Automatic injection device with reconstitution processing support

Abstract

The present invention provides an automatic infusion device, cartridges, a system, and a method for improving the preparation and administration of drugs using an automatic infusion device. [Solution] An automatic injector 4 for administering a drug, comprising a housing 6, a cartridge housing 300 having first and second cartridge compartments configured to receive a cartridge and containing first and second drug components, and a drive module and processing unit configured to move a plunger rod between a retracted position and an extended position, the processing unit comprising the steps of: controlling the drive module to move the plunger rod from a first position to a mixing position at a mixing speed, controlling the drive module to position a first stopper at a position where the first and second drug components are mixed, and providing a start signal after a certain number of complete reversals of the automatic injector 4 have been performed.

Description

Technical Field

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

Background Art

[0002] Subcutaneous syringes are widely used to deliver fluids to the body. It is known to make subcutaneous syringes applicable to manual operation. However, automatic injection devices such as electronic automatic injection devices have been developed and are widely used to assist in administering fluids or drugs to the body.

[0003] There is an increasing interest in automatic injection devices to perform as much as possible of the injection process automatically to avoid relying on the user to perform specific tasks accurately. In particular, it may be beneficial to automate the process of preparing and administering a fluid such as a drug, such as when the drug needs to be mixed before injection and the administration of the drug requires multiple steps. Furthermore, it may be advantageous to incorporate sensors into such devices to enable precise control in varying situations.

Summary of the Invention

Problems to be Solved by the Invention

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

Means for Solving the Problems

[0005] Thus, an automatic injection device for preparing and / or administering a medicament such as a drug from a cartridge is disclosed.

[0006] The automatic injection device comprises a housing, a cartridge storage section, a drive module, and a processing unit.

[0007] The cartridge housing is configured to receive a cartridge, such as a cartridge comprising a first stopper and a cartridge compartment containing a drug. The cartridge compartment has a first cartridge compartment containing a first drug component of the drug and a second cartridge compartment containing a second drug component of the drug.

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

[0009] 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 the first plunger rod position to the mixing plunger rod position and to provide a start signal after multiple complete inversions of the automatic injector have been performed.

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

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

[0012] The start signal may be given as an indication that the first drug component and the second drug component have been reconstituted, for example, completely mixed.

[0013] The term "complete inversion" means an inversion that satisfies predetermined requirements regarding the angular velocity at which the inversion is performed and / or the angle over which the inversion of the automatic injector is performed. The term "inversion" usually refers to an inversion of an automatic injector, performed automatically or manually by the user.

[0014] Reversal can be defined as a rotation of approximately 180 degrees of an automatic injector. One example of reversal is the rotation of the automatic injector from a position where the needle is pointing upwards to a position where the needle is pointing downwards, or vice versa. An alternative example of reversal is a 180-degree rotation of the automatic injector, starting from an initial position where the longitudinal axis of the automatic injector is in the horizontal plane and the needle is pointing to the left, and then rotating to a final position where the longitudinal axis of the automatic injector re-enters the horizontal plane and the needle is pointing to the right, with the needle pointing upwards.

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

[0016] The number of complete inversions required for the processing unit to issue a start signal may depend on the viscosity of the drug components being mixed. To achieve effective mixing of the drug components and activate the start signal, drug component variants with relatively high viscosity typically require more complete inversions, such as 10 or 20 or even more, while drug component variants with relatively low viscosity may require fewer complete inversions, such as 5 or 10. Thus, viscous drug components require more inversions than drug component formulations with lower viscosity.

[0017] A cartridge for an automatic injector, such as the automatic injector of the present disclosure, is also disclosed. The cartridge comprises a first stopper and a cartridge compartment containing a drug. The cartridge compartment has a first cartridge portion containing a first drug component of the drug and a second cartridge portion containing a second drug component of the drug. The cartridge may have a first cartridge end and a second cartridge end, and may have a cartridge outlet at the first cartridge end. The cartridge is configured to be received by a cartridge housing of an automatic injector, such as the cartridge housing of the automatic injector of the present disclosure, by inserting, for example, the second end of the cartridge through the cartridge housing opening of the automatic injector.

[0018] A system comprising an automatic injection device, such as the automatic injection device of this disclosure, and a cartridge, such as the cartridge of this disclosure, is also disclosed.

[0019] Also disclosed is a method for operating an automatic injector such as the automatic injector described herein, the automatic injector comprising a cartridge housing configured to receive a cartridge such as the cartridge described herein, the cartridge comprising, for example, a first stopper and a cartridge compartment containing a drug, the cartridge compartment comprising a first cartridge compartment containing a first drug component of the drug and a second cartridge compartment containing a second drug component of the drug. The automatic injector may further comprise a plunger rod configured to move the first stopper.

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

[0021] The first plunger rod position may be a premixed plunger rod position. The premixed plunger rod position can be selected to position the first stopper at a location where fluid communication between the first cartridge subcompartment and the second cartridge subcompartment has not yet been established. Alternatively, the first plunger rod position may be a plunger rod retracted position, such as the initial plunger rod position.

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

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

[0024] An advantage of the present disclosure is that the processing unit provides a start signal only after a plurality of complete inversions have been performed, whereby it is ensured that the drugs constituting the first drug component and the second drug component are mixed into a homogeneous solution before injection is performed.

[0025] A further advantage of the present disclosure is that the automatic injector can be operated without measuring the temperature of the drug because the target of the automatic injector is lowered by omitting the temperature sensing element.

[0026] Therefore, the processing unit can be configured to operate independently of the temperature of the drug in the cartridge received in the cartridge housing unit.

[0027] Actual experience has clearly established that with certain drugs, in supporting the safe preparation of the drug, physical agitation, i.e., inversion, of the automatic injection device is far more efficient, whereby a fully reconstituted homogeneous drug can be injected into the patient's skin in the shortest possible time. In an example, even when waiting for a long time and exposing the mixed drug components to an elevated temperature, the final homogeneity of the mixed / reconstituted drug cannot be improved beyond the homogeneity achievable at room temperature. On the contrary, in contrast to this, when applying even minimal physical agitation, i.e., fewer physical inversions, the homogeneity of the reconstituted drug is significantly improved. Physical agitation should be understood as inversion, in contrast to shaking motion. This is because shaking motion tends to introduce a large number of air bubbles into the mixture. In a liquid with low viscosity, the air bubbles will disappear again quite rapidly. However, in a liquid with high viscosity, it takes a long time for the air bubbles to disappear. Since the number of air bubbles needs to be reduced and / or completely removed to a certain level before an accurate dose of the drug can be injected, when the viscosity of the drug is high, introducing a large number of air bubbles into the drug solution during the mixing procedure is quite undesirable. Furthermore, during the process of performing a dry shot before injection, there is a risk that a larger portion of the drug will be discharged because the drug is carried in the air bubbles. Therefore, it is quite preferable to use inversion rather than a shaking operation for mixing the first drug and the second drug.

[0028] A further advantage of the present disclosure is that it can provide an automatic injection device that is easy to use and reduces the risk of accidentally administering a drug that does not have sufficient homogeneity.

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

[0030] It is envisioned that any example or element as described in relation to any one aspect can be modified where it should be modified and used in conjunction with any other aspect or example.

[0031] The start signal can be generated after the automatic injector has performed the above number of complete inversions and when the second cartridge subcompartment is pointing upward relative to the first cartridge subcompartment. The automatic injector may preferably have an upward-pointing orientation substantially along the vertical axis or within 45 degrees of the vertical axis. An upward-pointing orientation is advantageous for releasing air from the cartridge subcompartment without discharging the drug.

[0032] The processing unit may be configured to perform a dry run after the above number of complete inversions have been performed. A dry run may be performed, for example, only when the second cartridge sub-section is pointing upwards compared to the first cartridge sub-section.

[0033] After the required number of successful / complete inversions have been performed, the automatic injector will visually indicate this, for example, by sound and / or light, and can automatically proceed to perform a priming when the needle is pointing upwards, i.e., when the second cartridge subcompartment is pointing upwards relative to the first cartridge subcompartment. It is advantageous to perform the priming after a complete inversion, as any remaining air bubbles after recombination assist in mixing during inversion. Once the priming is performed, the drug is ready for injection.

[0034] A prerequisite for the physical agitation to function well is that the inversion takes place after the two drug components have been mixed, but before any bubbles have been expelled from the cartridge compartment. When bubbles are present, the mixed drug components are able to swirl / move / slide around within the cartridge compartment as a result of the physical input. Bubbles are typically bubbles having a volume at least comparable to the total volume of the mixed drug components. Preferably, in this invention, bubbles are not defined by their volume, but by the cross-sectional area they partially or completely cover when the cartridge is oriented vertically. Preferably, the bubbles are large enough to cover 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 compartment, or at least 75% of the cross-sectional area of ​​the second cartridge compartment, or at least 100% of the cross-sectional area of ​​the second cartridge compartment.

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

[0036] The cartridge may have a cartridge outlet at a first cartridge end. The cartridge may have a cartridge back surface at a second cartridge end, for example, facing the cartridge outlet. The cartridge back surface may have a cartridge rear end opening. The cartridge rear end opening may allow a plunger rod, such as a plunger rod of an automatic dispensing device, to access the first stopper.

[0037] The cartridge compartment may contain a drug. The cartridge outlet may be configured to communicate fluidly with the compartment, for example, at the first cartridge end. The cartridge may be configured to release the drug through the cartridge outlet. The cartridge outlet may be configured to be coupled with a needle, such as a subcutaneous injection needle, to allow the drug to be released through the needle.

[0038] The cartridge includes a first stopper that is movable within the cartridge compartment. The cartridge may also include a second stopper that is movable within the cartridge compartment. The second stopper may be located between the first stopper and the cartridge outlet. The cartridge may also include a third stopper that is movable within the cartridge compartment. The third stopper may be located between the second stopper and the cartridge outlet. The first stopper, the second stopper, and / or the third stopper can be made movable within the cartridge compartment toward the cartridge outlet in the direction of the first stopper, for example toward the first cartridge end. For example, when the first stopper, the second stopper, and / or the third stopper move, for example toward the first stopper and / or toward the cartridge outlet, the drug can be released through the cartridge outlet.

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

[0040] The first cartridge compartment may contain a first pharmaceutical component of the drug. The second cartridge compartment may contain a second pharmaceutical component of the drug. Each of the first pharmaceutical component and / or the second pharmaceutical component may be a powder composition, a fluid, a liquid, a gel, a gas, and / or any combination thereof.

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

[0042] The cartridge may have a bypass portion, which enables fluid communication between a first cartridge compartment and a second cartridge compartment when, for example, a second stopper is positioned within the bypass portion. The cartridge may have multiple bypass portions that enable fluid communication between adjacent cartridge compartments when, for example, stoppers separating adjacent cartridge compartments are positioned within the bypass portions.

[0043] The automatic dispensing device of this disclosure may be a reusable automatic dispensing device. A reusable automatic dispensing device may be particularly useful when the cartridge has multiple subcompartments. For example, an automatic dispensing device for a multi-compartment or multi-chamber cartridge may be more advanced, and therefore it may be beneficial to allow the automatic dispensing device to be used more than once. For example, the automatic dispensing device may provide an automated process for mixing drug components, such as mixing the drug components to be initially supplied to different subcompartments of the cartridge.

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

[0045] A cartridge assembly may include a needle, such as a needle assembly that includes a needle. A needle assembly may include a needle cover and / or needle hub. A cartridge assembly may include a cartridge holder. The cartridge holder may be configured to engage with the needle assembly. The cartridge holder may allow the needle assembly to be mounted to a cartridge.

[0046] A cartridge may include a cartridge coding mechanism, and / or a cartridge assembly may include a cartridge and a cartridge coding mechanism. The cartridge coding mechanism may include one or more of the following: colors, barcodes, RFID tags, NFC tags, identification numbers, and QR codes (registered trademarks). For example, the cartridge coding mechanism may include colors and / or arrays of colors. The cartridge coding mechanism may be positioned to surround or partially surround a portion of the cartridge compartment in which a stopper, such as a first stopper, is initially positioned. For example, such a position of the cartridge coding mechanism can make the cartridge coding mechanism more readable because the stopper can form a background for the cartridge coding mechanism. The stopper, such as a first stopper, may be light in color, such as light gray or white. The stopper, such as a first stopper, may be dark in color, such as dark blue, dark gray, or black. The stopper may form a dark background for the cartridge coding mechanism. The stopper, such as a first stopper, can reduce light reflection, for example, to make the cartridge coding mechanism even more readable.

[0047] The cartridge code mechanism may be positioned at a specific location on the cartridge, independently of a stopper, such as a first stopper. For example, the cartridge code mechanism may be positioned at a certain code distance from the second cartridge end. All cartridges may have their cartridge code mechanisms positioned at the same location, for example, at a code distance from the second cartridge end. Such uniform positioning of the cartridge code mechanisms reduces the complexity and size of the automatic filling device, as the cartridge code mechanism is read at the same location for all suitable cartridges.

[0048] The cartridge and cartridge coding mechanism may be manufactured as a single element. For example, the cartridge coding mechanism may be a specific form of the cartridge. Alternatively, the cartridge coding mechanism may be attached to the cartridge, for example, by being fixed to the cartridge with adhesive. For example, the cartridge coding mechanism may be a color code printed on the cartridge.

[0049] The cartridge code mechanism may indicate one or more cartridge specifications, such as the drug in the cartridge, the concentration of the drug in the cartridge, the viscosity of the drug in the cartridge, the volume and / or mass of the drug in the cartridge, or the position of the stopper within the cartridge compartment. The cartridge code mechanism may indicate the position of a first stopper where the air in the cartridge compartment is reduced, such as when it is reduced to an amount suitable for minimizing and / or injection. The cartridge code mechanism may indicate the amount of drug contained in the cartridge. The cartridge code mechanism may indicate a specific type of cartridge, such as an ID number for a particular type of cartridge.

[0050] An automatic injection device, such as the processing unit of an automatic injection device, can be configured to determine one or more cartridge specifications based on an ID number, for example, by a table lookup. The cartridge code mechanism may indicate an appropriate speed, such as the optimal speed, of stopper movement, such as stopper movement at different stages of motion, such as during mixing, drowning, and / or injection. The cartridge code mechanism may indicate an appropriate speed, such as the optimal speed, of first stopper movement, such as the speed of movement of the first stopper at different stages of motion, such as during mixing, drowning, and / or injection. The cartridge code mechanism may indicate the time required for optimal mixing of the first and second drug components. The cartridge code mechanism may indicate an appropriate residence time of the drug, such as the time to ensure the drug is distributed into the tissue, for example, a preferred time to wait before retracting the needle after injection. The cartridge code mechanism may indicate the amount of kinetic energy required for optimal mixing of the first and second drug components. The cartridge coding mechanism may indicate the number of complete inversions required for the drugs in the two compartments of the cartridge to be completely mixed. The movement from the first plunger rod position to the mixing plunger rod position may be based on a coding signal indicating the cartridge coding mechanism, defined by the number of complete inversions required for the drugs in the cartridge.

[0051] The cartridge coding mechanism may indicate a threshold angular velocity required for the reversal of the automatic injector to be considered a complete reversal. The cartridge coding mechanism may indicate a threshold reversal angle required for the reversal of the automatic injector to be considered a complete reversal.

[0052] The number of complete inversions may depend on the measured inversion angle and angular velocity, which are performed manually by the user.

[0053] The automatic injector may be a forward-filling automatic injector. The automatic injector includes a cartridge housing configured to receive cartridges. The cartridge housing may be configured to receive a cartridge assembly comprising a cartridge. The cartridge assembly may include a cartridge holder. The cartridge housing may have a cartridge housing opening. The cartridge housing may be configured to receive cartridges by inserting the cartridge through the cartridge housing opening, such as by the second end of the cartridge. The cartridge may be inserted in the cartridge housing direction. The cartridge housing direction may, for example, be opposite to the direction of the first stopper when the cartridge is received into the cartridge housing. The cartridge may be in a first angular position when inserted into the cartridge housing. The cartridge may be held in the cartridge housing in a second angular position after the cartridge has been inserted into the cartridge housing.

[0054] The cartridge housing can be configured to receive a cartridge assembly comprising a cartridge and a cartridge holder. The cartridge assembly can be held within the cartridge housing by one or more cartridge holding members of the cartridge holder that engage with members of the cartridge housing.

[0055] The cartridge and / or cartridge assembly can be locked within the cartridge housing, for example, to prevent the cartridge and / or cartridge assembly from coming out of the cartridge housing. The cartridge and / or cartridge assembly can be locked within the cartridge housing by the movement of the plunger rod of the automatic injection device.

[0056] The automatic dispensing device may be equipped with a cartridge sensor. The cartridge housing may be equipped with a cartridge sensor. The cartridge sensor may be configured to detect whether a cartridge and / or cartridge assembly is accepted into the cartridge housing. The cartridge sensor may provide a cartridge sensor signal indicating whether or not a cartridge and / or cartridge assembly is accepted into the cartridge housing. The cartridge sensor may provide a cartridge detection signal indicating that a cartridge and / or cartridge assembly is accepted into the cartridge housing. The cartridge sensor signal may include a cartridge detection signal.

[0057] The automatic injection device may be an electronic automatic injection device. The automatic injection device may be equipped with a battery. The housing may accommodate the battery. The battery may be a rechargeable battery. For example, the battery may be a lithium-ion battery, a nickel-cadmium battery, or a nickel-metal hydride battery. The battery may be configured to be charged by connecting a charger.

[0058] The automatic injection device includes a drive module. The drive module can be coupled to move the plunger rod, such as by operating or advancing it between the plunger rod retracted position and the plunger rod extended position. The movement of the plunger rod can enable the cartridge and / or cartridge assembly to be locked within the cartridge housing. For example, the cartridge and / or cartridge assembly can be locked within the cartridge housing by advancing the plunger rod from the plunger rod retracted position.

[0059] The drive module may comprise one or more electronic elements. The drive module may be configured to receive power from a battery. The drive module may be electrically connected to a battery to receive power. The drive module may be housed in a housing. The drive module may comprise a motor, such as an electromechanical motor, such as a DC motor, such as a brushless or brushless DC motor. The drive module may comprise a solenoid motor. The drive module may comprise a shape memory metal engine. The drive module may comprise a spring configuration configured to actuate a plunger rod. The drive module may include a pressurized gas configured to actuate a plunger rod.

[0060] The automatic dispensing device may include a plunger rod, such as a plunger rod that is movable by a drive module. The plunger rod may be configured to move a stopper, such as a first stopper on a cartridge. For example, when the plunger rod is moved toward a plunger rod extension position, such as from a first plunger rod position to a mixing plunger rod position and / or from the mixing plunger rod position to a second plunger rod position, the plunger rod may be configured to move the first stopper toward the cartridge outlet for purposes such as mixing two drug components and / or releasing the drug from the cartridge compartment through the cartridge outlet and / or releasing air from the cartridge compartment through the cartridge outlet.

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

[0062] The plunger rod can be moved from a first plunger rod position, etc., toward a plunger rod extension position, etc., to a mixing plunger rod position. The mixing plunger rod position may be a position where the first drug component and the second drug component are mixed, such as by being combined. The mixing plunger rod position may be a position where the second stopper is positioned within the bypass portion, for example, to enable fluid communication between the first cartridge portion and the second cartridge portion.

[0063] The plunger rod can be moved from a mixing plunger rod position, for example, toward a plunger rod extension position, to a second plunger rod position. The second plunger rod position may also be a preparation plunger rod position. The preparation plunger rod position can be selected to position the first stopper where air is being released from the cartridge compartment. For example, the preparation plunger rod position can be selected to position the first stopper where the amount of air in the cartridge compartment is reduced to a minimum and / or suitable amount for injection.

[0064] The plunger rod can be moved from a second plunger rod position, such as a plunger rod extension position, to an injection plunger rod position. The injection plunger rod position may be a position where the drug is being released and / or injected from the cartridge compartment. For example, the injection plunger rod position can be selected to position the first stopper at a position where the amount of drug in the cartridge compartment is reduced, such as a position close to the cartridge outlet. The injection plunger rod position may also be the plunger rod extension position.

[0065] The plunger rod may be moved toward the plunger rod retracted position, for example, to the plunger rod retracted position. For example, the plunger rod may be moved toward the plunger rod retracted position, for example, to the plunger rod retracted position, from the injection plunger rod position and / or the plunger rod extended position, after the injection is complete.

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

[0067] The processing unit can be configured to receive a trigger event and, after receiving the trigger event, to control the drive module to move the plunger rod to the injection plunger rod position, for example, after the movement of the plunger rod to a preceding plunger rod position, such as the second plunger rod position, is complete.

[0068] The automatic dispensing device may be equipped with a discharge sensor, such as a plunger rod position sensor. The discharge sensor may be configured to detect discharge, such as the release of drug and / or air, within the cartridge compartment. The discharge sensor may be configured to detect and / or determine the position of the plunger rod and / or the position of the first stopper. The discharge sensor may be configured to detect conditions indicating the position of the plunger rod and / or the position of the first stopper. The discharge sensor may be configured to provide a discharge sensor signal. The discharge sensor signal may indicate the position of the plunger rod and / or the first stopper.

[0069] The discharge sensor may include a tachometer, for example, a tachometer on the drive module. The tachometer can be configured to count the rotation of the drive module, such as the motor of the drive module, or the rotation of the drive module from a set point, such as the plunger rod's retracted position. The count of the drive module's rotation can be used to determine the actual position of the plunger rod, such as the premixing plunger rod position, the mixing plunger rod position, the preparation plunger rod position, the injection plunger rod position, the plunger rod extended position, and / or the plunger rod retracted position.

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

[0071] The cartridge may be lockable within the cartridge housing. For example, the cartridge can be locked within the cartridge housing to prevent it from coming out. The movement of the plunger rod toward the extended position can lock the cartridge within the cartridge housing. For example, the movement of the plunger rod toward the mixing plunger rod position can lock the cartridge within the cartridge housing. The movement of the plunger rod toward the retracted position can unlock the cartridge from the cartridge housing. For example, the movement of the plunger rod toward the retracted position can unlock the cartridge within the cartridge housing. When the plunger rod is not in the retracted position and / or not close to the retracted position, the cartridge can be locked within the cartridge housing. Coordinating the position of the plunger rod with the locking of the cartridge within the cartridge housing provides the advantage of limiting or preventing the cartridge from being released when the automatic dispensing device is in operation.

[0072] The automatic injection device may be equipped with an orientation sensor. The orientation sensor may be configured to provide an orientation signal indicating the orientation of the cartridge when the cartridge is received in the cartridge housing. The orientation signal may indicate the orientation of the cartridge relative to gravity, such as the direction of gravity. The orientation signal may also be an acceleration signal, such as a triaxial acceleration signal. The orientation signal may include acceleration data, such as acceleration data in three dimensions. The orientation signal may include acceleration data indicating the acceleration of the device.

[0073] The orientation sensor can be configured to detect an orientation indicating the orientation of a cartridge, such as the orientation of the cartridge and / or the orientation of an automatic dispensing device. The detected orientation may be relative to gravity, such as the direction of gravity. The orientation sensor can be configured to detect the direction of gravity and / or whether the direction of gravity is within a given range of directions. The orientation sensor may include an accelerometer. The orientation sensor may include multiple accelerometers, such as three accelerometers configured to detect acceleration in three dimensions, such as a three-dimensional accelerometer. The orientation sensor may include a tilt sensor, a triaxial accelerometer, a monoaxial accelerometer, a magnetometer and / or a combination thereof, and the orientation sensor can provide measures of roll, pitch and azimuth, acceleration and / or tilt in one or more directions.

[0074] The orientation sensor can be configured to provide dynamic signals, such as linear acceleration and / or velocity and / or position 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 of the position and / or motion of the device. The processing unit can be configured to convert motion sensor signals, such as orientation signals, from one domain to another, for example, by integrating the acceleration signal with respect to time to derive a velocity signal and / or integrating the velocity signal with respect to time to derive a position signal.

[0075] The orientation sensor can be configured to detect whether the cartridge is in a predetermined orientation. The orientation sensor can be configured to detect whether the direction of the automatic dispensing device indicates that the cartridge is in a predetermined orientation. The predetermined orientation may be vertical. The predetermined orientation may be within 45 degrees from the vertical, such as within 30 degrees from the vertical. The predetermined orientation may be such that the cartridge is oriented such that its longitudinal axis is within 45 degrees from the vertical, such as within 30 degrees from the vertical, and the cartridge outlet is in a vertical position above the cartridge compartment.

[0076] Detection of automatic injector reversal may be performed using a single-axis or multi-axis gyroscope sensor that senses the dynamic angular velocity, such as the angular velocity of the automatic injector during reversal, and the angle the automatic injector is at during reversal. Therefore, the orientation sensor may be a single-axis or multi-axis gyroscope sensor.

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

[0078] By using an orientation sensor with spatial resolution of a single accelerometer axis, that is, by detecting changes in signal level and sign reversal, it is possible to detect some details about rotation. For example, if an orientation sensor, which is a uniaxial accelerometer, is perfectly calibrated vertically upward and in a stable state, i.e., affected only by gravity, rotation outward from the vertical can be determined by detecting an acceleration level that decreases in accordance with the projection of vertical gravity onto the accelerometer sensing axis (i.e., by a coefficient determined by the cosine of the tilt angle).

[0079] A two-axis accelerometer detects motion along two individual axes, namely the x and y axes, which are perpendicular to each other. The x and y axes together define a two-dimensional sensing plane. When implementing a one-axis or two-axis accelerometer in an orientation sensor as described herein, the accelerometer is typically positioned so that the x-axis is parallel to the longitudinal axis of the automatic injection device, and therefore capable of detecting acceleration along this direction. As a result, the y-axis is oriented perpendicular to the longitudinal axis in such a setting, and therefore capable of detecting acceleration along this y-axis direction only.

[0080] Motion within the two-dimensional plane defined by a two-axis accelerometer can be detected accurately. However, motion outside this two-dimensional plane, such as 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 of motion detection by the two-axis accelerometer. Therefore, rotation of the automatic injector can cause a shift in the signals observed for the two-axis sensors. However, if the x-axis or y-axis sensor is not position-aligned in the direction of rotation of the automatic injector, the sensor will yield 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 sensing axis will yield a sensing signal in response to the physical rotation of the automatic injector performed by the user. This means that the reversal of the automatic injector cannot be accurately observed and / or recorded.

[0081] Due to the actual circumstances in which these sensors are implemented, some level of sensing outside the x / y two-dimensional plane may be observed in some cases. However, such signals are significantly weaker compared to acceleration along the specified x and y operating axes, where there is no predetermined level of sensing. Therefore, such out-of-plane signals are difficult to use in practice when a reliable orientation signal should be detected. Since the design of the automatic infusion device is not intended to restrict the user in how the user holds the automatic infusion device or in the direction in which the user inverts the automatic infusion device to perform the inversion necessary to mix the drug, a two-axis accelerometer does not always yield results as accurate as a three-axis accelerometer.

[0082] Compared to a two-axis accelerometer, using a three-axis accelerometer (also referred to as a tri-axial accelerometer below) improves sensitivity. By using a three-axis accelerometer instead, it becomes possible to detect motion in the z-axis direction in addition to the x-axis and y-axis directions. Since the z-axis direction is perpendicular to both the x and y axes, it is possible to observe the motion of the automatic injection device in a different dimensional plane than that defined by the x and y axes. Thus, a three-axis accelerometer defines a three-dimensional sensing plane defined by the x, y, and z axes.

[0083] By selecting an accelerometer with spatial resolution in three axes, the resolution of the third axis adds this additional information, thus resolving any remaining uncertainty arising from rotations within or outside the appropriate two-dimensional spatial plane. This means that an unrecorded sensor in an automated injector with a triaxial accelerometer can accurately detect and calculate motion / rotation not only within any single two-dimensional spatial plane, but throughout the entire handling motion, i.e., including rotational motion that changes based on hand / arm joint ergonomics, etc. This means that all inversions in the automated injector can be accurately observed and recorded.

[0084] Therefore, the automatic injector may further include an orientation sensor configured to detect the orientation of the cartridge and / or the orientation of the automatic injector. Automatic injector reversal can be performed using the orientation sensor. The orientation sensor may include multiple accelerometers, such as a triaxial accelerometer.

[0085] The processing unit can be coupled to an orientation sensor. The processing unit can be configured to receive an orientation signal indicating, for example, the orientation of the cartridge when it is received in the cartridge housing and / or the orientation of the automatic injector. The processing unit can be configured to receive an orientation signal indicating the angle over which the automatic injector acts in angular velocity and / or reversal. The processing unit can be further configured to provide a start signal after multiple complete reversals of the automatic injector have been performed, the number of complete reversals being based on the orientation signal indicating the angle over which the automatic injector acts in angular velocity and / or complete reversal.

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

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

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

[0089] The processing unit can be configured to control the drive module based on orientation signals. For example, the processing unit can be configured to control the drive module to move the plunger rod to the mixing plunger rod position and / or the second plunger rod position and / or the injection plunger rod position based on orientation signals. For example, the processing unit can be configured to control the drive module to move the plunger rod to the mixing plunger rod position and / or the second plunger rod position and / or the injection plunger rod position only if the orientation signal indicates that the angle of inclination between the vertical and the longitudinal axis extending along the cartridge is within 45 degrees, such as within 30 degrees from the vertical, and / or that the cartridge outlet is in a vertical position above the cartridge compartment.

[0090] A first motion parameter can be determined, for example, based on a direction signal. The processing unit can be configured to determine the first motion parameter. The first motion parameter can be based on the cumulative motion of the automatic injector. The first motion parameter can indicate the amount of motion of the automatic injector over a set period, such as since the completion of the movement of the plunger rod to the mixing plunger rod position and / or a predetermined preceding time, such as a preceding second. The first motion parameter can be based on a cumulative measure of direction over time, such as since the completion of the movement of the plunger rod to the mixing plunger rod position and / or a predetermined preceding time, such as a preceding second. The first motion parameter can indicate that the device is being shaken. Shaking the device while the two drug components are mixing can cause the drug to foam excessively. Excessive foaming of the drug may necessitate an increased recombination time. To prevent foaming, if shaking of the device is detected, the speed of the plunger rod's movement can be adjusted, for example, by reducing it. Conversely, gently shaking the apparatus can accelerate reconstruction without causing foaming, resulting in a reduction in the required reconstruction time. Therefore, the amount of shaking can influence the determination of the reconstruction time.

[0091] Alternatively or additionally, the first motion parameter may indicate that the automatic injector has been rotated from a vertical orientation in which the first end of the automatic injector, such as the distal end of the automatic injector, points substantially upward to an inverted orientation in which the first end of the automatic injector points substantially downward. The first motion parameter may indicate the number of inversions and / or complete inversions of the automatic injector. The processing unit may be configured to detect and / or count the number of inversions / complete inversions.

[0092] The inversion may include reversing the automatic injector from a orientation in which the first end of the automatic injector points substantially upward to a reversed orientation in which the first end of the automatic injector points substantially downward. For example, the inversion may include reversing the automatic injector from a orientation in which the first end of the automatic injector points within 45 degrees of upward to a reversed orientation in which the first end of the automatic injector points within 45 degrees of downward. Alternatively or additionally, the inversion may include reversing the automatic injector from a orientation in which the first end of the automatic injector points substantially downward to a reversed orientation in which the first end of the automatic injector points substantially upward. For example, the inversion may include reversing the automatic injector from a orientation in which the first end of the automatic injector points within 45 degrees of downward to a reversed orientation in which the first end of the automatic injector points within 45 degrees of upward.

[0093] Rotational motion of the automatic injection device, which rotates the automatic injection device from an initial position where the longitudinal axis of the automatic injection device is in the horizontal plane and the first end of the automatic injection device points to the left, to a position where the longitudinal axis of the automatic injection device is in the horizontal plane and the first end of the automatic injection device points to the right, can also constitute an inversion.

[0094] Therefore, inversion can be defined as a nearly 180-degree rotation of the automatic injector. The orientation at the start and end positions when inversion is performed is not fixed.

[0095] A downward rotation can be detected when the automatic injection device is rotated from a position pointing 40 degrees upward to a position pointing 135 degrees upward, i.e., 45 degrees downward. An upward rotation can be detected between rotations from 45 degrees downward, i.e., 135 degrees upward, to 30 degrees upward. Therefore, both upward and downward rotations can be detected before the reversal is complete. Thus, 90 to 105 rotations within a preset time can be used to calculate the reversal frequency based on interpolation of this data to estimate a rotation of approximately 180 degrees.

[0096] Inversion can be considered a complete inversion by an automated injector when it is performed at an angular velocity exceeding the default threshold. A complete inversion also signifies a successful inversion. The default threshold for angular velocity can be defined as an inversion frequency of at least 0.5 inversions per second. This corresponds to at least one inversion every two seconds. The purpose of lowering the frequency threshold is to ensure that the inversion is strong enough to effectively aid in the mixing of the first and second drug components. The inversion frequency can be used in embedded software to determine whether the inversion is effective or not.

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

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

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

[0100] Alternatively, or in combination, inversion can be considered a complete inversion by an automated injection device when the angle exceeds a default threshold. The default threshold for the angle may be at least 90 degrees, preferably at least 135 degrees, more preferably at least 150 degrees, and even more preferably at least 165 degrees, such as 180 degrees.

[0101] Typically, holding an automatic injector in one's hand to invert it over a range greater than 205 degrees of rotation, such as from 45 degrees to the right to 180 degrees to the left, is difficult and / or uncomfortable for the user. The default angle threshold may be less than 220 degrees, such as less than 205 degrees, such as less than 190 degrees.

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

[0103] The rotational motion of the automatic injection device from the starting angular position to the ending angular position can be considered a complete reversal by the automatic injection device in the following cases: If the starting angular position is between a first vertical orientation in which the distal end of the automatic infusion device points upward and a first horizontal position in which the distal end of the automatic infusion device points laterally along the horizontal axis, The termination angular position is between a second horizontal position in which the distal end of the automatic injector is pointing laterally along the horizontal axis in the opposite direction to that of the first horizontal position, and a second vertical orientation in which the distal end of the automatic injector is pointing downward, and The default angle threshold between the first angular position and the second angular position is at least 90 degrees, preferably at least 135 degrees, more preferably at least 150 degrees, and even more preferably at least 165 degrees, such as 180 degrees.

[0104] The rotational motion of the automatic injection device from the starting angular position to the ending angular position can be considered a complete reversal by the automatic injection device in the following cases: If the starting angular position is between a first vertical orientation in which the distal end of the automatic injector points downward and a first horizontal position in which the distal end of the automatic injector points laterally along the horizontal axis, The termination angular position is between a second horizontal position in which the distal end of the automatic injection device points laterally along the horizontal axis in the opposite direction to that of the first horizontal position, and a second vertical orientation in which the distal end of the automatic injection device points upward, and The default angle threshold between the first angular position and the second angular position is at least 90 degrees, preferably at least 135 degrees, more preferably at least 150 degrees, and even more preferably at least 165 degrees, such as 180 degrees.

[0105] Therefore, the automatic injector can undergo a complete inversion when it is rotated 180 degrees vertically, for example, from vertically upward to vertically downward. The 180-degree inversion can be performed over a maximum of 2 seconds, i.e., at a minimum inversion frequency of 0.5 Hz. Alternatively, or in addition, the automatic injector can undergo a complete inversion when it is rotated 180 degrees vertically, for example, from a vertical orientation at an angle of 0 to 30 degrees relative to the upward direction to a vertically downward direction at an angle of 0 to 30 degrees relative to the downward direction. Alternatively, or in addition, the automatic injector can undergo a complete inversion when it is rotated 180 degrees vertically, for example, from a vertical orientation at an angle of 25 to 65 degrees relative to the upward direction to a vertically downward direction at an angle of 25 to 65 degrees relative to the downward direction. Alternatively, or in addition, an automatic injection device can undergo a complete inversion when rotated 180 degrees vertically, such as from vertically upward at an angle of 45 to 75 degrees relative to the upward direction to vertically downward at an angle of 45 to 75 degrees relative to the downward direction.

[0106] The frequency threshold can be based on the cartridge coding mechanism, such as a coding signal indicating the cartridge coding mechanism. Alternatively or additionally, the frequency threshold can be based on the temperature of the drug, such as a temperature signal indicating the drug's temperature.

[0107] Ideally, the specified physical input for low-viscosity drugs may be, for example, five 180-degree inversions, but if the measured inversion angle remains significantly below that level, it may be assumed that a greater number of inversions are required, for example, ten inversions where the angle per inversion reaches 90 degrees. Alternatively, the specified physical input for low-viscosity drugs may be, for example, ten 180-degree inversions, but if the measured inversion angle remains significantly below that level, it may be assumed that a greater number of inversions are required, for example, twenty inversions where the angle per inversion reaches 90 degrees. Therefore, the number of complete inversions may increase if the automatic injector experiences inversions with lower degrees of angular motion and / or angular velocity.

[0108] The number of inversions can be a setting code signal indicating the cartridge code mechanism, which specifies the number of inversions required for the medication to be thoroughly mixed. Therefore, an automatic dispensing device does not have to be pre-programmed to require a specific number of inversions, such as inverting all cartridges used by the device. Instead, the automatic dispensing device can be programmed to require an individual number of inversions specified on the cartridge code mechanism.

[0109] The processing unit can be configured to provide feedback, via the user interface of an automatic injection device, etc., when a default / predetermined number of complete inversions and / or inversions, i.e., inversions including both complete inversions and incomplete inversions that do not meet the requirements for completion, are completed. The processing unit can also provide visual and / or acoustic feedback to the user when the above number of complete inversions have been performed.

[0110] Alternatively, or in combination, the processing unit may provide the user with visual and / or acoustic feedback for each complete inversion. For example, using a 3-axis accelerometer to count the number of complete / successful inversions with a sufficient rotation angle that are given sufficiently quickly and repeated a sufficient number of times, the automatic injector device could provide acoustic feedback through an internal speaker, for example, giving a "tick" sound each time an inversion is successful. Furthermore, visual feedback, for example, across a graphic progress bar included in the interface, could be provided for all complete inversions during the inversion sequence or for each complete inversion. This would help the user perform the inversions accurately.

[0111] The predetermined number of complete inversions can be based on the amount of kinetic energy added to the mixed drug during reconstitution; for example, the predetermined number of complete inversions can be correlated with the amount of kinetic energy added to the mixed drug during reconstitution. The predetermined number of complete inversions may be between 1 and 20, such as 5, between 3 and 7, between 1 and 10, or between 1 and 20. Alternatively, the predetermined number of complete inversions may be greater than 10, such as greater than 15 or greater than 20.

[0112] The predetermined number of complete inversions may be based on a cartridge coding mechanism, such as a coding signal indicating the cartridge coding mechanism.

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

[0114] Alternatively or additionally, acceleration can be monitored to ensure it does not exceed a predetermined upper threshold. This upper threshold may represent acceleration known to be associated with a risk of foaming. For example, acceleration exceeding a predetermined upper threshold may be known to be associated with a risk of foaming.

[0115] The total amount of energy applied to the automatic injector, based on measurements of the rotational acceleration of the automatic injector and / or the count of reversals and / or complete reversals, can be continuously evaluated, for example, to give real-time commands to the user performing such motion, if the energy level is considered too low, for example, below a predetermined lower threshold, and / or if the energy level is considered too high, for example, above a predetermined upper threshold. The predetermined lower threshold may be an energy level. The predetermined upper threshold may be an energy level at which the motion is considered to increase the risk of foaming.

[0116] The first motion parameter can indicate the oscillation frequency of the automatic injection device's motion, such as the number of reversals and / or complete reversals per second.

[0117] For example, an automatic injection device such as a cartridge housing can be configured to accept a cartridge assembly that includes a cartridge and a cartridge coding mechanism.

[0118] The automatic dispensing device may be equipped with a code sensor. The code sensor may be configured to read a cartridge code mechanism, such as a cartridge code mechanism of a cartridge and / or cartridge assembly that indicates one or more cartridge specifications. The code sensor may be configured to provide a code signal indicating the cartridge code mechanism.

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

[0120] The processing unit can be configured to determine, based on a code signal, whether the cartridge is counterfeit, / or used, / or contaminated with foreign matter, / or contains an incorrect dosage, and / or contains the wrong medication.

[0121] The code sensor may include an optical sensor. The code sensor may include an optical sensor including a transmitter and receiver, such as an optical transmitter and optical receiver. The code sensor can be configured to read a cartridge code mechanism. The code sensor can be configured to read color codes, bar codes, RFID tags, NFC tags, identification numbers, QR codes (registered trademark), and / or any combination thereof. The movement of the plunger rod, such as position, velocity, and / or delay, can be based on a code signal. For example, the movement of the plunger rod to the mixing plunger rod position and / or the second plunger rod position and / or the injection plunger rod position can be based on a cartridge code mechanism, such as a code signal. For example, controlling the drive module to move the plunger rod to the mixing plunger rod position and / or the second plunger rod position can be based on a code signal. The processing unit can be configured to control the drive module based on a code signal. For example, the processing unit can be configured to control the drive module to move the plunger rod to the mixed plunger rod position and / or the second plunger rod position based on a code signal.

[0122] The movement of the plunger rod can be optimized for several types of cartridges by basing it on cartridge specifications, such as code signals. For example, dry runs can be performed with reduced or no drug release, thereby increasing dose accuracy and / or reducing patient discomfort, even when using multiple different cartridges. Additionally or alternatively, the mixing procedure can be performed with reduced foaming by knowing the cartridge specifications.

[0123] The movement of the plunger rod can be optimized for several types of cartridges by basing it on cartridge specifications, such as a code signal. For example, after it is detected that a cartridge has been accepted into the cartridge housing and a first input signal is received, the plunger rod can be held in the mixing plunger rod position for a certain period of time according to the cartridge specifications, thereby ensuring proper mixing and / or reducing patient discomfort, even when using multiple different cartridges.

[0124] The automatic injection device may be equipped with a resistance sensor. The resistance sensor may be configured to provide a resistance signal. The resistance signal may indicate resistance to the movement of the plunger rod. The processing unit may be coupled to the resistance sensor. The processing unit may be configured to receive the resistance signal.

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

[0126] The resistance sensor can be configured to determine the power consumed by the drive module by measuring, for example, the electrical resistance, current, and / or voltage of the drive module, and / or a combination thereof. The resistance sensor may include an electrical resistance sensor, a current sensor, and / or a voltage sensor. The drive module may also include a resistance sensor.

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

[0128] The motion of the plunger rod can be based on a resistance signal. For example, the motion of the plunger rod to the mixing plunger rod position and / or the second plunger rod position and / or the injection plunger rod position can be based on resistance to the motion of the plunger rod, such as a resistance signal. For example, controlling the drive module to move the plunger rod to the mixing plunger rod position can be based on a resistance signal. The processing unit can be configured to control the drive module based on a resistance signal. For example, the processing unit can be configured to control the drive module to move the plunger rod to the mixing plunger rod position based on a resistance signal.

[0129] The automatic dispensing device may be equipped with a temperature sensor. The temperature sensor may be configured to provide a temperature signal, such as a temperature signal indicating the temperature of the automatic dispensing device and / or the cartridge and / or the drug, for example, the temperature of the drug in the cartridge when the cartridge is received into the cartridge housing. The temperature sensor may include an infrared sensor, such as an infrared optical sensor. The temperature sensor and the code sensor may utilize a common optical sensor, such as a common optical sensor. Therefore, an optical sensor, such as an infrared optical sensor, can be used for both temperature detection and reading the cartridge code mechanism.

[0130] The processing unit can be coupled to a temperature sensor. The processing unit can be configured to receive a temperature signal.

[0131] The movement of the plunger rod to the mixing plunger rod position and / or the second plunger rod position and / or the injection plunger rod position may further be based on the temperature of the automatic injection device and / or the cartridge and / or the drug. The movement of the plunger rod to the mixing plunger rod position and / or the second plunger rod position and / or the injection plunger rod position may further be based on a temperature signal.

[0132] The processing unit can be configured to control the drive module to move the plunger rod to the mixing plunger rod position and / or the preparation plunger rod position and / or the injection plunger rod position, based on a temperature signal in addition to a start signal.

[0133] The automatic dispensing device may be equipped with 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 in the cartridge housing. The temperature control unit may be configured to raise and / or lower the temperature of the cartridge and / or the drug. This allows for control over temperature-dependent steps in the procedure, for example, to expedite their execution.

[0134] The temperature control unit may include a heating element. The heating element can be configured to raise the temperature of the automatic injection device and / or the cartridge and / or the chemical. The heating element may be a resistance heating element. The heating element may be a light source, such as an infrared lamp. The heating element may be a dielectric heating element. The heating element may be a thermoelectric element, such as a Peltier element.

[0135] The temperature control unit may include a cooling element. The cooling element may be configured to lower the temperature of the automatic injector and / or cartridge and / or chemical. The cooling element may be a thermoelectric element such as a Peltier element.

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

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

[0138] The automatic injection device may be equipped with an input device, such as a first input device. The first input device may be a button, a contact sensing area, or a microphone. The first input device may be configured to provide a first input signal. The first input signal may indicate 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 indicate a second user interaction with the first input device.

[0139] The processing unit can be coupled to a first input device. The processing unit can be configured to receive a first input signal and / or a second input signal. The processing unit can be configured to control the drive module to move the plunger rod to the mixed plunger rod position only after receiving the first input signal. The processing unit can be configured to control the drive module to move the plunger rod to the second plunger rod position only after receiving the second input signal.

[0140] The automatic injection device may include a contact member. The contact member may be configured to be compressed against the injection site. The contact member may be movable between an extended position and a retracted position. The contact member may be biased toward the extended position, for example by a contact member spring. The contact member may be configured to move toward the retracted position when compressed against the injection site, for example. The contact member and / or contact member sensor may be configured to provide a contact member signal indicating the position of the contact member. The automatic injection device and / or contact member may include a contact member sensor configured to detect the position of the contact member. The contact member sensor may be configured to provide a contact member signal indicating the contact member.

[0141] 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 presence of the contact member in the first contact member position may indicate that the contact member is close to the retracted contact member position. The presence of the contact member in the first contact member position may indicate that the contact member is being compressed against the injection site. The presence of the contact member in the first contact member position may indicate that the needle positioned on the cartridge is sufficiently pressed into the skin to begin injecting the drug.

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

[0143] 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 cartridge specifications, such as a code signal or a cartridge code mechanism. For example, a processing unit can 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 injection plunger rod position, based on a code signal.

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

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

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

[0147] The motion of the plunger rod may include motions having a plunger rod velocity, such as a mixing plunger rod velocity, a second plunger rod velocity, and / or an injection plunger rod velocity. The plunger rod velocity may be based on the position of the plunger rod. The plunger rod can be moved at the mixing plunger rod velocity from a first plunger rod position, for example, to a mixing plunger rod position. The plunger rod can be moved at the second plunger rod velocity from a mixing plunger rod position, for example, to a second plunger rod position. The plunger rod can be moved at the injection plunger rod velocity from a mixing plunger rod position and / or a second plunger rod position, for example, to an injection plunger rod position.

[0148] The plunger rod speeds, such as the mixing plunger rod speed, the second plunger rod speed, and / or the injection plunger rod speed, may be constant. The plunger rod speeds, such as the mixing plunger rod speed, the second plunger rod speed, and / or the injection plunger rod speed, may vary, for example, over time and / or distance. The mixing plunger rod speed may be between 1 mm / second and 3 mm / second, such as 1.7 mm / second.

[0149] The processing unit can be configured to control the drive module to move the plunger rod from a first plunger rod position, such as a mixing plunger rod position, at the mixing plunger rod speed. The processing unit can be configured to control the drive module to move the plunger rod from a second plunger rod position, such as a mixing plunger rod position, at the second plunger rod speed. The processing unit can be configured to control the drive module to move the plunger rod from a second plunger rod position, such as an injection plunger rod position, at the injection plunger rod speed.

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

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

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

[0153] The processing unit can be configured to determine the mixing plunger rod speed, the second plunger rod speed, and / or the injection plunger rod speed based on a code signal and / or a direction signal and / or a first motion parameter and / or a resistance signal.

[0154] One or more elapsed times, such as delays, may precede the movement of the plunger rod, such as the movement to the mixing plunger rod position, the second plunger rod position, and the injection plunger rod position. For example, for the plunger rod to move to the second plunger rod position, a reconfiguration time may have elapsed since the plunger rod's movement to the mixing plunger rod position was completed. The reconfiguration time can be selected to allow sufficient time to ensure that the drugs are reconfigured, for example, by ensuring that the first and second drug components are sufficiently mixed, such as by dissolving.

[0155] Depending on the circumstances, the reconstruction time can be very short. The reconstruction time could be less than 1 degree, less than 5 degrees, or less than 10 degrees. Alternatively, the reconstruction time could be more than 5 minutes, more than 1 minute, more than 10 seconds, or more than 1 second. The reconstruction time could be 3 minutes, between 2 and 5 minutes, or between 1 and 10 minutes.

[0156] The processing unit may be further configured to control the drive module to move the plunger rod to the mixing plunger rod position and / or the second plunger rod position and / or the injection plunger rod position based on one or more elapsed time intervals, such as a delay time. 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 a reconstruction time has elapsed since the plunger rod has completed its movement to the mixing plunger rod position.

[0157] The reconstruction time can be based on the cartridge specifications, for example, the reconstruction time can be based on the cartridge coding mechanism, for example, the reconstruction time can be based on the coding signal. The processing unit can be configured to determine the reconstruction time based on the coding signal.

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

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

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

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

[0162] To move the plunger rod towards the retracted position, such as to the plunger rod retracted position, after the plunger rod has completed its movement to the injection plunger rod position, it may be necessary for a residence time to elapse since the completion of the plunger rod's movement to the injection plunger rod position. The residence time can be selected to allow sufficient time to ensure that the drug is dispersed in the tissue. The residence time may be influenced by the drug and / or the concentration and / or volume and / or temperature of the drug. The residence time may be based on the cartridge specifications, for example, the residence time may be based on the cartridge coding mechanism, for example, the residence time may be based on the coding signal.

[0163] The processing unit can be configured to control the drive module so that the plunger rod is moved toward the plunger rod retracted position only after a dwell time has elapsed following the completion of the plunger rod's movement to the injection plunger rod position.

[0164] The dwell time can be based on the cartridge specifications, for example, the dwell time can be based on the cartridge coding mechanism, for example, the dwell time can be based on the coding signal. The processing unit can be configured to determine the dwell time based on the coding signal.

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

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

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

[0168] The processing unit may be configured to determine the residence time based on a code signal and / or a direction signal and / or a first motion parameter and / or a resistance signal.

[0169] The above and other features and advantages of the present invention will be readily apparent to those skilled in the art by the following detailed description of exemplary embodiments with reference to the accompanying drawings. [Brief explanation of the drawing]

[0170] [Figure 1] This figure shows an exemplary automatic injection device. [Figure 2] This figure shows an exemplary automatic injection device with a cartridge. [Figure 3] This is a schematic diagram showing an example cartridge. [Figure 4a] This is a schematic diagram showing an exemplary cartridge assembly with an exemplary cartridge coding mechanism. [Figure 4b] This is a schematic diagram showing an exemplary cartridge assembly with an exemplary cartridge coding mechanism. [Figure 4c] This is a schematic diagram showing an exemplary cartridge assembly with an exemplary cartridge coding mechanism. [Figure 4d] This is a schematic diagram showing an exemplary cartridge assembly with an exemplary cartridge coding mechanism. [Figure 5]This is a schematic diagram showing an exemplary automatic injection device with a cartridge assembly. [Figure 6a] This is a schematic diagram showing an automatic injection device and cartridge assembly. [Figure 6b] This is a schematic diagram showing an automatic injection device and cartridge assembly. [Figure 6c] This is a schematic diagram showing an automatic injection device and cartridge assembly. [Figure 6d] This is a schematic diagram showing an automatic injection device and cartridge assembly. [Figure 7] This is a block diagram of an exemplary automatic injection device. [Figure 8a] This is a schematic diagram showing an exemplary cartridge assembly and a plunger rod in an exemplary position. [Figure 8b] This is a schematic diagram showing an exemplary cartridge assembly and a plunger rod in an exemplary position. [Figure 8c] This is a schematic diagram showing an exemplary cartridge assembly and a plunger rod in an exemplary position. [Figure 8d] This is a schematic diagram showing an exemplary cartridge assembly and a plunger rod in an exemplary position. [Figure 8e] This is a schematic diagram showing an exemplary cartridge assembly and a plunger rod in an exemplary position. [Figure 8f] This is a schematic diagram showing an exemplary cartridge assembly and a plunger rod in an exemplary position. [Figure 9] This figure shows an illustrative graph of resistance versus position. [Figure 10] This is a flowchart illustrating an example method. [Figure 11] This is a flowchart illustrating an example method. [Figure 12a] This is a schematic diagram illustrating an exemplary user interface. [Figure 12b] This is a schematic diagram illustrating an exemplary user interface. [Figure 12c]This is a schematic diagram illustrating an exemplary user interface. [Figure 12d] This is a schematic diagram illustrating an exemplary user interface. [Figure 13a] This is a schematic diagram illustrating the exemplary motion of an exemplary automatic injection device. [Figure 13b] This is a schematic diagram illustrating the exemplary motion of an exemplary automatic injection device. [Figure 13c] This is a schematic diagram illustrating the exemplary motion of an exemplary automatic injection device. [Modes for carrying out the invention]

[0171] Various embodiments will be described below with reference to the drawings. Throughout, similar reference numerals refer to similar elements. Therefore, similar elements will not be described in detail with respect to each drawing. It should also be noted that the drawings are intended solely to facilitate the description of the embodiments. The drawings are not intended to be an exhaustive description of the claimed invention, nor are they intended to be a limitation on the scope of the claimed invention. In addition, the illustrated embodiments do not necessarily have all the aspects or advantages shown. Aspects or advantages described with respect to a particular embodiment are not necessarily limited to that embodiment and may be practiced in any other embodiment, even if not illustrated or explicitly described in that way.

[0172] Figure 1 shows an exemplary automatic infusion device 4. The automatic infusion device 4 can be configured to administer a drug. The automatic infusion device 4 may also be an electronic automatic infusion device.

[0173] The automatic injection device 4 comprises a housing 6. The automatic injection device 4 comprises a cartridge housing 300. The cartridge housing is configured to receive a cartridge and / or a cartridge assembly containing a cartridge. The cartridge may contain a drug.

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

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

[0176] The user interface 1100 may include a first input member 1108, such as a button, as shown in the diagram. The first input member 1108 can enable user input from the user. For example, the first input member 1108 can be used to receive a press from the user to proceed to the next step.

[0177] The user interface 1100 may include a first output member 1110, such as a plurality of LEDs, as shown in the diagram. The first output member 1110 can enable user output to the user. The user interface 1100 may also include a second input member (not shown), such as a speaker. The second output member may be configured to provide an audible output to the user. For example, the first output member 1110 and / or the second output member can be used to show the user a certain step in a procedure and / or to show an error message.

[0178] Figure 2 shows an exemplary system 2. System 2 comprises an automatic injection device 4 as described in relation to Figure 1, and an exemplary cartridge 700 that is received in a cartridge housing 300. The cartridge 700 is shown having a needle cover 908. The needle cover 908 extends from the contact member 1102 to allow the needle cover 908 to be removed from the cartridge 700.

[0179] Figure 3 schematically shows an exemplary cartridge 700, such as a cartridge 700 configured to be received in the cartridge housing of an automatic injector, like the automatic injector described in relation to the preceding figures.

[0180] The cartridge 700 comprises a cartridge compartment 702. The cartridge compartment 702 may be configured to contain a drug. The cartridge 700 has a first end 718 and a second end 720. The cartridge 700 comprises a cartridge outlet 714 located at the first cartridge end 718. The cartridge may be configured to release a drug through the cartridge outlet 714.

[0181] The cartridge includes a first stopper 708 that is movable within the cartridge compartment, for example toward the first cartridge end, in a first stopper direction 722. For example, the drug can be released through the cartridge outlet 714 as the first stopper 708 moves in the first stopper direction. The cartridge includes a cartridge back surface 716 at the second cartridge end. The cartridge back surface 716 has a cartridge rear end opening to allow the plunger rod to access the first stopper 708.

[0182] As shown in the diagram, the cartridge 700 can be a two-chamber cartridge. The cartridge includes a second stopper 710 that is movable inside the cartridge compartment 702, for example toward the first cartridge end, for example in the first stopper direction 722. The cartridge compartment 702 may have a first cartridge compartment 704 and a second cartridge compartment 706. The first cartridge compartment 704 is located between the first stopper 708 and the second stopper 710. The second cartridge compartment 706 is located between the second stopper 710 and the cartridge outlet 714. The cartridge includes a bypass section 712 to enable fluid communication between the first cartridge compartment and the second cartridge compartment. The bypass section 712 enables fluid communication between the first cartridge compartment and the second cartridge compartment when the second stopper 710 is positioned within the bypass section 712.

[0183] The first cartridge section 704 contains the first drug component 792 of the drug 790. The first drug component 792 may be a liquid, as illustrated. The second cartridge section 706 contains the second drug component 794 of the drug 790. The second drug component 794 may be a powder composition. By positioning the second stopper 710 within the bypass section 712, the first drug component 792 can be fed into the second cartridge section 706 via the bypass section 712, thereby mixing the first drug component 792 and the second drug component 794 to obtain the compound drug 790.

[0184] Figures 4a to 4d schematically show an exemplary cartridge assembly 600. The cartridge assembly 600 comprises an exemplary cartridge 700 and an exemplary cartridge coding mechanism 1000. The cartridge 700 has a first cartridge end 718 and a second cartridge end 720. The first stopper direction 722 is the direction from the second cartridge end 720 to the first cartridge end 718. The cartridge coding mechanism 1000 is positioned near the second cartridge end 720, for example, closer to the second cartridge end 720 than to the first cartridge end 718. In another exemplary cartridge assembly, the cartridge coding mechanism 1000 may be positioned near the first cartridge end 720.

[0185] Figures 4a to 4d illustrate different types of exemplary cartridge-cord mechanisms 1000.

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

[0187] Figure 4b illustrates an exemplary cartridge assembly 600 in which the cartridge coding mechanism 1000 includes a barcode. The cartridge coding mechanism 1000 may include one or more barcodes. The barcode may indicate a number that represents the code of the cartridge coding mechanism 1000.

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

[0189] Figure 4d illustrates an exemplary cartridge assembly 600 in which the cartridge coding mechanism 1000 includes an electromagnetically readable tag, such as an RFID tag or an NFC tag. The electromagnetically readable tag may contain data indicating the code of the cartridge coding mechanism 1000.

[0190] Figure 5 shows an exemplary system 2. System 2 comprises an automatic injection device 4, as described, for example, in relation to Figure 1, and an exemplary cartridge assembly 600. The cartridge assembly 600 comprises a cartridge 700 having a cartridge compartment 702, a needle assembly 900, and a cartridge cord mechanism 1000. The cartridge assembly 600 is received within the automatic injection device 4.

[0191] The cartridge assembly 600 includes a cartridge holder 800. The cartridge holder 800 is configured to retract the cartridge 700 into the cartridge housing 300 of the automatic injection device 4. The cartridge holder 800 includes a cartridge holding member 808. The cartridge holding member 808 engages with the cartridge housing 300 to receive and hold the cartridge 700 and the cartridge assembly 600 within the cartridge housing 300.

[0192] The needle assembly 900 comprises a needle 902 and a needle hub 904. The needle assembly 900 is attached to the cartridge 700 by the needle hub 904 having a cartridge holder coupling portion 906, such as a screw coupling portion, which engages with the needle assembly coupling portion 812 of the cartridge holder 800, for example. The needle 902 extends through the cartridge outlet 714 of the cartridge 700. The cartridge outlet 714 can be shielded by an elastic seal through which the needle 902 passes when the needle assembly 900 is attached to the cartridge 700.

[0193] The automatic injection device 4 includes a code sensor 24 configured to read the cartridge code mechanism 1000. As shown in the figure, when the cartridge assembly 600 is inserted, the cartridge code mechanism 1000 aligns with the code sensor 24.

[0194] The automatic injection device 4 comprises a plunger rod 400. The plunger rod 400 is configured to advance the first stopper of the cartridge 700. The plunger rod 400 comprises an outer plunger rod 404 having an internal thread and an inner plunger rod 402 having an external thread. The thread of the inner plunger rod 402 engages with the thread of the outer plunger rod 404. The outer plunger rod 404 is prevented from rotating relative to the housing of the automatic injection device. The motion of the plunger rod 400 includes the rotation of the inner plunger rod 402. The rotation of the inner plunger rod 402 results in the translational motion of the outer plunger rod 404, which is constrained to rotate. The outer plunger rod 404 is configured to move the first stopper of the cartridge 700 in the first stopper direction 722 when it is translated in the first stopper direction 722.

[0195] The drive module 500 is coupled to actuate the plunger rod 400. The drive module 500 can be electrically connected to a battery to receive power. The drive module 500 includes a motor 502, such as an electromechanical motor, such as a DC motor. The drive module 500 includes a transmission 504 for coupling the motor 502 to the plunger rod 402 inside the plunger rod 400.

[0196] The illustrated example includes a motor 502, which may be an electromechanical motor, but it will be readily apparent that the automatic injection device 4 can also be implemented with an alternative drive module, which may include a solenoid motor configured to actuate a plunger rod 400, a shape memory metal engine, a spring configuration and / or pressurized gas, etc.

[0197] The automatic injection device 4 includes a discharge sensor 26, such as a plunger rod position sensor. The discharge sensor 26 is configured to detect the position of the plunger rod 400. In the illustrated example, the discharge sensor 26 includes a tachometer configured to count / detect the rotations of the motor 502. Thus, the position of the plunger rod 400 can be determined based on the count of rotations of the motor 502. Based on the determination of the position of the plunger rod 400, the discharge sensor 26 can detect the release of the drug and / or air in the cartridge compartment. The position of the plunger rod 400 can indicate the position of the first stopper of the cartridge 700; for example, the most advanced position of the plunger rod 400 can indicate the position of the first stopper of the cartridge 700, for example, while the cartridge 700 is inside the cartridge housing 300.

[0198] Figures 6a to 6d schematically show the automatic injection device 4 and the cartridge assembly 600. Figures 6a to 6d schematically show exemplary positions of the contact member 1102 of the automatic injection device 4 in various situations.

[0199] The automatic injection device 4 includes a cartridge housing 300 configured to receive and hold a cartridge. The automatic injection device 4 includes a contact member 1102. The contact member 1102 may be movable between an extended contact member position and a retracted contact member position. The contact member 1102 includes a contact member projection 1112. The contact member projection 1112 is configured to move together with the contact member 1102. The contact member 1102 can be biased toward the extended contact member position, for example, by a contact member spring (not shown).

[0200] The contact member includes a needle cover engaging member 1114. The needle cover engaging member 1114 is configured to contact the needle cover contact surface of the needle cover, which is positioned on the cartridge inserted into the cartridge housing 300, for example.

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

[0202] The position of the first contact member can be detected by covering the first contact member sensor 1130 and the second contact member sensor 1132. The position of the second contact member can be detected by not covering the first contact member sensor 1130 and the second contact member sensor 1132. The extended position of the contact member can be detected by not covering the first contact member sensor 1130 and the second contact member sensor 1132.

[0203] Figure 6a schematically shows the automatic injection device 4 with no cartridge and / or cartridge assembly accepted. The contact member 1102 is in the extended position. The cartridge can be inserted into the cartridge housing 300 in the cartridge housing direction 322 through the contact member 1102 which defines the cartridge housing opening 301.

[0204] Figure 6b schematically shows the automatic injection device 4 into which the cartridge assembly 600 is received. The cartridge assembly 600 comprises a cartridge 700, a cartridge holder 800, and a needle assembly 900. The needle assembly comprises a needle 902 and a needle cover 908. The needle cover has a needle cover contact surface 910. The needle cover contact surface 910 engages with the needle cover engaging member 1114 of the contact member 1102. The contact member 1102 is in a second contact member position, for example, when the needle cover 908 is present and the needle cover contact surface 910 is in contact with the needle cover engaging member 1114. The contact member projection 1112 covers the second contact member sensor 1132. The contact member projection 1112 does not cover the first contact member sensor 1130.

[0205] Figure 6c schematically shows the automatic injection device 4 into which the cartridge assembly 600 is received. Compared to Figure 6b, the needle cover 908 has been removed. The contact member 1102 is in the extended position. The contact member 1102 is allowed to move to the extended position because the needle cover contact surface 910 does not contact the needle cover engaging member 1114. The contact member projection 1112 moves with the contact member 1102. The contact member projection 1112 does not cover the second contact member sensor 1132. The contact member projection 1112 does not cover the first contact member sensor 1130.

[0206] Figure 6d schematically shows the automatic injection device 4 into which the cartridge assembly 600 is received. The contact member 1102 is in the first contact member position. The first contact member position may be the retracted contact member position or close to the retracted contact member position. By pressing the contact member 1102 against the injection site, the contact member 1102 can be moved to the first contact member position, thereby inserting the needle 902 into the injection site. The contact member projection 1112 moves with the contact member 1102. The contact member projection 1112 covers the first contact member sensor 1130. The contact member projection 1112 covers the second contact member sensor 1132.

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

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

[0209] The automatic injection device 4 includes an orientation sensor 22. The orientation sensor 22 is configured to provide an orientation signal indicating the orientation of the cartridge being received in the automatic injection device 4. For example, the orientation sensor 22 may be configured to detect the orientation of the automatic injection device 4. The orientation of the cartridge can be determined based on the orientation of the automatic injection device 4. The orientation sensor 22 may be configured to detect the direction of gravity. For example, the orientation sensor 22 may include an accelerometer.

[0210] The orientation sensor 22 may be a single-axis or multi-axis gyroscope sensor that senses the dynamic angular velocity, such as the angular velocity of the automatic injection device during reversal, and the angle that the automatic injection device acts upon during reversal.

[0211] The processing unit 20 is coupled to the orientation sensor 22. The processing unit 20 can be configured to receive an orientation signal. The processing unit 20 can determine the orientation of the cartridge based on the orientation signal. The processing unit 20 can control the drive module 500 based on the orientation signal. For example, the processing unit 20 can be configured to control the drive module 500 to move the plunger rod based on the orientation signal. For example, the processing unit 20 can be configured to control the drive module 500 to move the plunger rod toward a plunger rod extension position, such as the premixing plunger rod position and / or the mixing plunger rod position and / or the preparation plunger rod position, only when the cartridge outlet is pointing upward. Alternatively or additionally, the processing unit 20 can provide a user output via the user interface 1100 based on the orientation signal.

[0212] The processing unit 20 can be configured to receive orientation signals 22 from an orientation sensor indicating the angular velocity during reversal and / or the angle affected by the automatic injection device. The processing unit 20 can be further configured to provide a start signal after multiple complete reversals of the automatic injection device have been performed, the number of complete reversals being determined based on the angular velocity and / or the angle affected by the automatic injection device 4 during the complete reversal, as indicated by the orientation signals 22 from the orientation sensor.

[0213] The automatic injection device 4 includes a code sensor 24. The code sensor 24 is configured to read the cartridge code mechanism and provide a code signal indicating the cartridge code mechanism. For example, the code sensor can be configured to read / detect a color code.

[0214] The processing unit 20 is coupled to the code sensor 24. The processing unit 20 is configured to receive code signals. Based on the code signals, the processing unit 20 can determine the cartridge code mechanism of the cartridge assembly. Based on the code signals, the processing unit 20 can control the drive module 500. For example, the processing unit 20 can be configured to control the drive module 500 to move the plunger rod toward a plunger rod extension position such as the premixing plunger rod position and / or the mixing plunger rod position and / or the preparation plunger rod position and / or the injection plunger rod position, based on the code signals. The processing unit 20 can be configured to determine thresholds such as a plunger rod threshold and / or a resistance threshold, based on the code signals. Alternatively or additionally, the processing unit 20 can provide user output via the user interface 1100 based on the code signals.

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

[0216] The processing unit 20 is coupled to the discharge sensor 26. The processing unit 20 is configured to receive the discharge sensor signal. The processing unit 20 can determine the position of the plunger rod based on the discharge sensor signal. The processing unit 20 can control the drive module 500 based on the discharge sensor signal. For example, the processing unit 20 can be configured to control the drive module 500 to start, stop, or continue the movement of the plunger rod based on the discharge sensor signal. For example, the processing unit 20 can be configured to determine the current plunger rod position based on the discharge sensor signal. Based on the discharge sensor signal, it can be determined that the plunger rod is in the premixing plunger rod position and / or the mixing plunger rod position and / or the preparation plunger rod position and / or the injection plunger rod position. Alternatively or additionally, the processing unit 20 can provide user output via the user interface 1100 based on the discharge sensor signal.

[0217] The automatic injection device 4 includes a cartridge sensor 28. The cartridge sensor 28 is configured to detect that a cartridge assembly has been accepted into the automatic injection device 4. The cartridge sensor 28 provides a cartridge sensor signal indicating that a cartridge assembly has been accepted.

[0218] The processing unit 20 is coupled to the cartridge sensor 28. The processing unit 20 is configured to receive the cartridge sensor signal. The processing unit 20 can control the drive module 500 based on the cartridge sensor signal. For example, the processing unit 20 may be configured to control the drive module 500 to start the movement of the plunger rod when the cartridge assembly is accepted and / or only when the cartridge assembly is accepted. Alternatively or additionally, the processing unit 20 may provide a user output via the user interface 1100 based on the cartridge sensor signal. The code sensor 24 and the cartridge sensor 28 may be the same sensor; for example, the code sensor 24 may be configured to detect the acceptance of the cartridge assembly and then read the cartridge code mechanism.

[0219] The automatic injection device 4 includes a needle sensor 30. The needle sensor 30 is configured to detect the needle of the cartridge assembly, and / or the needle assembly, and / or the needle cover of the needle assembly, when the cartridge assembly is received into the automatic injection device 4. The needle sensor 30 provides a needle signal indicating the presence of the needle of the cartridge assembly, and / or the needle assembly, and / or the needle cover of the needle assembly.

[0220] The processing unit 20 is coupled to the needle sensor 30. The processing unit 20 is configured to receive a needle signal. The processing unit 20 can control the drive module 500 based on the needle signal. For example, the processing unit 20 can be configured to control the drive module 500 to initiate movement of the plunger rod toward a plunger rod extension position, such as the premixing plunger rod position and / or the mixing plunger rod position and / or the preparation plunger rod position and / or the injection plunger rod position, only if a needle is present and / or absent, such as when the needle cover is removed. Detection of the needle cover can indicate the presence of a needle. The processing unit 20 can be configured to control the drive module 500 to initiate movement only if the needle cover has been detected and is subsequently not detected, such as when it is removed. Alternatively or additionally, the processing unit 20 can provide user output via the user interface 1100 based on the needle signal. The needle sensor 30 may be part of a contact member sensor, as illustrated in Figure 6.

[0221] The automatic injection device 4 includes a resistance sensor 32. The resistance sensor 32 is configured to detect the resistance to the movement of the plunger rod of the automatic injection device 4. The resistance sensor 32 can be configured to detect the resistance to the movement of the plunger rod based on measurements from the drive module 500. For example, the resistance sensor 32 can be configured to detect the motor current of the drive module 500. The resistance sensor 32 is configured to provide a resistance signal indicating the resistance to the movement of the plunger rod.

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

[0223] An automatic injection device 4 having all of the above-mentioned elements is illustrated. However, alternatively, the automatic injection device may have only one of the above-mentioned elements or any combination of one or more of the above-mentioned elements.

[0224] The automatic injection device includes a user interface 1100. The user interface 1100 may include one or more input members, such as a first input member, for receiving user input. The user interface is configured to provide a user input signal indicating the user input being received. The user interface 1100 may provide a first input signal and / or a second input signal.

[0225] The processing unit 20 is coupled to the user interface 1100. The processing unit 20 is configured to receive user input signals, such as a first input signal and / or a second input signal. The processing unit 20 can control the drive module 500 based on the user input signals. For example, the processing unit 20 can be configured to control the drive module 500 to move the plunger rod towards a plunger rod extension position, such as a premixing plunger rod position and / or a mixing plunger rod position and / or a preparation plunger rod position and / or an injection plunger rod position, based on and / or in accordance with the user input signals.

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

[0227] Figures 8a–8f schematically show exemplary cartridge assemblies 600 and plunger rods 400. The cartridge assembly 600 comprises a cartridge 700, similar to the cartridge described in relation to Figure 3, a cartridge holder 800, and a needle assembly 900. For clarity, an automatic injection device including a plunger rod 400 is not shown.

[0228] The cartridge holder 800 includes a cartridge holding member 808. The cartridge holding member 808 is configured to engage with the cartridge housing of the automatic injection device. The cartridge holder 800 also includes a needle assembly coupling portion 812. The needle assembly coupling portion 812 is configured to engage with the cartridge holder coupling portion 906 of the needle assembly 900. The needle assembly coupling portion 812 allows the needle to be attached to the cartridge 700.

[0229] The needle assembly 900 comprises a needle 902 and a needle hub 904. The needle assembly 900 is attached to the cartridge 700 by the needle hub 904 having a cartridge holder coupling portion 906, such as a screw coupling portion, which engages with the needle assembly coupling portion 812 of the cartridge holder 800, for example. The needle 902 extends through the cartridge exit 714 of the cartridge 700.

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

[0231] Figure 8b schematically shows the plunger rod 400 in an exemplary premixed plunger rod position. Compared to Figure 8a, the plunger rod 400 is moved toward the plunger rod extended position. The front end 410 of the plunger rod 400 abuts against the first stopper 708. Thus, the movement of the plunger rod 400 in the first plunger rod direction 422 causes the first stopper 708 to begin moving in the first stopper direction 722. The second stopper 710 is located, for example, behind the bypass portion 712, which does not form a fluid connection between the first sub-compartment 704 and the second sub-compartment 706.

[0232] Figure 8c schematically shows a situation in which the plunger rod 400 is in an exemplary position where a fluid connection is established between the first subcompartment 704 and the second subcompartment 706 via the bypass portion 712. The front end 410 of the plunger rod 400 abuts against the first stopper 708. The plunger rod 400 moves the first stopper 708 in the first stopper direction 722 by moving in the first plunger rod direction 422. The second stopper 710 is located within the bypass portion 712, which forms a fluid connection between the first subcompartment 704 and the second subcompartment 706. Therefore, for example, the movement of the plunger rod 400 in the first plunger rod direction 422 causes further movement of the first stopper 708 in the first stopper direction 722, which in turn causes the contents of the first subcompartment 704, such as a first pharmaceutical component (not shown), to be delivered to the second subcompartment 706 through the bypass portion 712.

[0233] Figure 8d schematically shows the plunger rod 400 in an exemplary mixing plunger rod position. The front end 410 of the plunger rod abuts against the first stopper 708. The first stopper 708 abuts against the second stopper 710. The first sub-compartment 704 is compressed. The second stopper 710 is positioned behind the bypass portion 712. Thus, the fluid connection between the first sub-compartment 704 and the second sub-compartment 706 is closed.

[0234] Figure 8e schematically shows the plunger rod 400 in an exemplary ready plunger rod position. Compared to Figure 8d, the plunger rod 400 is moved toward the plunger rod extended position, for example, to release air from the cartridge compartment 702.

[0235] Figure 8f schematically shows the plunger rod 400 in an exemplary injection plunger rod position. For example, after injection is complete, the plunger rod 400 may be in the injection plunger rod position. The first stopper 708 and the second stopper 710 are located close to the cartridge outlet 714. For example, the contents of the cartridge compartment, such as a drug, are being released through, for example, the cartridge outlet 714 and / or the needle 902. A residual amount of drug may remain in the cartridge.

[0236] Figure 9 shows an exemplary trace T of the resistance Re to the motion of the plunger rod as the plunger rod position P is determined. The plunger rod is moved from the plunger rod retracted position PR to the plunger rod extended position PE. At the beginning of the motion, the resistance to the motion of the plunger rod is constant Ex1, for example, the plunger rod has not yet pressed the stopper. Subsequently, the front end of the plunger rod contacts the first stopper of the cartridge, and the resistance to the motion of the plunger rod increases Ex2. This increase in resistance is caused by the resistance to the motion of the first stopper, for example, due to friction. The resistance may decrease slightly after the first stopper has started to move, as illustrated. As the plunger rod approaches the plunger rod extended position PE, the resistance may increase again Ex3, for example, due to the first stopper approaching the end of the cartridge.

[0237] Trace T is an example of the resistance to plunger rod movement when the accepted cartridge is new and / or unused and / or a normal cartridge. Cartridge parameters can be determined based on resistance and / or plunger rod position. Cartridge parameters can be determined based on one or more thresholds, such as resistance thresholds Re1 and / or high resistance threshold Re2, and / or plunger rod thresholds P1 and / or second plunger rod threshold P2.

[0238] Other situations, such as when an accepted cartridge is clearly used and / or defective, are illustrated by additional exemplary traces T2, T3, and T4.

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

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

[0241] Trace T4 indicates, for example, an exemplary situation in which the resistance to motion increases above a high resistance threshold Re2 after the plunger rod position has passed a first plunger rod threshold P1. Such a situation may indicate that the first stopper is being prevented from moving, for example, by a faulty cartridge. After such a situation, the plunger rod can be retracted to the plunger rod retracted position, and an error message may be provided through the user interface.

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

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

[0244] The automatic dispensing device may include a cartridge housing configured to receive a cartridge comprising a first stopper and a cartridge compartment containing a drug. The cartridge compartment may have a first cartridge compartment containing a first drug component of the drug and a second cartridge compartment containing a second drug component of the drug. The automatic dispensing device may further include a plunger rod configured to move the first stopper.

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

[0246] The second plunger rod position may be a preparation plunger rod position. The preparation plunger rod position can be selected to position the first stopper at a location where the amount of air in the cartridge compartment is reduced to a suitable amount for injection.

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

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

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

[0250] Step 6006, which moves the plunger rod from the mixing plunger rod position to the second plunger rod position, may require that a start signal be given. The start signal may be given after several complete inversions of the automatic injector have been performed and when the second cartridge subcompartment is pointing upward relative to the first cartridge subcompartment.

[0251] Step 6008, which involves receiving a trigger event, may include receiving a user input signal from a user interface, such as receiving a trigger event from a trigger member, which may occur, for example, when a user presses a button. The trigger event may occur when a user instructs the start of injection. The trigger event may occur when a user presses the front portion of the automatic injection device against the intended injection site. The trigger event may include a contact member signal indicating that a contact member of the automatic injection device is in a first contact member position.

[0252] As a result of moving the plunger rod to the injection plunger rod position 6010, the drug can be dispensed through the cartridge outlet, such as through the needle. The step of moving the plunger rod 6010 can be performed after step 6008, which receives a trigger event, for example, after step 6006, which moves the plunger rod to the second plunger rod position, is completed.

[0253] Figure 11 shows a flowchart of an exemplary method 6000''. Method 6000'' includes the same steps as those described in relation to the preceding figures. However, method 6000'' is an example of a method that includes additional steps, namely, a step 6014 of receiving a first input signal; a step 6016 of detecting that a cartridge has been received in the cartridge housing of an automatic injector, for example; a step 6018 of determining the orientation of the cartridge; a step 6020 of reading the cartridge code mechanism; a step 6022 of detecting the removal of the needle cover; a step 6024 of moving the plunger rod to a first plunger rod position, such as the premixed plunger rod position; a step 6026 of detecting resistance to the movement of the plunger rod; and a step 6019 of determining a start signal.

[0254] Step 6014, receiving a first input signal, may include receiving a user input signal from a user interface, for example, arising from a user pressing a button. The first input signal may arise from a user turning on an automatic injector.

[0255] Step 6016 for detecting that a cartridge has been accepted may include detecting that a user has inserted a cartridge into the cartridge housing through the cartridge housing opening. Step 6016 for detecting that a cartridge has been accepted may also include detecting that a cartridge is present in the cartridge housing.

[0256] Step 6014, which receives the first input signal, and step 6016, which detects that the cartridge has been accepted, may be replaced.

[0257] Step 6018, which determines the orientation of the cartridge, may include determining the orientation using an orientation sensor such as an accelerometer. Step 6018, which determines the orientation of the cartridge, may also include determining the orientation of the automatic dispensing device. Step 6018, which determines the orientation of the cartridge, may also include determining whether the cartridge outlet is pointing upwards or downwards.

[0258] Method 6000'' includes step 6020 of reading the cartridge code mechanism. The cartridge code mechanism may indicate one or more cartridge specifications. Subsequent steps of Method 6000'' may include adaptations based on the cartridge specifications. For example, subsequent steps of Method 6000'' may be adjusted for a specific cartridge that is received and identified.

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

[0260] Step 6024, which moves the plunger rod to the first plunger rod position, may include the initial movement of the first stopper of the cartridge, for example, by moving the first stepper without initiating the mixing of the two component drugs.

[0261] Step 6024, which moves the plunger rod to the first plunger rod position, can be performed after step 6016, which detects that the cartridge has been accepted into the cartridge housing, and step 6014, which receives the first input signal. For example, step 6024, which moves the plunger rod to the first plunger rod position, can be performed only after step 6016, which detects the cartridge, and step 6014, which receives the first input signal.

[0262] Step 6024, which moves the plunger rod to the first plunger rod position, can be performed simultaneously with step 6020, which reads the cartridge code mechanism.

[0263] Step 6026, which detects resistance to the movement of the plunger rod, can be performed simultaneously with step 6024, which moves the plunger rod to a first plunger rod position, as illustrated. Step 6026, which detects resistance to the movement of the plunger rod, can indicate cartridge parameters of an accepted cartridge, such as whether the cartridge is new, used, or defective.

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

[0265] Step 6004, which moves the plunger rod to the mixed plunger rod position, may be based on one or more of the following: the cartridge cord mechanism, removal of the stylus cover, resistance to the movement of the plunger rod, and / or the orientation of the cartridge.

[0266] Step 6006, which moves the plunger rod to the second plunger rod position, may require that a reconstruction time has elapsed since the plunger rod has completed its movement to the mixed plunger rod position. Method 6000'' includes a step 6019 for determining the reconstruction time. Step 6019 for determining the reconstruction time may be based on one or more of the following: the cartridge cord mechanism, the removal of the needle cover, the resistance to the movement of the plunger rod, and / or the orientation of the cartridge. Step 6019 for determining the reconstruction time may include determining a first motion parameter, such as the amount of motion of the automatic injector, such as the shaking of the automatic injector, and / or the number of reversals of the automatic injector. The first motion parameter may be determined based on an orientation signal from an orientation sensor, such as an accelerometer. Step 6019 for determining the reconstruction time may include receiving the orientation signal.

[0267] Step 6019, which determines the reconstruction time, can be determined based on a combination of the first motion parameters and / or cartridge-code mechanism.

[0268] Step 6006, which moves the plunger rod to the second plunger rod position, may be based on one or more of the following: the cartridge cord mechanism, removal of the stylus cover, resistance to the movement of the plunger rod, and / or the orientation of the cartridge.

[0269] Step 6010, which moves the plunger rod to the injection plunger rod position, may be based on one or more of the cartridge cord mechanism, removal of the needle cover, and / or resistance to the movement of the plunger rod.

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

[0271] Figs. 12a to 12d schematically illustrate an exemplary user interface 1100 of an exemplary automatic injection device 4 such as the automatic injection device 4 illustrated in Fig. 1.

[0272] The user interface 1100 includes a first output member 1110 such as, for example, a plurality of LEDs, as illustrated. The first output member 1110 can enable user output to the user. The first output member 1110 can be used to indicate a certain step in the procedure to the user and / or to indicate an error message. The first output agent 1110 includes a first LED 1116, a second LED 1118, and a third LED 1120.

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

[0274] The user interface 1100 includes a contact member 1102, for example, at the front end of the automatic injection device 4. The contact member 1102 can be configured to be pressed against the injection site. The contact member 1102 can 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 by blinking.

[0275] The user interface 1100 includes a first input member 1108, such as, for example, a button. The first input member 1108 can enable user input from the user. For example, the first input member 1108 can be used to receive a press from the user to proceed to the next step. The first input member 1108 can serve as a fourth output member of the user interface 1100. For example, the first input member 1108 may be configured to light up, such as by blinking.

[0276] Fig. 12a schematically shows a situation of the user interface 1100 where none of the output members are active, for example, where the automatic injection device 4 can be turned off.

[0277] FIG. 12b schematically shows a situation of the user interface 1100 where the first input member 1108 and the contact member 1102 are lit, such as by flashing. The first input member 1108 and the contact member 1102 can flash synchronously and / or asynchronously. The situation shown can be a situation indicating that the user should press the first input member 1108 and / or insert a cartridge through the contact member 1102. The situation shown can be a situation after the automatic injection device is turned on.

[0278] FIG. 12c schematically shows a situation of the user interface 1100 where the first input member 1108 and the second LED 1118 are lit, such as by flashing. The situation shown can be a situation indicating that the user should press the first input member 1108 to proceed to the next step. The situation shown can be a situation after mixing the drug components and / or before performing an air shot.

[0279] FIG. 12d schematically shows a situation of the user interface 1100 where the first input member 1108, the contact member 1102, and the third LED 1120 are lit, such as by flashing. The first input member 1108, the contact member 1102, and the third LED 1120 can flash synchronously and / or asynchronously. The situation shown can be a situation indicating that the user should press the contact member 1102 against the intended injection site to inject the drug. The situation shown can be a situation before injecting the drug.

[0280] FIGS. 13a to 13c schematically show an exemplary movement of the exemplary automatic injection device 4, such as the movement of the first motion parameter.

[0281] FIG. 13a shows the automatic injection device 4 in the first position, where the first end 4a of the automatic injection device 4 points substantially upward. The second end 4b of the automatic injection device 4 points substantially downward.

[0282] Figure 13b shows the automatic injection device 4 moved to the second position, with the first end 4a of the automatic injection device 4 pointing substantially downwards. The second end 4b of the automatic injection device 4 points substantially upwards.

[0283] Figure 13c shows an automatic injector 4 being moved to a third position, such as behind a first position, with the first end 4a of the automatic injector 4 pointing substantially upwards and the second end 4b of the automatic injector 4 pointing substantially downwards. The first motion parameter may indicate the number of reversals of the automatic injector 4, such as the number of times the automatic injector 4 has been moved from the first position to the second position, and optionally to the third position, such as returning to the first position. A processing unit (not shown in Figure 13) may be configured to detect and / or count the number of reversals.

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

[0285] Similarly, in the illustrated example, the first end 4a of the automatic injection device 4 in the second position points directly downwards, but it may suffice for the first end 4a of the automatic injection device 4 to point, for example, within 45 degrees from downwards.

[0286] The reconstruction time may depend on a complete inversion, as described in relation to Figure 13. For example, reconstruction may require a certain number of inversions, such as five, at frequencies within a default / predetermined frequency range, such as between 0.3 and 1.2 Hz. For example, the reconstruction time may be the time used to perform that number of complete inversions. The required number of complete inversions and / or frequency range can be determined based on the cartridge-code mechanism, for example, the cartridge-code mechanism may indicate the number of inversions and / or the frequency range of the inversions.

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

Claims

1. An automated infusion device for administering drugs, Housing and A cartridge housing is configured to receive a cartridge comprising a cartridge code mechanism, a first stopper, and a cartridge compartment containing the drug, - The cartridge section comprises a first cartridge section containing a first drug component of the drug and a second cartridge section containing a second drug component of the drug. - The cartridge cord mechanism is, - Multiple reversals, and - Frequency range and / or frequency threshold To show, Cartridge housing section, A drive module is coupled to move the plunger rod between a retracted position and an extended position, wherein the plunger rod is configured to move the first stopper, and the drive module is configured to move the plunger rod. A code sensor configured to read the aforementioned cartridge code mechanism, A processing unit coupled to the drive module and the code sensor, - A step of receiving a code signal indicating the cartridge code mechanism from the code sensor, - A step of controlling the drive module to move the plunger rod from a first plunger rod position to a mixing plunger rod position at a mixing plunger rod speed, wherein the mixing plunger rod position is selected to position the first stopper at a position where the first drug component is mixed with the second drug component. - After multiple complete inversions of the automatic injection device have been performed within the frequency range for inversion and / or at least at the frequency threshold, a start signal is provided. A processing unit and An automatic injection device equipped with the following features.

2. The automatic injection device according to claim 1, wherein the reversal frequency reverses at least 0.5 times per second.

3. The automatic injection device according to claim 1 or 2, wherein the reversal frequency is less than 10 times per second.

4. The automatic injection device according to any one of claims 1 to 3, wherein the frequency threshold is 0.3 Hz to 10 Hz.

5. The automatic injection device according to any one of claims 1 to 4, wherein the start signal is generated after the multiple complete inversions of the automatic injection device have been performed and when the second cartridge portion is pointing upward compared to the first cartridge portion.

6. The automatic injection device according to any one of claims 1 to 5, further comprising an orientation sensor configured to detect the orientation of the cartridge and / or the orientation of the automatic injection device.

7. The automatic injection device according to claim 6, wherein the detection of the reversal of the automatic injection device is performed using the orientation sensor.

8. The automatic injection device according to claim 6 or 7, wherein the orientation sensor includes one or more accelerometers.

9. The automatic injection device according to any one of claims 1 to 8, further comprising a temperature sensor configured to provide a temperature signal indicating the temperature of the automatic injection device and / or the cartridge and / or the drug, wherein the processing unit is coupled to the temperature sensor and further configured to receive the temperature signal from the temperature sensor.

10. The automatic injection device according to claim 9, wherein the frequency threshold is based on the temperature signal.

11. The automatic injection device according to any one of claims 1 to 10, wherein the processing unit is further configured to control the drive module to move the plunger rod from the mixing plunger rod position to the second plunger rod position upon receiving the start signal.

12. The automatic injection device according to any one of claims 1 to 11, wherein the processing unit is further configured to perform a dry run after the multiple inversions have been performed, and the dry run is performed only when the second cartridge portion is pointing upward compared to the first cartridge portion.

13. A system comprising an automatic injection device according to any one of claims 1 to 12 and a cartridge, wherein the cartridge comprises a cartridge code mechanism, a first stopper, and a cartridge compartment containing the drug, the cartridge compartment having a first cartridge portion containing a first drug component of the drug and a second cartridge portion containing a second drug component of the drug, and the cartridge code mechanism exhibits multiple complete reversals.

14. The system according to claim 13, wherein the cartridge cord mechanism further indicates a frequency range and / or frequency threshold.

15. A method for controlling an automatic injection device according to any one of claims 1 to 12, or a system according to claim 13, - A step of receiving a code signal indicating multiple complete inversions, - A step of moving the plunger rod from a first plunger rod position to a mixing plunger rod position at a mixing plunger rod speed, wherein the mixing plunger rod position is selected to position the first stopper at a position where the first drug component is mixed with the second drug component. - After multiple complete inversions of the automatic injection device have been performed, the step of providing a start signal and Methods that include...

16. The method described above is - A step of receiving a code signal indicating the frequency range and / or frequency threshold, - After multiple complete inversions of the automatic injection device have been performed within the frequency range for the inversion and / or at a frequency of at least the frequency threshold, a start signal is provided. The method according to claim 15, further comprising:

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