WO2020195033A1 - Dispositif d'administration de solution médicamenteuse et procédé de commande de dispositif d'administration de solution médicamenteuse - Google Patents

Dispositif d'administration de solution médicamenteuse et procédé de commande de dispositif d'administration de solution médicamenteuse 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
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English (en)
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/ja
Publication of WO2020195033A1 publication Critical patent/WO2020195033A1/fr

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

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.

Landscapes

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

Abstract

La présente invention concerne un dispositif d'administration de solution médicamenteuse qui est utilisé dans un état où le corps de l'appareil est fixé à un cerceau adhérant à la peau. Le corps de l'appareil renferme, dans un boîtier, un réservoir rempli d'une solution médicamenteuse, un tube d'alimentation en liquide sortant du réservoir, et une unité de calcul pour commander l'écoulement de la solution médicamenteuse à partir du réservoir, et est pourvu d'une partie d'engagement qui expose la partie d'extrémité distale du tube d'alimentation en liquide à l'extérieur du boîtier. Le cerceau est muni d'une partie de canule à insérer par voie sous-cutanée et d'un orifice de raccordement muni d'une partie d'extrémité à emboîter dans la partie d'engagement. Le dispositif d'administration de solution de médicament est en outre pourvu d'un dispositif de détection de raccordement servant à détecter le raccordement entre la partie d'engagement et l'orifice de raccordement. Ceci permet à l'unité de calcul de commander l'écoulement de la solution médicamenteuse à partir du réservoir sur la base de signaux provenant du dispositif de détection de raccordement.
PCT/JP2020/001260 2019-03-22 2020-01-16 Dispositif d'administration de solution médicamenteuse et procédé de commande de dispositif d'administration de solution médicamenteuse WO2020195033A1 (fr)

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Cited By (2)

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Publication number Priority date Publication date Assignee Title
WO2023181799A1 (fr) * 2022-03-22 2023-09-28 テルモ株式会社 Canule de dispositif d'administration de solution médicamenteuse et dispositif d'administration de solution médicamenteuse comprenant la canule
WO2024070145A1 (fr) * 2022-09-29 2024-04-04 テルモ株式会社 Orifice de canule, dispositif de berceau et dispositif d'administration de solution de médicament

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JP2000009586A (ja) * 1998-06-19 2000-01-14 Canon Inc レンズ測定装置
JP2005201348A (ja) * 2004-01-15 2005-07-28 Showa Corp 定量分配器
JP2013232375A (ja) * 2012-05-01 2013-11-14 Furukawa Electric Co Ltd:The コネクタ、給電システム
WO2016075976A1 (fr) * 2014-11-11 2016-05-19 テルモ株式会社 Dispositif d'administration de solution de médicament
WO2018066378A1 (fr) * 2016-10-05 2018-04-12 テルモ株式会社 Dispositif d'administration de médicament liquide et procédé de commande pour dispositif d'administration de médicament liquide

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Publication number Priority date Publication date Assignee Title
EP3082912B1 (fr) 2013-12-17 2018-05-30 Novo Nordisk A/S Dispositif motorisé d'administration de médicament à caractéristiques de sécurité de charge
EP3520843A4 (fr) 2016-09-27 2020-04-15 Terumo Kabushiki Kaisha Dispositif d'administration de médicament liquide

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2000009586A (ja) * 1998-06-19 2000-01-14 Canon Inc レンズ測定装置
JP2005201348A (ja) * 2004-01-15 2005-07-28 Showa Corp 定量分配器
JP2013232375A (ja) * 2012-05-01 2013-11-14 Furukawa Electric Co Ltd:The コネクタ、給電システム
WO2016075976A1 (fr) * 2014-11-11 2016-05-19 テルモ株式会社 Dispositif d'administration de solution de médicament
WO2018066378A1 (fr) * 2016-10-05 2018-04-12 テルモ株式会社 Dispositif d'administration de médicament liquide et procédé de commande pour dispositif d'administration de médicament liquide

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023181799A1 (fr) * 2022-03-22 2023-09-28 テルモ株式会社 Canule de dispositif d'administration de solution médicamenteuse et dispositif d'administration de solution médicamenteuse comprenant la canule
WO2024070145A1 (fr) * 2022-09-29 2024-04-04 テルモ株式会社 Orifice de canule, dispositif de berceau et dispositif d'administration de solution de médicament

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