BR112019025845B1 - AUTO-INJECTOR TO ADMINISTER A MEDICATION - Google Patents

Abstract

Disclosed herein is an autoinjector for administering a medicament, the autoinjector comprising: a housing; a cartridge receiver configured to receive a cartridge comprising a first stopper and a cartridge compartment containing the medicament, the cartridge compartment having a first cartridge subcompartment containing a first medicament component of the medicament and a second cartridge subcompartment containing a second component of medicine of the medicine; a drive module coupled to move a plunger rod between a retracted position of the plunger rod and an extended position of the plunger rod, the plunger rod being configured to move the first stopper; a processing unit coupled to the drive module, wherein the processing unit is configured to control the drive module to move the plunger rod from a first plunger rod position to a mixing position of the plunger rod at a speed mixing position of the plunger rod, wherein the mixing position of the plunger rod is selected to position the first stopper in a position in which the first medicament component is mixed with the second medicament component, and to provide a signal (. ..).

Description

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

FUNDAMENTALS

[002] Hypodermic syringes are widely used to release fluids into the body. It is known to have hypodermic syringes applicable for manual operation. However, autoinjectors, such as electronic autoinjectors, have been developed and are widely used to help deliver fluid or medication to the body.

[003] To avoid relying on users to correctly perform certain tasks, it is of increasing interest that the autoinjector automatically performs as much of the injection process as possible. Especially, when drug administration requires several steps, such as if the drug needs to be mixed before injection, it may be beneficial to automate the process of preparing and administering the fluid, such as a medicine.

[004] Furthermore, it may be advantageous to incorporate sensors into such a device, to allow precise control under varying circumstances. SUMMARY

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

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

[007] The autoinjector comprises: a housing; a cartridge receiver; a drive module; and a processing unit.

[008] The cartridge receiver is configured to receive a cartridge, such as a cartridge comprising a first stopper and a cartridge compartment containing the medicament. The cartridge compartment has a first cartridge subcompartment containing a first medicament component of the medicament and a second cartridge subcompartment containing a second medicament component of the medicament.

[009] The drive module is configured to move a plunger rod between a retracted position of the plunger rod and an extended position of the plunger rod. The plunger rod is configured to move the first cork.

[0010] The processing unit is coupled to the drive module. The processing unit is configured to: control the drive module to move the plunger rod from a first plunger rod position to a mixing plunger rod position; provide a start signal after several complete autoinjector inversions have been performed.

[0011] The mixing position of the plunger rod is selected to position the first stopper in a position where the first drug component is mixed with the second drug component.

[0012] The processing unit is further configured to control the drive module to move the plunger rod from the first plunger rod position to the plunger rod mixing position with a plunger rod mixing speed. The mixing speed of the plunger rod can be constant speed or a variable speed.

[0013] The start signal can be given as an indication that the first medicine component and the second medicine component have been, for example, reconstituted, for example completely mixed.

[0014] By the term a 'complete inversion' is intended an inversion that satisfies predefined requirements in terms of an angular velocity at which the inversion is carried out and/or the angle over which the autoinjector inversion extends. By the term inversion is normally meant an inversion of the autoinjector, which is performed automatically or manually by a user.

[0015] An inversion can be defined as an approximate 180 degree rotation of the autoinjector. An example of a reversal is rotating the autoinjector from a position where the autoinjector has the needle pointing up to a position where the needle is pointing down or vice versa. An alternative example of an inversion is a 180-degree rotational movement of the autoinjector, rotating it from an initial position where the longitudinal axis of the autoinjector is in the horizontal plane and the needle is pointing to the left, to a direction in which the needle is pointing. upwards, and to a final position, where the longitudinal axis of the autoinjector is once again in the horizontal plane, this time with the needle pointing to the right.

[0016] Inversion can be an inversion around an axis in a horizontal plane.

[0017] The number of complete inversions required for the start signal to be given by the processing unit may depend on the viscosity of the drug components, which are mixed. Drug component variants with high relative viscosity will typically require more complete inversions, for example 10 or 20 or even more complete inversions, whereas drug component variants with relatively lower viscosity may require a lower number of complete inversions. , for example 5 or 10 inversions, for an effective mixing of the drug components to be obtained and the start signal to be activated. Thus, viscous drug components require more inversions than less viscous drug component formulations.

[0018] Also disclosed is a cartridge for an autoinjector, such as the disclosed autoinjector. The cartridge comprises a first stopper and a cartridge compartment containing the medicament. The cartridge compartment has a first cartridge subcompartment containing a first medicament component of the medicament and a second cartridge subcompartment containing a second medicament component of the medicament. The cartridge may have a first cartridge end and a second cartridge end and have a cartridge outlet at the first cartridge end. The cartridge is configured to be received by an autoinjector cartridge receiver, such as a disclosed autoinjector cartridge receiver, for example by inserting the second end of the cartridge through an opening of the autoinjector cartridge receiver.

[0019] Also disclosed is a system comprising an autoinjector, such as the disclosed autoinjector, and a cartridge, such as the disclosed cartridge.

[0020] Also disclosed is a method for operating an autoinjector, such as the disclosed autoinjector, e.g., an autoinjector comprising a cartridge receiver configured to receive a cartridge, such as the disclosed cartridge, e.g., a cartridge comprising a first stopper and a cartridge compartment containing the medicament, the cartridge compartment having a first cartridge subcompartment containing a first medicament component of the medicament and a second cartridge subcompartment containing a second medicament component of the medicament. The autoinjector may further comprise a plunger rod configured to move the first stopper.

[0021] The method comprises: moving the plunger rod from a first plunger rod position to a plunger rod mixing position with a plunger rod mixing speed, wherein the plunger rod mixing position is selected to position the first stopper in a position where the first medicament component is mixed with the second medicament component; performing several complete inversions of the autoinjector; and moving the plunger rod from the mixing position of the plunger rod to a second position of the plunger rod after the start signal has been given.

[0022] The first position of the plunger rod may be a premix position of the plunger rod. The premix position of the plunger rod may be selected to position the first stopper in a position where fluidic communication between the first cartridge subcompartment and the second cartridge subcompartment is not yet established. Alternatively, the first position of the plunger rod may be a retracted position of the plunger rod, for example a home position of the plunger rod.

[0023] The second position of the plunger rod may be a preparation position of the plunger rod. The priming position of the plunger rod can be selected to position the first stopper in a position where air in the cartridge compartment is reduced to an amount appropriate for injection. Alternatively, the second plunger rod position may be a plunger rod injection position. The second position of the plunger rod may be the extended position of the plunger rod.

[0024] The method may further comprise receiving a triggering event; and moving the plunger rod to a plunger rod injection position following reception of the triggering event, for example after completion of movement of the plunger rod to the second plunger rod position.

[0025] The triggering event may, for example, be an effect of a button press, an effect of an elapsed waiting time, and/or an effect of a predetermined user behavior. The triggering event may be indicative of the autoinjector being pressed against the injection site.

[0026] It is an advantage of the present disclosure that the processing units provide a start signal only after several complete inversions have been performed thereby ensuring that the medicament, constituting the first medicament component and the second medicament component, is mixed. until a homogeneous solution before an injection is about to take place.

[0027] It is an additional advantage of the present disclosure that the autoinjector can be operated without taking measurements of the temperature of the medicine, since omitting a temperature sensing element decreases the price of the autoinjector.

[0028] Thus, the processing unit can be configured to operate independently of the temperature of the medicine in the cartridge received in the cartridge receiver.

[0029] Practical experience has clearly established that with specific medicines, physical agitation, i.e. inversion of the auto-injector, is much more effective in sustaining safe preparation of the medicine, thereby providing a perfectly reconstituted homogeneous medicine to be injected into the patient's skin. in the shortest possible time. In the examples, even if you wait an extended period of time and expose the mixed drug components to elevated temperatures, the final homogeneity of the mixed/reconstituted drug product may not improve much over what can be achieved at room temperature. Opposite to this, however, when applying even minimal physical agitation, that is, even few physical inversions, the homogeneity of the reconstituted medicine significantly improves. By physical agitation is to be understood inversions as opposed to stirring movements since the latter has a tendency to introduce a large number of air bubbles into the mixtures. In a liquid with low viscosity, air bubbles disappear again relatively quickly. However, in liquids with a high viscosity, it takes a long time for the air bubbles to disappear. Because the number of air bubbles needs to be decreased to a level and/or completely removed before an accurate dose of medication can be injected, introducing a large number of air bubbles into the liquid medication during the mixing procedure is highly undesirable if the medicine has a high viscosity. Additionally, during the process of creating an air jet before injection, there is a risk that a larger portion of the drug is evacuated because it is carried in the air bubbles. Using inversions as opposed to stirring movements in mixing the first and second medicines is therefore highly preferable.

[0030] It is an additional advantage of the present disclosure that an autoinjector can be provided that is easier to use, and reduces the risk of erroneous administration of a medicine, which has not achieved sufficient homogeneity.

[0031] Thus, it is an additional advantage of the present disclosure that patient safety is increased.

[0032] It is considered that any modalities or elements as described in connection with any aspect can be used with any aspects or modalities, mutatis mutandis.

[0033] The start signal can be generated after the number of complete inversions of the autoinjector has been performed and when the second subcompartment of the cartridge is pointing upward compared to the first subcompartment of the cartridge. The autoinjector may preferably have an upward-pointing orientation substantially along a vertical axis, or within 45 degrees of the vertical axis. The upward-pointing orientation is advantageous for releasing air from the cartridge compartment without ejecting medication.

[0034] The processing unit can be configured to perform an air blast after the number of complete inversions has been performed. The air jet can for example be performed only when the second sub-compartment of the cartridge is pointing upwards compared to the first sub-compartment of the cartridge.

[0035] When the required number of successful/complete inversions has been performed, the autoinjector can validate this, for example by sound and/or visually by light, and automatically proceed to perform an air blast when the needle is pointing upwards, this is when the second cartridge sub-compartment is pointing upwards compared to the first cartridge sub-compartment. It is advantageous for air blasting to be performed after complete inversions because the air bubble left after reconstitution helps mixing during inversions. Having performed the air blast, the medicine can be ready for injection.

[0036] A precondition for physical agitation to work well is that inversions are provided after the two medicament components have been mixed, but before evacuating air bubbles from the cartridge compartment. When air bubbles are present, the mixed drug components will be allowed to swirl/move/slide around the inside of the cartridge compartment as a result of physical entry. By air bubbles is usually meant air bubbles having a volume at least comparable to the combined volume of the mixed medicament components. Preferably, in the present invention the air bubbles are not defined by their volume, but by the cross-sectional area that they cover in part or in full when the cartridge is vertically oriented. Preferably, the air bubbles are large enough to encompass at least 25% of the cross-sectional area of the second cartridge compartment, such as at least 50% of the cross-sectional area of the second cartridge sub-compartment or at least 75% of the cross-sectional area of the second sub-compartment. of the cartridge or 100% of the cross-sectional area of the second subcompartment of the cartridge.

[0037] The processing unit may be further configured to control the drive module to move the plunger rod from the plunger rod mixing position to a second plunger rod position upon reception of the start signal. The second position of the plunger rod may be selected to position the first stopper in a position where the air in the cartridge compartment is reduced to an amount appropriate for injection.

[0038] The cartridge may have a cartridge outlet at the first end of the cartridge. The cartridge may comprise a rear face of the cartridge, for example at the second end of the cartridge, such as opposite the outlet of the cartridge. The rear face of the cartridge may comprise a rear end opening of the cartridge. The rear end opening of the cartridge may provide access for a plunger rod, such as the autoinjector plunger rod, to the first stopper.

[0039] The cartridge compartment can contain the medicine. The cartridge outlet may be configured for fluidic communication with the housing, for example at the first end of the cartridge. The cartridge may be configured to expel medication through the cartridge outlet. The outlet of the cartridge may be configured to be coupled with a needle, such as a hypodermic needle, to provide medication to be expelled through the needle.

[0040] The cartridge comprises a first movable stopper within the cartridge compartment. The cartridge may comprise a second movable stopper within the cartridge compartment. The second stopper may be between the first stopper and the cartridge outlet. The cartridge may comprise a third movable stopper within the cartridge compartment. The third cork may be between the second cork and the cartridge outlet. The first stopper, the second stopper, and/or the third stopper may be movable within the cartridge compartment in the direction of the cartridge exit, for example in a direction of the first stopper, such as in the direction of the first end of the cartridge. For example, the medicine may be expelled through the cartridge exit in the movement of the first stopper, the second stopper, and/or the third stopper, for example in the direction of the first stopper and/or in the direction of the cartridge exit.

[0041] The cartridge may be a dual chamber cartridge. The cartridge compartment may have a first cartridge subcompartment and a second cartridge subcompartment. The first subcompartment of the cartridge may be between the first stopper and the second stopper. The second subcompartment of the cartridge may be between the second stopper and the cartridge outlet and/or the third stopper.

[0042] The first subcompartment of the cartridge may contain a first medicament component of the medicament. The second subcompartment of the cartridge may contain a second medicament component of the medicament. Each of the first medicament component and/or the second medicament component may be a powder composition, a fluid, a liquid, a gel, a gas, and/or any combination thereof.

[0043] The first drug component and/or the second drug component may be solutes, such as a powder composition. The first medicament component and/or the second medicament component may be a solvent, such as a fluid composition, such as a liquid composition. The second medicament component may be a powder composition and the first medicament component may be a fluid composition, for example water or ethanol or saline or buffer solution or preservative solution. The second drug component may be a solute. The first medicament component may be a solvent. It is considered that the medicine can be any medicine being injected via a hypodermic needle, for example after reconstitution of the medicine. The medicine may be a growth hormone. The medicine could be human growth hormone. The medication may be a depot version, such as a long-acting version, of human growth hormone. The second medicament component may be a human growth hormone powder composition.

[0044] The cartridge may have a bypass section providing fluid communication between the first subcompartment of the cartridge and the second subcompartment of the cartridge, for example when the second stopper is positioned in the bypass section. The cartridge may have a plurality of bypass sections providing fluid communication between neighboring subcompartments of the cartridge, for example when a stopper separating the neighboring subcompartment from the cartridge is positioned in the bypass section.

[0045] The disclosed autoinjector may be a reusable autoinjector. A reusable autoinjector may be especially useful when the cartridge comprises a plurality of subcompartments. For example, an autoinjector for a multichamber or multichamber cartridge may be more advanced, and therefore it may be beneficial to allow the autoinjector to be used more than once. For example, the autoinjector may provide automated processes for mixing drug components, such as for mixing drug components initially provided in different subcompartments of the cartridge.

[0046] The cartridge can be understood as part of a cartridge assembly. The cartridge assembly may comprise the cartridge. Additionally, the cartridge assembly may comprise a needle, such as a needle assembly comprising a needle, a needle cap, a cartridge holder, and/or a cartridge code trace.

[0047] The cartridge assembly may comprise the needle, such as the needle assembly comprising the needle. The needle assembly may comprise a needle cap and/or a needle hub. The cartridge assembly may comprise a cartridge holder. The cartridge holder can be configured to engage with the needle assembly. The cartridge holder may provide attachment of the needle assembly to the cartridge.

[0048] The cartridge may comprise a cartridge code trace and/or the cartridge assembly may comprise the cartridge and the cartridge code trace. The cartridge code trace may comprise one or more of a color, a bar code, an RFID label, an NFC label, an identification number, and a QR code. For example, the cartridge code trace may comprise a color and/or a sequence of colors. The cartridge code trace 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 trace can increase the legibility of the cartridge code trace, for example since the cork can form a background for the cartridge code trace. The cork, like the first cork, may be a light color, such as light gray or white. The cork, like the first cork, may be a dark color, such as dark blue, dark gray, or black. The cork can form a dark background for the cartridge code trace. The stopper, like the first stopper, can reduce light reflection, for example to further increase the readability of the cartridge code trace.

[0049] The cartridge code trace can be positioned in a specific position on the cartridge, for example independently of the stopper(s), such as the first stopper. For example, the cartridge code trace may be positioned at a code distance from the second end of the cartridge. All cartridges can have their cartridge code trace positioned in the same position, for example positioned at code distance from the second end of the cartridge. Such a uniform position of the cartridge code trace can decrease the complexity, and decreased size, of the autoinjector, as the cartridge code trace is placed in the same position for all suitable cartridges.

[0050] The cartridge and the cartridge code trace can be manufactured as one element. For example, the cartridge code trace may be a certain shape of the cartridge. Alternatively, the cartridge code trace may be attached to the cartridge, such as secured, for example by glue, to the cartridge. For example, the cartridge code trace may be a color code printed on the cartridge.

[0051] The cartridge code trace may be indicative of one or more specifications of the cartridge, such as medication in the cartridge, concentration of medication in the cartridge, viscosity of medication in the cartridge, volume and/or mass of medication in the cartridge, positions of the stopper(s) in the cartridge compartment, etc. The cartridge code trace may be indicative of a position of the first stopper in which the air in the cartridge compartment is reduced, such as minimized and/or reduced to an amount appropriate for injection. The cartridge code dash may be indicative of the amount of medication contained in the cartridge. The cartridge code trace may be indicative of a specific cartridge type, such as an ID number of the specific cartridge type.

[0052] The autoinjector, such as the autoinjector processing unit, can be configured to determine one or more cartridge specifications based on an ID number, for example by table lookup. The cartridge code trace may be indicative of a suitable, such as ideal, speed of cork movement, such as cork movement at different phases of movement, such as during mixing, during air blasting, and/or injection. . The cartridge code trace may be indicative of a suitable, such as ideal speed of movement of the first cork, such as the speed of movement of the first cork at different phases of movement, such as during mixing, during air blasting, and/or injection. The cartridge code trace may be indicative of the time required for optimal mixing of the first drug component and the second drug component. The cartridge code trace may be indicative of a suitable residence time for the medicine, e.g. time to ensure that the medicine is distributed within the tissue, e.g. favorable time to wait after injection before retracting the needle. The cartridge code trace may be indicative of the amount of motion energy required for optimal mixing of the first drug component and the second drug component. The cartridge code trace may be indicative of the number of complete inversions required for the medications in the two compartments of the cartridge to be completely mixed. Movement from the first position of the plunger rod to the mixing position of the plunger rod may be based on the encoded signal of the cartridge code trace defined by the number of complete inversions required for the medicament in the cartridge.

[0053] The cartridge code trace may be indicative of a threshold of an angular velocity that is required for an autoinjector inversion to be noted as a complete inversion. The cartridge code trace may be indicative of a threshold flip angle that is required for an autoinjector flip to be noted as a complete flip.

[0054] The number of complete inversions may depend on the measured inversion angles and the angular speed at which the inversions are performed manually by a user.

[0055] The autoinjector may be a front-loaded autoinjector. The autoinjector comprises a cartridge receiver configured to receive the cartridge. The cartridge receiver may be configured to receive a cartridge assembly comprising the cartridge. The cartridge assembly may comprise a cartridge holder. The cartridge receiver may have a cartridge receiver opening. The cartridge receiver may be configured to receive the cartridge by inserting the cartridge, such as the second end of the cartridge, through the cartridge receiver opening. The cartridge can be inserted in a cartridge receiving direction. The receiving direction of the cartridge may be opposite to the direction of the first stopper, for example when the cartridge is received in the cartridge receiver. The cartridge may be in a first angular position when inserted into the cartridge receiver. The cartridge may be retained in the cartridge receiver in a second angular position, for example after insertion of the cartridge into the cartridge receiver.

[0056] The cartridge receiver may be configured to receive a cartridge assembly comprising the cartridge and a cartridge holder. The cartridge assembly may be retained in the cartridge receiver by one or more cartridge retaining members of the cartridge holder engaging with members of the cartridge receiver.

[0057] The cartridge and/or cartridge assembly may be lockable in the cartridge receiver, for example the cartridge and/or cartridge assembly may be locked in the cartridge receiver to prevent removal of the cartridge and/or cartridge assembly. cartridge receiver cartridge. The cartridge and/or cartridge assembly may be locked into the cartridge receiver by movement of a plunger rod of the autoinjector.

[0058] The autoinjector may comprise a cartridge sensor. The cartridge receiver may comprise the cartridge sensor. The cartridge sensor may be configured to detect cartridge reception and/or cartridge assembly in the cartridge receiver. The cartridge sensor may provide a cartridge sensor signal indicative of whether the cartridge and/or cartridge assembly is received at the cartridge receiver. The cartridge sensor may provide a cartridge detection signal indicative of the cartridge and/or cartridge assembly being received at the cartridge receiver. The cartridge sensor signal may comprise the cartridge detection signal.

[0059] The autoinjector may be an electronic autoinjector. The autoinjector may comprise a battery. The housing can accommodate the battery. The battery may be a rechargeable battery. For example, the battery may be a Lithium-ion battery or a NiCd battery or a NiMH battery. The battery can be configured to be charged by connecting a charger.

[0060] The autoinjector comprises a drive module. The drive module may be coupled to move, such as actuate, such as advance, a plunger rod, such as between a retracted position of the plunger rod and an extended position of the plunger rod. Movement of the plunger rod may provide for the cartridge and/or cartridge assembly to be locked into the cartridge receiver. For example, the cartridge and/or cartridge assembly may be locked into the cartridge receiver by advancing the plunger rod from a retracted position of the plunger rod.

[0061] The drive module may comprise one or more electrical elements. The drive module can be configured to receive electrical power from the battery. The drive module can be electrically connected to the battery to receive electrical power. The drive module can be accommodated by the housing. The drive module may comprise a motor, such as an electromechanical motor, such as a DC motor, for example a brushed or brushless DC motor. The drive module may comprise a solenoid motor. The drive module may comprise a motor shape with memory metal. The drive module may comprise a spring arrangement configured to actuate the plunger rod. The actuation module may comprise a pressurized gas configured to actuate the plunger rod.

[0062] The autoinjector may comprise a plunger rod, such as the plunger rod movable by the drive module. The plunger rod may be configured to move a stopper, such as the first stopper of the cartridge. For example, when the plunger rod is moved in the direction of an extended plunger rod position, such as from the first plunger rod position to the plunger rod mixing position and/or from the plunger rod mixing position to the second position of the plunger rod, the plunger rod may be configured to move the first stopper in the direction of the cartridge outlet, such as to mix the two medicament components and/or to expel medicament from the cartridge compartment through the outlet of the cartridge and/or to expel air from the cartridge compartment through the cartridge outlet.

[0063] The plunger rod can be moved to the first position of the plunger rod, such as a premix position of the plunger rod, such as in the direction of the extended position of the plunger rod, such as from a retracted position of the piston rod. The first plunger rod position may be a premix position of the plunger rod. The premix position of the plunger rod may be selected to position the first stopper in a position where fluidic communication between the first cartridge subcompartment and the second cartridge subcompartment is not yet established.

[0064] The plunger rod can be moved to the mixing position of the plunger rod, such as in the direction of the extended position of the plunger rod, such as from the first position of the plunger rod. The mixing position of the plunger rod may be a position in which the first medicament component and the second medicament component are mixed, such as combined. The mixing position of the plunger rod may be a position in which the second stopper is positioned in the bypass section, such as to provide fluidic communication between the first subcompartment of the cartridge and the second subcompartment of the cartridge.

[0065] The plunger rod may be moved to a second position of the plunger rod, such as in the direction of the extended position of the plunger rod, such as the mixing position of the plunger rod. The second plunger rod position may be in a plunger rod priming position. The plunger rod priming position can be selected to position the first stopper in a position where air has been expelled from the cartridge compartment. For example, the priming position of the plunger rod may be selected to position the first stopper in a position where the air in the cartridge compartment is reduced, such as minimized and/or reduced to an amount appropriate for injection.

[0066] The plunger rod can be moved to a plunger rod injection position, such as in the direction of the extended position of the plunger rod, such as the second position of the plunger rod. The injection position of the plunger rod may be in a position where medication has been expelled and/or injected from the cartridge housing. For example, the injection position of the plunger rod may be selected to position the first stopper in a position where the medicament in the cartridge compartment is reduced, such as minimized, such as in a position near the exit of the cartridge. The injection position of the plunger rod may be the extended position of the plunger rod.

[0067] The plunger rod can be moved in the direction of a retracted position of the plunger rod, for example to the retracted position of the plunger rod. For example, the plunger rod may be moved in the direction of the plunger rod retracted position, e.g. to the plunger rod retracted position, after completion of the injection, such as from the plunger rod injection position and/or the extended position of the plunger rod.

[0068] The processing unit can be configured to move the plunger rod to the plunger rod mixing position, the second plunger rod position, the plunger rod injection position, the plunger rod extended position and/or the retracted position of the plunger rod.

[0069] The processing unit may be configured to receive a trigger event, and control the drive module to move the plunger rod to the plunger rod injection position following receipt of the trigger event, such as after completion of moving the plunger rod to a preceding plunger rod position, such as the second plunger rod position.

[0070] The autoinjector may comprise an ejection sensor, such as a plunger rod position sensor. The ejection sensor may be configured to detect ejection, such as the expulsion of medicament and/or air in the cartridge compartment. The ejection sensor may be configured to detect and/or determine the position of the plunger rod and/or the position of the first stopper. The ejection sensor may be configured to detect conditions indicative of the position of the plunger rod and/or the position of the first cork. The ejection sensor may be configured to provide an ejection sensor signal. The ejection sensor signal may be indicative of the position of the plunger rod and/or the first stopper.

[0071] The ejection sensor may comprise a tachometer, for example a drive module tachometer. The tachometer can be configured to count the revolutions of the drive module, such as a drive module motor, such as the drive module revolutions from a set point, such as a point at which the position of the drive rod. plunger is known, as is the retracted position of the plunger rod of the plunger rod. The revolution count of the drive module can be used to determine the actual position of the plunger rod, such as the premix position of the plunger rod, the mixing position of the plunger rod, the priming position of the plunger rod, plunger, the injection position of the plunger rod, the extended position of the plunger rod, and/or the retracted position of the plunger rod.

[0072] The processing unit may be coupled to the ejection sensor, such as the tachometer. The processing unit may receive from the ejection sensor a first ejection sensor signal, such as a tachometer signal, indicative of the revolution count of the drive module. The processing unit may determine the position of the plunger rod based on the first ejection sensor signal. The processing unit may receive a second ejection sensor signal, e.g. from the ejection sensor, indicative of the plunger rod being in a known position, such as the retracted position of the plunger rod and/or the first position of the plunger rod. piston. The processing unit may determine the position of the plunger rod based on the first ejection sensor signal and the second ejection sensor signal.

[0073] The cartridge may be lockable in the cartridge receiver, for example the cartridge may be locked in the cartridge receiver to prevent removal of the cartridge from the cartridge receiver. Movement of the plunger rod toward the extended position of the plunger rod may lock the cartridge in the cartridge receiver. For example, movement of the plunger rod to the mixing position of the plunger rod may lock the cartridge in the cartridge receiver. Movement of the plunger rod toward the retracted position of the plunger rod may unlock the cartridge from the cartridge receiver. For example, movement of the plunger rod to the retracted position of the plunger rod may unlock the cartridge in the cartridge receiver. The cartridge may be locked in the cartridge receiver when the plunger rod is not in the plunger rod retracted position and/or near the plunger rod retracted position. The connection of the position of the plunger rod with the cartridge lock in the cartridge receiver can provide the advantage that the release of the cartridge can be restricted or prevented when the autoinjector is active.

[0074] The autoinjector may comprise an orientation sensor. The orientation sensor may be configured to provide an orientation signal indicative of the orientation of the cartridge, for example when the cartridge is received at the cartridge receiver. The orientation signal may be indicative of the cartridge's orientation relative to gravity, such as in reaction to the direction of gravity. The guidance signal may be an acceleration signal, for example a triaxial acceleration signal. The guidance signal may comprise acceleration data, for example three-dimensional acceleration data. The guidance signal may comprise acceleration data indicative of the acceleration of the device.

[0075] The orientation sensor may be configured to detect a cartridge orientation and/or an orientation indicative of the cartridge orientation, such as an autoinjector orientation. The detected orientation can 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 if the direction of gravity is within a certain range of a predetermined direction. The orientation sensor may comprise an accelerometer. The orientation sensor may comprise a plurality of accelerometers, such as three accelerometers, such as three accelerometers arranged to detect acceleration in three dimensions, such as a three-dimensional accelerometer. The orientation sensor may comprise a tilt sensor, a triaxial accelerometer, a single-axis accelerometer, a magnetometer and/or any combination thereof, and the orientation sensor may provide a measurement of transverse inclination, longitudinal inclination and azimuth, a measurement of acceleration and/or inclination in one or more directions.

[0076] The orientation sensor can be configured to provide dynamic signals, for example linear acceleration and/or velocity and/or positional location and/or additional rotational acceleration and/or rotational velocity in one, two or three dimensions. The orientation sensor can be configured to provide full inertial sensing for the position and/or movement of the device. The processing unit may be configured to transform motion sensor signals, such as the orientation signal, from one domain into another domain, for example time integration of an acceleration signal to derive a velocity signal and /or time integration to derive a position signal from a velocity signal, etc.

[0077] The orientation sensor may be configured to detect whether the cartridge is in a predetermined orientation. The orientation sensor may be configured to detect whether the orientation of the autoinjector is indicative of the cartridge being in the predetermined orientation. The default orientation can be a vertical orientation. The default orientation may be an orientation within 45 degrees of vertical, such as within 30 degrees of vertical. The predetermined orientation may be an orientation in which the cartridge is oriented such that a longitudinal axis of the cartridge is within 45 degrees of the vertical, such as within 30 degrees of the vertical, and in which the cartridge exit is above the cartridge chamber. , such as in a vertical position above the cartridge chamber.

[0078] Detection of autoinjector inversions can be implemented using single- or multi-axis gyroscopic sensors, which are sensitive to dynamic angular velocity, such as the angular velocity of the autoinjector during an inversion and the angle that the autoinjector traverses during an inversion. Thus, the orientation sensor can be a single-axis or multi-axis gyroscopic sensor.

[0079] The orientation sensor may be configured to provide an angle signal indicating the angle of the cartridge, for example when the cartridge is received at the cartridge receiver. The orientation sensor may be configured to provide an angular velocity signal indicative of the angular velocity of the cartridge, for example when the cartridge is received at the cartridge receiver.

[0080] Using an orientation sensor with a spatially resolved single-axis accelerometer makes it possible to detect some details about rotations, that is, by detecting changes in signal level and signal reversals. For example, if the orientation sensor being a single-axis accelerometer is perfectly calibrated in the vertical orientation and under stable conditions, that is, it is only influenced by gravitational forces, rotations outside the vertical orientation can be determined by detecting the level of acceleration that the projection of the vertical gravitational force on the axis of the sensitivity accelerometer decreases in line (this is decreased by the factor determined by the cosine of the inclination angle).

[0081] Using a two-axis accelerometer, movement along two individual axes, i.e. an x-axis and a y-axis oriented perpendicular to each other, is detected. The x and y axes together define a two-dimensional plane of sensitivity. When implementing a single-axis or two-axis accelerometer into an orientation sensor as described herein, the accelerometer will normally be placed so that the x-axis is parallel with the longitudinal axis of the autoinjector and thus capable of detecting acceleration along this axis. direction. The y-axis consequently in such a scenario will be oriented perpendicular to the longitudinal axis and thus only be able to detect acceleration along this y-axis direction.

[0082] Movement within the two-dimensional plane defined by the two-axis accelerometer is accurately detected. However, two-dimensional out-of-plane motion, for example motion in a different y-axis direction, cannot be detected with the same accuracy using a two-axis accelerometer. The more the plane of motion differs from the two-dimensional plane defined by the two-axis accelerometer, the greater the inaccuracy in detecting motion by the two-axis accelerometer. Rotation of the autoinjector can thus give rise to the altered signals observed for the biaxial sensor. However, if the x-axis or y-axis sensor is not aligned in the direction in which the auto injection is rotated, the sensor will produce a lower output. If the rotation is performed in a spatial plane orthogonal to the plane defined by the two-dimensional accelerometer, only the common sensory axis will produce a sensory signal as a response to the physical rotation of the autoinjector performed by the user. This means that the autoinjector inversions could not be observed and/or recorded correctly.

[0083] Due to the practical circumstances of implementing these sensors, some level of sensitivity outside the two-dimensional x/y plane may in some cases be observed. However, such signals are significantly weaker compared to acceleration along the specified x and y axes of operation and without any predefined sensitivity level. Thus, such out-of-plane signals are in practice difficult to use if a reliable guidance signal is to be detected. Because the design of the autoinjector is not intended to limit the user in the way the user holds the autoinjector and in the direction in which the user inverts the autoinjector in order to perform the inversion required to mix the medication, a two-axis accelerometer will not always provide results. as accurate as a three-axis accelerometer.

[0084] Compared to a two-axis accelerometer, improved sensitivity is obtained using a triaxial accelerometer, also referred to as a triaxial accelerometer in the following. Using a triaxial accelerometer instead allows the detection of motion in a z-axial direction in addition to the x-axis and y-axis directions being detected. Since the z-axial direction is perpendicular to both the x-axis and the y-axis, movement of the autoinjector in a different dimensional plane than that defined by the x and y axes is observable. The triaxial accelerometer thus defines a three-dimensional plane of sensitivity defined by the x, y, and z axes.

[0085] By selecting an accelerometer with three axes of spatial resolution, any residual uncertainty arising from rotation within or outside an appropriate two-dimensional spatial plane is resolved as the third axis of resolution will add this extra information. This means that an autoinjector orientation sensor with a triaxial accelerometer will be able to accurately detect and calculate motion/rotation, including rotational motions that do not remain within any single two-dimensional spatial plane, but vary throughout the handling motion, i.e. based on the ergonomics of the hand/arm articulation, etc. This means that all autoinjector reversals can be observed and recorded correctly.

[0086] The autoinjector may thus further comprise an orientation sensor being configured to detect an orientation of the cartridge and/or an orientation of the autoinjector. Autoinjector flips can be implemented using the orientation sensor. The orientation sensor may comprise a plurality of accelerometers, such as for example a triaxial accelerometer.

[0087] The processing unit may be coupled to the orientation sensor. The processing unit may be configured to receive the orientation signal, for example indicative of the orientation of the cartridge, for example when the cartridge is received at the cartridge receiver, and/or indicative of the orientation of the autoinjector. The processing unit may be configured to receive the guidance signal indicative of the angular velocity and/or the angle transposed by the autoinjector in an inversion. The processing unit may be further configured to provide the start signal after several complete inversions of the autoinjector have been performed, wherein the number of complete inversions is based on the guidance signal indicative of the angular velocity and/or the angle traversed by the autoinjector. in a complete inversion.

[0088] The movement of the plunger rod to the plunger rod mixing position and/or to the second plunger rod position and/or to the plunger rod injection position may be based on the orientation of the cartridge, e.g. example in the guidance sign. For example, the movement of the plunger rod from the first plunger rod position to the mixing position of the plunger rod may be based on the guidance signal.

[0089] For example, movement of the plunger rod to the plunger rod mixing position and/or to the second plunger rod position and/or to the plunger rod injection position may require an angle of inclination between a vertical and a 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.

[0090] The drive module control for moving the plunger rod to the plunger rod mixing position and/or the plunger rod priming position and/or the plunger rod injection position may be based on the orientation of the cartridge, for example the orientation signal.

[0091] The processing unit can be configured to control the drive module based on the guidance signal. For example, the processing unit may be configured to control the drive module to move the plunger rod to the plunger rod mixing position and/or to the second plunger rod position and/or to the injection position. of the plunger rod based on the guidance signal. For example, the processing unit may be configured to control the drive module to move the plunger rod to the plunger rod mixing position and/or to the second plunger rod position and/or to the injection position. of the plunger rod only if the guidance sign indicates that an angle of inclination between a vertical and a longitudinal axis extending along the cartridge is within 45 degrees, such as within 30 degrees, of the vertical, and/or if the outlet of the cartridge is in a vertical position above the cartridge compartment.

[0092] A first motion parameter can be determined, for example based on the orientation signal. The processing unit may be configured to determine the first motion parameter. The first movement parameter may be based on the cumulative movement of the autoinjector. The first motion parameter may be indicative of an amount of movement of the autoinjector during a set period of time, such as from completion of movement of the plunger rod to the mixing position of the plunger rod, and/or a predetermined preceding time. , just like the previous 1 second. The first motion parameter may be based on a cumulative measurement of the guidance signal over time, for example from the completion of piston rod movement to the piston rod mixing position, and/or a predetermined preceding time, such as the preceding 1 second. The first motion parameter may be indicative of the device being shaken. Shaking the device while the two medication components are mixed may cause excess medication to foam. Foaming of excess medication may require increased reconstitution time. To prevent foam formation, the speed of movement of the plunger rod can be adjusted, for example decreased if agitation of the device is detected. Conversely, gently shaking the device would accelerate reconstitution without foaming, thereby decreasing the necessary reconstitution time. Therefore, the amount of agitation may influence the determined reconstitution time.

[0093] Alternatively or additionally, the first motion parameter may be indicative of the autoinjector being rotated, for example from a vertical orientation, such as wherein a first end of the autoinjector, such as a distal end of the autoinjector, points substantially upward, for an inverted orientation in which the first end of the autoinjector points substantially downward. The first motion parameter may be indicative of the 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.

[0094] An inversion may comprise inverting the autoinjector from an orientation in which the first end of the autoinjector points substantially upward, to an inverted orientation in which the first end of the autoinjector points substantially downward. For example, an inversion may comprise inverting the autoinjector from an orientation in which the first end of the autoinjector points within 45 degrees upward, to an inverted orientation in which the first end of the autoinjector points within 45 degrees downward. Alternatively or additionally, an inversion may comprise inverting the autoinjector from an orientation in which the first end of the autoinjector points substantially downward, to an inverted orientation in which the first end of the autoinjector points substantially upward. For example, an inversion may comprise inverting the autoinjector from an orientation in which the first end of the autoinjector points within 45 degrees downward, to an inverted orientation in which the first end of the autoinjector points within 45 degrees upward.

[0095] A rotational movement of the autoinjector, rotating it from an initial position where the longitudinal axis of the autoinjector is in the horizontal plane and the first end of the autoinjector is pointing to the left to a position, where the longitudinal axis of the autoinjector is in the plane horizontal with the first end of the autoinjector pointing to the right, may also constitute an inversion.

[0096] Thus, an inversion can be defined as a rotation of the autoinjector of approximately 180 degrees. The orientation in the starting position and in the final position when performing an inversion is not fixed.

[0097] 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, that is, 45 degrees downward. Upward rotation can be detected during a rotation from 45 degrees downward, that is, 135 degrees upward, to 30 degrees upward. Thus, up and down rotations can be detected before the inversion is complete. Thus, a rotation of 90 to 105 degrees within a preset time can be used to calculate the inversion frequency based on an extrapolation of this data to estimate a rotation of approximately 180 degrees.

[0098] An inversion can be judged a complete inversion by the autoinjector if it is performed with an angular velocity above a standard threshold. By complete inversion a successful inversion is also intended. The default threshold for angular velocity can be set to an inversion frequency of at least 0.5 inversions per second. This corresponds to at least one inversion per 2 seconds. The purpose of a frequency threshold is to ensure that the inversions are powerful enough to effectively help mix the first drug component and the second drug component. The inversion frequency can be used in embedded software to determine whether the inversion is valid or not.

[0099] Alternatively, or additionally, the default frequency threshold for angular velocity can be set to at least 1 inversion per second. This corresponds to at least half a rotation per second.

[00100] The standard threshold for angular velocity can further be defined as an inversion frequency of less than 10 inversions per second, less than 5 inversions per second, or less than 2 inversions per second, or preferably less than 1.5 inversions per second. The upper limit of the frequency threshold can be used to filter out shake-like events that would otherwise be erroneously recorded as inversions.

[00101] The frequency threshold may be between 0.3 and 10 Hz, such as between 0.3 and 5 Hz, between 0.3 and 2 Hz, such as between 0.5 and 1.5 Hz, such as between 0.5 and 0.9 Hz, such as 0.7 Hz. The frequency threshold may be based on the cartridge code trace, such as an encoder signal indicative of the cartridge code trace.

[00102] Alternatively, or in combination, an inversion can be judged a complete inversion by the autoinjector if it transposes an angle above a standard threshold. The standard threshold for the angle may be 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 for example 180 degrees.

[00103] Typically, it will be difficult and/or uncomfortable for a user to hold the autoinjector in their hands to invert the autoinjector by an extent more than a 205 degree rotational movement, for example from 45 degrees in the right direction to 180 degrees in the right direction. left direction. The default threshold for the angle can be less than 220 degrees, such as less than 205 degrees, such as less than 190 degrees.

[00104] The inversion can be an inversion around an axis in a horizontal plane.

[00105] A rotational movement of the autoinjector from a starting angular position to a final angular position can be judged a complete inversion by the autoinjector if: - the starting angular position is between a first vertical orientation with a distal end of the autoinjector pointing upwards and a first horizontal position with the distal end of the autoinjector pointing to one side along a horizontal axis; - the final angular position is between a second horizontal position with the distal end of the autoinjector pointing sideways along a horizontal axis in a direction opposite to that in the first horizontal position and second vertical orientation with the distal end of the autoinjector pointing downward, and - the standard threshold for 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, even more preferably at least 165 degrees, such as 180 degrees.

[00106] A rotational movement of the autoinjector from a starting angular position to a final angular position can be judged a complete inversion by the autoinjector if: - the starting angular position is between a first vertical orientation with a distal end of the autoinjector pointing downwards and a first horizontal position with the distal end of the autoinjector pointing sideways along a horizontal axis; - the final angular position is between a second horizontal position with the distal end of the autoinjector pointing sideways along a horizontal axis in a direction opposite to that in the first horizontal position and second vertical orientation with the distal end of the autoinjector pointing upward, and - the standard threshold for 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, even more preferably at least 165 degrees, such as 180 degrees.

[00107] The autoinjector can thus undergo a complete inversion, when it is vertically inverted 180 degrees, for example rotation from vertically pointing upwards to vertically pointing downwards. The 180 degree inversion can occur for a maximum of 2 seconds, that is, with a minimum inversion frequency of 0.5 Hz. Alternatively, or in addition, the autoinjector can undergo a complete inversion when it is vertically inverted 180 degrees , for example rotation from vertically pointing at an angle of 0 to 30 degrees compared to the upward direction to vertically pointing downward at an angle of 0 to 30 degrees compared to the downward direction. Alternatively, or in addition, the autoinjector may undergo a complete inversion when it is vertically inverted 180 degrees, for example rotation from vertically pointing at an angle of 25 to 65 degrees compared with the upward direction to vertically downward pointing at a angle of 25 to 65 degrees compared to downward. Alternatively, or in addition, the autoinjector may undergo a complete inversion, where it is vertically inverted 180 degrees, for example rotation from vertically pointing upwards at an angle of 45 to 75 degrees compared with the upward direction to vertically pointing downwards. at an angle of 45 to 75 degrees compared to downward.

[00108] The frequency threshold may be based on the cartridge code trace, such as a code signal indicative of the cartridge code trace. Alternatively or additionally, the frequency threshold may be based on the temperature of the medicament, such as a temperature signal indicating the temperature of the medicament.

[00109] Ideally the specified physical input for low viscosity medicament would be for example 5 inversions of 180 degrees, however if the continuously measured inversion angles remain significantly below then it would be envisaged to require a higher number of inversions, for example 10 inversions if the angle by inversion would go down to 90 degrees. Alternatively, the specified physical input for low viscosity drug would be for example 10 inversions of 180 degrees, however if the continuously measured inversion angles remained significantly below then it would be envisaged to require a higher number of inversions, e.g. 20 inversions if the angle by inversion it went down to 90 degrees. The complete inversion number may therefore increase if the autoinjector experiences inversions having a lower degree of angular motion and/or angular velocity.

[00110] The number of inversions may be the adjusted code signal indicative of the cartridge code trace, the cartridge code trace defining the number of inversions necessary for the medicine to be sufficiently mixed. The autoinjector may therefore not be preset to require a specific number of inversions, for example inversions for all cartridges used with the device. Instead, the autoinjector can be adjusted to require the individual number of inversions defined in the cartridge code trace.

[00111] The processing unit may be configured to provide feedback, such as via the autoinjector user interface, when a default/predefined number of full inversions and/or inversions, that is, including both the full inversions and the non-inversion. complete, not satisfying the requirements to be complete, was complete. The processing unit may provide visible and/or acoustic feedback to the user when the number of complete inversions has been performed.

[00112] Alternatively or in combination, the processing unit may provide visual feedback and/or acoustic feedback to the user for each complete inversion. Using for example a 3-axis accelerometer to count the number of complete/successful inversions having for example a sufficient rotation angle provided quickly enough and repeated a sufficient number of times, the autoinjector device can provide acoustic feedback via a internal speaker for example giving a 'tick' for each successful inversion. Furthermore, visual feedback through for example a graphical progress bar included in the interface, may be given for the total number of or for each of the complete inversions during the inversion sequence. This helps the user to perform inversions correctly.

[00113] The predefined number of complete inversions may be based on an amount of motion energy applied to the mixed drug during reconstitution, for example the predefined number of complete inversions may be correlated with the amount of motion energy applied to the mixed drug during the reconstitution. The predefined number of full inversions may be between 1 and 20, such as between 1 and 10, such as between 3 and 7, such as 5. The predefined number of full inversions may alternatively be above 10, such as above 15, or such as above 20.

[00114] The predefined number of complete inversions may be based on the cartridge code trace, such as a code signal indicative of the cartridge code trace.

[00115] The first motion parameter may be indicative of a combined rotation between opposite vertical orientations in combination with the angular speed of rotation and/or a waiting/delay period between such reversals. The processing unit can, for example, in addition to counting the number of inversions and/or complete inversions, measure the rotational acceleration of the autoinjector. The processing unit can estimate the force and energy acting on the drug to be reconstituted, for example based on the measurement of rotational acceleration of the autoinjector and/or counting the number of inversions and/or complete inversions. The processing unit may provide feedback, for example via the user interface, when a predefined amount of energy has been applied to the autoinjector and/or cartridge.

[00116] Alternatively or additionally, it can be monitored that the acceleration does not exceed a predefined upper threshold. The predefined upper threshold may be indicative of accelerations known to be associated with the risk of foaming. For example, accelerations above the predefined upper threshold may be known to be associated with the risk of foaming.

[00117] The total amount of energy applied to the autoinjector, such as based on measuring the rotational acceleration of the autoinjector and/or counting the number of inversions and/or complete inversions, can be evaluated continuously to give real-time instructions e.g. for a user to perform such a movement, if the energy level is considered very low, for example below a predefined lower threshold, and/or if the energy level is considered high, for example above a predefined upper threshold. The predefined lower threshold can be an energy level. The predefined upper threshold may be an energy level where movement is considered to increase the risk of foam formation.

[00118] The first movement parameter may be indicative of a movement frequency of the autoinjector, such as the number of inversions and/or complete inversions per second.

[00119] The autoinjector, for example the cartridge receiver, may be configured to receive a cartridge assembly comprising the cartridge and a cartridge code trace.

[00120] The autoinjector may comprise a code sensor. The code sensor may be configured to read a cartridge code trace, such as the cartridge code trace of the cartridge and/or the cartridge assembly for example indicative of one or more specifications of the cartridge. The code sensor may be configured to provide a code signal indicative of the cartridge code trace.

[00121] The processing unit may be coupled to the code sensor. The processing unit can be configured to receive the code signal. The processing unit may be configured to receive from the code sensor a code signal indicative of the cartridge code trace. The movement of the plunger rod, such as the movement from the first position of the plunger rod to the mixing position of the plunger rod, may be based on the code signal.

[00122] The processing unit can be configured to determine an unauthorized cartridge, such as a counterfeit cartridge and/or a used cartridge, and/or a tampered cartridge, and/or a cartridge containing a wrong dose, and/or a cartridge containing a wrong medicine, based on the code signal.

[00123] The code sensor may comprise an optical sensor. The code sensor may comprise an optical sensor comprising a transmitter and a receiver, such as a light transmitter and a light receiver. The code sensor can be configured to read the cartridge code trace. The code sensor can be configured to read color codes, bar codes, RFID tags, NFC tags, ID numbers, QR codes, and/or any combination thereof.

[00124] The movement of the piston rod, such as positions, speed and/or delays, may be based on the code signal. For example, the movement of the plunger rod to the plunger rod mixing position and/or the second plunger rod position and/or the plunger rod injection position may be based on the cartridge code trace, for example in the code sign. For example, control of the drive module to move the plunger rod to the plunger rod mixing position and/or to the second plunger rod position may be based on the code signal. The processing unit can be configured to control the drive module based on the code signal. For example, the processing unit may be configured to control the drive module to move the plunger rod to the plunger rod mixing position and/or to the second plunger rod position based on the code signal.

[00125] Basing the movement of the plunger rod on the cartridge specification, for example on the code signal, provides that the movement of the plunger rod can be optimized for different types of cartridges. For example, the air jet can be performed with reduced or no expulsion of medication, thus increasing dosage accuracy and/or reducing patient discomfort, for example even with different cartridges. Additionally or alternatively, the mixing procedure can be carried out with reduced foaming by knowing the cartridge specifications.

[00126] Basing the movement of the plunger rod on the cartridge specification, for example on the code signal, provides that the movement of the plunger rod can be optimized for different types of cartridges. For example, the plunger rod may be held in a mixing position of the plunger rod for a time depending on the specification of the cartridge following detection of the cartridge which is received in the cartridge receiver and reception of the first input signal thereby ensuring appropriate mixing and/or reduction of discomfort for the patient, for example even with different cartridges.

[00127] The autoinjector may comprise a resistance sensor. The resistance sensor can be configured to provide a resistance signal. The resistance signal may be indicative of resistance against the movement of the piston rod. The processing unit can be coupled to the resistance sensor. The processing unit can be configured to receive the resistance signal.

[00128] The resistance signal may be indicative of resistance against movement of the plunger rod in one direction, such as movement in the direction of the extended position of the plunger rod. For example, the resistance signal may be indicative of the force required to move the plunger rod, for example in the direction of the extended position of the plunger rod.

[00129] The resistance sensor can be configured to determine the electrical energy consumed by the drive module, for example by measuring the electrical resistance, electrical current, and/or electrical voltage of the drive module and/or a combination thereof. The resistance sensor may comprise an electrical resistance sensor, an electrical current sensor, and/or an electrical voltage sensor. The drive module may comprise the resistance sensor.

[00130] The resistance sensor may be configured to measure pressure and/or force applied to a plunger rod front end of the plunger rod. The front end of the plunger rod may be configured to engage with the first stopper of the cartridge. The resistance sensor can be configured to measure pressure and/or force between the plunger rod and the cork. For example, the resistance sensor may comprise a pressure transducer and/or a force transducer at the front end of the plunger rod. The plunger rod may comprise the resistance sensor.

[00131] The movement of the plunger rod may be based on the resistance signal. For example, movement of the plunger rod to the plunger rod mixing position and/or the second plunger rod position and/or the plunger rod injection position may be based on resistance against rod movement. of the piston, for example in the resistance signal. For example, control of the drive module to move the plunger rod to the plunger rod mixing position may 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 may be configured to control the drive module to move the plunger rod to the mixing position of the plunger rod based on the resistance signal.

[00132] The autoinjector may comprise a temperature sensor. The temperature sensor may be configured to provide a temperature signal, such as a temperature signal indicative of the temperature of the autoinjector and/or the cartridge and/or the medicament, such as the temperature of the medicament in the cartridge, for example when the cartridge is received at the cartridge receiver. The temperature sensor may comprise an infrared sensor, such as an optical infrared sensor. The temperature sensor and the code sensor may use a common optical sensor, such as a common optical sensor. Thus, the optical sensor, such as an infrared optical sensor can be used to both sense the temperature and read the cartridge code trace.

[00133] The processing unit can be coupled to the temperature sensor. The processing unit can be configured to receive the temperature signal.

[00134] The movement of the plunger rod to the plunger rod mixing position and/or to the second plunger rod position and/or to the plunger rod injection position may be additionally based on the temperature of the autoinjector and /or the cartridge and/or the medicine. The movement of the plunger rod to the plunger rod mixing position and/or to the second plunger rod position and/or to the plunger rod injection position may additionally be based on the temperature signal.

[00135] The processing unit may be configured to control the drive module to move the plunger rod to the plunger rod mixing position and/or to the plunger rod priming position and/or to the plunger rod mixing position. plunger rod injection based on the temperature signal in addition to being based on the start signal.

[00136] The autoinjector may comprise a temperature control unit. The temperature control unit may be configured to change the temperature of the cartridge, for example when the cartridge is received at the cartridge receiver. The temperature control unit can be configured to raise and/or lower the temperature of the cartridge and/or the medicine. The steps of the procedure being temperature dependent can thus be controlled, for example, in order to carry out the steps faster.

[00137] The temperature control unit may comprise a heating element. The heating element may be configured to raise the temperature of the autoinjector and/or the cartridge and/or the medication. The heating element may be a resistive heating element. The heating element may be a light source, 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.

[00138] The temperature control unit may comprise a cooling element. The cooling element may be configured to lower the temperature of the autoinjector and/or the cartridge and/or the drug. The cooling element may be a thermoelectric element, such as a Peltier element.

[00139] The temperature control unit may comprise a thermoelectric element, such as a Peltier element. The thermoelectric element can be used to raise or lower the temperature, such as by using the Peltier effect, or to transfer heat from one side of the element to the other with electrical energy consumption. The thermoelectric element can be used to raise or lower the temperature depending on the direction of the current.

[00140] The temperature control unit may comprise a contact element configured to be in contact with the cartridge, for example when the cartridge is received in the cartridge receiver. The temperature control unit may comprise a coil element. The coil member may be configured to surround an entire perimeter of the cartridge, for example when the cartridge is received in the cartridge receiver.

[00141] The autoinjector may comprise an input device, such as a first input device. The first input device can be a button or touch-sensitive area or a microphone. The first input device may be configured to provide the first input signal. The first input signal may be indicative of a first user interaction with the first input device. The first input device may be configured to provide a second input signal. The second input signal may be indicative of a second user interaction with the first input device.

[00142] The processing unit may be coupled to the first input device. The processing unit may be configured to receive the first input signal and/or the second input signal. The processing unit may be configured to control the drive module to move the plunger rod to the plunger rod mixing position only after receiving the first input signal. The processing unit may 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.

[00143] The autoinjector may comprise a contact member. The contact member may be configured to be pressed against the injection site. The contact member may be movable between an extended contact member position and a retracted contact member position. The contact member may be tilted toward the extended contact member position, for example by a contact member spring. The contact member may be configured to be moved in the direction of the retracted position of the contact member, for example when pressed against the injection site. The contact member and/or a contact member sensor may be configured to provide a signal indicative of the position of the contact member. The autoinjector and/or contact member may comprise a contact member sensor configured to detect the position of the contact member. The contact member sensor may be configured to provide the contact member signal indicative of the contact member.

[00144] The contact member may be in a first contact member position, for example between the extended contact member position and the retracted contact member position. The contact member being in the first contact member position may indicate that the contact member is close to the retracted contact member position. The contact member being in the first contact member position may indicate that the contact member is pressed against the injection site. The contact member being in the first contact member position may indicate that a needle positioned in the cartridge is pressed sufficiently into the skin for injection of the medication to begin.

[00145] The processing unit can be coupled to the contact member. The processing unit may be configured to receive the contact member signal. The triggering event may comprise the contact member signal being indicative of the contact member being in a first contact member position. The contact member can be a triggering member.

[00146] The positions of the plunger rod, such as the first plunger rod position, the mixing position of the plunger rod, the second position of the plunger rod and/or the injection position of the plunger rod may be based on in a cartridge specification, such as in the cartridge code trace, such as in the code sign. For example, the processing unit may be configured to determine plunger rod positions, such as the first plunger rod position, the mixing plunger rod position, the second plunger rod position, and/or the plunger rod injection based on the code signal.

[00147] 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 in the cartridge orientation, such as the orientation signal. For example, the processing unit may be configured to determine plunger rod positions, such as the first plunger rod position, the mixing plunger rod position, the second plunger rod position, and/or the plunger rod injection based on the guidance signal.

[00148] The positions of the plunger rod, such as the first plunger rod position, the mixing position of the plunger rod, the second position of the plunger rod and/or the injection position of the plunger rod may be based on in shaking the device, as in the first motion parameter. For example, the processing unit may be configured to determine plunger rod positions, such as the first plunger rod position, the mixing plunger rod position, the second plunger rod position, and/or the plunger rod injection based on the first motion parameter.

[00149] The positions of the plunger rod, such as the first plunger rod position, the mixing position of the plunger rod, the second position of the plunger rod and/or the injection position of the plunger rod may be based on in the resistance against the movement of the piston rod, as in the resistance sign. For example, the processing unit may be configured to determine plunger rod positions, such as the first plunger rod position, the mixing plunger rod position, the second plunger rod position, and/or the of the plunger rod based on the resistance signal.

[00150] The processing unit may be configured to determine plunger rod positions, such as the first plunger rod position, the mixing plunger rod position, the second plunger rod position, and/or the of the piston rod, based on the code signal and/or the guidance signal and/or the first motion parameter and/or the resistance signal.

[00151] The movement of the plunger rod may comprise movement having a plunger rod speed, such as a plunger rod mixing speed, a second plunger rod speed and/or an injection plunger rod speed. The speed of the plunger rod may be based on the position of the plunger rod. The plunger rod can be moved to the plunger rod mixing position, such as from the first plunger rod position, with a plunger rod mixing speed. The plunger rod can be moved to the second plunger rod position, such as from the mixing position of the plunger rod, with a second plunger rod speed. The plunger rod can be moved to the plunger rod injection position, such as from the plunger rod mixing position and/or the second plunger rod position, with a plunger rod injection speed.

[00152] The speed of the plunger rod, such as the mixing speed of the plunger rod, the second speed of the plunger rod, and/or the injection speed of the plunger rod can be constant. The plunger rod speed, such as the plunger rod mixing speed, the second plunger rod speed, and/or the plunger rod injection speed may be variable, for example varying with time and/or with the distance.

[00153] The mixing speed of the plunger rod can be between 1 mm/second and 3 mm/second, such as 1.7 mm/second.

[00154] The processing unit may be configured to control the drive module to move the plunger rod to the plunger rod mixing position, such as from the first plunger rod position, with the mixing speed of the plunger rod. piston. The processing unit may be configured to control the drive module to move the plunger rod to the second plunger rod position, such as from the mixing position of the plunger rod, with the second plunger rod speed. The processing unit may be configured to control the drive module to move the plunger rod to the plunger rod injection position, such as from the second plunger rod position, with the plunger rod injection speed.

[00155] The plunger rod mixing speed, the second plunger rod speed, and/or the plunger rod injection speed may be based on a cartridge specification, such as the cartridge code trace, as in the code signal. The processing unit may be configured to determine the plunger rod mixing speed, the second plunger rod speed, and/or the plunger rod injection speed, based on the code signal.

[00156] The plunger rod mixing speed, the second plunger rod speed, and/or the plunger rod injection speed may be based on the orientation of the cartridge, such as the orientation signal. The processing unit may be configured to determine the plunger rod mixing speed, the second plunger rod speed, and/or the plunger rod injection speed, based on the guidance signal.

[00157] The mixing speed of the plunger rod, the second speed of the plunger rod, and/or the injection speed of the plunger rod may be based on the first motion parameter. The processing unit may be configured to determine the plunger rod mixing speed, the second plunger rod speed, and/or the plunger rod injection speed, based on the first motion parameter.

[00158] The mixing speed of the plunger rod, the second speed of the plunger rod, and/or the injection speed of the plunger rod, may be based on the resistance against movement of the plunger rod, such as in the signal of resistance. The processing unit may be configured to determine the plunger rod mixing speed, the second plunger rod speed, and/or the plunger rod injection speed, based on the resistance signal.

[00159] The processing unit may be configured to determine the plunger rod mixing speed, the second plunger rod speed, and/or the plunger rod injection speed, based on the code signal and/or on the orientation signal and/or on the first movement parameter and/or on the resistance signal.

[00160] The movements of the plunger rod, such as movement to the mixing position of the plunger rod, to the second position of the plunger rod, to the injection position of the plunger rod, may be preceded by one or more elapsed times, such as delays. For example, movement of the plunger rod to the second plunger rod position may require that a reconstitution time has elapsed since the completion of movement of the plunger rod to the mixing position of the plunger rod. The reconstitution time may be chosen to allow sufficient time to ensure that the medicament is reconstituted, for example that the first medicament component and the second medicament component have been sufficiently mixed, such as dissolved.

[00161] In some circumstances the reconstitution time may be very short. The reconstitution time may be less than 10 seconds, such as less than 5 seconds, such as less than 1 second. Alternatively, the reconstitution time may be more than 1 second, such as more than 10 seconds, such as more than 1 minute, such as more than 5 minutes.

[00162] The reconstitution time can be between 1 and 10 minutes, such as between 2 and 5 minutes, such as 3 minutes.

[00163] The processing unit may be further configured to control the drive module to move the plunger rod to the plunger rod mixing position and/or the second plunger rod position and/or to the injection position of the plunger rod based on one or more elapsed times, such as dwell times. For example, the processing unit may be further configured to control the drive module to move the plunger rod to the second plunger rod position only after the reconstitution time has elapsed from the completion of movement of the plunger rod to the mixing position of the plunger rod.

[00164] The reconstitution time may be based on a cartridge specification, for example the reconstitution time may be based on the cartridge code trace, for example the reconstitution time may be based on the code signal. The processing unit may be configured to determine the reconstitution time based on the code signal.

[00165] Alternatively or additionally, the reconstitution time may be based on the guidance signal. The processing unit may be configured to determine the reconstitution time based on the guidance signal.

[00166] Alternatively or additionally, the reconstitution time may be based on the first movement parameter. The processing unit may be configured to determine the reconstitution time based on the first motion parameter.

[00167] Alternatively or additionally, the reconstitution time may be based on the resistance against the movement of the plunger rod, such as the resistance signal. The processing unit can be configured to determine the reconstitution time based on the resistance signal.

[00168] The processing unit may be configured to determine the reconstitution time based on the code signal and/or the orientation signal and/or the first motion parameter and/or the resistance signal.

[00169] The plunger rod may be moved in the direction of the plunger rod retracted position, such as to the plunger rod retracted position, following completion of the movement of the plunger rod to the plunger rod injection position . The processing unit may be configured to control the drive module to move the plunger rod in the direction of the plunger rod retracted position following completion of the plunger rod movement to the plunger rod injection position.

[00170] The movement of the plunger rod in the direction of the plunger rod retracted position, such as to the plunger rod retracted position, such as after completion of the plunger rod movement to the plunger rod injection position , may require that a dwell time has elapsed, for example from the completion of the plunger rod movement to the plunger rod injection position. The dwell time can be chosen to allow sufficient time to ensure the medication is distributed within the tissue. Dwell time may be influenced by the medication and/or medication concentration and/or the amount of medication and/or the temperature of the medication. The dwell time may be based on a cartridge specification, for example the dwell time may be based on the cartridge code trace, for example the dwell time may be based on the code signal.

[00171] The processing unit may be configured to control the drive module to move the plunger rod in the direction of the plunger rod retracted position only after the dwell time has elapsed from the completion of the plunger rod movement to the injection position of the plunger rod.

[00172] The dwell time may be based on a cartridge specification, for example the dwell time may be based on the cartridge code trace, for example the dwell time may be based on the code signal. The processing unit may be configured to determine the dwell time based on the code signal.

[00173] Alternatively or additionally, the dwell time may be based on the guidance signal. The processing unit may be configured to determine the dwell time based on the guidance signal.

[00174] Alternatively or additionally, the dwell time may be based on the first movement parameter. The processing unit may be configured to determine the dwell time based on the first motion parameter.

[00175] Alternatively or additionally, the residence time may be based on the resistance against the movement of the plunger rod, such as the resistance signal. The processing unit can be configured to determine the dwell time based on the resistance signal.

[00176] The processing unit may be configured to determine the dwell time based on the code signal and/or the guidance signal and/or the first motion parameter and/or the resistance signal.

BRIEF DESCRIPTION OF THE DRAWINGS

[00177] The above and other features and advantages of the present invention will become readily apparent to those skilled in the art by the following detailed description of exemplary embodiments thereof with reference to the accompanying drawings, in which: Fig. 1 illustrates an autoinjector exemplary; Fig. 2 illustrates an exemplary autoinjector with a cartridge; Fig. 3 schematically illustrates an exemplary cartridge; Fig. 4a-d schematically illustrate an exemplary cartridge assembly with exemplary cartridge code traces; Fig. 5 schematically illustrates an exemplary autoinjector with a cartridge assembly; Fig. 6 a-d schematically illustrates an autoinjector and cartridge assembly; Fig. 7 shows a block diagram of an exemplary autoinjector; Fig. 8a-f schematically illustrates an exemplary cartridge assembly and a plunger rod in exemplary positions; Fig. 9 shows an exemplary plot of resistance vs. resistance. position; Fig. 10 shows a flow diagram of an exemplary method; Fig. 11 shows a flow diagram of an exemplary method; Fig. 12 a-d schematically illustrates an exemplary user interface; and Fig. 13 a-c schematically illustrates an exemplary movement of an exemplary autoinjector.

DETAILED DESCRIPTION

[00178] Various embodiments are described below with reference to the figures. Equal reference numerals everywhere refer to equal elements. Equal elements will therefore not be described in detail with respect to the description of each figure. It should also be mentioned that the figures are only intended to facilitate the description of the embodiments. These are not intended as an exhaustive description of the claimed invention or as a limitation of the scope of the claimed invention. Furthermore, an illustrated embodiment does not need to have all aspects or advantages presented. An aspect or advantage described in conjunction with a particular embodiment is not necessarily limited to that embodiment and may be practiced in any other embodiments even if not illustrated, or if not as explicitly described.

[00179] Fig. 1 illustrates an exemplary autoinjector 4. The autoinjector 4 can be configured to administer a medication. Autoinjector 4 may be an electronic autoinjector.

[00180] 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 may contain medicine.

[00181] The cartridge receiver 300 has a cartridge receiver opening 301. The cartridge receiver 300 is configured to receive the cartridge and/or the cartridge assembly through the cartridge receiver opening 301 in a cartridge receiving direction 304 along a longitudinal axis L.

[00182] The autoinjector 4 may comprise a user interface 1100, as illustrated. The autoinjector 4 comprises a trigger member, such as the contact member 1102. The contact member 1102 may be configured to be pressed against an injection site. The contact member 1102 may be movable in the receiving direction of the cartridge 304, relative to the housing, if pressed against the injection site. Contact member 1102 may be part of user interface 1100.

[00183] The user interface 1100 may comprise a first input member 1108 as illustrated, for example, a button. The first input member 1108 may provide a user input from a user. For example, the first input member 1108 may be used to receive a nudge from a user to proceed to a next step.

[00184] The user interface 1100 may comprise a first output member 1110 as illustrated, for example, a plurality of LEDs. The first exit member 1110 may provide a user exit for a user. The user interface 1100 may comprise a second output member (not shown), for example a speaker. The second output member may be configured to provide an audible output to the user. For example, the first output member 1110 and/or the second output member may be used to indicate a step in the procedure to the user and/or to indicate an error message.

[00185] Fig. 2 illustrates an exemplary system 2. The system 2 comprises an autoinjector 4, as described in relation to Fig. 1, and an exemplary cartridge 700 received in the cartridge receiver 300. The cartridge 700 is shown with a cover of needle 908. The needle cap 908 extending from the contact member 1102 to permit removal of the needle cap 908 from the cartridge 700.

[00186] Fig. 3 schematically illustrates an exemplary cartridge 700, such as a cartridge 700 being configured to be received in the cartridge receiver of an autoinjector, such as the autoinjector described in relation to the previous figures.

[00187] Cartridge 700 comprises a cartridge compartment 702. Cartridge compartment 702 may be configured to contain a medicament. The cartridge 700 has a first termination 718 and a second termination 720. The cartridge 700 comprises a cartridge outlet 714 at the first end of the cartridge 718. The cartridge may be configured to expel medicament through the cartridge outlet 714.

[00188] The cartridge comprises a first stopper 708 movable within the cartridge compartment, for example in a first stopper direction 722, for example, towards the first end of the cartridge. For example, the medicament may be expelled through the outlet of the cartridge 714 upon movement of the first stopper 708 in the first direction of the stopper. The cartridge comprises a face-off cartridge 716 at the second end of the cartridge. The opposite face cartridge 716 comprises an opposite end opening cartridge to provide access for the first stopper 708 to a plunger rod.

[00189] As illustrated, cartridge 700 may be a dual chamber cartridge. The cartridge comprises a second stopper 710 movable within the cartridge compartment 702, e.g. in the first stopper direction 722, e.g. in the direction of the first end of the cartridge. Cartridge compartment 702 comprises a first cartridge subcompartment 704 and a second cartridge subcompartment 706. The first cartridge subcompartment 704 is between the first stopper 708 and the second stopper 710. The second cartridge subcompartment 706 is between the second stopper 710 and cartridge outlet 714. The cartridge comprises a bypass section 712 for providing fluidic communication between the first cartridge subcompartment and the second cartridge subcompartment. The bypass section 712 provides fluid communication between the first cartridge subcompartment and the second cartridge subcompartment when the second stopper 710 is positioned in the bypass section 712.

[00190] The first subcompartment of the cartridge 704 contains a first medicament component 792 of the medicament 790. The first medicament component 792 may be a liquid as illustrated. The second subcompartment of the cartridge 706 contains a second medicament component 794 of the medicament 790. The second medicament component 794 may be a powder composition. By positioning the second stopper 710 within the diverter section 712, the first medicament component 792 may be transmitted into the second subcompartment of the cartridge 706 via the diverter section 712, thereby mixing the first medicament component 792 and the second component. of medicine 794 to obtain the combined medicine 790.

[00191] Figs. 4a-d schematically illustrate an exemplary cartridge assembly 600. The cartridge assembly 600 comprises an exemplary cartridge 700 and an exemplary cartridge code trace 1000. The cartridge 700 has a first cartridge end 718 and a second cartridge end 720. The first stopper direction 722 is from the second end of the cartridge 720 to the first end of the cartridge 718. The cartridge code trace 1000 is positioned closer to the second end of the cartridge 720, e.g., closer to the second end of the cartridge 720 than the first end of the cartridge 718. In another exemplary cartridge assembly, the cartridge code trace 1000 may be positioned near the first end of the cartridge 720.

[00192] Figs. 4a-d illustrate different types of traces of the exemplary cartridge code 1000.

[00193] Fig. 4a illustrates an exemplary assembly of cartridge 600, in which the cartridge code trace 1000 comprises two bands. The two bands can be colored, for example, differently colored. The combination and/or sequence of colors may be indicative of a 1000 cartridge code dash code.

[00194] Fig. 4b illustrates an exemplary assembly of cartridge 600, wherein the cartridge code trace 1000 comprises a barcode. Cartridge code trace 1000 may comprise one or more barcodes. The barcode may be indicative of a number indicative of a 1000 cartridge code dash code.

[00195] Fig. 4c illustrates an exemplary assembly of cartridge 600, in which the cartridge code trace 1000 comprises differently shaved stripes. For example, as illustrated, the cartridge code trace 1000 may comprise two bands in which the first band is shaved at 45 degrees, and the second band is shaved at -45 degrees. Scraping, and/or scraping of the stripes relative to each other, may be indicative of a 1000 cartridge code trace code.

[00196] Fig. 4d illustrates an exemplary assembly of cartridge 600, wherein the cartridge code trace 1000 comprises an electromagnetically readable tag, such as an RFID tag or an NFC tag. The electromagnetically readable label may contain data that is indicative of a cartridge code 1000 dash code.

[00197] Fig. 5 illustrates an exemplary system 2. The system 2 comprises an autoinjector 4, as described, for example, in relation to Fig. 1, and an exemplary cartridge assembly 600. The cartridge assembly 600 comprises a cartridge 700 with a cartridge housing 702, a needle assembly 900, and a cartridge dash code 1000. The cartridge assembly 600 is received at the autoinjector 4.

[00198] The cartridge assembly 600 comprises a cartridge holder 800. The cartridge holder 800 is configured to retain the cartridge 700 in the cartridge receiver 300 of the autoinjector 4. The cartridge holder 800 comprises a cartridge retention member 808. The cartridge retaining member 808 engages with the cartridge receiver 300 for receiving and retaining the cartridge 700 and mounting the cartridge 600 in the cartridge receiver 300.

[00199] The needle assembly 900 comprises a needle 902 and a needle hub 904. The needle assembly 900 is connected to the cartridge 700, for example, by the needle hub 904 having a connecting portion to the cartridge holder 906, e.g. example, a connecting portion in line, being in engagement with a needle mounting connecting portion 812 of the cartridge holder 800. The needle 902 extends through the cartridge outlet 714 of the cartridge 700. The cartridge outlet 714 may be locked by a resilient seal being penetrated by the needle 902 when the needle assembly 900 is connected to the cartridge 700.

[00200] The autoinjector 4 comprises a code sensor 24 configured to read the cartridge trace code 1000. When the cartridge assembly 600 is inserted as shown, the cartridge trace code 1000 is aligned with the code sensor 24 .

[00201] The autoinjector 4 comprises a plunger rod 400. The plunger rod 400 is configured to advance a first cartridge stopper 700. The plunger rod 400 comprises an outer plunger rod 404 with an internal thread, and an inner rod of piston 402 with an external thread. The internal thread of the plunger rod 402 is secured to the external thread of the plunger rod 404. The external plunger rod 404 is prevented from rotating relative to the autoinjector housing. Movement of the plunger rod 400 comprises rotation of the inner plunger rod 402. Rotation of the inner plunger rod 402 results in translational movement of the outer plunger rod 404, due to the outer plunger rod 404 being rotationally restricted. The outer rod of the plunger 404, when translationally moved in the direction of the first stopper 722, is configured to touch the first stopper of the cartridge 700, and to move the first stopper in the direction of the first stopper 722.

[00202] The drive module 500 is connected to drive the plunger rod 400. The drive module 500 is electrically connected to a battery to receive electrical energy. The drive module 500 comprises a motor 502, such as an electromechanical motor, such as a DC motor. The drive module 500 comprises a transmission 504 for connecting the motor 502 to the inner piston rod 402 of the piston rod 400.

[00203] Although the example shown comprises a motor 502, which may be an electromechanical motor, it will be readily understood that the autoinjector 4 may be realized having an alternative drive module, such as comprising a solenoid motor, a metal shape memory motor , an arrangement of springs and/or a pressurized gas configured to activate the plunger rod 400.

[00204] The autoinjector 4 comprises an ejection sensor 26, such as a plunger rod position sensor. The ejection sensor 26 is configured to detect the position of the plunger rod 400. In the illustrated example, the ejection sensor 26 comprises a tachometer configured to count/detect the revolutions of the engine 502. Thus, the position of the plunger rod 400 can be determined based on the revolution count of the engine 502. The ejection sensor 26 can, based on sensing the position of the plunger rod 400, detect the expulsion of the medicament and/or air in the cartridge compartment. The position of the plunger rod 400 may be indicative of the position of the first stopper of the cartridge 700, for example, the most forward position of the plunger rod 400, for example while the cartridge 700 is in the cartridge receiver 300, may be indicative from the position of the first stopper of cartridge 700.

[00205] Figs. 6a-d schematically illustrate an autoinjector 4 and a cartridge assembly 600. Figs. 6a-d schematically illustrate exemplary positions of a contact member 1102 of the autoinjector 4 in various situations.

[00206] The autoinjector 4 comprises a cartridge receiver 300 configured to receive and retain a cartridge. The autoinjector 4 comprises a contact member 1102. The contact member 1102 may be movable between an extended position of the contact member and a retracted position of the contact member. The contact member 1102 comprises a protrusion contact member 1112. The protrusion contact member 1112 is configured to move with the contact member 1102. The contact member 1102 may be tilted, for example, through of a contact member spring (not shown), in the direction of the extended contact member position.

[00207] The contact member comprises a needle cap coupling member 1114. The needle cap coupling member 1114 is configured to contact a needle cap mating face, for example, of a needle cap positioned in the cartridge inserted into cartridge receiver 300.

[00208] The autoinjector 4 comprises a contact member sensor 1104 configured to detect a position of the contact member 1102. The contact member sensor 1104 comprises a first contact member sensor 1130 and a second contact member sensor 1132. The first sensor of the contact member 1130 and the second sensor of the contact member 1132 may be optical sensors. The contact member sensor 1104 detects the position of the contact member 1102 through the protrusion contact member 1112 covering the first sensor of the contact member 1132 when the contact member 1102 is in a first position of the contact member , and the protrusion contact part member 1112 covering the second sensor of the contact member 1132 when the contact member 1102 is in a second position of the contact member.

[00209] The first contact member position can be detected by the sensor of the first contact member 1130 being covered and the sensor of the second contact member 1132 being covered. The position of the second contact member can be detected by the first sensor of the contact member 1130 being not covered and the second sensor of the contact member 1132 being covered. The extended position of the contact member can be detected by the first contact member sensor 1130 not being covered and the second contact member sensor 1132 not being covered.

[00210] Fig. 6a schematically illustrates the autoinjector 4 without any cartridge and/or the cartridge assembly received. Contact member 1102 is in the extended contact member position. A cartridge may be inserted into the cartridge receiver 300 in the cartridge receiving direction 322 through the contact member 1102 defining an opening of the cartridge receiver 301.

[00211] Fig. 6b schematically illustrates the autoinjector 4 with a received cartridge assembly 600. 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 cap 908. The needle cap has a face that touches the needle cap. 910. The face touching the needle cap 910 engages the needle cap coupling member 1114 of the contact member 1102. The contact member 1102 is in the second position of the contact member, e.g., caused by the presence of the needle cap. needle 908 and the meeting face of the needle cap 910 on the needle cap coupling member 1114. The protrusion contact part member 1112 covers the second sensor of the contact member 1132. The protrusion contact part member 1132. protrusion 1112 does not cover the first sensing contact member 1130.

[00212] Fig. 6c schematically illustrates the autoinjector 4 with an assembly of the received cartridge 600. Compared to Fig. 6b, the needle cap 908 has been removed. The contact member 1102 is in the extended contact member position. The contact member 1102 is allowed to be moved to the extended position of the contact member since the needle cap abutment face 910 does not touch the needle cap coupling member 1114. The protrusion contact member 1112 moved with the contact member 1102. The protrusion contact part member 1112 does not cover the second sensor contact member 1132. The protrusion contact part member 1112 does not cover the first sensor contact member 1130.

[00213] Fig. 6d schematically illustrates the autoinjector 4 with an assembly of the received cartridge 600. Contact member 1102 is in the first contact member position. The first position of the contact member may be the retracted contact member position, or close to the contact member position. The contact member 1102 may have been moved to the first position of the contact member by the contact member 1102 being pressed against an injection site, thereby inserting the needle 902 into the injection site. The protrusion contact part member 1112 has moved with the contact member 1102. The protrusion contact part member 1112 covers the first sensor of the contact member 1130. The protrusion contact part member 1112 covers the second sensor from contact member 1132.

[00214] Fig. 7 shows a block diagram of an exemplary autoinjector 4. The autoinjector 4 comprises a plurality of sensors 22, 24, 26, 28, 30, 32, a processing unit 20, a drive module 500, and a user interface 1100. Sensors 22, 24, 26, 28, 30, 32 are connected to the processing unit 20. The user interface 1100 is connected to the processing unit 20. The processing unit is connected to the module drive 500.

[00215] 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 The processing unit 20 is configured to provide user outputs by through user interface 1100.

[00216] The autoinjector 4 comprises an orientation sensor 22. The orientation sensor 22 is configured to provide an orientation signal indicative of the orientation of a cartridge received in the autoinjector 4. For example, the orientation sensor 22 may be configured to detect the 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 the direction of gravity. For example, the orientation sensor 22 may comprise an accelerometer.

[00217] The orientation sensor 22 may be a single- or multi-axis gyroscopic sensor, which is sensitive to dynamic angular velocity, such as the angular velocity of the autoinjector during an inversion and the angle at which the autoinjector rotates during an inversion.

[00218] The processing unit 20 is connected to the orientation sensor 22. The processing unit 20 can be configured to receive the orientation signal. The processing unit 20 may determine the orientation of the cartridge based on the orientation signal. The processing unit 20 can control the drive module 500 based on the guidance signal. For example, the processing unit 20 may be configured to control the drive module 500 to move the plunger rod based on the guidance signal. For example, the processing unit 20 may be configured to control the drive module 500 to move the plunger rod toward the extended position of the plunger rod, such as to a premix position of the plunger rod and/or a plunger rod mixing position and/or the plunger rod priming position, only if the cartridge outlet is pointing up. Alternatively or additionally, the processing unit 20 may provide user output via the user interface 1100 based on the guidance signal.

[00219] The processing unit 20 can be configured to receive an orientation signal from the orientation sensor 22 indicative of the angular velocity and/or the angle traversed by the autoinjector during an inversion. The processing unit 20 may also be configured to provide the start signal after several complete inversions of the autoinjector have been performed, wherein the number of complete inversions is based on the orientation signal from the orientation sensor 22 indicative of the angular velocity. and/or the angle transposed by autoinjector 4 in a complete inversion.

[00220] The autoinjector 4 comprises a code sensor 24. The code sensor 24 is configured to read a cartridge trace code, and provide a code signal indicative of a cartridge trace code. For example, the code sensor can be configured to read/detect a color code.

[00221] The processing unit 20 is connected to the code sensor 24. The processing unit 20 is configured to receive the code signal. The processing unit 20 may determine the cartridge trace code 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 may be configured to control the drive module 500 to move the plunger rod in the direction of the extended position of the plunger rod, such as toward the premix position of the plunger rod and/or the plunger rod mixing position and/or the plunger rod priming position and/or the plunger rod injection position, based on the code signal. The processing unit 20 may be configured to determine a threshold, such as a plunger rod threshold, and/or a resistance threshold, based on the code signal. Alternatively or additionally, the processing unit 20 may provide user input through the user interface 1100 based on the code signal.

[00222] The autoinjector 4 comprises an ejection sensor 26, such as a plunger rod position sensor. The ejection sensor 26 is configured to detect the position of the plunger rod of the autoinjector 4, and provide an ejection sensor signal indicative of the position of the plunger rod. The ejection sensor 26 may comprise a tachometer connected to the drive module 500.

[00223] The processing unit 20 is connected to the ejection sensor 26. The processing unit 20 is configured to receive the ejection sensor signal. The processing unit 20 may determine the position of the plunger rod based on the ejection sensor signal. The processing unit 20 may control the drive module 500 based on the ejection sensor signal. For example, the processing unit 20 may be configured to control the drive module 500 to start, stop, or continue movement of the plunger rod based on the signal from the ejection sensor. For example, the processing unit 20 may be configured to determine a present position of the plunger rod based on the ejection sensor signal. The plunger rod being in the plunger rod premix position and/or the plunger rod mixing position and/or the plunger rod priming position and/or the plunger rod injection position may be determined based on the ejection sensor signal. Alternatively or additionally, the processing unit 20 may provide user output via the user interface 1100 based on the ejection sensor signal.

[00224] The autoinjector 4 comprises a cartridge sensor 28. The cartridge sensor 28 is configured to detect the reception of a cartridge assembly in the autoinjector 4. The cartridge sensor 28 provides a signal from the cartridge sensor indicative of the reception of a cartridge assembly.

[00225] The processing unit 20 is connected to the cartridge sensor 28. The processing unit 20 is configured to receive the signal from the cartridge sensor. The processing unit 20 may control the drive module 500 based on the cartridge sensor signal. For example, the processing unit 20 may be configured to control the drive module 500 to initiate movement of the plunger rod if a cartridge assembly is received, and/or only if a cartridge assembly is received. Alternatively or additionally, the processing unit 20 may provide user output via the user interface 1100 based on the cartridge sensor signal.

[00226] Code sensor 24 and cartridge sensor 28 may be the same sensor, for example, code sensor 24 may be configured to detect receipt of a cartridge assembly and subsequently read the cartridge trace code.

[00227] The autoinjector 4 comprises a needle sensor 30. The needle sensor 30 is configured to detect a needle, and/or a needle assembly, and/or a needle cap of a needle assembly, of the cartridge assembly. , when the cartridge assembly is received in the autoinjector 4. The needle sensor 30 provides a needle signal indicative of the presence of a needle, and/or a needle assembly, and/or a needle cap of a needle assembly, cartridge assembly.

[00228] The processing unit 20 is connected to the needle sensor 30. The processing unit 20 is configured to receive the needle signal. The processing unit 20 can control the drive module 500 based on the needle signal. For example, the processing unit 20 may be configured to control the drive module 500 to initiate movement of the plunger rod, e.g., in the direction of the extended position of the plunger rod, such as toward the premix position of the piston rod. plunger rod and/or the plunger rod mixing position and/or the plunger rod priming position and/or the plunger rod injection position, only if a needle is present, and/or only if a Needle cover is not present as removed. Detection of a needle cap may be indicative of a needle being present. The processing unit 20 may be configured to control the drive module 500 to initiate only if a needle cap has been detected, and subsequently is not detected, for example, it has been removed. Alternatively or additionally, the processing unit 20 may provide user output via the user interface 1100 based on the needle signal.

[00229] The needle sensor 30 may be part of the contact sensor member, as exemplified in Fig. 6.

[00230] The autoinjector 4 comprises a resistance sensor 32. The resistance sensor 32 is configured to detect resistance against movement of the plunger rod of the autoinjector 4. The resistance sensor 32 may be configured to detect resistance against movement of the plunger rod based on measurements from the drive module 500. For example, the resistance sensor 32 can be configured to detect electrical current from a motor of the drive module 500. The resistance sensor 32 is configured to provide a signal resistance indicator indicating the resistance against movement of the piston rod.

[00231] The processing unit 20 is connected to the resistance sensor 32. The processing unit 20 is configured to receive the resistance signal. The processing unit 20 may be configured to determine the resistance against movement of the plunger rod based on the resistance signal. The processing unit 20 may control the drive module 500 based on the resistor signal. For example, the processing unit 20 may 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 may be configured to control the drive module 500 to start, stop, or continue movement of the plunger rod based on the resistance signal. Alternatively or additionally, the processing unit 20 may provide user output via the user interface 1100 based on the resistor signal.

[00232] The autoinjector 4 is illustrated comprising all of the elements mentioned above. However, alternatively, the autoinjector may comprise only one or any combination of one or more of the elements mentioned above.

[00233] The autoinjector comprises a user interface 1100. The user interface 1100 may comprise one or more input members, for example a first input member, for receiving a user input. The user interface is configured to provide a signal indicative of user input from received user input. The user interface 1100 may provide a first input signal and/or a second input signal.

[00234] The processing unit 20 is connected to the user interface 1100. The processing unit 20 is configured to receive the user input signal, such as the first input signal and/or the second input signal. The processing unit 20 may control the drive module 500 based on the user input signal. For example, the processing unit 20 may be configured to control the drive module 500 to move the plunger rod in the direction of the extended position of the plunger rod, such as toward the premix position of the plunger rod and/or the mixing position of the plunger rod and/or the priming position of the plunger rod and/or the injection plunger rod, based on the user input signal and/or after the user input signal.

[00235] The autoinjector comprises a housing 6 accommodating sensors 22, 24, 26, 28, 30, 32, processing unit 20, user interface 1100, and drive module 500.

[00236] Figs. 8a to f schematically illustrate exemplary cartridge assemblies 600 and a plunger rod 400. The cartridge assembly 600 comprises a cartridge 700, such as the cartridge described with respect to Fig. 3, a cartridge holder 800, and a needle assembly. 900. For intelligibility, the autoinjector comprising the plunger rod 400 is not shown.

[00237] The cartridge holder 800 comprises a cartridge retention member 808. The cartridge retention member 808 is configured for coupling with an autoinjector cartridge receiver. The cartridge holder 800 comprises a needle mount connection portion 812. The needle mount connection portion 812 is configured to couple with a cartridge holder connection portion 906 of the needle assembly 900. needle assembly 812 allows coupling of a needle to cartridge 700.

[00238] The needle assembly 900 comprises a needle 902 and a needle hub 904. The needle assembly 900 is connected to the cartridge 700, for example through the needle hub 904 having a connecting portion to the cartridge holder 906, e.g. example, an in-line connection portion, being in coupling with a needle mounting connection portion 812 of the cartridge holder 800. The needle 902 extends through the cartridge outlet 714 of the cartridge 700.

[00239] Fig. 8a schematically illustrates a situation in which the plunger rod 400 is in a retracted position from the exemplary plunger rod. Cartridge 700 may be a new cartridge. The first stopper 708 is positioned in a starting position. The second stopper 710 is in an initial position, for example, behind the bypass section 712, wherein the bypass section 712 does not form a fluid connection between the first sub-compartment 704 and the second sub-compartment 706.

[00240] Fig. 8b schematically illustrates a situation in which the plunger rod 400 is in an exemplary position of premixing the plunger rod. Compared to Fig. 8a, the plunger rod 400 is moved in the direction of an extended plunger rod position. A front end of the plunger rod 410 of the plunger rod 400 touches the first stopper 708. In this way, the plunger rod 400 began to move the first stopper 708 in the first stopper direction 722, moving in the first stopper rod direction 722. plunger 422. The second stopper 710 is in a position, for example behind the bypass section 712, where the bypass section 712 does not form a fluid connection between the first sub-compartment 704 and the second sub-compartment 706.

[00241] Fig. 8c schematically illustrates a situation in which the plunger rod 400 is in an exemplary position in which a fluid connection is established between the first sub-compartment 704 and the second sub-compartment 706 via the bypass section 712. The termination The front of the plunger rod 410 of the plunger rod 400 touches the first stopper 708. The plunger rod 400 has moved the first stopper 708 in the first stopper direction 722, moving in the first direction of the plunger rod 422. The second stopper 710 is in the bypass section 712, wherein the bypass section 712 forms a fluid connection between the first subcompartment 704 and the second subcompartment 706. In this way, further movement of the first stopper 708 in the first stopper direction 722, for example, through movement of the plunger rod 400 in the first direction of the plunger rod 422, will transmit the contents of the first subcompartment 704, e.g., a first medicament component (not shown) into the second subcompartment 706, e.g., through the bypass section 712.

[00242] Fig. 8d schematically illustrates a situation in which the plunger rod 400 is in an exemplary mixing position of the plunger rod. The end termination of the plunger rod 410 touches the first stopper 708. The first stopper 708 touches the second stopper 710. The first subcompartment 704 is compressed. The second stopper 710 is in a position after the bypass section 712. In this way, the fluid connection between the first subcompartment 704 and the second subcompartment 706 has been closed.

[00243] Fig. 8e schematically illustrates a situation in which the plunger rod 400 is in an exemplary plunger rod preparation position. Compared to Fig. 8d, the plunger rod 400 is moved in the direction of the extended position of the plunger rod, for example, to expel air from the cartridge compartment 702.

[00244] Fig. 8f schematically illustrates a situation in which the plunger rod 400 is in an exemplary plunger rod injection position. For example, after completing the injection, the plunger rod 400 may be in the plunger rod injection position. The first stopper 708 and the second stopper 710 are in a position proximate to the outlet of the cartridge 714. The contents of the cartridge component, for example, the medicine, have been expelled, for example, through the outlet of the cartridge 714 and/or the needle 902. A residual volume of medication may remain in the cartridge.

[00245] Fig. 9 shows an exemplary trace T of the resistance Re against the movement of the plunger rod dependent on the position P of the plunger rod. The plunger rod is moved from a retracted position of the PR plunger rod to an extended position of the PE plunger rod. At the beginning of the movement, the resistance against the movement of the piston rod is constant Ex1, for example, the piston rod does not yet push a cork. Then, a front end of the plunger rod touches a first stopper of the cartridge, and the resistance against movement of the plunger rod increases Ex2. The increased resistance is caused by resistance against movement of the first cork, for example due to frictional force. Resistance may decrease slightly after the first cork starts to move, as illustrated. When the plunger rod approaches the extended position of the PE plunger rod, the resistance may increase again Ex3, for example, due to the first stopper approaching the cartridge termination.

[00246] Trace T is an example of the resistance against movement of the plunger rod when the cartridge received is a new and/or unused and/or normal cartridge. Determining a normal cartridge parameter can be based on the resistance and/or position of the plunger rod. Determining the cartridge parameter can be based on one or more thresholds, such as resistance thresholds, such as a low resistance threshold Re1 and/or a high resistance threshold Re2, and/or plunger rod thresholds, such as a first threshold of piston rod P1 and/or a second threshold of piston rod P2.

[00247] Other situations, such as situations in which the received cartridge is apparently used and/or defective, are exemplified by the additional exemplary traces, T2, T3, T4.

[00248] Trace T2 illustrates an exemplary situation in which resistance against movement increases above the low resistance threshold Re1 before the position of the plunger rod has reached the first plunger rod threshold P1. Such a situation could, for example, indicate a defective cartridge, or that something is blocking the plunger rod from moving. After such a situation, the plunger rod can be retracted to the plunger rod retracted position and an error message can be provided through a user interface.

[00249] Trace T3 illustrates an exemplary situation in which the resistance against movement was not increased above the low threshold resistance Re1 before the position of the plunger rod had reached the second threshold of the plunger rod P2. Such a situation may, for example, indicate a cartridge in which the first stopper is in a forward position, for example a used cartridge. After such a situation, the plunger rod can be retracted to the plunger rod retracted position and an error message can be provided through a user interface.

[00250] Trace T4 illustrates an exemplary situation in which the resistance against movement increases above the high resistance threshold Re2, for example, after the position of the piston rod has passed the first threshold of the piston rod P1. Such a situation may, for example, indicate that the first stopper is blocked from moving, for example, the cartridge may be defective. After such a situation, the plunger rod can be retracted to the plunger rod retracted position and an error message can be provided through a user interface.

[00251] 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 can be individually determined for the received cartridge . For example, the autoinjector processing unit may be configured to determine one or more of the thresholds, based on a cartridge trace code of the cartridge and/or the assembly of the received cartridge.

[00252] Fig. 10 shows a flowchart of an exemplary method 6000 for operating an autoinjector. The method 6000 comprises: moving the plunger rod 6004 from a first plunger rod position to a plunger rod mixing position with a plunger rod mixing speed; moving plunger rod 6006 from the mixing position of the plunger rod to a second position of the plunger rod after the start signal has been given. Method 6000 may further comprise receiving a trigger event6008; and moving the plunger rod 6010 to a plunger rod injection position.

[00253] The autoinjector may comprise a cartridge receiver configured to receive a cartridge comprising a first stopper and a cartridge compartment containing the medicament. The cartridge compartment may have a first cartridge subcompartment containing a first medicament component of the medicament and a second cartridge subcompartment containing a second medicament component of the medicament. The autoinjector may further comprise a plunger rod configured to move the first stopper.

[00254] The mixing position of the plunger rod can be selected to position the first stopper in a position where the first drug component is mixed with the second drug component.

[00255] The second position of the plunger rod may be a preparation position of the plunger rod. The priming position of the plunger rod can be selected to position the first stopper in a position where the air in the cartridge compartment is reduced to an amount appropriate for injection.

[00256] Moving the plunger rod 6004 to the mixing position of the plunger rod may follow detection of the cartridge being received at the cartridge receiver and/or the reception of a first input signal. For example, moving the plunger rod 6004 to the plunger rod mixing position can be performed only after a cartridge is detected and the first input signal is received.

[00257] Alternatively or additionally, moving the plunger rod 6004 to the mixing position of the plunger rod may be preceded by determining the orientation of the cartridge (as described in more detail in relation to Fig. 12). For example, moving the plunger rod 6004 to the mixing position of the plunger rod may require the cartridge outlet to be pointing upward, for example, determined by determining the orientation of the cartridge. Movement of the 6004 plunger rod to the plunger rod mixing position may be temporarily paused if the cartridge orientation is not within a predefined range of orientations.

[00258] Moving the plunger rod 6006 to the second plunger rod position may require the cartridge outlet to be pointing upward, for example, determined by determining the orientation of the cartridge. Moving the 6006 plunger rod to the second plunger rod position may be temporarily paused if the cartridge orientation is not within a pre-defined range of orientations.

[00259] Moving the plunger rod 6006 from the mixing position of the plunger rod to the second position of the plunger rod may require that the start signal has been given. The start signal may be given after several complete inversions of the autoinjector have been performed and when the second subcompartment of the cartridge is pointing upward compared to the first subcompartment of the cartridge.

[00260] Receiving the trigger event 6008 may comprise receiving a user input signal from a user interface, e.g., receiving the trigger event from a trigger member, e.g., originating from the user pressing a button. The triggering event may originate from a user indicating the start of the injection. The triggering event may originate from a user pressing a front portion of the autoinjector against an intended injection site. The triggering event may comprise a signal from the contact member being indicative of a contact member of the autoinjector being in a first position of the contact member.

[00261] Moving the plunger rod 6010 to the injection position of the plunger rod may result in the ejection of the medicine through the exit of the cartridge, such as through a needle. Moving the plunger rod 6010 may follow reception of the triggering event 6008, for example, after completion of movement 6006 of the plunger rod to the second position of the plunger rod.

[00262] Fig. 11 shows a flow diagram of an exemplary method 6000''. Method 6000 '' comprises the same steps as method 6000 as explained in relation to the previous figure. However, method 6000'' is an example of a method comprising additional steps of receiving 6014 a first input signal; detecting 6016 receipt of the cartridge, for example in the autoinjector cartridge receiver; determine 6018 the orientation of the cartridge; and read 6020 a trace of cartridge code; detect 6022 needle cap removal; moving 6024 the plunger rod to the first position of the plunger rod, such as a premix position of the plunger rod; detect 6026 resistance against movement of the piston rod; and determine 6019 the start signal.

[00263] Receiving 6014 of the first input signal may comprise receiving a user input signal from a user interface, for example originating from a user pressing a button. The first input signal may originate from a user turning on the autoinjector.

[00264] Detection 6016 of receiving the cartridge may comprise detecting a user inserting the cartridge into the cartridge receiver through a cartridge receiver opening. Detecting cartridge reception 6016 may comprise detecting the presence of a cartridge in the cartridge receiver.

[00265] Receiving 6014 of the first input signal and detecting 6016 of receiving the cartridge can be interchanged.

[00266] Determining 6018 the orientation of the cartridge may comprise determining the orientation by an orientation sensor, such as an accelerometer. Determining 6018 the orientation of the cartridge may comprise determining the orientation of the autoinjector. Determining 6018 the orientation of the cartridge may comprise determining whether an outlet of the cartridge is pointed upward.

[00267] Method 6000 '' comprises reading 6020 a cartridge code trace. The cartridge code dash may be indicative of one or more cartridge specifications. Subsequent steps of method 6000'' may comprise adaptations based on cartridge specifications. For example, subsequent steps of method 6000'' may be adapted to the specific cartridge received and identified.

[00268] Detection 6022 of removal of the needle cap may be a prerequisite for initiating movement of the plunger rod. For example, removal of the needle cap may be indicative of intended use of the received cartridge.

[00269] Movement 6024 of the plunger rod to the first position of the plunger rod may comprise initial movement of a first stopper of the cartridge, for example movement of the first stopper without beginning mixing of a two-component medicament.

[00270] Movement 6024 of the plunger rod to the first position of the plunger rod may follow the detection 6016 of the cartridge that is received in the cartridge receiver and the reception 6014 of the first input signal. For example, movement 6024 of the plunger rod to the first position of the plunger rod may be performed only after a cartridge is detected 6016 and the first input signal is received 6014.

[00271] Movement 6024 of the plunger rod to the first position of the plunger rod may be performed concurrently with the steps of reading 6020 of the cartridge code trace.

[00272] Detection 6026 of resistance against movement of the plunger rod can be performed simultaneously with movement 6024 of the plunger rod to the first position of the plunger rod, as illustrated. Detection 6026 of resistance against movement of the plunger rod may be indicative of received cartridge cartridge parameters, such as whether the cartridge is new or used or defective.

[00273] Movement 6004 of the plunger rod to the mixing position of the plunger rod may follow the reading 6020 of the cartridge code trace, the detection 6022 of removal of the needle cap, the movement 6024 of the plunger rod to the premix position of the plunger rod, detecting 6026 the resistance against movement of the plunger rod, and determining 6018 the orientation of the cartridge.

[00274] Movement 6004 of the plunger rod to the mixing position of the plunger rod may be based on one or more cartridge code traces, removal of the needle cap, resistance against movement of the plunger rod and/or cartridge orientation.

[00275] Movement 6006 of the plunger rod to the second plunger rod position may require that a reconstitution time has elapsed since the completion of the movement of the plunger rod to the mixing position of the plunger rod. Method 6000’’ comprises a step of determining 6019 the reconstitution time. Determination 6019 of reconstitution time may be based on one or more of cartridge code trace, removal of the needle cover, resistance against movement of the plunger rod and/or orientation of the cartridge. Determining 6019 the reconstitution time may comprise determining a first motion parameter, such as a quantity of autoinjector movement, such as agitation of the autoinjector and/or various inversions 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. Determining 6019 the reconstitution time may comprise receiving a guidance signal.

[00276] Determination 6019 of the reconstitution time can be determined based on a combination of the first motion parameter and/or the cartridge code trace.

[00277] Movement 6006 of the plunger rod to the second position of the plunger rod may be based on one or more cartridge code traces, removal of the needle cap, resistance against movement of the plunger rod, and/or orientation of the cartridge.

[00278] Movement 6010 of the plunger rod to the injection position of the plunger rod may be based on one or more cartridge code traces, removal of the needle cover and/or resistance against movement of the plunger rod.

[00279] Method 6000 and/or method 6000'' may include a first step of receiving the cartridge.

[00280] Figs. 12a-d schematically illustrate an exemplary user interface 1100 of an exemplary autoinjector 4, such as an autoinjector 4 as illustrated in Fig. 1.

[00281] The user interface 1100 comprises a first output member 1110 as illustrated, for example a plurality of LEDs. The first exit member 1110 may provide a user exit for a user. The first output member 1110 may be used to indicate a step in the procedure to the user and/or indicate an error message. The first output member 1110 comprises a first LED 1116, a second LED 1118, and a third LED 1120.

[00282] User interface 1100 may comprise a second output member (not shown), for example a speaker.

[00283] The user interface 1100 comprises a contact member 1102, for example at a front end of the autoinjector 4. The contact member 1102 may be configured to press against an injection site. The contact member 1102 may serve as a third output member of the user interface 1100, for example the contact member 1102 may be configured to light up, such as blinking.

[00284] User interface 1100 comprises a first input member 1108, for example a button. The first input member 1108 may provide a user input of a user. For example, the first input member 1108 may be used to receive a press from a user to proceed to a 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 illuminate, such as blinking.

[00285] Fig. 12a schematically illustrates a user interface 1100 situation in which none of the output members are active, for example the autoinjector 4 may be turned off.

[00286] Fig. 12b schematically illustrates a user interface situation 1100 in which the first input member 1108 and the contact member 1102 light up, such as blinking. The first input member 1108 and the contact member 1102 may flash synchronously and/or asynchronously. The situation shown may be a situation indicating that the user must press the first input member 1108 and/or insert a cartridge through the contact member 1102. The situation shown may be a situation following which the autoinjector is turned on.

[00287] Fig. 12c schematically illustrates a user interface situation 1100 in which the first input member 1108 and the second LED 1118 light up, such as blinking. The situation shown may be a situation indicating that the user must press the first input member 1108 to proceed to a next step. The situation shown may be a situation following mixing of medication components and/or prior to performing an air blast.

[00288] Fig. 12d schematically illustrates a user interface situation 1100 in which the first input member 1108 and the contact member 1102 and the third LED 1120 light up, 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 an intended injection site to inject the medicine. The situation shown may be a situation before injecting the medicine.

[00289] Figs. 13a-c schematically illustrate an exemplary movement of an exemplary autoinjector 4, such as a movement of the first movement parameter.

[00290] Fig. 13a shows the autoinjector 4 in a first position, in which a first end 4a of the autoinjector 4 points substantially upwards. A second end 4b of the autoinjector 4 points substantially downwards.

[00291] Fig. 13b shows the autoinjector 4 having been moved to a second position, in which the first end 4a of the autoinjector 4 points substantially downwards. The second end 4b of the autoinjector 4 points substantially upwards.

[00292] Fig. 13c shows the autoinjector 4 having been moved to a third position, such as back to the first position, wherein the first end 4a of the autoinjector 4 points substantially upward. The second end 4b of the autoinjector 4 points substantially downwards.

[00293] The first movement parameter may be indicative of the number of inversions of the autoinjector 4, such as the number of times the autoinjector 4 has been moved from the first position to the second position and optionally to the third position, such as back to the first position. The processing unit (not shown in Fig. 13) may be configured to detect and/or count the number of inversions.

[00294] Although, in the example shown, the first end 4a of the autoinjector 4 in the first and third positions point directly upward, it may be sufficient for the first end 4a of the autoinjector 4 to point within, for example, 45 degrees upward.

[00295] Similarly, although in the example shown, the first end 4a of the autoinjector 4 in the second position points directly downwards, it may be sufficient for the first end 4a of the autoinjector 4 to point within, for example, 45 degrees downwards.

[00296] The reconstitution time may be dependent on the complete inversions as described in relation to Fig 13. For example, the reconstitution may require a certain number of inversions being performed, such as 5, with a frequency within a default range/ predefined frequency range, such as between 0.3 and 1.2 Hz. For example the reconstitution time may be the time used to perform the number of complete inversions. The required number of complete inversions and/or frequency range may be determined based on the cartridge code trace, for example the cartridge code trace may be indicative of the number of inversions and/or frequency range for the inversions.

[00297] Although particular features have been shown and described, it will be understood that they are not intended to limit the claimed invention, and it will be obvious to those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the claimed invention . The specification and drawings are consequently to be considered in an illustrative rather than a restrictive sense. The claimed invention is intended to encompass all alternatives, modifications and equivalents.

Claims (25)

1. Auto-injector (4) for administering a medicine, the auto-injector comprising: a housing (6); a cartridge receiver (300) configured to receive a cartridge assembly; the cartridge assembly comprising a cartridge (700) and a cartridge code trace (1000), the cartridge (700) comprising: - a first stopper (708); - a cartridge compartment (702) containing the medicament, the cartridge compartment (702) having a first cartridge subcompartment (704) containing a first medicament component (792) of the medicament and a second cartridge subcompartment (706) containing a second medicament component (794) of the medicament; - a second stopper (710); and - a bypass section (712) providing fluid communication between the first cartridge subcompartment (704) and the second cartridge subcompartment (706); an orientation sensor (22) configured to detect an orientation of the cartridge (700) and/or an orientation of the autoinjector (4); and a drive module (500) coupled to move a plunger rod (400) between a retracted position of the plunger rod and an extended position of the plunger rod, the plunger rod (400) being configured to move the first stopper ( 708); wherein the autoinjector further comprises a processing unit (20) coupled to the drive module (500), wherein the processing unit (20) is configured to: - control the drive module (500) to move the plunger rod (400) from a first plunger rod position to a plunger rod mixing position with a plunger rod mixing speed, wherein the plunger rod mixing position is selected to position the first stopper (708) in a position where the first medicament component (792) is mixed with the second medicament component (794); - providing a start signal after several complete inversions of the autoinjector (4) have been carried out, characterized by the fact that the cartridge assembly comprises the cartridge (700) and the cartridge code trace (1000), and the autoinjector ( 4) comprises a code sensor (24) configured to read the cartridge code trace (1000), and wherein the processing unit (20) is coupled to the code sensor (24) and further configured to receive from the code sensor (24) a code signal indicative of the cartridge code trace, wherein the cartridge code trace (1000) defines the number of complete inversions required for the medicament in the cartridge (700). 2. Autoinjector (4) according to claim 1, characterized in that the processing unit (20) is configured to operate independently of the temperature of the medicine in the cartridge (700) received in the cartridge receiver (300). 3. Autoinjector (4) according to any one of the preceding claims, characterized by the fact that the start signal is generated after the number of complete inversions of the autoinjector (4) has been performed and when the second subcompartment of the cartridge (706 ) is pointing up compared to the first cartridge sub-chamber (704). 4. Autoinjector according to any one of the preceding claims, characterized in that the detection of inversions of the autoinjector (4) is implemented using the orientation sensor (22). 5. Autoinjector (4) according to any one of the preceding claims, characterized in that the orientation sensor (22) comprises one or more accelerometers, such as an accelerometer or a plurality of accelerometers. 6. Autoinjector (4) according to any one of the preceding claims, characterized in that the orientation sensor (22) comprises a tilt sensor, a triaxial accelerometer, a single-axis accelerometer, a magnetometer and/or any combination of the same. 7. Autoinjector (4) according to any one of the preceding claims, characterized in that the orientation sensor (22) comprises a triaxial accelerometer. 8. Autoinjector (4) according to any one of the preceding claims, characterized in that the orientation sensor (22) comprises a single or multiple axis gyroscopic sensor. 9. Autoinjector (4) according to claim 8, characterized by the fact that the multi-axis gyroscopic sensor is a triaxial gyroscopic sensor. 10. Autoinjector (4) according to any one of the preceding claims, characterized in that the processing unit (20) is further configured to control the drive module (500) to move the plunger rod (400) from the position mixing position of the plunger rod to a second position of the plunger rod upon reception of the start signal. 11. Autoinjector (4) according to any one of the preceding claims, characterized in that the processing unit (20) is further configured to determine a first motion parameter based on the cumulative movement of the autoinjector (4). 12. Autoinjector (4) according to claim 11, characterized by the fact that the first movement parameter is indicative of the number of complete inversions of the autoinjector (4). 13. Autoinjector (4) according to claim 11 or 12, characterized in that the first movement parameter is indicative of a movement frequency of the autoinjector (4). 14. Autoinjector (4) according to any of the previous claims, characterized by the fact that an inversion is judged to be a complete inversion by the autoinjector (4) if it is carried out with an angular velocity above a standard threshold. 15. Autoinjector (4) according to claim 14, characterized in that the standard threshold for angular velocity is defined as an inversion frequency of at least 0.3 inversion per second, such as at least 0.5 inversion per second. 16. Autoinjector (4) according to claim 14 or 15, characterized in that the orientation sensor (22) is configured to provide an angular velocity signal indicative of the angular velocity of the cartridge (700) when the cartridge (700 ) is received at the cartridge receiver (300). 17. Autoinjector (4) according to any one of the preceding claims, characterized in that the inversion is an inversion around an axis in a horizontal plane. 18. Autoinjector (4) according to any of the previous claims, characterized by the fact that an inversion is judged to be a complete inversion by the autoinjector (4) if it transposes an angle above a standard threshold. 19. Autoinjector (4) according to claim 18, characterized in that the standard threshold for the 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, for example, 180 degrees. 20. Autoinjector (4) according to claim 18 or 19, characterized in that a rotational movement of the autoinjector (4) from a starting angular position to a final angular position is judged to be a complete inversion by the autoinjector (4) if : - the starting angular position is between a first vertical orientation with a distal end of the autoinjector (4) pointing upwards and a first horizontal position with the distal end of the autoinjector (4) pointing sideways along a horizontal axis; - the final angular position is between a second horizontal position with the distal end of the autoinjector (4) pointing to the side along a horizontal axis in a direction opposite to that in the first horizontal position and second vertical orientation with the distal end of the autoinjector ( 4) pointing downwards, and - the standard threshold for 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, even more preferably at least 165 degrees, such as, for example, 180 degrees. 21. Autoinjector (4) according to claim 18 or 19, characterized in that a rotational movement of the autoinjector (4) from a starting angular position to a final angular position is judged to be a complete inversion by the autoinjector (4) if : - the starting angular position is between a first vertical orientation with a distal end of the autoinjector (4) pointing downwards and a first horizontal position with the distal end of the autoinjector (4) pointing sideways along a horizontal axis; - the final angular position is between a second horizontal position with the distal end of the autoinjector (4) pointing to the side along a horizontal axis in a direction opposite to that in the first horizontal position and second vertical orientation with the distal end of the autoinjector ( 4) pointing upwards, and - the standard threshold for 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, even more preferably at least 165 degrees, such as, for example, 180 degrees. 22. Autoinjector (4) according to any one of the preceding claims, characterized by the fact that the processing unit (20) is further configured to provide visual feedback and/or acoustic feedback to the user when the number of complete inversions has been carried out, and/or for each complete inversion. 23. Autoinjector (4) according to any one of the preceding claims, characterized by the fact that the processing unit (20) is additionally configured to perform an air jet after the number of inversions has been performed, wherein the jet air pressure is only performed when the second cartridge sub-compartment (706) is pointing upwards compared to the first cartridge sub-compartment (704). 24. Autoinjector (4) according to any one of the preceding claims, characterized by the fact that the angular velocity threshold and/or the angle threshold are defined by the autoinjector (4) or by the cartridge code trace (1000). 25. Autoinjector (4) according to any one of the preceding claims, characterized in that the number of complete inversions depends on the measured inversion angles and the angular speed at which the inversions are performed manually by a user.