Autoinjector measures remaining battery capacity before recharging is required

Abstract

Described herein is an autoinjector for administering a medication, the autoinjector having the ability to initiate the autoinjector process only if the autoinjector battery is sufficiently charged.

Description

[Technical field]

[0001] The present disclosure relates to autoinjectors, such as electronic autoinjectors, and systems having an autoinjector and a cartridge, the autoinjector having a feature that allows a user to initiate an autoinjector procedure only if the autoinjector battery is sufficiently charged. [Background technology]

[0002] Autoinjectors, such as electronic autoinjectors, have been developed and are widely used to assist in the administration of fluids or medicines (medications) to the body. The most common type of autoinjection device adapted to receive and release a dose of a drug-filled cartridge (also referred to as a reservoir or container) is generally elongated and, for example, in pen form to be held in one hand of a user, and utilizes a so-called cartridge holder adapted to receive and mount the cartridge in the device. Correspondingly, most pen-type drug delivery devices have a generally cylindrical cartridge holder for receiving and holding, in a mounted position, a generally cylindrical drug-filled cartridge, the cartridge having a body with a proximally opposed and axially movable piston and a housing in which a drug release mechanism is located, the mechanism having an axially movable piston rod adapted to engage the piston of the mounted cartridge and thereby release a dose of drug from the cartridge. Between the cartridge holder and the body, coupling means are provided that enable the user to remove the cartridge holder from the body and reattach it when a used cartridge is replaced with a new cartridge. The cartridge is inserted into the cartridge holder by axial movement through a proximal opening. Conventionally, the coupling means are in the form of a threaded connection or a bayonet coupling.

[0003] However, using electronic means creates the risk of electrical current passing through the body, thereby causing an electric shock in the user. In particular, conventional hypodermic needles are made of metal and therefore conductive. Electrical shock can cause serious injuries, which can be potentially life-threatening, especially if the device is tied to the main power grid.

[0004] Particularly in the field of medical devices such as autoinjectors, safety is an important issue. Thus, precautions are necessary to prevent or reduce the risk of electric shock in users of autoinjectors. Furthermore, precautions are the subject of industry standards such as ISO 11608 and IEC 60601, which relate to needle-based injection systems for medical use and medical electrical equipment.

[0005] WO2017114912 describes an autoinjector with a charger safety feature that ensures that when a cartridge is inserted into the autoinjector, an opening in the autoinjector housing that would allow charging of a battery internal to the autoinjector cannot be accessed.

[0006] Some autoinjectors further include a configuration that ensures that the cartridge remains locked inside the autoinjector once the autoinjector process is initiated. The cartridge may be locked, for example, by movement of a plunger rod into the cartridge for release of the medicinal product. Examples of such locking solutions are described in WO2017114906.

[0007] When combining the cartridge locking of WO2017114906 and the charger safety features of WO2017114912, if the autoinjector battery runs out of power partway through a drug delivery step, a situation may arise where there is not enough battery power to perform the drug delivery and then drive the plunger rod so that the cartridge returns to the unlocked position from the autoinjector, thereby allowing the cartridge to be removed from the autoinjector after use. If the autoinjector runs out of power it is permanently disabled and the device cannot be charged when the cartridge is inserted because without battery power and for safety reasons the cartridge cannot be released from the autoinjector.

[0008] US Patent Publication No. 20180236181 discloses an autoinjector having a main control unit, which determines whether the battery has sufficient charge to complete the entire drug delivery process, including a drug warming step prior to the start of the drug delivery step. If the battery has sufficient charge, the autoinjector device may prompt the user to start the drug delivery process. Alternatively, if the battery does not have sufficient charge, the autoinjector device may display a request message to charge the battery prior to the start of the drug delivery process. The autoinjector requires more energy at lower temperatures to perform the entire drug delivery process due to the increased viscosity of the drug solution. Therefore, the autoinjector has a heating unit. If the autoinjector determines that the temperature is below a preset threshold, the autoinjector automatically operates the heating unit to warm the drug solution to a suitable operating temperature prior to drug administration. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] International Publication No. 2017114912 [Patent Document 2] International Publication No. 2017114906 [Patent Document 3] US Patent Application Publication No. 20180236181 Summary of the Invention [Problem to be solved by the invention]

[0010] Therefore, there is a need for an autoinjector that ensures that the battery does not run out of power before the cartridge can be removed from the autoinjector and allows the autoinjector battery to be recharged. There is also a need for a more compactly constructed autoinjector that reduces the number of functional parts, e.g., heating units, to ensure that the autoinjector does not run out of power during the drug delivery process, even at lower temperatures. [Means for solving the problem]

[0011] In autoinjectors with rechargeable batteries and user interfaces with modules that prompt the user to recharge the battery when the remaining battery voltage is at or below a predetermined minimum battery voltage value, the minimum battery voltage value is often set at room temperature. However, this becomes problematic when using autoinjectors for delivery of high viscosity medicines, as the viscosity of liquid medicines increases the lower the temperature of the medicine. This effect is more noticeable when temperatures are below 15 degrees Celsius for many high viscosity liquids.

[0012] Because the force required to expel a liquid medicine through a small cartridge outlet increases as the viscosity of the medicine increases, more battery voltage is required to expel a high viscosity medicine through a thin needle than to expel a low viscosity liquid. Thus, if the temperature of the medicine is lower than the temperature used to define the lower predetermined value, a situation may arise where the voltage drops to zero and the battery runs out of power before the autoinjector process, e.g., the medicine expulsion process, is complete.

[0013] Furthermore, battery performance is temperature dependent: the colder the battery, the faster it will run out of power and require recharging.

[0014] Thus, disclosed herein is an autoinjector for administering a pharmaceutical agent, the autoinjector comprising: - a cartridge receiver configured to receive a cartridge, the cartridge having a cartridge outlet, a cartridge compartment containing a medicinal product, and a first stopper; - a plunger rod configured to move a first stopper within the cartridge compartment to release the medicament through the cartridge outlet; - a drive module configured to move the plunger rod from a retracted plunger rod position to an extended plunger rod position; - a temperature sensor configured to measure a temperature of the autoinjector; - a rechargeable battery configured to power at least the drive module when moving the plunger rod; - a battery calculation module configured to calculate a residual electric battery voltage level of a rechargeable battery; a processing unit coupled to the temperature sensor, the battery calculation module, and the drive module.

[0015] The remaining electric battery voltage level of a rechargeable battery may provide a measure of the remaining residual electric battery power.

[0016] The processing unit is - Receives the measured temperature from the temperature sensor; - receiving a calculated residual electric battery voltage level of the rechargeable battery from a battery calculation module; - obtaining a preset threshold value indicating a minimum electrical battery voltage level required to perform an autoinjector process at a temperature measured by the temperature sensor; - comparing the calculated remaining electric battery voltage level with a derived preset threshold value.

[0017] The processing unit may be further configured to initiate the autoinjector process only if the calculated remaining electric battery voltage level is greater than a preset threshold.

[0018] Also disclosed herein is a method of ensuring that a rechargeable battery within an autoinjector contains sufficient voltage to enable the autoinjector to perform an autoinjector procedure, the autoinjector comprising: - a cartridge receiver configured to receive a cartridge containing the pharmaceutical product; - a temperature sensor configured to measure a temperature of the autoinjector; - a rechargeable battery configured to power at least a drive module to move a plunger rod within the autoinjector; - a battery calculation module configured to calculate a residual electric battery voltage level of a rechargeable battery; - a processing unit coupled to the temperature sensor, the battery calculation module and the drive module, the processing unit being configured to perform the method.

[0019] The method is: - receiving a measured temperature from a temperature sensor; - receiving a calculated remaining electric battery voltage level of the rechargeable battery from a battery calculation module; - obtaining a preset threshold value indicative of a minimum electrical battery voltage level required to perform an autoinjector process at a measured temperature; - comparing the calculated remaining electric battery voltage level with the obtained preset threshold value.

[0020] The method may further include initiating an autoinjector process only if the calculated remaining electric battery voltage level is greater than a preset threshold.

[0021] Additionally disclosed herein is a system having an autoinjector and a cartridge having a cartridge outlet, a cartridge compartment containing a pharmaceutical agent, and a first stopper.

[0022] The preset threshold represents a measurement of the minimum electrical battery voltage required to perform an autoinjector procedure. The preset threshold may also be obtained indirectly by calculating an estimated count of remaining injection cycles that a user may perform without recharging the battery.

[0023] Although a check on the remaining battery voltage level at the time of activating the autoinjector is introduced, the processing unit is able to refuse to activate the autoinjector step that advances the plunger rod, which may lock the cartridge inside the autoinjector, in case the battery voltage level falls below the acceptable limit. This ensures that the cartridge does not get stuck in the autoinjector without the option to recharge the battery, allowing the movement of the plunger rod to a position where the cartridge is unlocked and can be removed again from the autoinjector. The autoinjector according to the above takes into account the temperature effect on the viscosity of the medicine and the temperature dependent battery performance. The temperature sensor measurements ensure that the medicine viscosity correlated to the battery voltage required to reconstitute and inject the medicine can be taken into account when calculating the minimum acceptable battery voltage level required to perform the autoinjector step.

[0024] With the above autoinjector, systems and methods advantageously provide an autoinjector that ensures that the battery is fully charged before an autoinjector process is allowed to begin, thus ensuring that an entire autoinjector process can be completed before additional recharging of the battery is required, independent of the temperature at which the autoinjector is used to perform a pharmaceutical delivery process.

[0025] This further ensures that the cartridge does not become stuck in the autoinjector midway through an autoinjector process, such as a pharmaceutical delivery process, as a result of the battery running out of power during the process.

[0026] It is contemplated that any embodiment or element described in connection with any one aspect may be used with any other aspect or embodiment, mutatis mutandis.

[0027] Autoinjector temperature means the temperature measured by an autoinjector temperature sensor at any location within the autoinjector. In one or more embodiments, the autoinjector temperature is one or more of the following: - Ambient temperature, and / or - the temperature in the vicinity of the medicine in the cartridge, and / or - a temperature indicating the temperature of the medicine in the cartridge, and / or - The temperature of the autoinjector near the battery, and / or - Temperature, which indicates the temperature of the battery, and / or - Any combination of the above.

[0028] Most often, the autoinjector temperature is the ambient temperature measured near the battery inside the autoinjector. Ambient temperature may also characterize the battery's ability to power the autoinjector system, as at low temperatures the battery may be limited in supporting the autoinjector process.

[0029] In one or more instances, the minimum allowable battery voltage level is programmed into a control system within the autoinjector. Thus, the minimum allowable battery voltage level may be obtained / calculated by the control system after obtaining the measured temperature. The minimum allowable battery voltage level may be higher for lower temperatures.

[0030] In one or more examples, the processing unit may be further configured to prompt a user to recharge the battery if the calculated remaining electric battery voltage level is less than a preset threshold required to perform an autoinjector procedure at the measured temperature.

[0031] In one or more embodiments, the temperature sensor, the battery calculation module, and the processing unit are configured to perform the steps outlined above and prompt the user to recharge the battery if the cartridge is not received in the autoinjector and the calculated remaining electric battery voltage level is less than a preset threshold required to perform an autoinjector procedure at the measured temperature. Thus, the autoinjector performs a battery capacity test at the measured temperature and prompts the user that the battery needs to be recharged before initiation of a pharmaceutical delivery autoinjector procedure can occur. Alternatively, the cartridge may be inserted into the autoinjector and the processing unit checks whether there is a sufficient electric battery voltage level to perform an autoinjector procedure at the measured temperature. However, if there is not a sufficient electric battery voltage level to perform an autoinjector procedure, the plunger rod is not permitted to move from the stored position to initiate the autoinjector procedure.

[0032] The autoinjector step can be one or more of the following: - a first plunger rod movement step, in which the plunger rod is moved from a retracted plunger rod position to a locked plunger rod position, and in the locked plunger rod position, the cartridge is locked inside the autoinjector; - a second plunger rod moving step, in which the plunger rod is moved from a lock plunger rod position to a first stopper plunger rod position carrying the plunger rod in contact with the first stopper; - a third plunger rod moving step, the plunger rod moving the first stopper to move the second stopper to a bypass position within the cartridge compartment to establish a fluid connection between the first cartridge sub-compartment and the second cartridge sub-compartment within the cartridge compartment; - a fourth plunger rod moving step, wherein the plunger rod moves the first stopper into contact with the second stopper to mix the pharmaceutical ingredients in the first cartridge sub-compartment and the second cartridge sub-compartment; - a fourth plunger rod movement step in which the plunger rod is moved to an extended plunger rod position, in which the medicinal product is expelled from the cartridge, such as being completely expelled from the cartridge; - The cartridge can be removed from the autoinjector and the autoinjector reset to its original position; - Any drug delivery process having a combination of the above steps.

[0033] The fourth plunger rod movement step may also be referred to as a drug reconstitution step.

[0034] The fifth plunger rod movement step may also be referred to as the drug release step.

[0035] During reconfiguration of the autoinjector, the plunger rod moves to the retracted position.

[0036] When the cartridge is removed from the autoinjector, a new cartridge can be inserted into the autoinjector.

[0037] Reconstitution refers to mixing dry pharmaceutical ingredients with liquid pharmaceutical ingredients to obtain a mixed medicinal product ready for delivery to a patient, which may be a human being or an animal such as a cat, dog, horse, cow, sheep or pig.

[0038] The dry pharmaceutical ingredient can be, for example, a lyophilized pharmaceutical ingredient.

[0039] Reconstitution is typically performed just prior to delivery of the pharmaceutical agent.

[0040] The drug release step refers to moving the plunger rod from a retracted plunger rod position to an extended plunger rod position in which the drug is released from the cartridge compartment through the cartridge outlet. Delivery of the drug to the patient can occur during this step.

[0041] The autoinjector process can be a complete injection cycle including at least a first plunger rod movement step, a drug reconstitution step, a drug release step, and a resetting of the autoinjector to its original position where the cartridge can be removed from the autoinjector, thereby allowing insertion of a new cartridge into the autoinjector.

[0042] In one or more instances, the preset thresholds indicative of the voltage required to perform the autoinjector process are set to a first fixed threshold for temperatures above the predetermined threshold temperature and a second fixed threshold for temperatures at or below the predetermined threshold temperature. In this way, the autoinjector distinguishes between the battery voltage required at high temperatures and the battery voltage required at low temperatures. The first fixed threshold may indicate a minimum electrical battery voltage level required to perform the autoinjector process at the predetermined threshold temperature. This ensures that when the autoinjector is used at temperatures above the predetermined threshold temperature, there is always sufficient battery voltage to perform the process, since the battery voltage required to perform the autoinjector process decreases with increasing temperature.

[0043] The second threshold may be twice as high as the first threshold, and thus may be set equal to twice the minimum electrical battery voltage level required to perform the autoinjector process at a given threshold temperature, whereby a higher requirement on the battery voltage level remaining in the battery is used when the temperature sensor measures a lower temperature below the given threshold temperature.

[0044] The second threshold may be between 3000MV and 4500MV, such as between 3500MV and 4000MV, such as between 3800MV and 3900MV, such as 3850MV.

[0045] The predetermined threshold temperature may be at or below 15 degrees Celsius, such as at or below 14 degrees Celsius, such as at or below 13 degrees Celsius, such as at or below 12 degrees Celsius. Depending on the viscosity of the medicament in the cartridge adapted to be received in the autoinjector, the predetermined threshold temperature may be higher than 15 degrees Celsius.

[0046] In one or more instances, the preset threshold increases as the measured temperature decreases. The preset threshold thereby takes into account that as temperature decreases, the viscosity of the medicine increases, which requires a higher battery voltage level to expel the medicine from the cartridge. Also, at lower temperatures, there is a higher battery voltage consumption. These factors increase the battery voltage level required to perform the autoinjector step at lower temperatures.

[0047] In one or more instances, the processing unit is further configured to prevent initiating an autoinjector process if the measured temperature is at or below a predetermined threshold temperature.

[0048] In one or more instances, initiation of the autoinjector process occurs only if the calculated remaining electric battery voltage level is greater than the preset threshold by at least a predetermined tolerance value, which can be viewed as a safety margin to ensure that sufficient battery voltage is available if the temperature decreases further during the time the autoinjector performs the autoinjector process.

[0049] The predetermined tolerance may be at least 5%, such as at least 10%, such as at least 15%, such as at least 20%, such as at least 30%, such as at least 40%, such as at least 50%, such as at least 60%, such as at least 70%, such as at least 80%, such as at least 90%, such as at least 100%, etc., greater than the minimum electrical battery voltage level required to perform the autoinjector process at the measured temperature. Even higher tolerance values ​​may be envisioned.

[0050] The predetermined tolerance may increase as temperature decreases. This allows for situations where battery voltage consumption is not increasing in a predictable manner as temperature decreases.

[0051] In one or more instances, the cartridge further comprises a cartridge code feature, the cartridge code feature comprising information indicative of at least a pharmaceutical viscosity at at least one preset temperature, and the autoinjector further comprises a cartridge code sensor coupled to the processing unit and configured to receive information indicative of at least a pharmaceutical viscosity at at least one preset temperature from the cartridge code feature when the cartridge is received in the autoinjector. An example of information indicative of at least a pharmaceutical viscosity at at least one preset temperature is information of a concentration of a pharmaceutical in the cartridge combined with information of a type of pharmaceutical in the cartridge. When having information on both pharmaceutical type and concentration, the viscosity at at least one temperature, such as room temperature, may be known.

[0052] Different tolerances may further be obtained based on the drug type information in the cartridge. Thus, in situations where different drugs are to be handled by the autoinjector, the calculation of the minimum acceptable battery voltage level may additionally include knowledge of drug viscosity and / or temperature dependent viscosity of the drug. In some cases, this information regarding the possible drugs to be delivered using the autoinjector is provided in a cartridge code that is read by the autoinjector upon loading the cartridge.

[0053] The code sensor may be configured to read a cartridge code feature, such as a cartridge code feature of the cartridge and / or a cartridge code feature affixed to the cartridge. The code sensor may be configured to transmit a code signal indicative of the cartridge code feature. The code sensor may be configured to read the cartridge code feature at multiple positions. The cartridge code sensor may be movable. The cartridge code sensor may have multiple sensors, such as multiple transmitters and / or receivers.

[0054] The code sensor may include an optical sensor. The code sensor may include an optical sensor having a transmitter and a receiver, such as an optical transmitter and an optical receiver. The code sensor may be configured to read a cartridge code feature. The code sensor may be configured to read a QR code, a bar code, a color code, and / or any combination thereof. Thus, the cartridge code feature may be a QR code, a bar code, a color code, and / or any combination thereof.

[0055] The processing unit may be coupled to the code sensor and may be configured to receive a code signal indicative of the cartridge code feature from the code sensor.

[0056] In one or more embodiments, the preset threshold indicating a minimum electrical battery voltage level required to perform the autoinjector step at the measured temperature also depends on the pharmaceutical viscosity, and the processing unit: - receiving information from the cartridge code feature indicative of at least a pharmaceutical viscosity at at least one preset temperature; - obtaining a preset threshold value indicative of a minimum value of voltage required to perform an autoinjector step based on both the temperature measured by the temperature sensor and the information indicative of at least a pharmaceutical product viscosity at the at least one preset temperature obtained from the cartridge code feature; The method is further configured as follows.

[0057] Drug viscosity is temperature dependent, therefore the viscosity of a drug at any particular temperature is stored in the cartridge code feature as a curve.

[0058] In one or more embodiments, the autoinjector further comprises a user interface coupled to the processing unit, the processing unit comprising: A) the difference between the calculated remaining electric battery voltage level and a preset threshold indicating the minimum electric battery voltage level required to perform the autoinjector process at the measured temperature is less than a predetermined tolerance; or B) the calculated remaining electric battery voltage level is less than a preset threshold at the measured temperature; If so, the user is configured to prompt the user via a user interface to recharge the battery.

[0059] The user interface may have multiple LEDs including a first LED, and the user interface instructs the user to recharge the battery by flashing the first LED. Flashing means that the first LED may continuously emit light having a first color. Alternatively, the first LED may blink. The color of the light of the first LED may be red to indicate that the user should pay attention to the battery level.

[0060] The first LED is A) the difference between the calculated remaining electric battery voltage level and a preset threshold indicating the minimum electric battery voltage level required to perform the autoinjector process at the measured temperature becomes greater than a predetermined tolerance; or B) until the calculated remaining electric battery voltage level is greater than a preset threshold at the measured temperature. It may flash.

[0061] After the battery is sufficiently recharged, the first LED may stop flashing and the second LED may be turned on, e.g., emitting a light having a different color than the color of the first LED, e.g., green compared to the red of the first LED. The flashing of the second color is meant to indicate to the user that the battery is sufficiently recharged to perform the autoinjector procedure at the temperature measured by the temperature sensor.

[0062] In one or more embodiments, the battery computing module comprises: - The time since the rechargeable battery was last charged, - Rechargeable battery life and - The voltage that a rechargeable battery has used since it was last charged, and and configured to calculate at least one of: The processing unit is - The time since the rechargeable battery was last charged, - Rechargeable battery life and - The voltage that a rechargeable battery has used since it was last charged, and a predetermined threshold indicating a minimum electrical battery voltage level required to perform the autoinjector process at the measured temperature based on at least one of the following:

[0063] As batteries age, performance often decreases. Thus, taking into account the aging of the battery is relevant to ensuring that the battery provides sufficient voltage levels to the drive module to allow the full autoinjector process to be performed. Also, if an extended period of time has passed since the battery was last recharged, the voltage levels available within the battery may have decreased. Taking this into account along with recording previous voltage level consumption may also assist the battery calculation module in performing the most accurate calculation of the remaining battery voltage level capacity within the battery.

[0064] When the autoinjector is turned on, a start-up method may be executed which determines whether the battery voltage level is high enough to allow the processing unit to allow the autoinjector process to proceed. The method comprises measuring by means of a temperature sensor a temperature indicative of the temperature of the autoinjector, e.g. the ambient temperature and / or the temperature close to the rechargeable battery and / or the drug temperature. A measurement of the battery voltage level is also measured in the same sequence by means of a battery calculation module.

[0065] The method further includes determining whether the temperature is above a predetermined threshold temperature, such as 15 degrees Celsius, or such as 12 degrees Celsius. If the temperature is above the predetermined threshold temperature, the processing unit determines whether a sufficient electric battery voltage level is present to perform an autoinjector procedure. Such an autoinjector procedure may be at least one injection cycle. In some cases, a tolerance may be added such that a sufficient electric battery voltage level is set to include the threshold. The determination is made by comparing the measured battery voltage level, indicative of a remaining battery voltage level, to a pre-set threshold required to perform the autoinjector procedure at the measured temperature.

[0066] If there is a sufficient electric battery voltage level to perform the autoinjector procedure, the processing unit communicates to the user that the autoinjector is ready for use, i.e., the user may perform the autoinjector procedure.

[0067] If there is not a sufficient electric battery voltage level to perform the autoinjector procedure, the processing unit communicates to the user that the battery needs to be recharged before the autoinjector is ready for use, i.e., before the user can perform the autoinjector procedure, and the method is repeated before the autoinjector procedure can be commenced.

[0068] If the temperature measured in the first step is determined to be below the predetermined threshold temperature, the processing unit determines whether a sufficient electric battery voltage level is present to perform not one but two autoinjector steps, e.g., two full injection cycles. If a sufficient electric battery voltage level is present to perform two autoinjector steps, the processing unit communicates to the user that the autoinjector is ready for use, i.e., that the user may perform the autoinjector steps.

[0069] If there is not a sufficient electrical battery voltage level to perform the two autoinjector steps, the processing unit communicates to the user that the battery needs to be recharged before the autoinjector is ready for use, i.e. before the user may perform the autoinjector steps. The method is repeated before the autoinjector steps can be initiated. The temperature is typically not measured again until the device performs a new self-test verification, i.e. until the method is run again.

[0070] Additionally or alternatively, if the temperature falls below a threshold temperature, e.g., below 10-15 degrees Celsius, such as below 15 degrees Celsius, when the autoinjector is turned on, the autoinjector may be configured to prevent the autoinjector from performing any autoinjector steps until the temperature increases to a level above the threshold temperature, e.g., 15 degrees Celsius. The threshold temperature depends on the pharmaceutical agent that the autoinjector is to deliver.

[0071] The reason that the autoinjector prevents the autoinjector step from being performed at very low temperatures is that the drug viscosity is too high and therefore the autoinjector step would require more energy than the battery capacity calculation would estimate. Additionally, battery capacity decreases at lower temperatures.

[0072] In one or more embodiments, the autoinjector further comprises a temperature control unit coupled to the processing unit, the temperature control unit configured to heat the autoinjector, the processing unit configured to: - get the measured temperature, measured by the temperature sensor; - start heating the autoinjector if the measured temperature is below the predefined heating-start temperature; - obtaining a second measurement of the measured temperature, measured by the temperature sensor; - stopping heating of the autoinjector when the second temperature exceeds a predetermined heating-stop temperature and / or after the autoinjector has been heated for a predetermined time; The method is further configured as follows.

[0073] A predetermined heat-stop temperature means a preset temperature at which the temperature of the autoinjector is considered acceptably high in order for the autoinjector step to be performed. At the predetermined / preset heat-stop temperature, the viscosity of the pharmaceutical product and / or the battery is typically at a temperature where the amount of battery voltage required to perform the autoinjector step is within what is considered normal / acceptable.

[0074] Heating in an autoinjector may be more localized heating, such as localized heating of the cartridge / medicinal product within the cartridge as the cartridge is inserted into the autoinjector.

[0075] Thus, in one or more embodiments, the autoinjector further comprises a temperature control unit coupled to the processing unit, the temperature control unit configured to heat the cartridge compartment containing the pharmaceutical agent when the cartridge is received within the autoinjector, the processing unit further comprising: - acquiring a medicine temperature measured by the temperature sensor or a second temperature sensor; - initiate heating of the cartridge compartment containing the drug product if the drug product temperature falls below a predefined heating-onset temperature; - stopping heating of the cartridge compartment containing the drug product when the drug product temperature exceeds a predetermined heating-stop temperature and / or after the cartridge compartment containing the drug product has been heated for a predetermined time; The method is further configured as follows.

[0076] The cartridge may be made of glass and / or polymer.

[0077] The cartridge may have a cartridge outlet, for example, at a first cartridge end. The cartridge outlet may be configured for fluid communication, for example, with a compartment at the first cartridge end. The cartridge may be configured to release a medicinal product through the cartridge outlet. The cartridge outlet may be configured to be coupled with an injection needle, such as a hypodermic needle, to provide the medicinal product to be released through the injection needle.

[0078] The cartridge may be a dual chamber cartridge. The cartridge compartment may have a first cartridge subcompartment and a second cartridge subcompartment. The first cartridge subcompartment may be between the first stopper and the second stopper. The second cartridge subcompartment may be between the second stopper and the cartridge outlet and / or the third stopper.

[0079] The first cartridge subcompartment may contain a first pharmaceutical component of the pharmaceutical. The second cartridge subcompartment may contain a second pharmaceutical component of the pharmaceutical. Each of the first pharmaceutical component and / or the second pharmaceutical component may be a dry composition, a fluid, a liquid, a gel, a gas, and / or any combination thereof. The first pharmaceutical component and / or the second pharmaceutical component may be a solute, such as a dry composition. The first pharmaceutical component and / or the second pharmaceutical component may be a liquid composition, such as a fluid composition, such as a solvent. The second pharmaceutical component may be a dry composition and the first pharmaceutical component may be a fluid composition, e.g., water or ethanol or saline or a buffer or a preservative solution. The second pharmaceutical component may be a solute. The first pharmaceutical component may be a solvent. It is envisioned that the pharmaceutical may be any pharmaceutical that is injectable via a hypodermic needle, for example, after reconstitution of the pharmaceutical.

[0080] The pharmaceutical agent may be growth hormone. The pharmaceutical agent may be human growth hormone. Thus, the pharmaceutical agent may be made for the treatment of human growth hormone, hGH, but this is only an exemplary use of the autoinjector. The pharmaceutical agent may be a long-acting version of human growth hormone, such as a depo-version or hGH pro-drug. The pharmaceutical agent may be lonapegsomatropin. The second pharmaceutical component may be a dry composition of human growth hormone.

[0081] The cartridge can have a bypass zone to provide fluid communication between, for example, a first cartridge subcompartment and a second cartridge subcompartment when, for example, a second stopper is positioned in the bypass zone. The cartridge can have multiple bypass zones to provide fluid communication between adjacent cartridge subcompartments when, for example, stoppers separating adjacent cartridge subcompartments are positioned in the respective bypass zones.

[0082] The disclosed autoinjector can be a reusable autoinjector. A reusable autoinjector can be particularly beneficial when a cartridge has multiple subcompartments. For example, an autoinjector for a multi-compartment or multi-chamber cartridge can be more advanced and therefore beneficial to allow the autoinjector to be used more than once. For example, the autoinjector can provide an automated process for mixing pharmaceutical ingredients, such as mixing pharmaceutical ingredients initially provided in different subcompartments of the cartridge.

[0083] The cartridge outlet may be an injection needle having an internal needle diameter. The preset threshold value indicative of the voltage required to execute the autoinjector step at the measured temperature may further depend on the internal needle diameter. The thinner the injection needle, the higher the force required to expel the medication from the cartridge compartment through the needle. Thinner injection needles are often desired because they introduce a lower amount of discomfort to the user. Also, there is usually a requirement for the autoinjector to expel the medication within a relatively short amount of time, such as 15 seconds, 14 seconds, 13 seconds, 12 seconds, 11 seconds, 10 seconds, or less. The combination of a thin injection needle and a short expulsion time adds requirements to the plunger rod force and thereby the battery voltage level required for the drive module to drive the plunger rod. Thus, this information may be included in the processing unit when the processing unit obtains the preset threshold value.

[0084] In one or more embodiments, the inner needle diameter is between 145 μm and 160 μm, such as between 146 μm and 159 μm, such as between 147 μm and 158 μm, such as between 148 μm and 157 μm, such as between 149 μm and 156 μm, such as between 150 μm and 155 μm, such as between 151 μm and 154 μm, such as between 152 μm and 153 μm, such as 153 μm. The needle can be, for example, a 31 gauge needle.

[0085] The cartridge may have a first stopper movable within the cartridge compartment, for example, in a first stopper direction toward the first cartridge end. For example, the medicinal product may be expelled through the cartridge outlet upon movement of the first stopper, for example, in the first stopper direction. Air may also be expelled from the cartridge, such as from the cartridge compartment, through the cartridge outlet.

[0086] The cartridge can have a cartridge back at a second cartridge end, e.g., opposite the cartridge outlet. The cartridge back can have a cartridge back end opening. The cartridge back end opening can provide access to the first stopper of the plunger rod.

[0087] The cartridge receiver may be configured to receive a cartridge through the cartridge receiver opening such that the cartridge may be inserted within the cartridge receiver through the cartridge receiver opening. The cartridge receiver may be configured to receive a cartridge through the cartridge receiver opening in a cartridge-receiving direction such that the cartridge-receiving direction may be along the longitudinal axis.

[0088] In one or more embodiments, movement of the plunger rod from a retracted plunger rod position to a locking plunger rod position located between the retracted plunger rod position and the extended plunger rod position locks the cartridge within the autoinjector, and the processing unit - the calculated remaining voltage of the rechargeable battery is less than the value of the voltage required to perform the autoinjector process at the measured temperature, or - the difference between the calculated remaining voltage of the rechargeable battery and the value of the voltage required to perform the autoinjector step at the measured temperature is less than a predetermined tolerance; The plunger rod may be further configured to prevent movement of the plunger rod to the locked plunger rod position when the plunger rod is in a locked position.

[0089] In one or more embodiments, the autoinjector comprises: - a housing containing a cartridge receiver, a plunger rod, a drive module, a temperature sensor, a rechargeable battery, a battery computation module, and a processing unit; - a connector opening in the housing, enabling the autoinjector to be connected to a voltage supply in order to recharge the rechargeable battery; It further has:

[0090] The voltage supply may be a mains power socket, a USB port, a laptop, and / or an external battery. The housing may house a first electrical connector accessible through a connector opening in the housing. The first electrical connector may receive a second electrical connector of the voltage supply.

[0091] The autoinjector is - an elongated ejector movable along a longitudinal axis between a first ejector position and a second ejector position, the ejector member configured to follow movement of a cartridge along the longitudinal axis when the cartridge is received within a cartridge receiver; - The connector may further include a blocking member coupled to the ejector member, the blocking member configured to move between a blocking position in which the connector opening is blocked and a non-blocking position in which the connector opening is not blocked, and when the ejector member is in the second ejector position, the blocking member is in the blocking position, and when the ejector member is in the first ejector position, the blocking member is in the non-blocking position.

[0092] This provides a blockage of the connector opening, thereby preventing connection to an external power supply, such as a main grid, when the cartridge is received in the autoinjector. This further provides a limit to the insertion of the cartridge when the autoinjector is connected to an external power supply, such as a main grid. The safety mechanism thereby provided in the autoinjector reduces the risk of serious electric shock in a user of the autoinjector. This may prevent simultaneous connection to the injection needle and to an external power supply.

[0093] Thus, a safety mechanism independent of the user-chosen sequence may be provided, thereby preventing simultaneous connection to an external power supply, such as the mains grid, for example via a charger and the use of an autoinjector to administer medicines.

[0094] The ejector member may be configured to follow movement of the cartridge along the longitudinal axis so that insertion of the cartridge may be determinative of whether the connector opening is blocked, thereby providing a safety feature that is particularly advantageous for autoinjectors for replaceable cartridges, such as disposable cartridges, and / or where an injection needle is attached to the cartridge prior to insertion of the cartridge into the autoinjector.

[0095] The housing can have a connector opening. The connector opening can be a hole in the housing. The connector opening can be configured to allow passage of the second electrical connector, such as to allow access to the first electrical connector. The connector opening can be sized for the first electrical connector and / or the second electrical connector.

[0096] The battery may be configured to be charged by connection of the first electrical connector and the second electrical connector. The rechargeable battery of the autoinjector may be a Li-ion battery or a NiCd battery or a NiMH battery.

[0097] The first electrical connector may receive the second electrical connector. The second electrical connector may electrically connect the first electrical connector to a power supply. The connection of the first electrical connector and the second electrical connector may provide charging of the battery, such as by providing power from the power supply to the battery. The first electrical connector and / or the second electrical connector may be a USB compatible connector. The first electrical connector may be a female connector. The second electrical connector may be a male connector.

[0098] The autoinjector can have an ejector having an ejector member. The ejector can be configured to eject the cartridge from the cartridge receiver.

[0099] The ejector member can have an ejector abutment surface. The ejector abutment surface can be configured to abut a surface of the cartridge, such as a cartridge back surface. The cartridge back surface can abut the ejector abutment surface upon insertion of the cartridge into the cartridge receiver. The ejector member can be moved toward a second ejector position upon insertion of the cartridge into the cartridge receiver, such as in a receiving direction by movement of the cartridge back surface in the receiving direction causing movement of the ejector abutment surface in the receiving direction.

[0100] In one or more embodiments, in the first ejector position, a cartridge is not within the autoinjector. Thus, when a cartridge is not received within the cartridge receiver, the ejector member can be in the first ejector position. When a cartridge is received within the cartridge receiver, the ejector member can be in the second ejector position.

[0101] In one or more embodiments, the ejector member is spring-loaded. Thus, the ejector member can be an ejector resilient member. When the cartridge is received in the autoinjector, the ejector resilient member can be compressed and the blocking member is moved to the blocking position.

[0102] The autoinjector and / or the ejector of the autoinjector may have an ejector resilient member configured to exert a force on the ejector member, the ejector resilient member configured to bias the ejector member toward the first ejector position, e.g., opposite the receiving direction.

[0103] The blocking member may be configured to close and / or block the connector opening. The blocking member is configured to move between a blocking position and an unblocking position. In the blocking position, the connector opening is blocked and access to the first electrical connector, e.g., to the second electrical connector, is prevented and / or limited, and in the unblocking position, the connector opening is unblocked and access to the first electrical connector, e.g., to the second electrical connector, is allowed and / or is not prevented and / or limited.

[0104] The blocking member may be movable between the blocking position and the non-blocking position by a translational movement. Alternatively or in addition, the blocking member may be movable between the blocking position and the non-blocking position by a rotational movement. The blocking member may be movable between the blocking position and the non-blocking position along the longitudinal axis. Alternatively, the blocking member may be movable between the blocking position and the non-blocking position perpendicular to the longitudinal axis. For example, the blocking member may be moved rotationally about the longitudinal axis between the blocking position and the non-blocking position.

[0105] The blocking member can be a door, such as a sliding door. For example, the blocking member in the blocking position can completely block the connector opening. Alternatively, for example, the blocking member in the blocking position can partially block the connector opening.

[0106] The blocking member can be configured to block the connector opening when the cartridge is received in the cartridge receiver. Alternatively or additionally, the blocking member can be configured to prevent insertion of the cartridge into the cartridge receiver when the first electrical connector and the second electrical connector are connected, such as when an electrical connector, such as the second electrical connector, is inserted through the connector opening. For example, the blocking member can be prevented from moving to the blocking position when the first electrical connector is coupled to the second electrical connector. For example, movement of the blocking member can be prevented by the first electrical connector and / or the second electrical connector, e.g., the first electrical connector and / or the second electrical connector can obstruct a path of movement of the blocking member toward the blocking position.

[0107] Insertion of the cartridge into the cartridge receiver may cause movement of the blocking member. For example, the blocking member may be coupled to the ejector member, such as translational movement of the ejector member to the blocking member. Insertion of the cartridge into the cartridge receiver may cause movement of the ejector member, and movement of the ejector member may cause movement of the blocking member. Thus, insertion of the cartridge into the cartridge receiver may cause movement of the blocking member. Alternatively or in addition, if the blocking member is prevented from moving to the blocking position, for example, if the first electrical connector is coupled to the second electrical connector, the ejector member may be prevented from moving to the second ejector position. Thus, insertion of the cartridge into the cartridge receiver may be prevented if the first electrical connector is coupled to the second electrical connector.

[0108] The shutoff member may have a first shutoff coupling member. The ejector member may have a second shutoff coupling member. The first shutoff coupling member and the second shutoff coupling member may engage to cause translational movement of the ejector member to the shutoff member. The first shutoff coupling member may have a slot and / or a protrusion. The second shutoff coupling member may have a protrusion and / or a slot. The second shutoff coupling member and the first shutoff coupling member may be movably connected. The second shutoff coupling member and / or the first shutoff coupling member may allow an amount of clearance such that only a portion of the ejector movement translates to the shutoff member movement.

[0109] The movement of the ejector member from the third ejector position to the second ejector position may cause the blocking member to move from the non-blocking position to the blocking position and / or may cause the blocking member to move from the non-blocking position to the blocking position. The third ejector position may be between the first ejector position and the second ejector position. For example, the ejector member may move from the first ejector position toward the second ejector position, such as when a cartridge is inserted into the cartridge receiver, and from the third ejector position located between the first ejector position and the second ejector position, the movement of the ejector member is transmitted to the blocking member, so that the blocking member moves toward the blocking position.

[0110] Alternatively or additionally, movement of the ejector member from the fourth ejector position to the first ejector position moves the blocking member from the blocking position to the non-blocking position. The fourth ejector position can be between the first and second ejector positions. The fourth ejector position can be the third ejector position. For example, the ejector member can move from the second ejector position toward the first ejector position, such as when a cartridge is removed from a cartridge receiver, and from a fourth ejector position located between the first and second ejector positions, the movement of the ejector member is transmitted to the blocking member, such that the blocking member moves toward the non-blocking position.

[0111] The second blocking coupling member having slots and / or protrusions and the first blocking coupling member having protrusions and / or slots may allow for a certain amount of clearance and may facilitate the transmission of such exemplified movements.

[0112] The blocking member and / or the first blocking coupling member of the blocking member may have a first blocking member stop and a second blocking member stop. For example, the first blocking coupling member may have a slot with a first blocking member stop and a second blocking member stop. The second blocking coupling member may have a protrusion arranged to capture the first blocking member stop by movement in one direction along the longitudinal axis and to capture the second blocking member stop by movement in the other direction along the longitudinal axis. For example, the second blocking coupling member may capture the first blocking member stop when the ejector member moves toward the first ejector position, such as when the cartridge is removed from the cartridge receiver. The second blocking coupling member may capture the second blocking member stop when the ejector member moves toward the second ejector position, such as when the cartridge is inserted into the cartridge receiver.

[0113] Alternatively or additionally, the ejector member and / or the second blocking coupling member of the ejector member may have a first blocking member stop and a second blocking member stop. For example, the second blocking coupling member may have a slot with a first blocking member stop and a second blocking member stop. The first blocking coupling member may have a protrusion arranged to capture the first blocking member stop by movement in one direction along the longitudinal axis and to capture the second blocking member stop by movement in the other direction along the longitudinal axis. For example, the first blocking coupling member may capture the first blocking member stop when the ejector member moves toward a first ejector position, such as when a cartridge is removed from the cartridge receiver. The first blocking coupling member may capture the second blocking member stop when the ejector member moves toward a second ejector position, such as when a cartridge is inserted into the cartridge receiver.

[0114] Providing such a non-fixed connection between the ejector member and the blocking member provides a shorter device, such that a long sliding movement of the ejector member, for example, translates into a shorter movement of the blocking member.

[0115] Alternatively, the first and second blocking coupling members may be fixedly connected, for example the ejector member and the blocking member may be fixedly connected against movement along the longitudinal axis.

[0116] Movement of the ejector member to the second ejector position may require movement of the blocking member to the blocking position. For example, if the blocking member is prevented from moving to the blocking position, e.g., when the second electrical connector is mated to the first electrical connector, movement of the ejector member to the second ejector position may be limited and / or impossible, thereby preventing the cartridge from being received in the cartridge receiver when the second electrical connector is connected, e.g., when a charger is connected to an autoinjector to charge a battery.

[0117] In one or more embodiments, the autoinjector further includes an ejector lock configured for rotation at least part of a pivot from an initial angular position to a first angular position when the plunger rod moves from a retracted plunger rod position toward an extended plunger rod position, and rotation of the ejector lock retains the ejector member in a longitudinal and rotated position.

[0118] The ejector lock may be configured to limit movement of the ejector member, such as along a longitudinal axis.

[0119] In one or more embodiments, the ejector member has an ejector support surface that supports the cartridge and cartridge holder when the cartridge is received within the cartridge receiver, and when rotation of the ejector lock holds the ejector member in a longitudinal and / or rotational position, the cartridge and cartridge holder are also held in a longitudinal and / or rotational position.

[0120] In one or more instances, the blocking member remains in the blocking position during the autoinjector step.

[0121] The drive module may be configured to receive power from a battery. The drive module may be electrically connected to the battery to receive power. The drive module may be housed by a housing. The drive module may have a motor, such as an electro-mechanical motor, such as a DC motor, e.g., a DC motor with or without brushes. The drive module may have a solenoid motor. The drive module may have a shape memory alloy engine. The drive module may have a spring arrangement configured to actuate a plunger rod. The drive module may have a pressurized gas configured to actuate a plunger rod.

[0122] The cartridge receiver may have a cartridge receiver compartment configured to receive the cartridge assembly by at least one cartridge retaining member when inserted through the cartridge receiver opening along a longitudinal axis in a receiving direction, the cartridge receiver having a passageway through which the at least one cartridge retaining member moves at least in the receiving direction, the member preventing movement beyond a retaining position in a direction opposite the receiving direction.

[0123] The elongate ejector may have a longitudinal ejector slot extending from the ejector stationary portion toward the ejector support surface. The elongate ejector may be suspended for movement along a longitudinal direction and may be spring-loaded in a direction opposite to the receiving direction.

[0124] The ejector lock may be supported to pivot at least a portion of the way and maintained in a longitudinal position relative to the housing. The ejector lock may have an ejector lock support portion configured to align with the longitudinal ejector slot at a first angle, slide along the longitudinal ejector slot, and be brought into alignment with the ejector stationary portion at a second angle, whereby the ejector stationary portion and the ejector lock support member in combination may form a stop that is disengaged at the first angle and engaged at the second angle.

[0125] It is thus realized that the ejector lock, by effectively turning it at the second angle, introduces a stop by which the support member receives the stationary part. If the stationary part is otherwise prevented from descending onto the support member, the stop prevents further movement of the stationary part beyond the support member in the receiving direction. The stop thus contributes to preventing the cartridge from moving beyond the stop position relative to the housing in the receiving direction.

[0126] At the very least, when the needle of the cartridge assembly penetrates the skin of a patient, a force is transmitted from the needle to the cartridge and acts to urge the cartridge rearward in a receiving direction against the stop as it engages. The stop at least contributes to maintaining the position of the cartridge as otherwise accurate administration of the medication may be impeded.

[0127] When the ejector is in a stopped position, by means of a stop, the ejector support surface on which an end portion of the cartridge or cartridge assembly may rest to prevent unintended movement in the receiving direction.

[0128] The autoinjector enables convenient front loading of the cartridges housed in the cartridge assembly, without increasing the risk of needle injury during loading of the autoinjector with the cartridges housed in the cartridge assembly, since the needle on the cartridge assembly can be protected by a needle cover reliably attached to the cartridge assembly.

[0129] The autoinjector enables convenient front loading by overcoming a spring-loaded bias when the cartridge meets the support surface of the ejector, guiding the cartridge retaining member out of the passageway to a position where the cartridge is prevented from moving out of the cartridge receiver, and orienting the ejector lock to prevent movement in the receiving direction past a stop such that the cartridge maintains its position within the housing when pressure against the injection needle in the receiving direction is at least partially transmitted to the cartridge. It is important that the cartridge maintain its position because otherwise accurate administration of the medication would be impeded.

[0130] It will be appreciated that the various distances should be dimensioned such that when the cartridge is in the retaining position, the support surface of the ejector lock is adjacent to the stationary portion of the ejector, whereby the cartridge is locked or in a locked position prevented from both forward and rearward movement, the rearward movement being the same as the receiving direction. When the stop is engaged, i.e. when the ejector lock is at the second angle, the cartridge can be locked, whereas when the stop is disengaged, i.e. when the ejector lock is at the first angle, the cartridge can be unlocked.

[0131] In one or more instances, the ejector lock support member extends axially from a wall of the ejector lock, e.g., in the form of a pin, to support the ejector at the laterally extending ejector stationary portion. In one or more instances, the ejector lock support member extends laterally along a border or edge of the ejector lock to support the ejector at the laterally extending ejector stationary portion or at the axially extending stationary portion.

[0132] In one or more embodiments, one or more of the ejector lock support portion, the ejector stationary portion, and the ejector slot are recessed within the ejector lock or the ejector.

[0133] It will be appreciated that the ejector lock may be supported, for example, in a bearing, which allows the lock to pivot or be redirected, for example, at least partially in a pivot direction, while preventing longitudinal movement.

[0134] In one or more embodiments, the ejector includes an ejector rod having an ejector support surface, the ejector rod having an ejector rod bore for forming a longitudinal passage, the ejector support surface being disposed at one end of the ejector rod and having a disk or annular shape, whereby the disk or annular shape can form a support for the cartridge all around the periphery of its end portion and resting thereon. The aperture of the bore is located at a central portion of the ejector abutment surface. The bore provides clearance for the plunger to move over at least some of its displacement independent of the ejector to move a first stopper of the cartridge and release at least a portion of the pharmaceutical product from the cartridge.

[0135] In one or more embodiments, the ejector rod has an ejector collar disposed about the ejector support surface. The ejector collar can have an internal diameter that is larger than an external diameter of the end portion of the cartridge or cartridge assembly such that when the end portion of the cartridge or cartridge assembly abuts the ejector support surface, the collar receives the end portion of the cartridge or cartridge assembly in a central location relative to the ejector rod. The cartridge or cartridge assembly can thereby be guided to abut robustly on the ejector support surface. In one or more embodiments, the ejector collar has an internal chamfered surface that improves guiding of the cartridge or cartridge assembly toward the ejector support surface.

[0136] In one or more instances, the ejector has an ejector rod configured with one or more ejector cutouts to form one or more ejector cogs between the ejector cutouts, and the ejector lock is configured with one or more ejector lock cogs between each of the one or more ejector lock cutouts, whereby the one or more ejector cogs may abut with the one or more ejector lock cogs to form a stop when engaged. The stop is engaged by aligning the cogs of the ejector and ejector lock. Reorienting at least a portion of a pivot about the longitudinal axis of the ejector lock may disengage the stop, whereby the ejector cog can be received within the ejector lock cutout. In this manner, the cogs and cutouts form complementary cogs and cutouts.

[0137] The one or more cogs of the ejector rod and the one or more complementary cutouts of the ejector lock are disposed at an angular range about the longitudinal axis so that the cogs can be accommodated in their entirety or in part by the complementary cutouts. The cogs may extend, for example, 45 degrees and the complementary cutouts may extend 45 degrees plus an angular range to allow clearance when the cogs move longitudinally or out of the cutouts of the ejector rod and thus the ejector lock.

[0138] The cutout, cog, and the angle at which the complementary cog and cutout are located implicitly define a first angular position in which the ejector lock and ejector rod are angularly positioned relative to one another to allow movement of the cartridge assembly in the receiving direction, and a second angular position in which the ejector lock and ejector rod are angularly positioned relative to one another to limit movement of the cartridge assembly in the receiving direction at least to be limited from moving beyond a preset longitudinal position.

[0139] In the second angular position, at least one cog of the ejector rod abuts end-to-end with at least one cog of the ejector lock, whereas in the first angular position, at least one cog of the ejector rod is received within a complementary cutout.

[0140] The ejector cog has an end portion designated as the ejector stationary portion and the ejector lock cog has an end portion designated as the ejector lock support portion. The ejector lock support portion supports the ejector stationary portion when the stop is engaged.

[0141] Thus, the cogs have respective end portions that abut one another when the stops are engaged. The ejector rod cutout and the ejector lock cutout have respective bottom portions. The bottom portions may extend between side portions separating the cogs and the cutouts.

[0142] At the longitudinal position of the ejector rod where the cogs are adjacent to each other, the ejector is defined by its length relative to the ejector lock, at which the cartridge or cartridge assembly is restricted from further movement in the receiving direction by means of a stop. The ejector may be suspended by a resilient member to move in a direction opposite to the receiving direction, in which case the cogs of the ejector rod move away from the cogs of the ejector lock.

[0143] As mentioned above, the cartridge or cartridge assembly may, in one or more instances, be supported in a disk or toroidal shape defined by a surrounding collar.

[0144] In one or more instances, the ejector rod has four cogs and four cutouts and the ejector lock has four complementary cogs and four complementary cutouts, providing a good tradeoff between the amount of rotation required to reorient the ejector rod and ejector lock relative to one another from a secure locked position to an open position, and the mechanical robustness of the cogs.

[0145] In one or more instances, the cog and cutout have equal angular size, for example, 45 degrees or 60 degrees, and in both cases the angular extent is subtracted to allow clearance between the cog and the cutout.

[0146] In one or more instances, one or more of the cutouts and cogs have a substantially rectangular shape.

[0147] Thus, one or more cutouts, such as the ejector cutout and / or the ejector lock cutout, have an edge perpendicular to the longitudinal axis and an edge along the longitudinal axis such that, due to the edge along the longitudinal axis, it is possible to obtain at least a good engagement between the ejector rod and the lock to maintain the relative angular position when the stop is engaged.

[0148] In one or more instances, the ejector cutouts receive the ejector lock cogs, and the ejector lock cutouts receive the ejector cogs, in a complementary fashion, such that the spaces between the cogs are substantially filled to conform to a cylindrical object. However, angular clearance is typically required between the cogs to allow for sufficiently low friction for longitudinal movement and to accommodate variations that occur during manufacture of the ejector and ejector lock.

[0149] In one or more instances, the cutouts and cogs include triangular portions, arcs, or other polygons or curves.

[0150] In one or more instances, the one or more cutouts and the one or more cogs have portions that are angled with respect to the longitudinal axis and with respect to an axis perpendicular to the longitudinal axis.

[0151] The portion angled relative to the longitudinal axis may be one or more of an end portion of one or more cogs, a bottom portion of one or more cutouts, and a side portion of one or more cogs or cutouts.

[0152] In order to ensure smooth longitudinal movement, any angles between the side and bottom portions should be 90 degrees or greater, and any angles between the side and end portions should be 90 degrees or greater, to prevent the creation of a nose or overhang behind which the cog can get stuck in an improper location.

[0153] In some embodiments where the portion is tilted, the ejector cutouts may receive the ejector lock cogs, and the ejector lock cutouts may receive the ejector cogs, in a complementary fashion, such that the spaces between the cogs are substantially filled to conform to a cylindrical object. However, angular clearance is typically required between the cogs to allow for sufficiently low friction for longitudinal movement.

[0154] In one or more embodiments, the ejector cogs and lock cogs have end portions that are angled relative to the longitudinal axis at an angle of less than 40 degrees, or less than 30 degrees, or less than 20 degrees relative to an orthogonal portion of the longitudinal axis.

[0155] When the stop is engaged by reorienting the lock, the angled end portion may contribute such that further reorienting the lock creates a longitudinal clamping force that acts against the ejector and is transmitted through the ejector to the cartridge and / or cartridge assembly. In this manner, it may be possible to at least substantially eliminate clearances that arise due to manufacturer variability.

[0156] The end portions of the lock cog and the ejector cog are tilted at substantially the same angle so that the end portions are aligned with one another. In one or more embodiments, a bottom portion of the cutout can be tilted by substantially the same angle so that the cog fits into the cutout.

[0157] Thus, the cogs have respective end portions that abut one another when the stops are engaged. The angled end portions, and possibly manufacturer variances, can result in a reduction in the desired clamping force or clearance at the locking angular position where the ejector and lock cogs do not align center-to-center, but offset to some degree from them.

[0158] Thereby, it may be possible to clamp the cartridge in a more accurate longitudinal position and ensure that the dimensional tolerance of the cartridge length does not result in or at least does not result in the risk of fluid being expelled from the cartridge when pressing the needle against the skin. Thus, the risk of unintended backward movement of the cartridge due to a short cartridge length in combination with an over-retracted locking position is reduced. If the cartridge is not prevented from such unintended backward movement, the plunger rod in contact with the stopper may possibly instantly push the medicinal product out before the needle is properly inserted into the patient's skin, and thus the full dose is not administered to the patient.

[0159] In one or more embodiments, the ejector has an ejector rod configured with a substantially cylindrical portion having one or more chamfers about a longitudinal axis to form a rotationally symmetric end portion, and the ejector lock is configured with one or more complementary chamfer cuts to form a complementary rotationally symmetric end portion.

[0160] In one or more instances, the chamfer is positioned such that the end portion extends substantially perpendicular to the longitudinal axis. An end portion that extends substantially perpendicular to the longitudinal axis can extend less than 180 degrees, such as less than 120 degrees or less than 90 degrees.

[0161] In one or more embodiments, the autoinjector has a plunger rod and the ejector has an ejector rod spring-loaded by a spring ejector member, and the plunger rod and the bore are configured for relative longitudinal movement, whereby the ejector and plunger rod can be tightly integrated and the plunger rod can be moved along the longitudinal axis at least a distance without bearing the ejector rod along and vice versa.

[0162] The ejector rod may have a cylindrical object with a bore extending therethrough, with the above-mentioned cutouts and cogs located at one end of the cylindrical object and the above-mentioned disk or torus shape disposed at the other end.

[0163] In one or more instances, the bore through the ejector rod and the outer surface of the plunger rod are configured with coupling means and complementary coupling means, respectively, that maintain relative angular position and allow relative longitudinal movement. A track may be formed on the wall of the bore that engages with a groove in the plunger rod, extending along a straight line along the longitudinal axis, and / or vice versa, thereby providing angular retention while allowing longitudinal movement.

[0164] In one or more embodiments, the plunger rod has an inner plunger rod part and an outer plunger rod part, the inner plunger rod part and the outer plunger rod part are connected by threads, the inner plunger rod part is held in a bearing that allows the inner plunger rod part to rotate while preventing longitudinal movement, and the outer plunger rod part is held in an angular position relative to the housing.

[0165] Thereby, the outer plunger part can be actuated to move longitudinally by rotation of the inner plunger rod part and configured to move a first stopper of the cartridge to expel at least a portion of the medicament from the cartridge.

[0166] In one or more embodiments, the inner plunger rod component is rotationally driven by a drive module, which may include a motor and one or more of a transmission and gearing for coupling the motor to the inner plunger rod. The inner plunger rod component may have a spindle portion that engages with internal threads in the outer plunger rod component.

[0167] In one or more instances, the outer plunger rod component is held in an angular position relative to the housing at a point where a longitudinally extending plunger rod groove is formed in a wall of the outer plunger rod that engages a longitudinally extending bead or track on an inner wall of the ejector rod bore. This configuration allows displacement of the outer plunger rod relative to the ejector rod, and vice versa, over at least a distance while maintaining a relative angular position therebetween.

[0168] In one or more embodiments, the autoinjector has an angle retaining slot and an angle retaining guide configured to engage with one another and disposed on or within the cartridge receiver or a member rigidly coupled to the cartridge receiver and on the ejector rod.

[0169] The ejector rod is thereby suspended by the cartridge receiver for angular retention and for longitudinal displacement over at least a distance.

[0170] In one or more embodiments, an angle retaining slot is configured in a member that houses the ejector rod and plunger rod when in the retracted position, and the angle retaining slot can be adjacent to the ejector rod when it is retracted. The member that can house a motor coupled to drive the internal plunger rod can have a collar that provides a curb or seat for a spring that provides a spring-loading force for the ejector. An angle retaining guide is then placed on the ejector rod.

[0171] In one or more embodiments, the ejector lock has an ejector lock guide pin configured to engage with a plunger rod track provided in the plunger rod such that longitudinal movement of the plunger rod provides for reorientation of the ejector lock about the longitudinal axis, at least over a preset range.

[0172] Thereby, it is possible to drive the autoinjector with a single motor that at one displacement of the plunger rod provides for the deflection of the lock and at another displacement of the plunger rod provides for the ejection of a dose of medicinal product from the cartridge. At least the plunger rod track can be configured such that the plunger rod deflects the ejector lock and disengages a stop in a retracted position with the plunger rod at a position at a distance from the cartridge. The plunger rod track can be configured such that the stop is engaged in an advanced position of the plunger rod at least when it abuts or presses against a stop of the cartridge.

[0173] In one or more instances, movement of the plunger rod in the receiving direction through at least a range of longitudinal positions provides for reorienting the ejector lock to a first angular position whereby the stop is disengaged at a retracted position of the plunger rod.

[0174] In one or more embodiments, the ejector lock is comprised of an ejector lock bore for receiving at least an end portion of an outer plunger rod and an ejector lock guide pin extending inwardly from a wall of the ejector lock bore, the outer plunger rod being comprised of a plunger rod track that engages the ejector lock guide pin and extends from a distal edge of the plunger rod toward the cartridge assembly opening, the plunger rod track having at least one track portion that leads to the ejector lock guide pin from a first angle to a second angle, the first angle and the second angle being angularly spaced to reorient the ejector lock from the first angular position to the second angular position.

[0175] Thereby, rotation of the inner plunger rod part can occur about the longitudinal movement of the outer plunger rod part to at least engage the cartridge at least at one longitudinal position of the outer plunger rod part and provide rotation of the ejector lock at another longitudinal position of the outer plunger rod part to either lock or unlock the ejector member rod.

[0176] In one or more embodiments, the track is configured to rotate the ejector lock via the guide pin to a position that unlocks the ejector rod when the external plunger rod is in an extreme longitudinal position away from the cartridge receiver opening. The track may rotate the ejector lock via the guide pin to another position that locks the ejector rod when the external plunger rod is in a less extreme longitudinal position away from the cartridge receiver opening. Thus, as the external plunger rod member is moved from the extreme position in the direction opposite to insertion, the ejector lock moves from the ejector unlocked position to the ejector locked position.

[0177] It will be appreciated that the angular position of the guide pin relative to the cog and cutout and the angular position of the outer plunger rod relative to the ejector rod are synchronized such that a rotation imparted to the ejector lock by the track via the guide pin will allow the cogs to be abutted end-to-end in the second angular position and will allow the cogs to be received within the cutout in the first angular position, where it will be appreciated that in the first angular position the ejector is unlocked by the ejector lock and in the second angular position the ejector is locked by the ejector lock.

[0178] In one or more instances, the ejector member and the ejector lock length when adjacent one another such that the cogs are accommodated by complementary cutouts.

[0179] The ejector lock may, for example, be disposed in a bearing that allows the lock to pivot or be pivoted at least partially while preventing longitudinal movement.

[0180] In one or more embodiments, at least one track segment leading to the guide pin from the first angle to the second angle is tilted at an angle of about 40 to 50 degrees relative to the longitudinal axis.

[0181] In one or more instances, at least one track portion leading to the guide pin from the first angle to the second angle is an intermediate portion that continues from a first longitudinally extending track portion and continues to a second longitudinally extending track portion. In one or more instances, the first track portion is wider than the second track portion. In one or more instances, the first track portion is wider than the second track portion, and the first track portion can have an inclined guide surface or chicane that guides the guide pin into the intermediate track portion. The first track portion can extend from the first angle to the second angle. The inclined guide surface can be inclined at an angle of about 40-50 degrees relative to the longitudinal axis. The track is generally comprised of track portions that extend longitudinally or at a steep inclination angle, such that a smooth turning is provided for the guide pin, typically in the latter case by an angle of inclination that is no closer to the longitudinal orthogonal portion than about 30 degrees. Thereby, for that reason at least, the guide pin does not get stuck in the track.

[0182] In one or more embodiments, the track has a width in at least a portion of the track equal to the dimension of the guide pin plus a clearance, the dimension of the guide pin may be its diameter, or the diameter or circumference or width of the pin, and the clearance may be 50% less than the dimension of the guide pin, or 20% less than the dimension of the guide pin, or 10% less than the dimension of the guide pin.

[0183] The first entry portion of the plunger rod track can be wider than the intermediate and second portions of the plunger rod track, such that the ejector lock guide pin can be received at a wider angle and guided into the track, which can prevent the ejector lock guide pin from unintentionally impeding the movement of the plunger rod.

[0184] In one or more embodiments, the plunger rod track is configured as a recess extending from a plunger rod distal edge of the outer plunger rod, the depth of the recess matching the length of the guide pins so that they fully engage to redirect the ejector lock.

[0185] In one or more embodiments, the ejector lock is coupled to a resilient member that biases the ejector lock toward a second angular position, whereby a more retracted position of the plunger rod is required to disengage the ejector lock. This is particularly beneficial when the entry portion of the plunger rod track receives the ejector lock guide pin at a wider angle.

[0186] In some instances, the autoinjector includes a drive module having a motor and one or more of a transmission and gearing for coupling the motor to an internal plunger rod. The drive module may be powered from one or more of a battery and a power supply. The drive module may be controlled via a microprocessor programmed to control the plunger rod via the drive module in response to a user-activated control, such as a push button.

[0187] The autoinjector may further include a resistance sensor configured to provide a resistance signal indicative of resistance to movement of the plunger rod, and the processing unit may be coupled to the resistance sensor.

[0188] The processing unit is - controlling the drive module to move, e.g., advance, the plunger rod toward an extended plunger rod position at a plunger rod speed; - Determine the plunger rod position, - receiving the resistance signal and controlling the drive module to adjust the movement of the plunger rod if the resistance signal indicates resistance to movement of the plunger rod above a high resistance threshold; It may be further configured as follows.

[0189] The high resistance threshold may be based on the plunger rod position.

[0190] The housing may house a resistive sensor.

[0191] Also disclosed herein is a method of controlling an autoinjector, the method comprising: - receiving a cartridge having a first stopper; - moving the plunger rod toward an extended plunger rod position at a plunger rod velocity; - Determining the plunger rod position; - receiving a resistance signal indicative of resistance to movement of the plunger rod; - adjusting the movement of the plunger rod when the resistance signal indicates resistance to the movement of the plunger rod above a high resistance threshold; and the high resistance threshold is based on the plunger rod position.

[0192] By applying additional force to the stopper(s) in this manner, optimization of dosing accuracy is achieved through more complete emptying of the drug cartridge during injection, and maintaining such increased force over a period of time, thereby forcing the deformation / compression of the stopper into better contact (fill) with the internal cartridge shoulder area, thereby forcing outward any residual drug therein. Additionally, improved drug utilization is provided, as less drug can be wasted from each cartridge.

[0193] The plunger rod speed can be further optimized, for example leading to an optimization of the duration of the injection procedure, e.g. the time needed to inject the medicine and / or the time to prepare for injection, and further increasing patient safety, e.g. by reducing the risk of incorrect dosing of the medicine.

[0194] In addition, improved accuracy of medication usage is obtained, which allows for the amount of unused medication to be reduced, thus reducing the cost of unused medication.

[0195] The high resistance threshold can be based on the plunger rod position. The high resistance threshold can be a first high resistance threshold and / or a second high resistance threshold and / or a third high resistance threshold.

[0196] The processing unit may be configured to determine the high resistance threshold based on, for example, the plunger rod position. The high resistance threshold may be a first high resistance threshold when the plunger rod position is between the retracted plunger rod position and the first plunger rod position. Alternatively or additionally, the high resistance threshold may be a second high resistance threshold when the plunger rod position is between the second plunger rod position and the extended plunger rod position.

[0197] The second high resistance threshold may be higher than the first high resistance threshold to ensure effective emptying of the cartridge without risk of leakage at the stopper or septum at the end of injection, due to the low flow resistance of the injection needle contributing to pressure within the cartridge when the second high resistance threshold corresponds to an extended plunger rod position at the end of injection of the medicinal product.

[0198] The first high resistance threshold may be between 50 and 80 N, such as 50 N, 55 N, 60 N, 65 N, 70 N, 75 N, or 80 N. In an illustrative example, the first high resistance threshold is 55 N.

[0199] The second high resistance threshold may be between 70 and 100 N, such as between 75 and 85 N, or such as between 80 and 90 N, or such as 70 N, 75 N, 80 N, 85 N, or 90 N. In an illustrative example, the second high resistance threshold is 80 N.

[0200] The high resistance threshold can be a third high resistance threshold when the plunger rod position is between the first plunger rod position and the second plunger rod position. The high resistance threshold can be a third high resistance threshold when the plunger rod position is a third plunger rod position. The third plunger rod position can be between the first plunger rod position and the second plunger rod position.

[0201] The third high resistance threshold may be higher than the first high resistance threshold. The third high resistance threshold may be lower than the second high resistance threshold. The third high resistance threshold may be between the first high resistance threshold and the second high resistance threshold.

[0202] The high resistance threshold, e.g., a third high resistance threshold, may increase as the plunger rod position is moved from the first plunger rod position to the second plunger rod position.

[0203] The distance between the extended plunger rod position and the first plunger rod position can be between 1 and 3 mm, such as 2 mm.

[0204] The distance between the retracted plunger rod position and the first plunger rod position can be between 0 and 60 mm.

[0205] The distance between the retracted plunger rod position and the first plunger rod position can be between 50 and 60 mm, such as 55 mm, 56 mm, or 57 mm.

[0206] The resistance sensor may be configured to measure a pressure and / or force applied to a plunger rod front end of the plunger rod. The plunger rod front end may be configured to engage a first stopper of the cartridge. The resistance sensor may be configured to measure a pressure and / or force between the plunger rod and the stopper. For example, the resistance sensor may include a pressure transducer and / or a force transducer on the plunger rod front end. The plunger rod may include a resistance sensor.

[0207] Alternatively or in addition, the resistance sensor may be configured to determine a current through the drive module and / or may be configured to determine power consumed by the drive module. For example, the resistance sensor may be configured to measure an electrical resistance, a current, and / or a voltage of the drive module. The resistance sensor may include an electrical resistance sensor, a current sensor, and / or a voltage sensor. The resistance signal may be based on power consumed by the drive module, such as a determined power consumed by the drive module. The resistance signal may be based on a current through the drive module, such as a measured current through the drive module. The drive module may include a resistance sensor.

[0208] For example, due to the cost and architectural complexity of applying a dedicated force sensor between the plunger and cartridge stopper, instead of applying such a force sensor, a practical way to monitor the equivalent plunger force and / or resistance may be through monitoring the current through the drive module, such as through the motor of the drive module. For electromechanical systems, this correlates well to the output. The force acting on an inductor within a magnetic field can be expressed as F=B*I*l, where B is the magnetic field strength, I is the inductor current, and l is the length of the inductor within the magnetic field.

[0209] The plunger rod position, such as the plunger rod position at a particular moment in time, may be determined by, for example, a processing unit. The plunger rod position may be determined based on detection from a sensor, such as a plunger rod position sensor.

[0210] The autoinjector may include a plunger rod position sensor. The plunger rod position sensor may be configured to detect a position of the plunger rod and / or a position of the first stopper. The drive module may include a plunger rod position sensor.

[0211] The autoinjector can have a tachometer. The plunger rod position sensor can have a tachometer. The plunger rod position sensor can be a tachometer. The tachometer can be configured to count revolutions of the drive module, such as a motor of the drive module, such as revolutions of the drive module from a set point, such as a point where the position of the plunger rod is known, such as a retracted plunger rod position, such as a fully retracted position of the plunger rod. The counting of revolutions of the drive module can be used to determine a plunger rod position, i.e., the position of the plunger rod at a particular moment in time.

[0212] The tachometer may be configured to provide a tachometer signal indicative of a count of revolutions of the drive module. The processing unit may be coupled to the tachometer. The processing unit may be configured to receive the tachometer signal. The processing unit may be configured to determine a current plunger rod position based on the tachometer signal.

[0213] The processing unit may be coupled to the plunger rod position sensor. The processing unit may receive a first plunger rod position sensor signal, such as a tachometer signal, from the plunger rod position sensor indicating a count of rotations of the drive module. The processing unit may determine a position of the plunger rod based on the first plunger rod position sensor signal, e.g., the tachometer signal. The processing unit may receive a second plunger rod position sensor signal, e.g., from the plunger rod position sensor indicating the plunger rod is in a known position, such as in a fully retracted position, e.g., in a retracted plunger rod position. The processing unit may be configured to determine a position of the plunger rod based on the first plunger rod position sensor signal, e.g., the tachometer signal, and the second plunger rod position sensor signal. The processing unit may be configured to determine a plunger rod position based on the tachometer signal and the retracted plunger rod position. For example, the processing unit may be configured to determine the plunger rod position based on the number of revolutions of the drive module since the plunger rod was at a retracted plunger rod position.

[0214] Adjusting the plunger rod travel may include decreasing the plunger rod velocity.

[0215] Regulating the movement of the plunger rod may include stopping the movement of the plunger rod.

[0216] Regulating the movement of the plunger rod can include preventing movement of the plunger rod toward a retracted plunger rod position during the dwell time. Alternatively or additionally, regulating the movement of the plunger rod can include maintaining a position of the plunger rod during the dwell time. Preventing retraction or movement toward the retracted plunger rod position can prevent backflow of medicinal product due to a drop in pressure inside the cartridge.

[0217] Adjusting the movement of the plunger rod can include moving the plunger rod to a retracted plunger rod position. For example, the plunger rod can be moved to the retracted plunger rod position after a dwell time.

[0218] Regulating the movement of the plunger rod can include gradually decreasing the plunger rod velocity, stopping the plunger rod velocity, preventing movement of the plunger rod toward the retracted plunger rod position, and moving the plunger rod to the retracted plunger rod position after a dwell time.

[0219] The movement of the plunger rod may be readjusted after adjusting the movement of the plunger rod. The processing unit may be configured to control the drive module to readjust the movement of the plunger rod after adjusting the movement of the plunger rod. For example, the movement of the plunger rod may be readjusted after adjusting the movement of the plunger rod if resistance to the movement of the plunger rod falls below a high resistance threshold. The processing unit may be configured to control the drive module to readjust the movement of the plunger rod after adjusting the movement of the plunger rod if the resistance signal indicates that resistance to the movement of the plunger rod falls below a high resistance threshold. Readjusting the movement of the plunger rod may include increasing a plunger rod velocity.

[0220] The plunger rod velocity may be variable. For example, the plunger rod velocity may be based on a plunger rod position. The plunger rod velocity may be a first plunger rod velocity when the plunger rod position is between a retracted plunger rod position and a fourth plunger rod position. The plunger rod velocity may be a second plunger rod velocity when the plunger rod position is between a fifth plunger rod position and an extended plunger rod position. The second plunger rod velocity may be lower than the first plunger rod velocity. Alternatively, the second plunger rod velocity may be higher than the first plunger rod velocity. The processing unit may be configured to determine the plunger rod velocity, for example, based on the plunger rod position.

[0221] The fourth plunger rod position can be the first plunger rod position. The fifth plunger rod position can be the second plunger rod position. The first plunger rod position and the second plunger rod position can be the same plunger rod position. The fourth plunger rod position and the fifth plunger rod position can be the same plunger rod position.

[0222] A cartridge, such as a cartridge receiver of an autoinjector, such as a cartridge configured to be received by an autoinjector, can have a cartridge outlet at a first cartridge end. The cartridge can have a cartridge back at, for example, a second cartridge end opposite the cartridge outlet. The cartridge back can have a cartridge back end opening. The cartridge back end opening can provide access to the first stopper for a plunger rod, such as a plunger rod of an autoinjector.

[0223] The cartridge compartment can include a medicinal product. The cartridge outlet can be configured for fluid communication with the cartridge compartment, for example at a first cartridge end. The cartridge can be configured to release the medicinal product through the cartridge outlet. The cartridge outlet can be configured to be coupled with an injection needle, such as a hypodermic needle, to provide the medicinal product to be released through the injection needle.

[0224] The first stopper of the cartridge may be movable within the cartridge compartment. The cartridge may have a second stopper movable within the cartridge compartment. The second stopper may be between the first stopper and the cartridge outlet. The cartridge may have a third stopper movable within the cartridge compartment. The third stopper may be between the second stopper and the cartridge outlet. The first stopper, the second stopper, and / or the third stopper may be movable within the cartridge compartment, e.g., toward the cartridge outlet in a first stopper direction, such as toward the first cartridge end. For example, when the first stopper, the second stopper, and / or the third stopper move in the first stopper direction and / or toward the cartridge outlet, the pharmaceutical product may be released through the cartridge outlet.

[0225] It is contemplated that any embodiment or element described in connection with any one aspect may be used with any other aspect or embodiment, mutatis mutandis.

[0226] These and other features and advantages of the present invention will become readily apparent to those skilled in the art from the following detailed description of illustrative embodiments thereof, when read in conjunction with the accompanying drawings. [Brief description of the drawings]

[0227] [Figure 1] 1 illustrates an exemplary autoinjector. [Diagram 2] 1 shows an exemplary autoinjector with an exemplary cartridge as viewed from two different orientations. [Diagram 3] 1 shows an exemplary autoinjector with an exemplary cartridge as viewed from two different orientations. [Figure 4] 1 shows an exemplary autoinjector with an electrical connector. [Figure 5A] 1 illustrates generally the components of an exemplary autoinjector. [Figure 5B] 1 illustrates generally the components of an exemplary autoinjector. [Figure 6A] 1A-1C are schematic diagrams illustrating the insertion and removal of an exemplary cartridge within an exemplary autoinjector. [Figure 6B] 1A-1C are schematic diagrams illustrating the insertion and removal of an exemplary cartridge within an exemplary autoinjector. [Figure 6C] 1A-1C are schematic diagrams illustrating the insertion and removal of an exemplary cartridge within an exemplary autoinjector. [Figure 6D] 1A-1C are schematic diagrams illustrating the insertion and removal of an exemplary cartridge within an exemplary autoinjector. [Figure 7A] 10A and 10B illustrate an exemplary coupling between a blocking member and an ejector member. [Figure 7B] 10A and 10B illustrate an exemplary coupling between a blocking member and an ejector member. [Figure 7C] 10A and 10B illustrate an exemplary coupling between a blocking member and an ejector member. [Figure 7D] 10A and 10B illustrate an exemplary coupling between a blocking member and an ejector member. [Figure 7E] 10A and 10B illustrate an exemplary coupling between a blocking member and an ejector member. [Figure 7F] 10A and 10B illustrate an exemplary coupling between a blocking member and an ejector member. [Figure 8A] 1 illustrates an exemplary blocking member. [Figure 8B]1 illustrates an exemplary blocking member. [Figure 9] 1 illustrates a schematic diagram of an exemplary drive module and plunger rod. [Figure 10] 1 illustrates generally exemplary components of an exemplary autoinjector. [Figure 11] 1 illustrates an exemplary cartridge. [Figure 12] 1 shows an exemplary cartridge holder along with a cartridge. [Figure 13] 1 shows a cross section of an exemplary cartridge assembly along with a needle assembly. [Figure 14] 1 illustrates an exemplary cartridge receiver. [Figure 15] 1 illustrates an exemplary cartridge receiver along with an ejector. [Figure 16A] 1 illustrates a detailed view of a first section and a second section of an exemplary cartridge receiver compartment. [Figure 16B] 1 illustrates an exemplary cartridge retaining member inbound and outbound journey. [Figure 17A] FIG. 2 is a cross-sectional view of a first area of ​​an exemplary cartridge receiver compartment. [Figure 17B] FIG. 13 is a cross-sectional view of a second area of ​​an exemplary cartridge receiver compartment. [Figure 18] 13A-13C show detailed views of alternative first and second sections of an exemplary cartridge receiver compartment; [Figure 19] An exemplary external plunger rod is shown. [Figure 20] 1 illustrates an exemplary ejector. [Figure 21] An exemplary ejector lock is shown. [Figure 22A] 1 illustrates various positions of an exemplary ejector relative to an exemplary ejector lock. [Figure 22B] 1 illustrates various positions of an exemplary ejector relative to an exemplary ejector lock. [Figure 22C] 1 illustrates various positions of an exemplary ejector relative to an exemplary ejector lock. [Figure 22D] 1 illustrates various positions of an exemplary ejector relative to an exemplary ejector lock. [Figure 23] 1 shows a cross section of an exemplary system having an autoinjector and cartridge assembly. [Figure 24A] 1 shows a cross section of a portion of an exemplary system having an autoinjector and cartridge assembly. [Figure 24B] 1 shows a cross section of a portion of an exemplary system having an autoinjector and cartridge assembly. [Figure 24C] 1 shows a cross section of a portion of an exemplary system having an autoinjector and cartridge assembly. [Figure 24D] 1 shows a cross section of a portion of an exemplary system having an autoinjector and cartridge assembly. [Figure 25A] The examples show various positions of an exemplary ejector relative to an ejector lock with a cog having a beveled surface. [Figure 25B] The examples show various positions of an exemplary ejector relative to an ejector lock with a cog having a beveled surface. [Figure 26] FIG. 1 shows a block diagram of an exemplary autoinjector. [Figure 27] 1 illustrates a schematic diagram of an exemplary autoinjector. [Figure 28A] 1 shows an exemplary graph of resistance threshold versus plunger position. [Figure 28B] 1 shows an exemplary graph of resistance threshold versus plunger position. [Figure 28C] 1 shows an exemplary graph of resistance threshold versus plunger position. [Figure 28D] 1 shows an exemplary graph of resistance threshold versus plunger position. [Figure 28E] 1 shows an exemplary graph of resistance threshold versus plunger position. [Figure 28F]1 shows an exemplary graph of resistance threshold versus plunger position. [Figure 29] 1 shows an example graph of resistance versus plunger position. [Figure 30A] 1 shows an example graph of plunger speed versus plunger position. [Figure 30B] 1 shows an example graph of plunger speed versus plunger position. [Figure 30C] 1 shows an example graph of plunger speed versus plunger position. [Figure 30D] 1 shows an example graph of plunger speed versus plunger position. [Figure 30E] 1 shows an example graph of plunger speed versus plunger position. [Diagram 31] 1 shows a flow chart of an exemplary method. [Diagram 32] 1 shows a flow chart of an exemplary method. [Diagram 33] 1 shows a flow chart of an exemplary method. [Diagram 34] 1 shows a flow chart of an exemplary method. [Diagram 35] 1 shows a flow chart of an exemplary method. [Diagram 36] FIG. 1 shows a block diagram of an exemplary autoinjector. [Figure 37] 1 shows a flow chart of an exemplary method. [Figure 38] 1 shows a flow chart of an exemplary method. [Figure 39] 1 shows the temperature dependence of viscosity of lonapegsomatropin at a pharmaceutical solution concentration of 22.0 mg / mL hGH. [Figure 40A] 1 shows exemplary measurements of required injection force 1250 as a function of plunger rod position when the cartridges contain 13.3 mg hGH / mL lonapegsomatropin drug solution and 5.2 mg hGH / mL lonapegsomatropin drug solution, respectively. [Figure 40B]1 shows exemplary measurements of required injection force 1250 as a function of plunger rod position when the cartridges contain 13.3 mg hGH / mL lonapegsomatropin drug solution and 5.2 mg hGH / mL lonapegsomatropin drug solution, respectively. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0228] Various embodiments are described below with reference to the figures. Similar reference numerals refer to similar elements throughout. Thus, similar elements will not be described in detail with respect to the description of each figure. It should also be noted that the figures are intended only to facilitate the description of the embodiments. They are not intended as an exclusive description of the claimed invention or as a limitation on the scope of the claimed invention. In addition, an illustrated embodiment need not have all aspects or advantages shown. An aspect or advantage described in connection with a particular embodiment is not necessarily limited to that embodiment and can be implemented in any other embodiment even if not so illustrated or not so explicitly described.

[0229] The term "user" refers to a human being who uses the autoinjector to self-administer a medicine. In this regard, a user may also be designated a "patient." Thus, one use case of an autoinjector is the self-administration of a medicine. The autoinjector is described with this use case in mind. However, in another use case, an assistant, e.g., a nurse or home caregiver, may operate the autoinjector to administer a medicine to a patient. The latter use case is also enabled by the present disclosure of the autoinjector. A user may use the autoinjector in connection with the user's daily activities.

[0230] The same reference numbers are used throughout to refer to the same or corresponding parts.

[0231] 1 illustrates an exemplary autoinjector. The autoinjector 4 may be configured to administer a pharmaceutical agent. The autoinjector 4 may be an electronic autoinjector, e.g., the autoinjector 4 may be connectable to a power supply (not shown), such as an external battery or a power plug.

[0232] The autoinjector 4 has a housing 6. The autoinjector 4 has a cartridge receiver 300. The cartridge receiver is configured to receive a cartridge and / or a cartridge assembly having a cartridge. The cartridge may contain a pharmaceutical product.

[0233] The cartridge receiver 300 has a cartridge receiver opening 301. The cartridge receiver 300 is configured to receive a cartridge and / or cartridge assembly through the cartridge receiver opening 301 in a cartridge-receiving direction 304 along a longitudinal axis L.

[0234] The autoinjector 4 may have a user interface 1100, as illustrated. The autoinjector 4 may have a trigger member, such as a contact member 1102. The contact member 1102 may be configured to be pressed against an injection site on the patient's skin. The contact member 1102 may be movable in a cartridge-receiving direction 304 relative to the housing when pressed against the injection site. The contact member 1102 may be a component of the user interface 1100.

[0235] The user interface 1100 has a first input member 1108, e.g., a button. The first input member 1108 may provide user input from a user. For example, the first input member 1108 may be used to receive a press from a user to proceed to the next step.

[0236] The user interface 1100 has a first output member 1110 as illustrated, e.g., a plurality of LEDs. The first output member 1110 may provide a user output to a user. The user interface 1100 may have a second output member (not shown), e.g., a speaker. The second output member may be configured to provide an audible output to the user. For example, the first output member 1110 and / or the second output member may be used to indicate a step in a procedure and / or to indicate an error message to a user.

[0237] The autoinjector 4 may have a cover (not shown) to protect the autoinjector from dust and dirt when not in use.

[0238] The user interface 1100 may have a first LED 1106 that flashes when the battery needs charging. By flashing, it is meant that the first LED 1106 may continuously emit light in a particular color. Alternatively, the first LED 1106 may blink. The color of the light from the first LED 1106 may be red to indicate that the user needs to pay attention to the battery level.

[0239] The first LED 1106: A) the difference between the calculated remaining electric battery voltage level and a preset threshold indicating the minimum electric battery voltage level required to perform the autoinjector process at the measured temperature becomes greater than a predetermined tolerance; or B) until the calculated remaining electric battery voltage level is greater than a preset threshold at the measured temperature. It may flash.

[0240] After the battery is sufficiently recharged, the first LED 1106 may stop flashing and the second LED may be turned on, e.g., emitting a light having a different color than the color of the first LED 1106, e.g., green compared to the red of the first LED. The flashing of the second color is meant to indicate to the user that the battery is sufficiently recharged to perform the autoinjector procedure at the temperature measured by the temperature sensor.

[0241] 2 illustrates an exemplary system 2 having an autoinjector with a cartridge. The system 2 includes an autoinjector 4 as described in connection with FIG. 1 and an exemplary cartridge 700 received in a cartridge receiver 300 by front loading. The cartridge 700 is shown with a needle cover 908. The needle cover 908 extends outwardly from a contact member 1102 to allow removal of the needle cover 908 from the cartridge 700.

[0242] By front loading it is understood that at least the cartridge 700 is received with its needle end pointing out of the cartridge receiver opening 301. When the cartridge is being inserted, in particular when it is fully or nearly fully inserted, the cartridge or cartridge assembly may be substantially covered by the housing or contact member 1102. In particular in this situation the needle cover 908 serves as a protective means allowing the user to at least press against the needle cover 908 or its tip to fully insert the cartridge without being hurt by the needle. When the cartridge is fully inserted and in the holding position, it is possible to detach the needle cover so that the autoinjector is ready for use to inject the medicinal product contained in the cartridge or a part thereof. After use, i.e. when a dose of medicinal product has been injected, the needle cover is attached so that it again serves as a protective means allowing the user to at least press against the needle cover 908 or its tip to remove the cartridge without being hurt by the needle.

[0243] Figure 3 shows the autoinjector 4 together with the cartridge, with the autoinjector turned 180 degrees compared to the view of the autoinjector in Figures 1-2. The autoinjector 4 has a first electrical connector 12 (see Figures 5A-5B). The first electrical connector 12 is accessible through a connector opening 14 in the housing 6. The first electrical connector 12 receives a second electrical connector 18 (see, for example, Figure 4).

[0244] The connection of the second electrical connector 18 and the first electrical connector 12 may, for example, provide for charging a battery (not visible) of the autoinjector 4. The battery may be housed by the housing 6. Alternatively or in addition, the connection of the second electrical connector 18 and the first electrical connector 12 may provide for the transfer of data to / from the autoinjector 4, such as to / from a memory of the autoinjector 4.

[0245] The autoinjector 4 has a blocking member 100, 100'. The blocking member is configured to move between a blocking position and an unblocking position. In the blocking position, the connector opening 14 is blocked, e.g., closed, as illustrated in FIG. 3. In the unblocking position, the connector opening 14 is not blocked, e.g., open. In the unblocking position, the second electrical connector 18 (see, e.g., FIG. 4) and the first electrical connector 12 may be connectable through the connector opening 14. In the blocking position, the blocking member 100, 100' may prevent connection of the second electrical connector 18 and the first electrical connector 12.

[0246] The blocking member 100 may be movable along the longitudinal axis L, such as movable between a blocking position and a non-blocking position along the longitudinal axis L. For example, the blocking member 100 may be, for example, a sliding element that slides along the longitudinal axis L.

[0247] Alternatively, the blocking member 100' may be movable perpendicular to the longitudinal axis L, such as movable between a blocking position and a non-blocking position perpendicular to the longitudinal axis L. For example, the blocking member 100' may be a rotating element that rotates, for example, about the longitudinal axis L.

[0248] The position of the blocking members 100, 100' may be determined by insertion of the cartridge 700 into the cartridge receiver 300. When the cartridge 700 is received in a cartridge receiver 300, such as that shown in FIG. 3, the blocking members 100, 100' may be in a blocking position. When the cartridge is not received in a cartridge receiver, such as that shown in FIG. 4, the blocking members 100, 100' may be in a non-blocking position.

[0249] 4 shows an exemplary autoinjector 4, as described in connection with the previous figures, with the second electrical connector 18 connected to the first electrical connector 12. The blocking member is in a non-blocking position to allow connection of the second electrical connector 18 to the first electrical connector 12 through the connector opening 14 in the housing 6.

[0250] The blocking member may be prevented from moving to the blocking position. For example, the second electrical connector 18 may prevent the blocking member from moving to the blocking position. For example, the second electrical connector 18 may block the path of movement of the blocking member toward the blocking position.

[0251] Insertion of a cartridge into the cartridge receiver 300 may cause movement of the blocking member 100. For example, insertion of a cartridge into the cartridge receiver 300 may require movement of the blocking member to a blocking position. Thus, a blocking member that is prevented from moving to the blocking position may prevent insertion of a cartridge. Thus, when the first electrical connector is connected to the second electrical connector 18, insertion of a cartridge into the cartridge receiver 300 may be prevented.

[0252] 5A and 5B diagrammatically illustrate selected parts of an exemplary autoinjector as described in connection with the previous figures.

[0253] 5A and 5B illustrate an ejector 200 of an autoinjector. The ejector 200 has an ejector member 202. The ejector member 202 is movable along a longitudinal axis L. The ejector member 202 is movable between a first ejector position shown in FIG. 5A and a second ejector position shown in FIG. 5B. When the cartridge 700 is received in the cartridge receiver 300 (see above figure), the ejector member 202 is configured to follow the movement of the cartridge 700 (only partially shown). As illustrated, when the cartridge 700 is received, the ejector member 202 is moved to the second ejector position. As shown in FIG. 5A, when the cartridge 700 is not received in the cartridge receiver, the ejector member 202 can be in the first ejector position. As shown in FIG. 5B, when the cartridge 700 is received within the cartridge receiver, the ejector member 202 can be in a second ejector position.

[0254] The ejector member 202 has an ejector abutment surface 204. The ejector abutment surface 204 is configured to abut a surface, such as a cartridge back surface 716 of the cartridge 700. By inserting the cartridge 700 into the cartridge receiver, the cartridge back surface 716 can abut the ejector abutment surface 204 and the ejector member 202 can be urged toward the second ejector position.

[0255] An autoinjector, such as autoinjector ejector 200, has an ejector resilient member 218, such as a spring. The ejector resilient member 218 is configured to exert a force on the ejector member 202. For example, the ejector resilient member 218 can be configured to bias the ejector member 202 toward a first ejector position. For example, the ejector resilient member 218 can cause the ejector member 202 to be in the first ejector position when the cartridge 700 is not received in the cartridge receiver and / or when removed from the cartridge receiver. As shown in FIG. 5B, the ejector resilient member 218 can be compressed when the cartridge 700 is received in the cartridge receiver.

[0256] 5A and 5B illustrate an autoinjector shutoff member 100. An ejector member 202 is coupled to the shutoff member 100. The shutoff member 100 has a first shutoff coupling member 102. The ejector member has a second shutoff coupling member 208. The first shutoff coupling member 102 and the second shutoff coupling member 208 engage to provide translational movement of the ejector member 202 to the shutoff member 100.

[0257] As shown in Fig. 5B, when the ejector member 202 is in the second ejector position, the blocking member 100 is in the blocking position. As shown in Fig. 5A, when the ejector member 202 is in the first ejector position, the blocking member 100 is in the non-blocking position.

[0258] 5A, the second electrical connector 18 can be connected to the first electrical connector 12. In the blocking position, the blocking member 100 is positioned in front of the first electrical connector 12. Thereby, the second electrical connector 18 cannot be connected to the first electrical connector 12 when the blocking member 100 is in the blocking position.

[0259] Conversely, as seen in Fig. 5A, due to the second electrical connector 18 being connected to the first electrical connector 12, the blocking member 100 is not movable to the blocking position. Thus, the ejector member 202 may be prevented from moving to the second ejector position. Thus, when the second electrical connector 18 is connected to the first electrical connector 12, insertion of the cartridge may be prevented.

[0260] The blocking member 100 has a first blocking member stop portion 104 and a second blocking member stop portion 106. The first blocking coupling member 102 is formed as a slot having the first blocking member stop portion 104 and the second blocking member stop portion 106.

[0261] The second blocking coupling member 208 may have a protrusion arranged to capture the first blocking member stop 104 upon movement in one direction, e.g., along the longitudinal axis, and the second blocking member stop 106 upon movement in another direction. For example, the second blocking coupling member 208 may capture the first blocking member stop 104 upon movement of the ejector member toward a first ejector position, such as removal of the cartridge 700 from the cartridge receiver, as shown in FIG. 5A. The second blocking coupling member 208 may capture the second blocking member stop 106 upon movement of the ejector member toward a second ejector position, such as insertion of the cartridge 700 into the cartridge receiver, as shown in FIG. 5B.

[0262] Figures 6A-6D generally illustrate the insertion and removal of an exemplary cartridge within an exemplary autoinjector 4, such as the autoinjector described in connection with Figures 1-4. Figures 6A-6D show only selected parts of the exemplary autoinjector 4.

[0263] The autoinjector 4 has a first electrical connector 12 and a cartridge receiver 300 configured to receive a cartridge 700 .

[0264] The autoinjector 4 includes an ejector member 202 and an ejector resilient member 218. The ejector member 202 includes an ejector abutment surface 204 configured to abut a surface, such as a cartridge rear surface 716, of the cartridge 700. The autoinjector further includes a blocking member 100 coupled to the ejector member 202. In the illustrated example, the ejector member 202 and the blocking member 100 are fixedly connected. The blocking member 100 is configured to, for example, block a connector opening to the first electrical connector 12 when the blocking member is in a blocking position.

[0265] 6A-6D is a cartridge assembly 600 having a cartridge 700. The cartridge 700 has a cartridge compartment 702. The cartridge compartment 702 may contain or be configured to contain a medicinal product. The cartridge has a cartridge back surface 716 configured to abut the ejector abutment surface 204 of the ejector member 202.

[0266] The cartridge assembly 600 includes a needle assembly 900. The needle assembly 900 includes a needle 902, such as a hypodermic needle, and a needle cover 908. The needle cover 908 covers the needle 902, such as to avoid contact with the needle 902. The needle cover 908 is removable. The needle cover 908 may be removed prior to initiating injection of a medicinal product.

[0267] 6A shows a first situation in which the cartridge 700 is about to be received in the cartridge receiver 300 in the cartridge receiving direction 304. The cartridge back surface 716 is adjacent to the ejector abutment surface 204. The ejector member 202 is in a first ejector position. The blocking member 100 is in a non-blocking position.

[0268] 6C illustrates a second situation following the first situation, in which the cartridge 700 is moved to be received within the cartridge receiver 300. When the cartridge 700 is received within the cartridge receiver 300, it can be retained within the cartridge receiver 300. The cartridge receiver 300 is configured to selectively retain the cartridge 700 within the cartridge receiver 300. The ejector member 202 is in the second ejector position and the blocking member 100 is in the blocking position. The ejector resilient member 218 is compressed. The cartridge 700 retained within the cartridge receiver 300 prevents the ejector resilient member 218 from moving the ejector member 202 toward the first ejector position.

[0269] In the case where the second electrical connector is connected to the first electrical connector 12, the blocking member 100 is prevented from moving to the blocking position, and thus the ejector member 202 is prevented from moving to the second ejector position because the ejector member 202 and the blocking member 100 are connected. Thus, when the second electrical connector is connected to the first electrical connector 12, the cartridge 700 cannot be received in the cartridge receiver 300, for example, to be held in the cartridge receiver 300.

[0270] 6B shows an optional third condition between the first and second conditions, in which the cartridge 700 is urged further into the cartridge receiver 300 in the cartridge-receiving direction 304. The ejector member is moved beyond the second ejector position. The ejector resilient member 218 is compressed and the blocking member 100 is moved beyond the blocking position. This condition illustrates an example of how the cartridge receiver 300 selectively retains the cartridge 700 within the cartridge receiver 300.

[0271] For example, the cartridge receiver 300 may hold the cartridge 700 following the cartridge 700 being urged in the cartridge-receiving direction causing movement of the ejector member 202 past the second ejector position a first time. The cartridge receiver 300 may release the cartridge 700 following the cartridge 700 being urged in the cartridge-receiving direction causing movement of the ejector member 202 past the second ejector position a second time.

[0272] FIG. 6D shows a fourth situation in which the cartridge 700 is released from the cartridge receiver 300 and the ejector resilient member 218 is moved in the opposite direction to the cartridge receiving direction 304 by expanding. The ejector resilient member 218 moves the ejector member 202 toward the first ejector position. The retaining member of the cartridge receiver 300 does not prevent the cartridge 700 from moving, and the ejector resilient member 218 moves the ejector member 202 toward the first ejector position. By moving the ejector member 202 to the first ejector position, the blocking member 100 is moved to the non-blocking position. Thus, the connection of the second electrical connector to the first electrical connector 12 is again possible.

[0273] Releasing the cartridge 700 from the cartridge receiver 300 may involve moving the cartridge in the cartridge-receiving direction 304 as described in relation to Figure 6B. Thus, the optional situation shown in Figure 6B may also be optionally inserted between the situation of Figure 6C and the situation of Figure 6D.

[0274] Figures 7A-7F diagrammatically illustrate an exemplary coupling between a blocking member 100 and an ejector member 202. The blocking member 100 and the ejector member 202 may be of an exemplary autoinjector, such as the autoinjector described in connection with Figures 1-4. Figures 7A-7F show only selected parts of the exemplary autoinjector.

[0275] An autoinjector, such as an ejector of an autoinjector, has an ejector resilient member 218, such as a spring. The ejector resilient member 218 is configured to exert a force on the ejector member 202. For example, the ejector resilient member 218 can be configured to bias the ejector member 202 toward a first ejector position. The ejector member 202 can be movable between a first ejector position and a second ejector position. The first ejector position can be a position of the ejector member 202 when a cartridge is not received in the cartridge receiver. The second ejector position can be a position of the ejector member 202 when a cartridge is received in the cartridge receiver. The ejector member 202 can be in other positions, such as a third ejector position and / or a fourth ejector position. The third ejector position and / or the fourth ejector position may be between the first ejector position and the second ejector position.

[0276] For example, when the blocking member 100 is in the blocking position, the blocking member 100 is configured to block the connector opening to the first electrical connector 12 .

[0277] The ejector member 202 is coupled to the blocking member 100. The blocking member 100 has a first blocking coupling member 102. The ejector member has a second blocking coupling member 208. The first blocking coupling member 102 and the second blocking coupling member 208 are engaged to translate the ejector member 202 in response to the movement of the blocking member 100.

[0278] The blocking member 100 has a first blocking member stop 104 and a second blocking member stop 106. The first blocking coupling member 102 is formed as a slot having the first blocking member stop 104 and the second blocking member stop 106. The second blocking coupling member 208 is arranged to capture the second blocking member stop 106 by movement in one direction, e.g., in the cartridge receiving direction 304, and to capture the first blocking member stop 104 by movement in the opposite direction, e.g., opposite to the cartridge receiving direction 304.

[0279] 7A, for example, shows a first situation in which a cartridge is not received in the cartridge receiver. The ejector member 202 is in the first ejector position and the blocking member 100 is in the non-blocking position. Thus, the second electrical connector can be connected to the first electrical connector 12.

[0280] 7B shows a second situation, for example, when a cartridge is received in the cartridge receiver. The ejector member 202 is in a third ejector position. Compared to the previous figure, the ejector member 202 has moved in a cartridge-receiving direction 304, for example, caused by the insertion of a cartridge in the cartridge receiver. The second blocking coupling member 208 is adjacent to the second blocking member stop 106. Thus, from the third ejector position, the movement of the ejector member 202 in the cartridge-receiving direction 304 results in the movement of the blocking member 100 in the cartridge-receiving direction 304.

[0281] 7C shows a third situation, where the cartridge has been pushed further in the cartridge receiving direction 304, for example, for receiving the cartridge in a cartridge receiver. The ejector member 202 is in the second ejector position. The blocking member 100 is in the blocking position. Compared to the previous figure, the ejector member 202 has moved, for example, caused by the cartridge being received in the cartridge receiver in the cartridge receiving direction 304. The second blocking coupling member 208 has moved together with the ejector member 202, and due to the abutment with the second blocking member stop 106, the movement of the ejector member 202 to the second ejector position moves the blocking member 100 to the blocking position.

[0282] FIG. 7D shows a fourth situation in which the ejector member 202 is in a position and the second coupling member 208 is not adjacent to either the first blocking member stop 104 or the second blocking member stop 106. For example, such a position can be between the second ejector position and the third ejector position and / or the fourth ejector position. For example, the ejector member 202 can be in such a position after the cartridge is received in the cartridge receiver. In the illustrated situation, for example, in the illustrated position of the ejector member 202, the movement of the ejector member 202 does not immediately translate to the movement of the blocking member. The engagement of the first blocking coupling member 102 and the second blocking coupling member 208 allows a certain distance of slack between the movement of the ejector member 202 and the movement of the blocking member 100.

[0283] FIG. 7E shows a fifth situation, for example, in which the cartridge has been released from the cartridge receiver and is thus moved in the opposite direction to the cartridge receiving direction 304. The ejector member 202 is in the fourth ejector position. The blocking member is in the blocking position. Compared to the previous figures, the ejector member 202 has moved in the opposite direction to the cartridge receiving direction 304 to the fourth ejector position, for example, caused by the ejector elastic member (see previous figures). The second blocking coupling member 208 is adjacent to the first blocking member stop 104. Thus, the movement of the ejector member 202 in the opposite direction to the cartridge receiving direction 304 from the fourth ejector position results in the movement of the blocking member 100 in the opposite direction to the cartridge receiving direction 304.

[0284] FIG. 7F shows a sixth situation, for example, when the cartridge is removed from the cartridge receiver. The ejector member 202 is in the first ejector position. The blocking member 100 is in the non-blocking position. Compared to the previous figures, the ejector member 202 has moved, for example, caused by the ejector elastic member (see previous figures) and by the cartridge being removed from the cartridge receiver. The second blocking coupling member 208 has moved together with the ejector member 202, and due to the abutment with the first blocking member stop 104, the movement of the ejector member 202 to the first ejector position moves the blocking member 100 to the non-blocking position.

[0285] Figures 8A and 8B show an exemplary blocking member 100' of an exemplary autoinjector, such as the autoinjector of Figures 1-4. The blocking member 100' illustrated in Figures 8A and 8B is a rotating blocking member. The blocking member 100' is configured to rotate in a direction of rotation DR in response to translational movement of the ejector member in the cartridge-receiving direction.

[0286] 8A shows the blocking member 100' in a non-blocking position. The second electrical connector 18 is connected to the first electrical connector 12.

[0287] 8B shows the blocking member 100' in the blocking position. The connection of the second electrical connector to the first electrical connector 12 is prevented by the blocking member 100'. Compared to FIG. 8A, the blocking member 100' has been rotated in the direction of rotation DR to the blocking position.

[0288] FIG. 9 illustrates generally an exemplary drive module 500 and plunger rod 400, such as the drive module 500 and plunger rod 400 for an autoinjector as described in connection with the previous figures.

[0289] The plunger rod 400 is configured to advance a first stopper of a cartridge, such as a cartridge received in an autoinjector, such as a cartridge received in a cartridge receiver of an autoinjector, such as the cartridge described in connection with FIG. 11. The plunger rod 400 has an outer plunger rod 404 having internal threads, and an inner plunger rod 402 having external threads. The threads of the inner plunger rod 402 engage with the threads of the outer plunger rod 404. The outer plunger rod 404 is prevented from rotating relative to a housing of the autoinjector. Movement of the plunger rod 400 causes rotation of the inner plunger rod 402. Rotation of the inner plunger rod 402 results in translational movement of the outer plunger rod 404 due to the outer plunger rod 404 being prevented from rotating. The outer plunger rod 404 is configured to abut a first stopper of the cartridge when moving translationally in the first stopper direction 722 and to move the first stopper in the first stopper direction 722 .

[0290] The drive module 500 is coupled to actuate the plunger rod 400. The drive module 500 is electrically connected to a battery for receiving power. The drive module 500 has a motor 502, such as an electro-mechanical motor, such as a DC motor. The drive module 500 has a transmission 504 for coupling the motor 502 to the inner plunger rod 402 of the plunger rod 400.

[0291] The illustrated example has a motor 502 which may be an electro-mechanical motor, however, it will be readily appreciated that the autoinjector 4 may be implemented with alternative drive modules, such as having a solenoid motor, a shape memory alloy engine, a spring arrangement, and / or pressurized gas configured to actuate the plunger rod 400.

[0292] FIG. 10 illustrates generally exemplary components of an exemplary autoinjector 4, such as the autoinjector 4 described in connection with the previous figures. The second electrical connector 18 may be connected to the first electrical connector 12. By doing so, the battery 10 of the autoinjector may be charged. The battery 10 may provide power to the motor 502. The processing unit 20 may be powered by power from the battery 10. The processing unit 20 may control the flow of power to the motor 502. For example, the processing unit 20 may control the motor 502 to turn on or off. The processing unit 20, the motor 502, the battery 10, and the first electrical connector 12 are housed within a housing 6 of the autoinjector 4.

[0293] FIG. 11 illustrates generally an exemplary cartridge 700, such as cartridge 700 configured to be received within a cartridge receiver of an autoinjector, such as the autoinjector described in connection with the previous figures.

[0294] The cartridge 700 has a cartridge compartment 702. The cartridge compartment 702 may be configured to contain a medication. The cartridge 700 has a first end 718 and a second end 720. The cartridge 700 has a cartridge outlet 714 at the first cartridge end 718. The cartridge may be configured to release the medication through the cartridge outlet 714. The cartridge outlet 714 may be sealed by a needle-penetrable sealing. The sealing may be made of rubber and may optionally have a piercing that both enables a needle to penetrate the sealing and seals the medication when a needle does not penetrate the sealing.

[0295] The cartridge has a first stopper 708 that is movable within the cartridge compartment, e.g., in a first stopper direction 722, e.g., toward a first cartridge end. For example, a pharmaceutical agent may be released through a cartridge outlet 714 upon movement of the first stopper 708 in the first stopper direction. The cartridge has a cartridge back end 716 at the second cartridge end. The cartridge back end 716 has a cartridge back end opening to provide access to the first stopper 708 for a plunger rod.

[0296] As illustrated, the cartridge 700 can be a dual chamber cartridge. The cartridge has a second stopper 710 movable within the cartridge compartment 702, e.g., in a first stopper direction 722, e.g., toward a first cartridge end. The cartridge compartment 702 has a first cartridge subcompartment 704 and a second cartridge subcompartment 706. The first cartridge subcompartment 704 is between a first stopper 708 and a second stopper 710. The second cartridge subcompartment 706 is between a second stopper 710 and a cartridge outlet 714. The second cartridge subcompartment 706 can have a pharmaceutical product, e.g., a pharmaceutical product dried by lyophilization, e.g., a dried pharmaceutical product. The cartridge has a bypass area 712 to provide fluid communication between the first cartridge subcompartment and the second cartridge subcompartment. The bypass section 712 provides fluid communication between the first cartridge sub-compartment and the second cartridge sub-compartment when the second stopper 710 is positioned within the bypass section 712 .

[0297] The first cartridge sub-compartment 704 contains a first pharmaceutical component 792 of the drug product 790. The first pharmaceutical component 792 can be a liquid as illustrated. The second cartridge sub-compartment 706 contains a second pharmaceutical component 794 of the drug product 790. The second pharmaceutical component 794 can be a dry composition. By positioning the second stopper 710 in the bypass region 712, the first pharmaceutical component 792 can be transferred into the second cartridge sub-compartment 706 through the bypass region 712, thereby mixing the first pharmaceutical component 792 and the second pharmaceutical component 794 to achieve the combined drug product 790.

[0298] The cartridge 700 may have a generally cylindrical shape. However, the bypass section 712 may form a protrusion from the generally cylindrical shape.

[0299] FIG. 12 shows a cartridge holder together with a cartridge. The cartridge holder 800 receives at least a portion of the cartridge 700 by frictional engagement. Like the cartridge 700, the cartridge holder 800 may have an overall cylindrical shape. The inner diameter of the cartridge holder 800 matches the outer diameter of the cartridge. The cartridge holder may be made of a plastic material, whereas the cartridge is typically made of glass or a glass-like material, and the cartridge may also be made of a plastic material.

[0300] As shown, the cartridge holder 800 receives the first cartridge end 718 of the cartridge. The cartridge holder 800 has a cartridge holder slot 814 that receives the bypass section 712, shown in FIG. 11 as a protruding member. The cartridge holder introduces a coupling option to the cartridge in the form of a needle assembly coupling portion 812, which may take the form of threading as shown, and a cartridge retaining member 808. The cartridge retaining member 808 may take the form of a protrusion extending from the generally cylindrical shape of the cartridge holder 800. The cartridge retaining member 808 may be located at or adjacent to an edge of the cartridge holder at the end opposite the cartridge assembly exit opening 806. In one or more instances, the cartridge retaining member 808 is located a greater distance from the edge than shown.

[0301] The needle assembly coupling portion 812 allows for coupling of the cartridge 700 to a needle assembly, via a cartridge holder 800, as will be described in further detail below.

[0302] 13 shows a cross section of the cartridge assembly along with the needle assembly. Note that the cartridge 700 is shown without a stopper, but with a bypass section 712.

[0303] The needle assembly 900 is coupled to the cartridge holder by a needle assembly mating portion 812 and a cartridge holder mating portion 906 of the needle assembly and cartridge holder, respectively. The mating portions 812 and 906 may be in the form of threading.

[0304] The needle assembly 900 has a needle hub 904 that holds a needle 902. The needle hub 904 may have a bore at one end thereof through which the needle extends and on a sidewall in which the needle assembly mating portion 812 is disposed. The needle assembly 900 also has a needle cover 908 that may be coupled to the needle hub by a frictional bond.

[0305] 14 shows a cartridge receiver. The cartridge receiver 300 has a cartridge receiver compartment 302 configured to receive a cartridge assembly 600 through a cartridge receiver opening 301. The cartridge receiver compartment 302 has a first area at a first distance from the cartridge receiver opening 301 having inwardly extending first guide members 312 spaced apart to form a passageway 316 therebetween. The inwardly extending first guide members 312 form a first bore that receives the cartridge assembly 600 when inserted through the cartridge receiver opening 301. The diameter of the bore is slightly larger than the outer diameter of the cartridge assembly 600 excluding the cartridge retaining member 808, but smaller than the diameter of a circle enclosing a cross section of the cartridge assembly 600 and the cartridge retaining member 808. The cartridge retaining member 808 is thereby unable to pass through the first guide member 312 unless the cartridge is redirected about the longitudinal axis L, such that the cartridge retaining member passes through the passageway 316 .

[0306] The cartridge receiver compartment 302 has an additional second area 330 having a torus shape at a second distance distal to the cartridge receiver opening 301 from the first distance. The second area 330 has a second guide member 322. The second guide member 322 is arranged with a surface inclined about the longitudinal axis and in an angular position, so that the cartridge retaining member 808 passing through the passage 316 next to the first guide member 312 in the receiving direction is guided behind the first guide member 312 by changing the angular orientation about the longitudinal axis L.

[0307] The second guide member 322 forms a second bore which also receives the cartridge assembly 600. The diameter of the second bore is substantially the same as the first bore, i.e. slightly larger than the outer diameter of the cartridge assembly 600 excluding the cartridge retaining member 808, but smaller than the diameter of a circle enclosing a cross section of the cartridge assembly 600 and the cartridge retaining member 808. The cartridge retaining member 808 is thereby unable to pass through the second guide member 322. It is thus provided that the cartridge assembly is turned when the cartridge retaining member 808 descends onto the second guide member 322.

[0308] The cartridge receiver 300 has flanges and coupling means such as an opening 352 for coupling other components of the autoinjector (not shown). The cartridge receiver 300 also has a base 354 having a bore 356 for a spring (not shown) that provides a spring-bias to the contact member 1102, which may be guided by a guide rod (not shown) housed in the bore 350.

[0309] Figure 15 shows the cartridge receiver with the ejector. In this view, the cartridge receiver 300 is shown in a different perspective than in Figure 14. The ejector 200 is shown extending out of the cartridge receiver 300 from the other end of the cartridge receiver different from the end of the cartridge receiver opening.

[0310] FIG. 16A shows a detailed view of the first and second areas 310, 330 of the cartridge receiver compartment. In this view, portions of the first and second areas 310, 330 are cut upwards along the longitudinal axis and folded out from their overall annular shape. The functional aspects of the first and second areas 310, 330 are described in relation to FIG. 16B below. The dashed line at the bottom of FIG. 16A indicates the orientation of the longitudinal axis L, in this representation to the left, and the point in the receiving direction. The cartridge receiver opening (not shown in this description) is located towards the right side. Thus, the first area 310 is disposed closer to the cartridge receiver opening than the second area 330. The curved dashed line DR to the left indicates the direction of rotation about the longitudinal axis when the first and second areas 310, 330 are disposed as annular members.

[0311] The first section 310 has a first guide member 312 and the second section 330 has a second guide member 322 .

[0312] The first guide members 312 extend across a first guide member angle 314 and are spaced apart to form a passage 316 at a passage angle 318 between the first guide members 312 .

[0313] The second guide member 322 has a first surface 324 and a second surface 326 (see, e.g., FIG. 18 ). The first surface and the second surface are alternately arranged and separated by a first riser portion 340. The first surface is divided into sections 344 and 346, which are separated by a second riser portion 342, in the exemplary embodiment of FIG. 16A . Similarly, the second surface is divided into sections 344 and 346, which are separated by a second riser portion 342, in the exemplary embodiment of FIG. 16A . The first surface is tilted to the longitudinal axis about the radial axis and is angularly disposed to extend at least partially across the passage angle 318 and the first guide member angle 314.

[0314] The first guide member 312 has a first guide surface that faces the cartridge receiver opening, i.e., faces to the right in this representation, and forms a convex tip shape with an apex oriented toward the cartridge receiver opening.

[0315] The first guide member 312 also has a surface that faces away from the cartridge receiver opening, i.e., to the left in this notation, and forms a concave shape with an inclined portion 334 at an inclination angle 336 that leads toward the retaining portion 328 at or about the bottom of the concave shape at the retaining angle 332. The inclined portion 334 is inclined with respect to the longitudinal axis and perpendicular thereto, so that when the cartridge retaining member 808 is urged toward the inclined portion 334 by the spring-loaded ejector 200, a deflection of the cartridge is provided. The deflection brings the cartridge retaining member 808 into the retaining portion 328. A retaining surface 348 is provided substantially along the longitudinal axis to restrict further deflection of the cartridge assembly.

[0316] Additionally, the first guide member 312 also has an ejection surface 338 having a slope inclined relative to the longitudinal axis and perpendicular thereto such that when the cartridge retaining member 808 is urged toward the sloped portion 338 by the spring-loaded ejector 200, the cartridge is caused to turn.

[0317] 16B shows the inbound and outbound journeys of the cartridge retaining member. The cartridge retaining member 808 is depicted as an object having a circular cross section, for example in the form of a guide pin, although it may have other shapes. The cartridge retaining member 808 is shown in different positions indexed by numbers following the reference numeral, for example 808-1 indicates the position of the cartridge retaining member 808 in position 1.

[0318] The dashed lines indicate the so-called inbound journey and the dotted lines indicate the so-called outbound journey of the cartridge retaining member 808. To avoid cluttering the figure, not all reference numbers are inserted, but the reference numbers used in Fig. 16A apply to Fig. 16B for similarly shaped elements.

[0319] When the cartridge assembly 600 with the cartridge retaining member 808 is inserted starting in the receiving direction, the cartridge retaining member 808 follows an inbound journey. Illustratively, the inbound journey may start at position 1 or position 2 or position 3 at different angles. At position 2, the cartridge retaining member 808 may pass straight into the passageway 316 to position 6, whereas at position 1, the first guide member 312 starts at position 4 where the cartridge retaining member descends onto the first guide member and provides a turning of the cartridge retaining member and continues by a given turning and longitudinal movement as it is guided into the passageway 316. Also, at position 3 on the other side of the passageway 316, the first guide member 312 starts at position 5 where the cartridge retaining member descends onto the first guide member and provides a turning of the cartridge retaining member and continues by a given turning and longitudinal movement as it is guided into the passageway 316. Thus, substantially regardless of the angle at which the cartridge retaining member is received, it is guided into the passageway 316 .

[0320] Continuing its journey from a position such as position 6 in the passage in the receiving direction, the cartridge retaining member descends onto the second guide member 322 of the second section 330, in particular onto its first section 344. Due to the inclined surface of the first section 344, a turning of the cartridge retaining member 808 is provided, so that the cartridge retaining member 808 turns from position 7 to position 8, where it meets one of the first riser portions 340 preventing further rotation. At this position, the user inserting the cartridge assembly feels that the cartridge assembly stops moving, and therefore intuitively releases the force used for insertion. At this position 8, the release of the force causes the spring-loaded ejector to push the cartridge assembly and the cartridge retaining member 808 outwardly against the receiving direction to position 9. At position 9, the cartridge retaining member 808 drops onto the angled portion 334 of the first guide member 312 which leads towards the retaining portion 328 at or around the bottom of the concave shape at the retaining angle 332. The cartridge retaining member 808 and, therefore, the cartridge, remains in the retaining position, position 10, due to the spring-loaded ejector acting to urge the cartridge retaining member 808 outward.

[0321] It should be noted that as the cartridge retaining member moves outward over the second riser portion 342, it passes the point of no return and the inbound journey is not entirely reversible. Thus, if the user eases the force used for insertion before position 8 but after the point of no return, the cartridge will still ultimately be in the retained position.

[0322] While in the holding position, the cartridge and cartridge assembly can be prevented from moving in the receiving direction by a lock that introduces a stop, so that the cartridge remains in its holding position even if a force is applied to overcome the spring-load on the cartridge or cartridge assembly, for example, during the needle penetration of the skin. When the lock is released again to remove the stop, the outbound journey can begin.

[0323] The outbound journey begins at position 10 and is initiated when the spring-loaded force is overcome in the receiving direction, for example, by the user pressing on the needle cover of the cartridge assembly. The cartridge retaining member then descends onto the second face 326 (see, e.g., FIG. 18 ), in particular onto its first section 344, at position 808-11. It is then brought to position 12. At this position, a user ejecting the cartridge assembly feels that the cartridge assembly stops moving as the cartridge retaining member 808 meets the first riser portion 340, thus intuitively releasing the force used to eject the cartridge assembly. Upon releasing the force, the spring-loaded ejector urges the cartridge assembly and cartridge retaining member 808 outward, opposite the receiving direction, to position 13, where the cartridge retaining member 808 meets the ejection surface 338 which guides the cartridge retaining member 808 within the passage 316 towards position 14 and outward to position 15, where the cartridge assembly is fully ejected and can be handled as needed, for example to remove the cartridge from the cartridge assembly and dispose of the cartridge.

[0324] It will be noted that the direction of rotation DR is defined by the direction of inclination of the first and second faces, as these define in which direction the turning is given.

[0325] It will be noted that, with respect to the length of the ejector rod 202 and the length of its ejector cog 226, which will be described in more detail below, the cartridge retaining member 808 should be allowed to move between a first extreme position L1 and a second extreme position L2 spaced apart by a longitudinal distance L12. At position L2, the cartridge retaining member 808 is in its retaining position, i.e., a position advanced toward the cartridge receiver opening. At position L1, the cartridge retaining member 808 is in a "deepest" position in the receiving direction given by the second face 326 or its area 346. Thus, the ejector should be allowed to move the distance L12. In one or more instances, position L3 may be located at a "deeper" position than L1, in which case the ejector should allow the cartridge assembly retaining member 808 to move between L3 and L2.

[0326] 17A is a cross-sectional view of a first area of ​​the cartridge receiver compartment. The cross-sectional view is perpendicular to the longitudinal axis and shows first guide member angle 314 and passageway angle 318 that extend across first guide member 312 and passageway 316, respectively. The outwardly pointed apex of the first guide member is shown at the central angle of first guide member angle 314. The first bore is indicated by reference numeral 320.

[0327] The arrows designated by the capital letter "R" indicate a radial axis perpendicular to the longitudinal axis.

[0328] 17B is a cross-sectional view of the second section of the cartridge receiver compartment showing first section 344 and second section 346 perpendicular to the longitudinal axis and separated by first riser portion 340 and second riser portion 342.

[0329] Each one of the first regions 344 and each one of the second regions 346 may extend over a region angle. The region angle may be, for example, about 15 degrees.

[0330] 18 shows a detailed view of alternative first and second sections of the cartridge receiver compartment. The first guide member 312 in the first section 310 has a concave shape with an angled portion 334 that extends across the retention angle 332.

[0331] The second guide member 322 in the second section 330 has first faces 324 that extend at least partially across the passage angle 318 and the first guide member angle 314. The second faces 326 extend alternately between the first faces. A first riser portion 340 separates the first faces 324 and the second faces 326.

[0332] 19 shows an outer plunger rod 404. The outer plunger rod 404 is carried by the plunger 400 and has a plunger rod front end 410 having dimensions that allow it to extend inside the cartridge and move the stopper therein. The outer plunger rod 404 may be moved by an inner plunger rod (not shown), which may be coupled by threading such that reorienting the inner plunger rod provides longitudinal movement of the outer plunger rod 404. The outer plunger rod 404 may be held at an angle about a longitudinal axis by means of a plunger rod groove 408 extending longitudinally in the outer wall of the outer plunger rod.

[0333] The outer plunger rod 404 is defined by a plunger rod track 406. The track 406 may extend from an edge of the outer plunger rod 404 at an end other than a plunger rod front end 410. The plunger rod track 406 has at least a first track portion 428 that guides an ejector lock guide pin 216 (see, e.g., FIG. 21 ) from a first angle to a second angle that are angularly spaced apart to redirect an ejector lock 212 (see, e.g., FIG. 21 ) from a first angular position to a second angular position. The second track portion 432 extends from the plunger rod distal edge 424 along the longitudinal axis L toward and connecting with the first track portion 428, and may be inclined relative to the longitudinal axis at an angle of about 45 degrees, e.g., about 30-45 degrees, relative to the longitudinal axis L. Thereby, the second track portion 432 receives the ejector lock guide pin 216 when the outer plunger rod 404 is in a forward position toward the cartridge receiver opening 301 to expel the medicament by moving the first stopper 708 in the first stopper direction, as described above. When the second track portion 432 receives the ejector lock guide pin 216, the ejector lock 212 is angularly positioned to prevent the ejector rod 202 from moving backwards. The third track portion 430 connects with the first track portion 428 and continues along the longitudinal axis toward the plunger rod front end 410. The third track portion 430 thereby receives the ejector lock guide pin 216 when the outer plunger rod 404 is in a rearward position opposite the cartridge receiver opening 301, where the outer plunger rod 404 moves rearward away from the first stopper 708. Thus, the longitudinal position of the outer plunger rod 404 is: - engaging / disengaging with / from the first stopper 708 to release the medicament or withdrawing from the first stopper 708 to refrain from releasing the medicament or removing the cartridge assembly 600; - Locking / unlocking the ejector rod 202 via rotation of the ejector lock 212 It has a dual function.

[0334] This is explained in more detail below.

[0335] Thus, the outer plunger rod part 404 is defined by a plunger rod track 406 which engages the ejector lock guide pin 216 and extends from the plunger rod distal edge 424 towards the plunger rod front end 410 and thus towards the cartridge receiver opening 301.

[0336] 20 shows an ejector and ejector lock. The ejector is generally designated 200 and has an ejector rod 202. The ejector lock is configured to engage the ejector rod by turning and thereby introducing a stop that prevents the ejector rod 202 from moving in a receiving direction.

[0337] The ejector rod 202 has an ejector collar 224 disposed about the ejector support surface 204, which supports the cartridge at a cartridge back surface 716, which may have the form of a rim. The ejector rod 202 has an ejector rod bore 222 for forming all of the longitudinal passageways through the ejector rod 202. The ejector rod bore 222 allows the outer plunger rod 404 to move along the longitudinal axis.

[0338] The ejector rod 202 is configured with one or more ejector cutouts 228 to form one or more ejector cogs 226 between the ejector cutouts 228. Complementarily, the ejector lock 212 is configured with one or more ejector lock cogs 232 between one or more ejector lock cutouts 230, respectively. The ejector lock 212 is supported, for example, in a bearing that allows the lock to rotate or be rotated at least a portion of a pivot while preventing longitudinal movement. The ejector lock 212 may have a flange or recess that engages with a complementary recess or protrusion to maintain the ejector lock 212 in a fixed longitudinal position while allowing it to be rotated at least a portion of a pivot. The ejector cutout 228 is also referred to as an ejector slot 228.

[0339] As shown, the ejector lock 212 has an angular position such that the ejector lock cog 232 is aligned with the ejector cutout 228. Thus, because the ejector lock cog 232 and the ejector cog 226 have substantially the same length, the ejector rod 202 can move in the receiving direction until the end portion 206 of the ejector cog is adjacent the bottom portion 214 of the ejector lock cutout 230. Thus, the bottom portion 214 of the ejector lock cutout 230 is adjacent the end portion 206 of the ejector cog 226. The end portion 206 of the ejector rod 202 is also referred to as the ejector stationary portion 206.

[0340] When the ejector lock 212 is turned such that the ejector cog 226 aligns with the ejector lock cog 232, a stop is introduced and the ejector rod 202 is prevented from moving in the receiving direction. The stop is introduced because, at the angular position of the ejector lock 212, the end portion 206 of the ejector rod 202 abuts the ejector lock support portion 234 of the ejector lock 212. The ejector lock support portion 234 of the ejector lock 212 is also referred to as the ejector lock support portion 234.

[0341] The ejector rod 202 may be prevented from deflecting by means of an angle retaining guide 207 when it engages with an angle retaining slot 238 (see, e.g., FIG. 18 ), which is located on or within the cartridge receiver 300 or a member rigidly coupled to the cartridge receiver 300.

[0342] 21 shows the ejector lock. The ejector lock 212 is now shown in more detail. It can be seen that the ejector lock 212 is comprised of an ejector lock bore 240 that receives at least an end portion of the outer plunger rod 404. The ejector lock guide pin 216 resides in the ejector lock bore 240 and extends inwardly from its wall.

[0343] 22A-22D show various positions of the ejector relative to the ejector lock. In FIG. 22A, the ejector rod 202 is shown in an extreme longitudinal forward position relative to the ejector lock 212, which is spring-loaded when the cartridge assembly is not inserted through the cartridge receiver opening, e.g., as shown in FIG. 1. It can be seen that the ejector cogs 226 are aligned with the ejector lock cutouts 230, but displaced from each other, such that the stops are disengaged and thus the ejector rod 202 is allowed to move to the extreme position in the receiving direction. Thereby, the inbound and outbound journeys described in connection with FIG. 16B can occur during insertion or ejection of the cartridge assembly.

[0344] In Figure 22B, for example, the ejector rod 202 is shown in an extreme longitudinal rear position when the cartridge assembly retaining member 808 is in contact with the retaining mechanism second section 330. This position of the cartridge assembly retaining member 808 corresponds to positions L1 or L3 shown in Figure 16B.

[0345] In Figure 22C, the ejector rod 202 is shown in a longitudinal position with the cartridge assembly retaining member 808 in a retaining position adjacent the bottom of the concave shape of the first guide member 312 of the first section 310. This position of the cartridge assembly retaining member 808 corresponds to position L2 shown in Figure 16B.

[0346] 22D shows the ejector rod 202 in the same longitudinal position as in FIG. 22C, but with the ejector lock 212 reoriented so that the stop is engaged. In this situation, the ejector cog 226 is end-to-end adjacent the ejector lock cog 232. Thus, the end portion 206 of the ejector cog 226 is end-to-end adjacent the end portion 234 of the ejector lock cog 232.

[0347] Thus, at least both the length of the ejector rod 202 and the length of the cogs and cutouts should be dimensioned to allow the cartridge assembly retaining member 808 to move between positions L1 & L2 and L3 & L2.

[0348] Thus, the elongated ejector 200 is suspended for movement along the longitudinal axis L and is enabled to move beyond a stop position 250 (see, e.g., FIG. 22B) in a first angular position of the ejector lock 212 and is prevented from moving beyond the stop position 250 by the ejector cog 226 adjacent the ejector lock cog 232 in a second angular position of the ejector lock 212 (see, e.g., FIG. 22D). In the first angular position of the ejector lock, the elongated ejector is enabled to move beyond the stop position, such as when the ejector cog enters the ejector lock cutout 230 between the ejector lock cogs 232 to a further extreme position 251. In one or more instances, the ejector rod is a substantially cylindrical rod having a substantially cylindrical portion and disposed coaxially with the ejector lock.

[0349] FIG. 23 shows a cross-section of an exemplary system 2 having an autoinjector 4 and a cartridge assembly 600, for example as described in relation to FIG. 1. The cartridge assembly 600 includes a cartridge 700 having a cartridge compartment 702, a needle assembly 900, and a cartridge code feature 1000. The cartridge assembly 600 is received in the autoinjector 4. The autoinjector 4 includes an ejector rod 202 as described above. The ejector rod 202 is suspended for longitudinal movement and spring-loaded by an ejector spring 236, which spring-loads the ejector rod 202 in a direction opposite to the receiving direction. Thereby, during insertion of the cartridge assembly 600, a spring force exerted by the ejector spring 236 must be overcome to insert the cartridge assembly 600 into a position where the cartridge assembly 600 is held in the holding position.

[0350] The cartridge assembly 600 has a cartridge holder 800. The cartridge holder 800 is configured for holding the cartridge 700 within the cartridge receiver 300 of the autoinjector 4. The cartridge holder 800 has a cartridge retaining member 808. The cartridge retaining member 808 engages the cartridge receiver 300 for receiving and retaining the cartridge 700 and the cartridge assembly 600 within the cartridge receiver 300.

[0351] The needle assembly 900 has a needle 902 and a needle hub 904. The needle assembly 900 is attached to the cartridge 700, for example, by the needle hub 904 having a cartridge holder mating portion 906, e.g., a threaded mating portion that engages with a needle assembly mating portion 812 of the cartridge holder 800. The needle 902 extends through a cartridge outlet 714 of the cartridge 700. The cartridge outlet 714 may be blocked by an elastic sealing that is pierced by the needle 902 when the needle assembly 900 is attached to the cartridge 700.

[0352] The autoinjector 4 has a code sensor 24 configured to read the cartridge code features 1000. As shown, when the cartridge assembly 600 is inserted, the cartridge code features 1000 are aligned with the code sensor 24.

[0353] The autoinjector 4 has a plunger rod 400. The plunger rod 400 is configured to advance a first stopper of the cartridge 700. The plunger rod 400 has an outer plunger rod 404 with internal threads and an inner plunger rod 402 with external threads. The threads of the inner plunger rod 402 engage with the threads of the outer plunger rod 404. The outer plunger rod 404 is prevented from rotating relative to the housing of the autoinjector. Movement of the plunger rod 400 causes rotation of the inner plunger rod 402. Rotation of the inner plunger rod 402 results in translational movement of the outer plunger rod 404 due to the outer plunger rod 404 being rotationally restricted. The outer plunger rod 404 is configured to abut a first stopper of the cartridge 700 when moving translationally in the first stopper direction 722 , causing the first stopper to move in the first stopper direction 722 .

[0354] The drive module 500 is coupled to actuate the plunger rod 400. The drive module 500 is electrically connected to a battery to receive power. The drive module 500 has a motor 502, such as an electro-mechanical motor, such as a DC motor. The drive module 500 has a transmission 504 for coupling the motor 502 to the inner plunger rod 402 of the plunger rod 400.

[0355] The illustrated example has a motor 502 which may be an electro-mechanical motor, however, it will be readily appreciated that the autoinjector 4 may be implemented with alternative drive modules, such as having a solenoid motor, a shape memory alloy engine, a spring arrangement, and / or pressurized gas configured to actuate the plunger rod 400.

[0356] The autoinjector 4 includes an ejection sensor 26, such as a plunger rod position sensor. The ejection sensor 26 is configured to detect a position of the plunger rod 400. In the illustrated example, the ejection sensor 26 includes a tachometer configured to count / detect the revolutions of the motor 502. Thus, the position of the plunger rod 400 may be determined based on the counting of the revolutions of the motor 502. The ejection sensor 26 may detect the ejection of the medicament and / or air in the cartridge compartment based on the detection of the position of the plunger rod 400. The position of the plunger rod 400 may indicate a position of the first stopper of the cartridge 700, e.g., a most advanced position of the plunger rod 400 while receiving the cartridge 700 may indicate a position of the first stopper of the cartridge 700.

[0357] 24A-24D show cross-sections of a portion of an exemplary system having an autoinjector and cartridge assembly. The autoinjector 4 has a cartridge receiver 300 configured to receive and hold a cartridge. The autoinjector 4 has 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 has a contact member protrusion component 1112. The contact member protrusion component 1112 is configured to move with the contact member 1102. The contact member 1102 may be biased toward the extended contact member position by, for example, a contact member spring (not shown).

[0358] The contact member has a needle cover engagement member 1114 configured to abut a needle cover abutment surface of a needle cover positioned on a cartridge 700 inserted into the cartridge receiver 300, for example.

[0359] The autoinjector 4 has a contact member sensor 1104 configured to detect the position of the contact member 1102. The contact member sensor 1104 has a first contact member sensor 1130 and a second contact member sensor 1132. The first contact member sensor 1130 and the second contact member sensor 1132 may be optical sensors. The contact member sensor 1104 detects the position of the contact member 1102 by a contact member protrusion part 1112 that covers the first contact member sensor 1130 when the contact member 1102 is in the first contact member position and a contact member protrusion part 1112 that covers the second contact member sensor 1132 when the contact member 1102 is in the second contact member position.

[0360] The first contact member position may be detected by the covered first contact member sensor 1130 and the covered second contact member sensor 1132. The second contact member position may be detected by the uncovered first contact member sensor 1130 and the covered second contact member sensor 1132. The extended contact member position may be detected by the uncovered first contact member sensor 1130 and the uncovered second contact member sensor 1132.

[0361] 24A illustrates a schematic of the autoinjector 4 with an unreceived cartridge and / or cartridge assembly. The contact member 1102 is in an extended contact member position. A cartridge can be inserted into the cartridge receiver 300 in a cartridge-receiving direction 304 through the contact member 1102, which defines a cartridge receiver opening 301.

[0362] FIG. 24B illustrates diagrammatically the autoinjector 4 with the cartridge assembly 600 received. The cartridge assembly includes the cartridge 700, the cartridge holder 800, and the needle assembly 900. The needle assembly includes a needle 902 and a needle cover 908. The needle cover 908 includes a needle cover abutment surface 910. The needle cover abutment surface 910 engages a needle cover engagement member 1114 of the contact member 1102. The contact member 1102 is in a second contact member position, caused, for example, by the presence of the needle cover 908 and the abutment of the needle cover abutment surface 910 on the needle cover engagement member 1114. The contact member protrusion part 1112 covers the second contact member sensor 1132. The contact member protrusion part 1112 does not cover the first contact member sensor 1130.

[0363] FIG. 24C illustrates diagrammatically the autoinjector 4 with the cartridge assembly 600 received. In comparison to FIG. 24B, the needle cover 908 has been removed. The contact member 1102 is in the extended contact member position. The contact member 1102 is allowed to move to the extended contact member position because the needle cover abutment surface 910 is not adjacent to the needle cover engagement member 1114. The contact member protrusion part 1112 is moving together with the contact member 1102. The contact member protrusion part 1112 does not cover the second contact member sensor 1132. The contact member protrusion part 1112 does not cover the first contact member sensor 1130.

[0364] FIG. 24D illustrates diagrammatically the autoinjector 4 with the cartridge assembly 600 received. The contact member 1102 is in a first contact member position. The first contact member position may be at or near the retracted contact member position. The contact member 1102 may have been moved to the first contact member position by the contact member 1102 being pressed against the injection site, thereby inserting the injection needle 902 into the injection site. The contact member protrusion part 1112 is moving together with the contact member 1102. The contact member protrusion part 1112 covers the first contact member sensor 1130. The contact member protrusion part 1112 covers the second contact member sensor 1132.

[0365] 25A-25B show various positions of the ejector relative to the ejector lock in an embodiment where the cogs have inclined faces. In FIG. 25A, the ejector rod 202 and the ejector lock 212 are in a mutual position where the stops are engaged. However, it can be seen that the ejector lock cog 232 and the ejector cog 226 have inclined end portions adjacent to each other. Thus, further reorienting the ejector lock 212 by a few degrees or a fraction of an angle can move the ejector 200 in the opposite direction to the receiving direction so as to be rigidly displaced to and against the cartridge or cartridge assembly. Thereby, it is possible to reduce or eliminate the clearance that would otherwise allow a slight movement, for example a fraction of a millimeter, but would cause the dose to be ejected inaccurately. The amount of clamping force may be controlled, for example, by monitoring the current drawn by a motor coupled to drive the ejector lock.

[0366] 25B, the ejector 200 and ejector lock 212 are in a mutually disengaged position. The bottom portion of the ejector cutout 228 and / or the bottom portion of the ejector lock cutout 230 may be angled by the same angle as the end portions of the cogs to match the cogs, or may have a substantially flat bottom portion substantially perpendicular to the longitudinal axis, as shown.

[0367] According to a first item, an autoinjector (4) for governing injection of a medicinal product from a cartridge containing the medicinal product is provided, the autoinjector (4) comprising a housing (6) and a cartridge receiver (300) having a cartridge receiver compartment (302) configured to receive a cartridge assembly (600) by at least one cartridge retaining member (808) when inserted through the cartridge receiver opening (301) along a longitudinal axis (L) in a receiving direction, the cartridge receiver (300) having a passageway (316) through which the at least one cartridge retaining member (808) moves in at least the receiving direction, and a member (312) for preventing movement beyond a retaining position in a direction opposite to the cartridge receiving direction (304), and one or more ejector cutouts (228) for defining one or more ejector cogs (226) between the ejector cutouts (228). and an elongated ejector (200) formed of an ejector support surface (204) supporting an ejector rod (202), and an ejector lock (212) supported for at least a portion of its pivoting and maintained in a longitudinal position relative to the housing (6), the ejector lock (212) being positioned between one or more ejector lock cutouts (230). and one or more ejector lock cogs (232), wherein the elongated ejector (200) is suspended for movement along the longitudinal axis (L) and is enabled to move beyond a stop position (250) in a first angular position of the ejector locks (212) and prevented from moving beyond the stop position (250) by an ejector cog (226) adjacent the ejector lock cog (232) in a second angular position of the ejector locks (212).

[0368] In a first angular position of the ejector lock, the elongated ejector is enabled to move beyond a stop position as the ejector cog enters the ejector lock cutout. In one or more embodiments, the ejector rod is a substantially cylindrical rod having a substantially cylindrical portion and disposed coaxially with the ejector lock.

[0369] The ejector lock may be directly or indirectly coupled to a drive means having a motor for rotating to and from a first angular position and a second angular position. In one or more embodiments, the ejector lock is rotated by mutual manipulation.

[0370] In one or more examples, the ejector rod 202 has an ejector rod bore 222 that forms a longitudinal passageway through the ejector rod 202, and the plunger rod 400 is disposed to move longitudinally. The plunger rod may have an outer plunger rod with an internal longitudinal thread coupled such that rotation of the inner plunger rod moves the outer plunger rod longitudinally, and an inner plunger rod, such as a threaded rod. The outer plunger rod may be prevented from rotating, and the inner plunger rod may be supported to rotate and maintained at a fixed longitudinal position. The inner plunger rod may be driven by a motor.

[0371] In one or more instances, the ejector lock is operable to rotate to and from a first angular position and a second angular position by being coupled to a plunger rod, whereby longitudinal displacement of the plunger rod rotates the ejector lock.

[0372] 26 shows a block diagram of an exemplary autoinjector 4. The autoinjector 4 has a number of sensors 22, 24, 26, 28, 30, 32, 34, a processing unit 20, a drive module 500, and a user interface 1100. The sensors 22, 24, 26, 28, 30, 32, 34 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.

[0373] The processing unit 20 receives signals from the sensors 22, 24, 26, 28, 30, 32, 34, and the user interface 1100. The processing unit 20 is configured to control the drive module 500. The processing unit 20 may control the drive module 500 based on one or more of the signals received from the sensors 22, 24, 26, 28, 30, 32, 34, and the user interface 1100.

[0374] The autoinjector 4 includes an orientation sensor 22. The orientation sensor 22 is configured to provide an orientation signal indicative of an orientation of a cartridge received within the autoinjector 4. For example, the orientation sensor 22 may be configured to detect an orientation of the autoinjector 4. The orientation of the cartridge may be determined based on the orientation of the autoinjector 4. The orientation sensor 22 may be configured to detect the direction of gravity. For example, the orientation sensor 22 may include an accelerometer.

[0375] The processing unit 20 is coupled to the orientation sensor 22. The processing unit 20 is configured to receive the orientation signal. The processing unit 20 may determine an orientation of the cartridge based on the orientation signal. The processing unit 20 may control the drive module 500 based on the orientation signal. For example, the processing unit 20 may be configured to control the drive module 500 to move the plunger rod based on the orientation signal. For example, the processing unit 20 may be configured to control the drive module 500 to move the plunger rod toward an extended plunger rod position only if the cartridge outlet points in an upward direction. Alternatively or in addition, the processing unit 20 may provide a user output via the user interface 1100 based on the orientation signal.

[0376] The autoinjector 4 has a code sensor 24. The code sensor 24 is configured to read a cartridge code feature. The code sensor 24 is configured to provide a code signal indicative of the cartridge code feature. For example, the code sensor may be configured to read / detect a color code.

[0377] The processing unit 20 is coupled to the code sensor 24. The processing unit 20 is configured to receive the code signal. The processing unit 20 may determine a cartridge code feature of the cartridge assembly based on the code signal. The processing unit 20 may be configured to determine a first plunger rod position and / or a second plunger rod position based on the code signal. The processing unit 20 may control the drive module 500 based on the code signal. For example, the processing unit 20 may be configured to control the drive module 500 to move the plunger rod toward an extended plunger rod position based on the code signal. Alternatively or in addition, the processing unit 20 may provide a user output via the user interface 1100 based on the code signal.

[0378] The autoinjector 4 includes a plunger rod position sensor 26. The plunger rod position sensor 26 is configured to detect a position of a plunger rod of the autoinjector 4 and provide a plunger rod position sensor signal indicative of the position of the plunger rod. The plunger rod position sensor 26 may include a tachometer coupled to the drive module 500.

[0379] The processing unit 20 is coupled to the plunger rod position sensor 26. The processing unit 20 is configured to receive the plunger rod position sensor signal. The processing unit 20 may determine a position of the plunger rod based on the plunger rod position sensor signal. The processing unit 20 may control the drive module 500 based on the plunger rod position sensor signal. For example, the processing unit 20 may be configured to control the drive module 500 to start, stop, or continue the movement of the plunger rod based on the plunger rod position sensor signal. For example, the processing unit 20 may be configured to determine a plunger rod position based on the plunger rod position sensor signal. Alternatively or in addition, the processing unit 20 may provide a user output via the user interface 1100 based on the plunger rod position sensor signal.

[0380] The processing unit 20 is coupled to the cartridge sensor 28. The processing unit 20 is configured to receive a cartridge sensor signal. The processing unit 20 may control the drive module 500 based on the cartridge sensor signal. For example, the processing unit 20 may be configured to control the drive module 500 to initiate movement of the plunger rod when and / or only when a cartridge assembly is received. Alternatively or in addition, the processing unit 20 may provide a user output via the user interface 1100 based on the cartridge sensor signal.

[0381] 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 receipt of a cartridge assembly and thereafter read the cartridge code features.

[0382] The autoinjector 4 has a needle sensor 30. The needle sensor 30 is configured to detect the needle and / or needle assembly and / or needle cover of the needle assembly of the cartridge assembly when the cartridge assembly is received within the autoinjector 4. The needle sensor 30 provides a needle signal indicative of the presence of the needle and / or needle assembly and / or needle cover of the needle assembly of the cartridge assembly.

[0383] The processing unit 20 is coupled to the needle sensor 30. The processing unit 20 is configured to receive the needle signal. The processing unit 20 may control the drive module 500 based on the needle signal. For example, the processing unit 20 may be configured to control the drive module 500 to start moving the plunger rod only if a needle is present and / or only if a needle cover is not present, such as removed. Detection of the needle cover may indicate that a needle is present. The processing unit 20 may be configured to control the drive module 500 to start only if a needle cover is detected and subsequently removed. Alternatively or in addition, the processing unit 20 may provide a user output via the user interface 1100 based on the needle signal.

[0384] The autoinjector 4 comprises a temperature sensor 32. The temperature sensor 32 is configured to detect a temperature, such as the temperature of the autoinjector and / or the temperature of the cartridge and / or the temperature of the pharmaceutical product. The temperature sensor 32 is configured to provide a temperature signal indicative of the temperature.

[0385] The processing unit 20 is coupled to the temperature sensor 32. The processing unit 20 is configured to receive a temperature signal. The processing unit 20 may be configured to determine a temperature, such as a temperature of the autoinjector and / or a temperature of the cartridge and / or a temperature of the pharmaceutical product, based on the temperature signal. The processing unit 20 may control the drive module 500 based on the temperature signal. For example, the processing unit 20 may be configured to control the drive module 500 to move the plunger rod towards an extended plunger rod position based on the temperature signal. Alternatively or in addition, the processing unit 20 may provide a user output via the user interface 1100 based on the temperature signal.

[0386] The autoinjector 4 has a resistance sensor 34. The resistance sensor 34 is configured to detect resistance to movement of a plunger rod of the autoinjector 4. The resistance sensor 34 may be configured to detect resistance to movement of the plunger rod based on a measurement of the drive module 500. For example, the resistance sensor 34 may be configured to detect a current of a motor of the drive module 500. For example, the resistance sensor 34 may be configured to determine a current through the drive module. Alternatively or in addition, the resistance sensor 34 may be configured to measure a pressure and / or force applied to a plunger rod front end of the plunger rod. The resistance sensor 34 is configured to provide a resistance signal indicative of a resistance to movement of the plunger rod.

[0387] The processing unit 20 is coupled to the resistance sensor 34. The processing unit 20 is configured to receive the resistance signal. The processing unit 20 may be configured to determine a resistance to movement of the plunger rod based on the resistance signal. The processing unit 20 may control the drive module 500 based on the resistance signal. For example, the processing unit 20 may be configured to control the drive module 500 to adjust the movement of the plunger rod based on the resistance signal. For example, the processing unit 20 may be configured to control the drive module 500 to start, stop, or continue the movement of the plunger rod based on the resistance signal.

[0388] The movement of the plunger rod results in a plunger rod velocity. The processing unit 20 may be configured to determine the plunger rod velocity. The processing unit 20 may be configured to control the drive module 500 to adjust, e.g., readjust, the movement of the plunger rod if the resistance signal indicates that the resistance to the movement of the plunger rod exceeds a high resistance threshold. The processing unit 20 may further be configured to control the drive module 500 to adjust, e.g., readjust, the movement of the plunger rod, where adjusting the movement of the plunger rod may include increasing or decreasing the plunger rod velocity. Alternatively or in addition, the processing unit 20 may provide a user output via the user interface 1100 based on the resistance signal. The high resistance threshold may be based on a plunger rod position. The processing unit 20 may be configured to determine the high resistance threshold based, for example, on a plunger rod position. The processing unit 20 may be configured to determine the high resistance threshold based, for example, on a plunger rod position sensor signal received from the plunger rod position sensor 26.

[0389] An autoinjector 4 is illustrated having all of the above-mentioned sensors, however, the autoinjector may alternatively have only one or any combination of one or more of the above-mentioned sensors.

[0390] The autoinjector has a user interface 1100. The user interface 1100 may have one or more input members, such as a first input member, for receiving user input. The user interface is configured to provide a user input signal indicative of the received user input.

[0391] The processing unit 20 is coupled to the user interface 1100. The processing unit 20 is configured to receive a user input signal. The processing unit 20 may control the drive module 500 based on the user input signal. For example, the processing unit 20 may be configured to control the drive module 500 to move the plunger rod toward an extended plunger rod position based on the user input signal.

[0392] The autoinjector has a housing 6 which houses the sensors 22 , 24 , 26 , 28 , 30 , 32 , 34 , a processing unit 20 , a user interface 1100 , and a drive module 500 .

[0393] Figure 27 illustrates a schematic of a system 2 having an exemplary autoinjector 4 with an inserted cartridge assembly having a cartridge 700 and a needle assembly 900. The autoinjector 4 as shown in Figure 27 illustrates different ways of implementing sensing of plunger rod position and resistance to movement of the plunger rod.

[0394] The plunger rod has an outer plunger rod 404 with internal threads and an inner plunger rod 402 with external threads. The threads of the inner plunger rod 402 engage with the threads of the outer plunger rod 404. The outer plunger rod 404 is prevented from rotating relative to the housing 6 of the autoinjector 4. Due to the outer plunger rod 404 being rotationally restricted, rotation of the inner plunger rod 402 results in translational movement of the outer plunger rod 404. The outer plunger rod 404 is configured to abut a first stopper 708 of the cartridge 700 when moving translationally in a first stopper direction 722, causing the first stopper to move in the first stopper direction 722. The plunger rod front end 410 is configured to abut the first stopper 708.

[0395] A motor 502 is coupled to drive the plunger rod through a transmission 504. The motor 502 rotates a first part of the transmission 504, which rotates a second part of the transmission 504, which is coupled to rotate the inner plunger rod 402.

[0396] The motor 502 is controlled by a processing unit 20. The autoinjector 4, such as the motor 502 and / or the processing unit 20, is powered by a battery 10, such as a rechargeable battery.

[0397] A position of the plunger rod, such as a position of the outer plunger rod 404 and / or a position of the plunger rod front end 410, may be determined by one or more position sensors 26a, 26b, 26c. For example, as illustrated, the plunger rod position may be determined by position sensor 26a, which is configured to sense a position through a linear sensor coupled to a plunger rod, such as the outer plunger rod 404. Alternatively or in addition, and as illustrated, the plunger rod position may be determined by position sensor 26b, such as a tachometer, which is configured to count / detect rotations of the motor 502. Alternatively or in addition, and as illustrated, the plunger rod position may be determined by position sensor 26c, such as a tachometer, which is configured to count / detect rotations of the transmission 504 and / or components of the transmission 504.

[0398] Resistance to the movement of the plunger rod may be determined by one or more resistance sensors 34a, 34b, 34c, 34d. For example, as illustrated, resistance to the movement of the plunger rod may be determined by resistance sensor 34a, such as a force sensor, positioned at the front of cartridge 700, such that as the plunger rod advances first stopper 708, the cartridge presses against sensor 34a. Alternatively or in addition, and as illustrated, resistance to the movement of the plunger rod may be determined by resistance sensor 34b, such as a force sensor, positioned on plunger rod front end 410. Alternatively or in addition, and as illustrated, resistance to the movement of the plunger rod may be determined by resistance sensor 34c, such as a force sensor, positioned to sense a recoil force from the plunger rod on first stopper 708, such as sensor 34c positioned behind inner plunger rod 402. Alternatively or additionally, and as illustrated, the resistance to movement of the plunger rod can be determined by a resistance sensor 34d, which is configured to measure / detect the amount of current and / or power drawn by the motor 502.

[0399] 28A shows a resistance graph 1200 illustrating a high resistance threshold as a function of a stopper position / plunger rod position, such as a high resistance threshold and a plunger rod position as described in connection with the previous figures, and / or a stopper position associated with the plunger rod position as described in connection with the previous figures. The plunger rod 400 is configured to move the first stopper 708, and thus the position of the first stopper 708 is determined by the position of the plunger rod 400. Thus, the position of the first stopper 708 may correspond to the position of the plunger rod 400. The plunger rod position may specify a plunger rod front end, such as a part of the plunger rod that contacts the first stopper 708.

[0400] The resistance graph 1200 has a first axis 1200X indicating the stopper position / plunger rod position and a second axis 1200Y indicating the resistance. The solid and dashed lines illustrate different instances of how the high resistance threshold can vary depending on the stopper position / plunger rod position.

[0401] 28B-28F illustrate the cartridge 700 with the plunger rod 400 and the first stopper 708 in the context of corresponding exemplary plunger rod positions described below. FIG. 28B shows the plunger rod 400 in a retracted plunger rod position 1228. FIG. 28C shows the plunger rod 400 in a position between the retracted plunger rod position 1228 and the first plunger rod position 1220. The first stopper 708 has moved accordingly. FIG. 28D shows the plunger rod 400 in the first plunger rod position 1220. The first stopper 708 has moved accordingly to the first stopper position. FIG. 28E shows the plunger rod 400 in the second plunger rod position 1222. The first stopper 708 has moved accordingly to the second stopper position. 28F shows the plunger rod 400 in a position between the second plunger rod position 1222 and the extended plunger rod position 1229. The first stopper 708 has moved accordingly. The plunger rod position illustrated in FIG. 28F can be the extended plunger rod position 1229.

[0402] 28A, when the plunger rod position is between the retracted plunger rod position 1228 and the first plunger rod position 1220, the high resistance threshold may be a first high resistance threshold 1201. When the plunger rod position is between the second plunger rod position 1222 and the extended plunger rod position 1229, the high resistance threshold may be a second high resistance threshold 1202.

[0403] The second high resistance threshold 1202 may be higher than the first high resistance threshold 1201. For example, the first high resistance threshold 1201 may be between 50 and 80N, such as 50N, 55N, 60N, 65N, 70N, 75N, or 80N. For example, the second high resistance threshold 1202 may be between 70 and 100N, such as between 75 and 85N, or between 80 and 90N, or between 70 and 100N, such as 70N, 75N, 80N, 85N, or 90N. In an illustrative example, the first high resistance threshold 1201 is 500N and the second high resistance threshold 1202 is 80N.

[0404] As illustrated by the solid lines, when the plunger rod position is between the first plunger rod position 1220 and the extended plunger rod position 1229, the high resistance threshold may be a second high resistance threshold 1202. Alternatively or in addition, when the plunger rod position is between the first plunger rod position 1220 and the second plunger rod position 1222, such as when the plunger rod position is at a third plunger rod position 1223, the high resistance threshold may be a third high resistance threshold 1204. The third high resistance threshold 1204 may be higher than the first high resistance threshold 1201. The third high resistance threshold 1204 may be lower than the second high resistance threshold 1202.

[0405] The high resistance threshold may increase with plunger rod position. For example, as illustrated, the high resistance threshold may increase as the plunger rod moves from a first plunger rod position 1220 to a second plunger rod position 1222. The solid and dashed lines illustrate example ways in which the high resistance threshold may increase as the plunger rod moves from a first plunger rod position 1220 to a second plunger rod position 1222. The first slope 1206 illustrates a step change increase. The second slope 1208 illustrates a non-linear increase. The third slope 1210 illustrates a linear increase.

[0406] FIG. 29 shows an exemplary trace T of the resistance R to the movement of the plunger rod as a function of the position of the plunger rod P. The plunger rod moves from the retracted position 1228 to the extended position 1229. At the beginning of the movement, the resistance to the movement of the plunger rod is constant (Ex1), e.g., the plunger rod does not yet push the stopper. Then, the plunger rod front end of the plunger rod abuts the first stopper of the cartridge and the resistance to the movement of the plunger rod increases (Ex2). The increased resistance is caused by the resistance to the movement of the first stopper, e.g., due to frictional forces. As illustrated, the resistance may decrease slightly after the first stopper starts to move. When the plunger rod approaches the extended plunger rod position 1229, the resistance may increase again (Ex3), e.g., due to the first stopper approaching the end of the cartridge.

[0407] Trace T is illustrative of the resistance to plunger rod movement when the received cartridge is new and / or reused and / or a normal cartridge. Additional illustrative trace T1 illustrates other situations where the received cartridge is obviously defective.

[0408] Trace T1 illustrates an example situation where, for example, resistance to movement increases above a first high resistance threshold 1201 before the plunger rod position exceeds a first plunger rod position 1220. Such a situation may indicate, for example, that the first stopper is blocked from moving, e.g., that the cartridge may be defective. Following such a situation, the plunger rod may be retracted to a retracted position and an error message may be provided via a user interface.

[0409] At a particular plunger rod position, such as the first plunger rod position 1220, the high resistance threshold may be changed, for example, to allow for a higher resistance before halting plunger rod movement. As illustrated, at the end of the plunger rod's forward movement, the resistance R increases to a resistance above the first high resistance threshold 1201, for example, at the second plunger rod position 1222. However, because the high resistance threshold at the second plunger rod position is the second high resistance threshold 1202, plunger rod movement continues. Eventually, as illustrated, the resistance to movement may reach the second high resistance threshold 1202, for example, between the second plunger rod position and the extended plunger rod position 1229, and plunger rod movement may be stopped.

[0410] The thresholds, such as the first high resistance threshold 1201 and / or the second high resistance threshold 1202, may be determined individually for a received cartridge. For example, the processing unit may be configured to determine one or more of the thresholds based on a cartridge code feature of the received cartridge and cartridge assembly.

[0411] 30A shows a velocity graph 1300 illustrating plunger rod velocity as a function of stopper position / plunger rod position, such as plunger rod velocity and plunger rod position as described in connection with the previous figures, and / or a stopper position associated with the plunger rod position as described in connection with the previous figures. The plunger rod 400 is configured to move the first stopper 708, and thus the position of the first stopper is determined by the position of the plunger rod 400. Thus, the position of the first stopper may correspond to the position of the plunger rod 400. The plunger rod position may specify the plunger rod front end, such as the part of the plunger rod that contacts the first stopper 708.

[0412] The velocity graph 1300 has a first axis 1300X that indicates the stopper position / plunger rod position and a second axis 1300Y that indicates the velocity, such as the plunger rod velocity. The solid and dashed lines illustrate different instances of how the plunger rod velocity can vary depending on the stopper position / plunger rod position.

[0413] 30B-30E illustrate the cartridge 700 with the plunger rod 400 and the first stopper 708 in the context of corresponding exemplary plunger rod positions described below. FIG. 30B shows the plunger rod 400 in a position between the retracted plunger rod position 1228 and the fourth plunger rod position 1224. FIG. 30C shows the plunger rod 400 in the fourth plunger rod position 1224. The first stopper 708 has moved accordingly to the fourth stopper position. FIG. 30D shows the plunger rod 400 in the fifth plunger rod position 1226. The first stopper 708 has moved accordingly to the fifth stopper position. FIG. 30E shows the plunger rod 400 in a position between the fifth plunger rod position 1226 and the extended plunger rod position 1229. The first stopper 708 has moved accordingly. The plunger rod position illustrated in FIG.

[0414] As illustrated by the graph in FIG. 30A, the plunger rod velocity can be based on the plunger rod position. For example, when the plunger rod position is between the retracted plunger rod position 1228 and the fourth plunger rod position 1224, the plunger rod velocity can be the first plunger rod velocity 1240. When the plunger rod position is between the fifth plunger rod position 1226 and the extended plunger rod position 1229, the plunger rod velocity can be the second plunger rod velocity 1242. The second plunger rod velocity 1242 can be lower than the first plunger rod velocity 1240. Alternatively, the second plunger rod velocity 1242 can be higher than the first plunger rod velocity 1240 to effectively empty the cartridge.

[0415] A plunger rod position may correspond to another plunger rod position. For example, the fourth plunger rod position 1224 may be the first plunger rod position 1220 as mentioned in connection with FIG. 28. The fifth plunger rod position 1226 may be the second plunger rod position 1222 as mentioned in connection with FIG. 28.

[0416] The plunger rod velocity may decrease with respect to the plunger rod position. For example, the plunger rod velocity may decrease as the plunger rod moves from the fourth plunger rod position 1224 to the fifth plunger rod position 1226. The solid line illustrates an exemplary linear decrease in the plunger rod velocity as the plunger rod moves from the fourth plunger rod position 1224 to the fifth plunger rod position 1226. Other examples may be non-linear decreases and step change decreases, as illustrated by the dashed lines.

[0417] FIG. 31 shows a flow chart of an exemplary method 3000 of operating and / or controlling an autoinjector, such as the autoinjector described in connection with the previous figures.

[0418] The method 3000 includes receiving a cartridge having a first stopper (3001), moving a plunger rod toward an extended plunger rod position (3002), determining a plunger rod position (3004), receiving a resistance signal (3006), and adjusting movement of the plunger rod (3010).

[0419] Receiving the cartridge (3001) can include receiving the cartridge within a cartridge receiver of the autoinjector.

[0420] Moving the plunger rod (3002) can include moving the plunger rod from a stored plunger rod position. Moving the plunger rod can include moving the plunger rod in a first plunger rod orientation.

[0421] Determining the plunger rod position 3004 may be determined by a processing unit of the autoinjector. Determining the plunger rod position 3004 may be based on detection from a sensor, such as, for example, a plunger rod position sensor having a tachometer.

[0422] Receiving a resistance signal (3006) can include receiving a resistance signal from a resistance sensor. The resistance signal can be indicative of resistance to movement of the plunger rod, such as movement in a first plunger rod direction, such as movement toward an extended plunger rod position.

[0423] Regulating the movement (3010) may include stopping the movement of the plunger rod. Alternatively or in addition, regulating the movement (3010) may include preventing the movement of the plunger rod toward a stored plunger rod position during the dwell time, e.g., to prevent backflow of the medicinal product. Alternatively or in addition, regulating the movement (3010) may include maintaining a position of the plunger rod during the dwell time, e.g., to prevent backflow of the medicinal product. Alternatively or in addition, regulating the movement (3010) may include moving the plunger rod toward a stored plunger rod position. Alternatively or in addition, regulating the movement (3010) may include decreasing the plunger rod velocity.

[0424] Adjusting the movement of the plunger rod (3010) may be based on the resistance signal. For example, the movement of the plunger rod may be adjusted to keep the resistance below a high resistance threshold. Adjusting the movement of the plunger rod (3010) may include adjusting the movement of the plunger rod when the resistance signal indicates resistance to the movement of the plunger rod above the high resistance threshold. The high resistance threshold may be based on the plunger rod position, for example, the high resistance threshold may be a first high resistance threshold when the plunger rod position is within one range and a second high resistance threshold when the plunger rod position is within a second range.

[0425] The steps of the exemplary method 3000, such as step 3002 of moving a plunger rod, step 3004 of determining a plunger rod position, step 3006 of receiving a resistance signal, and step 3010 of adjusting the movement of the plunger rod, may be controlled by a processing unit, such as a processing unit of an autoinjector.

[0426] FIG. 32 shows a flow chart of an exemplary method 3300 for moving a plunger rod in an autoinjector.

[0427] First, the plunger rod is moved (3302), for example, in a first plunger rod direction and at, for example, a first plunger rod velocity.

[0428] The resistance to the movement of the plunger rod is monitored continuously, etc. A first resistance criterion 3304 determines whether the resistance to the movement of the plunger rod exceeds a second high resistance threshold. If the resistance to the movement of the plunger rod does not exceed the second high resistance threshold by a second resistance criterion 3308 (first resistance criterion 3304 is answered negatively), it determines whether the resistance to the movement of the plunger rod exceeds the first high resistance threshold. If the resistance to the movement of the plunger rod does not exceed the first high resistance threshold (second resistance criterion 3304 is answered negatively), the movement of the plunger rod continues (3302). The first plunger threshold can be less than the second high resistance threshold.

[0429] The position of the plunger rod is monitored, such as continuously monitored. If the resistance to the movement of the plunger rod exceeds a first high resistance threshold by the first position criterion 3310 (second resistance criterion 3308 is answered affirmatively), it is determined whether the plunger rod has reached and / or exceeded a predetermined plunger rod position, such as a first plunger rod position, a second plunger rod position, a third plunger rod position, a fourth plunger rod position, and / or a fifth plunger rod position (see, e.g., FIGS. 28 and 30 for example positions). If the plunger rod position has reached and / or exceeded a predetermined plunger rod position (first position criterion 3310 is answered affirmatively), the movement of the plunger rod continues (3302). Thus, if the plunger rod reaches and / or exceeds a predetermined plunger rod position, the first high resistance threshold may be exceeded.

[0430] If the plunger rod position does not reach and / or exceed the predefined plunger rod position (first position criterion 3310 is answered negatively), the movement of the plunger rod is stopped (3312) and an error may be communicated to a user, for example, via a user interface. Thus, an error may be assumed if the plunger rod exceeds a first high resistance threshold before reaching and / or exceeding the predefined plunger rod position.

[0431] If the resistance to the movement of the plunger rod exceeds a second high resistance threshold (first resistance criterion 3304 is answered affirmatively), the movement of the plunger rod is stopped 3306 and the end of the injection can be assumed. Upon stopping the movement of the plunger rod 3306, the plunger rod can be locked in its position for a dwell time, e.g., to prevent a sudden drop in pressure within the cartridge, e.g., to prevent backflow of the medicine.

[0432] FIG. 33 shows a flow chart of an exemplary method 3100 of moving a plunger rod in an autoinjector.

[0433] First, the plunger rod is moved, for example, in a first plunger rod direction at a first plunger rod velocity (3102).

[0434] Resistance to the movement of the plunger rod is monitored, such as continuously monitored. A first resistance criterion 3104 determines whether the resistance to the movement of the plunger rod exceeds a first high resistance threshold. If the resistance to the movement of the plunger rod exceeds the first high resistance threshold (first resistance criterion 3104 is answered affirmatively), the movement of the plunger rod is stopped (3106) and an error may be communicated to a user, for example, via a user interface.

[0435] The position of the plunger rod is monitored, such as by continuing to monitor. If the resistance to the movement of the plunger rod does not exceed a first high resistance threshold by the first position criterion 3108 (first resistance criterion 3104 is answered negatively), it is determined whether the plunger rod has reached and / or exceeded a predetermined plunger rod position, such as a first plunger rod position, a second plunger rod position, a third plunger rod position, a fourth plunger rod position, and / or a fifth plunger rod position (see, e.g., FIGS. 28 and 30 for example positions). If the plunger rod position has not reached and / or exceeded a predetermined plunger rod position (first position criterion 3108 is answered negatively), the movement of the plunger rod continues (3102) at the first plunger rod velocity.

[0436] When the plunger rod position reaches and / or exceeds a predetermined plunger rod position (first position criterion 3108 is answered affirmatively), the plunger rod is moved 3110, for example, in the first plunger rod direction at a second plunger rod velocity. The second plunger rod velocity can be less than the first plunger rod velocity. Reducing the plunger rod velocity reduces the amount of medication that needs to be forced through the injection needle with each injection, thereby reducing the amount of force required to advance the stopper.

[0437] A second resistance criterion 3112 determines whether the resistance to the movement of the plunger rod exceeds a second high resistance threshold. If the resistance to the movement of the plunger rod does not exceed the second high resistance threshold (second resistance criterion 3112 is answered negatively), the movement of the plunger rod continues 3110 at the second plunger rod velocity.

[0438] If the resistance to the movement of the plunger rod exceeds a second high resistance threshold (second resistance criterion 3112 is answered affirmatively), the movement of the plunger rod is stopped 3114 and the end of the injection can be assumed. Upon stopping the movement of the plunger rod 3114, the plunger rod can be locked in its position for a dwell time, e.g., to prevent a sudden drop in pressure within the cartridge, e.g., to prevent backflow of the medicine.

[0439] FIG. 34 shows a flow chart of an exemplary method 3200 for moving a plunger rod in an autoinjector.

[0440] First, the plunger rod is moved (3202), for example, in a first plunger rod direction, for example, at a first plunger rod velocity.

[0441] The resistance to the movement of the plunger rod is monitored, such as continuously monitored, etc. Resistance criterion 3204 determines whether the resistance to the movement of the plunger rod exceeds a high resistance threshold, such as a first high resistance threshold and / or a second high resistance threshold.

[0442] If the resistance to the movement of the plunger rod does not exceed the high resistance threshold (resistance criterion 3204 is answered negatively), the speed of the movement of the plunger rod is increased (3206).

[0443] If the resistance to the movement of the plunger rod exceeds a high resistance threshold (resistance criterion 3204 is answered affirmatively), then speed criterion 3208 determines if the plunger rod velocity is zero, i.e., if the plunger rod is not moving.

[0444] If the plunger rod velocity is not zero (speed criterion 3208 is answered negatively), the plunger rod velocity is reduced 3210. If the plunger rod velocity is zero (speed criterion 3208 is answered positively), the process is stopped 3212. Upon stopping 3212, the plunger rod may be locked in position for a dwell time, e.g., to prevent backflow of medicinal product, e.g., to prevent a sudden drop in pressure within the cartridge.

[0445] A high resistance threshold for resistance criterion 3204 may be determined based on the position of the plunger rod. The plunger rod position may also be used to determine if sufficient drug has been released when stopping 3212 the process and / or if an error caused the process to stop too early. A corresponding message may be provided to the user, for example via the user interface.

[0446] Method 3200 adjusts the speed as high as possible without exceeding a resistance threshold.

[0447] FIG. 35 shows a flow chart of an exemplary method 3400 for moving a plunger rod in an autoinjector.

[0448] First, the plunger rod is moved (3402), for example, in a first plunger rod direction, for example, at a first plunger rod velocity.

[0449] The resistance to the movement of the plunger rod is monitored continuously, etc. A first resistance criterion 3404 determines whether the resistance to the movement of the plunger rod exceeds a first high resistance threshold.

[0450] If the resistance to the movement of the plunger rod does not exceed the first high resistance threshold (first resistance criterion 3404 is answered negatively), the speed of the movement of the plunger rod is increased (3406).

[0451] The position of the plunger rod is monitored continuously, etc. If the resistance to the movement of the plunger rod exceeds a first high resistance threshold by the first position criterion 3408 (first resistance criterion 3404 is answered affirmatively), it is determined whether the plunger rod has reached and / or exceeded a predetermined plunger rod position, such as a first plunger rod position, a second plunger rod position, a third plunger rod position, a fourth plunger rod position, and / or a fifth plunger rod position (e.g., see FIGS. 28 and 30 for example positions).

[0452] If the plunger rod position does not reach and / or exceed the predetermined plunger rod position (first position criterion 3408 is answered negatively), the speed of plunger rod movement is reduced (3410).

[0453] If the plunger rod position reaches and / or exceeds the predetermined plunger rod position (first position criterion 3408 is answered affirmatively), the plunger rod movement may continue. Thus, if the plunger rod reaches and / or exceeds the predetermined plunger rod position, the first high resistance threshold may be exceeded. In this case, the second resistance criterion 3412 determines whether the resistance to the plunger rod movement exceeds a second high resistance threshold.

[0454] If the resistance to the movement of the plunger rod does not exceed the second high resistance threshold (second resistance criterion 3412 is answered negatively), the speed of the movement of the plunger rod is increased (3406).

[0455] If the resistance to the movement of the plunger rod exceeds a second high resistance threshold (second resistance criterion 3412 is answered affirmatively), then speed criterion 3414 determines if the plunger rod velocity is zero, i.e., if the plunger rod is not moving.

[0456] If the plunger rod velocity is not zero (speed criterion 3414 answered negatively), the plunger rod velocity is decreased (3410). If the plunger rod velocity is zero (speed criterion 3414 answered positively), the process is stopped (3416). Upon stopping (3416), the plunger rod may be locked in position for a dwell time to prevent backflow of medication, for example, to prevent a sudden drop in pressure within the cartridge. Upon stopping (3416), the end of the injection may be assumed.

[0457] Method 3400 adjusts the speed as high as possible without exceeding a resistance threshold.

[0458] 36 illustrates a block diagram of an exemplary autoinjector 4. The autoinjector 4 includes a rechargeable battery 10, a battery calculation module 40 configured to calculate a remaining electric battery voltage level of the rechargeable battery 10, thereby verifying a measurement of the remaining electric battery voltage level, a drive module 500, a temperature sensor 32 configured to measure a temperature of the autoinjector 4, a processing unit 20, and a user interface 1100. The user interface 1100, the temperature sensor 32, the drive module 500, and the battery calculation module 40 are coupled to the processing unit 20. The processing unit 20 is also coupled to the drive module 500.

[0459] Autoinjector temperature means the temperature measured by an autoinjector temperature sensor anywhere within the autoinjector. In one or more embodiments, the autoinjector temperature is one or more of the following: - Ambient temperature, and / or - the temperature in the vicinity of the medicine in the cartridge, and / or - a temperature indicating the temperature of the medicine in the cartridge, and / or - The temperature of the autoinjector near the battery, and / or - Temperature, which indicates the temperature of the battery, and / or - Any combination of the above.

[0460] The processing unit 20 receives the value of the measured temperature from the temperature sensor 32. The processing unit 20 also receives the value of the calculated remaining electric battery voltage level of the rechargeable battery 10 from the battery calculation module 40. Based on at least those two values, the processing unit 20 derives a pre-set threshold value indicative of a minimum electric battery voltage level required to perform an autoinjector process at the temperature measured by the temperature sensor.

[0461] The autoinjector step can be one or more of the following: a first plunger rod movement step, in which the plunger rod 400 is moved from a retracted plunger rod position to a locked plunger rod position, in which the cartridge 700 is locked inside the autoinjector 4; - a second plunger rod movement step in which the plunger rod 400 is moved from a lock plunger rod position to a first stopper plunger rod position in which the plunger rod 400 is carried in contact with the first stopper 708; a third plunger rod movement step, in which the plunger rod 400 moves the first stopper 708 to move the second stopper 710 to the bypass area 712 inside the cartridge to establish a fluid connection between the first cartridge sub-compartment 704 and the second cartridge sub-compartment 706 inside the cartridge compartment 702; a fourth plunger rod movement step in which the plunger rod 400 moves the first stopper 708 into contact with the second stopper 710 to mix the pharmaceutical ingredients in the first cartridge sub-compartment 704 and the second cartridge sub-compartment 706; a fifth plunger rod movement step in which the plunger rod 400 is moved to an extended plunger rod position, in which the medicinal product is expelled from the cartridge, such as being completely expelled from the cartridge; - the cartridge 700 can be removed from the autoinjector and the autoinjector 4 reset to its original position; - Any drug delivery process having a combination of the above steps.

[0462] The autoinjector step can be a drug reconstitution step and / or a drug release step, or the like. For example, the autoinjector step can be a complete injection cycle including a drug reconstitution step, a drug release step, and resetting the autoinjector to its original position where the cartridge can be removed from the autoinjector, thereby allowing for insertion of a new cartridge into the autoinjector.

[0463] The preset threshold may be defined as the minimum voltage level required to perform a full injector cycle. Alternatively, the preset threshold may be obtained indirectly by calculating an estimated count of remaining injection cycles without recharging the battery.

[0464] The processing unit 20 further compares the calculated remaining electric battery voltage level with the obtained preset threshold value.

[0465] If the comparison results in the processing unit 20 finding that the remaining electric battery voltage level is greater than the preset threshold required to perform the autoinjector procedure at the measured temperature, the autoinjector initiates the autoinjector procedure.

[0466] Alternatively, if the comparison results in the processing unit 20 finding that the remaining electrical battery voltage level is less than a pre-set threshold required to perform the autoinjector procedure at the measured temperature, the autoinjector will instruct the user to recharge the battery 10. The processing unit 20 may send a signal to the user interface 1100 with instructions / information for the user.

[0467] 37 shows a flow chart of a method 4000 for determining whether the battery voltage level is high enough to allow the processing unit 20 to proceed with the autoinjector process. Alternatively, the method detects whether the battery needs to be recharged first. The method 4000 may be executed when the autoinjector is turned on.

[0468] The method 4000 comprises measuring 4002 the temperature of the autoinjector 4, for example the temperature close to the rechargeable battery, by means of the temperature sensor 32. A measurement 4004 of the battery voltage level is also measured in the same sequence, by means of the battery calculation module 40.

[0469] Method 4000 further includes determining 4010 whether the temperature is above a predetermined threshold temperature, such as 15 degrees Celsius or 12 degrees Celsius. If the temperature is above the predetermined threshold temperature (yes option at 4010), the processing unit determines 4012 whether a sufficient electric battery voltage level is present to perform an autoinjector process, e.g., a full injection cycle. The determination is performed by comparing the measured battery voltage level, indicative of the remaining battery voltage level, to a pre-set threshold value required to perform the autoinjector process at the measured temperature.

[0470] If there is a sufficient electric battery voltage level to perform the autoinjector procedure (yes option at 4012), the processing unit 20 communicates to the user that the autoinjector is ready for use, i.e., the autoinjector procedure may proceed (4014).

[0471] If there is not a sufficient electric battery voltage level to perform the autoinjector procedure (no option at 4012), the processing unit communicates to the user (4016) that the battery needs to be recharged before the autoinjector is ready for use, i.e., before the user can perform the autoinjector procedure. Method 4000 is repeated before the autoinjector procedure can be initiated.

[0472] If it is determined in 4002 that the measured temperature is below the predetermined threshold temperature (no option in 4010), the processing unit determines (4022) whether the electric battery voltage level is sufficient to perform not one but two autoinjector steps, e.g., two full injection cycles.

[0473] If the electric battery voltage level is sufficient to perform two autoinjector steps (yes option at 4022), the processing unit communicates to the user that the autoinjector is ready for use, i.e., the autoinjector steps may proceed (4014).

[0474] If the electrical battery voltage level is not sufficient to perform two autoinjector steps (no option at 4022), the processing unit communicates to the user to recharge the battery before the autoinjector is ready for use (4016). Method 4000 is repeated before the autoinjector steps can be initiated. Temperature is typically not measured again until the device performs a new self-test verification, i.e., executes method 4000 again.

[0475] For temperatures below a given threshold temperature, e.g., 15 or 12 degrees Celsius, the battery voltage threshold may be 3850 mV voltage, and measuring to this voltage will ensure an operational battery capacity of a minimum of two injection cycles. A voltage below this threshold may be interpreted as less than two injection cycles of capacity.

[0476] In an alternative method 4000' as illustrated in FIG. 38, the autoinjector may be configured to require the temperature to exceed a first temperature threshold before allowing the autoinjector to initiate the autoinjector process. If the temperature measured in 4002 is found to be below a first threshold temperature in 4010', such as 15 degrees Celsius or 12 degrees Celsius (no option in 4010'), the autoinjector prevents the autoinjector process from starting. The method 4000 is repeated until the temperature is measured to be above the first temperature threshold before the autoinjector process can be initiated. If the temperature measured in 4002 is found to be above the first threshold temperature in 4010' (yes option in 4010'), the process proceeds as described in FIG. 37.

[0477] The temperature sensor can be placed in a Nordic Semiconductor nRF8001 chip as part of the Bluetooth chip. The voltage responsible for determining the remaining battery charge level can be measured using an ADC input to a microprocessor, for example an Atmel ATXmega256A3U-MH processor.

[0478] The pharmaceutical agent can be human growth hormone. However, this is only an exemplary use of the autoinjector. The pharmaceutical agent can be a depo-version or pro-drug, such as a long-acting version of human growth hormone. The pharmaceutical agent can be lonapegsomatropin. The second pharmaceutical component can be a dry composition of human growth hormone.

[0479] For example, the viscosity of the reconstituted drug manufacturing solution of Human Growth Hormone-Lonapegsomatropin is increased compared to water. The viscosity of the reconstituted drug manufacturing solution affects the performance of the autoinjector. For example, hydraulic losses affect the injection time at a constant drug manufacturing solution pressure, and hydraulic losses are dependent on viscosity. Thus, viscosity affects injection time.

[0480] Viscosity is also likely to affect the mixing kinetics during the reconstitution process, thus influencing the time required for reconstitution to be performed by the autoinjector. The viscosities of three different strengths of human growth hormone (hGH) lonapegsomatropin are summarized in Table 1. [Table 1]

[0481] The viscosity of lonapegsomatropine at 25 degrees Celsius is shown in Table 1. However, as the temperature is lowered, the viscosity increases significantly, as seen in FIG. 39, which shows the temperature dependence of the viscosity of lonapegsomatropine at a pharmaceutical solution concentration of 22.0 mg / mL hGH. Thus, the viscosity of reconstituted lonapegsomatropine pharmaceutical solution is strongly temperature dependent. Thus, the requirements for the battery voltage level necessary to perform an autoinjector step, such as a complete injection cycle, are strongly dependent on the temperature of the autoinjector and pharmaceutical.

[0482] Table 2 shows the specificities for the autoinjector for delivery of lonapegsomatropin at different lonapegsomatropin drug solution concentrations. [Table 2]

[0483] The autoinjector attempts a constant stopper speed of 90 mm / min during the entire injection cycle. When doing so, it monitors the plunger rod force (motor current). If it exceeds 55 N (and 80 N in the last stage), the autoinjector reduces the plunger rod speed until the plunger rod force is within acceptable levels. Whether the condition is met depends on the actual stopper friction, which can vary from approximately 6 N to 22 N. The plunger rod force further depends on the actual internal needle diameter of the needle, since the resistance scales with the internal diameter by up to a factor of four.

[0484] 40A and 40B show measurements of the required injection force 1250 as a function of plunger rod position when the cartridge contains 13.3 mg hGH / mL and 5.2 mg hGH / mL lonapegsomatropine drug solution, respectively. A first high resistance threshold 1201 and a second high resistance threshold 1202 are also illustrated in both figures. As can be seen by comparing FIG. 40A and FIG. 40B, the injection force is strongly dependent on the concentration of the lonapegsomatropine drug solution, which is directly correlated to the viscosity of the lonapegsomatropine drug solution, as seen in Table 1. Thus, the higher the concentration of the lonapegsomatropine drug solution, and therefore the higher the viscosity of the lonapegsomatropine drug solution, the higher the required injection force and therefore the higher the battery power requirements.

[0485] While particular configurations have been shown and described, they are not intended to limit the claimed invention, and it will be understood that various changes and modifications may be made by those skilled in the art without departing from the spirit and scope of the claimed invention. Accordingly, the specification and drawings are to be regarded in an illustrative rather than a restrictive sense. The claimed invention is intended to cover all alternatives, modifications, and equivalents. [Explanation of symbols]

[0486] 2. System 4 Autoinjector 6. Chassis 10 Battery 12 First Electrical Connector 14 Connector opening 18 Second Electrical Connector 20 Processing Unit 22 Orientation Sensor 24 Code Sensor 26 Plunger Rod Position Sensor 28 Cartridge Sensor 30 Syringe Needle Sensor 32 Temperature Sensor 34 Resistance Sensor 40 Battery Calculation Module 100, 100' blocking member 102 First insulating coupling member 104 First blocking member stop portion 106 Second blocking member stop portion 200 Ejector 202 Ejector member 204 Ejector abutment surface 206 End part 207 Angle holding guide 208 Second blocking coupling member 212 Ejector Lock 214 Bottom part 216 Ejector lock guide pin 218 Ejector elastic member 222 Ejector Rod Bore 224 Ejector collar 226 Ejector Cog 228 Ejector Cutout 230 Ejector Lock Cutout 232 Ejector Lock Cog 234 End part 236 Ejector spring 240 Ejector Lock Bore 250 Stop position 251 Extreme Positions 300 Cartridge Receiver 301 Cartridge receiver opening 302 Cartridge Receiver Compartment 304 Receiving direction 310 First Area 312 First guide member 314 First guide member angle Aisle 316 318 Passage Angle 322 Second guide member 324 First Side 326 Second Side 328 Holding part 330 Second Area 332 Holding angle 334 Slope section 336 Tilt angle 338 Discharge surface 340 First riser section 342 Second riser section 344 area 346 area 348 Holding surface 350 Bore 352 Aperture 354 Base material 356 Bore 400 plunger rod 402 Internal plunger rod 404 External plunger rod 406 Plunger Rod Track 408 Plunger Rod Track 410 plunger rod front end 424 Plunger rod distal edge 428 First Track Part 430 Third Track Section 432 Second Track Section 500 Drive Module 502 Motor 504 Transmission 600 Cartridge Assembly 700 Cartridges 701 Dual Chamber Cartridge 702 Cartridge Components 704 1st Cartridge Subcomponent 706 Second Cartridge Subcomponent 708 First Stopper 710 Second Stopper 712 Bypass Area 714 Cartridge outlet 716 Cartridge back 718 First Edge 720 Second End 722 First stopper direction 790 Pharmaceuticals 792 First Pharmaceutical Ingredient 794 Secondary Pharmaceutical Ingredients 800 Cartridge Holder 806 Cartridge assembly outlet opening 808 Cartridge holding member 812 Needle assembly connecting part 814 Cartridge holder slot 900 Needle Assembly 902 Syringe needle 904 Needle Hub 906 Cartridge holder connection part 908 Needle Cover 910 Injection needle cover / abutment surface 1000 Cartridge Code Features 1100 User Interface 1102 Contact member 1104 Contact member sensor 1106 First LED 1108 First input member 1110 First output member 1112 Contact member protruding parts 1114 Needle cover engagement member 1130 first contact member sensor 1132 second contact member sensor 1200 Resistance Graph 1200X position axis 1200Y resistance axis 1201 First high resistance threshold 1202 Second high resistance threshold 1204 3rd High Resistance Threshold 1206 First Slope 1208 Second Slope 1210 Third Slope 1220 1st plunger rod position 1222 Second Plunger Rod Position 1223 3rd plunger rod position 1224 4th plunger rod position 1226 5th plunger rod position 1228 Retracted plunger rod position 1229 Extended plunger rod position 1240 First plunger rod speed 1242 Second Plunger Rod Speed 1250 Injection force according to plunger rod position 1300 Speed ​​Graph 1300X position axis 1300Y speed axis 3000 ways 3001 To receive 3002 To move 3004 To decide 3006 Receiving 3010 Adjustment 3100 method 3102 moving a plunger rod at a first speed 3104 First Resistance Standard 3106 Stopping the movement of the plunger rod 3108 First Position Reference 3110 moving the plunger rod at a second speed 3112 Second Resistance Standard 3114 Stopping the movement of the plunger rod 3200 method 3202 moving a plunger rod at a first speed 3204 Resistance Standard 3206 Increasing Speed 3208 Speed ​​Standard 3210 Decreasing speed 3212 Stopping the movement of the plunger rod 3300 method 3302 moving a plunger rod at a first speed 3304 First Resistance Standard 3306 Stopping the movement of the plunger rod 3308 Second Resistance Standard 3310 First Position Reference 3312 Stopping the movement of the plunger rod 3400 method 3402 moving a plunger rod at a first speed 3404 First Resistance Standard 3406 Increasing Speed 3408 First Position Reference 3410 Decreasing speed 3412 Second Resistance Standard 3414 Speed ​​Standard 3416 Stopping the movement of the plunger rod 4000, 4000' way 4002 Measuring the temperature of the autoinjector 4004 Measuring battery voltage level 4010, 4010' Temperature above a given threshold temperature 4012 Sufficient voltage to run the autoinjector process 4014 Autoinjector is ready for use 4016 Battery needs recharging 4022 Sufficient voltage to run two autoinjector steps

Claims

1. An autoinjector (4) for administering a drug, comprising: a cartridge receiver (300) configured to receive a cartridge (700), said cartridge (700) having a cartridge outlet (714), a cartridge compartment (702) containing said medicament, and a first stopper (708); a plunger rod (400) configured to move the first stopper (708) inside the cartridge compartment (702) to expel the medicament through the cartridge outlet (714); a drive module (500) configured to move said plunger rod (400) from a retracted plunger rod position to an extended plunger rod position; a temperature sensor (32) configured to measure the temperature of said autoinjector (4); a rechargeable battery (10) configured to power at least said drive module (500) when moving said plunger rod (400); a battery calculation module (40) configured to calculate the remaining electric battery voltage level of said rechargeable battery; a processing unit (20) coupled to said temperature sensor (32), said battery calculation module (40) and said drive module (500); and The processing unit (20) receiving the measured temperature from the temperature sensor (32); receiving the calculated remaining electric battery voltage level of the rechargeable battery from the battery calculation module (40); - obtaining a preset threshold value indicative of a minimum electric battery voltage level required to perform an autoinjector process at the temperature measured by the temperature sensor; comparing said calculated remaining electric battery voltage level with said obtained preset threshold; - Initiating the autoinjector process only if the calculated remaining electric battery voltage level is greater than the preset threshold. The autoinjector (4) is configured as follows.

2. 2. The autoinjector of claim 1, wherein the processing unit is further configured to prompt a user to recharge the battery if the calculated remaining electric battery voltage level is less than the preset threshold required to perform the autoinjector process at the measured temperature.

3. 2. The autoinjector of claim 1, wherein the temperature sensor, the battery calculation module, and the processing unit are configured to perform the steps of claim 1 and to prompt the user to recharge the battery when no cartridge is received within the autoinjector and the calculated remaining electrical battery voltage level is less than the preset threshold required to perform the autoinjector process at the measured temperature.

4. The autoinjector step includes: a first plunger rod movement step in which the plunger rod (400) is moved from the retracted plunger rod position to a locking plunger rod position, in which the cartridge (700) is locked inside the autoinjector (4); a second plunger rod moving step in which the plunger rod (400) is moved from the lock plunger rod position to a first stopper plunger rod position that brings the plunger rod (400) into contact with the first stopper (708); a third plunger rod moving step, in which the plunger rod (400) moves the first stopper (708) to move a second stopper (710) into a bypass area (712) inside the cartridge to establish a fluid connection between a first cartridge sub-compartment (704) and a second cartridge sub-compartment (706) inside the cartridge compartment (702); a fourth plunger rod moving step, in which the plunger rod (400) moves the first stopper (708) into contact with the second stopper (710) to mix the drug components of the first cartridge sub-compartment (704) and the second cartridge sub-compartment (706); a fifth plunger rod movement step in which the plunger rod (400) is moved to the extended plunger rod position, in which the medicament is expelled from the cartridge, such as completely expelled from the cartridge; - resetting the autoinjector (4) to its original position, allowing the cartridge (700) to be removed from the autoinjector; - an overall drug delivery process comprising a combination of the above steps; 2. The autoinjector (4) of claim 1, wherein the autoinjector (4) is one or more of:

5. The temperature of the autoinjector (4) is ambient temperature, and / or the temperature in the cartridge adjacent to the medicament, and / or a temperature indicating the temperature of the medicament in the cartridge, and / or the temperature of the autoinjector near the battery, and / or a temperature indicative of the temperature of the battery, and / or - Any combination of the above 2. The autoinjector (4) of claim 1, wherein the autoinjector (4) is one or more of:

6. 2. The autoinjector (4) of claim 1, wherein the preset thresholds indicative of the voltage required to perform the autoinjector process are set to a first fixed threshold for temperatures above a predetermined threshold temperature and a second fixed threshold for temperatures below the predetermined threshold temperature.

7. 7. The autoinjector (4) of claim 6, wherein the second threshold is twice as high as the first threshold.

8. 7. The autoinjector (4) of claim 6, wherein the second threshold is between 3000MV and 4500MV, such as between 3500MV and 4000MV, such as between 3800MV and 3900MV, such as 3850MV.

9. 7. The autoinjector (4) of claim 6, wherein the predetermined threshold temperature is 15 degrees Celsius or less, such as 14 degrees Celsius or less, such as 13 degrees Celsius or less, such as 12 degrees Celsius or less.

10. 2. The autoinjector (4) of claim 1, wherein the preset threshold increases when the measured temperature decreases.

11. An autoinjector (4) as described in claim 5, wherein the preset threshold value increases when the measured temperature decreases.

12. 7. The autoinjector (4) of claim 6, wherein the processing unit is further configured to prevent initiation of the autoinjector process if the measured temperature is below the predetermined threshold temperature.

13. 2. The autoinjector (4) of claim 1, wherein the initiation of the autoinjector process occurs only if the calculated remaining electric battery voltage level is greater than the preset threshold by at least a predetermined tolerance value.

14. 14. The autoinjector (4) of claim 13, wherein the predetermined tolerance value is at least 5% greater than the minimum electric battery voltage level required to perform the autoinjector process at the measured temperature, such as at least 10%, such as at least 15%, such as at least 20%, such as at least 30%, such as at least 40%, such as at least 50%, such as at least 60%, such as at least 70%, such as at least 80%, such as at least 90%, or such as at least 100%.

15. 14. The autoinjector (4) of claim 13, wherein the predetermined tolerance increases with decreasing temperature.

16. 2. The autoinjector of claim 1, wherein the cartridge further comprises a cartridge code feature having information indicative of at least a drug viscosity at at least one preset temperature, and the autoinjector further comprises a cartridge code sensor coupled to the processing unit and configured to receive the information indicative of at least the drug viscosity at at least one preset temperature from the cartridge code feature when the cartridge is received within the autoinjector.

17. The preset threshold indicating the minimum electrical battery voltage level required to perform the autoinjector step at the measured temperature is also dependent on the drug viscosity, and the processing unit: - receiving information from said cartridge code feature (1000) indicative of at least said drug viscosity at at least one preset temperature; - obtaining the preset threshold value indicative of the minimum value of the voltage required to perform the autoinjector step based on both the temperature measured by the temperature sensor and the information indicative of at least the drug viscosity at at least one preset temperature obtained from the cartridge code feature (1000); 17. The autoinjector (4) of claim 16, further configured to:

18. 17. The autoinjector (4) of claim 16, wherein the drug viscosity is temperature dependent and the viscosity of the drug at any particular temperature is stored in the cartridge code feature (1000) as a curve.

19. The autoinjector (4) further comprises a user interface (1100) coupled to the processing unit (20), the processing unit (20) comprising: A) the difference between the calculated remaining electric battery voltage level and the preset threshold indicating the minimum electric battery voltage level required to perform the autoinjector process at the measured temperature is less than the predetermined tolerance; or B) if the calculated remaining electric battery voltage level is less than the preset threshold at the measured temperature; 2. The autoinjector of claim 1, wherein the autoinjector is configured to prompt a user via the user interface to recharge the battery.

20. 20. The autoinjector of claim 19, wherein the user interface has a plurality of LEDs including a first LED, and the user interface prompts the user to recharge the battery by flashing the first LED.

21. A) until the difference between the calculated remaining electric battery voltage level and the preset threshold indicating the minimum electric battery voltage level required to perform the autoinjector process at the measured temperature is greater than the predetermined tolerance; or B) until the calculated remaining electric battery voltage level is greater than the preset threshold at the measured temperature; 21. The autoinjector (4) of claim 20, wherein the first LED flashes.

22. The battery calculation module (40) - the time since the rechargeable battery was last charged, - the life of said rechargeable battery, and - the voltage used since the rechargeable battery was last charged; configured to calculate at least one of The processing unit - the time since the rechargeable battery was last charged, the life of the rechargeable battery, - the voltage used since the rechargeable battery was last charged; deriving an updated preset threshold value indicative of the minimum electric battery voltage level required to perform the autoinjector process at the measured temperature based on at least one of:

23. The autoinjector further comprises a temperature control unit coupled to the processing unit, the temperature control unit configured to heat the autoinjector, and the processing unit configured to: - obtaining the measured temperature measured by the temperature sensor; - initiating heating of the autoinjector when the measured temperature is below a predetermined heating-onset temperature; obtaining a second measurement of the measured temperature measured by said temperature sensor; - stopping the heating of the autoinjector when the second temperature exceeds a predetermined heating-off temperature and / or after the autoinjector has been heated for a predetermined time.

2. The autoinjector (4) of claim 1, further configured to:

24. 2. The autoinjector of claim 1, wherein the cartridge outlet is an injection needle having an internal needle diameter, and the preset threshold indicating the voltage required to perform the autoinjector process at the measured temperature is dependent on the internal needle diameter.

25. 25. An autoinjector (4) according to claim 24, wherein the inner needle diameter is between 145 μm and 160 μm, such as between 146 μm and 159 μm, such as between 147 μm and 158 μm, such as between 148 μm and 157 μm, such as between 149 μm and 156 μm, such as between 150 μm and 155 μm, such as between 151 μm and 154 μm, such as between 152 μm and 153 μm, for example 153 μm.

26. 25. The autoinjector (4) of claim 24, wherein the needle is a 31 gauge needle.

27. movement of the plunger rod (400) from the retracting plunger rod position to a locking plunger rod position located between the retracting plunger rod position and the extending plunger rod position locks the cartridge (700) within the autoinjector (4), and the processing unit (20) - the calculated remaining voltage of the rechargeable battery is less than the value of the voltage required to perform the autoinjector process at the measured temperature, or - if the difference between the calculated remaining voltage of the rechargeable battery and the value of the voltage required to perform the autoinjector process at the measured temperature is less than the predetermined tolerance value.

2. The autoinjector (4) of claim 1, further configured to prevent movement of the plunger rod (400) to the locked plunger rod position.

28. The autoinjector (4) a housing (6) containing said cartridge receiver (300), said plunger rod (400), said drive module (500), said temperature sensor (32), said rechargeable battery (10), said battery computing module (40) and said processing unit (20); a connector opening (14) in the housing (6) that allows the autoinjector (4) to be connectable to a voltage supply in order to recharge the rechargeable battery (10); an elongated ejector (200) having an ejector member (202) movable along a longitudinal axis between a first ejector position and a second ejector position, the ejector member (202) being configured to follow movement of the cartridge (700) along the longitudinal axis when the cartridge (700) is received within the cartridge receiver (300); a blocking member (100) coupled to said ejector member (202); and 2. The autoinjector of claim 1, wherein the blocking member is configured to move between a blocking position in which the connector opening is blocked and an unblocking position in which the connector opening is not blocked, and wherein the blocking member is in the blocking position when the ejector member is in the second ejector position, and the blocking member is in the unblocking position when the ejector member is in the first ejector position.

29. 29. The autoinjector (4) of claim 28, wherein in the first ejector position, the cartridge is not within the autoinjector.

30. 29. The autoinjector of claim 28, wherein the ejector member is a resilient ejector member, and when the cartridge is received within the autoinjector, the resilient ejector member is compressed and the blocking member is moved to the blocking position.

31. 29. The autoinjector of claim 28, further comprising an ejector lock configured for rotation of at least a portion of a pivot from an initial angular position to a first angular position as the plunger rod moves from the retracted plunger rod position toward the extended plunger rod position, wherein the rotation of the ejector lock holds the ejector member in a longitudinal and / or rotated position.

32. 29. The autoinjector of claim 28, wherein the ejector member has an ejector support surface that supports the cartridge and the cartridge holder when the cartridge is received in the cartridge receiver, and when the rotation of the ejector lock holds the ejector member in a longitudinal and / or rotated position, the cartridge and the cartridge holder are also held in a longitudinal and / or rotated position.

33. 29. The autoinjector (4) of claim 28, wherein the blocking member remains in the blocking position during the autoinjector stroke.

34. 10. A system comprising: the autoinjector (4) of claim 1; and a cartridge (700) having a cartridge outlet (714), a cartridge compartment (702) containing a drug, and a first stopper (708).

35. 1. A method for ensuring that a rechargeable battery (10) in an autoinjector (4) contains a sufficient voltage level to enable the autoinjector to perform an autoinjector procedure, comprising: The autoinjector comprises: a cartridge receiver (300) configured to receive a cartridge (700) containing a drug; a temperature sensor (32) configured to measure the temperature of said autoinjector (4); a rechargeable battery (10) configured to power at least a drive module (500) for moving a plunger rod (400) within said autoinjector; a battery calculation module (40) configured to calculate the remaining electric battery voltage level of said rechargeable battery; a processing unit (20) coupled to said temperature sensor (32), said battery calculation module (40) and said drive module (500), said processing unit (20) being configured to perform said method; and The method comprises: receiving said measured temperature from said temperature sensor (32); receiving the calculated remaining electric battery voltage level of the rechargeable battery (10) from the battery calculation module (40); - obtaining a preset threshold value indicative of a minimum electric battery voltage level required to perform the autoinjector process at the measured temperature; - comparing said calculated remaining electric battery voltage level with said obtained preset threshold value; - initiating the autoinjector process only if the calculated remaining electric battery voltage level is greater than the preset threshold; A method comprising:

36. 36. The system of claim 35, wherein the method further comprises prompting a user to recharge the battery if the calculated remaining electric battery voltage level is less than the preset threshold required to perform the autoinjector process at the measured temperature.

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