Front-loaded autoinjector for administering medicament

Abstract

To provide an autoinjector, such as an electronic autoinjector, with an improved automation of preparing and administering a medicament.SOLUTION: Disclosed is a method for controlling an autoinjector 4, 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 positioned at the first cartridge end. The cartridge has 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 6, a cartridge receiver 300, 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 auto-injectors, such as electronic auto-injectors, cartridges for auto-injectors, systems including auto-injectors and cartridges, and methods for operating auto-injectors. [Background technology]

[0002] Hypodermic syringes are widely used to deliver fluids to the body. It is known to have hypodermic syringes that are adaptable for manual operation. However, auto-injectors, such as electronic auto-injectors, have been developed and are widely used to assist in the administration of fluids or medications to the body.

[0003] There is increasing interest in auto-injectors performing the injection process as automatically as possible so as not to have to rely on the user to correctly perform certain tasks. It can be beneficial to automate the process of preparing and administering fluids, such as medication, particularly when the administration of the medication requires several steps, such as when the medication needs to be mixed prior to injection. Summary of the Invention

[0004] There is a need for auto-injectors, such as electronic auto-injectors, that provide improved automation of medication preparation and administration. The present disclosure provides auto-injectors, cartridges, systems, and methods for improving medication preparation and administration by auto-injectors.

[0005] Accordingly, an automatic injector for dispensing and / or administering a medicament from a cartridge is disclosed. The cartridge has a first cartridge end and a second cartridge end, and a cartridge outlet at the first cartridge end. The cartridge includes a cartridge chamber having a first cartridge compartment (subcompartment) containing a first medicament component of the medicament and a second cartridge compartment containing a second medicament component of the medicament.

[0006] The auto-injector includes 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 and is configured to receive the cartridge by inserting the second end of the cartridge through the cartridge receiver opening.

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

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

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

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

[0012] The processing unit is configured to receive a first input signal, receive a cartridge detection signal, receive an orientation signal, control the drive module to move the plunger rod to the mixing plunger rod position in response to receiving the cartridge detection signal and the first input signal, and control the drive module to move the plunger rod to the prime plunger rod position after completion of movement of the plunger rod to the mixing plunger rod position.

[0013] The processing unit may be further configured to receive a trigger event and, upon receipt of the trigger event after completion of 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.

[0014] Also disclosed is a cartridge for an auto-injector, such as the auto-injector disclosed above. The cartridge has a first cartridge end and a second cartridge end, with a cartridge outlet at the first cartridge end. The cartridge includes a cartridge chamber. The cartridge chamber has a first cartridge chamber containing a first pharmaceutical component of a medicament and a second cartridge chamber containing a second pharmaceutical component of the medicament. 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 a cartridge receiver opening of the auto-injector.

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

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

[0017] The method includes the steps of receiving a first input signal, detecting receipt of the cartridge into the cartridge receiver, determining an orientation of the cartridge, moving the plunger rod to a mixing plunger rod position upon detecting 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 movement of the plunger rod to the mixing plunger rod position.

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

[0019] The trigger event may be, for example, the result of pressing a button, the result of the passage of a short pause, and / or the result of a predetermined action by the user. The trigger event may indicate that the auto-injector is being pressed against an injection site.

[0020] An advantage of the present disclosure is that the processes involved in the preparation and / or administration of pharmaceutical agents are increasingly automated. A further advantage is that this increased automation results in increased safety in the preparation and / or administration of pharmaceutical agents.

[0021] A further advantage of the present disclosure is the ability to provide an auto-injector that is easier to use and reduces the risk of accidental administration of medication.

[0022] An advantage of the present disclosure is that it can facilitate determining the characteristics of a received cartridge.A further advantage of the present disclosure is that it can enable an auto-injector to operate in response to the characteristics of a received cartridge.

[0023] The present disclosure may enable the determination or notification of an accepted cartridge as being a used cartridge and / or a defective cartridge and / or a counterfeit cartridge and / or a cartridge containing a medication not approved for the device. Thus, an advantage of the present disclosure may be, for example, the increased safety of an auto-injector by preventing or restricting the use of cartridges that are not new in the auto-injector.

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

[0025] It is contemplated that any embodiment or element described in connection with any one aspect may be used with any other aspect or embodiment, mutatis mutandis.

[0026] The cartridge has a cartridge outlet at a first cartridge end. The cartridge can have a cartridge rear face at a second cartridge end, e.g., opposite the cartridge outlet. The cartridge rear face can have a cartridge rear opening. The cartridge rear opening can provide access to the first stopper for a plunger rod, such as a plunger rod of an auto-injector.

[0027] The cartridge chamber can contain a medicament. A cartridge outlet can be configured to communicate with the cartridge chamber, for example, at a first cartridge end. The cartridge can be configured to eject the medicament through the cartridge outlet. The cartridge outlet can be configured to couple with a needle, such as a hypodermic needle, to effect ejection of the medicament through the needle.

[0028] The cartridge includes a first stopper movable within the cartridge chamber. The cartridge can include a second stopper movable within the cartridge chamber. The second stopper can be between the first stopper and the cartridge outlet. The cartridge can include a third stopper movable within the cartridge chamber. The third stopper can be between the second stopper and the cartridge outlet. The first stopper, the second stopper, and / or the third stopper can be movable within the cartridge chamber toward the cartridge outlet, e.g., in a first stopper direction, such as toward the first cartridge end. For example, a drug can be expelled through the cartridge outlet upon movement of the first stopper, the second stopper, and / or the third stopper, e.g., toward the first stopper and / or toward the cartridge outlet.

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

[0030] The first cartridge chamber can contain a first pharmaceutical component of the medicament. The second cartridge chamber can contain a second pharmaceutical component of the medicament. Each of the first pharmaceutical component and / or the second pharmaceutical component can be a powder composition, a fluid, a liquid, a gel, a gas, and / or any combination thereof. The first pharmaceutical component and / or the second pharmaceutical component can be a solute, such as a powder composition. The first pharmaceutical component and / or the second pharmaceutical component can be a solvent, such as a fluid composition, such as a liquid composition. The second pharmaceutical component can be a powder composition, and the first pharmaceutical component can be a fluid composition, such as water, ethanol, saline, a buffer, or a preservative solution. The second pharmaceutical component can be a solute. The first pharmaceutical component can be a solvent. It is contemplated that the medicament can be any medicament that can be injected through a hypodermic needle, for example, after reconstitution of the medicament. The medicament can be growth hormone. The medicament can be human growth hormone. The drug may be a depot formulation, such as a long-acting form 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 that provides communication between the first cartridge chamber and the second cartridge chamber when, for example, the second stopper is located in the bypass portion. The cartridge can have multiple bypass portions that provide communication between adjacent cartridge chambers when, for example, the stopper separating the adjacent cartridge chambers is located in the bypass portion.

[0032] Reusable auto-injectors, such as those disclosed above, can be particularly useful when the cartridge includes multiple chambers. For example, auto-injectors for multi-chamber or multi-compartment cartridges may be more advanced, and thus may benefit from the ability to use the auto-injector more than once. For example, the auto-injector may provide an automated process for mixing drug components, such as mixing drug components originally 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, a needle cover, a cartridge holder, and / or a needle, such as a needle assembly including a cartridge code feature.

[0034] The cartridge assembly can include a needle, such as a needle assembly including 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 provide attachment of the needle assembly to the cartridge.

[0035] The cartridge can include a cartridge code feature, and / or the cartridge assembly can include a cartridge and a 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. For example, the cartridge code feature can include a color and / or a sequence of colors. The cartridge code feature can be positioned to surround or partially surround a portion of the cartridge chamber where a stopper, such as the first stopper, is initially located. Such a location of the cartridge code feature can enhance readability of the cartridge code feature, for example, because 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 light gray or white. The stopper, such as the first stopper, can be a dark color, such as 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, for example, to further enhance readability of the cartridge code feature.

[0036] The cartridge code feature may be located at a specific location on the cartridge independent of a stopper, e.g., the first stopper. For example, the cartridge code feature may be located a code distance from the second cartridge end. All cartridges may have their respective cartridge code features located at the same location, e.g., a code distance from the second cartridge end. Such uniform location of the cartridge code features may reduce the complexity and size of the auto-injector because the cartridge code feature is read at the same location on all suitable cartridges.

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

[0038] The cartridge code feature can indicate one or more cartridge specifications, such as the medication in the cartridge, the concentration of the medication in the cartridge, the viscosity of the medication in the cartridge, the volume and / or mass of the medication in the cartridge, the position of a stopper within the cartridge chamber, etc. The cartridge code feature can indicate the position of a first stopper at which air in the cartridge chamber is reduced, e.g., minimized and / or reduced to an amount suitable for injection. The cartridge code feature can indicate the amount of medication contained in the cartridge. The cartridge code feature can indicate a particular type of cartridge, such as an ID number for a particular type of cartridge. An auto-injector, such as a processing unit of the auto-injector, can be configured to determine one or more cartridge specifications based on the ID number, e.g., via a look-up table. The cartridge code feature can indicate an appropriate speed, such as an optimal speed, for stopper movement, such as stopper movement during various stages of movement, such as during mixing, air evacuation, and / or injection. The cartridge code feature can indicate an appropriate, e.g., optimal, speed for movement of the first stopper, such as the speed of movement of the first stopper at various stages of movement, such as during mixing, air evacuation, and / or injection. The cartridge code feature can indicate the time required for optimal mixing of the first and second drug components. The cartridge code feature can indicate an appropriate dwell time for the drug, e.g., a preferred wait time before retracting the needle after injection, e.g., 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 includes a cartridge receiver configured to receive a cartridge. The cartridge receiver may be configured to receive a cartridge assembly including a cartridge. The cartridge assembly may include a cartridge holder. The cartridge receiver has a cartridge receiver opening. The cartridge receiver may be configured to receive the cartridge by inserting the cartridge, such as the second end of the cartridge, through the cartridge receiver opening. The cartridge may be inserted in a cartridge-receiving direction. The cartridge-receiving direction may be, for example, opposite to a first stopper direction when the cartridge is received in the cartridge receiver. The cartridge may be in a first angular position when inserted into the cartridge receiver. The cartridge may be held in the cartridge receiver in a second angular position, for example, after the cartridge is inserted 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 retained in the cartridge receiver by one or more cartridge retaining members of the cartridge holder that engage members of the cartridge receiver.

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

[0042] The auto-injector can include a cartridge sensor. The cartridge receiver can include a cartridge sensor. The cartridge sensor can be configured to detect receipt of a cartridge and / or cartridge assembly into the cartridge receiver. The cartridge sensor can provide a cartridge sensor signal indicative of whether the cartridge and / or cartridge assembly has been received by the cartridge receiver. The cartridge sensor can provide a cartridge detect signal indicative of the cartridge and / or cartridge assembly housed in the cartridge receiver. The cartridge sensor signal can include a cartridge detect signal.

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

[0044] The auto-injector includes a drive module. The drive module can be coupled to move, e.g., actuate, e.g., advance, a plunger rod, e.g., between a plunger rod retracted position and a plunger rod extended position. Movement of the plunger rod can result in locking of the cartridge and / or cartridge assembly to the cartridge receiver. For example, the cartridge and / or cartridge assembly can be locked to the cartridge receiver by advancing the plunger rod from the plunger rod retracted position.

[0045] The drive module can include 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 contained in a housing. The drive module can include a motor, such as an electromechanical motor, such as a DC motor, for example, a brushed or brushless DC motor. The drive module can include a solenoid motor. The drive module can include a shape memory metal engine. The drive module can include a spring device configured to actuate the plunger rod. The drive module can include pressurized gas configured to actuate the plunger rod.

[0046] The automatic injector can include a plunger rod, such as a plunger rod that can be moved by a drive module. The plunger rod can be configured to move a stopper, such as a first stopper, of a cartridge. For example, when the plunger rod is moved toward the plunger rod extended position, the plunger rod can be configured to move the first stopper toward the cartridge outlet, for example, to expel medication and / or air from the cartridge chamber through the cartridge outlet.

[0047] The plunger rod can be moved, for example, from a plunger rod retracted position, for example, toward an extended plunger rod position, to a pre-mix plunger rod position, which can be a position where communication between the first cartridge chamber and the second cartridge chamber is not yet established.

[0048] The plunger rod can be moved from, for example, a plunger rod retracted position and / or a pre-mixing plunger rod position, for example, toward an extended plunger rod position, to a mixing plunger rod position. The mixing plunger rod position can be a position where the first and second drug components are combined, e.g., mixed. The mixing plunger rod position can be a position where the second stopper is positioned in the bypass portion, for example, to provide communication between the first and second cartridge chambers.

[0049] The plunger rod can be moved from, for example, a plunger rod retracted position and / or a mixing plunger rod position, for example, toward a plunger rod extended position, to a prime plunger rod position. The prime plunger rod position can be a position where air is expelled from the cartridge chamber. For example, the prime plunger rod position can be selected to position the first stopper at a position where air in the cartridge chamber is reduced, e.g., minimized, and / or reduced to an amount suitable for injection.

[0050] The plunger rod can be moved, for example, from a plunger rod retracted position and / or a prime plunger rod position, toward an injection plunger rod position, for example, toward an extended plunger rod position. The injection plunger rod position can be a position where the medication is expelled from the cartridge chamber and / or injected. For example, the injection plunger rod position can be selected to position the first stopper at a position where the medication in the cartridge chamber is reduced, for example, minimized, such as near the cartridge outlet. The injection plunger rod position can be the extended plunger rod position.

[0051] The plunger rod can be moved toward, e.g., to, the plunger rod retracted position, e.g., from an injection plunger rod position and / or an extended plunger rod position, etc., toward, e.g., to, the plunger rod retracted position after an injection is completed.

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

[0053] The automatic injector can include an ejection sensor, such as a plunger rod position sensor. The ejection sensor can be configured to detect an ejection, such as the ejection of medication and / or air, from the cartridge chamber. The ejection sensor can be configured to detect and / or determine the position of the plunger rod and / or the position of the first stopper. The ejection sensor can be configured to detect a condition indicative of the position of the plunger rod and / or the position of the first stopper. The ejection sensor can be configured to provide an ejection sensor signal. The ejection sensor signal can represent the position of the plunger rod and / or the first stopper.

[0054] The ejection sensor can include a revolution counter, such as a revolution counter on the drive module. The revolution counter can be configured to count the number of revolutions of the drive module, such as the number of revolutions of the drive module from a predetermined point where the position of the plunger rod is known, such as a plunger rod retracted position of the plunger rod. The number of revolutions of the drive module can be used to determine the actual position of the plunger rod, such as a pre-mix plunger rod position, a mix plunger rod position, a prime plunger rod position, an inject plunger rod position, a plunger rod extended position, and / or a plunger rod retracted position.

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

[0056] The cartridge may be lockable to the cartridge receiver, e.g., the cartridge can be locked to the cartridge receiver to prevent removal of the cartridge from the cartridge receiver. The cartridge can be locked to the cartridge receiver by moving the plunger rod toward the plunger rod extended position. For example, the cartridge can be locked to the cartridge receiver by moving the plunger rod to the mixing plunger rod position. The cartridge can be unlocked from the cartridge receiver by moving the plunger rod toward the plunger rod retracted position. For example, the cartridge can be unlocked from the cartridge receiver by moving the plunger rod to the plunger rod retracted position. The cartridge can be locked to the cartridge receiver when the plunger rod is not at and / or near the plunger rod retracted position. Coupling the position of the plunger rod with the lock of the cartridge in the cartridge receiver can provide the advantage of limiting or preventing release of the cartridge when the auto-injector is activated.

[0057] The auto-injector can include an orientation sensor. The orientation sensor can be configured to provide an orientation signal indicative of the orientation of the cartridge, for example, when the cartridge is received by 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 an orientation representative of the cartridge, such as the orientation of the cartridge and / or the orientation of the auto-injector. The detected orientation can be an orientation relative to gravity, such as an orientation relative to the direction of gravity. The orientation sensor can be configured to detect the direction of gravity and / or detect whether the direction of gravity is within a certain range of a predetermined direction. The orientation sensor can include an accelerometer. The orientation sensor can include multiple accelerometers, such as three accelerometers, e.g., three accelerometers arranged to detect acceleration in three dimensions, e.g., a three-dimensional accelerometer. The orientation sensor can include a tilt sensor, a three-axis accelerometer, a single-axis accelerometer, a magnetometer, and / or any combination thereof, and can provide roll, pitch, and azimuth measurements, acceleration and / or tilt measurements in one or more directions, etc.

[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 45-degree vertical range, such as within a 30-degree vertical range. The predetermined orientation can be an orientation in which the cartridge is oriented such that the longitudinal axis of the cartridge is within a 45-degree vertical range, such as within a 30-degree vertical range, and the cartridge outlet is located above the cartridge chamber, such as in a vertical position above the cartridge chamber.

[0060] The processing unit may be connected to the orientation sensor and may be configured to receive an orientation signal representative of, for example, the orientation of the cartridge received in the cartridge receiver and / or the orientation of the auto-injector.

[0061] Movement of the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the inject plunger rod position can be based on an orientation of the cartridge, e.g., an orientation signal. For example, movement of the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the inject plunger rod position can require that the tilt angle between the vertical and a longitudinal axis extending along the cartridge is within 45 degrees, such as within 30 degrees, and that the cartridge outlet is at a higher vertical position than the cartridge chamber.

[0062] Control of the drive module to move the plunger rod to the mix plunger rod position and / or the prime plunger rod position and / or the inject plunger rod position can be based on the orientation of the cartridge, for example, an orientation signal.

[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 a mixing plunger rod position and / or a prime plunger rod position and / or an 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 a prime plunger rod position and / or an injection plunger rod position only if the orientation signal indicates that the tilt angle between vertical and a longitudinal axis extending along the cartridge is within 45 degrees, such as within 30 degrees, of vertical, and / or if the cartridge outlet is at a higher vertical position than the cartridge chamber.

[0064] The auto-injector can include a code sensor. The code sensor can be configured to read a cartridge code feature, such as a cartridge code feature of the cartridge that represents one or more cartridge specifications. The code sensor can be configured to provide a code signal that represents 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 may be configured to determine non-genuine (unapproved) cartridges, such as counterfeit cartridges and / or used cartridges and / or tampered cartridges and / or cartridges with the wrong dose and / or cartridges containing the wrong medication, based on the code signal.

[0066] The code sensor can include an optical sensor. The code sensor can include an optical sensor including 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, bar codes, RFID tags, NFC tags, identification numbers, QR codes, 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 mix plunger rod position and / or the prime plunger rod position and / or the injector plunger rod position can be based on a cartridge code feature, e.g., a code signal. For example, control of a 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 to move the plunger rod to the prime plunger rod position based on the code signal.

[0068] Moving the plunger rod based on cartridge specifications, such as a code signal, allows the movement of the plunger rod to be optimized for several types of cartridges, for example, even for different cartridges, which may result in less or no medication ejection when performing an air purge, thereby improving dose accuracy and / or reducing patient discomfort.

[0069] Moving the plunger rod based on cartridge specifications, such as a code signal, allows the movement of the plunger rod to be optimized for several types of cartridges, for example, by having the plunger rod remain in the mixing plunger rod position for a time period according to the cartridge specifications after detecting receipt of the cartridge into the cartridge receiver and receiving the first input signal, proper mixing can be ensured and / or patient discomfort can be reduced, for example, even with different cartridges.

[0070] The automatic injector may include a resistance sensor. The resistance sensor may be configured to provide a resistance signal. The resistance signal may represent resistance to movement of the plunger rod. A processing unit may be connected to the resistance sensor. The processing unit may be configured to receive the resistance signal.

[0071] The processing unit may be configured to determine non-genuine cartridges, such as counterfeit cartridges and / or used cartridges and / or tampered cartridges and / or cartridges with the wrong dose and / or cartridges containing the wrong medication, based on the code signal and / or the resistance signal.

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

[0073] The resistance sensor can be configured to determine the power consumed by the drive module, for example, by measuring 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 plunger rod front end. The plunger rod front end can be configured to engage with a 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 plunger rod front end. The plunger rod can include the resistance sensor.

[0075] Movement of the plunger rod can be based on the resistance signal. For example, movement of the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the inject plunger rod position can be based on resistance to movement of the plunger rod, e.g., based on the resistance signal. For example, control of a drive module to move the plunger rod to the mixing plunger rod position can be based on the 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 to move the plunger rod to the mixing plunger rod position based on the resistance signal.

[0076] Movement of the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the inject plunger rod position can require resistance to movement of the plunger rod to exceed a low resistance threshold, e.g., a resistance signal indicating that resistance to movement of the prime plunger rod exceeds a 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 if the resistance signal indicates that resistance to movement of the plunger rod exceeds a low resistance threshold, e.g., after completion of movement of the plunger rod to the pre-mixing plunger rod position. The low resistance threshold can be between 1 N and 15 N, e.g., between 5 N and 11 N. The low resistance threshold can be 1 N, 5 N, or 10 N.

[0077] The cartridge parameter may be based on a resistance to movement of the plunger rod, for example a resistance signal. The processing unit may be configured to determine the cartridge parameter 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, such as a predetermined plunger rod position between the plunger rod retracted position and the plunger rod extended position, and the resistance signal indicates resistance to plunger rod movement above a low resistance threshold, for example, representing sufficient force required to move the plunger rod, it indicates that the plunger rod has engaged the first stop.

[0079] The cartridge parameters can indicate that the cartridge is not full, such as used, and / or empty. For example, if the current plunger rod position reaches a plunger rod threshold, such as a predetermined plunger rod position between the plunger rod retracted position and the plunger rod extended position, and the resistance signal indicates resistance to plunger rod movement below a low resistance threshold, e.g., representing a small force required to move the plunger rod, the first stop is in the advanced position.

[0080] The cartridge parameters may indicate, for example, that the cartridge is defective and / or that no needle is attached and / or that the attached needle is blocked if the resistance signal indicates resistance to plunger rod movement above a high resistance threshold, representing a large force required to move the plunger rod, and thus indicates that advancement of the plunger rod and / or first stopper is somehow impeded. The high resistance threshold may be between 8N and 25N, for example, between 10N and 20N. The high resistance threshold may be 8N, 11N, or 15N.

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

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

[0083] The auto-injector 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 auto-injector and / or cartridge and / or medicament. The temperature sensor can include an infrared sensor, such as an infrared optical sensor.

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

[0085] Movement of the plunger rod to the mix plunger rod position and / or prime plunger rod position and / or inject plunger rod position may be based on the temperature of the auto-injector and / or cartridge and / or medicament, for example, based on a temperature signal.

[0086] The auto-injector, such as a 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 a mix plunger rod position and / or a prime plunger rod position and / or an inject plunger rod position based on the temperature signal.

[0087] The auto-injector can include an input device, such as a first input device. The first input device can be a button, a touch-sensitive 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 mixed 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 automatic injector can include a contact member. The contact member can be configured to be pressed against an 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 toward the contact member extended position, for example, by a contact member spring. The contact member can be configured to move toward the contact member retracted position, for example, when pressed against the injection site. The contact member and / or contact member sensor can be configured to provide a contact member signal representative of the position of the contact member. The automatic injector and / or contact member can include 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 in a first contact member position, for example, between the contact member extended position and the contact member retracted position. The contact member in the first contact member position can indicate that the contact member is close to the contact member retracted position. The contact member in the first contact member position can indicate that the contact member is pressed against the injection site. The contact member in the first contact member position can indicate that a needle disposed in the cartridge is sufficiently depressed into the skin to initiate injection of the medicament.

[0091] The contact member may be in a second contact member position, such as between the contact member extended position and the first contact member position, e.g., between the contact member extended position and the contact member retracted position. The contact member in the second contact member position can indicate that the contact member is restrained from being biased to the contact member extended position. The contact member in the second contact member position can indicate that a needle cover, such as a needle with a needle cover, is located 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 in a first contact member position. The contact member can be a trigger member.

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

[0094] A 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 initiate movement of the plunger rod only if the needle is present and / or only if the needle cover is not present.

[0095] The needle sensor can include a contact member. For example, the contact member can be configured to be positioned in the second contact member position when a needle cover, such as a needle with a needle cover, is present on the cartridge. Movement of the plunger rod can be based on the position of the contact member, e.g., based on the contact member signal. 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, e.g., based on the contact member signal. For example, 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 the contact member signal to indicate 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.

[0096] Alternatively or additionally, movement of the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the injecting plunger rod position can be based on detection of the needle cover. For example, movement of the plunger rod to the mixing plunger rod position and / or the prime plunger rod position and / or the injecting plunger rod position can require that the needle cover is detected after receipt of the cartridge into the cartridge receiver, and then the needle cover is not detected, e.g., the needle cover is detected to have 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 if the contact member signal indicates that the contact member is not in a second contact member position, such as indicating that the contact member is in a contact member extended position.

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

[0099] The pre-mix plunger rod speed, the mixing plunger rod speed, the prime plunger rod speed, and / or the injection plunger rod speed can be based on a cartridge specification, e.g., based on a cartridge code feature, e.g., based on a code signal. The processing unit can be configured to determine the pre-mix plunger rod speed, the mixing plunger rod speed, the prime plunger rod speed, and / or the injection plunger rod speed based on the code signal.

[0100] The pre-mix plunger rod speed, the mixing plunger rod speed, the prime plunger rod speed, and / or the injection plunger rod speed can be based on a temperature, such as the temperature of the auto-injector and / or the cartridge and / or the medicament, e.g., based on a temperature signal. The processing unit can be configured to determine the pre-mix plunger rod speed, the mixing plunger rod speed, the prime 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, e.g., the plunger rod retracted position to, a pre-mixing plunger rod position at a pre-mixing plunger rod velocity. The processing unit can be configured to control the drive module to move the plunger rod from, e.g., the pre-mixing plunger rod position to, a mixing plunger rod position at a mixing plunger rod velocity. The processing unit can be configured to control the drive module to move the plunger rod from, e.g., the mixing plunger rod position to, a prime plunger rod position at a prime plunger rod velocity. The processing unit can be configured to control the drive module to move the plunger rod from, e.g., the prime plunger rod position to, an injection plunger rod position at an injection plunger rod velocity.

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

[0103] One or more elapsed periods, such as a delay, can occur before a plunger rod movement, such as movement to a pre-mixing plunger rod position, a mixing plunger rod position, a prime plunger rod position, an injection plunger rod position, and / or a plunger rod retracted position. For example, movement of the plunger rod to the prime plunger rod position and / or movement of the plunger rod to the injection plunger rod position can require a reconstitution time to elapse after completion of movement of the plunger rod to the mixing plunger rod position. The reconstitution time can be selected to allow sufficient time to ensure reconstitution of the medication, e.g., to ensure sufficient mixing of the first and second medication components. The reconstitution time can be based on cartridge specifications, e.g., the reconstitution time can be based on cartridge code features, e.g., the reconstitution time can be based on a 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 retracted 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 a recovery time has elapsed since completion of movement of the plunger rod to the mixing plunger rod position. Alternatively, or additionally, the processing unit can be configured to control the drive module to move the plunger rod to the injection plunger rod position only after a recovery time has elapsed since completion of movement of the plunger rod to the mixing plunger rod position.

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

[0106] For example, after completion of movement of the plunger rod to the injection plunger rod position, movement of the plunger rod toward, e.g., to, the plunger rod retracted position can require a dwell time to elapse from completion of 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 agent is distributed to the tissue. The dwell time can be dependent on the agent and / or agent concentration and / or agent amount. The dwell time can be based on cartridge specifications, e.g., the dwell time can be based on cartridge code features, e.g., the dwell time can be based on a 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 a dwell time has elapsed from completion of movement of the plunger rod towards the injection plunger rod position.

[0108] The auto-injector can include a user interface, such as a user interface that allows for user input and / or can provide a visual 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 an output, such as an audible and / or visible 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 the first user output via a first output member.

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

[0111] The processing unit can be configured to provide a user output indicative of the orientation signal via a user interface, for example, when moving the plunger rod to the mix plunger rod position and / or the prime plunger rod position. The user output indicative of the orientation signal can include a beep with a varying beep interval based on the orientation signal. For example, the varying beep interval can be faster when the orientation signal is far from the predetermined orientation and / or vertical, and / or the varying beep interval can be slower when the orientation signal is closer to the predetermined orientation and / or vertical.

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

[0113] [Figure 1] 1 shows a typical auto-injector. [Figure 2] 1 shows a typical auto-injector with a cartridge. [Figure 3] 1 shows a schematic representation of a typical cartridge. [Figure 4] 1A-1D show schematic diagrams of a typical cartridge assembly with typical cartridge code features. [Figure 5] 1 shows a schematic representation of a typical auto-injector with a cartridge assembly. [Figure 6] 1 a) to d) show schematic diagrams of an auto-injector and cartridge assembly. [Figure 7] 1 shows a block diagram of a typical auto-injector. [Figure 8] 10 a)-10 f) show schematic diagrams of a typical cartridge assembly and plunger rod in typical positions. [Figure 9] 1 shows a typical graph of resistance versus position. [Figure 10] 1 shows a flow diagram of an exemplary method. [Figure 11] 1 shows a flow diagram of an exemplary method. [Figure 12] 1 shows a flow diagram of an exemplary method. [Figure 13] a) to d) show schematic diagrams of typical user interfaces. [Figure 14] 1 shows a flow diagram of an exemplary method. DETAILED DESCRIPTION OF THE INVENTION

[0114] Various embodiments will now be described with reference to the drawings. Like reference numerals refer to like elements throughout. Accordingly, 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 intended only to facilitate the description of the embodiments. They are not intended to provide an exhaustive description of the claimed invention, nor are they intended to limit the scope of the claimed invention. In addition, an illustrated embodiment need not necessarily have all of the aspects or advantages shown. An aspect or advantage discussed in connection with a particular embodiment is not necessarily limited to that embodiment and may be implemented in any other embodiment, even if not so illustrated or explicitly stated.

[0115] Figure 1 shows a typical auto-injector 4. The auto-injector 4 may be configured to administer a medication. The auto-injector 4 may be an electronic auto-injector.

[0116] 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 contain a medication.

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

[0118] The auto-injector 4 may include a user interface 1100, as shown. The auto-injector 4 may include a trigger member, such as a contact member 1102. The contact member 1102 may be configured to be pressed against an injection site. When pressed against the injection site, the contact member 1102 may be movable relative to the housing in a cartridge-receiving direction 304. 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, that can provide user input from a user. For example, the first input member 1108 can be used to accept a press 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. The first output member 1110 can provide a user output to a user. The user interface 1100 can include a second output member (not shown), such as 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 steps in a procedure and / or to inform the user of error messages.

[0121] Figure 1 shows a typical auto-injector 4. The auto-injector 4 may be configured to administer a medication. 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 contain a medication.

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

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

[0125] The user interface 1100 may include a first input member 1108, such as a button, as shown. The first input member 1108 may provide user input from a user. For example, the first input member 1108 may be used to accept a press from the user to proceed to the next step.

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

[0127] Figure 2 illustrates an exemplary system 2. System 2 includes an auto-injector 4 as described in connection with Figure 1 and an exemplary cartridge 700 received in a cartridge receiver 300. 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] FIG. 3 illustrates schematically a typical cartridge 700, such as the 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 medication. 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 medication through the cartridge outlet 714.

[0130] The cartridge includes a first stopper 708 that can move within the cartridge chamber, e.g., toward a first cartridge end, e.g., in a first stopper direction 722. For example, medication can be expelled through a cartridge outlet 714 when the first stopper 708 moves in the first stopper direction. The cartridge includes a cartridge rear face 716 at the second cartridge end. The cartridge rear face 716 includes a cartridge rear end opening for providing a plunger rod access to the first stopper 708.

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

[0132] The first cartridge chamber 704 contains a first pharmaceutical component 792 of the pharmaceutical 790. The first pharmaceutical component 792 may be a liquid, as shown. The second cartridge chamber 706 contains a second pharmaceutical component 794 of the pharmaceutical 790. The second pharmaceutical component 794 may be a powder composition. Positioning the second stopper 710 in the bypass portion 712 transports the first pharmaceutical component 792 through the bypass portion 712 into the second cartridge chamber 706, allowing the first pharmaceutical component 792 and the second pharmaceutical component 794 to mix to form the combination pharmaceutical 790.

[0133] 4a-4d schematically illustrate an exemplary cartridge assembly 600. The cartridge assembly 600 includes an exemplary cartridge 700 and an exemplary cartridge code feature 1000. The cartridge 700 has a first cartridge end 718 and a second cartridge end 720. A first stop direction 722 is from the second cartridge end 720 to the first cartridge end 718. The cartridge code feature 1000 is disposed near the second cartridge end 720, e.g., closer to the second cartridge end 720 than to the first cartridge end 718. In another exemplary cartridge assembly, the cartridge code feature 1000 may be disposed near the first cartridge end 718.

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

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

[0136] 4b shows an exemplary cartridge assembly 600 in which the cartridge code feature 1000 comprises a bar code. The cartridge code feature 1000 can comprise one or more bar codes. The bar codes can display numbers that represent the code of the cartridge code feature 1000.

[0137] 4c shows an exemplary cartridge assembly 600 in which the cartridge code feature 1000 includes strips with different checkerboard patterns. For example, as shown, the cartridge code feature 1000 can include two strips, with the first strip being checkerboard at 45 degrees and the second strip being checkerboard at -45 degrees. The checkerboard and / or the checkerboard of the strips relative to each other can represent a code for the cartridge code feature 1000.

[0138] 4d shows an exemplary 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 illustrates an exemplary system 2. System 2 includes an auto-injector 4, for example as described in relation to Figure 1, and an exemplary cartridge assembly 600. Cartridge assembly 600 includes a cartridge 700 having a cartridge chamber 702, a needle assembly 900, and a cartridge code feature 1000. Cartridge assembly 600 is received in auto-injector 4.

[0140] The cartridge assembly 600 includes a cartridge holder 800. The cartridge holder 800 is configured to hold the cartridge 700 in the cartridge receiver 300 of the automatic injector 4. The cartridge holder 800 includes a cartridge retaining member 808. The cartridge retaining member 808 engages with the cartridge receiver 300 to receive and retain the cartridge 700 and 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 the needle hub 904 having a cartridge holder coupling portion 906, e.g., a threaded portion, that engages with 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 may be blocked by an elastic seal that is pierced 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 automatic injector 4 includes a plunger rod 400. The plunger rod 400 is configured to advance a first stopper of the cartridge 700. The plunger rod 400 includes an outer plunger rod 404 with a female thread and an inner plunger rod 402 with a male thread. The threads of the inner plunger rod 402 engage with the threads of the outer plunger rod 404. Rotation of the outer plunger rod 404 relative to the housing of the automatic injector is prevented. Movement of the plunger rod 400 causes rotation of the inner plunger rod 402. Rotation of the inner plunger rod 402 results in translation of the outer plunger rod 404 because rotation of the outer plunger rod 404 is restricted. When the outer plunger rod 404 translates in a first stopper direction 722, it abuts the first stopper of the cartridge 700 and moves the first stopper in the first stopper direction 722.

[0144] A drive module 500 is coupled 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, such as 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] While the illustrated example includes a motor 502 that may be an electromechanical motor, it will be readily appreciated that auto-injectors 4 having other drive modules are possible, including, for example, a solenoid motor, a shape memory metal engine, a spring device, and / or pressurized gas configured to actuate the plunger rod 400.

[0146] The auto-injector 4 includes 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 400. In the illustrated example, the ejection sensor 26 includes a tachometer configured to count / detect rotations of the motor 502. Thus, the position of the plunger rod 400 can be determined based on the total number of rotations of the motor 502. The ejection sensor 26 can detect the ejection of medication and / or air from the cartridge chamber based on detecting the position of the plunger rod 400. The position of the plunger rod 400 can represent the position of a 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 to 6d show a schematic representation of an auto-injector 4 and cartridge assembly 600. Figures 6a to 6d show a schematic representation of typical positions of the contact member 1102 of the auto-injector 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 with the contact member 1102. The contact member 1102 may be biased toward the contact member extended position by, for example, a contact member spring (not shown).

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

[0150] The automatic 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 a 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 second contact member sensor 1132 when the contact member 1102 is in the second contact member position.

[0151] A 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. A second contact member position can be detected by the first contact member sensor 1130 being uncovered and the second contact member sensor 1132 being covered. A contact member extended position can be detected by the first contact member sensor 1130 being uncovered and the second contact member sensor 1132 being uncovered.

[0152] 6a shows a schematic representation of the auto-injector 4 without a cartridge and / or cartridge assembly. The contact member 1102 is in a contact member extended position. A cartridge can be inserted into the cartridge receiver 300 in a cartridge-receiving direction 304 through the contact member 1102, which defines the cartridge receiver opening 301.

[0153] 6b schematically illustrates the auto-injector 4 receiving the cartridge assembly 600. The cartridge assembly 600 includes the cartridge 700, the cartridge holder 800, and the 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 that engages with the needle cover engagement member 1114 of the contact member 1102. The contact member 1102 is in a second contact member position, which is 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 engagement 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 auto-injector 4 receiving the cartridge assembly 600. Compared to Figure 6b, the needle cover 908 has been removed. The contact member 1102 is in the contact member extended position. Because the needle cover abutment surface 910 is not abutting the needle cover engagement member 1114, the contact member 1102 can move to the contact member extended position. The contact member protrusion 1112 also moves 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] 6d shows a schematic representation of the auto-injector 4 receiving the cartridge assembly 600. The contact member 1102 is in a first contact member position, which may be at or near the contact member retracted position. The needle 902 can be inserted into the injection site by moving the contact member 1102 to the first contact member position by pressing the contact member 1102 against the injection site. The contact member protrusion 1112 also moves 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] 7 shows a block diagram of a typical auto-injector 4. The auto-injector 4 comprises a plurality of sensors 22, 24, 26, 28, 30, 32, 34, a processing unit 20, a driver 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 driver 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 includes an orientation sensor 22. The orientation sensor 22 is configured to provide an orientation signal representative of the orientation of the cartridge received in the auto-injector 4. For example, the orientation sensor 22 may be configured to detect the orientation of the auto-injector 4. The orientation of the cartridge may be determined based on the orientation of the auto-injector 4. The orientation sensor 22 may be configured to detect the direction of gravity. For example, the orientation sensor 22 may 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 toward a pre-mixing plunger rod position, a mixing plunger rod position, a prime plunger rod position, etc., only if the cartridge outlet faces upward. Alternatively or additionally, the processing unit 20 can provide a user output via the user interface 1100 based on the orientation signal.

[0160] The auto-injector 4 includes a code sensor 24. The code sensor 24 is configured to read cartridge code features and provide a code signal representative of the cartridge code features. For example, the code sensor may 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 the code signal. The processing unit 20 can determine cartridge code characteristics 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 to move the plunger rod toward a pre-mixing plunger rod position, a mixing plunger rod position, a prime plunger rod position, and / or an injection plunger rod position, etc., based on the code signal. The processing unit 20 can be configured to determine a threshold, such as a plunger rod threshold and / or a resistance threshold, based on the code signal. Alternatively or additionally, the processing unit 20 can provide a user output via the user interface 1100 based on the code signal.

[0162] The auto-injector 4 includes an ejection sensor 26, such as a plunger rod position sensor, configured to detect the position of the plunger rod of the auto-injector 4 and provide an ejection sensor signal indicative of the position of the plunger rod. The ejection sensor 26 may include a tachometer coupled to the drive module 500.

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

[0164] The auto-injector 4 includes a cartridge sensor 28. The cartridge sensor 28 is configured to detect receipt of a cartridge assembly in the auto-injector 4. The cartridge sensor 28 provides a cartridge sensor signal indicative of receipt 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 initiate movement of the plunger rod if and / or only if the cartridge assembly is accepted. Alternatively, or additionally, 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 cartridge sensor 28 may be the same sensor, for example, the code sensor 24 may be configured to detect receipt of the cartridge assembly and then read the cartridge code features.

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

[0168] The processing unit 20 is connected to the needle sensor 30. The processing unit 20 is configured to receive a 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 initiate movement of the plunger rod toward, e.g., an extended plunger rod position, such as 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, only if a needle is present and / or only if a needle cover is not present, e.g., removed. Detection of the needle cover can indicate the presence of a needle. The processing unit 20 can be configured to control the drive module 500 to initiate operation only if a needle cover is detected and then subsequently not detected, e.g., removed. Alternatively, or additionally, 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.

[0170] The auto-injector 4 includes a temperature sensor 32. The temperature sensor 32 is configured to detect a temperature, such as the temperature of the auto-injector and / or cartridge and / or medicament. The temperature sensor 32 is configured to provide a temperature signal representative of the temperature.

[0171] The processing unit 20 is connected to the temperature sensor 32. The processing unit 20 is configured to receive a temperature signal. The processing unit 20 can be configured to determine a temperature, such as a temperature of the auto-injector and / or cartridge and / or medicament, 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 to move the plunger rod toward an extended plunger rod position, such as 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, based on the temperature signal. The processing unit 20 can determine a position of the plunger rod based on the temperature signal. For example, the processing unit 20 can be configured to determine 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 based on the temperature signal. Alternatively or additionally, the processing unit 20 can provide a user output via the user interface 1100 based on the temperature signal.

[0172] The auto-injector 4 includes a resistance sensor 34. The resistance sensor 34 is configured to detect resistance to movement of the plunger rod of the auto-injector 4. The resistance sensor 34 can be configured to detect resistance to movement of the plunger rod based on measurements from the drive module 500. For example, the resistance sensor 34 can be configured to detect current in a motor of the drive module 500. The resistance sensor 34 is configured to provide a resistance signal representative of resistance to 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 the resistance signal. The processing unit 20 can be configured to determine a resistance to 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 movement of the plunger rod based on the resistance signal. Alternatively, or in addition, the processing unit 20 can provide a user output via the user interface 1100 based on the resistance signal.

[0174] An auto-injector 4 is illustrated that includes all of the above-described sensors. However, the auto-injector may alternatively include only one of the above-described sensors or any combination of one or more of the above-described sensors.

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

[0176] The processing unit 20 is connected to the user interface 1100. The processing unit 20 is configured to receive a user input signal, 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 to move the plunger rod toward 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, based on and / or in accordance with the user input signal.

[0177] The auto-injector comprises a housing 6 that houses the 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 illustrate an exemplary cartridge assembly 600 and plunger rod 400. Cartridge assembly 600 includes a cartridge 700, such as the cartridge described in connection with Figure 3, a cartridge holder 800, and a needle assembly 900. For clarity, the auto-injector including plunger rod 400 is not shown.

[0179] The cartridge holder 800 includes a cartridge retaining member 808. The cartridge retaining member 808 is configured to engage a cartridge receiver of the automatic injector. The cartridge holder 800 includes a needle assembly mating portion 812. The needle assembly mating portion 812 is configured to engage with the cartridge holder mating portion 906 of the needle assembly 900. The needle assembly mating portion 812 allows for attachment of a 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 the needle hub 904 having a cartridge holder coupling 906, e.g., a threaded portion, that engages with the needle assembly coupling 812 of the cartridge holder 800. The needle 902 extends through the cartridge outlet 714 of the cartridge 700.

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

[0182] FIG. 8b schematically illustrates a situation in which the plunger rod 400 is in a typical pre-mix plunger rod position. Compared to FIG. 8a, the plunger rod 400 moves toward the plunger rod extended position. The plunger rod front end 410 of the plunger rod 400 abuts the first stopper 708. Thus, the plunger rod 400 begins 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, for example, in a position rearward of the bypass portion 712, where the bypass portion 712 does not provide communication between the first chamber 704 and the second chamber 706.

[0183] 8c schematically illustrates the plunger rod 400 in a typical position where communication is established between the first chamber 704 and the second chamber 706 via the bypass portion 712. The plunger rod front end 410 of the plunger rod 400 abuts the first stopper 708. The plunger rod 400 moves in the first plunger rod direction 422, causing the first stopper 708 to move in the first stopper direction 722. The second stopper 710 is located in the bypass portion 712, where the bypass portion 712 establishes communication between the first chamber 704 and the second chamber 706. In this manner, further movement of the first stopper 708 in the first stopper direction 722, e.g., by movement of the plunger rod 400 in the first plunger rod direction 422, transports the contents of the first chamber 704, e.g., a first pharmaceutical component (not shown), into the second chamber 706, e.g., through the bypass portion 712.

[0184] 8d shows a schematic representation of the plunger rod 400 in a typical mixing plunger rod position. The plunger rod front end 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 beyond the bypass portion 712. Thus, communication between the first chamber 704 and the second chamber 706 is closed.

[0185] Figure 8e shows a schematic diagram of plunger rod 400 in a typical prime plunger rod position, as compared to Figure 8d, where plunger rod 400 has been moved toward the extended plunger rod position, for example, to expel air from cartridge chamber 702.

[0186] 8f schematically illustrates a situation in which the plunger rod 400 is in a typical injection plunger rod position. For example, after a complete injection, the plunger rod 400 can be in the injection plunger rod position. The first stopper 708 and the second stopper 710 are in a position proximate to the cartridge outlet 714. The contents of the cartridge components, e.g., a medication, have been expelled, e.g., through the cartridge outlet 714 and / or the needle 902. Residual medication may remain in the cartridge.

[0187] FIG. 9 shows a typical progression 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), e.g., the plunger rod has not yet pressed the stopper. After that, the plunger rod tip 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 the resistance to the movement of the first stopper due to, e.g., frictional forces. As shown, the resistance may decrease slightly after the first stopper begins to move. As the plunger rod approaches the plunger rod extended position PE, the resistance may increase again (Ex3), e.g., due to the first stopper approaching the end of the cartridge.

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

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

[0190] Transition T2 illustrates a typical situation in which resistance to movement increases beyond the low resistance threshold Re1 before the plunger rod position reaches the first plunger rod threshold P1. Such a situation may indicate, for example, that the cartridge is defective or that something is obstructing plunger rod movement. 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 illustrates a typical situation in which resistance to movement does not increase beyond the low resistance threshold Re1 before the plunger rod position reaches the second plunger rod threshold P2. Such a situation may indicate, for example, a cartridge with the first stopper in the advanced position, such as a used cartridge. In response to such a situation, the plunger rod may be returned to the plunger rod retracted position, and an error message may be provided via the user interface.

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

[0193] Thresholds 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 the received cartridge. For example, a processing unit of the auto-injector can be configured to determine one or more of the thresholds based on a cartridge code feature of the received cartridge and / or cartridge assembly.

[0194] 10 shows a flow diagram of an exemplary method 4000 for operating an auto-injector. The method 4000 includes step 4002 of receiving a first input signal, step 4004 of detecting receipt of a cartridge, for example, in a cartridge receiver of the auto-injector, step 4006 of moving a plunger rod to a mixing plunger rod position, step 4008 of determining an orientation of the cartridge, step 4010 of moving the plunger rod to a prime plunger rod position based on the orientation of the cartridge, step 4012 of receiving a trigger event, and step 4014 of moving the plunger rod to an injection plunger rod position.

[0195] The step 4002 of receiving a first input signal may include receiving a user input signal from a user interface, for example, by a user pressing a button. The first input signal may also be caused by a user turning on the auto-injector.

[0196] Detecting receipt of a cartridge 4004 can include detecting a user inserting a cartridge into the cartridge receiver through a cartridge receiver opening. Detecting receipt of a cartridge 4004 can include detecting the presence of a cartridge in the cartridge receiver.

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

[0198] The step 4006 of moving the plunger rod to the mixing plunger rod position may occur after detecting 4004 the cartridge received by the cartridge receiver and receiving 4002 the first input signal. For example, the step 4006 of moving the plunger rod to the mixing plunger rod position may be performed only after detecting 4004 the cartridge and receiving 4002 the first input signal.

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

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

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

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

[0203] Receiving a trigger event 4012 can include receiving a user input signal from a user interface, such as receiving a trigger event from a trigger member by, for example, a user pressing a button. The trigger event can be a user indicating an injection is to begin. The trigger event can be a user pressing the front of the automatic injector against an intended injection site. The trigger event can include a contact member signal indicating that a contact member of the automatic injector is in a first contact member position.

[0204] Movement 4014 of the plunger rod to the injection plunger rod position can result in expulsion of the medication through the cartridge outlet, such as through a needle. Movement 4014 of the plunger rod can occur following receipt of a trigger event 4012, for example, after completion of movement 4010 of the plunger rod to the prime plunger rod position.

[0205] 11 shows a flow diagram of an exemplary method 4000'. Method 4000' includes the same steps as method 4000 described in connection with the previous figure. However, method 4000' is an example of a method that includes the additional steps of reading a cartridge code feature 4016, detecting a temperature 4018, detecting removal of a needle cover 4024, moving a plunger rod to a pre-mix plunger rod position 4020, and detecting resistance to movement of the plunger rod 4022.

[0206] The method 4000' includes a step 4016 of reading a cartridge code feature. The cartridge code feature can indicate one or more cartridge specifications. Subsequent steps of the method 4000' can include adapting based on the cartridge specifications. For example, subsequent steps of the method 4000' can be tailored to the particular cartridge that has been received and identified.

[0207] The step of detecting 4018 the temperature may include detecting the temperature of the cartridge and / or a temperature indicative of the temperature of the cartridge. Subsequent steps of the method 4000' may include adapting based on the temperature.

[0208] As shown, the step of reading cartridge code features 4016 and the step of detecting temperature 4018 may be performed simultaneously, although sequential performance is also possible in the alternative.

[0209] Detecting removal of the needle cover 4024 may be a prerequisite for initiating movement of the plunger rod, for example, removal of the needle cover may indicate intent to use the received cartridge.

[0210] Step 4020 of moving the plunger rod to a pre-mixing plunger rod position can include an initial movement of the first stopper of the cartridge, e.g., a movement of the first stopper without initiating mixing of the two-component drug.

[0211] Detecting resistance to movement of the plunger rod 4022 can be performed simultaneously with moving the plunger rod to the pre-mix plunger rod position 4020, as shown. Detecting resistance to movement of the plunger rod 4022 can indicate cartridge parameters of the received cartridge, such as whether the cartridge is new, unused, or defective.

[0212] Step 4006 of moving the plunger rod to the mixing plunger rod position can be followed by 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 resistance to 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 a cartridge code feature, temperature, removal of the needle cover, and / or resistance to 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 a cartridge code feature, temperature, removal of the needle cover, and / or resistance to movement of the plunger rod.

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

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

[0217] 12 shows a flow diagram of an exemplary embodiment of an exemplary method 4000'. The illustrated flow diagram may be an exemplary embodiment in a processing unit of an auto-injector.

[0218] The procedure is initiated by receiving a first input signal 5002. A user may initiate the procedure by turning on the device, for example by providing the first input signal via a user interface.

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

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

[0221] Reading 5006 the cartridge code features is followed by sensing 5008 a temperature, such as the temperature of the received cartridge.

[0222] Following the detection of temperature 5008 and reading of cartridge code features 5006, the needle cover is detected 5010 to be present or removed. If the needle cover is not removed, a user output may be provided, for example via a user interface, prompting the user 5042 to remove the needle cover. If or when the needle cover is removed 5010, the plunger rod is moved 5012 to a pre-mix plunger rod position. During this movement, resistance to movement of the plunger rod is measured.

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

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

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

[0226] After the plunger rod is moved 5016 to the mixing plunger rod position, a delay 5018 is inserted to reconstitute the combined drug components into a drug for injection. The delay 5018 may be between 1 and 12 minutes, such as between 3 and 10 minutes. During the delay, a user output may be provided via the user interface, and the user output may indicate the reconstitution.

[0227] After the medication has been reconstituted and / or a suitable delay for medication reconstitution has elapsed 5018, the orientation of the cartridge is assessed 5020. The orientation of the cartridge can be assessed from a measurement of the orientation of the auto-injector. The orientation must be acceptable for performing air evacuation, e.g., the cartridge outlet should be pointing upwards so that air can be expelled and / or reduced. If the orientation 5020 is not acceptable, e.g., the cartridge outlet is not pointing upwards and / or the cartridge is not within 45 degrees of vertical, the user can be prompted 5046, e.g., via a user interface, to correctly orient the auto-injector, e.g., with the cartridge outlet pointing upwards.

[0228] If or when the orientation is acceptable 5020, 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 reading 5006 a cartridge code feature and / or detecting 5008 a temperature.

[0229] After moving the plunger rod to the prime plunger rod position 5022, the user is prompted, e.g., via a user interface, to perform a visual inspection 5024 of the medication. For example, the user may be provided with the possibility to abort the procedure if medication sediment is visible. To accept the visual quality of the medication, the user may provide a second input signal, e.g., by pressing a button on the user interface. The button used to provide the second input signal may be the same button used to provide the first input signal. After reconstitution of the medication and / or after a suitable delay 5018 for reconstitution of the medication, the user may cease being prompted to perform the visual inspection 5024 and / or the procedure may be aborted if a rest period of, e.g., 4-5 hours has elapsed.

[0230] After receiving the second input signal 5026, the user may be prompted 5028, for example via a user interface, to begin injection of the medication. The user may inject the medication by causing a trigger event, for example by pressing a contact member of the auto-injector toward the intended injection site, for example by inserting the needle into tissue at the intended injection site. The user is continually prompted 5028 to begin the injection until a trigger event is received 5030.

[0231] After receiving 5030 a trigger event, the plunger rod is moved 5032 to an injection plunger rod position, for example, to expel the medicament from the cartridge, such as to inject the medicament into tissue at the intended injection site.

[0232] It may be preferable to delay needle retraction to allow for medication to be dispensed into the tissue after the plunger rod has been moved to the injection plunger rod position 5032. Thus, the auto-injector may prompt the user, e.g., via a user interface, to wait 5034 for a set dwell time, e.g., between 1 and 15 seconds.

[0233] After receiving 5030 a trigger event and / or moving 5032 the plunger rod to the injection plunger rod position and / or prompting the user to wait a set dwell time 5034, skin contact is assessed 5036, e.g., whether the contact member is still pressed against the intended injection site. If skin contact is still present after the dwell time, the user is notified 5048 that an injection has occurred and / or that they may remove the auto-injector from the injection site.

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

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

[0236] 13a-13d illustrate schematically an exemplary user interface 1100 of a typical auto-injector 4, such as the auto-injector 4 shown in FIG.

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

[0238] The user interface 1100 may include a second output member (not shown), such as a speaker.

[0239] The user interface 1100 includes a contact member 1102, for example, at the front end of the auto-injector 4. The contact member 1102 can be configured to be pressed against an 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 a light, such as a flashing light.

[0240] The user interface 1100 includes a first input member 1108, such as a button. The first input member 1108 can provide user input from a user. For example, the first input member 1108 can be used to accept a press 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 a light, such as a flashing light.

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

[0242] 13b schematically illustrates a situation in the user interface 1100 in which the first input member 1108 and the contact members 1102 are emitting light, such as flashing. The first input member 1108 and the contact members 1102 may flash synchronously and / or asynchronously. The situation shown may be a situation that signals to the user that they should press the first input member 1108 and / or insert a cartridge through the contact members 1102. The situation shown may be a situation after the auto-injector has been turned on.

[0243] 13c schematically illustrates a state of the user interface 1100 in which the first input member 1108 and the second LED 1118 are emitting light, such as flashing. The illustrated state may indicate that the user should proceed to the next step by pressing the first input member 1108. The illustrated state may be after mixing of the pharmaceutical ingredients and / or before air evacuation.

[0244] 13d schematically illustrates a situation of the user interface 1100 in which the first input member 1108, the contact member 1102, and the third LED 1120 are emitting light, such as flashing. The first input member 1108, the contact member 1102, and the third LED 1120 can flash synchronously and / or asynchronously. The situation shown may be a situation that indicates that the user should press the contact member 1102 against the intended injection site to inject the medication. The situation shown may be a situation prior to injecting the medication.

[0245] Figure 14 shows a flow diagram of a variation of the exemplary embodiment shown in Figure 12. The illustrated flow diagram may be an exemplary embodiment for a processing unit of an auto-injector.

[0246] The procedure is initiated by receiving a first input signal 5002. A user may initiate the procedure by turning on the device, for example by providing the first input signal via a user interface.

[0247] Following receipt 5002 of the first input signal, it is determined whether acceptance of the cartridge into the cartridge receiver of the auto-injector is detected 5004. If not, an output can be provided 5040 via the user interface.

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

[0249] Reading 5006 the cartridge code features is followed by sensing 5008 a temperature, such as the temperature of the received cartridge.

[0250] Following the detection of temperature 5008 and reading of cartridge code features 5006, the needle cover is detected 5010 to be present or removed. If the needle cover is not removed, a user output may be provided, for example via a user interface, prompting the user 5042 to remove the needle cover. If or when the needle cover is removed 5010, the plunger rod is moved 5012 to a pre-mix plunger rod position. During this movement, resistance to movement of the plunger rod is measured.

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

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

[0253] If the resistance 5014 is acceptable, the orientation of the cartridge is evaluated 5020. The orientation of the cartridge can be evaluated from a measurement of the orientation of the auto-injector. The orientation must be acceptable for combining the first and second pharmaceutical components, e.g., to avoid excessive foaming during the process. For example, an acceptable orientation may be for the cartridge to have the cartridge outlet pointing upward. If the orientation 5020 is not acceptable, e.g., the cartridge outlet is not pointing upward and / or the cartridge is not within 45 degrees of vertical, the user can be prompted 5046, e.g., via a user interface, to correctly orient the auto-injector, e.g., with the cartridge outlet pointing upward.

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

[0255] After the plunger rod is moved 5016 to the mixing plunger rod position, a delay 5018 is inserted to reconstitute the combined drug components into a drug for injection. The delay 5018 may be between 1 and 12 minutes, such as between 3 and 10 minutes. During the delay, a user output may be provided via the user interface, and the user output may indicate the progress of the reconstitution. The delay may be dependent on cartridge specifications, for example, from reading 5006 of the cartridge code feature.

[0256] After the medication is reconstituted and / or a suitable delay for medication reconstitution has elapsed 5018, 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 reading 5006 a cartridge code feature and / or detecting 5008 a temperature.

[0257] The 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, e.g., via a user interface, to perform a visual inspection 5024 of the medication. For example, the user may be provided with the possibility to abort the procedure if medication sediment is visible. To accept the visual quality of the medication, the user may provide a second input signal, e.g., by pressing a button on the user interface. The button used to provide the second input signal may be the same button used to provide the first input signal. After reconstitution of the medication and / or after a suitable delay 5018 for reconstitution of the medication, the user may cease being prompted to perform the visual inspection 5024 and / or the procedure may be aborted if a rest period of, e.g., 4-5 hours has elapsed.

[0259] After receiving the second input signal 5026, the user may be prompted 5028, for example via a user interface, to begin injection of the medication. The user may inject the medication by causing a trigger event, for example by pressing a contact member of the auto-injector toward the intended injection site, for example by inserting the needle into tissue at the intended injection site. The user is continually and / or repeatedly prompted 5028 to begin the injection until a trigger event is received 5030.

[0260] After receiving 5030 a trigger event, the plunger rod is moved 5032 to an injection plunger rod position, for example, to expel the medicament from the cartridge, such as to inject the medicament into tissue at the intended injection site.

[0261] It may be preferable to delay retraction and / or removal of the needle to allow for delivery of the medication into the tissue after the plunger rod has been moved to the injection plunger rod position 5032. Thus, the auto-injector may prompt the user, e.g., via a user interface, to wait a set dwell time 5034, e.g., between 1 and 15 seconds, before retracting the needle.

[0262] After receiving 5030 a trigger event and / or moving 5032 the plunger rod to the injection plunger rod position and / or prompting the user to wait a set dwell time 5034, skin contact is assessed 5036, e.g., whether the contact member is still pressed against the intended injection site. If skin contact is still present after the dwell time, the user is notified 5048 that an injection has occurred and / or that they may remove the auto-injector from the injection site.

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

[0264] After movement 5038 of the plunger rod to the plunger rod retracted position, the cartridge can be removed and discarded.

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

[0266] (Item 1) 1. An automatic injector for dispensing and / or administering a medicament from a cartridge having a first cartridge end and a second cartridge end, a cartridge outlet located in the first cartridge end, and a cartridge chamber comprising a first cartridge chamber containing a first medicament component of the medicament and a second cartridge chamber containing a second medicament component, comprising: Housing and a cartridge receiver having a cartridge receiver opening configured to receive the cartridge by insertion of the second end of the cartridge through the cartridge receiver opening; a cartridge sensor configured to detect receipt of a cartridge into the cartridge receiver and to provide a cartridge detection signal indicative of receipt of a cartridge into the cartridge receiver; a drive module coupled to move a plunger rod configured to move the first stopper between a plunger rod retracted position and a plunger rod extended position; an orientation sensor configured to provide an orientation signal indicative of an orientation of a cartridge received by the cartridge receiver; a processing unit connected to the orientation sensor, the cartridge sensor, and the drive module; It is equipped with The processing unit receiving a first input signal; receiving the cartridge detection signal; controlling the drive module to move the plunger rod to a mixing plunger rod position in response to receiving the cartridge detect signal and the first input signal; receiving the orientation signal; Based on the orientation signal, upon completion of movement of the plunger rod to the mix plunger rod position, controlling the drive module to move the plunger rod to a prime plunger rod position. 1. An auto-injector configured as follows:

[0267] (Item 2) The processing unit Receive trigger events, upon receiving the trigger event after completion of movement of the plunger rod to the prime plunger rod position, controlling the drive module to move the plunger rod to an injection plunger rod position. Item 1. The auto-injector of item 1, further configured as follows:

[0268] (Item 3) 3. The automatic injector of claim 1 or 2, wherein the orientation sensor comprises an accelerometer.

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

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

[0271] (Item 6) 6. The automatic injector of claim 4 or 5, wherein control of the drive module to move the plunger rod to the prime plunger rod position is based on the code signal.

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

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

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

[0275] (Item 10) 10. The automatic injector of any one of items 1 to 9, further comprising a resistance sensor configured to provide a resistance signal representative of resistance to movement of the plunger rod, wherein the processing unit is connected to the resistance sensor and configured to receive the resistance signal.

[0276] (Item 11) Item 11. The automatic injector of item 10, wherein the processing unit is configured to determine whether the cartridge is genuine based on the resistance signal.

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

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

[0279] (Item 14) 14. The automatic injector of any of items 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 if the resistance signal indicates that resistance to movement of the plunger rod exceeds a low resistance threshold.

[0280] (Item 15) 15. The automatic injector of any one of items 1 to 14, comprising a first input device configured to provide a first input signal, the first input signal representing a first user interaction via the first input device, and the processing unit connected to the first input device.

[0281] (Item 16) 16. The automatic injector of any one of items 1 to 15, comprising a contact member movable between a contact member extended position and a contact member retracted position, the contact member being biased towards the contact member extended position and 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 representative of the position of the contact member, and the processing unit being connected to the contact member and configured to receive the contact member signal.

[0282] (Item 17) Item 17. The automatic injector of item 16 when dependent on item 2, wherein the trigger event includes the contact member signal representing the contact member being in a first contact member position.

[0283] (Item 18) Item 16 or 17, the automatic injector, wherein the contact member is configured to be positioned in a second contact member position when a 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.

[0284] (Item 19) 19. The automatic injector according to any one of items 1 to 18, wherein 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 tilt angle between the vertical and a 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.

[0285] (Item 20) 20. The automatic injector of any one of items 1 to 19, wherein 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, wherein the movement of the plunger rod to the pre-mixing plunger rod position has a pre-mixing plunger rod velocity, and the movement of the plunger rod to the mixing plunger rod position has a mixing plunger rod velocity, and the pre-mixing plunger rod velocity is faster than the mixing plunger rod velocity.

[0286] (Item 21) 21. The automatic injector according to any one of items 1 to 20, wherein 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 recovery time has elapsed since completion of movement of the plunger rod to the mixing plunger rod position.

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

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

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

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

[0291] (Item 26) 26. The automatic injector of any one of items 1 to 25, wherein control of the drive module to move the plunger rod to the mixing plunger rod position is based on the orientation signal.

[0292] (Item 27) Item 27. The automatic injector of item 26, 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 orientation signal indicates that the tilt angle between the vertical and a 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.

[0293] (Item 28) 28. The automatic injector of any one of items 1 to 27, wherein movement of the plunger rod to the mixing plunger rod position locks the cartridge into the cartridge receiver.

[0294] (Item 29) 29. The automatic injector of any one of items 1 to 28, wherein movement of the plunger rod to the plunger rod retracted position unlocks the cartridge in the cartridge receiver.

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

[0296] (Item 31) 31. A cartridge for an automatic injector comprising a first cartridge end and a second cartridge end, a cartridge outlet located at the first cartridge end, and a cartridge chamber having a first cartridge chamber containing a first pharmaceutical component of a medicament and a second cartridge chamber containing a second pharmaceutical component of the medicament, the cartridge being configured to be received in a cartridge receiver of the automatic injector described in any one of items 1 to 30 by inserting the second cartridge end through a cartridge receiver opening of the automatic injector.

[0297] (Item 32) A system comprising the automatic injector according to any one of items 1 to 30 and the cartridge according to item 31.

[0298] (Item 33) 1. A method for operating an automatic injector comprising: a cartridge receiver configured to receive a cartridge having a first cartridge end and a second cartridge end, a cartridge outlet located in the first cartridge end, and a cartridge chamber having a first cartridge chamber containing a first drug component of a medicament and a second cartridge chamber containing a second drug component of the medicament; and a plunger rod, comprising: receiving a first input signal; detecting receipt of a cartridge into said cartridge receiver; moving the plunger rod to a mixing plunger rod position in response to detecting receipt of a cartridge into the cartridge receiver and receiving the first input signal; determining the orientation of the cartridge; moving the plunger rod to a prime plunger rod position after completing movement of the plunger rod to the mix plunger rod position based on an orientation of the cartridge; A method comprising:

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

Claims

1. 1. An automatic injector for dispensing and / or administering a medicament from a cartridge, the cartridge having a first cartridge end and a second cartridge end, and a cartridge outlet located in the first cartridge end, the cartridge having a cartridge chamber including a first cartridge chamber containing a first medicament component of the medicament and a second cartridge chamber containing a second medicament component of the medicament, Housing and a cartridge receiver having a cartridge receiver opening; a code sensor configured to detect receipt of the cartridge into the cartridge receiver and provide a cartridge detection signal indicative of receipt of the cartridge into the cartridge receiver, and configured to read a cartridge code feature and provide a code signal representative of the cartridge code feature; a drive module coupled to move a plunger rod configured to move the first stopper between a plunger rod retracted position and a plunger rod extended position; an orientation sensor configured to provide an orientation signal indicative of an orientation of the cartridge when received by the cartridge receiver; a processing unit connected to the orientation sensor, the code sensor, and the drive module; and The processing unit receiving a first input signal; receiving the cartridge detection signal; receiving the code signal; receiving the orientation signal; receiving the cartridge detect signal and the first input signal to control the drive module to move the plunger rod to a mixing plunger rod position; and controlling the drive module to move the plunger rod to a prime plunger rod position after completion of movement of the plunger rod to the mix plunger rod position; 1. An auto-injector configured as follows:

2. 2. The automatic injector of claim 1, wherein 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 reconfiguration time has elapsed since completion of movement of the plunger rod to the mixing plunger rod position.

3. The automatic injector of claim 2 , wherein the reconfiguration time is based on the code signal.

4. The processing unit A trigger event is received, and Upon receiving the trigger event, control the drive module to move the plunger rod to an injection plunger rod position after the plunger rod has completed moving to the prime plunger rod position.

4. The automatic injector of claim 1, further configured to:

5. 5. The automatic injector of claim 1, wherein the orientation sensor comprises an accelerometer.

6. 6. The automatic injector of claim 1, further comprising a first input device configured to provide the first input signal, the first input signal representing a first user interaction via the first input device, and the processing unit connected to the first input device.

7. 7. The automatic injector of claim 1, wherein control of the drive module to move the plunger rod to the prime plunger rod position is based on the orientation signal.

8. 8. The automatic injector of claim 7, wherein 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 tilt angle between the vertical and a longitudinal axis extending along the cartridge is within 45 degrees of the vertical and the cartridge outlet is at a higher vertical position than the cartridge chamber.

9. 9. The automatic injector of claim 1, wherein 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, wherein movement of the plunger rod to the pre-mixing plunger rod position has a pre-mixing plunger rod velocity, and movement of the plunger rod to the mixing plunger rod position has a mixing plunger rod velocity, and the pre-mixing plunger rod velocity is faster than the mixing plunger rod velocity.

10. 10. The automatic injector of claim 1, wherein control of the drive module to move the plunger rod to the mixing plunger rod position is based on the orientation signal.

11. 11. The automatic injector of claim 10, 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 orientation signal indicates that a tilt angle between vertical and a longitudinal axis extending along the cartridge is within 45 degrees of vertical and the cartridge outlet is at a higher vertical position than the cartridge chamber.

12. 12. The automatic injector of any one of claims 1 to 11, wherein the medicament is human growth hormone, such as the medicament having product code ACP-011.

13. 13. A cartridge for an automatic injector, the cartridge having a first cartridge end and a second cartridge end, and a cartridge outlet located in the first cartridge end, the cartridge having a cartridge chamber having a first cartridge chamber containing a first pharmaceutical component of a medicament and a second cartridge chamber containing a second pharmaceutical component of the medicament, the cartridge being configured to be received in a cartridge receiver of an automatic injector according to any one of claims 1 to 12 by inserting the second cartridge end of the cartridge through the cartridge receiver opening of the automatic injector.

14. A system comprising an automatic injector according to any one of claims 1 to 12 and a cartridge according to claim 13.

15. 1. A method for operating an automatic 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 a cartridge outlet located at the first cartridge end, the cartridge having a cartridge chamber having a first cartridge chamber containing a first drug component of a medicament and a second cartridge chamber containing a second drug component of the medicament, the method comprising: receiving a first input signal; detecting receipt of a cartridge into said cartridge receiver and reading a cartridge code feature; determining an orientation of the cartridge; moving the plunger rod to a mixing plunger rod position in response to detecting receipt of a cartridge into the cartridge receiver and receiving the first input signal; after completion of movement of the plunger rod to the mix plunger rod position, moving the plunger rod to a prime plunger rod position; A method comprising:

16. 16. The method of claim 15, further comprising the step of the processing unit moving the plunger rod to the prime plunger rod position only after a predetermined reconfiguration time has elapsed since completion of movement of the plunger rod to the mix plunger rod position.

17. The method of claim 16 , wherein the reconstruction time is based on the code signal.

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