Medicament cartridge, medicament injection device and medicament injection system

Abstract

The medicament cartridge has a pre-filled syringe, an outer barrel, a cap, a needle guard, a sleeve, and a cartridge spring. The cap can take a locked state in which the cap cannot be detached from the outer barrel and an unlocked state in which the cap can be detached from the outer barrel with the cap embedded in the cartridge front opening of the outer barrel.

Description

Technical Field

[0001] This application relates to a pharmaceutical cartridge, a pharmaceutical injection device, and a pharmaceutical injection system for injecting pharmaceuticals. Background Technology

[0002] Self-injection therapy, where the patient administers the injection themselves, is becoming increasingly common, and medication infusion devices for use in self-injection are being developed. Pre-filled syringes are known as a type of syringe used in this type of self-injection. A pre-filled syringe is a syringe pre-filled with medication, and sometimes an injection needle is also attached to the syringe. By using a pre-filled syringe, the patient is excluded from filling the syringe or attaching the injection needle, and the medication can be injected while maintaining the cleanliness of the pre-filled syringe during manufacturing. For example, Patent Document 1 discloses a medication infusion device using such a pre-filled syringe.

[0003] Existing technical documents

[0004] Patent documents

[0005] Patent Document 1: Japanese Patent Publication No. 2014-516634 Summary of the Invention

[0006] The problem that the invention aims to solve

[0007] There is a demand for pharmaceutical injection devices that offer superior operability and safety. This application provides, through a non-limiting exemplary embodiment, a pharmaceutical injection device, a pharmaceutical injection system, and a pharmaceutical cartridge used therein that offer excellent operability and safety.

[0008] Solution for solving the problem

[0009] An embodiment of the present invention provides a drug cartridge comprising: a pre-filled syringe having a drug, a syringe body having a syringe cylindrical space for dispensing the drug and a syringe opening located at one end of the syringe cylindrical space, an injection needle located on the side of the syringe body opposite to the syringe opening and communicating with the syringe cylindrical space, a limiter movable in the syringe cylindrical space and disposed on the side of the syringe opening, and a needle guard covering the front end of the injection needle and removable; an outer casing having a front opening and a rear opening and a cylindrical space between the rear opening and the front opening, and holding the pre-filled syringe within the cylindrical space such that a portion of the injection needle and a portion of the needle guard protrude from the front opening; and a cap embedded in the front opening such that it fits and covers the needle guard, and the cap is integral with the needle guard. The cap is detached from the outer cylinder of the box; a needle protector having a protective portion and being movable axially within the cylindrical space of the box, and the needle protector being movable between a first engagement position where the front end of the protective portion is retracted from the front end of the injection needle protruding from the front opening of the box and a second engagement position where the front end of the protective portion protrudes from the front end of the injection needle protruding from the front opening of the box in the state of cap detachment; a sleeve being movable axially within the cylindrical space of the box between a first position located on the rear opening side of the box and a second position located on the front opening side of the box, and engaging with the outer cylinder of the box at the first position; and a box spring applying force to the needle protector toward the front opening side of the box, wherein, when the cap is embedded in the front opening of the box, the cap can be in a locked state in which it cannot be detached from the outer cylinder of the box and an unlocked state in which it can be detached from the outer cylinder of the box.

[0010] A pharmaceutical injection device according to one embodiment of the present invention comprises: a housing having a cylindrical space capable of holding a pharmaceutical cartridge and a cylindrical opening communicating with the cylindrical space; a piston unit including a piston, a piston gear for driving the piston along a piston axis, and a latching unit partially inserted into the rear opening of the cartridge and holding the pharmaceutical cartridge; a needle removal motor for advancing and retracting the piston unit along the piston axis; an injection motor for advancing and retracting the piston along the piston axis; a control circuit for controlling the needle removal motor and the injection motor; and an interface for inputting commands to the control circuit.

[0011] Invention Effects

[0012] According to at least one embodiment of the present invention, a drug injection device, a drug injection system, and a drug cartridge used therein are provided that are excellent in terms of operability and safety. Attached Figure Description

[0013] Figure 1A This is a perspective view showing the appearance of a drug injection system equipped with a drug cartridge and a drug injection device.

[0014] Figure 1B This is a three-dimensional diagram showing a state of a drug injection system in use.

[0015] Figure 1C This is a three-dimensional diagram showing a state of a drug injection system in use.

[0016] Figure 1D This is a three-dimensional diagram showing a state of a drug injection system in use.

[0017] Figure 1E This is a three-dimensional diagram showing a state of a drug injection system in use.

[0018] Figure 1F This is a three-dimensional diagram showing a state of a drug injection system in use.

[0019] Figure 1G This is a three-dimensional diagram showing a state of a drug injection system in use.

[0020] Figure 1H This is a three-dimensional diagram showing a state of a drug injection system in use.

[0021] Figure 2 This is an exploded perspective view of a pre-filled syringe.

[0022] Figure 3 This is an exploded 3D view of the medicine cartridge (excluding the pre-filled syringe).

[0023] Figure 4 This is a 3D exploded view of the hat.

[0024] Figure 5 This is a 3D view of the outer cylinder of the box.

[0025] Figure 6 It is a 3D diagram of the needle protector.

[0026] Figure 7 This is an exploded 3D view of the sleeve.

[0027] Figure 8 This is a diagram showing the assembly sequence of the medicine cartridge.

[0028] Figure 9A This is a schematic cross-sectional view of the reagent cartridge in one state, passing through the axis.

[0029] Figure 9B This is a schematic cross-sectional view of the reagent cartridge in one state, passing through the axis.

[0030] Figure 9CThis is a schematic cross-sectional view of the reagent cartridge in one state, passing through the axis.

[0031] Figure 9D This is a schematic cross-sectional view of the reagent cartridge in one state, passing through the axis.

[0032] Figure 10A It is a three-dimensional view of the medicine container in one state after the outer casing has been removed.

[0033] Figure 10B It is a three-dimensional view of the medicine container in one state after the outer casing has been removed.

[0034] Figure 10C It is a three-dimensional view of the medicine container in one state after the outer casing has been removed.

[0035] Figure 10D It is a three-dimensional view of the medicine container in one state after the outer casing has been removed.

[0036] Figure 11A It is a three-dimensional view of the medicine cartridge with the needle protector protruding.

[0037] Figure 11B It is a three-dimensional view of the medicine cartridge with the needle protector protruding.

[0038] Figure 12A This is a three-dimensional view of the disassembled outer casing of the drug injection device.

[0039] Figure 12B This is a three-dimensional view of the front shell viewed from the inside.

[0040] Figure 13 It is a three-dimensional decomposed view of the main body.

[0041] Figure 14 This is a block diagram showing the structure of the circuitry of the drug injection device.

[0042] Figure 15 This is a 3D view of the drive unit.

[0043] Figure 16A It is a three-dimensional view of the piston unit after the piston shell has been removed.

[0044] Figure 16B It is an exploded perspective view of the piston unit after the piston shell has been removed.

[0045] Figure 16C It is a diagram showing the positional relationship of the first plane, the second plane, and the third plane as viewed from the front end.

[0046] Figure 16D This is an exploded 3D view of the latch unit.

[0047] Figure 16E This is the front view of the latch unit.

[0048] Figure 17A This is a cross-sectional view illustrating the situation where the piston unit holds the drug cartridge.

[0049] Figure 17B This is a cross-sectional view illustrating the situation where the piston unit holds the drug cartridge.

[0050] Figure 17C This is a cross-sectional view illustrating the situation where the piston unit holds the drug cartridge.

[0051] Figure 18A This is a partial cross-sectional view illustrating the situation where the piston unit holds the drug cartridge.

[0052] Figure 18B This is a partial cross-sectional view illustrating the situation where the piston unit holds the drug cartridge.

[0053] Figure 18C This is a partial cross-sectional view illustrating the situation where the piston unit holds the drug cartridge.

[0054] Figure 18D This is a partial cross-sectional view illustrating the situation where the piston unit holds the drug cartridge.

[0055] Figure 19A This is a side view illustrating the situation where the piston unit holds the drug cartridge.

[0056] Figure 19B This is a side view illustrating the situation where the piston unit holds the drug cartridge.

[0057] Figure 19C This is a side view illustrating the situation where the piston unit holds the drug cartridge.

[0058] Figure 20A It is a perspective view showing the vicinity of the engagement part between the piston unit and the drug cartridge when the piston unit releases the drug cartridge.

[0059] Figure 20B It is a perspective view showing the vicinity of the engagement part between the piston unit and the drug cartridge when the piston unit releases the drug cartridge.

[0060] Figure 21A It is a perspective view showing the vicinity of the engagement part between the piston unit and the drug cartridge when the piston unit releases the drug cartridge.

[0061] Figure 21B It is a perspective view showing the vicinity of the engagement part between the piston unit and the drug cartridge when the piston unit releases the drug cartridge.

[0062] Figure 22A It is a perspective view showing the vicinity of the engagement part between the piston unit and the drug cartridge when the piston unit releases the drug cartridge.

[0063] Figure 22B It is a perspective view showing the vicinity of the engagement part between the piston unit and the drug cartridge when the piston unit releases the drug cartridge.

[0064] Figure 23A This is a 3D view of the drive unit.

[0065] Figure 23B This is a 3D view of the drive unit.

[0066] Figure 23C This is a 3D view of the drive unit.

[0067] Figure 23D This is a 3D view of the drive unit.

[0068] Figure 23E This is a 3D view of the drive unit.

[0069] Figure 23F This is a 3D view of the drive unit.

[0070] Figure 24A This is a three-dimensional diagram illustrating the operation of the sliding unit.

[0071] Figure 24B This is a three-dimensional diagram illustrating the operation of the sliding unit.

[0072] Figure 24C This is a three-dimensional diagram illustrating the operation of the sliding unit.

[0073] Figure 24D This is a three-dimensional diagram illustrating the operation of the sliding unit.

[0074] Figure 24E This is a three-dimensional diagram illustrating the operation of the sliding unit.

[0075] Figure 25A This is a three-dimensional diagram illustrating the needle insertion completion detector and the needle withdrawal completion detector.

[0076] Figure 25B This is a three-dimensional diagram illustrating the needle insertion completion detector and the needle withdrawal completion detector.

[0077] Figure 26A This is a three-dimensional diagram illustrating the needle protector detector.

[0078] Figure 26B This is a three-dimensional diagram illustrating the needle protector detector.

[0079] Figure 27 This is a flowchart illustrating the operation of a drug injection system.

[0080] Figure 28 This is a flowchart illustrating the operation of a drug injection system.

[0081] Figure 29 This is a flowchart illustrating the operation of a drug injection system.

[0082] Figure 30 This is a flowchart illustrating the operation of a drug injection system.

[0083] Figure 31 This is a flowchart illustrating the operation of a drug injection system.

[0084] Figure 32 This is a flowchart illustrating the operation of a drug injection system.

[0085] Figure 33 This is a flowchart illustrating the operation of a drug injection system.

[0086] Figure 34 This is a flowchart illustrating the operation of a drug injection system.

[0087] Figure 35 This is a flowchart illustrating the operation of a drug injection system.

[0088] Figure 36 This is a flowchart illustrating the operation of a drug injection system.

[0089] Figure 37 This is a flowchart illustrating the operation of a drug injection system.

[0090] Figure 38 This is a flowchart illustrating the operation of a drug injection system.

[0091] Figure 39 This is a flowchart illustrating the operation of a drug injection system. Detailed Implementation

[0092] The drug injection device for self-administering medications is preferably designed for use by individuals who do not require extensive experience. Furthermore, it is preferred to be easy to operate and highly safe. The drug cartridge and drug injection device of the present invention are suitable for pre-filled syringes equipped with injection needles, suppressing the possibility of the injection needle protruding from the drug cartridge and being accessed by the operator at times other than during injection. The outline of the drug cartridge, drug injection device, and drug injection system of the present invention is described below.

[0093] [Project 1]

[0094] A medicine container, wherein,

[0095] The reagent cartridge includes:

[0096] A pre-filled syringe includes a drug, a syringe body having a syringe cylindrical space for dispensing the drug and a syringe opening located at one end of the syringe cylindrical space, an injection needle located on the side of the syringe body opposite to the syringe opening and communicating with the syringe cylindrical space, a limiter movable in the syringe cylindrical space and disposed on the side of the syringe opening, and a needle guard covering the front end of the injection needle and removable.

[0097] The outer casing has a front opening and a rear opening, and a cylindrical space between the rear opening and the front opening, and holds the pre-filled syringe in the cylindrical space with a portion of the injection needle and a portion of the needle guard protruding from the front opening.

[0098] A cap is inserted into the front opening of the box in such a way that it fits into and covers the needle guard, and the cap is detachable from the outer cylinder of the box integrally with the needle guard;

[0099] A needle protector having a protective part and being movable along the axial direction of the cylindrical space of the box, and the needle protector being movable between a first engagement position in which the front end of the protective part is retracted from the front end of the injection needle protruding from the front opening of the box and a second engagement position in which the front end of the protective part protrudes from the front end of the injection needle protruding from the front opening of the box in the cap-free state;

[0100] A sleeve, which is axially movable within the cylindrical space of the box between a first position located on the rear opening side of the box and a second position located on the front opening side of the box, and engages with the outer cylinder of the box at the first position; and

[0101] A box spring applies force to the needle protector towards the front opening of the box.

[0102] When the cap is embedded in the front opening of the box, the cap can be in a locked state where it cannot be detached from the outer cylinder of the box, and in an unlocked state where it can be detached from the outer cylinder of the box.

[0103] [Project 2]

[0104] According to the reagent cartridge described in Project 1, wherein,

[0105] When the cap is embedded in the front opening of the box.

[0106] The needle protector abuts against the cap and overcomes the force of the box spring to be located in the first engaging position.

[0107] [Project 3]

[0108] According to the reagent cartridge described in Project 2, wherein,

[0109] With the cap inserted into the opening of the box and the sleeve in the first position, the cap is in a locked state.

[0110] With the cap inserted into the front opening of the box and the sleeve in the second position, the sleeve makes the cap unlocked and the needle protector locked in the first engaging position.

[0111] [Project 4]

[0112] According to the reagent cartridge described in Project 3, wherein...

[0113] One end of the box spring abuts against the needle protector, and the other end of the box spring abuts against the sleeve.

[0114] When the cap is inserted into the front opening of the box, the sleeve moves from the first position to the second position under the action of an external force, overcoming the force of the box spring, and the cap is removed.

[0115] [Project 5]

[0116] According to the reagent cartridge described in Project 4, wherein...

[0117] After the cap is removed, the external force is released, and the sleeve moves from the second position to the first position under the action of the box spring.

[0118] The sleeve keeps the needle protector in an unlocked state, so that the needle protector moves from the first engaged position to the second engaged position under the action of the box spring.

[0119] [Project 6]

[0120] According to the reagent cartridge described in Project 5, wherein,

[0121] In the second engaging position, the needle protector engages with the outer cylinder of the box in a manner that prevents it from moving toward the first engaging position.

[0122] [Project 7]

[0123] According to the reagent cartridge described in Project 1, wherein,

[0124] In the first position, the sleeve engages with the outer cylinder of the box in a manner that prevents it from moving to the second position.

[0125] [Project 8]

[0126] According to the reagent cartridge described in Project 1, wherein,

[0127] The syringe body has a flange disposed near the syringe opening.

[0128] The outer cylinder of the box has a slit located near the rear opening of the box.

[0129] The flange of the syringe body is inserted into the slit of the outer cylinder of the cartridge, thereby holding the pre-filled syringe in the outer cylinder of the cartridge.

[0130] [Project 9]

[0131] According to the reagent cartridge described in Project 1, wherein,

[0132] The cap includes a cap body and a cap spring that engages with the needle guard. The cap body has a cylindrical torso, a first elastic support portion located at one end of the torso, and a first engaging claw located at the other end of the first elastic support portion and having an abutment surface at the front end. The cap spring is disposed within the torso.

[0133] The outer cylinder of the box has a cap-locking portion on the inner surface located on the front opening side of the box.

[0134] With the cap embedded in the front opening of the box, the cap body surrounds the front opening of the box, the first engaging claw is inserted into the outer cylinder of the box from the front opening of the box, and the cap engages with the cap engaging part in a manner that prevents it from disengaging from the front opening of the box.

[0135] [Project 10]

[0136] According to the reagent cartridge described in Project 9, wherein...

[0137] The protective portion of the needle protector has an end face and a needle protector opening provided on the end face, and has a cylindrical shape defining a cylindrical space for accommodating a portion of the syringe body of the pre-filled syringe.

[0138] The needle protector also has a second elastic support portion connected at one end to one end of the protective part opposite to the opening of the needle protector, and a protrusion disposed at the other end of the second elastic support portion.

[0139] The outer cylinder of the box has a first opening located on the rear opening side of the box and a second opening located on the front opening side of the box, which is closer to the first opening side than the first opening side.

[0140] When the needle protector is in the first engaging position, the protrusion engages with the first opening.

[0141] When the needle protector is in the second engaging position, the protrusion engages with the second opening.

[0142] [Project 11]

[0143] According to the reagent cartridge described in Project 10, wherein,

[0144] The protrusion has an inclined portion located on the protective portion side and inclined towards the outer cylinder side of the box, a recess provided in the inclined portion, a top adjacent to the inclined portion, a side portion adjacent to the top on the opposite side of the inclined portion, and an inner surface portion located inside the inclined portion, the top portion, and the side portion.

[0145] The outer cylinder of the box has an inwardly projecting portion that protrudes from the edge of the front opening side of the second opening toward the center of the second opening.

[0146] When the protrusion is engaged with the second opening, the inclined portion of the protrusion abuts against the edge of the front opening side of the second opening, and the protrusion inside the opening engages with the recess of the inclined portion.

[0147] [Project 12]

[0148] According to the reagent cartridge described in Project 11, wherein,

[0149] The sleeve has: an inner sleeve portion having a front opening and a space for receiving a portion of the pre-filled syringe; an outer sleeve portion disposed separately from the inner sleeve portion and having a rear opening; a sleeve abutment surface located on the side of the front opening of the outer sleeve portion; and slits respectively provided in the inner sleeve portion and the outer sleeve portion.

[0150] Within the cylindrical space of the outer cylinder of the box, the sleeve abutment surface is located on the front opening side of the box, at least the protrusion of the needle protector and the second elastic support portion are located between the inner cylinder portion and the outer cylinder portion, and the slit of the inner cylinder portion and the slit of the outer cylinder portion are aligned with the second elastic support portion and the protrusion in the same radial direction in a section perpendicular to the axis of the cylindrical space of the box.

[0151] [Project 13]

[0152] According to the reagent cartridge described in Project 12, wherein,

[0153] With the cap inserted into the opening in the box and the sleeve in the second position.

[0154] The sleeve abutting surface of the sleeve abuts against the abutting surface of the first engaging claw of the cap.

[0155] The first elastic support portion deforms, thereby releasing the engagement between the first engaging claw and the cap engaging portion of the outer cylinder of the box.

[0156] The inner cylindrical portion of the sleeve abuts against the inner surface of the protrusion of the needle protector, thereby suppressing the deformation of the second elastic support portion.

[0157] [Project 14]

[0158] According to the reagent cartridge described in Project 12, wherein,

[0159] When the cap is removed from the front opening of the box and the sleeve is in the first position, under the action of the box spring, the edge of the first opening abuts against the inclined portion of the protrusion, and the second elastic support portion deforms inward to enter the slit of the inner cylinder, thereby disengaging the protrusion from the first opening inward, and the needle protector moves from the first engaging position to the second engaging position.

[0160] In the second engaging position, the inner cylinder of the sleeve abuts against the inner surface of the protrusion of the needle protector, thereby suppressing the deformation of the second elastic support.

[0161] [Project 15]

[0162] According to the reagent cartridge described in Project 14, wherein,

[0163] The sleeve has a third elastic support portion with one end located near the rear opening of the sleeve, and a second engaging claw located at the other end of the third elastic support portion and having an abutment surface at the front end.

[0164] The outer cylinder of the box has a sleeve engagement portion on the inner surface located on the rear opening side of the box.

[0165] When the sleeve is in the first position, the second engaging claw of the sleeve engages with the sleeve engaging portion of the outer cylinder of the box, thereby suppressing the movement of the sleeve to the second position.

[0166] [Project 16]

[0167] A practice medicine cartridge, wherein,

[0168] The practice reagent cartridge includes:

[0169] The outer cylinder of the box has a rear opening and a front opening, as well as a cylindrical space between the rear opening and the front opening.

[0170] The cap is embedded in the front opening of the box;

[0171] A needle protector having a protective part, capable of moving along the axial direction of the cylindrical space of the box, and capable of moving between a first engaging position located on the rear opening side of the box and a second engaging position where the front end of the protective part protrudes from the front opening of the box when the cap is detached;

[0172] A sleeve, movable axially between a pre-filled syringe within the cylindrical space of the box and the outer cylinder of the box, and between a first position located on the rear opening side of the box and a second position located on the front opening side of the box, closer to the first position than the first position; and

[0173] A box spring applies force to the needle protector in a manner that protrudes from the front opening of the box.

[0174] When the cap is embedded in the front opening of the box, the cap can be in a locked state where it cannot be detached from the outer cylinder of the box, and in an unlocked state where it can be detached from the outer cylinder of the box.

[0175] [Project 17]

[0176] A drug injection device, wherein,

[0177] The drug injection device includes:

[0178] A shell having a cylindrical space capable of containing a pharmaceutical cartridge as described in any one of items 1 to 15 and a cylindrical opening communicating with said cylindrical space;

[0179] A piston unit includes a piston, a piston gear that drives the piston along the piston axis, and a latching unit that is partially inserted into the rear opening of the cartridge and holds the cartridge.

[0180] A needle-pulling motor that causes the piston unit to move forward and backward along the piston axis;

[0181] An injection motor is used to propel the piston forward and backward along the piston axis.

[0182] Control circuitry that controls the needle removal motor and the injection motor; and

[0183] An interface that inputs commands to the control circuit.

[0184] [Project 18]

[0185] According to the drug injection device described in Project 17, wherein...

[0186] The latching unit includes a cylinder latching member that engages with the outer cylinder of the medicine cartridge and a sleeve abutting portion that abuts against the sleeve of the medicine cartridge.

[0187] When the medicine cartridge is inserted into the cartridge space from the cartridge opening, the sleeve abutment portion of the latching unit enters inward from the rear opening of the box and abuts against the sleeve of the medicine cartridge, thereby releasing the engagement between the sleeve and the outer cylinder of the box.

[0188] As the medicine cartridge is inserted, the sleeve abutment causes the sleeve to move relative to the outer cylinder of the box towards the second position, and the cylinder latch enters inward from the rear opening of the box.

[0189] When the filling of the medicine cartridge is completed, the sleeve reaches the second position, and the cylinder latch engages with the outer cylinder of the box.

[0190] [Project 19]

[0191] According to the pharmaceutical injection device described in Project 18, wherein...

[0192] The control circuit is based on input from the interface.

[0193] By rotating the needle removal motor, the piston unit is advanced, thereby inserting the needle.

[0194] By rotating the injection motor, the piston advances from its initial position, thereby moving the limiter and injecting the medication.

[0195] The needle is removed by reversing the needle removal motor after rotating the injection motor by a predetermined amount, thereby causing the piston unit to retract.

[0196] [Project 20]

[0197] According to the drug injection device described in Project 19, wherein...

[0198] The drug injection device also includes a needle protector detector for detecting the discharge of the needle protector.

[0199] After needle removal, the control circuit reverses the injection motor, causing the piston to retract to a needle guard discharge position that is further back than its initial position.

[0200] As the piston retracts, the latching unit rotates about the piston axis, and the contact between the sleeve abutment and the sleeve is released.

[0201] The sleeve moves from the second position to the first position under the action of the box spring, making the needle protector unlocked. Thus, the needle protector moves from the first engaged position to the second engaged position under the action of the box spring.

[0202] The needle protector detector detects the discharge of the needle protector.

[0203] [Project 21]

[0204] According to the drug injection device described in Project 20, wherein...

[0205] The needle protector detector includes: a light-emitting element that illuminates a portion of the needle protector; and a light-receiving element that detects light emitted from the light-emitting element and reflected by the needle protector or light that passes through the needle protector.

[0206] [Project 22]

[0207] According to the drug injection device described in Project 21, wherein...

[0208] Based on the detection signal from the needle protector detector, the control circuit reverses the injection motor, causing the piston to retract to a cylinder discharge position that is further back than the needle protector discharge position.

[0209] As the piston retracts, the latching unit rotates around the piston axis, and the engagement between the cylinder latch and the outer cylinder of the box is released.

[0210] [Project 23]

[0211] The pharmaceutical injection device according to any one of items 20 to 22, wherein,

[0212] The piston has a spiral-shaped contact surface located on the front end side.

[0213] The latching unit has a through hole for the piston to be inserted and a limiting portion located on the inner surface of the through hole.

[0214] The contact surface of the piston abuts against the limiting part of the latching unit, thereby causing the latching unit to rotate about the piston axis as the piston moves forward and backward.

[0215] [Project 24]

[0216] The pharmaceutical injection device according to any one of items 17 to 23, wherein...

[0217] The drug injection device also includes a door that can cover the cylinder opening in an openable and closable manner.

[0218] [Project 25]

[0219] A drug delivery system, wherein,

[0220] The drug injection system includes:

[0221] The reagent cartridges described in any one of items 1 to 15; and

[0222] The drug injection device as described in any one of items 17 to 24.

[0223] Hereinafter, an example of a drug cartridge, drug injection device, and drug injection system according to this embodiment will be described in detail with reference to the accompanying drawings. The drug injection system described below is an example of an embodiment. The embodiment is not limited to the following method and various modifications can be made. In the accompanying drawings referred to in the following description, reference numerals in the drawings not mentioned in the description are sometimes omitted for ease of understanding.

[0224] (Structure of a drug delivery system)

[0225] [Overview of Drug Infusion Systems]

[0226] Figure 1A This is a perspective view showing the appearance of a drug injection system 300 equipped with a drug cartridge 100 and a drug injection device 200. Figures 1B to 1H These are perspective views showing a state of the drug injection system 300 in use.

[0227] The medicine cartridge 100 has a cap 110 and an outer casing 120, and a pre-filled syringe 10 is also provided inside the outer casing 120. Figure 2 )(exist Figure 1A (The pre-filled syringe 10, held within the outer casing 120, is not shown). As described in detail below, the pre-filled syringe 10 is filled with medication and fitted with an injection needle 12. A cap 110 covers the injection needle 12 of the held pre-filled syringe 10. However, the cap 110 is configured to be locked so that it is difficult to remove even if the operator wants to remove the cap 110 by hand.

[0228] The drug injection device 200 includes an outer casing 201. The outer casing 201 has, for example, a cylindrical shape of a thickness that is easy for an operator to hold with one hand. In this embodiment, the outer casing 201 has a cylindrical shape consisting of two generally flat planes and a curved surface connecting the two planes. However, the shape of the outer casing 201 is not limited to this, and may also be a cylindrical shape or a square shape, etc.

[0229] A cylindrical opening 201a is provided on one end face of the cylindrical outer casing 201. The cylindrical opening 201a communicates with a cylindrical space 280a located inside the outer casing 201 and capable of holding the medicine cartridge 100. A door 203 is provided in the cylindrical opening 201a that opens toward the inside of the cylindrical space 280a.

[0230] A skin contact surface 201b is also provided on the end face of the outer casing 201 where the tube opening 201a is provided. In addition, the outer casing 201 is provided with a display window 201d, an injection button 254, a selection (up) button 255, a selection (down) button 256, and a return button 257.

[0231] When using the drug injection system 300, the drug cartridge 100 is inserted into the cartridge space 280a inside the drug injection device 200 through the cartridge opening 201a by pressing the rear door 203 of the drug cartridge 100.

[0232] like Figure 1B As shown, with the medicine cartridge 100 fully loaded into the medicine injection device 200, a portion of the cap 110 protrudes from the outer casing 201. When the medicine cartridge 100 is fully loaded, the cap 110 is released from its locking mechanism. Thus, as... Figure 1C As shown, the cap 110 can be removed. At this time, the injection needle 12 of the pre-filled syringe 10 is located on the inner side of the outer casing 201, closer to the barrel opening 201a. Therefore, during normal handling, contact between the injection needle and body parts such as fingers is prevented.

[0233] When the operator presses the front end of the drug injection device 200 against the injection site on the body and presses the injection button 254, as... Figure 1D As shown, the cartridge 100 of the pre-filled syringe 10 advances to insert the injection needle 12 into the body. In this specification, moving the cartridge 100 and the components of the injection device 200 in the direction F that causes the injection needle 12 to pierce the injection site is called advancing, and moving the cartridge 100 and the components of the injection device 200 in the direction B that withdraws the injection needle is called retracting. In addition, when the components of the cartridge 100 and the injection device 200 have a shape with long sides along the directions F and B, the side of each component facing the injection needle 12 is sometimes referred to as "front," and the side of each component opposite to the injection needle 12 is sometimes referred to as "rear." Instead of "front" and "rear," they may also be referred to as "first" and "second," or "second" and "first."

[0234] When the medication administration is complete, the medication cartridge 100 retracts, and the injection needle 12 is stored inside the outer casing 201. When the medication injection device 200 is detached from the injection site, as... Figure 1E As shown, the needle guard 130 of the drug cartridge 100 advances to cover the injection needle 12, a portion of which protrudes from the cartridge opening 201a. Subsequently, the connection between the drug cartridge 100 and the drug injection device 200 is released, as... Figure 1F As shown, the reagent cartridge 100 further protrudes slightly from the cartridge opening 201a.

[0235] The operator pinches the needle guard 130 of the medicine cartridge 100 to remove the medicine cartridge 100 from the medicine injection device 200. At this time, as Figure 1G As shown, the injection needle 12 of the medication cartridge 100 is covered by a needle protector 130. This prevents the injection needle 12 from coming into contact with parts of the body such as fingers. Then, as... Figure 1H As shown, the door 203 seals the opening 201a of the cylinder.

[0236] Thus, according to the drug injection system 300, the operator can fill the drug cartridge 100 into the drug injection system 300 without making contact with the injection needle 12, and then remove the used drug cartridge 100. Since the pre-filled syringe 10 is filled with medication and also has an injection needle installed, it can be injected in its clean state (sterilized state) as it was manufactured. The structure of the drug cartridge 100 and the drug injection device 200 will be described in detail below.

[0237] [Construction of the pre-filled syringe 10 and the drug cartridge 100]

[0238] <Pre-filled syringe 10>

[0239] Figure 2 This is an exploded perspective view of a pre-filled syringe 10. The pre-filled syringe 10 includes a syringe body 11, an injection needle 12, a stopper 13, and a needle guard 14. The syringe body 11 has a syringe cylindrical space 11s and a syringe opening 11a located at one end of the syringe cylindrical space 11s, and is filled with a drug. The injection needle 12 is located on the side of the syringe body 11 opposite to the syringe opening 11a and communicates with the syringe cylindrical space 11s. A flange 11b is provided in the syringe body 11 on the side of the syringe opening 11a. The stopper 13 is disposed on the side of the syringe opening 11a of the syringe cylindrical space 11s. The stopper 13 is movable along a cylindrical axis within the cylindrical space of the syringe body 11. The piston 221 of the drug injection device 200 (described later) presses the stopper 13, thereby releasing the drug from the tip of the injection needle 12.

[0240] The needle 12 of the pre-filled syringe 10 is covered by a needle guard 14 for protection, maintenance of sterility, and prevention of accidental puncture by the operator. A locking portion 14a is provided on the outer surface of the needle guard 14. The locking portion 14a is, for example, a protrusion or depression on the outer surface of the needle guard 14. The needle guard 14 is inserted into the hole of the cap 110 of the drug cartridge 100 (described later) and is integrally removed from the pre-filled syringe 10 together with the cap 110. The locking portion 14a engages with the cap 110 in such a way that the needle guard 14 is removed from the pre-filled syringe 10 together with the cap 110 during removal. The locking portion 14a is not limited to... Figure 2The method shown can also be other than the one shown. The engaging portion 14a can also be a rough surface that makes large frictional contact with the inner surface of the hole in the cap 110. Alternatively, the needle guard 14 can be without the engaging portion 14a, but have an outer diameter slightly larger than the hole in the cap 110, so that the needle guard 14 frictionally engages with the cap 110 when pressed into the hole in the cap 110.

[0241] The type of drug filled in the pre-filled syringe 10 can be one or more. Furthermore, the amount of drug can vary. That is, even pre-filled syringes 10 of the same shape can contain different types and / or amounts of drug.

[0242] <Pharmacy Cylinder 100>

[0243] Figure 3 This is an exploded perspective view of the cartridge 100 with the pre-filled syringe 10 removed. The cartridge 100 with the pre-filled syringe 10 removed is also referred to as box 105.

[0244] The syringe cartridge 100 includes a cap 110, an outer casing 120, a needle protector 130, a cartridge spring 140, a sleeve 150, and a syringe retainer 160. Components other than the cartridge spring 140 are made of, for example, resin. The cartridge spring 140 is made of, for example, steel.

[0245] The syringe cartridge 100 has a cylindrical shape. The direction parallel to the axis a of the cylindrical shape of the syringe cartridge 100 is called the axial direction A. In addition, in a section perpendicular to axis a, a radial direction R centered on axis a is defined. These directions are sometimes referenced in the same way with reference to the axes of the outer cartridge 120, the needle protector 130, the cartridge spring 140, and the syringe retainer 160.

[0246] Figure 4 This is an exploded perspective view of the cap 110. The cap 110 includes a cap body 111 and a cap spring 112. The cap body 111 has a cylindrical torso 111c, an elastic support portion 111d (first elastic support portion), and a locking claw 111e (first locking claw). In this embodiment, the cap body 111 has a pair of elastic support portions 111d. The pair of elastic support portions 111d are arranged radially apart from each other relative to the axis 111j of the cylindrical torso 111c, with one end of each located at one end of the torso 111c. The locking claw 111e is located at the other end of each elastic support portion 111d. The locking claw 111e has an abutment surface 111f on its outer side in the radial direction. The elastic support portion 111d is capable of flexing toward the center side in the radial direction R.

[0247] A cap spring 112 is disposed within the body 111c of the cap body 111. In this embodiment, the cap spring 112 has a plurality of claws 112c. The claws 112c are arranged such that their front ends face the front end of the body 111c and the axis 111j within the space within the body 111c. The claws 112c can engage with the engaging portion 14a of the needle guard 14 of the pre-filled syringe 10.

[0248] Figure 5 This is a perspective view of the outer casing 120. The outer casing 120 has a cylindrical shape. In this embodiment, the outer casing 120 is composed of planar portions 120p and 120q with generally planar shapes and curved portions 120r and 120s with partially cylindrical side surfaces. The curved portions 120r and 120s connect the planar portions 120p and 120q, respectively. This shape prevents the medicine cartridge 100 from rolling on a table or similar surface. Furthermore, when filling the medicine cartridge 100 into the medicine dispensing device 200, the operator can easily determine the filling angle (rotation angle about the axis of the cylindrical shape). For example, if the filling angle of the medicine cartridge 100 is adjusted so that the two planes of the cylindrical shape of the outer casing 120 are parallel to the two planes of the outer casing 201 of the medicine dispensing device 200, the medicine cartridge 100 can be correctly filled into the medicine dispensing device 200.

[0249] The outer casing 120 has a rear opening 120b at the rear end, a front opening 120a at the front end, and a cylindrical space 120c between the rear opening 120b and the front opening 120a. The inner surface of the outer casing 120 on the side of the rear opening 120b also has a pair of sleeve engaging portions 120k. Figure 9A The sleeve engagement part 120k can be an opening, claw, recess, etc.

[0250] Additionally, the outer casing 120 includes a cap engaging portion 120d, a first opening 120f, a second opening 120e, a third opening 120g, a window 120h, a recess 120i, a slit 120j, and a piston unit engaging portion 120n. In this embodiment, the outer casing 120 has two cap engaging portions 120d, two second openings 120e, two first openings 120f, and two third openings 120g. One cap engaging portion 120d, one second opening 120e, one first opening 120f, and one third opening 120g are provided on each of the curved surfaces 120r and 120s. In this embodiment, the cap engaging portions 120d, the second openings 120e, the first openings 120f, and the third openings 120g are arranged in a row parallel to the axis of the cylindrical shape of the outer casing 120.

[0251] The cap latch 120d is located on the side of the front opening 120a of the outer tube 120. The first opening 120f is located on the side of the rear opening 120b of the outer tube 120. The second opening 120e is located closer to the front opening 120a than the first opening 120f of the outer tube 120. The third opening 120g is, for example, located closer to the rear opening 120b than the first opening 120f.

[0252] The cap engaging portion 120d is a recess, opening, or protrusion that can engage with engaging claws, protrusions, etc. Hereinafter, unless the shape is specifically mentioned, the engaging portion refers to a recess, opening, or protrusion that can engage with engaging claws, protrusions, etc.

[0253] The first opening 120f, the second opening 120e, and the third opening 120g are each through openings reaching the outer surface and inner surface of the outer casing 120. The outer casing 120 also has an inwardly projecting portion 120m that protrudes from the edge of the front opening 120a side of the second opening 120e toward the center of the second opening 120e.

[0254] A window 120h, a recess 120i, and a slit 120j are located on the flat portion 120p. The window 120h has a long side, for example, along the axis of the outer casing 120. The slit 120j is located on the side of the rear opening 120b of the outer casing 120 and extends in a direction perpendicular to the axis of the outer casing 120. The recess 120i is, for example, located between the window 120h and the slit 120j.

[0255] The piston unit engaging portion 120n engages with the piston unit 286 of the drug injection device 200 as described later. In this embodiment, the piston unit engaging portion 120n is an opening.

[0256] Figure 6 This is a perspective view of the needle protector 130. The needle protector 130 has a protective part 130c, an elastic support part 130d (second elastic support part), and a protrusion 130e. In addition, the needle protector 130 has an opening 130g and a reflective part 130r located at a position further rearward than the opening 130g.

[0257] The protective part 130c has a cylindrical shape that defines a needle protector cylindrical space capable of accommodating a portion of the syringe body 11 of the pre-filled syringe 10. The protective part 130c includes an end face 130cf and a needle protector opening 130a provided on the end face 130cf.

[0258] One end of the elastic support portion 130d is connected to one end of the protective portion 130c on the opposite side of the same end portion 130cf. A protrusion 130e is provided at the other end of the elastic support portion 130d. In this embodiment, the needle protector 130 has a pair of protrusions 130e and an elastic support portion 130d, and the pair of elastic support portions 130d are symmetrically arranged sandwiching the shaft 130j of the needle protector 130.

[0259] The protrusion 130e has: an inclined portion 130ea located on the side of the protective portion 130c and inclined outward, i.e., on the side of the outer tube 120 when the needle protector 130 is inserted into the outer tube 120 of the box; a recess 130eb located on the inclined portion 130ea; a top 130ec adjacent to the inclined portion 130ea; a side portion 130ed adjacent to the top 130ec on the side opposite to the inclined portion 130ea in the direction in which the elastic support portion 130d extends; and an inner surface portion 130ef located on the inner side relative to the inclined portion 130ea, the top 130ec, and the side portion 130ed.

[0260] Figure 7 This is an exploded perspective view of the sleeve 150. The sleeve 150 includes an inner cylinder portion 151 and a sleeve body 152. The inner cylinder portion 151 has a cylindrical shape with a space for accommodating a portion of a pre-filled syringe, and has a sleeve front opening 151a on the front bottom surface of the cylindrical shape. In addition, the inner cylinder portion 151 has a pair of slits 151e on the side of the cylindrical shape. The slits 151e have a long side in a direction parallel to the axis 150j.

[0261] The sleeve body 152 includes an outer cylinder portion 152c and a base portion 152d. In this embodiment, the sleeve body 152 includes one pair of outer cylinder portions 152c. One pair of outer cylinder portions 152c is connected to the front end of the base portion 152d. A sleeve rear opening 152b is provided on the rear side of the base portion 152d.

[0262] Each outer cylinder portion 152c has a partially cylindrical side profile. These outer cylinder portions 152c are symmetrically arranged to sandwich the shaft 150j of the sleeve 150. At the front end of each outer cylinder portion 152c, a wedge-shaped portion 152j is provided for disengaging the engaging claw 111e of the cap 110 from the cap engaging portion 120d of the outer cylinder 120. In addition, each outer cylinder portion 152c has a slit 152e with a long side in a direction parallel to the shaft 150j.

[0263] The sleeve body 152 also includes an elastic support portion 152f, a locking claw 152g (second locking claw), and a protrusion 152i. In this embodiment, the sleeve body 152 has a pair of elastic support portions 152f, a locking claw 152g, and a protrusion 152i. One end of each pair of elastic support portions 152f is connected to the vicinity of the sleeve rear opening 152b. The locking claw 152g is connected to the other end of the elastic support portion 152f. The locking claw 152g has an abutment surface 152h on its outer side in the radial direction. The elastic support portion 152f is capable of flexing in the radial direction. The protrusion 152i is disposed adjacent to the slit 152e in the base 152d.

[0264] The inner cylinder portion 151 is connected to the front end of the base portion 152d of the sleeve body 152. At this time, as... Figure 3 As shown, an outer cylinder portion 152c is arranged separately from the inner cylinder portion 151 along a radial direction centered on axis 150j. Furthermore, the slit 151e of the inner cylinder portion 151 and the slit 152e of the outer cylinder portion 152c are aligned radially. As described later, a needle protector 130 is inserted between the inner cylinder portion 151 and the outer cylinder portion 152c.

[0265] The constituent components of the aforementioned medicine cartridge are as follows: Figure 3 As shown in the assembly configuration. The cap 110 is inserted into the front opening 120a of the outer cylinder 120. The needle protector 130 is inserted between the inner cylinder portion 151 and the outer cylinder portion 152c of the sleeve 150, with the box spring 140 inserted into the cylindrical space of the needle protector. The needle protector 130, box spring 140, and sleeve 150 are inserted into the cylindrical space 120c of the outer cylinder 120.

[0266] For reference Figure 7 as well as Figure 3 As explained, the slit 151e of the inner cylinder 151 and the slit 152e of the outer cylinder 152c are aligned in the radial direction. Furthermore, the needle protector 130 and the sleeve 150 are aligned such that at least the protrusion 130e and the elastic support portion 130d of the needle protector 130 are aligned with the slits 151e of the inner cylinder 151 and the slits 152e of the outer cylinder 152c of the sleeve 150 in the same radial direction (same orientation) in a section perpendicular to axis a. Therefore, the needle protector 130 is located between the inner cylinder 151 and the outer cylinder 152c, but the elastic support portion 130d can flex in the radial direction.

[0267] Insert the pre-filled syringe 10 into the assembled box 105. Figure 8As shown, the pre-filled syringe 10 is inserted into the rear opening 120b of the outer casing 120, starting with the needle guard 14. The flange 11b of the syringe body 11 is inserted into the slit 120j of the outer casing 120, and the outer edge of the syringe retainer 160 is also inserted into the slit 120j in the same way, thereby holding the pre-filled syringe 10 in the outer casing 120.

[0268] In this state, the pre-filled syringe 10 held inside can be visually confirmed through the window 120h of the outer casing 120. Furthermore, it can be confirmed that the pre-filled syringe 10 is filled with medication.

[0269] A label 192 may also be affixed to the outer surface of the outer casing 120, indicating information related to the type and amount of medicine filled into the pre-filled syringe 10, as well as the manufacturing date and expiration date of the pre-filled syringe 10. When the medicine cartridge 100 is equipped with the label 192, the label 192 is preferably not covered by the window 120h.

[0270] A wireless tag 190 may also be provided in the recess 120i of the outer casing 120. The wireless tag 190, also known as RFID (Radio Frequency Identification), is capable of transmitting and receiving information via short-range communication using UHF or HF radio waves. The wireless tag 190 may include a memory storing information related to the type and amount of medication filled in the pre-filled syringe 10, as well as the manufacturing date and expiration date of the pre-filled syringe 10. The wireless tag 190 is covered by a seal 191. The wireless tag 190 may also be a type that allows for external tracking or rewriting of information to record usage. In this case, the wireless tag 190 is preferably equipped with security features to prevent tampering of recorded information, allowing only an authorized author to track and rewrite the information.

[0271] [The action of the potion cylinder 100]

[0272] Next, the operation of the medicine cartridge 100 will be explained. In normal use, after the medicine cartridge 100 is filled into the medicine injection device 200, the cap 110 is removed, and the needle protector 130 is protruded (discharged), etc. However, for ease of understanding, the operation of the medicine cartridge 100 will be explained in the state of being separated from the medicine injection device 200. Figures 9A to 9D This is a schematic cross-sectional view of the reagent cartridge 100 in various states, passing through axis A. Figures 10A to 10D Is with Figures 9A to 9D The diagrams shown correspond to different states of the medicine cartridge 100, and also show the state with the outer cartridge 120 removed. For ease of understanding, in... Figures 9A to 9D The diagram of a portion of the structure of the reagent cartridge 100 is omitted.

[0273] [Table 1]

[0274]

[0275] (1) Before loading ( Figure 9A , Figure 10A )

[0276] The reagent cartridge 100 is in the state before being filled into the reagent injection device 200. (Refer to...) Figure 8 As explained, the pre-filled syringe 10 is inserted into the slit 120j of the outer casing 120 via the flange 11b of the syringe body 11, thereby being supported within the cylindrical space of the casing and unable to move relative to the outer casing 120. In this state, a portion of the injection needle 12 and a portion of the needle guard 14 of the pre-filled syringe 10 protrude from the front opening 120a of the casing.

[0277] A cap 110 is inserted into the front opening 120a of the outer casing 120. In this state, the cap body 111 surrounds the front opening 120a, and the engaging claw 111e is inserted into the outer casing 120 from the front opening 120a and engages with the cap engaging portion 120d of the outer casing 120. Therefore, the cap 110 cannot be detached from the front opening 120a. The cap 110 fits into and covers the needle guard 14.

[0278] The sleeve 150 is disposed outside the syringe body 11 of the pre-filled syringe 10 and is movable along the axial direction A within the cylindrical space. In the initial state, as... Figure 9A As shown, the sleeve 150 is positioned at a first position on the side of the rear opening 120b of the box. In this state, the engaging claw 152g of the sleeve 150 engages with the sleeve engaging portion 120k of the outer cylinder 120 located on the inner surface of the outer cylinder 120 on the side of the rear opening 120b, and the sleeve 150 is engaged with the outer cylinder 120. Therefore, movement of the sleeve 150 to a second position, which is the forward position, is suppressed.

[0279] The needle protector 130 is movable along axis A within the cylindrical space of the box. In the initial state, the needle protector 130 is positioned in a first engagement position where the front end of the protective portion 130c is retracted from the front end of the injection needle 12 protruding from the front opening 120a of the box. In this state, the protrusion 130e of the needle protector 130 engages with the first opening 120f of the outer cylinder 120 of the box.

[0280] like Figure 9A As shown, the box spring 140 is disposed within the protective portion 130c of the needle protector 130. One end of the box spring 140 abuts against the needle protector 130, and the other end of the box spring 140 abuts against the sleeve 150. Specifically, one end of the box spring 140 abuts against the end portion 130cf of the needle protector 130. Figure 6The inner surface of the sleeve 150 abuts against the inner surface of the sleeve 150, and the other end abuts against the front end of the inner cylinder portion 151 of the sleeve 150. Figure 7 (Abutting). In the initial state, the box spring 140 is compressed against its force.

[0281] Before being filled into the drug injection device, the cap 110 is inserted into the front opening 120a of the outer cylinder 120. The engaging claw 111e of the cap 110 engages with the cap engaging portion 120d of the outer cylinder 120, thus preventing the cap 110 from detaching from the outer cylinder 120 and locking it in a locked state. At this time, the front end of the protective portion 130c of the needle protector 130 abuts against the rear end of the body 111c of the cap 110.

[0282] Thus, when the medicine cartridge 100 is not filled into the medicine injection device 200, a cap 110 is installed and locked at the front opening 120a of the medicine cartridge 100. Therefore, even if the operator accidentally tries to remove the cap 110, it is difficult to remove, preventing the injection needle 12 from being exposed due to the cap 110 detaching from the outer cylinder 120 and preventing the operator from coming into contact with the exposed injection needle 12.

[0283] Furthermore, the engaging claw 152g of the sleeve 150 engages with the sleeve engaging portion 120k of the outer cylinder 120 of the box, thereby suppressing the movement of the sleeve 150 along the axial direction A. Therefore, even if the operator mistakenly or intentionally presses the sleeve 150 in through the rear opening 120b of the box using their fingers or the like, the movement of the sleeve 150 is suppressed.

[0284] (2) Filling status of the medicine cartridge 100 ( Figure 9B , Figure 10B )

[0285] When the medicine cartridge 100 is loaded into the medicine injection device 200, as described in detail below, the latching unit 230 is inserted from the rear opening 120b of the cartridge, pushing the locking claw 152g in the forward direction while tilting the locking claw 152g of the sleeve 150 inward. Thus, as... Figure 9B As shown, the sleeve 150 moves forward against the force of the box spring 140, moving to the second position. The latching unit 230 engages with the outer cylinder 120, so the sleeve 150, which abuts against the latching unit 230, is in a locked state and cannot move.

[0286] At this time, the wedge-shaped portion 152j at the front end of the outer cylinder portion 152c of the sleeve body 152 of the sleeve 150 enters between the abutting surface 111f of the engaging claw 111e of the cap 110 and the inner surface of the outer cylinder 120 of the box, thereby causing the elastic support portion 111d to flex inward, and the engagement between the engaging claw 111e and the cap engaging portion 120d is released. As a result, the cap 110 is in an unlocked state that can be disengaged from the outer cylinder 120 of the box. In addition, the sleeve 150 moves to the second position, so that the inner surface portion 130ef of the protrusion 130e of the needle protector 130 abuts or approaches the side of the inner cylinder portion 151 of the sleeve 150.

[0287] In this state, the operator can remove the cap 110 using their fingers. When the cap 110 is removed, the needle guard 14 is also removed.

[0288] (3) The state after removing the hat ( Figure 9C , Figure 10C )

[0289] With the cap 110 removed, there are no physical elements that would hinder the advancement of the needle protector 130. Therefore, under the force generated by the box spring 140, the needle protector 130 is forced forward (protruding). Accompanying this, the inclined portion 130ea of ​​the protrusion 130e abuts against the edge of the first opening 120f, and the elastic support portion 130d flexes inward. However, the inner surface portion 130ef of the protrusion 130e abuts against the inner cylindrical portion 151 of the sleeve 150, thereby suppressing further deformation of the elastic support portion 130d. Therefore, the needle protector 130 remains locked in the second position by the sleeve 150.

[0290] In this state, the injection needle 12 protrudes from the front opening 120a of the housing. As described later, in the pre-needle state, the injection needle 12 is located in the outer casing 201 ( Figure 1C When the operator presses the injection button 254, the entire cartridge 100 moves forward and the injection needle 12 pierces the operator's injection site.

[0291] (4) The state of the needle protector after it is ejected ( Figure 9D , Figure 10D )

[0292] When the injection is complete, the entire cartridge 100 retracts, thereby removing the needle. As a result, the injection needle 12 is inserted into the outer casing 201. Figure 1C The sleeve 150 retracts inward. As described later, when the latching unit 230 rotates along with the retraction of the piston 221, the engagement between the latching unit 230 and the engaging pawl 152g of the sleeve 150 is released, and the sleeve 150 becomes retractable. As a result, under the force of the box spring 140, the sleeve 150 retracts and moves from the second position towards... Figure 9DThe first position is shown. Additionally, the engaging claw 152g of the sleeve 150 engages with the sleeve engaging portion 120k located on the inner surface of the outer cylinder 120. Therefore, the sleeve 150 cannot move in the first position.

[0293] The sleeve 150 moves to the first position, thereby forming a space inside the protrusion 130e of the needle protector 130 (axis a side), allowing deformation of the elastic support portion 130d. Therefore, the inclined portion 130ea of ​​the protrusion 130e abuts against the edge of the first opening 120f, and the elastic support portion 130d flexes inward (axis a side). Figure 9C As a result, the protrusion 130e disengages from the first opening 120f inward (towards axis a), and under the force of the box spring 140, the needle protector 130 moves from the first engaging position to the second engaging position. Thus, as... Figure 9D As shown, the protrusion 130e of the needle protector 130 engages with the second opening 120e of the outer cylinder 120. In this state, the protective portion 130c of the needle protector 130 surrounds the injection needle 12, and the front end of the protective portion 130c protrudes beyond the front end of the injection needle 12 that protrudes from the front opening 120a of the box.

[0294] Figure 11A as well as Figure 11B This is a 3D view of the medication cartridge with the needle protector protruding. (Example) Figure 11A As shown, when the protrusion 130e and the second opening 120e are engaged, the inclined portion 130ea of ​​the protrusion 130e abuts against the edge of the front opening 120a side of the second opening 120e, and the protrusion 120m inside the opening abuts against the recess 130eb of the inclined portion 130ea. Figure 6 The locking mechanism prevents the needle protector 130 from being pulled out even when using a finger. This locking mechanism inhibits the deformation of the elastic support portion 130d, making it difficult to pull out the needle protector 130.

[0295] Additionally, when using your fingers to press the needle protector 130 in, such as Figure 11B As shown, the side portion 130ed of the protrusion 130e abuts against the edge of the rear opening 120b side of the second opening 120e. The side portion 130ed has a beveled surface that forms a recessed angle relative to the edge of the rear opening 120b side of the second opening 120e on the outer cylinder of the box. Therefore, by abutting against the edge of the second opening 120e, the elastic support portion 130d ( Figure 6 A force is applied parallel to the direction in which the elastic support portion 130d extends. Therefore, by applying a force that does not act in the direction in which the elastic support portion 130d deflects, deflection of the elastic support portion 130d is suppressed. As a result, the protrusion 130e is prevented from disengaging from the second opening 120e. That is, it is difficult to press the needle protector 130 in.

[0296] Thus, when the injection is completed, the injection needle 12 is covered by the needle protector 130. This prevents the operator from accidentally contacting the injection needle 12 when removing the used cartridge 100 from the medication injection device 200. Furthermore, the needle protector 130 is locked in a position where it is difficult to move forward or backward. Therefore, even if the operator or a third party disposes of the removed cartridge 100, contact with the cartridge 100 caused by the injection needle pricking a finger can be prevented by various methods of handling the cartridge 100.

[0297] Therefore, according to the medication cartridge of this embodiment, removing the cap is difficult until the medication cartridge is filled into the medication infusion device, thereby preventing accidental removal of the cap that could lead to contact between the finger and the injection needle or contamination of the injection needle. Furthermore, when the cap is removed, the injection needle is located inside the medication infusion device, ensuring safety. Moreover, after injection, the needle protector covers the injection needle and is locked in this state, allowing for safe disposal of the used medication cartridge.

[0298] [Structure of the drug injection device 200]

[0299] <Structure Overview of the Drug Injection Device 200>

[0300] Figure 12A This is a perspective view showing the disassembled outer casing 201 of the drug injection device 200. The drug injection device 200 has a main body 202 housed within the outer casing 201.

[0301] The outer casing 201 includes, for example, an upper casing 201A, a lower casing 201B, and a front casing 201C. As described above, the upper casing 201A is equipped with a display window 201d, an injection button 254, a selection (up) button 255, a selection (down) button 256, and a return button 257. An emergency hole 201Bc may also be provided in the lower casing 201B. In addition, a removable screw 206 may be installed in the emergency hole 201Bc.

[0302] Figure 12B This is a perspective view of the front end housing 201C from the inside. The front end housing 201C has a cylindrical opening 201a, and a door 203 is disposed on its inner side. The door 203 is mounted on the front end housing 201C and is rotatable about an axis 203j. The door 203 is forced by a torsion spring 204 in the direction of blocking the cylindrical opening 201a.

[0303] Figure 13 This is an exploded perspective view of the main body 202. The main body 202 includes an upper housing 280A, a lower housing 280B, a circuit board 281, a drive device 284, a touch sensor unit 287, a sliding unit 288, a display device 258, and a battery 252. The upper housing 280A and the lower housing 280B are combined to form a cylindrical space 280a containing a medicine cartridge 100. Figure 1A The housing 280 is formed on the circuit board 281. Figure 14 The block diagram shown illustrates the functional circuit.

[0304] The drive unit 284 includes a motor unit 285 and a piston unit 286. The motor unit 285 moves the piston unit 286 forward and backward, thereby moving the medicine cartridge 100, which is engaged with the piston unit 286, forward and backward, performing needle insertion and removal. Additionally, it moves the piston 221 of the piston unit 286 forward and backward to inject medicine and release the engagement between the piston unit 286 and the medicine cartridge 100.

[0305] The display device 258 displays information about the pre-charged syringe 10 held in the drug cartridge 100, or shows the status of the drug infusion device 200 to the operator, or displays the operating sequence. The battery 252 supplies power to operate the drug infusion device 200.

[0306] Figure 14 This is a block diagram showing the circuit structure of the drug injection device 200. The main body 202 includes a control circuit 251 including an arithmetic unit such as a CPU, a memory 253 for storing computer programs, data, etc., a buzzer 259, and a clock 260.

[0307] The control circuit 251 receives instructions from the interface 283, which serves as the injection button 254, the selection (up) button 255, the selection (down) button 256, and the return button 257. It reads the program stored in the memory 253 at an opportune time based on a clock signal received from the clock 260, and controls the various components, including the injection motor 265 and the needle removal motor 268 (described later), according to the sequence of the computer program. The sequence of the computer program is illustrated in the following description and the flowcharts in the accompanying drawings. The buzzer 259 initiates a report based on the control of the control circuit 251, thereby reporting to the operator.

[0308] The main body 202 also includes a motor driver 264, an injection motor 265, a motor driver 267, and a needle removal motor 268. The injection motor 265 and the needle removal motor 268 are assembled into the motor unit 285 of the drive unit 284 and function as a power source. The motor drivers 264 and 267 generate current for driving these motors based on the control circuit 251.

[0309] The main body 202 also includes various sensors. Specifically, the main body 202 includes a rotary encoder 266, a cartridge filling detector 271, a cartridge locking detector 272, a cartridge removal detector 273, a skin contact detector 274, a cap detector 275, a needle protector detector 276, a needle insertion completion detector 277, a needle withdrawal completion detector 278, and an origin detector 279. These detectors are described in detail below.

[0310] The main body 202 may also include various communication devices. Specifically, the main body 202 may include an infrared communicator 261, a wireless communicator 262, and an RF-ID reader-writer 263. The infrared communicator 261 and the wireless communicator 262 transmit and receive information with the outside world through infrared communication and wireless communication, etc. The wireless communicator 262 may be a transceiver using a short-range wireless communication standard such as BLE (Bluetooth Low Energy, a registered trademark of Bluetooth). For example, it may also be a device that stores the time when the operator uses the drug infusion device 200, the type of drug, the dosage, etc., in the memory 253 during use, and transmits this information to external machines such as smartphones, tablet terminals, or dedicated machines for managing the drug infusion device 200 at a specified time using the infrared communicator 261 or the wireless communicator 262. Alternatively, it may be a device that transmits the aforementioned information from a portable machine to servers such as hospitals or drug manufacturers via mobile phone lines or Internet lines.

[0311] RF-ID reader-writer 263 reads medication information transmitted from the radio tag 190 of the medication cartridge 100, including information related to the type and amount of medication filled in the pre-filled syringe 10, the manufacturing date of the pre-filled syringe 10, and its expiration date. The read information is input into the control circuit 251 and displayed on the display device 258, or used to control the operation of the medication injection device 200.

[0312] <Structure of Drive Unit 284>

[0313] Figure 15 This is a perspective view of the drive unit 284. For ease of understanding, some parts of its structure are omitted from the diagram.

[0314] The drive unit 284 includes an injection motor 265, a needle removal motor 268, and a piston unit 286 including a piston 221. The needle removal motor 268 causes the piston unit 286 to move forward and backward along the piston shaft 221j. The injection motor 265 also causes the piston 221 to move forward and backward along the piston shaft 221j. Therefore, the drive unit 284 is composed of the motor unit 285 and the piston unit 286.

[0315] Motor unit 285 includes an injection motor 265, a rotary encoder 266, a gear assembly 211, a drive gear 212, a needle removal motor 268, a gear assembly 213, and a drive screw 214. Gear assembly 211 includes one or more gears and transmits the rotational force of the injection motor 265 to the drive gear 212. When the rotation of the injection motor 265 reverses, the rotation of the drive gear 212 also reverses. Gear assembly 213 also includes one or more gears and transmits the rotational force of the needle removal motor 268 to the drive screw 214. The drive screw 214 has a rod shape and external threads formed on its outer surface.

[0316] Piston unit 286 includes piston 221, latching unit 230, piston housing 220, and nut 223. Piston housing 220 supports piston 221 so that it can rotate about an axis and move axially. Piston housing 220 has a support portion 220c, and nut 223 is fixed to the support portion 220c. Nut 223 has a hole with internal threads and is inserted into drive screw 214 of motor unit 285 in a threaded engagement state.

[0317] When the needle-removing motor 268 of the motor unit 285 rotates, the rotational force is transmitted to the drive screw 214 via the gear device 213, causing the drive screw 214 to rotate. The nut 223 is fixed to the piston unit 286, so it does not rotate with the drive screw 214, but moves forward or backward relative to the drive screw 214. Thus, the piston unit 286 moves forward or backward.

[0318] The rotary encoder 266 includes an encoder plate 266A and a pulse encoder 266B. The encoder plate 266A is mounted on the rotating shaft of the injection motor 265. The encoder plate 266A has notches arranged at equal intervals along its circumference. The pulse encoder 266B includes a light-emitting element and a light-receiving element, and is arranged such that the outer periphery of the encoder plate 266A is located between the light-emitting element and the light-receiving element. As the encoder plate 266A rotates, the light emitted from the light-emitting element is intermittently detected by the light-receiving element. Thus, the rotary encoder 266 generates a pulse signal with a pulse number corresponding to the rotational speed (rotational amount) of the injection motor 265, thereby detecting the rotational speed of the injection motor 265.

[0319] Figure 16A This is a 3D view of the piston unit 286 after removing the piston housing 220. Figure 16BThis is an exploded perspective view of the piston unit 286 after removing the piston housing 220. The piston unit 286 includes a piston 221, a latching unit 230, a piston gear 224, a bearing 225, and an origin detector 279. The piston 221 advances the limiter 13 of the pre-filled syringe 10 supported on the cartridge 100 to inject the drug. The piston gear 224 drives the piston 221 along the piston shaft 221j. The latching unit 230 partially inserts into the rear opening 120b of the cartridge 100 and holds the cartridge 100 in place.

[0320] The piston 221 has a rod shape and a front end 221a and a base 221b. External threads are formed on the side of the base 221b. The piston 221 has a shape formed by cutting parallel to the piston shaft 221j using two planes that clamp the piston shaft 221j, and has an I-shape in a section perpendicular to the piston shaft 221j.

[0321] The notch twists at the front end 221a, and the piston 221 has a helical abutment surface at the front end 221a. Specifically, the piston 221 has a pair of first planes 222a at its base 221b that sandwich the piston shaft 221j. Additionally, the piston 221 has a pair of second planes 222b and a pair of third planes 222c at the front end 221a. The second planes 222b are located between the first planes 222a and the third planes 222c, and the third planes 222c are located at the foremost end of the piston 221. A helical surface 222d is disposed between the first planes 222a and the second planes 222b, and a helical surface 222e is disposed between the second planes 222b and the third planes 222c. The helical surface 222d, the second planes 222b, the helical surface 222e, and the third plane 222c are sometimes referred to as a helical structure.

[0322] Figure 16C The diagram shows the positional relationship of the first plane 222a, the second plane 222b, and the third plane 222c in a cross-section perpendicular to the piston shaft 221j of the piston 221, as viewed from the front end. Relative to the first plane 222a, the second plane 222b and the third plane 222c are positioned after rotating counterclockwise around the piston shaft 221j. The angle between the first plane 222a and the second plane 222b is α1, and the angle between the first plane 222a and the third plane 222c is α2 (α1 < α2), which is greater than α1.

[0323] Figure 16D This is an exploded perspective view of latch unit 230. Figure 16EThis is a front view of the latching unit 230 viewed from the front. The latching unit 230 includes a syringe force application member 231, a syringe force application spring 232, a front latching base 233A, a rear latching base 233B, a pair of cylinder latching members 235, a pair of cylinder latching springs 237, a cylinder filling detector 271, and a cylinder locking detector 272.

[0324] The front latch base 233A and the rear latch base 233B are combined to form a latch base 233, which supports the syringe force-applying member 231 and the barrel latch 235. The latch base 233 has a through hole 233c and a pair of arms 233d surrounding the through hole 233c. A pair of limiting portions 233e are disposed inside the through hole 233c. Figure 16E As shown, a pair of limiting portions 233e are symmetrically arranged relative to the piston shaft 221j. Therefore, the through hole 233c has the same I-shape as the piston 221 in a plane perpendicular to the piston shaft 221j. A pair of arm portions 233d extend towards the front end and each has a sleeve abutment portion 233g at the front end. The sleeve abutment portion 233g is an inclined surface that is inclined inward (towards the shaft 221j side).

[0325] The syringe force-applying member 231 has an annular abutment portion 231a with a hole 231c and a pair of legs 231b connected to the abutment portion 231a. The legs 231b are inserted into the latch base 233 and supported on the latch base 233 in a manner that allows them to move in a direction parallel to the piston shaft 221j of the piston 221. A syringe force-applying spring 232 is disposed between the latch base 233 and the syringe force-applying member 231, and the syringe force-applying spring 232 applies force to the syringe force-applying member 231 in the forward direction. A claw is provided at the front end of the leg 231b, which engages with the latch base 233 to prevent the syringe force-applying member 231 from falling off.

[0326] A pair of latching members 235 cover the latch base 233 from the outside. Each latching member 235 has a protrusion 235c and a shaft 235d. The protrusion 235c is located at the front end of the latching member 235 and protrudes outward. An outwardly inclined abutment surface 235t is provided on the outer peripheral side of the front end of the protrusion 235c. The shaft 235d extends in a direction perpendicular to the piston shaft 221j and is located on the outer peripheral side of the protrusion 235c. The latch base 233 is provided with a bearing portion 233h that receives and supports the shaft 235d of the latching member 235. Each of the pair of latching members 235 is capable of swinging about its corresponding shaft 235d.

[0327] Hooks at both ends of the latch spring 237 are respectively hooked on the rear end sides of the pair of latch locking members 235. Thus, in the pair of latch locking members 235, the rear end side is closer to the inside relative to the protrusion 235c, and the protrusion 235c located on the front end side is exerted with force outward.

[0328] At both ends of a pair of latching members 235 in the circumferential direction and adjacent to the latching spring 237, there are protrusions 235e and recesses 235g. The protrusion 235e of one latching member 235 and the recess 235g of the other latching member 235 are loosely engaged. As will be described later, when the latching unit 230 is inserted into the medicine cartridge 100, the latching spring 237 swings. At this time, the engaging portion of the protrusion 235e and the recess 235g functions as a shaft, thereby allowing the latching spring 237 to extend and retract stably, and the swinging of the latching spring 237 can also proceed smoothly.

[0329] In the latching unit 230, the sleeve abutment portion 233g of the arm portion 233d abuts against the abutment surface 152h of the engaging claw 152g provided on the sleeve 150 of the medicine cartridge 100, thereby releasing the lock of the sleeve 150 of the medicine cartridge 100 from the first position and moving the sleeve 150 to the second position. On the other hand, the protrusion 235c engages with the outer cylinder 120 of the medicine cartridge 100, causing the latching unit 230 to hold the medicine cartridge 100.

[0330] The cylinder latch 235 may also include an emergency abutment 235s. If, for some reason, the piston unit 286 cannot be disengaged from the cartridge 100, the abutment 235s can be pressed from the outside, causing the protrusions 235c of the pair of cylinder latches 235 to move inward. This allows the protrusions 235c to be disengaged from the outside from the outer casing 120 of the cartridge. In this case, the emergency access can be made through the emergency port 201Bc (… Figure 12A Remove screw 206, insert a slender pin through emergency hole 201Bc, and press the abutment 235s to swing a pair of cylinder latches 235.

[0331] like Figure 16B As shown, the piston gear 224 has a cylindrical shape with a hole 224c, and an internal thread is formed in the hole 224c. Additionally, a spur gear is provided on the outer surface of the piston gear 224. The rear end of the piston gear 224 is inserted into a bearing 225, and the piston gear 224 is rotatably supported on the piston housing 220 by means of the bearing 225.

[0332] The piston 221 is inserted into the through hole 233c of the latch base 233 of the latch unit 230 and the hole 224c of the piston gear 224.

[0333] When the piston 221, which is inserted into the latch unit 230 and the piston gear 224, is housed in the piston housing 220, the piston 221 is restricted from rotating around the piston shaft 221j by a limiting surface that abuts against or approaches the first plane 222a of the piston 221 and is disposed inside the piston housing 220.

[0334] Reference Figure 15 When the drive gear 212 of the motor unit 285 rotates, the piston gear 224, which meshes with the drive gear 212, Figure 16A The piston 221 rotates. Accompanying this, the piston 221 moves forward or backward. During this time, while a pair of limiting portions 233e protruding into the through hole 233c of the latching unit 230 are located at the base 221b, the first plane 222a of the piston 221 approaches or abuts against the limiting portions 233e, and the latching unit 230 does not rotate. During the retraction of the piston 221, while the limiting portions 233e of the latching unit 230 are located at the front end 221a, the latching unit 230 rotates about the piston axis 221j with the orientation of the helical surface 222d, the second plane 222b, the helical surface 222e, and the third plane 222c.

[0335] <Piston unit 286 holding the cartridge 100>

[0336] This describes how piston unit 286 controls the drug cartridge 100. Figures 17A to 17C , Figures 18A to 18D as well as Figures 19A to 19C These are diagrams illustrating the configuration of the piston unit 286 holding the drug cartridge 100. In these diagrams, Figures 17A to 17C The cross-section of the latching unit 230 passing through the arm 233d is shown. Figures 18A to 18D The outer cylinder 120 of the medicine cartridge 100 is shown in cross-section. Figures 19A to 19C This is a view taken from the side.

[0337] When the medicine cartridge 100 is inserted into the cartridge opening 201a of the medicine injection device 200 ( Figure 1A , Figure 1B ),like Figure 17A , Figure 18A , Figure 19A As shown, the rear opening 120b of the outer cylinder 120 of the cartridge 100 is close to the piston unit 286. The cartridge filling detector 271 is separated from the cartridge 100, therefore the cartridge filling detector 271 does not detect the cartridge 100 (in an open state). Figure 19A Furthermore, the cylinder latch 235 did not rotate, therefore the cylinder locking detector 272 also did not detect any rotation of the cylinder latch 235 (in an open state). Figure 18A ).

[0338] like Figure 17B , Figure 18BAs shown, the insertion of the medicine cartridge 100 into the medicine injection device 200 progresses, with the front end of the piston unit 286 inserting into the interior of the outer cylinder 120 of the medicine cartridge 100 through the rear opening 120b. The sleeve abutment portion 233g of the arm portion 233d of the piston unit 286 abuts against the abutment surface 152h of the engaging claw 152g located near the rear opening 152b of the sleeve 150, and the elastic support portion 152f flexes inward. As a result, the engagement between the sleeve engaging portion 120k of the outer cylinder 120 and the engaging claw 152g is released.

[0339] When the medicine cartridge 100 is further inserted into the medicine injection device 200, the piston unit 286 moves towards the front end of the medicine cartridge 100, and the sleeve 150 is also pressed towards the front end by the piston unit 286. At this moment, as Figure 18B As shown, the protrusion 235c of the latching unit 230 is not inserted into the outer cylinder 120. The cylinder filling detector 271 and the cylinder locking detector 272 remain in the off state.

[0340] As the medicine cartridge 100 is further inserted into the medicine injection device 200, the abutment surface 235t of the protrusion 235c abuts against the inner edge of the rear opening 120b of the cartridge, thereby causing the cartridge latch 235 to overcome the force of the cartridge latch spring 237 and rotate inward about the axis 235d. Thus, as... Figure 18C As shown, the protrusion 235c is inserted into the outer cylinder 120 of the box through the rear opening 120b. Additionally, the cylinder locking detector 272 detects the rotation of the cylinder latch 235 and engages. Figure 19B As shown, at this time, the cylinder filling detector 271 remains disconnected.

[0341] When the medicine cartridge 100 is further inserted into the medicine injection device 200, such as Figure 18D As shown, the protrusion 235c engages with the piston unit engaging portion 120n. At this time, the cylinder latch locking member 235 rotates outward about the axis 235d under the force of the cylinder latch locking spring 237. As a result, the cylinder locking detector 272 is disengaged.

[0342] The piston unit 286 completes the gripping of the drug cartridge 100 by engaging the protrusion 235c of the latch locking member 235 with the piston unit engaging portion 120n, thereby completing the filling of the drug cartridge 100 into the drug injection device 200. The protrusion 235c of the latch locking member 235 is pushed outward by the latch locking spring 237, thus maintaining the state in which the protrusion 235c is inserted into the piston unit engaging portion 120n, which is an opening. That is, the piston unit 286 is locked in a state of gripping the drug cartridge 100. Figure 19C As shown, at this time, the filling detector 271 detects that the reagent cartridge 100 is fully filled and becomes connected.

[0343] On the other hand, such as Figure 17C As shown, with the arm 233d of the piston unit 286 abutting against the engaging claw 152g of the sleeve 150, the sleeve 150 moves to a second position within the medicine cartridge 100. Therefore, when the medicine cartridge 100 is fully loaded into the medicine injection device 200, the cap 110 becomes unlocked and can be disengaged from the outer cylinder 120.

[0344] The outputs of the cartridge filling detector 271 and the cartridge locking detector 272 when the drug injection device 200 is filled with the drug cartridge 100 are shown in the following table.

[0345] [Table 2]

[0346]

[0347] Thus, the cylinder filling detector 271 detects the correct position when filling is complete and the cylinder locking detector 272 detects that the latching unit 230 has been activated, thereby enabling accurate detection of the filling of the drug cylinder 100 and the gripping of the drug cylinder 100 by the piston unit 286.

[0348] <Release of the agent cartridge 100 by piston unit 286>

[0349] This describes the release of the drug cartridge 100 by the piston unit 286. When the injection of the drug, in other words, is completed, the piston unit 286 retracts, thereby withdrawing the needle. Then, by the retraction of the piston 221, the piston unit 286 releases the drug cartridge 100. Figure 20A , Figure 21A as well as Figure 22A This is a perspective view showing the vicinity of the engagement portion between the piston unit 286 and the drug cartridge 100 when the piston unit 286 releases from the drug cartridge 100. Figure 20B , Figure 21B as well as Figure 22B respectively with Figure 20A , Figure 21A as well as Figure 22A Correspondingly, this is a three-dimensional view after the outer casing 120 of the medicine cartridge 100 has been removed.

[0350] Figure 20A as well as Figure 20B The image shows the piston unit 286 holding the drug cartridge 100. The sleeve abutment portion 233g of the arm portion 233d of the piston unit 286 abuts against the abutment surface 152h of the engaging claw 152g of the sleeve 150, and the elastic support portion 152f flexes inward. The protrusion 235c of the cylinder latch 235 is inserted into the piston unit engaging portion 120n, which serves as an opening.

[0351] The release of the cartridge 100 from this state is achieved by the piston 221 retracting to the needle guard discharge position and the cartridge discharge position, thereby causing the latching unit 230 to rotate about the piston shaft 221j. For example... Figure 16B , Figure 16C , Figure 16E As shown, piston 221 has an I-shaped cross-section and is twisted at the front end 221a. When piston 221 retracts and passes through the through hole 233c of latch base 233 at the front end 221a, latch unit 230 rotates counterclockwise when viewed from the front end side, according to the orientation of helical surface 222d, second plane 222b, helical surface 222e, and third plane 222c.

[0352] When the limiting portion 233e of the through hole 233c in the latch base 233 is close to or abuts against the second plane 222b, that is, when the piston 221 is retracted to the needle holder discharge position, firstly, the abutment between the sleeve abutment portion 233g of the arm portion 233d of the piston unit 286 and the abutment surface 152h of the elastic support portion 152f of the engaging claw 152g of the sleeve 150 is released. Thus, the sleeve 150 becomes a retractable state, as shown in the reference... Figure 9D As explained, under the force of the box spring 140, the sleeve 150 retracts and moves from the second position to the first position. Figure 21A as well as Figure 21B The image shows the state after the sleeve 150 has retracted. At this time, the protrusion 235c of the latch 235 also rotates counterclockwise when viewed from the front, but a portion of the protrusion 235c is still located within the opening of the piston unit engagement portion 120n. Therefore, the cartridge 100 is held by the piston unit 286.

[0353] The latching unit 230 rotates further, so that the limiting portion 233e located in the through hole 233c of the latching base 233 approaches or abuts against the third plane 222c. Figure 16B , Figure 16C , Figure 16E ( ) below, that is, when the piston has retracted to the cylinder discharge position, such as Figure 22A as well as Figure 22B As shown, the protrusion 235c of the cylinder latch 235 disengages from the opening of the piston unit engaging portion 120n. This releases the cartridge 100 from the piston unit 286. That is, the cartridge 100 is now unlocked, allowing the operator to dispense the cartridge 100, specifically by pinching the cartridge 100 and removing it from the dispensing device 200.

[0354] <Action of drive unit 284>

[0355] Reference Figures 23A to 23F The operation of the drive unit 284 will be explained. Figures 23A to 23FThis is a perspective view of the drive unit 284. For ease of understanding, the piston housing 220 is not shown in these figures. After the agent cartridge 100 is held by the piston unit 286 through the aforementioned actions, the drive unit 284 performs the following actions.

[0356] 1. Initial state ( Figure 23A )

[0357] In the initial state of the drug cartridge 100 being filled into the drug injection device 200, the front end 221a of the piston 221 is located at a position that is further forward than the latch base 233 of the latch unit 230.

[0358] 2. (Needle, Figure 23B )

[0359] When the operator presses the injection button 254, the needle removal motor 268 causes the drive screw 214 to rotate. This causes the piston unit 286 to advance. The spur gear of the piston gear 224 has a wide tooth width, so even when the piston unit 286 advances, the drive gear 212 and the piston gear 224 remain engaged.

[0360] 3. Drug injection ( Figure 23C )

[0361] The injection motor 265 rotates the drive gear 212, which in turn rotates the piston gear 224 meshing with the drive gear 212. This causes the piston 221 to advance, and the piston 221 causes the pre-filled syringe's limiter 13 ( Figure 2 (Move forward.) Thus, the medicine is administered to the operator.

[0362] 4. Removing the needle ( Figure 23D )

[0363] With piston 221 forward, needle removal motor 268 reverses, thereby driving screw 214 to reverse as well, and piston unit 286 retracts. Drive gear 212 and piston gear 224 remain engaged.

[0364] 5. Sleeve locking released ( Figure 23E )

[0365] The injection motor 265 reverses the drive gear 212, and the piston gear 224 meshing with the drive gear 212 also reverses. As a result, the piston 221 retracts to the needle guard discharge position. The front end 221a of the piston 221 passes through the through hole 233c of the latch base 233, thereby causing the latch unit 230 to rotate counterclockwise by an angle α1 when viewed from the front end side. Figure 23EIn the indicated state, the second plane 222b approaches or abuts against the limiting portion 233e of the through hole 233c located in the latch base 233, and the abutment between the sleeve abutment portion 233g of the piston unit 286 arm 233d and the abutment surface 152h of the elastic support portion 152f of the engaging claw 152g of the sleeve 150 is released. As described above, the sleeve 150 moves from the second position to the first position in the drug cartridge 100, and the needle protector 130 is ejected. The ejection of the needle protector 130 is detected by the needle protector detector 276.

[0366] 6. Lock Release ( Figure 23F )

[0367] Piston 221 retracts further to the cartridge discharge position, and latching unit 230 rotates further counterclockwise by an angle (α2-α1). That is, it rotates by an angle α2 from the initial state. The third plane 222c approaches or abuts against the limiting portion 233e of the through hole 233c located in latching base 233, and the protrusion 235c of cartridge latch 235 disengages from the opening of piston unit engaging portion 120n. As a result, cartridge 100 is released from piston unit 286. In this state, the rear end of piston 221 presses against origin detector 279, and origin detector 279 detects that piston 221 has retracted to the origin position. Based on the output of origin detector 279, injection motor 265 stops, and retraction of piston 221 also stops.

[0368] 7. Restore to the initial position ( Figure 23A )

[0369] After the reagent cartridge 100 is removed, the injection motor 265 causes the drive gear 212 to rotate clockwise, and the piston gear 224, which meshes with the drive gear 212, also rotates clockwise. Thus, as... Figure 23A As shown, piston 221 advances to the initial position. The initial position is determined by the position where it stops after passing the origin detector 279, and by a specified amount of movement obtained from the pulse output of the rotary encoder.

[0370] According to the drive device of this embodiment, the medication cartridge is released after the needle protector is ejected, thereby controlling the removal of the medication cartridge only when the ejection of the needle protector can be confirmed. Therefore, the medication cartridge filled into the medication injection device can be handled more safely.

[0371] <Other Structures>

[0372] <Sliding Unit 288>

[0373] Reference Figures 24A to 24EThe structure and operation of the sliding unit 288 will be described. The sliding unit 288 applies force in the direction that discharges (advances) the drug cartridge 100 inserted into the drug injection device 200. The sliding unit 288 includes a sliding member 241 adjacent to the cartridge space 280a and supported on the lower housing 280B in a manner movable along the extension of the cartridge space 280a. Figure 13 The sliding member 241 has a force-applying member 242 that applies force to the sliding member toward the front end of the drug injection device 200. In this embodiment, the force-applying member 242 is a torsion spring. The sliding member 241 has a locking protrusion 241c at its rear end.

[0374] like Figure 24A As shown, before the drug cartridge 100 is filled into the drug injection device 200, the force-applying member 242 applies force to the sliding member 241 towards the front end. When the drug cartridge 100 is inserted into the cartridge opening 201a of the drug injection device 200, as... Figure 24B As shown, the rear end of the outer cylinder 120 of the medicine cartridge 100 engages with the engaging protrusion 241c. When the medicine cartridge 100 is further inserted, the sliding member 241 overcomes the force of the force-applying member 242 and moves towards the rear end together with the medicine cartridge 100.

[0375] like Figure 24C As shown, when the medicine cartridge 100 is further inserted, the piston unit 286 holds the medicine cartridge 100, and the filling of the medicine cartridge 100 is completed. In this state, the sliding member 241 is forced towards the front end by the force-applying member 242, but the medicine cartridge 100 does not move due to the holding by the piston unit 286.

[0376] As described above, once the injection is complete, the latching unit 230 rotates, thereby disengaging the arm 233d of the piston unit 286 from the engaging claw 152g of the sleeve 150, and the sleeve 150 moves to the first position. Thus, as... Figure 24D As shown, the needle protector 130 protrudes and covers the injection needle 12.

[0377] As the latching unit rotates further, when the engagement between the protrusion 235c of the latching member 235 and the outer cylinder 120 of the medicine cartridge 100 is released, the medicine cartridge 100 and the sliding member 241, which is forced forward by the force-applying member 242, advance together. Thus, as... Figure 24E As shown, the needle protector 130 of the medicine cartridge 100 protrudes significantly from the opening 201a of the medicine injection device 200, making it easy for the operator to pinch and pull out the medicine cartridge 100.

[0378] <Needle insertion completion detector 277 and needle withdrawal completion detector 278>

[0379] Figure 25A as well as Figure 25BThis is a perspective view of the drive device 284 in which the piston unit 286 holds the medicine cartridge 100. The piston housing 220 of the piston unit 286 has a light-shielding portion 220d. The needle completion detector 227 and the needle withdrawal completion detector 278 are, for example, light-blocking devices. The needle withdrawal completion detector 278 detects the light-shielding portion 220d when the medicine cartridge 100 is in the initial position, that is, when the medicine cartridge 100 has been filled into the medicine injection device 200. The needle completion detector 227 detects the light-shielding portion 220d when the piston unit 286 has advanced and the needle has been inserted.

[0380] <Needle Protector Detector 276>

[0381] Figure 26A as well as Figure 26B This is a perspective view illustrating the needle protector detector 276. The needle protector detector 276 is, for example, a reflective photoelectric sensor including a light-emitting element and a light-receiving element, and detects the state in which the needle protector 130 protrudes (is ejected) to protect the injection needle 12. The light-emitting element illuminates a portion of the needle protector 130, and the light-receiving element detects the light emitted from the light-emitting element and reflected by the needle protector 130, or the light transmitted through the needle protector 130. For example, as... Figure 6 As shown, when detecting the reflector 130r located at the rear end of the needle protector 130, a needle protector detector 276 is positioned near the window 120h of the outer cylinder 120 of the drug cartridge 100 into the drug injection device 200. The needle protector detector 276 can be installed either on the upper housing 280A or on the flexible substrate 282 on which the antenna of the RF-ID reader-writer 263 is installed.

[0382] like Figure 26A As shown, when the needle protector 130 is in the first engaged position, the needle protector detector 276 is located on the opening 130g of the needle protector 130. Therefore, the needle protector detector 276 does not detect the discharge of the needle protector 130. Figure 26B As shown, when the needle protector 130 is ejected and in the second engaged position, the needle protector detector 276 is located on the reflective portion 130r of the needle protector 130. Therefore, for example, the output signal of the needle protector detector 276 increases, detecting the ejection of the needle protector 130.

[0383] <Cap detector 275, Cylinder removal detector 273>

[0384] The cap detector 275 and the cylinder removal detector 273 are, for example, microswitches. Figure 13As shown, the cap detector 275 and the cartridge removal detector 273 are located near the cartridge space 280a of the housing 280, and are positioned such that when the cartridge 100 is filled, they are in contact with the cap 110 and the outer cartridge 120 of the cartridge 100, respectively, and the switch is pressed. The cartridge removal detector 273 outputs a detection signal (on) during the filling of the cartridge 100 into the drug dispensing device 200, and the cap detector 275 outputs a detection signal (on) during the installation of the cap 110 into the cartridge 100. When the cap 110 is removed, the cap detector 275 is turned off, and when the cartridge 100 is discharged, the cartridge removal detector 273 is turned off.

[0385] <Skin Contact Detector 274>

[0386] like Figure 13 As shown, a skin contact detector 274 is disposed in the touch sensor unit 287. The skin contact detector 274, such as a touch sensor or an electrostatic capacitance sensor, detects skin contact. The detection surface of the skin contact detector 274 contacts the skin contact surface 201b from the inside, or the detection surface constitutes the skin contact surface 201b. The skin contact detector 274 is activated during the period when the skin contact surface 201b is in contact with the skin.

[0387] (Operation of the drug injection system 300)

[0388] The following is for reference Figure 14 as well as Figures 27 to 39 An example of the control method for the drug injection device 200, the operation, usage sequence, and operating method of the drug injection system 300 including the drug cartridge 100 and the drug injection device 200 will be described. Figures 27 to 39 This is a flowchart illustrating the control of the drug injection device 200 and the operation of the drug injection system 300.

[0389] The drug injection device 200 and the control circuit 251 can operate in standby mode and operating mode, and the control circuit 251 can switch between standby mode and operating mode. In standby mode, the control circuit 251 can, for example, only detect the output of the tube extraction detector 273, while other detectors and other structures are inactive or in a low-power standby state.

[0390] Main process actions, Figure 27 >

[0391] The operator loads the medication cartridge 100 into the medication injection device 200 (S10). The medication injection device 200 identifies the loaded medication cartridge 100 (S20). The operator removes the cap 110 of the medication cartridge 100 (S30), bringing the medication injection device 200 into contact with the skin (S40). When the operator presses the injection button 254 (S50), the needle is automatically inserted (S60). Then, the medication is injected (S70). After the medication injection is complete, the needle is automatically withdrawn (S80). When the operator detaches the medication injection device 200 from the injection site (S90), the needle protector 130 is ejected (S100). Afterwards, when the operator removes the medication cartridge 100 (S110), the final procedure is performed (S120). The following describes each sub-process in detail.

[0392] <Cylinder insertion process, Figure 28 >

[0393] The medication dispensing device 200 operates in standby mode. During standby mode operation, when the medication cartridge 100 is being filled into the medication dispensing device 200, the control circuit 251 switches from standby mode to operating mode based on the output (on) of the cartridge removal detector 273. Specifically, the operator inserts the medication cartridge 100 into the cartridge opening 201a of the medication dispensing device 200 (S11). Based on the detection signal from the cartridge removal detector 273 (S12), the control circuit 251 switches from standby mode to operating mode, i.e., the main power is turned on (S13). The control circuit 251 maintains standby mode until the cartridge removal detector 273 detects the filling of the medication cartridge 100. After the main power is turned on, the control circuit 251 detects that the cartridge filling detector 271 is turned on and the cartridge locking detector 272 is turned off in the order shown in Table 2 (S14), and detects that the medication cartridge 100 has been correctly filled. It should be noted that, as shown in Table 2, as long as the filling detector 271 is detected as on and the locking detector 272 is off, it can be confirmed that the drug cartridge 100 is correctly assembled into the drug dispensing device 200. Therefore, the main power supply can be turned on when either the filling detector 271 or the locking detector 272 is on, switching from standby mode to operating mode. Afterwards, the control circuit 251 causes the display device 258 to display the startup animation (S15), and the process returns to the main flow.

[0394] Drug identification process, Figure 29 >

[0395] Control circuit 251 uses RF-ID reader-writer 263 to read out medication-related information stored in the wireless tag 190 of the medicine cartridge 100 (S21). Then, control circuit 251 causes display device 258 to display the read information (S22). For example, control circuit 251 causes display device 258 to display text information such as "Medicine of ○○. Expiry date ○○...". Figure 29 Although not shown in the diagram, if the usage period has expired, or a mark indicating that the medication has been used up has been written, or if the type of medication is not suitable for the medication injection device 200, the control circuit 251 may also cause the display device 258 to display a message to the operator that the inserted medication cartridge is unusable, and proceed to the cartridge removal process (S11).

[0396] <Helmet Removal Procedure> Figure 30 >

[0397] The control circuit 251 causes the display device 258 to prompt the operator to remove the cap 110 (S31). For example, the display device 258 may display text information such as "Please remove the cap". It can also display images or animations. The operator removes the cap 110 (S32). The control circuit 251 detects that the cap detector 275 is off (S33) and uses the RF-ID reader-writer 263 to write a mark indicating that the medication cartridge 100 has been used up on the wireless tag 190. Thus, after the cap 110 is removed, the medication cartridge 100, which has been expelled after injection has ceased, can be identified, preventing the use of the medication cartridge 100 from being used in a state where its cleanliness cannot be guaranteed due to the removal of the cap 110.

[0398] <Skin contact process, Figure 31 >

[0399] The control circuit 251 causes the display device 258 to prompt the operator to press the medication injection device 200 onto the injection site (S41). For example, the display device 258 may display "Please contact the injection site" or similar messages. The operator presses the entire medication injection device 200 onto the injection site as indicated by the display (S42). The control circuit 251 determines whether the skin contact detector 274 has detected skin contact (S43). If detected, the control circuit 251 terminates the process. If the skin contact detector 274 has not detected skin contact, the process is repeated.

[0400] <Injection button press procedure,> Figure 32 >

[0401] The control circuit 251 causes the display device 258 to display a message urging the operator to press the injection button 254 (S51). For example, the display device 258 may display "Please press the injection button." The operator presses the injection button 254 according to the display (S52). The control circuit 251 determines whether the injection button 254 has been pressed (S53). If the pressing of the injection button 254 is detected, the process ends. If the pressing of the injection button 254 is not detected, the process is repeated.

[0402] Automated needle insertion process Figure 33 >

[0403] Control circuit 251 causes display device 258 to report to the operator that a needle has been inserted (S61). For example, control circuit 251 causes display device 258 to display "needle" or similar information. Then, needle removal motor 268 is rotated forward (S62), causing piston unit 286 to advance. After needle completion detector 277 detects that piston unit 286 has moved to the needle position (S63), control circuit 251 stops needle removal motor 268 (S64). This process is repeated until needle completion detector 277 detects that the needle has been inserted.

[0404] Automatic injection process, Figure 34 >

[0405] Control circuit 251 causes display device 258 to display a message to the operator indicating that an injection has been performed (S71). For example, control circuit 251 causes display device 258 to display "injection" or similar information. Then, injection motor 265 is rotated forward (S72), causing piston 221 to advance from its initial position, thereby moving limiter 13 of pre-filled syringe 10 to inject the medication. Control circuit 251 determines whether piston 221 has advanced by an amount corresponding to the prescribed dosage (S73). This determination can, for example, use the detection signal from rotary encoder 266. Alternatively, when the full amount of medication filled in pre-filled syringe 10 is administered, control circuit 251 detects the movement of limiter 13 of pre-filled syringe 10. Figure 2 When the syringe reaches the front end of the cylindrical space 11s, the change in motor current caused by the increased load on the injection motor 265.

[0406] When the control circuit 251 determines that the piston has advanced at a rate corresponding to the prescribed dosage, it stops the injection motor 265 (S74). The control circuit 251 then instructs the display device 258 to display a message urging the operator not to immediately remove the medication injection device 200 (S75). For example, the control circuit 251 may display a message such as "Please keep in contact with skin." Afterward, the control circuit 251 uses the clock 260 to determine whether the prescribed holding time has elapsed (S76). If the prescribed holding time has elapsed, the process ends.

[0407] Automatic needle removal process Figure 35 >

[0408] Control circuit 251 reverses the needle removal motor 268 (S81) and retracts the piston unit 286 and the medicine cartridge 100 held by it. Furthermore, it determines whether the needle removal completion detector 278 has detected the piston unit 286 moving towards the needle removal position (S82). If detected, control circuit 251 stops the needle removal motor 268 (S83), ending the process.

[0409] The process of separating from the skin, Figure 36 >

[0410] The control circuit 251 causes the display device 258 to display a message urging the operator to detach the medication injection device 200 from the skin (S91). For example, the control circuit 251 causes the display device 258 to display "Please detach from the skin," etc. When the operator detaches the medication injection device 200 from the skin (S92), the control circuit 251 determines whether the skin contact detector 274 has detected skin detachment (S93). If detected, the process ends.

[0411] Needle ejection procedure Figure 37 >

[0412] The control circuit 251 causes the display device 258 to display a message urging the operator to wait (S101). For example, the control circuit 251 causes the display device 258 to display "Please wait" or similar messages. After that, the injection motor 265 is reversed (S102), causing the piston to retract to a needle discharge position that is further back than its initial position.

[0413] As shown in Table 1 and the description of the above-mentioned medicine cartridge 100, "(4) The state after the needle protector is discharged ( Figure 9D , Figure 10DAs described in the document, as the piston 221 retracts, the latching unit 230 rotates around the piston shaft 221j, and the contact between the sleeve abutment portion 233g and the sleeve 150 is released. Furthermore, the sleeve 150 moves from the second position to the first position under the force of the box spring 140. Thus, the needle protector 130 becomes unlocked. The needle protector 130 moves from the first engaged position to the second engaged position under the force of the box spring 140.

[0414] The control circuit 251 determines whether the piston 221 has retracted to the needle protector discharge position based on the output of the rotary encoder (S103). Specifically, the control circuit 251 determines whether the piston 221 has retracted to the needle protector discharge position where the contact between the sleeve 150 of the medicine cartridge 100 and the latching unit 230 is released, as described above. If the control circuit 251 detects that the piston 221 has retracted to the needle protector discharge position, it stops the injection motor 265 (S104). When the contact between the sleeve 150 of the medicine cartridge 100 and the latching unit 230 is released, the sleeve 150 of the medicine cartridge 100 moves to the first position, the lock at the first engagement position of the needle protector 130 is released, and the needle protector 130 moves from the first engagement position to the second engagement position. That is, the needle protector 130 is discharged.

[0415] Next, the control circuit 251 determines whether the needle protector detector 276 has detected the discharge of the needle protector 130 (S105). If it has, the process ends. If the discharge of the needle protector 130 cannot be detected, the display device 258 displays the message that the needle protector has not been discharged (S106), and waits until discharge is detected. Alternatively, if the discharge of the needle protector 130 is not detected after a constant time, the control circuit 251 ends the process and interrupts the main process. Figure 27 The control circuit 251 causes the display device 258 to display a message urging the drug infusion device 200 to terminate abnormally. For example, the control circuit 251 causes the display device 258 to display a message urging the drug infusion device 200 to terminate abnormally and to contact the physician receiving treatment.

[0416] <Cylinder removal process, Figure 38 >

[0417] Control circuit 251 causes display device 258 to display a message to the operator indicating that the operation of removing the medicine cartridge 100 has been performed (S111). For example, control circuit 251 causes display device 258 to display "Cylinder removed" or similar messages. Next, control circuit 251 reverses injection motor 265 (S112). As a result, piston 221 retracts from needle holder discharge position to a further retracted cartridge discharge position. Accompanying the piston retraction, latch unit 230 rotates further around piston shaft 221j, and the engagement between cartridge latch 235 and outer cartridge 120 is released. As a result, medicine cartridge 100 is released from piston unit 286, making it removable.

[0418] Control circuit 251 determines whether origin detector 279 is in contact with piston 221, that is, whether piston 221 has retracted to the origin position (S113). If origin detector 279 detects contact with piston 221, control circuit 251 stops injection motor 265 (S114).

[0419] The control circuit 251 also determines whether the cartridge filling detector 271 has detected the filling of the medicine cartridge 100 (S115). If the filling of the medicine cartridge 100 is not detected, that is, if the medicine cartridge 100 has been released from the piston unit 286, the control circuit 251 causes the display device 258 to display a message urging the operator to remove the cartridge (S116). For example, the control circuit 251 causes the display device 258 to display a message such as "Please remove the cartridge".

[0420] When the operator removes the medicine cartridge (S117), the control circuit 251 determines whether the cartridge removal detector 273 detects contact with the medicine cartridge 100 (S118). If no contact is detected, the medicine cartridge 100 is removed, thus ending the process.

[0421] If the filling detector 271 detects that the cartridge 100 is filled (S115), the piston unit 286 maintains the state of holding the cartridge 100 for some reason, and the cartridge 100 is not removed. In this case, the control circuit 251 terminates the process and switches the main process ( Figure 27 If the processing is interrupted, the aforementioned abnormal termination processing will be performed.

[0422] End processing flow Figure 39 >

[0423] The control circuit 251 causes the display device 258 to display the next injection schedule to the operator (S121). For example, the control circuit 251 causes the display device 258 to display "Next injection date is ○ month ○ day", etc. In addition, the control circuit 251 causes the injection motor 265 to rotate forward (S122).

[0424] During the cylinder removal process, the control circuit 251 uses the position of the piston 221, which has stopped based on the detection of the origin detector 279, as a reference, and determines whether the piston 221 has advanced to the initial position based on the output of the rotary encoder 266 (S123). After the output of the rotary encoder 266 reaches a predetermined value, the control circuit 251 stops the injection motor 265 (S124). Then, the main power supply is disconnected, and the operation mode is switched to standby mode (S125).

[0425] According to the operation of the drug injection system 300 of this embodiment, various detectors monitor various states during the injection operation and report the next steps to the operator based on the detection results. Therefore, the operator can easily and confidently perform the drug injection operation without worrying about whether the operation sequence is correct. Furthermore, during the series of actions from removing the cap 110 of the drug cartridge 100 to injecting the drug, removing the drug cartridge 100 from the drug injection device 200, and discarding it, the injection needle 12 is covered by the needle protector 130 and is not exposed. Therefore, the operator does not need to worry about the injection needle 12 pricking their finger or snagging their clothing, and can use the drug injection system 300 with peace of mind.

[0426] (Other methods)

[0427] The structure of the medicine cartridge 100 and medicine injection device 200 described in the above embodiments is an example, and various modifications can be made.

[0428] In particular, the shape and position of the various engaging parts and engaging claws are not limited to the examples shown in the figures, and various changes can be made. Furthermore, the position and detection method of the various detectors are not limited to the embodiments described above, and various changes can be made. Among the springs exemplified as force-applying elements, various springs such as coil springs, tension springs, leaf springs, and torsion springs can be used. In addition to metal springs, various springs made of resin can also be used. Leaf springs and elastic members made of resin are not limited to the examples given in the embodiments, and various elastomers can be used.

[0429] The information displayed by the display device described in the above embodiments is one example. It can display other content, or it can replace the display on the display device or sound a buzzer together with the display on the display device to report to the operator.

[0430] Additionally, while the cartridge 100 includes a pre-filled syringe 10, cartridges without the pre-filled syringe 10 can also be prepared as practice cartridges. These practice cartridges, lacking the pre-filled syringe 10, cannot actually perform needle insertion and removal; they function identically to the cartridge 100 except for the absence of medication administration. Therefore, operators new to the medication injection device 200 can use these practice cartridges for training purposes to familiarize themselves with the procedure.

[0431] Industrial applicability

[0432] The drug cartridge, drug injection device, and drug injection system of the present invention are suitable for use as devices for injecting various drugs.

[0433] Explanation of reference numerals in the attached figures

[0434] 10: Pre-filled syringe; 11: Syringe body; 12: Injection needle; 13: Limiter; 14: Needle guard; 100: Drug cartridge; 110: Cap; 120: Outer casing; 120a: Front opening of casing; 120b: Rear opening of casing; 120c: Cylindrical space of casing; 130: Needle protector; 130c: Protective part; 140: Casing spring; 150: Sleeve; 200: Drug injection device; 201: Outer casing; 251: Control circuit; 265: Injection motor; 268: Needle removal motor; 283: Interface; 286: Piston unit; 300: Drug injection system.

Claims

1. A medicine container, wherein, The reagent cartridge includes: A pre-filled syringe includes a drug, a syringe body having a syringe cylindrical space for dispensing the drug and a syringe opening located at one end of the syringe cylindrical space, an injection needle located on the side of the syringe body opposite to the syringe opening and communicating with the syringe cylindrical space, a limiter movable in the syringe cylindrical space and disposed on the side of the syringe opening, and a needle guard covering the front end of the injection needle and removable. The outer casing has a front opening and a rear opening, and a cylindrical space between the rear opening and the front opening, and holds the pre-filled syringe in the cylindrical space with a portion of the injection needle and a portion of the needle guard protruding from the front opening. A cap is inserted into the front opening of the box in such a way that it fits into and covers the needle guard, and the cap is detachable from the outer cylinder of the box integrally with the needle guard; A needle protector having a protective part and being movable along the axial direction of the cylindrical space of the box, and the needle protector being movable between a first engagement position in which the front end of the protective part is retracted from the front end of the injection needle protruding from the front opening of the box and a second engagement position in which the front end of the protective part protrudes from the front end of the injection needle protruding from the front opening of the box in the cap-free state; A sleeve that is axially movable within the cylindrical space of the box between a first position located on the rear opening side of the box and a second position located on the front opening side of the box, and engages with the outer cylinder of the box at the first position. as well as A box spring applies force to the needle protector towards the front opening of the box. When the cap is inserted into the front opening of the box, the cap can be in a locked state where it cannot be detached from the outer cylinder of the box, and in an unlocked state where it can be detached from the outer cylinder of the box. The needle protector abuts against the cap and overcomes the force of the box spring to be located in the first engaged position. With the cap inserted into the opening of the box and the sleeve in the first position, the cap is in a locked state. With the cap inserted into the front opening of the box and the sleeve in the second position, the sleeve makes the cap unlocked and the needle protector locked in the first engaging position.

2. The pharmaceutical cartridge according to claim 1, wherein, One end of the box spring abuts against the needle protector, and the other end of the box spring abuts against the sleeve. When the cap is inserted into the front opening of the box, the sleeve moves from the first position to the second position under the action of an external force, overcoming the force of the box spring, and the cap is removed.

3. The pharmaceutical cartridge according to claim 2, wherein, After the cap is removed, the external force is released, and the sleeve moves from the second position to the first position under the action of the box spring. The sleeve keeps the needle protector in an unlocked state, so that the needle protector moves from the first engaged position to the second engaged position under the action of the box spring.

4. The pharmaceutical cartridge according to claim 3, wherein, In the second engaging position, the needle protector engages with the outer cylinder of the box in a manner that prevents it from moving toward the first engaging position.

5. The pharmaceutical cartridge according to claim 1, wherein, The syringe body has a flange disposed near the syringe opening. The outer cylinder of the box has a slit located near the rear opening of the box. The flange of the syringe body is inserted into the slit of the outer cylinder of the cartridge, thereby holding the pre-filled syringe in the outer cylinder of the cartridge.

6. The pharmaceutical cartridge according to claim 1, wherein, The cap includes a cap body and a cap spring that engages with the needle guard. The cap body has a cylindrical torso, a first elastic support portion located at one end of the torso, and a first engaging claw located at the other end of the first elastic support portion and having an abutment surface at the front end. The cap spring is disposed within the torso. The outer cylinder of the box has a cap-locking portion on the inner surface located on the front opening side of the box. With the cap embedded in the front opening of the box, the cap body surrounds the front opening of the box, the first engaging claw is inserted into the outer cylinder of the box from the front opening of the box, and the cap engages with the cap engaging part in a manner that prevents it from disengaging from the front opening of the box.

7. The pharmaceutical cartridge according to claim 6, wherein, The protective portion of the needle protector has an end face and a needle protector opening provided on the end face, and has a cylindrical shape defining a cylindrical space for accommodating a portion of the syringe body of the pre-filled syringe. The needle protector also has a second elastic support portion connected at one end to one end of the protective part opposite to the opening of the needle protector, and a protrusion disposed at the other end of the second elastic support portion. The outer cylinder of the box has a first opening located on the rear opening side of the box and a second opening located on the front opening side of the box, which is closer to the first opening side than the first opening side. When the needle protector is in the first engaging position, the protrusion engages with the first opening. When the needle protector is in the second engaging position, the protrusion engages with the second opening.

8. The pharmaceutical cartridge according to claim 7, wherein, The protrusion has an inclined portion located on the protective portion side and inclined towards the outer cylinder side of the box, a recess provided in the inclined portion, a top adjacent to the inclined portion, a side portion adjacent to the top on the opposite side of the inclined portion, and an inner surface portion located inside the inclined portion, the top portion, and the side portion. The outer cylinder of the box has an inwardly projecting portion that protrudes from the edge of the front opening side of the second opening toward the center of the second opening. When the protrusion is engaged with the second opening, the inclined portion of the protrusion abuts against the edge of the front opening side of the second opening, and the protrusion inside the opening engages with the recess of the inclined portion.

9. The pharmaceutical cartridge according to claim 8, wherein, The sleeve has: an inner sleeve portion having a front opening and a space for receiving a portion of the pre-filled syringe; an outer sleeve portion being disposed separately from the inner sleeve portion and having a rear opening; and a sleeve abutment surface located on the side of the front opening of the outer sleeve portion. And slits, which are respectively provided in the inner cylinder portion and the outer cylinder portion. Within the cylindrical space of the outer cylinder of the box, the sleeve abutment surface is located on the front opening side of the box, at least the protrusion of the needle protector and the second elastic support portion are located between the inner cylinder portion and the outer cylinder portion, and the slit of the inner cylinder portion and the slit of the outer cylinder portion are aligned with the second elastic support portion and the protrusion in the same radial direction in a section perpendicular to the axis of the cylindrical space of the box.

10. The pharmaceutical cartridge according to claim 9, wherein, With the cap inserted into the opening in the box and the sleeve in the second position. The sleeve abutting surface of the sleeve abuts against the abutting surface of the first engaging claw of the cap. The first elastic support portion deforms, thereby releasing the engagement between the first engaging claw and the cap engaging portion of the outer cylinder of the box. The inner cylindrical portion of the sleeve abuts against the inner surface of the protrusion of the needle protector, thereby suppressing the deformation of the second elastic support portion.

11. The pharmaceutical cartridge according to claim 9, wherein, When the cap is removed from the front opening of the box and the sleeve is in the first position, under the action of the box spring, the edge of the first opening abuts against the inclined portion of the protrusion, and the second elastic support portion deforms inward to enter the slit of the inner cylinder, thereby disengaging the protrusion from the first opening inward, and the needle protector moves from the first engaging position to the second engaging position. In the second engaging position, the inner cylinder of the sleeve abuts against the inner surface of the protrusion of the needle protector, thereby suppressing the deformation of the second elastic support.

12. The pharmaceutical cartridge according to claim 11, wherein, The sleeve has a third elastic support portion with one end located near the rear opening of the sleeve, and a second engaging claw located at the other end of the third elastic support portion and having an abutment surface at the front end. The outer cylinder of the box has a sleeve engagement portion on the inner surface located on the rear opening side of the box. When the sleeve is in the first position, the second engaging claw of the sleeve engages with the sleeve engaging portion of the outer cylinder of the box, thereby suppressing the movement of the sleeve to the second position.

13. A pharmaceutical injection device, wherein, The drug injection device includes: The shell has a cylindrical space capable of containing a pharmaceutical cartridge as described in any one of claims 1 to 12 and a cylindrical opening communicating with said cylindrical space; A piston unit includes a piston, a piston gear that drives the piston along the piston axis, and a latching unit that is partially inserted into the rear opening of the cartridge and holds the cartridge. A needle-pulling motor that causes the piston unit to move forward and backward along the piston axis; An injection motor is used to propel the piston forward and backward along the piston axis. A control circuit that controls the needle removal motor and the injection motor; as well as An interface that inputs commands to the control circuit. The latching unit includes a cylinder latching member that engages with the outer cylinder of the medicine cartridge and a sleeve abutting portion that abuts against the sleeve of the medicine cartridge. When the medicine cartridge is inserted into the cartridge space from the cartridge opening, the sleeve abutment portion of the latching unit enters inward from the rear opening of the box and abuts against the sleeve of the medicine cartridge, thereby releasing the engagement between the sleeve and the outer cylinder of the box. As the medicine cartridge is inserted, the sleeve abutment causes the sleeve to move relative to the outer cylinder of the box towards the second position, and the cylinder latch enters inward from the rear opening of the box. When the filling of the medicine cartridge is completed, the sleeve reaches the second position, and the cylinder latch engages with the outer cylinder of the box.

14. The drug injection device according to claim 13, wherein, The control circuit is based on input from the interface. By rotating the needle removal motor, the piston unit is advanced, thereby inserting the needle. By rotating the injection motor, the piston advances from its initial position, thereby moving the limiter and injecting the medication. The needle is removed by reversing the needle removal motor after rotating the injection motor by a predetermined amount, thereby causing the piston unit to retract.

15. The drug injection device according to claim 14, wherein, The drug injection device also includes a needle protector detector for detecting the discharge of the needle protector. After needle removal, the control circuit reverses the injection motor, causing the piston to retract to a needle guard discharge position that is further back than its initial position. As the piston retracts, the latching unit rotates about the piston axis, and the contact between the sleeve abutment and the sleeve is released. The sleeve moves from the second position to the first position under the action of the box spring, making the needle protector unlocked. Thus, the needle protector moves from the first engaged position to the second engaged position under the action of the box spring. The needle protector detector detects the discharge of the needle protector.

16. The drug injection device according to claim 15, wherein, The needle protector detector includes: a light-emitting element that illuminates a portion of the needle protector; and a light-receiving element that detects light emitted from the light-emitting element and reflected by the needle protector or light that passes through the needle protector.

17. The drug injection device according to claim 16, wherein, Based on the detection signal from the needle protector detector, the control circuit reverses the injection motor, causing the piston to retract to a cylinder discharge position that is further back than the needle protector discharge position. As the piston retracts, the latching unit rotates around the piston axis, and the engagement between the cylinder latch and the outer cylinder of the box is released.

18. The pharmaceutical injection device according to any one of claims 15 to 17, wherein, The piston has a spiral-shaped contact surface located on the front end side. The latching unit has a through hole for the piston to be inserted and a limiting portion located on the inner surface of the through hole. The contact surface of the piston abuts against the limiting part of the latching unit, thereby causing the latching unit to rotate about the piston axis as the piston moves forward and backward.

19. The pharmaceutical injection device according to any one of claims 13 to 18, wherein, The drug injection device also includes a door that can cover the cylinder opening in an openable and closable manner.

20. A drug injection system, wherein, The drug injection system includes: The pharmaceutical cartridge according to any one of claims 1 to 12; and The drug injection device according to any one of claims 13 to 19.

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