WO2016132936A1 - Liquid drug administration device - Google Patents

Liquid drug administration device Download PDF

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Publication number
WO2016132936A1
WO2016132936A1 PCT/JP2016/053586 JP2016053586W WO2016132936A1 WO 2016132936 A1 WO2016132936 A1 WO 2016132936A1 JP 2016053586 W JP2016053586 W JP 2016053586W WO 2016132936 A1 WO2016132936 A1 WO 2016132936A1
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WO
WIPO (PCT)
Prior art keywords
plunger
administration device
solution administration
screw shaft
nut
Prior art date
Application number
PCT/JP2016/053586
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French (fr)
Japanese (ja)
Inventor
近藤晃
Original Assignee
テルモ株式会社
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Filing date
Publication date
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Publication of WO2016132936A1 publication Critical patent/WO2016132936A1/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
    • 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
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • 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
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons

Definitions

  • the present invention relates to a portable drug solution administration device that continuously or intermittently administers a drug solution filled in a cylinder into a living body under the action of a plunger.
  • Japanese Patent Application Publication No. 2010-535057 discloses a configuration (first configuration) in which a plunger and a drive unit are screw-engaged and the plunger is moved under the rotational action of the screw. (See FIG. 17a and FIG. 17b of JP 2010-535057 A).
  • this special table 2010-535057 discloses a configuration (second configuration) in which a piston provided in a cylinder and a plunger rod that presses the piston toward the tip side are detachable (second configuration). (See FIG. 15a and FIG. 15b of JP-T 2010-535057).
  • the chemical solution is not filled in the cylinder before using the chemical solution administration device. Therefore, the user needs to fill the cylinder with an appropriate amount of the chemical solution from the chemical solution container such as a vial before using the chemical solution administration device.
  • the plunger rod can be separated from the piston, so that when the chemical liquid administration device is used (during chemical administration), the piston is There is a possibility that the plunger rod moves away from the plunger rod and is displaced to the distal end side, and free flow occurs (the drug solution in the cylinder is administered unintentionally).
  • the present invention has been made in consideration of such problems, and provides a chemical solution administration device that can easily and quickly fill a cylinder with an appropriate amount of chemical solution and prevent free flow.
  • the purpose is to do.
  • a drug solution administration device is a portable drug solution administration device that continuously or intermittently administers a drug solution filled in a cylinder into a living body under the action of a plunger.
  • a feed screw shaft extending along the axial direction of the plunger, a drive unit for rotationally driving the feed screw shaft, and the plunger under the rotational action of the feed screw shaft in a state of being screwed to the feed screw shaft
  • a movement restricting portion for restricting movement of the plunger toward the distal end side with respect to the nut portion in a combined state.
  • the nut portion at the initial position does not contact the plunger, so that the position of the plunger can be manually changed according to the amount of liquid medicine to be filled. it can.
  • the movement restricting portion restricts the movement of the plunger toward the distal end side with respect to the nut portion, so that free flow can be prevented.
  • the movement restricting portion is provided on the plunger and has a flexible leg extending along the axial direction of the plunger, and is provided on the leg and provided on the nut portion.
  • a claw portion that can contact a receiving surface directed in a direction opposite to the traveling direction with respect to the plunger may be included.
  • the leg portion when the nut portion is moved from the initial position to the use position, the leg portion can be bent and the claw portion can be guided and brought into contact with the receiving surface of the nut portion. Thereby, the movement to the front end side of the plunger with respect to a cylinder can be controlled reliably.
  • a through hole through which the claw portion is inserted is formed in the nut portion, and a tapered nail side contact surface that contacts a wall surface forming the through hole is formed in the claw portion. May be.
  • the claw side contact surface can be slid to the wall surface constituting the through hole of the nut portion, so that the resistance force when the claw portion is passed through the through hole can be made relatively small. Therefore, it is possible to suppress the plunger from being pushed by the nut portion when the claw portion is passed through the through hole and progressing to the distal end side.
  • a tapered hole-side contact surface that contacts the nail-side contact surface may be formed on the wall surface forming the through-hole. According to such a structure, the resistance force at the time of letting a nail
  • the through hole may expand toward the distal end side of the plunger. According to such a configuration, the claw portion can be easily introduced into the through hole.
  • the feed screw shaft may be disposed coaxially with the plunger, and a pair of the claw portions may be provided so as to face each other with the feed screw shaft interposed therebetween.
  • the medicinal solution administration device can be configured in a compact manner, and the claw portion can be efficiently suppressed from being detached from the receiving surface of the nut portion.
  • the position of the plunger can be manually changed when filling the cylinder with the chemical solution, an appropriate amount of the chemical solution can be easily and quickly filled into the cylinder.
  • an appropriate amount of the chemical solution can be easily and quickly filled into the cylinder.
  • FIG. 7A is a cross-sectional explanatory view of the disposable part according to the first modification
  • FIG. 7B is a cross-sectional explanatory view of the disposable part according to the second modification
  • FIG. 7C is a cross-sectional description of the disposable part according to the third modification.
  • the drug solution administration device 10 is a portable drug solution administration device 10 that continuously or intermittently administers a drug solution filled in a cylindrical body 36 into a living body under the pressing action of a plunger 38. It is configured as a formula insulin pump.
  • the drug solution administration device 10 is not limited to the patch type, and may be a tube type or the like.
  • the drug solution administration device 10 includes a cradle 14 provided with a seal portion 12 that can be attached to the skin of a user (patient), and a drug solution administration device body 16 that is detachably provided on the cradle 14. It has.
  • the cradle 14 has a substantially rectangular support plate 18 to which the seal portion 12 is fixed, and a locking wall 20 provided on the outer peripheral edge of the support plate 18.
  • a cannula mechanism 22 having a cannula placed in the living body using a puncture mechanism (not shown) is attached to the corner of the support plate 18.
  • the locking wall 20 is formed with a mounting hole 26 into which the mounting claw 24 of the drug solution administration device body 16 is fitted.
  • the drug solution administration device main body 16 has a disposable disposable part 28 and a reusable reuse part 30.
  • the disposable part 28 includes a flat box-shaped base part 32 opened on one side (Z2 direction).
  • the base portion 32 has a substantially rectangular shape corresponding to the support plate 18 in plan view.
  • the base portion 32 is provided with a cannula accommodating portion 34 in which the cannula mechanism 22 is accommodated when the drug solution administration device main body 16 is attached to the cradle 14.
  • the base portion 32 includes a cylindrical body 36 filled with a chemical solution, a plunger 38 provided in the cylindrical body 36, a feed screw shaft 40 disposed coaxially with the plunger 38, A nut portion 42 screwed to the feed screw shaft 40 is provided.
  • the cylindrical body 36 extends in a cylindrical shape along the longitudinal direction (X1, X2 direction) of the base portion 32.
  • the distal end portion (end portion in the X1 direction) of the cylindrical body 36 has an outer diameter and an inner diameter that are reduced toward the distal end.
  • an introduction port 44 (see FIG. 1) for introducing the chemical liquid into the cylindrical body 36 and a lead-out port 46 for guiding the chemical liquid in the cylindrical body 36 are formed. Yes.
  • the introduction port 44 is closed by a closing member 48 made of rubber or the like (see FIG. 4).
  • the outlet port 46 communicates with the outlet pipe 50 that guides the fluid in the cylindrical body 36 to the cannula mechanism 22.
  • the plunger 38 is integrally formed of a resin material or the like, and is provided in the cylinder 36 so as to be slidable in a liquid-tight manner along the axial direction of the cylinder 36.
  • the plunger 38 has a plunger main body 52 that constitutes the distal end side, and a pusher 54 that is provided on the plunger main body 52 and constitutes the rear end side.
  • a pair of packings 56 are attached to the rear end side of the plunger body 52 formed in a cylindrical shape.
  • the distal end portion of the plunger main body 52 has a substantially conical shape, and the outer diameter is reduced toward the distal end.
  • the pusher 54 includes a pair of first extending portions 58 and a pair of second extending portions 60 extending from the plunger main body 52 to the outside of the cylindrical body 36 rearward (X2 direction), and a first extending portion. 58 and a pair of connecting portions 62 that connect the second extending portion 60.
  • the pair of first extending portions 58 are disposed apart from each other along the short direction (Y1, Y2 direction) of the base portion 32.
  • a first engagement portion 66 with which the auxiliary tool 230 (see FIG. 6) can be engaged is provided.
  • the pair of second extending portions 60 are spaced apart from each other along the short direction of the base portion 32.
  • a rear end portion of each second extending portion 60 is provided with a second abutting surface 68 with which the nut portion 42 abuts and a second engaging portion 70 with which the operation assisting tool 230 can be engaged.
  • the first extension part 58 and the second extension part 60 face each other in a state of being separated from each other along the height direction (Z1, Z2 direction) of the base part 32.
  • the pusher 54 of the plunger 38 configured in this manner is provided with a movement restricting portion 72 that restricts the movement of the distal end side of the plunger 38 relative to the nut portion 42 while being engaged with the nut portion 42.
  • the detailed configuration of the movement restricting unit 72 will be described later.
  • the feed screw shaft 40 is rotationally driven by the drive unit 76 with its end in the X1 direction being pivotally supported by a bearing 74 provided in the base portion 32.
  • the drive unit 76 includes a battery 78 as a power source, a motor 80 driven by the battery 78, a gear box (power transmission mechanism) 82 that transmits the rotational driving force of the motor 80 at a reduced speed, and an output gear of the gear box 82.
  • a spur gear 86 that meshes with 84 is fixed, and has a transmission shaft 88 that is locked to the feed screw shaft 40 so as to be integrally rotatable.
  • the battery 78 and the transmission shaft 88 are provided on the base portion 32 constituting the disposable portion 28, and the motor 80 and the gear box 82 are provided on the lid 90 (see FIG. 1) constituting the reuse portion 30. Yes.
  • the cost of the disposable unit 28 can be reduced by using the motor 80 and the gear box 82 as the reuse unit 30.
  • the lid 90 is detachably provided on the base portion 32 so as to close the opening of the base portion 32.
  • the battery 78 is provided with a terminal 92 that is electrically connected to the motor 80 of the reuse unit 30 when the reuse unit 30 is attached to the disposable unit 28.
  • the transmission shaft 88 is pivotally supported by a pair of bearings 94 provided on the base portion 32 in a state of being arranged coaxially with the feed screw shaft 40.
  • the transmission shaft 88 is screw-engaged with the feed screw shaft 40.
  • the engagement structure between the transmission shaft 88 and the feed screw shaft 40 can be arbitrarily set.
  • the movement restricting portion 72 is formed integrally with the plunger 38 by a resin material or the like, and is provided at a pair of leg portions 96 extending rearward from each connecting portion 62 and a rear end portion of each leg portion 96. And a pair of claw portions 98.
  • a feed screw shaft 40 is disposed between the pair of leg portions 96.
  • Each leg part 96 has flexibility, and can be bent along the thickness direction (Y1, Y2 direction).
  • the pair of claw portions 98 are opposed to each other with the feed screw shaft 40 being sandwiched between the first engagement portion 66 and the second engagement portion 70.
  • the claw portion 98 projects outward from the rear end portion of the leg portion 96 (the side opposite to the side where the feed screw shaft 40 is located).
  • a tapered claw-side contact surface 100 that is inclined inward (side on which the feed screw shaft 40 is located) in the X2 direction is formed.
  • the claw portion 98 is formed narrower in the X2 direction (the dimensions in the Z1 direction and the Z2 direction are smaller).
  • the nut portion 42 is integrally formed of a resin material, and includes a nut portion main body 102 formed in a substantially rectangular parallelepiped shape and a slide portion 104 provided on the nut portion main body 102.
  • the nut portion main body 102 is formed with a screw hole 106 into which the feed screw shaft 40 is screwed and a pair of rectangular through holes 108 formed so as to sandwich the screw hole 106 from both sides and through which the claw portion 98 is inserted. Yes.
  • the screw hole 106 is located substantially at the center of the nut portion main body 102.
  • a tapered hole-side contact surface 110 that contacts the claw-side contact surface 100 is formed on the wall surface constituting the through-hole 108 (see FIG. 2). That is, the hole-side contact surface 110 is inclined outward toward the distal end side of the plunger 38. Further, the through hole 108 expands toward the distal end side of the plunger 38. Thereby, the claw portion 98 can be easily introduced into the through hole 108. However, the through hole 108 can be arbitrarily formed.
  • a reinforcing cover 112 made of, for example, a metal material is attached to the outer surface of the nut body 102.
  • the slide portion 104 slides with respect to the guide wall 114 having a substantially L-shaped cross section provided on the base portion 32 and extending along the axial direction of the plunger 38. Thereby, the nut part 42 moves smoothly along the axial direction of the feed screw shaft 40 under the rotating action of the feed screw shaft 40.
  • the drug solution administration device 10 is basically configured as described above, and the operation and effects thereof will be described next.
  • the user takes out the disposable part 28 to which the adapter 200 is attached from the packaging container.
  • the cylindrical body 36 of the disposable part 28 is not filled with the chemical solution, and the nut part 42 is in an initial position where it does not contact the plunger 38 (see FIG. 2).
  • one end portion of the introduction needle 202 of the adapter 200 passes through the closing member 48 and is positioned in the cylindrical body 36, and the connection passage 206 of the adapter 200 communicates with the inner hole of the outlet pipe 50. To do.
  • the user operates the pusher 54 to slide the plunger 38 along the axial direction with respect to the cylinder 36 so that an appropriate amount of the chemical solution can be filled in the cylinder 36.
  • the position of the plunger 38 can be manually changed according to the filling amount of the chemical solution.
  • the user may operate by directly picking the pusher 54, or may operate the pusher 54 using an operation assisting tool 230 shown in FIG.
  • the disposable part 28 to which the adapter 200 is attached is set in the filling machine 210 so that the X1 direction thereof is vertically upward.
  • the connection passage 206 of the adapter 200 communicates with the cylinder 214 via the suction passage 212 of the filling machine 210.
  • a chemical solution container 222 such as a vial in which the chemical solution is hermetically stored by the stopper member 220 is attached to the adapter 200.
  • the other end portion of the introduction needle 202 of the adapter 200 passes through the plug member 220 and is positioned in the chemical solution container 222, and the end portion of the air needle 204 of the adapter 200 passes through the plug member 220 and is stored in the chemical solution container 222.
  • the piston 216 in the cylinder 214 of the filling machine 210 is driven to suck the air in the cylinder 36 into the cylinder 214 via the outlet pipe 50, the connection passage 206, and the suction passage 212.
  • the chemical solution in the chemical solution container 222 is introduced into the cylindrical body 36 through the introduction needle 202 and air is introduced into the chemical solution container 222 through the air needle 204.
  • medical solution in the cylinder 36 is completed in the stage where the storage space in the cylindrical body 36 was satisfy
  • the nut portion 42 in the initial position does not come into contact with the plunger 38, so that the position of the plunger 38 can be manually changed according to the filling amount of the chemical liquid. Thereby, it is possible to easily and quickly fill the cylindrical body 36 with an appropriate amount of the chemical solution.
  • the user removes the disposable part 28 from the filling machine 210 and removes the adapter 200 from the disposable part 28, and then attaches the reuse part 30 to the disposable part 28.
  • the power of the battery 78 of the disposable unit 28 is supplied to the components of the reuse unit 30, and the output gear 84 of the gear box 82 of the reuse unit 30 meshes with the spur gear 86 of the disposable unit 28.
  • priming of the drug solution administration device main body 16 is performed. Specifically, the motor 80 is rotated by operating a remote controller (not shown). Then, since the rotational driving force of the motor 80 is transmitted to the feed screw shaft 40 via the gear box 82, the spur gear 86, and the transmission shaft 88, the feed screw shaft 40 rotates and the nut portion 42 slides on the guide wall 114. While proceeding to the plunger 38 side.
  • the leg part 96 bends so that the pair of claw parts 98 come close to each other.
  • the claw portion 98 passes through the through hole 108, the claw portion 98 returns to its original position, thereby contacting the receiving surface 116 of the nut portion 42 that is directed in the direction opposite to the traveling direction with respect to the plunger 38.
  • the reinforcing cover 112 of the nut portion 42 contacts the first contact surface 64 and the second contact surface 68 of the plunger 38. Thereby, the nut part 42 becomes a use position which can press the plunger 38 to the front end side (refer FIG. 5).
  • the user attaches the seal portion 12 to a predetermined position on the skin, and uses the puncture mechanism to place the cannula locked to the cradle 14 in the living body.
  • medical solution in the cylinder 36 is continuously or intermittently administered in the living body by mounting
  • a force toward the distal end side of the cylindrical body 36 may act on the plunger 38 due to a change in atmospheric pressure.
  • the movement of the plunger 38 relative to the front end side of the plunger 38 with respect to the nut portion 42 is restricted by the claw portion 98 of the movement restricting portion 72 coming into contact with the receiving surface 116 of the nut portion 42. Therefore, the plunger 38 does not move to the tip side. Thereby, it can prevent that the chemical
  • the claw part 98 is guided to the receiving surface 116 of the nut part 42 by bending the leg part 96. Can be contacted. Thereby, the movement to the front end side of the plunger 38 with respect to the cylinder 36 can be controlled reliably.
  • the claw-side contact surface 100 having a tapered shape is formed on the claw portion 98, the resistance force when the claw portion 98 is passed through the through hole 108 can be made relatively small. Therefore, it is possible to prevent the plunger 38 from being pushed by the nut portion 42 and traveling toward the distal end side when the claw portion 98 is passed through the through hole 108.
  • the tapered hole side contact surface 110 that contacts the claw side contact surface 100 is formed on the wall surface constituting the through hole 108, the resistance force when the claw portion 98 is passed through the through hole 108 is further reduced. be able to.
  • the drug solution administration device 10 can be configured compactly.
  • the claw portion 98 can be efficiently prevented from being detached from the receiving surface 116 of the nut portion 42.
  • the filling machine 210 may not be at the user's hand when the cylindrical body 36 is filled with the chemical solution.
  • the chemical solution container 222 is mounted on the adapter 200 with the disposable portion 28 standing so that the X1 direction thereof is vertically upward, and the plunger 38 is moved backward using the operation assisting tool 230.
  • the pressure in the cylindrical body 36 is reduced, so that the chemical liquid in the chemical liquid container 222 is introduced into the cylindrical body 36 through the introduction needle 202.
  • the backward movement of the plunger 38 is stopped.
  • the nut portion 42 is in the initial position where it does not come into contact with the plunger 38, an appropriate amount of the chemical solution can be easily and quickly filled into the cylindrical body 36.
  • the user can directly pick the pusher 54 and move the plunger 38 without using the operation assisting tool 230.
  • the chemical solution administration device 10 is not limited to the configuration described above.
  • the drug solution administration device 10 may include disposable parts 28A to 28C according to the first to third modifications shown in FIGS. 7A to 7C.
  • the disposable part 28A includes a side where the feed screw shaft 40 is located from a position of the leg part 96 that is a predetermined distance away from the claw part 98 toward the tip side (X1 direction).
  • the disposable part 28B includes a nut part 122 in which the through hole 108 is not formed, and a receiver that goes over the nut part 122 from the outside and is oriented in the X2 direction of the nut part 122. And a movement restricting portion 126 having a claw portion 124 that contacts the surface 123. Further, on each surface where the receiving surface 123 and the claw portion 124 come into contact, there are provided a protruding portion and a receiving portion (not shown) that engage with each other. In this case, since it is not necessary to form the through-hole 108 in the nut part 122, the rigidity of the nut part 122 can be improved.
  • the disposable part 28C according to the third modification includes a nut part 128 in which the through hole 108 is not formed.
  • the nut portion 128 includes a leg portion 132 that extends from the nut portion main body 130 toward the distal end side (X1 direction), and a claw portion 134 that is provided at the distal end portion of the leg portion 132.
  • a movement restricting portion 136 that engages with the claw portion 134 is provided at the rear end portion of the plunger 38. Even with such a configuration, movement of the distal end side of the plunger 38 with respect to the nut portion 128 can be restricted at the use position of the nut portion 128.

Abstract

The present invention relates to a liquid drug administration device. The liquid drug administration device (10) continuously or intermittently administers a liquid drug, filled into a cylindrical body (36), into a living body as a result of a pressing action on a plunger (38). The liquid drug administration device (10) comprises: a nut section (42) that, as a result of rotation of a feed screw shaft (40), moves from an initial position where same is not in contact with the plunger (38) to a usage position where same is in contact with the plunger (38) and the plunger (38) can be pressed; and a travel restriction section (72) that restricts movement of the nut section (42) towards the tip side of the plunger (38), in the usage position.

Description

薬液投与装置Chemical solution administration device
 本発明は、筒体内に充填した薬液をプランジャの押圧作用下に生体内に持続的又は間欠的に投与する携帯型の薬液投与装置に関する。 The present invention relates to a portable drug solution administration device that continuously or intermittently administers a drug solution filled in a cylinder into a living body under the action of a plunger.
 この種の薬液投与装置として、例えば、特表2010-535057号公報には、プランジャと駆動部とをねじ係合し、ねじの回転作用下にプランジャを移動させる構成(第1の構成)が開示されている(特表2010-535057号公報の図17a及び図17b参照)。また、この特表2010-535057号公報には、筒体内に設けられたピストンと、ピストンを先端側に押圧するプランジャロッドとを分離可能に設ける構成(第2の構成)が開示されている(特表2010-535057号公報の図15a及び図15b参照)。 As this type of chemical solution administration device, for example, Japanese Patent Application Publication No. 2010-535057 discloses a configuration (first configuration) in which a plunger and a drive unit are screw-engaged and the plunger is moved under the rotational action of the screw. (See FIG. 17a and FIG. 17b of JP 2010-535057 A). In addition, this special table 2010-535057 discloses a configuration (second configuration) in which a piston provided in a cylinder and a plunger rod that presses the piston toward the tip side are detachable (second configuration). (See FIG. 15a and FIG. 15b of JP-T 2010-535057).
 ところで、一般的に、薬液投与装置の使用前において、筒体内に薬液は充填されていない。そのため、ユーザは、薬液投与装置の使用に先立って、バイアル等の薬液容器から筒体内に適切な量の薬液を充填する必要がある。 By the way, in general, the chemical solution is not filled in the cylinder before using the chemical solution administration device. Therefore, the user needs to fill the cylinder with an appropriate amount of the chemical solution from the chemical solution container such as a vial before using the chemical solution administration device.
 しかしながら、特表2010-535057号公報の第1の構成を採用した場合、筒体に対するプランジャの位置を変更する際にねじを回転させる必要があるため、適切な量の薬液を筒体内に容易且つ迅速に充填することができないことがある。 However, when the first configuration of Japanese Patent Application Publication No. 2010-535057 is adopted, it is necessary to rotate the screw when changing the position of the plunger with respect to the cylindrical body. It may not be possible to fill quickly.
 また、特表2010-535057号公報の第2の構成を採用した場合、プランジャロッドがピストンに対して分離可能であるため、薬液投与装置の使用時(薬液投与中)に、気圧変化によってピストンがプランジャロッドから離間して先端側に変位し、フリーフローが発生する(筒体内の薬液が意図せずに投与される)おそれがある。 In addition, when the second configuration of Japanese Patent Publication No. 2010-535057 is adopted, the plunger rod can be separated from the piston, so that when the chemical liquid administration device is used (during chemical administration), the piston is There is a possibility that the plunger rod moves away from the plunger rod and is displaced to the distal end side, and free flow occurs (the drug solution in the cylinder is administered unintentionally).
 本発明は、このような課題を考慮してなされたものであり、適切な量の薬液を筒体内に容易且つ迅速に充填することができると共にフリーフローを防止することができる薬液投与装置を提供することを目的とする。 The present invention has been made in consideration of such problems, and provides a chemical solution administration device that can easily and quickly fill a cylinder with an appropriate amount of chemical solution and prevent free flow. The purpose is to do.
 上記目的を達成するために、本発明に係る薬液投与装置は、筒体内に充填した薬液をプランジャの押圧作用下に生体内に持続的又は間欠的に投与する携帯型の薬液投与装置であって、前記プランジャの軸線方向に沿って延在した送りねじ軸と、前記送りねじ軸を回転駆動させる駆動部と、前記送りねじ軸に螺合した状態で当該送りねじ軸の回転作用下に前記プランジャに接触しない初期位置から前記プランジャに接触して当該プランジャを押圧可能な使用位置に移動するナット部と、前記プランジャに設けられ、前記使用位置で前記ナット部に係合し、前記ナット部に係合した状態で前記ナット部に対する前記プランジャの先端側への移動を規制する移動規制部と、を備えていることを特徴とする。 In order to achieve the above object, a drug solution administration device according to the present invention is a portable drug solution administration device that continuously or intermittently administers a drug solution filled in a cylinder into a living body under the action of a plunger. , A feed screw shaft extending along the axial direction of the plunger, a drive unit for rotationally driving the feed screw shaft, and the plunger under the rotational action of the feed screw shaft in a state of being screwed to the feed screw shaft A nut portion that contacts the plunger from an initial position that does not contact the plunger and moves to a use position where the plunger can be pressed; and is provided on the plunger, engages with the nut portion at the use position, and engages with the nut portion. And a movement restricting portion for restricting movement of the plunger toward the distal end side with respect to the nut portion in a combined state.
 本発明に係る薬液投与装置によれば、筒体内に薬液を充填する際、初期位置にあるナット部はプランジャに接触しないため、薬液の充填量に応じてプランジャの位置を手動で変更することができる。これにより、適切な量の薬液を筒体内に容易且つ迅速に充填することができる。また、薬液投与装置の使用時に、気圧変化が生じたとしても移動規制部によってナット部に対するプランジャの先端側への移動が規制されているので、フリーフローを防止することができる。 According to the liquid medicine administration device of the present invention, when filling the liquid medicine into the cylinder, the nut portion at the initial position does not contact the plunger, so that the position of the plunger can be manually changed according to the amount of liquid medicine to be filled. it can. As a result, it is possible to easily and quickly fill the cylinder with an appropriate amount of the chemical solution. Further, even when a change in atmospheric pressure occurs during use of the drug solution administration device, the movement restricting portion restricts the movement of the plunger toward the distal end side with respect to the nut portion, so that free flow can be prevented.
 上記の薬液投与装置において、前記移動規制部は、前記プランジャに設けられて当該プランジャの軸線方向に沿って延在した可撓性を有する脚部と、前記脚部に設けられて前記ナット部のうち前記プランジャに対する進行方向とは反対方向を指向する受け面に接触可能な爪部と、を有していてもよい。 In the above-described drug solution administration device, the movement restricting portion is provided on the plunger and has a flexible leg extending along the axial direction of the plunger, and is provided on the leg and provided on the nut portion. A claw portion that can contact a receiving surface directed in a direction opposite to the traveling direction with respect to the plunger may be included.
 このような構成によれば、ナット部を初期位置から使用位置に移動させた際に、脚部を撓ませて爪部をナット部の受け面に導き接触させることができる。これにより、筒体に対するプランジャの先端側への移動を確実に規制することができる。 According to such a configuration, when the nut portion is moved from the initial position to the use position, the leg portion can be bent and the claw portion can be guided and brought into contact with the receiving surface of the nut portion. Thereby, the movement to the front end side of the plunger with respect to a cylinder can be controlled reliably.
 上記の薬液投与装置において、前記ナット部には、前記爪部が挿通する貫通孔が形成され、前記爪部には、前記貫通孔を構成する壁面に接触するテーパ状の爪側接触面が形成されていてもよい。 In the medicinal solution administration device, a through hole through which the claw portion is inserted is formed in the nut portion, and a tapered nail side contact surface that contacts a wall surface forming the through hole is formed in the claw portion. May be.
 このような構成によれば、爪側接触面をナット部の貫通孔を構成する壁面に滑らせることができるので、爪部を貫通孔に通す際の抵抗力を比較的小さくすることができる。よって、爪部を貫通孔に通すときにプランジャがナット部に押されて先端側に進行することを抑えることができる。 According to such a configuration, the claw side contact surface can be slid to the wall surface constituting the through hole of the nut portion, so that the resistance force when the claw portion is passed through the through hole can be made relatively small. Therefore, it is possible to suppress the plunger from being pushed by the nut portion when the claw portion is passed through the through hole and progressing to the distal end side.
 上記の薬液投与装置において、前記貫通孔を構成する壁面には、前記爪側接触面に接触するテーパ状の孔側接触面が形成されていてもよい。このような構成によれば、爪部を貫通孔に通す際の抵抗力をより低減することができる。 In the above-described drug solution administration device, a tapered hole-side contact surface that contacts the nail-side contact surface may be formed on the wall surface forming the through-hole. According to such a structure, the resistance force at the time of letting a nail | claw part pass through a through-hole can be reduced more.
 上記の薬液投与装置において、前記貫通孔は、前記プランジャの先端側に向かって拡大していてもよい。このような構成によれば、爪部を貫通孔に導入させ易くすることができる。 In the above chemical solution administration device, the through hole may expand toward the distal end side of the plunger. According to such a configuration, the claw portion can be easily introduced into the through hole.
 上記の薬液投与装置において、前記送りねじ軸は、前記プランジャと同軸に配設され、前記爪部は、前記送りねじ軸を挟んで互いに対向するように一対設けられていてもよい。 In the drug solution administration device, the feed screw shaft may be disposed coaxially with the plunger, and a pair of the claw portions may be provided so as to face each other with the feed screw shaft interposed therebetween.
 このような構成によれば、薬液投与装置をコンパクトに構成することができると共に爪部がナット部の受け面から離脱することを効率的に抑制することができる。 According to such a configuration, the medicinal solution administration device can be configured in a compact manner, and the claw portion can be efficiently suppressed from being detached from the receiving surface of the nut portion.
 本発明によれば、筒体内に薬液を充填する際、プランジャの位置を手動で変更することができるので、適切な量の薬液を筒体内に容易且つ迅速に充填することができる。また、薬液投与装置を使用する際、移動規制部によってナット部に対するプランジャの先端側への移動が規制されているので、フリーフローを防止することができる。 According to the present invention, since the position of the plunger can be manually changed when filling the cylinder with the chemical solution, an appropriate amount of the chemical solution can be easily and quickly filled into the cylinder. Moreover, when using a chemical | medical solution administration apparatus, since the movement to the front end side of the plunger with respect to a nut part is controlled by the movement control part, a free flow can be prevented.
本発明に係る薬液投与装置の分解斜視図である。It is a disassembled perspective view of the chemical | medical solution administration apparatus which concerns on this invention. 図1のディスポ部の平面図である。It is a top view of the disposable part of FIG. プランジャ及びナット部等の斜視図である。It is a perspective view, such as a plunger and a nut part. 第1薬液充填方法を説明する模式図である。It is a schematic diagram explaining the 1st chemical | medical solution filling method. 使用時における薬液投与装置を構成するディスポ部の平面図である。It is a top view of the disposable part which comprises the chemical | medical solution administration apparatus at the time of use. 第2薬液充填方法を説明する模式図である。It is a schematic diagram explaining the 2nd chemical | medical solution filling method. 図7Aは第1変形例に係るディスポ部の断面説明図であり、図7Bは第2変形例に係るディスポ部の断面説明図であり、図7Cは第3変形例に係るディスポ部の断面説明図である。7A is a cross-sectional explanatory view of the disposable part according to the first modification, FIG. 7B is a cross-sectional explanatory view of the disposable part according to the second modification, and FIG. 7C is a cross-sectional description of the disposable part according to the third modification. FIG.
 以下、本発明に係る薬液投与装置について好適な実施形態を挙げ、添付の図面を参照しながら説明する。 Hereinafter, preferred embodiments of the drug solution administration device according to the present invention will be described with reference to the accompanying drawings.
 本実施形態に係る薬液投与装置10は、筒体36内に充填した薬液をプランジャ38の押圧作用下に生体内に持続的又は間欠的に投与する携帯型の薬液投与装置10であって、パッチ式のインスリンポンプとして構成されている。ただし、薬液投与装置10は、パッチ式に限定されるものではなく、チューブ式等であってもよい。 The drug solution administration device 10 according to the present embodiment is a portable drug solution administration device 10 that continuously or intermittently administers a drug solution filled in a cylindrical body 36 into a living body under the pressing action of a plunger 38. It is configured as a formula insulin pump. However, the drug solution administration device 10 is not limited to the patch type, and may be a tube type or the like.
 図1に示すように、薬液投与装置10は、ユーザ(患者)の皮膚に貼着可能なシール部12が設けられたクレードル14と、クレードル14に着脱自在に設けられた薬液投与装置本体16とを備えている。 As shown in FIG. 1, the drug solution administration device 10 includes a cradle 14 provided with a seal portion 12 that can be attached to the skin of a user (patient), and a drug solution administration device body 16 that is detachably provided on the cradle 14. It has.
 クレードル14は、シール部12が固着された略長方形状の支持板18と、支持板18の外周縁部に設けられた係止壁20とを有している。支持板18の角部には、図示しない穿刺機構を用いて生体内に留置されるカニューレを有するカニューレ機構22が装着されている。係止壁20には、薬液投与装置本体16の装着爪24が嵌合する装着孔26が形成されている。 The cradle 14 has a substantially rectangular support plate 18 to which the seal portion 12 is fixed, and a locking wall 20 provided on the outer peripheral edge of the support plate 18. A cannula mechanism 22 having a cannula placed in the living body using a puncture mechanism (not shown) is attached to the corner of the support plate 18. The locking wall 20 is formed with a mounting hole 26 into which the mounting claw 24 of the drug solution administration device body 16 is fitted.
 薬液投与装置本体16は、使い捨てのディスポ部28と、再利用可能なリユース部30とを有している。ディスポ部28は、片側(Z2方向)が開口した平箱形状のベース部32を備えている。ベース部32は、平面視で支持板18に対応した略長方形状をなしている。ベース部32には、薬液投与装置本体16をクレードル14に装着した際に、カニューレ機構22が収容されるカニューレ収容部34が設けられている。 The drug solution administration device main body 16 has a disposable disposable part 28 and a reusable reuse part 30. The disposable part 28 includes a flat box-shaped base part 32 opened on one side (Z2 direction). The base portion 32 has a substantially rectangular shape corresponding to the support plate 18 in plan view. The base portion 32 is provided with a cannula accommodating portion 34 in which the cannula mechanism 22 is accommodated when the drug solution administration device main body 16 is attached to the cradle 14.
 図2に示すように、ベース部32には、薬液が充填される筒体36と、筒体36内に設けられたプランジャ38と、プランジャ38と同軸に配設された送りねじ軸40と、送りねじ軸40に螺合されたナット部42とが設けられている。 As shown in FIG. 2, the base portion 32 includes a cylindrical body 36 filled with a chemical solution, a plunger 38 provided in the cylindrical body 36, a feed screw shaft 40 disposed coaxially with the plunger 38, A nut portion 42 screwed to the feed screw shaft 40 is provided.
 筒体36は、ベース部32の長手方向(X1、X2方向)に沿って円筒状に延在している。筒体36の先端部(X1方向の端部)は、外径及び内径が先端に向かって縮径している。このような筒体36の先端部には、筒体36内に薬液を導入するための導入ポート44(図1参照)と、筒体36内の薬液を導出する導出ポート46とが形成されている。導入ポート44は、ゴム等で構成された閉塞部材48によって閉塞されている(図4参照)。導出ポート46には、筒体36内の流体をカニューレ機構22に導く導出管50が連通している。 The cylindrical body 36 extends in a cylindrical shape along the longitudinal direction (X1, X2 direction) of the base portion 32. The distal end portion (end portion in the X1 direction) of the cylindrical body 36 has an outer diameter and an inner diameter that are reduced toward the distal end. At the tip of the cylindrical body 36, an introduction port 44 (see FIG. 1) for introducing the chemical liquid into the cylindrical body 36 and a lead-out port 46 for guiding the chemical liquid in the cylindrical body 36 are formed. Yes. The introduction port 44 is closed by a closing member 48 made of rubber or the like (see FIG. 4). The outlet port 46 communicates with the outlet pipe 50 that guides the fluid in the cylindrical body 36 to the cannula mechanism 22.
 プランジャ38は、樹脂材料等で一体的に成形されており、筒体36の軸線方向に沿って液密に摺動可能に筒体36内に設けられている。図2及び図3に示すように、プランジャ38は、先端側を構成するプランジャ本体52と、プランジャ本体52に設けられて後端側を構成する押し子54とを有している。プランジャ本体52のうち円筒状に形成された後端側には、一対のパッキン56が装着されている。また、プランジャ本体52の先端部は、略円錐形状をなしており先端に向かって外径が縮径している。 The plunger 38 is integrally formed of a resin material or the like, and is provided in the cylinder 36 so as to be slidable in a liquid-tight manner along the axial direction of the cylinder 36. As shown in FIGS. 2 and 3, the plunger 38 has a plunger main body 52 that constitutes the distal end side, and a pusher 54 that is provided on the plunger main body 52 and constitutes the rear end side. A pair of packings 56 are attached to the rear end side of the plunger body 52 formed in a cylindrical shape. The distal end portion of the plunger main body 52 has a substantially conical shape, and the outer diameter is reduced toward the distal end.
 押し子54は、プランジャ本体52から後方(X2方向)に向かって筒体36の外側まで延出した一対の第1延出部58及び一対の第2延出部60と、第1延出部58及び第2延出部60を連結する一対の連結部62とを含む。 The pusher 54 includes a pair of first extending portions 58 and a pair of second extending portions 60 extending from the plunger main body 52 to the outside of the cylindrical body 36 rearward (X2 direction), and a first extending portion. 58 and a pair of connecting portions 62 that connect the second extending portion 60.
 一対の第1延出部58は、ベース部32の短手方向(Y1、Y2方向)に沿って互いに離間して配設されている。各第1延出部58の後端部には、ナット部42が当接する第1当接面64と、筒体36に薬液を充填する際にプランジャ38の摺動操作を補助するための操作補助具230(図6参照)が係合可能な第1係合部66とが設けられている。 The pair of first extending portions 58 are disposed apart from each other along the short direction (Y1, Y2 direction) of the base portion 32. A first abutting surface 64 with which the nut portion 42 abuts at the rear end portion of each first extending portion 58, and an operation for assisting the sliding operation of the plunger 38 when the cylindrical body 36 is filled with a chemical solution. A first engagement portion 66 with which the auxiliary tool 230 (see FIG. 6) can be engaged is provided.
 一対の第2延出部60は、ベース部32の短手方向に沿って互いに離間して配設されている。各第2延出部60の後端部には、ナット部42が当接する第2当接面68と、前記操作補助具230が係合可能な第2係合部70とが設けられている。第1延出部58と第2延出部60とは、ベース部32の高さ方向(Z1、Z2方向)に沿って互いに離間した状態で対向している。このように構成されたプランジャ38の押し子54には、ナット部42に係合した状態でナット部42に対するプランジャ38の先端側の移動を規制する移動規制部72が設けられている。移動規制部72の詳細な構成については追って説明する。 The pair of second extending portions 60 are spaced apart from each other along the short direction of the base portion 32. A rear end portion of each second extending portion 60 is provided with a second abutting surface 68 with which the nut portion 42 abuts and a second engaging portion 70 with which the operation assisting tool 230 can be engaged. . The first extension part 58 and the second extension part 60 face each other in a state of being separated from each other along the height direction (Z1, Z2 direction) of the base part 32. The pusher 54 of the plunger 38 configured in this manner is provided with a movement restricting portion 72 that restricts the movement of the distal end side of the plunger 38 relative to the nut portion 42 while being engaged with the nut portion 42. The detailed configuration of the movement restricting unit 72 will be described later.
 送りねじ軸40は、そのX1方向の端部がベース部32に設けられた軸受74によって軸支された状態で駆動部76によって回転駆動される。駆動部76は、動力源としての電池78と、電池78によって駆動するモータ80と、モータ80の回転駆動力を減速して伝達するギヤボックス(動力伝達機構)82と、ギヤボックス82の出力歯車84に噛み合う平歯車86が固定されて送りねじ軸40に一体回転可能に係止された伝達軸88とを有している。 The feed screw shaft 40 is rotationally driven by the drive unit 76 with its end in the X1 direction being pivotally supported by a bearing 74 provided in the base portion 32. The drive unit 76 includes a battery 78 as a power source, a motor 80 driven by the battery 78, a gear box (power transmission mechanism) 82 that transmits the rotational driving force of the motor 80 at a reduced speed, and an output gear of the gear box 82. A spur gear 86 that meshes with 84 is fixed, and has a transmission shaft 88 that is locked to the feed screw shaft 40 so as to be integrally rotatable.
 本実施形態では、電池78及び伝達軸88がディスポ部28を構成するベース部32に設けられ、モータ80及びギヤボックス82がリユース部30を構成する蓋体90(図1参照)に設けられている。このように、モータ80及びギヤボックス82等をリユース部30とすることにより、ディスポ部28のコストの削減を図ることができる。なお、蓋体90は、ベース部32の開口を閉塞するようにしてベース部32に着脱可能に設けられている。 In the present embodiment, the battery 78 and the transmission shaft 88 are provided on the base portion 32 constituting the disposable portion 28, and the motor 80 and the gear box 82 are provided on the lid 90 (see FIG. 1) constituting the reuse portion 30. Yes. Thus, the cost of the disposable unit 28 can be reduced by using the motor 80 and the gear box 82 as the reuse unit 30. The lid 90 is detachably provided on the base portion 32 so as to close the opening of the base portion 32.
 電池78には、ディスポ部28にリユース部30を装着した際にリユース部30のモータ80に電気的に接続する端子92が設けられている。伝達軸88は、送りねじ軸40と同軸に配設された状態でベース部32に設けられた一対の軸受94によって軸支されている。本実施形態では、伝達軸88は、送りねじ軸40に対してねじ係合している。ただし、伝達軸88と送りねじ軸40の係合構造は任意に設定可能である。 The battery 78 is provided with a terminal 92 that is electrically connected to the motor 80 of the reuse unit 30 when the reuse unit 30 is attached to the disposable unit 28. The transmission shaft 88 is pivotally supported by a pair of bearings 94 provided on the base portion 32 in a state of being arranged coaxially with the feed screw shaft 40. In the present embodiment, the transmission shaft 88 is screw-engaged with the feed screw shaft 40. However, the engagement structure between the transmission shaft 88 and the feed screw shaft 40 can be arbitrarily set.
 移動規制部72は、樹脂材料等によってプランジャ38と一体成形されており、各連結部62から後方に向かって延出した一対の脚部96と、各脚部96の後端部に設けられた一対の爪部98とを有している。一対の脚部96の間には、送りねじ軸40が配設されている。各脚部96は、可撓性を有しており、その厚み方向(Y1、Y2方向)に沿って撓ませることができる。 The movement restricting portion 72 is formed integrally with the plunger 38 by a resin material or the like, and is provided at a pair of leg portions 96 extending rearward from each connecting portion 62 and a rear end portion of each leg portion 96. And a pair of claw portions 98. A feed screw shaft 40 is disposed between the pair of leg portions 96. Each leg part 96 has flexibility, and can be bent along the thickness direction (Y1, Y2 direction).
 一対の爪部98は、第1係合部66及び第2係合部70の間に位置した状態で送りねじ軸40を挟んで互いに対向している。爪部98は、脚部96の後端部から外側(送りねじ軸40が位置する側とは反対側)に突出している。爪部98の外側面には、X2方向に向かって内側(送りねじ軸40が位置する側)に傾斜したテーパ状の爪側接触面100が形成されている。また、爪部98は、X2方向に向かって幅狭に(Z1方向、Z2方向の寸法が小さく)形成されている。 The pair of claw portions 98 are opposed to each other with the feed screw shaft 40 being sandwiched between the first engagement portion 66 and the second engagement portion 70. The claw portion 98 projects outward from the rear end portion of the leg portion 96 (the side opposite to the side where the feed screw shaft 40 is located). On the outer surface of the claw portion 98, a tapered claw-side contact surface 100 that is inclined inward (side on which the feed screw shaft 40 is located) in the X2 direction is formed. The claw portion 98 is formed narrower in the X2 direction (the dimensions in the Z1 direction and the Z2 direction are smaller).
 ナット部42は、樹脂材料によって一体的に成形されており、略直方体形状に形成されたナット部本体102と、ナット部本体102に設けられたスライド部104とを有している。ナット部本体102には、送りねじ軸40が螺合するねじ孔106と、ねじ孔106を両側から挟むようにして形成されて爪部98が挿通する一対の四角形状の貫通孔108とが形成されている。 The nut portion 42 is integrally formed of a resin material, and includes a nut portion main body 102 formed in a substantially rectangular parallelepiped shape and a slide portion 104 provided on the nut portion main body 102. The nut portion main body 102 is formed with a screw hole 106 into which the feed screw shaft 40 is screwed and a pair of rectangular through holes 108 formed so as to sandwich the screw hole 106 from both sides and through which the claw portion 98 is inserted. Yes.
 ねじ孔106は、ナット部本体102の略中央に位置している。貫通孔108を構成する壁面には、爪側接触面100に接触するテーパ状の孔側接触面110が形成されている(図2参照)。すなわち、孔側接触面110は、プランジャ38の先端側に向かって外側に傾斜している。また、貫通孔108は、プランジャ38の先端側に向かって拡大している。これにより、爪部98を貫通孔108に導入させ易くすることができる。ただし、貫通孔108は、任意に形成することができる。 The screw hole 106 is located substantially at the center of the nut portion main body 102. A tapered hole-side contact surface 110 that contacts the claw-side contact surface 100 is formed on the wall surface constituting the through-hole 108 (see FIG. 2). That is, the hole-side contact surface 110 is inclined outward toward the distal end side of the plunger 38. Further, the through hole 108 expands toward the distal end side of the plunger 38. Thereby, the claw portion 98 can be easily introduced into the through hole 108. However, the through hole 108 can be arbitrarily formed.
 ナット部本体102の外面には、例えば、金属材料等で構成された補強カバー112が装着されている。スライド部104は、ベース部32に設けられてプランジャ38の軸線方向に沿って延在した断面略L字状の案内壁114に対してスライドする。これにより、ナット部42は、送りねじ軸40の回転作用下に送りねじ軸40の軸線方向に沿って円滑に移動する。 A reinforcing cover 112 made of, for example, a metal material is attached to the outer surface of the nut body 102. The slide portion 104 slides with respect to the guide wall 114 having a substantially L-shaped cross section provided on the base portion 32 and extending along the axial direction of the plunger 38. Thereby, the nut part 42 moves smoothly along the axial direction of the feed screw shaft 40 under the rotating action of the feed screw shaft 40.
 本実施形態に係る薬液投与装置10は、基本的に以上のように構成されるものであり、次にその動作並びに作用効果について説明する。 The drug solution administration device 10 according to the present embodiment is basically configured as described above, and the operation and effects thereof will be described next.
 先ず、ユーザは、包装容器からアダプタ200が装着されたディスポ部28を取り出す。この状態で、ディスポ部28の筒体36内には薬液は充填されておらず、ナット部42はプランジャ38に接触しない初期位置にある(図2参照)。また、図4に示すように、アダプタ200の導入針202の一端部が閉塞部材48を貫通して筒体36内に位置すると共にアダプタ200の接続通路206と導出管50の内孔とが連通する。 First, the user takes out the disposable part 28 to which the adapter 200 is attached from the packaging container. In this state, the cylindrical body 36 of the disposable part 28 is not filled with the chemical solution, and the nut part 42 is in an initial position where it does not contact the plunger 38 (see FIG. 2). As shown in FIG. 4, one end portion of the introduction needle 202 of the adapter 200 passes through the closing member 48 and is positioned in the cylindrical body 36, and the connection passage 206 of the adapter 200 communicates with the inner hole of the outlet pipe 50. To do.
 次いで、ユーザは、筒体36内に適切な量の薬液を充填することができるように、押し子54を操作してプランジャ38を筒体36に対して軸線方向に沿って摺動させる。このとき、ナット部42はプランジャ38に接触しない初期位置にあるため、薬液の充填量に応じてプランジャ38の位置を手動で変更することができる。なお、ユーザは、押し子54を直接摘んで操作してもよいし、後述する図6に示す操作補助具230を用いて押し子54を操作してもよい。 Next, the user operates the pusher 54 to slide the plunger 38 along the axial direction with respect to the cylinder 36 so that an appropriate amount of the chemical solution can be filled in the cylinder 36. At this time, since the nut portion 42 is in the initial position where it does not come into contact with the plunger 38, the position of the plunger 38 can be manually changed according to the filling amount of the chemical solution. Note that the user may operate by directly picking the pusher 54, or may operate the pusher 54 using an operation assisting tool 230 shown in FIG.
 その後、アダプタ200が装着されたディスポ部28をそのX1方向が鉛直上方に向くように充填機210にセットする。この状態で、アダプタ200の接続通路206は、充填機210の吸引通路212を介してシリンダ214内に連通する。 Thereafter, the disposable part 28 to which the adapter 200 is attached is set in the filling machine 210 so that the X1 direction thereof is vertically upward. In this state, the connection passage 206 of the adapter 200 communicates with the cylinder 214 via the suction passage 212 of the filling machine 210.
 そして、薬液が栓部材220により密閉保存されているバイアル等の薬液容器222をアダプタ200に対して装着する。これにより、アダプタ200の導入針202の他端部が栓部材220を貫通して薬液容器222内に位置すると共に、アダプタ200の空気針204の端部が栓部材220を貫通して薬液容器222内に位置する。 Then, a chemical solution container 222 such as a vial in which the chemical solution is hermetically stored by the stopper member 220 is attached to the adapter 200. As a result, the other end portion of the introduction needle 202 of the adapter 200 passes through the plug member 220 and is positioned in the chemical solution container 222, and the end portion of the air needle 204 of the adapter 200 passes through the plug member 220 and is stored in the chemical solution container 222. Located in.
 続いて、充填機210のシリンダ214内のピストン216を駆動させて筒体36内の空気を導出管50、接続通路206、吸引通路212を介してシリンダ214内に吸引する。これにより、薬液容器222内の薬液が導入針202を介して筒体36内に導入されると共に空気針204を介して薬液容器222内に空気が導入されることとなる。そして、筒体36内の収容空間が薬液で満たされた段階で筒体36内への薬液の充填が完了する。 Subsequently, the piston 216 in the cylinder 214 of the filling machine 210 is driven to suck the air in the cylinder 36 into the cylinder 214 via the outlet pipe 50, the connection passage 206, and the suction passage 212. As a result, the chemical solution in the chemical solution container 222 is introduced into the cylindrical body 36 through the introduction needle 202 and air is introduced into the chemical solution container 222 through the air needle 204. And the filling of the chemical | medical solution in the cylinder 36 is completed in the stage where the storage space in the cylindrical body 36 was satisfy | filled with the chemical | medical solution.
 このように、筒体36内に薬液を充填する際、初期位置にあるナット部42はプランジャ38に接触しないため、薬液の充填量に応じてプランジャ38の位置を手動で変更することができる。これにより、適切な量の薬液を筒体36内に容易且つ迅速に充填することができる。 Thus, when the chemical liquid is filled into the cylindrical body 36, the nut portion 42 in the initial position does not come into contact with the plunger 38, so that the position of the plunger 38 can be manually changed according to the filling amount of the chemical liquid. Thereby, it is possible to easily and quickly fill the cylindrical body 36 with an appropriate amount of the chemical solution.
 次に、ユーザは、充填機210からディスポ部28を取り外すと共にディスポ部28からアダプタ200を取り外した後、ディスポ部28にリユース部30を装着する。これにより、ディスポ部28の電池78の電力がリユース部30の構成部品に供給され、リユース部30のギヤボックス82の出力歯車84がディスポ部28の平歯車86に噛み合う。 Next, the user removes the disposable part 28 from the filling machine 210 and removes the adapter 200 from the disposable part 28, and then attaches the reuse part 30 to the disposable part 28. As a result, the power of the battery 78 of the disposable unit 28 is supplied to the components of the reuse unit 30, and the output gear 84 of the gear box 82 of the reuse unit 30 meshes with the spur gear 86 of the disposable unit 28.
 その後、薬液投与装置本体16のプライミングを行う。具体的には、図示しないリモコン等を操作してモータ80を回転駆動させる。そうすると、モータ80の回転駆動力がギヤボックス82、平歯車86、伝達軸88を介して送りねじ軸40に伝達されるため、送りねじ軸40が回転し、ナット部42が案内壁114をスライドしながらプランジャ38側に進行する。 Thereafter, priming of the drug solution administration device main body 16 is performed. Specifically, the motor 80 is rotated by operating a remote controller (not shown). Then, since the rotational driving force of the motor 80 is transmitted to the feed screw shaft 40 via the gear box 82, the spur gear 86, and the transmission shaft 88, the feed screw shaft 40 rotates and the nut portion 42 slides on the guide wall 114. While proceeding to the plunger 38 side.
 ナット部42の孔側接触面110が移動規制部72の爪側接触面100に接触すると、一対の爪部98が互いに近接するように脚部96が撓む。そして、爪部98が貫通孔108を通り抜けると、爪部98は元の位置に復帰することによりナット部42のうちプランジャ38に対する進行方向とは反対方向を指向する受け面116に接触する。また、このとき、ナット部42の補強カバー112がプランジャ38の第1当接面64及び第2当接面68に接触する。これにより、ナット部42は、プランジャ38を先端側に押圧可能な使用位置となる(図5参照)。 When the hole side contact surface 110 of the nut part 42 contacts the claw side contact surface 100 of the movement restricting part 72, the leg part 96 bends so that the pair of claw parts 98 come close to each other. When the claw portion 98 passes through the through hole 108, the claw portion 98 returns to its original position, thereby contacting the receiving surface 116 of the nut portion 42 that is directed in the direction opposite to the traveling direction with respect to the plunger 38. At this time, the reinforcing cover 112 of the nut portion 42 contacts the first contact surface 64 and the second contact surface 68 of the plunger 38. Thereby, the nut part 42 becomes a use position which can press the plunger 38 to the front end side (refer FIG. 5).
 その後、さらに、ナット部42を進行させることにより、筒体36内の薬液がプランジャ38に押圧されて導出管50の内孔が薬液で満たされてプライミングが完了する。 Thereafter, by further advancing the nut portion 42, the chemical solution in the cylindrical body 36 is pressed by the plunger 38, the inner hole of the outlet tube 50 is filled with the chemical solution, and the priming is completed.
 続いて、ユーザは、シール部12を皮膚の所定位置に貼着して、穿刺機構を用いてクレードル14に係止されているカニューレを生体内に留置させる。そして、薬液投与装置本体16をクレードル14に装着し、モータ80を回転制御することにより筒体36内の薬液が生体内に持続的又は間欠的に投与されることとなる。 Subsequently, the user attaches the seal portion 12 to a predetermined position on the skin, and uses the puncture mechanism to place the cannula locked to the cradle 14 in the living body. And the chemical | medical solution in the cylinder 36 is continuously or intermittently administered in the living body by mounting | wearing the cradle 14 with the chemical | medical solution administration apparatus main body 16 and carrying out rotation control of the motor 80. FIG.
 このような薬液投与装置10では、気圧変化によってプランジャ38に筒体36の先端側に向かう力が作用することがある。しかしながら、このような場合であっても、移動規制部72の爪部98がナット部42の受け面116に接触することにより、ナット部42に対するプランジャ38の先端側への移動が規制されているため、プランジャ38が先端側に移動することはない。これにより、筒体36内の薬液が意図せずに生体内に投与されること(フリーフロー)を防止することができる。 In such a chemical solution administration device 10, a force toward the distal end side of the cylindrical body 36 may act on the plunger 38 due to a change in atmospheric pressure. However, even in such a case, the movement of the plunger 38 relative to the front end side of the plunger 38 with respect to the nut portion 42 is restricted by the claw portion 98 of the movement restricting portion 72 coming into contact with the receiving surface 116 of the nut portion 42. Therefore, the plunger 38 does not move to the tip side. Thereby, it can prevent that the chemical | medical solution in the cylinder 36 is administered in the living body unintentionally (free flow).
 本実施形態に係る薬液投与装置10によれば、ナット部42を初期位置から使用位置に移動させた際に、脚部96を撓ませることにより爪部98をナット部42の受け面116に導き接触させることができる。これにより、筒体36に対するプランジャ38の先端側への移動を確実に規制することができる。 According to the drug solution administration device 10 according to the present embodiment, when the nut part 42 is moved from the initial position to the use position, the claw part 98 is guided to the receiving surface 116 of the nut part 42 by bending the leg part 96. Can be contacted. Thereby, the movement to the front end side of the plunger 38 with respect to the cylinder 36 can be controlled reliably.
 本実施形態では、爪部98にテーパ状の爪側接触面100を形成しているので、爪部98を貫通孔108に通す際の抵抗力を比較的小さくすることができる。よって、爪部98を貫通孔108に通すときにプランジャ38がナット部42に押されて先端側に進行することを抑えることができる。また、貫通孔108を構成する壁面に爪側接触面100に接触するテーパ状の孔側接触面110を形成しているので、爪部98を貫通孔108に通す際の抵抗力をより低減することができる。 In this embodiment, since the claw-side contact surface 100 having a tapered shape is formed on the claw portion 98, the resistance force when the claw portion 98 is passed through the through hole 108 can be made relatively small. Therefore, it is possible to prevent the plunger 38 from being pushed by the nut portion 42 and traveling toward the distal end side when the claw portion 98 is passed through the through hole 108. In addition, since the tapered hole side contact surface 110 that contacts the claw side contact surface 100 is formed on the wall surface constituting the through hole 108, the resistance force when the claw portion 98 is passed through the through hole 108 is further reduced. be able to.
 さらに、送りねじ軸40をプランジャ38と同軸に配設して送りねじ軸40を挟んで互いに対向するように一対の爪部98を設けているので、薬液投与装置10をコンパクトに構成することができると共に爪部98がナット部42の受け面116から離脱することを効率的に抑制することができる。 Further, since the feed screw shaft 40 is disposed coaxially with the plunger 38 and the pair of claws 98 are provided so as to face each other with the feed screw shaft 40 interposed therebetween, the drug solution administration device 10 can be configured compactly. In addition, the claw portion 98 can be efficiently prevented from being detached from the receiving surface 116 of the nut portion 42.
 ところで、本実施形態に係る薬液投与装置10において、筒体36内に薬液を充填する際に、充填機210がユーザの手元にないことがある。このような場合、次のように筒体36内への薬液の充填を行うことも可能である。すなわち、先ず、図6に示す操作補助具230の一対の係合脚232を押し子54の第1係合部66及び第2係合部70に係合させた状態で操作補助具230のプレート部234を摘んでプランジャ38を最先端位置まで移動させる。この状態で、アダプタ200の接続通路206を蓋材208によって閉塞する。 By the way, in the chemical solution administration device 10 according to the present embodiment, the filling machine 210 may not be at the user's hand when the cylindrical body 36 is filled with the chemical solution. In such a case, it is also possible to fill the cylindrical body 36 with a chemical solution as follows. That is, first, the plate portion of the operation assisting device 230 with the pair of engaging legs 232 of the operation assisting device 230 shown in FIG. 6 engaged with the first engaging portion 66 and the second engaging portion 70 of the pusher 54. 234 is picked and the plunger 38 is moved to the foremost position. In this state, the connection passage 206 of the adapter 200 is closed by the lid member 208.
 その後、ディスポ部28をそのX1方向が鉛直上方に向くように立てた状態で薬液容器222をアダプタ200に装着し、操作補助具230を用いてプランジャ38を後退させる。これにより、筒体36内の圧力が低下するため、薬液容器222内の薬液が導入針202を介して筒体36内に導入される。そして、適切な量の薬液が筒体36内に充填された時点でプランジャ38の後退を停止する。この場合であっても、ナット部42はプランジャ38に接触しない初期位置にあるため、適切な量の薬液を筒体36内に容易且つ迅速に充填することができる。なお、このような充填方法において、ユーザは、操作補助具230を用いることなく押し子54を直接摘みプランジャ38を移動させることも可能である。 Thereafter, the chemical solution container 222 is mounted on the adapter 200 with the disposable portion 28 standing so that the X1 direction thereof is vertically upward, and the plunger 38 is moved backward using the operation assisting tool 230. As a result, the pressure in the cylindrical body 36 is reduced, so that the chemical liquid in the chemical liquid container 222 is introduced into the cylindrical body 36 through the introduction needle 202. Then, when the appropriate amount of the chemical solution is filled into the cylindrical body 36, the backward movement of the plunger 38 is stopped. Even in this case, since the nut portion 42 is in the initial position where it does not come into contact with the plunger 38, an appropriate amount of the chemical solution can be easily and quickly filled into the cylindrical body 36. In such a filling method, the user can directly pick the pusher 54 and move the plunger 38 without using the operation assisting tool 230.
 本実施形態に係る薬液投与装置10は、上述した構成に限定されない。薬液投与装置10は、図7A~図7Cに示す第1~第3変形例に係るディスポ部28A~28Cを備えていてもよい。 The chemical solution administration device 10 according to the present embodiment is not limited to the configuration described above. The drug solution administration device 10 may include disposable parts 28A to 28C according to the first to third modifications shown in FIGS. 7A to 7C.
 図7Aに示すように、第1変形例に係るディスポ部28Aは、脚部96のうち爪部98から先端側(X1方向)に所定距離だけ離れた位置から送りねじ軸40が位置する側とは反対側に突出してナット部42が接触する凸部120を有している。この場合、薬液投与時にナット部42に作用する圧力を低減することができるので、プランジャ38の押圧時にナット部42が変形することを抑えることができる。 As shown in FIG. 7A, the disposable part 28A according to the first modified example includes a side where the feed screw shaft 40 is located from a position of the leg part 96 that is a predetermined distance away from the claw part 98 toward the tip side (X1 direction). Has a convex portion 120 that protrudes to the opposite side and contacts the nut portion 42. In this case, it is possible to reduce the pressure acting on the nut portion 42 during the administration of the chemical solution, so that the nut portion 42 can be prevented from being deformed when the plunger 38 is pressed.
 図7Bに示すように、第2変形例に係るディスポ部28Bは、貫通孔108が形成されていないナット部122と、ナット部122を外側から乗り越えてナット部122のうちX2方向に指向する受け面123に接触する爪部124を有する移動規制部126と、を備えている。また、受け面123と爪部124が接触するそれぞれの面上には、互いを係合する図示しない突起部と受け部を備えている。この場合、ナット部122に貫通孔108を形成しなくてもよいため、ナット部122の剛性を向上させることができる。 As shown in FIG. 7B, the disposable part 28B according to the second modified example includes a nut part 122 in which the through hole 108 is not formed, and a receiver that goes over the nut part 122 from the outside and is oriented in the X2 direction of the nut part 122. And a movement restricting portion 126 having a claw portion 124 that contacts the surface 123. Further, on each surface where the receiving surface 123 and the claw portion 124 come into contact, there are provided a protruding portion and a receiving portion (not shown) that engage with each other. In this case, since it is not necessary to form the through-hole 108 in the nut part 122, the rigidity of the nut part 122 can be improved.
 図7Cに示すように、第3変形例に係るディスポ部28Cは、貫通孔108が形成されていないナット部128を備えている。ナット部128は、ナット部本体130から先端側(X1方向)に延出した脚部132と、脚部132の先端部に設けられた爪部134とを有する。また、プランジャ38の後端部には、爪部134に係合する移動規制部136が設けられている。このような構成であっても、ナット部128の使用位置でプランジャ38のナット部128に対する先端側の移動を規制することができる。 As shown in FIG. 7C, the disposable part 28C according to the third modification includes a nut part 128 in which the through hole 108 is not formed. The nut portion 128 includes a leg portion 132 that extends from the nut portion main body 130 toward the distal end side (X1 direction), and a claw portion 134 that is provided at the distal end portion of the leg portion 132. A movement restricting portion 136 that engages with the claw portion 134 is provided at the rear end portion of the plunger 38. Even with such a configuration, movement of the distal end side of the plunger 38 with respect to the nut portion 128 can be restricted at the use position of the nut portion 128.

Claims (6)

  1.  筒体(36)内に充填した薬液をプランジャ(38)の押圧作用下に生体内に持続的又は間欠的に投与する携帯型の薬液投与装置(10)であって、
     前記プランジャ(38)の軸線方向に沿って延在した送りねじ軸(40)と、
     前記送りねじ軸(40)を回転駆動させる駆動部(76)と、
     前記送りねじ軸(40)に螺合した状態で当該送りねじ軸(40)の回転作用下に前記プランジャ(38)に接触しない初期位置から前記プランジャ(38)に接触して当該プランジャ(38)を押圧可能な使用位置に移動するナット部(42、122、128)と、
     前記プランジャ(38)に設けられ、前記使用位置で前記ナット部(42、122、128)に係合し、前記ナット部(42、122、128)に係合した状態で前記ナット部(42、122、128)に対する前記プランジャ(38)の先端側への移動を規制する移動規制部(72、126、136)と、を備えていることを特徴とする薬液投与装置(10)。
    A portable drug solution administration device (10) for continuously or intermittently administering a drug solution filled in a cylindrical body (36) into a living body under the pressing action of a plunger (38),
    A lead screw shaft (40) extending along the axial direction of the plunger (38);
    A drive unit (76) for rotationally driving the feed screw shaft (40);
    The plunger (38) comes into contact with the plunger (38) from the initial position where it does not contact the plunger (38) under the rotational action of the feed screw shaft (40) in a state of being screwed to the feed screw shaft (40). A nut portion (42, 122, 128) that moves to a useable position,
    It is provided in the plunger (38), engages with the nut part (42, 122, 128) in the use position, and engages with the nut part (42, 122, 128) in the state of being engaged with the nut part (42, 122, 128). 122, 128) and a movement restricting portion (72, 126, 136) for restricting movement of the plunger (38) toward the distal end side with respect to 122, 128).
  2.  請求項1記載の薬液投与装置(10)において、
     前記移動規制部(72、126)は、前記プランジャ(38)に設けられて当該プランジャ(38)の軸線方向に沿って延在した可撓性を有する脚部(96)と、
     前記脚部(96)に設けられて前記ナット部(42、122)のうち前記プランジャ(38)に対する進行方向とは反対方向を指向する受け面(116、123)に接触可能な爪部(98、124)と、を有していることを特徴とする薬液投与装置(10)。
    The medicinal-solution administration device (10) according to claim 1,
    The movement restricting portions (72, 126) are provided on the plunger (38) and have flexible leg portions (96) extending along the axial direction of the plunger (38),
    A claw portion (98) provided on the leg portion (96) and capable of contacting a receiving surface (116, 123) of the nut portion (42, 122) oriented in a direction opposite to the traveling direction with respect to the plunger (38). , 124), and a chemical liquid administration device (10).
  3.  請求項2記載の薬液投与装置(10)において、
     前記ナット部(42)には、前記爪部(98)が挿通する貫通孔(108)が形成され、
     前記爪部(98)には、前記貫通孔(108)を構成する壁面に接触するテーパ状の爪側接触面(100)が形成されていることを特徴とする薬液投与装置(10)。
    The medicinal-solution administration device (10) according to claim 2,
    The nut part (42) is formed with a through hole (108) through which the claw part (98) is inserted,
    The drug solution administration device (10), wherein the claw portion (98) is formed with a tapered claw side contact surface (100) that contacts a wall surface constituting the through hole (108).
  4.  請求項3記載の薬液投与装置(10)において、
     前記貫通孔(108)を構成する壁面には、前記爪側接触面(100)に接触するテーパ状の孔側接触面(110)が形成されていることを特徴とする薬液投与装置(10)。
    The medicinal-solution administration device (10) according to claim 3,
    A drug solution administration device (10), wherein a taper-shaped hole side contact surface (110) contacting the nail side contact surface (100) is formed on a wall surface constituting the through hole (108). .
  5.  請求項3又は4に記載の薬液投与装置(10)において、
     前記貫通孔(108)は、前記プランジャ(38)の先端側に向かって拡大していることを特徴とする薬液投与装置(10)。
    In the medicinal-solution administration device (10) according to claim 3 or 4,
    The medicinal-solution administration device (10), wherein the through hole (108) is enlarged toward the distal end side of the plunger (38).
  6.  請求項2~5のいずれか1項に記載の薬液投与装置(10)において、
     前記送りねじ軸(40)は、前記プランジャ(38)と同軸に配設され、
     前記爪部(98、124)は、前記送りねじ軸(40)を挟んで互いに対向するように一対設けられていることを特徴とする薬液投与装置(10)。
    The drug solution administration device (10) according to any one of claims 2 to 5,
    The feed screw shaft (40) is disposed coaxially with the plunger (38),
    A pair of the claw portions (98, 124) are provided so as to face each other across the feed screw shaft (40).
PCT/JP2016/053586 2015-02-20 2016-02-05 Liquid drug administration device WO2016132936A1 (en)

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