Autoinjector with reconstitution support - Patent application

Abstract

To provide an autoinjector, a cartridge, a system, and a method for improving the preparation and administration of a medicament with an autoinjector.SOLUTION: An autoinjector for administering a medicament comprises: a housing; a cartridge receiver configured to receive a cartridge comprising a first stopper and a cartridge compartment containing the medicament; a drive module to move a plunger rod between a retracted plunger rod position and an extended plunger rod position; and a processing unit coupled to the drive module, where the processing unit is configured to control the drive module to move the plunger rod from a first plunger rod position to a mix plunger rod position with a mix plunger rod speed.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to autoinjectors, such as electronic autoinjectors, autoinjector cartridges, systems including autoinjectors and cartridges, and methods for operating autoinjectors. [Background technology]

[0002] Hypodermic syringes are widely used to deliver fluids to the body. It is known to adapt hypodermic syringes to manual operation. However, autoinjectors, such as electronic autoinjectors, have been developed and are widely used to assist in administering fluids or medications to the body.

[0003] There is increasing interest in having automatic injection devices perform as much of the injection process automatically as possible to avoid relying on the user to accurately perform certain tasks. It can be beneficial to automate the process of preparing and administering fluids, such as medications, particularly when the administration of the medication requires multiple steps, such as when the medication needs to be mixed before injection. Furthermore, it can be advantageous to incorporate sensors into such devices to allow for precise control in changing conditions. Summary of the Invention [Problem to be solved by the invention]

[0004] There is a need for autoinjectors, such as electronic autoinjectors, that provide improved automation of medication preparation and administration. The present disclosure provides autoinjectors, cartridges, systems, and methods for improving medication preparation and administration by autoinjectors. [Means for solving the problem]

[0005] Accordingly, an autoinjector for preparing and / or administering a medication, such as a medicament, from a cartridge is disclosed.

[0006] The autoinjector includes a housing, a cartridge receiver, a drive module, and a processing unit.

[0007] The cartridge receiver is configured to receive a cartridge, such as a cartridge including a first stopper and a medicament-containing cartridge compartment, the cartridge compartment having a first cartridge sub-compartment containing a first drug component of the medicament and a second cartridge sub-compartment containing a second drug component of the medicament.

[0008] The drive module is configured to move the plunger rod between a plunger rod retracted position and a plunger rod extended position. The plunger rod is configured to move the first stopper.

[0009] A processing unit is coupled to the drive module and is configured to control the drive module to move the plunger rod from the first plunger rod position to the mixing plunger rod position and to provide a start signal after multiple complete reversals of the autoinjector have been performed.

[0010] The mixing plunger rod position is selected to position the first stopper at a location where the first drug component will be mixed with the second drug component.

[0011] The processing unit is further configured to control the drive module to move the plunger rod from the first plunger rod position to the mixing plunger rod position at a mixing plunger rod velocity, which may be a constant velocity or a varying velocity.

[0012] The initiation signal may be given as an indication that the first and second drug components have been, for example, reconstituted, eg, thoroughly mixed.

[0013] The term "full reversal" refers to a reversal that meets certain requirements regarding the angular velocity at which the reversal is performed and / or the angle over which the reversal of the autoinjector extends. The term reversal typically refers to a reversal of the autoinjector that is performed automatically or manually by a user.

[0014] A flip can be defined as approximately a 180-degree rotation of the autoinjector. One example of a flip is a rotation of the autoinjector from a position where the needle of the autoinjector is pointing up to a position where the needle is pointing down, or vice versa. An alternative example of a flip is a 180-degree rotational movement of the autoinjector from an initial position where the longitudinal axis of the autoinjector is in a horizontal plane and the needle is pointing to the left, to a direction where the needle is pointing up, to a final position where the longitudinal axis of the autoinjector is again in a horizontal plane and the needle is now pointing to the right.

[0015] The inversion may be about an axis in the horizontal plane.

[0016] The number of complete inversions required for a start signal to be provided by the processing unit may depend on the viscosity of the pharmaceutical ingredients being mixed. Higher viscosity pharmaceutical ingredient variants will typically require more complete inversions, e.g., 10 or 20 or even more complete inversions, while lower viscosity pharmaceutical ingredient variants may require fewer complete inversions, e.g., 5 or 10 complete inversions, to obtain effective mixing of the pharmaceutical ingredients and activate the start signal. Thus, more viscous pharmaceutical ingredients will require more inversions than less viscous pharmaceutical ingredient formulations.

[0017] Also disclosed is a cartridge for an autoinjector, such as the autoinjector of the present disclosure. The cartridge includes a first stopper and a cartridge compartment containing a medicament. The cartridge compartment has a first cartridge sub-compartment containing a first drug component of the medicament and a second cartridge sub-compartment containing a second drug component of the medicament. The cartridge can have a first cartridge end and a second cartridge end, and can have a cartridge outlet at the first cartridge end. The cartridge is configured to be received by a cartridge receiver of an autoinjector, such as the cartridge receiver of the present disclosure, for example, by inserting the second end of the cartridge through a cartridge receiver opening of the autoinjector.

[0018] Also disclosed is a system including an autoinjector, such as the autoinjector of the present disclosure, and a cartridge, such as the cartridge of the present disclosure.

[0019] Also disclosed are methods for operating an autoinjector, such as the autoinjector of the present disclosure, including a cartridge receiver configured to receive a cartridge, such as the cartridge of the present disclosure, the cartridge including, for example, a first stopper and a medicament-containing cartridge compartment, the cartridge compartment having a first cartridge sub-compartment containing a first drug component of the medicament and a second cartridge sub-compartment containing a second drug component of the medicament. The autoinjector can further include a plunger rod configured to move the first stopper.

[0020] The method includes moving the plunger rod at a mixing plunger rod velocity from a first plunger rod position to a mixing plunger rod position, the mixing plunger rod position being selected to position the first stopper at a location where the first drug component is mixed with the second drug component; performing multiple complete reversals of the automatic injection device; and, after a start signal is given, moving the plunger rod from the mixing plunger rod position to the second plunger rod position.

[0021] The first plunger rod position may be a premix plunger rod position. The premix plunger rod position may be selected to position the first stopper at a position where fluid communication between the first cartridge sub-section and the second cartridge sub-section has not yet been established. Alternatively, the first plunger rod position may be a plunger rod retracted position, e.g., an initial plunger rod position.

[0022] The second plunger rod position may be a prime plunger rod position. The prime plunger rod position may be selected to position the first stopper at a position where air in the cartridge compartment is reduced to an amount suitable for injection. Alternatively, the second plunger rod position may be an injection plunger rod position. The second plunger rod position may be a plunger rod extended position.

[0023] The method can further include receiving a trigger event and, after receiving the trigger event, moving the plunger rod to the injection plunger rod position, e.g., after completing movement of the plunger rod to the second plunger rod position. The trigger event can be, for example, the completion of a button press, the expiration of a timeout, and / or the completion of a predetermined user behavior. The trigger event can indicate that the automatic injection device is being pressed against the injection site.

[0024] An advantage of the present disclosure is that the processing unit provides a start signal only after multiple complete inversions have been performed, thereby ensuring that the drugs comprising the first and second drug components are mixed into a homogenous solution before injection occurs.

[0025] A further advantage of the present disclosure is that the autoinjector can be operated without measuring the temperature of the medication, as the elimination of the temperature sensing element lowers the target for the autoinjector.

[0026] The processing unit can therefore be configured to operate independently of the temperature of the medicament within the cartridge received in the cartridge receiver.

[0027] Practical experience has clearly established that, depending on the particular drug, physical agitation, i.e., inversion, of the autoinjector is far more effective in supporting the safe preparation of the drug, thereby enabling a fully reconstituted, homogeneous drug to be injected into the patient's skin in the shortest possible time. In practice, even if a long waiting time and exposure of the mixed drug components to elevated temperatures are required, the final homogeneity of the mixed / reconstituted drug cannot be significantly improved over that achievable at room temperature. In contrast, when minimal physical agitation, i.e., fewer physical inversions, are applied, the homogeneity of the reconstituted drug is significantly improved. Physical agitation should be understood as inversion, as opposed to shaking, because shaking tends to introduce numerous air bubbles into the mixture. In low-viscosity liquids, the air bubbles again disappear fairly quickly. However, in high-viscosity liquids, it takes a long time for the air bubbles to disappear. Because the number of air bubbles must be reduced to a certain level and / or completely removed before an accurate dose of medication can be injected, if the medication is highly viscous, it is highly undesirable to introduce a large number of air bubbles into the medication solution during the mixing procedure. Furthermore, during the process of priming prior to injection, there is a risk that a larger portion of the medication will be expelled because the medication is carried in air bubbles. Therefore, it is highly preferable to use inversion rather than a shaking action to mix the first and second medications.

[0028] A further advantage of the present disclosure is the ability to provide an autoinjector that is easy to use and reduces the risk of accidentally administering a medication that is not sufficiently homogenous.

[0029] Thus, a further advantage of the present disclosure is improved patient safety.

[0030] It is contemplated that any embodiment or element described in connection with any one embodiment may be used, mutatis mutandis, with any other embodiment or embodiment.

[0031] The start signal can be generated after the above number of complete inversions of the autoinjector have been performed and when the second cartridge sub-section is pointing up compared to the first cartridge sub-section. The autoinjector can preferably have an up-pointing orientation substantially along a vertical axis or within 45 degrees of a vertical axis. The up-pointing orientation is advantageous for releasing air from the cartridge compartment without expelling the medication.

[0032] The processing unit can be configured to perform a blank shot after the number of complete inversions has been performed. The blank shot can be performed, for example, only when the second cartridge sub-section is pointing up compared to the first cartridge sub-section.

[0033] After the required number of successful / complete inversions have been performed, the autoinjector may indicate this, e.g., audibly and / or visually by light, and may automatically proceed to perform a blank shot when the needle is pointing up, i.e., when the second cartridge sub-compartment is pointing up compared to the first cartridge sub-compartment. A blank shot is advantageously performed after a complete inversion, as any air bubbles remaining after reconstitution will aid mixing during inversion. Once the blank shot has been performed, the medication is ready to be injected.

[0034] A prerequisite for good physical stirring is that the inversion occurs after the two pharmaceutical components are mixed but before the air bubbles are expelled from the cartridge compartment. When air bubbles are present, the mixed pharmaceutical components are able to swirl / move / slide around within the cartridge compartment as a result of the physical input. Air bubbles are typically air bubbles having a volume at least comparable to the total volume of the mixed pharmaceutical components. Preferably, in the present invention, air bubbles are not defined by their volume, but by the cross-sectional area that they partially or completely cover when the cartridge is oriented vertically. Preferably, the air bubbles are large enough to cover at least 25% of the cross-sectional area of ​​the second cartridge sub-section, such as at least 50% of the cross-sectional area of ​​the second cartridge sub-section, or at least 75% of the cross-sectional area of ​​the second cartridge sub-section, or at least 100% of the cross-sectional area of ​​the second cartridge sub-section.

[0035] The processing unit can be further configured to, upon receiving the start signal, control the drive module to move the plunger rod from the mixing plunger rod position to a second plunger rod position, which can be selected to position the first stopper at a position where air in the cartridge compartment is reduced to an amount suitable for injection.

[0036] The cartridge can have a cartridge outlet at a first cartridge end. The cartridge can include a cartridge back at a second cartridge end, e.g., opposite the cartridge outlet. The cartridge back can include a cartridge rear opening. The cartridge rear opening can allow a plunger rod, such as a plunger rod of an autoinjector, to access the first stopper.

[0037] The cartridge compartment can contain a medicament. A cartridge outlet, for example, at a first cartridge end, can be configured to be in fluid communication with the compartment. The cartridge can be configured to release the medicament through the cartridge outlet. The cartridge outlet can be configured to be coupled to a needle, such as a hypodermic needle, to allow the medicament to be released through the needle.

[0038] The cartridge includes a first stopper movable within the cartridge compartment. The cartridge may include a second stopper movable within the cartridge compartment. The second stopper may be between the first stopper and the cartridge outlet. The cartridge may include a third stopper movable within the cartridge compartment. The third stopper may be between the second stopper and the cartridge outlet. The first stopper, the second stopper, and / or the third stopper may be movable within the cartridge compartment toward the cartridge outlet, e.g., in the direction of the first stopper, e.g., toward the first cartridge end. For example, movement of the first stopper, the second stopper, and / or the third stopper, e.g., in the direction of the first stopper and / or toward the cartridge outlet, may release a drug through the cartridge outlet.

[0039] The cartridge may be a dual-chamber cartridge. The cartridge compartment may have a first cartridge sub-compartment and a second cartridge sub-compartment. The first cartridge sub-compartment may be between the first stopper and the second stopper. The second cartridge sub-compartment may be between the second stopper and the cartridge outlet and / or the third stopper.

[0040] The first cartridge sub-compartment can contain a first pharmaceutical component of the medicament. The second cartridge sub-compartment 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.

[0041] The first pharmaceutical component and / or the second pharmaceutical component may be a solute, such as a powder composition. The first pharmaceutical component and / or the second pharmaceutical component may be a solvent, such as a fluid composition, such as a liquid composition. The second pharmaceutical component may be a powder composition, and the first pharmaceutical component may be a fluid composition, such as water, ethanol, saline, a buffer, or a preservative solution. The second pharmaceutical component may be a solute. The first pharmaceutical component may be a solvent. It is contemplated that the pharmaceutical may be any pharmaceutical that is injectable, for example, via a hypodermic needle, after reconstitution of the pharmaceutical. The pharmaceutical may be a growth hormone. The pharmaceutical may be human growth hormone. The pharmaceutical may be a depot version, such as a long-acting version, of human growth hormone. The second pharmaceutical component may be a powder composition of human growth hormone.

[0042] The cartridge may have a bypass portion that allows fluid communication between a first cartridge part-section and a second cartridge part-section, for example, when a second stopper is positioned within the bypass portion. The cartridge may have multiple bypass portions that allow fluid communication between adjacent cartridge part-sections, for example, when stoppers separating adjacent cartridge part-sections are positioned within the bypass portion.

[0043] The autoinjector of the present disclosure can be a reusable autoinjector. Reusable autoinjectors can be particularly useful when the cartridge includes multiple subcompartments. For example, autoinjectors for multi-compartment or multi-chamber cartridges can be more sophisticated and, therefore, it can be beneficial to allow the autoinjector to be used more than once. For example, the autoinjector can provide an automated process for mixing drug components, such as first mixing drug components provided in different subcompartments of the cartridge.

[0044] The cartridge may be included as part of a cartridge assembly. The cartridge assembly may include the cartridge. In addition, the cartridge assembly may include, for example, a needle assembly including a needle, a needle cover, a cartridge holder, and / or a cartridge code mechanism.

[0045] 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 allow the needle assembly to be attached to the cartridge.

[0046] The cartridge can include a cartridge code feature, and / or a cartridge assembly can include a cartridge and a cartridge code feature. The cartridge code feature can include one or more of a color, a bar code, 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 an arrangement of colors. The cartridge code feature can be positioned to surround or partially surround a portion of the cartridge compartment in which a stopper, such as a first stopper, is initially positioned. For example, such a position of the cartridge code feature can make the cartridge code feature easier to read because the stopper can form a background for the cartridge code feature. A stopper, such as a first stopper, can be a light color, such as light gray or white. A stopper, such as a 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. A stopper, such as a first stopper, can reduce light reflection, for example, to make the cartridge code feature even easier to read.

[0047] The cartridge code feature may be positioned at a specific location on the cartridge independent of a stopper, such as the first stopper. For example, the cartridge code feature may be positioned a code distance from the second cartridge end. All cartridges may have their cartridge code feature positioned in the same location, e.g., a code distance from the second cartridge end. Such uniform location of the cartridge code feature may reduce the complexity and size of the autoinjector, since the cartridge code feature is read at the same location for all appropriate cartridges.

[0048] The cartridge and cartridge code feature may be manufactured as a single element. For example, the cartridge code feature may be a specific feature of the cartridge. Alternatively, the cartridge code feature may be attached to the cartridge, for example, secured to the cartridge by adhesive. For example, the cartridge code feature may be a color code printed on the cartridge.

[0049] The cartridge code feature may indicate one or more cartridge specifications, such as the drug in the cartridge, the concentration of the drug in the cartridge, the viscosity of the drug in the cartridge, the volume and / or mass of the drug in the cartridge, the position of a stopper within a cartridge compartment, etc. The cartridge code feature may indicate a first stopper position at which air in the cartridge compartment is reduced, such as minimized and / or reduced to an amount suitable for injection. The cartridge code feature may indicate the amount of drug contained within the cartridge. The cartridge code feature may indicate a particular type of cartridge, such as an ID number for that particular type of cartridge.

[0050] The autoinjector, such as the processing unit of the autoinjector, can be configured to determine one or more cartridge specifications based on the ID number, for example, by table lookup. The cartridge code feature may indicate an appropriate speed, such as optimal, of stopper movement, such as stopper movement during different phases of movement, such as during mixing, blanking, and / or injection. The cartridge code feature may indicate an appropriate speed, such as optimal, of first stopper movement, such as the speed of first stopper movement during different phases of movement, such as during mixing, blanking, and / or injection. The cartridge code feature may indicate a time required for optimal mixing of the first and second drug components. The cartridge code feature may indicate an appropriate drug dwell time, such as a time to ensure drug distribution into the tissue, e.g., a preferred time to wait before retracting the needle after injection. The cartridge code feature may indicate an amount of kinetic energy required for optimal mixing of the first and second drug components. The cartridge code mechanism may indicate the number of complete inversions required to completely mix the medicaments in the two compartments of the cartridge. The movement from the first plunger rod position to the mixing plunger rod position can be based on a code signal indicating the cartridge code mechanism defined by the number of complete inversions required for the medicaments in the cartridge.

[0051] The cartridge code feature may indicate a threshold angular velocity that is required for a reversal of the autoinjector to be considered a complete reversal.The cartridge code feature may indicate a threshold reversal angle that is required for a reversal of the autoinjector to be considered a complete reversal.

[0052] The number of complete reversals may depend on the measured reversal angle and angular velocity at which the reversals are manually performed by the user.

[0053] The autoinjector may be a forward-filling autoinjector. The autoinjector includes a cartridge receiving portion configured to receive a cartridge. The cartridge receiving portion can be configured to receive a cartridge assembly including the cartridge. The cartridge assembly can include a cartridge holder. The cartridge receiving portion can have a cartridge receiving portion opening. The cartridge receiving portion can be configured to receive the cartridge by inserting the cartridge, such as the second end of the cartridge, through the cartridge receiving portion opening. The cartridge can be inserted in a cartridge receiving direction. The cartridge receiving direction can, for example, be opposite to the direction of the first stopper when the cartridge is received in the cartridge receiving portion. The cartridge can be in a first angular position when inserted into the cartridge receiving portion. The cartridge can be held in the cartridge receiving portion in a second angular position, for example, after the cartridge is inserted into the cartridge receiving portion.

[0054] The cartridge receiving portion can be configured to receive a cartridge assembly comprising a cartridge and a cartridge holder. The cartridge assembly can be retained within the cartridge receiving portion by one or more cartridge retaining members of the cartridge holder that engage members of the cartridge receiving portion.

[0055] The cartridge and / or cartridge assembly can be locked within the cartridge receiving portion, for example, to prevent the cartridge and / or cartridge assembly from being removed from the cartridge receiving portion. The cartridge and / or cartridge assembly can be locked within the cartridge receiving portion by movement of a plunger rod of an autoinjector.

[0056] The autoinjector can include a cartridge sensor. The cartridge receiver can include a cartridge sensor. The cartridge sensor can be configured to detect when a cartridge and / or cartridge assembly is received in the cartridge receiver. The cartridge sensor can provide a cartridge sensor signal indicative of whether the cartridge and / or cartridge assembly is received in the cartridge receiver. The cartridge sensor can provide a cartridge detect signal indicative of when the cartridge and / or cartridge assembly is received in the cartridge receiver. The cartridge sensor signal can include a cartridge detect signal.

[0057] The autoinjector may be an electronic autoinjector. The autoinjector may include a battery. A housing may house the battery. The battery may be a rechargeable battery. For example, the battery may be a lithium-ion battery, a nickel-cadmium battery, or a nickel-metal hydride battery. The battery may be configured to be charged by connecting a charger.

[0058] The autoinjector includes a drive module. The drive module can be coupled to actuate, advance, or otherwise move the plunger rod, such as between a plunger rod retracted position and a plunger rod extended position. Movement of the plunger rod can enable the cartridge and / or cartridge assembly to be locked within the cartridge receiver. For example, the cartridge and / or cartridge assembly can be locked within the cartridge receiver by advancing the plunger rod from the plunger rod retracted position.

[0059] The drive module can include one or more electronic 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 by a housing. The drive module can include a motor, such as an electromechanical motor, e.g., a DC motor, e.g., a DC motor with or without brushes. 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 arrangement configured to actuate the plunger rod. The drive module can include pressurized gas configured to actuate the plunger rod.

[0060] The autoinjector can include a plunger rod, such as a plunger rod movable 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 a plunger rod extended position, such as from a first plunger rod position to a mixing plunger rod position and / or from a mixing plunger rod position to a second plunger rod position, the plunger rod can be configured to move the first stopper toward the cartridge outlet, such as to mix two drug components and / or expel drug from a cartridge compartment through a cartridge outlet and / or expel air from a cartridge compartment through a cartridge outlet.

[0061] The plunger rod can be moved from, such as a plunger rod retracted position, to, such as a plunger rod extended position, to a first plunger rod position, such as a premix plunger rod position. The first plunger rod position can be a premix plunger rod position. The premix plunger rod position can be selected to position the first stopper at a position where fluid communication between the first cartridge sub-section and the second cartridge sub-section has not yet been established.

[0062] The plunger rod can be moved, such as from a first plunger rod position, to a mixing plunger rod position, such as from a plunger rod extended position. The mixing plunger rod position can be a position where the first and second drug components are mixed, such as combined. The mixing plunger rod position can be a position where a second stopper is positioned within the bypass portion, such as to allow fluid communication between the first and second cartridge sub-compartments.

[0063] The plunger rod can be moved to a second plunger rod position, such as from a mixing plunger rod position, to a plunger rod extended position. The second plunger rod position can be a primed plunger rod position. The primed plunger rod position can be selected to position the first stopper at a position where air is being released from the cartridge compartment. For example, the primed plunger rod position can be selected to position the first stopper at a position where air in the cartridge compartment is minimized and / or reduced to an amount suitable for injection.

[0064] The plunger rod can be moved from, e.g., a second plunger rod position, to, e.g., a plunger rod extended position, to an injection plunger rod position. The injection plunger rod position can be a position where medicament is being expelled and / or injected from a cartridge compartment. For example, the injection plunger rod position can be selected to position the first stopper at a position where medicament in the cartridge compartment is reduced, e.g., minimized, such as near a cartridge outlet. The injection plunger rod position can be a plunger rod extended position.

[0065] The plunger rod may be moved toward the plunger rod retracted position, e.g., to the plunger rod retracted position. For example, the plunger rod can be moved from, e.g., an injection plunger rod position and / or an extended plunger rod position, e.g., to the plunger rod retracted position after completion of an injection.

[0066] The processing unit can be configured to move the plunger rod to a mixing plunger rod position, a second plunger rod position, an injection plunger rod position, a plunger rod extended position, and / or a plunger rod retracted position.

[0067] The processing unit can be configured to receive a trigger event and, after receiving the trigger event, control the drive module to move the plunger rod to the injection plunger rod position, e.g., after completion of movement of the plunger rod to a previous plunger rod position, such as the second plunger rod position.

[0068] The autoinjector can include an ejection sensor, such as a plunger rod position sensor. The ejection sensor can be configured to detect ejection, such as release, of medication and / or air within the cartridge compartment. 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 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 be indicative of the position of the plunger rod and / or the first stopper.

[0069] The dispensing sensor may include a tachometer, such as a tachometer in a drive module. The tachometer may be configured to count rotations of a drive module, such as a motor in the drive module, such as rotations of the drive module from a set point, such as a known plunger rod position, such as a plunger rod retracted position of the plunger rod. Counting the rotations of the drive module may be used to determine an actual position of the plunger rod, such as a premix plunger rod position, a mixing plunger rod position, a prime plunger rod position, an injection plunger rod position, a plunger rod extended position, and / or a plunger rod retracted position.

[0070] The processing unit can be coupled to a dispensing sensor, such as a tachometer. The processing unit can receive a first dispensing sensor signal, such as a tachometer signal, from the dispensing sensor indicating a count of rotations of the drive module. The processing unit can determine a position of the plunger rod based on the first dispensing sensor signal. For example, the processing unit can receive a second dispensing sensor signal from the dispensing sensor indicating that the plunger rod is at a known position, such as a plunger rod retracted position and / or a first plunger rod position. The processing unit can determine a position of the plunger rod based on the first dispensing sensor signal and the second dispensing sensor signal.

[0071] The cartridge may be lockable within the cartridge housing; for example, the cartridge can be locked within the cartridge housing to prevent removal of the cartridge from the cartridge housing. Movement of the plunger rod toward the plunger rod extended position can lock the cartridge within the cartridge housing. For example, movement of the plunger rod to the mixing plunger rod position can lock the cartridge within the cartridge housing. Movement of the plunger rod toward the plunger rod retracted position can unlock the cartridge from the cartridge housing. For example, movement of the plunger rod to the plunger rod retracted position can unlock the cartridge within the cartridge housing. The cartridge can be locked within the cartridge housing when the plunger rod is not in and / or near the plunger rod retracted position. Coupling the plunger rod position with locking the cartridge within the cartridge housing can advantageously limit or prevent release of the cartridge when the autoinjector is activated.

[0072] The autoinjector 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 in the cartridge receiver. The orientation signal can indicate the orientation of the cartridge relative to gravity, such as relative to the direction of gravity. The orientation signal can be an acceleration signal, for example, a three-axis acceleration signal. The orientation signal can include acceleration data, for example, acceleration data in three dimensions. The orientation signal can include acceleration data indicative of the acceleration of the device.

[0073] The orientation sensor can be configured to detect an orientation indicative of the orientation of the cartridge, such as the orientation of the cartridge and / or the orientation of the autoinjector. The detected orientation may be relative to gravity, such as relative to the direction of gravity. The orientation sensor can be configured to detect the direction of gravity and / or whether the direction of gravity is within a range of predetermined directions. The orientation sensor may include an accelerometer. The orientation sensor may include multiple accelerometers, such as three accelerometers configured to detect acceleration in three dimensions, such as a three-dimensional accelerometer. The orientation sensor may include a tilt sensor, a three-axis accelerometer, a single-axis accelerometer, a magnetometer, and / or combinations thereof, and the orientation sensor can provide measures of roll, pitch, and azimuth, acceleration and / or tilt in one or more directions.

[0074] The orientation sensor may be configured to provide dynamic signals, such as linear acceleration and / or velocity and / or position in one, two or three dimensions and / or additional rotational acceleration and / or velocity. The orientation sensor may be configured to provide full inertial sensing of the position and / or motion of the device. The processing unit may be configured to convert motion sensor signals, such as orientation signals, from one domain to another, such as integrating the acceleration signal with respect to time to derive a velocity signal and / or integrating with respect to time to derive a position signal from the velocity signal.

[0075] 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 autoinjector 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 45 degrees from vertical, such as within 30 degrees from vertical. The predetermined orientation can be an orientation in which the cartridge is oriented such that the longitudinal axis of the cartridge is within 45 degrees from vertical, such as within 30 degrees from vertical, and the cartridge outlet is above the cartridge compartment, such as in a vertical position above the cartridge compartment.

[0076] Detection of autoinjector inversion may be performed using a single or multi-axis gyroscopic sensor that senses dynamic angular velocity, such as the angular velocity of the autoinjector during inversion, and the angle spanned by the autoinjector during inversion. Thus, the orientation sensor may be a single or multi-axis gyroscopic sensor.

[0077] The orientation sensor can be configured to provide, for example, an angle signal indicative of the angle of the cartridge when received in the cartridge receiving portion. The orientation sensor can be configured to provide, for example, an angular velocity signal indicative of the angular velocity of the cartridge when received in the cartridge receiving portion.

[0078] By using an orientation sensor with the spatial resolution of a single accelerometer axis, i.e., by detecting signal level changes and sign reversals, it is possible to detect some details about the rotation. For example, if the orientation sensor is a single-axis accelerometer perfectly calibrated vertically upward and is in a steady state, i.e., affected only by gravity, then rotation outward from the vertical can be determined by detecting acceleration levels that fall off in line with the projection of the accelerometer sensitive axis onto vertical gravity (i.e., by a factor determined by the cosine of the tilt angle).

[0079] Using a dual-axis accelerometer, movement along two individual axes, the x-axis and the y-axis, are detected, which are oriented perpendicular to one another. The x-axis and the y-axis together define a two-dimensional sensing plane. When implementing a single-axis or dual-axis accelerometer in an orientation sensor as described herein, the accelerometer is typically positioned so that the x-axis is parallel to the longitudinal axis of the autoinjector and is therefore capable of detecting acceleration along this direction. As a result, the y-axis is oriented perpendicular to the longitudinal axis in such a setup and is therefore only capable of detecting acceleration along this y-axis direction.

[0080] Movement within the two-dimensional plane defined by the two-axis accelerometer is accurately detected. However, movement outside of this two-dimensional plane, such as movement in a different y-axis direction, cannot be detected with the same accuracy using a two-axis accelerometer. The more the plane of movement differs from the two-dimensional plane defined by the two-axis accelerometer, the greater the inaccuracy in the detection of movement by the two-axis accelerometer. Thus, rotation of the autoinjector can cause a shift in the signal observed for the two-axis sensor. However, if the x-axis or y-axis sensor is not aligned with the direction in which the autoinjector is rotated, the sensor will produce a lower output. If rotation is performed in a spatial plane orthogonal to the plane defined by the two-dimensional accelerometer, only the common sensing axis will produce a sensing signal in response to the physical rotation of the autoinjector performed by the user. This means that flipping of the autoinjector cannot be accurately observed and / or recorded.

[0081] Due to the practical implementation of these sensors, some level of sensing outside the x / y two-dimensional plane may be observed in some cases. However, such signals are significantly weaker than acceleration along the designated x and y operating axes, which does not have any predetermined level of sensing. Therefore, such out-of-plane signals are difficult to use in practice if a reliable orientation signal is to be detected. Because the design of the autoinjector is not intended to restrict the user in how they hold the autoinjector and in which direction they can invert it to perform the inversion required to mix medications, a two-axis accelerometer may not always provide results as accurate as a three-axis accelerometer.

[0082] Compared to a two-axis accelerometer, the use of a three-axis accelerometer, hereinafter also referred to as a tri-axial accelerometer, improves sensitivity. The use of a tri-axial accelerometer instead allows for the detection of motion in the z-axis direction in addition to the x- and y-axes. Because the z-axis direction is perpendicular to both the x- and y-axes, motion of the automatic injection device can be observed in a different dimensional plane than that defined by the x- and y-axes. Thus, a tri-axial accelerometer defines a three-dimensional sensing plane defined by the x-, y-, and z-axes.

[0083] By selecting an accelerometer with spatial resolution in three axes, any remaining uncertainty arising from rotation in or out of the appropriate two-dimensional spatial plane is resolved, as the third axis of resolution adds this additional information. This means that an autoinjector sensor with a three-axis accelerometer will be able to accurately detect and calculate movement / rotation not just within any single two-dimensional spatial plane, but throughout the entire handling motion, including rotational movements that vary based on hand / arm ergonomics, etc. This means that all rotations of the autoinjector can be accurately observed and recorded.

[0084] Thus, the autoinjector may further include an orientation sensor configured to detect the orientation of the cartridge and / or the orientation of the autoinjector. The autoinjector reversal may be performed using the orientation sensor. The orientation sensor may include multiple accelerometers, such as, for example, three-axis accelerometers.

[0085] The processing unit can be coupled to the orientation sensor. The processing unit can be configured to receive an orientation signal, for example, indicating an orientation of the cartridge when received in the cartridge receiver and / or indicating an orientation of the autoinjector. The processing unit can be configured to receive an orientation signal indicating an angular velocity and / or an angle covered by the autoinjector in reversals. The processing unit can be further configured to provide a start signal after multiple full reversals of the autoinjector have been performed, the number of full reversals being based on the orientation signal indicating the angular velocity and / or the angle covered by the autoinjector in reversals.

[0086] Movement of the plunger rod to the mixing plunger rod position and / or the second plunger rod position and / or the injection plunger rod position can be based on an orientation of the cartridge, e.g., an orientation signal. For example, movement of the plunger rod from the first plunger rod position to the mixing plunger rod position can be based on an orientation signal.

[0087] For example, movement of the plunger rod to the mixing plunger rod position and / or the second plunger rod position and / or the injection plunger rod position may require that the inclination angle between the vertical and the longitudinal axis extending along the cartridge is within 45 degrees, such as within 30 degrees, and / or that the cartridge outlet is in a vertical position above the cartridge compartment.

[0088] Control of the drive module to move the plunger rod to the mixing plunger rod position and / or the preparation plunger rod position and / or the injection plunger rod position can be based on the orientation of the cartridge, for example, an orientation signal.

[0089] 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 second 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 the second plunger rod position and / or an injection plunger rod position only when 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 that the cartridge outlet is in a vertical position above the cartridge compartment.

[0090] The first motion parameter can be determined, for example, based on the orientation signal. The processing unit can be configured to determine the first motion parameter. The first motion parameter can be based on cumulative motion of the autoinjector. The first motion parameter can indicate the amount of motion of the autoinjector for a set period of time, such as the completion of movement of the plunger rod to the mixing plunger rod position and / or a preceding predetermined time, such as the preceding one second. The first motion parameter can be based on a cumulative measure of orientation over time, such as the completion of movement of the plunger rod to the mixing plunger rod position and / or a preceding predetermined time, such as the preceding one second. The first motion parameter can indicate that the device is being shaken. Shaking the device while mixing two drug components can cause excessive foaming of the drug. Excessive foaming of the drug can require an increased reconstitution time. To prevent foaming, the speed of plunger rod movement can be adjusted, for example, reduced, if shaking of the device is detected. Conversely, gentle shaking of the device may accelerate reconstitution without foaming, thereby reducing the required reconstitution time. Thus, the amount of shaking can affect the determination of reconstitution time.

[0091] Alternatively or additionally, the first motion parameter may indicate that the autoinjector is rotated from one vertical orientation, in which a first end of the autoinjector, e.g., a distal end of the autoinjector, points substantially up, to an inverted orientation, in which the first end of the autoinjector points substantially down. The first motion parameter may indicate the number of inversions and / or full inversions of the autoinjector. The processing unit may be configured to detect and / or count the number of inversions / full inversions.

[0092] Inversion may include flipping the autoinjector from an orientation in which the first end of the autoinjector points substantially upward to an inverted orientation in which the first end of the autoinjector points substantially downward. For example, inversion may include flipping the autoinjector from an orientation in which the first end of the autoinjector points within 45 degrees of upward to an inverted orientation in which the first end of the autoinjector points within 45 degrees of downward. Alternatively or additionally, inversion may include flipping the autoinjector from an orientation in which the first end of the autoinjector points substantially downward to an inverted orientation in which the first end of the autoinjector points substantially upward. For example, inversion may include flipping the autoinjector from an orientation in which the first end of the autoinjector points within 45 degrees of downward to an inverted orientation in which the first end of the autoinjector points within 45 degrees of upward.

[0093] Rotational movement of the autoinjector from an initial position in which the longitudinal axis of the autoinjector is in a horizontal plane and the first end of the autoinjector points to the left to a position in which the longitudinal axis of the autoinjector is in a horizontal plane and the first end of the autoinjector points to the right may also constitute inversion.

[0094] Thus, a reversal can be defined as a rotation of the autoinjector approximately 180 degrees. The orientation of the start and end positions when performing a reversal is not fixed.

[0095] A downward rotation can be detected when the autoinjector is rotated from a 40-degree angle to a 135-degree angle, i.e., a 45-degree angle. An upward rotation can be detected between a 45-degree angle, i.e., a 135-degree angle, and a 30-degree angle. Therefore, both upward and downward rotations can be detected before the reversal is complete. Therefore, 90 to 105 rotations within a preset time can be used to calculate the reversal frequency based on interpolation of this data to estimate a near 180-degree rotation.

[0096] A reversal can be considered a complete reversal by the autoinjector if it is performed at an angular velocity above a default threshold. A complete reversal also signifies a successful reversal. The default threshold for angular velocity can be defined as a reversal frequency of at least 0.5 reversals per second, which corresponds to at least one reversal per two seconds. The purpose of the lower frequency threshold is to ensure that the reversal is strong enough to effectively aid in the mixing of the first and second pharmaceutical components. The reversal frequency can be used in the built-in software to determine whether the reversal is effective.

[0097] Alternatively, or additionally, the default frequency threshold for angular velocity may be defined as at least one reversal per second, which corresponds to at least one half rotation per second.

[0098] The default threshold for angular velocity may be further defined as a reversal frequency of less than 10 reversals per second, less than 5 reversals per second, less than 2 reversals per second, or preferably less than 1.5 reversals per second. The upper reversal frequency limit can be used to filter out events such as shaking that would otherwise be erroneously recorded as reversals.

[0099] The frequency threshold may be between 0.3 and 10 Hz, such as between 0.5 and 0.9 Hz, such as between 0.5 and 1.5 Hz, such as between 0.3 and 5 Hz, between 0.3 and 2 Hz, such as 0.7 Hz. The frequency threshold may be based on a cartridge code feature, such as a code signal indicative of the cartridge code feature.

[0100] Alternatively, or in combination, a reversal may be considered a complete reversal by the autoinjector if it spans an angle above a default threshold, which may be at least 90 degrees, such as at least 120 degrees, preferably at least 135 degrees, more preferably at least 150 degrees, and even more preferably at least 165 degrees, such as 180 degrees.

[0101] Typically, it is difficult and / or uncomfortable for a user to hold the autoinjector in their hand to flip it through a range of rotational movement greater than 205 degrees, such as from 45 degrees in a right-handed direction to 180 degrees in a left-handed direction. The default threshold angle may be less than 220 degrees, such as less than 205 degrees, such as less than 190 degrees.

[0102] The inversion may be about an axis in the horizontal plane.

[0103] A rotational movement of the autoinjector from a start angular position to an end angular position can be considered a complete reversal by the autoinjector if: If the starting angular position is between a first vertical orientation in which the distal end of the autoinjector is pointing up and a first horizontal position in which the distal end of the autoinjector is pointing sideways along a horizontal axis, the end angular position is between a second horizontal position in which the distal end of the autoinjector points sideways along the horizontal axis in an opposite direction to that in the first horizontal position, and a second vertical orientation in which the distal end of the autoinjector points downward; and Where the default threshold angle between the first and second angular positions is at least 90 degrees, such as at least 120 degrees, preferably at least 135 degrees, more preferably at least 150 degrees, and even more preferably at least 165 degrees, such as 180 degrees.

[0104] A rotational movement of the autoinjector from a start angular position to an end angular position can be considered a complete reversal by the autoinjector if: If the starting angular position is between a first vertical orientation in which the distal end of the autoinjector is pointing down and a first horizontal position in which the distal end of the autoinjector is pointing sideways along a horizontal axis, the end angular position is between a second horizontal position in which the distal end of the autoinjector points sideways along the horizontal axis in an opposite direction to that in the first horizontal position, and a second vertical orientation in which the distal end of the autoinjector points upward; and Where the default threshold angle between the first and second angular positions is at least 90 degrees, such as at least 120 degrees, preferably at least 135 degrees, more preferably at least 150 degrees, even more preferably at least 165 degrees, such as 180 degrees.

[0105] Thus, the autoinjector can undergo a complete reversal when flipped 180 degrees vertically, e.g., from a vertically upward orientation to a vertically downward orientation. The 180-degree reversal can occur for a maximum of 2 seconds, i.e., with a minimum reversal frequency of 0.5 Hz. Alternatively, or in addition, the autoinjector can undergo a complete reversal when rotated 180 degrees vertically, e.g., from a vertical orientation at an angle of 0-30 degrees relative to the upward orientation to a vertically downward orientation at an angle of 0-30 degrees relative to the downward orientation. Alternatively, or in addition, the autoinjector can undergo a complete reversal when rotated 180 degrees vertically, e.g., from a vertical orientation at an angle of 25-65 degrees relative to the upward orientation to a vertically downward orientation at an angle of 25-65 degrees relative to the downward orientation. Alternatively, or in addition, the autoinjector can undergo a complete flip when rotated 180 degrees vertically, such as from a vertically upward orientation at an angle of 45-75 degrees relative to the upward orientation to a vertically downward orientation at an angle of 45-75 degrees relative to the downward orientation.

[0106] The frequency threshold can be based on a cartridge code feature, such as a code signal indicative of the cartridge code feature. Alternatively or additionally, the frequency threshold can be based on the temperature of the medicament, such as a temperature signal indicative of the temperature of the medicament.

[0107] Ideally, the specified physical input for a low-viscosity drug may be, for example, five 180-degree reversals, but may be assumed to require more reversals if the measured reversal angle remains significantly below, such as, for example, 10 reversals at 90 degrees per reversal. Alternatively, the specified physical input for a low-viscosity drug may be, for example, 10 180-degree reversals, but may be assumed to require more reversals if the measured reversal angle remains significantly below, such as, for example, 20 90-degree reversals per reversal. Thus, the number of complete reversals may increase if the autoinjector experiences reversals having a lower degree of angular motion and / or angular velocity.

[0108] The number of inversions can be a set code signal indicative of a cartridge code mechanism that defines the number of inversions required to ensure adequate mixing of the medication. Thus, the autoinjector need not be pre-programmed to require a specific number of inversions, such as inversion of every cartridge used by the device. Instead, the autoinjector can be programmed to require a discrete number of inversions defined on the cartridge code mechanism.

[0109] The processing unit can be configured to provide feedback, such as via a user interface of the autoinjector, when a default / predetermined number of complete reversals and / or reversals have been completed, i.e., including both complete reversals and incomplete reversals that do not meet the requirements to be completed. The processing unit can provide visual and / or audible feedback to the user when the number of complete reversals has been performed.

[0110] Alternatively, or in combination, the processing unit may provide visual and / or audio feedback to the user after each complete reversal. For example, using a three-axis accelerometer to count the number of complete / successful reversals, e.g., given quickly enough and with a sufficient rotation angle repeated a sufficient number of times, the power injector device may provide audio feedback through an internal speaker, e.g., providing a "tick" sound after each successful reversal. Additionally, visual feedback, e.g., over a graphical progress bar included in the interface, may be provided for all complete reversals or after each complete reversal during the reversal sequence. This may assist the user in accurately performing the reversals.

[0111] The predetermined number of full inversions can be based on the amount of kinetic energy imparted to the mixed drug during reconstitution, e.g., the predetermined number of full inversions can be correlated to the amount of kinetic energy imparted to the mixed drug during reconstitution. The predetermined number of full inversions can be between 1 and 20, such as between 3 and 7, such as between 1 and 10, such as 5. The predetermined number of full inversions can alternatively be greater than 10, such as greater than 15, or greater than 20.

[0112] The predetermined number of complete reversals may be based on a cartridge code mechanism, such as a code signal indicative of the cartridge code mechanism.

[0113] The first motion parameter can indicate a compound rotation between opposing perpendicular orientations combined with an angular velocity of rotation and / or a wait period / delay between such reversals. The processing unit can, for example, measure the rotational acceleration of the autoinjector in addition to the number of reversals and / or full reversals counted. The processing unit can, for example, estimate the force and energy acting on the drug to be reconstituted based on the measure of the rotational acceleration of the autoinjector and / or the number of reversals and / or full reversals counted. The processing unit can provide feedback, for example, via a user interface, when a predetermined amount of energy has been applied to the autoinjector and / or cartridge.

[0114] Alternatively or additionally, acceleration can be monitored to ensure it does not exceed a predetermined upper threshold. The predetermined upper threshold can be indicative of an acceleration known to be associated with a risk of foaming. For example, accelerations above the predetermined upper threshold can be known to be associated with a risk of foaming.

[0115] The total amount of energy applied to the autoinjector, such as based on measuring the rotational acceleration of the autoinjector and / or counting reversals and / or full reversals, can be continuously evaluated, e.g., to provide real-time instructions to the user to perform such exercises when the energy level is deemed too low, e.g., below a predetermined lower threshold, and / or when the energy level is deemed high, e.g., above a predetermined upper threshold. The predetermined lower threshold may be an energy level. The predetermined upper threshold may be an energy level at which exercise is deemed to increase the risk of foaming.

[0116] The first motion parameter may indicate the frequency of the autoinjector motion, such as the number of reversals and / or complete reversals per second.

[0117] An autoinjector, for example a cartridge receiver, can be configured to receive a cartridge assembly including a cartridge and a cartridge code mechanism.

[0118] The autoinjector can include a code sensor configured to read a cartridge code feature, such as a cartridge code feature on a cartridge and / or cartridge assembly that indicates one or more cartridge specifications, and to provide a code signal indicative of the cartridge code feature.

[0119] The processing unit can be coupled to the code sensor. The processing unit can be configured to receive a code signal. The processing unit can be configured to receive a code signal from the code sensor indicative of the cartridge code mechanism. Movement of the plunger rod, such as movement from the first plunger rod position to the mixing plunger rod position, can be based on the code signal.

[0120] The processing unit may be configured to determine fraudulent cartridges, such as counterfeit cartridges and / or used cartridges and / or tampered cartridges and / or cartridges containing the wrong dose and / or cartridges containing the wrong medication, based on the code signal.

[0121] The code sensor may include an optical sensor. The code sensor may include an optical sensor including a transmitter and a receiver, such as an optical transmitter and an optical receiver. The code sensor may be configured to read a cartridge code feature. The code sensor may be configured to read a color code, a bar code, an RFID tag, an NFC tag, an identification number, a QR code, and / or any combination thereof. The movement of the plunger rod, such as position, speed, and / or delay, may be based on the code signal. For example, movement of the plunger rod to the mixing plunger rod position and / or the second plunger rod position and / or the infusion plunger rod position may be based on the cartridge code feature, such as the code signal. For example, controlling the drive module to move the plunger rod to the mixing plunger rod position and / or the second plunger rod position may be based on the code signal. The processing unit may 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 mixed plunger rod position and / or the second plunger rod position based on the code signal.

[0122] Basing the plunger rod movement on cartridge specifications, e.g., code signals, allows the plunger rod movement to be optimized for several types of cartridges. For example, blank shots can be performed with reduced or no drug release, thereby increasing dose accuracy and / or reducing patient discomfort, e.g., even with different cartridges. Additionally or alternatively, mixing procedures can be performed with reduced foaming by knowing the cartridge specifications.

[0123] Basing the plunger rod movement on cartridge specifications, e.g., a code signal, allows the plunger rod movement to be optimized for certain types of cartridges. For example, after a cartridge is detected as being received in the cartridge receiver and a first input signal is received, the plunger rod can be held in a mixing plunger rod position for a period of time according to the cartridge specifications, thereby ensuring proper mixing with different cartridges and / or reducing patient discomfort, for example.

[0124] The autoinjector can include a resistance sensor. The resistance sensor can be configured to provide a resistance signal. The resistance signal can be indicative of resistance to movement of the plunger rod. A processing unit can be coupled to the resistance sensor. The processing unit can be configured to receive the resistance signal.

[0125] The resistance signal can indicate resistance to movement of the plunger rod in one direction, such as toward the extended position. For example, the resistance signal can indicate a force required to move the plunger rod, such as toward the extended position.

[0126] 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 may include an electrical resistance sensor, a current sensor, and / or a voltage sensor. The drive module may include the resistance sensor.

[0127] The resistance sensor may be configured to measure pressure and / or force applied to a plunger rod front end of the plunger rod. The plunger rod front end may be configured to engage a first stopper of the cartridge. The resistance sensor may be configured to measure pressure and / or force between the plunger rod and the stopper. For example, the resistance sensor may include a pressure transducer and / or a force transducer on the plunger rod front end. The plunger rod may include the resistance sensor.

[0128] The movement of the plunger rod can be based on the resistance signal. For example, the movement of the plunger rod to the mixing plunger rod position and / or the second plunger rod position and / or the injection plunger rod position can be based on resistance to the movement of the plunger rod, e.g., a resistance signal. For example, controlling the 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.

[0129] The autoinjector can include a temperature sensor. The temperature sensor can be configured to provide a temperature signal, such as a temperature signal indicative of the temperature of the autoinjector and / or the cartridge and / or the medicament, e.g., the temperature of the medicament within the cartridge when the cartridge is received within the cartridge receiver. The temperature sensor can include an infrared sensor, such as an infrared optical sensor. The temperature sensor and the code sensor can utilize a common optical sensor, such as a common optical sensor. Thus, an optical sensor, such as an infrared optical sensor, can be used to both sense the temperature and read the cartridge code feature.

[0130] The processing unit may be coupled to the temperature sensor and may be configured to receive the temperature signal.

[0131] The movement of the plunger rod to the mixing plunger rod position and / or the second plunger rod position and / or the injector plunger rod position can be further based on a temperature of the autoinjector and / or the cartridge and / or the medicament. The movement of the plunger rod to the mixing plunger rod position and / or the second plunger rod position and / or the injector plunger rod position can be further based on a temperature signal.

[0132] 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 preparation plunger rod position and / or the injection plunger rod position based on the temperature signal in addition to based on the start signal.

[0133] The autoinjector can include a temperature control unit. The temperature control unit can be configured to change the temperature of the cartridge, for example, when the cartridge is received in the cartridge receiver. The temperature control unit can be configured to raise and / or lower the temperature of the cartridge and / or medication, thereby controlling temperature-dependent steps of the procedure, for example, to perform these steps more quickly.

[0134] The temperature control unit may include a heating element. The heating element may be configured to increase the temperature of the autoinjector and / or the cartridge and / or the medication. The heating element may be a resistive heating element. The heating element may be a light source, such as an infrared lamp. The heating element may be a dielectric heating element. The heating element may be a thermoelectric element, such as a Peltier element.

[0135] The temperature control unit may include a cooling element configured to reduce the temperature of the autoinjector and / or cartridge and / or medication, and may be a thermoelectric element, such as a Peltier element.

[0136] The temperature control unit may include a thermoelectric element, such as a Peltier element, which can be used to increase or decrease the temperature by using the Peltier effect, for example, to transfer heat from one side of the element to the other by consuming electrical energy, and which can be used to increase or decrease the temperature depending on the direction of the current.

[0137] The temperature control unit can include, for example, a contact element configured to contact the cartridge when the cartridge is received in the cartridge receiving portion. The temperature control unit can also include a coil element. For example, the coil element can be configured to surround the entire periphery of the cartridge when the cartridge is received in the cartridge receiving portion.

[0138] The autoinjector 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 be indicative of 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 be indicative of a second user interaction with the first input device.

[0139] The processing unit can be coupled 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 second plunger rod position only after receiving the second input signal.

[0140] The autoinjector can include a contact member. The contact member can be configured to be compressed 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 be moved toward the contact member retracted position, for example, when compressed against the injection site. The contact member and / or contact member sensor can be configured to provide a contact member signal indicative of the position of the contact member. The autoinjector 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.

[0141] The contact member can 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 may indicate that the contact member is close to the contact member retracted position. The contact member in the first contact member position may indicate that the contact member is compressed against the injection site. The contact member in the first contact member position may indicate that a needle positioned on the cartridge is sufficiently pressed into the skin to initiate injection of the medicament.

[0142] The processing unit can be coupled to the contact member. The processing unit can be configured to receive a contact member signal. The trigger event can include the contact member signal indicating that the contact member is in a first contact member position. The contact member can be a trigger member.

[0143] The plunger rod positions, such as the first plunger rod position, the mixing plunger rod position, the second plunger rod position, and / or the infusion plunger rod position, may be based on a cartridge specification, such as a cartridge code mechanism, such as a code signal. For example, the processing unit can be configured to determine the plunger rod positions, such as the first plunger rod position, the mixing plunger rod position, the second plunger rod position, and / or the infusion plunger rod position, based on the code signal.

[0144] The plunger rod positions, such as the first plunger rod position, the mixing plunger rod position, the second plunger rod position, and / or the injection plunger rod position, may be based on an orientation of the cartridge, such as an orientation signal. For example, the processing unit can be configured to determine the plunger rod positions, such as the first plunger rod position, the mixing plunger rod position, the second plunger rod position, and / or the injection plunger rod position, based on the orientation signal. The plunger rod positions, such as the first plunger rod position, the mixing plunger rod position, the second plunger rod position, and / or the injection plunger rod position, may also be based on a shaking of the device, such as a first motion parameter. For example, the processing unit can be configured to determine the plunger rod positions, such as the first plunger rod position, the mixing plunger rod position, the second plunger rod position, and / or the injection plunger rod position, based on the first motion parameter.

[0145] The plunger rod positions, such as the first plunger rod position, the mixing plunger rod position, the second plunger rod position, and / or the injection plunger rod position, may be based on resistance to the motion of the plunger rod, such as a resistance signal. For example, the processing unit can be configured to determine the plunger rod positions, such as the first plunger rod position, the mixing plunger rod position, the second plunger rod position, and / or the injection plunger rod position, based on the resistance signal.

[0146] The processing unit may be configured to determine a plunger rod position, such as a first plunger rod position, a mixing plunger rod position, a second plunger rod position, and / or an injection plunger rod position, based on the code signal and / or the orientation signal and / or the first motion parameter and / or the resistance signal.

[0147] The plunger rod movement can include movement with a plunger rod velocity, such as a blending plunger rod velocity, a second plunger rod velocity, and / or an injection plunger rod velocity. The plunger rod velocity can be based on the plunger rod position. The plunger rod can be moved from, e.g., a first plunger rod position, to a blending plunger rod position at a blending plunger rod velocity. The plunger rod can be moved from, e.g., a blending plunger rod position, to a second plunger rod position at a second plunger rod velocity. The plunger rod can be moved from, e.g., a blending plunger rod position and / or a second plunger rod position, to a injection plunger rod position at an injection plunger rod velocity.

[0148] The plunger rod velocities, such as the mixing plunger rod velocity, the second plunger rod velocity, and / or the infusion plunger rod velocity, may be constant. The plunger rod velocities, such as the mixing plunger rod velocity, the second plunger rod velocity, and / or the infusion plunger rod velocity, may vary, e.g., vary over time and / or distance. The mixing plunger rod velocity may be between 1 mm / sec and 3 mm / sec, e.g., 1.7 mm / sec.

[0149] The processing unit can be configured to control the drive module to move the plunger rod from, e.g., a first 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 second plunger rod position at a second plunger rod velocity. The processing unit can be configured to control the drive module to move the plunger rod from, e.g., the second plunger rod position to an injection plunger rod position at an injection plunger rod velocity.

[0150] The mixing plunger rod velocity, the second plunger rod velocity, and / or the infusion plunger rod velocity may be based on a cartridge specification, such as a cartridge code mechanism, such as a code signal. The processing unit can be configured to determine the mixing plunger rod velocity, the second plunger rod velocity, and / or the infusion plunger rod velocity based on the code signal.

[0151] The mixing plunger rod velocity, the second plunger rod velocity, and / or the infusion plunger rod velocity may be based on an orientation of the cartridge, such as the orientation signal. The processing unit can be configured to determine the mixing plunger rod velocity, the second plunger rod velocity, and / or the infusion plunger rod velocity based on the orientation signal.

[0152] The mixing plunger rod velocity, the second plunger rod velocity, and / or the infusion plunger rod velocity may be based on the first motion parameter. The processing unit may be configured to determine the mixing plunger rod velocity, the second plunger rod velocity, and / or the infusion plunger rod velocity based on the first motion parameter. The mixing plunger rod velocity, the second plunger rod velocity, and / or the infusion plunger rod velocity may be based on resistance to the motion of the plunger rod, such as a resistance signal. The processing unit may be configured to determine the mixing plunger rod velocity, the second plunger rod velocity, and / or the infusion plunger rod velocity based on the resistance signal.

[0153] The processing unit may be configured to determine a mixing plunger rod velocity, a second plunger rod velocity and / or an infusion plunger rod velocity based on the code signal and / or the orientation signal and / or the first motion parameter and / or the resistance signal.

[0154] One or more elapsed times, such as a delay, can precede the movement of the plunger rod, such as movement to the mixing plunger rod position, the second plunger rod position, and the injection plunger rod position. For example, movement of the plunger rod to the second 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 that the drug is reconstituted, e.g., that the first and second drug components are thoroughly mixed, e.g., dissolved.

[0155] In some circumstances, the reconfiguration time can be very short. The reconfiguration time can be less than 10 degrees, such as less than 1 degree, such as less than 5 degrees. Alternatively, the reconfiguration time can be greater than 1 second, such as greater than 1 minute, such as greater than 5 minutes, such as greater than 10 seconds. The reconfiguration time can be between 1 and 10 minutes, such as between 2 and 5 minutes, such as 3 minutes.

[0156] The processing unit can be further configured to control the drive module to move the plunger rod to the mixing plunger rod position and / or the second plunger rod position and / or the infusion plunger rod position based on one or more elapsed times, such as a delay time. For example, the processing unit can be further configured to control the drive module to move the plunger rod to the second plunger rod position only after a reconfiguration time has elapsed since the plunger rod completed moving to the mixing plunger rod position.

[0157] The reconfiguration time can be based on cartridge specifications, e.g., the reconfiguration time can be based on a cartridge code feature, e.g., the reconfiguration time can be based on a code signal. The processing unit can be configured to determine the reconfiguration time based on the code signal.

[0158] Alternatively or additionally, the reconstruction time may be based on the orientation signal. The processing unit may be configured to determine the reconstruction time based on the orientation signal.

[0159] Alternatively or additionally, the reconstruction time may be based on the first motion parameter. The processing unit may be configured to determine the reconstruction time based on the first motion parameter.

[0160] Alternatively or additionally, the reconstruction time may be based on resistance to the movement of the plunger rod, such as a resistance signal. The processing unit may be configured to determine the reconstruction time based on the resistance signal. The processing unit may be configured to determine the reconstruction time based on the code signal, the orientation signal, the first movement parameter, and / or the resistance signal.

[0161] The plunger rod can be moved toward a plunger rod retracted position, such as to a plunger rod retracted position, after movement of the plunger rod to the injection plunger rod position is completed. The processing unit can be configured to control the drive module to move the plunger rod toward the plunger rod retracted position after movement of the plunger rod to the injection plunger rod position is completed.

[0162] For example, a dwell time may be required to elapse after completion of plunger rod movement to the injection plunger rod position before the plunger rod can be moved toward the plunger rod retracted position, such as to the plunger rod retracted position, after completion of plunger rod movement to the injection plunger rod position. The dwell time may be selected to allow sufficient time to ensure the agent is dispersed throughout the tissue. The dwell time may be influenced by the agent and / or agent concentration and / or agent amount and / or agent temperature. The dwell time may be based on cartridge specifications, e.g., the dwell time may be based on a cartridge coding mechanism, e.g., the dwell time may be based on a coding signal.

[0163] The processing unit can be configured to control the drive module to move the plunger rod toward the plunger rod retracted position only after a dwell time has elapsed since the plunger rod completed movement to the injection plunger rod position.

[0164] The dwell time can be based on cartridge specifications, e.g., the dwell time can be based on a cartridge code feature, e.g., the dwell time can be based on a code signal. The processing unit can be configured to determine the dwell time based on the code signal.

[0165] Alternatively or additionally, the dwell time may be based on the orientation signal. The processing unit may be configured to determine the dwell time based on the orientation signal.

[0166] Alternatively or additionally, the dwell time may be based on the first motion parameter. The processing unit may be configured to determine the dwell time based on the first motion parameter.

[0167] Alternatively or additionally, the dwell time may be based on resistance to movement of the plunger rod, such as a resistance signal. The processing unit may be configured to determine the dwell time based on the resistance signal.

[0168] The processing unit may be configured to determine the dwell time based on the code signal and / or the orientation signal and / or the first movement parameter and / or the resistance signal.

[0169] These and other features and advantages of the present invention will become readily apparent to those skilled in the art from the following detailed description of illustrative embodiments thereof, when read in conjunction with the accompanying drawings. [Brief explanation of the drawings]

[0170] [Figure 1] FIG. 1 illustrates an exemplary autoinjector. [Figure 2] 1 illustrates an exemplary autoinjector having a cartridge. [Figure 3] FIG. 1 is a schematic diagram illustrating an exemplary cartridge. [Figure 4a] FIG. 1 is a schematic diagram illustrating an exemplary cartridge assembly having an exemplary cartridge code mechanism. [Figure 4b] FIG. 1 is a schematic diagram illustrating an exemplary cartridge assembly having an exemplary cartridge code mechanism. [Figure 4c] FIG. 1 is a schematic diagram illustrating an exemplary cartridge assembly having an exemplary cartridge code mechanism. [Figure 4d] FIG. 1 is a schematic diagram illustrating an exemplary cartridge assembly having an exemplary cartridge code mechanism. [Figure 5]FIG. 1 is a schematic diagram illustrating an exemplary autoinjector having a cartridge assembly. [Figure 6a] Schematic diagram showing the autoinjector and cartridge assembly. [Figure 6b] Schematic diagram showing the autoinjector and cartridge assembly. [Figure 6c] Schematic diagram showing the autoinjector and cartridge assembly. [Figure 6d] Schematic diagram showing the autoinjector and cartridge assembly. [Figure 7] FIG. 1 is a block diagram of an exemplary autoinjector. [Figure 8a] FIG. 1 is a schematic diagram showing an exemplary cartridge assembly and plunger rod in an exemplary position. [Figure 8b] FIG. 1 is a schematic diagram showing an exemplary cartridge assembly and plunger rod in an exemplary position. [Figure 8c] FIG. 1 is a schematic diagram showing an exemplary cartridge assembly and plunger rod in an exemplary position. [Figure 8d] FIG. 1 is a schematic diagram showing an exemplary cartridge assembly and plunger rod in an exemplary position. [Figure 8e] FIG. 1 is a schematic diagram showing an exemplary cartridge assembly and plunger rod in an exemplary position. [Figure 8f] FIG. 1 is a schematic diagram showing an exemplary cartridge assembly and plunger rod in an exemplary position. [Figure 9] FIG. 1 illustrates an exemplary graph of resistance versus position. [Figure 10] 1 is a flow diagram of an exemplary method. [Figure 11] 1 is a flow diagram of an exemplary method. [Figure 12a] FIG. 1 is a schematic diagram illustrating an exemplary user interface. [Figure 12b] FIG. 1 is a schematic diagram illustrating an exemplary user interface. [Figure 12c]FIG. 1 is a schematic diagram illustrating an exemplary user interface. [Figure 12d] FIG. 1 is a schematic diagram illustrating an exemplary user interface. [Figure 13a] 1A-1C are schematic diagrams illustrating exemplary movements of an exemplary autoinjector. [Figure 13b] 1A-1C are schematic diagrams illustrating exemplary movements of an exemplary autoinjector. [Figure 13c] 1A-1C are schematic diagrams illustrating exemplary movements of an exemplary autoinjector. DETAILED DESCRIPTION OF THE INVENTION

[0171] 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. The drawings are not intended as an exhaustive description of the claimed invention, nor as limitations on the scope of the claimed invention. Additionally, an illustrated embodiment need not have all aspects or advantages shown. An aspect or advantage described in connection with a particular embodiment is not necessarily limited to that embodiment and can be practiced in any other embodiment, even if not so illustrated or explicitly described.

[0172] 1 illustrates an exemplary autoinjector 4. The autoinjector 4 can be configured to administer medication. The autoinjector 4 can be an electronic autoinjector.

[0173] The autoinjector 4 comprises a housing 6. The autoinjector 4 comprises a cartridge receiving portion 300. The cartridge receiving portion is configured to receive a cartridge and / or a cartridge assembly comprising a cartridge. The cartridge can contain a medication.

[0174] The cartridge receiving portion 300 has a cartridge receiving portion opening 301. The cartridge receiving portion 300 is configured to receive a cartridge and / or cartridge assembly through the cartridge receiving portion opening 301 in a cartridge receiving direction 304 along the longitudinal axis L.

[0175] The autoinjector 4 may include a user interface 1100, as shown. The autoinjector 4 includes a trigger member, such as a contact member 1102. The contact member 1102 may be configured to be compressed against an injection site. When compressed against the injection site, the contact member 1102 may be movable relative to the housing in the cartridge receiving direction 304. The contact member 1102 may be part of the user interface 1100.

[0176] The user interface 1100 may include an illustrative first input member 1108, such as a button. The first input member 1108 may allow for user input from a user. For example, the first input member 1108 may be used to receive a press from a user to proceed to the next step.

[0177] The user interface 1100 may include a first output member 1110, such as a plurality of LEDs, that may provide a user output to a user. The user interface 1100 may also include a second input 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 indicate a step in a procedure to the user and / or to indicate an error message.

[0178] 2 illustrates an exemplary system 2. System 2 includes an autoinjector 4, as described in connection with FIG. 1, and an exemplary cartridge 700 received within cartridge receiving portion 300. Cartridge 700 is shown with a needle cover 908. Needle cover 908 extends from contact member 1102 to allow needle cover 908 to be removed from cartridge 700.

[0179] FIG. 3 schematically illustrates an exemplary cartridge 700, such as a cartridge 700 configured to be received within a cartridge receiver of an autoinjector, such as the autoinjector described in connection with the preceding figures.

[0180] The cartridge 700 includes a cartridge compartment 702. The cartridge compartment 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 release the medication through the cartridge outlet 714.

[0181] The cartridge includes a first stopper 708 that is movable within the cartridge compartment, e.g., toward a first cartridge end, e.g., in a first stopper direction 722. For example, medicament can be released through a cartridge outlet 714 in response to movement of the first stopper 708 toward the first stopper. The cartridge includes a cartridge backside 716 at the second cartridge end. The cartridge backside 716 includes a cartridge rear opening to allow a plunger rod access to the first stopper 708.

[0182] As illustrated, cartridge 700 can be a dual-chamber cartridge. The cartridge includes a second stopper 710 movable within cartridge compartment 702, e.g., toward a first cartridge end, e.g., in a first stopper direction 722. Cartridge compartment 702 can include a first cartridge sub-compartment 704 and a second cartridge sub-compartment 706. First cartridge sub-compartment 704 is between first stopper 708 and second stopper 710. Second cartridge sub-compartment 706 is between second stopper 710 and cartridge outlet 714. Cartridge includes a bypass portion 712 for enabling fluid communication between the first cartridge sub-compartment and the second cartridge sub-compartment. Bypass portion 712 enables fluid communication between the first cartridge sub-compartment and the second cartridge sub-compartment when second stopper 710 is positioned within bypass portion 712.

[0183] The first cartridge sub-compartment 704 contains a first drug component 792 of the drug 790. The first drug component 792 may be a liquid, as illustrated. The second cartridge sub-compartment 706 contains a second drug component 794 of the drug 790. The second drug component 794 may be a powder composition. Positioning the second stopper 710 within the bypass portion 712 allows the first drug component 792 to be forced through the bypass portion 712 and into the second cartridge sub-compartment 706, whereby the first drug component 792 and the second drug component 794 mix to form the combined drug 790.

[0184] 4a-4d schematically illustrate an exemplary cartridge assembly 600. The cartridge assembly 600 includes an exemplary cartridge 700 and an exemplary cartridge code mechanism 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 mechanism 1000 is positioned 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 mechanism 1000 may be positioned near the first cartridge end 720.

[0185] 4a-4d illustrate different types of exemplary cartridge code mechanisms 1000. FIG.

[0186] 4a illustrates an exemplary cartridge assembly 600 in which the cartridge code mechanism 1000 includes two strips. The two strips may be colored, for example, different colors. The color combination and / or sequence may indicate the code of the cartridge code mechanism 1000.

[0187] 4b illustrates an exemplary cartridge assembly 600 in which the cartridge code feature 1000 includes a bar code. The cartridge code feature 1000 can include one or more bar codes. The bar code can display a number that indicates the code of the cartridge code feature 1000.

[0188] 4c illustrates an exemplary cartridge assembly 600 in which the cartridge code mechanism 1000 includes strips with different checkerboard patterns. For example, as illustrated, the cartridge code mechanism 1000 may include two strips, with the first strip having a 45-degree checkerboard pattern and the second strip having a -45-degree checkerboard pattern. The checkerboard patterns and / or the checkerboard patterns of the strips relative to each other may indicate a code for the cartridge code mechanism 1000.

[0189] 4d illustrates an exemplary cartridge assembly 600 in which the cartridge code feature 1000 includes an electromagnetically readable tag, such as an RFID tag or an NFC tag. The electromagnetically readable tag can contain data indicative of the code of the cartridge code feature 1000.

[0190] 5 illustrates an exemplary system 2. System 2 includes an autoinjector 4, such as that described in connection with FIG. 1, and an exemplary cartridge assembly 600. Cartridge assembly 600 includes a cartridge 700 having a cartridge compartment 702, a needle assembly 900, and a cartridge cord mechanism 1000. Cartridge assembly 600 is received within autoinjector 4.

[0191] The cartridge assembly 600 includes a cartridge holder 800 configured to retract the cartridge 700 into the cartridge receiving portion 300 of the autoinjector 4. The cartridge holder 800 includes a cartridge retaining member 808 that engages the cartridge receiving portion 300 to receive and retain the cartridge 700 and cartridge assembly 600 within the cartridge receiving portion 300.

[0192] 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 mating portion 906, e.g., a threaded mating portion, that engages with the needle assembly mating 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 a resilient seal that is penetrated by the needle 902 when the needle assembly 900 is attached to the cartridge 700.

[0193] The autoinjector 4 includes a code sensor 24 configured to read a cartridge code feature 1000. As shown, when the cartridge assembly 600 is inserted, the cartridge code feature 1000 is aligned with the code sensor 24.

[0194] The autoinjector 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 having an internal thread and an inner plunger rod 402 having an external thread. The threads of the inner plunger rod 402 engage with the threads of the outer plunger rod 404. The outer plunger rod 404 is prevented from rotating relative to the housing of the autoinjector. Movement of the plunger rod 400 includes rotation of the inner plunger rod 402. Rotation of the inner plunger rod 402 results in translational movement of the outer plunger rod 404 due to the rotational constraint of the outer plunger rod 404. The outer plunger rod 404 is configured to abut a first stopper of the cartridge 700 and move the first stopper in the first stopper direction 722 when translated in the first stopper direction 722 .

[0195] The drive module 500 is coupled to actuate the plunger rod 400. The drive module 500 can be 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 504 for coupling the motor 502 to the inner plunger rod 402 of the plunger rod 400.

[0196] While the illustrated example includes a motor 502 that may be an electromechanical motor, it will be readily appreciated that the automatic injection device 4 may also be implemented with modules that include alternative drives, such as a solenoid motor, a shape memory metal engine, a spring arrangement and / or pressurized gas configured to actuate the plunger rod 400.

[0197] The autoinjector 4 includes a discharge sensor 26, such as a plunger rod position sensor. The discharge sensor 26 is configured to detect the position of the plunger rod 400. In the illustrated example, the discharge sensor 26 includes a tachometer configured to count / detect rotations of the motor 502. Thus, the position of the plunger rod 400 can be determined based on counting the rotations of the motor 502. The discharge sensor 26 can detect the release of medication and / or air within the cartridge compartment based on the determination of the position of the plunger rod 400. The position of the plunger rod 400 can indicate the position of the first stop of the cartridge 700; for example, the most advanced position of the plunger rod 400 can indicate the position of the first stop of the cartridge 700, for example, while the cartridge 700 is within the cartridge receiving portion 300.

[0198] Figures 6a-6d schematically illustrate the autoinjector 4 and cartridge assembly 600. Figures 6a-6d also schematically illustrate exemplary positions of the contact member 1102 of the autoinjector 4 in various situations.

[0199] The autoinjector 4 includes a cartridge receiving portion 300 configured to receive and hold a cartridge. The autoinjector 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).

[0200] 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 positioned on a cartridge inserted into the cartridge receiving portion 300, for example.

[0201] The automatic injection device 4 includes a contact member sensor 1104 configured to detect the position of the contact member 1102. The contact member sensor 1104 includes a first contact member sensor 1130 and a second contact member sensor 1132. The first contact member sensor 1130 and the second contact member sensor 1132 may be optical sensors. The contact member sensor 1104 detects the position of the contact member 1102 by the contact member protrusion 1112 covering the first contact member sensor 1132 when the contact member 1102 is in the first contact member position and by the contact member protrusion 1112 covering the second contact member sensor 1132 when the contact member 1102 is in the second contact member position.

[0202] The first contact member position can be detected by the first contact member sensor 1130 being covered and the second contact member sensor 1132 being covered. The second contact member position can be detected by the first contact member sensor 1130 being uncovered and the second contact member sensor 1132 being covered. The 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.

[0203] 6a schematically illustrates the autoinjector 4 without a cartridge and / or cartridge assembly installed. The contact member 1102 is in the contact member extended position. The contact member 1102 defines a cartridge receiving opening 301 through which a cartridge can be inserted into the cartridge receiving portion 300 in a cartridge receiving direction 322.

[0204] FIG. 6b schematically illustrates the autoinjector 4 in which the cartridge assembly 600 is received. The cartridge assembly 600 includes a cartridge 700, a cartridge holder 800, and a needle assembly 900. The needle assembly includes a needle 902 and a needle cover 908. The needle cover has a needle cover abutment surface 910 that engages with the needle cover engagement member 1114 of the contact member 1102. The contact member 1102 is in the second contact member position, for example, with the needle cover 908 present and the needle cover abutment surface 910 abutting 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.

[0205] Figure 6c schematically shows the autoinjector 4 in which the cartridge assembly 600 has been received. Compared to Figure 6b, the needle cover 908 has been removed. The contact member 1102 is in the contact member extended position. The contact member 1102 is allowed to be moved to the contact member extended position because the needle cover abutment surface 910 does not abut the needle cover engagement member 1114. The contact member protrusion 1112 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.

[0206] FIG. 6d schematically illustrates the autoinjector 4 receiving the cartridge assembly 600. The contact member 1102 is in a first contact member position. The first contact member position may be the contact member retracted position or may be close to the contact member retracted position. By pressing the contact member 1102 against the injection site, the contact member 1102 can be moved to the first contact member position, thereby inserting the needle 902 into the injection site. The contact member protrusion 1112 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.

[0207] 7 shows a block diagram of an exemplary autoinjector 4. The autoinjector 4 includes a plurality of sensors 22, 24, 26, 28, 30, and 32, a processing unit 20, a drive module 500, and a user interface 1100. The sensors 22, 24, 26, 28, 30, and 32 are coupled to the processing unit 20. The user interface 1100 is coupled to the processing unit 20. The processing unit is coupled to the drive module 500.

[0208] The processing unit 20 receives signals from the sensors 22, 24, 26, 28, 30, 32 and the user interface 1100. The processing unit 20 is configured to control the drive module 500. The processing unit 20 may control the drive module 500 based on one or more of the received signals from the sensors 22, 24, 26, 28, 30, 32 and the user interface 1100. The processing unit 20 is configured to provide a user output via the user interface 1100.

[0209] The autoinjector 4 includes an orientation sensor 22. The orientation sensor 22 is configured to provide an orientation signal indicative of the orientation of a cartridge received within the autoinjector 4. For example, the orientation sensor 22 can be configured to detect the orientation of the autoinjector 4. The orientation of the cartridge can be determined based on the orientation of the autoinjector 4. The orientation sensor 22 can be configured to detect the direction of gravity. For example, the orientation sensor 22 may include an accelerometer.

[0210] Orientation sensor 22 may be a single or multi-axis gyroscopic sensor that senses dynamic angular velocity, such as the angular velocity of the autoinjector during inversion, and the angle subtended by the autoinjector during inversion.

[0211] The processing unit 20 is coupled to the orientation sensor 22. The processing unit 20 can be configured to receive an 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 plunger rod extended position, such as a premix plunger rod position and / or a mixing plunger rod position and / or a ready plunger rod position, only if the cartridge outlet is pointing up. Alternatively or additionally, the processing unit 20 can provide a user output via the user interface 1100 based on the orientation signal.

[0212] The processing unit 20 may be configured to receive an orientation signal 22 from the orientation sensor that indicates the angular velocity and / or angle spanned by the autoinjector during the reversal. The processing unit 20 may be further configured to provide a start signal after multiple complete reversals of the autoinjector have been performed, the number of complete reversals being based on the orientation signal from the orientation sensor 22 that indicates the angular velocity and / or angle spanned by the autoinjector 4 during the complete reversal.

[0213] The autoinjector 4 includes a code sensor 24. The code sensor 24 is configured to read the cartridge code mechanism and provide a code signal indicative of the cartridge code mechanism. For example, the code sensor may be configured to read / detect a color code.

[0214] The processing unit 20 is coupled to the code sensor 24. The processing unit 20 is configured to receive the code signal. The processing unit 20 can determine a cartridge code feature of the cartridge assembly based on the code signal. The processing unit 20 can control the drive module 500 based on the code signal. For example, the processing unit 20 can be configured to control the drive module 500 to move the plunger rod toward a plunger rod extended position, such as a premix plunger rod position, a mixing plunger rod position, a ready plunger rod position, and / or an injection plunger rod position, 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.

[0215] The power injection device 4 includes a dispense sensor 26, such as a plunger rod position sensor. The dispense sensor 26 is configured to detect the position of the plunger rod of the power injection device 4 and provide a dispense sensor signal indicative of the plunger rod position. The dispense sensor 26 may include a tachometer coupled to the drive module 500.

[0216] The processing unit 20 is coupled to the dispensing sensor 26. The processing unit 20 is configured to receive a dispensing sensor signal. The processing unit 20 can determine a position of the plunger rod based on the dispensing sensor signal. The processing unit 20 can control the drive module 500 based on the dispensing 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 dispensing sensor signal. For example, the processing unit 20 can be configured to determine a current plunger rod position based on the dispensing sensor signal. Based on the dispensing sensor signal, it can be determined that the plunger rod is in a premix plunger rod position, a mixing plunger rod position, a ready 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 dispensing sensor signal.

[0217] The autoinjector 4 includes a cartridge sensor 28. The cartridge sensor 28 is configured to detect when a cartridge assembly has been received within the autoinjector 4. The cartridge sensor 28 provides a cartridge sensor signal indicating that the cartridge assembly has been received.

[0218] The processing unit 20 is coupled 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. The code sensor 24 and the cartridge sensor 28 can be the same sensor; for example, the code sensor 24 can be configured to detect acceptance of the cartridge assembly and then read a cartridge code feature.

[0219] The autoinjector 4 includes a needle sensor 30. The needle sensor 30 is configured to detect the needle of the cartridge assembly and / or the needle assembly and / or the needle cover of the needle assembly when the cartridge assembly is received within the autoinjector 4. The needle sensor 30 provides a needle signal indicative of the presence of the needle of the cartridge assembly and / or the needle assembly and / or the needle cover of the needle assembly.

[0220] The processing unit 20 is coupled 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 a plunger rod extended position, such as a premix plunger rod position, a mixing plunger rod position, a ready plunger rod position, and / or an inject plunger rod position, only if a needle is present and / or only if a needle cover is not present, such as if the needle cover is removed. Detection of a needle cover can indicate the presence of a needle. The processing unit 20 can be configured to control the drive module 500 to initiate only if a needle cover has been detected and subsequently is not detected, such as if the needle cover has been removed. Alternatively or additionally, the processing unit 20 can provide a user output via the user interface 1100 based on the needle signal. The needle sensor 30 can be part of a contact member sensor, as illustrated in FIG. 6 .

[0221] The autoinjector 4 includes a resistance sensor 32. The resistance sensor 32 is configured to detect resistance to movement of a plunger rod of the autoinjector 4. The resistance sensor 32 may be configured to detect resistance to movement of the plunger rod based on measurements from the drive module 500. For example, the resistance sensor 32 may be configured to detect a current in a motor of the drive module 500. The resistance sensor 32 is configured to provide a resistance signal indicative of the resistance to movement of the plunger rod.

[0222] The processing unit 20 is coupled to the resistance sensor 32. The processing unit 20 is configured to receive the resistance signal. The processing unit 20 can be configured to determine a resistance to the movement of the plunger rod based on the resistance signal. The processing unit 20 can control the drive module 500 based on the resistance signal. For example, the processing unit 20 can be configured to control the drive module 500 to adjust the movement of the plunger rod based on the resistance signal. For example, the processing unit 20 can be configured to control the drive module 500 to start, stop, or continue the movement of the plunger rod based on the resistance signal. Alternatively or additionally, the processing unit 20 can provide a user output via the user interface 1100 based on the resistance signal.

[0223] The autoinjector 4 is illustrated as including all of the elements described above. However, alternatively, the autoinjector may include only one of the elements described above, or any combination of one or more of the elements described above.

[0224] The autoinjector includes a user interface 1100. The user interface 1100 can include one or more input members, such as a first input member, for receiving user input. The user interface is configured to provide a user input signal indicative of the user input being received. The user interface 1100 can provide the first input signal and / or the second input signal.

[0225] The processing unit 20 is coupled 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 a plunger rod extended position, such as a premix plunger rod position, a mixing plunger rod position, a ready plunger rod position, and / or an injection plunger rod position, based on and / or in accordance with the user input signal.

[0226] The autoinjector comprises a housing 6 that houses the sensors 22 , 24 , 26 , 28 , 30 , 32 , the processing unit 20 , the user interface 1100 , and the drive module 500 .

[0227] 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 FIG. 3, a cartridge holder 800, and a needle assembly 900. For clarity, the autoinjector including plunger rod 400 is not shown.

[0228] The cartridge holder 800 includes a cartridge retaining member 808. The cartridge retaining member 808 is configured to engage with a cartridge receiving portion of an autoinjector. 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 a needle to be attached to the cartridge 700.

[0229] 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 coupling 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.

[0230] 8a schematically illustrates a situation in which the plunger rod 400 is in an exemplary plunger rod retracted position. The cartridge 700 may be a new cartridge. The first stopper 708 is positioned in an initial position. The second stopper 710 is in an initial position, for example, behind the bypass portion 712, which does not form a fluid connection between the first sub-section 704 and the second sub-section 706.

[0231] FIG. 8b schematically illustrates a situation in which the plunger rod 400 is in an exemplary premix plunger rod position. Compared to FIG. 8a, the plunger rod 400 has been moved 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 positioned, for example, behind the bypass portion 712, such that the bypass portion 712 does not form a fluid connection between the first subsection 704 and the second subsection 706.

[0232] 8c schematically illustrates a situation in which the plunger rod 400 is in an exemplary position in which a fluid connection is established between the first subsection 704 and the second subsection 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 the first stopper 708 in the first stopper direction 722 by moving in the first plunger rod direction 422. The second stopper 710 is within the bypass portion 712, which forms the fluid connection between the first subsection 704 and the second subsection 706. Thus, further movement of the first stopper 708 in the first stopper direction 722, for example, due to movement of the plunger rod 400 in the first plunger rod direction 422, forces the contents of the first sub-compartment 704, such as, for example, a first pharmaceutical component (not shown), into the second sub-compartment 706, for example, through the bypass portion 712.

[0233] 8d schematically illustrates a situation in which the plunger rod 400 is in an exemplary mixed plunger rod position. The plunger rod front end 410 abuts the first stopper 708. The first stopper 708 abuts the second stopper 710. The first partial section 704 is compressed. The second stopper 710 is in a position behind the bypass section 712. Thus, the fluid connection between the first partial section 704 and the second partial section 706 is closed.

[0234] 8e schematically illustrates the plunger rod 400 in an exemplary ready plunger rod position. In comparison to FIG. 8d, the plunger rod 400 has been moved toward the extended plunger rod position, e.g., to expel air from the cartridge compartment 702.

[0235] 8f schematically illustrates a situation in which the plunger rod 400 is in an exemplary injection plunger rod position. For example, after an injection is completed, the plunger rod 400 may 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 compartment, such as, for example, a medication, have been expelled, for example, through the cartridge outlet 714 and / or the needle 902. A residual amount of medication may remain in the cartridge.

[0236] FIG. 9 shows an example trace T of the resistance Re to plunger rod movement as a function of plunger rod position P. The plunger rod is moved from the plunger rod retracted position PR to the plunger rod extended position PE. At the beginning of the movement, the resistance to plunger rod movement is constant (Ex1), e.g., the plunger rod does not yet press the stopper. Then, the front end of the plunger rod abuts the first stopper of the cartridge, and the resistance to plunger rod movement increases (Ex2). The increase in resistance is caused by the first stopper's resistance to movement, e.g., due to frictional forces. The resistance may decrease slightly after the first stopper begins to move, as shown. 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.

[0237] Trace T is an example of resistance to plunger rod movement when the cartridge being received is a new and / or unused and / or normal cartridge. The cartridge parameter determination can be based on the resistance and / or plunger rod position. The cartridge parameter determination 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.

[0238] Other situations, such as situations where the received cartridge has clearly been used and / or is defective, are illustrated by additional exemplary traces T2, T3, T4.

[0239] Trace T2 shows an example situation in which resistance to movement increases above the low resistance threshold Re1 before the plunger rod position reaches the first plunger rod threshold P1. Such a situation can indicate, for example, that there is a defect in the cartridge or that something is preventing the plunger rod from moving. After such a situation, the plunger rod can be retracted to the plunger rod retracted position, and an error message can be provided through the user interface.

[0240] Trace T3 illustrates an exemplary situation in which the resistance to motion does not increase above the low resistance threshold Re1 before the plunger rod position reaches the second plunger rod threshold P2. Such a situation may indicate a cartridge with the first stopper in the advanced position, such as a used cartridge. After such a situation, the plunger rod can be retracted to the plunger rod retracted position, and an error message can be provided through the user interface.

[0241] Trace T4 illustrates an exemplary situation in which, for example, after the plunger rod position passes the first plunger rod threshold P1, resistance to movement increases above the high resistance threshold Re2. Such a situation may indicate, for example, that the first stopper is inhibited from moving, e.g., a possible cartridge defect. After such a situation, the plunger rod may be retracted to the plunger rod retracted position, and an error message may be provided via the user interface.

[0242] Thresholds such as the low resistance threshold Re1, the high resistance threshold Re2, the first plunger rod threshold P1, and / or the second plunger rod threshold P2 may be determined individually for a received cartridge. For example, a processing unit of an autoinjector may be configured to determine one or more of the thresholds based on a cartridge code feature of a received cartridge and / or cartridge assembly.

[0243] 10 shows a flowchart of an exemplary method 6000 for operating an autoinjector. Method 6000 includes step 6004 of moving a plunger rod from a first plunger rod position to a mixing plunger rod position at a mixing plunger rod velocity, and step 6006 of moving the plunger rod from the mixing plunger rod position to a second plunger rod position after a start signal is given. Method 6000 can further include step 6008 of receiving a trigger event and step 6010 of moving the plunger rod to an injection plunger rod position.

[0244] The autoinjector can include a cartridge receiver configured to receive a cartridge including a first stopper and a medicament-containing cartridge compartment. The cartridge compartment can have a first cartridge sub-compartment containing a first drug component of the medicament and a second cartridge sub-compartment containing a second drug component of the medicament. The autoinjector can further include a plunger rod configured to move the first stopper.

[0245] The mixing plunger rod position can be selected to position the first stopper at a location where the first drug component is mixed with the second drug component.

[0246] The second plunger rod position may be a primed plunger rod position, which may be selected to position the first stopper at a position where the air in the cartridge compartment is reduced to an amount suitable for injection.

[0247] Step 6004 of moving the plunger rod to the mixing plunger rod position can occur after detecting that a cartridge has been received within the cartridge receiver and / or receiving a first input signal. For example, step 6004 of moving the plunger rod to the mixing plunger rod position can be performed only after a cartridge has been detected and a first input signal has been received.

[0248] Alternatively or additionally, step 6004 of moving the plunger rod to the mixing plunger rod position can be preceded by determining the orientation of the cartridge (as described in more detail in FIG. 12 ). For example, step 6004 of moving the plunger rod to the mixing plunger rod position can require that the outlet of the cartridge is pointing up, which is determined, for example, by determining the orientation of the cartridge. Step 6004 of moving the plunger rod to the mixing plunger rod position can be temporarily aborted if the orientation of the cartridge is not within a predetermined range of orientations.

[0249] Moving the plunger rod to the second plunger rod position 6006 may require that the cartridge outlet point up, which is determined, for example, by determining an orientation of the cartridge. Moving the plunger rod to the second plunger rod position 6006 may be temporarily aborted if the orientation of the cartridge is not within a predetermined range of orientations.

[0250] Step 6006 of moving the plunger rod from the mixing plunger rod position to the second plunger rod position may require a start signal to be given, which may be given after several complete inversions of the autoinjector have been performed and when the second cartridge sub-section is pointing up compared to the first cartridge sub-section.

[0251] Receiving a trigger event 6008 can include, for example, receiving a user input signal from a user interface, such as receiving a trigger event from a trigger member, e.g., resulting from a user pressing a button. The trigger event can also occur from a user indicating the start of an injection. The trigger event can also occur from a user pressing a front portion of the autoinjector against an intended injection site. The trigger event can include a contact member signal indicating that a contact member of the autoinjector is in a first contact member position.

[0252] Moving the plunger rod to the injection plunger rod position 6010 can result in expulsion of medication through the cartridge outlet, such as through a needle. Moving the plunger rod 6010 can occur after receiving a trigger event 6008, such as after moving the plunger rod to a second plunger rod position 6006 is completed.

[0253] FIG. 11 shows a flowchart of an exemplary method 6000″. Method 6000″ includes the same steps of method 6000 as described in connection with the preceding figures. However, method 6000″ is illustrative of a method that includes additional steps: step 6014 of receiving a first input signal; step 6016 of detecting receipt of a cartridge within a cartridge receptacle of, for example, an autoinjector; step 6018 of determining a cartridge orientation; step 6020 of reading a cartridge code feature; step 6022 of detecting removal of a needle cover; step 6024 of moving a plunger rod to a first plunger rod position, such as a premix plunger rod position; step 6026 of detecting resistance to movement of the plunger rod; and step 6019 of determining a start signal.

[0254] Receiving a first input signal 6014 may include, for example, receiving a user input signal from a user interface, such as from a user pressing a button. The first input signal may also result from a user turning on the autoinjector.

[0255] Detecting 6016 that a cartridge has been received can include detecting a user inserting a cartridge into the cartridge receiving portion through the cartridge receiving portion opening. Detecting 6016 that a cartridge has been received can include detecting a presence of a cartridge in the cartridge receiving portion.

[0256] Step 6014 of receiving a first input signal and step 6016 of detecting that a cartridge has been received may be interchanged.

[0257] Determining 6018 the orientation of the cartridge can include determining the orientation with an orientation sensor such as an accelerometer. Determining 6018 the orientation of the cartridge can include determining the orientation of the autoinjector. Determining 6018 the orientation of the cartridge can include determining whether the outlet of the cartridge is pointing up.

[0258] Method 6000'' includes a step 6020 of reading a cartridge code feature. The cartridge code feature can indicate one or more cartridge specifications. Subsequent steps of method 6000'' can include adapting based on the cartridge specifications. For example, subsequent steps of method 6000'' can be tailored to the particular cartridge received and identified.

[0259] Detecting needle cover removal 6022 may be a prerequisite for initiating plunger rod movement. For example, needle cover removal may indicate that the received cartridge is being used as intended.

[0260] Step 6024 of moving the plunger rod to a first plunger rod position can include an initial movement of a first stopper of the cartridge, for example, moving the first stopper without initiating mixing of the two component drugs.

[0261] Step 6024 of moving the plunger rod to a first plunger rod position may occur after step 6016 of detecting that a cartridge has been received within the cartridge receiver and step 6014 of receiving a first input signal. For example, step 6024 of moving the plunger rod to a first plunger rod position may occur only after step 6016 of detecting a cartridge and step 6014 of receiving a first input signal.

[0262] The step 6024 of moving the plunger rod to a first plunger rod position may be performed simultaneously with the step 6020 of reading the cartridge code feature.

[0263] Detecting resistance to plunger rod movement 6026 can be performed simultaneously with moving the plunger rod to the first plunger rod position 6024, as illustrated. Detecting resistance to plunger rod movement 6026 can indicate cartridge parameters of the cartridge being received, such as whether the cartridge is new, used, or defective.

[0264] Step 6004 of moving the plunger rod to the mixing plunger rod position can be performed after step 6020 of reading the cartridge code mechanism, step 6022 of detecting needle cover removal, step 6024 of moving the plunger rod to the premixing plunger rod position, step 6026 of detecting resistance to plunger rod movement, and step 6018 of determining the cartridge orientation.

[0265] Step 6004 of moving the plunger rod to the mixing plunger rod position can be based on one or more of a cartridge code mechanism, removal of the needle cover, resistance to plunger rod movement, and / or cartridge orientation.

[0266] Step 6006 of moving the plunger rod to the second plunger rod position may require that a reconfiguration time has elapsed since completion of movement of the plunger rod to the mixing plunger rod position. Method 6000'' includes step 6019 of determining a reconfiguration time. Step 6019 of determining a reconfiguration time may be based on one or more of a cartridge code mechanism, removal of a needle cover, resistance to plunger rod movement, and / or cartridge orientation. Step 6019 of determining a reconfiguration time may include determining a first motion parameter, such as an amount of autoinjector movement, such as shaking of the autoinjector, and / or a number of autoinjector inversions. The first motion parameter may be determined based on an orientation signal, such as from an orientation sensor, such as an accelerometer. Step 6019 of determining a reconfiguration time may include receiving an orientation signal.

[0267] The step 6019 of determining the reconfiguration time may be determined based on a combination of the first motion parameter and / or the cartridge code mechanism.

[0268] Step 6006 of moving the plunger rod to a second plunger rod position can be based on one or more of a cartridge code mechanism, removal of the needle cover, resistance to plunger rod movement, and / or cartridge orientation.

[0269] The step 6010 of moving the plunger rod to the injection plunger rod position can be based on one or more of a cartridge code mechanism, removal of the needle cover, and / or resistance to movement of the plunger rod.

[0270] Method 6000 and / or method 6000'' may include a first step of receiving a cartridge.

[0271] 12a-12d schematically illustrate an exemplary user interface 1100 of an exemplary autoinjector 4, such as the autoinjector 4 illustrated in FIG.

[0272] The user interface 1100 includes a first output member 1110, such as a plurality of LEDs, illustratively. The first output member 1110 may provide a user output to a user. The first output member 1110 may be used to indicate a step in a procedure to the user and / or to display an error message. The first output member 1110 includes a first LED 1116, a second LED 1118, and a third LED 1120.

[0273] The user interface 1100 may also include a second output member (not shown), such as a speaker.

[0274] The user interface 1100 includes a contact member 1102, for example, at the front end of the autoinjector 4. The contact member 1102 can be configured to be pressed against an injection site. The contact member 1102 can serve as a third output member of the user interface 1100; for example, the contact member 1102 can be configured to illuminate, such as flash.

[0275] The user interface 1100 includes a first input member 1108, such as a button. The first input member 1108 can allow for user input from a user. For example, the first input member 1108 can be used to receive a press from the user to proceed to the next step. The first input member 1108 can serve as a fourth output member of the user interface 1100; for example, the first input member 1108 can be configured to illuminate, such as flash.

[0276] FIG. 12a shows schematically a situation of the user interface 1100 in which none of the output members are active, for example the autoinjector 4 may be turned off.

[0277] 12b schematically illustrates a situation in which the first input member 1108 and the contact member 1102 are illuminated, such as flashing. The first input member 1108 and the contact member 1102 can flash synchronously and / or asynchronously. The situation shown may be a situation indicating that the user should press the first input member 1108 and / or insert a cartridge via the contact member 1102. The situation shown may be a situation after the autoinjector has been turned on.

[0278] 12c schematically illustrates a situation in which the first input member 1108 and the second LED 1118 are illuminated, such as flashing. The situation shown may be a situation indicating that the user should press the first input member 1108 to proceed to the next step. The situation shown may be a situation after mixing the pharmaceutical ingredients and / or before performing a blank shot.

[0279] 12d 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 illuminated, 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 indicating 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.

[0280] 13a-13c schematically illustrate an exemplary movement of an exemplary autoinjector 4, such as the movement of a first movement parameter.

[0281] Figure 13a shows the autoinjector 4 in a first position, with a first end 4a of the autoinjector 4 pointing substantially upwards and a second end 4b of the autoinjector 4 pointing substantially downwards.

[0282] Figure 13b shows the autoinjector 4 being moved to a second position, with the first end 4a of the autoinjector 4 pointing substantially downwards and the second end 4b of the autoinjector 4 pointing substantially upwards.

[0283] Figure 13c shows the autoinjector 4 being moved to a third position, such as backward relative to the first position, with the first end 4a of the autoinjector 4 pointing substantially up. The second end 4b of the autoinjector 4 pointing substantially down. The first motion parameter may indicate the number of inversions of the autoinjector 4, such as the number of times the autoinjector 4 is moved from the first position to the second position and, optionally, to a third position, such as back to the first position. A processing unit (not shown in Figure 13) may be configured to detect and / or count the number of inversions.

[0284] In the illustrated example, the first end 4a of the automatic injection device 4 in the first and third positions points straight up, but it may be sufficient for the first end 4a of the automatic injection device 4 to point, for example, within 45 degrees of upward.

[0285] Similarly, in the illustrated example, the first end 4a of the automatic injection device 4 in the second position points straight down, but it may be sufficient for the first end 4a of the automatic injection device 4 to point, for example, within 45 degrees of downward.

[0286] The reconfiguration time may depend on the number of full reversals, as described in connection with FIG. 13 . For example, the reconfiguration may require that a certain number of reversals, such as five, be performed at a frequency within a default / predetermined frequency range, such as between 0.3 and 1.2 Hz. For example, the reconfiguration time may be the time used to perform that number of full reversals. The number of full reversals and / or frequency range required may be determined based on a cartridge code mechanism, e.g., the cartridge code mechanism may indicate the number of reversals and / or the frequency range of the reversals.

[0287] While certain features have been illustrated and described, it will be understood that these features are not intended to limit the claimed invention, and it will be apparent to those skilled in the art that various changes and modifications can be made without departing from the spirit and scope of the claimed invention. Accordingly, the specification and drawings are to be regarded in an illustrative rather than a restrictive sense. The claimed invention is intended to cover all alternatives, modifications, and equivalents.

Claims

1. 1. An automatic injection device for administering a medication, comprising: Housing and a cartridge receiving portion configured to receive a cartridge assembly comprising a cartridge and a cartridge code mechanism, the cartridge comprising a first stopper and a cartridge compartment containing the medicament, the cartridge compartment having a first cartridge sub-compartment containing a first drug component of the medicament and a second cartridge sub-compartment containing a second drug component of the medicament, the cartridge code mechanism indicating an amount of kinetic energy required to optimally mix the first drug component with the second drug component; a code sensor configured to read the cartridge code feature; an orientation sensor configured to detect the orientation of the cartridge and / or the automatic injection device; a drive module coupled to move a plunger rod between a plunger rod retracted position and a plunger rod extended position, the plunger rod configured to move the first stopper; a processing unit coupled to the code sensor, the drive module, and the orientation sensor; receiving a code signal from the code sensor indicative of the cartridge code mechanism; controlling the drive module to move the plunger rod at a mixing plunger rod velocity from a first plunger rod position to a mixing plunger rod position selected to position the first stopper at a location where the first drug component is mixed with the second drug component; receiving an orientation signal; determining a first motion parameter, the first motion parameter indicative of a frequency of motion of the automatic injection device, the first motion parameter being based on a cumulative measure of the orientation signal over time; controlling the drive module to move the plunger rod from the mixing plunger rod position to a second plunger rod position upon receiving an initiation signal, the initiation signal indicating that the first drug component and the second drug component have been reconstituted; a processing unit configured to perform An automatic injection device comprising:

2. 2. The automatic injection device of claim 1, wherein the first movement parameter is based on a cumulative measure of the orientation signal since completion of movement of the plunger rod to the mixing plunger rod position.

3. 3. The autoinjector of claim 1, wherein the first motion parameter indicates that the device is being shaken.

4. 4. The autoinjector of claim 1, wherein the first motion parameter is indicative of a number of inversions of the autoinjector and / or a number of complete inversions of the autoinjector.

5. 5. The automatic injection device of claim 1, wherein the second plunger rod position is selected to position the first stopper at a position where the air in the cartridge compartment is reduced to an amount suitable for injection.

6. 6. The automatic injection device of claim 1, wherein the first plunger rod position is a premix plunger rod position, and the premix plunger rod position is selected to position the first stopper at a position where fluid communication between the first cartridge sub-section and the second cartridge sub-section has not yet been established.

7. 7. The automatic injection device of claim 1, wherein the processing unit is further configured to control the drive module to move the plunger rod to the second plunger rod position only after a reconfiguration time has elapsed since the plunger rod completed its movement to the mixing plunger rod position.

8. 8. The autoinjector of claim 1, wherein the cartridge code feature comprises one or more of a color, an array of colors, a bar code, an RFID tag, an NFC tab, an identification number, or a QR code.

9. 9. The automatic injection device of claim 1, wherein the processing unit is further configured to control the drive module to move the plunger rod to the second plunger rod position only after a reconfiguration time has elapsed since the plunger rod completed its movement to the mixing plunger rod position, and the processing unit is further configured to determine the reconfiguration time based on the code signal.

10. 10. The automatic injection device of claim 1, wherein the cartridge receiving portion is configured to receive a cartridge assembly comprising the cartridge and a cartridge code mechanism, the automatic injection device comprises a cartridge sensor configured to detect that the cartridge is received in the cartridge receiving portion, and the processing unit is coupled to the cartridge sensor and further configured to receive a cartridge sensor signal from the cartridge sensor indicating whether the cartridge is received in the cartridge receiving portion.

11. 11. The autoinjector of claim 1, wherein the processing unit is further configured to provide feedback when a predetermined amount of energy has been applied to the autoinjector and / or the cartridge.

12. 12. The autoinjector of claim 1, wherein the drive module is an electromechanical motor, the drive module being connected to a battery for receiving power.

13. 12. The autoinjector of claim 1, wherein the drive module comprises a spring arrangement configured to actuate the plunger rod.

14. 12. The autoinjector of claim 1, wherein the drive module includes pressurized gas configured to actuate the plunger rod.

15. 15. The automatic injection device of claim 1, wherein the processing unit is further configured to receive a trigger event and control the drive module to move the plunger rod to an injection plunger rod position after receiving the trigger event.

16. 16. A system comprising an automatic injection device for administering a medicament according to any one of claims 1 to 15, and a cartridge, the cartridge comprising a first stopper and a cartridge compartment containing the medicament, the cartridge compartment having a first cartridge sub-compartment containing a first medicament component of the medicament and a second cartridge sub-compartment containing a second medicament component of the medicament.

17. 17. The system of claim 16, wherein the first pharmaceutical component comprises a fluid composition and the second pharmaceutical component comprises a powder composition.

18. 16. A method of controlling an autoinjector according to any one of claims 1 to 15, comprising the steps of: moving a plunger rod from a first plunger rod position to a mixing plunger rod position at a mixing plunger rod speed, the mixing plunger rod position being selected to position the first stopper at a location where the first drug component is mixed with the second drug component; receiving an orientation signal; determining a first motion parameter, the first motion parameter indicative of a frequency of motion of the automatic injection device, the first motion parameter being based on a cumulative measure of the orientation signal over time; moving the plunger rod from the mixing plunger rod position to a second plunger rod position upon receiving an initiation signal, the initiation signal indicating that the first drug component and the second drug component have been reconstituted; A method comprising:

Images