WO2013136801A1 - Dispositif d'administration de médicament - Google Patents

Dispositif d'administration de médicament Download PDF

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Publication number
WO2013136801A1
WO2013136801A1 PCT/JP2013/001719 JP2013001719W WO2013136801A1 WO 2013136801 A1 WO2013136801 A1 WO 2013136801A1 JP 2013001719 W JP2013001719 W JP 2013001719W WO 2013136801 A1 WO2013136801 A1 WO 2013136801A1
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WO
WIPO (PCT)
Prior art keywords
cylinder
piston
flow path
chemical solution
puncture
Prior art date
Application number
PCT/JP2013/001719
Other languages
English (en)
Japanese (ja)
Inventor
孝博 相馬
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2013136801A1 publication Critical patent/WO2013136801A1/fr

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    • 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
    • A61M5/148—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags
    • 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
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • 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
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion means
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated

Definitions

  • the present invention relates to a drug solution administration device, which is suitable for application when, for example, insulin is administered into the body.
  • type 1 diabetes is a chronic disease that requires treatment to inject an appropriate amount of insulin at an appropriate time.
  • manual administration using a syringe or manual administration using an injector has been performed.
  • an automatic drug solution administration system capable of programming the dose and administration time has been developed.
  • This system consists of an infusion pump, a dedicated infusion set, and a catheter.
  • a system in which a drug administration device is made portable is also used.
  • a small and lightweight infusion pump that is fixed to the body surface with a double-sided tape without using the infusion set.
  • a patch-type drug solution administration device has been introduced in which a catheter is directly inserted from the device (for example, see Patent Document 1).
  • the liquid medicine is delivered from the liquid medicine storage section filled with the liquid medicine into the patient's body using a pump.
  • a cylinder part is provided with a suction port for suctioning a chemical solution and a discharge port for discharging a chemical solution, and a check valve is provided at each of the suction port and the discharge port.
  • a piston type pump is known in which one of check valves provided at each of the suction port and the discharge port is opened by changing the internal pressure of the pump.
  • the present invention has been made in consideration of the above points, and intends to propose a small-sized chemical solution administration device capable of quantitatively delivering a chemical solution.
  • a housing portion provided with an inflow side flow path used when inhaling the chemical liquid and an outflow side flow path used when discharging the chemical liquid
  • a cylinder portion that is rotatably fitted in the housing portion, a piston that is rotatable and slidable in the cylinder portion, a stopper that limits a rotation range of the cylinder portion relative to the housing portion, and a fixed to the piston.
  • the cylinder portion is connected to the inflow side flow path when the cylinder portion rotates to one end of a rotation range limited by the stopper, and the cylinder portion is connected to the rotation range.
  • One cylinder port that is connected to the outflow side flow path when rotated to the end is provided, and the piston is configured so that the cylinder portion is in a period until the cylinder portion reaches one end or the other end of the rotation range. And the cylinder part reaches one end or the other end of the rotation range so that the cylinder port is stopped after being connected to the inflow side flow path or the outflow side flow path.
  • the piston shaft is slid in the cylinder portion by rotating with respect to the cylinder portion.
  • the piston can be slid in the cylinder part after rotating the cylinder part together with the piston and switching the cylinder port to the inflow side flow path or the outflow side flow path only by controlling the rotation of the piston shaft. It is possible to deliver a fixed amount of a chemical solution while having a simple configuration without providing a valve.
  • the piston can be slid in the cylinder part after rotating the cylinder part together with the piston and switching the cylinder port to the inflow side flow path or the outflow side flow path only by the rotation control of the piston. It is possible to deliver a fixed amount of a chemical solution with a simple configuration without providing a check valve. Thus, it is possible to realize a small-sized pump and a chemical solution administration device capable of quantitatively delivering the chemical solution.
  • a drug solution administration system 1 wirelessly communicates a signal corresponding to a user's input instruction with a portable drug solution administration device 2 that is held and used by being affixed to the user's skin.
  • the controller 3 that transmits to the drug solution administration device 2 and the charger 4 (FIG. 21) that charges the rechargeable battery 206 (FIG. 11) provided inside the drug solution administration device 2 are configured.
  • the chemical liquid administration device 2 stores therein a chemical liquid (for example, insulin), and administers the chemical liquid into the user's body in accordance with a control signal transmitted from the controller 3.
  • a chemical liquid for example, insulin
  • the drug solution administration device 2 includes a drug solution storage and delivery unit 10, a drive control unit 20, and a puncture channel unit 30 that are detachable from each other.
  • the puncture channel unit 30 is slid from the front with respect to the drug solution storage / delivery unit 10 and the drive control unit 20.
  • the medicinal solution administration device 2 is used by being attached to the skin of the user in such a state.
  • the size of the medicinal solution administration device 2 may be small enough to be attached to the user's skin, for example, a substantially rectangular parallelepiped shape having a width of 34 mm, a length of 43 mm, and a height of 12 mm.
  • the chemical storage / delivery unit 10 includes a lower casing part 101 that is open on the upper side and has a space inside, and an upper casing that is screwed into the opening of the lower casing part 101.
  • the portion 102 is formed into a flat and substantially rectangular parallelepiped shape.
  • the chemical solution storage and delivery unit 10 is provided with a chemical solution bag 110, a filter unit 120, a delivery unit 130, a compression unit 150, and the like in a space formed by the lower casing unit 101 and the upper casing unit 102.
  • the lower housing part 101 is provided with a sticking part 103 made of double-sided tape or the like on the bottom face 101A.
  • the medicinal solution administration device 2 is held by the user when the sticking portion 103 is stuck on the user's skin.
  • the bottom surface 101 ⁇ / b> A of the lower housing 101 is formed of a transparent material so that the amount of the chemical stored in the chemical bag 110 can be seen from the outside. This makes it possible to check the remaining amount of the chemical solution even after the chemical solution administration device 2 is attached to the user's skin.
  • Engagement portions 101B to E which are protrusions extending in the direction in which the drive control unit 20 is arranged, are provided on the side surfaces along the longitudinal direction (hereinafter also referred to as the front-rear direction) of the lower housing unit 101. It has been.
  • the engaging portions 101B to E are brought into close contact with the chemical solution storage and delivery portion 10 and the drive control portion 20 by engaging with engagement receiving portions 201A to 201D (FIG. 11) described later.
  • the lower casing unit 101 is provided with a waterproof packing 101F on a surface in close contact with the upper casing unit 102, and the lower casing unit 101 is screwed to the upper casing unit 102 via the waterproof packing 101F (not shown). Since it is screwed or ultrasonically fused, it is possible to prevent liquid from entering the internal space from between the lower casing portion 101 and the upper casing portion 102.
  • a hole 101G for inserting the leaf spring release rod 154 is provided on the side surface of the lower casing portion 101 along the front-rear direction.
  • a duckbill-like valve packing (not shown) is inserted into the hole 101G, and the hole is closed when the leaf spring release rod 154 is removed.
  • a bottom 101 ⁇ / b> A of the lower housing part 101 is provided with a hole 101 ⁇ / b> K into which the injection part 104 is fitted to inject a chemical liquid into the chemical liquid bag 110.
  • the peripheral part of the hole 104K realizes a waterproof function by fitting the injection part 104, which is an elastic member fused to the chemical solution bag 110, and the lower housing part 101.
  • the lower casing portion 101 is provided with a concave portion 101H on the front side, which is a space into which a part of the puncture channel portion 30 is fitted when the puncture channel portion 30 is engaged with the drug solution storage and delivery unit 10. . Further, the lower casing portion 101 is provided with projections 101I and 101J protruding in opposite directions to guide the puncture flow path portion 30 so as to be slid and engaged with the medicinal solution storage / delivery portion 10 from the front direction. It is provided along.
  • the upper housing part 102 is provided with projecting parts 102A and 102B protruding in the front-rear direction so as to be continuous with the projecting parts 101I and 101J of the lower housing part 101 in the front-rear direction.
  • the upper housing portion 102 is formed such that the central portion 102C sandwiched between the protrusion portions 102A and 102B is one step lower than the other portions in order to form the protrusion portions 102A and 102B.
  • Waterproof gaskets are inserted into the joints of the protrusions 101I and 101J of the lower housing part 101 and the protrusions 102A and 102B and the central part 102C of the upper housing part.
  • the chemical solution bag 110 as the chemical solution storage unit is formed from a rectangular sheet 111 made of, for example, polyurethane, vinyl chloride, or polyethylene.
  • the sheet 111 is a central portion in the longitudinal direction and is a portion (hereinafter also referred to as a central portion) 112 that becomes the bottom surface of the chemical solution bag 110 that is a flexible thermoplastic resin.
  • At least three odd or more (five in the present embodiment) fold lines 113 and 114 are provided at equal intervals on both sides of the sheet.
  • an even number of portions (hereinafter also referred to as folding portions) 115 and 116 having a predetermined width are formed on the sheet 111 between the adjacent folds 113 and 114, respectively.
  • the sheet 111 has portions (hereinafter also referred to as end portions) 117 and 118 that are longer than half of the length in the longitudinal direction in the central portion 112 on the further end side than the folds 113 and 114 from the most ends in the longitudinal direction. Provided.
  • the folds 113 and 114 are alternately folded into a mountain fold and a valley fold so that the fold portions 115 and 116 overlap the center portion 112, and as shown in FIG. Part of the end side overlaps.
  • the overlapping portions of the end portions 117 and 118 are fused, and the edges in the width direction are fused.
  • the edge in the width direction of the sheet 111 is fused, the edge is fused so that the nozzle 105 that connects the space surrounded by the sheet 111 and the external space is sandwiched between the edges.
  • an injection portion 104 having a check valve (not shown) formed of, for example, synthetic rubber or the like is provided to inject a chemical solution into the chemical solution bag 110 from the outside.
  • a chemical solution bag 110 as shown in FIG. 5C is formed.
  • the medical solution bag 110 formed in this way is folded so that the adjacent folding portions 115 and 116 are in contact with each other in a state where the medical solution is not filled, and the central portion 112 and the end portions 117 and 118 are Overlap.
  • the chemical solution bag 110 is not crushed so that the central portion 112 and the end portions 117 and 118 are in contact with each other without leaving the chemical solution inside when the chemical solution filled therein is sent to the outside through the nozzle 105. Can be sent to the outside.
  • the conventional chemical solution bag is generally formed by fusing the edges of two films, and the chemical solution is injected into the space formed by the two films. As the distance approaches, the distance between the two films becomes shorter.
  • the conventional chemical solution administration device using the chemical solution bag in the space where the chemical solution bag is stored, when the chemical solution is injected near the edge of the chemical solution bag, a useless space is formed in the portion where the chemical solution bag does not expand. It will be.
  • the conventional drug solution bag has a problem in that the drug solution administration device is enlarged.
  • the chemical solution bag 110 has the folding portions 115 and 116 in the longitudinal direction, the folding portions 115 and 116 separate the center portion 112 and the end portions 117 and 118 when the chemical solution is injected. It spreads in the direction (vertical direction).
  • the chemical solution bag 110 can expand in the vertical direction even when it is near the edge of the chemical solution bag 110 when the chemical solution is injected by expanding the folding parts 115 and 116.
  • the space formed with the casing 102 when the chemical solution is injected, a wasteful space is not formed even in a portion near the edge of the chemical solution bag 110, and the chemical solution administration device 2 can be downsized. Yes, thus improving usability.
  • the filter unit 120 is connected to a side surface of the upper lid 121 having an opening on the lower side and a space in the interior, and a nozzle 105 communicating the inner space and the chemical solution bag 110.
  • a channel pipe 106 communicating with the delivery unit 130 is connected.
  • the filter unit 120 is provided with an air vent filter 122 that allows gas to pass but not liquid to close the opening of the upper lid 121.
  • the air vent filter 122 is fixed between the upper lid 121 and the lower lid 123 that closes the opening of the upper lid 121 so as to be sandwiched between the O-rings 124 and 125 along the circumferential direction.
  • the upper lid 121 and the lower lid 123 are in close contact with each other by, for example, ultrasonic fusion.
  • the lower lid 123 is provided with a hole 123A penetrating in the vertical direction.
  • the filter unit 120 can discharge only the gas from the inner space of the upper lid 121 through the hole 123A provided in the lower lid 123 without discharging the chemical solution.
  • the delivery unit 130 is a valveless pump that does not have a valve, and is an internal space provided inside the housing unit 131 (this is the interior of the housing).
  • a cylindrical cylinder part 132 is fitted into 131 ⁇ / b> A so as to be rotatable in the circumferential direction.
  • the cylinder part 132 has a cylindrical shape with one end opened, and a columnar piston 133 is inserted into the internal space 132A of the cylinder part 132 (also referred to as a cylinder internal space) from this one end side.
  • each part of the delivery part 130 will be described by defining one end side of the cylinder part 132 as a lower side and the other end side as an upper side.
  • a female thread 132B is formed on the inner peripheral surface of the cylinder part 132 from the center to the lower end.
  • the female screw 132B is configured to mesh with a male screw 133C formed on the outer peripheral surface of a boss 133B fixed to the piston shaft 133A of the piston 133.
  • the disc-shaped lid portion 132C that forms the upper end portion of the cylinder portion 132 has a cylindrical shape that projects upward on the upper surface along the central axis of the lid portion 132C (coaxial with the central axis of the cylinder portion 132).
  • a protrusion 132D is provided.
  • the protrusion 132D serves as an axis when the cylinder part 132 rotates. Therefore, hereinafter, the protrusion 132D is referred to as a shaft portion 132D.
  • one rectangular parallelepiped protrusion 132E protruding outward is formed on the outer peripheral surface of the lid 132C.
  • this lid portion 132C is provided with one cylinder port 132F communicating with the cylinder internal space 132A.
  • the cylinder port 132F has a center on a line segment (not shown) connecting the center axis of the lid portion 132C (coaxial with the center axis of the cylinder portion 132) and the protrusion 132E. It is provided at a position displaced from the shaft by a predetermined amount.
  • the casing 131 is fixed to the lower casing 101 (FIG. 3) of the chemical storage / delivery unit 10.
  • the housing part 131 is provided with a housing internal space 131A that is substantially the same diameter as the outer diameter of the cylinder part 132 and slightly longer than the cylinder part 132, and the cylinder part 132 is fitted into the housing internal space 131A. Is done.
  • a recess 131B is formed on the upper surface of the inner wall forming the housing inner space 131A (also referred to as the inner wall upper surface) along the central axis of the housing inner space 131A.
  • a cylindrical protruding portion 142 whose height is shorter than the base portion 137B by the thickness of the sliding nylon washer 143 is formed at the center of the lower surface of the inner wall forming the housing internal space 131A (also referred to as the inner wall lower surface).
  • the protruding portion 142 is formed with a hole 131C having a diameter larger than that of the piston shaft 133A.
  • a coil spring having a shape along the circumferential direction of the housing internal space 131A between the lower surface of the inner wall having the protruding portion 142 forming the housing internal space 131A and the lower end of the cylinder part 132 fitted in the housing internal space 131A. 134 is arranged.
  • This coil spring 134 pushes up the lower end of the cylinder part 132 via the washer 135, thereby urging the cylinder part 132 upward (that is, on the cylinder port 132F side).
  • the cylinder portion 132 is always fitted into the recess 131B on the upper surface of the inner wall forming the housing internal space 131A in the shaft portion 132D of the lid portion 132C, and the upper surface of the lid portion 132C. Is in close contact with the upper surface of the inner wall.
  • the portion facing the outer peripheral surface of the lid portion 132C of the cylinder portion 132 that is, the upper end of the inner wall peripheral surface
  • a semicircular arc-shaped groove 131 ⁇ / b> D extending along a half circumference along the rotation direction of the cylinder portion 132 is formed.
  • a protrusion 132E formed on the outer peripheral surface of the lid portion 132C of the cylinder portion 132 is slidably fitted into the groove 131D.
  • the groove 131D and the protruding portion 132E function as a stopper that restricts the rotation of the cylinder portion 132 relative to the housing portion 131 to a half rotation.
  • the rotation range of the cylinder part 132 is limited to a half rotation from the position where the protrusion 132E contacts the one end 131E of the groove 131D to the position where the other end 131F contacts.
  • the channel 131G is a channel used when a chemical solution is drawn into the cylinder part 132 from the outside, and is hereinafter referred to as an in-channel 131G.
  • the channel 131H is a channel used when the chemical liquid is discharged from the cylinder part 132 to the outside, and is hereinafter referred to as an out channel 131H.
  • the in-flow path 131G is connected to the flow path pipe 106, and the out flow path 131H is connected to the flow path pipe 107.
  • the in-flow channel 131G is a groove extending from the central axis of the housing internal space 131A on a line segment (not shown) connecting the one end 131E and the other end 131F of the groove 131D. It is provided at a position shifted by a predetermined amount on the one end 131E side of 131D.
  • the out channel 131H is provided at a position opposite to the in channel 131G across the central axis of the housing internal space 131A.
  • shift amount from the center axis of the in-flow path 131G and the out-flow path 131H is equal to the deviation
  • the cylinder port 132F is positioned directly below the in-flow path 131G. In this case, the cylinder port 132F and the in-flow path 131G are connected.
  • the cylinder port 132F is blocked by the upper surface of the inner wall.
  • the cylinder portion 132 fitted in the housing internal space 131A has a rotation range in the circumferential direction limited to a half rotation, and the cylinder port 132F is connected to the in-flow path 131G when rotating to one end of the rotation range. When rotating to the other end of the rotation range, the cylinder port 132F is connected to the out flow path 131H.
  • X ring or O ring packing along the circumferential direction so that there is no gap between the piston 133 and the inner wall peripheral surface of the cylinder internal space 132A on the outer peripheral surface of the piston 133 inserted into the cylinder internal space 132A. 136 is provided.
  • the piston shaft 133A fixed to the piston 133 has a coil spring 141 sandwiched from the tip end portion 137A of the drive shaft 137 inserted through the hole 131C of the protruding portion 142 formed on the lower surface of the inner wall of the housing inner space 131A from the lower end side. And is connected to the drive shaft 137.
  • the drive shaft 137 includes a tip portion 137A having a predetermined length having an inner diameter substantially the same as the outer shape of the piston shaft 133A, and a base portion 137B having an outer diameter substantially the same as the outer diameter of the piston shaft 133A.
  • the drive shaft 137 is provided with a bevel gear 137C at the end opposite to the tip 137A, and sandwiches the tip of the protruding portion 142 formed on the lower surface of the inner wall of the housing internal space 131A and the nylon washer 143 for sliding.
  • the bevel gear 137 ⁇ / b> C attached in (1) is engaged with the bevel gear 139 ⁇ / b> A provided on the rotation shaft 139 of the drive magnet 138 (FIG. 7), thereby being connected to the rotation shaft 139.
  • a rotation detection magnet 140 for detecting the rotation of the drive shaft 137 is provided on the side surface of the drive magnet 138.
  • the driving magnet 138 is provided at a position facing the power transmission magnet 209 (FIGS. 11 and 12) across the upper casing 102 and the lower casing 202 (FIG. 11) of the drive controller 20, and will be described later. In this manner, it is attracted to and rotated by the power transmission magnet 209 that rotates through the motor 207 and the gear head 208.
  • the rotation ratio of the bevel gears 139A and 137C is determined so that when the rotation shaft 139 makes one rotation, the drive shaft 137 also makes one rotation.
  • the drive shaft 137 has a tip 137A connected to the piston shaft 133A via the coil spring 141, and can transmit a rotational force to the piston shaft 133A.
  • the coil spring 141 extends to the drive shaft 137, and the piston
  • the shaft 133A can slide in the axial direction (vertical direction).
  • the coil spring 141 extends as much as the piston shaft 133A is pushed upward. Further, the fitting of the male screw 133C of the piston shaft 133A and the female screw 132B of the cylinder part 132 is urged.
  • the frictional force between the male screw 133C of the piston shaft 133A and the female screw 132B of the cylinder part 132 is set to be larger than the frictional force between the cylinder part 132 and the inner wall forming the housing internal space 131A.
  • the piston 133 slides in the cylinder internal space 132A in the axial direction (vertical direction) by the internal thread 132B of the cylinder portion 132 and the external thread 133C of the piston shaft 133A.
  • the piston shaft 133A rotates via the drive shaft 137, until the projection 132E of the cylinder part 132 contacts the one end part 131E or the other end part 131F of the groove 131D, the cylinder After the part 132 and the piston 133 rotate together, the protrusion 132E of the cylinder part 132 contacts the one end part 131E or the other end part 131F of the groove 131D and the rotation of the cylinder part 132 stops, and then the coil spring 141 The piston 133 slides in the cylinder inner space 132A of the stopped cylinder part 132.
  • the cylinder part 132 has a protruding part 132E that contacts the other end part 131F of the groove 131D.
  • the piston 133 is stopped at the contact position, and the piston 133 is located at the top dead center.
  • the cylinder port 132F is connected to the outflow path 131H by being positioned directly below the outflow path 131H.
  • the cylinder part 132 and the piston 133 rotate together until the protrusion part 132E of the cylinder part 132 comes into contact with the one end part 131E from the other end part 131F of the groove 131D. During this time, the piston 133 does not slide with respect to the cylinder part 132.
  • the cylinder port 132F is connected to the in-flow path 131G by being positioned directly below the in-flow path 131G.
  • a flow path is switched from the out flow path 131H to the in flow path 131G first.
  • the cylinder internal space 132A is connected to the filter unit 120 (FIG. 3) via the cylinder port 132F, the in-flow path 131G, and the flow-path pipe 106.
  • the chemical solution loaded in the chemical solution bag 110 passes through the filter unit 120, the flow channel pipe 106, the in-flow channel 131 ⁇ / b> G, and the cylinder port 132 ⁇ / b> F, and between the lid portion 132 ⁇ / b> C and the piston 133 in the cylinder unit 132. Is injected into the cylinder inner space 132A.
  • the prescribed number of rotations is set to the number of rotations of the drive shaft 137 required until the piston 133 reaches the bottom dead center after the cylinder part 132 and the piston 133 start to rotate together. Therefore, when the rotation of the drive shaft 137 stops, the piston 133 is located at the bottom dead center.
  • the delivery unit 130 sucks the chemical into the cylinder internal space 132A.
  • the cylinder port 132F is connected to the outflow path 131H by being positioned directly below the outflow path 131H. In this manner, the delivery unit 130 switches the flow path from the in-flow path 131G to the out-flow path 131H.
  • the cylinder internal space 132A is connected to the valve body 108 (FIG. 3) provided in the upper housing portion 102 via the cylinder port 132F, the out flow path 131H, and the flow path pipe 107.
  • the cylinder portion 132 is biased upward by the coil spring 134, so that the upper surface of the lid portion 132C always rotates in close contact with the upper surface of the inner wall of the housing internal space 131A. Thereby, the delivery unit 130 can avoid a situation in which a gap is formed between the lid 132C and the upper surface of the inner wall and the chemical liquid flows out into the gap.
  • the chemical injected into the cylinder internal space 132A between the lid portion 132C in the cylinder portion 132 and the piston 133 passes through the cylinder port 132F, the out flow path 131H, and the flow path pipe 107 to the valve body 108. Discharged.
  • the valve body 108 closes the flow path when nothing is inserted, and opens the flow path when the nozzle 302 (FIG. 15) provided in the puncture flow path section 30 is inserted to open the flow path tube 107. And the nozzle 302 are communicated with each other.
  • the drive shaft 137 is rotated as shown in FIG. Stop.
  • the specified number of rotations is the same as the number of rotations at the time of suction, and the drive shaft 137 required until the piston 133 reaches the top dead center after the cylinder part 132 and the piston 133 start to rotate together.
  • the number of rotations is set. Therefore, when the rotation of the drive shaft 137 stops, the piston 133 is located at the top dead center.
  • the delivery unit 130 discharges the chemical solution from the cylinder unit 132.
  • the delivery unit 130 delivers the drug solution stored in the drug solution bag 110 to the user's body through the flow channel provided in the puncture flow channel unit 30.
  • the delivery unit 130 is until the protrusion 132E of the cylinder 132 reaches the one end 131E or the other end 131F of the groove 131D.
  • the connection destination of the cylinder port 132F is switched to the in-flow path 131G or the out-flow path 131H.
  • the delivery unit 130 rotates the cylinder part 132 together with the piston 133 only by controlling the rotation of the piston shaft 133A (that is, controlling the number of rotations and the direction of rotation), so that the cylinder port 132F is connected to the in-flow path 131G or the out-flow path.
  • the piston 133 can be slid in the cylinder part 132 after switching to 131H.
  • the delivery unit 130 can perform the quantitative delivery of the chemical liquid only by the rotation control of the piston shaft 133A, for example, the switching of the connection destination of the cylinder port 132F and the sliding of the piston 133 are separately controlled. Compared with a pump that must be, it is possible to deliver a fixed amount with simple control.
  • the compression unit 150 includes a press plate 151, a support unit 152, and a plate spring 153.
  • the holding plate 151 is a plate material having an area larger than the central portion 112 of the chemical solution bag 110 and is provided on the upper side of the chemical solution bag 110.
  • the holding plate 151 is supported by a support portion 152 fixed to the lower casing portion 101 so as to be rotatable in a direction away from and approaching the chemical solution bag 110 around the connecting portions 151A and 152A formed of, for example, a hinge mechanism.
  • the plate spring 153 is a plate material provided in a state of being bent in a substantially V shape between the holding plate 151 and the upper housing portion 102, and the plate portions that are bent in a substantially V shape and are opposed to each other are separated from each other.
  • the force works in the direction to open (the direction to open). Therefore, when the leaf spring 153 is disposed between the holding plate 151 and the upper housing portion 102, the holding plate 151 is always pressed against the chemical solution bag 110 side with a constant force.
  • the compression portion 150 is a plate spring release rod between the holding plate 151 and the plate spring 153 through the hole 101G of the lower housing portion 101 before the chemical solution is injected into the chemical solution bag 110 (FIG. 4A). 154 is inserted. At this time, in the compression unit 150, the presser plate 151 can freely rotate without the plate spring 153 pressing the presser plate 151.
  • the compression portion 150 presses the holding plate 151 against the chemical solution bag 110 side.
  • the pressing plate 151 sandwiches the chemical solution bag 110 with the lower housing 101 and the presser plate 151 applies a constant positive pressure to the chemical solution bag 110 (FIG. 4B).
  • the compression unit 150 can discharge the dissolved gas to the outside through the filter unit 120.
  • the compression unit 150 presses the chemical solution bag 110 in a direction to be crushed, so that the chemical solution stored in the chemical solution bag 110 is pushed out without leaving inside. Thus, it can be sent out.
  • the drive control unit 20 is formed in a substantially U-shape having a recess 20 ⁇ / b> A that matches the shape of the puncture flow channel portion 30 so that the puncture flow channel portion 30 is inserted from the front direction. Is done.
  • the drive control unit 20 is a space formed between an upper housing part 201 that is open on the lower side and has a space inside, and a lower housing part 202 that is screwed into the opening of the upper housing part 201.
  • a charging antenna 203 a substrate 204, a communication antenna 205, a rechargeable battery 206, a motor 207, a gear head 208, a power transmission magnet 209, magnetic sensors 210 and 211, and the like.
  • the outer surface along the front-rear direction of the upper housing part 201 is provided with engagement receiving parts 201A to 201D that are grooves for engaging with the engagement parts 101B to E provided in the chemical solution storage and delivery part 10, respectively.
  • a bolus switch 201E that is pressed down by the user when a certain amount of chemical solution is temporarily administered (bolus administration) is provided.
  • the bolus switch 201E is provided at a position recessed from the upper surface of the upper housing portion 201, and can be prevented from being accidentally pressed by the user, for example, by turning over.
  • the lower casing 202 is provided with a waterproof packing 202A on the surface that is in close contact with the upper casing 201, and the upper casing 201 is screwed to the lower casing 202 via the waterproof packing 202A (not shown). Since it is screwed or ultrasonically fused, it is possible to prevent liquid from entering the internal space from between the upper casing portion 201 and the lower casing portion 202.
  • the charging antenna 203 is affixed on the upper surface of the lower housing
  • a CPU Central A board unit 204 on which a communication antenna 205 for transmitting and receiving signals to and from an electrical circuit such as a processing unit (RAM), a random access memory (RAM), and a read only memory (ROM) and the controller 3 is disposed above the charging antenna 203. It is provided to overlap.
  • RAM processing unit
  • RAM random access memory
  • ROM read only memory
  • a rechargeable battery 206 is provided on the upper surface of the lower casing unit 202, which is charged by electricity supplied from the charging antenna 203 and supplies electricity to each unit during driving.
  • a motor 207 for example, a motor 207, a gear head 208, and a power transmission magnet 209 are provided so as to overlap in order from the top at a position facing the driving magnet 138 of the drug solution storage and delivery unit 10.
  • a magnetic sensor 210 is provided on the upper surface of the lower housing unit 202.
  • the motor 207 rotates the power transmission magnet 209 via the gear head 208. As shown in FIG. 12, the power transmission magnet 209 is opposed to the driving magnet 138 so as to have a polarity attracting the driving magnet 138 in a state where the chemical storage / delivery unit 10 and the drive control unit 20 are in close contact with each other. To be placed.
  • the power transmission magnet 209 When the power transmission magnet 209 is rotated by the motor 207 via the gear head 208, the power transmission magnet 209 rotates with its own rotation while attracting the driving magnet 138 by magnetic force.
  • the motor 207 rotates the rotating shaft 139 in a non-contact manner via the gear head 208, the power transmission magnet 209, and the driving magnet 138 to rotate the driving shaft 137 connected to the piston shaft 133A, thereby The piston 133 is rotated and the piston 133 is slid.
  • the motor 207 rotates the rotating shaft 139 and the driving shaft 137 in a non-contact manner through the magnetic force of the power transmission magnet 209 and the driving magnet 138, the rotating shaft 139 and the driving shaft 137 rotate following the rotation of the motor 207. It is necessary to detect whether or not Therefore, the magnetic sensor 210 that detects that the rotation shaft 139 and the drive shaft 137 are rotating is disposed on the circumference on which the rotation detection magnet 140 moves.
  • the magnetic sensor 210 detects the magnetic force of the rotation detecting magnet 140, it detects that the rotating shaft 139 and the drive shaft 137 have made one rotation by detecting the magnetic force again.
  • the magnetic sensor 210 can detect the rotation of the cylinder part 132 and the piston 133 and the sliding of the piston 133 by detecting that the rotation shaft 139 and the drive shaft 137 are rotating.
  • the number of rotations is detected in units of one rotation, but the number of rotations may be detected more finely by increasing the number of magnetic sensors 210.
  • the microcomputer 220 (FIG. 21) is a magnetic sensor 210 provided in the same space formed by the upper housing portion 201 and the lower housing portion 202 and is a different space. It is possible to check the drive of the sending unit 130 provided in the space formed by the lower housing unit 101 and the upper housing unit 102 without contact.
  • a connector unit 212 for transmitting and receiving various signals is provided. As shown in FIGS. 13A and 13B, the connector portion 212 has a structure in which a waterproof rubber 212B covers the outside of the electrical connector portion 212A in which a plurality of spring connectors 212C for transmitting and receiving electricity and various signals are collected. It becomes.
  • the connector part 350 (FIG. 15) of the puncture flow path part 30 connected to the connector part 212 also has a waterproof rubber outside the electric connector part 350A in which a plurality of connector parts 350C for transmitting and receiving electricity and various signals are collected. The structure is covered with 350B.
  • the waterproof rubber 212B and 350B can prevent the liquid from touching the electrical connector units 212A and 350B.
  • the length is not contacted at the limit where insertion is permitted (when sufficient insertion is not performed).
  • This pin is provided and connected to the ground potential on the puncture flow path section 30 side, and it is checked whether the potential of this pin is the ground potential or not on the drive control section 20 side. In this case, the insertion of the puncture channel 30 is monitored by displaying an alarm indicating that the puncture channel 30 is insufficiently inserted.
  • the puncture channel portion 30 is fitted in the space between the recess 101H and the recess 20A formed in a state where the drug solution storage / delivery unit 10 and the drive control unit 20 are engaged. It has an elongated shape.
  • the puncture flow path part 30 is provided with each part in the internal space of the housing part 301 that forms the outer shell. 14A shows an external configuration, and FIG. 14B shows an internal configuration. Further, in FIG. 15, for convenience of explanation, a part is shown in cross section.
  • the housing unit 301 When the puncture flow path unit 30 is fitted to the drug solution storage and delivery unit 10, the housing unit 301 includes a bottom surface 301 ⁇ / b> A located on the same plane as the bottom surface 101 ⁇ / b> A of the lower housing unit 101 and the center of the upper housing unit 102. A bottom surface 301B located at a height facing and adjacent to the portion 102C.
  • the housing portion 301 is provided at a position where a convex portion 301C that fits into the concave portion 102D of the upper housing portion 102 when the puncture flow path portion 30 is fitted to the drug solution storage and delivery portion 10 faces the concave portion 102D in the bottom surface 301B. .
  • the casing 301 includes a protrusion 101I of the lower casing 101 and a protrusion 102A of the upper casing 102, a protrusion 101J of the lower casing 101, and a protrusion of the upper casing 102.
  • Guide grooves 301D and 301E that respectively engage with the portion 102B are formed on the side surfaces along the front-rear direction.
  • the casing 301 is provided with a recess 301Q on the upper surface 301F for hooking a user's finger when removing the puncture channel 30 from the drug solution storage / delivery unit 10 and the drive controller 20 that are fitted.
  • the casing 301 is curved from the upper surface 301F to the front surface 301G, and an angle adjustment mechanism 340, which will be described in detail later, is provided on the curved surface 301H.
  • the casing 301 is provided with a hole 301I at a position facing the valve body 108 of the chemical liquid storage / delivery section 10 in a state where the puncture flow path section 30 is fitted to the chemical liquid storage / delivery section 10.
  • the nozzle 302 to be inserted is fixed so as to penetrate the hole 301I.
  • the nozzle 302 is fixed without providing a gap with the hole 301I.
  • One end of the nozzle 302 is inserted into the valve body 108 in a state where the puncture flow path section 30 is fitted to the drug solution storage and delivery section 10 and communicates with the flow path pipe 107.
  • the nozzle 302 is connected to a running water sensor 303 at the other end.
  • the flowing water sensor 303 detects whether or not the passing chemical solution is flowing.
  • a heating source and a temperature sensor are used separately.
  • a combination of a resistor, a heater wire, a semiconductor, and a temperature sensor as a source, a thermo file, a platinum resistor, a semiconductor, and the like can be applied.
  • the flowing water sensor 303 has a puncture channel needle 304 connected to the end opposite to the end to which the nozzle 302 is connected, and allows the nozzle 302 and the puncture channel needle 304 to communicate with each other.
  • the puncture flow path needle 304 is bent so that one end side connected to the running water sensor 303 is folded back on the S-shape, is arranged along the front-rear direction therefrom, and reaches the bottom surface 301A on the other end side.
  • the puncture channel needle 304 is made of a metal member, but is a 28 gauge hollow tube, for example, which can be easily bent.
  • the puncture channel needle 304 is fixed by a fixing portion 305 that protrudes inward from the housing portion 301 at a position immediately after being folded back on the S-shape.
  • the puncture flow path needle 304 is spirally wound with a part (hereinafter also referred to as an elastic portion) 304A on the front side from the position fixed to the fixing portion 305.
  • the elastic portion 304A is extendable in the front-rear direction.
  • the puncture channel needle 304 has a sharply sharp shape at a tip portion (hereinafter also referred to as a tip portion) 304B that is bent so as to reach the bottom surface 301A.
  • the puncture flow path needle 304 having such a shape sends the drug solution flowing from the flowing water sensor 303 to the outside through the inner space from the distal end portion 304B.
  • the puncture channel needle 304 is covered with, for example, the sheath portion 310 from the distal end portion 304B to the elastic portion 304A.
  • the sheath part 310 is made of, for example, Teflon (registered trademark) or polyethylene, and the sheath 311 has flexibility, and is soft, for example, made of Teflon (registered trademark), polyolefin, or polyurethane. It is comprised by the expansion
  • the material that is soft and easily deformed and has the property of not returning to the extension 312 include a material that is crosslinked by ultraviolet rays at a high temperature, such as a heat-shrinkable tube, such as polyolefin, Teflon (registered trademark), silicon.
  • Polyvinyl chloride, polyvinyl fluoride fluoride, etc. can be used.
  • the sheath 311 covers most of the puncture channel needle 304 from the distal end 304B to the front of the elastic portion 304A, and is not fixed to the puncture channel needle 304.
  • the extending portion 312 covers the puncture channel needle 304 from a position overlapping one end side of the elastic portion 304A side of the sheath 311 to just before the elastic portion 304A, and one end on the fixed portion 305 side is the puncture channel needle. The other end is fixed to the sheath 311.
  • the extending portion 312 is fixed so as to seal the gap between the puncture flow path needle 304 and the sheath 311 along the circumferential direction so that the liquid does not leak from the gap at both fixed ends.
  • a caulking 306 that fixes the puncture flow path needle 304 and the sheath 311 together is provided at a predetermined position closer to the distal end portion 304B than the elastic portion 304A of the puncture flow path needle 304.
  • the caulking 306 is made of a material that deforms when a certain force is applied, such as aluminum or copper.
  • the caulking 306 is crushed from the left and right direction after the puncture flow path needle 304 and the sheath 311 are inserted into the ring hole from the ring shape, and a part of the vertical direction overlaps, and the puncture flow path needle 304 and the sheath 311 are overlapped. Tighten and fix. Thereby, the sheath 311 is fixed so as not to slip with respect to the puncture flow path needle 304.
  • the caulking 306 is bonded to the sheath 311 and does not leave the sheath 311 even when the caulking 306 is loosened.
  • the puncture flow path part 30 is provided in front of the caulking 306 and a movement restricting part 307 at a position away from the caulking 306 by a predetermined distance.
  • the predetermined distance is a distance at which the puncture flow path needle 304 and the sheath 311 protrude from the bottom surface 301A of the housing 301, that is, a depth at which the puncture flow path needle 304 and the sheath 311 are punctured to the user. It is the same distance as the distance, and is set to 10 mm in the present embodiment.
  • the movement restricting portion 307 is fixed to the housing portion 301 and is arranged so that the puncture flow path needle 304 and the sheath portion 310 can be inserted into a hole provided in the center without contacting.
  • the puncture flow path section 30 is provided with a puncture mechanism 320 at a position behind the caulking 306 and ahead of the extension section 312.
  • the puncture mechanism 320 includes a fixed plate 321, a spring 322, a support plate 323, and a pressing portion 324.
  • the fixing plate 321 is fixed to the housing part 301 and is arranged so that the puncture flow path needle 304 and the sheath part 310 can be inserted into a hole provided in the center without contact.
  • a spring 322 is disposed in front of the fixed plate 321.
  • the spring 322 is arranged so as to pass through the inner space without contact between the puncture flow path needle 304 and the sheath portion 310, and is arranged in a state where it is sandwiched between the fixed plate 321 and the support plate 323 and compressed more than the natural length. Is done.
  • the support plate 323 is arranged so that the puncture flow path needle 304 and the sheath portion 310 are inserted without contacting each other, and is a surface on the opposite side to the surface where the spring 322 is in contact with the puncture flow path needle 304 and the sheath portion.
  • the push portion 324 is supported below 310.
  • the support plate 323 is held so as not to move forward by the puncture release mechanism 330 at a position lower than a position where the pressing portion 324 is supported on the same surface as the surface supporting the pressing portion 324.
  • the pressing portion 324 has a substantially cylindrical shape, and has a negative shape (one character type) whose tip is long in the vertical direction and short in the horizontal direction.
  • the pressing portion 324 is supported by the support plate 323 so that the tip is located between members overlapping on the lower side of the portion of the caulking 306 extending in the vertical direction.
  • the puncture release mechanism 330 includes a limiting portion 331, a spring 332, and an actuator 333.
  • the restricting portion 331 has a portion extending in the front-rear direction and a portion extending in the up-down direction so that the cross section has a substantially L shape, and is provided near the center of the portion extending in the front-rear direction.
  • the rotary shaft 331A is held rotatably.
  • the restricting portion 331 is disposed so as to support the support plate 323 with the surface on the rotating shaft 331A side of the portion extending in the vertical direction, and restricts the support plate 323 from moving in the forward direction.
  • the restriction portion 331 has a spring 332 connected to the lower surface on the front side of the rotation shaft 331A of the portion extending in the front-rear direction, and the protrusion 333A of the actuator 333 is in contact with the upper surface on the rear side of the rotation shaft 331A.
  • the spring 332 has one end connected to the restricting portion 331 and the other end connected to the bottom surface 301B side of the housing portion 301, and is arranged in a state in which a force is always applied in the direction of contraction.
  • the actuator 333 is configured to move the protruding portion 333A in the front-rear direction when electric power is supplied, and is disposed in a state where the protruding portion 333A is in contact with the limiting portion 331.
  • the spring 322 is sandwiched between the fixed plate 321 and the support plate 323 and compressed more than the natural length, the limiting portion 331 is in contact with the support plate 323, and the projection 333A of the actuator 333 is disposed in contact with the limiting portion 331.
  • the state is also referred to as an initial state (FIGS. 15 and 17A).
  • the puncture flow path needle 304 and the sheath 311 are illustrated in a straight state that is not bent, but in reality, a part thereof is bent as described above.
  • the contracted spring 322 extends to return to the natural length and pushes the support plate 323 and the pressing portion 324 in the forward direction.
  • the pushing portion 324 pushed in the forward direction pushes the caulking 306 forward together with the puncture channel needle 304 and the sheath 311 until the caulking 306 comes into contact with the movement restricting portion 307.
  • the caulking 306 moves in the forward direction while sandwiching the puncture channel needle 304 and the sheath 311 along the caulking guide 308 in which the upper portion of the portions extending in the vertical direction overlaps on the upper side.
  • the cross section of the caulking guide 308 has a U-shape with an opening at the bottom, and the caulking 306 fits from the direction in which the caulking guide 308 is opened in the overlapping portion on the upper side. Is retained.
  • the elastic portion 304A of the puncture channel needle 304 is extended (FIG. 17B).
  • the puncture flow path needle 304 and the sheath 311 protrude from the bottom surface 301A of the housing 301, and the distal end 304B punctures the user and enters the user's body together with the sheath 311.
  • the spring 322 continues to extend even after the caulking 306 comes into contact with the movement restricting portion 307, and the tip of the pressing portion 324 enters between the members overlapping below the caulking 306. At this time, the pusher 324 opens the overlapping members below the caulking 306 on both sides, and loosens the tightening of the caulking 306 with respect to the puncture channel needle 304 and the sheath 311.
  • the sheath 311 is fixed to the caulking 306 and cannot move, so the extension portion 312 having one end fixed to the puncture channel needle 304 extends as the elastic portion 304A contracts.
  • the sheath portion 310 is maintained in a state in which the distal end portion of the sheath 311 protrudes from the bottom surface 301A because the elongated portion 312 that extends at one end does not return to the original shape (FIG. 17C).
  • the puncture channel section 30 punctures with the metal puncture channel needle 304 having a sharp tip 304B, and then inserts only the flexible sheath 311 into the body. Subsequently, the puncture channel needle 304 made of metal can be returned to the outside of the body.
  • the medicinal solution administration device 2 does not leave the metal puncture channel needle 304 in the body while the user is using it, and can continue to insert only the flexible sheath 311 into the body. It is possible to reduce pain and discomfort to the user, thus improving usability.
  • one end of the sheath is connected to the needle through a packing, and after the needle and the sheath are punctured into the skin, the sheath is inserted into the packing portion when the needle is pulled out of the body. It was made to slide and stay in that position.
  • the gap between the needle and the sheath is closed with the packing, so that the liquid medicine leaks, or when the seal is strengthened, the friction between the needle and the packing increases and the needle does not return sufficiently. There was a possibility.
  • the medicinal solution administration device 2 since the medicinal solution administration device 2 is fixed without providing a gap with the puncture channel needle 304 at one end of the extending portion 312, the medicinal solution does not leak. In addition, there is no hindrance to the puncturing operation due to the friction between the packing and the needle.
  • the puncture flow path section 30 (FIGS. 14 and 15) is forward of the movement restricting section 307 and on the curved surface 301H of the housing section 301, the angle at which the puncture flow path needle 304 and the sheath 311 project with respect to the bottom surface 301A (
  • an angle adjustment mechanism 340 for adjusting the projection angle is also provided. Since the bottom surface 301A is in contact with the user's skin, the protruding angle is the same as the angle of the puncture flow path needle 304 and the sheath 311 with respect to the user's skin (hereinafter also referred to as the puncture angle).
  • the angle adjustment mechanism 340 is supported by a support portion 341 made of an L-shaped column whose one end is fixed to the housing portion 301.
  • the support portion 341 is a concentric circular shape at the end surface arranged to be orthogonal to the left-right direction on the side opposite to the one end fixed to the housing portion 301, and a plurality of (four in this embodiment) concave portions at a predetermined angle. 341A is provided.
  • the concave portion 341A is provided at a position where the puncture angle of the puncture channel needle 304 and the sheath 311 is 20 ° to 90 °, as will be described in detail later.
  • the angle adjusting mechanism 340 is provided with a central portion 342 having a convex portion 342A projecting so as to be concentric with the concave portion 341A and fitted into the concave portion 341A at a position facing the end surface of the support portion 341.
  • the central portion 342 is supported by the support portion 341 at a position where the protruding convex portion 342A fits into the concave portion 341A while being pressed toward the support portion 341 by the screw 345 through the spring 343 and the spring pressing plate 344.
  • the central portion 342 is provided with a shaft portion 346 in a direction orthogonal to the rotation axis when the center portion 342 rotates.
  • the shaft portion 346 has a cylindrical shape, one end is connected to the holding portion 347 that holds the puncture channel needle 304 and the sheath 311, and the other end is connected to the knob portion 348 that is held when the angle is adjusted by the user. Is done.
  • the holding portion 347 is a tube having an inner diameter that is thicker than the outer shape of the sheath 311, and the puncture flow path needle 304 and the sheath 311 are inserted therethrough, and the puncture flow path needle 304 and the sheath 311 are held without being fixed.
  • the knob portion 348 includes a knob 348A held by the user and a knob support portion 348B that supports the knob 348A.
  • the knob portion 348 is placed so that both ends of the knob support portion 348B are hooked on rail portions 301K and 301M whose left and right sides of the opening 301J provided on the curved surface 301H of the housing portion 301 are L-shaped in cross section.
  • the knob support portion 348B is placed so as to be sandwiched between the housing portion 301 and the panel portion 349 provided on the curved surface 301H of the housing portion 301.
  • the panel portion 349 opens so that the knob 348A can move in a direction along the curved surface 301H (hereinafter also referred to as a curved direction), and has a shape that is longer in the curved direction than the rail portions 301K and 301M. is doing.
  • a waterproof packing 348C is provided on the edge of the upper surface of the knob support portion 348B, and prevents liquid from entering the housing portion 301 from between the knob support portion 348B and the panel portion 349.
  • the holding portion 347 is rotated according to the rotation of the shaft portion 346 around the center portion 342 when the knob portion 348 is moved in the bending direction by the user. .
  • the angle adjusting mechanism 340 sets the protrusion angle of the puncture flow path needle 304 held by the holding portion 347 and the bottom surface 301A of the sheath 311 to 20 ° to 90 °.
  • Change in range. 20A shows a case where the protrusion angle is 90 °
  • FIG. 20B shows a case where the protrusion angle is 20 °.
  • the angle adjusting mechanism 340 can change the puncture angle of the puncture flow path needle 304 and the sheath 311 with respect to the user's epidermis arranged in parallel with the bottom surface 301A in the range of 20 ° to 90 °.
  • the puncture channel needle 304 and the sheath 311 are set so that the tip 304B does not come out of the bottom 301A at a puncture angle at which the distance between the tip 304B and the bottom surface 301A varies depending on the puncture angle.
  • distal end portion 304B of the puncture channel needle 304 and the distal end of the sheath 311 are arranged so as to close the opening 301N provided in the bottom surface 301A and come into contact with the outer periphery of the sheath 311. Held by the unit 309.
  • the tip holding portion 309 is fitted to an L-shaped rib provided inside the bottom surface 301A, and both sides are shifted in the front-rear direction along the inside of the front surface 301G and the back surface 301V of the 301. Due to the flexibility, even if the distal end portion 304B of the puncture flow path needle 304 and the distal end of the sheath 311 are moved to the angle adjusting mechanism 340, they can follow it and continue to close the opening 301N. Accordingly, liquid can be prevented from entering the housing portion 301.
  • the tip holding portion 309 includes an air vent filter 309A that covers the tip portion 304B of the puncture channel needle 304 and the tip of the sheath 311 at a position further ahead of the tip portion 304B of the puncture channel needle 304. Provided.
  • the air vent filter 309A can discharge only the air present in the puncture channel needle 304 to the outside without leaking the drug solution flowing through the puncture channel needle 304 before use by the user. .
  • the angle adjustment mechanism 340 can change the protrusion angle of the puncture flow path needle 304 and the bottom surface 301A of the sheath 311 with respect to the bottom surface 301A within a range of 20 ° to 90 ° according to the operation of the user.
  • the human body has skins such as epidermis and dermis from about 1.5 mm to 4 mm from the body surface, and there is subcutaneous tissue at a depth of about 4 mm to 9 mm from the body surface inside, and further inside Have muscles.
  • insulin when administered from the outside, it is generally administered to a subcutaneous tissue at a depth of about 4 mm to 9 mm from the surface in consideration of burden on the user, pain, absorption rate of insulin, and the like.
  • the medicinal-solution administration device 2 can change the puncture angle of the puncture flow path needle 304 and the sheath 311 with respect to the user's epidermis within the range of 20 ° to 90 ° by the angle adjusting mechanism 340.
  • the angle adjusting mechanism 340 By adjusting, it is possible to puncture to an arbitrary depth, and it is possible to reliably puncture the subcutaneous tissue that is optimal for all users.
  • by administering a drug solution to the dermis layer it is possible to obtain the same medicinal effect with a small amount of drug solution compared to when administered subcutaneously, and therefore it is possible to set the puncture distance to the dermis.
  • the medicinal solution administration device 2 can improve usability.
  • the connector unit 350 is adhered to the hole 301P provided at a position facing the connector unit 212 of the drive control unit 20 without a gap.
  • the connector portion 350 covers the outside of the electrical connector portion 350A in which a plurality of connector portions 350C for transmitting and receiving electricity and various signals are collected with a waterproof rubber 350B. Constructed.
  • the medicinal solution administration device 2 includes the puncture channel unit 30 provided with the puncture channel needle 304 for puncturing the user's skin, the medicinal solution storage and delivery unit 10 provided with the medicinal solution bag 110 for storing the medicinal solution, and the delivery.
  • the drive control unit 20 provided with the motor 207 for operating the unit 130 and the substrate unit 204 is provided separately.
  • the conventional medicinal solution administration device since the needle for puncturing the user's skin, the medicinal solution bag for storing the medicinal solution, the motor, etc. are all provided in the same housing, for example, when puncture fails, When itching and inflammation occur, the entire device must be replaced, which is not only convenient but also increases the economic burden.
  • the controller 3 includes a microcomputer 361, a battery 362, a battery monitoring unit 363, a mode switch 364, a numerical value setting switch 365, a display unit 366, a transmission unit 367, a reception unit 368, and a communication antenna 369.
  • the microcomputer 361 is a computer including a CPU, a RAM, a ROM, and the like.
  • the CPU reads and executes a basic program stored in the ROM and executes the overall control, and the CPU is stored in the ROM.
  • Various processes are executed by reading various programs into the RAM and executing them.
  • the battery 362 supplies power to each unit.
  • the battery monitoring unit 363 monitors the presence / absence and remaining amount of the battery 362 and notifies the microcomputer 361 of it.
  • the mode switch 364 is a switch for setting a basal mode in which a chemical solution is continuously administered for a long time and a bolus mode in which a chemical solution is temporarily administered.
  • the numerical value setting switch 365 is a switch for setting the dose per hour and the administration time of the drug solution.
  • the microcomputer 361 displays the contents corresponding to the operation on the mode switch 364 and the numerical value setting switch 365 on the display unit 366 and transmits a signal indicating the contents to the drug solution administration device 2 via the transmission unit 367 and the communication antenna 369. To do.
  • the microcomputer 361 when the microcomputer 361 receives the signal transmitted from the drug solution administration device 2 by the communication antenna 369, the microcomputer 361 acquires the signal via the receiving unit 368, and displays the contents corresponding to the signal on the display unit 366 to the user. Notification is performed and processing corresponding to the content is executed.
  • the electric circuit is operated by the power supply supplied from the rechargeable battery 206, and the microcomputer 220 provided in the drive control unit 20 performs overall control.
  • the microcomputer 220 is a computer including a CPU, a RAM, a ROM, and the like.
  • the CPU reads and executes a basic program stored in the ROM and executes the overall control, and the CPU is stored in the ROM.
  • Various processes are executed by reading various programs into the RAM and executing them.
  • the microcomputer 220 When the microcomputer 220 receives the signal transmitted from the controller 3 received by the communication antenna 205 via the receiving unit 222, the microcomputer 220 operates each unit according to the content of the signal.
  • the puncture angle is adjusted by filling the drug solution bag with a necessary amount of insulin and operating the angle adjustment mechanism 340, and the controller 3 sets the dose and administration time of the basal mode and the bolus mode.
  • the microcomputer 220 After being sent to the administration device 2 and stored in the RAM of the drug solution administration device, the microcomputer 220 signals that the administration of the drug solution is started with the drug solution administration device 2 attached to the user via the application unit 103. Is supplied from the controller 3, it is confirmed by connection of the connector parts 212 and 350 whether or not the puncture flow path part 30 is connected to the drive control part 20.
  • the microcomputer 220 drives the puncture release mechanism 330 to puncture the user with the puncture channel needle 304 and the sheath 311. Then, a prescribed amount of insulin is rotated so as to fill the space of the sheath portion inserted into the living body with priming (priming), the motor 207 is rotated, and the delivery unit 130 is driven to send the solution.
  • the microcomputer 220 sends the stored medicinal solution dosage or the medicinal solution administration set by the controller 3 when the arbitrary administration of the bolus is transmitted from the controller 3.
  • the motor 207 is rotated to drive the delivery unit 130 to administer the drug solution into the user's body.
  • the drug solution stored in advance in the drug solution bag 110 via the injection unit 104 is used via the filter unit 120, the delivery unit 130, the running water sensor 303, the puncture channel needle 304, the sheath 311, and the like. It is administered to the body of a person.
  • the microcomputer 220 monitors the number of rotations of the motor 207 via the encoder 223 and detects whether or not the chemical solution is flowing via the flow detection control unit 224.
  • the flow detection control unit 224 heats the thermistor of the flowing water sensor 303 and monitors the temperature change of the thermistor.
  • microcomputer 220 detects whether or not the sending unit 130 is driven based on the magnetic force detected by the magnetic sensor 210.
  • the microcomputer 220 performs again when the motor 207 is not rotating normally, when the delivery unit 130 is not normally driven, or when no chemical is flowing, and when the state does not change, Each unit is stopped, and a message to that effect is transmitted to the controller 3 via the transmission unit 221 and the communication antenna 205.
  • the microcomputer 220 controls the receiving / charging circuit 225 to receive the electromagnetic wave supplied from the charger 4 via the charging antenna 203 to charge the rechargeable battery 206.
  • the rechargeable battery 206 is provided with a battery safety circuit unit 226.
  • the battery safety circuit unit 226 monitors overcharge, overdischarge and battery temperature during charging to prevent thermal runaway.
  • the charger 4 includes an outlet 401, an AC / DC converter 402, a high frequency converter 403, and a transmission antenna 404.
  • the charger 4 converts alternating current sent from the outlet 401 into direct current by the AC / DC converter 402, converts it to high frequency by the high frequency conversion unit 403 for transmission by the transmission antenna 404, and then passes through the transmission antenna 404. Then, electromagnetic waves are transmitted to the drug solution administration device 2.
  • the drug solution storage and delivery unit 10 including the drug solution bag 110 and the puncture channel unit 30 including the puncture channel needle 304 and the sheath 311 are used only once from the hygiene viewpoint that the drug solution is used.
  • the drive control unit 20 that does not use the chemical solution can be used many times by attaching and detaching the chemical solution storage and delivery unit 10 and the puncture flow path unit 30. At this time, since the rechargeable battery 206 of the drive control unit 20 is charged by the charger, it can be used multiple times.
  • the present invention is not limited to this, and a mechanism different from such a mechanism may be used to switch the connection destination of the cylinder port to suck and discharge the chemical liquid.
  • the delivery unit 500 shown in FIG. 22 is a valveless pump that does not have a valve, like the delivery unit 130, and is in the internal space (cylinder internal space) 501A of the cylindrical cylinder portion 501 that is open at one end.
  • a cylindrical piston 502 is inserted from one end side.
  • each part of the sending part 500 will be described by defining one end side of the cylinder part 501 as a lower side and the other end side as an upper side.
  • An annular groove 503 is formed at the center of the inner peripheral surface of the cylinder portion 501.
  • the groove 503 includes a semicircular arc-shaped first semicircular arc-shaped groove 503A extending from the predetermined position S1 at the center of the inner peripheral surface along the circumferential direction, and the first semicircular arc-shaped groove 503A.
  • a first linear groove 503B having a predetermined length extending downward in the axial direction from the end position S2 of the first end, and a circumferential direction from the end position S3 of the first straight groove 503B.
  • first semicircular groove 503 ⁇ / b> A and the second semicircular groove 503 ⁇ / b> C are positioned to face each other across the central axis of the cylinder portion 501. Therefore, as shown in FIG. 22C, when the cylinder portion 501 is viewed from directly above, the groove 503 looks like an annular shape.
  • the first semicircular groove 503A is located slightly lower at the end position S2 than at the end position S1, and from the end position S1 to the end position S1. It is gently inclined downward toward the position S2.
  • the second semicircular groove 503C is located slightly higher at the distal end position S4 than at the distal end position S3, and is gently upward from the distal end position S3 toward the distal end position S4. Tilted.
  • a disc-shaped lid portion 501B that forms the upper end portion of the cylinder portion 501 is provided with a cylinder port 501C, which is a semicircular arc-shaped long hole, in communication with the cylinder internal space 501A.
  • the cylinder port 501C is provided at a position shifted by a predetermined amount from the central axis of the lid portion 501B (coaxial with the central axis of the cylinder portion 501).
  • this cylinder port 501C is located between the front end position S1 and the front end position S2 of the first semicircular arc groove 503A when the cylinder portion 501 is viewed from directly above. Located inside the arc.
  • the piston 502 is provided with, for example, an X ring or O ring packing 504 along the circumferential direction so that there is no gap between the piston 502 and the inner wall peripheral surface of the cylinder internal space 501A at the upper part of the outer peripheral surface. .
  • the piston 502 is formed with one protrusion 502A protruding outward at the lower part of the outer peripheral surface.
  • the protrusion 502A is slidably fitted into the groove 503 of the cylinder 501 with a structure in which a rubber or the like is prevented from slipping around the bearing that rotates only to the right.
  • the protrusion 502A slides along the second semicircular groove 503C and the first semicircular groove 503A which are substantially orthogonal to the axial direction of the piston 502 and slightly inclined, the protrusion 502A
  • the axial force that is added is transmitted to the cylinder portion 501 as a rotational force orthogonal to the axial direction.
  • the cylinder portion 501 rotates halfway while the protrusion 502A slides along the first semicircular groove 503A and the second semicircular groove 503C.
  • the sending section 500 switches the connection destination of the cylinder port 501C to the suction flow pipe 106 or the discharge flow pipe 107 by rotating the cylinder 501 halfway in this way.
  • the piston 502 slides in the axial direction without rotating the cylinder portion 501 while the protrusion 502A slides along the first linear groove 503B and the second linear groove 503D. become.
  • the piston 502 when the chemical solution is sucked into the cylinder part 501 of the delivery part 500, the piston 502 is first located at the top dead center as an initial state. At this time, the protrusion 502A of the piston 502 is located at the position S1 of the tip of the first semicircular arc groove 503A.
  • the cylinder portion 501 When the piston 502 further slides toward the bottom dead center, the cylinder portion 501 further rotates while the inside of the cylinder portion 501 and the flow path pipe 106 are in communication with each other, and the flow path pipe 106 and the cylinder port 501C are connected at the bottom dead center. Communicate at the end and stop.
  • the chemical solution loaded in the chemical solution bag 110 is injected into the space between the lid portion 501B in the cylinder portion 501 and the piston 502 through the filter portion 120, the flow path pipe 106, and the cylinder port 501C.
  • the delivery unit 500 sucks the chemical into the cylinder unit 501.
  • the protrusion 502A slides along the second linear groove 503D and the piston 502 slides from the bottom dead center to the top dead center.
  • the delivery unit 500 discharges the chemical solution from the cylinder unit 501.
  • the delivery unit 500 switches the connection destination of the cylinder port 501 and sucks and discharges the chemical solution.
  • the piston 502 is linearly moved in the axial direction by being connected to the rotating shaft 139 of the driving magnet 138 via a crank mechanism or the like, for example.
  • the delivery portion 500 needs to slide not on the second linear groove 503D side but on the first semicircular groove 503A side. .
  • the delivery unit 500 has a structure in which the outer periphery of the projecting portion 502A is rotated only to the right, and is provided with a slip stopper such as rubber on the outer periphery, or the width of the end of the second linear groove 503D is reduced.
  • the protrusion 502A is made difficult to slide from the position S1 to the second linear groove 503D by providing a protrusion at the end or by forming the end narrower than the other parts.
  • 502A is slid not on the second linear groove 503D side but on the first semicircular groove 503A side.
  • the delivery portion 500 needs to be slid not to the first linear groove 503B but to the second semicircular groove 503C.
  • the protrusion 502A has a structure in which the outer periphery turns only to the right, and a rubber or the like is provided on the outer periphery, or the end of the first linear groove 503B is narrowed at the end.
  • the protrusion 502A is made difficult to slide from the position S3 to the first linear groove 503B side by providing a protrusion or by forming the end narrower than the other parts.
  • the second semicircular groove 503C is slid.
  • connection destination of the cylinder port 132F is switched to the in-flow path 131G or the out-flow path 131H by rotating the cylinder part 132 halfway (180 degrees).
  • the rotation of the cylinder part 132 is not limited to a half rotation, for example, 1/4 rotation as long as the connection destination of the cylinder port 132F can be switched by rotating the cylinder part 132. Or 2/3 rotation.
  • the groove 131D that functions as a stopper that restricts the rotation of the cylinder part 132 to a half rotation is provided on the housing part 131 side, and the protruding part 132E that fits into the groove 131D is provided on the cylinder part 132 side. I tried to provide it.
  • a groove that functions in the same manner as the groove 131D is provided at the upper end of the outer peripheral surface of the cylinder portion 132, and a protrusion that fits into the groove is provided at the upper end of the inner wall peripheral surface of the housing portion 131. Good.
  • various other mechanisms may be used as long as the mechanism functions as a stopper capable of limiting the rotation of the cylinder part 132.
  • the frictional force between the piston 133 and the inner wall forming the cylinder inner space 132A causes the cylinder part 132 and the housing inner space 131A to move.
  • the cylinder part 132 and the piston 133 may be rotated integrally so as to be larger than the frictional force with the inner wall to be formed.
  • the coil spring 141 that urges the piston shaft 133A upward can be omitted.
  • the lubricant may be applied to the inner wall forming the housing internal space 131A.
  • X-ring or O-ring packing may be provided along the circumferential direction on the inner wall circumferential surface side of the cylinder inner space 132A, not on the piston 133 side, and silicon rubber may be provided on the piston 133.
  • a gasket made of butadiene rubber or the like may be attached.
  • the coil spring 141 is used as the biasing member that biases the piston shaft 133A upward (in the axial direction).
  • the present invention is not limited thereto, and any member other than the coil spring may be used instead of the coil spring as long as the member can bias the piston shaft 133A upward.
  • the coil spring 134 is used as a biasing member that biases the cylinder portion 132 upward (on the cylinder port 132F side).
  • any member other than the coil spring may be used instead of the coil spring as long as the member can bias the cylinder portion 132 upward.
  • the present invention can be applied to the medical field, for example.

Abstract

La présente invention concerne un dispositif d'administration de médicament apte à procurer une quantité fixe d'un médicament tout en étant compact. Lorsqu'une tige de piston (133A) est mise en rotation, jusqu'à ce qu'une saillie (132E) d'un cylindre (132) atteigne une extrémité (131E ou 131F) d'une rainure (131D), la partie de raccordement du cylindre (132) est commutée à un conduit d'entrée (131G) ou à un conduit de sortie (131H) au moyen dudit cylindre (132) et d'un piston (133) qui effectuent ensemble une rotation, puis le piston (133) coulisse au moyen d'une tige de piston (133A) pivotant par rapport au cylindre (132) qui est arrêté.
PCT/JP2013/001719 2012-03-16 2013-03-14 Dispositif d'administration de médicament WO2013136801A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2012060915 2012-03-16
JP2012-060915 2012-03-16

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WO2013136801A1 true WO2013136801A1 (fr) 2013-09-19

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS4310434Y1 (fr) * 1966-06-28 1968-05-07
US3680558A (en) * 1970-05-27 1972-08-01 Robert F Kapelowitz Syringe with multiple compartments
JPS58137883U (ja) * 1982-03-12 1983-09-16 西原　義晃 流体吐出装置
JPH03260377A (ja) * 1990-03-09 1991-11-20 Nippon Fuiidaa Kogyo Kk 往復動ポンプ
WO1994012227A1 (fr) * 1992-12-01 1994-06-09 Tetsuro Higashikawa Seringue
JP2010501283A (ja) * 2006-08-23 2010-01-21 メドトロニック ミニメド インコーポレイテッド 貯蔵容器内のプランジャを駆動するための駆動デバイスを用いる注入媒体送達デバイスおよび方法

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS4310434Y1 (fr) * 1966-06-28 1968-05-07
US3680558A (en) * 1970-05-27 1972-08-01 Robert F Kapelowitz Syringe with multiple compartments
JPS58137883U (ja) * 1982-03-12 1983-09-16 西原　義晃 流体吐出装置
JPH03260377A (ja) * 1990-03-09 1991-11-20 Nippon Fuiidaa Kogyo Kk 往復動ポンプ
WO1994012227A1 (fr) * 1992-12-01 1994-06-09 Tetsuro Higashikawa Seringue
JP2010501283A (ja) * 2006-08-23 2010-01-21 メドトロニック ミニメド インコーポレイテッド 貯蔵容器内のプランジャを駆動するための駆動デバイスを用いる注入媒体送達デバイスおよび方法

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