WO2018180758A1 - Ensemble cylindre, procédé d'utilisation de seringue, appareil d'injection de liquide médicinal et procédé d'assemblage associé - Google Patents

Ensemble cylindre, procédé d'utilisation de seringue, appareil d'injection de liquide médicinal et procédé d'assemblage associé Download PDF

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Publication number
WO2018180758A1
WO2018180758A1 PCT/JP2018/010999 JP2018010999W WO2018180758A1 WO 2018180758 A1 WO2018180758 A1 WO 2018180758A1 JP 2018010999 W JP2018010999 W JP 2018010999W WO 2018180758 A1 WO2018180758 A1 WO 2018180758A1
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WO
WIPO (PCT)
Prior art keywords
pusher
gasket
rotation
barrel
rib
Prior art date
Application number
PCT/JP2018/010999
Other languages
English (en)
Japanese (ja)
Inventor
有延学
沖原等
百貫祐亮
飯渕るり子
桝田多恵子
Original Assignee
テルモ株式会社
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.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2019509586A priority Critical patent/JPWO2018180758A1/ja
Publication of WO2018180758A1 publication Critical patent/WO2018180758A1/fr

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Classifications

    • 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms

Definitions

  • the present invention relates to a barrel assembly including a gasket and a pusher, a method of using a syringe, a chemical solution administration device, and an assembly method thereof.
  • a barrel assembly including a cylindrical body that can be filled with a chemical solution, a gasket that is slidably disposed in the cylindrical body, and a pusher that presses the gasket and moves the gasket in the distal direction is known.
  • a syringe that pushes out the chemical liquid filled in the barrel when the user presses the pusher in the distal direction with a finger (see, for example, JP-A-2013-192577).
  • a liquid feeding mechanism portion of a syringe pump type liquid medicine administration device that pushes the pusher forward by the drive portion to push out the liquid medicine filled in the cylinder body from the inside of the cylinder body and administer it into the living body.
  • a liquid feeding mechanism portion of a syringe pump type liquid medicine administration device that pushes the pusher forward by the drive portion to push out the liquid medicine filled in the cylinder body from the inside of the cylinder body and administer it into the living body.
  • connection structure between the gasket and the pusher is such that a female screw provided on the gasket and a male screw provided on the tip of the pusher are screwed together. It is common. For this reason, the conventional barrel assembly does not have a structure that prevents the relative rotation between the pusher and the gasket and prevents the pusher from being detached from the gasket.
  • the present invention has been made in consideration of such problems, and uses a barrel assembly and a syringe that can prevent relative rotation between the pusher and the gasket and prevent the pusher from being detached from the gasket. It is an object of the present invention to provide a method, a drug solution administration device, and an assembly method thereof.
  • a barrel assembly of the present invention is configured to be connected to a gasket that can be filled with a chemical solution, a gasket that is slidably disposed in the barrel, and the gasket.
  • a pusher capable of pressing the gasket in the tip direction, and one of the gasket and the pusher is provided with a rotation prevention groove, and the other of the gasket and the pusher is provided with the rotation prevention groove.
  • An anti-rotation protrusion configured to be inserted into the anti-rotation protrusion, and the engagement between the anti-rotation groove and the anti-rotation protrusion prevents relative rotation between the gasket and the pusher, and the gasket.
  • first Ribs are provided, by the engagement between the second rib and the first rib, withdrawal of the pusher from the gasket is prevented.
  • the relative rotation between the gasket and the pusher is prevented by the engagement between the rotation prevention groove and the rotation prevention protrusion, and the engagement between the first rib and the second rib allows the Removal of the pusher from the gasket is prevented. For this reason, it becomes possible to prevent relative rotation between the pusher and the gasket and to prevent the pusher from being detached from the gasket.
  • the rotation prevention groove may be provided in the gasket, and the rotation prevention protrusion may be provided in the pusher.
  • This structure makes it possible to easily provide a rotation prevention structure between the gasket and the pusher.
  • the gasket has a recess opening in a base end surface of the gasket, the pusher has a distal end inserted into the recess, and the rotation prevention groove is provided on an inner peripheral surface of the recess.
  • the rotation preventing projection may be provided on the outer peripheral surface of the tip of the pusher and extend along the axis of the pusher.
  • This configuration improves the rigidity of the anti-rotation groove and anti-rotation protrusion. For this reason, the engagement force between the groove for preventing rotation and the protrusion for preventing rotation is increased, and a better anti-rotation function can be obtained.
  • the gasket has a recess opening in a base end surface of the gasket, the pusher has a distal end portion inserted into the recess, and the first rib is provided on an inner peripheral surface of the recess. It extends in the circumferential direction, and the second rib may be provided on the outer peripheral surface of the tip portion of the pusher and extend in the circumferential direction.
  • This configuration improves the rigidity of the first rib and the second rib. For this reason, the engagement force of the 1st rib and the 2nd rib is raised, and a further better detachment prevention function is obtained.
  • the gasket has a recess opening in the base end surface of the gasket, the pusher has a distal end portion inserted into the recess, and the recess has a first recess opening in the base end surface of the gasket. And a second recess formed concentrically with the first recess and adjacent to the distal end side of the first recess and having a smaller diameter than the first recess, and the anti-rotation groove includes the second recess
  • the rotation preventing projection is provided on the outer peripheral surface of the tip end portion on the tip side of the second rib and is provided on the inner peripheral surface of the gasket.
  • the first rib is provided on the inner peripheral surface of the first recess and extends in the circumferential direction
  • the second rib is provided on the outer peripheral surface of the tip portion of the pusher. And extending in the circumferential direction, the protrusion of the anti-rotation protrusion
  • the end face may be located radially inward of the projecting end face of the second rib.
  • An anti-rotation portion comprising an anti-rotation groove and an anti-rotation protrusion is provided on the tip side of the separation preventing portion comprising the first rib and the second rib, and the rotation prevention portion is provided by the separation prevention portion. Is also provided on the inner side in the radial direction, the gasket and the pusher can be connected without hindrance in the assembly process.
  • a plurality of the rotation preventing grooves may be provided around the gasket axis at intervals of 5 to 20 °.
  • the anti-rotation groove and the anti-rotation groove are not closely aligned with each other when the pusher is attached to the gasket.
  • the rotation preventing protrusion can be engaged.
  • a plurality of the rotation preventing projections are provided around the axis of the pusher, and the number of the rotation preventing projections may be smaller than that of the rotation preventing grooves.
  • This configuration makes it possible to more easily engage the anti-rotation groove with the anti-rotation protrusion.
  • a plurality of the first ribs may be provided at intervals in the circumferential direction, and the second rib may be formed in an annular shape that extends once in the circumferential direction.
  • the separation preventing function can be exhibited regardless of the relative position in the circumferential direction between the gasket and the pusher, and the separation preventing ability can be improved.
  • the barrel assembly is a syringe in which the pusher is pushed by a user, and a filling space formed by the barrel and the gasket may be filled with a chemical solution.
  • This configuration allows the gasket to be interlocked and rotated in the barrel by rotating the pusher, so that the gasket can be easily released from the barrel inner surface before use of the syringe. By releasing the sticking, the initial sliding resistance can be lowered. That is, in general, there is a case where an operation of pushing the pusher is performed before using the syringe, and there is a possibility of liquid leakage and accompanying contamination. The possibility described above can be reduced by applying the barrel assembly of the present invention to a syringe.
  • the base end of the pusher may be provided with a pusher flange protruding outward, and the outer periphery of the pusher flange may be provided with a groove or a protrusion for hooking a finger.
  • This configuration makes it easy to rotate the pusher.
  • the pusher is inserted into the barrel through a base end opening of the barrel, and a flange portion projecting outward is provided at a base end portion of the barrel, and the barrel assembly includes the flange A rotation assisting member configured to be mounted on a portion, the rotation assisting member projecting inward and having a pusher rotation projection facing the proximal end opening of the barrel; Is provided with an inclined portion that is opposed to the pusher rotation protrusion on the proximal side of the pusher rotation protrusion when the pusher is in the initial position and is inclined with respect to the pusher axis. When the pusher advances in the distal direction, the pusher may rotate by the inclined portion being pushed by the pusher rotation protrusion.
  • the pusher has a pressing part capable of pressing the gasket in the distal direction, and the gasket has a pressed part provided at a position facing the pressing part, and in the initial state of the syringe,
  • the pressing portion and the pressed portion are spaced apart in the axial direction, and when the pusher moves forward in the distal direction, the pressing portion is the pressed portion of the gasket after the pusher starts to rotate. You may contact.
  • the present invention is a syringe provided with a barrel filled with a chemical, a gasket slidably disposed in the barrel, and a pusher connected to the gasket and capable of pressing the gasket in a distal direction.
  • the one of the gasket and the pusher is provided with a rotation prevention groove, and the other of the gasket and the pusher is provided with a rotation prevention protrusion inserted into the rotation prevention groove. Relative rotation between the gasket and the pusher is prevented by engaging the rotation preventing groove with the rotation preventing projection, and the gasket is provided with a first rib projecting in the radial direction.
  • the pusher is provided with a second rib that protrudes in the radial direction and engages with or faces the tip surface of the first rib, and the first rib and the second rib By engagement Detachment of the pusher from the gasket is prevented, and the method of use is to rotate the pusher before moving the gasket forward, so that the rotation prevention groove and the rotation prevention protrusion are engaged.
  • This configuration makes it possible to easily release the gasket from adhering to the inner surface of the barrel before using the syringe.
  • the present invention is also a chemical solution administration device for administering a chemical solution into a living body, wherein any of the barrel assemblies described above, a drive unit that advances the pusher of the barrel assembly in the distal direction, A barrel assembly and a housing for accommodating the drive unit, wherein the barrel has a flange portion having a major axis and a minor axis at a proximal end portion, and the pusher is a distal end connected to the gasket And a rod portion provided with a slot opened on the outer peripheral surface of the pusher, and the drive portion has a feed screw inserted into the slot, and the short shaft of the flange portion and the rod The opening direction of the slot of the rod part substantially coincides.
  • the barrel assembly is easily arranged at a predetermined position in the housing in a state in which the phase around the axis of the barrel and the pusher is adjusted to an appropriate position and the position is maintained. It becomes possible. Therefore, when the barrel assembly is disposed in the housing, the distance between the gasket and the pusher is not changed, and the gasket is not moved, so that liquid leakage and accompanying contamination can be prevented. .
  • the present invention also relates to a method of assembling a chemical solution administration device for administering a chemical solution into a living body, wherein the chemical solution administration device is provided with a flange portion having a major axis and a minor axis at a proximal end portion, A gasket that is slidably disposed in the barrel, a tip portion connected to the gasket, and a rod portion provided with a slot that opens to an outer peripheral surface.
  • a pusher that can push the pusher in the tip direction, a drive unit that has a feed screw inserted in the slot, and advances the pusher in the tip direction, and a barrel assembly that has the barrel, the gasket, and the pusher And a housing for accommodating the drive unit, wherein one of the gasket and the pusher is provided with a rotation preventing groove, and the other of the gasket and the pusher is provided with the rotation preventing groove.
  • An anti-rotation protrusion inserted into the gasket, the gasket is provided with a first rib projecting radially toward the pusher, and the pusher projects radially toward the gasket.
  • a second rib that engages with or faces the tip surface of the first rib
  • the assembly method includes a gasket insertion step of inserting the gasket at a predetermined position in the barrel;
  • the first rib and the second rib are engaged with each other while the minor axis of the flange portion and the opening direction of the slot of the rod portion are substantially aligned, and the rotation preventing groove is rotated.
  • the sea urchin said barrel assembly including a placement step of placing in said housing.
  • FIG. 4A is a perspective view of the gasket.
  • FIG. 4B is a cross-sectional view of the gasket.
  • FIG. 5 is a sectional view taken along line VV in FIG. 3. It is a perspective view of the front end side of a pusher. It is a perspective view of the syringe which is a barrel assembly which concerns on 2nd Embodiment of this invention. It is a principal part expanded sectional view of the syringe shown in FIG.
  • FIG. 10A is a first explanatory view of a method of using the syringe shown in FIG.
  • FIG. 10B is a second explanatory diagram of a method of using the syringe shown in FIG.
  • FIG. 10A is a first explanatory view of a method of using the syringe shown in FIG.
  • FIG. 10B is a second explanatory diagram of a method of using the syringe shown in FIG.
  • FIG. 17A is a second explanatory diagram (perspective view) of a connection step in the method of assembling the drug solution administration device.
  • FIG. 17B is a second explanatory diagram (cross-sectional view) of a connection step in the method of assembling the drug solution administration device. It is a 3rd explanatory drawing of the assembly method of a chemical
  • the barrel assembly 10A according to the first embodiment of the present invention shown in FIGS. 1 and 2 is connected to the hollow barrel 12, the gasket 14 slidably disposed in the barrel 12, and the gasket 14.
  • a pusher 16 capable of pressing the gasket 14 in the distal direction is provided.
  • This barrel assembly 10A is a syringe 11A in which the pusher 16 is pushed by the user.
  • the syringe 11A is a prefilled syringe in which a drug solution M is filled in advance in a filling space 13 formed by the barrel 12 and the gasket 14 at the time of product provision.
  • the barrel 12 has a substantially cylindrical shape and a trunk portion 12a having a proximal end opening formed at the proximal end, a shoulder portion 12b having a diameter reduced from the distal end portion of the trunk portion 12a, and a distal end of the barrel portion 12a. It has a nozzle 12c and a flange portion 12d that protrudes radially outward from the base end of the body portion 12a.
  • the nozzle 12c has a diameter reduced from the center of the front end of the body 12a with respect to the body 12a and extends in the front end direction.
  • the flange portion 12d is formed in a non-circular shape having a short axis and a long axis.
  • the gasket 14 is inserted into the barrel 12 through a proximal end opening that opens at the proximal end of the body 12a.
  • the proximal end side of the barrel 12 is liquid-tightly sealed by the gasket 14.
  • the gasket 14 is made of an elastic material such as a rubber material.
  • the outer periphery of the gasket 14 is in liquid-tight contact with the inner peripheral surface of the body 12a and is slidably disposed in the body 12a.
  • the gasket 14 is provided with a rotation preventing groove 20 and a first rib 30 projecting radially toward the pusher 16.
  • the gasket 14 has a recess 22 that opens to the proximal end surface 14 a of the gasket 14.
  • the recess 22 has a first recess 22a that is open on the base end surface 14a of the gasket 14, a concentric shape with the first recess 22a, adjacent to the distal end side of the first recess 22a, and a smaller diameter than the first recess 22a. 2 recesses 22b.
  • shaft of the gasket 14 of the 1st recessed part 22a and the 2nd recessed part 22b is substantially circular.
  • the rotation preventing groove 20 is provided on the inner peripheral surface of the second recess 22b and extends along the axis of the gasket 14.
  • a plurality of anti-rotation grooves 20 are provided at equal intervals in the circumferential direction so as to surround the shaft of the gasket 14.
  • the plurality of anti-rotation grooves 20 form an annular concavo-convex structure on the inner peripheral surface of the second recess 22b.
  • the rotation preventing groove 20 is provided on the radially inner side with respect to the first rib 30.
  • the rotation preventing grooves 20 are provided around the axis of the gasket 14, for example, at intervals of 5 to 20 °, and preferably at intervals of 5 to 10 °.
  • channel 20 for rotation prevention means the angle of the circumferential direction center position of the groove
  • the first rib 30 is provided on the inner peripheral surface of the first recess 22a and extends in the circumferential direction.
  • a plurality of first ribs 30 are provided at intervals in the circumferential direction (four in the illustrated example at equal intervals in the circumferential direction).
  • a plurality of convex portions 14b are provided at the base end portion of the gasket 14 at intervals in the circumferential direction.
  • the plurality of convex portions 14 b protrude from the base end surface 14 a of the gasket 14 in the base end direction.
  • a plurality of notch grooves 14 c are provided at the base end portion of the gasket 14 at intervals in the circumferential direction.
  • the plurality of cutout grooves 14c are open on the base end surface 14a of the gasket 14 and the inner peripheral surface of the recess 22 (first recess 22a).
  • the pusher 16 includes a shaft portion 24 that constitutes a main portion (body) of the pusher 16, and a distal end portion 26 that protrudes from the distal end of the shaft portion 24 in the distal direction and is connected to the gasket 14. And a pusher flange 28 protruding outward in the radial direction from the base end of the shaft portion 24.
  • the shaft portion 24 has four plate-like ribs 24 a that extend along the axis of the pusher 16 and project radially from the axis of the pusher 16. Due to the four plate-like ribs 24a, the cross-sectional shape of the shaft portion 24 in a plane perpendicular to the axis of the pusher 16 is formed in a cross shape.
  • the tip end portion 26 is inserted into the recess 22 of the gasket 14.
  • the distal end portion 26 is provided with a distal end concave portion 27 that opens in the distal direction.
  • tip part 26 is comprised by the hollow shape.
  • a groove portion 28 a for hooking a user's finger is provided on the outer peripheral portion of the pusher flange 28.
  • a plurality of grooves 28a are provided at intervals in the circumferential direction. Only one groove 28a may be provided.
  • a protrusion for hooking a user's finger may be provided on the outer peripheral portion of the pusher flange 28 in place of or in addition to the groove portion 28a. In this case, only one finger hooking projection may be provided, or a plurality of projections may be provided at intervals in the circumferential direction.
  • the pusher 16 is provided with an anti-rotation protrusion 21 inserted into the anti-rotation groove 20 and a second rib 31 protruding radially outward toward the gasket 14. It has been.
  • the rotation preventing projection 21 is provided on the outer peripheral surface of the distal end portion 26 of the pusher 16 and extends along the axis of the pusher 16.
  • the rotation preventing projection 21 is provided on the tip side of the second rib 31.
  • a plurality (four in the illustrated example) of anti-rotation protrusions 21 are provided at intervals in the circumferential direction.
  • the protruding end surface of the rotation preventing protrusion 21 is located on the radially inner side than the protruding end surface of the second rib 31. Relative rotation between the gasket 14 and the pusher 16 is prevented by the engagement between the rotation prevention groove 20 and the rotation prevention protrusion 21.
  • the second rib 31 is provided on the outer peripheral surface of the distal end portion 26 of the pusher 16, extends in the circumferential direction, and engages with the distal end surface of the first rib 30.
  • the second rib 31 may be spaced apart from the tip surface of the first rib 30 in the tip direction and may face the tip surface.
  • the 2nd rib 31 is formed in the cyclic
  • the 1st rib 30 may be formed in the cyclic
  • a rotation prevention groove is provided on the outer peripheral surface of the distal end portion 26 of the pusher 16, and the rotation prevention groove is inserted into the inner peripheral surface of the recess 22 of the gasket 14.
  • a protrusion may be provided.
  • a rotation preventing groove may be provided on the base end surface 14a of the gasket 14, and a rotation preventing projection inserted into the rotation preventing groove may be provided on the distal end surface 24b of the shaft portion 24.
  • a rotation prevention groove may be provided on the distal end surface 24b of the shaft portion 24, and a rotation prevention protrusion inserted into the rotation prevention groove may be provided on the proximal end surface 14a of the gasket 14.
  • the gasket 14 is provided with a first rib projecting radially outward, and the pusher 16 is provided with a second rib projecting radially inward.
  • first rib and second rib Detachment of the pusher 16 from the gasket 14 may be prevented.
  • the barrel assembly 10A according to this embodiment configured as described above has the following effects.
  • the relative rotation between the gasket 14 and the pusher 16 is prevented by the engagement between the rotation prevention groove 20 and the rotation prevention protrusion 21, and the first rib 30 and the second rib 31 are separated from each other.
  • the engagement prevents the pusher 16 from being detached from the gasket 14. For this reason, relative rotation between the pusher 16 and the gasket 14 can be prevented, and separation of the pusher 16 from the gasket 14 can be prevented.
  • the barrel assembly 10A is a syringe 11A in which the pusher 16 is pushed by the user, and the filling space 13 formed by the barrel 12 and the gasket 14 is filled with the chemical solution M.
  • the following usage method can be implemented using the syringe 11A.
  • the pusher 16 is rotated to rotate the gasket 14 in the barrel 12 through the engagement between the rotation prevention groove 20 and the rotation prevention protrusion 21 (rotation step).
  • rotation step the gasket 14 is released from the inner surface of the barrel 12.
  • the gasket 14 is advanced in the barrel 12 by advancing the pusher 16 after at least the gasket 14 starts to rotate (advancing step).
  • the advance timing of the advance step may be after the start of the rotation of the pusher 16 by the rotation step. For this reason, the user only has to push the pusher 16 in the distal direction after gripping and rotating the pusher 16.
  • the pusher 16 may be connected to the gasket 14 immediately before using the syringe 11A.
  • the gasket 14 can be rotated in the barrel 12 by rotating the pusher 16, so that the gasket 14 can be applied to the inner surface of the barrel 12 before the syringe 11A is used. Fixing can be easily released. By releasing the sticking, the initial sliding resistance of the gasket 14 can be lowered. That is, in general, there is a case where an operation of pushing the pusher is performed before using the syringe, and there is a possibility of liquid leakage and accompanying contamination. By applying the barrel assembly 10A to the syringe 11A, the above possibility can be reduced.
  • the rotation prevention groove 20 is provided in the gasket 14, and the rotation prevention protrusion 21 is provided in the pusher 16. With this configuration, a structure for preventing rotation between the gasket 14 and the pusher 16 can be easily provided.
  • the gasket 14 has a recess 22 that opens to the base end surface 14 a of the gasket 14, and the pusher 16 has a distal end portion 26 that is inserted into the recess 22.
  • the rotation preventing groove 20 is provided on the inner peripheral surface of the recess 22 and extends along the axis of the gasket 14.
  • the rotation preventing projection 21 is provided on the outer peripheral surface of the distal end portion 26 of the pusher 16 and extends along the axis of the pusher 16.
  • the first rib 30 is provided on the inner peripheral surface of the recess 22 and extends in the circumferential direction
  • the second rib 31 is provided on the outer peripheral surface of the distal end portion 26 of the pusher 16 and extends in the circumferential direction.
  • the recess 22 has a first recess 22a that is open on the base end surface 14a of the gasket 14, a concentric shape with the first recess 22a, adjacent to the distal end side of the first recess 22a, and a smaller diameter than the first recess 22a. 2 recesses 22b.
  • the anti-rotation groove 20 is provided on the inner peripheral surface of the second recess 22 b, and the anti-rotation protrusion 21 is provided on the outer peripheral surface of the front end portion 26 on the front end side of the second rib 31.
  • the first rib 30 is provided on the inner peripheral surface of the first recess 22 a, and the second rib 31 is provided on the outer peripheral surface of the distal end portion 26 of the pusher 16.
  • the protruding end surface of the rotation preventing protrusion 21 is located on the radially inner side with respect to the protruding end surface of the second rib 31.
  • the anti-rotation portion composed of the anti-rotation groove 20 and the anti-rotation protrusion 21 is provided on the tip side of the anti-detachment portion composed of the first rib 30 and the second rib 31, and the anti-rotation portion is provided.
  • the portion is provided on the radially inner side than the separation preventing portion.
  • a plurality of anti-rotation grooves 20 are provided around the axis of the gasket 14 at intervals of 5 to 20 °. By providing a plurality of anti-rotation grooves 20 at such intervals, when the pusher 16 is mounted on the gasket 14, the positions of the anti-rotation grooves 20 and the anti-rotation protrusions 21 are not strictly aligned, The rotation preventing groove 20 and the rotation preventing projection 21 can be engaged with each other.
  • a plurality of rotation prevention protrusions 21 are provided around the axis of the pusher 16, and the number of rotation prevention protrusions 21 is smaller than that of the rotation prevention grooves 20. With this configuration, the rotation prevention groove 20 and the rotation prevention protrusion 21 can be more easily engaged.
  • a plurality of first ribs 30 are provided at intervals in the circumferential direction, and the second ribs 31 are formed in an annular shape that extends once in the circumferential direction.
  • a pusher flange 28 that protrudes outward is provided at the proximal end of the pusher 16, and a groove 28 a or a protrusion for hooking a finger is provided on the outer periphery of the pusher flange 28. With this configuration, the pusher 16 can be easily rotated.
  • the barrel assembly 10B according to the second embodiment of the present invention shown in FIG. 7 is filled with the chemical solution M in the barrel 12, and the pusher 16a is pushed by the user so that the chemical solution is obtained. It is configured as a syringe 11B that pushes out M.
  • the rotation auxiliary member 36 is attached to the barrel 12.
  • the rotation assisting member 36 has a pusher rotation protrusion 38 that protrudes inward and faces the proximal end opening of the barrel 12.
  • the rotation assisting member 36 includes a U-shaped base plate 40 having a base portion 40a and a pair of arm portions 40b extending from the base portion 40a, and a first portion provided on the base portion 40a of the base plate 40.
  • An engagement claw 42 and two second engagement claws 44 provided on the free end side of the pair of arm portions 40b of the base plate 40 are provided.
  • the first engagement claw 42 engages with the edge on one end side in the short axis direction of the flange portion 12d of the barrel 12, and the second engagement claw 44 has the short axis of the flange portion 12d. It is engaged with the edge on the other end side in the direction.
  • the pusher rotation protrusion 38 protrudes inward from the base portion 40a.
  • a rotation guide 46 is provided on the shaft portion 24 of the pusher 16a.
  • the rotation guide 46 is provided so as to bulge from the surface of the plate-like rib 24 a of the shaft portion 24.
  • the rotation guide 46 has an inclined portion 48 (inclined surface) inclined with respect to the axis of the pusher 16a.
  • the inclined portion 48 is inclined so that the distance from the surface of the plate-like rib 24a increases in the proximal direction.
  • the inclined portion 48 is opposed to the pusher rotation protrusion 38 on the proximal side with respect to the pusher rotation protrusion 38 when the pusher 16a is in the initial position.
  • the inclined portion 48 may or may not be in contact with the pusher rotation protrusion 38. If the inclined portion 48 is not in contact with the pusher rotation protrusion 38 when the pusher 16a is in the initial position, the inclined portion 48 is preferably located in the vicinity of the pusher rotation protrusion 38.
  • the pusher flange 29 provided at the base end portion of the shaft portion 24 in FIG.
  • the pusher 16a has a pressing portion 50 capable of pressing the gasket 14A in the distal direction.
  • the pressing part 50 is configured by a tip surface 24 b of the shaft part 24.
  • the gasket 14 ⁇ / b> A has a pressed portion 52 provided at a position facing the pressing portion 50.
  • the pressed portion 52 is configured by a base end portion (base end surface 14a and convex portion 14b) of the gasket 14A. In the initial state of the syringe 11B, the pressing portion 50 and the pressed portion 52 are separated in the axial direction.
  • the gasket 14A includes a recess 23 having a first recess 23a and a second recess 23b adjacent to each other in the axial direction.
  • the first recess 23a and the second recess 23b are respectively formed deeper in the axial direction than the first recess 22a and the second recess 22b of the gasket 14 described above.
  • the anti-rotation groove 20 a provided on the inner peripheral surface of the second recess 23 b is formed longer in the axial direction than the anti-rotation groove 20 of the gasket 14.
  • the distal end portion 26a of the pusher 16a inserted into the recess 23 is configured to be longer in the axial direction than the distal end portion 26 of the pusher 16 described above.
  • the distal end surface of the distal end portion 26a of the pusher 16a and the bottom surface 23c of the concave portion 23 of the gasket 14A are larger than the axial separation distance between the pressing portion 50 and the pressed portion 52. Are spaced apart in the axial direction.
  • the pressing portion 50 and the pressed portion 52 are not limited to the above combination.
  • the tip surface of the tip portion 26a of the pusher 16a forms a pressing portion
  • the bottom surface 23c (second recess portion) of the recess 23 of the gasket 14A may constitute the pressed part.
  • the pusher 16a is rotated by the inclined portion 48 being pushed by the pusher rotation protrusion 38 when the pusher 16a moves forward in the distal direction. That is, as shown in FIG. 10A, when the user pushes the pusher 16a in the distal direction, the pusher 16a starts to move forward with respect to the barrel 12, and the inclined portion 48 also moves forward. At this time, due to the action of the pusher rotation projection 38 and the inclined portion 48, a part of the force that the pusher 16 a moves forward is converted into a force that rotates the pusher 16 a.
  • the gasket 14A can be easily rotated by performing an operation of pushing the pusher 16a in the distal direction. For this reason, before use of the syringe 11B, the sticking release of the gasket 14A can be more easily performed.
  • a rotation assisting member 36A shown in FIG. 11 may be used.
  • the rotation assisting member 36A has a U-shaped mounting groove 54 into which the flange portion 12d of the barrel 12 can be inserted, and is slid along the distal end surface and the proximal end surface of the flange portion 12d from the side of the barrel 12. It is configured to be attachable to the portion 12d. With this configuration, the rotation assisting member 36A can be easily attached to the flange portion 12d.
  • the medicinal solution administration device 56 continuously administers the medicinal solution M filled in the barrel 66 into the living body under a pressing action of the pusher 70 over a relatively long time (for example, several minutes to several hours).
  • the chemical solution administration device 56 may intermittently administer the chemical solution M into the living body.
  • the drug solution M include protein preparations, narcotic analgesics, diuretics and the like.
  • a patch-type needle-attached tube 59 is connected to the drug solution administration device 56 as the administration device 58, and the drug solution M discharged from the barrel 66 passes through the needle-attached tube 59 to the body of the patient. Injected into.
  • the tube 59 with a needle is connected to a connector 60 that can be connected to the tube tip 66 c of the barrel 66, a flexible liquid feeding tube 61 having one end connected to the connector 60, and the other end of the liquid feeding tube 61.
  • a patch portion 62 that can be attached to the skin S and a puncture needle 63 protruding from the patch portion 62 are provided.
  • the puncture needle 63 is punctured substantially perpendicular to the skin S.
  • the puncture needle 63 may be punctured obliquely with respect to the skin S.
  • the administration device 58 connected to the drug solution administration device 56 is not limited to the above-described patch-type tube 59 with a needle, and is, for example, a device in which a puncture needle (such as a winged needle) is connected to the tip of the liquid delivery tube 61. May be.
  • the administration device 58 may be a bent needle that can be connected to the tube tip portion 66 c of the barrel 66 without using the liquid feeding tube 61.
  • the bent needle is bent, for example, approximately 90 ° downward from the tube tip 66c of the barrel 66, and punctures perpendicularly to the skin S as the drug solution administration device 56 is fixed (attached) to the skin S. Is done.
  • the barrel tip portion 66c of the barrel 66, the administration device 58, and a part of the needle may be inside the barrel 66, and the tip of the needle may protrude from the barrel 66. Even in this case, the needle is punctured perpendicularly to the skin S as the drug solution administration device 56 is fixed (attached) to the skin S.
  • the medicinal solution administration device 56 is connected to the barrel 66 filled with the medicinal solution M, the gasket 68 slidably disposed in the barrel 66, and connected to the gasket 68 and the barrel 66.
  • a pusher 70 that is movable in the axial direction with respect to the actuator, a drive unit 72 that advances the pusher 70 in the distal direction, and a barrel assembly 10C that includes the barrel 66, the gasket 68, and the pusher 70, and the drive unit 72 are accommodated.
  • a housing 74 a housing 74.
  • a battery for supplying power necessary for the operation of the drug solution administration device 56, a control unit (microcomputer) for controlling the operation of the drug solution administration device 56, a speaker, and the like are arranged in the housing 74.
  • the housing 74 has an upper housing 74A and a lower housing 74B.
  • the housing 74 is provided with a plurality of buttons 76a to 76d for various operations and a plurality of light emitting portions 78a and 78b for informing the operation state of the drug solution administration device 56 and the like.
  • the barrel 66 is formed in a hollow cylindrical shape having a filling space 67 for the chemical solution M therein. As shown in FIGS. 13 and 14, the barrel 66 has an inner diameter and an outer diameter that are constant in the axial direction and a base end that is open at the base end, and an inner diameter and an outer diameter that extend from the distal end of the barrel 66a toward the distal end. It has a shoulder portion 66b whose diameter is reduced in a tapered shape, a tube tip portion 66c protruding from the shoulder portion 66b in the distal direction, and a flange portion 66d protruding outward in the radial direction from the base end of the body portion 66a.
  • a chemical discharge port 66e communicating with the filling space 67 is formed in the tube tip portion 66c.
  • the lumen of the tube tip portion 66c constitutes a flow path that connects the chemical solution discharge port 66e and the filling space 67.
  • the flange portion 66d is formed in a non-circular shape having a major axis and a minor axis.
  • the chemical solution M is filled in the barrel 66 in advance.
  • the drug solution M may be filled in the barrel 66 immediately before using the drug solution administration device 56.
  • the chemical solution discharge port 66e is liquid-tightly sealed by a sealing member 69 made of an elastic resin material such as a rubber material or an elastomer material.
  • the sealing member 69 is punctured by a needle 60a provided on the connector 60 when the connector 60 shown in FIG. 12 is connected to the tube tip portion 66c.
  • the sealing member 69 is fixed to the tip of the barrel 66 by a cap 73 having an opening at the tip. The distal end surface of the sealing member 69 is exposed from the opening of the cap 73.
  • the gasket 68 is made of an elastic resin material such as a rubber material or an elastomer material, and the outer peripheral portion thereof is in liquid-tight contact with the inner peripheral surface of the barrel 66 (body portion 66a), so that the base end side of the filling space 67 is liquid-filled. Closely closed. Similar to the gasket 14 shown in FIG. 3 and the like, the gasket 68 has a first recess 22a in which the rotation preventing groove 20 is provided on the inner peripheral surface, and a second rib in which the first rib 30 is provided on the inner peripheral surface. A recess 22 having a recess 22b is provided.
  • the pusher 70 is a member that can move in the axial direction in order to push out the chemical M.
  • a gasket 68 is connected to the distal end portion 26 of the pusher 70.
  • the pusher 70 includes a rod portion 80 that constitutes a main portion (body) of the pusher 70, and a distal end portion 26 that protrudes from the distal end of the rod portion 80 in the distal direction and is connected to the gasket 68.
  • the distal end portion 26 of the pusher 70 is inserted into the concave portion 22 of the gasket 68.
  • the distal end portion 26 has the same configuration as the distal end portion 26 of the pusher 16 shown in FIG.
  • the rod portion 80 is provided with a slot 80 a that extends along the axis of the pusher 70 and opens to the outer peripheral surface (lower surface) of the rod portion 80.
  • the slot 80 a is also opened in the proximal direction at the proximal end portion of the rod portion 80.
  • the drive unit 72 includes an advance mechanism 82 that advances the pusher 70 in the distal direction, and a drive mechanism 84 that drives the advance mechanism 82 to advance the pusher 70 in the distal direction.
  • the drive mechanism 84 includes a motor 85 (for example, a geared motor) and a pinion 86 that is a drive gear fixed to the output shaft of the motor 85.
  • the advance mechanism 82 includes a feed screw 88 that is rotationally driven by a pinion 86 and a nut member 90 that is screwed into the feed screw 88.
  • the feed screw 88 is disposed along the axis of the barrel 66 and is inserted into the slot 80 a of the pusher 70.
  • the feed screw 88 includes a large gear 88a that is a driven gear that meshes with the pinion 86, and a male screw 88b that is formed on the outer peripheral surface on the tip side of the large gear 88a over a predetermined range in the axial direction.
  • the proximal end portion of the feed screw 88 is rotatably supported by a support member 93 fixed to the chassis member 92.
  • the distal end portion 26 of the feed screw 88 is rotatably supported by a distal end side support member 94 fixed to the chassis member 92.
  • the nut member 90 is a female screw portion that is made of, for example, a hard resin material and has a female screw 91 (screw hole) into which the male screw 88b of the feed screw 88 is screwed. As the feed screw 88 rotates, the nut member 90 moves in the axial direction.
  • the nut member 90 includes a nut main body 90a in which a female screw 91 is formed, and a slide portion 90b provided at one end of the nut main body 90a.
  • the nut member 90 may be omitted and the pusher 70 may be provided with the female screw 91 and the slide portion 90b.
  • a pair of holes 90c penetrating in the axial direction is formed in the nut main body 90a, and a claw 80b (FIG. 15) provided at the base end of the rod 80 is engaged with the pair of holes 90c. ing.
  • a reinforcing cover 90d made of, for example, a metal material is attached to the outer surface of the nut main body 90a. The reinforcing cover 90d is held by a plurality of holding portions 80c provided at the proximal end of the pusher 70.
  • the slide portion 90 b is supported by a guide rail 89 that is fixed to the chassis member 92 and extends in parallel with the feed screw 88 so as to be slidable in the axial direction. For this reason, the nut member 90 can move smoothly in the axial direction of the pusher 70 as the feed screw 88 rotates.
  • the slide portion 90 b is inserted into a guide groove 89 a formed in the guide rail 89.
  • the guide groove 89 a extends along the axial direction of the pusher 70.
  • the barrel 66 and the drive unit 72 are fixed to the housing 74 via a chassis member 92 fixed to the lower housing 74B.
  • the chassis member 92 is fixed to the housing 74 by a plurality of fastening parts 95 (screws in the illustrated example).
  • the barrel 66 is fixed to the chassis member 92 by engaging with the chassis member 92 at the flange portion 66d.
  • the chassis member 92 includes a base plate portion 98 and a flange mounting portion 100 that protrudes from the upper surface of the base plate portion 98 in the thickness direction (upward) of the base plate portion 98 and has a flange portion 66d mounted thereon.
  • a support portion that supports the barrel 66 and the drive portion 72 may be provided integrally with the housing 74.
  • the chemical solution administration device 56 When using the chemical solution administration device 56, the chemical solution administration device 56 is taken out of the cold storage, left at room temperature, and returned to room temperature. Next, the surface (tip surface) of the sealing member 69 that is a connection portion with the connector 60 is wiped off with, for example, alcohol cotton, so that the connection portion is sterilized. Next, an administration device 58 is connected to the drug solution administration device 56.
  • the power button 76a when the power button 76a is pressed for a predetermined time or longer (long press), the first light emitting unit 78a is lit in the first color, the start sound is notified from the speaker, and the power is turned on.
  • the priming button 76b when the priming button 76b is continuously pressed, the first light emitting portion 78a blinks in the first color, and priming (filling the flow path in the administration device 58 with the drug solution M) is performed. In this case, the completion of the priming can be grasped by visually confirming that the chemical M has dripped from the needle tip 63a.
  • the drug solution administration device 56 is attached to the patient by being attached to the skin S or attached to clothes.
  • the puncture needle 63 is punctured into the skin S.
  • the chemical solution administration device 56 may be attached to the patient.
  • the first light emitting unit 54a blinks in the second color (color different from the first color), and liquid feeding (administration of the drug solution M) is started. .
  • the motor 85 is driven to rotate from the pinion 86 to the feeding screw 88 having the large gear 88a. Power is transmitted.
  • the feed screw 88 rotates, the nut member 90 screwed with the feed screw 88 moves forward, and the pusher 70 is pushed forward by the nut member 90 and moves forward.
  • medical solution M in the barrel 66 is extruded.
  • the medicinal solution M pushed out from the barrel 66 is administered (injected) into the patient's body through the administration device 58 punctured by the patient.
  • the cap 73 and the sealing member 69 are attached to the tube tip portion 66 c so that the sealing member 69 is sandwiched between the tip end surface of the tube tip portion 66 c of the barrel 66 and the cap 73.
  • the cap 73 engages with the outer peripheral portion of the tube tip portion 66c, and the tip opening is sealed in a liquid-tight manner by the sealing member 69.
  • the gasket 68 is inserted into the barrel 66 by, for example, a vacuum stopper method (gasket insertion step).
  • the first rib 30 and the second rib 31 are made with the short axis of the flange portion 66 d of the barrel 66 and the opening direction of the slot 80 a of the rod portion 80 being substantially coincident with each other.
  • the gasket 68 and the pusher 70 are connected by inserting the anti-rotation protrusion 21 into the anti-rotation groove 20 (connection step). Thereby, the barrel assembly 10C assembled in a predetermined state is obtained.
  • the barrel assembly 10C is disposed in the housing 74 so that the feed screw 88 is inserted into the slot 80a of the rod portion 80 (arrangement step).
  • an assembly is prepared in which the drive unit 72 is attached to the chassis member 92 and the chassis member 92 is fixed to the lower housing 74B.
  • the barrel assembly 10C is assembled to the lower housing 74B.
  • the flange portion 66 d of the barrel 66 is inserted and held in the flange mounting portion 100 of the chassis member 92.
  • the nut member 90 is advanced toward the pusher 70 by rotating the feed screw 88, and the base end portion of the pusher 70 and the nut member 90 are connected.
  • the claw portion 80b of the pusher 70 is inserted into the hole portion 90c of the nut member 90 while elastically deforming inward, and the claw portion 80b moves over the hole portion 90c so that the claw portion 80b becomes the base of the nut member 90. Engage with the end face.
  • the drug solution administration device 56 has the following effects.
  • the engagement between the rotation prevention groove 20 and the rotation prevention protrusion 21 prevents relative rotation between the barrel 66 and the pusher 70, and the relationship between the first rib 30 and the second rib 31. Accordingly, the pusher 70 is prevented from being detached from the barrel 66.
  • the barrel assembly 10C is brought into a predetermined position in the housing 74 in a state where the phase around the axis of the barrel 66 and the pusher 70 is adjusted to an appropriate position and the position is maintained. It can be easily arranged. For this reason, when the barrel assembly 10C is disposed in the housing 74, the distance between the gasket 68 and the pusher 70 is not changed, and the gasket 68 is not moved. Can be prevented.

Abstract

La présente invention concerne un ensemble cylindre (10A) pourvu d'un cylindre (12), d'un joint d'étanchéité (14) et d'un piston (16). Une rainure de prévention de rotation (20) disposée sur un élément parmi le joint d'étanchéité (14) et le piston (16), et une saillie de prévention de rotation (21) disposée sur l'autre élément parmi le joint d'étanchéité (14) et le piston (16) sont en prise pour empêcher la rotation relative du joint d'étanchéité (14) et du piston (16). Une première nervure (30) formée sur le joint d'étanchéité (14) et une seconde nervure (31) formée sur le piston (16) sont en prise pour empêcher le piston (16) d'être séparé du joint d'étanchéité (14).
PCT/JP2018/010999 2017-03-30 2018-03-20 Ensemble cylindre, procédé d'utilisation de seringue, appareil d'injection de liquide médicinal et procédé d'assemblage associé WO2018180758A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2019509586A JPWO2018180758A1 (ja) 2017-03-30 2018-03-20 バレル組立体、シリンジの使用方法、薬液投与装置及びその組立方法

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Application Number Priority Date Filing Date Title
JP2017067599 2017-03-30
JP2017-067599 2017-03-30

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPWO2020203239A1 (fr) * 2019-03-29 2020-10-08
JP2022524197A (ja) * 2019-03-11 2022-04-28 ニコベンチャーズ トレーディング リミテッド エアロゾル供給デバイス

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040049161A1 (en) * 1999-02-09 2004-03-11 Shearn James G. J. Directly engaged syringe driver system
WO2007015469A1 (fr) * 2005-08-01 2007-02-08 Nipro Corporation Piston pour dispositif d’injection, seringue et seringue préremplie utilisant celui-ci
WO2014045393A1 (fr) * 2012-09-21 2014-03-27 テルモ株式会社 Joint de seringue

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040049161A1 (en) * 1999-02-09 2004-03-11 Shearn James G. J. Directly engaged syringe driver system
WO2007015469A1 (fr) * 2005-08-01 2007-02-08 Nipro Corporation Piston pour dispositif d’injection, seringue et seringue préremplie utilisant celui-ci
WO2014045393A1 (fr) * 2012-09-21 2014-03-27 テルモ株式会社 Joint de seringue

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2022524197A (ja) * 2019-03-11 2022-04-28 ニコベンチャーズ トレーディング リミテッド エアロゾル供給デバイス
JP7432286B2 (ja) 2019-03-11 2024-02-16 ニコベンチャーズ トレーディング リミテッド エアロゾル供給デバイス
JPWO2020203239A1 (fr) * 2019-03-29 2020-10-08
WO2020203239A1 (fr) * 2019-03-29 2020-10-08 テルモ株式会社 Kit de piston, kit de seringue, et seringue pré-remplie
JP7397065B2 (ja) 2019-03-29 2023-12-12 テルモ株式会社 プランジャーキット、シリンジキット及びプレフィルドシリンジ

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