Pre-loaded automatic syringe for administering a drug

Abstract

To provide an auto injector, such as an electronic auto injector, with improved automation of preparing and administering a medicament.SOLUTION: Disclosed herein are a method for controlling an autoinjector, and an autoinjector for administering a medicament from a cartridge. The cartridge has a first cartridge end and a second cartridge end, and has a cartridge outlet located at the first cartridge end. The cartridge comprises a cartridge compartment with a first cartridge subcompartment containing a first medicament component of the medicament and a second cartridge subcompartment containing a second medicament component of the medicament. The autoinjector comprises a housing, a cartridge receiver, a cartridge sensor, a drive module, an orientation sensor, and a processing unit.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present disclosure relates to an autoinjector such as an electronic autoinjector, a cartridge for an autoinjector, a system comprising an autoinjector and a cartridge, and a method for operating an autoinjector.

Background Art

[0002] Subcutaneous syringes are widely used to deliver fluid to the body. It is known to have subcutaneous syringes applicable to manual operation. However, autoinjectors such as electronic autoinjectors have been developed and are widely used to assist in the administration of fluid or drugs to the body.

[0003] There is an increasing interest in autoinjectors being able to perform the injection process as automatically as possible, without relying on the correct execution of certain tasks by the user. In particular, it can be beneficial to automate the process of preparing and administering a fluid such as a drug, such as when it is necessary to mix the drug prior to injection, or when the administration of the drug requires several steps.

Summary of the Invention

[0004] There is a need for an autoinjector such as an electronic autoinjector with improved automation of drug preparation and administration. The present disclosure provides an autoinjector, a cartridge, a system, and a method for improving the preparation and administration of drugs by an autoinjector.

[0005] Accordingly, an autoinjector for preparing and / or administering a drug from a cartridge is disclosed. The cartridge has a first cartridge end and a second cartridge end, and has a cartridge outlet at the first cartridge end. The cartridge comprises a cartridge chamber. The cartridge chamber has a first cartridge sub-compartment for containing a first drug component of the drug and a second cartridge sub-compartment for containing a second drug component of the drug.

[0006] The auto-injector comprises a housing, a cartridge receiver, a cartridge sensor, a drive module, an orientation sensor, and a processing unit.

[0007] The cartridge receiver has a cartridge receiver opening. The cartridge receiver is configured to receive a cartridge by inserting a second end of the cartridge through the cartridge receiver opening.

[0008] The cartridge sensor is configured to detect the receipt of the cartridge into the cartridge receiver and provide a cartridge detection signal indicating that the cartridge is received in the cartridge receiver.

[0009] The drive module is combined to move the plunger rod between a plunger rod retracted position and a plunger rod extended position. The plunger rod is configured to move a first stopper, for example when the plunger rod is moved towards the plunger rod extended position.

[0010] The orientation sensor is configured to provide an orientation signal indicating the orientation of the cartridge, for example when the cartridge is received in the cartridge receiver.

[0011] The processing unit is connected to the orientation sensor, the cartridge sensor, and the drive module.

[0012] The processing unit receives a first input signal, receives the cartridge detection signal, receives the orientation signal, controls the drive module to move the plunger rod to a mixed plunger rod position in response to the receipt of the cartridge detection signal and the first input signal, and controls the drive module to move the plunger rod to a prime plunger rod position after completion of the movement of the plunger rod to the mixed plunger rod position.

[0013] The processing unit can be further configured to control the drive module to receive a trigger event and, in response to receiving the trigger event after completion of the movement of the plunger rod to the prime plunger rod position, move the plunger rod to the injection plunger rod position.

[0014] Furthermore, a cartridge for an auto-injector such as the auto-injector disclosed above is disclosed. The cartridge has a first cartridge end and a second cartridge end, and has a cartridge outlet at the first cartridge end. The cartridge includes a cartridge chamber. The cartridge chamber has a first cartridge compartment for containing a first drug component of the drug and a second cartridge compartment for containing a second drug component of the drug. The cartridge is configured to be received by a cartridge receiver of an auto-injector such as the cartridge receiver of the auto-injector disclosed above by inserting the second end of the cartridge through the cartridge receiver opening of the auto-injector.

[0015] Furthermore, a system comprising an auto-injector such as the auto-injector disclosed above and a cartridge such as the cartridge disclosed above is disclosed.

[0016] Also disclosed is a method for operating an auto-injector such as the auto-injector disclosed above, such an auto-injector being an auto-injector comprising, for example, a plunger rod and a cartridge receiver configured to receive a cartridge, the cartridge being a cartridge having, for example, a first cartridge end and a second cartridge end and having a cartridge outlet at the first cartridge end, such as the cartridge disclosed above.

[0017] The method includes receiving a first input signal, detecting the receipt of a cartridge into a cartridge receiver, determining the orientation of the cartridge, moving a plunger rod to a mixing plunger rod position in response to detecting the receipt of the cartridge into the cartridge receiver and receiving the first input signal, and moving the plunger rod to a prime plunger rod position after completion of the movement of the plunger rod to the mixing plunger rod position.

[0018] The method can further include receiving a trigger event and moving the plunger rod to an injection plunger rod position in response to receiving the trigger event after completion of the movement of the plunger rod to the prime plunger rod position.

[0019] The trigger event can be, for example, as a result of pressing a button, as a result of the passage of a short pause, and / or as a result of a predetermined action of the user. The trigger event can indicate that the autoinjector is pressed against the injection site.

[0020] An advantage of the present disclosure is that the steps related to the preparation and / or administration of the drug are becoming increasingly automated. A further advantage is that such an improvement in automation results in an improvement in the safety in the preparation and / or administration of the drug.

[0021] A further advantage of the present disclosure is that it can provide an autoinjector that is easier to use and reduces the risk of accidental drug administration.

[0022] An advantage of the present disclosure is that it can assist in determining the characteristics of the received cartridge. A further advantage of the present disclosure is that the autoinjector can be operated according to the characteristics of the received cartridge.

[0023] The present disclosure can determine or notify that the received cartridge is a used cartridge and / or a defective cartridge and / or a counterfeited cartridge and / or a cartridge containing a drug not approved for use with the device. Thus, an advantage of the present disclosure may be, for example, that the safety of the autoinjector is increased because the use of non-new cartridges in the autoinjector can be prevented or restricted.

[0024] Thus, a further advantage of the present disclosure is, for example, that the safety of the patient is improved by reducing the risk of transmission of infection and / or reducing the risk of dosage error of the drug.

[0025] Any embodiment or element described in connection with any one aspect can be used in any other aspect or embodiment with necessary modifications.

[0026] The cartridge has a cartridge outlet at a first cartridge end. The cartridge can include a cartridge rear face at a second cartridge end, such as, for example, on the opposite side of the cartridge outlet. The cartridge rear face can include a cartridge rear end opening. The cartridge rear end opening can provide access to a first stopper on a plunger rod, such as a plunger rod of an autoinjector.

[0027] The cartridge chamber can contain a drug. The cartridge outlet can be configured to communicate with the cartridge chamber, for example, at the first cartridge end. The cartridge can be configured to discharge the drug through the cartridge outlet. The cartridge outlet can be coupled to a needle, such as a hypodermic needle, to effect discharge of the drug through the needle.

[0028] The cartridge includes a first stopper movable inside the cartridge chamber. The cartridge can include a second stopper movable inside the cartridge chamber. The second stopper may be between the first stopper and the cartridge outlet. The cartridge can include a third stopper movable inside the cartridge chamber. The third stopper may be between the second stopper and the cartridge outlet. The first stopper, the second stopper, and / or the third stopper may be movable inside the cartridge chamber toward the cartridge outlet, for example, in the direction of the first stopper, such as toward the first cartridge end. For example, the drug can be discharged through the cartridge outlet when the first stopper, the second stopper, and / or the third stopper move, for example, in the direction of the first stopper and further toward / alternatively the cartridge outlet.

[0029] The cartridge may be a two-chamber cartridge. The cartridge chamber can have a first cartridge compartment and a second cartridge compartment. The first cartridge compartment may be between the first stopper and the second stopper. The second cartridge compartment may be between the second stopper and the cartridge outlet and / or the third stopper.

[0030] The first cartridge chamber can accommodate the first drug component of the drug. The second cartridge chamber can accommodate the second drug component of the drug. Each of the first drug component and / or the second drug component may be a powder composition, a fluid, a liquid, a gel, a gas, and / or any combination thereof. The first drug component and / or the second drug component may be a solute such as a powder composition. The first drug component and / or the second drug component may be a solvent such as a fluid composition like a liquid composition. The second drug component may be a powder composition, and the first drug component may be a fluid composition such as, for example, water or ethanol or physiological saline or buffer solution or preservative solution. The second drug component may be a solute. The first drug component may be a solvent. The drug is considered to be, for example, any drug that can be injected via a subcutaneous injection needle after reconstitution (reconstitution) of the drug. The drug may be a growth hormone. The drug may be a human growth hormone. The drug may be a depot agent such as a long-acting type of human growth hormone. The second drug component may be a powder composition of human growth hormone.

[0031] The cartridge can have a bypass portion, and the bypass portion provides communication between the first cartridge chamber and the second cartridge chamber, for example, when the second stopper is located in the bypass portion. The cartridge can have a plurality of bypass portions that provide communication between adjacent cartridge chambers, for example, when a stopper separating adjacent cartridge chambers is located in the bypass portion.

[0032] A reusable autoinjector, such as the autoinjector disclosed above, can be particularly useful when the cartridge comprises a plurality of chambers. For example, an autoinjector for a multi-chamber or multi-chamber cartridge may be more advanced and thus it may be beneficial that the autoinjector can be used more than once. For example, the autoinjector can provide an automated process for mixing drug components, such as mixing drug components initially provided in different chambers of the cartridge.

[0033] The cartridge may be configured as part of a cartridge assembly. The cartridge assembly can include a cartridge. Further, the cartridge assembly can include a needle, such as a needle assembly that includes a needle cover, a cartridge holder, and / or a cartridge code feature.

[0034] The cartridge assembly can include a needle, such as a needle assembly that includes a needle. The needle assembly can include a needle cover and / or a needle hub. The cartridge assembly can include a cartridge holder. The cartridge holder can be configured to engage with the needle assembly. The cartridge holder can effect attachment of the needle assembly to the cartridge.

[0035] The cartridge can include a cartridge code feature, and / or the cartridge assembly can include the cartridge and the cartridge code feature. The cartridge code feature can include one or more of a color, a barcode, an RFID tag, an NFC tag, an identification number, and a QR code (registered trademark). For example, the cartridge code feature can include a color and / or an arrangement of colors. The cartridge code feature can be arranged to surround or partially surround a portion of the cartridge chamber where a stopper, such as a first stopper, is initially located. Such a position of the cartridge code feature can enhance the readability of the cartridge code feature because, for example, the stopper can form a background for the cartridge code feature. The stopper, such as the first stopper, can be a light color, such as a light gray or white. The stopper, such as the first stopper, can be a dark color, such as a dark blue, dark gray, or black. The stopper can form a dark background for the cartridge code feature. The stopper, such as the first stopper, can reduce light reflection and further enhance the readability of the cartridge code feature, for example.

[0036] The cartridge code feature portion may be arranged at a specific position on the cartridge independently of a stopper such as a first stopper, for example. For example, the cartridge code feature portion can be arranged at a code distance from a second cartridge end. All cartridges can have respective cartridge code feature portions arranged at the same position, such as being arranged at a code distance from a second cartridge end. Such a uniform arrangement of the cartridge code feature portions can reduce the complexity and size of the auto-injector because the cartridge code feature portions are read at the same position in all suitable cartridges.

[0037] The cartridge and the cartridge code feature portion can be manufactured as one element. For example, the cartridge code feature portion may be a specific form of the cartridge. Alternatively, the cartridge code feature portion can be attached to the cartridge, such as being fixed to the cartridge with an adhesive, for example. For example, the cartridge code feature portion may be a color code printed on the cartridge.

[0038] The cartridge code feature part can indicate one or more cartridge specifications such as the drug in the cartridge, the concentration of the drug in the cartridge, the viscosity of the drug in the cartridge, the volume and / or mass of the drug in the cartridge, the position of the stopper in the cartridge chamber, etc. The cartridge code feature part can indicate the position of the first stopper when the air in the cartridge chamber is reduced, for example minimized, and / or further reduced to an amount suitable for injection. The cartridge code feature part can indicate the amount of drug contained in the cartridge. The cartridge code feature part can indicate a specific type of cartridge, such as the ID number of a specific type of cartridge. An auto-injector, such as the processing unit of the auto-injector, can be configured to determine one or more cartridge specifications based on the ID number, for example by reference to a look-up table. The cartridge code feature part can indicate an appropriate speed, such as an optimal speed, for the movement of the stopper, such as the movement of the stopper at various stages of movement such as during mixing, during air expulsion, and / or during injection. The cartridge code feature part can indicate an appropriate speed, such as an optimal speed, for the movement of the first stopper, such as the speed of movement of the first stopper at various stages of movement such as during mixing, during air expulsion, and / or during injection. The cartridge code feature part can indicate the time required for optimal mixing of the first drug component and the second drug component. The cartridge code feature part can indicate an appropriate dwell time for the drug, such as a preferred waiting time until the needle retracts after injection, for example a time to ensure distribution of the drug to the tissue.

[0039] The auto-injector may be a pre-loaded auto-injector. The auto-injector comprises a cartridge receiver configured to receive a cartridge. The cartridge receiver can be configured to receive a cartridge assembly comprising a cartridge. The cartridge assembly can comprise a cartridge holder. The cartridge receiver has a cartridge receiver opening. The cartridge receiver can be configured to receive a cartridge by inserting the cartridge through the cartridge receiver opening, such as the second end of the cartridge. The cartridge can be inserted in a cartridge receiving direction. The cartridge receiving direction may be, for example, opposite to the first stopper direction when the cartridge is received by the cartridge receiver. The cartridge may be in a first angular position when inserted into the cartridge receiver. The cartridge can be held in the cartridge receiver at a second angular position, for example, after inserting the cartridge into the cartridge receiver.

[0040] The cartridge receiver can be configured to receive a cartridge assembly comprising a cartridge and a cartridge holder. The cartridge assembly can be held in the cartridge receiver by one or more cartridge holding members of the cartridge holder that engage with a member of the cartridge receiver.

[0041] The cartridge and / or the cartridge assembly may be lockable in the cartridge receiver, for example, the cartridge and / or the cartridge assembly can be locked in the cartridge receiver to prevent removal of the cartridge and / or the cartridge assembly from the cartridge receiver. The cartridge and / or the cartridge assembly can be locked in the cartridge receiver by the movement of the plunger rod of the auto-injector.

[0042] The auto-injector can be provided with a cartridge sensor. The cartridge receiver can be provided with the cartridge sensor. The cartridge sensor can be configured to detect the acceptance of the cartridge and / or the cartridge assembly into the cartridge receiver. The cartridge sensor can provide a cartridge sensor signal indicating whether the cartridge and / or the cartridge assembly is received in the cartridge receiver. The cartridge sensor can provide a cartridge detection signal indicating the cartridge and / or the cartridge assembly housed in the cartridge receiver. The cartridge sensor signal can include the cartridge detection signal.

[0043] The auto-injector can be an electronic auto-injector. The auto-injector can be provided with a battery. The housing can accommodate the battery. The battery can be a rechargeable battery. For example, the battery can be a Li-ion battery or a NiCd battery or a NiMH battery. The battery can be configured to be charged by connection to a charger.

[0044] The auto-injector is provided with a drive module. The drive module can be combined to move, for example, the plunger rod between a plunger rod retracted position and a plunger rod extended position, for example, actuated, for example, advanced. The movement of the plunger rod can result in locking of the cartridge and / or the cartridge assembly into the cartridge receiver. For example, the cartridge and / or the cartridge assembly can be locked into the cartridge receiver by advancing the plunger rod from the plunger rod retracted position.

[0045] The drive module can comprise one or more electrical elements. The drive module can be configured to receive power from a battery. The drive module can be electrically connected to the battery to receive power. The drive module can be housed in a housing. The drive module can comprise a motor such as an electromechanical motor like a DC motor, for example, a brushed or brushless DC motor. The drive module can comprise a solenoid motor. The drive module can comprise a shape memory metal engine. The drive module can comprise a spring device configured to actuate a plunger rod. The drive module can comprise a pressurized gas configured to actuate a plunger rod.

[0046] The autoinjector can comprise a plunger rod such as a plunger rod that can be moved by the drive module. The plunger rod can be configured to move a stopper such as a first stopper of the cartridge. For example, when the plunger rod is moved towards the plunger rod extended position, the plunger rod can be configured to move the first stopper towards the cartridge outlet, for example, to discharge a drug from the cartridge chamber through the cartridge outlet and / or to discharge air from the cartridge chamber through the cartridge outlet.

[0047] The plunger rod can be moved, for example, from a plunger rod retracted position towards a plunger rod extended position to a pre-mixing plunger rod position. The pre-mixing plunger rod position can be a position where the communication between the first cartridge chamber and the second cartridge chamber has not yet been established.

[0048] The plunger rod can be moved from, for example, a plunger rod retracted position and / or a pre-mixing plunger rod position, etc., towards, for example, a plunger rod extended position, to a mixing plunger rod position. The mixing plunger rod position may be a position where mixing occurs, such as where the first drug component and the second drug component are combined. The mixing plunger rod position may be a position where the second stopper is positioned in the bypass portion so as to provide communication, for example, between the first cartridge chamber and the second cartridge chamber.

[0049] The plunger rod can be moved from, for example, a plunger rod retracted position and / or a mixing plunger rod position, etc., towards, for example, a plunger rod extended position, to a prime plunger rod position. The prime plunger rod position may be a position where air is discharged from the cartridge chamber. For example, the prime plunger rod position can be selected such that the first stopper is positioned at a position where the air in the cartridge chamber is reduced, for example, minimized, and further reduced to an amount suitable for injection.

[0050] The plunger rod can be moved from, for example, a plunger rod retracted position and / or a prime plunger rod position, etc., towards, for example, a plunger rod extended position, to an injection plunger rod position. The injection plunger rod position may be a position where the drug is discharged from the cartridge chamber and further injected. For example, the injection plunger rod position can be selected such that the first stopper is positioned at a position where the drug in the cartridge chamber is reduced, for example, minimized, such as a position close to the cartridge outlet. The injection plunger rod position may be the plunger rod extended position.

[0051] The plunger rod can be moved, for example, toward the plunger rod retracted position, such as to the plunger rod retracted position. For example, after completion of injection, the plunger rod can be moved from, for example, the injection plunger rod position and / or the plunger rod extended position, etc., toward the plunger rod retracted position, such as to the plunger rod retracted position.

[0052] The processing unit can be configured to move the plunger rod to the pre-mixing plunger rod position, the mixing plunger rod position, the prime plunger rod position, the injection plunger rod position, the plunger rod extended position, and / or the plunger rod retracted position.

[0053] The auto-injector can include a discharge sensor such as a plunger rod position sensor. The discharge sensor can be configured to detect discharge such as discharge of the drug and / or air in the cartridge chamber. The discharge sensor can be configured to detect and / or determine the position of the plunger rod and / or the position of the first stopper. The discharge sensor can be configured to detect a state indicating the position of the plunger rod and / or the position of the first stopper. The discharge sensor can be configured to provide a discharge sensor signal. The discharge sensor signal can represent the position of the plunger rod and / or the first stopper.

[0054] The discharge sensor can include a tachometer, such as a tachometer of a drive module. The tachometer can be configured to count the number of rotations of a drive module, such as the number of rotations of a motor of the drive module, from a predetermined point where the position of the plunger rod, such as the plunger rod retracted position of the plunger rod, is known. The number of rotations of the drive module can be used to determine the actual position of the plunger rod, such as the pre-mixing plunger rod position, the mixing plunger rod position, the prime plunger rod position, the injection plunger rod position, the plunger rod extended position, and / or the plunger rod retracted position.

[0055] The processing unit can be connected to a discharge sensor such as a tachometer. The processing unit can receive a first discharge sensor signal such as a tachometer signal indicating the rotational speed of the drive module from the discharge sensor. The processing unit can determine the position of the plunger rod based on the first discharge sensor signal. The processing unit can receive a second discharge sensor signal indicating that the plunger rod is in a known position such as a plunger rod retracted position, for example, from the discharge sensor. The processing unit can determine the position of the plunger rod based on the first discharge sensor signal and the second discharge sensor signal.

[0056] The cartridge may be lockable in the cartridge receiver, for example, the cartridge can be locked in the cartridge receiver to prevent removal of the cartridge from the cartridge receiver. The cartridge can be locked in the cartridge receiver by moving the plunger rod towards the plunger rod extended position. For example, the cartridge can be locked in the cartridge receiver by moving the plunger rod to a mixed plunger rod position. The lock of the cartridge in the cartridge receiver can be released by moving the plunger rod towards the plunger rod retracted position. For example, the lock of the cartridge in the cartridge receiver can be released by moving the plunger rod to the plunger rod retracted position. The cartridge can be locked in the cartridge receiver when the plunger rod is not at or near the plunger rod retracted position. Associating the position of the plunger rod with the locking of the cartridge in the cartridge receiver can provide the advantage of restricting or preventing the release of the cartridge when the auto-injector is in operation.

[0057] The auto-injector can be provided with an orientation sensor. The orientation sensor can be configured to provide an orientation signal indicating the orientation of the cartridge, for example when the cartridge is received in the cartridge receiver. The orientation signal can indicate the orientation of the cartridge relative to gravity, such as the orientation of the cartridge relative to the direction of gravity.

[0058] The orientation sensor can be configured to detect the orientation of the cartridge, such as the orientation of the cartridge and / or the orientation of the auto-injector. The detected orientation can be the orientation relative to gravity, such as the orientation relative to the direction of gravity. The orientation sensor can be configured to detect the direction of gravity, and further and / or alternatively can be configured to detect whether the direction of gravity is within a specific range of a predetermined direction. The orientation sensor can include an accelerometer. The orientation sensor can include a plurality of accelerometers, such as three accelerometers arranged to detect acceleration in three dimensions, such as a three-dimensional accelerometer. The orientation sensor can include an inclinometer, a three-axis accelerometer, a one-axis accelerometer, a magnetometer, and / or any combination thereof, and the orientation sensor can provide measurements of roll, pitch, and azimuth, measurements of acceleration and / or inclination in one or more directions, and the like.

[0059] The orientation sensor can be configured to detect whether the cartridge is in a predetermined orientation. The orientation sensor can be configured to detect whether the orientation of the auto-injector indicates that the cartridge is in a predetermined orientation. The predetermined orientation can be a vertical orientation. The predetermined orientation can be an orientation within a range of 45 degrees of vertical, such as within a range of 30 degrees of vertical. The predetermined orientation can be such that the cartridge is oriented with its longitudinal axis within a range of 45 degrees of vertical, such as within a range of 30 degrees of vertical, and the cartridge outlet is in a vertical position above the cartridge chamber, such as in an orientation located above the cartridge chamber.

[0060] The processing unit can be connected to the orientation sensor. The processing unit can be configured to receive an orientation signal representing the orientation of the cartridge received in the cartridge receiver and / or the orientation of the autoinjector, for example.

[0061] The movement of the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the injection plunger rod position can be based on the orientation of the cartridge, such as an orientation signal for example. For example, the movement of the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the injection plunger rod position can require that the inclination angle between the vertical and the longitudinal axis extending along the cartridge be within 45 degrees, such as within 30 degrees, and that the cartridge outlet be in a vertical position higher than the cartridge chamber.

[0062] The control of the drive module for moving the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the injection plunger rod position can be based on the orientation of the cartridge, such as an orientation signal for example.

[0063] The processing unit can be configured to control the drive module based on the orientation signal. For example, the processing unit can be configured to control the drive module to move the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the injection plunger rod position based on the orientation signal. For example, the processing unit can be configured to control the drive module to move the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the injection plunger rod position only when the orientation signal indicates that the inclination angle between the vertical and the longitudinal axis extending along the cartridge is within 45 degrees, such as within 30 degrees of the vertical, and / or when the cartridge outlet is in a vertical position higher than the cartridge chamber.

[0064] The auto-injector can be provided with a code sensor. The code sensor can be configured to read cartridge code features such as, for example, the cartridge code feature of a cartridge representing one or more cartridge specifications. The code sensor can be configured to provide a code signal representing the cartridge code feature. A processing unit can be connected to the code sensor. The processing unit can be configured to receive the code signal.

[0065] The processing unit can be configured to determine, based on the code signal, unauthorised (unapproved) cartridges such as counterfeit cartridges and / or used cartridges and / or tampered cartridges and / or cartridges with incorrect dosages and / or cartridges containing the wrong drug.

[0066] The code sensor can be provided with an optical sensor. The code sensor can be provided with an optical sensor comprising a transmitter and a receiver such as an optical transmitter and an optical receiver. The code sensor can be configured to read cartridge code features. The code sensor can be configured to read color codes, barcodes, RFID tags, NFC tags, identification numbers, QR codes (registered trademark), and / or any combination thereof.

[0067] The movement of the plunger rod can be based on a code signal. For example, the movement of the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the injection plunger rod position can be based on cartridge code features, such as a code signal. For example, the control of the drive module to move the plunger rod to the prime plunger rod position can be based on a code signal. The processing unit can be configured to control the drive module based on the code signal. For example, the processing unit can be configured to control the drive module based on the code signal to move the plunger rod to the prime plunger rod position.

[0068] The movement of the plunger rod based on cartridge specifications, such as a code signal, enables the optimization of the movement of the plunger rod for several types of cartridges. For example, even for different cartridges, the discharge of the drug can be reduced or even eliminated when discharging air, thereby improving the dosage accuracy and / or reducing the discomfort of the patient.

[0069] The movement of the plunger rod based on cartridge specifications, such as a code signal, enables the optimization of the movement of the plunger rod for several types of cartridges. For example, by keeping the plunger rod at the mixing plunger rod position for a time according to the cartridge specifications after detecting the acceptance of the cartridge into the cartridge receiver and receiving the first input signal, appropriate mixing can be ensured and / or the discomfort of the patient can be reduced, even for different cartridges.

[0070] The auto-injector can be provided with a resistance sensor. The resistance sensor can be configured to provide a resistance signal. The resistance signal can represent the resistance to the movement of the plunger rod. The processing unit can be connected to the resistance sensor. The processing unit can be configured to receive the resistance signal.

[0071] The processing unit can be configured to determine an irregular cartridge such as a counterfeit cartridge and / or a used cartridge and / or a tampered cartridge and / or a cartridge with incorrect dosage and / or a cartridge containing incorrect medicine based on a code signal and / or a resistance signal.

[0072] The resistance signal can represent the resistance to the movement of the plunger rod in one direction, such as the movement towards the plunger rod extended position. For example, the resistance signal can represent the force required to move the plunger rod towards the plunger rod extended position.

[0073] The resistance sensor can be configured to determine the power consumed by the drive module by measuring, for example, the electrical resistance, current, and / or voltage of the drive module, and / or a combination thereof. The resistance sensor can include an electrical resistance sensor, a current sensor, and / or a voltage sensor. The drive module can include the resistance sensor.

[0074] The resistance sensor can be configured to measure the pressure and / or force applied to the front end of the plunger rod of the plunger rod. The front end of the plunger rod can be configured to engage with the first stopper of the cartridge. The resistance sensor can be configured to measure the pressure and / or force between the plunger rod and the stopper. For example, the resistance sensor can include a pressure transducer and / or a force transducer at the front end of the plunger rod. The plunger rod can include the resistance sensor.

[0075] The movement of the plunger rod can be based on a resistance signal. For example, the movement of the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the injection plunger rod position can be based on the resistance to the movement of the plunger rod, for example, it can be based on a resistance signal. For example, the control of the drive module to move the plunger rod to the mixing plunger rod position can be based on a resistance signal. The processing unit can be configured to control the drive module based on the resistance signal. For example, the processing unit can be configured to control the drive module based on the resistance signal to move the plunger rod to the mixing plunger rod position.

[0076] The movement of the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the injection plunger rod position can require that the resistance to the movement of the plunger rod exceeds a low-resistance threshold, for example, such as when the resistance signal indicates that the resistance to the movement of the prime plunger rod exceeds the low-resistance threshold. For example, the processing unit can be configured to control the drive module to move the plunger rod to the mixing plunger rod position only when the resistance signal indicates that the resistance to the movement of the plunger rod exceeds the low-resistance threshold, for example, after the completion of the movement of the plunger rod to the pre-mixing plunger rod position. The low-resistance threshold can be between 1N and 15N, for example, between 5N and 11N. The low-resistance threshold can be 1N, 5N, or 10N.

[0077] The cartridge parameters can be based on the resistance to the movement of the plunger rod, for example, such as a resistance signal. The processing unit can be configured to determine the cartridge parameters based on the resistance signal.

[0078] The cartridge parameters can indicate that the cartridge is unused and / or full. For example, when the current plunger rod position reaches a plunger rod threshold value such as a predetermined plunger rod position between the plunger rod retracted position and the plunger rod extended position, and the resistance signal indicates a resistance to the movement of the plunger rod that exceeds a low resistance threshold value representing, for example, sufficient force required to move the plunger rod, it indicates that the plunger rod has engaged with the first stopper.

[0079] The cartridge parameters can indicate that the cartridge is not full and / or empty, such as being used. For example, when the current plunger rod position reaches a plunger rod threshold value such as a predetermined plunger rod position between the plunger rod retracted position and the plunger rod extended position, and the resistance signal indicates a resistance to the movement of the plunger rod that is below a low resistance threshold value representing, for example, a small force required to move the plunger rod, it indicates that the first stopper is in the forward position.

[0080] The cartridge parameters can indicate that there is a defect in the cartridge and / or the needle is not attached and / or the attached needle is blocked, for example, when the resistance signal indicates a resistance to the movement of the plunger rod that exceeds a high resistance threshold value representing a large force required to move the plunger rod, thus indicating that the forward movement of the plunger rod and / or the first stopper is blocked in some way. The high resistance threshold value can be, for example, between 8 N and 25 N, such as between 10 N and 20 N. The high resistance threshold value can be 8 N, 11 N, or 15 N.

[0081] Threshold values such as the plunger rod threshold value, the low resistance threshold value, and / or the high resistance threshold value can be determined based on the cartridge and / or cartridge code feature portion. The cartridge code feature portion can represent threshold values such as the plunger rod threshold value, the low resistance threshold value, and / or the high resistance threshold value.

[0082] The processing unit can be configured to determine thresholds such as a plunger rod threshold, a low resistance threshold, and / or a high resistance threshold based on a code signal.

[0083] The autoinjector can include a temperature sensor. The temperature sensor can be configured to provide a temperature signal such as a temperature signal representative of the temperature of the autoinjector and / or the cartridge and / or the drug. The temperature sensor can include an infrared sensor such as an infrared optical sensor.

[0084] The processing unit can be connected to the temperature sensor. The processing unit can be configured to receive the temperature signal.

[0085] The movement of the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the injection plunger rod position can be based on the temperature of the autoinjector and / or the cartridge and / or the drug, for example, based on a temperature signal.

[0086] The autoinjector, such as the processing unit, can be configured to control the drive module based on the temperature signal. For example, the processing unit can be configured to control the drive module to move the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the injection plunger rod position based on the temperature signal.

[0087] The auto-injector can be provided with an input device such as a first input device. The first input device can be a button or a touch sensor area or a microphone. The first input device can be configured to provide a first input signal. The first input signal can represent a first user interaction with the first input device. The first input device can be configured to provide a second input signal. The second input signal can represent a second user interaction with the first input device.

[0088] The processing unit can be connected to the first input device. The processing unit can be configured to receive the first input signal and / or the second input signal. The processing unit can be configured to control the drive module to move the plunger rod to the mixing plunger rod position only after receiving the first input signal. The processing unit can be configured to control the drive module to move the plunger rod to the prime plunger rod position only after receiving the second input signal.

[0089] The auto-injector can be provided with a contact member. The contact member can be configured to be pressed against the injection site. The contact member can be movable between a contact member extended position and a contact member retracted position. The contact member can be biased towards the contact member extended position, for example by a contact member spring. The contact member can be configured to move towards the contact member retracted position when pressed against the injection site, for example. The contact member and / or the contact member sensor can be configured to provide a contact member signal representing the position of the contact member. The auto-injector and / or the contact member can be provided with a contact member sensor configured to detect the position of the contact member. The contact member sensor can be configured to provide a contact member signal indicative of the contact member.

[0090] The contact member may be, for example, at a first contact member position between a contact member extended position and a contact member retracted position. The contact member at the first contact member position can indicate that the contact member is close to the contact member retracted position. The contact member at the first contact member position can indicate that the contact member is pressed against the injection site. The contact member at the first contact member position can indicate that the needle disposed in the cartridge is fully pushed into the skin for the start of drug injection.

[0091] The contact member may be, for example, at a second contact member position between the contact member extended position and the contact member retracted position, such as between the contact member extended position and the first contact member position. The contact member at the second contact member position can indicate that the contact member is restricted from being biased towards the contact member extended position. The contact member at the second contact member position can indicate that a needle cover, such as a needle having a needle cover, is positioned on the cartridge.

[0092] A processing unit can be connected to the contact member. The processing unit can be configured to receive a contact member signal. The trigger event can include a contact member signal indicating that the contact member is at the first contact member position. The contact member may be a trigger member.

[0093] The auto-injector can include a needle sensor. The needle sensor can be configured to detect, for example, the needle of the cartridge assembly and / or the needle assembly and / or the needle cover of the needle assembly when the cartridge assembly is received in the auto-injector and / or the cartridge receiver of the auto-injector. The needle sensor can provide a needle signal indicating the presence of the needle and / or the needle assembly and / or the needle cover of the needle assembly.

[0094] The processing unit can be connected to the needle sensor. The processing unit can be configured to receive a needle signal. The processing unit can be configured to control the drive module based on the needle signal. For example, the processing unit can be configured to control the drive module to start the movement of the plunger rod only when a needle is present and / or only when a needle cover is not present.

[0095] The needle sensor can include a contact member. For example, the contact member can be configured to be located at a second contact member position when a needle cover, such as a needle having a needle cover, is present on the cartridge. The movement of the plunger rod can be based on the position of the contact member, for example, based on a contact member signal. The movement of the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the injection plunger rod position can be based on the position of the contact member, for example, based on a contact member signal. For example, the movement of the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the injection plunger rod position can require that the contact member signal indicates that the contact member is not at the second contact member position, such as when the contact member signal indicates that the contact member is at the contact member extended position.

[0096] Alternatively, or in addition, the movement of the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the injection plunger rod position can be based on the detection of the needle cover. For example, the movement of the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the injection plunger rod position can require that the needle cover is detected after the cartridge is received in the cartridge receiver and then the needle cover is not detected, for example, it is detected that the needle cover has been removed.

[0097] The processing unit can be configured to control the drive module to move the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the injection plunger rod position based on the contact member signal. For example, the processing unit can be configured to control the drive module to move the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the injection plunger rod position only when the contact member signal indicates that the contact member is not in the second contact member position, such as when the contact member signal indicates that the contact member is in the contact member extended position.

[0098] The movement of the plunger rod can include a movement having a plunger rod speed such as a first plunger rod speed and / or a second plunger rod speed. The speed of the plunger rod can be based on the position of the plunger rod. The plunger rod can be moved from the plunger rod retracted position, etc., to the pre-mixing plunger rod position at the pre-mixing plunger rod speed. The plunger rod can be moved from the pre-mixing plunger rod position, etc., to the mixing plunger rod position at the mixing plunger rod speed. The plunger rod can be moved from the mixing plunger rod position, etc., to the prime plunger rod position at the prime plunger rod speed. The plunger rod can be moved from the prime plunger rod position, etc., to the injection plunger rod position at the injection plunger rod speed. The pre-mixing plunger rod speed can be faster than the mixing plunger rod speed. The mixing plunger rod speed can be between 1 mm / second and 3 mm / second, such as 1.7 mm / second.

[0099] The pre-mixing plunger rod speed, the mixing plunger rod speed, the priming plunger rod speed, and / or the injection plunger rod speed can be based on the cartridge specification, for example, can be based on the cartridge code feature part, for example, can be based on the code signal. The processing unit can be configured to determine the pre-mixing plunger rod speed, the mixing plunger rod speed, the priming plunger rod speed, and / or the injection plunger rod speed based on the code signal.

[0100] The pre-mixing plunger rod speed, the mixing plunger rod speed, the priming plunger rod speed, and / or the injection plunger rod speed can be based on temperature, such as the temperature of the auto-injector and / or the cartridge and / or the drug, for example, can be based on the temperature signal. The processing unit can be configured to determine the pre-mixing plunger rod speed, the mixing plunger rod speed, the priming plunger rod speed, and / or the injection plunger rod speed based on the temperature signal.

[0101] The processing unit can be configured to control the drive module to move the plunger rod from the plunger rod retracted position, etc. to the pre-mixing plunger rod position at the pre-mixing plunger rod speed. The processing unit can be configured to control the drive module to move the plunger rod from the pre-mixing plunger rod position, etc. to the mixing plunger rod position at the mixing plunger rod speed. The processing unit can be configured to control the drive module to move the plunger rod from the mixing plunger rod position, etc. to the priming plunger rod position at the priming plunger rod speed. The processing unit can be configured to control the drive module to move the plunger rod from the priming plunger rod position, etc. to the injection plunger rod position at the injection plunger rod speed.

[0102] The processing unit can be configured to control the drive module to drive the plunger rod to move to the pre-mixing plunger rod position in response to receiving a cartridge detection signal and a first input signal. The processing unit can be configured to control the drive module to drive the plunger rod to move to the mixing plunger rod position after the movement of the plunger rod to the pre-mixing plunger rod position is completed.

[0103] One or more elapsed times, such as a delay, can exist before the movement of the plunger rod, such as movement to the pre-mixing plunger rod position, the mixing plunger rod position, the prime plunger rod position, the injection plunger rod position, and / or the plunger rod retraction position. For example, the movement of the plunger rod to the prime plunger rod position and / or the movement of the plunger rod to the injection plunger rod position can require that an elapsed recovery time has passed after the movement of the plunger rod to the mixing plunger rod position is completed. The recovery time is selected to ensure the recovery of the drug and to allow sufficient time, for example, to ensure sufficient mixing of the first drug component and the second drug component. The recovery time can be based on the cartridge specification. For example, the recovery time can be based on the cartridge code feature. For example, the recovery time can be based on the code signal.

[0104] The processing unit can be configured to control the drive module to move the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the injection plunger rod position and / or the plunger rod retraction position based on one or more elapsed times. For example, the processing unit can be configured to control the drive module to move the plunger rod to the prime plunger rod position only after an elapsed recovery time from the completion of the movement of the plunger rod to the mixing plunger rod position. Alternatively, or in addition to this, the processing unit can be configured to control the drive module to move the plunger rod to the injection plunger rod position only after an elapsed recovery time from the completion of the movement of the plunger rod to the mixing plunger rod position.

[0105] After the completion of the movement of the plunger rod to the injection plunger rod position of the plunger rod, the plunger rod can be moved, for example, towards the plunger rod retraction position up to the plunger rod retraction position. The processing unit can be configured to control the drive module to move the plunger rod towards the plunger rod retraction position after the completion of the movement of the plunger rod to the injection plunger rod position.

[0106] For example, after the completion of the movement of the plunger rod to the injection plunger rod position, the movement of the plunger rod towards the plunger rod retraction position, for example, reaching the plunger rod retraction position, can require, for example, an elapsed dwell time from the completion of the movement of the plunger rod to the injection plunger rod position. The dwell time can be selected to allow sufficient time to ensure that the drug is distributed to the tissue. The dwell time can depend on the drug and / or the concentration of the drug and / or the amount of the drug. The dwell time can be based on the cartridge specification, for example, the dwell time can be based on the cartridge code feature, for example, the dwell time can be based on the code signal.

[0107] The processing unit can be configured to control the drive module to move the plunger rod towards the plunger rod retracted position only after the residence time has elapsed since the completion of the movement of the plunger rod to the injection plunger rod position.

[0108] The auto-injector can be provided with a user interface such as a user interface that enables user input, and further can provide visible and / or audible output to the user. The user interface can include a first input member, a second input member, a contact member, and / or a first output member. The first output member can be configured to provide output such as visible and / or audible output to the user. The first output member can include an LED and / or a speaker.

[0109] The processing unit can be configured to provide one or more user outputs via the user interface. The one or more user outputs can include a first user output and / or a second user output. For example, the processing unit can provide a first user output via the first output member.

[0110] The processing unit can be configured to provide, via the user interface, a user output indicating, for example, the completion of injection, after the residence time has elapsed since the completion of the movement of the plunger rod to the injection plunger rod position.

[0111] The processing unit can be configured to provide a user output indicating an orientation signal via a user interface. For example, when moving the plunger rod to a mixing plunger rod position and / or a prime plunger rod position. The user output indicating the orientation signal can include a beep sound whose beep sound interval changes based on the orientation signal. For example, the changing beep sound interval can be fast when the orientation signal is at a predetermined orientation and / or far from vertical, and / or the changing beep sound interval can be slow when the orientation signal is at a predetermined orientation and / or close to vertical.

[0112] A more detailed description continues below with reference to the drawings.

Brief Description of the Drawings

[0113]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

[0114] Hereinafter, various embodiments will be described with reference to the drawings. Like reference numerals refer to like elements throughout. Therefore, like elements will not be described in detail with respect to the description of each figure. It should also be noted that the drawings are only intended to facilitate the description of the embodiments. They are not intended to describe the invention recited in the claims without omission, nor are they intended to limit the scope of the invention recited in the claims. In addition, the illustrated embodiments do not necessarily have all of the shown aspects or advantages. An aspect or advantage described in connection with a particular embodiment is not necessarily limited to that embodiment and can be implemented in any other embodiment even if not so illustrated or specified.

[0115] FIG. 1 shows a typical autoinjector 4. The autoinjector 4 can be configured to administer a drug. The autoinjector 4 can be an electronic autoinjector.

[0116] The autoinjector 4 includes a housing 6. The autoinjector 4 includes a cartridge receiver 300. The cartridge receiver is configured to receive a cartridge and / or a cartridge assembly including the cartridge. The cartridge can contain a drug.

[0117] The cartridge receiver 300 has a cartridge receiver opening 301. The cartridge receiver 300 is configured to receive a cartridge and / or a cartridge assembly in a cartridge receiving direction 304 along the longitudinal axis L through the cartridge receiver opening 301.

[0118] As shown in the figure, the auto-injector 4 can include a user interface 1100. The auto-injector 4 includes a trigger member such as a contact member 1102. The contact member 1102 can be configured to be pressed against an injection site. The contact member 1102 may be movable in the cartridge receiving direction 304 relative to the housing when pressed against the injection site. The contact member 1102 may be part of the user interface 1100.

[0119] The user interface 1100 includes a first input member 1108 such as a button, for example. The first input member 1108 can provide a user input from the user. For example, the first input member 1108 can be used to receive a pressing operation from the user to proceed to the next step.

[0120] The user interface 1100 includes a first output member 1110 as shown, such as a plurality of LEDs, for example. The first output member 1110 can provide a user output to the user. The user interface 1100 can include a second output member (not shown) such as a speaker, for example. The second output member can be configured to provide an audible output to the user. For example, the first output member 1110 and / or the second output member can be used to inform the user of the steps in the procedure and / or an error message.

[0121] Figure 1 shows a typical auto-injector 4. The auto-injector 4 can be configured to administer a drug. The auto-injector 4 may be an electronic auto-injector.

[0122] The auto-injector 4 comprises a housing 6. The auto-injector 4 comprises a cartridge receiver 300. The cartridge receiver is configured to receive a cartridge and / or a cartridge assembly including the cartridge. The cartridge can accommodate a drug.

[0123] The cartridge receiver 300 has a cartridge receiver opening 301. The cartridge receiver 300 is configured to receive the cartridge and / or the cartridge assembly in a cartridge receiving direction 304 along the longitudinal axis L through the cartridge receiver opening 301.

[0124] The auto-injector 4 can comprise a user interface 1100 as shown in the figure. The auto-injector 4 comprises a trigger member such as a contact member 1102. The contact member 1102 can be configured to be pressed against an injection site. The contact member 1102 may be movable in the cartridge receiving direction 304 relative to the housing when pressed against the injection site. The contact member 1102 may be part of the user interface 1100.

[0125] The user interface 1100 can comprise a first input member 1108 as shown in the figure, such as a button for example. The first input member 1108 can provide a user input from the user. For example, the first input member 1108 can be used to receive a pressing operation from the user to proceed to the next step.

[0126] The user interface 1100 can include a first output member 1110 as shown, for example, a plurality of LEDs. The first output member 1110 can provide a user output to the user. The user interface 1100 can include a second output member (not shown), for example, a speaker. The second output member can be configured to provide an audible output to the user. For example, the first output member 1110 and / or the second output member can be used to inform the user of the steps in the procedure and / or an error message.

[0127] Figure 2 shows a typical system 2. The system 2 includes an auto-injector 4 as described in connection with FIG. 1 and a typical cartridge 700 received in a cartridge receiver 300. The cartridge 700 is shown with a needle cover 908. The needle cover 908 extends out of the contact member 1102 so that the needle cover 908 can be removed from the cartridge 700.

[0128] Figure 3 schematically shows a typical cartridge 700, such as a cartridge 700 configured to be received in a cartridge receiver of an auto-injector, such as the auto-injector described in connection with the previous figures.

[0129] The cartridge 700 includes a cartridge chamber 702. The cartridge chamber 702 can be configured to contain a medicament. The cartridge 700 has a first end 718 and a second end 720. The cartridge 700 includes a cartridge outlet 714 at the first cartridge end 718. The cartridge can be configured to eject the medicament through the cartridge outlet 714.

[0130] The cartridge comprises a first stopper 708 that can move, for example, in a first stopper direction 722 towards a first cartridge end within a cartridge chamber. For example, a medicament can be discharged through a cartridge outlet 714 when the first stopper 708 moves in the first stopper direction. The cartridge comprises a cartridge rear face 716 at a second cartridge end. The cartridge rear face 716 comprises a cartridge rear end opening for providing access to the first stopper 708 on a plunger rod.

[0131] As shown in the figure, the cartridge 700 may be a two-chamber cartridge. The cartridge comprises a second stopper 710 that can move, for example, in a first stopper direction 722 towards a first cartridge end within a cartridge chamber 702. The cartridge chamber 702 includes a first cartridge compartment 704 and a second cartridge compartment 706. The first cartridge compartment 704 is located between the first stopper 708 and the second stopper 710. The second cartridge compartment 706 is located between the second stopper 710 and the cartridge outlet 714. The cartridge comprises a bypass portion 712 for providing communication between the first cartridge compartment and the second cartridge compartment. The bypass portion 712 provides communication between the first cartridge compartment and the second cartridge compartment when the second stopper 710 is located in the bypass portion 712.

[0132] The first cartridge compartment 704 houses a first medicament component 792 of a medicament 790. The first medicament component 792 may be a liquid, as shown in the figure. The second cartridge compartment 706 houses a second medicament component 794 of the medicament 790. The second medicament component 794 may be a powder composition. By positioning the second stopper 710 in the bypass portion 712, the first medicament component 792 can be carried to the second cartridge compartment 706 via the bypass portion 712, thereby mixing the first medicament component 792 and the second medicament component 794 to obtain a combined medicament 790.

[0133] Figures 4a - 4d schematically illustrate a typical cartridge assembly 600. The cartridge assembly 600 includes a typical cartridge 700 and a typical cartridge code feature 1000. The cartridge 700 has a first cartridge end 718 and a second cartridge end 720. The first stopper direction 722 is the direction from the second cartridge end 720 to the first cartridge first 718. The cartridge code feature 1000 is disposed near the second cartridge end 720, for example, closer to the second cartridge end 720 than the first cartridge end 718. In another typical cartridge assembly, the cartridge code feature 1000 may be disposed near the first cartridge end 718.

[0134] Figures 4a - 4d show different types of typical cartridge code features 1000.

[0135] Figure 4a shows a typical cartridge assembly 600 in which the cartridge code feature 1000 comprises two strips. The two strips may be colored, for example, with different colors. The combination and / or sequence of colors can represent the code of the cartridge code feature 1000.

[0136] Figure 4b shows a typical cartridge assembly 600 in which the cartridge code feature 1000 comprises a barcode. The cartridge code feature 1000 can comprise one or more barcodes. The barcode can indicate numbers representing the code of the cartridge code feature 1000.

[0137] Figure 4c shows a typical cartridge assembly 600 in which the cartridge code feature 1000 comprises strips of different lattice patterns. For example, as shown, the cartridge code feature 1000 can comprise two strips, with the first strip having a 45-degree lattice pattern and the second strip having a -45-degree lattice pattern. The lattice and / or the lattice of the strips relative to each other can represent the code of the cartridge code feature 1000.

[0138] Figure 4d shows a typical cartridge assembly 600 in which the cartridge code feature 1000 comprises an electromagnetically readable tag such as an RFID tag or an NFC tag. The electromagnetically readable tag can contain data representing the code of the cartridge code feature 1000.

[0139] Figure 5 shows a typical system 2. The system 2 comprises an autoinjector 4 as described, for example, in connection with Figure 1, and a typical cartridge assembly 600. The cartridge assembly 600 comprises a cartridge 700 having a cartridge chamber 702, a needle assembly 900, and a cartridge code feature 1000. The cartridge assembly 600 is received by the autoinjector 4.

[0140] The cartridge assembly 600 comprises a cartridge holder 800. The cartridge holder 800 is configured to hold the cartridge 700 in the cartridge receiver 300 of the autoinjector 4. The cartridge holder 800 comprises a cartridge holding member 808. The cartridge holding member 808 engages with the cartridge receiver 300 to receive and hold the cartridge 700 and the cartridge assembly 600 in the cartridge receiver 300.

[0141] The needle assembly 900 includes a needle 902 and a needle hub 904. The needle assembly 900 is attached to the cartridge 700 by a needle hub 904 having a cartridge holder coupling portion 906, such as a threaded portion, that engages, for example, the needle assembly coupling portion 812 of the cartridge holder 800. The needle 902 extends through the cartridge outlet 714 of the cartridge 700. The cartridge outlet 714 can be sealed by an elastic seal that is penetrated by the needle 902 when the needle assembly 900 is attached to the cartridge 700.

[0142] The auto-injector 4 includes a code sensor 24 configured to read the cartridge code feature 1000. When the cartridge assembly 600 is inserted, the cartridge code feature 1000 aligns with the code sensor 24 as shown.

[0143] The auto-injector 4 includes a plunger rod 400. The plunger rod 400 is configured to advance the first stopper of the cartridge 700. The plunger rod 400 includes an outer plunger rod 404 having a female thread and an inner plunger rod 402 having a male thread. The thread of the inner plunger rod 402 engages the thread of the outer plunger rod 404. Rotation of the outer plunger rod 404 relative to the housing of the auto-injector is prevented. Movement of the plunger rod 400 includes rotation of the inner plunger rod 402. Rotation of the inner plunger rod 402 results in translational movement of the outer plunger rod 404 because rotation of the outer plunger rod 404 is restricted. The outer plunger rod 404 is configured to abut against the first stopper of the cartridge 700 and move the first stopper in the first stopper direction 722 when translating in the first stopper direction 722.

[0144] The drive module 500 is combined to actuate the plunger rod 400. The drive module 500 is electrically connected to a battery to receive power. The drive module 500 includes a motor 502 such as an electromechanical motor like a DC motor. The drive module 500 includes a transmission mechanism 504 for coupling the motor 502 to the inner plunger rod 402 of the plunger rod 400.

[0145] The illustrated example includes a motor 502 which may be an electromechanical motor, but it can be easily understood that an autoinjector 4 having other drive modules including, for example, a solenoid motor, a shape memory metal engine, a spring device, and / or a pressurized gas configured to actuate the plunger rod 400 is also feasible.

[0146] The autoinjector 4 includes a discharge sensor 26 such as a plunger rod position sensor. The discharge sensor 26 is configured to detect the position of the plunger rod 400. In the illustrated example, the discharge sensor 26 includes a tachometer configured to count / detect the rotation of the motor 502. Accordingly, the position of the plunger rod 400 can be clarified based on the total number of rotations of the motor 502. The discharge sensor 26 can detect the discharge of the drug and / or air in the cartridge chamber based on the detection of the position of the plunger rod 400. The position of the plunger rod 400 can represent the position of the first stopper of the cartridge 700. For example, the most advanced position of the plunger rod 400 when the cartridge 700 is in the cartridge receiver 300 can represent the position of the first stopper of the cartridge 700.

[0147] Figures 6a - 6d schematically show the autoinjector 4 and the cartridge assembly 600. Figures 6a - 6d schematically show typical positions of the contact member 1102 of the autoinjector 4 in various situations.

[0148] The auto-injector 4 includes a cartridge receiver 300 configured to receive and hold a cartridge. The auto-injector 4 includes a contact member 1102. The contact member 1102 may be movable between a contact member extended position and a contact member retracted position. The contact member 1102 includes a contact member protrusion 1112. The contact member protrusion 1112 is configured to move together with the contact member 1102. The contact member 1102 can be biased toward the contact member extended position, for example, by a contact member spring (not shown).

[0149] The contact member includes a needle cover engagement member 1114. The needle cover engagement member 1114 is configured to contact, for example, a needle cover contact surface of a needle cover located on a cartridge inserted into the cartridge receiver 300.

[0150] The auto-injector 4 includes a contact member sensor 1104 configured to detect the position of the contact member 1102. The contact member sensor 1104 includes a first contact member sensor 1130 and a second contact member sensor 1132. The first contact member sensor 1130 and the second contact member sensor 1132 may be optical sensors. The contact member sensor 1104 detects the position of the contact member 1102 by the contact member protrusion 1112 that covers the first contact member sensor 1130 when the contact member 1102 is in the first contact member position, and the contact member protrusion 1112 that covers the second contact member sensor 1132 when the contact member 1102 is in the second contact member position.

[0151] The first contact member position can be detected by the first contact member sensor 1130 being covered and the second contact member sensor 1132 being covered. The second contact member position can be detected by the first contact member sensor 1130 not being covered and the second contact member sensor 1132 being covered. The contact member extended position can be detected by the first contact member sensor 1130 not being covered and the second contact member sensor 1132 not being covered.

[0152] Figure 6a schematically shows the autoinjector 4 in a state where the cartridge and / or the cartridge assembly is not received. The contact member 1102 is in the contact member extended position. The cartridge can be inserted into the cartridge receiver 300 in the cartridge receiving direction 304 through the contact member 1102 that defines the cartridge receiver opening 301.

[0153] Figure 6b schematically shows the autoinjector 4 that has received the cartridge assembly 600. The cartridge assembly 600 includes a cartridge 700, a cartridge holder 800, and a needle assembly 900. The needle assembly includes a needle 902 and a needle cover 908. The needle cover has a needle cover abutment surface 910. The needle cover abutment surface 910 engages with the needle cover engaging member 1114 of the contact member 1102. The contact member 1102 is in the second contact member position caused, for example, by the presence of the needle cover 908 and the abutment of the needle cover abutment surface 910 against the needle cover engaging member 1114. The contact member protrusion 1112 covers the second contact member sensor 1132. The contact member protrusion 1112 does not cover the first contact member sensor 1130.

[0154] Figure 6c schematically shows the autoinjector 4 that has received the cartridge assembly 600. Compared with Figure 6b, the needle cover 908 has been removed. The contact member 1102 is in the contact member extended position. Since the needle cover abutment surface 910 is not in contact with the needle cover engaging member 1114, the contact member 1102 can move to the contact member extended position. The contact member protrusion 1112 also moves together with the contact member 1102. The contact member protrusion 1112 does not cover the second contact member sensor 1132. The contact member protrusion 1112 does not cover the first contact member sensor 1130.

[0155] Figure 6d schematically shows the auto-injector 4 receiving the cartridge assembly 600. The contact member 1102 is in the first contact member position. The first contact member position may be the contact member retracted position or near the contact member retracted position. By pressing the contact member 1102 against the injection site to move the contact member 1102 to the first contact member position, the needle 902 can be inserted into the injection site. The contact member protrusion 1112 also moves together with the contact member 1102. The contact member protrusion 1112 covers the first contact member sensor 1130. The contact member protrusion 1112 covers the second contact member sensor 1132.

[0156] Figure 7 shows a block diagram of a typical auto-injector 4. The auto-injector 4 includes a plurality of sensors 22, 24, 26, 28, 30, 32, 34, a processing unit 20, a drive module 500, and a user interface 1100. The sensors 22, 24, 26, 28, 30, 32, 34 are connected to the processing unit 20. The user interface 1100 is connected to the processing unit 20. The processing unit is connected to the drive module 500.

[0157] The processing unit 20 receives signals from the sensors 22, 24, 26, 28, 30, 32, 34 and the user interface 1100. The processing unit 20 is configured to control the drive module 500. The processing unit 20 can control the drive module 500 based on one or more of the received signals from the sensors 22, 24, 26, 28, 30, 32, 34 and the user interface 1100. The processing unit 20 is configured to provide a user output via the user interface 1100.

[0158] The auto-injector 4 is provided with an orientation sensor 22. The orientation sensor 22 is configured to provide an orientation signal representing the orientation of the cartridge received by the auto-injector 4. For example, the orientation sensor 22 can be configured to detect the orientation of the auto-injector 4. The orientation of the cartridge can be determined based on the orientation of the auto-injector 4. The orientation sensor 22 can be configured to detect the direction of gravity. For example, the orientation sensor 22 can include an accelerometer.

[0159] The processing unit 20 is connected to the orientation sensor 22. The processing unit 20 is configured to receive the orientation signal. The processing unit 20 can determine the orientation of the cartridge based on the orientation signal. The processing unit 20 can control the drive module 500 based on the orientation signal. For example, the processing unit 20 can be configured to control the drive module 500 to move the plunger rod based on the orientation signal. For example, the processing unit 20 can be configured to control the drive module 500 to move the plunger rod towards the plunger rod extended position, such as the pre-mixing plunger rod position and / or the mixing plunger rod position and / or the prime plunger rod position, only when the cartridge outlet is facing upwards. Alternatively, or in addition, the processing unit 20 can provide a user output via the user interface 1100 based on the orientation signal.

[0160] The auto-injector 4 is provided with a code sensor 24. The code sensor 24 is configured to read the cartridge code feature and provide a code signal representing the cartridge code feature. For example, the code sensor can be configured to read / detect a color code.

[0161] The processing unit 20 is connected to the code sensor 24. The processing unit 20 is configured to receive a code signal. The processing unit 20 can determine the cartridge code feature of the cartridge assembly based on the code signal. The processing unit 20 can control the drive module 500 based on the code signal. For example, the processing unit 20 can be configured to control the drive module 500 based on the code signal to move the plunger rod towards the plunger rod extended position to positions such as the pre-mixing plunger rod position and / or the mixing plunger rod position and / or the prime plunger rod position and / or the injection plunger rod position. The processing unit 20 can be configured to determine thresholds such as a plunger rod threshold and / or a resistance threshold based on the code signal. Instead of, or in addition to, this, the processing unit 20 can provide a user output via the user interface 1100 based on the code signal.

[0162] The auto-injector 4 comprises an ejection sensor 26 such as a plunger rod position sensor. The ejection sensor 26 is configured to detect the position of the plunger rod of the auto-injector 4 and provide an ejection sensor signal indicating the position of the plunger rod. The ejection sensor 26 can comprise a tachometer combined with the drive module 500.

[0163] The processing unit 20 is connected to the discharge sensor 26. The processing unit 20 is configured to receive a discharge sensor signal. The processing unit 20 can determine the position of the plunger rod based on the discharge sensor signal. The processing unit 20 can control the drive module 500 based on the discharge sensor signal. For example, the processing unit 20 can be configured to control the drive module 500 to start, stop, or continue the movement of the plunger rod based on the discharge sensor signal. For example, the processing unit 20 can be configured to determine the current plunger rod position based on the discharge sensor signal. Based on the discharge sensor signal, it can be determined that the plunger rod is at the pre-mixing plunger rod position and / or the mixing plunger rod position and / or the prime plunger rod position and / or the injection plunger rod position. Instead of, or in addition to, this, the processing unit 20 can provide a user output via the user interface 1100 based on the discharge sensor signal.

[0164] The auto-injector 4 comprises a cartridge sensor 28. The cartridge sensor 28 is configured to detect the acceptance of the cartridge assembly in the auto-injector 4. The cartridge sensor 28 provides a cartridge sensor signal indicating the acceptance of the cartridge assembly.

[0165] The processing unit 20 is connected to the cartridge sensor 28. The processing unit 20 is configured to receive a cartridge sensor signal. The processing unit 20 can control the drive module 500 based on the cartridge sensor signal. For example, the processing unit 20 can be configured to control the drive module 500 to start the movement of the plunger rod only when the cartridge assembly has been accepted and / or when the cartridge assembly has been accepted. Instead of, or in addition to, this, the processing unit 20 can provide a user output via the user interface 1100 based on the cartridge sensor signal.

[0166] The code sensor 24 and the cartridge sensor 28 may be the same sensor. For example, the code sensor 24 can be configured to detect the acceptance of the cartridge assembly and then read the cartridge code feature.

[0167] The auto-injector 4 includes a needle sensor 30. The needle sensor 30 is configured to detect the needle of the cartridge assembly and / or the needle assembly and / or the needle cover of the needle assembly when the cartridge assembly is received by the auto-injector 4. The needle sensor 30 provides a needle signal indicating the presence of the needle of the cartridge assembly and / or the needle assembly and / or the needle cover of the needle assembly.

[0168] The processing unit 20 is connected to the needle sensor 30. The processing unit 20 is configured to receive the needle signal. The processing unit 20 can control the drive module 500 based on the needle signal. For example, the processing unit 20 can be configured to control the drive module 500 to start the movement of the plunger rod towards, for example, the plunger rod extended position, such as to the pre-mixing plunger rod position and / or the mixing plunger rod position and / or the prime plunger rod position and / or the injection plunger rod position, only if the needle is present and / or alternatively only if the needle cover is removed and not detected. Detection of the needle cover can indicate the presence of the needle. The processing unit 20 can be configured to control the drive module 500 to start the operation only if the needle cover is detected and then, for example, removed and not detected. Instead of or in addition to this, the processing unit 20 can provide a user output via the user interface 1100 based on the needle signal.

[0169] The needle sensor 30 may be part of a contact member sensor, as illustrated in FIG. 6.

[0170] The auto-injector 4 is provided with a temperature sensor 32. The temperature sensor 32 is configured to detect a temperature such as the temperature of the auto-injector and / or the cartridge and / or the drug. The temperature sensor 32 is configured to provide a temperature signal representing the temperature.

[0171] The processing unit 20 is connected to the temperature sensor 32. The processing unit 20 is configured to receive the temperature signal. The processing unit 20 can be configured to determine a temperature such as the temperature of the auto-injector and / or the cartridge and / or the drug based on the temperature signal. The processing unit 20 can control the drive module 500 based on the temperature signal. For example, the processing unit 20 can be configured to control the drive module 500 based on the temperature signal to move the plunger rod towards the plunger rod extension position to positions such as the pre-mixing plunger rod position and / or the mixing plunger rod position and / or the priming plunger rod position and / or the injection plunger rod position. The processing unit 20 can determine the position of the plunger rod based on the temperature signal. For example, the processing unit 20 can be configured to determine the pre-mixing plunger rod position and / or the mixing plunger rod position and / or the priming plunger rod position and / or the injection plunger rod position based on the temperature signal. Alternatively, or in addition to this, the processing unit 20 can provide a user output via the user interface 1100 based on the temperature signal.

[0172] The auto-injector 4 is provided with a resistance sensor 34. The resistance sensor 34 is configured to detect the resistance to the movement of the plunger rod of the auto-injector 4. The resistance sensor 34 can be configured to detect the resistance to the movement of the plunger rod based on the measured value of the drive module 500. For example, the resistance sensor 34 can be configured to detect the current of the motor of the drive module 500. The resistance sensor 34 is configured to provide a resistance signal representing the resistance to the movement of the plunger rod.

[0173] The processing unit 20 is connected to the resistance sensor 34. The processing unit 20 is configured to receive a resistance signal. The processing unit 20 can be configured to determine the resistance to the movement of the plunger rod based on the resistance signal. The processing unit 20 can control the drive module 500 based on the resistance signal. For example, the processing unit 20 can be configured to control the drive module 500 to adjust the movement of the plunger rod based on the resistance signal. For example, the processing unit 20 can be configured to control the drive module 500 to start, stop, or continue the movement of the plunger rod based on the resistance signal. Alternatively, or in addition to this, the processing unit 20 can provide a user output via the user interface 1100 based on the resistance signal.

[0174] An auto-injector 4 including all of the above-described sensors is illustrated. However, alternatively, the auto-injector can comprise only one of the above-described sensors, or any combination consisting of one or more of the above-described sensors.

[0175] The auto-injector comprises a user interface 1100. The user interface 1100 can comprise one or more input members for receiving user input, such as a first input member for example. The user interface is configured to provide a user input signal representing the received user input. The user interface 1100 can provide a first input signal and / or a second input signal.

[0176] The processing unit 20 is connected to the user interface 1100. The processing unit 20 is configured to receive user input signals such as a first input signal and / or a second input signal. The processing unit 20 can control the drive module 500 based on the user input signal. For example, the processing unit 20 can be configured to control the drive module 500 based on and / or in accordance with the user input signal to move the plunger rod towards the plunger rod extended position, such as to a pre-mixing plunger rod position and / or a mixing plunger rod position and / or a prime plunger rod position and / or an injection plunger rod position.

[0177] The auto-injector comprises a housing 6 that houses sensors 22, 24, 26, 28, 30, 32, 34, a processing unit 20, a user interface 1100, and a drive module 500.

[0178] Figures 8a - 8f schematically show a typical cartridge assembly 600 and a plunger rod 400. The cartridge assembly 600 comprises a cartridge 700, such as the cartridge described in relation to Figure 3, a cartridge holder 800, and a needle assembly 900. For clarity, an auto-injector with the plunger rod 400 is not shown.

[0179] The cartridge holder 800 comprises a cartridge holding member 808. The cartridge holding member 808 is configured to engage with the cartridge receiver of the auto-injector. The cartridge holder 800 comprises a needle assembly coupling portion 812. The needle assembly coupling portion 812 is configured to engage with the cartridge holder coupling portion 906 of the needle assembly 900. The needle assembly coupling portion 812 enables attachment of the needle to the cartridge 700.

[0180] The needle assembly 900 includes a needle 902 and a needle hub 904. The needle assembly 900 is attached to the cartridge 700 by a needle hub 904 having a cartridge holder coupling portion 906, such as a threaded portion, that engages, for example, the needle assembly coupling portion 812 of the cartridge holder 800. The needle 902 extends through the cartridge outlet 714 of the cartridge 700.

[0181] FIG. 8a schematically shows a situation where the plunger rod 400 is in a typical plunger rod retracted position. The cartridge 700 may be a new cartridge. The first stopper 708 is located in the initial position. The second stopper 710 is in an initial position, for example, behind the bypass portion 712, where the bypass portion 712 does not form a communication between the first chamber 704 and the second chamber 706.

[0182] FIG. 8b schematically shows a situation where the plunger rod 400 is in a typical pre-mixing plunger rod position. Compared with FIG. 8a, the plunger rod 400 moves toward the plunger rod extended position. The front end portion 410 of the plunger rod 400 of the plunger rod 400 abuts against the first stopper 708. Accordingly, the plunger rod 400 has started to move the first stopper 708 in the first stopper direction 722 by moving in the first plunger rod direction 422. The second stopper 710 is in a position, for example, behind the bypass portion 712, where the bypass portion 712 does not form a communication between the first chamber 704 and the second chamber 706.

[0183] FIG. 8c schematically shows a situation where the plunger rod 400 is in a typical position where communication between the first chamber 704 and the second chamber 706 is established via the bypass portion 712. The plunger rod front end portion 410 of the plunger rod 400 abuts against the first stopper 708. The plunger rod 400 moves the first stopper 708 in the first stopper direction 722 by moving in the first plunger rod direction 422. The second stopper 710 is located in the bypass portion 712, where the bypass portion 712 forms communication between the first chamber 704 and the second chamber 706. In this way, for example, further movement of the first stopper 708 in the first stopper direction 722 due to movement of the plunger rod 400 in the first plunger rod direction 422 causes the contents of the first chamber 704, such as a first drug component (not shown), to be conveyed to the second chamber 706 through, for example, the bypass portion 712.

[0184] FIG. 8d schematically shows a situation where the plunger rod 400 is in a typical mixed plunger rod position. The plunger rod front end portion 410 abuts against the first stopper 708. The first stopper 708 abuts against the second stopper 710. The first chamber 704 is compressed. The second stopper 710 is located on the other side of the bypass portion 712. Therefore, the communication between the first chamber 704 and the second chamber 706 is closed.

[0185] FIG. 8e schematically shows a situation where the plunger rod 400 is in a typical prime plunger rod position. Compared with FIG. 8d, the plunger rod 400 is moving toward the plunger rod extended position, for example, to discharge air from the cartridge chamber 702.

[0186] Figure 8f schematically shows a situation where the plunger rod 400 is in a typical injection plunger rod position. For example, after a complete injection, the plunger rod 400 can be positioned at the injection plunger rod position. The first stopper 708 and the second stopper 710 are located near the cartridge outlet 714. The contents of the cartridge components, such as a drug, have been discharged through, for example, the cartridge outlet 714 and / or the needle 902. Residual drug may remain in the cartridge.

[0187] Figure 9 shows a typical transition T of the resistance Re to the movement of the plunger rod depending on the position P of the plunger rod. The plunger rod moves from the plunger rod retracted position PR to the plunger rod extended position PE. At the beginning of the movement, the resistance to the movement of the plunger rod is constant (Ex1), for example, the plunger rod has not yet pushed against the stopper. Thereafter, the tip of the plunger rod of the plunger rod abuts against the first stopper of the cartridge, and the resistance to the movement of the plunger rod increases (Ex2). The increase in resistance is caused by, for example, the resistance to the movement of the first stopper due to frictional force. As shown, the resistance may slightly decrease after the first stopper starts to move. When the plunger rod approaches the plunger rod extended position PE, the resistance may increase again (Ex3), for example, due to the first stopper approaching the end of the cartridge.

[0188] The transition T is an example of the resistance to the movement of the plunger rod when the received cartridge is new and / or unused and / or a normal cartridge. The determination of the cartridge parameters can be based on the resistance and / or the position of the plunger rod. The determination of the cartridge parameters can be based on one or more thresholds, such as resistance thresholds such as a low resistance threshold Re1 and / or a high resistance threshold Re2, and / or plunger rod thresholds such as a first plunger rod threshold P1 and / or a second plunger rod threshold P2.

[0189] Other situations, such as where the received cartridge is clearly used and / or defective, are illustrated by further typical transitions T2, T3, T4.

[0190] Transition T2 shows a typical situation where the resistance to movement increases beyond a low-resistance threshold Re1 before the plunger rod position reaches a first plunger rod threshold P1. Such a situation may indicate, for example, that the cartridge is defective or that something is obstructing the movement of the plunger rod. In response to such a situation, the plunger rod can be returned to the plunger rod retracted position, and an error message can be provided via the user interface.

[0191] Transition T3 shows a typical situation where the resistance to movement does not increase beyond a low-resistance threshold Re1 before the plunger rod position reaches a second plunger rod threshold P2. Such a situation can indicate, for example, a used cartridge, such as a cartridge where the first stopper is in the forward position. In response to such a situation, the plunger rod can be returned to the plunger rod retracted position, and an error message can be provided via the user interface.

[0192] Transition T4 shows a typical situation where, for example, after the plunger rod position passes a first plunger rod threshold P1, the resistance to movement increases beyond a high-resistance threshold Re2. Such a situation may indicate, for example, that the movement of the first stopper is obstructed and, for example, that the cartridge may be defective. In response to such a situation, the plunger rod can be returned to the plunger rod retracted position, and an error message can be provided via the user interface.

[0193] Threshold values such as a low resistance threshold Re1, a high resistance threshold Re2, a first plunger rod threshold P1, and / or a second plunger rod threshold P2 can be determined individually for a received cartridge. For example, a processing unit of an autoinjector can be configured to determine one or more of the threshold values based on a cartridge code feature of the received cartridge and / or cartridge assembly.

[0194] FIG. 10 shows a flowchart of an exemplary method 4000 for operating an autoinjector. Method 4000 includes receiving a first input signal at step 4002, detecting acceptance of a cartridge at step 4004, such as in a cartridge receiver of the autoinjector, moving a plunger rod to a mixing plunger rod position at step 4006, determining an orientation of the cartridge at step 4008, moving the plunger rod to a prime plunger rod position based on the orientation of the cartridge at step 4010, receiving a trigger event at step 4012, and moving the plunger rod to an injection plunger rod position at step 4014.

[0195] Receiving a first input signal at step 4002 can include receiving a user input signal from a user interface, such as by a user pressing a button. The first input signal may be provided by a user turning on the autoinjector.

[0196] Detecting acceptance of a cartridge at step 4004 can include detecting that a user inserts a cartridge through a cartridge receiver opening into the cartridge receiver. Detecting acceptance of a cartridge at step 4004 can include detecting the presence of a cartridge in the cartridge receiver.

[0197] It is also possible to interchange receiving a first input signal at step 4002 and detecting acceptance of a cartridge at step 4004.

[0198] The step 4006 of moving the plunger rod to the mixing plunger rod position can be performed after the detection 4004 of the cartridge received in the cartridge receiver and the reception 4002 of the first input signal. For example, the step 4006 of moving the plunger rod to the mixing plunger rod position can be executed only after the cartridge is detected 4004 and the first input signal is received 4002.

[0199] The step 4008 of determining the orientation of the cartridge can include determining the orientation by an orientation sensor such as an accelerometer. The step 4008 of determining the orientation of the cartridge can include determining the orientation of the auto-injector. The step 4008 of determining the orientation of the cartridge can include determining whether the outlet of the cartridge is facing upward.

[0200] Alternatively, or in addition to this, the orientation of the cartridge can be determined 4008 prior to the movement 4006 of the plunger rod to the mixing plunger rod position. For example, the movement 4006 of the plunger rod to the mixing plunger rod position can require that the outlet of the cartridge be facing upward (e.g., determined by determining 4008 the orientation of the cartridge).

[0201] After completion of the movement of the plunger rod to the mixing plunger rod position, the plunger rod can be moved 4010 to the prime plunger rod position. The movement 4010 of the plunger rod to the prime plunger rod position can be performed after the movement of the plunger rod to the mixing plunger rod position and completion of an additional predetermined delay, for example, to enable reconstitution of the drug.

[0202] The movement 4010 of the plunger rod to the prime plunger rod position can require that the outlet of the cartridge faces upward (e.g., as determined by step 4008 of determining the orientation of the cartridge). If the orientation of the cartridge is not within a predetermined range of orientations, the movement 4010 of the plunger rod to the prime plunger rod position can be temporarily stopped.

[0203] The step 4012 of receiving a trigger event can include receiving a user input signal from a user interface, such as receiving a trigger event from a trigger member by the user pressing a button. The trigger event can be by an instruction from the user to start an injection. The trigger event can be by the user pressing the front part of the autoinjector against the intended injection site. The trigger event can include the contact member signal indicating that the contact member of the autoinjector is in the first contact member position.

[0204] The movement 4014 of the plunger rod to the injection plunger rod position can result in the discharge of the drug passing through the cartridge outlet, such as passing through the needle. The movement 4014 of the plunger rod can be performed following the reception of the trigger event 4012, for example, after the completion of the movement 4010 of the plunger rod to the prime plunger rod position.

[0205] FIG. 11 shows a flowchart of a typical method 4000'. The method 4000' includes the same steps as the method 4000 described in relation to the previous figure. However, the method 4000' is an example of a method that includes additional steps of reading a cartridge code feature 4016, detecting a temperature 4018, detecting the removal of the needle cover 4024, moving the plunger rod to a pre-mixing plunger rod position 4020, and detecting the resistance to the movement of the plunger rod 4022.

[0206] Method 4000’ includes a step 4016 of reading a cartridge code feature portion. The cartridge code feature portion can indicate one or more cartridge specifications. Subsequent steps of method 4000’ can include an adaptation based on the cartridge specification. For example, subsequent steps of method 4000’ can be adjusted according to a specific cartridge that has been received and identified.

[0207] The step 4018 of detecting temperature can include detecting the temperature of the cartridge and / or a temperature indicating the temperature of the cartridge. Subsequent steps of method 4000’ can include an adaptation based on the temperature.

[0208] As illustrated, the step 4016 of reading the cartridge code feature portion and the step 4018 of detecting temperature can be executed simultaneously. However, in an alternative, sequential execution is also possible.

[0209] The step 4024 of detecting the removal of the needle cover can be a prerequisite for the start of the movement of the plunger rod. For example, the removal of the needle cover can indicate the intention to use the received cartridge.

[0210] The step 4020 of moving the plunger rod to the pre-mixing plunger rod position can include the initial movement of a first stopper of the cartridge, such as the movement of a first stopper that does not start the mixing of a two-component drug.

[0211] The step 4022 of detecting the resistance to the movement of the plunger rod can be executed simultaneously with the step 4020 of moving the plunger rod to the pre-mixing plunger rod position, as illustrated. The step 4022 of detecting the resistance to the movement of the plunger rod can indicate the cartridge parameters of the received cartridge, such as whether the cartridge is new, unused, or not defective.

[0212] Step 4006 of moving the plunger rod to the mixing plunger rod position can be performed following step 4016 of reading the cartridge code feature, step 4018 of detecting the temperature, step 4024 of detecting the removal of the needle cover, step 4020 of moving the plunger rod to the pre-mixing plunger rod position, and step 4022 of detecting the resistance to the movement of the plunger rod.

[0213] Step 4006 of moving the plunger rod to the mixing plunger rod position can be based on one or more of the cartridge code feature, the temperature, the removal of the needle cover, and / or the resistance to the movement of the plunger rod.

[0214] Step 4010 of moving the plunger rod to the prime plunger rod position can be based on one or more of the cartridge code feature, the temperature, the removal of the needle cover, and / or the resistance to the movement of the plunger rod.

[0215] Step 4014 of moving the plunger rod to the injection plunger rod position can be based on one or more of the cartridge code feature, the temperature, the removal of the needle cover, and / or the resistance to the movement of the plunger rod.

[0216] Method 4000 and / or method 4000' can include a first step of receiving a cartridge.

[0217] FIG. 12 shows a flowchart of a typical embodiment of a typical method 4000'. The illustrated flowchart may be a typical embodiment in the processing unit of an auto-injector.

[0218] This procedure is started by receiving 5002 a first input signal. The user can start the procedure by bringing about the first input signal, for example, via a user interface by turning on the device.

[0219] Following the reception 5002 of the first input signal, it is determined 5004 whether the acceptance of the cartridge into the cartridge receiver of the automatic injector of the cartridge has been detected. If not, an output can be provided 5040 via the user interface.

[0220] When the cartridge is detected 5004, or when the cartridge is detected 5004 after the reception 5002 of the first input signal, the reading 5006 of the cartridge code feature is performed.

[0221] Following the reading 5006 of the cartridge code feature, the detection 5008 of the temperature, such as the temperature of the received cartridge, is performed.

[0222] Following the detection 5008 of the temperature and the reading 5006 of the feature of the cartridge code, it is detected 5010 whether, for example, the needle cover is removed. If the needle cover has not been removed, for example, a user output can be provided via the user interface, and the user can be prompted 5042 to remove the needle cover. When the needle cover has been removed 5010 or when the needle cover has been removed 5010, the plunger rod is moved 5012 to the pre-mixing plunger rod position. During this movement, the resistance to the movement of the plunger rod is measured.

[0223] The resistance to the movement is analyzed 5014, and it is determined whether it is acceptable. This analysis can be based on the reading 5006 of the cartridge code feature and / or the detected 5008 temperature.

[0224] If the resistance 5014 is not acceptable, for example, a user output can be provided 5044 via the user interface. The output can indicate that the cartridge should be replaced. Subsequently, the plunger rod is moved 5038 to the plunger rod retracted position, such as the starting position of the plunger rod.

[0225] If the resistance 5014 is acceptable, the plunger rod is moved 5016 to a mixing plunger rod position, for example, to combine a first drug component and a second drug component.

[0226] After the plunger rod has been moved 5016 to the mixing plunger rod position, a delay 5018 is inserted to restore the combined drug components to an injectable drug. The delay 5018 can be between 1 and 12 minutes, such as between 3 and 10 minutes. During the delay, user output can be provided via the user interface, and the user output can indicate restoration.

[0227] After the drug has been restored and / or after a delay 5018 suitable for drug restoration has elapsed, the orientation of the cartridge is evaluated 5020. The orientation of the cartridge can be evaluated from the measurement of the orientation of the auto-injector. The orientation must be acceptable with respect to the execution of air expulsion, and for example, the cartridge outlet of the cartridge should face upward so that air can be expelled and further reduced or the like. If the orientation 5020 is not acceptable, for example, if the cartridge outlet does not face upward and / or the cartridge is not within the range of 45 degrees vertical, the user can be prompted 5046 to orient the auto-injector in the correct orientation, for example, to face the cartridge outlet upward, via the user interface.

[0228] When the orientation is acceptable 5020 or when the orientation is acceptable, the plunger rod is moved 5022 to a prime plunger rod position, for example, to expel air from the cartridge chamber. The prime plunger rod position can be determined based on the reading 5006 of the cartridge code feature and / or the detection 5008 of the temperature.

[0229] After moving the plunger rod to the prime plunger rod position 5022, the user is prompted, for example via a user interface, to perform a visual inspection 5024 of the drug. For example, the user can be provided with the possibility of aborting the procedure if a precipitate of the drug is visible. To accept the visual quality of the drug, the user can provide a second input signal, for example by pressing a button on the user interface. The button used to provide the second input signal may be the same as the button used to provide the first input signal. After restoration of the drug and / or after a delay 5018 suitable for restoration of the drug, for example when a pause of 4-5 hours has elapsed, it is possible to stop prompting the user to perform the visual inspection 5024 and furthermore / or to abort the procedure.

[0230] After receiving the second input signal 5026, the user can be prompted, for example via a user interface, to start injecting the drug 5028. The user can inject the drug by causing a trigger event, for example by inserting a needle into the tissue of the intended injection site, for example by pressing the contact member of the autoinjector against the intended injection site. The user is continuously prompted 5028 to start the injection until the trigger event is received 5030.

[0231] After receiving the trigger event 5030, the plunger rod is moved 5032 to the injection plunger rod position, for example to expel the drug in the cartridge, such as to inject the drug into the tissue of the intended injection site.

[0232] After the plunger rod has been moved 5032 to the injection plunger rod position, it may be preferable to delay the retraction of the needle so that the drug can be distributed into the tissue. Thus, the autoinjector prompts the user to wait for a set dwell time, for example between 1 and 15 seconds, for example via a user interface 5034.

[0233] After receiving a trigger event 5030 and / or moving the plunger rod to the injection plunger rod position 5032 and / or prompting the user to wait for a set dwell time 5034, for example, it is evaluated 5036 whether contact with the skin exists, such as whether the contact member is still pressed against the intended injection site. If contact with the skin still exists after the dwell time, the user is notified 5048 that an injection has been performed and / or that the autoinjector may be removed from the injection site.

[0234] If contact 5036 with the skin is lost and / or when contact with the skin is lost, the plunger rod is moved 5038 to the plunger rod retracted position.

[0235] After the movement 5038 of the plunger rod to the plunger rod retracted position, the cartridge can be removed and discarded.

[0236] Figures 13a - 13d schematically show a typical user interface 1100 of a typical autoinjector 4 such as the autoinjector 4 shown in Figure 1.

[0237] The user interface 1100 comprises a first output member 1110 as shown, for example, a plurality of LEDs. The first output member 1110 can provide a user output to the user. The first output member 1110 can be used to inform the user of the steps in the procedure and / or to indicate an error message. The first output member 1110 comprises a first LED 1116, a second LED 1118, and a third LED 1120.

[0238] The user interface 1100 can comprise a second output member (not shown), for example, a speaker.

[0239] The user interface 1100 includes, for example, a contact member 1102 at the front end of the auto-injector 4. The contact member 1102 can be configured to be pressed against the injection site. The contact member 1102 can function as a third output member of the user interface 1100. For example, the contact member 1102 can be configured to emit light such as blinking.

[0240] The user interface 1100 includes a first input member 1108 such as a button. The first input member 1108 can provide a user input from the user. For example, the first input member 1108 can be used to receive a pressing operation from the user to proceed to the next step. The first input member 1108 can function as a fourth output member of the user interface 1100. For example, the first input member 1108 can be configured to emit light such as blinking.

[0241] FIG. 13a schematically shows a situation of the user interface 1100 where none of the output members are operating, for example, when the auto-injector 4 is off.

[0242] FIG. 13b schematically shows a situation of the user interface 1100 where the first input member 1108 and the contact member 1102 are emitting light such as blinking. The first input member 1108 and the contact member 1102 can blink synchronously, or alternatively / as well as blink asynchronously. The illustrated situation can be a situation that notifies that the user should press the first input member 1108 and / or insert the cartridge through the contact member 1102. The illustrated situation can be a situation after the auto-injector has been turned on.

[0243] FIG. 13c schematically shows the situation of the user interface 1100 where the first input member 1108 and the second LED 1118 emit light such as blinking. The illustrated situation may be a situation that notifies that the user should proceed to the next step by pressing the first input member 1108. The illustrated situation may be a situation after mixing the drug components and / or before discharging the air.

[0244] FIG. 13d schematically shows the situation of the user interface 1100 where the first input member 1108, the contact member 1102, and the third LED 1120 emit light such as blinking. The first input member 1108, the contact member 1102, and the third LED 1120 can blink synchronously and / or can blink asynchronously. The illustrated situation may be a situation that notifies that the user should press the contact member 1102 against the intended injection site to inject the drug. The illustrated situation may be a situation before injecting the drug.

[0245] FIG. 14 shows a flowchart of a variant of the exemplary embodiment shown in FIG. 12. The illustrated flowchart may be an exemplary embodiment in the processing unit of the autoinjector.

[0246] This procedure is started by receiving 5002 a first input signal. The user can start the procedure by bringing about the first input signal, for example, via the user interface, by turning on the device.

[0247] Following the reception 5002 of the first input signal, it is determined 5004 whether the acceptance of the cartridge of the autoinjector into the cartridge receiver has been detected. If not, an output can be brought about 5040 via the user interface.

[0248] When the cartridge is detected 5004 or when the cartridge is detected 5004 after the reception 5002 of the first input signal, the reading 5006 of the cartridge code feature is performed.

[0249] Following the reading 5006 of the cartridge code feature part, detection 5008 of the temperature such as the temperature of the received cartridge is performed.

[0250] Following the detection 5008 of the temperature and the reading 5006 of the feature part of the cartridge code, it is detected 5010 whether it has been removed, such as whether there is a needle cover. If the needle cover has not been removed, for example, user output can be provided via the user interface, and the user can be prompted 5042 to remove the needle cover. When the needle cover has been removed 5010 or when the needle cover has been removed 5010, the plunger rod is moved 5012 to the pre-mixing plunger rod position. During this movement, the resistance to the movement of the plunger rod is measured.

[0251] The resistance to the movement is analyzed 5014, and it is determined whether it is acceptable. This analysis can be based on the reading 5006 of the cartridge code feature part and / or the detected temperature 5008.

[0252] If the resistance 5014 is not acceptable, for example, user output can be provided 5044 via the user interface. The output can indicate that the cartridge should be replaced. Subsequently, the plunger rod is moved 5038 to the plunger rod retracted position, such as the starting position of the plunger rod.

[0253] If the resistance 5014 is acceptable, the orientation of the cartridge is evaluated 5020. The orientation of the cartridge can be evaluated from the measurement of the orientation of the auto-injector. The orientation must be an acceptable orientation for combining the first drug component and the second drug component, for example, to avoid excessive foaming during the process. For example, an acceptable orientation may be that the cartridge outlet of the cartridge faces upward. If the orientation 5020 is not acceptable, for example, the cartridge outlet does not face upward and / or the cartridge is not within the range of 45 degrees vertical, the user can be prompted 5046 to orient the auto-injector correctly, for example, to face the cartridge outlet upward, for example, via the user interface.

[0254] When the orientation is acceptable 5020 or when the orientation is acceptable, the plunger rod is moved 5016 to the mixing plunger rod position, for example, to combine the first drug component and the second drug component.

[0255] After the plunger rod is moved 5016 to the mixing plunger rod position, a delay 5018 is inserted to restore the combined drug components to an injectable drug. The delay 5018 may be between 1 and 12 minutes, such as between 3 and 10 minutes. During the delay, user output can be provided via the user interface, and the user output can indicate the progress of the restoration. The delay may be a delay according to the cartridge specification from the reading 5006 of the cartridge code feature, for example.

[0256] After the drug is restored and / or after the delay suitable for the restoration of the drug has elapsed 5018, the plunger rod is moved 5022 to the prime plunger rod position, for example, to discharge air from the cartridge chamber. The prime plunger rod position can be determined based on the reading 5006 of the cartridge code feature and / or the detection 5008 of the temperature.

[0257] Determination of the orientation before moving the plunger rod to the prime plunger rod position can be omitted, for example, by assuming that the orientation of the auto-injector has not changed from the orientation determined before moving the plunger rod to the mixing plunger rod position. In another embodiment (not shown), the orientation can be determined both before moving the plunger rod to the mixing plunger rod position and before moving the plunger rod to the prime plunger rod position.

[0258] After moving the plunger rod to the prime plunger rod position 5022, the user is prompted, for example via a user interface, to perform a visual inspection 5024 of the medicament. For example, the user can be provided with the possibility of aborting the procedure if a precipitate of the medicament is visually detected. To accept the visual quality of the medicament, the user can provide a second input signal, for example by pressing a button of the user interface. The button used to provide the second input signal may be the same as the button used to provide the first input signal. After restoration of the medicament and / or after a delay 5018 suitable for restoration of the medicament, for example when a pause time of 4-5 hours has elapsed, prompting the user to perform the visual inspection 5024 can be aborted and / or the procedure can be aborted.

[0259] After receiving the second input signal 5026, the user can be prompted, for example via a user interface, to start injection of the medicament 5028. The user can inject the medicament by providing a trigger event, for example by inserting a needle into the tissue of the intended injection site by pressing the contact member of the auto-injector towards the intended injection site. The user is continuously and / or repeatedly prompted 5028 to start the injection until the trigger event is received 5030.

[0260] After receiving the trigger event 5030, the plunger rod is moved 5032 to the injection plunger rod position, for example, to expel the drug in the cartridge, such as injecting the drug into the tissue at the intended injection site.

[0261] After the plunger rod has been moved 5032 to the injection plunger rod position, it may be preferable to delay the retraction and / or removal of the needle so that the drug can be distributed into the tissue. Thus, the autoinjector prompts the user to wait for a set dwell time, for example, between 1 and 15 seconds, before retracting the needle, such as via a user interface 5034.

[0262] After receiving the trigger event 5030 and / or moving the plunger rod 5032 to the injection plunger rod position and / or prompting the user to wait for the set dwell time 5034, skin contact is evaluated 5036, for example, such as whether the contact member is still pressed against the intended injection site. If skin contact still exists after the dwell time, the user is notified 5048 that the injection has been made and / or that the autoinjector may be removed from the injection site.

[0263] If skin contact 5036 is lost and / or when skin contact is lost, the plunger rod is moved 5038 to the plunger rod retracted position.

[0264] After the plunger rod has been moved 5038 to the plunger rod retracted position, the cartridge can be removed and discarded.

[0265] Exemplary autoinjectors, cartridges, systems, and methods are described in the following items.

[0266] (Item 1) An automatic injector for formulating and / or administering a medicament from a cartridge having a first cartridge end and a second cartridge end, having a cartridge outlet located at the first cartridge end, and comprising a cartridge chamber having a first cartridge chamber for containing a first medicament component of the medicament and a second cartridge chamber for containing a second medicament component of the medicament, a housing, a cartridge receiver having a cartridge receiver opening and configured to receive a cartridge by insertion of a second end of the cartridge through the cartridge receiver opening, a cartridge sensor configured to detect receipt of the cartridge into the cartridge receiver and to provide a cartridge detection signal indicating that the cartridge has been received into the cartridge receiver, a drive module combined to move a plunger rod configured to move a first stopper between a plunger rod retracted position and a plunger rod extended position, an orientation sensor configured to provide an orientation signal representing the orientation of the cartridge received in the cartridge receiver, a processing unit connected to the orientation sensor, the cartridge sensor, and the drive module and comprising, wherein the processing unit · receives a first input signal, · receives the cartridge detection signal, · controls the drive module to move the plunger rod to a mixing plunger rod position in response to receipt of the cartridge detection signal and the first input signal, · receives the orientation signal, · controls the drive module to move the plunger rod to a prime plunger rod position in response to completion of the movement of the plunger rod to the mixing plunger rod position based on the orientation signal is configured as such, an automatic injector.

[0267] (Item 2) The processing unit is configured to: · Receive a trigger event, · After receiving the trigger event after completion of the movement of the plunger rod to the prime plunger rod position, control the drive module to move the plunger rod to the injection plunger rod position. The automatic injector according to item 1, further configured as described above.

[0268] (Item 3) The orientation sensor includes an accelerometer. The automatic injector according to item 1 or 2.

[0269] (Item 4) Comprising a code sensor configured to read a cartridge code feature and provide a code signal representing the cartridge code feature. The processing unit is connected to the code sensor and configured to receive the code signal. The automatic injector according to any one of items 1 to 3.

[0270] (Item 5) The processing unit is configured to determine an irregular cartridge based on the code signal. The automatic injector according to item 4.

[0271] (Item 6) The control of the drive module for moving the plunger rod to the prime plunger rod position is based on the code signal. The automatic injector according to item 4 or 5.

[0272] (Item 7) The movement of the plunger rod to the prime plunger rod position has a prime plunger rod speed, and the prime plunger rod speed is based on the code signal. The automatic injector according to any one of items 4 to 6.

[0273] (Item 8) The movement of the plunger rod to the mixing plunger rod position has a mixing plunger rod speed, and the mixing plunger rod speed is based on the code signal, the automatic syringe according to any one of items 4 to 7.

[0274] (Item 9) The movement of the plunger rod to the injection plunger rod position has an injection plunger rod speed, and the injection plunger rod speed is based on the code signal, the automatic syringe according to any one of items 4 to 8.

[0275] (Item 10) Comprising a resistance sensor configured to provide a resistance signal representing the resistance to the movement of the plunger rod, the processing unit is connected to the resistance sensor and configured to receive the resistance signal, the automatic syringe according to any one of items 1 to 9.

[0276] (Item 11) The processing unit is configured to determine an irregular cartridge based on the resistance signal, the automatic syringe according to item 10.

[0277] (Item 12) The processing unit is configured to determine cartridge parameters based on the resistance signal, the automatic syringe according to item 10 or 11.

[0278] (Item 13) The control of the drive module for moving the plunger rod to the mixing plunger rod position is based on the resistance signal, the automatic syringe according to any one of items 10 to 12.

[0279] (Item 14) The processing unit is configured to control the drive module to move the plunger rod to the mixing plunger rod position only when the resistance signal indicates that the resistance to the movement of the plunger rod exceeds a low-resistance threshold value. The automatic syringe according to any one of Items 10 to 13.

[0280] (Item 15) Comprising a first input device configured to provide a first input signal, the first input signal representing a first user interaction by the first input device, the processing unit being connected to the first input device. The automatic syringe according to any one of Items 1 to 14.

[0281] (Item 16) Comprising a contact member capable of moving between a contact member extended position and a contact member retracted position, the contact member being biased towards the contact member extended position, the contact member being configured to be moved towards the contact member retracted position when pressed against an injection site, the contact member being configured to provide a contact member signal representing the position of the contact member, the processing unit being connected to the contact member and configured to receive the contact member signal. The automatic syringe according to any one of Items 1 to 15.

[0282] (Item 17) The trigger event includes the contact member signal indicating that the contact member is in a first contact member position. The automatic syringe according to Item 16 when dependent on Item 2.

[0283] (Item 18) The contact member is configured to be located in a second contact member position when the needle cover is present on the cartridge, and the processing unit is configured to control the drive module to move the plunger rod to the mixing plunger rod position based on the contact member signal. The automatic syringe according to Item 16 or 17.

[0284] (Item 19) The processing unit is configured to control the drive module to move the plunger rod to the prime plunger rod position only when the orientation signal indicates that the inclination angle between the vertical and the longitudinal axis extending along the cartridge is within 45 degrees of the vertical and the cartridge outlet is at a vertical position higher than the cartridge chamber, the automatic syringe according to any one of items 1 to 18.

[0285] (Item 20) The processing unit is configured to control the drive module to move the plunger rod to a pre-mixing plunger rod position upon receiving the cartridge detection signal and the first input signal, the movement of the plunger rod to the pre-mixing plunger rod position having a pre-mixing plunger rod speed, the movement of the plunger rod to the mixing plunger rod position having a mixing plunger rod speed, the pre-mixing plunger rod speed being faster than the mixing plunger rod speed, the automatic syringe according to any one of items 1 to 19.

[0286] (Item 21) The processing unit is configured to control the drive module to move the plunger rod to the prime plunger rod position and / or the injection plunger rod position only after an elapsed recovery time from the completion of the movement of the plunger rod to the mixing plunger rod position, the automatic syringe according to any one of items 1 to 20.

[0287] (Item 22) The recovery time is based on the code signal, the automatic syringe according to item 21 when dependent on any one of items 4 to 9.

[0288] (Item 23) The processing unit is configured to control the drive module to move the plunger rod to the plunger rod retraction position after completion of the movement of the plunger rod to the injection plunger rod position, the automatic syringe according to any one of items 1 to 22.

[0289] (Item 24) The processing unit is configured to control the drive module to move the plunger rod toward the retraction position only after a residence time has elapsed since completion of the movement of the plunger rod to the injection plunger rod position, the automatic syringe according to any one of items 1 to 23.

[0290] (Item 25) The processing unit is configured to provide user output via a user interface after a residence time has elapsed since completion of the movement of the plunger rod to the injection plunger rod position, the automatic syringe according to any one of items 1 to 24.

[0291] (Item 26) Control of the drive module for moving the plunger rod to the mixing plunger rod position is based on the orientation signal, the automatic syringe according to any one of items 1 to 25.

[0292] (Item 27) The processing unit is configured to control the drive module to move the plunger rod to the mixing plunger rod position only when the orientation signal indicates that the inclination angle between the vertical and the longitudinal axis extending along the cartridge is within 45 degrees of the vertical and the cartridge outlet is at a vertical position higher than the cartridge chamber, the automatic syringe according to item 26.

[0293] (Item 28) Movement of the plunger rod to the mixing plunger rod position locks the cartridge in the cartridge receiver, the autoinjector according to any one of items 1 to 27.

[0294] (Item 29) Movement of the plunger rod to the plunger rod retracted position unlocks the lock of the cartridge in the cartridge receiver, the autoinjector according to any one of items 1 to 28.

[0295] (Item 30) The medicament is a human growth hormone such as a medicament having formulation code ACP-011, the autoinjector according to any one of items 1 to 29.

[0296] (Item 31) An autoinjector cartridge having a first cartridge end and a second cartridge end, having a cartridge outlet located at the first cartridge end, and having a first cartridge chamber containing a first drug component of the drug and a second cartridge chamber containing a second drug component of the drug, and configured to be received in the cartridge receiver of the autoinjector according to any one of items 1 to 30 by inserting the second cartridge end through the autoinjector cartridge receiver opening.

[0297] (Item 32) A system comprising an autoinjector according to any one of items 1 to 30 and a cartridge according to item 31.

[0298] (Item 33) A cartridge having a first cartridge end and a second cartridge end, having a cartridge outlet located at the first cartridge end, and comprising a first cartridge chamber containing a first drug component of a drug and a second cartridge chamber containing a second drug component of the drug, a cartridge receiver configured to receive the cartridge, and a plunger rod, a method for operating an autoinjector comprising: · Receiving a first input signal; · Detecting receipt of the cartridge by the cartridge receiver; · In response to detecting receipt of the cartridge by the cartridge receiver and receiving the first input signal, moving the plunger rod to a mixing plunger rod position; · Determining the orientation of the cartridge; · Based on the orientation of the cartridge, after completion of the movement of the plunger rod to the mixing plunger rod position, moving the plunger rod to a prime plunger rod position A method comprising.

[0299] (Item 34) · Receiving a trigger event; · In response to receiving the trigger event after completion of the movement of the plunger rod to the prime plunger rod position, moving the plunger rod to an injection plunger rod position The method according to item 33, further comprising.

Claims

1. An automatic syringe for formulating and / or administering a medicament from a cartridge, said cartridge having a first cartridge end and a second cartridge end and having a cartridge outlet located at said first cartridge end, and said cartridge having a cartridge chamber comprising a first cartridge chamber containing a first drug component of said medicament and a second cartridge chamber containing a second drug component of said medicament, in an automatic syringe, a housing, a cartridge receiver having a cartridge receiver opening, a cartridge sensor configured to detect the receipt of the cartridge into said cartridge receiver and to provide a cartridge detection signal indicating that the cartridge has been received into said cartridge receiver, a drive module coupled to move a plunger rod configured to move a first stopper between a plunger rod retracted position and a plunger rod extended position, an orientation sensor configured to provide an orientation signal representative of the orientation of the cartridge when received in said cartridge receiver, a contact member having a needle cover engaging member configured to contact a needle cover contact surface of a needle cover located on said cartridge inserted into said cartridge receiver, said contact member being configured to move between a contact member extended position and a contact member retracted position, said contact member being biased toward said contact member extended position, said contact member being moved toward said contact member retracted position when pressed against an injection site, said contact member being configured to move to a first contact member position indicative of said contact member being pressed against said injection site, said contact member being configured to move to a second contact member position between said contact member extended position and said first contact member position indicative of said needle cover being located on said cartridge, and said contact member being configured to provide a contact member signal representative of the position of said contact member, the orientation sensor, the cartridge sensor, the drive module, and a processing unit connected to the contact member and having the processing unit receives a first input signal, receives the cartridge detection signal, receives the orientation signal, receives the contact member signal, receives the cartridge detection signal and the first input signal, and controls the drive module to move the plunger rod to the mixing plunger rod position, after completion of the movement of the plunger rod to the mixing plunger rod position, controls the drive module to move the plunger rod to the prime plunger rod position, and controls the drive module to move the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the injection plunger rod position based on the contact member signal An autoinjector configured as such.

2. The processing unit receives a trigger event, after completion of the movement of the plunger rod to the prime plunger rod position, upon receiving the trigger event, controls the drive module to move the plunger rod to the injection plunger rod position The autoinjector according to claim 1, further configured as such.

3. The orientation sensor has an accelerometer. The autoinjector according to claim 1 or 2.

4. It has a code sensor configured to read a cartridge code feature portion and provide a code signal representing the cartridge code feature portion, and the processing unit is connected to the code sensor and configured to receive the code signal. The automatic injector according to any one of claims 1 to 3.

5. The processing unit is configured to determine an unapproved cartridge based on the code signal. The automatic injector according to claim 4.

6. The control of the drive module that moves the plunger rod to the prime plunger rod position is based on the code signal. The automatic injector according to claim 4 or 5.

7. The movement of the plunger rod to the prime plunger rod position has a prime plunger rod speed, and the prime plunger rod speed is based on the code signal. The automatic injector according to any one of claims 4 to 6.

8. The movement of the plunger rod to the mixing plunger rod position has a mixing plunger rod speed, and the mixing plunger rod speed is based on the code signal. The automatic injector according to any one of claims 4 to 7.

9. The movement of the plunger rod to the injection plunger rod position has an injection plunger rod speed, and the injection plunger rod speed is based on the code signal. The automatic injector according to any one of claims 4 to 8.

10. It has a resistance sensor configured to provide a resistance signal representing the resistance to the movement of the plunger rod, and the processing unit is connected to the resistance sensor and configured to receive the resistance signal. The automatic injector according to any one of claims 1 to 9.

11. The automatic injector according to claim 10, wherein the processing unit is configured to determine an unapproved cartridge based on the resistance signal.

12. The automatic injector according to claim 10 or 11, wherein the processing unit is configured to determine cartridge parameters based on the resistance signal.

13. The automatic injector according to any one of claims 10 to 12, wherein control of the drive module that moves the plunger rod to the mixing plunger rod position is based on the resistance signal.

14. The automatic injector according to any one of claims 10 to 13, wherein the processing unit is configured to control the drive module to move the plunger rod to the mixing plunger rod position only when the resistance signal indicates that the resistance to movement of the plunger rod exceeds a low-resistance threshold value.

15. The automatic injector according to any one of claims 1 to 14, comprising a first input device configured to provide a first input signal, the first input signal representing a first user interaction by the first input device, and the processing unit being connected to the first input device.

16. The automatic injector according to claim 2, wherein the trigger event includes the contact member signal indicating that the contact member is in the first contact member position.

17. The automatic injector according to any one of claims 1 to 16, wherein control of the drive module that moves the plunger rod to the prime plunger rod position is based on the direction signal.

18. The processing unit is configured to control the drive module to move the plunger rod to the prime plunger rod position only if the orientation signal indicates that the inclination angle between the vertical and the longitudinal axis extending along the cartridge is within a range of 45 degrees from the vertical and the cartridge outlet is at a vertical position higher than the cartridge chamber. The automatic syringe according to claim 17.

19. The processing unit is configured to control the drive module to move the plunger rod to a pre-mixing plunger rod position upon receiving the cartridge detection signal and the first input signal. The movement of the plunger rod to the pre-mixing plunger rod position has a pre-mixing plunger rod speed, and the movement of the plunger rod to the mixing plunger rod position has a mixing plunger rod speed. The pre-mixing plunger rod speed is faster than the mixing plunger rod speed. The automatic syringe according to any one of claims 1 to 18.

20. The processing unit is configured to control the drive module to move the plunger rod to the prime plunger rod position and / or the injection plunger rod position only after a predetermined reconstruction time has elapsed since the completion of the movement of the plunger rod to the mixing plunger rod position. The automatic syringe according to any one of claims 1 to 19.

21. The reconstruction time is based on the code signal. The automatic syringe according to claim 20 when dependent on any one of claims 4 to 9.

22. The processing unit is configured to control the drive module to move the plunger rod to the plunger rod retracted position after the completion of the movement of the plunger rod to the injection plunger rod position. The automatic syringe according to any one of claims 1 to 21.

23. The processing unit is configured to control the drive module to move the plunger rod toward the retracted position only after a predetermined residence time has elapsed since the completion of the movement of the plunger rod to the injection plunger rod position. The automatic syringe according to any one of claims 1 to 22.

24. The processing unit is configured to provide a user output via a user interface after a predetermined residence time has elapsed since the completion of the movement of the plunger rod to the injection plunger rod position. The automatic syringe according to any one of claims 1 to 23.

25. The control of the drive module to move the plunger rod to the mixing plunger rod position is based on the orientation signal. The automatic syringe according to any one of claims 1 to 24.

26. The processing unit is configured to control the drive module to move the plunger rod to the mixing plunger rod position only when the orientation signal indicates that the inclination angle between the vertical and the longitudinal axis extending along the cartridge is within the range of 45 degrees from the vertical and the cartridge outlet is at a higher vertical position than the cartridge chamber. The automatic syringe according to claim 25.

27. The movement of the plunger rod to the mixing plunger rod position locks the cartridge in the cartridge receiver. The automatic syringe according to any one of claims 1 to 26.

28. The movement of the plunger rod to the plunger rod retracted position unlocks the lock of the cartridge to the cartridge receiver. The automatic syringe according to any one of claims 1 to 27.

29. The drug is a human growth hormone such as a drug having a formulation code ACP-011. The automatic syringe according to any one of claims 1 to 28.

30. A cartridge for use in an autoinjector according to any one of claims 1 to 29, the cartridge having a first cartridge end and a second cartridge end and having a cartridge outlet located at the first cartridge end, the cartridge having a cartridge chamber having a first cartridge compartment for containing a first drug component of a drug and a second cartridge compartment for containing a second drug component of the drug, and the cartridge being configured to be received in a cartridge receiver of an autoinjector according to any one of claims 1 to 29 by inserting the second cartridge end through an opening of the cartridge receiver of the autoinjector. **Claim 31** A system having an autoinjector according to any one of claims 1 to 29 and a cartridge according to claim 30. **Claim 32** A method for operating an auto-injector having a plunger rod and a cartridge receiver configured to receive a cartridge, the cartridge having a first cartridge end and a second cartridge end and having a cartridge outlet located at the first cartridge end, and the cartridge having a cartridge chamber with a first cartridge chamber for containing a first drug component of a drug and a second cartridge chamber for containing a second drug component of the drug, the auto-injector further having a contact member having a needle cover engaging member configured to abut a needle cover abutment surface of a needle cover positioned on the cartridge inserted in the cartridge receiver, the contact member being configured to be movable between a contact member extended position and a contact member retracted position, the contact member being moved toward the contact member retracted position when pressed against an injection site, the contact member being configured to be movable to a first contact member position indicative of the contact member being pressed against the injection site, the contact member being configured to be movable to a second contact member position between the contact member extended position and the first contact member position indicative of the needle cover being positioned on the cartridge, and the contact member being configured to provide a contact member signal indicative of the position of the contact member, in a method for operating an auto-injector Receiving, from a first input device configured to provide a first input signal, the first input signal, the first input signal representing a first user interaction by the first input device, Detecting acceptance of the cartridge into the cartridge receiver Determining the orientation of the cartridge Receiving the contact member signal Moving the plunger rod to a mixing plunger rod position in response to detecting acceptance of the cartridge into the cartridge receiver and receiving the first input signal After completion of the movement of the plunger rod to the mixing plunger rod position, moving the plunger rod to a prime plunger rod position comprising each of said steps being controlled by a processing unit of said auto-injector, a method, wherein movement of said plunger rod to said mixing plunger rod position and / or said prime plunger rod position and / or an injection plunger rod position is based on said contact member signal. **Claim 33** receiving a trigger event; after completion of the movement of the plunger rod to the prime plunger rod position, in response to receiving the trigger event, moving the plunger rod to an injection plunger rod position further comprising The method according to claim 32, wherein each of said steps is controlled by the processing unit of said auto-injector. **Claim 34** The method according to claim 32 or 33, wherein the step of moving the plunger rod to the mixing plunger rod position is based on the orientation of the cartridge. **Claim 35** The method according to any one of claims 32 to 34, wherein the step of moving the plunger rod to the prime plunger rod position is based on the orientation of the cartridge.

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