WO2020195033A1 - Drug solution administration device and method for controlling drug solution administration device - Google Patents

Drug solution administration device and method for controlling drug solution administration device Download PDF

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Publication number
WO2020195033A1
WO2020195033A1 PCT/JP2020/001260 JP2020001260W WO2020195033A1 WO 2020195033 A1 WO2020195033 A1 WO 2020195033A1 JP 2020001260 W JP2020001260 W JP 2020001260W WO 2020195033 A1 WO2020195033 A1 WO 2020195033A1
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WO
WIPO (PCT)
Prior art keywords
drug solution
unit
connection
fitting
connection port
Prior art date
Application number
PCT/JP2020/001260
Other languages
French (fr)
Japanese (ja)
Inventor
勝平 佐々木
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2021508115A priority Critical patent/JP7407795B2/en
Publication of WO2020195033A1 publication Critical patent/WO2020195033A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps

Definitions

  • the present invention relates to a drug solution administration device and a method for controlling the drug solution administration device.
  • the drug solution administration device shown in Patent Document 1 below has an injection section (injection disposable section) provided with an injection member (cannula) for injecting the drug solution into the living body, and a liquid delivery member (liquid delivery disposable section) for feeding the drug solution to the injection member.
  • a liquid feeder equipped with a liquid dispenser that feeds liquid to the unit and the liquid feed reuse unit, a detection unit that detects the connection and separation between the injection unit and the liquid supply unit, and a control unit that controls the operation of the liquid dispenser.
  • the detection unit includes a contact member provided on one surface of the housing of the injection disposable unit and a switch provided on one surface of the connecting portion of the liquid feeding disposable unit.
  • the control unit limits the administration operation by the liquid dispenser based on the result of the detection unit detecting that the injection unit and the liquid supply unit are connected. , It is said that unintended administration of drug solution into the living body can be prevented.
  • the cannula provided in the injection section and the liquid delivery section are provided.
  • the connection state of the liquid dispenser with the liquid supply pipe is not always good.
  • the connection between the cannula and the liquid feed pipe is unstable after connection, there is a concern that the chemical liquid may leak from these connection parts, and the poor connection between the cannula and the liquid feed pipe may cause a highly accurate chemical liquid. It was a factor that hindered administration.
  • an object of the present invention is to provide a drug solution administration device capable of detecting the connection state between the cannula and the liquid delivery pipe, and to provide a control method of the drug solution administration device capable of highly accurate drug solution administration. And.
  • the drug solution administration device of the present invention for achieving such an object relates to a drug solution administration device used by attaching the device body to a cradle that adheres to the skin.
  • the main body of the device accommodates a reservoir filled with a chemical solution, a liquid feed pipe extending from the reservoir, and a calculation unit for controlling the discharge of the chemical liquid from the reservoir in a housing, and the tip of the liquid feed pipe is accommodated.
  • a fitting portion that is exposed to the outside of the housing is provided.
  • the cradle has a cannula that is punctured and inserted subcutaneously and a connecting port that has a fitting end that connects to the fitting.
  • the drug solution administration device further includes a connection detection device that detects the connection between the fitting portion and the connection port.
  • a drug solution administration device capable of detecting a connection state between a cannula and a liquid delivery pipe, and to provide a control method of a drug solution administration device capable of highly accurate drug solution administration. it can.
  • FIG. 2 is an enlarged cross-sectional view (No. 2) illustrating a connection detection device provided in the drug solution administration device of the first embodiment. It is a flowchart explaining the control method of the drug solution administration apparatus of 1st Embodiment. It is sectional drawing (the 1) excerpt of the main part of the drug solution administration apparatus of 2nd Embodiment. It is sectional drawing (the 2) excerpt of the main part of the drug solution administration apparatus of 2nd Embodiment. It is a block diagram of the drug solution administration apparatus of 2nd Embodiment.
  • FIG. 1 is an exploded perspective view for explaining the overall configuration of the drug solution administration device 1 of the first embodiment.
  • FIG. 2 is a plan view of a main part of the drug solution administration device 1 of the first embodiment.
  • FIG. 3 is a block diagram of the drug solution administration device 1 of the first embodiment.
  • the drug solution administration device 1 shown in these figures is a device for continuously administering the drug solution into the body of a patient. This drug solution administration device 1 can administer insulin, analgesics, anticancer therapeutic agents, HIV agents, iron chelating agents, pulmonary hypertension therapeutic agents and the like.
  • Such a drug solution administration device 1 has a device main body 20, a cradle 30, an administration port 40 installed in the cradle 30, a connection detection device 50 provided in the device main body 20 and the administration port 40, and a remote controller 60.
  • the apparatus main body 20 can be detachably separated into the reuse portion 20a and the disposable portion 20b.
  • FIG. 2 corresponds to a plan view of the disposable portion 20b, the cradle 30, and the administration port 40 of the apparatus main body 20.
  • the detailed configuration of the drug solution administration device 1 will be described in the order of the reuse unit 20a and the disposable unit 20b, the cradle 30, the administration port 40, the connection detection device 50, and the remote controller 60 constituting the device main body 20. explain.
  • the device main body 20 is attached by sliding in the direction from the first end to the second end of the cradle 30.
  • This direction (mounting direction) is defined as the first direction X, and the direction orthogonal to the first direction X and orthogonal to the direction in which the device main body 20 and the cradle 30 overlap when the drug solution is administered is the second direction.
  • Y width direction
  • the second direction Y is a direction that is substantially parallel to the surface of the living body when the drug solution is administered by the drug solution administration device 1.
  • the direction in which the apparatus main body 20 and the cradle 30 overlap, that is, the direction orthogonal to the first direction X and the second direction Y is defined as the third direction Z (vertical direction).
  • the third direction Z is a direction orthogonal to the surface of the living body when the drug solution is administered by the drug solution administration device 1. That is, the lower side of the third direction Z is the direction toward the surface of the living body.
  • the reuse unit 20a includes a lid 11, a circuit board 12, and a liquid feed drive unit 13.
  • the reuse unit 20a is a portion in which the electronic control functions of the apparatus main body 20 are centrally arranged.
  • the reuse unit 20a is configured to accommodate an electronic control function inside the lid 11 shown in FIG.
  • a circuit board 12 and a liquid feeding drive unit 13 are housed inside the lid 11.
  • the circuit board 12 is provided with a main body output unit 14, a main body communication unit 15, and a main body calculation unit 16.
  • the liquid feeding drive unit 13 includes a motor, a gear unit, and the like.
  • the reuse unit 20a is provided with a sensor 52 of the connection detection device 50 described below as an electronic control function.
  • the lid 11 is fitted to the housing 21 of the disposable portion 20b described later, and the upper surface in the third direction Z is the top surface of the drug solution administration device 1.
  • the main surface side (lower side of the third direction Z) of the housing 11 toward the disposable portion 20b has a configuration in which the above-mentioned electronic control function is housed.
  • the main surface refers to the connecting surface between the reuse unit 20a and the disposable unit 20b.
  • the circuit board 12 is fixed inside the lid 11, and the liquid feed drive unit 13, the main body output unit 14, the main body communication unit 15, the main body calculation unit 16, and the sensor 52 described above are connected to each other. These are installed. Further, the circuit board 12 includes a power supply unit (not shown) for supplying electric power from the battery 23a arranged in the disposable unit 20b to be described later to each unit via wiring.
  • the liquid feed driving unit 13 drives the pusher of the reservoir 22 provided in the disposable unit 20b.
  • the liquid feeding drive unit 13 is composed of, for example, a motor driven by a battery and a plurality of stages of gears that rotate in conjunction with the drive of the motor.
  • the liquid feeding drive unit 13 is not limited to these configurations, and may have a mechanism for discharging the chemical liquid from the reservoir 22.
  • the main body output unit 14 outputs the alarm W.
  • the alarm W output by the main body output unit 14 for example, one that emits vibration or sound alone or in combination thereof is applied, and may further emit light.
  • the main body communication unit 15 is a part that performs wireless communication with the paired remote controller 60.
  • the main body communication unit 15 has a transmission unit and a reception unit, and is a portion that performs wireless communication using radio waves in a predetermined wavelength band, and particularly performs wireless communication using ultra-high frequency waves or microwaves.
  • the main body communication unit 15 performs wireless communication with a communication distance of about 100 m.
  • ZigBee IEEE802.154: frequency 2.4 GHz
  • Bluetooth registered trademark: IEEE802.5.1: frequency 2.4 GHz
  • wireless LAN IEEE802.11a / b / g: frequency 2. Standardized wireless communication technology such as 4 GHz, 5 GHz is applied.
  • the main unit calculation unit 16 controls the operation of the liquid feed drive unit 13 based on the signal transmitted from the paired remote controller 60 and the signal acquired by the sensor 52, thereby discharging the chemical solution from the reservoir 22. To control. Further, the main body calculation unit 16 controls the operations of the main body output unit 14 and the main body communication unit 15.
  • Such a main body arithmetic unit 16 includes, for example, a CPU (Central Processing Unit), a RAM (Random Access Memory), and a ROM (Read Only Memory), which are not shown here. The control of drug solution administration executed by the main body calculation unit 16 will be described in detail in the subsequent control method of the drug solution administration device.
  • the disposable portion 20b includes a housing 21, a reservoir 22 housed inside the housing 21, and a battery box 23.
  • the upper surface (main surface side) of the housing 21 is covered with the lid 11 of the reuse portion 20a.
  • the housing 21 is a rectangular parallelepiped that is substantially rectangular in top view, and all corners are rounded. When in use, the housing 21 stands on the bottom surface 21d of the housing facing the cradle 30 and the side surface of the housing standing toward the reuse portion 20a side (upper side in the third direction Z) around the bottom surface 21d of the housing. It has a part 21e. The space surrounded by the housing bottom surface 21d and the housing side surface portion 21e forms the storage portion 21a.
  • the storage unit 21a stores the reservoir 22 and the battery 23a, which will be described later.
  • the storage portion 21a is a concave portion having a large opening on the main surface side of the flat box-shaped housing 21.
  • the storage portion 21a is open toward the reuse portion 20a.
  • the opening of the storage portion 21a is closed by the lid 11 of the reuse portion 20a.
  • a back surface storage portion 21b is provided at one of the corners on the bottom surface of the flat box-shaped housing 21, in which a part of the bottom surface is recessed upward in the third direction Z.
  • the volume of the storage portion 21a is larger than the volume of the backside storage portion 21b.
  • the bottom surface 26 of the back surface storage portion 21b is convex toward the main surface side in the housing 21. More specifically, the bottom surface 26 of the back surface storage portion 21b is recessed from the bottom surface 21d of the housing toward the opening side of the storage portion 21a at least according to the height of the wall portion 25.
  • a fitting portion 21c exposed to the back surface storage portion 21b is formed on the wall portion 25 that separates the storage portion 21a and the back surface storage portion 21b. Further, the back surface accommodating portion 21b accommodates the administration port 40 in a state of being installed in the cradle 30 described later.
  • the fitting portion 21c is provided on the wall portion 25.
  • the fitting portion 21c has a substantially cylindrical tubular hole 28 projecting from the wall portion 25 toward the back surface storage portion 21b, and a connecting needle tube 22b.
  • the connecting needle tube 22b is fluidly connected to the liquid feeding tube 22a and is exposed to the back surface accommodating portion 21b at the substantially center in the axial direction of the tubular hole 28.
  • the connecting needle tube 22b is the tip end portion of the liquid feeding pipe 22a extending from the reservoir 22, and may be formed integrally with the liquid feeding pipe 22a.
  • the central axis of the tubular hole 28 is substantially parallel to the bottom surface of the storage portion 21a or the bottom surface 21d of the housing.
  • the tubular hole 28 protects the connecting needle tube 22b by projecting from the wall portion 25 so as to surround the periphery of the connecting needle tube 22b.
  • the connecting needle tube 22b projects from the wall portion 25 toward the second end portion side in the first direction X in the tubular hole 28.
  • the reservoir 22 has a syringe shape including an outer cylinder in which a drug solution to be administered to a patient is stored inside and a pusher having a gasket fitted in the outer cylinder.
  • the reservoir 22 is housed in the storage portion 21a of the housing 21.
  • a chemical liquid discharge port is provided at the tip of the outer cylinder of the reservoir 22, and the liquid supply pipe 22a is connected via the discharge port.
  • the reservoir 22 is not limited to the syringe shape, and various shapes such as a soft bag can be adopted.
  • FIG. 4 is a perspective view of the device main body 20 in the chemical solution administration device of the first embodiment, in which the device main body 20 in which the reuse portion 20a and the disposable portion 20b are combined is viewed from the back surface storage portion 21b side of the disposable portion 20b. It is a view. As shown in this figure, the tip of the liquid feeding pipe 22a is located on the back surface storage portion 21b side at substantially the center of the fitting portion 21c (cylinder hole 28) formed in the housing 21 of the disposable portion 20b of the apparatus main body 20. It is in a pulled out state. The tubular hole 28 and the connecting needle tube 22b project toward the second end side in the first direction X in which the device main body 20 is attached to the cradle 30.
  • the tip of the liquid feeding pipe 22a is located on the back surface storage portion 21b side at substantially the center of the fitting portion 21c (cylinder hole 28) formed in the housing 21 of the disposable portion 20b of the apparatus main body 20. It is in a pulled out state.
  • a gear is provided at the end of the pusher of the reservoir 22, and in a state where the reuse portion 20a and the disposable portion 20b are connected, the gear provided at the end of the pusher is , It is fitted with the gear of the liquid feeding drive unit 13 constituting the reuse unit 20a.
  • the pusher of the reservoir 22 is pushed into the outer cylinder by the drive of the liquid feeding drive unit 13, and the chemical liquid is discharged from the tip of the liquid feeding pipe 22a (connecting needle tube 22b) through the discharge port of the outer cylinder. It has become.
  • the battery box 23 stores the battery 23a that serves as a power source for the liquid feeding drive unit 13 that constitutes the reuse unit 20a and other components, and is fixed to the storage unit 21a of the housing 21.
  • the battery box 23 includes an electrode for connecting the battery 23a housed inside to a power supply unit provided on the circuit board 12 of the reuse unit 20a.
  • the battery box 23 and the battery 23a may be provided as components of the reuse unit 20a.
  • the cradle 30 has an adhesive portion 32, a mounting surface portion 31a, and a side wall portion 31b, and an administration port 40 described later is attached to the cradle 30.
  • the cradle 30 is used by adhering it to the skin.
  • the cradle 30 holds the administration port 40, and the apparatus main body 20 in a state where the above-mentioned reuse portion 20a and the disposable portion 20b are coupled is mounted.
  • the device body 20 is attached to the cradle 30 by sliding the device body 20 on the cradle 30 toward the second end side in the first direction X with respect to the cradle 30 adhered on the skin surface.
  • Such a cradle 30 includes a mounting surface portion 31a, a side wall portion 31b, and an adhesive portion 32.
  • the adhesive portion 32 is a soft sheet member provided on the surface of the mounting surface portion 31a opposite to the side on which the device main body 20 is mounted, and has adhesiveness to the skin.
  • the adhesive portion 32 is provided on the back surface (skin side surface) of the mounting surface portion 31a in a wide range of the mounting surface portion 31a, avoiding the through hole 31d that projects the cannula portion 41 of the administration port 40 described later. There is.
  • the cradle 30 is configured to be able to support the apparatus main body 20.
  • the cradle 30 has a substantially flat plate-shaped mounting surface portion 31a and a side wall portion 31b.
  • the mounting surface portion 31a is formed in a substantially rectangular shape with curved corners when viewed from above.
  • a side wall portion 31b that stands substantially perpendicular to the mounting surface portion 31a is formed on at least three sides of the mounting surface portion 31a that is substantially rectangular in top view. For this reason, a plurality of side walls are erected from the mounting surface portion 31a in the direction opposite to the skin.
  • the side of the mounting surface portion 31a on the first end side in the first direction X does not have a side wall portion that is substantially perpendicular to the mounting surface portion 31a. That is, at this position, the mounting surface portion 31a is open.
  • FIG. 5 is a perspective view for explaining the attachment of the device main body 20 to the cradle 30 in the drug solution administration device 1 of the first embodiment.
  • the device main body 20 when the device main body 20 is mounted on the cradle 30, the device is mounted on the mounting surface 31a from the side having no side wall portion 31b toward the second end side in the first direction X. Slide the main body 20.
  • the mounting surface portion 31a includes a holding portion 31c for holding the administration port 40.
  • the holding portion 31c is provided in a region on the second end side in the first direction X in a top view of the mounting surface portion 31a.
  • the holding portion 31c is a plurality of ribs erected from the mounting surface portion 31a around the through hole 31d described later.
  • the mounting surface portion 31a has a through hole 31d.
  • the cannula portion 41 is punctured and inserted into the skin through the through hole 31d.
  • a rib standing in the direction opposite to the skin is provided, and the rib supports the lower surface of the administration port 40.
  • FIG. 6 is a cross-sectional view (No. 1) of the main part of the drug solution administration device of the first embodiment, which is the administration port 40 immediately before mounting the device main body 20 on the cradle 30 holding the administration port 40. It is a cross-sectional view of the vicinity.
  • FIG. 7 is a cross-sectional view (No. 2) of an excerpt of a main part of the drug solution administration device of the first embodiment, in which the administration port in a state where the apparatus main body 20 is attached to the cradle 30 holding the administration port 40. It is sectional drawing around 40.
  • administering port 40 The drug solution supplied from the reservoir 22 of the device body 20 is administered to the patient through the administration port 40.
  • the administration port 40 holds the cannula portion 41 that is punctured into the patient's skin and is held by the holding portion 31c of the mounting surface portion 31a in the cradle 30.
  • Such an administration port 40 includes a substantially cylindrical cannula report 42, a lid member 43 and a seal member 44 located on the top surface of the cannula report 42, a connection port 45 connected to the apparatus main body 20, and a connection port 45. It is provided with a cap 46 for sealing the end face. Further, the administration port 40 is provided with a detected portion 51 that constitutes the connection detection device 50 described below.
  • the cannula portion 41 is a tubular member for introducing a drug solution such as insulin into the living body in a state of being punctured by the living body.
  • a cannula portion 41 is formed of, for example, a resin material.
  • the resin material forming the cannula portion 41 for example, polyurethane, nylon, ethylene-tetrafluoroethylene copolymer (ETFE) or the like can be used.
  • EFE ethylene-tetrafluoroethylene copolymer
  • a puncture device not shown
  • the cannula portion 41 is inserted into the living body together with the internal needle 400. After the cannula portion 41 is inserted into the living body, the puncture device is removed from the cradle 30 and discarded.
  • the cannula report 42 has a substantially cylindrical body portion and holds the cannula portion 41.
  • the cannula portion 41 holds the cannula portion 41 on the lower surface of the cannula report hollow portion 42a.
  • the proximal end of the cannula portion 41 is formed into a funnel shape that expands upward in the third direction Z in the side view of the drug solution administration device 1, and is fixed to the fixed portion in the cannula report hollow portion 42a. ing.
  • the distal end of the cannula portion 41 projects through the lower surface of the cannula report 42 from the through hole 31d beyond the lower surface of the cradle 30. ..
  • the top surface of the cannula report 42 is liquidtightly sealed by the lid member 43 and the sealing member 44 inside the lid member 43.
  • the top surface of the cannula report 42 faces the bottom surface 26.
  • the lid member 43 together with the seal member 44, seals the top opening of the cannula report 42.
  • the lid member 43 has a through hole 43a coaxial with the axial direction of the cannula portion 41.
  • the inner needle 400 can be inserted into the cannula report 42 having the through hole 43a and the cannula portion 41 (see FIG. 6).
  • the seal member 44 is configured so that the inner needle 400 can be inserted into the cannula portion 41, and the chemical liquid leaks from the inside of the cannula portion 41 after the inner needle 400 is removed from the through hole 43a of the lid member 43. Prevent it from coming out.
  • Examples of the material of the seal member 44 include rubber and the like.
  • connection port 45 extends from the side peripheral portion of the cannula report 42, and has a connection port main body 49 having a space continuous with the cannula hollow portion 42a and an opening forming one end of the connection port main body 49. It has a 47 and a cap 46 that tightly seals the opening 47.
  • the first end side of the connection port main body 49 in the first direction X is the fitting end 48 that fits into the fitting 21c.
  • the end face of the fitting end portion 48 is covered with a cap 46. That is, the opening 47 is closed by the cap 46.
  • connection port 45 and the cannula report 42 communicate with each other through the opening on the second end side of the connection port 45 in the first direction X.
  • the connection port 45 has a substantially cylindrical shape having a hollow portion.
  • the first end side of the connection port 45 in the first direction X has an opening 47.
  • the cap 46 tightly seals the opening of the connection port 45.
  • the cap 46 is a substantially cylindrical member having a cap end surface 46b on one end side and an opening on the other end side of the cap peripheral surface 46a.
  • the cap 46 is attached so as to cover the outer periphery and the end face of the opening 47 from the end face of the opening 47 toward the second end side in the first direction X. More specifically, the cap peripheral surface 46a engages with an engaging groove provided on the outer periphery of the connection port 45 (or opening 47).
  • the cap end surface 46b may have a flat shape, but ribs may be provided along the opening shape of the connection port 45 in order to improve the sealing property.
  • such a cap 46 is made of a material having the following characteristics (i) to (iii).
  • the tip of the connecting needle tube 22b can be inserted from the outside of the connecting port 45.
  • the space between the tip of the inserted connecting needle tube 22b and the connecting port 45 can be kept liquidtight.
  • the hole formed in the cap 46 by inserting the connecting needle tube 22b is closed after the connecting needle tube 22b is removed.
  • Examples of the material having the above-mentioned characteristics (i) to (iii) include rubber and the like.
  • FIG. 8 is an enlarged cross-sectional view (No. 1) for explaining the connection detection device 50 provided in the drug solution administration device 1 of the first embodiment, and is an axial direction (that is, that is) of the cylindrical connection port 45 in the administration port 40. , Is a cross-sectional view taken along the first direction X).
  • FIG. 9 is an enlarged cross-sectional view (No. 2) for explaining the connection detection device 50 provided in the drug solution administration device 1 of the first embodiment, showing the axial direction of the cylindrical connection port 45 in the administration port 40.
  • FIG. 5 is a cross-sectional view of a normal plane (ie, along a second direction Y).
  • connection detection device 50 is both views showing a state in which the device main body 20 is attached to the cradle 30 holding the administration port 40.
  • the configuration of the connection detection device 50 will be described with reference to FIGS. 8 and 9 and FIGS. 6 and 7 above.
  • connection detection device 50 when the device main body 20 is attached to the cradle 30 in which the administration port 40 is installed, the connection port 45 of the administration port 40 is attached to the fitting portion 21c of the device main body 20. It is a device for detecting that it has been fitted.
  • a connection detection device 50 is composed of a detected unit 51 provided in the administration port 40 and a sensor 52 as a detection unit provided in the device main body 20.
  • the detected unit 51 is arranged at a site where the device main body 20 and the administration port 40 are close to each other or in contact with each other in the state of use of the drug solution administration device 1.
  • the detected portion 51 is provided in the administration port 40. More specifically, the detected portion 51 is arranged in the region of the connection port 45 on the first end side in the first direction X.
  • the detected portion 51 is arranged in the opening 47 of the connection port 45 in the administration port 40.
  • the detected portion 51 is arranged on the outer periphery of the opening 47. In these cases, it is preferable to provide the detected portion 51 on the cap 46. In this case, the detected portion 51 can be formed by arranging the resin containing the magnetic member on the peripheral surface 46a of the cap.
  • the layered magnetic portion 51a is molded over the entire circumference of the cap peripheral surface 46a.
  • the detected portion 51 that covers the outer peripheral surface of the opening 47 can be formed, so that detection is possible regardless of the mounting orientation of the cap 46.
  • a magnetic material magnetic powder such as iron, cobalt, nickel, and ferrite can be used.
  • various rubber materials and additives such as a vulcanizing agent can be appropriately used.
  • the sensor 52 is provided as a detection unit for detecting the fitting of the connection port 45 into the fitting unit 21c, and is set according to the type of the detection unit 51.
  • the sensor 52 may be a magnetic sensor 52a capable of detecting the magnitude of the magnetic field (magnetic field) and further measuring the direction of the magnetic field.
  • a magnetic sensor 52a may be, for example, a magnetoresistive element or a Hall element.
  • the magnetic sensor 52a is attached to a position where the magnetic force of the magnetic portion 51a provided in the administration port 40 can be detected in a state where the apparatus main body 20 is normally attached to the cradle 30 in which the administration port 40 is installed. ..
  • Such a magnetic sensor 52a is arranged so as to hang down from the reuse portion 20a of the apparatus main body 20, for example, toward the peripheral wall of the fitting portion 21c in the disposable portion 20b.
  • the detection unit of the magnetic sensor 52a is arranged in the storage unit 21a, and the detected unit 51 is arranged in the back surface storage unit 21b.
  • the detection unit of the magnetic sensor 52a is arranged in at least a part of the region along the peripheral surface of the tubular hole 28 in the storage unit 21a.
  • the magnetic sensor 52a faces the magnetic portion 51a with the bottom surface of the optical housing 21 sandwiched between them. It is preferable that a plurality of such magnetic sensors 52a are provided so as to face the magnetic portion 51a. In this case, it is preferable that the magnetic portion 51a is arranged so as to surround the central axis of the opening 47, and that each magnetic sensor 52a and the magnetic portion 51a face each other in the same state. As a result, the strength of the magnetic force detected by each magnetic sensor 52a becomes uniform, and it can be detected that the axis surrounded by the magnetic portion 51a and the central axis of the substantially cylindrical connection port 45 are substantially parallel. ..
  • the remote controller 60 operates the drive of the device main body 20.
  • the remote controller 60 includes a display unit 61, an operation unit 62, a controller output unit 63, a controller communication unit 64, and a controller calculation unit 65 that controls them.
  • the remote controller 60 having these may be one in which a dedicated program is installed in a mobile terminal such as a smartphone. The details of each component are as follows.
  • the display unit 61 displays various setting contents related to driving the device main body 20, input contents by the operation unit 62 described below, administration history in the device main body 20, and the like.
  • the operation unit 62 is a user interface portion for the user to input insulin administration settings by the device main body 20, execution and stop of control of the device main body 20, selection of display contents on the display unit 61, and the like.
  • Such an operation unit 62 may be, for example, a keypad or a touch panel provided on the display surface of the display unit 61.
  • the display unit 61 displays a selection button, a numeric keypad, or the like for the touch panel.
  • the controller output unit 63 outputs the alarm W in response to an instruction from the controller calculation unit 65 described below.
  • the alarm W for example, a controller output unit 63 that emits vibration, sound, light emission, or the like alone or in combination is applied.
  • the controller communication unit 64 is a part that communicates with the paired device main body 20.
  • the controller communication unit 64 is composed of a transmission unit and a reception unit.
  • the controller communication unit 64 is a part that performs wireless communication with the main body communication unit 15 on the device main body 20 side, and the same standardized wireless communication technology as the main body communication unit 15 is applied.
  • the controller calculation unit 65 causes the display unit 61 to display various settings input in the operation unit 62, causes the controller communication unit 64 to transmit various settings to the device main body 20, and alerts the controller output unit 63. W is output.
  • the controller calculation unit 65 as described above is provided with, for example, a CPU (Central Processing Unit), a RAM (Random Access Memory), and a ROM (Read Only Memory), which are not shown here.
  • the above-mentioned input, display, communication, and output are executed by such a controller calculation unit 65.
  • the user of the drug solution administration device 1 assembles the device main body 20 by combining the reuse unit 20a and the disposable unit 20b filled with the drug solution in the reservoir 22 prior to performing the drug solution administration by the drug solution administration device 1.
  • the electric power from the battery 23a arranged in the disposable unit 20b is supplied to the power supply unit provided on the circuit board 12 of the reuse unit 20a, and the main body calculation unit 16 provided in the reuse unit 20a is activated.
  • the main unit arithmetic unit 16 executes a predetermined program and waits for a priming instruction from the user.
  • the user of the chemical solution administration device 1 pushes out the chemical solution filled in the reservoir 22 by operating the operation unit 62 of the remote controller 60 so as to fill the inside of the liquid delivery pipe 22a drawn from the outer cylinder of the reservoir 22.
  • Prime is performed so that air is discharged from the tip of the connecting needle tube 22b.
  • the user of the drug solution administration device 1 installs the administration port 40 for the cradle 30.
  • the user first adheres the cradle 30 to the skin by the adhesive portion 32.
  • the administration port 40 is installed in the holding portion 31c of the cradle 30 in a predetermined state by using a dedicated jig such as a puncture device (not shown).
  • a dedicated jig such as a puncture device (not shown).
  • the cannula portion 41 of the administration port 40 and the inner needle 400 in the cannula portion 41 are punctured and inserted into the user's skin.
  • the inner needle 400 is removed from the inside of the cannula portion 41, and the cannula portion 41 is placed subcutaneously.
  • the priming-executed device main body 20 is attached to the cradle 30 in which the administration port 40 is installed.
  • the user operates the remote controller 60 to input to start the administration of the drug solution.
  • the program of the control method of the drug solution administration device described below is executed.
  • FIG. 10 is a flowchart for explaining a control method of the drug solution administration device 1 according to the first embodiment.
  • the CPU of each device constituting the main body calculation unit 16 of the drug solution administration device 1 described with reference to FIG. 3 uses a program recorded in a ROM or RAM. It is realized by executing.
  • the control method of the drug solution administration device 1 will be described in the order shown in the flowchart of FIG. 10 with reference to FIG. 3 and the required figure.
  • step S101 the main body calculation unit 16 determines whether or not the main body communication unit 15 has received the instruction to start the administration of the drug solution.
  • the instruction to start the administration of the drug solution is an instruction based on the input from the operation unit 62 of the remote controller 60 by the user, and the information of the administration start instruction input from the operation unit 62 is the main body communication from the controller communication unit 64. It is transmitted to the unit 15.
  • the main body calculation unit 16 waits until the main body communication unit 15 determines that the administration start instruction has been received (YES), and when it determines that the administration start instruction has been received (YES), the main body calculation unit 16 proceeds to the next step S102. move on.
  • step S102 the main body calculation unit 16 refers to the signal from the sensor 52, the connection port 45 of the administration port 40 is fitted into the fitting portion 21c of the device main body 20, and the connection needle tube 22b and the cannula unit 41 are normal. Determine if it is connected to.
  • the main body calculation unit 16 determines that the connection is normally made (YES).
  • the main body calculation unit 16 determines that the connection is not normally performed (NO).
  • the threshold values set in each sensor 52 do not have to be the same value.
  • the signal strength detected by each sensor 52 is tested in advance in a state where the connection port 45 of the administration port 40 is normally fitted to the fitting portion 21c in the housing 21 of the disposable portion 20b of the apparatus main body 20. It is assumed that it has been acquired. Then, it is assumed that the threshold value of the signal strength detected by each sensor 52 is set based on the acquired value.
  • the state in which the connection port 45 is normally fitted into the fitting portion 21c means that the central axes of the respective central axes are in a state in which the cylindrical connection port 45 is fitted into the substantially cylindrical fitting portion 21c. It shall be in a substantially parallel state.
  • the main unit calculation unit 16 is normally connected (YES) when all the signal intensities from each sensor 52 exceed or exceed the threshold values set in advance. Judgment is made, and in other cases, it is judged that the connection is not normally performed (NO).
  • step S103 if it is determined that the connection is normally made (YES), the process proceeds to step S103, and if it is determined that the connection is not normally made (NO), the process proceeds to step S104.
  • step S103 the main body calculation unit 16 starts the liquid feeding process of discharging the chemical solution from the reservoir 22 by driving the liquid feeding driving unit 13, and ends the series of processes.
  • step S104 the main body calculation unit 16 instructs the main body output unit 14 to output an alarm.
  • the main body output unit 14 outputs an alarm, notifies the user of the drug solution administration device 1 that the cannula unit 41 and the connecting needle tube 22b are not normally connected, and the administration port 40 is installed. It prompts the cradle 30 to be reattached to the apparatus main body 20.
  • the main body calculation unit 16 instructs the main body communication unit 15 to transmit a poor connection.
  • the main body communication unit 15 transmits a connection failure notification to the controller communication unit 64.
  • the controller calculation unit 65 instructs the controller output unit 63 to output an alarm when the controller communication unit 64 receives the notification of the connection failure.
  • the controller output unit 63 outputs an alarm and notifies the user of the drug solution administration device 1 that the cannula unit 41 and the connecting needle tube 22b are not normally connected, so that the administration port 40 is installed. It is urged to reattach the cradle 30 and the apparatus main body 20. After that, a series of processes is completed.
  • the sensor 52 detects that the signal from the detected unit 51 has been turned off. Then, it may return to step S102.
  • the connection state between the fitting portion 21c and the connection port 45 may be constantly monitored by the sensor 52.
  • the magnetic portion 51a is provided so as to surround the connection port 45 in the administration port 40, and the position of the apparatus main body 20 facing the fitting portion 21c into which the connection port 45 is fitted.
  • the magnetic sensor 52a is provided on the surface. Therefore, the fitted state of the connection port 45 with respect to the fitting portion 21c can be directly detected by the signal strength from the magnetic sensor 52a. Further, this makes it possible to detect the connection between the connecting needle tube 22b held by the fitting portion 21c and the connecting port 45. Further, by providing the plurality of magnetic sensors 52a, it is possible to detect whether or not the connection port 45 is fitted in parallel with the fitting portion 21c.
  • FIG. 11 is a cross-sectional view (No. 1) of the main part of the chemical solution administration device 2 of the second embodiment.
  • FIG. 12 is a cross-sectional view (No. 2) of an excerpt of a main part of the drug solution administration device 2 of the second embodiment.
  • FIG. 13 is a block diagram of the drug solution administration device 2 of the second embodiment.
  • the difference between the drug solution administration device 2 of the second embodiment shown in these figures and the drug solution administration device 1 of the first embodiment is the configuration of the connection detection device 70, and the other components are the same. Therefore, only the configuration of the connection detection device 70 will be described here.
  • connection detection device 70 is a device for detecting that the connection port 45 is fitted into the fitting portion 21c when the device main body 20 is attached to the cradle 30 in which the administration port 40 is installed.
  • a connection detection device 70 is an intermediate between a switch pressing member 71 provided in the administration port 40, a micro switch 72 as a detection unit provided in the device main body 20, and a disposable part 20b of the device main body 20. It is composed of a member 73 and a protruding member 74.
  • the chemical solution administration device 2 may be provided with a plurality of these members. Each configuration will be described below.
  • the switch pressing member 71 is for pressing the micro switch 72 described below.
  • a switch pressing member 71 is provided on the first end surface of the connection port 45 in the administration port 40 in the first direction X.
  • the switch pressing member 71 is provided in a state of being held by the cap 46 at a position where the open end of the connection port 45 is extended.
  • the switch pressing member 71 is a convex portion 71a provided on the cap end surface 46b.
  • the convex portion 71a is preferably provided so that at least a part of the convex portion 71a overlaps with the position where the opening edge of the opening 47 is extended in the first direction X.
  • the convex portion 71a is preferably provided in the upper region of the opening edge of the opening 47 in the third direction Z. This makes it easier to arrange the microswitch 72, which will be described later, extending from the reuse unit 20a. Since connection detection can be performed based on the position of the reuse unit 20a constituting the device main body 20, positioning accuracy can be improved.
  • the convex portion 71a is preferably formed of a material that is harder than the cap 46. It is important that the switch pressing member 71 does not interfere with the sealed state of the connection port 45 by the cap 46 and the fitting of the connection port 45 into the fitting portion 21c. Further, the switch pressing member 71 may be a partially deformed cap 46 or may be molded at the same time as the cap 46. Alternatively, the switch pressing member 71 may be a separate body from the cap 46.
  • each switch pressing member 71 is provided at each position extending the open end of the connection port 45.
  • the switch pressing members 71 are preferably provided at positions separated from each other, and are arranged so as to be symmetrical with respect to the center of the cap end surface 46b or the opening end surface of the connection port 45.
  • the micro switch 72 is provided as a detection unit for detecting the fitting of the connection port 45 into the fitting portion 21c.
  • the microswitch 72 is arranged at a position where it is directly or indirectly pressed by the switch pressing member 71 when the apparatus main body 20 is attached to the cradle 30 on which the administration port 40 is installed while sliding. ..
  • a detection relay portion A is provided on the bottom surface 28a of the tubular hole 28 of the fitting portion 21c at a position facing the switch pressing member 71 described above.
  • the micro switch 72 is arranged so as to hang down from the reuse portion 20a of the apparatus main body 20 toward the disposable portion 20b, for example.
  • the micro switch 72 is arranged in the accommodating portion 21a and the switch pressing member 71 is arranged in the back surface accommodating portion 21b via the detection relay unit A.
  • the micro switch 72 detects the fit of the connection port 45 into the fitting portion 21c by detecting the response from the detection relay unit A.
  • the micro switches 72 are provided at positions corresponding to the respective switch pressing members 71.
  • connection detection can be performed based on the position of the reuse unit 20a constituting the device main body 20, so that the positioning accuracy can be improved.
  • micro switch 72 is connected to the main body calculation unit 16. Further, the micro switch 72 is directly or indirectly pressed by the switch pressing member 71 of the administration port 40 when the apparatus main body 20 is attached to the cradle 30 on which the administration port 40 is installed while sliding. Turns on.
  • the micro switch 72 may be provided in the reuse unit 20a if it is turned on in such a case.
  • the detection relay unit A directly or indirectly transmits the input from the pressing member 71 to the microswitch 72 between the disposable member (cradle 30 to which the administration port 40 is connected, the disposable unit 20b) and the reuse unit 20a. At a position facing the microswitch 72, it is provided at least at one position on the bottom surface of the fitting portion 21c in the disposable portion 20b of the apparatus main body 20.
  • the detection relay unit A is provided according to the number and position of the pressing member 71 and / or the microswitch 72.
  • the detection relay portion A may be an opening provided on the disposable portion 20b, but it is preferable that the opening is liquid-tightly closed by an intermediate member 73 having flexibility.
  • the intermediate member 73 may have a film shape or a plug shape.
  • the intermediate member 73 is pressed by the switch pressing member 71 described above when the apparatus main body 20 is attached to the cradle 30 in which the administration port 40 is installed while sliding, and projects toward the microswitch 72 side.
  • Such an intermediate member 73 is formed of, for example, a rubber member.
  • the detection relay unit A may further include a protruding member 74 in addition to the intermediate member 73.
  • the projecting member 74 is provided on the surface of the intermediate member 73 toward the micro switch 72 side, and is micro when the device main body 20 is slid and attached to the cradle 30 in which the administration port 40 is installed. Press the switch 72 directly.
  • the projecting member 74 is selected from those that can reliably transmit the input from the switch pressing member 71 according to the detection method of the micro switch 72.
  • the projecting member 74 may be made of a material harder than the intermediate member 73.
  • the protruding member 74 and the micro switch 72 may be used as a contact sensor using a known detection method.
  • control method of the drug solution administration device 2 is carried out in the same manner as the control method of the drug solution administration device 1 of the first embodiment.
  • the determination as to whether or not the liquid feeding pipe 22a and the cannula portion 41 are normally connected is performed as follows. That is, when the micro switch 72 is turned on, the main body calculation unit 16 determines that the connection is normally made (YES), and if the micro switch 72 is not turned on, the connection is not normally made (NO). to decide.
  • the main body calculation unit 16 is normally connected when all the microswitches 72 of each connection detection device 70 are turned on (YES). In other cases, it is determined that the connection is not normal (NO).
  • the switch pressing member 71 is provided at the tip of the connection port 45 in the administration port 40, and the position of the device main body 20 facing the fitting portion 21c into which the connection port 45 is fitted.
  • the micro switch 72 is provided on the surface. Therefore, the fitted state of the connection port 45 with respect to the fitting portion 21c can be directly detected by turning on / off the micro switch 72. Further, this makes it possible to detect the connection between the connecting needle tube 22b held by the fitting portion 21c and the cannula portion 41 communicating with the connecting port 45. Further, by providing a plurality of sets of switch pressing members 71 and a micro switch 72, it is possible to detect whether or not the connection port 45 is fitted in parallel with the fitting portion 21c.
  • the cannula portion 41 held in the administration port 40 and the connection extended from the reservoir 22 are connected. It is possible to detect a poor connection with the needle tube 22b and urge the user of the drug solution administration device 2 to reattach it. That is, the connection between the fitting end portion 48 and the connecting needle tube 22b can be detected in the vicinity of the connecting portion. As a result, in the drug solution administration device 2, it is possible to prevent the drug solution from leaking from the connection portion between the device main body 20 and the administration port 40, and to perform highly accurate drug solution administration.

Abstract

The present invention relates to a drug solution administration device which is used in a state where the device body is attached to a cradle adhering to the skin. The device body stores, in a housing, a reservoir filled with a drug solution, a liquid supply tube extending from the reservoir, and a computation unit for controlling the discharge of the drug solution from the reservoir, and is provided with an engagement part which exposes the distal end part of the liquid supply tube to the outside of the housing. The cradle has a cannula part to be inserted subcutaneously and a connection port having a fit-in end part to be connected to the engagement part. The drug solution administration device is further provided with a connection detection device for detecting the connection between the engagement part and the connection port. This enables the computation unit to control the discharge of the drug solution from the reservoir on the basis of signals from the connection detection device.

Description

薬液投与装置および薬液投与装置の制御方法Control method of drug solution administration device and drug solution administration device
 本発明は、薬液投与装置および薬液投与装置の制御方法に関する。 The present invention relates to a drug solution administration device and a method for controlling the drug solution administration device.
 近年、皮下注射や静脈内注射などによって、患者の体内に薬液を持続的に投与する治療法が行われている。例えば、糖尿病患者に対する治療法として、患者の体内に微量のインスリンを持続的に投与する治療が実施されている。この治療法に用いられる薬液投与装置の一例として、下記特許文献1に示すものがある。 In recent years, a treatment method in which a drug solution is continuously administered into a patient's body by subcutaneous injection or intravenous injection has been performed. For example, as a treatment method for a diabetic patient, a treatment in which a small amount of insulin is continuously administered into the body of the patient is carried out. As an example of the drug solution administration device used in this treatment method, there is one shown in Patent Document 1 below.
 下記特許文献1に示す薬液投与装置は、生体内に薬液を注入する注入部材(カニューレ)を備えた注入部(注入ディスポ部)と、注入部材に薬液を送液する送液部材(送液ディスポ部および送液リユース部)に送液する送液器を備えた送液部と、注入部と送液部との連結分離を検出する検出部と、送液器の動作を制御する制御部とを有する。検出部は、注入ディスポ部の筐体の一面に備えられた当接部材と、送液ディスポ部の連結部の一面に設けられたスイッチを含んでいる。 The drug solution administration device shown in Patent Document 1 below has an injection section (injection disposable section) provided with an injection member (cannula) for injecting the drug solution into the living body, and a liquid delivery member (liquid delivery disposable section) for feeding the drug solution to the injection member. A liquid feeder equipped with a liquid dispenser that feeds liquid to the unit and the liquid feed reuse unit, a detection unit that detects the connection and separation between the injection unit and the liquid supply unit, and a control unit that controls the operation of the liquid dispenser. Has. The detection unit includes a contact member provided on one surface of the housing of the injection disposable unit and a switch provided on one surface of the connecting portion of the liquid feeding disposable unit.
 このような構成の薬液投与装置によれば、制御部において、注入部と送液部とが連結した状態であることを検出部が検出した結果に基づき、送液器による投与動作を制限すれば、生体内への意図しない薬液の投与が防止できるとしている。 According to the drug solution administration device having such a configuration, if the control unit limits the administration operation by the liquid dispenser based on the result of the detection unit detecting that the injection unit and the liquid supply unit are connected. , It is said that unintended administration of drug solution into the living body can be prevented.
国際公開第2016/075976号International Publication No. 2016/075976
 しかしながら以上のような注入部と送液部とが分離可能に連結する薬液投与装置においては、これらが連結された状態であっても、注入部に設けられたカニューレと、送液部に設けられた送液器の送液管との接続状態が良好であるとは限らない。また、連結後、カニューレと送液管との接続状態が不安定な場合に、これらの接続部分から薬液が漏れ出すことが懸念され、カニューレと送液管との接続の不具合が精度の高い薬液投与を阻害する要因となっていた。 However, in the above-mentioned chemical solution administration device in which the injection section and the liquid delivery section are separably connected, even when they are connected, the cannula provided in the injection section and the liquid delivery section are provided. The connection state of the liquid dispenser with the liquid supply pipe is not always good. In addition, if the connection between the cannula and the liquid feed pipe is unstable after connection, there is a concern that the chemical liquid may leak from these connection parts, and the poor connection between the cannula and the liquid feed pipe may cause a highly accurate chemical liquid. It was a factor that hindered administration.
 そこで本発明は、カニューレと送液管との接続状態を検知することが可能な薬液投与装置を提供すること、および精度の高い薬液投与が可能な薬液投与装置の制御方法を提供することを目的とする。 Therefore, an object of the present invention is to provide a drug solution administration device capable of detecting the connection state between the cannula and the liquid delivery pipe, and to provide a control method of the drug solution administration device capable of highly accurate drug solution administration. And.
 このような目的を達成するための本発明の薬液投与装置は、皮膚に接着するクレードルに対して装置本体を装着することで使用する薬液投与装置に関する。装置本体は、薬液が充填されるリザーバと、リザーバから延設された送液管と、リザーバからの薬液の排出を制御する演算部と、を筐体内に収容し、送液管の先端部を筐体外へ露出させる嵌合部を備える。クレードルは、皮下に穿刺挿入されるカニューレ部と、嵌合部と接続する嵌入端部を有する接続ポートとを有する。薬液投与装置は、さらに、嵌合部と接続ポートとの接続を検知する接続検知装置を備える。 The drug solution administration device of the present invention for achieving such an object relates to a drug solution administration device used by attaching the device body to a cradle that adheres to the skin. The main body of the device accommodates a reservoir filled with a chemical solution, a liquid feed pipe extending from the reservoir, and a calculation unit for controlling the discharge of the chemical liquid from the reservoir in a housing, and the tip of the liquid feed pipe is accommodated. A fitting portion that is exposed to the outside of the housing is provided. The cradle has a cannula that is punctured and inserted subcutaneously and a connecting port that has a fitting end that connects to the fitting. The drug solution administration device further includes a connection detection device that detects the connection between the fitting portion and the connection port.
 本発明によれば、カニューレと送液管との接続状態を検知することが可能な薬液投与装置を提供すること、および精度の高い薬液投与が可能な薬液投与装置の制御方法を提供することができる。 According to the present invention, it is possible to provide a drug solution administration device capable of detecting a connection state between a cannula and a liquid delivery pipe, and to provide a control method of a drug solution administration device capable of highly accurate drug solution administration. it can.
第1実施形態の薬液投与装置の全体構成を説明するための分解斜視図である。It is an exploded perspective view for demonstrating the whole structure of the drug solution administration apparatus of 1st Embodiment. 第1実施形態の薬液投与装置の要部の平面図である。It is a top view of the main part of the drug solution administration apparatus of 1st Embodiment. 第1実施形態の薬液投与装置のブロック図である。It is a block diagram of the drug solution administration apparatus of 1st Embodiment. 第1実施形態の薬液投与装置における装置本体の斜視図である。It is a perspective view of the apparatus main body in the drug solution administration apparatus of 1st Embodiment. 第1実施形態の薬液投与装置におけるクレードルに対する装置本体の装着を説明するための斜視図である。It is a perspective view for demonstrating the attachment of the apparatus main body with respect to the cradle in the chemical solution administration apparatus of 1st Embodiment. 第1実施形態の薬液投与装置の要部を抜粋した断面図(その1)である。It is sectional drawing (the 1) excerpt of the main part of the drug solution administration apparatus of 1st Embodiment. 第1実施形態の薬液投与装置の要部を抜粋した断面図(その2)である。It is sectional drawing (the 2) excerpt of the main part of the drug solution administration apparatus of 1st Embodiment. 第1実施形態の薬液投与装置に設けられた接続検知装置を説明する拡大断面図(その1)である。It is an enlarged cross-sectional view (the 1) explaining the connection detection apparatus provided in the chemical solution administration apparatus of 1st Embodiment. 第1実施形態の薬液投与装置に設けられた接続検知装置を説明する拡大断面図(その2)である。FIG. 2 is an enlarged cross-sectional view (No. 2) illustrating a connection detection device provided in the drug solution administration device of the first embodiment. 第1実施形態の薬液投与装置の制御方法を説明するフローチャートである。It is a flowchart explaining the control method of the drug solution administration apparatus of 1st Embodiment. 第2実施形態の薬液投与装置の要部を抜粋した断面図(その1)である。It is sectional drawing (the 1) excerpt of the main part of the drug solution administration apparatus of 2nd Embodiment. 第2実施形態の薬液投与装置の要部を抜粋した断面図(その2)である。It is sectional drawing (the 2) excerpt of the main part of the drug solution administration apparatus of 2nd Embodiment. 第2実施形態の薬液投与装置のブロック図である。It is a block diagram of the drug solution administration apparatus of 2nd Embodiment.
 以下、本発明を適用した各実施形態を図面に基づいて詳細に説明する。なお、各実施形態においては、同一の構成要素には同一の符号を付し、重複する説明は省略する。 Hereinafter, each embodiment to which the present invention is applied will be described in detail with reference to the drawings. In each embodiment, the same components are designated by the same reference numerals, and duplicate description will be omitted.
≪第1実施形態≫
<薬液投与装置の構成>
 図1は、第1実施形態の薬液投与装置1の全体構成を説明するための分解斜視図である。図2は、第1実施形態の薬液投与装置1の要部の平面図である。また図3は、第1実施形態の薬液投与装置1のブロック図である。これらの図に示す薬液投与装置1は、患者の体内に薬液を持続的に投与するための装置である。この薬液投与装置1は、インスリン、鎮痛薬、抗癌治療薬、HIV薬、鉄キレート薬、肺高血圧症治療薬等を投与できる。
<< First Embodiment >>
<Configuration of drug solution administration device>
FIG. 1 is an exploded perspective view for explaining the overall configuration of the drug solution administration device 1 of the first embodiment. FIG. 2 is a plan view of a main part of the drug solution administration device 1 of the first embodiment. Further, FIG. 3 is a block diagram of the drug solution administration device 1 of the first embodiment. The drug solution administration device 1 shown in these figures is a device for continuously administering the drug solution into the body of a patient. This drug solution administration device 1 can administer insulin, analgesics, anticancer therapeutic agents, HIV agents, iron chelating agents, pulmonary hypertension therapeutic agents and the like.
 このような薬液投与装置1は、装置本体20、クレードル30、クレードル30に設置される投与ポート40、装置本体20と投与ポート40に設けられた接続検知装置50、およびリモートコントローラ60を有する。このうち装置本体20は、リユース部20aとディスポ部20bとに結合可能に分離できる。図2は、装置本体20のディスポ部20b、クレードル30、および投与ポート40の平面図に相当する。 Such a drug solution administration device 1 has a device main body 20, a cradle 30, an administration port 40 installed in the cradle 30, a connection detection device 50 provided in the device main body 20 and the administration port 40, and a remote controller 60. Of these, the apparatus main body 20 can be detachably separated into the reuse portion 20a and the disposable portion 20b. FIG. 2 corresponds to a plan view of the disposable portion 20b, the cradle 30, and the administration port 40 of the apparatus main body 20.
 以下、これらの図に基づいて、薬液投与装置1の詳細な構成を、装置本体20を構成するリユース部20aおよびディスポ部20b、クレードル30、投与ポート40、接続検知装置50、リモートコントローラ60の順に説明する。 Hereinafter, based on these figures, the detailed configuration of the drug solution administration device 1 will be described in the order of the reuse unit 20a and the disposable unit 20b, the cradle 30, the administration port 40, the connection detection device 50, and the remote controller 60 constituting the device main body 20. explain.
 なお、装置本体20が、クレードル30の第1端から第2端に向かう方向にスライドすることで、装着される。この方向(装着方向)を第1の方向Xとし、第1の方向Xと直交し、薬液投与装置1の薬液投与時における装置本体20とクレードル30が重なる方向とも直交する方向を第2の方向Y(幅方向)とする。すなわち、第2の方向Yは、薬液投与装置1の薬液投与時において生体表面と略平行となる方向である。装置本体20とクレードル30が重なる方向、すなわち第1の方向Xと第2の方向Yとも直交する方向を第3の方向Z(上下方向)とする。ここで、第3の方向Zは、薬液投与装置1の薬液投与時において生体表面と直交する方向である。すなわち、第3の方向Zの下側は生体表面に向かう方向である。 The device main body 20 is attached by sliding in the direction from the first end to the second end of the cradle 30. This direction (mounting direction) is defined as the first direction X, and the direction orthogonal to the first direction X and orthogonal to the direction in which the device main body 20 and the cradle 30 overlap when the drug solution is administered is the second direction. Let it be Y (width direction). That is, the second direction Y is a direction that is substantially parallel to the surface of the living body when the drug solution is administered by the drug solution administration device 1. The direction in which the apparatus main body 20 and the cradle 30 overlap, that is, the direction orthogonal to the first direction X and the second direction Y is defined as the third direction Z (vertical direction). Here, the third direction Z is a direction orthogonal to the surface of the living body when the drug solution is administered by the drug solution administration device 1. That is, the lower side of the third direction Z is the direction toward the surface of the living body.
[リユース部20a(装置本体20)]
 リユース部20aは、蓋体11と、回路基板12と、送液駆動部13と、を有する。リユース部20aは、装置本体20の電子制御機能が集約的に配置された部分である。このリユース部20aは、図1に示した蓋体11の内部に、電子制御機能を収容して構成されている。蓋体11の内部には、回路基板12と、送液駆動部13と、を収容する。回路基板12には、本体出力部14、本体通信部15、および本体演算部16が設けられている。送液駆動部13は、モータや歯車部等を有する。またリユース部20aには、以降に説明する接続検知装置50のセンサ52が電子制御機能として設けられている。
[Reuse unit 20a (device body 20)]
The reuse unit 20a includes a lid 11, a circuit board 12, and a liquid feed drive unit 13. The reuse unit 20a is a portion in which the electronic control functions of the apparatus main body 20 are centrally arranged. The reuse unit 20a is configured to accommodate an electronic control function inside the lid 11 shown in FIG. A circuit board 12 and a liquid feeding drive unit 13 are housed inside the lid 11. The circuit board 12 is provided with a main body output unit 14, a main body communication unit 15, and a main body calculation unit 16. The liquid feeding drive unit 13 includes a motor, a gear unit, and the like. Further, the reuse unit 20a is provided with a sensor 52 of the connection detection device 50 described below as an electronic control function.
-蓋体11-
 蓋体11は、以降に説明するディスポ部20bの筐体21と嵌合するものであり、第3の方向Zの上側の面は、薬液投与装置1の天面となる。筐体11のディスポ部20bに向かう主面側(第3の方向Zの下側)は、上述した電子制御機能が収容された構成となっている。ここで、主面とは、リユース部20aとディスポ部20bとの接続面を指す。
-Lid 11-
The lid 11 is fitted to the housing 21 of the disposable portion 20b described later, and the upper surface in the third direction Z is the top surface of the drug solution administration device 1. The main surface side (lower side of the third direction Z) of the housing 11 toward the disposable portion 20b has a configuration in which the above-mentioned electronic control function is housed. Here, the main surface refers to the connecting surface between the reuse unit 20a and the disposable unit 20b.
-回路基板12-
 回路基板12は、蓋体11内に固定されたもので、上述した送液駆動部13、本体出力部14、本体通信部15、本体演算部16、およびセンサ52を相互に接続する状態で、これらを搭載する。またこの回路基板12は、以降に説明するディスポ部20bに配置される電池23aからの電力を、配線を介して各部に供給するための電源部(図示省略)を備えている。
-Circuit board 12-
The circuit board 12 is fixed inside the lid 11, and the liquid feed drive unit 13, the main body output unit 14, the main body communication unit 15, the main body calculation unit 16, and the sensor 52 described above are connected to each other. These are installed. Further, the circuit board 12 includes a power supply unit (not shown) for supplying electric power from the battery 23a arranged in the disposable unit 20b to be described later to each unit via wiring.
-送液駆動部13-
 送液駆動部13は、ディスポ部20bに設けられたリザーバ22の押し子を駆動させるものである。この送液駆動部13は、例えば電池によって駆動されるモータおよび、モータの駆動によって連動して回転する複数段の歯車で構成されている。なお、送液駆動部13は、これらの構成に限らず、リザーバ22から薬液を排出させる機構を有するものであればよい。
-Liquid feed drive unit 13-
The liquid feed driving unit 13 drives the pusher of the reservoir 22 provided in the disposable unit 20b. The liquid feeding drive unit 13 is composed of, for example, a motor driven by a battery and a plurality of stages of gears that rotate in conjunction with the drive of the motor. The liquid feeding drive unit 13 is not limited to these configurations, and may have a mechanism for discharging the chemical liquid from the reservoir 22.
-本体出力部14-
 本体出力部14は、警報Wを出力する。この本体出力部14が出力する警報Wとしては、例えば振動または音などを単独で、またはこれらを併用して発するものが適用され、さらに光を発するものであってもよい。
-Main unit output unit 14-
The main body output unit 14 outputs the alarm W. As the alarm W output by the main body output unit 14, for example, one that emits vibration or sound alone or in combination thereof is applied, and may further emit light.
-本体通信部15-
 本体通信部15は、ペアリングされたリモートコントローラ60との間で無線通信を行う部分である。この本体通信部15は、発信部と受信部とを有し、所定の波長帯域の電波を使った無線通信を行う部分であり、特に極超短波またはマイクロ波を用いた無線通信を行う。
-Main unit communication unit 15-
The main body communication unit 15 is a part that performs wireless communication with the paired remote controller 60. The main body communication unit 15 has a transmission unit and a reception unit, and is a portion that performs wireless communication using radio waves in a predetermined wavelength band, and particularly performs wireless communication using ultra-high frequency waves or microwaves.
 ここでは、本体通信部15において、通信距離が100m前後の無線通信が行われることとする。具体的には、ZigBee(IEEE802.15.4:周波数2.4GHz)、Bluetooth(登録商標:IEEE802.15.1:周波数2.4GHz)、無線LAN(IEEE802.11a/b/g:周波数2.4GHz,5GHz)等の規格化された無線通信技術が適用される。 Here, it is assumed that the main body communication unit 15 performs wireless communication with a communication distance of about 100 m. Specifically, ZigBee (IEEE802.154: frequency 2.4 GHz), Bluetooth (registered trademark: IEEE802.5.1: frequency 2.4 GHz), wireless LAN (IEEE802.11a / b / g: frequency 2. Standardized wireless communication technology such as 4 GHz, 5 GHz) is applied.
-本体演算部16-
 本体演算部16は、ペアリングされたリモートコントローラ60から送信された信号、およびセンサ52で取得した信号に基づいて、送液駆動部13の動作を制御することにより、リザーバ22からの薬液の排出を制御する。また本体演算部16は、本体出力部14、および本体通信部15の動作を制御する。このような本体演算部16は、例えばここでの図示を省略したCPU(Central Processing Unit)、RAM(Random Access Memory)、ROM(Read Only Memory)を備えたものである。本体演算部16によって実行される、薬液投与の制御は、以降の薬液投与装置の制御方法において詳細に説明する。
-Main unit calculation unit 16-
The main unit calculation unit 16 controls the operation of the liquid feed drive unit 13 based on the signal transmitted from the paired remote controller 60 and the signal acquired by the sensor 52, thereby discharging the chemical solution from the reservoir 22. To control. Further, the main body calculation unit 16 controls the operations of the main body output unit 14 and the main body communication unit 15. Such a main body arithmetic unit 16 includes, for example, a CPU (Central Processing Unit), a RAM (Random Access Memory), and a ROM (Read Only Memory), which are not shown here. The control of drug solution administration executed by the main body calculation unit 16 will be described in detail in the subsequent control method of the drug solution administration device.
[ディスポ部20b(装置本体20)]
 ディスポ部20bは、筐体21と、この筐体21の内部に収納されたリザーバ22、および電池ボックス23を備えている。筐体21の上面(主面側)は、リユース部20aの蓋体11によって覆われる。
[Disposable part 20b (device body 20)]
The disposable portion 20b includes a housing 21, a reservoir 22 housed inside the housing 21, and a battery box 23. The upper surface (main surface side) of the housing 21 is covered with the lid 11 of the reuse portion 20a.
-筐体21-
 筐体21は、上面視で略矩形状である長方体であり、いずれの角部も丸く形成されている。筐体21は、使用時において、クレードル30上に対向する筐体底面21dと、筐体底面21dの周囲においてリユース部20a側(第3の方向Zの上側)に向かって立設する筐体側面部21eとを有する。筐体底面21dおよび筐体側面部21eで取り囲まれる空間は、収納部21aを形成する。収納部21aは後述のリザーバ22や電池23a等を収容する。収納部21aは、平箱形状の筐体21の主面側を大きく開口した凹状部である。すなわち、収納部21aは、リユース部20aに向かって開口している。このような筐体21は、収納部21aの開口が、リユース部20aの蓋体11によって閉塞される。平箱形状の筐体21の底面における角部のうちの1箇所には、該底面の一部を、第3の方向Zの上方向に向かって凹ませた裏面収納部21bが設けられる。収納部21aの容積は、裏面収納部21bの容積よりも大きい。また裏面収納部21bの底面26は、筐体21内において、主面側に向かって凸となっている。より詳細には、裏面収納部21bの底面26は、少なくとも壁部25の高さに応じて筐体底面21dから収納部21aの開口側にも向かって凹んでいる。これらの収納部21aと裏面収納部21bとを隔てる壁部25には、裏面収納部21b側に露出する嵌合部21cが形成されている。また、裏面収納部21bは、以降に説明するクレードル30に設置された状態の投与ポート40が収容される。
-Case 21-
The housing 21 is a rectangular parallelepiped that is substantially rectangular in top view, and all corners are rounded. When in use, the housing 21 stands on the bottom surface 21d of the housing facing the cradle 30 and the side surface of the housing standing toward the reuse portion 20a side (upper side in the third direction Z) around the bottom surface 21d of the housing. It has a part 21e. The space surrounded by the housing bottom surface 21d and the housing side surface portion 21e forms the storage portion 21a. The storage unit 21a stores the reservoir 22 and the battery 23a, which will be described later. The storage portion 21a is a concave portion having a large opening on the main surface side of the flat box-shaped housing 21. That is, the storage portion 21a is open toward the reuse portion 20a. In such a housing 21, the opening of the storage portion 21a is closed by the lid 11 of the reuse portion 20a. At one of the corners on the bottom surface of the flat box-shaped housing 21, a back surface storage portion 21b is provided in which a part of the bottom surface is recessed upward in the third direction Z. The volume of the storage portion 21a is larger than the volume of the backside storage portion 21b. Further, the bottom surface 26 of the back surface storage portion 21b is convex toward the main surface side in the housing 21. More specifically, the bottom surface 26 of the back surface storage portion 21b is recessed from the bottom surface 21d of the housing toward the opening side of the storage portion 21a at least according to the height of the wall portion 25. A fitting portion 21c exposed to the back surface storage portion 21b is formed on the wall portion 25 that separates the storage portion 21a and the back surface storage portion 21b. Further, the back surface accommodating portion 21b accommodates the administration port 40 in a state of being installed in the cradle 30 described later.
 嵌合部21cは、壁部25上に設けられている。嵌合部21cは、壁部25から裏面収納部21b側に向かって突出する略円筒形状の筒孔28と、接続針管22bとを有する。接続針管22bは、送液管22aに流体接続するとともに、筒孔28の軸方向略中心において、裏面収納部21b側に露出する。接続針管22bは、リザーバ22から延設された送液管22aの先端部であり、送液管22aと一体で形成されてもよい。筒孔28の中心軸は、収納部21aの底面あるいは、筐体底面21dと略平行とされている。筒孔28は、壁部25から、接続針管22bの周囲を囲むように突出することで、接続針管22bを保護する。接続針管22bは、筒孔28内において壁部25から第1の方向Xの第2端部側に向けて突出する。 The fitting portion 21c is provided on the wall portion 25. The fitting portion 21c has a substantially cylindrical tubular hole 28 projecting from the wall portion 25 toward the back surface storage portion 21b, and a connecting needle tube 22b. The connecting needle tube 22b is fluidly connected to the liquid feeding tube 22a and is exposed to the back surface accommodating portion 21b at the substantially center in the axial direction of the tubular hole 28. The connecting needle tube 22b is the tip end portion of the liquid feeding pipe 22a extending from the reservoir 22, and may be formed integrally with the liquid feeding pipe 22a. The central axis of the tubular hole 28 is substantially parallel to the bottom surface of the storage portion 21a or the bottom surface 21d of the housing. The tubular hole 28 protects the connecting needle tube 22b by projecting from the wall portion 25 so as to surround the periphery of the connecting needle tube 22b. The connecting needle tube 22b projects from the wall portion 25 toward the second end portion side in the first direction X in the tubular hole 28.
-リザーバ22-
 リザーバ22は、患者に投与する薬液が内部に貯留された外筒と、外筒に嵌入されるガスケットを備える押し子とを備えるシリンジ形状を有している。リザーバ22は、筐体21における収納部21a内に収納される。リザーバ22の外筒の先端には薬液の排出ポートが設けられており、排出ポートを介して送液管22aが接続されている。なお、リザーバ22は、シリンジ形状に限定されることはなく、ソフトバック等の種々の形状を採用できる。
-Reservoir 22-
The reservoir 22 has a syringe shape including an outer cylinder in which a drug solution to be administered to a patient is stored inside and a pusher having a gasket fitted in the outer cylinder. The reservoir 22 is housed in the storage portion 21a of the housing 21. A chemical liquid discharge port is provided at the tip of the outer cylinder of the reservoir 22, and the liquid supply pipe 22a is connected via the discharge port. The reservoir 22 is not limited to the syringe shape, and various shapes such as a soft bag can be adopted.
 図4は、第1実施形態の薬液投与装置における装置本体20の斜視図であって、リユース部20aとディスポ部20bとを結合させた装置本体20を、ディスポ部20bの裏面収納部21b側から見た図である。この図に示すように、送液管22aの先端は、装置本体20のディスポ部20bの筐体21に形成された嵌合部21c(筒孔28)の略中央において、裏面収納部21b側に引き出された状態となっている。筒孔28及び接続針管22bは、クレードル30に装置本体20が取り付けられる第1の方向Xの第2端部側に向かって突出している。 FIG. 4 is a perspective view of the device main body 20 in the chemical solution administration device of the first embodiment, in which the device main body 20 in which the reuse portion 20a and the disposable portion 20b are combined is viewed from the back surface storage portion 21b side of the disposable portion 20b. It is a view. As shown in this figure, the tip of the liquid feeding pipe 22a is located on the back surface storage portion 21b side at substantially the center of the fitting portion 21c (cylinder hole 28) formed in the housing 21 of the disposable portion 20b of the apparatus main body 20. It is in a pulled out state. The tubular hole 28 and the connecting needle tube 22b project toward the second end side in the first direction X in which the device main body 20 is attached to the cradle 30.
 図1~図3に戻り、リザーバ22の押し子の端部には歯車が設けられており、リユース部20aとディスポ部20bとを結合させた状態において、押し子の端部に設けた歯車は、リユース部20aを構成する送液駆動部13の歯車と嵌合される。これにより、送液駆動部13の駆動によってリザーバ22の押し子が外筒に押し込まれ、外筒の排出ポートを介して送液管22aの先端(接続針管22b)から薬液が排出される構成となっている。 Returning to FIGS. 1 to 3, a gear is provided at the end of the pusher of the reservoir 22, and in a state where the reuse portion 20a and the disposable portion 20b are connected, the gear provided at the end of the pusher is , It is fitted with the gear of the liquid feeding drive unit 13 constituting the reuse unit 20a. As a result, the pusher of the reservoir 22 is pushed into the outer cylinder by the drive of the liquid feeding drive unit 13, and the chemical liquid is discharged from the tip of the liquid feeding pipe 22a (connecting needle tube 22b) through the discharge port of the outer cylinder. It has become.
-電池ボックス23-
 電池ボックス23は、リユース部20aを構成する送液駆動部13およびその他の構成要素の電源となる電池23aを収納するものであり、筐体21の収納部21aに対して固定されている。この電池ボックス23は、内部に収納した電池23aを、リユース部20aの回路基板12に設けられた電源部に接続するための電極を備えている。なお、この電池ボックス23および電池23aは、リユース部20aの構成要素として設けられてもよい。
-Battery box 23-
The battery box 23 stores the battery 23a that serves as a power source for the liquid feeding drive unit 13 that constitutes the reuse unit 20a and other components, and is fixed to the storage unit 21a of the housing 21. The battery box 23 includes an electrode for connecting the battery 23a housed inside to a power supply unit provided on the circuit board 12 of the reuse unit 20a. The battery box 23 and the battery 23a may be provided as components of the reuse unit 20a.
[クレードル30]
 クレードル30は、接着部32と、載置面部31aと、側壁部31bとを有し、後述の投与ポート40が取り付けられる。クレードル30は、皮膚に接着させて用いられる。クレードル30は、投与ポート40を保持すると共に、上述したリユース部20aとディスポ部20bとを結合させた状態の装置本体20が装着される。皮膚表面上に接着されたクレードル30に対して、クレードル30上において第1の方向Xの第2端部側に向かって装置本体20をスライドさせることで、装置本体20がクレードル30に取り付けられる。このようなクレードル30は、載置面部31aと、側壁部31bと、接着部32とを備えている。
[Cradle 30]
The cradle 30 has an adhesive portion 32, a mounting surface portion 31a, and a side wall portion 31b, and an administration port 40 described later is attached to the cradle 30. The cradle 30 is used by adhering it to the skin. The cradle 30 holds the administration port 40, and the apparatus main body 20 in a state where the above-mentioned reuse portion 20a and the disposable portion 20b are coupled is mounted. The device body 20 is attached to the cradle 30 by sliding the device body 20 on the cradle 30 toward the second end side in the first direction X with respect to the cradle 30 adhered on the skin surface. Such a cradle 30 includes a mounting surface portion 31a, a side wall portion 31b, and an adhesive portion 32.
-接着部32-
 接着部32は、載置面部31aにおいて、装置本体20が装着される側とは逆側の面に設けられた軟質のシート部材であり、皮膚に対する接着性を有する。この接着部32は、載置面部31aの裏面(皮膚側の面)において、後述する投与ポート40のカニューレ部41を突出させる貫通孔31dを避けて、載置面部31aの広い範囲に設けられている。
-Adhesive part 32-
The adhesive portion 32 is a soft sheet member provided on the surface of the mounting surface portion 31a opposite to the side on which the device main body 20 is mounted, and has adhesiveness to the skin. The adhesive portion 32 is provided on the back surface (skin side surface) of the mounting surface portion 31a in a wide range of the mounting surface portion 31a, avoiding the through hole 31d that projects the cannula portion 41 of the administration port 40 described later. There is.
-載置面部31a、側壁部31b-
 クレードル30は、装置本体20を担持可能に構成される。クレードル30は、略平板状の載置面部31aと、側壁部31bとを有している。載置面部31aは、上面視で角部が湾曲した略矩形状に形成されている。クレードル30に装置本体20が装着されると、載置面部31a上には、装置本体20における筐体21が載置される。
-Mounting surface portion 31a, side wall portion 31b-
The cradle 30 is configured to be able to support the apparatus main body 20. The cradle 30 has a substantially flat plate-shaped mounting surface portion 31a and a side wall portion 31b. The mounting surface portion 31a is formed in a substantially rectangular shape with curved corners when viewed from above. When the device main body 20 is mounted on the cradle 30, the housing 21 of the device main body 20 is mounted on the mounting surface portion 31a.
 上面視で略矩形状の載置面部31aの少なくとも3つの辺には、載置面部31aに対して略垂直に立設する側壁部31bが形成されている。このため、載置面部31aから皮膚とは反対方向へ、複数の側壁が立設している。載置面部31aの第1の方向Xの第1端部側の辺には、載置面部31aに対して略垂直に連続する側壁部を有していない。すなわち、この位置において、載置面部31aは開放されている。 A side wall portion 31b that stands substantially perpendicular to the mounting surface portion 31a is formed on at least three sides of the mounting surface portion 31a that is substantially rectangular in top view. For this reason, a plurality of side walls are erected from the mounting surface portion 31a in the direction opposite to the skin. The side of the mounting surface portion 31a on the first end side in the first direction X does not have a side wall portion that is substantially perpendicular to the mounting surface portion 31a. That is, at this position, the mounting surface portion 31a is open.
 図5は、第1実施形態の薬液投与装置1におけるクレードル30に対する装置本体20の装着を説明するための斜視図である。この図に示すように、クレードル30に装置本体20を装着させる際には、載置面部31aに対し、側壁部31bを有しない側から第1の方向Xの第2端部側に向かって装置本体20をスライドさせる。 FIG. 5 is a perspective view for explaining the attachment of the device main body 20 to the cradle 30 in the drug solution administration device 1 of the first embodiment. As shown in this figure, when the device main body 20 is mounted on the cradle 30, the device is mounted on the mounting surface 31a from the side having no side wall portion 31b toward the second end side in the first direction X. Slide the main body 20.
 また図1、図2、および図5に示すように、載置面部31aは、投与ポート40を保持するための保持部31cを備えている。保持部31cは、載置面部31aの上面視において、第1の方向Xの第2端部側の領域に設けられている。保持部31cは、後述の貫通孔31dの周囲において、載置面部31aから立設する複数のリブである。図示しない穿刺装置により、カニューレ部41を皮膚に穿刺挿入する際に、投与ポート40を保持部31cに嵌合させることで、カニューレ部41及び投与ポート40をクレードル30に保持させる。 Further, as shown in FIGS. 1, 2, and 5, the mounting surface portion 31a includes a holding portion 31c for holding the administration port 40. The holding portion 31c is provided in a region on the second end side in the first direction X in a top view of the mounting surface portion 31a. The holding portion 31c is a plurality of ribs erected from the mounting surface portion 31a around the through hole 31d described later. When the cannula portion 41 is punctured and inserted into the skin by a puncture device (not shown), the administration port 40 is fitted into the holding portion 31c to hold the cannula portion 41 and the administration port 40 in the cradle 30.
 載置面部31aは、貫通孔31dを有する。カニューレ部41は貫通孔31dを通じて皮膚に穿刺挿入される。貫通孔31dの周囲には、皮膚とは反対方向に立設するリブが設けられ、リブは、投与ポート40の下面を支持する。 The mounting surface portion 31a has a through hole 31d. The cannula portion 41 is punctured and inserted into the skin through the through hole 31d. Around the through hole 31d, a rib standing in the direction opposite to the skin is provided, and the rib supports the lower surface of the administration port 40.
 図6は、第1実施形態の薬液投与装置の要部を抜粋した断面図(その1)であって、投与ポート40を保持した状態のクレードル30に装置本体20を装着する直前の投与ポート40付近の断面図である。また、図7は、第1実施形態の薬液投与装置の要部を抜粋した断面図(その2)であって、投与ポート40を保持したクレードル30に装置本体20を装着した状態においての投与ポート40付近の断面図である。 FIG. 6 is a cross-sectional view (No. 1) of the main part of the drug solution administration device of the first embodiment, which is the administration port 40 immediately before mounting the device main body 20 on the cradle 30 holding the administration port 40. It is a cross-sectional view of the vicinity. Further, FIG. 7 is a cross-sectional view (No. 2) of an excerpt of a main part of the drug solution administration device of the first embodiment, in which the administration port in a state where the apparatus main body 20 is attached to the cradle 30 holding the administration port 40. It is sectional drawing around 40.
[投与ポート40]
 装置本体20のリザーバ22から供給された薬液は、投与ポート40を通じて患者に投与される。投与ポート40は、患者の皮膚に穿刺されるカニューレ部41を保持し、クレードル30における載置面部31aの保持部31cに保持される。このような投与ポート40は、略円筒形状のカニューレポート42と、カニューレポート42の天面に位置する蓋部材43およびシール部材44と、装置本体20と接続する接続ポート45と、接続ポート45の端面を封止するキャップ46とを備えている。また投与ポート40には、以降に説明する接続検知装置50を構成する被検出部51が設けられている。
[Administration port 40]
The drug solution supplied from the reservoir 22 of the device body 20 is administered to the patient through the administration port 40. The administration port 40 holds the cannula portion 41 that is punctured into the patient's skin and is held by the holding portion 31c of the mounting surface portion 31a in the cradle 30. Such an administration port 40 includes a substantially cylindrical cannula report 42, a lid member 43 and a seal member 44 located on the top surface of the cannula report 42, a connection port 45 connected to the apparatus main body 20, and a connection port 45. It is provided with a cap 46 for sealing the end face. Further, the administration port 40 is provided with a detected portion 51 that constitutes the connection detection device 50 described below.
-カニューレ部41-
 カニューレ部41は、生体に穿刺された状態においてインスリンなどの薬液を生体に導入するための管状部材ある。このようなカニューレ部41は、例えば、樹脂材料によって形成される。カニューレ部41を形成する樹脂材料として、例えば、ポリウレタン、ナイロン、エチレン-テトラフルオロエチレン共重合体(ETFE)などを使用することができる。図示しない穿刺装置を用いて、カニューレ部41は内針400とともに生体内に挿入される。カニューレ部41が生体内に挿入された後に、穿刺装置はクレードル30から取り外され、廃棄される。
-Cannula section 41-
The cannula portion 41 is a tubular member for introducing a drug solution such as insulin into the living body in a state of being punctured by the living body. Such a cannula portion 41 is formed of, for example, a resin material. As the resin material forming the cannula portion 41, for example, polyurethane, nylon, ethylene-tetrafluoroethylene copolymer (ETFE) or the like can be used. Using a puncture device (not shown), the cannula portion 41 is inserted into the living body together with the internal needle 400. After the cannula portion 41 is inserted into the living body, the puncture device is removed from the cradle 30 and discarded.
-カニューレポート42-
 カニューレポート42は、略円筒形状の本体部を有し、カニューレ部41を保持する。カニューレ部41は、カニューレポート中空部42aの下面に、カニューレ部41を保持する。カニューレ部41の近位端部は、薬液投与装置1の側面視において、第3の方向Zの上方向に向かって拡大する漏斗形状に成形され、カニューレポート中空部42a内の固定部に固定されている。投与ポート40をクレードル30に保持させた状態において、カニューレ部41の遠位端(すなわち、カニューレの先端)は、カニューレポート42の下面を通じて、貫通孔31dからクレードル30の下面を超えて突出している。カニューレポート42の天面は、蓋部材43と、その内側のシール部材44とによって液密に封止される。薬液投与装置1の使用時において、カニューレポート42の天面は、底面26に対向する。
-Cannula Report 42-
The cannula report 42 has a substantially cylindrical body portion and holds the cannula portion 41. The cannula portion 41 holds the cannula portion 41 on the lower surface of the cannula report hollow portion 42a. The proximal end of the cannula portion 41 is formed into a funnel shape that expands upward in the third direction Z in the side view of the drug solution administration device 1, and is fixed to the fixed portion in the cannula report hollow portion 42a. ing. With the administration port 40 held in the cradle 30, the distal end of the cannula portion 41 (ie, the tip of the cannula) projects through the lower surface of the cannula report 42 from the through hole 31d beyond the lower surface of the cradle 30. .. The top surface of the cannula report 42 is liquidtightly sealed by the lid member 43 and the sealing member 44 inside the lid member 43. When using the drug solution administration device 1, the top surface of the cannula report 42 faces the bottom surface 26.
-蓋部材43-
 蓋部材43は、シール部材44とともに、カニューレポート42の天面開口を封止する。蓋部材43には、カニューレ部41の軸方向と同軸上に貫通穴43aを有する。この貫通穴43aを有するカニューレポート42、およびカニューレ部41内に、内針400が挿通可能な構成となっている(図6参照)。
-Lid member 43-
The lid member 43, together with the seal member 44, seals the top opening of the cannula report 42. The lid member 43 has a through hole 43a coaxial with the axial direction of the cannula portion 41. The inner needle 400 can be inserted into the cannula report 42 having the through hole 43a and the cannula portion 41 (see FIG. 6).
-シール部材44-
 シール部材44は、カニューレ部41内に内針400を挿し込むことができるように構成されるとともに、内針400が蓋部材43の貫通穴43aから抜去された後にカニューレ部41内から薬液が漏れ出ることを防止する。シール部材44の材料としては、例えばゴム等が挙げられる。
-Seal member 44-
The seal member 44 is configured so that the inner needle 400 can be inserted into the cannula portion 41, and the chemical liquid leaks from the inside of the cannula portion 41 after the inner needle 400 is removed from the through hole 43a of the lid member 43. Prevent it from coming out. Examples of the material of the seal member 44 include rubber and the like.
-接続ポート45-
 接続ポート45は、カニューレポート42の側周部から延設されるとともに、カニューレポート中空部42aと連続する空間を有する接続ポート本体部49と、接続ポート本体部49の一端部を形成する開口部47と、開口部47を液密に封止するキャップ46と、を有する。薬液投与装置1の使用状態において、接続ポート本体部49の第1の方向Xの第1端部側は、嵌合部21cに嵌入する嵌入端部48となる。嵌入端部48は、端面がキャップ46で覆われている。すなわち、開口部47は、キャップ46で閉塞されている。接続ポート45とカニューレポート42とは、接続ポート45の第1の方向Xの第2端側開口を通じて、連通している。本実施形態では、接続ポート45は中空部を有する略円筒形状をなしている。接続ポート45における、第1の方向Xの第1端側は、開口部47 を有する。装置本体20をクレードル30に装着した状態において、接続ポート45の開口部47は、嵌合部21cに嵌入される。これにより、装置本体20とクレードル30とが接続され、装置本体20から送液された薬液は、接続ポート45および、カニューレポート42を通じてカニューレ部41まで送達される。
-Connection port 45-
The connection port 45 extends from the side peripheral portion of the cannula report 42, and has a connection port main body 49 having a space continuous with the cannula hollow portion 42a and an opening forming one end of the connection port main body 49. It has a 47 and a cap 46 that tightly seals the opening 47. In the state of use of the chemical solution administration device 1, the first end side of the connection port main body 49 in the first direction X is the fitting end 48 that fits into the fitting 21c. The end face of the fitting end portion 48 is covered with a cap 46. That is, the opening 47 is closed by the cap 46. The connection port 45 and the cannula report 42 communicate with each other through the opening on the second end side of the connection port 45 in the first direction X. In the present embodiment, the connection port 45 has a substantially cylindrical shape having a hollow portion. The first end side of the connection port 45 in the first direction X has an opening 47. With the device main body 20 mounted on the cradle 30, the opening 47 of the connection port 45 is fitted into the fitting portion 21c. As a result, the device main body 20 and the cradle 30 are connected, and the chemical solution sent from the device main body 20 is delivered to the cannula section 41 through the connection port 45 and the cannula report 42.
-キャップ46-
 キャップ46は、接続ポート45の開口部を液密に封止する。キャップ46は、キャップ周面46aを挟んで、一端側にキャップ端面46b、他端側に開口を有する略円筒形状の部材である。キャップ46は、開口部47端面から第1の方向Xの第2端側方向に向かって、開口部47の外周及び端面を覆うようにして取り付けられる。より詳細には、キャップ周面46aは、接続ポート45(あるいは、開口部47)の外周上に設けられた係合溝部と係合する。これにより、接続ポート45が嵌合部21cに挿入された状態において、接続ポート45と嵌合部21cとの間のシール部材としても機能する。キャップ端面46bは平面形状でもよいが、シール性を高めるために接続ポート45の開口形状に沿ってリブを設けてもよい。装置本体20をクレードル30に装着させると、接続針管22bが、キャップ端面46bを貫通する。これにより、送液管22a、接続ポート45、カニューレポート42、およびカニューレ部41が連通した送液路が形成される。
-Cap 46-
The cap 46 tightly seals the opening of the connection port 45. The cap 46 is a substantially cylindrical member having a cap end surface 46b on one end side and an opening on the other end side of the cap peripheral surface 46a. The cap 46 is attached so as to cover the outer periphery and the end face of the opening 47 from the end face of the opening 47 toward the second end side in the first direction X. More specifically, the cap peripheral surface 46a engages with an engaging groove provided on the outer periphery of the connection port 45 (or opening 47). As a result, when the connection port 45 is inserted into the fitting portion 21c, it also functions as a sealing member between the connection port 45 and the fitting portion 21c. The cap end surface 46b may have a flat shape, but ribs may be provided along the opening shape of the connection port 45 in order to improve the sealing property. When the device body 20 is attached to the cradle 30, the connecting needle tube 22b penetrates the cap end surface 46b. As a result, a liquid feeding path is formed in which the liquid feeding pipe 22a, the connection port 45, the cannula report 42, and the cannula portion 41 communicate with each other.
 このようなキャップ46は、次の(i)~(iii)の特性を備えた材料によって形成されていることが好ましい。(i)接続ポート45の外側から接続針管22bの先端を挿入することができる。(ii)挿し込まれた接続針管22bの先端と接続ポート45との間を液密に保つことができる。(iii)接続針管22bが挿し込まれることによってキャップ46に形成された穴は、接続針管22bが抜去された後に塞がる。以上のような(i)~(iii)の特性を備えた材料としては、例えばゴム等が挙げられる。 It is preferable that such a cap 46 is made of a material having the following characteristics (i) to (iii). (I) The tip of the connecting needle tube 22b can be inserted from the outside of the connecting port 45. (Ii) The space between the tip of the inserted connecting needle tube 22b and the connecting port 45 can be kept liquidtight. (Iii) The hole formed in the cap 46 by inserting the connecting needle tube 22b is closed after the connecting needle tube 22b is removed. Examples of the material having the above-mentioned characteristics (i) to (iii) include rubber and the like.
[接続検知装置50]
 図8は、第1実施形態の薬液投与装置1に設けられた接続検知装置50を説明する拡大断面図(その1)であって、投与ポート40における円筒形状の接続ポート45の軸方向(すなわち、第1の方向X)に沿った断面図である。また図9は、第1実施形態の薬液投与装置1に設けられた接続検知装置50を説明する拡大断面図(その2)であって、投与ポート40における円筒形状の接続ポート45の軸方向を法線とした面の(すなわち、第2の方向Yに沿った)断面図である。図8および図9とも、投与ポート40を保持したクレードル30に装置本体20を装着した状態の図である。以下、図8および図9と、先の図6および図7に基づいて接続検知装置50の構成を説明する。
[Connection detection device 50]
FIG. 8 is an enlarged cross-sectional view (No. 1) for explaining the connection detection device 50 provided in the drug solution administration device 1 of the first embodiment, and is an axial direction (that is, that is) of the cylindrical connection port 45 in the administration port 40. , Is a cross-sectional view taken along the first direction X). Further, FIG. 9 is an enlarged cross-sectional view (No. 2) for explaining the connection detection device 50 provided in the drug solution administration device 1 of the first embodiment, showing the axial direction of the cylindrical connection port 45 in the administration port 40. FIG. 5 is a cross-sectional view of a normal plane (ie, along a second direction Y). 8 and 9 are both views showing a state in which the device main body 20 is attached to the cradle 30 holding the administration port 40. Hereinafter, the configuration of the connection detection device 50 will be described with reference to FIGS. 8 and 9 and FIGS. 6 and 7 above.
 これらの図に示す接続検知装置50は、投与ポート40が設置されたクレードル30に対して装置本体20を装着させた場合に、装置本体20の嵌合部21cに投与ポート40の接続ポート45が嵌入されたことを検知するための装置である。このような接続検知装置50は、投与ポート40に設けられた被検出部51と、装置本体20に設けられた検知部としてのセンサ52とによって構成されている In the connection detection device 50 shown in these figures, when the device main body 20 is attached to the cradle 30 in which the administration port 40 is installed, the connection port 45 of the administration port 40 is attached to the fitting portion 21c of the device main body 20. It is a device for detecting that it has been fitted. Such a connection detection device 50 is composed of a detected unit 51 provided in the administration port 40 and a sensor 52 as a detection unit provided in the device main body 20.
-被検出部51-
 被検出部51は、薬液投与装置1の使用状態において、装置本体20と投与ポート40とが接近する部位、あるいは、接触する部位に配置される。被検出部51は、投与ポート40に設けられる。より詳細には、被検出部51は、接続ポート45における、第1の方向Xの第1端部側の領域に配置される。被検出部51は、投与ポート40における接続ポート45の開口部47に配置される。あるいは、被検出部51は、開口部47の外周に配置される。これらの場合、被検出部51を、キャップ46に被検出部51を設けることが好ましい。この場合、キャップ周面46aに磁性部材を含む樹脂を配置することで、被検出部51を形成できる。より詳細には、キャップ46の製造時に、キャップ周面46aの全周にわたって、層状の磁性部51aを成型する。これにより、開口部47の外周面を覆う被検出部51とすることができるため、キャップ46の取付けの向きによらず検出が可能になる。このような磁性材料としては、鉄、コバルト、ニッケル、フェライトなどの磁性粉を使用できる。キャップ46の材料としては、各種ゴム材料や加硫剤等の添加剤を適宜用いることができる。
-Detected part 51-
The detected unit 51 is arranged at a site where the device main body 20 and the administration port 40 are close to each other or in contact with each other in the state of use of the drug solution administration device 1. The detected portion 51 is provided in the administration port 40. More specifically, the detected portion 51 is arranged in the region of the connection port 45 on the first end side in the first direction X. The detected portion 51 is arranged in the opening 47 of the connection port 45 in the administration port 40. Alternatively, the detected portion 51 is arranged on the outer periphery of the opening 47. In these cases, it is preferable to provide the detected portion 51 on the cap 46. In this case, the detected portion 51 can be formed by arranging the resin containing the magnetic member on the peripheral surface 46a of the cap. More specifically, at the time of manufacturing the cap 46, the layered magnetic portion 51a is molded over the entire circumference of the cap peripheral surface 46a. As a result, the detected portion 51 that covers the outer peripheral surface of the opening 47 can be formed, so that detection is possible regardless of the mounting orientation of the cap 46. As such a magnetic material, magnetic powder such as iron, cobalt, nickel, and ferrite can be used. As the material of the cap 46, various rubber materials and additives such as a vulcanizing agent can be appropriately used.
-センサ52-
 センサ52は、嵌合部21cへの接続ポート45の嵌入を検知するための検知部として設けられたもので、被検出部51の種類に応じて設定される。被検知部51を磁性部51aとした場合、センサ52は、磁場(磁界)の大きさを検知できればよく、さらに磁場の方向を計測できる磁気センサ52aであってもよい。このような磁気センサ52aは、例えば磁気抵抗素子やホール素子であってよい。磁気センサ52aは、投与ポート40が設置されたクレードル30に対して装置本体20を正常に装着させた状態において、投与ポート40に設けた磁性部51aの磁力を検出可能な位置に取り付けられている。
-Sensor 52-
The sensor 52 is provided as a detection unit for detecting the fitting of the connection port 45 into the fitting unit 21c, and is set according to the type of the detection unit 51. When the detected portion 51 is a magnetic portion 51a, the sensor 52 may be a magnetic sensor 52a capable of detecting the magnitude of the magnetic field (magnetic field) and further measuring the direction of the magnetic field. Such a magnetic sensor 52a may be, for example, a magnetoresistive element or a Hall element. The magnetic sensor 52a is attached to a position where the magnetic force of the magnetic portion 51a provided in the administration port 40 can be detected in a state where the apparatus main body 20 is normally attached to the cradle 30 in which the administration port 40 is installed. ..
 このような磁気センサ52aは、例えば装置本体20のリユース部20aから、ディスポ部20bにおける嵌合部21cの周壁に向かって垂下される状態で配置されている。検出可能な状態において、磁気センサ52aの検知部は収納部21aに配置され、被検出部51は裏面収納部21bに配置される。磁気センサ52aの検知部は、収納部21a内において、筒孔28の周面に沿った領域の少なくとも一部に配置される。これにより、装置本体20を構成するリユース部20aの位置を基準とした接続検知が可能となるため、位置決め精度を向上させることができる。 Such a magnetic sensor 52a is arranged so as to hang down from the reuse portion 20a of the apparatus main body 20, for example, toward the peripheral wall of the fitting portion 21c in the disposable portion 20b. In the detectable state, the detection unit of the magnetic sensor 52a is arranged in the storage unit 21a, and the detected unit 51 is arranged in the back surface storage unit 21b. The detection unit of the magnetic sensor 52a is arranged in at least a part of the region along the peripheral surface of the tubular hole 28 in the storage unit 21a. As a result, connection detection can be performed based on the position of the reuse unit 20a constituting the device main body 20, so that the positioning accuracy can be improved.
 装置本体20とクレードル30とが正しい位置で接続すると、磁気センサ52aは、光筐体21底面を挟んで、磁性部51aと対向する。このような磁気センサ52aは、磁性部51aに対向させる状態で、複数設けられていることが好ましい。この場合、磁性部51aは開口部47を中心の中心軸を囲むように配置され、かつ、各磁気センサ52aと、磁性部51aと、の対向状態が同一であることが好ましい。これにより、各磁気センサ52aで検出された磁力の強さが均一となることで、磁性部51aが囲む軸と、略円筒形の接続ポート45の中心軸とがほぼ平行であることを検知できる。 When the device main body 20 and the cradle 30 are connected at the correct positions, the magnetic sensor 52a faces the magnetic portion 51a with the bottom surface of the optical housing 21 sandwiched between them. It is preferable that a plurality of such magnetic sensors 52a are provided so as to face the magnetic portion 51a. In this case, it is preferable that the magnetic portion 51a is arranged so as to surround the central axis of the opening 47, and that each magnetic sensor 52a and the magnetic portion 51a face each other in the same state. As a result, the strength of the magnetic force detected by each magnetic sensor 52a becomes uniform, and it can be detected that the axis surrounded by the magnetic portion 51a and the central axis of the substantially cylindrical connection port 45 are substantially parallel. ..
[リモートコントローラ60]
 リモートコントローラ60は、装置本体20の駆動を操作するものである。リモートコントローラ60は、表示部61、操作部62、コントローラ出力部63、コントローラ通信部64、およびこれらを制御するコントローラ演算部65を備えている。これらを有するリモートコントローラ60は、スマートフォン等の携帯端末に専用プログラムをインストールしたものでもよい。各構成要素の詳細は次のようである。
[Remote controller 60]
The remote controller 60 operates the drive of the device main body 20. The remote controller 60 includes a display unit 61, an operation unit 62, a controller output unit 63, a controller communication unit 64, and a controller calculation unit 65 that controls them. The remote controller 60 having these may be one in which a dedicated program is installed in a mobile terminal such as a smartphone. The details of each component are as follows.
-表示部61-
 表示部61は、装置本体20の駆動に関する各種の設定内容、次に説明する操作部62による入力内容、また装置本体20での投与履歴等を表示する。
-Display unit 61-
The display unit 61 displays various setting contents related to driving the device main body 20, input contents by the operation unit 62 described below, administration history in the device main body 20, and the like.
-操作部62-
 操作部62は、装置本体20によるインスリンの投与設定、装置本体20の制御の実行や停止、および表示部61での表示内容の選択などをユーザが入力するためのユーザインターフェース部分である。このような操作部62は、例えばキーパッドや、表示部61の表示面に設けたタッチパネルであってもよい。操作部62が、タッチパネルである場合、表示部61は、タッチパネル用の選択ボタンやテンキーなどを表示する。
-Operation unit 62-
The operation unit 62 is a user interface portion for the user to input insulin administration settings by the device main body 20, execution and stop of control of the device main body 20, selection of display contents on the display unit 61, and the like. Such an operation unit 62 may be, for example, a keypad or a touch panel provided on the display surface of the display unit 61. When the operation unit 62 is a touch panel, the display unit 61 displays a selection button, a numeric keypad, or the like for the touch panel.
-コントローラ出力部63-
 コントローラ出力部63は、以降に説明するコントローラ演算部65からの指示により、警報Wを出力する。このコントローラ出力部63は、警報Wとして、例えば振動、音、発光などを単独で、または併用して発するものが適用される。
-Controller output unit 63-
The controller output unit 63 outputs the alarm W in response to an instruction from the controller calculation unit 65 described below. As the alarm W, for example, a controller output unit 63 that emits vibration, sound, light emission, or the like alone or in combination is applied.
-コントローラ通信部64-
 コントローラ通信部64は、ペアリングされた装置本体20との通信を行う部分である。このコントローラ通信部64は、発信部と受信部とで構成されている。このコントローラ通信部64は、装置本体20側の本体通信部15との間で無線通信を行う部分であり、本体通信部15と同様の規格化された無線通信技術が適用される。
-Controller communication unit 64-
The controller communication unit 64 is a part that communicates with the paired device main body 20. The controller communication unit 64 is composed of a transmission unit and a reception unit. The controller communication unit 64 is a part that performs wireless communication with the main body communication unit 15 on the device main body 20 side, and the same standardized wireless communication technology as the main body communication unit 15 is applied.
-コントローラ演算部65-
 コントローラ演算部65は、操作部62において入力された各種の設定を表示部61に表示させ、また各種の設定をントローラ通信部64から装置本体20に送信させ、またコントローラ出力部63に対して警報Wを出力させる。
-Controller calculation unit 65-
The controller calculation unit 65 causes the display unit 61 to display various settings input in the operation unit 62, causes the controller communication unit 64 to transmit various settings to the device main body 20, and alerts the controller output unit 63. W is output.
 以上のようなコントローラ演算部65は、例えばここでの図示を省略したCPU(Central Processing Unit)、RAM(Random Access Memory)、ROM(Read Only Memory)を備えたものである。このようなコントローラ演算部65によって前述の入力、表示、通信、出力が実行される。 The controller calculation unit 65 as described above is provided with, for example, a CPU (Central Processing Unit), a RAM (Random Access Memory), and a ROM (Read Only Memory), which are not shown here. The above-mentioned input, display, communication, and output are executed by such a controller calculation unit 65.
<薬液投与装置1の使用手順>
 次に、以上説明した構成の薬液投与装置1を使用する場合の手順を説明する。先ず薬液投与装置1のユーザは、薬液投与装置1による薬液投与を実施するに先立ち、リユース部20aと、リザーバ22に薬液を充填したディスポ部20bとを結合させ、装置本体20を組み立てる。これにより、ディスポ部20bに配置された電池23aからの電力が、リユース部20aの回路基板12に設けられた電源部に供給され、リユース部20aに設けられた本体演算部16が起動する。この状態で、本体演算部16は、所定のプログラムを実行しユーザからのプライミング命令を待つ。
<Procedure for using the drug solution administration device 1>
Next, a procedure in the case of using the drug solution administration device 1 having the above-described configuration will be described. First, the user of the drug solution administration device 1 assembles the device main body 20 by combining the reuse unit 20a and the disposable unit 20b filled with the drug solution in the reservoir 22 prior to performing the drug solution administration by the drug solution administration device 1. As a result, the electric power from the battery 23a arranged in the disposable unit 20b is supplied to the power supply unit provided on the circuit board 12 of the reuse unit 20a, and the main body calculation unit 16 provided in the reuse unit 20a is activated. In this state, the main unit arithmetic unit 16 executes a predetermined program and waits for a priming instruction from the user.
 次に、薬液投与装置1のユーザは、リモートコントローラ60の操作部62の操作により、リザーバ22に充填した薬液を、リザーバ22の外筒から引き出された送液管22a内を満たすように押し出し、接続針管22bの先端から空気を排出させるプライミングを実施させる。なお、リザーバ22から引き出された送液管22a内に予め薬液が満たされたディスポ部20bを準備することで、リユース部20aとディスポ部20bを結合させた際にプライミングを実行しなくてもよい。 Next, the user of the chemical solution administration device 1 pushes out the chemical solution filled in the reservoir 22 by operating the operation unit 62 of the remote controller 60 so as to fill the inside of the liquid delivery pipe 22a drawn from the outer cylinder of the reservoir 22. Prime is performed so that air is discharged from the tip of the connecting needle tube 22b. By preparing a disposable portion 20b filled with a chemical solution in advance in the liquid feeding pipe 22a drawn from the reservoir 22, it is not necessary to perform priming when the reuse portion 20a and the disposable portion 20b are combined. ..
 また図6を参照し、薬液投与装置1のユーザは、クレードル30に対して投与ポート40を設置する。この際、ユーザは、先ず接着部32によりクレードル30を皮膚に対して接着させる。次に、図示しない穿刺装置等の専用治具を用いて、クレードル30の保持部31cに所定状態で投与ポート40を設置する。これにより投与ポート40のカニューレ部41とカニューレ部41内の内針400とが、ユーザの皮膚に対して穿刺挿入した状態とする。その後、専用治具を投与ポート40から離脱させることにより、カニューレ部41の内部から内針400を抜去し、カニューレ部41を皮下に留置する。 Also, referring to FIG. 6, the user of the drug solution administration device 1 installs the administration port 40 for the cradle 30. At this time, the user first adheres the cradle 30 to the skin by the adhesive portion 32. Next, the administration port 40 is installed in the holding portion 31c of the cradle 30 in a predetermined state by using a dedicated jig such as a puncture device (not shown). As a result, the cannula portion 41 of the administration port 40 and the inner needle 400 in the cannula portion 41 are punctured and inserted into the user's skin. Then, by detaching the special jig from the administration port 40, the inner needle 400 is removed from the inside of the cannula portion 41, and the cannula portion 41 is placed subcutaneously.
 次に、図5を参照し、投与ポート40が設置されたクレードル30に対して、プライミング実行済みの装置本体20を装着する。その後、ユーザは、リモートコントローラ60を操作し、薬液の投与を開始する入力を行う。薬液投与開始の入力に応じて、以降に説明する薬液投与装置の制御方法のプログラムが実行される。 Next, referring to FIG. 5, the priming-executed device main body 20 is attached to the cradle 30 in which the administration port 40 is installed. After that, the user operates the remote controller 60 to input to start the administration of the drug solution. In response to the input of the start of drug solution administration, the program of the control method of the drug solution administration device described below is executed.
<薬液投与装置1の制御方法>
 図10は、第1実施形態に係る薬液投与装置1の制御方法を説明するためのフローチャートである。この図を用いて説明する薬液投与装置1の制御方法は、図3を用いて説明した薬液投与装置1の本体演算部16を構成する各装置のCPUが、ROMやRAMに記録されたプログラムを実行することにより実現される。以下、図3および必要図を参照しつつ、図10のフローチャートに示す順に、薬液投与装置1の制御方法を説明する。
<Control method of drug solution administration device 1>
FIG. 10 is a flowchart for explaining a control method of the drug solution administration device 1 according to the first embodiment. In the control method of the drug solution administration device 1 described with reference to FIG. 3, the CPU of each device constituting the main body calculation unit 16 of the drug solution administration device 1 described with reference to FIG. 3 uses a program recorded in a ROM or RAM. It is realized by executing. Hereinafter, the control method of the drug solution administration device 1 will be described in the order shown in the flowchart of FIG. 10 with reference to FIG. 3 and the required figure.
[ステップS101]
 ステップS101において、本体演算部16は、本体通信部15が薬液の投与を開始する指示を受信したか否かの判断を実施する。薬液の投与を開始する指示は、ユーザによるリモートコントローラ60の操作部62からの入力に基づく指示であって、操作部62から入力された投与開始の指示の情報は、コントローラ通信部64から本体通信部15に送信される。本体演算部16は、本体通信部15が、投与開始の指示を受信した(YES)と判断するまで待機し、投与開始の指示を受信した(YES)と判断した場合に、次のステップS102に進む。
[Step S101]
In step S101, the main body calculation unit 16 determines whether or not the main body communication unit 15 has received the instruction to start the administration of the drug solution. The instruction to start the administration of the drug solution is an instruction based on the input from the operation unit 62 of the remote controller 60 by the user, and the information of the administration start instruction input from the operation unit 62 is the main body communication from the controller communication unit 64. It is transmitted to the unit 15. The main body calculation unit 16 waits until the main body communication unit 15 determines that the administration start instruction has been received (YES), and when it determines that the administration start instruction has been received (YES), the main body calculation unit 16 proceeds to the next step S102. move on.
[ステップS102]
 ステップS102において、本体演算部16は、センサ52からの信号を参照し、装置本体20の嵌合部21cに、投与ポート40の接続ポート45が嵌入され、接続針管22bとカニューレ部41とが正常に接続されたか否かを判断する。この際、本体演算部16は、センサ52からの信号強度が、予め設定された閾値を超えている、または閾値以上である場合には、正常に接続された(YES)と判断する。一方、本体演算部16は、センサ52からの信号強度が、予め設定された閾値以下である、または閾値を超えていない場合には、正常に接続されていない(NO)と判断する。
[Step S102]
In step S102, the main body calculation unit 16 refers to the signal from the sensor 52, the connection port 45 of the administration port 40 is fitted into the fitting portion 21c of the device main body 20, and the connection needle tube 22b and the cannula unit 41 are normal. Determine if it is connected to. At this time, when the signal strength from the sensor 52 exceeds the preset threshold value or is equal to or higher than the threshold value, the main body calculation unit 16 determines that the connection is normally made (YES). On the other hand, when the signal strength from the sensor 52 is equal to or less than a preset threshold value or does not exceed the threshold value, the main body calculation unit 16 determines that the connection is not normally performed (NO).
 なお、装置本体20に複数のセンサ52が設けられている場合、各センサ52に設定されている閾値は同一の値である必要はない。この場合、装置本体20のディスポ部20bの筐体21における嵌合部21cに対し、投与ポート40の接続ポート45が正常に嵌入された状態において、各センサ52で検知される信号強度が予め実験的に取得されていることとする。そして、取得された値に基づいて、各センサ52で検出される信号強度の閾値が設定されていることとする。ここで、嵌合部21cに対して接続ポート45が正常に嵌入された状態とは、略円筒形状の嵌合部21cに円筒形状の接続ポート45を嵌入させた状態において、それぞれの中心軸が略平行な状態であることとする。 When a plurality of sensors 52 are provided in the device main body 20, the threshold values set in each sensor 52 do not have to be the same value. In this case, the signal strength detected by each sensor 52 is tested in advance in a state where the connection port 45 of the administration port 40 is normally fitted to the fitting portion 21c in the housing 21 of the disposable portion 20b of the apparatus main body 20. It is assumed that it has been acquired. Then, it is assumed that the threshold value of the signal strength detected by each sensor 52 is set based on the acquired value. Here, the state in which the connection port 45 is normally fitted into the fitting portion 21c means that the central axes of the respective central axes are in a state in which the cylindrical connection port 45 is fitted into the substantially cylindrical fitting portion 21c. It shall be in a substantially parallel state.
 この場合、本体演算部16は、各センサ52からの信号強度の全てが、それぞれに予め設定された閾値を超えている、または閾値以上である場合には、正常に接続された(YES)と判断し、それ以外の場合には正常に接続されていない(NO)と判断する。 In this case, the main unit calculation unit 16 is normally connected (YES) when all the signal intensities from each sensor 52 exceed or exceed the threshold values set in advance. Judgment is made, and in other cases, it is judged that the connection is not normally performed (NO).
 そして、正常に接続された(YES)と判断した場合には、ステップS103に進み、正常に接続されていない(NO)と判断した場合にはステップS104に進む。 Then, if it is determined that the connection is normally made (YES), the process proceeds to step S103, and if it is determined that the connection is not normally made (NO), the process proceeds to step S104.
[ステップS103]
 ステップS103において、本体演算部16は、送液駆動部13の駆動によりリザーバ22から薬液を排出する送液処理を開始し、一連の処理を終了させる。
[Step S103]
In step S103, the main body calculation unit 16 starts the liquid feeding process of discharging the chemical solution from the reservoir 22 by driving the liquid feeding driving unit 13, and ends the series of processes.
[ステップS104]
 一方、ステップS104において、本体演算部16は、本体出力部14に対して警報の出力を指示する。これにより、本体出力部14が警報を出力し、薬液投与装置1のユーザに対して、カニューレ部41と接続針管22bとが正常に接続されていないことを通知し、投与ポート40が設置されたクレードル30に対する装置本体20の装着のし直しを促す。
[Step S104]
On the other hand, in step S104, the main body calculation unit 16 instructs the main body output unit 14 to output an alarm. As a result, the main body output unit 14 outputs an alarm, notifies the user of the drug solution administration device 1 that the cannula unit 41 and the connecting needle tube 22b are not normally connected, and the administration port 40 is installed. It prompts the cradle 30 to be reattached to the apparatus main body 20.
 また、本体演算部16は、本体通信部15に対して、接続不良の送信の実施を指示する。これにより、本体通信部15は、コントローラ通信部64に対して接続不良の通知を送信する。コントローラ演算部65は、コントローラ通信部64が接続不良の通知を受信したことにより、コントローラ出力部63に対して警報の出力を指示する。これにより、コントローラ出力部63が警報を出力し、薬液投与装置1のユーザに対して、カニューレ部41と接続針管22bとが正常に接続されていないことを通知することで、投与ポート40が設置されたクレードル30と、装置本体20との装着のやり直しを促す。その後、一連の処理を終了させる。ここで、装置本体20と、投与ポート40付きのクレードル30とを、ユーザが再接続することが必要な場合、センサ52は、被検出部51からの信号がオフになったことを検知することで、ステップS102に戻るようにしてもよい。あるいは、ステップS103で送液処理が開始された後、すなわち送液中に亘って、嵌合部21cと接続ポート45との接続状態を、センサ52により常にモニタリングするようにしてもよい。 Further, the main body calculation unit 16 instructs the main body communication unit 15 to transmit a poor connection. As a result, the main body communication unit 15 transmits a connection failure notification to the controller communication unit 64. The controller calculation unit 65 instructs the controller output unit 63 to output an alarm when the controller communication unit 64 receives the notification of the connection failure. As a result, the controller output unit 63 outputs an alarm and notifies the user of the drug solution administration device 1 that the cannula unit 41 and the connecting needle tube 22b are not normally connected, so that the administration port 40 is installed. It is urged to reattach the cradle 30 and the apparatus main body 20. After that, a series of processes is completed. Here, when the user needs to reconnect the device main body 20 and the cradle 30 with the administration port 40, the sensor 52 detects that the signal from the detected unit 51 has been turned off. Then, it may return to step S102. Alternatively, after the liquid feeding process is started in step S103, that is, during the liquid feeding, the connection state between the fitting portion 21c and the connection port 45 may be constantly monitored by the sensor 52.
<第1実施形態の効果>
 以上説明した第1実施形態の薬液投与装置1は、投与ポート40における接続ポート45を囲む状態で磁性部51aを設け、装置本体20において接続ポート45が嵌入される嵌合部21cに対向する位置に磁気センサ52aを設けた構成である。このため、嵌合部21cに対する接続ポート45の嵌入状態を、磁気センサ52aからの信号強度によって直接的に検出することができる。またこれにより、嵌合部21cに保持された接続針管22bと、接続ポート45との接続を検知することが可能である。また複数の磁気センサ52aを設けることにより、嵌合部21cに対して接続ポート45が平行に嵌入した状態であるか否かを検知することができる。
<Effect of the first embodiment>
In the drug solution administration device 1 of the first embodiment described above, the magnetic portion 51a is provided so as to surround the connection port 45 in the administration port 40, and the position of the apparatus main body 20 facing the fitting portion 21c into which the connection port 45 is fitted. The magnetic sensor 52a is provided on the surface. Therefore, the fitted state of the connection port 45 with respect to the fitting portion 21c can be directly detected by the signal strength from the magnetic sensor 52a. Further, this makes it possible to detect the connection between the connecting needle tube 22b held by the fitting portion 21c and the connecting port 45. Further, by providing the plurality of magnetic sensors 52a, it is possible to detect whether or not the connection port 45 is fitted in parallel with the fitting portion 21c.
 この結果、装置本体20を、クレードル30に装着した場合に、投与ポート40に保持されたカニューレ部41と、嵌合部21cとの接続不良を検知し、薬液投与装置1のユーザに装着のし直しを促すことが可能である。またこれにより、薬液投与装置1において、装置本体20と投与ポート40との接続部分からの薬液の漏れを防止できると共に、精度の高い薬液投与を実施することが可能になる。 As a result, when the apparatus main body 20 is attached to the cradle 30, a poor connection between the cannula portion 41 held in the administration port 40 and the fitting portion 21c is detected, and the apparatus main body 20 is attached to the user of the drug solution administration apparatus 1. It is possible to urge a fix. Further, this makes it possible to prevent the drug solution from leaking from the connection portion between the device main body 20 and the administration port 40 in the drug solution administration device 1, and to perform highly accurate drug solution administration.
≪第2実施形態≫
<薬液投与装置の構成>
 図11は、第2実施形態の薬液投与装置2の要部を抜粋した断面図(その1)である。また図12は、第2実施形態の薬液投与装置2の要部を抜粋した断面図(その2)である。さらに図13は、第2実施形態の薬液投与装置2のブロック図である。これらの図に示す第2実施形態の薬液投与装置2が、第1実施形態の薬液投与装置1と異なるところは、接続検知装置70の構成にあり、他の構成要素は同一である。したがって、ここでは、接続検知装置70の構成のみを説明する。
<< Second Embodiment >>
<Configuration of drug solution administration device>
FIG. 11 is a cross-sectional view (No. 1) of the main part of the chemical solution administration device 2 of the second embodiment. Further, FIG. 12 is a cross-sectional view (No. 2) of an excerpt of a main part of the drug solution administration device 2 of the second embodiment. Further, FIG. 13 is a block diagram of the drug solution administration device 2 of the second embodiment. The difference between the drug solution administration device 2 of the second embodiment shown in these figures and the drug solution administration device 1 of the first embodiment is the configuration of the connection detection device 70, and the other components are the same. Therefore, only the configuration of the connection detection device 70 will be described here.
[接続検知装置70]
 接続検知装置70は、投与ポート40が設置されたクレードル30に対して装置本体20を装着させた場合に、嵌合部21cに接続ポート45が嵌入されたことを検知するための装置である。このような接続検知装置70は、投与ポート40に設けられたスイッチ押圧部材71と、装置本体20に設けられた検知部としてのマイクロスイッチ72と、装置本体20のディスポ部20bに設けられた中間部材73、および突出部材74とによって構成されている。なお、薬液投与装置2は、これらの部材が複数設けられていてもよい。以下、各構成を説明する。
[Connection detection device 70]
The connection detection device 70 is a device for detecting that the connection port 45 is fitted into the fitting portion 21c when the device main body 20 is attached to the cradle 30 in which the administration port 40 is installed. Such a connection detection device 70 is an intermediate between a switch pressing member 71 provided in the administration port 40, a micro switch 72 as a detection unit provided in the device main body 20, and a disposable part 20b of the device main body 20. It is composed of a member 73 and a protruding member 74. The chemical solution administration device 2 may be provided with a plurality of these members. Each configuration will be described below.
-スイッチ押圧部材71-
 スイッチ押圧部材71は、次に説明するマイクロスイッチ72を押圧するためのものである。このようなスイッチ押圧部材71は、投与ポート40における接続ポート45の第1の方向Xの第1端面に設けられる。ここでは一例として、接続ポート45の開口端を延長した位置において、スイッチ押圧部材71が、キャップ46に保持される状態で設けられていることとする。より詳細には、スイッチ押圧部材71は、キャップ端面46bに設けられた凸状部71aである。凸状部71aは、第1の方向Xにおいて、開口部47の開口縁を延長した位置と、少なくとも凸状部71aの一部が重なるように設けられるのが好ましい。凸状部71aは、開口部47の開口縁のうち、第3の方向Zの上側の領域に設けられるのが好ましい。これにより、リユース部20aから延設される後述のマイクロスイッチ72を配置しやすくなる。装置本体20を構成するリユース部20aの位置を基準とした接続検知が可能となるため、位置決め精度を向上させることができる。凸状部71aは、キャップ46よりも固い材料から形成されるのが好ましい。なお、スイッチ押圧部材71は、キャップ46による接続ポート45の封止状態や、嵌合部21cに対する接続ポート45の嵌入を阻害しないことが重要である。また、スイッチ押圧部材71は、キャップ46の一部を変形したものや、キャップ46と同時に成型されてもよい。あるいは、スイッチ押圧部材71は、キャップ46とは別体のものであってもよい。
-Switch pressing member 71-
The switch pressing member 71 is for pressing the micro switch 72 described below. Such a switch pressing member 71 is provided on the first end surface of the connection port 45 in the administration port 40 in the first direction X. Here, as an example, it is assumed that the switch pressing member 71 is provided in a state of being held by the cap 46 at a position where the open end of the connection port 45 is extended. More specifically, the switch pressing member 71 is a convex portion 71a provided on the cap end surface 46b. The convex portion 71a is preferably provided so that at least a part of the convex portion 71a overlaps with the position where the opening edge of the opening 47 is extended in the first direction X. The convex portion 71a is preferably provided in the upper region of the opening edge of the opening 47 in the third direction Z. This makes it easier to arrange the microswitch 72, which will be described later, extending from the reuse unit 20a. Since connection detection can be performed based on the position of the reuse unit 20a constituting the device main body 20, positioning accuracy can be improved. The convex portion 71a is preferably formed of a material that is harder than the cap 46. It is important that the switch pressing member 71 does not interfere with the sealed state of the connection port 45 by the cap 46 and the fitting of the connection port 45 into the fitting portion 21c. Further, the switch pressing member 71 may be a partially deformed cap 46 or may be molded at the same time as the cap 46. Alternatively, the switch pressing member 71 may be a separate body from the cap 46.
 薬液投与装置2が複数のスイッチ押圧部材71を有する場合、各スイッチ押圧部材71は、接続ポート45の開口端を延長した各位置に設けられている。各スイッチ押圧部材71は、互いに離れた位置に設けられることが好ましく、キャップ端面46bまたは接続ポート45の開口部端面の中心に対して対称となるように配置される。 When the chemical solution administration device 2 has a plurality of switch pressing members 71, each switch pressing member 71 is provided at each position extending the open end of the connection port 45. The switch pressing members 71 are preferably provided at positions separated from each other, and are arranged so as to be symmetrical with respect to the center of the cap end surface 46b or the opening end surface of the connection port 45.
-マイクロスイッチ72-
 マイクロスイッチ72は、嵌合部21cへの接続ポート45の嵌入を検知するための検知部として設けられる。このマイクロスイッチ72は、投与ポート40が設置されたクレードル30に対して装置本体20をスライドさせながら装着させる場合に、スイッチ押圧部材71によって、直接的または間接的に押圧される位置に配置される。このとき、嵌合部21cの筒孔28の底面28aには、先に説明したスイッチ押圧部材71と対向する位置に、検知中継部Aが設けられている。
-Micro switch 72-
The micro switch 72 is provided as a detection unit for detecting the fitting of the connection port 45 into the fitting portion 21c. The microswitch 72 is arranged at a position where it is directly or indirectly pressed by the switch pressing member 71 when the apparatus main body 20 is attached to the cradle 30 on which the administration port 40 is installed while sliding. .. At this time, a detection relay portion A is provided on the bottom surface 28a of the tubular hole 28 of the fitting portion 21c at a position facing the switch pressing member 71 described above.
 マイクロスイッチ72は、例えば、装置本体20のリユース部20aから、ディスポ部20bに向かって垂下される状態で配置されている。薬液投与装置2の使用状態において、検知中継部Aを介して、マイクロスイッチ72は収納部21aに配置され、スイッチ押圧部材71は裏面収納部21bに配置される。マイクロスイッチ72は、検知中継部Aからの応答を検出することで、嵌合部21cへの接続ポート45の嵌入を検知する。スイッチ押圧部材71が複数設けられている場合であれば、それぞれのスイッチ押圧部材71に対応する位置に、それぞれマイクロスイッチ72が設けられていることとする。この場合、嵌合部21cに対して接続ポート45が正常に嵌入された状態、すなわち嵌合部21cに略円筒形状の接続ポート45を嵌入させた状態において、それぞれの中心軸が略平行な状態で、各スイッチ押圧部材71が対応する各マイクロスイッチ72を押圧するように、複数のマイクロスイッチが配置されていることとする。これにより、装置本体20を構成するリユース部20aの位置を基準とした接続検知が可能となるため、位置決め精度を向上させることができる。 The micro switch 72 is arranged so as to hang down from the reuse portion 20a of the apparatus main body 20 toward the disposable portion 20b, for example. In the state of use of the chemical solution administration device 2, the micro switch 72 is arranged in the accommodating portion 21a and the switch pressing member 71 is arranged in the back surface accommodating portion 21b via the detection relay unit A. The micro switch 72 detects the fit of the connection port 45 into the fitting portion 21c by detecting the response from the detection relay unit A. When a plurality of switch pressing members 71 are provided, it is assumed that the micro switches 72 are provided at positions corresponding to the respective switch pressing members 71. In this case, in a state where the connection port 45 is normally fitted into the fitting portion 21c, that is, in a state where the substantially cylindrical connection port 45 is fitted into the fitting portion 21c, the respective central axes are substantially parallel. Therefore, it is assumed that a plurality of microswitches are arranged so that each switch pressing member 71 presses each corresponding microswitch 72. As a result, connection detection can be performed based on the position of the reuse unit 20a constituting the device main body 20, so that the positioning accuracy can be improved.
 またマイクロスイッチ72は、本体演算部16と接続されている。さらにマイクロスイッチ72は、投与ポート40が設置されたクレードル30に対して装置本体20をスライドさせながら装着させた場合に、投与ポート40のスイッチ押圧部材71によって直接的または間接的に押圧されることによりオンとなる。なお、マイクロスイッチ72は、このような場合にオンとなれば、リユース部20aに設けられていてもよい。 Further, the micro switch 72 is connected to the main body calculation unit 16. Further, the micro switch 72 is directly or indirectly pressed by the switch pressing member 71 of the administration port 40 when the apparatus main body 20 is attached to the cradle 30 on which the administration port 40 is installed while sliding. Turns on. The micro switch 72 may be provided in the reuse unit 20a if it is turned on in such a case.
-検知中継部A-
 検知中継部Aは、使い捨て部材(投与ポート40が接続したクレードル30、ディスポ部20b)とリユース部20aとの間において、押圧部材71からの入力をマイクロスイッチ72に直接的または間接的に伝える。マイクロスイッチ72に対向する位置において、装置本体20のディスポ部20bにおける嵌合部21cの底面の少なくとも1箇所に設けられている。検知中継部Aは、押圧部材71及び/またはマイクロスイッチ72の数や位置に応じて設けられる。検知中継部Aは、ディスポ部20b上に設けられた開口であってもよいが、好ましくは、該開口が可撓性を有する中間部材73で、液密に塞がれているのが好ましい。中間部材73は、膜状であっても、栓体状であってもよい。中間部材73は、投与ポート40が設置されたクレードル30に対して装置本体20をスライドさせながら装着させる場合に、先に説明したスイッチ押圧部材71によって押圧されて、マイクロスイッチ72側に突出する。このような中間部材73は、例えばゴム部材によって形成される。
-Detection relay unit A-
The detection relay unit A directly or indirectly transmits the input from the pressing member 71 to the microswitch 72 between the disposable member (cradle 30 to which the administration port 40 is connected, the disposable unit 20b) and the reuse unit 20a. At a position facing the microswitch 72, it is provided at least at one position on the bottom surface of the fitting portion 21c in the disposable portion 20b of the apparatus main body 20. The detection relay unit A is provided according to the number and position of the pressing member 71 and / or the microswitch 72. The detection relay portion A may be an opening provided on the disposable portion 20b, but it is preferable that the opening is liquid-tightly closed by an intermediate member 73 having flexibility. The intermediate member 73 may have a film shape or a plug shape. The intermediate member 73 is pressed by the switch pressing member 71 described above when the apparatus main body 20 is attached to the cradle 30 in which the administration port 40 is installed while sliding, and projects toward the microswitch 72 side. Such an intermediate member 73 is formed of, for example, a rubber member.
-突出部材74-
 検知中継部Aは、中間部材73の他に、更に突出部材74を有してもよい。突出部材74は、中間部材73のマイクロスイッチ72側に向かう面に設けられたものであって、投与ポート40が設置されたクレードル30に対して装置本体20をスライドさせながら装着させる場合に、マイクロスイッチ72を直接押圧する。突出部材74は、マイクロスイッチ72の検出方法に応じて、スイッチ押圧部材71からの入力を確実に伝えられるものから選択される。スイッチ押圧部材71からの応力をマイクロスイッチ72に伝達しやすくするために、突出部材74を中間部材73よりも硬い材料で形成してもよい。あるいは、突出部材74と、マイクロスイッチ72と、を公知の検出方法を利用した接触センサとしてもよい。
-Protruding member 74-
The detection relay unit A may further include a protruding member 74 in addition to the intermediate member 73. The projecting member 74 is provided on the surface of the intermediate member 73 toward the micro switch 72 side, and is micro when the device main body 20 is slid and attached to the cradle 30 in which the administration port 40 is installed. Press the switch 72 directly. The projecting member 74 is selected from those that can reliably transmit the input from the switch pressing member 71 according to the detection method of the micro switch 72. In order to facilitate the transfer of stress from the switch pressing member 71 to the microswitch 72, the projecting member 74 may be made of a material harder than the intermediate member 73. Alternatively, the protruding member 74 and the micro switch 72 may be used as a contact sensor using a known detection method.
<薬液投与装置2の使用手順および薬液投与装置2の制御方法>
 以上説明した構成の薬液投与装置2を使用する場合の手順は、第1実施形態の薬液投与装置1を使用する場合の手順と同様に実施される。このため、ここでの説明は省略する。
<Procedure for using the drug solution administration device 2 and control method for the drug solution administration device 2>
The procedure for using the drug solution administration device 2 having the configuration described above is carried out in the same manner as the procedure for using the drug solution administration device 1 of the first embodiment. Therefore, the description here will be omitted.
<薬液投与装置2の制御方法>
 第2実施形態に係る薬液投与装置2の制御方法は、第1実施形態の薬液投与装置1の制御方法と同様に実施される。ただし、図10のフローチャートを用いて説明したステップS102において実施する、送液管22aとカニューレ部41とが正常に接続されたか否かの判断は、次のように行われる。すなわち本体演算部16は、マイクロスイッチ72がオンとなった場合に、正常に接続された(YES)と判断し、マイクロスイッチ72がオンとなっていなければ正常に接続されていない(NO)と判断する。
<Control method of drug solution administration device 2>
The control method of the drug solution administration device 2 according to the second embodiment is carried out in the same manner as the control method of the drug solution administration device 1 of the first embodiment. However, the determination as to whether or not the liquid feeding pipe 22a and the cannula portion 41 are normally connected, which is carried out in step S102 described with reference to the flowchart of FIG. 10, is performed as follows. That is, when the micro switch 72 is turned on, the main body calculation unit 16 determines that the connection is normally made (YES), and if the micro switch 72 is not turned on, the connection is not normally made (NO). to decide.
 なお、投与ポート40に複数のマイクロスイッチ72が設けられている場合、本体演算部16は、各接続検知装置70のマイクロスイッチ72が全てオンとなった場合に、正常に接続された(YES)と判断し、それ以外の場合には正常に接続されていない(NO)と判断する。 When a plurality of microswitches 72 are provided in the administration port 40, the main body calculation unit 16 is normally connected when all the microswitches 72 of each connection detection device 70 are turned on (YES). In other cases, it is determined that the connection is not normal (NO).
<第2実施形態の効果>
 以上説明した第2実施形態の薬液投与装置2では、投与ポート40における接続ポート45の先端にスイッチ押圧部材71を設け、装置本体20において接続ポート45が嵌入される嵌合部21cに対向する位置にマイクロスイッチ72を設けた構成である。このため、嵌合部21cに対する接続ポート45の嵌入状態を、マイクロスイッチ72のオン/オフによって直接的に検出することができる。またこれにより、嵌合部21cに保持された接続針管22bと、接続ポート45に連通するカニューレ部41との接続を検知することが可能である。また複数組のスイッチ押圧部材71とマイクロスイッチ72とを設けることにより、嵌合部21cに対して接続ポート45が平行に嵌入した状態であるか否かを検知することができる。
<Effect of the second embodiment>
In the drug solution administration device 2 of the second embodiment described above, the switch pressing member 71 is provided at the tip of the connection port 45 in the administration port 40, and the position of the device main body 20 facing the fitting portion 21c into which the connection port 45 is fitted. The micro switch 72 is provided on the surface. Therefore, the fitted state of the connection port 45 with respect to the fitting portion 21c can be directly detected by turning on / off the micro switch 72. Further, this makes it possible to detect the connection between the connecting needle tube 22b held by the fitting portion 21c and the cannula portion 41 communicating with the connecting port 45. Further, by providing a plurality of sets of switch pressing members 71 and a micro switch 72, it is possible to detect whether or not the connection port 45 is fitted in parallel with the fitting portion 21c.
 この結果、第1実施形態と同様に、装置本体20を投与ポート40が設置されたクレードル30に装着した場合に、投与ポート40に保持されたカニューレ部41と、リザーバ22から延設された接続針管22bとの接続不良を検知し、薬液投与装置2のユーザに装着のし直しを促すことが可能である。すなわち、嵌入端部48と接続針管22bとの接続を、接続部の近傍で検出することができる。これにより、薬液投与装置2において、装置本体20と投与ポート40との接続部分からの薬液の漏れを防止すると共に、精度の高い薬液投与を実施することが可能になる。 As a result, as in the first embodiment, when the apparatus main body 20 is attached to the cradle 30 in which the administration port 40 is installed, the cannula portion 41 held in the administration port 40 and the connection extended from the reservoir 22 are connected. It is possible to detect a poor connection with the needle tube 22b and urge the user of the drug solution administration device 2 to reattach it. That is, the connection between the fitting end portion 48 and the connecting needle tube 22b can be detected in the vicinity of the connecting portion. As a result, in the drug solution administration device 2, it is possible to prevent the drug solution from leaking from the connection portion between the device main body 20 and the administration port 40, and to perform highly accurate drug solution administration.
 1,2…薬液投与装置
 14…本体出力部
 15…本体通信部
 16…本体演算部
 20…装置本体
 21c…嵌合部
 22…リザーバ
 22a…送液管
 22b…接続針管
 30…クレードル
 40…投与ポート
 41…カニューレ部
 45…接続ポート
 50,70…接続検知装置
 51a…磁性部材
 52a…磁気センサ(検知部)
 60…リモートコントローラ
 63…コントローラ出力部
 64…コントローラ通信部
 71…スイッチ押圧部材
 72…マイクロスイッチ(検知部)
1, 2, ... Chemical administration device 14 ... Main body output unit 15 ... Main body communication unit 16 ... Main body calculation unit 20 ... Device main body 21c ... Fitting part 22 ... Reservoir 22a ... Liquid delivery tube 22b ... Connection needle tube 30 ... Cradle 40 ... Administration port 41 ... Cannula unit 45 ... Connection port 50, 70 ... Connection detection device 51a ... Magnetic member 52a ... Magnetic sensor (detection unit)
60 ... Remote controller 63 ... Controller output unit 64 ... Controller communication unit 71 ... Switch pressing member 72 ... Micro switch (detection unit)

Claims (13)

  1.  薬液が充填されるリザーバと、前記リザーバから延設された送液管と、前記リザーバからの薬液の排出を制御する演算部と、を筐体内に収容し、前記送液管の先端部を筐体外へ露出させる嵌合部を更に有する装置本体と、
     皮下に穿刺挿入されるカニューレ部と、前記嵌合部と接続する嵌入端部を有する接続ポートと、を保持するクレードルと、
     前記嵌合部と前記接続ポートとの接続を検知する接続検知装置と、
    を備え、
     前記演算部は、前記接続検知装置からの信号に基づいて前記リザーバから薬液の排出を制御することを特徴する薬液投与装置。
    A reservoir filled with a chemical solution, a liquid feed pipe extending from the reservoir, and a calculation unit for controlling the discharge of the chemical solution from the reservoir are housed in a housing, and the tip of the liquid feed pipe is encapsulated. A device body that further has a fitting part that is exposed to the outside of the body,
    A cradle that holds a cannula portion that is punctured and inserted under the skin and a connection port that has an fitting end portion that connects to the fitting portion.
    A connection detection device that detects the connection between the mating portion and the connection port,
    With
    The calculation unit is a chemical solution administration device, which controls discharge of a chemical solution from the reservoir based on a signal from the connection detection device.
  2.  前記演算部は、前記接続検知装置の検知部からの信号に基づいて前記嵌合部に前記接続ポートが嵌入したと判断した場合に、前記リザーバからの薬液の排出を実施する
     請求項1に記載の薬液投与装置。
    The first aspect of the present invention, wherein the calculation unit discharges the chemical solution from the reservoir when it is determined that the connection port has been fitted into the fitting unit based on a signal from the detection unit of the connection detection device. Drug administration device.
  3.  前記接続検知装置は、
     前記接続ポートの嵌入端部に設けられた被検出部と、前記嵌合部の周辺領域、または、前記嵌合部のいずれかに設けられた検知部としてのセンサとを有し、
    前記被検出部は、前記嵌合部と嵌合する位置に設けられている
     請求項1または2に記載の薬液投与装置。
    The connection detection device is
    It has a detected portion provided at the fitting end portion of the connection port and a sensor as a detection portion provided in the peripheral region of the fitting portion or in any of the fitting portions.
    The drug solution administration device according to claim 1 or 2, wherein the detected portion is provided at a position where the fitting portion is fitted.
  4.  前記接続ポートの嵌入端部は、前記送液管が貫通可能なキャップで閉塞され、
     前記被検出部は、前記キャップに設けられる
     請求項3に記載の薬液投与装置。
    The fitting end of the connection port is closed with a cap through which the liquid feed pipe can penetrate.
    The drug solution administration device according to claim 3, wherein the detected portion is provided on the cap.
  5.  前記被検出部が磁性体であり、前記センサが磁気センサである請求項3または4に記載の薬液投与装置。 The drug solution administration device according to claim 3 or 4, wherein the detected portion is a magnetic material and the sensor is a magnetic sensor.
  6.  前記演算部は、前記センサからの信号が予め設定された閾値に達した場合に、前記嵌合部に前記接続ポートが嵌入したと判断する
     請求項5に記載の薬液投与装置。
    The drug solution administration device according to claim 5, wherein the calculation unit determines that the connection port is fitted into the fitting unit when the signal from the sensor reaches a preset threshold value.
  7.  前記被検出部が、スイッチ押圧部材であり、
     前記検知部が、前記接続ポートが前記嵌合部に嵌入された状態において前記スイッチ押圧部材によって押圧されるマイクロスイッチである、
     請求項3に記載の薬液投与装置。
    The detected portion is a switch pressing member, and is
    The detection unit is a micro switch that is pressed by the switch pressing member in a state where the connection port is fitted in the fitting portion.
    The drug solution administration device according to claim 3.
  8.  前記演算部は、前記マイクロスイッチが押圧された場合に、前記嵌合部に前記接続ポートが嵌入したと判断する
     請求項7に記載の薬液投与装置。
    The drug solution administration device according to claim 7, wherein the calculation unit determines that the connection port is fitted into the fitting portion when the micro switch is pressed.
  9.  前記接続検知装置は、複数の前記スイッチ押圧部材と、前記各スイッチ押圧部材に対応して設けられた複数の前記マイクロスイッチとを有し、
     前記演算部は、前記複数のマイクロスイッチが全て押圧された場合に、前記嵌合部に前記接続ポートが嵌入したと判断する
     請求項7または8に記載の薬液投与装置。
    The connection detection device has a plurality of the switch pressing members and a plurality of the micro switches provided corresponding to the respective switch pressing members.
    The drug solution administration device according to claim 7 or 8, wherein the calculation unit determines that the connection port has been fitted into the fitting portion when all of the plurality of microswitches are pressed.
  10.  前記演算部からの指示によって警報を出力する出力部を備え、
     前記演算部は、前記嵌合部に前記接続ポートが嵌入されていないと判断した場合には、前記出力部に対して警報の出力を指示する
     請求項1~9のうちの何れか1項に記載の薬液投与装置。
    It is provided with an output unit that outputs an alarm according to an instruction from the calculation unit.
    When the calculation unit determines that the connection port is not fitted in the fitting unit, the calculation unit indicates any one of claims 1 to 9 instructing the output unit to output an alarm. The drug solution administration device described.
  11.  前記装置本体に設けられた通信部と、
     前記通信部を介して前記リザーバからの薬液排出の制御を設定するためのリモートコントローラとを備え、
     前記リモートコントローラは、警報を出力する出力部を備え、
     前記演算部は、前記嵌合部に前記接続ポートが嵌入されていないと判断した場合には、前記通信部から前記リモートコントローラに対して前記リモートコントローラの出力部からの警報の出力を指示する
     請求項1~10のうちの何れか1項に記載の薬液投与装置。
    The communication unit provided in the main body of the device and
    A remote controller for setting control of chemical discharge from the reservoir via the communication unit is provided.
    The remote controller includes an output unit that outputs an alarm.
    When the calculation unit determines that the connection port is not fitted in the fitting unit, the communication unit instructs the remote controller to output an alarm from the output unit of the remote controller. Item 2. The drug solution administration device according to any one of Items 1 to 10.
  12.  薬液が充填されるリザーバと、前記リザーバから延設された送液管と、前記リザーバからの薬液の排出を制御する演算部と、を筐体内に収容し、前記送液管の先端部を筐体外へ露出させる嵌合部を更に有する装置本体と、
     皮下に穿刺挿入されるカニューレ部と、前記嵌合部と接続する嵌入端部を有する接続ポートと、を保持するクレードルと、
     前記嵌合部と前記接続ポートとの接続を検知する接続検知装置と、
    を備え、
     前記演算部は、前記接続検知装置からの信号に基づいて前記リザーバから薬液の排出を制御することを特徴する薬液投与装置の制御方法。
    A reservoir filled with a chemical solution, a liquid feed pipe extending from the reservoir, and a calculation unit for controlling the discharge of the chemical solution from the reservoir are housed in a housing, and the tip of the liquid feed pipe is encapsulated. A device body that further has a fitting part that is exposed to the outside of the body,
    A cradle that holds a cannula portion that is punctured and inserted under the skin and a connection port that has an fitting end portion that connects to the fitting portion.
    A connection detection device that detects the connection between the mating portion and the connection port,
    With
    A control method for a chemical solution administration device, wherein the calculation unit controls discharge of a chemical solution from the reservoir based on a signal from the connection detection device.
  13.  前記接続検知装置の検知部からの信号に基づいて前記嵌合部に前記接続ポートが嵌入したと判断した場合に、前記リザーバからの薬液の排出を実施する
     請求項12に記載の薬液投与装置の制御方法。
    The drug solution administration device according to claim 12, wherein when it is determined that the connection port is fitted into the fitting portion based on a signal from the detection unit of the connection detection device, the drug solution is discharged from the reservoir. Control method.
PCT/JP2020/001260 2019-03-22 2020-01-16 Drug solution administration device and method for controlling drug solution administration device WO2020195033A1 (en)

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