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WO2024004329A1 - Dispositif d'administration de solution medicamenteuse - Google Patents

Dispositif d'administration de solution medicamenteuse Download PDF

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Publication number
WO2024004329A1
WO2024004329A1 PCT/JP2023/014960 JP2023014960W WO2024004329A1 WO 2024004329 A1 WO2024004329 A1 WO 2024004329A1 JP 2023014960 W JP2023014960 W JP 2023014960W WO 2024004329 A1 WO2024004329 A1 WO 2024004329A1
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WO
WIPO (PCT)
Prior art keywords
administration device
pusher
regulation
screw shaft
feed screw
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2023/014960
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English (en)
Japanese (ja)
Inventor
近藤晃
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
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 Terumo Corp filed Critical Terumo Corp
Publication of WO2024004329A1 publication Critical patent/WO2024004329A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons

Definitions

  • the present invention relates to a liquid drug administration device.
  • Japanese Patent No. 5,653,217 discloses a drug solution administration device that includes a vial (medicinal solution container), a stopper (gasket), a pusher, a feed screw shaft, a drive mechanism, and a battery.
  • the gasket is slidably disposed inside the chemical liquid container.
  • the pusher is connected to the base end of the gasket.
  • the feed screw shaft is threaded into a threaded portion provided on the pusher to move the pusher toward the distal end.
  • the drive mechanism includes a motor and rotates the feed screw shaft.
  • a battery provides power to the drive mechanism.
  • the rotation of the pusher is regulated by the frictional force generated between the inner circumferential surface of the liquid medicine container and the outer circumference of the gasket, and as a result, when the feed screw shaft is rotated, the pusher is rotated. This prevents it from rotating together with the feed screw shaft.
  • the present invention aims to solve the above-mentioned problems.
  • One aspect of the present invention provides a cylindrical liquid drug container that accommodates a drug liquid and has a liquid medicine discharge port at its tip, a gasket that is slidably and fluid-tightly disposed inside the liquid drug container, and a gasket that is arranged in a liquid-tight manner in a slidable manner.
  • a pressing force that includes a pusher that presses in the distal direction, and a feed screw shaft that has a second threaded portion that is screwed into a first threaded portion provided on the pusher and moves the pusher in the distal direction.
  • a drug solution administration device comprising: a mechanism; a drive mechanism that is driven by power supply from a battery to rotate the feed screw shaft; and a housing that accommodates the drug solution container, the pressing mechanism, and the drive mechanism,
  • the pusher further includes a rotation regulating part that regulates rotation of the pusher along the rotational direction of the feed screw shaft, and in an initial state of the liquid drug administration device, the pusher is spaced apart from the gasket, and the rotation regulating section
  • the part includes a regulating body fixed to the pusher and at least a portion extending along the axial direction of the feed screw shaft, and a regulating support part provided in the housing and supporting the regulating body.
  • the regulation support part is configured to move the regulation body in the distal direction as the pusher moves in the distal direction while preventing movement of the regulation body along the rotational direction of the feed screw shaft.
  • the pusher since the rotation of the pusher along the rotational direction of the feed screw shaft is regulated by the rotation regulating portion (the regulating body and the regulating support portion), the pusher can be efficiently moved in the distal direction by the rotation of the feed screw shaft. It can be moved.
  • the frictional force since it is not necessary to restrict the rotation of the pusher by the frictional force generated between the chemical liquid container and the gasket, the frictional force can be reduced.
  • the driving force required to move the gasket toward the distal end within the chemical liquid container can be reduced, so that the power consumption of the drive mechanism and battery can be saved. Therefore, since the size of the drive mechanism and battery can be reduced, the liquid medicine administration device can be made smaller.
  • FIG. 1 is a schematic plan view of a liquid medicine administration device according to an embodiment of the present invention.
  • FIG. 2 is a perspective view of the device main body and chassis structure of the drug solution administration device of FIG. 1.
  • FIG. 3 is a sectional view of the device main body and chassis structure of the drug solution administration device of FIG. 2.
  • FIG. 4 is a partially enlarged sectional view of FIG. 3.
  • FIG. 5 is a perspective view showing a part of the pressing plunger and the rotation regulating part.
  • FIG. 6 is a cross-sectional view taken along line VI-VI in FIG.
  • FIG. 7 is a block diagram of the control section.
  • FIG. 8 is a first explanatory diagram of the operation of the liquid drug administration device.
  • FIG. 9 is a second operation explanatory diagram of the liquid drug administration device.
  • FIG. 10 is an explanatory diagram of a rotation regulating section according to a modification.
  • a drug solution administration device 10 is used to administer a drug solution M into a living body.
  • the drug solution administration device 10 continuously administers the drug solution M filled in the drug solution container 16 into a living body over a relatively long period of time (eg, several minutes to several hours).
  • the drug solution administration device 10 may intermittently administer the drug solution M into a living body.
  • the drug solution M include protein preparations, narcotic analgesics, diuretics, and the like.
  • a patch-type needle-equipped tube 402 is connected to the drug solution administration device 10 as the administration device 400.
  • the needle-equipped tube 402 injects the medical solution M discharged from the medical solution container 16 into the patient's body.
  • the needle tube 402 includes a connector 404, a liquid feeding tube 406, a patch portion 408, and a puncture needle 410.
  • the connector 404 can be connected to the tip 40 (see FIG. 3) of the chemical liquid container 16.
  • the liquid feeding tube 406 has flexibility. One end of the liquid feeding tube 406 is connected to the connector 404. The other end of the liquid feeding tube 406 is connected to a patch section 408.
  • the patch part 408 can be attached to the skin S. Puncture needle 410 protrudes from patch portion 408 .
  • the puncture needle 410 punctures the skin S substantially perpendicularly. Note that the puncture needle 410 may puncture the skin S diagonally.
  • the administration device 400 connected to the drug solution administration device 10 is not limited to the above-described patch-type needle-equipped tube 402, but may have a structure in which a puncture needle (such as a winged needle) is connected to the tip of the liquid feeding tube 406, for example. There may be.
  • the liquid drug administration device 10 includes a device main body 12 and a housing 14 that accommodates the device main body 12.
  • the device main body 12 includes a chemical solution container 16, a gasket 18, a pressing mechanism 20, a drive mechanism 22, a battery 24, a rotation regulating section 26, a movement detecting section 28, and a control section 30.
  • the chemical liquid container 16 is formed into a hollow cylindrical shape with a chemical liquid chamber 32 inside.
  • the drug solution container 16 has a body portion 34, a flange portion 36, a shoulder portion 38, and a tip portion 40.
  • the body portion 34 extends in the axial direction (direction of arrow X) of the chemical liquid container 16.
  • the inner diameter and outer diameter of the body 34 are constant (substantially constant) over the entire length of the body 34 .
  • a proximal opening 42 is formed at the proximal end of the body portion 34 .
  • the flange portion 36 projects radially outward from the base end (end in the arrow X2 direction) of the body portion 34 and extends in an annular shape.
  • the diameter of the shoulder portion 38 decreases from the tip of the body portion 34 (the end in the direction of arrow X1).
  • the distal end portion 40 projects in the distal direction from the radially inner end of the shoulder portion 38 .
  • a chemical liquid discharge port 44 communicating with the chemical liquid chamber 32 is formed in the distal end portion 40 .
  • the chemical solution M is filled inside the chemical solution container 16 in advance.
  • the drug solution container 16 is preferably made of a transparent material.
  • the chemical liquid discharge port 44 is liquid-tightly sealed by a sealing member 46 made of an elastic resin material such as a rubber material or an elastomer material.
  • the sealing member 46 is punctured by a needle 412 provided on the connector 404 when the connector 404 shown in FIG. 1 is connected to the distal end portion 40.
  • the sealing member 46 is fixed to the tip 40 of the drug solution container 16 by a fixing cap 50 having an opening 48 at the tip. The distal end surface of the sealing member 46 is exposed through the opening 48 of the fixed cap 50.
  • the gasket 18 is slidably arranged inside the chemical liquid container 16.
  • the gasket 18 includes a gasket body 52 and an abutment member 54.
  • the gasket body 52 is made of an elastic first material.
  • the first material is an elastic resin material such as a rubber material or an elastomer material.
  • the outer circumferential surface of the gasket body 52 is in liquid-tight contact with the inner circumferential surface of the body 34 of the chemical liquid container 16 .
  • the gasket body 52 has a connection recess 56 that opens at the proximal end surface of the gasket body 52 .
  • a female thread 58 is formed on the inner peripheral surface of the connection recess 56 .
  • the distal end of the gasket body 52 is tapered in diameter toward the distal end.
  • the contact member 54 is made of a second material that is harder than the first material.
  • the second material is a hard resin material or a metal material.
  • the abutting member 54 has a connecting portion 60 and an abutting body 62.
  • a male thread 64 is formed on the outer peripheral surface of the connecting portion 60 and is threaded into the female thread 58 of the gasket body 52 .
  • the contact main body 62 projects radially outward from the base end of the connecting portion 60 .
  • the contact main body 62 extends in an annular shape along the circumferential direction of the connecting portion 60 .
  • the contact main body 62 has a flat pressed surface 66 facing toward the proximal end of the liquid medicine container 16 .
  • the pressing mechanism 20 presses the gasket 18 in the direction of the tip (arrow X1 direction).
  • the gasket 18 moves (advances) in the distal direction, the chemical liquid M in the chemical liquid chamber 32 is pushed out from the chemical liquid discharge port 44.
  • the pressing mechanism 20 has a pusher 68 and a feed screw shaft 70.
  • the tip of the pusher 68 is inserted into the drug solution container 16.
  • the pusher 68 includes a cylindrical pressing plunger 72 and an intermediate plunger 74 disposed inside the pressing plunger 72. That is, the pusher 68 has a telescopic structure that is extendable in the axial direction.
  • the pressing plunger 72 is made of, for example, injection molded resin material.
  • the pressing plunger 72 extends along the axial direction of the chemical liquid container 16.
  • the pressing plunger 72 has a plunger main body 76, a distal flange portion 78, a proximal flange portion 80, and a locking portion 82.
  • the plunger body 76 is formed into a cylindrical shape.
  • a female thread 84 is formed at the base end of the inner peripheral surface of the plunger body 76 (see FIG. 4).
  • the tip flange portion 78 projects radially outward from the tip portion of the plunger body 76.
  • the tip flange portion 78 extends in the circumferential direction of the plunger body 76.
  • the outer diameter (diameter) of the tip flange portion 78 is smaller than the inner diameter of the body portion 34 of the chemical liquid container 16 .
  • the tip flange portion 78 supports the tip portion of the pressing plunger 72 in a predetermined posture inside the chemical liquid container 16. In other words, the tip flange portion 78 prevents the axis of the pressing plunger 72 from being excessively inclined with respect to the axis of the liquid medicine container 16 inside the liquid medicine container 16 .
  • a tip notch portion 86 is formed in the tip flange portion 78 . That is, the tip flange portion 78 is formed in a C-shape.
  • the base end flange portion 80 projects radially outward from the base end portion of the plunger body 76.
  • the base end flange portion 80 extends in the circumferential direction of the plunger body 76.
  • the outer diameter (diameter) of the proximal flange portion 80 is smaller than the inner diameter of the body portion 34 of the drug solution container 16.
  • the base end flange portion 80 supports the base end portion of the pressing plunger 72 in a predetermined posture inside the chemical liquid container 16. In other words, the proximal flange portion 80 prevents the axis of the pressing plunger 72 from being excessively inclined with respect to the axis of the liquid medicine container 16 inside the liquid medicine container 16 .
  • a proximal notch portion 88 is formed in the proximal flange portion 80 . That is, the base end flange portion 80 is formed in a C-shape.
  • the size and shape of the proximal flange portion 80 are the same as the size and shape of the distal flange portion 78. Note that the size and shape of the base end flange portion 80 may be different from the size and shape of the distal end flange portion 78.
  • the distal end surface of the pressing plunger 72 includes a pressing surface 90 for pressing the pressed surface 66 (see FIG. 4) of the gasket 18 in the distal direction (arrow X1 direction).
  • the pressing surface 90 is a flat surface extending in a direction perpendicular to the axial direction of the pressing plunger 72. In the initial state of the liquid drug administration device 10, the pressing surface 90 is spaced apart from the gasket 18 (see FIG. 4).
  • the locking portion 82 is provided on the outer peripheral surface of the plunger body 76.
  • the locking portion 82 has a first protrusion 92 that protrudes radially outward from the outer peripheral surface of the plunger body 76, and a second protrusion 94 that protrudes distally from the protruding end of the first protrusion 92.
  • One end portion of a restriction body 118 of the rotation restriction portion 26, which will be described later, is connected to the locking portion 82.
  • the locking portion 82 is positioned so as to overlap the distal end notch 86 and the proximal notch 88 when viewed from the axial direction of the pressing plunger 72. That is, the locking portion 82 is located so as not to overlap the distal end flange portion 78 and the proximal end flange portion 80 when viewed from the axial direction of the pressing plunger 72 . As a result, an undercut portion is not formed in the pressing plunger 72, so that the pressing plunger 72 having the locking portion 82 can be easily injection molded.
  • the intermediate plunger 74 is formed in a cylindrical shape. In the initial state of the liquid drug administration device 10, the distal end of the intermediate plunger 74 does not protrude further in the distal direction than the distal end (pressing surface 90) of the pressing plunger 72. The intermediate plunger 74 is spaced apart from the chemical liquid container 16.
  • a male thread 96 is formed on the outer peripheral surface of the intermediate plunger 74 and is threaded into the female thread 84 of the pressing plunger 72.
  • a male thread 96 is not formed at the tip of the outer peripheral surface of the intermediate plunger 74 .
  • the tip of the male screw 96 is located in the proximal direction (in the direction of arrow X2) than the tip of the intermediate plunger 74. Therefore, the pressing plunger 72 does not slip out from the intermediate plunger 74 in the distal direction.
  • the base end of the male screw 96 is located at the base end of the intermediate plunger 74.
  • a female thread 98 is formed at the proximal end of the inner peripheral surface of the intermediate plunger 74 .
  • the feed screw shaft 70 has a rod portion 100 and a connecting portion 102.
  • the rod portion 100 is formed into a cylindrical shape.
  • the tip of the rod portion 100 does not protrude further in the distal direction than the tip (pressing surface 90) of the pressing plunger 72.
  • a male thread 104 is formed on the outer peripheral surface of the rod portion 100 and is threaded into the female thread 98 of the intermediate plunger 74 .
  • a male thread 104 is not formed at the tip of the outer peripheral surface of the rod portion 100.
  • the tip of the male screw 104 is located in the proximal direction (direction of arrow X2) with respect to the tip of the feed screw shaft 70. Therefore, the intermediate plunger 74 does not come off from the rod portion 100 in the distal direction.
  • the base end of the male thread 104 is located at the base end of the rod portion 100.
  • the connecting portion 102 is connected to the base end of the rod portion 100.
  • a driven gear 112 of the drive mechanism 22, which will be described later, is connected to the connecting portion 102.
  • Such a pressing mechanism 20 includes a female thread 98 (first threaded part) of the intermediate plunger 74, a male thread 104 (second threaded part) of the feed screw shaft 70, and a male thread 96 (third threaded part) of the intermediate plunger 74. , and a female thread 84 (fourth threaded portion) of the pressing plunger 72.
  • the frictional resistance between the female thread 84 of the pressing plunger 72 and the male thread 96 of the intermediate plunger 74 is greater than the frictional resistance between the male thread 104 of the feed screw shaft 70 and the female thread 98 of the intermediate plunger 74.
  • the drive mechanism 22 includes a motor 106, a drive gear 108, an intermediate gear 110, and a driven gear 112.
  • Motor 106 rotates drive gear 108 .
  • the motor 106 is arranged on the side of the pressing mechanism 20 (in the direction of arrow Y1).
  • Drive gear 108 is fixed to output shaft 114 of motor 106.
  • the intermediate gear 110 is arranged in the arrow Y2 direction of the drive gear 108 so as to mesh with the drive gear 108.
  • the driven gear 112 is arranged in the direction of arrow Y2 of the intermediate gear 110 so as to mesh with the intermediate gear 110.
  • the driving gear 108, the intermediate gear 110, and the driven gear 112 are arranged in a direction perpendicular to the axial direction of the feed screw shaft 70 (arrow Y direction).
  • a fitting hole 116 into which the connecting portion 102 fits is formed in the center of the driven gear 112.
  • the connecting portion 102 and the fitting hole 116 have a shape (non-circular shape) such that the driven gear 112 and the feed screw shaft 70 rotate together.
  • the battery 24 is a power source that supplies power to the motor 106 and the control unit 30.
  • the battery 24 may be either a primary battery or a secondary battery.
  • the battery 24 is arranged on the side of the chemical liquid container 16 (in the direction of arrow Y1). Further, the battery 24 is located in the direction of the arrow X1 of the motor 106.
  • the rotation regulating portion 26 regulates the rotation of the pusher 68 along the rotational direction of the feed screw shaft 70.
  • the rotation restriction section 26 includes a restriction main body 118 and a restriction support section 120.
  • the regulating body 118 is formed into a plate shape (thin plate shape) or a film shape.
  • the regulating body 118 extends along the axial direction of the feed screw shaft 70.
  • the restriction body 118 has a constant width (substantially constant width) or a substantially constant width over its entire length. The width of the regulating body 118 is narrower than the width of the proximal end notch 88 .
  • the regulating body 118 is made of a flexible material.
  • the regulating body 118 is formed so that it can be bent in the thickness direction. Note that the regulating body 118 is difficult to bend in the width direction.
  • the constituent material of the regulation body 118 is not particularly limited, but polyethylene terephthalate is preferable.
  • the regulating body 118 can be curved and deformed in the thickness direction.
  • the regulating body 118 is arranged so that the width direction of the regulating body 118 is along the arrow Z direction that is orthogonal to the arrow X direction and the arrow Y direction (see FIGS. 2, 5, and 6).
  • one end of the regulating body 118 is fixed to the locking portion 82 of the pressing plunger 72.
  • a locking hole 122 is formed at one end of the regulating body 118 .
  • the locking hole 122 is, for example, a rectangular through hole.
  • the first protrusion 92 of the locking portion 82 is inserted into the locking hole 122 .
  • a plurality of slits 124 are formed in the regulating body 118. The plurality of slits 124 are arranged at equal intervals in the extending direction of the regulating body 118.
  • the regulation support section 120 prevents the regulation body 118 from moving in the circumferential direction of the liquid medicine container 16, and regulates the movement of the pusher 68 in the distal direction.
  • the regulating body 118 is supported so that the body 118 can move in the distal direction.
  • the regulation support section 120 includes a support base 126, a pressing section 128, and a fastening member 130.
  • the support base 126 is formed into a block shape.
  • the support base 126 supports an intermediate portion between one end and the other end of the regulating body 118 in a U-shaped curve.
  • the support base 126 has a support stand 132, a curved support part 134, a first lateral support part 136, and a second lateral support part 138.
  • the support stand 132 is arranged on the bottom surface of a chassis structure 170 of the housing 14, which will be described later.
  • An upper surface 140 of the support base 132 facing in the opposite direction (direction of arrow Z1) to the bottom surface of the chassis structure 170 supports the regulating body 118 .
  • the curved support portion 134 projects upward from the upper surface 140 of the support base 132.
  • the curved support portion 134 includes a first support surface 142 , a second support surface 144 , and a third support surface 146 .
  • the first support surface 142 is a flat surface facing in the direction of arrow Y1 where the pressing mechanism 20 is located.
  • the second support surface 144 is a flat surface facing in a direction opposite to the direction of the first support surface 142 (arrow Y2 direction).
  • the third support surface 146 connects the first support surface 142 and the second support surface 144 to each other.
  • the third support surface 146 is formed in a convex shape toward the arrow X2 direction.
  • the third support surface 146 has an arcuate (semicircular) cross-sectional shape perpendicular to the Z direction.
  • the first lateral support portion 136 protrudes upward from the upper surface 140 of the support base 132.
  • the first lateral support part 136 is located between the curved support part 134 and the pressing mechanism 20.
  • the first lateral support portion 136 has a first side surface 148 facing the first support surface 142 .
  • the first side surface 148 is a flat surface facing in the direction of arrow Y2.
  • a first gap 150 is formed between the first support surface 142 and the first side surface 148, through which the regulating body 118 is inserted.
  • the first gap 150 is located in the direction of the arrow X2 of the proximal opening 42 of the drug solution container 16.
  • the second lateral support portion 138 is a wall portion forming the chassis structure 170.
  • the second side support portion 138 extends in the arrow X direction.
  • the second lateral support portion 138 is arranged in the direction of arrow Y2 of the curved support portion 134.
  • the second lateral support portion 138 has a second side surface 152 facing the second support surface 144 .
  • the second side surface 152 is a flat surface facing in the direction of arrow Y1.
  • a second gap 154 is formed between the second support surface 144 and the second side surface 152, through which the regulating body 118 is inserted.
  • the holding portion 128 is fastened to the curved support portion 134 by the fastening member 130 so as to cover the regulating body 118 from the direction of arrow Z1.
  • the holding portion 128 covers the first gap 150 and the second gap 154 from the arrow Z1 direction.
  • the feed screw shaft 70 rotates counterclockwise (in the direction of arrow R) when viewed from the proximal direction of the feed screw shaft 70 (direction of arrow X2). Therefore, a torque in the direction of arrow R acts on the pressing plunger 72. At this time, since the regulating body 118 is in contact with the upper surface 140 of the support base 132, rotation of the pressing plunger 72 along the rotational direction of the feed screw shaft 70 is prevented.
  • the movement detection unit 28 detects movement of the pusher 68.
  • the movement detection unit 28 includes a movement detection sensor 160 that detects movement of the regulating body 118 fixed to the pusher 68 (pressing plunger 72).
  • the movement detection sensor 160 is a non-contact photosensor. That is, movement detection sensor 160 includes a light emitting section and a light receiving section.
  • the movement detection sensor 160 detects the wall between the mutually adjacent slits 124 of the regulation body 118.
  • the movement detection sensor 160 is arranged, for example, between the chemical liquid container 16 and the regulation support part 120.
  • the movement detection sensor 160 is located on the side of the pressing mechanism 20 (in the direction of arrow Y2).
  • control section 30 includes a calculation section 162 and a storage section 164.
  • the calculation unit 162 is configured by a processor (processing circuit) such as a CPU (Central Processing Unit) or a GPU (Graphics Processing Unit).
  • processor processing circuit
  • CPU Central Processing Unit
  • GPU Graphics Processing Unit
  • the calculation section 162 includes a movement amount calculation section 166 and a motor control section 168.
  • the calculation unit 162 realizes the movement amount calculation unit 166 and the motor control unit 168 by executing a program stored in the storage unit 164.
  • the calculation unit 162 at least a portion of the movement amount calculation unit 166 and the motor control unit 168 may be realized by an integrated circuit. Examples of the integrated circuit include ASIC (Application Specific Integrated Circuit) and FPGA (Field-Programmable Gate Array).
  • the storage unit 164 includes volatile memory and nonvolatile memory.
  • volatile memory include RAM (Random Access Memory). This volatile memory is used as a working memory of the processor, and temporarily stores data necessary for processing or calculations.
  • nonvolatile memory include ROM (Read Only Memory) and flash memory. This non-volatile memory is used as storage memory. Programs, tables, maps, etc. are stored in the nonvolatile memory. At least a portion of storage unit 164 may be incorporated into a processor or integrated circuit as described above.
  • the movement amount calculation unit 166 calculates the movement amount of the pusher 68 (pressing plunger 72) based on the output signal of the movement detection sensor 160.
  • the motor control unit 168 controls the operation of the motor 106 based on the movement amount of the pusher 68 calculated by the movement amount calculation unit 166.
  • the housing 14 includes a chassis structure 170 and a housing body 172.
  • the chemical solution container 16, the pressing mechanism 20, the drive mechanism 22, and the rotation regulating section 26 are fixed to the chassis structure 170.
  • Chassis structure 170 includes a chassis body member 174, a stopper member 176, and a bearing member 178.
  • the chassis body member 174 has a base plate portion 180, an outer wall portion 182, a container support portion 184, and a motor support portion 186.
  • Base plate portion 180 forms the bottom of chassis body member 174 .
  • the outer wall portion 182 projects upward (in the direction of arrow Z1) from the outer edge of the base plate portion 180.
  • a portion of the outer wall portion 182 functions as the second lateral support portion 138 described above.
  • the container support portion 184 projects upward from the base plate portion 180 and supports the body portion 34 of the liquid medicine container 16 from below (in the direction of arrow Z2).
  • the motor support portion 186 projects upward from the base plate portion 180 and supports the motor 106 (see FIG. 6).
  • the stopper member 176 is attached to the base plate portion 180 while covering the body portion 34 of the chemical liquid container 16 from above (in the direction of arrow Z1).
  • the stopper member 176 prevents movement of the chemical liquid container 16 in the direction of arrow X1 with respect to the chassis body member 174 when the flange portion 36 of the chemical liquid container 16 comes into contact with the stopper member 176 .
  • the bearing member 178 rotatably supports the feed screw shaft 70 while being attached to the base plate portion 180 (see FIG. 3).
  • housing body 172 houses chassis structure 170. Further, the housing body 172 accommodates the device body 12 (chemical solution container 16, gasket 18, pressing mechanism 20, drive mechanism 22, battery 24, rotation regulating section 26, movement detecting section 28, and control section 30).
  • the housing main body 172 is provided with a window 190 for visually confirming the amount of the liquid medicine M remaining in the liquid medicine container 16. Note that the tip portion 40 of the chemical liquid container 16 protrudes from the housing body 172 in the direction of arrow X1. Therefore, the fixed cap 50 is exposed to the outside of the housing body 172.
  • the operation of the liquid drug administration device 10 during use will be described.
  • the pressing surface 90 of the pressing plunger 72 is located further away from the pressed surface 66 of the gasket 18 in the proximal direction (arrow X2 direction).
  • the medical solution M filled in the medical solution container 16 can be maintained in a sterile state.
  • the motor control unit 168 drives the motor 106.
  • the motor 106 is driven, the rotational driving force of the motor 106 is transmitted to the driven gear 112 via the driving gear 108 and the intermediate gear 110.
  • the feed screw shaft 70 rotates, so that torque acts on the pusher 68.
  • the rotation of the pressing plunger 72 along the rotational direction of the feed screw shaft 70 is regulated by the rotation regulating portion 26, the female thread 98 of the intermediate plunger 74 is disposed in the distal direction with respect to the male thread 104 of the feed screw shaft 70.
  • the pusher 68 pressing plunger 72 and intermediate plunger 74 moves linearly in the distal direction with respect to the feed screw shaft 70.
  • the pressing surface 90 of the pusher 68 comes into contact with the pressed surface 66 of the gasket 18, and the gasket 18 is pressed in the distal direction by the pusher 68.
  • the gasket 18 moves in the distal direction within the drug solution container 16, and the drug solution M in the drug solution container 16 is administered into the living body from the drug solution outlet 44 via the administration instrument 400.
  • a movement amount calculation unit 166 calculates the movement amount of the pusher 68 based on the output signal of the movement detection sensor 160 .
  • the motor control unit 168 then controls the motor 106 based on the amount of movement of the pusher 68 calculated by the movement amount calculation unit 166.
  • the motor control unit 168 stops driving the motor 106 when the movement amount of the pusher 68 calculated by the movement amount calculation unit 166 reaches the target value.
  • This embodiment has the following effects.
  • the rotation of the pusher 68 along the rotational direction of the feed screw shaft 70 is regulated by the rotation regulating portion 26 (the regulating body 118 and the regulating support portion 120), so that the pusher 68 is pushed by the rotation of the feed screw shaft 70.
  • the child 68 can be efficiently moved in the distal direction.
  • the frictional force can be reduced.
  • the driving force required to move the gasket 18 toward the distal end within the chemical liquid container 16 can be reduced, so that the power consumption of the drive mechanism 22 and battery 24 can be saved. Therefore, the size of the drive mechanism 22 and the battery 24 can be reduced, so the liquid drug administration device 10 can be made smaller.
  • the restriction support section 120 supports an intermediate portion between one end and the other end of the restriction main body 118.
  • the regulation body 118 can be supported by the regulation support part 120 in a well-balanced manner. Note that in other embodiments, one end portion of the regulating body 118 may be connected to the pusher 68 while being located outside the drug solution container 16.
  • the regulation body 118 is formed into a plate shape or a film shape.
  • the regulating body 118 can be placed in the gap between the chemical liquid container 16 and the pusher 68.
  • the regulation support part 120 supports the middle part of the regulation body 118 in a U-shaped curved state.
  • the regulation body 118 can be arranged compactly.
  • the regulating body 118 is inserted into the liquid medicine container 16 by moving the pusher 68 in the distal direction.
  • the pusher 68 includes an intermediate plunger 74 and a pressing plunger 72.
  • the intermediate plunger 74 has a female thread 98 (first threaded portion) and a male thread 96 (third threaded portion).
  • the pressing plunger 72 has a female thread 84 (fourth threaded portion) that is screwed into the male thread 96 and presses the gasket 18 .
  • the tip of the male thread 104 (second threaded portion) of the feed screw shaft 70 is located further toward the proximal end than the tip of the feed screw shaft 70 .
  • the regulating body 118 is fixed to the pressing plunger 72.
  • the intermediate plunger 74 moves in the distal direction with respect to the feed screw shaft 70 due to the rotation of the feed screw shaft 70, and when the female thread 98 of the intermediate plunger 74 is located at the tip of the male thread 104 of the feed screw shaft 70, the intermediate plunger 74 moves toward the tip of the feed screw shaft 70. Rotates with 70.
  • the pressing plunger 72 moves in the distal direction with respect to the intermediate plunger 74 due to the rotation of the intermediate plunger 74.
  • the pusher 68 since the pusher 68 is configured to be extendable, the length of the drug solution administration device 10 along the axial direction of the drug solution container 16 can be shortened. Thereby, the liquid medicine administration device 10 can be further downsized.
  • the intermediate plunger 74 is spaced apart from the chemical liquid container 16.
  • the liquid drug administration device 10 includes a movement detection section 28 for detecting movement of the pusher 68.
  • the movement of the pusher 68 can be detected by the movement detection section 28.
  • the liquid drug administration device 10 includes a movement amount calculation unit 166 that calculates the movement amount of the pusher 68 based on the signal detected by the movement detection unit 28.
  • the movement amount of the pusher 68 can be grasped by the movement amount calculation unit 166.
  • the movement detection section 28 includes a movement detection sensor 160 that detects movement of the restriction body 118.
  • the movement of the pusher 68 can be detected with high accuracy by detecting the movement of the regulating body 118 using the movement detection sensor 160. That is, for example, when the movement detection section 28 detects the movement of the drive mechanism 22, if some teeth of the gear are missing, the movement of the pusher 68 cannot be accurately detected.
  • the movement detection sensor 160 detects the movement of the regulating body 118, the movement of the pusher 68 can be detected with high accuracy even if some teeth of the gear of the drive mechanism 22 are missing.
  • the movement detection sensor 160 is a non-contact photosensor.
  • the rotation restriction section 26a includes a restriction main body 118 and a restriction support section 120a.
  • the regulation support section 120a includes a support base 126, a pressing section 128, a fastening member 130, and a support slit 200.
  • Support slit 200 is formed in outer wall portion 182 of chassis structure 170. Specifically, the support slit 200 is formed on a protruding end surface of a wall portion 174a of the outer wall portion 182 that protrudes from the end of the base plate portion 180 in the direction of arrow X2.
  • the slit width of the support slit 200 is slightly larger than the thickness of the regulating body 118.
  • the regulating body 118 is inserted into the first gap 150 and also into the support slit 200.
  • the regulating body 118 extends linearly along the axial direction of the chemical liquid container 16 over its entire length.
  • the regulating body 118 extends further in the direction of arrow X2 than the wall portion 174a of the chassis structure 170.
  • This modification has the following effects.
  • the regulation support part 120a supports the regulation body 118 so that the regulation body 118 extends linearly over the entire length.
  • the regulating body 118 can be smoothly moved in the distal direction as the pressing plunger 72 moves.
  • the regulation support part 120a includes a support slit 200 formed in the housing 14 into which the regulation body 118 is inserted, and a support that is located between one end of the regulation body 118 and the support slit 200 and supports the middle part of the regulation body 118. It has a base 126.
  • the regulation body 118 can be stably supported by the support base 126 and the support slit 200.
  • the movement detection section 28 may be arranged between the support base 126 and the wall section 174a.
  • the pusher 68 is not limited to a double-tube structure in which the intermediate plunger 74 is arranged inside the pressing plunger 72, but may have a multi-tube structure with three or more plungers.
  • the pusher 68 is not limited to a telescopic structure.
  • the pusher 68 may be formed only by the pressing plunger 72. In this case, the female thread 84 of the pressing plunger 72 is screwed into the male thread 104 of the feed screw shaft 70 .
  • This embodiment discloses the following contents.
  • the above-mentioned embodiment includes a cylindrical liquid medicine container (16) that accommodates a liquid medicine (M) and has a liquid medicine discharge port (44) at its tip, and a liquid medicine container that is slidably and liquid-tightly disposed inside the liquid medicine container.
  • a pressing mechanism (20) including a feed screw shaft (70) that moves the pusher in the distal direction; and a drive mechanism (20) that rotates the feed screw shaft by being driven by power supply from a battery (24).
  • a housing (14) that accommodates the drug solution container, the pressing mechanism, and the drive mechanism, the pusher along the rotational direction of the feed screw shaft.
  • a rotation regulating part (26, 26a) for regulating the rotation of the liquid medicine administration device, in an initial state of the liquid medicine administration device, the pusher is spaced apart from the gasket, and the rotation regulating part is fixed to the pusher.
  • a regulating body (118) at least partially extending along the axial direction of the feed screw shaft, and a regulating support part (120, 120a) provided in the housing and supporting the regulating body.
  • the regulation support part is configured to move the regulation body in the distal direction as the pusher moves in the distal direction while preventing movement of the regulation body along the rotational direction of the feed screw shaft.
  • a liquid drug administration device is disclosed that movably supports the regulating body.
  • one end of the regulating body is connected to the pusher while being located inside the liquid medicine container, and the regulating support part is connected to the one end and the other end of the regulating body.
  • the intermediate portion between the two may be supported.
  • one end portion of the regulating body may be connected to the pusher while being located outside the drug solution container.
  • the regulating body may be formed in a plate shape or a film shape.
  • the regulation support portion may support the intermediate portion of the regulation body in a U-shaped curved state.
  • the regulation support section may support the regulation body so that the regulation body extends linearly over the entire length.
  • the regulation support part includes a support slit (200) formed in the housing and into which the regulation body is inserted, and a support slit (200) located between one end of the regulation body and the support slit. It may also include a support base (126) that supports the intermediate portion of the restriction body.
  • the regulating body may be inserted into the interior of the liquid medicine container by movement of the pusher in the direction of the tip.
  • the pusher includes an intermediate plunger (74) having the first threaded portion and the third threaded portion (96), and a fourth threaded portion (84) that is threaded into the third threaded portion. and a pressing plunger (72) that presses the gasket, the tip of the second threaded portion is located in the proximal direction from the tip of the feed screw shaft, and the regulating body is configured to press the pressing plunger (72).
  • the intermediate plunger moves in the distal direction with respect to the feed screw shaft by rotation of the feed screw shaft, and the intermediate plunger moves in the forward direction with the first threaded portion located at the distal end of the second threaded portion.
  • the pressing plunger may rotate together with the screw shaft, and the pressing plunger may move in the distal direction relative to the intermediate plunger due to rotation of the intermediate plunger.
  • the intermediate plunger may be separated from the drug solution container.
  • the liquid medicine administration device described above may include a movement detection section (28) for detecting movement of the pusher.
  • the liquid medicine administration device described above may include a movement amount calculation section (166) that calculates the movement amount of the pusher based on the signal detected by the movement detection section.
  • the movement detection section may include a movement detection sensor (160) that detects movement of the regulating body.
  • the movement detection sensor may be a non-contact photosensor.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif (10) d'administration de solution médicamenteuse, lequel comporte: un réservoir (16) de solution médicamenteuse, un joint d'étanchéité (18), un piston (68), un mécanisme (20) de pression, un mécanisme (22) d'entraînement, un boîtier (14), et une unité (26) de régulation de rotation. L'unité (26) de régulation de rotation possède: un corps principal (118) de régulation fixé sur le piston (68) et dont au moins une partie s'étend dans la direction de l'axe d'une vis d'alimentation (70) du mécanisme de pression (20); et une unité (120) support de régulation. L'unité (120) support de régulation supporte le corps principal (118) de façon que celui-ci puisse se déplacer en direction d'une extrémité avant du piston (68), suite au déplacement en direction de ladite extrémité avant du piston (68), dans un état dans lequel le déplacement du corps principal (118) est empêché dans la direction de rotation de la vis d'alimentation (70).
PCT/JP2023/014960 2022-06-28 2023-04-13 Dispositif d'administration de solution medicamenteuse Ceased WO2024004329A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2022103374A JP2025110907A (ja) 2022-06-28 2022-06-28 薬液投与装置
JP2022-103374 2022-06-28

Publications (1)

Publication Number Publication Date
WO2024004329A1 true WO2024004329A1 (fr) 2024-01-04

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JP (1) JP2025110907A (fr)
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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015181869A (ja) * 2014-03-26 2015-10-22 テルモ株式会社 薬液投与装置
WO2016051999A1 (fr) * 2014-09-29 2016-04-07 テルモ株式会社 Dispositif de stockage de liquides médicamenteux, et dispositif d'administration de liquides médicamenteux
WO2019065946A1 (fr) * 2017-09-29 2019-04-04 テルモ株式会社 Ensemble piston, dispositif de dosage de solution médicamenteuse et procédé d'entraînement d'ensemble piston
JP2020110220A (ja) * 2019-01-08 2020-07-27 セイコーインスツル株式会社 送り装置及び携帯型注出装置
WO2020202852A1 (fr) * 2019-03-29 2020-10-08 テルモ株式会社 Appareil d'administration de médicament liquidev

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015181869A (ja) * 2014-03-26 2015-10-22 テルモ株式会社 薬液投与装置
WO2016051999A1 (fr) * 2014-09-29 2016-04-07 テルモ株式会社 Dispositif de stockage de liquides médicamenteux, et dispositif d'administration de liquides médicamenteux
WO2019065946A1 (fr) * 2017-09-29 2019-04-04 テルモ株式会社 Ensemble piston, dispositif de dosage de solution médicamenteuse et procédé d'entraînement d'ensemble piston
JP2020110220A (ja) * 2019-01-08 2020-07-27 セイコーインスツル株式会社 送り装置及び携帯型注出装置
WO2020202852A1 (fr) * 2019-03-29 2020-10-08 テルモ株式会社 Appareil d'administration de médicament liquidev

Also Published As

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