dot chain line IX in FIG. 図10は、第1の尿排出口と第2の尿排出口との位置関係を示す図である。FIG. 10 is a diagram showing the positional relationship between the first urine outlet and the second urine outlet. 図11は、図3のXI-XI切断線における断面図であって、カテーテル本体の形状が未圧縮の状態を示している。FIG. 11 is a cross-sectional view taken along the line XI-XI in FIG. 3 and showing the catheter body in an uncompressed state. 図12は、図3のXI-XI切断線における断面図であって、カテーテル本体の形状が圧縮された状態を示している。FIG. 12 is a cross-sectional view taken along the line XI-XI in FIG. 3 and showing a state in which the shape of the catheter body is compressed. 図13は、カテーテル本体の変形例を示す図であって、カテーテル本体の形状が未圧縮の状態を示している。FIG. 13 is a view showing a modified example of the catheter body, and shows a state in which the shape of the catheter body is not compressed. 図14は、カテーテル本体の変形例を示す図であって、カテーテル本体の形状が圧縮された状態を示している。FIG. 14 is a view showing a modified example of the catheter main body, in which the shape of the catheter main body is compressed. 図15は、カテーテル本体の変形例を示す図であって、カテーテル本体の形状が未圧縮の状態を示している。FIG. 15 is a view showing a modified example of the catheter main body, and shows a state in which the shape of the catheter main body is not compressed. 図16は、カテーテル本体の変形例を示す図であって、カテーテル本体の形状が圧縮された状態を示している。FIG. 16 is a view showing a modified example of the catheter main body, in which the shape of the catheter main body is compressed. 図17は、カテーテル本体の変形例を示す図であって、カテーテル本体の形状が未圧縮の状態を示している。FIG. 17 is a view showing a modified example of the catheter body, and shows a state in which the shape of the catheter body is not compressed. 図18は、本発明の一実施形態に係る尿道カテーテルのバルーンの形状の特徴を説明するための斜視図である。FIG. 18 is a perspective view for explaining the shape feature of the balloon of the urinary catheter according to the embodiment of the present invention. 図19は、本発明の一実施形態に係る尿道カテーテルのバルーンの形状の特徴を説明するための斜視図である。FIG. 19 is a perspective view for explaining the feature of the shape of the balloon of the urinary catheter according to one embodiment of the present invention. 図20は、本発明の一実施形態に係る尿道カテーテルのバルーンの形状の特徴を説明するための断面図である。FIG. 20 is a cross-sectional view for describing features of the shape of the balloon of the urinary catheter according to one embodiment of the present invention. 図21は、本発明の一実施形態に係る尿道カテーテルの効果を説明するための図である。FIG. 21 is a view for explaining the effect of the urinary catheter according to the embodiment of the present invention.
 以下では、本発明の実施の形態を、添付図面を参照して詳細に説明する。 Hereinafter, embodiments of the present invention will be described in detail with reference to the attached drawings.
 図1は、本発明の一実施形態に係る尿道カテーテル1の使用状態を示す図であって、膀胱内でバルーン4が未膨張の状態を示している。図2は、本発明の一実施形態に係る尿道カテーテル1の使用状態を示す図であって、膀胱内でバルーン4が膨張した状態を示している。 FIG. 1 is a view showing a usage state of a urethral catheter 1 according to an embodiment of the present invention, showing a balloon 4 in a non-inflated state in a bladder. FIG. 2 is a view showing a usage state of the urethral catheter 1 according to an embodiment of the present invention, and shows a state in which the balloon 4 is expanded in the bladder.
 尿道カテーテル1は、排尿が困難な患者の導尿を補助するための器具であり、カテーテル本体2と、操作部3と、バルーン4とを備えている。図1に示すように、バルーン4が未膨張の状態で、カテーテル本体2を、その先端部5が人体6の膀胱7に達するまで、人体6の尿道8に挿入することによって使用される。挿入後、バルーン4を膨張させて固定することによって、カテーテル本体2の抜け落ちが防止され、カテーテル本体2が膀胱7内に留置される。 The urinary catheter 1 is an instrument for assisting in the urine conversion of a patient who has difficulty in urination, and includes a catheter body 2, an operation unit 3 and a balloon 4. As shown in FIG. 1, the catheter body 2 is used by inserting it into the urethra 8 of the human body 6 until the tip 5 reaches the bladder 7 of the human body 6 with the balloon 4 uninflated. After insertion, the balloon 4 is expanded and fixed to prevent the catheter body 2 from falling off, and the catheter body 2 is indwelled in the bladder 7.
 そして、膀胱7に溜まった尿10は、カテーテル本体2の先端部5に形成された第1の尿排出口9からカテーテル本体2の内部を通って、操作部3から排出される。 Then, the urine 10 accumulated in the bladder 7 is discharged from the operation unit 3 through the inside of the catheter main body 2 from the first urine outlet 9 formed in the distal end portion 5 of the catheter main body 2.
 次に、本発明の一実施形態に係る尿道カテーテル1の構成を、より具体的に説明する。 Next, the configuration of the urinary catheter 1 according to an embodiment of the present invention will be described more specifically.
 図3は、本発明の一実施形態に係る尿道カテーテル1の平面図である。図4は、本発明の一実施形態に係る尿道カテーテル1の側面図である。図5は、図4のV-V切断線における断面図である。図6は、図5の二点鎖線VIで囲まれた部分の拡大図であって、バルーン4が未使用の状態を示す図である。図7は、図5の二点鎖線VIで囲まれた部分の拡大図であって、バルーン4が使用された状態を示す図である。図8は、図5の二点鎖線VIIIで囲まれた部分の拡大図であるが、カテーテル本体2は非表示となっている。図9は、図4の二点鎖線IXで囲まれた部分の拡大図である。 FIG. 3 is a plan view of a urinary catheter 1 according to an embodiment of the present invention. FIG. 4 is a side view of a urinary catheter 1 according to an embodiment of the present invention. FIG. 5 is a cross-sectional view taken along the line VV of FIG. FIG. 6 is an enlarged view of a portion surrounded by a two-dot chain line VI in FIG. 5 and showing the balloon 4 in an unused state. FIG. 7 is an enlarged view of a portion surrounded by a two-dot chain line VI in FIG. 5 and showing a state in which the balloon 4 is used. FIG. 8 is an enlarged view of a portion surrounded by a two-dot chain line VIII in FIG. 5, but the catheter main body 2 is hidden. FIG. 9 is an enlarged view of a portion surrounded by a two-dot chain line IX in FIG.
 まず、図3~図5に示すように、尿道カテーテル1は、カテーテル本体2と、操作部3と、バルーン4とを備えている。 First, as shown in FIGS. 3 to 5, the urinary catheter 1 includes a catheter body 2, an operation unit 3 and a balloon 4.
 カテーテル本体2は、可撓性のチューブからなり、その先端に硬質の先端部5が取り付けられている。例えば、キャップ状の先端部5にカテーテル本体2を挿し込むことによってインロー構造とし、当該インロー構造の合わせ面を溶着・接着等することによって互いに固定されている。 The catheter body 2 is made of a flexible tube, and a hard tip 5 is attached to the tip thereof. For example, the catheter body 2 is inserted into the cap-like distal end portion 5 to form an inlay structure, and the mating surfaces of the inlay structures are fixed to each other by welding, bonding or the like.
 カテーテル本体2および先端部5は、例えば、天然ゴムラテックス、合成ゴムラテックス等のゴムラテックス基材、シリコーン基材、熱可塑性エラストマー等のベース部材に、表面処理を施したもので構成されていてもよい。表面処理としては、例えば、ベース部材に潤滑性を付与する親水性コーティング、ベース部材に平滑性を付与するウレタンコーティング・フッ素コーティング、ベース部材に抗菌性を付与する銀コーティング等が挙げられる。これらの表面処理は、2種以上併用されていてもよい。 The catheter main body 2 and the distal end portion 5 may be made of, for example, a rubber latex base such as natural rubber latex or synthetic rubber latex, a silicone base, or a base member such as a thermoplastic elastomer and subjected to surface treatment. Good. Examples of the surface treatment include a hydrophilic coating that imparts lubricity to the base member, a urethane coating / fluorine coating that imparts smoothness to the base member, and a silver coating that imparts antimicrobial properties to the base member. Two or more of these surface treatments may be used in combination.
 図6および図7に示すように、カテーテル本体2には、尿排出用ルーメン11と、液体導入用ルーメン12と、変形用ルーメン13とが、カテーテル本体2の長手方向に沿って延びるように形成されている。 As shown in FIGS. 6 and 7, the catheter body 2 is formed so as to extend along the longitudinal direction of the catheter body 2 such as a urine discharge lumen 11, a fluid introduction lumen 12 and a deformation lumen 13. It is done.
 尿排出用ルーメン11は、患者の膀胱7内の尿10を体外に導くための通路であって、カテーテル本体2の長手方向一端部である基部14(図5参照)から他端部である先端部15まで貫通しており、カテーテル本体2の略中心に形成されている。尿排出用ルーメン11は、筒状の先端部5に形成された第1の尿排出口9に連通しており、この第1の尿排出口9を介して、尿が尿排出用ルーメン11に入り込むこととなる。第1の尿排出口9は、カテーテル本体2の長手方向にやや縦長な楕円形状に形成されており(図9参照)、例えば、カテーテル本体2の径方向に対向するように一対設けられていてもよい(図6および図7参照)。 The urine drainage lumen 11 is a passage for guiding the urine 10 in the patient's bladder 7 to the outside of the patient, and is a tip from the base 14 (see FIG. 5) which is one longitudinal end of the catheter body 2 It penetrates to the portion 15 and is formed substantially at the center of the catheter body 2. The urine discharge lumen 11 is in communication with a first urine discharge port 9 formed in the cylindrical distal end portion 5, and through the first urine discharge port 9, urine passes through the urine discharge lumen 11. It will enter. The first urine outlet 9 is formed in an elliptical shape slightly elongated in the longitudinal direction of the catheter body 2 (see FIG. 9), and for example, a pair is provided to face in the radial direction of the catheter body 2 (See FIGS. 6 and 7).
 また、カテーテル本体2には、図3に示すように、カテーテル本体2の長手方向において、バルーン4を挟んで第1の尿排出口9の反対側に、尿排出用ルーメン11に連通する第2の尿排出口37が形成されている。より具体的は、後述するバルーン4の第1端部25を貫通するように、第2の尿排出口37が形成されている。 Further, as shown in FIG. 3, the catheter body 2 communicates with the urine discharge lumen 11 on the opposite side of the first urine discharge port 9 with the balloon 4 in the longitudinal direction of the catheter body 2. The urine outlet 37 is formed. More specifically, a second urine outlet 37 is formed to penetrate a first end 25 of the balloon 4 described later.
 第2の尿排出口37は、第1の尿排出口9と同様に、カテーテル本体2の長手方向にやや縦長な楕円形状に形成されており、例えば、カテーテル本体2の径方向に対向するように一対設けられていてもよい。また、第2の尿排出口37は、図10に示すように、カテーテル本体2の径方向断面視において、液体導入用ルーメン12および変形用ルーメン13を避ける位置、この実施形態では、第1の尿排出口9を90°回転させた位置に配置されている。これにより、第2の尿排出口37が、液体導入用ルーメン12および変形用ルーメン13に干渉することが防止されている。 Similarly to the first urine outlet 9, the second urine outlet 37 is formed in an oval shape slightly longer in the longitudinal direction of the catheter body 2, and, for example, opposed in the radial direction of the catheter body 2 A pair may be provided. Further, as shown in FIG. 10, the second urine outlet 37 is located at a position avoiding the fluid introducing lumen 12 and the deforming lumen 13 in the radial sectional view of the catheter body 2, and in this embodiment, the first urine outlet 37. The urine outlet 9 is disposed at a position rotated by 90 °. Thereby, the second urine outlet 37 is prevented from interfering with the fluid introducing lumen 12 and the deforming lumen 13.
 液体導入用ルーメン12は、バルーン4に膨張用の液体を導入するための通路であって、尿排出用ルーメン11に沿って延びて形成されている。液体導入用ルーメン12は、カテーテル本体2の基部14を開放端として、当該基部14からカテーテル本体2の長手方向途中部まで形成されており、その終端部が行き止まり部16とされている。この行き止まり部16は、第1の尿排出口9とバルーン流通口17(後述)との間に配置されている。また、カテーテル本体2の周面31には、液体導入用ルーメン12に連通するバルーン流通口17が形成されている。 The fluid introducing lumen 12 is a passage for introducing an inflation fluid to the balloon 4 and is formed extending along the urine drainage lumen 11. The fluid introducing lumen 12 is formed from the base 14 to a midway in the longitudinal direction of the catheter body 2 with the base 14 of the catheter body 2 as an open end, and the end is a dead end 16. The dead end portion 16 is disposed between the first urine outlet 9 and the balloon circulation port 17 (described later). Further, in the circumferential surface 31 of the catheter main body 2, a balloon circulation port 17 communicating with the liquid introduction lumen 12 is formed.
 変形用ルーメン13は、カテーテル本体2を変形させて尿道カテーテル1を挿入および抜去し易くするための通路であって、尿排出用ルーメン11に沿って延びて形成されている。変形用ルーメン13は、カテーテル本体2の基部14を開放端として、当該基部14からカテーテル本体2の長手方向途中部まで形成されており、その終端部が行き止まり部18とされている。この行き止まり部18は、第1の尿排出口9とバルーン流通口17との間であって、カテーテル本体2の長手方向において、液体導入用ルーメン12の行き止まり部16と同じ長さ位置に配置されている。また、変形用ルーメン13は、液体導入用ルーメン12とは異なり、バルーン流通口17のような開口等で外部と流通しておらず、その開放端においてのみ外部と流通している。 The deformation lumen 13 is a passage for deforming the catheter body 2 to facilitate insertion and removal of the urinary catheter 1, and is formed extending along the urine drainage lumen 11. The deformation lumen 13 is formed from the base 14 to a midway in the longitudinal direction of the catheter body 2 with the base 14 of the catheter body 2 as an open end, and the end is a dead end 18. The dead end portion 18 is disposed between the first urine outlet 9 and the balloon communication port 17 and at the same longitudinal position as the dead end portion 16 of the fluid introducing lumen 12 in the longitudinal direction of the catheter body 2. ing. Further, unlike the liquid introduction lumen 12, the deformation lumen 13 does not circulate with the outside through an opening or the like such as the balloon circulation port 17, and circulates with the outside only at the open end thereof.
 操作部3は、医師や看護師等の介助者が扱う部分であり、尿排出用ポート19と、液体導入用ポート20と、変形用ポート21とを一体的に備えている。操作部3は、図3~図5に示すように、カテーテル本体2の延長線上に延びるファネル状の尿排出用ポート19の周面から、液体導入用ポート20および変形用ポート21が、互いに対称に分岐する三叉形状に形成されていてもよい。この操作部3は、例えば、カテーテル本体2と同じ材料からなり、カテーテル本体2に対してインサート成形することによって、カテーテル本体2に固定されていてもよい。なお、操作部3は、カテーテル本体2と異なる材料であってもよく、その場合、インサート成形、溶着、接着等によって、カテーテル本体2に固定されていてもよい。 The operation unit 3 is a portion handled by an assistant such as a doctor or a nurse, and integrally includes a urine discharge port 19, a liquid introduction port 20, and a deformation port 21. As shown in FIGS. 3 to 5, in the operation unit 3, the liquid introduction port 20 and the deformation port 21 are symmetrical to each other from the peripheral surface of the funnel-shaped urine discharge port 19 extending along the extension of the catheter body 2. It may be formed in the shape of a fork that branches into. The operation unit 3 may be made of, for example, the same material as the catheter body 2 and may be fixed to the catheter body 2 by insert molding on the catheter body 2. The operation unit 3 may be made of a material different from that of the catheter body 2, and in this case, it may be fixed to the catheter body 2 by insert molding, welding, adhesion or the like.
 また、図5に示すように、尿排出用ポート19、液体導入用ポート20および変形用ポート21には、それぞれ、尿排出用通路22、液体導入用通路23および変形用通路24が互いに独立して形成されている。尿排出用通路22は尿排出用ルーメン11に連通し、液体導入用通路23は液体導入用ルーメン12に連通し、変形用通路24は変形用ルーメン13に連通している。 Further, as shown in FIG. 5, in the urine discharge port 19, the liquid introduction port 20 and the deformation port 21, the urine discharge passage 22, the liquid introduction passage 23 and the deformation passage 24 are mutually independent. It is formed. The urine discharge passage 22 communicates with the urine discharge lumen 11, the fluid introduction passage 23 communicates with the fluid introduction lumen 12, and the deformation passage 24 communicates with the deformation lumen 13.
 尿排出用ポート19には、排出された尿を溜めるための蓄尿バッグ等の容器が接続される。また、液体導入用ポート20および変形用ポート21の先端には、例えば、シリンジを接続するためのバルブ39,40が設けられている。医師や看護師等の介助者は、バルーン膨張用の液体が充填されたシリンジをバルブ39に接続し、シリンジのプランジャを押すことによって、液体導入用通路23および液体導入用ルーメン12を介して、バルーン4に液体を注入することができる。また、医師や看護師等の介助者は、空のシリンジをバルブ40に接続し、シリンジのプランジャを引くことによって、変形用通路24および変形用ルーメン13内の空気をシリンジ内に収容して、変形用ルーメン13内を陰圧にすることができる。 The urine discharge port 19 is connected to a container such as a urine collection bag for storing the discharged urine. Further, for example, valves 39 and 40 for connecting a syringe are provided at the tips of the liquid introduction port 20 and the deformation port 21. An assistant such as a doctor or a nurse connects the syringe filled with the liquid for balloon inflation to the valve 39 and pushes the plunger of the syringe to pass the liquid introduction passage 23 and the liquid introduction lumen 12 Liquid can be injected into the balloon 4. Also, an assistant such as a doctor or a nurse connects an empty syringe to the valve 40 and pulls the plunger of the syringe to store the air in the deformation passage 24 and the deformation lumen 13 in the syringe, The pressure in the deformation lumen 13 can be negative.
 バルーン4は、カテーテル本体2を取り囲むように固定された第1端部25および第1端部25よりも先端部15側の第2端部26を有し、第1端部25と第2端部26との間に設けられ、患者の膀胱7内で球状に膨張する膜からなる膨張部27を有している。バルーン4は、膨張部27の内側において、バルーン流通口17につながっている。また、バルーン4の第1端部25および第2端部26は、例えば、溶着・接着等によってカテーテル本体2に固定されていてもよい。また、バルーン4の材料としては、例えば、ゴムラテックス、シリコーン、熱可塑性エラストマー等が挙げられる。 The balloon 4 has a first end 25 fixed so as to surround the catheter body 2 and a second end 26 closer to the distal end 15 than the first end 25, and the first end 25 and the second end An inflatable portion 27 is provided between the portion 26 and is a membrane that spherically inflates in the bladder 7 of the patient. The balloon 4 is connected to the balloon communication port 17 inside the inflation portion 27. Further, the first end 25 and the second end 26 of the balloon 4 may be fixed to the catheter body 2 by welding, adhesion or the like, for example. Moreover, as a material of the balloon 4, rubber latex, silicone, a thermoplastic elastomer etc. are mentioned, for example.
 また、膨張部27の内面には、図8に示すように、カテーテル本体2の周方向に沿って複数のリブ28が設けられていてもよい。複数のリブ28は、カテーテル本体2を取り囲むようにそれぞれが環状に形成され、カテーテル本体2の長手方向に沿って間隔を空けて配置されている。 Further, as shown in FIG. 8, a plurality of ribs 28 may be provided on the inner surface of the inflating portion 27 along the circumferential direction of the catheter body 2. The plurality of ribs 28 are each formed in an annular shape so as to surround the catheter body 2 and are spaced along the longitudinal direction of the catheter body 2.
 そして、医師や看護師等の介助者が、シリンジで液体導入用通路23に滅菌蒸留水等の膨張用液を注入することによって、当該膨張用液が、液体導入用ルーメン12およびバルーン流通口17を介してバルーン4内に入り込み、図7に示すように、バルーン4が球状に膨張する。 Then, an assistant such as a doctor or a nurse injects a dilation fluid such as sterile distilled water into the fluid introduction passage 23 with a syringe, whereby the dilation fluid is introduced into the liquid introduction lumen 12 and the balloon flow port 17. , And the balloon 4 expands spherically as shown in FIG.
 次に、カテーテル本体2の構成について、より詳細に説明する。 Next, the configuration of the catheter body 2 will be described in more detail.
 図11は、図3のXI-XI切断線における断面図であって、カテーテル本体2の形状が未圧縮の状態を示している。図12は、図3のXI-XI切断線における断面図であって、カテーテル本体2の形状が圧縮された状態を示している。図13は、カテーテル本体2の変形例を示す図であって、カテーテル本体2の形状が未圧縮の状態を示している。図14は、カテーテル本体2の変形例を示す図であって、カテーテル本体2の形状が圧縮された状態を示している。 FIG. 11 is a cross-sectional view taken along the line XI-XI in FIG. 3, and shows the catheter body 2 in an uncompressed state. FIG. 12 is a cross-sectional view taken along the line XI-XI in FIG. 3, and shows a state in which the shape of the catheter body 2 is compressed. FIG. 13 is a view showing a modified example of the catheter body 2 and shows a state in which the shape of the catheter body 2 is not compressed. FIG. 14 is a view showing a modified example of the catheter main body 2 and shows a state in which the shape of the catheter main body 2 is compressed.
 まず、図11および図12を参照して、カテーテル本体2は、前述したように、ゴムラテックス基材やシリコーン基材等の可撓性のあるソフト部材によって全体が構成されていてもよいが、例えば、尿道8の内壁(粘膜部)に接触する外層29と、外層29の内側に形成され、尿排出用ルーメン11の内壁を形成する内層30との二層構造であってもよい。内層30は、外層29よりも硬い部材で構成されていることが好ましい。 First, referring to FIGS. 11 and 12, as described above, the catheter body 2 may be entirely constituted by a flexible soft member such as a rubber latex base or a silicone base, For example, the outer layer 29 may be in contact with the inner wall (mucosal portion) of the urethra 8 and the inner layer 30 formed on the inner side of the outer layer 29 and forming the inner wall of the urine drainage lumen 11. The inner layer 30 is preferably made of a member harder than the outer layer 29.
 すなわち、カテーテル本体2は、比較的剛性(コシ)がある内層30からなるチューブ状の芯材が、当該芯材よりも柔らかく変形しやすい外層29でコーティングされた構成であることが好ましい。これにより、尿道カテーテル1を挿入する側である医師や看護師等の介助者にとっては、内層30の剛性のおかげで、挿入時に若干の抵抗があっても挿入し易く、尿道カテーテル1を挿入される側である患者にとっては、尿道8の内壁に接する部分が柔らかいので、痛みが軽減されるという利点がある。 That is, it is preferable that the catheter main body 2 has a configuration in which a tube-shaped core material composed of the inner layer 30 having relatively rigidity (stiffness) is coated with the outer layer 29 which is softer and more deformable than the core material. As a result, the rigidity of the inner layer 30 makes it easy for an assistant such as a doctor or nurse who is inserting the urinary catheter 1 to insert the urinary catheter 1 due to the rigidity of the inner layer 30. For the patient on the other side, the softness of the portion in contact with the inner wall of the urethra 8 has the advantage of reducing pain.
 外層29は、例えば、前述の天然ゴムラテックス、合成ゴムラテックス等のゴムラテックス基材、シリコーン基材等のベース部材に、表面処理を施したもので構成されていてもよい。一方、内層30は、例えば、硬質シリコーン、熱可塑性エラストマー等で構成されていてもよい。また、内層30には、外層29と同様に、前述の表面処理が施されていてもよい。 The outer layer 29 may be made of, for example, a rubber latex base such as the above-mentioned natural rubber latex or synthetic rubber latex, or a base member such as silicone base. On the other hand, the inner layer 30 may be made of, for example, hard silicone, thermoplastic elastomer or the like. In addition, the inner layer 30 may be subjected to the above-described surface treatment, similarly to the outer layer 29.
 また、カテーテル本体2は、基部14から先端部15(図5参照)まで一定の外径を有しており、例えば、2mm~10mmの外径を有している。 The catheter body 2 has a constant outer diameter from the base 14 to the distal end portion 15 (see FIG. 5), for example, an outer diameter of 2 mm to 10 mm.
 次に、カテーテル本体2の尿排出用ルーメン11、液体導入用ルーメン12および変形用ルーメン13の位置および形状について説明する。 Next, the positions and shapes of the urine discharge lumen 11, the liquid introduction lumen 12 and the deformation lumen 13 of the catheter body 2 will be described.
 尿排出用ルーメン11は、カテーテル本体2の径方向断面視において、その中心部に円形状に形成されている。尿排出用ルーメン11の内径は、例えば、2mm~5mm程度であってもよい。 The urine drainage lumen 11 is formed in a circular shape at the center of the catheter main body 2 in a radial cross-sectional view. The inner diameter of the urine drainage lumen 11 may be, for example, about 2 mm to 5 mm.
 液体導入用ルーメン12は、尿排出用ルーメン11の周囲において、尿排出用ルーメン11よりも小さな径を有する円形状に形成されている。液体導入用ルーメン12の内径は、例えば、0.1mm~0.8mm程度であってもよい。 The fluid introducing lumen 12 is formed in a circular shape having a diameter smaller than that of the urine discharging lumen 11 around the urine discharging lumen 11. The inner diameter of the liquid introducing lumen 12 may be, for example, about 0.1 mm to 0.8 mm.
 変形用ルーメン13は、尿排出用ルーメン11の周囲において、尿排出用ルーメン11を挟んで液体導入用ルーメン12と対向するように配置されている。変形用ルーメン13は、この実施形態では、カテーテル本体2の周面31に沿って湾曲した扁平形状に形成されている。より具体的には、変形用ルーメン13は、カテーテル本体2の径方向断面視において、尿排出用ルーメン11の中心Cから広がる中心角θが90°以下の扇形領域32の半径線分R,R上に、その一端部33および他端部34を有する扁平形状に形成されている。 The deformation lumen 13 is disposed around the urine discharge lumen 11 so as to face the liquid introduction lumen 12 across the urine discharge lumen 11. The deformation lumen 13 is formed in a flat shape that is curved along the circumferential surface 31 of the catheter body 2 in this embodiment. More specifically, in the radial direction cross-sectional view of the catheter main body 2, the deformation lumen 13 is a radial line segment R 1 of the fan-shaped region 32 whose central angle θ spreads from the center C of the urine drainage lumen 11 is 90 ° or less on R 2, it is formed in a flat shape having one end portion 33 and the other end portion 34.
 このような変形用ルーメン13が形成されているので、医師や看護師等の介助者が、シリンジで変形用ルーメン13内の空気を引いて陰圧にすることによって、変形用ルーメン13の外側面35と内側面36を密着させることができる。これにより、カテーテル本体2の一部を圧縮することができるので、カテーテル本体2の外径を小さくすることができる。その結果、尿道カテーテル1の挿入時に患者が感じる痛みを軽減することができる。 Since such a deformation lumen 13 is formed, an assistant such as a doctor or a nurse pulls the air in the deformation lumen 13 with a syringe to make it negative pressure, whereby the outer surface of the deformation lumen 13 is obtained. 35 and the inner surface 36 can be in close contact. Thereby, since a part of catheter body 2 can be compressed, the outside diameter of catheter body 2 can be made small. As a result, the pain felt by the patient when the urinary catheter 1 is inserted can be reduced.
 なお、変形用ルーメン13は、カテーテル本体2が内層30および外層29に二層構造である場合には、相対的に柔らかい外層29に形成されていることが好ましい。これにより、カテーテル本体2を容易に圧縮することができる。 When the catheter body 2 has a two-layer structure in the inner layer 30 and the outer layer 29, the deformation lumen 13 is preferably formed in the relatively soft outer layer 29. Thereby, the catheter body 2 can be easily compressed.
 また、変形用ルーメン13は、図11および図12に示すように、カテーテル本体2に1つだけ形成されていてもよいが、図13および図14に示すように、複数形成されていてもよい。この場合、一方の変形用ルーメン13(第2の変形用ルーメン)は、前述のように行き止まり部18によって先端部側が塞がれていてもよく、他方の変形用ルーメン13(第1の変形用ルーメン)は、バルーン流通口17を介してバルーン4に連通するように形成され、液体導入用ルーメン12を兼ねていてもよい。液体導入用ルーメン12を兼ねる場合でも、バルーン4が閉塞されているおかげで、当該液体導入用ルーメン12の開放端においてのみ外部と流通する形態となるため、ルーメン内を陰圧にすることができる。複数の変形用ルーメン13は、尿排出用ルーメン11を挟んで互いに対向するように配置されていてもよい。変形用ルーメン13が複数形成されていれば、カテーテル本体2を、より小さな径まで圧縮することができる。 Further, only one deformation lumen 13 may be formed in the catheter body 2 as shown in FIGS. 11 and 12, but a plurality of deformation lumens 13 may be formed as shown in FIGS. 13 and 14. . In this case, one end of the deformation lumen 13 (second deformation lumen) may be blocked by the dead end 18 as described above, and the other deformation lumen 13 (first deformation lumen) may be closed. The lumen) may be formed to communicate with the balloon 4 through the balloon communication port 17 and may also serve as the fluid introduction lumen 12. Even when the fluid introduction lumen 12 is also used, the balloon 4 is occluded so that the fluid is communicated with the outside only at the open end of the fluid introduction lumen 12, so that the inside of the lumen can be made negative pressure. . The plurality of deformation lumens 13 may be disposed to face each other with the urine discharge lumen 11 interposed therebetween. If a plurality of deformation lumens 13 are formed, the catheter body 2 can be compressed to a smaller diameter.
 また、変形用ルーメン13は、図15および図16に示す構成であってもよい。具体的には、カテーテル本体2の径方向断面視において、変形用ルーメン13の内側面36の長さLが、外側面35の長さLよりも長くてもよい(L>L)。 The deformation lumen 13 may be configured as shown in FIG. 15 and FIG. Specifically, in the radial cross section of the catheter body 2, the length L 2 of the inner side surface 36 of the deformation lumen 13 may be longer than the length L 1 of the outer side surface 35 (L 2 > L 1 ).
 この変形例では、カテーテル本体2の径方向断面視において、尿排出用ルーメン11の中心Cを通る第1方向Dおよび第1方向Dに直交する方向を第2方向Dと定義する。 In this modification, in the radial direction cross section of the catheter body 2 defines a direction perpendicular to the first direction D 1 and the first direction D 1 passes through the center C of the urinary drainage lumen 11 and the second direction D 2.
 変形用ルーメン13の外側面35は、第1方向Dの両側に均等に、円形のカテーテル本体2の周面31に沿う弧状に形成されている。このような形状の変形用ルーメン13の外側面35の長さL-(図15の上側の変形用ルーメン13において、変形用ルーメン13の一端部33と他端部34を繋ぐ上側の線分の長さ)は、たとえば、2mm~4mmであってもよい。 Outer surface 35 of the deformable lumen 13, equally on both sides of the first direction D 1, are formed in an arc shape along the circumferential surface 31 of the circular of the catheter body 2. The length L- 1 of the outer surface 35 of the deformation lumen 13 having such a shape (an upper line segment connecting one end 33 and the other end 34 of the deformation lumen 13 in the deformation lumen 13 on the upper side of FIG. ) May be, for example, 2 mm to 4 mm.
 一方、変形用ルーメン13の内側面36は、外側面35との協働によってカテーテル本体2の周面31に沿った扁平形状の変形用ルーメン13を区画するが、その形状は外側面35のように周面31と一定の距離を保って沿う弧状とは異なる。具体的には、変形用ルーメン13の内側面36は、その一部がカテーテル2の内方領域に向かって周面31から離れるように窪んでいる。この変形例では、変形用ルーメン13の内側面36は、変形用ルーメン13の一端部33および他端部34のそれぞれから外側面35に沿って(周面31と一定の距離を保って)第1方向Dに向かう一対の弧状の凸部46と、第1方向D付近においてカテーテル2の内方領域(この変形例では、中心Cの方向)に向かって周面31から離れるように窪む凹部45とを一体的に有する波状に形成されている。これにより、弧状の外側面35の長さL-よりも、波状の内側面36の長さL-は、長くなっている。波状の内側面36の長さL-(図15の上側の変形用ルーメン13において、変形用ルーメン13の一端部33と他端部34を繋ぐ下側の線分の長さ)は、たとえば、2.5mm~4.5mmであってもよい。 On the other hand, the inner surface 36 of the deformation lumen 13 defines a flat deformation lumen 13 along the circumferential surface 31 of the catheter body 2 in cooperation with the outer surface 35, but the shape is similar to the outer surface 35. The arc is different from the arc 31 along which the peripheral surface 31 is kept at a constant distance. Specifically, the inner side surface 36 of the deformation lumen 13 is recessed such that a portion thereof is separated from the circumferential surface 31 toward the inward region of the catheter 2. In this modification, the inner side surface 36 of the deformation lumen 13 is arranged along the outer side surface 35 from each of the one end 33 and the other end 34 of the deformation lumen 13 (with a constant distance from the circumferential surface 31). a pair of arcuate projection 46 toward the one direction D 1, (in this modification, the direction of the center C) inner region of the catheter 2 in the vicinity of the first direction D 1 recess away from the peripheral surface 31 toward the It is formed in the shape of a wave which has a concave portion 45 integrally. Thus, the length L- 2 of the wavy inner surface 36 is longer than the length L- 1 of the arc-shaped outer surface 35. The length L- 2 of the wavy inner surface 36 (the length of the lower segment connecting the one end 33 and the other end 34 of the deformation lumen 13 in the upper deformation lumen 13 in FIG. 15) is, for example, , 2.5 mm to 4.5 mm.
 これにより、変形用ルーメン13の内側面36の凹部45と尿排出用ルーメンの内周面47との距離(厚さT)は、たとえば、0.4mm~0.6mmであってもよく、変形用ルーメン13の内側面36の凸部46と尿排出用ルーメンの内周面47との距離(厚さT)は、たとえば、0.7mm~0.9mmであってもよい。 Thereby, the distance (thickness T 1 ) between the recess 45 of the inner side surface 36 of the deformation lumen 13 and the inner peripheral surface 47 of the urine discharge lumen may be, for example, 0.4 mm to 0.6 mm. The distance (thickness T 2 ) between the convex portion 46 of the inner side surface 36 of the deformation lumen 13 and the inner circumferential surface 47 of the urine discharge lumen may be, for example, 0.7 mm to 0.9 mm.
 また、尿排出用ルーメン11は、図15に示すように、カテーテル本体2の径方向断面視において、変形用ルーメン13の長手方向に沿う方向を長軸方向とする楕円形状に形成されている。より具体的には、第2方向Dに沿う方向を長軸方向とする楕円形状であってもよい。この変形例では、尿排出用ルーメン11は、変形用ルーメン13の一端部33および他端部34よりも外側(中心C)から離れる側に長軸の端部48,49をそれぞれ有する楕円形状に形成されている。 Further, as shown in FIG. 15, the urine discharge lumen 11 is formed in an elliptical shape whose major axis is a direction along the longitudinal direction of the deformation lumen 13 in the radial cross section of the catheter body 2. More specifically, the direction along the second direction D 2 may be an oval shape with the major axis direction. In this modification, the urine discharge lumen 11 is formed into an elliptical shape having the ends 48 and 49 of the major axis on the side away from the outside (center C) from the one end 33 and the other end 34 of the deformation lumen 13. It is formed.
 そして、この変形例にかかるカテーテル本体2では、変形用ルーメン13の内側面36の長さLが、外側面35の長さLよりも長い。そのため、図16に示すように変形用ルーメン13内の空気を引いて陰圧にしたときに、カテーテル本体2の周面31がa方向、a方向、b方向およびb方向に撓むように圧縮される。その結果、カテーテル本体2の周面31の一部が角張るという、いわゆる肉余りが発生することを抑制することができる。 In the catheter body 2 according to this modification, the length L 2 of the inner side surface 36 of the deformation lumen 13 is longer than the length L 1 of the outer side surface 35. Therefore, when a negative pressure by pulling air deforming lumen 13 as shown in FIG. 16, flexures peripheral surface 31 of the catheter body 2 is a 1 direction, a 2 direction, b in the first direction and b 2 directions It is compressed too much. As a result, it is possible to suppress the occurrence of a so-called excess of meat in which a part of the circumferential surface 31 of the catheter body 2 is angular.
 さらに、変形用ルーメン13の内側面36が波状であり、尿排出用ルーメン11が楕円形状であるため、圧縮によって内側面36に近づく外側面35を、内側面36の一対の凸部46に選択的に接触させることができる(凹部45には非接触)。これにより、内側面36の凹部45に対向する(第1方向D上にある)、尿排出用ルーメン11の内周面47の短軸の端部50,51に選択的に負荷を加えることができる。これにより、たとえばパンタグラフ状に、尿排出用ルーメン11をc方向、c方向、d方向およびd方向に変形させ、端部50,51を尿排出用ルーメン11内に突出させた形態にすることができるので、カテーテル本体2の更なる断面圧縮が可能となる。たとえば、圧縮前のカテーテル本体2の径をDc1としたときに、圧縮後のカテーテル本体2の径Dc2を、70~80%程度にすることができる。 Furthermore, since the inner surface 36 of the deformation lumen 13 is wavy and the urine discharge lumen 11 is elliptical, the outer surface 35 approaching the inner surface 36 due to compression is selected as the pair of convex portions 46 of the inner surface 36 Contact (not in contact with the recess 45). Thus, opposite to the recess 45 of the inner surface 36 (located on a first direction D 1), selectively applying a load to the end portion 50 and 51 of the minor axis of the inner circumferential surface 47 of the urinary drainage lumen 11 Can. Thus, for example, in a pantograph shape, the urine discharge lumen 11 is deformed in the c 1 direction, c 2 direction, d 1 direction and d 2 direction, and the end portions 50 and 51 are protruded into the urine discharge lumen 11. This enables further cross-sectional compression of the catheter body 2. For example, when the diameter of the catheter body 2 before compression is D c1 , the diameter D c2 of the catheter body 2 after compression can be about 70 to 80%.
 なお、この変形例にかかるカテーテル本体2においても、図11および図12と同様に、変形用ルーメン13は1つだけ形成されていてもよい。 Also in the catheter body 2 according to this modification, as in FIGS. 11 and 12, only one deformation lumen 13 may be formed.
 また、変形用ルーメン13は、図17に示すように、カテーテル本体2の周面31に沿った扁平形状ではあるが、周面31に沿って湾曲していなくてもよい。 In addition, although the deformation lumen 13 has a flat shape along the circumferential surface 31 of the catheter main body 2 as shown in FIG. 17, it may not be curved along the circumferential surface 31.
 次に、バルーン4の構成について、より詳細に説明する。 Next, the configuration of the balloon 4 will be described in more detail.
 図18および図19は、尿道カテーテル1のバルーン4の形状の特徴を説明するための斜視図であって、バルーン4が膨張した状態を示している。図18が、バルーン4をカテーテル本体2の先端部15側から見た図であり、図19が、バルーン4をカテーテル本体2の先端部15の反対側から見た図である。図20は、尿道カテーテル1のバルーンの形状の特徴を説明するための断面図である。図21は、尿道カテーテル1の効果を説明するための図である。 FIG. 18 and FIG. 19 are perspective views for explaining the characteristics of the shape of the balloon 4 of the urinary catheter 1, and show a state in which the balloon 4 is expanded. FIG. 18 is a view of the balloon 4 viewed from the side of the tip 15 of the catheter body 2 and FIG. 19 is a view of the balloon 4 viewed from the opposite side of the tip 15 of the catheter body 2. FIG. 20 is a cross-sectional view for describing the feature of the shape of the balloon of the urinary catheter 1. FIG. 21 is a view for explaining the effect of the urinary catheter 1.
 バルーン4は、この実施形態では、図18および図19に示すように、第1端部25から第2端部26へ向かってその周面に沿って延びる線状の凹部38(凹条)を有している。凹部38は、第1端部25を始端とし、第2端部26を終端とするように形成されている。これにより、例えば、図21に示すように、膨張したバルーン4の膨張部27を膀胱7の内壁(例えば、膀胱頸部)に接触させた状態において、膨張部27と膀胱7の内壁との間に、一定の空間41が形成されるようになっている。そして、第2の尿排出口37は、この空間41に露出するように、バルーン4の第1端部25の所定位置に形成されている。 In this embodiment, as shown in FIGS. 18 and 19, the balloon 4 has linear recesses 38 (concave lines) extending along the circumferential surface from the first end 25 to the second end 26. Have. The recess 38 is formed to start at the first end 25 and end at the second end 26. Thereby, for example, as shown in FIG. 21, in a state where the expanded portion 27 of the expanded balloon 4 is in contact with the inner wall (for example, the bladder neck) of the bladder 7, between the expanded portion 27 and the inner wall of the bladder 7 In addition, a constant space 41 is formed. The second urine outlet 37 is formed at a predetermined position of the first end 25 of the balloon 4 so as to be exposed to the space 41.
 凹部38は、図20に示すように、カテーテル本体2の周面31に沿う環状方向に互いに等しい間隔を空けて形成されている。例えば、この実施形態では、カテーテル本体2の径方向断面視において、その中心C(尿排出用ルーメン11の中心)周りに、120°の間隔を空けて合計3本形成されている。なお、凹部38は、3本に限らず、4本以上であってもよい。 The recesses 38 are formed at equal intervals in the annular direction along the circumferential surface 31 of the catheter body 2 as shown in FIG. For example, in this embodiment, a total of three are formed at intervals of 120 ° around the center C (the center of the urine drainage lumen 11) in the radial cross section of the catheter body 2. The number of recesses 38 is not limited to three, and may be four or more.
 また、膨張状態のバルーン4の内壁は、図20に示すように、カテーテル本体2の径方向断面視において、凹部38が形成された部位が、それ以外の平面領域42に対して内側に突出する凸部43として形成されている。一方、図20の「バルーン4´」は、バルーン4が未膨張の状態を示しており、この状態では、バルーン4´の外周面の凹部38に対応する位置に、凸部44が形成されている。バルーン4は、凹部38が形成された部位の膜厚T(凸部43,44の高さ)が、それ以外の部位(平面領域42)の膜厚Tよりも厚く形成されている。例えば、膜厚Tが0.3mm~1.5mmであり、膜厚Tが0.05mm~0.7mmである。つまり、未膨張時に凸部44が形成されていることで、バルーン4を膨張させたときに、凸部44とそれ以外の部分との間に膨張度合いに差が生じ、膨張後に凸部44の形成部位に凹部38が形成される。 Further, as shown in FIG. 20, in the radial cross section of the catheter main body 2, the inner wall of the balloon 4 in the expanded state projects inward with respect to the flat region 42 other than the portion where the recess 38 is formed. It is formed as a convex portion 43. On the other hand, "balloon 4 '" of FIG. 20 shows a state in which the balloon 4 is not inflated. In this state, the convex portion 44 is formed at a position corresponding to the concave portion 38 on the outer peripheral surface of the balloon 4'. There is. In the balloon 4, the film thickness T 1 (height of the convex portions 43 and 44) of the portion where the concave portion 38 is formed is formed thicker than the film thickness T 2 of the other portion (planar region 42). For example, the thickness T 1 is a 0.3 mm ~ 1.5 mm, thickness T 2 is 0.05 mm ~ 0.7 mm. That is, when the balloon 4 is inflated, the convexity 44 is formed when the balloon 4 is not inflated, so that there is a difference in the degree of expansion between the convexity 44 and the other parts. A recess 38 is formed at the formation site.
 以上のように、図21を参照して、膨張したバルーン4の膨張部27を膀胱7の内壁(例えば、膀胱頸部)に接触させた状態において、膨張部27と膀胱7の内壁との間に、一定の空間41が形成される。そして、この空間41に入り込むように、バルーン4には、複数の凹部38が形成されている。 As described above, referring to FIG. 21, between expanded portion 27 and the inner wall of bladder 7 in a state in which expanded portion 27 of expanded balloon 4 is in contact with the inner wall (for example, the bladder neck) of bladder 7. Thus, a constant space 41 is formed. A plurality of recesses 38 are formed in the balloon 4 so as to enter the space 41.
 膀胱7における尿10の液面位置が、図21の液面Sのように、第1の尿排出口9よりも高い位置にあれば、尿10を第1の尿排出口9を介して排出することができる。一方、図21の液面Sのように、尿10の液面が第1の尿排出口9よりも低い位置にあれば、第1の尿排出口9を介して排出することは困難である。このような場合でも、この尿道カテーテル1を使用すれば、第1の尿排出口9よりも低い位置に存在する尿10を、凹部38に沿って下方に流して空間41までガイドし、空間41に露出する第2の尿排出口37から排出することができる。その結果、バルーン4による抜け落ち防止機能を有しながら、膀胱7の内壁からバルーン4の頂部までの尿10を簡単に排出することができる
 以上、本発明の一実施形態について説明したが、本発明は、他の形態で実施することもできる。
Liquid level of the urine 10 in the bladder 7 is, as the liquid surface S 1 in FIG. 21, if a position higher than the first urine output port 9, the urine 10 via the first urine output port 9 It can be discharged. On the other hand, as the liquid surface S 2 in FIG. 21, if a position lower than the liquid level first urine outlet 9 of urine 10, it is discharged through the first urine output port 9 is difficult is there. Even in such a case, if this urinary catheter 1 is used, urine 10 present at a position lower than the first urine outlet 9 flows downward along the recess 38 and is guided to the space 41, The second urine outlet 37 exposed to the As a result, it is possible to easily discharge the urine 10 from the inner wall of the bladder 7 to the top of the balloon 4 while having the dropout prevention function by the balloon 4 In the above, one embodiment of the present invention has been described. Can also be implemented in other forms.
 例えば、前述の実施形態では、バルーン4が設けられた尿道カテーテル1のみを例に取り上げたが、本発明の「挿入および抜去時に患者が感じる痛みを軽減する」という観点では、バルーン4は設けられていなくてもよい。 For example, in the above embodiment, only the urethral catheter 1 provided with the balloon 4 is taken as an example, but the balloon 4 is provided from the viewpoint of "reducing pain felt by the patient at the time of insertion and removal" of the present invention. You do not have to.
 その他、特許請求の範囲に記載された事項の範囲で種々の設計変更を施すことが可能である。 In addition, various design changes can be made within the scope of matters described in the claims.
 本出願は、2017年9月7日に日本国特許庁に提出された特願2017-172173号に対応しており、この出願の全開示はここに引用により組み込まれるものとする。 This application corresponds to Japanese Patent Application No. 2017-172173 filed on Sep. 7, 2017, and the entire disclosure of this application is incorporated herein by reference.
 1 尿道カテーテル
 2 カテーテル本体
 3 操作部
 4 バルーン
 5 先端部
 6 人体
 7 膀胱
 8 尿道
 9 第1の尿排出口
 10 尿
 11 尿排出用ルーメン
 12 液体導入用ルーメン
 13 変形用ルーメン
 14 (カテーテル本体)基部
 15 (カテーテル本体)先端部
 16 行き止まり部
 17 バルーン流通口
 18 行き止まり部
 19 尿排出用ポート
 20 液体導入用ポート
 21 変形用ポート
 22 尿排出用通路
 23 液体導入用通路
 24 変形用通路
 25 (バルーン)第1端部
 26 (バルーン)第2端部
 27 (バルーン)膨張部
 28 リブ
 29 外層
 30 内層
 31 周面
 32 扇形領域
 33 (変形用ルーメン)一端部
 34 (変形用ルーメン)他端部
 35 (変形用ルーメン)外側面
 36 (変形用ルーメン)内側面
 37 第2の尿排出口
 38 凹部
 39 バルブ
 40 バルブ
 41 空間
 42 平面領域
 43 凸部
 44 凸部
 45 凹部
 46 凸部
 47 内周面
 48 端部
 49 端部
 50 端部
 51 端部
DESCRIPTION OF SYMBOLS 1 urinary catheter 2 catheter main body 3 operation part 4 balloon 5 tip 6 human body 7 bladder 8 urethra 9 first urine outlet 10 urine 11 lumen for urine 12 lumen for liquid introduction 13 deformation lumen 14 (catheter body) base 15 (Catheter body) Tip portion 16 Dead end 17 Balloon flow port 18 Dead end portion 19 Urine discharge port 20 Liquid introduction port 21 Deformation port 22 Urine drainage passage 23 Liquid introduction passage 24 Deformation passage 25 (balloon) 1st End portion 26 (balloon) second end portion 27 (balloon) inflating portion 28 rib 29 outer layer 30 inner layer 31 circumferential surface 32 fan-shaped area 33 (lumen for deformation) one end portion 34 (lumen for deformation) other end 35 (lumen for deformation ) Outer side 36 (lumen for deformation) inner side 37 second urine outlet 38 recess 39 valve 40 valve 41 space 42 plane area 43 convex section 44 convex section 45 concave section 46 convex section 47 inner circumferential surface 48 end 49 end 50 end 51 end

Claims (12)

  1.  患者の膀胱内に留置される先端部およびその反対側の基部を有する可撓性チューブからなるカテーテル本体と、
     前記カテーテル本体内に形成され、患者の膀胱内の尿を体外に導くための尿排出用ルーメンと、
     前記カテーテル本体内において前記尿排出用ルーメンに沿って延びて形成され、前記カテーテル本体の径方向断面視において、前記カテーテル本体の周面に沿う扁平形状の変形用ルーメンとを含む、尿道カテーテル。
    A catheter body consisting of a flexible tube having a tip to be placed in the patient's bladder and a base opposite the tip;
    A urine drainage lumen formed in the catheter body for guiding urine in the patient's bladder out of the body;
    A urinary catheter including: a flat-shaped deformation lumen extending along the urine discharge lumen in the catheter body, and viewed along a radial direction of the catheter body along the circumferential surface of the catheter body.
  2.  前記変形用ルーメンは、前記カテーテル本体の径方向断面視において、前記カテーテル本体の周面に沿って湾曲した扁平形状に形成されている、請求項1に記載の尿道カテーテル。 The urinary catheter according to claim 1, wherein the deformation lumen is formed in a flat shape that is curved along a circumferential surface of the catheter body in a radial cross-sectional view of the catheter body.
  3.  前記変形用ルーメンは、前記カテーテル本体の周面に近い外側面と、前記外側面に対向する内側面とを有し、
     前記変形用ルーメンの内側面の長さLが、前記外側面の長さLよりも長い、請求項2に記載の尿道カテーテル。
    The deformation lumen has an outer surface close to the circumferential surface of the catheter body, and an inner surface opposite to the outer surface.
    The length L 2 of the inner surface of the deforming lumen is longer than the length L 1 of the outer surface, urinary catheter according to claim 2.
  4.  前記尿排出用ルーメンは、前記カテーテル本体の径方向断面視において、前記変形用ルーメンの長手方向に沿う方向を長軸方向とする楕円形状に形成されている、請求項3に記載の尿道カテーテル。 The urinary catheter according to claim 3, wherein the urine drainage lumen is formed in an elliptical shape whose major axis is a direction along the longitudinal direction of the deformation lumen in a radial cross-sectional view of the catheter body.
  5.  前記変形用ルーメンは、前記カテーテル本体の径方向断面視において、前記尿排出用ルーメンの中心から広がる中心角90°以下の扇形領域の半径線分上に、その一端部および他端部を有している、請求項1~4のいずれか一項に記載の尿道カテーテル。 The deformation lumen has one end and the other end on a radial line segment of a fan-shaped region having a central angle of 90 ° or less extending from the center of the urine discharge lumen in a radial cross-sectional view of the catheter main body The urinary catheter according to any one of claims 1 to 4, wherein
  6.  前記カテーテル本体は、前記基部から前記先端部まで一定の外径を有している、請求項1~5のいずれか一項に記載の尿道カテーテル。 The urinary catheter according to any one of the preceding claims, wherein the catheter body has a constant outer diameter from the base to the tip.
  7.  前記カテーテル本体の外径が、2mm~10mmである、請求項6に記載の尿道カテーテル。 The urinary catheter according to claim 6, wherein the outer diameter of the catheter body is 2 mm to 10 mm.
  8.  前記カテーテル本体の前記先端部側に設けられ、患者の膀胱内で膨張するバルーン部と、
     前記バルーン部と連通するように前記カテーテル本体内において前記尿排出用ルーメンに沿って延びて形成され、前記バルーン部に膨張用の液体を導入するための液体導入用ルーメンとをさらに含む、請求項1~7のいずれか一項に記載の尿道カテーテル。
    A balloon portion provided on the distal end side of the catheter body and inflated in a patient's bladder;
    The catheter according to claim 1, further comprising: a fluid introducing lumen extending along the urine drainage lumen in the catheter body so as to be in communication with the balloon portion, and for introducing an inflation fluid into the balloon portion. The urinary catheter according to any one of 1 to 7.
  9.  前記変形用ルーメンは、前記尿排出用ルーメンを挟んで前記液体導入用ルーメンと対向するように配置されている、請求項8に記載の尿道カテーテル。 The urinary catheter according to claim 8, wherein the deformation lumen is disposed to face the liquid introduction lumen across the urine drainage lumen.
  10.  前記カテーテル本体の前記先端部側に設けられ、患者の膀胱内で膨張するバルーン部をさらに含み、
     前記変形用ルーメンは、前記バルーン部と連通するように前記カテーテル本体内において前記尿排出用ルーメンに沿って延びて形成され、前記バルーン部に膨張用の液体を導入するための液体導入用ルーメンを兼ねている、請求項1~7のいずれか一項に記載の尿道カテーテル。
    The distal end side of the catheter body further includes a balloon portion that inflates in a patient's bladder,
    The deformation lumen is formed along the urine drainage lumen in the catheter body so as to be in communication with the balloon portion, and a fluid introduction lumen for introducing an inflation liquid into the balloon portion. The urinary catheter according to any one of claims 1 to 7, which doubles as well.
  11.  前記変形用ルーメンは、前記液体導入用ルーメンを兼ねる第1の変形用ルーメンと、前記第1の変形用ルーメンとは異なり、前記カテーテル本体の前記先端部側が塞がれた第2の変形用ルーメンとを含む、請求項10に記載の尿道カテーテル。 Unlike the first deformation lumen which also serves as the liquid introduction lumen and the first deformation lumen, the deformation lumen is a second deformation lumen in which the tip end side of the catheter body is closed. The urinary catheter according to claim 10, comprising:
  12.  前記第1の変形用ルーメンと前記第2の変形用ルーメンとが、前記尿排出用ルーメンを挟んで互いに対向するように配置されている、請求項10または11に記載の尿道カテーテル。 The urinary catheter according to claim 10, wherein the first deformation lumen and the second deformation lumen are disposed to face each other with the urine discharge lumen interposed therebetween.
PCT/JP2018/033106 2017-09-07 2018-09-06 Urinary catheter WO2019049954A1 (en)

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WO2021203766A1 (en) * 2020-04-08 2021-10-14 微创优通医疗科技(嘉兴)有限公司 Medical catheter and medical system
KR20230026172A (en) * 2021-08-17 2023-02-24 주식회사 케이아이플렉스 Balloon urethral catheter

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JPH11507862A (en) * 1996-04-10 1999-07-13 バイオリンク コーポレーション Dual lumen catheter and method of using same
US8088078B2 (en) * 2003-02-17 2012-01-03 Pp-Technologies Ag Methods and apparatus for measuring pressure profiles
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JP2013233362A (en) * 2012-05-11 2013-11-21 Terumo Corp Stylet and urethral catheter set

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JPH11507862A (en) * 1996-04-10 1999-07-13 バイオリンク コーポレーション Dual lumen catheter and method of using same
US8088078B2 (en) * 2003-02-17 2012-01-03 Pp-Technologies Ag Methods and apparatus for measuring pressure profiles
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JP2013233362A (en) * 2012-05-11 2013-11-21 Terumo Corp Stylet and urethral catheter set

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021203766A1 (en) * 2020-04-08 2021-10-14 微创优通医疗科技(嘉兴)有限公司 Medical catheter and medical system
KR20230026172A (en) * 2021-08-17 2023-02-24 주식회사 케이아이플렉스 Balloon urethral catheter
KR102588174B1 (en) * 2021-08-17 2023-10-19 주식회사 케이아이플렉스 Balloon urethral catheter

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