Autoinjector with reconstitution handling support

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] SUMMARY 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 an increasing interest in having automatic injection devices perform as much of the injection process automatically as possible to avoid relying on the user to perform certain tasks accurately. It may be beneficial to automate the process of preparing and administering fluids such as medicines, especially when the administration of the medicine requires multiple steps, such as when the medicine needs to be mixed before injection. Furthermore, it may 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 the preparation and administration of medications by autoinjectors. [Means for solving the problem]

[0005] Accordingly, an autoinjector for preparing and / or administering a medicament, such as a drug, 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 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.

[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 is 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 a 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 provided as an indication that the first and second pharmaceutical components have, for example, been 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 spans. 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 the 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 given by the processing unit may depend on the viscosity of the pharmaceutical components being mixed. Higher viscosity pharmaceutical component variants will typically require more complete inversions, e.g., 10 or 20 or even more complete inversions, while lower viscosity pharmaceutical component variants may require fewer complete inversions, e.g., 5 or 10 complete inversions, to obtain effective mixing of the pharmaceutical components and activate the start signal. Thus, viscous pharmaceutical components will require more inversions than less viscous pharmaceutical component 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 medicament component of the medicament and a second cartridge sub-compartment containing a second medicament 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 a cartridge receiver of the autoinjector 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 that includes an autoinjector, such as an autoinjector of the present disclosure, and a cartridge, such as a cartridge of the present disclosure.

[0019] Also disclosed are methods for operating an autoinjector, such as the autoinjector of the present disclosure, the autoinjector 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 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 selected to position the first stopper at a location where the first pharmaceutical component is mixed with the second pharmaceutical component, performing multiple complete reversals of the autoinjector, 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, such as, for example, 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 achievement of a button press, the expiration of a timeout, and / or the achievement of a predetermined user behavior. The trigger event can indicate that the autoinjector is being pressed against an 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 constituting 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 may be operated without making measurements of the temperature of the medication, since the elimination of the temperature sensing element lowers the autoinjector's target.

[0026] The processing unit may 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 stirring, i.e., inversion, of the autoinjector is much more efficient in supporting the safe preparation of the drug, thereby allowing a completely reconstituted homogeneous drug to be injected into the patient's skin in the shortest possible time. In practice, even if waiting for a long time and exposing the mixed drug components to elevated temperatures, the final homogeneity of the mixed / reconstituted drug cannot be significantly improved over the homogeneity that can be achieved at room temperature. On the other hand, in contrast, when applying even minimal physical stirring, i.e., even fewer physical inversions, the homogeneity of the reconstituted drug is significantly improved. Physical stirring should be understood as inversion as opposed to shaking motion, since shaking motion tends to introduce a large number of 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. If the viscosity of the drug is high, it is highly undesirable to introduce a large number of air bubbles into the drug solution during the mixing procedure, since the number of air bubbles needs to be reduced to a certain level and / or completely removed before the correct dose of drug can be injected. Furthermore, during the process of blanking before injection, there is a risk that a larger portion of the drug will be expelled because it is carried in air bubbles. Therefore, it is highly preferable to use inversion rather than a shaking action to mix the first and second drugs.

[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 drug 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 may be generated after the above number of complete reversals 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 may preferably have an up-pointing orientation substantially along a vertical axis or within 45 degrees of the vertical axis. The up-pointing orientation is advantageous for releasing air from the cartridge compartment without expelling medicament.

[0032] The processing unit can be configured to perform a blank shot after the number of complete inversions have 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 automatically proceed to perform a blank shot when the needle is pointing up, i.e., when the second cartridge sub-section is pointing up compared to the first cartridge sub-section. A blank shot is advantageously performed after a complete inversion, since any air bubbles remaining after reconstitution will aid mixing during inversion. Once the blank shot has been performed, the drug is ready to be injected.

[0034] A prerequisite for physical stirring to work well is that the inversion is performed 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 in the cartridge compartment as a result of the physical input. An air bubble is usually an air bubble that has a volume at least comparable to the total volume of the mixed pharmaceutical components. Preferably, in the present invention, an air bubble is not defined by its volume, but by the cross-sectional area that it partially or completely covers when the cartridge is oriented vertically. Preferably, the air bubble is 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, the second plunger rod position 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. The cartridge outlet can be configured to be in fluid communication with the compartment, for example at a first cartridge end. The cartridge can be configured to release the medicament through the cartridge outlet. The cartridge outlet can be configured to be coupled with a needle, such as a hypodermic needle, to allow the medicament to be released through the needle.

[0038] The cartridge comprises a first stopper movable within the cartridge compartment. The cartridge may comprise a second stopper movable within the cartridge compartment. The second stopper may be between the first stopper and the cartridge outlet. The cartridge may comprise 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 towards the cartridge outlet in the direction of the first stopper, e.g., towards 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 towards the cartridge outlet, may release medicament 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, for example, water or ethanol or saline or a buffer or a preservative solution. The second pharmaceutical component may be a solute. The first pharmaceutical component may be a solvent. It is envisioned 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 the first and second cartridge part-sections, 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 a stopper separating adjacent cartridge part-sections is positioned within the bypass portion.

[0043] The autoinjector of the present disclosure may be a reusable autoinjector. A reusable autoinjector may be particularly useful when the cartridge comprises multiple subcompartments. For example, an autoinjector for a multi-compartment or multi-chamber cartridge may be more sophisticated and therefore may be beneficial to allow the autoinjector to be used more than once. For example, the autoinjector may provide an automatic process for mixing drug components, such as initially 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 a needle assembly including, for example, 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 the needle assembly. The cartridge holder can allow the needle assembly to be attached to the cartridge.

[0046] The cartridge may include a cartridge code feature, and / or the cartridge assembly may include a cartridge and a cartridge code feature. The cartridge code feature may 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 may include a color and / or an arrangement of colors. The cartridge code feature may be positioned surrounding or partially surrounding a portion of the cartridge compartment in which a stopper, such as the first stopper, is initially positioned. Such a position of the cartridge code feature may make the cartridge code feature easier to read, for example, because the stopper may form a background for the cartridge code feature. The stopper, such as the first stopper, may be a light color, such as a light gray or white color. The stopper, such as the first stopper, may be a dark color, such as a dark blue, dark gray, or black color. The stopper may form a dark background for the cartridge code feature. The stopper, such as the first stopper, may 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 particular 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 can have their cartridge code feature positioned at the same location, such as positioned a code distance from the second cartridge end. Such a uniform location of the cartridge code feature can reduce the complexity and size of the autoinjector, since the cartridge code feature is read at the same location for all suitable cartridges.

[0048] The cartridge and the cartridge code feature may be manufactured as one element. For example, the cartridge code feature may be a particular form of the cartridge. Alternatively, the cartridge code feature may be attached to the cartridge, for example, secured to the cartridge by an 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 in a cartridge compartment, etc. The cartridge code feature may indicate a first stopper position where 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 an amount of drug contained within the cartridge. The cartridge code feature may indicate a particular type of cartridge, such as an ID number for a particular type of cartridge.

[0050] The autoinjector, such as a 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 at different stages 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 speed of first stopper movement at different stages 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 dwell time of the drug, such as, for example, a time to ensure that the drug is distributed into the tissue, for example, 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 feature may indicate a number of complete inversions required for the medicaments in the two compartments of the cartridge to be completely mixed. The movement from the first plunger rod position to the mixing plunger rod position can be based on a code signal indicative of the cartridge code feature 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 at which a reversal of the autoinjector is required to be considered a complete reversal.The cartridge code feature may indicate a threshold reversal angle at which a reversal of the autoinjector is required to be considered a complete reversal.

[0052] The number of complete reversals may depend on the measured reversal angle and the 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 may be configured to receive a cartridge assembly including the cartridge. The cartridge assembly may include a cartridge holder. The cartridge receiving portion may have a cartridge receiving portion opening. The cartridge receiving portion may be configured to receive the cartridge by inserting the cartridge, such as a second end of the cartridge, through the cartridge receiving portion opening. The cartridge may be inserted in a cartridge receiving direction. The cartridge receiving direction may, for example, be opposite to a direction of the first stop when the cartridge is received in the cartridge receiving portion. The cartridge may be in a first angular position when inserted into the cartridge receiving portion. The cartridge may 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 may be configured to receive a cartridge assembly comprising a cartridge and a cartridge holder. The cartridge assembly may 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 may be locked into 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 may be locked into the cartridge receiving portion by movement of a plunger rod of an autoinjector.

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

[0057] The autoinjector may be an electronic autoinjector. The autoinjector may include a battery. The housing may house the battery. The battery may be a rechargeable battery. For example, the battery may be a lithium-ion battery or 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, etc., a 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 a 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 the mixing plunger rod position to a second plunger rod position, the plunger rod can be configured to move the first stopper toward a cartridge outlet, such as for mixing two drug components and / or expelling drug from a cartridge compartment through a cartridge outlet and / or expelling air from a cartridge compartment through a cartridge outlet.

[0061] The plunger rod can be moved to a first plunger rod position, such as a premix plunger rod position, from a plunger rod retracted position, such as a plunger rod extended position, such as a plunger rod extended 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 part-compartments.

[0063] The plunger rod can be moved to a second plunger rod position, such as from a mixed plunger rod position, such as 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, such as, a second plunger rod position, to, such as, 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, such as minimized, such as a position close to 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 an injection plunger rod position and / or a plunger rod extended 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 to a plunger rod retracted position.

[0067] The processing unit can be configured to receive a trigger event and, after receipt of 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 preceding plunger rod position, such as the second plunger rod position.

[0068] The autoinjector may include an ejection sensor, such as a plunger rod position sensor. The ejection sensor may be configured to detect an ejection, such as an ejection, of medication and / or air in the cartridge compartment. The ejection sensor may be configured to detect and / or determine a position of the plunger rod and / or a position of the first stopper. The ejection sensor may be configured to detect and / or determine a position of the plunger rod and / or a position of the first stopper. The ejection sensor may be configured to detect a condition indicative of a position of the plunger rod and / or a position of the first stopper. The ejection sensor may be configured to provide an ejection sensor signal. The ejection sensor signal may be indicative of a position of the plunger rod and / or a position of the first stopper.

[0069] The dispensing sensor may include a tachometer, such as a tachometer of a drive module. The tachometer may be configured to count rotations of a drive module, such as a motor of the drive module, such as rotations of the drive module from a set point, such as a point at which the position of the plunger rod is known, such as a plunger rod retracted position of the plunger rod. The counting of 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 dispense sensor, such as a tachometer. The processing unit can receive a first dispense sensor signal, such as a tachometer signal, from the dispense 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 dispense sensor signal. The processing unit can receive a second dispense sensor signal, for example, from the dispense sensor indicating that the plunger rod is in 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 dispense sensor signal and the second dispense sensor signal.

[0071] The cartridge may be lockable within the cartridge housing, e.g., the cartridge may be locked within the cartridge housing to prevent the cartridge from being removed from the cartridge housing. Movement of the plunger rod towards a plunger rod extended position may lock the cartridge within the cartridge housing. Movement of the plunger rod to a mixing plunger rod position may lock the cartridge within the cartridge housing. Movement of the plunger rod towards a plunger rod retracted position may unlock the cartridge from the cartridge housing. Movement of the plunger rod to a plunger rod retracted position may unlock the cartridge within the cartridge housing. The cartridge may be locked within the cartridge housing when the plunger rod is not at and / or close to the plunger rod retracted position. Coupling the position of the plunger rod with the locking of the cartridge within the cartridge housing may provide the advantage of limiting or preventing the cartridge from being released when the autoinjector is activated.

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

[0073] The orientation sensor may 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 may 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, 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 may 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, for example, linear acceleration and / or velocity and / or position in one, two or three dimensions and / or additional rotational acceleration and / or rotational 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, for example, integrating the acceleration signals 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 an orientation of the autoinjector indicates that the cartridge is in a predetermined orientation. The predetermined orientation may be a vertical orientation. The predetermined orientation may be an orientation within 45 degrees from vertical, such as within 30 degrees from vertical. The predetermined orientation may be an orientation where 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 flipping 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 flipping, and the angle spanned by the autoinjector during flipping. Thus, the orientation sensor may be a single or multi-axis gyroscopic sensor.

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

[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 upwards 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 in line with the projection of the accelerometer sensitive axis onto the vertical gravitational force (i.e., fall by a factor determined by the cosine of the tilt angle).

[0079] With a dual-axis accelerometer, movement is detected along two individual axes, the x-axis and the y-axis, which are oriented perpendicular to each other. 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 such that the x-axis is parallel to the longitudinal axis of the autoinjector and thus is 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 thus is 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 this two-dimensional plane, such as movement in a different y-axis direction, cannot be detected with the same accuracy using the 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 detecting the movement by the two-axis accelerometer. Thus, rotation of the autoinjector may cause a shift in the signal observed for the two-axis sensor. However, if the x-axis or y-axis sensor is not aligned in the direction in which the autoinjector is rotated, the sensor will provide a lower output. If a rotation is performed in a spatial plane orthogonal to the plane defined by the two-dimensional accelerometer, only the common sensing axis will provide a sensing signal in response to a physical rotation of the autoinjector performed by the user. This means that a flip of the autoinjector cannot be accurately observed and / or recorded.

[0081] Due to the practical circumstances of implementing these sensors, some level of sensing out of the x / y two-dimensional plane may be observed in some cases. However, such signals are significantly weaker compared to acceleration along the designated x and y operational axes, which does not have any level of predetermined sensing. Therefore, such out-of-plane signals are difficult to use in practice if a reliable orientation signal is to be detected. Dual-axis accelerometers do not always provide as accurate results as triple-axis accelerometers, because the design of the autoinjector is not intended to restrict the user in how he holds the autoinjector and in which direction he may flip the autoinjector to perform the flip required to mix the medication.

[0082] Compared to a two-axis accelerometer, the use of a three-axial accelerometer, also referred to below as a tri-axial accelerometer, improves sensitivity. The use of a three-axial accelerometer instead allows detection of motion in the z-axis direction in addition to the x- and y-axis directions. As the z-axis direction is perpendicular to both the x- and y-axes, motion of the autoinjector in a different dimensional plane than that defined by the x- and y-axes can be observed. 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 further 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, i.e., including rotational movements that vary based on hand / arm ergonomics, etc. This means that all flips of the autoinjector can be accurately observed and recorded.

[0084] Thus, the autoinjector may further comprise 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, a three-axis accelerometer.

[0085] The processing unit can be coupled to the orientation sensor. The processing unit can be configured to receive an orientation signal, for example, indicative of an orientation of the cartridge when the cartridge is received in the cartridge receiver and / or indicative of an orientation of the autoinjector. The processing unit can be configured to receive an orientation signal indicative of an angular velocity and / or an angle covered by the autoinjector in a reversal. 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 indicative of the angular velocity and / or the angle covered by the autoinjector in a full reversal.

[0086] 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 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 an orientation of the cartridge, such as 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 infusion plunger rod position based on the orientation signal. For example, the processing unit can be configured to control the drive module to move the plunger rod to the mixing plunger rod position and / or a second plunger rod position and / or an infusion plunger rod position only if the orientation signal indicates that an inclination angle between the vertical and a longitudinal axis extending along the cartridge is within 45 degrees, such as within 30 degrees, of the vertical and / or 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 a cumulative motion of the autoinjector. The first motion parameter can indicate an amount of motion of the autoinjector for a set period of time, such as a preceding predefined time, such as a preceding one second, since completion of the motion of the plunger rod to the mixing plunger rod position. The first motion parameter can be based on a cumulative measure of orientation over time, such as a preceding predefined time, such as a preceding one second, since completion of the motion of the plunger rod to the mixing plunger rod position. The first motion parameter can indicate that the device is being shaken. Shaking the device while the two drug components are mixing can cause excessive foaming of the drug. Excessive foaming of the drug can require an increased reconstitution time. To prevent foaming, the speed of the motion of the plunger rod 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 may affect the determination of reconstitution time.

[0091] Alternatively or additionally, the first motion parameter may be indicative of the autoinjector being rotated from one vertical orientation, e.g., where a first end of the autoinjector, such as a distal end of the autoinjector, points substantially up, to an inverted orientation, where the first end of the autoinjector points substantially down. The first motion parameter may be indicative of a number of inversions and / or complete inversions of the autoinjector. The processing unit may be configured to detect and / or count the number of inversions / complete inversions.

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

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

[0094] Thus, a reversal can be defined as a rotation of the autoinjector approximately 180 degrees. The orientation at 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 position pointing 40 degrees upward to a position pointing 135 degrees upward, i.e., 45 degrees downward. An upward rotation can be detected during a rotation from 45 degrees downward, i.e., 135 degrees upward, to 30 degrees upward. Thus, upward and downward rotations can be detected before the reversal is complete. Thus, 90 to 105 rotations within a preset time can be used to calculate the reversal frequency based on the interpolation of this data to estimate a rotation of approximately 180 degrees.

[0096] A reversal can be considered a complete reversal by the autoinjector if it is performed at an angular velocity above the default threshold. A complete reversal also means 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 1 reversal per 2 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 drug components. The reversal frequency can be used in the built-in software to determine whether the reversal is effective or not.

[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 half a 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 limit on the reversal frequency 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. The default threshold angle 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 greater than 205 degrees of rotational movement, 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 Wherein 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 points down and a first horizontal position in which the distal end of the autoinjector points 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 upwards; and Wherein 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.

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

[0106] The vibration 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 vibration frequency threshold can be based on a 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, 5 reversals of 180 degrees, but may be assumed to require a greater number of reversals, such as, for example, 10 reversals at angles up to 90 degrees per reversal, if the measured reversal angle remains significantly below continuously. Alternatively, the specified physical input for a low viscosity drug may be, for example, 10 reversals of 180 degrees, but may be assumed to require a greater number of reversals, such as, for example, 20 reversals at angles up to 90 degrees per reversal, if the measured reversal angle remains significantly below continuously. Thus, the number of complete reversals may be increased 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 feature that defines the number of inversions required for the medication to be adequately mixed. Thus, the autoinjector need not be pre-set to require a particular number of inversions, e.g., inversion of every cartridge used by the device. Instead, the autoinjector can be set to require a discrete number of inversions that are defined on the cartridge code feature.

[0109] The processing unit may 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 non-complete reversals that do not meet the requirements to be completed. The processing unit may provide visual and / or audio feedback to the user when the number of complete reversals have been performed.

[0110] Alternatively or in combination, the processing unit may provide visual and / or audio feedback to the user after each complete flip. For example, using a 3-axis accelerometer to count the number of complete / successful flips, e.g., given quickly enough and with a sufficient rotation angle repeated a sufficient number of times, the autoinjector device may provide audio feedback through an internal speaker, e.g., giving a "tick" sound for each successful flip. Additionally, visual feedback, e.g., over a graphic progress bar included in the interface, may be provided for all complete flips or for each complete flip during the flip sequence. This helps the user to perform the flips accurately.

[0111] The predetermined number of full inversions can be based on the amount of kinetic energy added to the mixed drug during reconstitution, for example, the predetermined number of full inversions can be correlated to the amount of kinetic energy added 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 feature, such as a code signal indicative of the cartridge code feature.

[0113] The first motion parameter can be indicative of 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 a 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, the acceleration can be monitored to ensure that 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, based on, for example, measurements of the rotational acceleration of the autoinjector and / or the number of reversals and / or complete reversals counted, can be continuously evaluated, for example, to provide real-time instructions to the user to perform such exercises, for example, when the energy level is deemed too low, for example, below a predetermined lower threshold, and / or when the energy level is deemed high, for example, 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 a frequency of motion of the autoinjector, 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 that can be configured to read a cartridge code feature, such as a cartridge code feature of a cartridge and / or cartridge assembly that indicates one or more cartridge specifications. The code sensor can be configured to provide a code signal indicative of the cartridge code feature.

[0119] A 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. A movement of the plunger rod, such as a movement from a first plunger rod position to a mixed 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 a position, a speed, and / or a delay, may be based on the code 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 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, dry firing 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] The plunger rod movement can be based on cartridge specifications, e.g., a code signal, allowing the plunger rod movement to be optimized for several 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, for example, ensuring proper mixing with different cartridges and / or reducing patient discomfort.

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

[0126] The resistance sensor may be configured to determine the power consumed by the drive module, for example, by measuring an electrical resistance, a current, and / or a 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 can be configured to measure a pressure and / or force applied to a plunger rod front end of the plunger rod. The plunger rod front end can be configured to engage a first stopper of the cartridge. The resistance sensor can be configured to measure a pressure and / or force between the plunger rod and the stopper. For example, the resistance sensor can include a pressure transducer and / or a force transducer on the plunger rod front end. The plunger rod can 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 infusion plunger rod position can be based on a 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 a temperature of the autoinjector and / or the cartridge and / or medicament, e.g., the temperature of the medicament in 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 temperature and read the cartridge code feature.

[0130] The processing unit may be coupled to the temperature sensor. The processing unit 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 a mixing plunger rod position and / or a preparation plunger rod position and / or an 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 increase and / or decrease the temperature of the cartridge and / or medicament, thereby controlling steps of the procedure that are temperature dependent, 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 medicament. The heating element may be a resistive heating element. The heating element may be a light source, for example 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 the cartridge and / or the medicament. The cooling element 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, such as by using the Peltier effect to transfer heat from one side of the element to the other by consuming electrical energy. The thermoelectric element 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 include a coil element. The coil element can be configured, for example, to surround an 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 or 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 may include a contact member. The contact member may be configured to be compressed against an injection site. The contact member may be movable between a contact member extended position and a contact member retracted position. The contact member may be biased toward the contact member extended position, for example, by a contact member spring. The contact member may be configured to be moved toward the contact member retracted position, for example, when compressed against an injection site. The contact member and / or the contact member sensor may be configured to provide a contact member signal indicative of a position of the contact member. The autoinjector and / or the contact member may include a contact member sensor configured to detect a position of the contact member. The contact member sensor may be configured to provide a contact member signal indicative of the contact member.

[0141] The contact member may be in a first contact member position, for example, between the contact member extended position and the contact member retracted position. The contact member in the first contact member position 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 may be coupled to the contact member. The processing unit may be configured to receive a contact member signal. The trigger event may include the contact member signal indicating that the contact member is in a first contact member position. The contact member may 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 feature, 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 may 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 be based on a shaking of the device, such as a first motion parameter. For example, the processing unit may 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 infusion plunger rod position, may be based on a 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 infusion 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 infusion 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 movement of the plunger rod can include movement with a plunger rod velocity, such as a mixed plunger rod velocity, a second plunger rod velocity, and / or an injection plunger rod velocity. The plunger rod velocity can be based on a position of the plunger rod. The plunger rod can be moved from a first plunger rod position, etc., to a mixed plunger rod position at a mixed plunger rod velocity. The plunger rod can be moved from a mixed plunger rod position, etc., to a second plunger rod position at a second plunger rod velocity. The plunger rod can be moved from a mixed plunger rod position and / or a second plunger rod position, etc., 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, such as 1.7 mm / sec.

[0149] The processing unit can be configured to control the drive module to move the plunger rod from the first plunger rod position, etc., to a mix plunger rod position at a mix plunger rod velocity. The processing unit can be configured to control the drive module to move the plunger rod from the mix plunger rod position, etc., 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 the second plunger rod position, etc., to an infusion plunger rod position at an infusion 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 feature, 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 a 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 the mixing plunger rod velocity, the second plunger rod velocity and / or the 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, may 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 may require a reconstitution time to elapse from completion of movement of the plunger rod to the mixing plunger rod position. The reconstitution time may be selected to allow sufficient time to ensure that the drug is reconstituted, e.g., that the first drug component and the second drug component are sufficiently mixed, e.g., dissolved.

[0155] In some circumstances, the reconfiguration time may be very short. The reconfiguration time may be less than 10 degrees, such as less than 1 degree, such as less than 5 degrees. Alternatively, the reconfiguration time may 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 may 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 movement of the plunger rod to the mixing plunger rod position is completed.

[0157] The reconfiguration time can be based on a cartridge specification, 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 a resistance to the motion 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 and / or the orientation signal and / or the first motion 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 the plunger rod movement to the injection plunger rod position is completed to move the plunger rod toward the plunger rod retracted position, such as to the plunger rod retracted position. The dwell time may be selected to allow sufficient time to ensure that the agent is dispersed in the tissue. The dwell time may be influenced by the agent and / or the agent concentration and / or the agent amount and / or the agent temperature. The dwell time may be based on cartridge specifications, e.g., the dwell time may be based on a cartridge code mechanism, e.g., the dwell time may be based on a code 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 completion of movement of the plunger rod to the injection plunger rod position.

[0164] The dwell time can be based on a cartridge specification, 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 motion 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] The above 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 description of the drawings]

[0170] [Figure 1] FIG. 1 illustrates an exemplary autoinjector device. [Diagram 2] FIG. 1 illustrates an exemplary autoinjector having a cartridge. [Diagram 3] FIG. 2 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. [Diagram 5]FIG. 1 is a schematic diagram illustrating an exemplary autoinjector having a cartridge assembly. [Figure 6a] FIG. 1 is a schematic diagram showing the autoinjector and cartridge assembly. [Figure 6b] FIG. 1 is a schematic diagram showing the autoinjector and cartridge assembly. [Figure 6c] FIG. 1 is a schematic diagram showing the autoinjector and cartridge assembly. [Figure 6d] FIG. 1 is a 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 a plunger rod in an exemplary position. [Figure 8b] FIG. 1 is a schematic diagram showing an exemplary cartridge assembly and a plunger rod in an exemplary position. [Figure 8c] FIG. 1 is a schematic diagram showing an exemplary cartridge assembly and a plunger rod in an exemplary position. [Figure 8d] FIG. 1 is a schematic diagram showing an exemplary cartridge assembly and a plunger rod in an exemplary position. [Figure 8e] FIG. 1 is a schematic diagram showing an exemplary cartridge assembly and a plunger rod in an exemplary position. [Figure 8f] FIG. 1 is a schematic diagram showing an exemplary cartridge assembly and a 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] 1 is a schematic diagram illustrating an exemplary movement of an exemplary autoinjector. [Figure 13b] 1 is a schematic diagram illustrating an exemplary movement of an exemplary autoinjector. [Figure 13c] 1 is a schematic diagram illustrating an exemplary movement of an exemplary autoinjector. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0171] Various embodiments will now be described with reference to the drawings. Similar reference numerals refer to similar elements throughout. Thus, similar 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 a limitation on the scope of the claimed invention. In addition, 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 may 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 a medication. The autoinjector 4 can be an electronic autoinjector.

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

[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 a 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. The contact member 1102 may be movable in the cartridge receiving direction 304 relative to the housing when compressed against the injection site. The contact member 1102 may be part of the user interface 1100.

[0176] The user interface 1100 can include an illustrative 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 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, for example, which may provide a user output to a user. The user interface 1100 may include a second input member (not shown), such as a speaker, for example. 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 receiver 300. Cartridge 700 is shown having 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 illustrates generally 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 comprises a cartridge compartment 702. The cartridge compartment 702 can be configured to contain a medicament. The cartridge 700 has a first end 718 and a second end 720. The cartridge 700 comprises a cartridge outlet 714 at the first cartridge end 718. The cartridge can be configured to release the medicament through the cartridge outlet 714.

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

[0182] Illustratively, the cartridge 700 can be a dual-chamber cartridge. The cartridge includes a second stopper 710 movable within the cartridge compartment 702, for example, in a first stopper direction 722, for example, toward a first cartridge end. The cartridge compartment 702 can have a first cartridge sub-compartment 704 and a second cartridge sub-compartment 706. The first cartridge sub-compartment 704 is between a first stopper 708 and a second stopper 710. The second cartridge sub-compartment 706 is between the second stopper 710 and a cartridge outlet 714. The cartridge includes a bypass portion 712 for allowing fluid communication between the first cartridge sub-compartment and the second cartridge sub-compartment. The bypass portion 712 allows fluid communication between the first cartridge sub-compartment and the second cartridge sub-compartment when the second stopper 710 is positioned within the 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. By positioning the second stopper 710 within the bypass portion 712, the first drug component 792 can be forced through the bypass portion 712 into the second cartridge sub-compartment 706, whereby the first drug component 792 and the second drug component 794 mix to provide a combined drug 790.

[0184] 4a-d show a schematic diagram of 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. The 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 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.

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

[0188] 4c illustrates an example cartridge assembly 600 in which the cartridge code feature 1000 includes strips with different checkerboard patterns. For example, as illustrated, the cartridge code feature 1000 may include two strips, with a first strip checkerboard at 45 degrees and a second strip checkerboard at -45 degrees. The checkerboard patterns and / or the checkerboard patterns of the strips relative to each other may indicate a code for the cartridge code feature 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 a 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 a 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 a needle assembly mating portion 812 of the cartridge holder 800. The needle 902 extends through a cartridge outlet 714 of the cartridge 700. The cartridge outlet 714 may be blocked by an elastomeric 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 comprises a plunger rod 400. The plunger rod 400 is configured to advance a first stopper of the cartridge 700. The plunger rod 400 comprises 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. The motion of the plunger rod 400 includes a rotation of the inner plunger rod 402. The rotation of the inner plunger rod 402 results in a translational motion of the outer plunger rod 404 due to the outer plunger rod 404 being rotationally constrained. The outer plunger rod 404 is configured, when translated in the first stopper direction 722 , to abut a first stopper of the cartridge 700 and move the first stopper 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] The illustrated example includes a motor 502 which may be an electromechanical motor, however, it will be readily appreciated that the automatic injection device 4 may be implemented with modules having alternative drives including 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 a position of the plunger rod 400. In the illustrated example, the discharge sensor 26 includes a tachometer configured to count / detect revolutions of the motor 502. Thus, the position of the plunger rod 400 can be determined based on counting the revolutions of the motor 502. The discharge sensor 26 can detect the release of medication and / or air in the cartridge compartment based on the determination of the position of the plunger rod 400. The position of the plunger rod 400 can be indicative of the position of the first stopper of the cartridge 700, e.g., a most advanced position of the plunger rod 400 can be indicative of the position of the first stopper of the cartridge 700, e.g., while the cartridge 700 is within the cartridge receiving portion 300.

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

[0199] The autoinjector 4 includes a cartridge receiver 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 engagement member 1114. The needle cover engagement 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 autoinjector 4 includes a contact member sensor 1104 configured to detect a 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] A first contact member position can be detected by the first contact member sensor 1130 being covered and the second contact member sensor 1132 being covered. A second contact member position can be detected by the first contact member sensor 1130 being uncovered and the second contact member sensor 1132 being covered. A contact member extended position can be detected by the first contact member sensor 1130 being uncovered and the second contact member sensor 1132 being uncovered.

[0203] 6a shows a schematic representation of the autoinjector 4 without a cartridge and / or cartridge assembly received therein. The contact members 1102 are in a contact member extended position. A cartridge can be inserted into the cartridge receiving portion 300 in a cartridge receiving direction 322 through the contact members 1102 which define a cartridge receiving portion opening 301.

[0204] FIG. 6b shows a schematic of the autoinjector 4 in which the cartridge assembly 600 is received. The cartridge assembly 600 comprises a cartridge 700, a cartridge holder 800 and a needle assembly 900. The needle assembly comprises a needle 902 and a needle cover 908. The needle cover has a needle cover abutment surface 910. The needle cover abutment surface 910 engages with a needle cover engagement member 1114 of the contact member 1102. The contact member 1102 is in the second contact member position, for example, by the needle cover 908 being 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] FIG. 6c shows diagrammatically the autoinjector 4 in which the cartridge assembly 600 has been received. In comparison to FIG. 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 shows a schematic of the autoinjector 4 in which the cartridge assembly 600 is received. The contact member 1102 is in a first contact member position. The first contact member position may be or may be close to the contact member retracted position. The contact member 1102 can be moved to the first contact member position by pressing the contact member 1102 against the injection site, 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 illustrates a block diagram of an exemplary autoinjector 4. The autoinjector 4 includes a plurality of sensors 22, 24, 26, 28, 30, 32, a processing unit 20, a drive module 500, and a user interface 1100. The sensors 22, 24, 26, 28, 30, 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 an orientation of a cartridge received within the autoinjector 4. For example, the orientation sensor 22 may be configured to detect an orientation of the autoinjector 4. The orientation of the cartridge may be determined based on the orientation of the autoinjector 4. The orientation sensor 22 may be configured to detect a direction of gravity. For example, the orientation sensor 22 may include an accelerometer.

[0210] The 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 an orientation of the cartridge based on the orientation signal. The processing unit 20 can control the drive module 500 based on the orientation signal. For example, the processing unit 20 can be configured to control the drive module 500 to move the plunger rod based on the orientation signal. For example, the processing unit 20 can be configured to control the drive module 500 to move the plunger rod towards 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 indicative of the angular velocity and / or angle spanned by the autoinjector 4 during a 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 indicative of the angular velocity and / or angle spanned by the autoinjector 4 in a complete reversal.

[0213] The autoinjector 4 includes a code sensor 24. The code sensor 24 is configured to read the cartridge code feature and provide a code signal indicative of the cartridge code feature. 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 and / or a mixing plunger rod position and / or 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 value, such as a plunger rod threshold value and / or a resistance threshold value, 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 autoinjector 4 includes a dispense sensor 26, such as a plunger rod position sensor. The dispense sensor 26 is configured to detect a position of a plunger rod of the autoinjector 4 and provide a dispense sensor signal indicative of the position of the plunger rod. 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 and / or a mixing plunger rod position and / or 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 the cartridge code feature.

[0219] The autoinjector 4 includes a needle sensor 30. The needle sensor 30 is configured to detect a needle of the cartridge assembly and / or a needle assembly and / or a 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 a needle of the cartridge assembly and / or a needle assembly and / or a 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 the needle signal. The processing unit 20 can control the drive module 500 based on the needle signal. For example, the processing unit 20 can be configured to control the drive module 500 to initiate movement of the plunger rod towards a plunger rod extended position, e.g., a premix plunger rod position and / or a mixing plunger rod position and / or a ready plunger rod position and / or an injection plunger rod position, only if a needle is present and / or only if a needle cover is not present, e.g., removed. The detection of the needle cover can indicate the presence of a needle. The processing unit 20 can be configured to control the drive module 500 to initiate only if a needle cover has been detected and then is not detected, e.g., removed. Alternatively or additionally, the processing unit 20 can provide a user output via the user interface 1100 based on the needle signal. 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 can be configured to detect resistance to movement of the plunger rod based on measurements of the drive module 500. For example, the resistance sensor 32 can 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] An autoinjector 4 is illustrated that includes 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 comprises a user interface 1100. The user interface 1100 may comprise one or more input members, such as, for example, a first input member, for receiving a user input. The user interface is configured to provide a user input signal indicative of the user input being received. The user interface 1100 may 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 towards 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 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 which houses the sensors 22 , 24 , 26 , 28 , 30 , 32 , a processing unit 20 , a user interface 1100 , and a drive module 500 .

[0227] 8a-8f show schematic diagrams of an exemplary cartridge assembly 600 and plunger rod 400. Cartridge assembly 600 includes a cartridge 700, such as the cartridge described in relation to 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 receiver 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 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.

[0230] 8a shows a schematic diagram of 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 subsection 704 and the second subsection 706.

[0231] 8b shows a schematic diagram of the situation in which the plunger rod 400 is in an exemplary premix plunger rod position. In comparison with FIG. 8a, the plunger rod 400 has been moved towards 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 starts to move the first stopper 708 in the first stopper direction 722 by the movement in the first plunger rod direction 422. The second stopper 710 is in a position, for example, behind the bypass portion 712, which does not form a fluid connection between the first partial section 704 and the second partial section 706.

[0232] 8c shows a schematic diagram of the plunger rod 400 in an exemplary position where 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 a movement in the first plunger rod direction 422. The second stopper 710 is in the bypass portion 712, which forms a 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, drives 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 shows a schematic diagram of the situation in which the plunger rod 400 is in an exemplary mixed plunger rod position. The plunger rod front end 410 abuts against the first stopper 708. The first stopper 708 abuts against the second stopper 710. The first 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] Fig. 8e shows the plunger rod 400 in a schematic diagram 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 shows a schematic diagram of the plunger rod 400 in an exemplary injection plunger rod position. For example, the plunger rod 400 may be in the injection plunger rod position after an injection is completed. 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, e.g., a drug, have been expelled, e.g., through the cartridge outlet 714 and / or the needle 902. A residual amount of drug may remain in the cartridge.

[0236] FIG. 9 shows an exemplary trace T of the resistance Re to the movement of the plunger rod as a function of the position P of the plunger rod. 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 the movement of the plunger rod is constant Ex1, e.g., the plunger rod does not yet press the stopper. Then, the plunger rod front end of the plunger rod abuts against the first stopper of the cartridge and the resistance to the movement of the plunger rod increases Ex2. The increase in resistance is caused by the resistance to the movement of the first stopper, e.g., due to frictional forces. The resistance may be slightly reduced after the first stopper starts to move, as illustrated. When 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 illustrative of the resistance to plunger rod motion when the cartridge being received is a new and / or unused and / or normal cartridge. The determination of the cartridge parameter can be based on the resistance and / or the plunger rod position. The determination of the cartridge parameter can be based on one or more thresholds, such as a resistance threshold, such as a low resistance threshold Re1 and / or a high resistance threshold Re2, and / or a plunger rod threshold, such as a first plunger rod threshold P1 and / or a second plunger rod threshold P2.

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

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

[0240] Trace T3 illustrates an exemplary situation where 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 spent cartridge. 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.

[0241] Trace T4 illustrates an exemplary situation where, for example, after the plunger rod position passes the first plunger rod threshold P1, resistance to motion increases above the high resistance threshold Re2. Such a situation may indicate, for example, that the first stopper is inhibited from moving, for example, that the cartridge may be defective. After such a situation, the plunger rod may be retracted to a 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 the autoinjector may be configured to determine one or more of the thresholds based on a cartridge code feature of the received cartridge and / or cartridge assembly.

[0243] 10 shows a flow diagram of an exemplary method 6000 for operating an autoinjector. The method 6000 includes a step 6004 of moving a plunger rod from a first plunger rod position to a mixing plunger rod position at a mixing plunger rod speed, and a 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. The method 6000 may further include a step 6008 of receiving a trigger event and a 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 cartridge compartment containing a medicament. 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. The primed 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.

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

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

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

[0251] The step 6008 of receiving a trigger event may include, for example, receiving a user input signal from a user interface, such as receiving a trigger event from a trigger member, for example resulting from a user pressing a button. The trigger event may occur from a user indicating the start of an injection. The trigger event may occur from a user pressing a front portion of the autoinjector against an intended injection site. The trigger event may 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 a 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 illustrates a flow diagram 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, namely, step 6014 of receiving a first input signal, step 6016 of detecting receipt of a cartridge within a cartridge receiver of, for example, an autoinjector, step 6018 of determining an orientation of the cartridge, 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, for example, from a user pressing a button. The first input signal may 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 accepted 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] The 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 the method 6000'' can include adapting based on the cartridge specifications. For example, subsequent steps of the method 6000'' can be tailored to the particular cartridge that is received and identified.

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

[0260] Moving the plunger rod to a first plunger rod position 6024 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] The step 6024 of moving the plunger rod to a first plunger rod position may occur after the step 6016 of detecting that a cartridge has been received within the cartridge receiver and the step 6014 of receiving a first input signal. For example, the step 6024 of moving the plunger rod to a first plunger rod position may be performed only after the step 6016 of detecting a cartridge and the 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 motion of the plunger rod 6026 can be performed simultaneously with moving the plunger rod to the first plunger rod position 6024, as illustrated. Detecting resistance to motion of the plunger rod 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 may be performed after step 6020 of reading the cartridge code feature, step 6022 of detecting removal of the needle cover, step 6024 of moving the plunger rod to the premixing plunger rod position, step 6026 of detecting resistance to movement of the plunger rod, and step 6018 of determining the orientation of the cartridge.

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

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

[0267] The step 6019 of determining a 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 feature, removal of the needle cover, resistance to movement of the plunger rod, and / or cartridge orientation.

[0269] The step 6010 of moving the plunger rod to an injection plunger rod position can be based on one or more of a cartridge code mechanism, removal of a 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 generally 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, illustratively a plurality of LEDs. The first output member 1110 may provide a user output to a user. The first output member 1110 may be used to indicate to a user a step in a procedure and / or to indicate an error message. The first output member 1110 includes a first LED 1116, a second LED 1118, and a third LED 1120.

[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 a 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 comprises a first input member 1108, such as a button. The first input member 1108 may enable user input from a user. For example, the first input member 1108 may be used to receive a press from the user to proceed to the next step. The first input member 1108 may serve as a fourth output member of the user interface 1100, for example, the first input member 1108 may be configured to light up, such as flash.

[0276] FIG. 12a shows diagrammatically 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 shows a schematic diagram of a situation of the user interface 1100 in which the first input member 1108 and the contact members 1102 are illuminated, such as flashing. The first input member 1108 and the contact members 1102 may flash synchronously and / or asynchronously. The situation shown may be a situation indicating that a user should press the first input member 1108 and / or insert a cartridge via the contact members 1102. The situation shown may be a situation after the autoinjector has been turned on.

[0278] 12c shows a schematic diagram of a situation in which the user interface 1100 has the first input member 1108 and the second LED 1118 illuminated, e.g., flashing. The situation shown may be a situation in which the user has pressed the first input member 1108 to indicate that the user should 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 shows a schematic diagram of a situation of the user interface 1100 in which the first input member 1108 and the contact member 1102 and the third LED 1120 are illuminated, such as flashing. The first input member 1108 and the contact member 1102 and the third LED 1120 may 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 show schematic diagrams of an exemplary motion of an exemplary autoinjector 4, such as the motion of a first motion 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 down and the second end 4b of the autoinjector 4 pointing substantially up.

[0283] Figure 13c shows the autoinjector 4 being moved to a third position, such as backwards 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 a number of reversals 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 reversals.

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

[0285] Similarly, in the illustrated example, the first end 4a of the automatic injection device 4 in the second position points straight down, however, 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 complete reversals as described in relation to FIG. 13. For example, the reconfiguration may require that a certain number of reversals be performed, such as 5, at a frequency within a default / predetermined frequency range, such as between 0.3-1.2 Hz. For example, the reconfiguration time may be the time used to perform that number of complete reversals. The number of complete reversals and / or frequency range required may be determined based on a cartridge code mechanism, for example, the cartridge code mechanism may indicate the number of reversals and / or the frequency range of 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 medicament, comprising: Housing and a cartridge receiving portion configured to receive a 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; 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 stop; a processing unit coupled to the drive module; 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 pharmaceutical component is mixed with the second pharmaceutical component; providing a start signal after a number of complete reversals of the autoinjector have been performed; a processing unit configured to 1. An automatic injection device comprising:

2. The automatic injection device of claim 1 , wherein the processing unit is configured to operate independently of a temperature of the medicament within the cartridge received in the cartridge receiver.

3. 3. The automatic injection device of claim 1, wherein the start signal is generated after a complete reversal of the number of times of the automatic injection device has been performed and when the second cartridge sub-section is pointing up compared to the first cartridge sub-section.

4. 4. The automatic injection device of claim 1, further comprising an orientation sensor configured to detect an orientation of the cartridge and / or an orientation of the automatic injection device.

5. 5. The autoinjector of claim 4, wherein the detection of inversion of the autoinjector is performed using the orientation sensor.

6. 6. The automatic injection device of claim 4 or 5, wherein the orientation sensor comprises one or more accelerometers, such as an accelerometer or multiple accelerometers.

7. 7. The autoinjector of claim 4, wherein the orientation sensor comprises a tilt sensor, a three-axis accelerometer, a single-axis accelerometer, a magnetometer and / or any combination thereof.

8. 8. The automatic injection device of claim 4, wherein the orientation sensor comprises a three-axis accelerometer.

9. 6. The autoinjector of claim 4 or 5, wherein the orientation sensor comprises a single or multi-axis gyroscopic sensor.

10. 10. The autoinjector of claim 9, wherein the multi-axis gyroscopic sensor is a three-axis gyroscopic sensor.

11. 11. The automatic injection device of claim 1, wherein the processing unit is further configured to control the drive module to move the plunger rod from the mixing plunger rod position to a second plunger rod position upon receiving the start signal.

12. 12. The autoinjector of claim 1, wherein the processing unit is further configured to determine a first motion parameter based on a cumulative motion of the autoinjector.

13. 13. The autoinjector of claim 12, wherein the first motion parameter is indicative of the number of complete reversals of the autoinjector.

14. 14. The autoinjector of claim 12 or 13, wherein the first motion parameter is indicative of a frequency of motion of the autoinjector.

15. 15. The autoinjector of claim 1, wherein a reversal is considered a complete reversal by the autoinjector if it is performed at an angular velocity above a default threshold.

16. 16. The autoinjector of claim 15, wherein the default threshold for the angular velocity is defined as a reversal frequency of at least 0.3 reversals per second, such as at least 0.5 reversals per second.

17. 17. The automatic injection device of claim 15 or 16, wherein the orientation sensor is configured to provide an angular velocity signal indicative of the angular velocity of the cartridge when the cartridge is received in the cartridge receiver.

18. 18. An automatic injection device according to any one of claims 1 to 17, wherein the inversion is about an axis in a horizontal plane.

19. 19. The autoinjector of claim 1, wherein a reversal is considered a complete reversal by the autoinjector if it spans an angle above a default threshold.

20. 20. The automatic injection device of claim 19, wherein the default threshold angle 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.

21. The rotational movement of the autoinjector from a start angular position to an end angular position comprises: if the starting angular position is between a first vertical orientation in which the distal end of the autoinjector points up and a first horizontal position in which the distal end of the autoinjector points sideways along a horizontal axis; the end angular position is between a second horizontal position in which the distal end of the autoinjector points laterally along a 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 21. An automatic injection device as described in claim 19 or 20, wherein a complete reversal by the automatic injection device is considered when the default threshold value of the angle between the first angular position and the second angular position 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.

22. The rotational movement of the autoinjector from a start angular position to an end angular position comprises: if the starting angular position is between a first vertical orientation in which the distal end of the autoinjector points down and a first horizontal position in which the distal end of the autoinjector points 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 a 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 upwards; and 21. An automatic injection device as described in claim 19 or 20, wherein a complete reversal by the automatic injection device is considered when the default threshold value of the angle between the first angular position and the second angular position 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.

23. 23. The automatic injection device of claim 1, wherein the processing unit is further configured to provide visual and / or acoustic feedback to the user when the number of complete reversals has been performed and / or after each complete reversal.

24. 24. The automatic injection device of claim 1, wherein the processing unit is further configured to perform a blank shot after the number of reversals has been performed, and the blank shot is performed only when the second cartridge sub-section is pointing up compared to the first cartridge sub-section.

25. 25. 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 feature, the automatic injection device comprises a code sensor configured to read the cartridge code feature, and the processing unit is coupled to the code sensor and further configured to receive a code signal from the code sensor indicative of the cartridge code feature.

26. 26. The automatic injection device of claim 25, wherein the cartridge code mechanism defines the number of complete inversions required for the medication in the cartridge.

27. 27. The autoinjector of claim 1, wherein the angular velocity threshold and / or the angle threshold are defined by the autoinjector or the cartridge code mechanism.

28. 28. An automatic injection device according to any one of claims 1 to 27, wherein the number of complete reversals depends on the measured reversal angle and the angular velocity at which the reversals are manually performed by a user.

Images