WO2025242808A1

WO2025242808A1 - Patient care system and method of monitoring injections

Info

Publication number: WO2025242808A1
Application number: PCT/EP2025/064150
Authority: WO
Inventors: Tage Korsdal Nielsen; Kurt Staecker Jensen; Abel Arturo ARREDONDO ZAMUDIO; Nils Berg Madsen; Rasmus Veel HAAHR
Original assignee: Ascendis Pharma AS
Current assignee: Ascendis Pharma AS
Priority date: 2024-05-23
Filing date: 2025-05-22
Publication date: 2025-11-27
Anticipated expiration: 2026-11-23

Abstract

A patient care system for monitoring injections and/or a patient's adherence to a prescribed treatment regimen comprises: an autoinjector for administering a medicament, such as a growth hormone, in particular to a patient, wherein the autoinjector is configured to receive a cartridge, in particular a dual chamber cartridge, with the medicament, wherein a dose of the medicament corresponds to a complete content of the medicament in the cartridge, wherein the cartridge comprises a code which is indicative of the dose, and wherein the autoinjector comprises a code reader for determining the code, wherein the autoinjector is further configured to administer at least approximately the complete content of the medicament in one administration, a computing device, in particular a mobile and/or a handheld computing device, wherein the autoinjector is configured to send the code which is indicative of the dose of the medicament to the computing device via a wireless or wired connection, in particular in response to or prior to the administering of the medicament, wherein the computing device is configured to store the code in conjunction with a time stamp that is either determined by the computing device or sent together with the code by the autoinjector, wherein the time stamp is indicative of the time and/or the date of the administering of the medicament and wherein the computing device is configured to store the code in conjunction with the time stamp on a storage device, which is internal to the computing device and/or on an external server system.

Description

Patient care system and method of monitoring injections

Technical Field

The present disclosure relates to patient care systems and methods of monitoring injections and/or a patient’s adherence to a prescribed treatment regimen.

Background

Autoinjectors, such as electronic autoinjectors, have been developed and are widely used to aid the administration of medicaments to a body of a patient, for example. The most common type of auto-injection devices, which are adapted to receive a drug filled cartridge (also termed reservoir or container) and expel a dose therefrom, are generally elongated e.g. pen-formed for being held in a user’s one hand and utilize a so-called cartridge holder adapted to receive and mount a cartridge in the device. Correspondingly, most pen-formed drug delivery devices comprise a generally cylindrical cartridge holder for receiving and holding a generally cylindrical drug-filled cartridge in a mounted position. The cartridge may comprise a proximally facing and axially displaceable piston, and a main body with a housing in which a drug expelling mechanism is arranged. The drug expelling mechanism may comprise an axially displaceable piston rod adapted to engage the piston of a mounted cartridge to thereby expel a dose of drug from the cartridge. Between the cartridge holder and the main body coupling means are provided allowing a user to remove the cartridge holder from the main body and reattach it when a used cartridge has been exchanged with a new cartridge or to reattach a new cartridge holder with a new cartridge, which could be a single piece unit. The cartridge is inserted in 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.

WO2017114912A1, the contents of this document are incorporated herein by reference, describes an autoinjector with a charger safety function, which ensures that the opening in the autoinjector housing allowing for charging of the battery inside the autoinjector cannot be accessed when a cartridge is inserted into the autoinjector.

Some autoinjectors further include features, which ensure that a cartridge remains locked inside the autoinjector once an autoinjection process has been initiated. The cartridge may be locked by movement of a plunger rod into the cartridge, e.g. for expelling of medicament. An example of such locking solution is described in W02017114906A1, the contents of this document are incorporated herein by reference.

Autoinjectors and associated methods are disclosed in WO2017114909 Al, WO2017114910 Al, WO2017114911 Al, and W02019002534A1, the contents of the mentioned documents are incorporated herein by reference.

US20180236181A1 discloses an autoinjector comprising a main control unit, which determines whether a battery has sufficient charge to complete a full drug delivery process including a warming process of the drug prior to the initiation of the drug delivery process. If the battery has enough charge, the autoinjector device may prompt the user to initiate the drug delivery process. Alternatively, if the battery does not have enough charge, the autoinjector device may display a request message to charge the battery prior to initiation of the drug delivery process. The autoinjector needs more energy at lower temperatures to perform a full drug delivery process due to the increased viscosity of the drug solution. Therefore, the autoinjector comprises a heating unit. If the autoinjector determines that the temperature is below a predefined threshold, the auto injector automatically operates the heating unit to warm up the drug solution to a suitable operating temperature prior to drug administration.

It may happen that a patient does not always follow a predefined dosing regimen. For example, the patient may forget to inject the dose, may inject the dose at a wrong time or may inject an incorrect dose. It may be beneficial or critical to monitor and/or control patient adherence to a predefined dosing regimen. EP3061013 Bl discloses a patient care system reporting adherence to a treatment regimen. Typically hand-held, electronically controlled injection devices for injecting pre-set doses of liquid medications are used within these patient care systems. These devices rely on a user to set a patient-specific dose to be injected. However, there is a risk that a user selects an incorrect dose, either too low or too high.

US2023/0021831 Al discloses single-shot, single-use autoinjectors. These autoinjectors may only be used once. After use, the autoinjectors are disposed of. A supplemental device may be connected to these autoinjectors, which may detect medicament expulsion and transmit injection data to a remote device. The autoinjectors themselves only consist of mechanical components. To dispense liquid from a product container, a torsion spring rotates a drive element, and the rotating drive element produces a propulsive movement of a propulsion element of a piston in the product container. The spring constant of the torsion spring must be adopted to the content of the cartridge (volume and viscosity) to ensure that the constrained spring stores enough energy for a single-shot. Therefore, only one specific type of cartridge may be used with such mechanic autoinjectors.

Summary

However, there is a need for a patient care system, which allows monitoring injections and/or a patient’s adherence to a prescribed treatment regimen in an easy and simple manner without relying on a user performing certain tasks correctly. In addition, there is a need for a patient care system that allows injections to be monitored using different types of cartridges with the same auto-injector, wherein the cartridges have a different volume and/or doses of medicament depending on the needs of the user. There is also a need for an easy and simple method of monitoring injections and/or a patient’s adherence to a prescribed treatment regimen of administering a medicament to a patient. Additionally, there is a need to provide a patient care system with increased security for operation of an autoinjector within the patient care system and for secure data transfer between the autoinjector and a remote device. Furthermore, there is a need for a patient care system in which requests send from in which computing resources are used optimally and energy-efficiently.

The respective object is satisfied by a patient care system and, respectively, by a method in accordance with the features of any one of the independent claims. Preferred embodiments of the present disclosure are described in the dependent claims.

In one aspect, the present disclosure relates to a patient care system for monitoring injections, in particular carried out on a patient, and/or a patient’s adherence to a prescribed treatment regimen. The patient care system comprises an autoinjector for administering a medicament to a patient, wherein the autoinjector is configured to receive a cartridge with the medicament, wherein a dose of the medicament corresponds to a complete content of the medicament in the cartridge, wherein the cartridge comprises a code which is indicative of the dose, and wherein the autoinjector comprises a code reader for determining the code, wherein the autoinjector is further configured to administer at least approximately the complete content of the medicament to the patient in one administration. Thus, at least approximately the complete content of the medicament is provided at once. In other words, it is provided in a single shot. The patient care system further comprises a computing device, in particular a mobile and/or a handheld computing device. The autoinjector is configured to send the code which is indicative of the dose of the medicament to the computing device via a wireless or wired connection, in particular in response to or prior to the administering of the medicament. The computing device is configured to store the code on a storage device, which is internal to the computing device and/or on an external server system.

The patient care system comprises the autoinjector and a computing device, such as a mobile phone or a smart phone. The computing device may host and execute an app or another computer programme by which the computing device may receive the code from the autoinjector and further process the received code. The autoinjector is configured to administer the complete content of the medicament in one administration. The cartridge may therefore be designed such that its content may be emptied in a single shot. Needless to say that, for technical reasons, a small amount of the contents may remain in the cartridge or autoinjector, but, at least in some embodiments, this shall still be considered to be administration of the complete content of the medicament. At least in some embodiments, for mainly technical reasons, a small amount of the medicament may remain in the cartridge or in the autoinjector, in particular in the needle. Therefore, the wording that at least approximately the complete content of the medicament to the patient is administered in one administration is used herein mainly to cover the case where such a small left over remains in the autoinjector or cartridge.

In some embodiments, the patient care system comprises an autoinjector for administering a medicament to a patient, wherein the autoinjector is configured to receive a cartridge with the medicament, wherein a predefined dose of the medicament corresponds to a partial amount of the medicament in the cartridge, wherein the cartridge comprises a code which is indicative of the predefined dose, and wherein the autoinjector comprises a code reader for determining the code, wherein the autoinjector is further configured to administer at least approximately the predefined dose of the medicament to the patient in one administration. Thus, at least approximately the predefined dose of the medicament is provided at once. In other words, it is provided in a single shot. The patient care system further comprises a computing device, in particular a mobile and/or a handheld computing device. The autoinjector is configured to send the code which is indicative of the predefined dose of the medicament to the computing device via a wireless or wired connection, in particular in response to or prior to the administering of the medicament. The computing device is configured to store the code on a storage device, which is internal to the computing device and/or on an external server system. The patient care system comprises the autoinjector and a computing device, such as a mobile phone or a smart phone. The computing device may host and execute an app or another computer programme by which the computing device may receive the code from the autoinjector and further process the received code. The autoinjector is configured to administer the predefined dose of the medicament in one administration. The cartridge may therefore be designed such that predefined dose may be administered in a single shot.

At least in some embodiments, there may be an option to provide the code manually to the computing device.

As the cartridge comprises a code, which is indicative of the dose, it may be possible to monitor and/or control the type of medicament and/or the dose that is applied. The autoinjector is able to detect the code via the code reader. The code may be transmitted to the computing device, where it may be stored and/or provided to an external server system. The external server system, which may be a cloud computing system, may then be a part of the patient care system. The storing of the code might be regarded as a confirmation that the dose was administered. Thus, the patient care system allows keeping track of administered doses and thereby allows for a monitoring or controlling of the patient’s adherence to a predefined regimen in a simple and easy way. Thus, the patient care system is easy to use as the dose contained in the cartridge is automatically determined by the autoinjector, and it can be automatically transmitted to a remote device when the user installs the cartridge into the autoinjector. A user or a doctor or the like may not have to do any additional action, such as providing the code manually to a data base system.

The storage of the obtained data, in particular the storing of the code, in the storage of the computing device or in an external storage, for example, in a cloud, may be done under a user account so that access to the stored data may be regulated and/or data protection regulations may be observed.

Reference is herein made to the user or to the patient. The terms may be seen as interchangeably. In particular, it could be the patient who administers the dose or it could be another user, such as parent, a doctor or a nurse or another caregiver, who administers the dose to the patient. The intended use of the autoinjector may, however, be such that it may be employed for selfadministering of a medicament. In some embodiments, the autoinjector may be configured to administer the complete content of the medicament to the patient in one administration in response to an activation of the autoinjector by a user. Thus, there may be an activation of the autoinjector in order to administer the medicament. The medicament is preferably administered in a single shot. This may increase safety when handling the autoinjector.

In some embodiments, the autoinjector comprises a drive module connected to a battery, such as a re-chargeable battery. The drive module comprises a motor, in particular an electric motor, and is coupled to move a plunger rod between a retracted plunger rod position and an extended plunger rod position and between the extended plunger rod position and the retracted plunger rod position. The cartridge comprises a stopper which is movable by the plunger rod to expel the cartridge content, when the cartridge is inserted in the autoinjector. The energy stored by the auto-injector, which can be used to move the plunger rod, is determined by the battery, such as the re-chargeable battery. This has the advantage that by using a battery with an appropriate charge capacity, a large number of suitable cartridges can be used, which differ in volume, dose and viscosity of the cartridge contents.

In some embodiments, the autoinjector further comprises a battery calculation module configured to calculate a residual electrical battery voltage level of the battery, such as of the re-chargeable battery, thereby proving a measure of the remaining residual electrical battery voltage level. The autoinjector may be configured to determine if the remaining residual electrical battery voltage is sufficient to perform an injection. The autoinjector may be configured to determine if the remaining residual electrical battery voltage is sufficient to expel the full cartridge-content of an installed cartridge. The autoinjector may be configured to determine if the remaining residual electrical battery voltage is sufficient to expel the full cartridge-content of an installed cartridge and subsequently removing the plunger rod to the retracted plunger rod position. The remaining residual electrical battery voltage that is needed for expelling the full cartridge content of an installed cartridge and optionally remove the plunger rod to a retracted plunger rod position may depend on the temperature of the medicament in the cartridge and/or the temperature of the surrounding environment in which the autoinjector is used. If the remaining residual electrical battery voltage is not sufficient, the autoinjector may send a notification to the remote device to prompt a user to charge the autoinjector before usage. The autoinjector may further send a notification to the remote device to indicate that the remaining residual electrical battery voltage level is high enough to expel the full content of a cartridge and subsequently move the plunger rod to a retracted plunger rod position. This has the advantage that the autoinjector can determine the content of the installed cartridge, e.g. volume, dose and viscosity and calculate if the autoinjector has enough power to perform an injection or otherwise urge a user to charge the autoinjector and optionally send a notification to the user when the autoinjector is sufficiently charged.

In some embodiments, for administering the complete content of the medicament in one administration, the autoinjector comprises a plunger rod and the cartridge comprises a stopper which is movable by the plunger rod, when the cartridge is inserted in the autoinjector, wherein during an administering process the plunger rod moves the stopper from an initial start position to a final position, in which the stopper is close to or in contact with a distal end of the cartridge in order to remove the complete content of the medicament in one administration from the cartridge. The medicament may thus be pressed out of the cartridge by a move of the stopper from its initial to its final position. At least in some embodiments, the autoinjector may be configured to detect the position of the stopper, when the stopper is in the initial position and/or the final position. The autoinjector may further be configured to communicate a signal, which is indicative of the position of the plunger rod and/or the stopper. Thereby, it is possible to monitor in an improved way that a complete dose has been administered.

In some embodiments, the code is at least one of the following: a colour code, a code comprising a sequence of colours, a bar code, a QR code, an identification number of the cartridge, a RFID tag, a NFC tag, a number code, a letter code.

As indicated above, the code may be indicative of the dose.

The code may contain information related to the drug, the size of the dose, the manufacturer, the expiration date, etc. In some embodiments, a colour code may be used to distinguish cartridges of different dosages of the same drug. For example, cartridges containing a first dose of a drug may be marked with a first colour code, such as a yellow colour code, while cartridges containing a second dose of the drug are marked with a second colour code, such as a red colour code. In some embodiments, a colour code can be a sequence of colours used to distinguish cartridges of different dosages of the same drug. For example, cartridges containing a first dose of a drug may be marked with a colour code comprising a sequence of first, second, third and so on colour codes, while cartridges containing a second dose of the drug may be marked with a colour code comprising a sequence of other first, second, third and so on colour codes.

In some embodiments, the computing device is connected or connectable to the external server system via a communications network, such as the internet. The external server system may be provided by a cloud computing system. The external server does not therefore have to be located locally. This may have the advantage that a third party, such as a healthcare provider or a care giver, may be granted access to the stored data in a simple manner. For example, the third party may simply log into a service that may be used to access the data on the server.

In some embodiments, the computing device is configured to store the code in conjunction with a time stamp that is either determined by the computing device or sent together with the code by the autoinjector. The time stamp may be indicative of the time and/or the date of the administering of the medicament. The time course of the administration of the injections may thus be monitored and/or recorded in an improved manner.

In some embodiments, the auto injector is configured to store and/or transmit the code to the computing device in conjunction with a time stamp. The time stamp may be indicative of the time and/or the date the medicament was administered. The time and/or the date the medicament was administered may be calculated based on the time elapsed between an internal reference time point and the administration of the medicament. The internal reference time point may be a specific time and/or date in a specific time zone. The specific time zone may be the Greenwich Mean Time (GMT). The time that has elapsed between the internal reference time point and the administration of the medicament may be measured in years and/or months and/or days and/or hours and/or minutes and/or seconds. The internal reference time point may be Jan 1, 1970 at 0 hours, 0 minutes and 0 seconds Greenwich Mean Time (GMT) and the time that has elapsed between the internal reference time point and the administration of the medicament may be measured in seconds. The computing device may convert the received time stamp from the auto injector to the actual time zone where the computing device is located. This has the advantage that the actual time of medicament administration is adapted to the user’s time zone. In some embodiments, the autoinjector is configured to determine whether the dose has been administered completely and to send a confirmation, which is indicative that the dose has been administered completely, wherein the computing device is configured to store the code in conjunction with the confirmation. This may further help to improve the monitoring of the proper administering of the doses. This has the advantage that not only the dose contained in a cartridge that is installed into the autoinjector is transmitted, but also a confirmation that the cartridge content has been expelled.

In some embodiments, the autoinjector is configured to determine whether the dose is administered completely based on a start position of a plunger rod of the autoinjector for moving a stopper of the cartridge and an end position of the plunger rod and/or a start position of the plunger rod and a resistance signal indicative of a resistance against a movement of the plunger rod from the start position to the end position. The autoinjector may be configured to determine the start position of the plunger rod, the end position of the plunger rod and/or the resistance signal and, optionally, to communicate the start position of the plunger rod, the end position of the plunger rod and/or the resistance signal to the computing device. At least in some embodiments, the start position of the plunger rod is a position at which air in the cartridge is removed to an amount appropriate for injection. The autoinjector may determine and confirm that the dose has been fully administered. Monitoring of compliance with a prescribed application schedule may thus be improved.

In some embodiments, the administration of the cartridge content may be aborted before the full content of the cartridge has been expelled. In some embodiments, the resistance against movement of the plunger rod will be above a high resistance threshold before the full content of the cartridge has been expelled and the autoinjector will abort the administration process.

In some embodiments, the autoinjector is removed from the injection site before the full cartridge content has been expelled and the autoinjector will abort the administration process. In some embodiments, if the administration process is aborted, only the part of the dose that was actually administered is transmitted to the computing device. In some embodiments, if the administration process was aborted, information which is indicative that the injection process was aborted is transmitted. In some embodiments, the autoinjector is configured to determine and optionally to communicate to the computing device at least one of the following:

(a) a status of the cartridge, in particular whether full, not full and/or empty,

(b) a position of a plunger rod and/or of a first stopper of the autoinjector,

(c) a resistance signal indicative of a resistance of a plunger rod against movement,

(d) a contact member signal obtainable from a contact member of the autoinj ector indicative of the position of a contact member,

(e) status information of the medicament, in particular a status of a medicament solution, wherein, optionally the status information comprises a number of inversions performed with the autoinj ector. The advantage of this is that the autoinj ector can determine that the medication in the cartridge has been properly prepared and administered. Therefore, the “confidence level” of the transmitted data is increased since not only a dose value is transmitted, but also confirmation that the medication was properly prepared and administered.

Status information about the autoinjector and/or the cartridge may thus be obtained and, if communicated, also be stored in conjunction with other obtained data. The medicament may be provided in form of a solution or in the form of a lyophilized powder which may need to be reconstituted prior injection. In some embodiments, it may be required to invert or shake the autoinjector loaded with the cartridge prior to administration of the medicament, in particular if the medicament must be reconstituted prior to administration. The number of inversion or shaking movements may be determined and communicated to the computing device. The number of shaking movements and/or inversions may for example be detected by use of one or more sensors, for example accelerometer sensors, inertial sensors, vibration sensors, shake sensors, rotation sensors or a combination thereof.

A required or desired number of inversions for preparing the medicament may be included in the cartridge code. The autoinjector may be configured to check whether the required or desired number of inversions have been carried out prior to the administering of the medicament.

In some embodiments, the autoinjector is configured to determine and optionally to communicate, in particular in one or more confirmation signals, at least one of the following: whether a needle cover is removed from the autoinjector prior to an injection and/or whether the device is pressed against an injection site during an injection, in particular based on a contact member signal obtained from pressing a contact member of the autoinjector against the injection site and/or by moving the contact member along the longitudinal axis; whether a dwell time, which is indicative of a time period during which the autoinjector is pressed against the injection site, exceeds a predefined threshold value; whether the complete content of the cartridge was administered; whether air was expelled from the cartridge, in particular such that air in the cartridge is reduced, optionally such as minimized and/or reduced to an amount appropriate for injection; whether the content of the cartridge was mixed, in particular homogeneously mixed, prior to the administering of the medicament; whether a reconstitution time exceeds a predefined threshold value prior to the administering of the medicament, wherein the reconstitution time is indicative of a time period between a mixing of the content of the cartridge and the injection of the medicament into the injection site, or whether a reconstitution time has elapsed since moving the plunger rod to a mix plunger rod position. Optionally, the threshold value is defined such that no excess foaming is present in the cartridge prior to the administering of the medicament. Further optionally, after the reconstitution time has elapsed, an air shot is conducted.

Any of the above confirmation signals may help to determine that a dose has been administered properly. In some embodiments, the autoinjector may be configured to generate and/or send an error message, if one or more of the above mentioned confirmation signals cannot be determined.

A measurement of an acceleration and/or orientation signal of the autoinjector can further be used to determine whether the autoinjector was shaken and/or inverted appropriately in order to ensure a sufficient mixing of the components of the medicament. The acceleration and/or orientation signal may indicate how many times the autoinjector has been shaken and/or inverted during a mixing of the components in the cartridge. In some embodiments, the acceleration or orientation signal may indicate how many times the autoinjector was rotated by more than 90 degrees, or by more than 135 degrees or by more than 180 degrees. The acceleration and/or orientation signal may indicate how many times the acceleration of the autoinjector exceeded a specific value.

In some embodiments, the autoinjector is configured to determine whether a measured acceleration and/or orientation signal fulfils at least one predefined condition. At least in some embodiments, the measured acceleration and/or orientation signal must at least reach a predefined threshold value for a predefined number of times in order to fulfil the predefined condition. The autoinjector may comprise at least one sensor, such as an acceleration sensor, to determine the acceleration and/or orientation signal.

In some embodiments, the computing device is configured to determine whether the dose is in accordance with an intended dose and/or in accordance with a predefined dosage regime stored on the computing device and/or the server system. In some embodiments, the computing device may confirm whether the dose corresponds to the intended dose prior to the injection of the dose and in response to receiving the code which is indicative of the dose from the autoinjector. The computing device may also be configured to inform the user that the dose in the autoinj ector corresponds to the intended dose or that the dose does not correspond to the intended dose.

In some embodiments, the computing device is configured to inform the user, in particular by use of a visual message displayed on a screen of the computing device and/or an acoustic signal output by a loudspeaker of the computing device that the dose is or is not in accordance with the predefined dosage regime. If the dose does not correspond to the intended dose, an alert may be output, in particular via the loud speaker or the display.

In some embodiments, the computing device is configured to store the code in conjunction with validation information, which indicates whether the dose is or is not in accordance with the predefined dosage regime. Thus, the validation information may be used to track back if a dose was applied in line with the dosage regime. This information may be stored together with a time stamp in order to check whether the dose has been applied in time according to the predefined dosage regime. In some embodiments, the time stamp may be included in the validation information. In some embodiments, an automated dose regiment compliance message is generated in response to the reception of the validation information. The compliance message may be sent to a user or a third person, such as a doctor.

In some embodiments, the computing device and/or the server system is configured to inform the user and/or a third person, e.g. a care giver, such as a doctor and/or a nurse and/or parents, when the validation information indicates that the dose is or is not in accordance with the predefined dosage regime. If this information is provided to the user and/or a third party prior to injection, misapplication of the drug may potentially be prevented. In addition, the validation information may be stored, in particular after the dose is injected, which later could be helpful in identifying any problems the patient may have encountered during treatment with the drug.

In some embodiments, the autoinjector and the computing device are configured to be linked together in order to communicate with each other via the wireless or wired connection by use of a pairing process. The pairing process may be an automatic pairing process. The paring process may serve to establish a communication channel, for example via Bluetooth, between the autoinjector and the computing device.

The autoinjector may be configured to emit a low power signal for pairing with a computing device. In some embodiments, the power may be such that pairing is only possible if the distance between the autoinjector and the computing device is below a critical distance, for example 1 meter.

The pairing process may require the manual entry of a registration code at the computing device. Optionally, the registration code is a unique key that is printed on the autoinjector. Optionally, the registration code may be based on the serial number of the autoinjector or a part of the serial number, such as the last 7 digits of the serial number, such as the last 6 digits of the serial number, such as the last 5 digits of the serial number, such as the last 4 digits of the serial number, such as the last 3 digits of the serial number, such as the last 2 digits of the serial number, such as the last digit of the serial number. The registration code may also be stored, for example together with the code which is indicative of the dose. Requiring the provision of the registration code at the computing device ensures that the user becomes well aware of which autoinjector is linked with the computing device. This may in particular be of relevance if the user owns more than one autoinj ector. Using the serial number of the autoinj ector as registration code may further simplify the pairing process and ensure the exact assignment to an autoinjector. The pairing process can be based on a standard process provided by a wireless communication technology, such as Bluetooth. The pairing process may start automatically when the autoinjector is in the vicinity of the computing device.

In some embodiments, the pairing process comprises tapping the autoinjector comprising a vibration sensor and the computing device comprising a vibration sensor together. The pairing of the autoinjector and the computing device can be established by tapping the autoinjector against the computing device and subsequently detecting a vibration pattern simultaneously in the autoinjector and the computing device. In some embodiments, the vibration sensor of the autoinjector is an inertial sensor and the computing device is a smartphone and the vibration sensor of the smartphone comprises an inertial sensor and/or a microphone.

In some embodiments, the pairing process comprises an autoinjector comprising a label, such as a QR code, and a computing device comprising a camera. The pairing of the autoinjector and the computing device can be established by the computing device taking a picture of the label of the autoinjector, such as the QR code of the autoinjector.

In some embodiments, the wireless connection is a Bluetooth connection. An example for a wired connection is a USB connection. Any other, in particular short-range, wireless or wired technology standard for exchanging data between electronic devices may also be used, such as transmitting data of an injection process via 5G or 4G/LTE mobile radio network in particular, a Narrowband Intemet-of-Things, NB-IoT or another suitable means, such as LoRa (LoRa comes from "long range" and is a commercial physical proprietary radio communication technique), Sigfox (also a commercial communication technique) or satellite-based communication.

In some embodiments, the computing device comprises a screen, in particular a touch screen. The computing device may be configured to display on the screen a plurality of injection sites for the administering of the dose. This may help a user to identify a suitable injection site.

In some embodiments, the computing device is configured to store previously used injection sites and to display the previously used injection sites. This may help a user to identify a suitable injection site for the next administration, which can reduce side-effects.

In some embodiments, the computing device is configured to enable a user to input an injection site used for administering the dose, in particular by enabling the user to provide a touch input on the corresponding injection site displayed on the screen. The user may therefrom input manually the injection site that was used for administering the dose. The injection site may also be stored on the computing device and/or on an external storage.

In some embodiments, the computing device is configured to enable a user to select or unselect or block an injection site, in particular by use of a touch input on the displayed injection site. The user is therefore enabled to configure the display of the injection sites. For example, by blocking an injection site, it might not be displayed any more or differently than the unblocked injection sites.

In some embodiments, the computing device is configured to categorize the injection sites of the plurality of injection sites into at least two different categories, for example with regard to a frequency of use of the injection sites, and to display differently the at least two different categories of injection sites. Thereby, some guidance may be provided to the user when selecting an injection site for administering the next dose.

In some embodiments, the computing device is configured to provide at least one suggestion for the next inj ection site. The computing device may be configured to suggest the next inj ection side based on a pre-given algorithm provided on the computing device.

In some embodiments, the computing device can be configured to enable a user, such as a patient, to input data related to therapy outcome. The computing device can be configured to display on the screen a graphical representation comprising on a first axis data related to the time of injection and on a second axis data related to therapy outcome. The computing device can be configured to display on the screen a graphical representation comprising on the first axis the time of injection of a medicament, such as human growth hormone, and on the second axis data related to therapy outcome, for example marker concentrations, such as IGF-1 levels, body weight, body height and/or growth rate.

In some embodiments, the computing device can be configured to display on the screen a graphical representation comprising on a first axis data relating to patient’s adherence to a prescribed treatment regimen and on a second axis data related to therapy outcome. The data relating to patient’s adherence to the prescribed treatment regimen may for example be the percentage of injections that were actually made by a user compared to intended injections that a user should have made. The computing device can be configured to display on the screen a graphical representation comprising on the first axis data relating to patient’s adherence to a prescribed treatment regimen, such as data relating to patient’s adherence to a prescribed treatment regimen with a medicament, such as human growth hormone, and on the second axis a therapy related outcome data, in particular marker concentrations, such as IGF-1 levels, body weight, body height and/or growth rate. In some embodiments, the computing device is configured to output a reminder, in particular a visual or an acoustic reminder, in accordance with a predefined schedule for the administering of the medicament. Thus, the computing device may support the patient to stick to the predefined schedule.

In some embodiments, the computing device is configured to inform the user to replace the cartridge. In some embodiments, the autoinjector is configured to determine whether an inserted cartridge is full, not full and/or empty and to send a message to the computing device that the cartridge is full, not full and/or empty. The computing device may thus support the patient to ensure that the correct dose will be applied.

In some embodiments, the cartridge is a dual chamber cartridge, wherein the medicament consists of at least two components, which are stored separately in two chambers of the cartridge prior to the administering of the medicament. The two components may be mixed before they are pressed out of the cartridge, so that the complete content may be applied in a single shot.

In some embodiments, the computing device is a first computing device, for example of a patient, and the system further comprises a second computing device, for example of a healthcare professional, and a third computing device, for example of a manufacturer of the autoinjector and/or the medicament, and the autoinjector is configured to send selectively data to the first, second or third computing device and/or at least some of the data is exchangeable between any two of the first, second and third computing device. In this way, for example, the correct appliance of doses may be monitored by a third party, such as a healthcare professional, while privacy of the patient may be ensured by only sending selected data to the third party. Furthermore, in some embodiments, a manufacturer could be enabled to obtain information about a proper functioning of the autoinjector.

At least in some aspects, the disclosure relates to a patient care system for monitoring injections carried out on a patient and/or a patient’s adherence to a prescribed treatment regimen, in particular a patient care system in accordance with any one of the preceding items or embodiments, the patient care system comprises: an autoinjector for administering a medicament, such as a growth hormone, to a patient, wherein the autoinjector is configured to receive a cartridge with the medicament, and a computing device, in particular a mobile and/or a handheld computing device, wherein the autoinjector is configured to send information to the computing device, wherein the information is related to the administering of the medicament to the patient, and wherein the autoinjector is configured to use at least a first data stream and a second data stream to provide the information to the computing device, wherein the first data stream is independent from the second data stream.

By use of two independent data streams, a more efficient way of operating the autoinjector may be employed and an efficient communication between the autoinjector and the computing device may be implemented before, during and/or after the application of a dose. The two data streams may be configured differently with respect to data privacy. Therefore, the two data streams may enable different sets of functions. For example, in a less secure first data stream, real-time device status messages which are selected from a plurality of defined status messages and which reflect a current status of the autoinjector can be transmitted. In a more secure second data stream, an injection log history can be provided to the computing device. The injection log history may include information that is related to the administration of the medicament, such as dose size, time, date, cartridge number, confirmation that the dose has been administered, etc.

By use of two data streams, the usage of the computational resources provided by the autoinjector may be improved or even optimized before, during and/or after the administration of the medicament. Furthermore, the predictability of processing tasks of the MCU is increased. Thereby the application safety of the autoinjector may be improved.

In some embodiments, the first data stream may be active before, during and/or after the preparation and/or administration of the medicament while the second data stream may be inactive at least in a time window before, during and/or after the preparation and/or administration of the medicament. When the second data stream is inactive, a risk of overloading a processor of the autoinjector can be reduced or avoided, in particular when the first data stream is used to send predefined status messages of the autoinjector. Thereby, for example, the device status may be communicated via the first data stream. By deactivating the second data stream during the safety-critical phase of the preparation of the medicament and/or injection, the safety of the autoinjector may be improved.

It may be advantageous, in particular for avoiding an overload of the processor, such as an overflow of a stack of the processor, when the autoinjector is configured to not respond to any messages that are received from the computing device during the time window while the second data stream is inactive. The risk that may be caused by so-called deny of service attacks by bombarding the autoinjector with messages can thus be reduced or minimized.

The second data stream may be deactivated if the autoinjector does not respond to an incoming request for data. The time window during which the second data stream is inactive, the autoinjector does not respond to an incoming request for data, may start with the detection, by the autoinj ector, of a first event and may end with the detection, by the autoinj ector, of a second event.

The first event may be that the autoinjector detects that the cartridge is received in the autoinjector; the start of the movement of the plunger rod; the start of movement of the first stopper or the start of movement of the first stopper from a position wherein the air within the cartridge is reduced to an amount appropriate for injection. The second event may be the detection that the first stopper is in contact with the distal end of the cartridge; the dwell time has expired after the plunger rod was moved to the extended plunger rod position; that the plunger rod is moved to the retracted plunger rod position or that the cartridge is removed from the autoinjector.

In certain embodiments the time window during which the second data stream is inactive starts when the autoinjector detects that the cartridge is received in the autoinjector and ends when the autoinjector detects that the first stopper is in contact with the distal end of the cartridge.

In certain embodiments the time window during which the second data stream is inactive starts when the autoinjector detects that the cartridge is received in the autoinjector and ends when the autoinjector detects that the dwell time has been expired after the plunger rod was moved to the extended plunger rod position. In certain embodiments the time window during which the second data stream is inactive starts when the autoinjector detects that the cartridge is received in the autoinjector and ends when the autoinjector detects that the plunger rod is moved to the retracted plunger rod position.

In certain embodiments the time window during which the second data stream is inactive starts when the autoinjector detects that the cartridge is received in the autoinjector and ends when the autoinjector detects that the cartridge is removed from the autoinjector.

In certain embodiments the time window during which the second data stream is inactive starts when the autoinjector starts movement of the plunger rod and ends when the autoinjector detects that the first stopper is in contact with the distal end of the cartridge.

In certain embodiments the time window during which the second data stream is inactive starts when the autoinjector starts movement of the plunger rod and ends when the autoinjector detects that the dwell time has been expired after the plunger rod was moved to the extended plunger rod position.

In certain embodiments the time window during which the second data stream is inactive starts when the autoinjector starts movement of the plunger rod and ends when the autoinjector detects that the plunger rod is moved to the retracted plunger rod position.

In certain embodiments the time window during which the second data stream is inactive starts when the autoinjector starts movement of the plunger rod and ends when the autoinjector detects that the cartridge is removed from the autoinjector.

In certain embodiments the time window during which the second data stream is inactive starts when the autoinjector detects the start of movement of the first stopper and ends when the autoinjector detects that the first stopper is in contact with the distal end of the cartridge.

In certain embodiments the time window during which the second data stream is inactive starts when the autoinjector detects the start of movement of the first stopper and ends when the autoinjector detects that the dwell time has expired after the plunger rod was moved to the extended plunger rod position. In certain embodiments the time window during which the second data stream is inactive starts when the autoinjector detects the start of movement of the first stopper and ends when the autoinjector detects that the plunger rod is moved to the retracted plunger rod position.

In certain embodiments the time window during which the second data stream is inactive starts when the autoinjector detects the start of movement of the first stopper and ends when the autoinjector detects that the cartridge is removed from the autoinjector.

In certain embodiments the time window during which the second data stream is inactive starts when the autoinjector detects the start of movement of the first stopper from a position wherein the air within the cartridge is reduced to an amount appropriate for injection and ends when the autoinjector detects that the first stopper is in contact with the distal end of the cartridge.

In certain embodiments the time window during which the second data stream is inactive starts when the autoinjector detects the start of movement of the first stopper from a position wherein the air within the cartridge is reduced to an amount appropriate for injection and ends when the autoinjector detects that the dwell time has expired after the plunger rod was moved to the extended plunger rod position.

In certain embodiments the time window during which the second data stream is inactive starts when the autoinjector detects the start of movement of the first stopper from a position wherein the air within the cartridge is reduced to an amount appropriate for injection and ends when the autoinjector detects that the plunger rod is moved to the retracted plunger rod position.

In certain embodiments the time window during which the second data stream is inactive starts when the autoinjector detects the start of movement of the first stopper from a position wherein the air within the cartridge is reduced to an amount appropriate for injection and ends when the autoinjector detects that the cartridge is removed from the autoinjector.

In some embodiments, the autoinjector may be configured to not respond to an incoming request for data and to deactivate the second data stream after the autoinjector reads a cartridge code feature. Thereby, both dose detection and deactivation of the second data stream may be triggered by installing the cartridge into the autoinjector. This has the advantage that both the determination of the dose and the deactivation of the second data stream may be carried without relying on a user performing certain tasks correctly.

In some embodiments, the autoinjector may be configured to not respond to an incoming request for data and to deactivate the second data stream after the autoinjector reads the cartridge code feature and determines an additional signal. The additional signal may be indicative of the start of the movement of the plunger rod; the start of movement of the first stopper or the start of movement of the first stopper from a position wherein the air within the cartridge is reduced to an amount appropriate for injection. Thereby, both dose detection and deactivation of the second data stream may be triggered by installing the cartridge into the autoinjector and receiving an additional signal. This has the advantage that both the determination of the dose and the deactivation of the second data stream may be carried without relying on a user performing certain tasks correctly.

In some embodiments, the autoinjector may be configured to not respond to an incoming request for data and to deactivate the second data stream after the autoinjector reads the cartridge code feature and activates the second data stream when the autoinjector detects that the cartridge has been removed from the autoinjector. Thereby, both dose detection and deactivation of the second data stream may be triggered by installing the cartridge into the autoinjector and the activation of the second data stream may be triggered by removing the cartridge from the autoinjector. This has the advantage that both the determination of the dose and the deactivation of the second data stream may be carried out without relying on a user performing certain tasks correctly and the installation and removal of the cartridge into or from the autoinjector selectively may either activates or deactivates the second data stream.

In some embodiments, the autoinjector may be configured to not respond to an incoming request for data and to deactivate the second data stream after the autoinjector reads the cartridge code feature and determines an additional signal and activate the second data stream when the autoinjector detects that a cartridge has been removed from the autoinjector. Thereby, both dose detection and deactivation of the second data stream may be triggered by installing the cartridge into the autoinjector and receiving an additional signal. This has the advantage that both the determination of the dose and the deactivation of the second data stream may be carried out without relying on a user performing certain tasks correctly and the installation and removal of the cartridge into or from the autoinjector selectively may either activate or deactivate the second data stream.

In certain embodiments, the autoinjector may be configured to not respond to an incoming request for data and to deactivate the second data stream when the autoinjector detects that the cartridge is received in the autoinjector and the autoinjector activates the second data stream when the autoinjector detects that the first stopper is in contact with the distal end of the cartridge.

In certain embodiments, the autoinjector reads the cartridge code feature and deactivates the second data stream when the autoinj ector detects that the cartridge is received in the autoinj ector and the autoinjector activates the second data stream when the autoinjector detects that the dwell time has expired after the plunger rod was moved to the extended plunger rod position.

In certain embodiments, the autoinjector reads the cartridge code feature and deactivates the second data stream when the autoinj ector detects that the cartridge is received in the autoinj ector and the autoinjector activates the second data stream when the autoinjector detects that the plunger rod is moved to the retracted plunger rod position.

In certain embodiments, the autoinjector reads the cartridge code feature and deactivates the second data stream when the autoinj ector detects that the cartridge is received in the autoinj ector and the autoinjector activates the second data stream when the autoinjector detects that the cartridge is removed from the autoinjector.

In certain embodiments, the autoinjector reads the cartridge code feature and deactivates the second data stream when the autoinjector starts movement of the plunger rod and the autoinjector activates the second data stream when the autoinjector detects that the first stopper is in contact with the distal end of the cartridge.

In certain embodiments, the autoinjector reads the cartridge code feature and deactivates the second data stream when the autoinjector starts movement of the plunger rod and the autoinjector activates the second data stream when the autoinjector detects that the dwell time has expired after the plunger rod was moved to the extended plunger rod position. In certain embodiments, the autoinjector reads the cartridge code feature and deactivates the second data stream when the autoinjector starts movement of the plunger rod and the autoinjector activates the second data stream when the autoinjector detects that the plunger rod is moved to the retracted plunger rod position.

In certain embodiments, the autoinjector reads the cartridge code feature and deactivates the second data stream when the autoinjector starts movement of the plunger rod and the autoinjector activates the second data stream when the autoinjector detects that the cartridge is removed from the autoinjector.

In certain embodiments, the autoinjector reads the cartridge code feature and deactivates the second data stream when the autoinjector detects the start of movement of the first stopper and the autoinjector activates the second data stream when the autoinjector detects that the first stopper is in contact with the distal end of the cartridge.

In certain embodiments, the autoinjector reads the cartridge code feature and deactivates the second data stream when the autoinjector detects the start of movement of the first stopper and the autoinjector activates the second data stream when the autoinjector detects that the dwell time has expired after the plunger rod was moved to the extended plunger rod position.

In certain embodiments, the autoinjector reads the cartridge code feature and deactivates the second data stream when the autoinjector detects the start of movement of the first stopper and the autoinjector activates the second data stream when the autoinjector detects that the plunger rod is moved to the retracted plunger rod position.

In certain embodiments, the autoinjector reads the cartridge code feature and deactivates the second data stream when the autoinjector detects the start of movement of the first stopper and the autoinjector activates the second data stream when the autoinjector detects that the cartridge is removed from the autoinjector.

In certain embodiments, the autoinjector reads the cartridge code feature and deactivates the second data stream when the autoinjector detects the start of movement of the first stopper from a position wherein the air within the cartridge is reduced to an amount appropriate for injection and the autoinjector activates the second data stream when the autoinjector detects that the first stopper is in contact with the distal end of the cartridge.

In certain embodiments, the autoinjector reads the cartridge code feature and deactivates the second data stream when the autoinjector detects the start of movement of the first stopper from a position wherein the air within the cartridge is reduced to an amount appropriate for injection and the autoinjector activates the second data stream when the autoinjector detects that the dwell time has expired after the plunger rod was moved to the extended plunger rod position.

In certain embodiments, the autoinjector reads the cartridge code feature and deactivates the second data stream when the autoinjector detects the start of movement of the first stopper from a position wherein the air within the cartridge is reduced to an amount appropriate for injection and the autoinjector activates the second data stream when the autoinjector detects that the plunger rod is moved to the retracted plunger rod position.

In certain embodiments, the autoinjector reads the cartridge code feature and deactivates the second data stream when the autoinjector detects the start of movement of the first stopper from a position wherein the air within the cartridge is reduced to an amount appropriate for injection and the autoinjector activates the second data stream when the autoinjector detects that the cartridge is removed from the autoinjector.

In some embodiments, the autoinjector is configured to administer a predefined dose of a medicament which corresponds to a partial administering of the content of the cartridge in the autoinjector. The autoinjector is configured to administer the predefined dose of the medicament in one administration. The cartridge may therefore be designed such that the predefined amount may be administered in a single shot. The cartridge code may encode the predefined amount of medicament. By using one cartridge with different cartridge codes encoding different medicament doses, the same cartridge with different cartridge codes can be used by the auto injector to administer different medicament doses.

In some embodiments, the autoinjector is configured to measure a forward motion of the plunger rod which is used to press the medicament out of the cartridge, for example through a control of an electric motor which drives the plunger rod. Thereby, the autoinjector is configured to determine the amount of drug which is expelled from the cartridge. The autoinjector may be configured to read the code from the cartridge and to determine, based on the code, the dose that is to be administered. The autoinjector may further be configured to administer the determined dose, in particular by controlling the electric motor such that the dose is driven out of the cartridge.

In some embodiments, the cartridge is a dual chamber cartridge having different components of the medicament in the two chambers of the cartridge, wherein the autoinjector is configured to mix the different components prior to the administration of the medicament to a patient. The components may thus be mixed by use of the autoinjector before administration of the dose.

In some embodiments, a dose of the medicament corresponds to a complete content of the medicament in the cartridge, and the autoinjector is configured to administer the complete content in one administration. A complete emptying of the dose may be detected in an efficient way. Therefore, in some embodiments, detection of a complete emptying of the cartridge may serve to detect that the dose has been administered correctly.

In some embodiments, the information is transmitted between autoinjector and computing device via at least one wireless connection, such as a Bluetooth connection, or at least one wired connection, such as an USB connection.

In some embodiments, different communication schemes are used to provide the first data stream and the second data stream to the computing device. The different communication schemes may make use of the same technology standard and of the same communication channel for transmitting the two data streams. For example, both communication schemes may be established via a Bluetooth communication channel.

In some embodiments, the information sent in the first data stream is of a different type of information than the information sent in the second data stream. The information in the first data stream may require a lower security level than the information in the second data stream. A first type of information may be sent by the first data stream and a second type of information may be sent by the second data stream. The first type of information may be selected from a first set of predefined information messages. The second type of information may be information that has been determined or measured in conjunction with the administration of a specific dose. In some embodiments, the first data stream is configured to provide one or more status messages from the autoinjector to the computing device. A status message may be a status message determined or obtained from a predefined set of status messages. Each status message of the set of status messages may include information about a state of the autoinjector and/or the cartridge.

In some embodiments, a predefined set of status messages may include a given number of status messages, such as nineteen status messages. In some embodiments, a symbol, such as a number, is defined for each status message and for providing a status message to the computing device, the autoinjector is configured to include the symbol or a representation thereof into the first data stream, wherein the computing device is further configured to identify the status message based on the received symbol. Thereby, the status message may be transmitted efficiently and rapidly.

In some embodiments, after reception of a status message, the computing device is configured to output, in particular to the user, a notification which is associated with the received status message. In some embodiments, the notification is obtained from a predefined set of notifications provided on the computing device, wherein each notification of the set of notifications is associated with one of the status messages. The status messages may therefore be used to inform a user in real time about the status of the autoinjector.

In some embodiments, the notification is output in form of at least one picture and/or animation or a text message on a display of the computing device or in form of an audio message. This may improve the user experience and allow for an interaction between the user and the autoinjector. In particular, in order to provide most value to the user, an interactive user interface may be displayed on a patient facing application. The rules/ algorithm for showing the instructions may be stored in the patient facing application. The instructions may be updated on the application by connecting to a centralized cloud in order to make it more adaptive.

In some embodiments, the autoinjector may be configured to not send any response to requests obtained from the computing device via the first data stream. Thus, in some embodiments, it is not intended that the computing device sends requests to the autoinjector. A processor of the autoinjector is therefore not “disturbed” by messages from the computing device during application or preparation of the medicament. The risks that may arise from denial of service attacks can thereby be reduced or even minimized.

Furthermore, in some embodiments, the autoinjector does not provide any response via the first data stream. The first data stream may thus be regarded as a unidirectional data stream which is only transmitted from the autoinjector to the computing device.

In some embodiments, the first data stream is permanently active between the autoinjector and the computing device in the time between the start and the end of the connection, in particular Bluetooth connection. Thus, in some embodiments, current status messages may be sent to the computing device in order to provide the user with real time status information about the autoinjector.

In some embodiments, the first data stream is encrypted, preferably using an encryption provided by a communication protocol, such as an encryption provided by Bluetooth. Privacy aspects may thereby be ensured.

In some embodiments, the autoinjector comprises a communication module for transmitting the data streams, and at least the first data stream is encrypted in the communication module. The communication module may be or comprises a Bluetooth chip.

In some embodiments, the first data stream includes one or more Bluetooth status messages, in particular Bluetooth unacknowledged status messages.

In some embodiments, the information received via the first data stream is only stored, in particular temporarily, on the computing device.

In some embodiments, the second data stream is configured to provide information related to the administering of the medicament from the autoinjector to the computing device. More sensitive and more user related data may be transmitted via the second data stream.

In some embodiments, the information in the second data stream includes at least one of the following: a dose log history; technical parameter in the dose log history; medical data; such as the current time and/or the size of the dose; data related to earlier injection events; dose of an earlier injection; a combination of a dose and a corresponding time of injection of the dose of an earlier injection; a combination of a dose, a confirmation signal and a corresponding time of injection of the dose of an earlier injection; injection sites used for earlier injections; information related to the cartridge, such as a cartridge code.

In some embodiments, the autoinjector may not send any response to requests obtained from the computing device via the second data stream. The second data stream may be a unidirectional data stream from the autoinjector to the computing device.

In some embodiments, the computing device is configured to send data, such as confirmation messages, to the autoinjector in response to receiving information in the second data stream. In some embodiments, the autoinjector is configured to set the second data stream temporally inactive, in particular during the preparation and/or administering of the medicament. In some embodiments, the second data stream is only active before and after the preparing and/or administering of the medicament, while it is inactive during preparing and/or administering of the medicament.

In some embodiments, the second data stream is encrypted, in particular by use of a two-step encryption scheme. The two-step encryption scheme may include a first encryption scheme and a second encryption scheme. The first encryption scheme may provide an end-to-end encryption. Thus, for example, the first encryption scheme may be employed to encrypt the second data stream between an application executed on the autoinjector and an application executed on the computing device. The second encryption scheme may provide an encryption on the already encrypted, by use of the first encryption scheme, second data stream for transmission of the second data stream over an air interface, for example via Bluetooth, between the autoinjector and the computing device. A secure protection of the second data stream between the application on the autoinjector and the application on the computing device can thus be achieved.

The computing device may be configured to transmit the second data stream to another computing device or a server using a corresponding two-step encryption scheme or using at least the first encryption scheme in order to ensure an end-to-end encryption.

In some embodiments, the second data stream is transmitted via Bluetooth. The information received via the second data stream is stored on the computing device. The computing device may be further configured to send at least some of the received information to an external server system, such as a cloud computing system.

At least in some aspects, the disclosure relates to a patient care system for monitoring injections carried out on a patient and/or a patient’s adherence to a prescribed treatment regimen, in particular a patient care system in accordance with any one of the preceding embodiments or items, wherein the patient care system comprises: an autoinjector for administering a medicament, such as a growth hormone, to a patient, wherein the autoinjector is configured to receive a cartridge, optionally a dual chamber cartridge, with the medicament, wherein, further optionally, a dose of the medicament corresponds to a complete content of the medicament in the cartridge, and a computing device, in particular a mobile and/or a handheld computing device, wherein the autoinjector is configured to send information to the computing device, wherein the information is related to the administering of the medicament to the patient, and wherein the autoinjector is configured to encrypt at least a portion of the information by use of an end-to-end encryption prior to the sending of the information to the computing device. Thereby a high level of security and in particular a high level of cybersecurity may be obtained. Privacy aspects of a user may thereby be ensured.

In some embodiments, the computing device is configured to decrypt the end-to-end encrypted information. Thus, the obtained information may be evaluated by the computing device or provided to a user of the computing device.

In some embodiments, the autoinjector is configured to use at least a first data stream and a second data stream to provide the information to the computing device, wherein at least one of the first data stream and the second data stream is encrypted.

In some embodiments, the encryption includes a two-step encryption process, wherein the information is encrypted in a first step by use of a first encryption scheme and afterwards in a second step by use of a second encryption scheme.

In some embodiments, the first encryption scheme is a proprietary encryption scheme. The encryption scheme can be implemented in the software, in particular in an application, stored on and/or executed by the autoinjector. The encryption scheme can be implemented in the software, in particular in an application, in another computing device or a server system which is in communication with the computing device. The proprietary encryption scheme may comprise a proprietary encryption algorithm, which may be a custom made encryption technique. Thereby, the encryption algorithm can be kept secret to add additional security. A high level of security may therefore be achieved.

In some embodiments, the second encryption scheme is a standard encryption scheme, such as an encryption scheme provided by Bluetooth. This may be easily implemented. The second encryption scheme may provide an additional encryption over the air interface between the autoinjector and the computing device.

In some embodiments, the first encryption scheme uses a symmetric encryption. Symmetric encryption involves using a single encryption key to encrypt and decrypt data. It may be easily implemented on the autoinjector and the computing device.

In some embodiments, the symmetric encryption uses an encryption key which is provided by the computing device or a server system, such as a cloud computing system, wherein the computing device is configured to connect to the server system. The encryption key could be provided by the server system so it could have been generated at a safe environment.

In some embodiments, the symmetric encryption uses an encryption key which is generated, in particular by use of an algorithm and/or on the computing device or on a server system, by taking account of a unique specification of the autoinjector, such as a serial number. The key thereby may be associated with the autoinjector. The security level may thereby be improved. Alternatively or additionally, the encryption key may comprise a mathematical constant, such as a large digit number, for example a ten-digit number.

In some embodiments, the first encryption scheme uses asymmetric encryption. This scheme uses two keys - one public and one private - to encrypt and decrypt data.

In some embodiments, a server system comprises a database in which data which is indicative of reported lost autoinjectors and/or lost computing devices is stored. The server system is configured to provide the key to the computing device only if the autoinjector and/or the computing device are/is not included in the database. Thereby, misuse of the autoinjector could be prevented.

In some embodiments, a key for symmetric encryption is incorporated, in particular by coding, in the autoinjector and/or the computing device. The functioning of the autoinjector may therefore be independent from access to the server.

In some embodiments, the autoinjector comprises a main processing unit and the autoinjector is configured to carry out the first encryption scheme on the main processing unit.

In some embodiments, the autoinjector comprises a communication module, such as a Bluetooth chip or a Bluetooth Low Energy Chip, for transmitting the information from the autoinjector to the computing device, and the autoinjector is configured to carry out the second encryption scheme on the communication module. Alternatively, in some embodiments, the first and the second encryption may be carried out on one or more processors of the autoinjector.

In some embodiments, the second encryption scheme may be provided by Bluetooth.

In some embodiments, the computing device is configured to decrypt the received information by use of a corresponding two-step decryption process. In some embodiments, the computing device comprises a main processing unit and the computing device is configured to carry out a corresponding first decryption scheme on the main processing unit.

In some embodiments, the computing device comprises a communication module, such as a Bluetooth chip or a Bluetooth Low Energy Chip, for receiving the information from the autoinjector, and the computing device is configured to carry out a corresponding second decryption scheme on the communication module.

In some embodiments, the computing device comprises one or more applications, which can be executed by the computing device, and the computing device is configured to use the one or more applications to carry out at least one and preferably both decryption schemes. The decryption of the received data can therefore be independent from the hardware architecture of the computing device. In some embodiments, the computing device is configured to provide the encrypted information to the server system, and the server system is configured to decrypt the received information. The received information may be stored either in the encrypted or decrypted form. The server system may be configured to store and execute software to decrypt the received information.

In another aspect, the disclosure relates to the use of a patient care system in accordance with embodiments of the present disclosure for monitoring injections and/or for monitoring a patient’s adherence to a prescribed treatment regimen.

In a further aspect, the disclosure relates to a method of monitoring injections and/or a patient’s adherence to a prescribed treatment regimen of administering a medicament to a patient using a patient care system, which comprises an autoinjector for administering the medicament and a computing device, in particular a patient care system in accordance with the present disclosure, the method comprises the following steps:

(a) providing the autoinjector such that it comprises a cartridge with the medicament, wherein the cartridge comprises a code which is indicative of the dose of the medicament in the cartridge, wherein the dose of the medicament corresponds to a complete content of the medicament in the cartridge,

(b) administering the complete content of the medicament in the cartridge in one administration to the patient,

(c) identifying, by the autoinjector, the code and sending the code via a wireless or wired connection to the computing device, in particular in response to or prior to the administering of the medicament, and

(d) storing, by the computing device, the code on a storage device, which is internal to the computing device and/or on an external server system.

In some embodiments, the method includes the steps of determining a time stamp and storing the code in conjunction with the time stamp. The time stamp is indicative of the time and/or the date of the administering of the medicament.

The computing device may be a first computing device, for example of a patient, and the patient care system may further comprise a second computing device, for example of a healthcare professional, and a third computing device, for example of a manufacturer of the autoinjector and/or the medicament. The computing devices may communicate with each other, and the autoinjector may send data to the computing devices. This may be done in a way that the privacy of a patient is respected.

In particular, the autoinjector may send selectively data to the first, second or third computing device. For example, no patient specific data is provided to the third computing device, which may be the device of the manufacturer, but information related to the functioning of the autoinjector might be provided to the third computing device, but not to the first or second computing device.

The first computing device may send data, such as data about injections, dose, time and/or date of an injection, used injection site, adherence, therapy outcome, adherence versus height/growth rate, to the second computing device. The first computing device may send data, such as error messages, to the third computing device.

The second computing device may send data, such as instructions to stop injections or use a different dose, to the first computing device. The second computing device may send data, such as error messages, to the third computing device.

The third computing device may send data, such as information about probl ems/updates or information about the autoinjector, to the first computing device. The third computing device may send data to the second computing device, such as information about probl ems/updates or information about the autoinjector.

In a further aspect, the disclosure relates to a method of monitoring injections and/or a patient’s adherence to a prescribed treatment regimen of administering a medicament to a patient using a patient care system, which comprises an autoinjector for administering the medicament to the patient and a computing device, in particular a patient care system in accordance with at least some embodiments of the present invention, the method comprising:

(a) providing the autoinjector such that it comprises a cartridge with the medicament,

(b) sending, by the autoinjector, information to the computing device, wherein the information is related to the status of the autoinjector, the preparation of the medicament and/or the administration of the medicament to the patient, wherein the information includes first and second information and the first information is sent in a first data stream and the second information is sent in a second data stream to the computing device, wherein the first data stream is independent from the second data stream.

In still a further aspect, the disclosure relates to a method of monitoring injections and/or a patient’s adherence to a prescribed treatment regimen using a patient care system which comprises an autoinjector for administering the medicament and a computing device, in particular a patient care system in accordance with at least some embodiments of the present disclosure, the method comprising:

(b) sending, by the autoinjector, information to the computing device, wherein the information is related to the status of the autoinjector, the preparation of the medicament and/or the administration of the medicament to the patient, and

(c) encrypting at least a portion of the information by use of an end-to-end encryption prior to the sending of the information to the computing device.

Features that are mentioned in connection with a device claim and that reflect a process step may also be included in a method claim.

Embodiments of the present disclosure may relate to a system comprising one or more processors; and one or more memories storing computer-readable instructions that, upon execution by the one or more processors, configure the system to carry out at least some of the steps of one of the methods as described herein. For example, a computer device as described herein may comprise one or more processors, and/or and one or more memories storing computer-readable instructions that, upon execution by the one or more processors, configure the system to carry out at least some of the steps of one of the methods as described herein. As another example, an autoinjector as described herein may comprise one or more processors, and/or and one or more memories storing computer-readable instructions that, upon execution by the one or more processors, configure the system to carry out at least some of the steps of one of the methods as described herein.

Furthermore, embodiments of the present disclosure may relate to one or more non-transitory computer-readable storage media storing instructions that, upon execution on a system, cause the system to perform operations in order to carry out at least some of the steps of one of the methods as described herein. The above and other features and advantages of the methods and systems of the present disclosure will become readily apparent to those skilled in the art by the following detailed description of exemplary embodiments thereof with reference to the attached drawings, in which:

Brief Description of the Drawings

Fig. 1 shows an exemplary autoinjector;

Figs. 2 and 3 show an exemplary autoinjector with an exemplary cartridge as seen from two different directions;

Fig. 4 shows an exemplary autoinjector with an electrical connector;

Figs. 5A-5B schematically illustrate parts of an exemplary autoinjector;

Figs. 6A-6D schematically illustrate insertion and removal of an exemplary cartridge in an exemplary autoinjector;

Figs. 7A-7F schematically illustrate an exemplary coupling between a blocking member and an ejector member;

Figs. 8A-8B schematically illustrate an exemplary blocking member;

Fig. 9 schematically illustrates an exemplary drive module and plunger rod; and

Fig. 10 schematically illustrates exemplary components of an exemplary autoinjector.

Fig. 11 schematically illustrates an exemplary cartridge;

Fig. 12 shows an exemplary cartridge holder with a cartridge;

Fig. 13 shows a cross section of an exemplary cartridge assembly with a needle assembly; Fig. 14 shows an exemplary cartridge receiver;

Fig. 15 shows an exemplary cartridge receiver with an ejector;

Fig. 16A shows a detailed view of the first section and second section of an exemplary cartridge receiver compartment;

Fig. 16B shows an inbound journey and an outbound journey of an exemplary cartridge retention member;

Figs. 17A-17B are cross-sectional views of a first section and second section of an exemplary cartridge receiver compartment;

Fig. 18 shows a detailed view of alternative first section and second section of an exemplary cartridge receiver compartment;

Fig. 19 shows an exemplary outer plunger rod;

Fig. 20 shows an exemplary ejector;

Fig. 21 shows an exemplary ejector lock;

Figs. 22A-22D show various positions of an exemplary ejector relative to an exemplary ejector lock;

Fig. 23 shows a cross section of an exemplary system comprising an autoinjector and a cartridge assembly;

Figs. 24A-24D show cross sections of a portion of an exemplary system comprising an autoinjector and a cartridge assembly; and

Fig. 25A-25B show various positions of an exemplary ejector relative to the ejector lock in an embodiment where the cogs have inclined faces. Fig. 26 shows a block diagram of an exemplary autoinjector;

Fig. 27 schematically illustrates an exemplary autoinjector;

Fig. 27 A shows an exemplary graph of resistance vs. position of the plunger rod;

Figs. 28A-F show an exemplary graph of resistance threshold vs. plunger position;

Fig. 29 shows a further exemplary graph of resistance vs plunger position;

Figs. 30A-30E show an exemplary graph of plunger speed vs. plunger position;

Fig. 31 shows a flow chart of an exemplary method;

Fig. 32 shows a flow chart of an exemplary method;

Fig. 33 shows a flow chart of an exemplary method;

Fig. 34 shows a flow chart of an exemplary method;

Fig. 35-35F show flow charts of exemplary methods;

Fig. 36 shows a block diagram of an exemplary autoinjector;

Fig. 37 shows a flow chart of an exemplary method;

Fig. 38 shows a flow chart of an exemplary method;

Fig. 39 shows the temperature dependence of the viscosity of lonapegsomatropin in a medicament solution concentration of 22.0 mg/mL hGH; Fig. 40A and Fig. 40B show an exemplary measure of the injection force 1250 needed as a function of the plunger rod position when the cartridge contains, respectively, a 13.3 mg hGH/mL and a 5.2 mg hGH/mL lonapegsomatropin medicament solution;

FIG. 41 shows a block diagram of an embodiment of a patient care system in accordance with the present disclosure;

FIG. 42 shows another example of start and end positions of a plunger rod and/or of a first stopper in a cartridge and a diagram showing plunger rod position over resistance against movement of the stopper;

FIG. 43 shows another example of start and end positions of a plunger rod and/or a first stopper in a cartridge and a diagram showing plunger rod position over resistance against movement of the stopper;

FIG. 44 shows another example of start and end positions of a plunger rod and/or of a stopper in a single chamber cartridge and a diagram showing plunger rod position over resistance against movement of the stopper;

FIG. 45 shows another example of a start position of a plunger rod and/or of a stopper in a single chamber cartridge and a diagram showing plunger rod position over resistance against movement of the stopper;

Fig. 46 shows a flow diagram of steps carried out in an embodiment of a method in accordance with the present disclosure;

FIG. 47A shows an example of injections sites on a human body as shown on a display of a computing device;

FIG. 47B shows another example of injections sites on a human body as shown on the display of the computing device;

FIG. 48 shows an exemplary embodiment of a patient care system in accordance with the present disclosure, and an example process flow between components of the system is illustrated. Fig. 49 shows a block diagram of a patient care system for monitoring inj ections carried out on a patient and/or a patient’s adherence to a prescribed treatment regimen.

Fig. 50 illustrates in a block diagram how a two-step encryption scheme is implemented in some embodiments.

Fig. 51 shows a table with an exemplary set of status messages.

Detailed Description

Various embodiments are described hereinafter with reference to the figures. Like reference numerals refer to like elements, where appropriate. Like elements will, thus, not be described in detail with respect to the description of each figure. It should also be noted that the figures are only intended to facilitate the description of the embodiments. They are not intended as an exhaustive description of the claimed invention or as a limitation on the scope of the claimed invention. In addition, an illustrated embodiment needs not have all the aspects or advantages shown. An aspect or an advantage described in conjunction with a particular embodiment is not necessarily limited to that embodiment and may be practiced in any other embodiments even if not so illustrated, or if not so explicitly described.

The term ‘autoinjector’ refers to a medical device designed to deliver a dose of a medicament to a user. In some embodiments, the autoinjector may automatically start the injection process after a user presses the autoinjector against an injection site. In some embodiments, the user manually presses an injection button to start the injection after the autoinjector has been pressed against an injection site.

The term ‘user’ refers to a human being using the autoinjector for self-administering a medicament. In this respect the user may also be designated a ‘patient’. Thus, one use case of the autoinjector is self-administration of a medicament. The autoinjector is described with this use case in mind. However, in another use case a care giver, e.g. a nurse or parent, may operate the autoinj ector to administer the medicament into the patient. The latter use case is also enabled by the present disclosure of the autoinjector. The use of the autoinjector can be incorporated into a patient's daily routine so that it is in accordance with a prescription. The term “send,” “sent,” “sending,” or any variation thereof may refer to transmitting data, including electronically transmitting data, whether by wireless or wired connection.

If not mentioned differently, the term “wireless” may relate to Bluetooth as a non-limiting example. Nevertheless, “wireless” may also refer to the transmission of data of an injection process via Bluetooth, a 5G or 4G/LTE mobile radio network, a Narrowband Intemet-of- Things, NB-IoT or another suitable means, such as LoRa, Sigfox or satellite-based communication.

The term “store,” “stored,” “storing,” or any variation thereof may refer to saving data in any computer readable medium.

The term “computer-readable medium” refers to any available medium that can be accessed by a computing device or processor. By way of example, and not limitation, such a medium may comprise RAM, ROM, EEPROM, flash memory, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer. Disk and disc, as used herein, includes compact disc (CD), laser disc, optical disc, digital versatile disc (DVD), floppy disk and Blu-ray® disc where disks usually reproduce data magnetically, while discs reproduce data optically with lasers. It should be noted that a computer-readable medium may be tangible and non-transitory. A computing device or may store and/or retrieve data from a computer-readable medium as described herein.

The term “computing device” as used herein includes mobile, portable, and/or handheld devices, including but not limited to laptops, tablets (including medical grade tablets), smartwatches and other wearable devices, mobile telephones, and smartphones. The term “computing device” may also include a computer such as a desktop computer, or server.

Figs. 1 to 40 describe in essence an exemplary autoinjector of a patient care system in accordance with the present disclosure. Furthermore, Figs. 41 to 51 describe exemplary embodiments of a patient care system in accordance with the present disclosure.

Fig. 1 shows an exemplary autoinj ector. The autoinj ector 4 may be configured for administering a medicament. The autoinjector 4 may be an electronic autoinjector, e.g. the autoinjector 4 may be connectable to an electrical power supply (not shown), such as an external battery or a power Plug.

The autoinjector 4 comprises a housing 6. The autoinjector 4 comprises a cartridge receiver 300. The cartridge receiver is configured to receive a cartridge and/or a cartridge assembly comprising a cartridge. The cartridge may contain the medicament.

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

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

The user interface 1100 comprises a first input member 1108, e.g. a button. The first input member 1108 may provide for a user input from a user. For example, the first input member 1108 may be used for receiving a push from a user to proceed to a next step.

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

The autoinjector 4 may comprise a cover (not shown) to protect the autoinjector from dirt and filth when not in use.

The user interface 1100 may comprise a first LED 1106, which flashes when the battery needs recharging. By flashing is meant that the first LED 1106 may continuously emit light at a specific colour. Alternative, the first LED 1106 may blink. The colour of the light from the first LED 1106 may be red to indicate that the user need to pay attention to the battery level.

The first LED 1106 may flash until:

A) the difference between a calculated residual electrical battery voltage level and a predefined threshold value indicative of the minimum electrical battery voltage level needed for performing the autoinj ector process at the measured temperature is larger than a predetermined tolerance value, or

B) the calculated residual electrical battery voltage level is larger than the predefined threshold value at the measured temperature.

After the battery has been sufficiently re-charged, the first LED 1106 may stop flashing and a second LED may be turned on, e.g. emitting light having a different colour than that of the first LED 1106, e.g. a green colour compared to a red colour of the first LED. The flashing of the second colour is meant to indicate to the user, that the battery has been sufficiently recharged for performing the autoinjector process at the temperature measured by the temperature sensor.

Fig. 2 shows an exemplary system 2 comprising an autoinjector 4 with a cartridge 700. The system 2 comprises the autoinjector 4, as described in relation to Fig. 1, and an exemplary cartridge 700 received in the cartridge receiver 300 by front loading. The cartridge 700 is shown with a needle cover 908. The needle cover 908 extends out of the contact member 1102 to allow removal of the needle cover 908 from the cartridge 700.

By front loading is understood that at least the cartridge 700 is received by insertion of a back end of the cartridge 700 through the cartridge receiver opening 301. The needle may be provided on the cartridge outlet. Alternatively, it can be attached after insertion of the cartridge 700 in the autoinjector. The needle end points out of the cartridge receiver opening 301. When the cartridge 700 is being inserted and especially when it is fully inserted or almost fully inserted, the cartridge or cartridge assembly may be substantially covered by the housing or the contact member 1102. Especially in this situation the needle cover 908 serves as a protective means that makes it possible for a user at least to press on the needle cover 908 or a tip thereof to fully insert the cartridge without being injured by the needle. When the cartridge is fully inserted and sits in a retention position it is possible to detach the needle cover such that the autoinjector is ready for use to inject the medicament or a portion thereof contained in the cartridge 700. After use, such as when a dose of medicament has been injected, the needle cover 908 is attached such that the needle cover again serves as a protective means that makes it possible for a user at least to press on the needle cover 908 or a tip thereof to remove the cartridge 700 without being injured by the needle.

Fig. 3 shows the autoinjector 4 with a cartridge, where the autoinjector 4 is turned by 180 deg. compared to the view of the autoinjector 4 in Figs. 1-2. The autoinjector 4 comprises a first electrical connector 12 (see Figs. 5A-B). The first electrical connector 12 is accessible via a connector opening 14 in the housing 6. The first electrical connector 12 accepts a second electrical connector 18 (see e.g. Fig. 4).

The connection of the second electrical connector 18 and the first electrical connector 12 may for example provide charging of a battery (not visible) of the autoinjector 4. The battery may be accommodated by the housing 6. Alternatively or additionally, the connection of the second electrical connector 18 and the first electrical connector 12 may provide transferring of data to/from the autoinjector 4, such as to/from a memory of the autoinjector 4.

The autoinj ector 4 comprises a blocking member 100, 100’ . The blocking member is configured to move between a blocking position and a non-blocking position. In the blocking position, the connector opening 14 is blocked, e.g. closed, as illustrated in Fig. 3. In the non-blocking position, the connector opening 14 is not blocked, e.g. open. In the non-blocking position a second electrical connector 18 (see e.g. Fig. 4) and the first electrical connector 12 may be connectable via the connector opening 14. In the blocking position, the blocking member 100, 100’ may prevent connection of a second electrical connector 18 and the first electrical connector 12.

The blocking member 100 may be movable along the longitudinal axis L, such as movable between the blocking position and the non-blocking position along the longitudinal axis L. For example, the blocking member 100 may be a sliding element, e.g. sliding along the longitudinal axis L.

Alternatively, the blocking member 100’ may be movable perpendicularly to the longitudinal axis L, such as movable between the blocking position and the non-blocking position perpendicular to the longitudinal axis L. For example, the blocking member 100’ may be a rotating element, e.g. rotating about the longitudinal axis L.

The position of the blocking member 100, 100’ may be determined by insertion of a cartridge 700 in the cartridge receiver 300. The blocking member 100, 100’ may be in the blocking position when the cartridge 700 is received in the cartridge receiver 300, such as shown in Fig. 3. The blocking member 100, 100’ may be in the non-blocking position when the cartridge is not received in the cartridge receiver, such as shown in Fig. 4.

Fig. 4 shows an exemplary autoinjector 4, as described in relation to previous figures, wherein a second electrical connector 18 is connected to the first electrical connector 12 (see Fig. 5A). The blocking member is in the non-blocking position to allow connection of the second electrical connector 18 to the first electrical connector 12 through the connector opening 14 of the housing 6.

The blocking member may be prevented to move to the blocking position. For example, the second electrical connector 18 may prevent the movement of the blocking member to the blocking position. For example, the second electrical connector 18 may obstruct the path of movement of the blocking member towards the blocking position.

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

Fig. 5 A and Fig. 5B schematically illustrate selected parts of an exemplary autoinjector as described in relation to previous figures.

Fig. 5 A and Fig. 5B illustrate an ejector 200 of the autoinjector. The ejector 200 comprises an ejector member 202. The ejector member 202 is movable along the 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. The ejector member 202 is configured to follow movement of a cartridge 700 (only showed in part) when the cartridge 700 is received in the cartridge receiver 300 (see above figs.). As illustrated, when the cartridge 700 is received, the ejector member 202 is moved to the second ejector position. The ejector member 202 may be in the first ejector position when the cartridge 700 is not received in the cartridge receiver, as shown in Fig. 5 A. The ejector member 202 may be in the second ejector position when the cartridge 700 is received in the cartridge receiver, as shown in Fig. 5B.

The ejector member 202 comprises an ejector abutment face 204. The ejector abutment face 204 is configured to abut a face, such as a cartridge back face 716, of the cartridge 700. By inserting the cartridge 700 into the cartridge receiver, the cartridge back face 716 may abut the ejector abutment face 204, and the ejector member 202 may be pushed towards the second ejector position.

The autoinjector, such as the ejector 200 of the autoinjector, comprises 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 may be configured to bias the ejector member 202 towards the first ejector position. For example, the ejector resilient member 218 may cause the ejector member 202 to be in the first ejector position, when a cartridge 700 is not received and/or being received in the cartridge receiver and/or being removed from the cartridge receiver. The ejector resilient member 218 may be compressed when the cartridge 700 is received in the cartridge receiver, as shown in Fig. 5B.

Fig. 5 A and Fig. 5B illustrate a blocking member 100 of the autoinjector. The ejector member 202 is coupled to the blocking member 100. The blocking member 100 comprises a first blocking coupling member 102. The ejector member 202 comprises a second blocking coupling member 208. The first blocking coupling member 102 and the second blocking coupling member 208 are in engagement to translate movement of the ejector member 202 to the blocking member 100.

The blocking member 100 is in the blocking position when the ejector member is in the second ejector position, as shown in Fig. 5B. The blocking member 100 is in the non-blocking position when the ejector member 202 is in the first ejector position, as shown in Fig. 5 A. In the non-blocking position, a second electrical connector 18 may be connected to the first electrical connector 12, as shown in Fig. 5 A. In the blocking position, the blocking member 100 is positioned in front of the first electrical connector 12. Thereby, the second electrical connector 18 may not be connected to the first electrical connector 12, when the blocking member 100 is in the blocking position.

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

The blocking member 100 comprises a first blocking member stop 104, and a second blocking member stop 106. The first blocking coupling member 102 is formed as a slot comprising the first blocking member stop 104 and the second blocking member stop 106.

The second blocking coupling member 208 may comprise a protrusion arranged to catch the first blocking member stop 104 by movement in one direction, and arranged to catch the second blocking member stop 106 by movement in another direction, e.g. along the longitudinal axis. For example, the second blocking coupling member 208 may catch the first blocking member stop 104, as shown in Fig. 5 A, upon movement of the ejector member towards the first ejector position, such as upon removal of the cartridge 700 from the cartridge receiver. The second blocking coupling member 208 may catch the second blocking member stop 106, as shown in Fig. 5B, upon movement of the ejector member towards the second ejector position, such as upon insertion of the cartridge 700 in the cartridge receiver.

Figs. 6A - 6D schematically illustrate insertion and removal of an exemplary cartridge 700 in an exemplary autoinjector 4, such as the autoinjector 4 as described in relation to Figs. 1-4. Figs. 6A - 6D show selected parts of the exemplary autoinjector 4.

The autoinjector 4 comprises a first electrical connector 12, and a cartridge receiver 300 configured to receive a cartridge 700. The autoinjector 4 comprises an ejector member 202 and an ejector resilient member 218. The ejector member 202 comprises an ejector abutment face 204 configured to abut a face, such as a cartridge back face 716, of the cartridge 700. The autoinjector further comprises a blocking member 100 coupled to the ejector member 202. In the example depicted, the ejector member 202 and the blocking member 100 are fixedly connected. The blocking member 100 is configured to block a connector opening to the first electrical connector 12, e.g. when the blocking member 100 is in a blocking position.

Also illustrated in Figs. 6A - 6D is a cartridge assembly 600 comprising the cartridge 700. The cartridge 700 comprises a cartridge compartment 702. The cartridge compartment 702 may contain a medicament or be configured to contain a medicament. The cartridge comprises a cartridge back face 716 configured to abut the ejector abutment face 204 of the ejector member 202.

The cartridge assembly 600 comprises a needle assembly 900. The needle assembly 900 comprises a needle 902, such as a hypodermic needle, and a needle cover 908. The needle cover 908 is covering 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 the injection of medicament.

Fig. 6A shows a first situation, wherein the cartridge 700 is about to be received in the cartridge receiver 300 in the cartridge receiving direction 304. The cartridge back face 716 has abutted the ejector abutment face 204. The ejector member 202 is in the first ejector position. The blocking member 100 is in the non-blocking position.

Fig. 6C shows a second situation following the first situation, wherein the cartridge 700 is moved in the cartridge receiver 300. The cartridge 700 may be retained in the cartridge receiver 300 when received in the cartridge receiver 300. The cartridge receiver 300 is configured to selectively retain the cartridge 700 in 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 being retained in the cartridge receiver 300 prevents the ejector resilient member 218 from causing the ejector member 202 to move towards the first ejector position. In case a second electrical connector had been connected to the first electrical connector 12, the blocking member 100 would be prevented from moving to the blocking position, and thus, the ejector member 202 would be prevented from moving to the second ejector position, since the ejector member 202 and the blocking member 100 are connected. Thus, the cartridge 700 would not be able to be received in the cartridge receiver 300, e.g. so as to be retained in the cartridge receiver 300, if the second electrical connector had been connected to the first electrical connector 12.

Fig. 6B shows an optional third situation between the first situation and the second situation, wherein the cartridge 700 is pushed further into the cartridge receiver 300 in the cartridge receiving direction 304. The ejector member is moved passed the second ejector position. The ejector resilient member 218 is compressed, and the blocking member 100 is moved passed the blocking position. This situation illustrates an example of how the cartridge receiver 300 may selectively retain the cartridge 700 in the cartridge receiver 300.

For example, the cartridge receiver 300 may retain the cartridge 700 following the cartridge 700 being pushed in the cartridge receiving direction causing movement of the ejector member 202 passed the second ejector position a first time. The cartridge receiver 300 may release the cartridge 700 following the cartridge 700 being pushed in the cartridge receiving direction and causing movement of the ejector member 202 passed the second ejector position a second time.

Fig. 6D shows a fourth situation, wherein the cartridge 700 is released from the cartridge receiver 300 and moved opposite the cartridge receiving direction 304 by the ejector resilient member 218 expanding. The ejector resilient member 218 causes the ejector member 202 to move towards the first ejector position. The retention member of the cartridge receiver 300 does not prevent movement of the cartridge 700, and the ejector resilient member 218 causes the ejector member 202 to move towards the first ejector position. By moving the ejector member 202 to the first ejector position, the blocking member 100 is moved to a non-blocking position. Thus, connection of a second electrical connector to the first electrical connector 12 is again possible.

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 Fig. 6B. Thus, the optional situation shown in Fig. 6B may optionally also be inserted between the situations of Figs. 6C and 6D.

Figs. 7A - 7F schematically illustrate an exemplary coupling between a blocking member 100 and an ejector member 202. The blocking member 100 and ejector member 202 may be that of an exemplary autoinjector, such as the autoinjector as described in relation to Figs. 1-4. Figs. 7A to 7F show selected parts of the exemplary autoinjector.

The autoinjector, such as an ejector of the autoinjector, comprises 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 may be configured to bias the ejector member 202 towards a first ejector position. The ejector member 202 may be movable between a first ejector position and a second ejector position. The first ejector position may be the position of the ejector member 202 when no cartridge is received in the cartridge receiver. The second ejector position may be the position of the ejector member 202 when a cartridge is received in the cartridge receiver. The ejector member 202 may 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.

The blocking member 100 is configured to block a connector opening to the first electrical connector 12, e.g. when the blocking member 100 is in a blocking position.

The ejector member 202 is coupled to the blocking member 100. The blocking member 100 comprises a first blocking coupling member 102. The ejector member 202 comprises a second blocking coupling member 208. The first blocking coupling member 102 and the second blocking coupling member 208 are in engagement to translate movement of the ej ector member 202 to movement of the blocking member 100.

The blocking member 100 comprises a first blocking member stop 104, and a second blocking member stop 106. The first blocking coupling member 102 is formed as a slot comprising the first blocking member stop 104 and the second blocking member stop 106. The second blocking coupling member 208 is arranged to catch the second blocking member stop 106 by movement in one direction, e.g. in the cartridge receiving direction 304, and arranged to catch the first blocking member stop 104 by movement in an opposite direction, e.g. opposite the cartridge receiving direction 304.

Fig. 7A shows a first situation, e.g. when no cartridge is received in the cartridge receiver. The ejector member 202 is in the first ejector position, and the blocking member 100 is in the nonblocking position. Thus, a second electrical connector may be connected to the first electrical connector 12.

Fig. 7B shows a second situation, e.g. wherein a cartridge is being received in the cartridge receiver. The ejector member 202 is in the third ejector position. Compared to the previous figure, the ejector member 202 has moved in the cartridge receiving direction 304, e.g. caused by insertion of a cartridge in the cartridge receiver. The second blocking coupling member 208 abuts the second blocking member stop 106. Thus, from the third ejector position, movement of the ejector member 202 in the cartridge receiving direction 304 will result in movement of the blocking member 100 in the cartridge receiving direction 304.

Fig. 7C shows a third situation, e.g. wherein the cartridge has been further pushed in the cartridge receiving direction 304, e.g. for receiving the cartridge in the cartridge receiver. The ejector member 202 is in the second ejector position. The blocking member 100 is in the blocking position. Comparing with the previous figure, the ejector member 202 has moved, e.g. caused by the cartridge being received in the cartridge receiver, in the cartridge receiving direction 304. The second blocking coupling member 208 has moved with the ejector member 202, and by abutment with the second blocking member stop 106 the movement of the ejector member 202 to the second ejector position has caused the blocking member 100 to move to the blocking position.

Fig. 7D shows a fourth situation, wherein the ejector member 202 is in a position, wherein second coupling member 208 does not abut any of the first blocking member stop 104 or the second blocking member stop 106. For example, such a position may be between the second ejector position and the third ejector position and/or the fourth ejector position. For example, the ejector member 202 may be in such a position after the cartridge has been received in the cartridge receiver. In the illustrated situation, e.g. in the illustrated position of the ejector member 202, movement of the ejector member 202 does not immediately translate into movement of the blocking member. The engagement of the first blocking coupling member 102 and the second blocking coupling member 208 allows a distance of slack between movement of the ejector member 202 and the blocking member 100.

Fig. 7E shows a fifth situation, e.g. wherein the cartridge is being released from the cartridge receiver, thus being moved opposite 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 figure, the ejector member 202 has moved opposite the cartridge receiving direction 304 to the fourth ejector position, e.g. caused by the ejector resilient member (see previous figs.). The second blocking coupling member 208 abuts the first blocking member stop 104. Thus, from the fourth ejector position, movement of the ejector member 202 opposite the cartridge receiving direction 304 will result in movement of the blocking member 100 opposite the cartridge receiving direction 304.

Fig. 7F shows a sixth situation, e.g. wherein the cartridge has been 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. Comparing with the previous figure, the ejector member 202 has moved, e.g. caused by the ejector resilient member (see previous figs.) and the cartridge being removed from the cartridge receiver. The second blocking coupling member 208 has moved with the ejector member 202, and by abutment with the first blocking member stop 104 the movement of the ejector member 202 to the first ejector position has caused the blocking member 100 to move to the non-blocking position.

Fig. 8A and Fig. 8B show an exemplary blocking member 100’ of an exemplary autoinjector, such as the autoinjector of Figs. 1-4. The blocking member 100’ as illustrated in Fig. 8A and Fig. 8B is a rotational 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.

Fig. 8A shows the blocking member 100’ being in the non-blocking position. A second electrical connector 18 is connected to the first electrical connector 12.

Fig. 8B shows the blocking member 100’ being in the blocking position. Connection of a second electrical connector to the first electrical connector 12 is prevented by the blocking member 100’. Compared to Fig. 8 A, the blocking member 100’ has been rotated in the direction of rotation DR, to the blocking position.

Fig. 9 schematically illustrates an exemplary drive module 500 and plunger rod 400. Such as a drive module 500 and a plunger rod 400 for an autoinjector as described in relation to previous figures.

The plunger rod 400 is configured to advance a first stopper of a cartridge, such as a cartridge described in relation to Fig. 11, such as a cartridge received in the autoinjector, such as received in the cartridge receiver of the autoinjector. The plunger rod 400 comprises an outer plunger rod 404 with an inner thread, and an inner plunger rod 402 with an outer thread. The thread of the inner plunger rod 402 is in engagement with the thread of the outer plunger rod 404. The outer plunger rod 404 is prevented from rotating relative to the housing of the autoinjector. The movement of the plunger rod 400 comprises rotation of the inner plunger rod 402. The 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, when moved translationally in the first stopper direction 722, is configured to abut the first stopper of the cartridge, and to move the first stopper in the first stopper direction 722.

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

Although the example shown comprises a motor 502, which may be an electro-mechanical motor, it will be readily understood that the autoinj ector 4 may be realised having an alternative drive module, such as comprising a solenoid motor, a shape memory metal engine, an arrangement of springs and/or a pressurized gas configured to actuate the plunger rod 400.

Fig. 10 schematically illustrates exemplary components of an exemplary autoinjector 4, such as the autoinjector 4 as described in relation to previous figures. A second electrical connector 18 may be connected to a first electrical connector 12. By doing so a battery 10 of the autoinjector may be charged. The battery 10 may supply electrical power to a motor 502. A processing unit 20 may be electrically powered by electrical power from the battery 10. The processing unit 20 may control the flow of electrical 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 is accommodated in the housing 6 of the autoinjector 4.

Fig. 11 schematically illustrates an exemplary cartridge 700, such as a cartridge 700 being configured to be received in the cartridge receiver of an autoinjector, such as the autoinjector described in relation to previous figures.

The cartridge 700 comprises a cartridge compartment 702. The cartridge compartment 702 may be configured for containing a medicament. The cartridge 700 has a first end 718 and a second end 720. The cartridge 700 comprises a cartridge outlet 714 at the first cartridge end 718. The cartridge may be configured to expel medicament through the cartridge outlet 714. The cartridge outlet 714 may be sealed by a needle penetrable sealing. The sealing may be made from rubber and optionally comprise a piercing which enables the needle to penetrate the sealing, while sealing the medicament when the needle is not penetrating the sealing.

The cartridge comprises a first stopper 708 movable inside the cartridge compartment, e.g. in a first stopper direction 722, e.g. towards the first cartridge end 718. For example, the medicament may be expelled through the cartridge outlet 714 upon movement of the first stopper 708 in the first stopper direction 722. The cartridge comprises a cartridge back face 716 at the second cartridge end. The cartridge back face 716 comprises a cartridge back end opening for providing access to the first stopper 708 for a plunger rod.

As illustrated, the cartridge 700 may be a dual chamber cartridge. The cartridge 700 comprises a second stopper 710 movable inside the cartridge compartment 702, e.g. in the first stopper direction 722, e.g. towards the first cartridge end 718. The cartridge compartment 702 comprises a first cartridge sub-compartment 704 and a second cartridge sub -compartment 706. The first cartridge sub-compartment 704 is between the first stopper 708 and the second stopper 710. The second cartridge sub-compartment 706 is between the second stopper 710 and the cartridge outlet 714. The second cartridge sub-compartment 706 may comprise a medicament, such as a dry medicament, such as a medicament dried by lyophilization. The cartridge comprises a bypass section 712 for providing fluid communication between the first cartridge sub-compartment 704 and the second cartridge sub-compartment 706. The bypass section 712 provides fluid communication between the first cartridge sub-compartment 704 and the second cartridge sub-compartment 706 when the second stopper 710 is positioned in the bypass section 712.

The first cartridge sub-compartment 704 contains a first medicament component 792 of the medicament 790. The first medicament component 792 may be a liquid as illustrated. The second cartridge sub-compartment 706 contains a second medicament component 794 of the medicament 790. The second medicament component 794 may be a dry composition. By positioning of the second stopper 710 within the bypass section 712, the first medicament component 792 may be transmitted into the second cartridge sub-compartment 706 via the bypass section 712, thereby mixing the first medicament component 792 and the second medicament component 794 to achieve the combined medicament 790.

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

Fig. 12 shows a cartridge holder 800 with a cartridge 700. The cartridge holder 800 accommodates at least a portion of the cartridge 700 by frictional coupling. Like the cartridge 700, the cartridge holder 800 may have a generally cylindrical form. An inner diameter of the cartridge holder 800 matches with an outer diameter of the cartridge 700. The cartridge holder 800 may be made from a plastics material, whereas the cartridge 700 typically is made from glass or a glass-like material; the cartridge 700 may also be made from a plastics material.

As shown, the cartridge holder 800 accommodates the first cartridge end 718 of the cartridge. The cartridge holder 800 has a cartridge holder slot 814 which accommodates the bypass section 712 which is shown in Fig. 11 as a protruding member. The cartridge holder 800 introduces coupling options to the cartridge 700 in the form of a needle assembly coupling portion 812, which as shown may take the form of a threading, and cartridge retention members 808. The cartridge retention members 808 may take the form of protrusions that extends from the generally cylindrical form of the cartridge holder 800. The cartridge retention members 808 may be located at or close to the rim of the cartridge holder 800 at the opposite end of the cartridge assembly outlet opening 806. In one or more examples, the cartridge retention members 808 are arranged at a greater distance from the rim than shown. The needle assembly coupling portion 812 makes it possible to couple the cartridge 700, via the cartridge holder 800, to a needle assembly as will be described in greater detail below.

Fig. 13 shows a cross section of a cartridge assembly 600 with a needle assembly 900. Note that the cartridge 700 is shown without stoppers, but with the bypass section 712.

The needle assembly 900 is coupled to the cartridge holder 800 by a respective needle assembly coupling portion 812 and cartridge holder coupling portion 906 of the needle assembly and the cartridge holder. The coupling portions 812 and 906 may be in the form of threading.

The needle assembly 900 comprises a needle hub 904 that holds a needle 902. The needle hub 904 may have a bore at its one end into which the needle extends and on sidewalls of which the needle assembly coupling portion 812 is arranged. The needle assembly 900 also comprises a needle cover 908 that may be coupled by frictional coupling to the needle hub 904.

Fig. 14 shows a cartridge receiver 300. 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 section, at a first distance from the cartridge receiver opening 301, with inwardly extending first guide members 312 that are spaced apart to form passages 316 between the inwardly extending first guide members 312. The inwardly extending first guide members 312 form a first bore accepting the cartridge assembly 600 when inserted through the cartridge receiver opening 301. The diameter of the bore is slightly larger than an outer diameter of the cartridge assembly 600 excluding the cartridge retention members 808, but is smaller than the diameter of a circle circumscribing the cross section of the cartridge assembly 600 and the cartridge retention members 808. The cartridge retention members 808 may thereby not pass a first guide member 312 unless the cartridge is turned about the longitudinal axis, L, such that the cartridge retention members pass through the passages 316.

The cartridge receiver compartment 302 has an additional second section 330, with an annular shape, at a second distance, more remote than the first distance, from the cartridge receiver opening 301. The second section 330 has second guide members 322. The second guide members 322 are arranged with inclined faces and at angular positions about the longitudinal axis such that a cartridge retention member 808 having passed the passage 316 next to a first guide member 312 in the receiving direction is guided behind the first guide member 312 by an angular turning about the longitudinal axis, L.

The second guide members 322 form a second bore also accepting the cartridge assembly 600. The diameter of the second bore is substantially the same as the first bore, such as slightly larger than an outer diameter of the cartridge assembly 600 excluding the cartridge retention members 808, but smaller than the diameter of a circle circumscribing the cross section of the cartridge assembly 600 and the cartridge retention members 808. The cartridge retention members 808 may thereby not pass a second guide member 322. So, when a cartridge retention member 808 lands on the second guide members 322, a turning of the cartridge assembly is inflicted.

The cartridge receiver 300 comprises flanges and coupling means such as opening 352 for coupling to other components of the autoinjector (not shown). The cartridge receiver 300 also comprises a base 354 comprising a bore 350 for a spring (not shown) providing a spring-bias to the contact member 1102, which may be guided by a guide rod (not shown) accommodated in a bore 350.

Fig. 15 shows the cartridge receiver 300 with an ejector 200. In this view the cartridge receiver 300 is shown in a different perspective than in Fig. 14. It is shown that an ejector 200 extends out of the cartridge receiver 300 from the other end of the cartridge receiver 300 than the cartridge receiver opening end.

Fig. 16A shows a detailed view of the first section 310 and the second section 330 of the cartridge receiver compartment. In this view, portions of the first section 310 and the second section 330 are cut up along the longitudinal axis and fold out from their generally annular shape. The functional aspects of the first section 310 and the second section 330 are described in connection with Fig. 16B below. The dashed line at the bottom of Fig. 16A indicates the orientation of the longitudinal axis, L, and points in the receiving direction, which in this depiction is to the left. The cartridge receiver opening (not shown in this depiction) is located towards the right-hand side. Thus, the first section 310 is arranged closer to the cartridge receiver opening than the second section 330. The curved dashed line to the left, DR, indicates a direction of rotation about the longitudinal axis when the first section 310 and the second section 330 are arranged as annular members. The first section 310 comprises first guide members 312 and the second section 330 comprises second guide members 322.

The first guide members 312 extends over first guide member angles 314 and are spaced apart to form passages 316 at passage angles 318 between the first guide members 312.

The second guide members 322 have first faces 324 and second faces 326 (see e.g. Fig. 18). The first faces and the second faces are arranged alternately and separated by first riser portions 340. The first faces are, in the exemplary embodiment of Fig. 16A, divided into sections 344 and 346 separated by a second riser portion 342. Similarly, the second faces are, in the exemplary embodiment of Fig. 16A, divided into sections 344 and 346 separated by second riser portions 342. The first faces are inclined about a radial axis to the longitudinal axis and angularly arranged to extend at least partly over passage angles 318 and first guide member angles 314.

The first guide members 312 have a first guide face that faces the cartridge receiver opening, i.e. to the right hand side in this depiction, and forms a convex pointing shape with an apex directed towards the cartridge receiver opening.

The first guide members 312 also have a face that faces away from the cartridge receiver opening, i.e. to the left hand side in this depiction, and forms a concave shape with a slope portion 334, at slope angles 336, leading towards a retention portion 328 at or about a bottom portion of the concave shape at a retention angle 332. The slope portion 334 is inclined relative to the longitudinal axis and relative to the orthogonal thereto such that a turning of the cartridge is inflicted when a cartridge retention member 808 is pushed towards the slope portion 334 by a spring-loaded ejector 200. The turning brings the cartridge retention member 808 to the retention portion 328. To limit further turning of the cartridge assembly, a retention face 348 is provided substantially along the longitudinal axis.

Further, the first guide members 312 also have an eject face 338 with a slope that is inclined relative to the longitudinal axis and relative to the orthogonal thereto such that a turning of the cartridge is inflicted when a cartridge retention member 808 is pushed towards the slope portion 338 by a spring-loaded ejector 200. Fig. 16B shows an inbound journey and an outbound j oumey of a cartridge retention member. The cartridge retention member 808 is depicted as an object with a circular cross section, e.g. in the form of a guide pin, but it may have other forms. The cartridge retention member 808 is shown at different positions indexed by a numeral following the reference numeral; for instance 808-1 indicates the position of the cartridge retention member 808 at position 1.

Dashed lines indicate a so-called inbound journey of the cartridge retention member 808 and dashed-dotted lines indicate a so-called outbound journey. To avoid cluttering the figure, not all reference numerals are inserted, however the reference numerals used in Fig. 16A apply to Fig. 16B for like-shaped elements.

When a cartridge assembly 600 with a cartridge retention member 808 is inserted, starting out in the receiving direction, the cartridge retention member 808 follows an inbound journey. As examples the inbound journey may start at position 1 or position 2 or position 3 at different angles. At position 2 the cartridge retention member 808 may pass straight into the passage 316 to position 6, whereas at position 1 the first guide member 312 inflicts a turning of the cartridge retention member, starting at position 4, where the cartridge retention member lands on the first guide member and continuing by the inflicted turning and longitudinal movement such that it is guided into the passage 316. Also, at position 3 on the other side of the passage 316, a first guide member 312 inflicts a turning of the cartridge retention member, starting at position 5, where the cartridge retention member lands on the first guide member and continuing by the inflicted turning and longitudinal movement such that it is guided into the passage 316. Thus, substantially irrespective of the angle at which the cartridge retention member is received, it is guided into the passage 316.

Continuing its journey from a position, such as position 6, in the passage, in the receiving direction, the cartridge retention member lands on a second guide member 322 of the second section 330 and in particular on a first section 344 thereof. Due to the inclined face of the first section 344, a turning of the cartridge retention member 808 is inflicted, such that the cartridge retention member 808 turns from position 7 to position 8, where it meets one of the first riser portions 340 which prevents further rotation. At this position, a user inserting the cartridge assembly will feel that the cartridge assembly stops moving, and will therefore intuitively release the force used for insertion. At this position 8, a release of the force will make the spring- loaded ejector push the cartridge assembly and the cartridge retention member 808 outwards, opposite the receiving direction, to position 9. At position 9 the cartridge retention member 808 lands on the slope portion 334 of a first guide member 312 leading towards the retention portion 328 at or about a bottom portion of the concave shape at a retention angle 332. Due to the spring-loaded ejector working to push the cartridge retention member 808 outwards, the cartridge retention member 808 and hence the cartridge stays in a retention position, position 10.

It should be noted that as the cartridge retention member travels out over the second riser portion 342, it passes a point of no return and the inbound journey is generally not reversible. So, should the user ease the force used for insertion before position 8, but after the point of no return, the cartridge still ends up in the retention position.

While in the retention position the cartridge and the cartridge assembly may be prevented from moving in the receiving direction by a lock that introduces a stop. Thereby the cartridge stays in its retention position even if a force overcoming the spring-load on the cartridge or cartridge assembly is applied e.g. while the needle penetrates the skin. When the lock is released again to remove the stop, an outbound journey may start.

An outbound journey starts out from position 10 and is initiated when the spring-loaded force is overcome in the receiving direction, e.g. by a user pressing on a needle cover of the cartridge assembly. The cartridge retention member then lands on the second face 326 (see e.g. Fig. 18) and in particular a first section 344 thereof at position 808-11. Therefrom, it is brought to positon 12. At this position, a user ejecting the cartridge assembly will feel that the cartridge assembly stops moving, since the cartridge retention member 808 meets a first riser portion 340, and will therefore intuitively release the force used for ejecting the cartridge assembly. In releasing the force, the spring-loaded ejector will push the cartridge assembly and the cartridge retention member 808 outwards, opposite the receiving direction, to position 13, where the cartridge retention member 808 meets an eject face 338 that guides the cartridge retention member 808 towards a position 14 in the passage 316 and onwards to a position 15 where the cartridge assembly is fully ejected and may be handled as needed e.g. to remove the cartridge from the cartridge assembly and dispose the cartridge. It is noted that the direction of rotation, DR, is defined by the direction of the slopes of the first face and second face since they define in which direction turning is inflicted.

With respect to the length of an ejector rod 202 and the length of ejector cogs 226 thereof, to be explained in greater detail further below, it is noted that the cartridge retention member 808 should be allowed to travel between a first and a second extreme positions, LI and L2, spaced apart at a longitudinal distance L12. At the position L2, the cartridge retention member 808 is at its retention position, i.e. an advanced position towards the cartridge receiver opening. At the position LI, the cartridge retention member 808 is at a ‘deepest’ position, in the receiving direction, given by the second face 326 or section 346 thereof. Thus, the ejector should be able to travel the distance L12. In one or more examples, the position L3 may be located at a ‘deeper’ position than LI, in which case the ejector should allow the cartridge assembly retention member 808 to travel between L3 and L2.

Fig. 17A is a cross-sectional view of the first section of the cartridge receiver compartment. This cross-sectional view is orthogonal to the longitudinal axis and shows first guide member angles 314 and passage angles 318 that extend over the first guide members 312 and the passage 316, respectively. The outwardly pointing apex of the first guide members is shown at a centre angle of the first guide member angles 314. The first bore is indicated by reference numeral 320.

The arrow designated by capital ‘R’ indicates a radial axis orthogonal to the longitudinal axis. Fig. 17B is a cross-sectional view of the second section of the cartridge receiver compartment. This cross-sectional view is orthogonal to the longitudinal axis and shows the first sections 344 and the second sections 346 separated by first riser portions 340 and second riser portions 342. Each of one of the first sections 344 and each of one of the second sections 346 may extend over section angles. Section angles may by e.g. about 15 degrees.

Fig. 18 shows a detailed view of alternative first section and second section of the cartridge receiver compartment. The first guide members 312 of the first section 310 have a concave shape with a slope portion 334 that extends across the retention angle 332.

The second guide members 322 of the second section 330 comprises a first face 324 that extends at least partly over passage angles 318 and first guide member angles 314. A second face 326 extends between first faces, alternately. The first riser portions 340 separate the first faces 324 and the second faces 326.

Fig. 19 shows an outer plunger rod 404. The outer plunger rod 404 is comprised by the plunger 400 and has a plunger rod front end 410 with a dimension that allows it to extend inside the cartridge to move a stopper therein. The outer plunger rod 404 may be moved by an inner plunger rod (not shown) and the inner plunger rod and the outer plunger rod may be coupled by threading such that turning of the inner plunger rod inflicts a longitudinal movement of the outer plunger rod 404. The outer plunger rod 404 may be retained at an angle about the longitudinal axis by means of a longitudinally extending plunger rod groove 408 in the outer wall of the outer plunger rod.

The outer plunger rod 404 is configured with a plunger rod track 406. The track 406 may extend from the rim of the outer plunger rod 404 at the other end than the plunger rod front end 410. The plunger rod track 406 has at least a first track portion 428 that leads 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 turn the ejector lock 212 (see e.g. Fig. 21) from the first angular position to the second angular position. A second track portion 432 extends from a plunger rod distal rim 424 along the longitudinal axis, L, towards and to connect with the first track portion 428 which is inclined with respect to the longitudinal axis e.g. at an angle of about 45°, e.g. about 30-45°, with respect to the longitudinal axis, L. Thereby the second track portion 432 accommodates the ejector lock guide pin 216 when the outer plunger rod 404 is in a forward position, towards the cartridge receiver opening 301, to expel a medicament by moving the first stopper 708 in the first stopper direction as mentioned above. When the second track portion 432 accommodates the ejector lock guide pin 216, the ejector lock 212 is angularly positioned to prevent the ejector rod 202 from moving backwards. A third track portion 430 connects with the first track portion 428 and continues along the longitudinal axis towards the plunger rod front end 410. Thereby the third track portion 430 accommodates the ejector lock guide pin 216 when the outer plunger rod 404 is in a backward position, opposite the cartridge receiver opening 301, whereat the outer plunger rod 404 is moved backwards, away from the first stopper 708. Thus, the longitudinal position of the outer plunger rod 404 has the dual function of:

(a) engaging/disengaging with/from the first stopper 708 to expel medicament or being withdrawn from the first stopper 708 to forgo expel of medicament or removing the cartridge assembly 600; and (b) locking/unlocking the ejector rod 202 via rotation of the ejector lock 212. This is explained in greater detail below.

Thus, the outer plunger rod part 404 is configured with a plunger rod track 406 that engages with the ejector lock guide pin 216 and extends from a plunger rod distal rim 424 towards plunger rod front end 410 and thus the cartridge receiver opening 301.

Fig. 20 shows an ejector and an ejector lock. The ejector is generally designated 200 and comprises an ejector rod 202. The ejector lock is configured to engage with the ejector rod by turning to thereby introduce a stop that prevents the ejector rod 202 from moving in the receiving direction.

The ejector rod 202 has an ejector collar 224 arranged about an ejector support face 204, which supports the cartridge at a cartridge back face 716, which may have the form of a rim. The ejector rod 202 has an ejector rod bore 222 to form a longitudinal passage all through the ejector rod 202. The ejector rod bore 222 allows the outer plunger rod 404 to move along the longitudinal axis.

The ejector rod 202 is configured with one or more ejector cut-outs 228 to form one or more ejector cogs 226 between the ejector cut-outs 228. Complementary therewith, 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 e.g. in a bearing that allows the lock to turn or be turned, at least a fraction of a revolution, while preventing a longitudinal movement. The ejector lock 212 may have a flange or a recess that engages with a complementary recess or protrusion, respectively, to maintain the ejector lock 212 in a fixed longitudinal position while allowing it to be turned at least a fraction of a revolution. The ejector cut-outs 228 are also denoted ejector slots 228.

As shown, the ejector lock 212 has an angular position such that the ejector lock cogs 232 align with the ejector cut-outs 228. The ejector rod 202 may thus move in the receiving direction until an end portion 206 of the ejector cogs abuts a bottom portion 214, of the ejector lock cutouts 230, since the ejector lock cogs 232 and the ejector cogs 226 have substantially the same length. Thus, a bottom portion 214 of the ejector lock cut-outs 230 abuts the end portion 206 of the ejector cogs 226. The end portion 206 of the ejector rod 202 is also denoted an ejector rest portion 206.

When the ejector lock 212 is turned such that ejector cogs 226 align with ejector lock cogs 232, a stop is introduced and the ejector rod 202 is prevented from moving in the receiving direction. The stop is introduced because, in that 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 denoted an ejector lock support portion 234.

The ejector rod 202 may be prevented from turning, by means of an angle retaining guide 207 when it engages with an angle retaining slot, wherein the angle retaining slot is arranged on or in the cartridge receiver 300 or a member rigidly coupled to the cartridge receiver 300.

Fig. 21 shows an ejector lock. The ejector lock 212 is shown in greater detail here. It may be seen that the ejector lock 212 is configured with an ejector lock bore 240 accepting at least an end portion of the outer plunger rod 404. An ejector lock guide pin 216 sits in the ejector lock bore 240 and extends inwardly from a wall thereof.

Fig. 22 A through 22D shows various positions of the ejector relative to the ejector lock. In Fig. 22A the ejector rod 202 is shown in a longitudinal forward extreme position, relative to the ejector lock 212, where it is spring-biased to be when a cartridge assembly is not inserted through the cartridge receiver opening, e.g. as shown in Fig. 1. It may be seen that the ejector cogs 226 are aligned with ejector lock cut-outs 230, although displaced far from each other, such that the stop is disengaged and the ejector rod 202 is thus allowed to move to an extreme position in the receiving direction. Thereby the inbound journey and the outbound journey described in connection with Fig. 16B may take place during insertion or ejection of a cartridge assembly.

In Fig. 22B the ejector rod 202 is shown in a longitudinal backward extreme position e.g. when a cartridge assembly retention member 808 is in contact with the second section 330 of the retention mechanism. This position of the cartridge assembly retention member 808 corresponds to the position LI or L3 shown in Fig. 16B. In Fig. 22C the ejector rod 202 is shown in a longitudinal position where the cartridge assembly retention member 808 is in the retention position abutting the bottom of the concave shape of the first guide member 312 of the first section 310. This position of the cartridge assembly retention member 808 corresponds to the position L2 shown in Fig. 16B.

In Fig. 22D the ejector rod 202 is shown in the same longitudinal position as in Fig. 22C, but the ejector lock 212 is turned such that the stop is engaged. In this situation the ejector cogs 226 abuts the ejector lock cogs 232 end-to-end. Thus, an end portion 206 of the ejector cogs 226 abuts the end portion 234 of the ejector lock cogs 232.

Thus, at least both of the length of the ejector rod 202 and the length of the cogs and the cutouts may be dimensioned to allow the cartridge assembly retention member 808 to travel between position LI and L2 and L3 and L2.

Thus, the elongated ejector 200 is suspended to move along the longitudinal axis, L, and is enabled to move beyond a stop position 250 (see e.g. Fig. 22B) at a first angular position of ejector lock 212 and is prevented from moving beyond the stop position 250 by the ejector cogs 226 abutting the ejector lock cogs 232 at a second angular position of the ejector lock 212 (see e.g. Fig. 22D). At the first angular position of ejector lock, the elongated ejector is enabled to move beyond the stop position, such as further until an extreme position 251 since the ejector cogs enter the ejector lock cut-outs 230 between the ejector lock cogs 232. In one or more examples, the ejector rod is a substantially cylindrical rod coaxially arranged with the ejector lock, which comprises a substantially cylindrical portion.

Fig. 23 shows a cross section of an exemplary system 2 comprising an autoinjector 4, as described, for example, in relation to Fig. 1, and a cartridge assembly 600. The cartridge assembly 600 comprises a cartridge 700 with 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 comprises the ejector rod 202 as described above. The ejector rod 202 is suspended for longitudinal movement and is spring-loaded by an ejector spring 236 which spring-loads the ejector rod 202 in the direction opposite of the receiving direction. Thereby, during insertion of the cartridge assembly 600, the spring force exercised by the ejector spring 236 has to be overcome to insert the cartridge assembly 600 into a position where it is held in a retention position. The cartridge assembly 600 comprises a cartridge holder 800. The cartridge holder 800 is configured for retention of the cartridge 700 in the cartridge receiver 300 of the autoinjector 4. The cartridge holder 800 comprises a cartridge retention member 808. The cartridge retention member 808 engages with the cartridge receiver 300 for reception and retention of the cartridge 700 and the cartridge assembly 600 in the cartridge receiver 300.

The needle assembly 900 comprises a needle 902 and a needle hub 904. The needle assembly 900 is attached to the cartridge 700, e.g. by the needle hub 904 having a cartridge holder coupling portion 906, e.g. a threaded coupling portion, being in engagement with a needle assembly coupling portion 812 of the cartridge holder 800. The needle 902 extends through the cartridge outlet 714 of the cartridge 700. The cartridge outlet 714 may be blocked by a resilient sealing being penetrated by the needle 902, when the needle assembly 900 is attached to the cartridge 700.

The autoinjector 4 comprises a code sensor 24 configured to read the cartridge code feature 1000. When the cartridge assembly 600 is inserted, as shown, the cartridge code feature 1000 is lined up with the code sensor 24.

The autoinjector 4 comprises a plunger rod 400. The plunger rod 400 is configured to advance a first stopper of the cartridge 700. The plunger rod 400 comprises an outer plunger rod 404 with an inner thread, and an inner plunger rod 402 with an outer thread. The thread of the inner plunger rod 402 is in engagement with the thread of the outer plunger rod 404. The outer plunger rod 404 is prevented from rotating relative to the housing of the autoinjector. The movement of the plunger rod 400 comprises rotation of the inner plunger rod 402. The 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, when moved translationally in the first stopper direction 722, is configured to abut the first stopper of the cartridge 700, and to move the first stopper in the first stopper direction 722.

The autoinjector 4 comprises an ejection sensor 26, such as a plunger rod position sensor. The ejection sensor 26 is configured to detect the position of the plunger rod 400. In the illustrated example, the ejection sensor 26 comprises a tachometer configured to count/detect the revolutions of the motor 502. Thus, the position of the plunger rod 400 may be determined based on the count of revolutions of the motor 502. The ejection sensor 26 may, based on the detection of the position of the plunger rod 400, detect the expelling of medicament and/or air in the cartridge compartment. The position of the plunger rod 400 may be indicative of the position of the first stopper of the cartridge 700.

Figs. 24A-D show cross sections of a portion of an exemplary system comprising an autoinjector and a cartridge assembly. The autoinjector 4 comprises a cartridge receiver 300 configured for receiving and retaining a cartridge. The autoinjector 4 comprises 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 comprises a contact member protruding part 1112. The contact member protruding part 1112 is configured to move with the contact member 1102. The contact member 1102 may be biased, e.g. by a contact member spring (not shown), towards the extended contact member position.

The contact member comprises a needle cover engagement member 1114. The needle cover engagement member 1114 is configured to abut a needle cover abutment face, e.g. of a needle cover positioned on the cartridge 700 inserted into the cartridge receiver 300.

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

The first contact member position may be detected by the first contact member sensor 1130 being covered and the second contact member sensor 1132 being covered. The second contact member position may be detected by the first contact member sensor 1130 not being covered and the second contact member sensor 1132 being covered. The extended contact member position may be detected by the first contact member sensor 1130 not being covered and the second contact member sensor 1132 not being covered.

Fig. 24A schematically illustrates the autoinjector 4 with no received cartridge and/or cartridge assembly. The contact member 1102 is in the extended contact member position. A cartridge may be inserted into the cartridge receiver 300 in the cartridge receiving direction 304 through the contact member 1102 defining a cartridge receiver opening 301.

Fig. 24B schematically illustrates the autoinjector 4 with a cartridge assembly 600 received. The cartridge assembly comprises a cartridge 700, a cartridge holder 800 and a needle assembly 900. The needle assembly comprises a needle 902 and a needle cover 908. The needle cover 908 has a needle cover abutment face 910. The needle cover abutment face 910 engages the needle cover engagement member 1114 of the contact member 1102. The contact member 1102 is in the second contact member position, e.g. caused by the presence of the needle cover 908 and the abutment of the needle cover abutment face 910 on the needle cover engagement member 1114. The contact member protruding part 1112 covers the second contact member sensor 1132. The contact member protruding part 1112 does not cover the first contact member sensor 1130.

Fig. 24C schematically illustrates the autoinjector 4 with a cartridge assembly 600 received. Compared 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 be moved to the extended contact member position since the needle cover abutment face 910 does not about the needle cover engagement member 1114. The contact member protruding part 1112 has moved with the contact member 1102. The contact member protruding part 1112 does not cover the second contact member sensor 1132. The contact member protruding part 1112 does not cover the first contact member sensor 1130.

Fig. 24D schematically illustrates the autoinjector 4 with a cartridge assembly 600 received. The contact member 1102 is in the first contact member position. The first contact member position may be the retracted contact member position, or close to the retracted contact member position. The contact member 1102 may have been moved to the first contact member position by the contact member 1102 being pressed against an injection site, thereby inserting the needle 902 into the injection site. The contact member protruding part 1112 has moved with the contact member 1102. The contact member protruding part 1112 covers the first contact member sensor 1130. The contact member protruding part 1112 covers the second contact member sensor 1132.

Fig. 25A-B shows 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 stop is engaged. However, it may be seen that the ejector lock cogs 232 and the ejector cogs 226 have inclined end portions that abut one another. Therefore, a further turning of the ejector lock 212 by a few degrees or a fraction of a degree may move the ejector 200 in the direction opposite of the receiving direction to displace it up to and tightly against the cartridge or cartridge assembly. Thereby, it is possible to reduce or eliminate clearances that would otherwise allow the cartridge to move slightly e.g. by as little as a fraction of a millimetre, but that could cause an inaccurate dose being expelled. The amount of tightening force may be controlled e.g. by monitoring current drawn by a motor coupled to drive the ejector lock.

In Fig. 25B the ejector 200 and the ejector lock 212 are in a mutual position where the stop is disengaged. Bottom portions of the ejector cut-outs 228 and/or the ejector lock cut-outs 230 may be inclined by the same angle as the end portions of the cogs to match the cogs or, as shown, have a substantially flat bottom portion, substantially orthogonal to the longitudinal axis.

According to a first item there is provided an autoinjector 4 for administering injection of a medicament from a cartridge containing the medicament, the autoinjector 4 comprising: a housing 6; a cartridge receiver 300 with a cartridge receiver compartment 302 configured to receive a cartridge assembly 600, with at least one cartridge retention member 808, when inserted through a cartridge receiver opening 301 along a longitudinal axis L in a receiving direction; wherein the cartridge receiver 300 has a passage 316 through which the at least one cartridge retention member 808 travels at least in the receiving direction, and a member 312 preventing movement beyond a retention position in a direction opposite of the cartridge receiving direction 304; an elongated ejector 200 that is configured with: an ejector support face 204 for supporting the cartridge or cartridge assembly 600 and an ejector rod 202 configured with one or more ejector cut-outs 228 to form one or more ejector cogs 226 between the ejector cut-outs 228; and an ejector lock 212 supported for turning at least a fraction of a revolution and maintained in a longitudinal position relative to the housing 6; wherein the ejector lock 212 is configured with one or more ejector lock cogs 232 between one or more ejector lock cut-outs 230; wherein the elongated ejector 200 is suspended to move along the longitudinal axis L and is enabled to move beyond a stop position 250 at a first angular position of ejector lock 212 and is prevented from moving beyond the stop position 250 by the ejector cogs 226 abutting the ejector lock cogs 232 at a second angular position of the ejector lock 212.

At the first angular position of ejector lock, the elongated ejector is enabled to move beyond the stop position since the ejector cogs enter the ejector lock cut-outs. In one or more examples, the ejector rod is a substantially cylindrical rod coaxially arranged with the ejector lock, which comprises a substantially cylindrical portion.

The ejector lock may be coupled directly or indirectly to drive means comprising a motor to rotate to and from the first angular position and the second angular position. In one or more examples, the ejector lock is rotated by manual operation.

In one or more examples, the ejector rod 202 has an ejector rod bore 222, forming a longitudinal passage through the ejector rod 202, wherein a plunger rod 400 is arranged to move longitudinally. The plunger rod may comprise an outer plunger rod with an inner, longitudinal thread, and an inner plunger rod, such as a threaded rod, coupled such that rotation of the inner plunger rod causes the outer plunger rod to move longitudinally. The outer plunger rod may be prevented from rotating, while the inner plunger rod is supported to rotate and kept in a fixed longitudinal position. The inner plunger rod may be driven by a motor. In one or more examples, the ejector lock is operated to rotate to and from the first angular position and the second angular position by being coupled to the plunger rod, whereby a longitudinal displacement of the plunger rod rotates the ejector lock.

Fig. 26 shows a block diagram of an exemplary autoinjector 4. The autoinjector 4 comprises a plurality 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.

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 received signals from the sensors 22, 24, 26, 28, 30, 32, 34 and the user interface 1100.

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

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 the 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 a 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 towards an extended plunger rod position only if the cartridge outlet is pointing upwards. Alternatively or additionally, the processing unit 20 may provide user output via the user interface 1100 based on the orientation signal.

The autoinjector 4 comprises 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 a cartridge code feature. For example, the code sensor may be configured to read/detect a colour code.

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 the cartridge code feature of the cartridge assembly based on the code signal. The processing unit 20 may be configured to determine a pre-mix plunger rod position wherein the first stopper 708 and/or the second stopper 710 has/have not reached the bypass section 712 yet, a mix pl unger rod position wherein the first stopper 708 and/or the second stopper 710 is/are positioned in the bypass section 712 and the first medicament component is mixed with the second medicament component, a prime plunger rod position wherein the first stopper 708 and/or the second stopper 710 is/are in a position wherein air in the cartridge compartment is reduced, such as minimized and/or reduced to an amount appropriate for injection and/or an injection plunger rod position wherein the first stopper 708 and/or the second stopper 710 is/are in contact with a distal end of the cartridge 700 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 towards the extended plunger rod position based on the code signal. Alternatively, or additionally, the processing unit 20 may provide user output via the user interface 1100 based on the code signal.

The autoinjector 4 comprises a plunger rod position sensor 26. The plunger rod position sensor 26 may be configured to detect the ejection, such as the expelling, of medicament and/or air in the cartridge compartment. The plunger rod position sensor 26 is configured to detect the position of the plunger rod 400 of the autoinjector 4, and/or the position of the first stopper 708 and/or the second stopper 710, and provide a plunger rod position sensor signal indicative of the position of the plunger rod 400 and/or the first stopper 708 and/or the second stopper 710. The plunger rod position sensor 26 may comprise a tachometer coupled to the drive module 500. The tachometer may be configured to count the revolutions of the drive module, such as a motor of the drive module 500, such as the revolutions of the drive module 500 from a set point, such as a point wherein the position of the plunger rod 400 is known, such as the retracted plunger rod position of the plunger rod 400. The count of revolutions of the drive module 500 may be used to determine the actual position of the plunger rod 400, such as a pre-mix plunger, a mix plunger rod position, a prime plunger rod position; an injection plunger rod position, an extended plunger rod position and/or a retracted plunger rod position. The processing unit 20 is coupled to the plunger rod position sensor 26, such as the tachometer. The processing unit 20 is configured to receive the plunger rod position sensor signal. The processing unit 20 may determine the position of the plunger rod 400 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 movement of the plunger rod 400 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 additionally, the processing unit 20 may provide user output via the user interface 1100 based on the plunger rod position sensor signal.

The processing unit 20 may receive from the plunger rod position sensor, such as from the tachometer, a first plunger rod position sensor signal, such as a tachometer signal, indicative of the count of revolutions of the drive module 500. The processing unit 20 may determine the position of the plunger rod 400 and/or the first stopper 708 and/or the second stopper 710 based on the first plunger rod position sensor signal. The processing unit 20 may receive a second plunger rod position sensor signal, e.g. from the plunger rod position sensor 26, indicative of the plunger rod being in a known position, such as the retracted plunger rod position. The processing unit 20 may determine the position of the plunger rod 400 and/or the first stopper 708 and/or the second stopper 710 based on the first plunger rod position sensor signal and the second plunger rod position sensor signal.

In some embodiments, the tachometer includes a disk having one or more discernable portions and an optical sensor. The disk is coupled to the motor to be rotated thereby and the optical sensor is configured to detect the discernable portions as they are rotated within a sensing area of the optical sensor. The discernable portions can be windows, slits, transparent portions, translucent portions and so forth. The tachometer can further utilize a light source to illuminate the discernible portions so that the optical sensor can easily detect the discernable portions. The optical sensor is configured to send a signal to the processing unit 20 in response to the detection. The processing unit 20 can be configured to receive the signals from the optical sensor to determine a number of rotations of the motor to thereby extrapolate a distance that the plunger rod has travelled during advancement. The processing unit 20 is coupled to the cartridge sensor 28. The processing unit 20 is configured to receive the cartridge sensor signal. The processing unit 20 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 start movement of the plunger rod if a cartridge assembly is received, and/or only if a cartridge assembly is received. Alternatively or additionally, the processing unit 20 may provide user output via the user interface 1100 based on the cartridge sensor signal.

The code sensor 24 and the cartridge sensor 28 may be the same sensor, e.g. the code sensor 24 may be configured to detect reception of a cartridge assembly and subsequently read the cartridge code feature.

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

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 movement of the plunger rod only if a needle is present, and/or only if a needle cover is not present, such as removed. Detection of a needle cover may be indicative of a needle being present. The processing unit 20 may be configured to control the drive module 500 to start only if a needle cover has been detected, and afterwards removed. Alternatively or additionally, the processing unit 20 may provide user output via the user interface 1100 based on the needle signal.

The autoinjector 4 comprises a temperature sensor 32. The temperature sensor 32 is configured to detect a temperature, such as a temperature of the autoinjector and/or of the cartridge and/or of the medicament. The temperature sensor 32 is configured to provide a temperature signal indicative of the temperature. The processing unit 20 is coupled to the temperature sensor 32. The processing unit 20 is configured to receive the temperature signal. The processing unit 20 may be configured to determine the temperature, such as the temperature of the autoinjector and/or of the cartridge and/or of the medicament 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 the extended plunger rod position based on the temperature signal. Alternatively or additionally, the processing unit 20 may provide user output via the user interface 1100 based on the temperature signal.

The autoinjector 4 comprises a resistance sensor 34. The resistance sensor 34 is configured to detect resistance against movement of the plunger rod of the autoinjector 4. The resistance sensor 34 may be configured to detect resistance against movement of the plunger rod based on measurements of the drive module 500. For example, the resistance sensor 34 may be configured to detect the electrical current of a motor of the drive module 500. For example, the resistance sensor 34 may be configured to determine the electrical current through the drive module. Alternatively or additionally, the resistance sensor 34 may be configured to measure 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 resistance against movement of the plunger rod.

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 the resistance against movement of the plunger rod based on the resistance signal. The processing unit 20 may control the drive module 500 based on the resistance signal. For example, the processing unit 20 may be configured to control the drive module 500 to adjust movement of the plunger rod based on the resistance signal. For example, the processing unit 20 may be configured to control the drive module 500 to start, stop or continue movement of the plunger rod based on the resistance signal.

Movement of the plunger rod results in a plunger rod speed. The processing unit 20 may be configured to determine the plunger rod speed. The processing unit 20 may be configured to control the drive module 500 to adjust, such as readjust, the movement of the plunger rod, if the resistance signal is indicative of resistance against movement of the plunger rod above a high resistance threshold. The processing unit 20 may further be configured to control the drive module 500 to adjust, such as readjust, the movement of the plunger rod, wherein adjusting the movement of the plunger rod may comprise increasing or decreasing the plunger rod speed. Alternatively or additionally, the processing unit 20 may provide user output via the user interface 1100 based on the resistance signal. The high resistance threshold may be based on the plunger rod position. The processing unit 20 may be configured to determine the high resistance threshold, e.g. based on the plunger rod position. The processing unit 20 may be configured to determine the high resistance threshold based on the plunger rod position sensor signal, e.g. received from the plunger rod position sensor 26.

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

The autoinjector comprises a user interface 1100. The user interface 1100 may comprise one or more input members, e.g. a first input member, for receiving a user input. The user interface is configured to provide a user input signal indicative of the received user input.

The processing unit 20 is coupled to the user interface 1100. The processing unit 20 is configured to receive the 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 towards the extended plunger rod position based on the user input signal.

The autoinjector comprises a housing 6 accommodating the sensors 22, 24, 26, 28, 30, 32, 34, processing unit 20, user interface 1100 and drive module 500.

Fig. 27 schematically illustrates a system 2 comprising an exemplary autoinjector 4 with an inserted cartridge assembly comprising a cartridge 700 and a needle assembly 900. The autoinjector 4 as shown in Fig. 27 illustrates different ways of implementing sensing of plunger rod position and resistance against movement of the plunger rod.

The plunger rod comprises an outer plunger rod 404 with an inner thread, and an inner plunger rod 402 with an outer thread. The thread of the inner plunger rod 402 is in engagement with the thread of the outer plunger rod 404. The outer plunger rod 404 is prevented from rotating relative to the housing 6 of the autoinjector 4 and the inner plunger rod 402 is prevented from moving along the longitudinal axis. 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, when moved translationally in the first stopper direction 722, is configured to abut the first stopper 708 of the cartridge 700, and to move the first stopper in the first stopper direction 722. The plunger rod front end 410 is configured to abut the first stopper 708.

A motor 502 is coupled to drive the plunger rod via 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.

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.

Position of the plunger rod, such as the position of the outer plunger rod 404 and/or the 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 a position sensor 26a configured to sense position through a linear sensor coupled to the plunger rod, such as the outer plunger rod 404. Alternatively or additionally, as also illustrated, the plunger rod position may be determined by a position sensor 26b, such as a tachometer, configured to count/detect the revolutions of the motor 502. Alternatively or additionally, as also illustrated, the plunger rod position may be determined by a position sensor 26c, such as a tachometer, configured to count/detect the revolutions of the transmission 504 and/or a part of the transmission 504.

Resistance against movement of the plunger rod may be determined by one or more resistance sensors 34a, 34b, 34c, and 34d. For example, as illustrated the resistance against movement of the plunger rod may be determined by a resistance sensor, such as a force sensor, 34a positioned in front of the cartridge 700, when the plunger rod advances the first stopper 708, the cartridge will press against the sensor 34a. Alternatively or additionally, as also illustrated, the resistance against movement of the plunger rod may be determined by a resistance sensor, such as a force sensor, 34b positioned on the plunger rod front end 410. Alternatively or additionally, as also illustrated, the resistance against movement of the plunger rod may be determined by a resistance sensor, such as a force sensor, 34c positioned to sense the reaction force from the plunger rod on first stopper 708, e.g. the sensor 34c may be positioned behind the inner plunger rod 402. Alternatively or additionally, as also illustrated, the resistance against movement of the plunger rod may be determined by a resistance sensor 34d configured to measure/detect the amount of current and/or power drawn by the motor 502.

Fig. 27A shows an exemplary trace T of resistance Re against movement of the plunger rod dependent on the position P of the plunger rod. The plunger rod is moved from a retracted plunger rod position PR to an extended plunger rod position PE. In the beginning of the movement, the resistance against movement of the plunger rod is constant Exl, e.g. the plunger rod does not yet push a stopper. Afterwards, a plunger rod front end of the plunger rod abuts a first stopper of the cartridge, and the resistance against movement of the plunger rod increases to Ex2. The increased resistance Ex2 is caused by the resistance against movement of the first stopper, e.g. due to frictional force. The resistance may decrease slightly after the first stopper has started moving, as illustrated. When the plunger rod approaches the extended plunger rod position PE, the resistance may increase again to Ex3, e.g. due to the first stopper approaching an end of the cartridge.

The trace T is an example of resistance against plunger rod movement when the cartridge received is a new and/or unused and/or normal cartridge.

Determining a cartridge parameter may be based on the resistance and/or plunger rod position. Determining the cartridge parameter may be based on one or more thresholds, such as resistance thresholds, such as a low resistance threshold Rel and/or a high resistance threshold Re2, and/or plunger rod thresholds, such as a first plunger rod threshold Pl and/or a second plunger rod threshold P2. Other situations, such as situations wherein the cartridge received is apparently used and/or flawed, are exemplified by additional exemplary traces, T2, T3, and T4.

Trace T2 illustrates an exemplary situation wherein the resistance against movement increases above the low resistance threshold Rel before the plunger rod position has reached the first plunger rod threshold Pl. Such situation may for example indicate a flawed cartridge, or that something is blocking the plunger rod from moving. Following such situation, the plunger rod may be retracted to the retracted plunger rod position and/or an error message may be provided through a user interface.

Trace T3 illustrates an exemplary situation wherein the resistance against movement has not increased above the low resistance threshold Rel before the plunger rod position has reached the second plunger rod threshold P2. Such situation may for example indicate a cartridge wherein the first stopper is in an advanced position, e.g. a used cartridge. Following such situation, the plunger rod may be retracted to the retracted plunger rod position and/or an error message may be provided through a user interface.

Trace T4 illustrates an exemplary situation wherein the resistance against movement increases above the high resistance threshold Re2, e.g. after the plunger rod position has passed the first plunger rod threshold Pl. Such situation may for example indicate that the first stopper is blocked from moving, e.g. the cartridge may be flawed. Following such situation, the plunger rod may be retracted to the retracted plunger rod position and/or an error message may be provided through a user interface. The thresholds, such as the low resistance threshold Rel, the high resistance threshold Re2, the first plunger rod threshold Pl, and/or the second plunger rod threshold P2 may be individually determined for the cartridge received. For example, the processing unit of the auto injector may be configured to determine one or more of the thresholds, based on a cartridge code feature of the cartridge and/or cartridge assembly received.

Fig. 28A shows a resistance graph 1200 illustrating a high resistance threshold depending on stopper position/plunger rod position, such as the high resistance threshold and the plunger rod position as described in relation to previous figures, and/or the stopper position associated with the plunger rod position as described in relation to previous figures. A plunger rod 400 is configured to move the first stopper 708, thus the position of the first stopper 708 is determined by the position of the plunger rod 400. Therefore, the position of the first stopper 708 may be corresponding to a position of the plunger rod 400. The plunger rod position may designate a plunger rod front end, such as the part of the plunger rod making contact with the first stopper 708.

The resistance graph 1200 has a first axis 1200X indicating stopper position/plunger rod position and a second axis 1200Y indicating resistance. Solid and dashed lines illustrate different examples of how the high resistance threshold may vary depending on stopper position/ plunger rod position.

Figs. 28B-F illustrates a plunger rod 400 and a cartridge 700 with a first stopper 708 in situations of corresponding exemplary plunger rod positions explained in the following. Fig. 28B shows the plunger rod 400 being in a retracted plunger rod position 1228. Fig. 28C shows the plunger rod 400 being in a position between the retracted plunger rod position 1228 and a first plunger rod position 1220. The first stopper 708 has been moved accordingly. Fig. 28D shows the plunger rod 400 being in the first plunger rod position 1220. The first stopper 708 has been moved accordingly to a first stopper position. Fig. 28E shows the plunger rod 400 being in a second plunger rod position 1222. The first stopper 708 has been moved accordingly to a second stopper position. Fig. 28F shows the plunger rod 400 being in a position between the second plunger rod position 1222 and an extended plunger rod position 1229. The first stopper 708 has been moved accordingly. The plunger rod position illustrated in Fig. 28F may be the extended plunger rod position 1229.

As illustrated by the graph in Fig. 28A, the high resistance threshold may be a first high resistance threshold 1201 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 second high resistance threshold 1202 when the plunger rod position is between the second plunger rod position 1222 and the extended plunger rod position 1229.

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 between 50-80 N, such as 50 N, 55 N, 60 N, 65 N, 70 N, 75 N, or 80 N. For example, the second high resistance threshold 1202 may be between 70-100 N, such as between 75-85 N, or such as between 80-90 N, or such as 70 N, 75 N, 80 N, 85 N, or 90 N. In an example, the first high resistance threshold 1201 is 50 N, and the second high resistance threshold 1202 is 80 N.

As illustrated by the solid line, the high resistance threshold may be the second high resistance threshold 1202 when the plunger rod position is between the first plunger rod position 1220 and the extended plunger rod position 1229. Alternatively or additionally, the high resistance threshold may be a third high resistance threshold 1204 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 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.

The high resistance threshold may be increasing as a function of the plunger rod position. For example, as illustrated, the high resistance threshold may be increasing as the plunger rod is moved from the first plunger rod position 1220 to the second plunger rod position 1222. The solid and dashed lines illustrate exemplary ways the high resistance threshold may increase as the plunger rod is moved from the first plunger rod position 1220 to the second plunger rod position 1222. A first slope 1206 illustrates a step-change increase. A second slope 1208 illustrates a non-linear increase. A third slope 1210 illustrates a linear increase.

Fig. 29 shows a further exemplary trace T of resistance R against movement of the plunger rod dependent on the position of the plunger rod P. The plunger rod is moved from a retracted position 1228 to an extended position 1229. In the beginning of the movement, the resistance against movement of the plunger rod is constant Exl, e.g. the plunger rod does not yet push a stopper. Afterwards, a plunger rod front end of the plunger rod abuts a first stopper of the cartridge, and the resistance against movement of the plunger rod increases Ex2. The increased resistance is caused by the resistance against movement of the first stopper, e.g. due to frictional force. The resistance may decrease slightly after the first stopper has started moving, as illustrated. 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 an end of the cartridge.

The trace T is an example of resistance against plunger rod movement when the cartridge received is a new and/or unused and/or normal cartridge. Other situations, such as situations wherein the cartridge received is apparently flawed, are exemplified by additional exemplary trace, Tl.

Trace Tl illustrates an exemplary situation wherein the resistance against movement increases above a first high resistance threshold 1201, e.g. before the plunger rod position has passed the first plunger rod position 1220. Such situation may for example indicate that the first stopper is blocked from moving, e.g. the cartridge may be flawed. Following such situation, the plunger rod may be retracted to the retracted position and an error message may be provided through a user interface. At a certain plunger rod position, such as the first plunger rod position 1220, the high resistance threshold may be changed, e.g. in order to allow for a higher resistance before aborting the movement of the plunger rod. As illustrated, at the end of the forward movement of the plunger rod, the resistance R increases, e.g. at the second plunger rod position 1222, to a resistance above the first high resistance threshold 1201. However, since the high resistance threshold at the second plunger rod position is a second high resistance threshold 1202, the movement of the plunger rod is continued. Eventually, as illustrated, the resistance against movement may reach the second high resistance threshold 1202, e.g. between the second plunger rod position and the extended plunger rod position 1229, and the movement of the plunger rod may be stopped.

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

Fig. 30A shows a speed graph 1300 illustrating a plunger rod speed depending on stopper position/plunger rod position, such as the plunger rod speed and the plunger rod position as described in relation to previous figures, and/or the stopper position associated with the plunger rod position as described in relation to previous figures. A plunger rod 400 is configured to move the first stopper 708, thus the position of the first stopper is determined by the position of the plunger rod 400. Therefore, the position of the first stopper may be corresponding to a position of the plunger rod 400. The plunger rod position may designate a plunger rod front end, such as the part of the plunger rod making contact with the first stopper 708.

The speed graph 1300 has a first axis 1300X indicating stopper position/plunger rod position and a second axis 1300Y indicating speed, such as plunger rod speed. Solid and dashed lines illustrate different examples of how plunger rod speed may vary depending on stopper position/plunger rod position.

Figs. 30B-E illustrate a plunger rod 400 and a cartridge 700 with a first stopper 708 in situations of corresponding exemplary plunger rod positions explained in the following. Fig. 30B shows the plunger rod 400 being in a position between a retracted plunger rod position 1228 and a fourth plunger rod position 1224. Fig. 30C shows the plunger rod 400 being in the fourth plunger rod position 1224. The first stopper 708 has been moved accordingly to a fourth stopper position. Fig. 30D shows the plunger rod 400 being in a fifth plunger rod position 1226. The first stopper 708 has been moved accordingly to a fifth stopper position. Fig. 30E shows the plunger rod 400 being in a position between the fifth plunger rod position 1226 and an extended plunger rod position 1229. The first stopper 708 has been moved accordingly. The plunger rod position illustrated in Fig. 30E may be the extended plunger rod position 1229.

As illustrated by the graph in Fig. 30A, the plunger rod speed may be based on the plunger rod position. For example, the plunger rod speed may be a first plunger rod speed 1240 when the plunger rod position is between the retracted plunger rod position 1228 and the fourth plunger rod position 1224. The plunger rod speed may be a second plunger rod speed 1242 when the plunger rod position is between the fifth plunger rod position 1226 and the extended plunger rod position 1229. The second plunger rod speed 1242 may be lower than the first plunger rod speed 1240. Alternatively, the second plunger rod speed 1242 may be higher than the first plunger rod speed 1240 in order to effectively empty the cartridge.

A plunger rod position may coincide with another plunger rod position. For example, the fourth plunger rod position 1224 may be the first plunger rod position 1220 as mentioned in relation to Fig. 28. The fifth plunger rod position 1226 may be the second plunger rod position 1222 as mentioned in relation to Fig. 28.

The plunger rod speed may be decreasing as a function of the plunger rod position. For example, the plunger rod speed may be decreasing as the plunger rod is moved from the fourth plunger rod position 1224 to the fifth plunger rod position 1226. The solid line illustrates an exemplary linear decrease of the plunger rod speed as the plunger rod is moved from the fourth plunger rod position 1224 to the fifth plunger rod position 1226. Other examples may be non-linear decrease and step-change decrease as exemplified by the dashed lines.

Fig. 31 shows a flow chart of an exemplary method 3000 for operating and/or controlling an autoinjector, such as the autoinjector as described in relation to previous figures. The method 3000 comprises receiving 3001 a cartridge comprising a first stopper; moving 3002 a plunger rod towards an extended plunger rod position; determining 3004 plunger rod position; receiving a resistance signal 3006; and adjusting 3010 the movement of the plunger rod.

Receiving 3001 the cartridge may comprise receiving the cartridge in a cartridge receiver of the autoinjector.

Moving 3002 the plunger rod may comprise moving the plunger rod from a retracted plunger rod position. Moving 3002 the plunger rod may comprise moving the plunger rod in a first plunger rod direction.

Determining 3004 plunger rod position may be determined by a processing unit of the autoinjector. Determining 3004 plunger rod position may be based on detection from a sensor, such as a plunger rod position sensor, e.g. comprising a tachometer.

Receiving a resistance signal 3006 may comprise receiving the resistance signal from a resistance sensor. The resistance signal may be indicative of resistance against movement of the plunger rod, such as movement towards the extended plunger rod position, such as movement in the first plunger rod direction.

Adjusting 3010 the movement may comprise stopping the movement of the plunger rod. Alternatively or additionally, adjusting 3010 the movement may comprise preventing movement of the plunger rod towards the retracted plunger rod position for a dwell time, e.g. in order to prevent back flow of medicament. Alternatively or additionally, adjusting 3010 the movement may comprise maintaining the position of the plunger rod for a dwell time, e.g. in order to prevent back flow of medicament. Alternatively or additionally, adjusting 3010 the movement may comprise moving the plunger rod to the retracted plunger rod position. Alternatively or additionally, adjusting 3010 the movement may comprise decreasing the plunger rod speed.

Adjusting 3010 the movement of the plunger rod may be based on the resistance signal. For example, the movement of the plunger rod may be adjusted such that the resistance is held below a high resistance threshold. Adjusting 3010 the movement of the plunger rod may comprise adjusting the movement of the plunger rod if the resistance signal is indicative of resistance against movement of the plunger rod above a high resistance threshold. The high resistance threshold may be based on the plunger rod position, e.g. the high resistance threshold may be a first high resistance threshold when the plunger rod position is within a one range, and a second high resistance threshold when the plunger rod position is within a second range.

Steps of the exemplary method 3000, e.g. the steps of moving 3002 a plunger rod; determining 3004 plunger rod position; receiving a resistance signal 3006; and adjusting 3010 the movement of the plunger rod, may be controlled by a processing unit, such as the processing unit of the autoinjector.

Fig. 32 shows a flow chart of an exemplary method 3300 for moving the plunger rod of an autoinjector.

Initially, the plunger rod is moved 3302, e.g. with a first plunger rod speed, e.g. in a first plunger rod direction.

The resistance against the movement of the plunger rod is monitored, such as continuously monitored. By a first resistance criterion 3304, it is determined whether resistance against movement of the plunger rod exceeds a second high resistance threshold. If the resistance against movement of the plunger rod does not exceed the second high resistance threshold (first resistance criterion 3304 is answered no), by a second resistance criterion 3308, it is determined whether resistance against movement of the plunger rod exceeds a first high resistance threshold. If the resistance against movement of the plunger rod does not exceed the first high resistance threshold (second resistance criterion 3304 is answered no), the movement of the plunger rod is continued 3302. The first high resistance threshold may be lower than the second high resistance threshold.

The position of the plunger rod is monitored, such as continuously monitored. If the resistance against movement of the plunger rod does exceed the first high resistance threshold (second resistance criterion 3308 is answered yes), by a first position criterion 3310, it is determined whether the plunger rod has reached and/or passed 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 exemplary positions). If the plunger rod position has reached and/or passed the predetermined plunger rod position (first position criterion 3310 is answered yes), the movement of the plunger rod is continued 3302. Thus, the first high resistance threshold may be exceeded if the plunger rod has reached and/or passed the predetermined plunger rod position.

If the plunger rod position has not reached and/or passed the predetermined plunger rod position (first position criterion 3310 is answered no), the movement of the plunger rod is stopped 3312, and an error may be communicated to the user, e.g. via a user interface. Thus, an error may be assumed if the first high resistance threshold is exceeded before the plunger rod has reached and/or passed the predetermined plunger rod position.

If the resistance against movement of the plunger rod does exceed the second high resistance threshold (first resistance criterion 3304 is answered yes), the movement of the plunger rod is stopped 3306 and end of injection may be assumed. In stopping 3306 the movement of the plunger rod, the plunger rod may be locked in its position for a dwell time, e.g. to prevent a sudden drop in pressure in the cartridge, e.g. to prevent back flow of medicament.

Fig. 33 shows a flow chart of an exemplary method 3100 for moving the plunger rod of an autoinjector.

Initially, the plunger rod is moved 3102 with a first plunger rod speed, e.g. in a first plunger rod direction. The resistance against the movement of the plunger rod is monitored, such as continuously monitored. By a first resistance criterion 3104, it is determined whether resistance against movement of the plunger rod exceeds a first high resistance threshold. If the resistance against movement of the plunger rod does exceed the first high resistance threshold (first resistance criterion 3104 is answered yes), the movement of the plunger rod is stopped 3106 and an error may be communicated to the user, e.g. via a user interface.

The position of the plunger rod is monitored, such as continuously monitored. If the resistance against movement of the plunger rod does not exceed the first high resistance threshold (first resistance criterion 3104 is answered no), by a first position criterion 3108, it is determined whether the plunger rod has reached and/or passed 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 exemplary positions). If the plunger rod position has not reached and/or passed the predetermined plunger rod position (first position criterion 3108 is answered no), the movement of the plunger rod is continued 3102 with the first plunger rod speed.

If the plunger rod position has reached and/or passed the predetermined plunger rod position (first position criterion 3108 is answered yes), the plunger rod is moved 3110 with a second plunger rod speed, e.g. in the first plunger rod direction. The second plunger rod speed may be lower than the first plunger rod speed. By lowering the plunger rod speed, the amount of medicament needing to be forced though the needle per time, is reduced, thereby reducing the amount of force needed to advance the stopper.

By a second resistance criterion 3112, it is determined whether resistance against movement of the plunger rod exceeds a second high resistance threshold. If the resistance against movement of the plunger rod does not exceed the second high resistance threshold (second resistance criterion 3112 is answered no), the movement of the plunger rod is continued 3110 with the second plunger rod speed.

If the resistance against movement of the plunger rod does exceed the second high resistance threshold (second resistance criterion 3112 is answered yes), the movement of the plunger rod is stopped 3114 and end of injection may be assumed. In stopping 3114 the movement of the plunger rod, the plunger rod may be locked in its position for a dwell time, e.g. to prevent a sudden drop in pressure in the cartridge, e.g. to prevent back flow of medicament.

Fig. 34 shows a flow chart of an exemplary method 3200 for moving the plunger rod of an autoinjector.

Initially, the plunger rod is moved 3202, e.g. with a first plunger rod speed, e.g. in a first plunger rod direction.

The resistance against the movement of the plunger rod is monitored, such as continuously monitored. By a resistance criterion 3204, it is determined whether resistance against movement of the plunger rod exceeds a high resistance threshold, such as a first high resistance threshold and/or a second high resistance threshold. If the resistance against movement of the plunger rod does not exceed the high resistance threshold (resistance criterion 3204 is answered no), the speed of the movement of the plunger rod is increased 3206.

If the resistance against movement of the plunger rod does exceed the high resistance threshold (resistance criterion 3204 is answered yes), it is determined by a speed criteria 3208 whether the plunger rod speed is zero, i.e. the plunger rod is not moving.

If the plunger rod speed is not zero (speed criteria 3208 is answered no) the plunger rod speed is reduced 3210. If the plunger rod speed is zero (speed criteria 3208 is answered yes) the process is stopped 3212. In stopping 3212, the plunger rod may be locked in its position for a dwell time, e.g. to prevent a sudden drop in pressure in the cartridge, e.g. to prevent back flow of medicament.

The high resistance threshold of resistance criterion 3204 may be determined based on the position of the plunger rod. The plunger rod position may also be used to determine whether in stopping 3212 the process, the medicament has been expelled sufficiently and/or an error caused the process to stop too early. A corresponding message may be provided to the user, e.g. via the user interface.

By the method 3200, the speed is adjusted to be as high as possible without exceeding the resistance thresholds.

Fig. 35 shows a flow chart of an exemplary method 3400 for moving the plunger rod of an autoinjector.

Initially, the plunger rod is moved 3402, e.g. with a first plunger rod speed, e.g. in a first plunger rod direction. The resistance against the movement of the plunger rod is monitored, such as continuously monitored. By a first resistance criterion 3404, it is determined whether resistance against movement of the plunger rod exceeds a first high resistance threshold.

If the resistance against movement of the plunger rod does not exceed the first high resistance threshold (first resistance criterion 3404 is answered no), the speed of the movement of the plunger rod is increased 3406. The position of the plunger rod is monitored, such as continuously monitored. If the resistance against movement of the plunger rod does exceed the first high resistance threshold (first resistance criterion 3404 is answered yes), by a first position criterion 3408, it is determined whether the plunger rod has reached and/or passed 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 exemplary positions).

If the plunger rod position has not reached and/or passed the predetermined plunger rod position (first position criterion 3408 is answered no), the speed of the movement of the plunger rod is decreased 3410.

If the plunger rod position has reached and/or passed the predetermined plunger rod position (first position criterion 3408 is answered yes), the movement of the plunger rod may be continued. Thus, the first high resistance threshold may be exceeded if the plunger rod has reached and/or passed the predetermined plunger rod position. In this case, by a second resistance criterion 3412, it is determined whether resistance against movement of the plunger rod exceeds a second high resistance threshold.

If the resistance against movement of the plunger rod does not exceed the second high resistance threshold (second resistance criterion 3412 is answered no), the speed of the movement of the plunger rod is increased 3406.

If the resistance against movement of the plunger rod does exceed the second high resistance threshold (second resistance criterion 3412 is answered yes), it is determined by a speed criteria 3414 whether the plunger rod speed is zero, i.e. the plunger rod is not moving.

If the plunger rod speed is not zero (speed criteria 3414 is answered no) the plunger rod speed is reduced 3410. If the plunger rod speed is zero (speed criteria 3414 is answered yes) the process is stopped 3416. In stopping 3416, the plunger rod may be locked in its position for a dwell time, e.g. to prevent a sudden drop in pressure in the cartridge, e.g. to prevent back flow of medicament. In stopping 3416 end of injection may be assumed.

By the method 3400, the speed is adjusted to be as high as possible without exceeding the resistance thresholds. Fig. 35 A shows a flow chart of an exemplary method 2000 for operating an autoinjector, such as the autoinjector as described in relation to the previous figures. The method 2000 comprises receiving 2001 a cartridge assembly; reading 2002 a cartridge code feature of the cartridge assembly; moving 2004 a plunger rod of the auto injector to a prime plunger rod position, wherein the prime plunger rod position is based on the cartridge code feature; receiving a trigger event 2006; and moving 2008 the plunger rod to an injection plunger rod position following reception of the trigger event. The prime plunger rod position may be selected to position the first stopper and/or the second stopper in a position wherein air in the cartridge compartment is reduced, such as minimized and/ or reduced to an amount appropriate for inj ection. The inj ection plunger rod position may be selected to position the first stopper and/or the second stopper in a position wherein the first stopper and/or the second stopper are in contact with the distal end of the cartridge. The trigger event may be indicative of a user pressing the autoinjector against an injection site.

The method 2000 furthermore comprises an optional step of determining 2010 an orientation of the cartridge. This step may be performed simultaneously with reading 2002 the cartridge code feature. However, alternatively the determining 2010 of the orientation may be performed before or after the reading 2002 of the cartridge code feature. If determining 2010 the orientation, movement 2004 of the plunger rod to the prime plunger rod position may be based on the determined orientation. For example, the movement 2004 may require that the determined orientation is within a predefined range, e.g. of vertical.

The method 2000 furthermore comprises an optional step of detecting 2012 a temperature. This step may be performed simultaneously with reading 2002 the cartridge code feature and/or determining 2010 the orientation. However, alternatively the detecting 2012 of the temperature may be performed before or after the reading 2002 of the cartridge code feature and/or before or after the determining 2010 of the orientation. If detecting 2012 the temperature, the prime plunger rod position may further be based on the detected temperature. Movement 2008 of the plunger rod to the injection plunger rod position may be based on the detected temperature. For example, the speed of the movement 2008 may be based on the detected temperature.

Steps of the exemplary method 2000, especially the steps of reading 2002 a cartridge code feature of the cartridge assembly; optionally determining 2010 an orientation of the cartridge; optionally detecting 2012 a temperature; moving 2004 a plunger rod of the auto injector to a prime plunger rod position; receiving a trigger event 2006; and moving 2008 the plunger rod to a injection plunger rod position, may be controlled by a processing unit, such as the processing unit of the auto injector.

Fig. 35B shows a flow chart of an exemplary method 4000 for operating an auto injector. The method 4000 comprises: receiving 4002 a first input signal; detecting 4004 reception of the cartridge, e.g. in a cartridge receiver of the auto injector; moving 4006 a plunger rod to a mix plunger rod position; determining 4008 orientation of the cartridge; moving 4010 the plunger rod to a prime plunger rod position based on the orientation of the cartridge; receiving 4012 a trigger event; and moving 4014 the plunger rod to an injection plunger rod position.

Receiving 4002 the first input signal may comprise receiving a user input signal from a user interface, e.g. originating from a user pressing a button. The first input signal may originate from a user turning on the auto injector. Detecting 4004 reception of the cartridge may comprise detection of a user inserting the cartridge into the cartridge receiver through a cartridge receiver opening. Detecting 4004 reception of the cartridge may comprise detecting presence of a cartridge in the cartridge receiver. Receiving 4002 the first input signal and detecting 4004 reception of the cartridge may be interchanged.

Moving 4006 the plunger rod to the mix plunger rod position may follow detection 4004 of the cartridge being received in the cartridge receiver and reception 4002 of the first input signal. For example, moving 4006 the plunger rod to the mix plunger rod position may be performed only after a cartridge is detected 4004 and the first input signal is received 4002.

Determining 4008 orientation of the cartridge may comprise determining orientation by an orientation sensor, such as an accelerometer. Determining 4008 orientation of the cartridge may comprise determining orientation of the auto injector. Determining 4008 orientation of the cartridge may comprise determining whether an outlet of the cartridge is pointing upwards.

Alternatively or additionally, moving 4006 the plunger rod to the mix plunger rod position may be preceded by determining 4008 orientation of the cartridge. For example, moving 4006 the plunger rod to the mix plunger rod position may require that the outlet of the cartridge is pointing upwards, e.g. determined by determining 4008 orientation of the cartridge. Moving 4010 the plunger rod to a prime plunger rod position may follow completion of movement of the plunger rod to the mix plunger rod position. Moving 4010 the plunger rod to a prime plunger rod position may follow completion of movement of the plunger rod to the mix plunger rod position and an additional predetermined delay, e.g. to allow reconstitution of the medicament. Moving 4010 the plunger rod to a prime plunger rod position may require that the outlet of the cartridge is pointing upwards, e.g. determined by determining 4008 orientation of the cartridge. Moving 4010 the plunger rod to a prime plunger rod position may be temporary paused if the orientation of the cartridge is not within a predefined range of orientations.

Receiving 4012 the trigger event may comprise receiving a user input signal from a user interface, e.g. receiving the trigger event from a trigger member, e.g. originating from a user pressing a button. The trigger event may originate from a user indicating a start of injection. The trigger event may originate from a user pressing a front part of the auto injector against an intended injection site. The trigger event may comprise a contact member signal being indicative of a contact member of the auto injector being in a first contact member position.

Moving 4014 the plunger rod to an injection plunger rod position may result in ejection of the medicament through the cartridge outlet, such as through a needle. Moving 4014 the plunger rod may follow reception of the trigger event 4012, such as after completion of movement 4010 of the plunger rod to the prime plunger rod position.

Fig.35C shows a flow chart of an exemplary method 4000'. The method 4000' comprises the same steps of the method 4000 as explained in relation to Fig. 35B. However, the method 4000' is an example of a method comprising additional steps of reading 4016 a cartridge code feature; detecting 4018 a temperature; detecting 4024 needle cover removal; moving 4020 the plunger rod to a pre-mix plunger rod position; and detecting 4022 resistance against movement of the plunger rod.

The method 4000' comprises reading 4016 a cartridge code feature. The cartridge code feature may be indicative of one or more cartridge specifications. The subsequent steps of the method 4000' may comprise adaptations based on the cartridge specifications. For example, subsequent steps of the method 4000' may be tailored to the specific cartridge received and identified. Optionally, detecting 4018 a temperature may comprise detecting a temperature of the cartridge and/or a temperature indicative of the temperature of the cartridge. The subsequent steps of the method 4000' may optionally comprise adaptations based on the temperature.

Reading 4016 the cartridge code feature and detecting 4018 the temperature may be performed simultaneously, as illustrated. However, alternatively, it may be performed sequentially.

Detecting 4024 needle cover removal may be a prerequisite of initiating movement of the plunger rod. For example, needle cover removal may be indicative of intended use of the cartridge received. Removing the needle cover at this stage is optional, as the needle cover could be removed at different points in time, for example at the beginning or even after an airshot (see below) has been carried out.

Moving 4020 the plunger rod to a pre-mix plunger rod position may comprise initial movement of a first stopper of the cartridge, e.g. movement of the first stopper without commencing mixing of a two-component medicament.

Detecting 4022 resistance against movement of the plunger rod may be performed simultaneously with moving 4020 the plunger rod to the pre-mix plunger rod position, as illustrated.

Detecting 4022 resistance against movement of the plunger rod may be indicative of cartridge parameters of the cartridge received, such as whether the cartridge is new or used or flawed.

Moving 4006 the plunger rod to the mix plunger rod position may follow reading 4016 the cartridge code feature, detecting 4018 the temperature, detecting 4024 needle cover removal, moving 4020 the plunger rod to the pre-mix plunger rod position, and detecting 4022 resistance against movement of the plunger rod.

Moving 4006 the plunger rod to the mix plunger rod position may be based on one or more of the cartridge code feature, the temperature, needle cover removal and/or resistance against movement of the plunger rod. Moving 4010 the plunger rod to the prime plunger rod position may be based on one or more of the cartridge code feature, the temperature, needle cover removal and/or resistance against movement of the plunger rod.

Moving 4014 the plunger rod to the injection plunger rod position may be based on one or more of the cartridge code feature, the temperature, needle cover removal and/or resistance against movement of the plunger rod. The method 4000 and/or the method 4000' may include a first step of receiving the cartridge.

Fig.35D shows a flow chart of an exemplary implementation of the exemplary method 4000'. The flow chart shown may be an exemplary implementation in a processing unit of an autoinjector.

The procedure is initiated by receiving 5002 a first input signal. A user may initiate the procedure by turning on the device thereby providing, e.g. via the user interface, the first input signal.

Following receipt 5002 of the first input signal, it is considered 5004 whether a cartridge is detected to be received in the cartridge receiver of the auto injector. If not, an output may be provided 5040 through the user interface.

If a cartridge is detected 5004, or when a cartridge is a detected 5004, after receiving 5002 the first input signal, a cartridge code feature is read 5006.

Following reading 5006 of the cartridge code feature, temperature is detected 5008, such as the temperature of the cartridge received. Following detection 5008 of the temperature and reading 5006 of the cartridge code feature, it is detected 5010 whether a needle cover is removed, such as not present. If a needle cover is not removed, a user output may be provided, e.g. through the user interface, prompting 5042 the user to remove the needle cover. If the needle cover is removed 5010, or when the needle cover is removed 5010, the plunger rod is moved 5012 to a pre-mix plunger rod position. During this movement resistance against movement of the plunger rod is measured. The resistance against movement is analysed 5014 to determine whether it is acceptable or not. This analysis may be based on the cartridge code feature read 5006 and/or the temperature detected 5008.

If the resistance 5014 is not acceptable, a user output may be provided 5044, e.g. via the user interface. The output may indicate that the cartridge is to be replaced. Subsequently, the plunger rod is moved 5038 to a retracted plunger rod position, such as the starting position of the plunger rod.

If the resistance 5014 is acceptable the plunger rod is moved 5016 to a mix plunger rod position, e.g. to combine a first medicament component and a second medicament component.

After the plunger rod is moved 5016 to the mix plunger rod position a delay 5018 is inserted to provide the combined medicament components to reconstitute the medicament for injection. The delay 5018 may be between 1 and 12 min, such as between 3 and 10 min. During a delay a user output may be provided via the user interface, the user output may be indicative for the reconstitution. After the medicament is reconstituted and/or the delay suitable for reconstitution of the medicament has lapsed 5018, the orientation of the cartridge is assessed 5020. The cartridge orientation may be assessed from measuring the orientation of the auto injector. The orientation should be acceptable for performing an air-shot, e.g. the cartridge outlet of the cartridge should be pointing upwards, such that air may be expelled and/or reduced. If the orientation 5020 is not acceptable, e.g. the cartridge outlet is not pointing upwards and/or the cartridge is not within 45 deg. of vertical, the user is prompted 5046, e.g. via the user interface, to orientate the auto injector correctly, e.g. point the cartridge outlet upwards.

If the orientation is acceptable 5020, or when the orientation is acceptable, the plunger rod is moved 5022 to a prime plunger rod position, e.g. to expel air from the cartridge compartment. The prime plunger rod position may be determined based on the cartridge code feature read 5006 and/or the temperature detected 5008.

After moving 5022 the plunger rod to the prime plunger rod position, the user is prompted, e.g. via the user interface, to perform a visual check 5024 of the medicament. For example, the user may be provided the possibility to abort the procedure if sediments of medicament are visible. To accept the visual quality of the medicament, the user may provide a second input signal, e.g. by pressing a buton of the user interface. The buton used for providing the second input signal may be the same buton as for providing the first input signal. The prompting of the user to perform the visual check 5024 may cease and/or the procedure may be aborted if a time out, e.g. 4-5 hours, after the medicament is reconstituted and/or after the delay suitable for reconstitution of the medicament has lapsed 5018.

After receiving the second input signal 5026, the user may be prompted 5028, e.g. via the user interface, to initiate injection of the medicament. The user may inject the medicament by providing a trigger event, e.g. by pressing a contact member of the auto injector towards an intended injection site, e.g. thereby inserting the needle into the tissue of the intended injection site. While not receiving 5030 the trigger event, the user is continuously prompted to initiate injection 5028. After receiving 5030 the trigger event, the plunger rod is moved 5032 to the injection plunger rod position, e.g. to eject the medicament of the cartridge, such as to inject the medicament into the tissue of the intended injection site.

After the plunger rod is moved 5032 to the injection plunger rod position, it may be preferred to delay retraction of the needle to allow the medicament to be distributed into the tissue. Thus, the auto injector prompts 5034 the user, e.g. via the user interface, to wait for a set dwell time, e.g. between 1 and 15 sec.

Following reception 5030 of the trigger event and/or movement 5032 of the plunger rod to the injection plunger rod position and/or prompting 5034 the user to wait for the set dwell time, skin contact is assessed 5036, e.g. whether the contact member is still pressed against the intended injection site. If, after the dwell time, the skin contact is still present, the user is prompted 5048 that injection is done and/or that the user may remove the auto injector from the injection site.

If and/or when the skin contact is lost 5036, the plunger rod is moved 5038 to the retracted plunger rod position. After movement 5038 of the plunger rod to the retracted plunger rod position, the cartridge may be removed and discarded.

In an alternative implementation of the exemplary method 4000', detecting 5010 whether a needle cover is removed or not present, is performed after moving 5022 the plunger rod to the prime plunger rod position. If a needle cover is not removed, a user output may be provided, e.g. through the user interface, prompting 5042 the user to remove the needle cover.

Fig.35E shows a flow chart of an exemplary method 6000 for operating an autoinjector. The method 6000 comprises: moving 6004 the plunger rod from a pre-mix plunger rod position to a mix plunger rod position with a mix plunger rod speed; moving 6006 the plunger rod from the mix plunger rod position to a prime plunger rod position after an onset signal has been given. The method 6000 may further comprise receiving 6008 a trigger event; and moving 6010 the plunger rod to an injection plunger rod position.

The autoinjector may comprise a cartridge receiver configured to receive a cartridge comprising a first stopper and a cartridge compartment containing the medicament. The cartridge compartment may have a first cartridge sub-compartment containing a first medicament component of the medicament and a second cartridge sub-compartment containing a second medicament component of the medicament. The autoinjector may further comprise a plunger rod configured to move the first stopper. The mix plunger rod position may be selected to position the first stopper in a position wherein the first medicament component is mixed with the second medicament component. The prime plunger rod position may be selected to position the first stopper in a position wherein air in the cartridge compartment is reduced to an amount appropriate for injection.

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

Alternatively or additionally, moving 6004 the plunger rod to the mix plunger rod position may be preceded by determining orientation of the cartridge. For example, moving 6004 the plunger rod to the mix plunger rod position may require that the outlet of the cartridge is pointing upwards, e.g. determined by determining orientation of the cartridge. Moving 6004 the plunger rod to the mix plunger rod position may be temporary paused if the orientation of the cartridge is not within a predefined range of orientations. Moving 6006 the plunger rod to the prime plunger rod position may require that the outlet of the cartridge is pointing upwards, e.g. determined by determining orientation of the cartridge. Moving 6006 the plunger rod to the prime plunger rod position may be temporary paused if the orientation of the cartridge is not within a predefined range of orientations. Moving 6006 the plunger rod from the mix plunger rod position to the prime plunger rod position may require that the onset signal has been given. The onset signal may be given after a number of completed inversions of the auto injector has been performed and when the second cartridge subcompartment is pointing upwards compared to the first cartridge subcompartment.

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

Moving 6010 the plunger rod to the injection plunger rod position may result in ejection of the medicament through the cartridge outlet, such as through a needle. Moving 6010 the plunger rod may follow reception of the trigger event 6008, e.g. after completion of movement 6006 of the plunger rod to the prime plunger rod position.

The method 6000 may include a first step of receiving the cartridge.

Fig. 35F shows a flow chart of an exemplary method 6000". The method 6000" comprises the same steps of the method 6000 as explained in relation to the previous figure. However the method 6000" is an example of a method comprising additional steps of receiving 6014 a first input signal; detecting 6016 reception of the cartridge, e.g. in the cartridge receiver of the auto injector; determining 6018 orientation of the cartridge; and reading 6020 a cartridge code feature; detecting 6022 needle cover removal ; moving 6024 the plunger rod to the pre- mix plunger rod position; detecting 6026 resistance against movement of the plunger rod; and determining 6019 onset signal. Receiving 6014 the first input signal may comprise receiving a user input signal from a user interface, e.g. originating from a user pressing a button. The first input signal may originate from a user turning on the auto injector. The step of detection 6022 needle cover removal could also be carried out at other times, such as at the beginning or even after an air shot.

Detecting 6016 reception of the cartridge may comprise detection of a user inserting the cartridge into the cartridge receiver through a cartridge receiver opening. Detecting 6016 reception of the cartridge may comprise detecting presence of a cartridge in the cartridge receiver.

Receiving 6014 the first input signal and detecting 6016 reception of the cartridge may be interchanged.

Determining 6018 orientation of the cartridge may comprise determining orientation by an orientation sensor, such as an accelerometer. Determining 6018 orientation of the cartridge may comprise determining orientation of the auto injector. Determining 6018 orientation of the cartridge may comprise determining whether an outlet of the cartridge is pointing upwards.

The method 6000" comprises reading 6020 a cartridge code feature. The cartridge code feature may be indicative of one or more cartridge specifications. The subsequent steps of the method 6000" may comprise adaptations based on the cartridge specifications. For example, subsequent steps of the method 6000" may be tailored to the specific cartridge received and identified.

Detecting 6022 needle cover removal may be a prerequisite of initiating movement of the plunger rod. For example, needle cover removal may be indicative of intended use of the cartridge received. Moving 6024 the plunger rod to the pre-mix plunger rod position may comprise initial movement of a first stopper of the cartridge, e.g. movement of the first stopper without commencing mixing of a two-component medicament. Moving 6024 the plunger rod to the pre-mix plunger rod position may follow detection 6016 of the cartridge being received in the cartridge receiver and reception 6014 of the first input signal. For example, moving 6024 the plunger rod to the pre-mix plunger rod position may be performed only after a cartridge is detected 6016 and the first input signal is received 6014.

Moving 6024 the plunger rod to the pre-mix plunger rod position may be performed concurrently with the steps of reading 6020 the cartridge code feature. Detecting 6026 resistance against movement of the plunger rod may be performed simultaneously with moving 6024 the plunger rod to the pre-mix plunger rod position, as illustrated. Detecting 6026 resistance against movement of the plunger rod may be indicative of cartridge parameters of the cartridge received, such as whether the cartridge is new or used or flawed. Moving 6004 the plunger rod to the mix plunger rod position may follow reading 6020 the cartridge code feature, detecting 6022 needle cover removal, moving 6024 the plunger rod to the pre-mix plunger rod position, detecting 6026 resistance against movement of the plunger rod, and determining 6018 orientation of the cartridge. Moving 6004 the plunger rod to the mix plunger rod position may be based on one or more of the cartridge code feature, needle cover removal, resistance against movement of the plunger rod and/or orientation of the cartridge.

Moving 6006 the plunger rod to the prime plunger rod position may require that a reconstitution time has elapsed since completion of movement of the plunger rod to the mix plunger rod position. The method 6000" comprises a step of determining 6019 the reconstitution time. Determining 6019 the reconstitution time may be based on one or more of the cartridge code feature, needle cover removal, resistance against movement of the plunger rod and/or orientation of the cartridge. Determining 6019 the reconstitution time may comprise determining a first movement parameter, such as an amount of movement of the auto injector, such as shaking the auto injector and/or a number of inversions of the auto injector. The first movement parameter may be determined based on an orientation signal, such as from an orientation sensor, such as an accelerometer. Determining 6019 the reconstitution time may comprise receiving an orientation signal.

Determining 6019 the reconstitution time may be determined based on a combination of the first movement parameter and/or the cartridge code feature.

Moving 6006 the plunger rod to the prime plunger rod position may be based on one or more of the cartridge code features, needle cover removal, resistance against movement of the plunger rod and/or orientation of the cartridge. Moving 6010 the plunger rod to the injection plunger rod position may be based on one or more of the cartridge code feature, needle cover removal and/or resistance against movement of the plunger rod. In an alternative implementation of the exemplary method 6000', detecting 6022 whether a needle cover is removed, such as not present is performed after moving 6006 the plunger rod to the prime plunger rod position.

The method 6000" may include a first step of receiving the cartridge.

Fig. 36 shows a block diagram of an exemplary autoinjector 4. The autoinjector 4 comprises a re-chargeable battery 10, a battery calculation module 40 configured to calculate a residual electrical battery voltage level of the re-chargeable battery 10, thereby proving a measure of the remaining residual electrical battery voltage level, a drive module 500, a temperature sensor 32 configured to measure a temperature of the auto injector 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.

By temperature of the autoinjector is meant a temperature measured by the autoinjector temperature sensor anywhere inside the autoinjector. In one or more examples, the temperature of the autoinjector is one or more of:

• an ambient temperature; and/or

• a temperature near the medicament in the cartridge; and/or

• a temperature indicative of a temperature of the medicament in the cartridge; and/or

• a temperature of the auto injector near the battery; and/or

• a temperature indicative of the temperature of the battery; and/or

• any combination of the above.

The processing unit 20 receives a value of the measured temperature from the temperature sensor 32. The processing unit 20 also receives a value of the calculated residual electrical battery voltage level of the re-chargeable battery 10 from the battery calculation module 40. Based on at least these two values, the processing unit 20 obtains a predefined threshold value indicative of the minimum electrical battery voltage level needed for performing an autoinjector process at the temperature measured by the temperature sensor.

The autoinjector process may be one or more of: - a first plunger rod movement process, where the plunger rod 400 is moved from the retracted plunger rod position to a locking plunger rod position, where a cartridge 700 is locked inside the autoinjector 4;

- a second plunger rod movement process, where the plunger rod 400 is moved from the locking plunger rod position to a first stopper plunger rod position bringing the plunger rod 400 in contact with the first stopper 708;

- a third plunger rod movement process, where the plunger rod 400 moves the first stopper 708 to cause a second stopper 710 inside the cartridge to move to a bypass section 712 for establishing 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 movement process, where the plunger rod 400 moves the first stopper 708 to contact the second stopper 710 for mixing of medicament components the first cartridge sub-compartment 704 and the second cartridge sub-compartment 706;

- a fifth plunger rod movement process, where the plunger rod 400 is moved to the extended plunger rod position, where at the extended plunger rod position, medicament has been expelled from the cartridge, such as fully expelled from the cartridge;

- a re-setting of the autoinjector 4 to an original position where the cartridge 700 may be removed from the autoinjector;

- a full medicament delivery process comprising a combination of the above processes.

The autoinjector process may be a medicament reconstitution process and/or a medicament expelling process, or similar. For example, the autoinjector process may a full injection cycle including the medicament reconstitution process, the medicament expelling process, and a resetting of the autoinjector to an original position where the cartridge may be removed from the autoinjector thereby allowing for insertion of a new cartridge in the autoinjector.

The predefined threshold value may be defined to be the minimum voltage level needed to perform a full injector cycle. Alternatively, the predefined threshold value may be obtained indirectly by calculating the estimated count of remaining injection cycles without a recharging of the battery.

The processing unit 20 further compares the calculated residual electrical battery voltage level with the obtained predefined threshold value. If the comparison results in the processing unit 20 finding the residual electrical battery voltage level to be larger than the predefined threshold value needed to perform the autoinjector process at the measured temperature, the autoinjector will initiate the autoinjector process.

Alternately, if the comparison results in the processing unit 20 finding the residual electrical battery voltage level to be smaller than the predefined threshold value needed to perform the autoinjector process 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.

Fig. 37 shows a flow chart of a method 7000 for determining whether battery voltage level is sufficiently high for the processing unit 20 to allow the autoinjector process to proceed. The method alternatively detects whether the battery need to be recharged first. The method 7000 may be run when the autoinjector is turned on.

The method 7000 comprises measuring 7002 the temperature of the autoinjector 4, e.g. the temperature close to the re-chargeable battery, by means of the temperature sensor 32. A measure 7004 of the battery voltage level is also measured in the same sequence by means of the battery calculation module 40.

The method 7000 further comprises determining 7010 if 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 (yes option in 7010), the processing unit determines 7012 if there is sufficient electrical battery voltage level to perform an autoinjector process, e.g. afull injection cycle. The determination is performed by comparing the measured battery voltage level indicative of the residual battery voltage level, with the predefined threshold value needed to perform the autoinjector process at the measured temperature.

If there is sufficient electrical battery voltage level to perform the autoinjector process (yes option in 7012), the processing unit 20 communicates to the user 7014 that the autoinjector is ready for use, so that the autoinjector process may proceed.

If there is not sufficient electrical battery voltage level to perform the autoinjector process (no option in 7012), the processing unit communicates to the user 7016 that the battery needs to be recharged before the autoinjector is ready for use, such as before the user may perform the autoinjector process. Before the autoinjector process may be initiated, the method 7000 is repeated.

If the temperature measured in 7002 is determined to be below the predetermined threshold temperature (no option in 7010), the processing unit determines 7022 if the electrical battery voltage level is sufficient to perform not one, but two autoinjector processes, e.g. two full injection cycles.

If the electrical battery voltage level is sufficient to perform two autoinjector processes (yes option in 7022), the processing unit communicates 7014 to the user that the autoinjector is ready for use, such as the autoinjector process may proceed.

If the electrical battery voltage level is not sufficient to perform two autoinjector processes (no option in 7022), the processing unit communicates 7016 to the user to re-charge the battery before the autoinjector is ready for use,. Before the autoinjector process may be initiated, the method 7000 is repeated. The temperature is normally not measured again till the devices makes a new self-test validation, such as when it runs the method 7000 again.

For temperatures below the predetermined threshold temperature, e.g. 15 or 12 degrees Celsius, the battery voltage threshold may be 3850 mV voltage, meaning that measuring to confirm this voltage will ensure operational battery capacity to a minimum of two injection cycles. A voltage below this threshold would be interpreted as capacity less than two injection cycles.

In an alternative method 9000’ as illustrated in Fig. 38, the autoinjector may be configured to require the temperature to be above a first temperature threshold value before the autoinjector will be allowed to start the autoinjector process. If the temperature measured in 9002 is found to be below the first threshold temperature, such as 15 degrees Celsius or such as 12 degrees Celsius in 9010’ (no option in 9010’), the autoinjector will prevent an initiation of the autoinjector process. Before the autoinjector process may be initiated, the method 9000 is repeated until the temperature is measured to be above the first temperature threshold value. If the temperature measured in 9002 is found to be above the first threshold temperature, in 9010’ (yes option in 9010’), the process proceeds as described in Fig. 37. The temperature sensor may sit within a Nordic Semiconductor nRF8001 chip as part of Bluetooth chip. The voltages responsible for determining remaining battery charge level may be measured using the ADC input on the micro-processor, e.g. a Atmel ATXmega256A3U-MH processor.

The medicament may be or may comprise human growth hormone. However, this is only an exemplary use of the autoinjector. The medicament may be a depot version or prodrug, such as a long-acting version, of human growth hormone. The medicament may be lonapegsomatropin. The second medicament component of a dual-chamber cartridge may be a dry composition of or comprising human growth hormone.

The viscosity of the human growth hormone lonapegsomatropin reconstituted medicament product solution is increased compared to e.g. water. The viscosity of the reconstituted medicament product solution impacts the performance of the autoinjector. Hydraulic pressure loss e.g. impacts the injection time at constant drug product solution pressure and the hydraulic pressure loss depends on the viscosity. Hence viscosity influences the injection time.

The viscosity is also likely to influence mixing dynamics during the reconstitution process, and hence impacts the time needed for the reconstitution performed with the autoinjector. Three viscosities at different strength of the human growth hormone (hGH) lonapegsomatropin are summarized in Table 1.

Table 1. Lonapegsomatropin medicament viscosities given as mg hGH.

The viscosity of lonapegsomatropin is shown in table 1 at 25 degrees Celsius. However, as seen in Fig. 39 showing the temperature dependence of the viscosity of lonapegsomatropin in a medicament solution concentration of 22.0 mg/mL hGH, the viscosity increases significantly when the temperature is lowered. Thus, the viscosity of the reconstituted lonapegsomatropin medicament solution is strongly temperature dependent. Hence the requirement to the battery voltage level needed for performing an autoinjector process such as e.g. a full injection cycle, depends strongly on the temperature of the autoinjector and the medicament.

Table 2 shows specifics on the autoinjector for delivery of lonapegsomatropin at different lonapegsomatropin medicament solution concentrations.

Table 2. Autoinjector and lonapegsomatropin medicament specificities.

The autoinjector attempts a constant stopper velocity of 90 mm/min during the whole of an injection cycle. When doing so, the autoinjector monitors the plunger rod force (motor current). If it exceeds 55 N (and 80 N in last stage), the autoinjector reduces the plunger rod velocity until the plunger rod force is within an acceptable level. Whether the condition is met depends on the actual stopper friction which may vary from approximately 6 N to 22 N. The plunger rod force further depends on the actual inner needle diameter of the needle, since the resistance scales with the inner diameter to fourth power.

Fig. 40A and Fig. 40B show a measure of the injection force 1250 needed as a function of the plunger rod position when the cartridge contains, respectively, a 13.3 mg hGH/mL and a 5.2 mg hGH/mL lonapegsomatropin medicament solution. The first high resistance threshold 1201 and the second high resistance threshold 1202 are also illustrated in both figures. As seen by comparing Fig. 40A and Fig. 40B, the injection force depends strongly on the concentration of the lonapegsomatropin medicament solution, which as seen in Table. 1 is directly correlated to the viscosity of the lonapegsomatropin medicament solution. Thus, the higher the concentration of the lonapegsomatropin medicament solution - and thereby also the viscosity of the lonapegsomatropin medicament solution - is, the higher the needed injection force - and thereby also the battery power requirement - is.

The patient care system 5011 described in the following may employ an autoinjector as described before or as described in the general description or as defined in the claims. Moreover, if reference is made to an autoinjector in the following, the autoinjector, for example, may be an autoinjector as described with regard to Figs. 1 to 40A, B or the autoinjector may at least comprise some of the functionalities as described before. The autoinjector may be configured to comprise a cartridge with a cartridge code feature that can be employed in a single shot-mode. The cartridge can be a single chamber or a dual chamber cartridge.

The patient care system 5011 of Fig. 41 may be used for monitoring injections carried out, by a patient or another user, on the patient and/or for monitoring the patient’s adherence to a prescribed treatment regimen. The prescribed treatment regimen may specify how a prescribed medication shall be administered. More specifically, it may indicate when, how often and in what dose the medication should be injected.

The patient care system 5011 comprises an autoinjector 5013, which is used for administering the medicament to the patient. The autoinjector 5013 is configured to receive a cartridge 5015 that contains the medicament in a specific dose 5017. Thus, the cartridge 5015 may be interchangeably arranged in the autoinjector 5013. The dose 5017 of the medicament corresponds to the complete content of the medicament in the cartridge 5015. The cartridge 5015 comprises a code 5019, which is indicative of the dose 5017. Thus, the code 5019 may specify the size of the dose 5017. The code 5019 may be a colour code, such as a colour code comprising a sequence of colours. Different colours may therefore specify different sizes of the dose 5017.

The autoinjector 5013 comprises a code reader 5021 for determining the code 5019. The code reader 5021 may for example be configured to determine the colour of the code 5019, if the code 5019 is a colour code. The code reader 5021 may be an optical sensorthat may for example read the code 5019 or, for example, determine the colour of the code 5019. Data read by the code reader 5021 may be transmitted in a wireless or a wired way. Thus, for example, the code reader 5021 may be directly or indirectly connected to a Bluetooth antenna, for example via a processing unit (see processing unit 20 in Fig. 26).

The code may also be at least one of the following: a code comprising a sequence of colours, a bar code, a QR code, an identification number of the cartridge, a letter code, a number code, a RFID tag, an NFC tag. The code with a sequence of colours, the bar code, the QR code or the identification number, the number code or the letter code may be detected by use of an optical sensor, for example, which may be integrated into the autoinjector 5013. A tag reader may read a RFID tag or a NFC tag. The tag reader may be included in the autoinjector 5013.

The code 5019 may further comprise information related to the medicament contained in the cartridge, such as the type of medicament, the size of the dose, the volume of the solution, the viscosity of the solution, the temperature dependence of the viscosity, the manufacturer, the expiration date, etc. The code 5019 may further comprise information related to the cartridge itself, such as the diameter, the length, the type of material, a single chamber cartridge, a dualchamber cartridge, a multi-chamber cartridge etc. The code 5019 may further comprise information to specific predetermined positions of the first stopper and/or the second stopper, such as the pre-mix plunger position, the mix plunger rod position, the prime plunger rod position and/or the injection plunger rod position. The code 5019 may further comprise information relating to the energy needed to move the plunger rod, e.g. electricity needed by the motor to move the plunger rod to the pre-mix plunger position, the mix plunger rod position, the prime plunger rod position and/or the injection plunger rod position. The code 5019 may further comprise information relating to specific resistance thresholds, such as the first high resistance threshold and the second high resistance threshold.

The autoinjector 5013 may administer at least approximately the complete content of the medicament to the patient in one administration. Thus, at least in some embodiment, the complete content and thus the full dose 5017 of the medicament is administered in one shot by the autoinjector 5013. For technical reasons, a small amount of the dose usually remains in the cartridge 5015, including the needle and/or the bypass section. Therefore, the wording that at least approximately the complete content is administered relates to the issue that the complete content of the cartridge is administered in one administration, but there may remain a very small amount of leftovers in the cartridge 5015.

The patient care system 5011 further comprises a computing device 5023, such as a mobile and/or a handheld computing device, which may include mobile phones, smart phones, and tablets. The autoinjector 5013 is configured to send the code 5019 which is indicative of the dose 5017 of the medicament to the computing device 5023 via a wireless or wired connection, in particular in response to or prior to the administering of the medicament. The computing device 5023 receives the code 5019 and stores the code 5019 on a storage device 5025, which is internal to the computing device 5023 and/or on an external server system 5027 to which the computing device 5023 may connect via the internet, for example.

In some embodiments, the computing device 5023 hosts and executes an app 5029 or another computer programme by which the computing device 5023 may receive the code 5019 from the autoinjector 5013 and which further processes the received code 5019. The computing device 5023 may further include a screen 5031 on which the computing device 5023 may provide a graphical user interface, which may display information in conjunction with the received code 5023.

As the cartridge 5015 comprises the code 5019, which is indicative of the dose 5017 in the cartridge 5015, it is possible to monitor and/or control the type of medicament and/or the dose that is applied via the computing device 5023 or, remotely, via the server system 5027, which may be a cloud computing system. The storing of the code 5019 and a confirmation signal, for example provided by a plunger rod position sensor, may indicate that the dose 5017 was indeed administered. Storing the code 5019 may therefore help to keep track of the administered doses 5017 and may allow, in particular in conjunction with the confirmation signal, for a monitoring or controlling of the patient’s adherence to a predefined regimen in a simple and easy way.

At least in some embodiments, the storage of the obtained data, in particular the storing of the code 5019, in the storage 5025 of the computing device 5023 or in an external storage on the server system 5027, for example, in a cloud computing system, may be done under a user account. The user account may be linked to the patient and access to the user account may be provided via the app executed by the computing device 5023. Furthermore, a third party, such as a doctor or caregiver, such as parents of the patient, in particular if the patient is a child, may be granted access to the stored data for example via the server system 5027.

In some embodiments, the computing device 5023 can be configured that a user, such as a patient, parent and/or a healthcare professional can input data related to therapy outcome. The computing device 5023 can be configured to display on the screen a graphical representation comprising on a first axis data relating to the time of injection or the time and the dose of injection and on a second axis data related to therapy outcome. The computing device can be configured to display on the screen a graphical representation comprising on the first axis the time of injection of a medicament or the time and the dose of injection of a medicament, such as human growth hormone, and on the second axis data related to therapy outcome in particular marker concentration such as IGF-1 levels, body weight, body height and/or growth rate.

In some embodiments, the computing device can be configured to display on the screen a graphical representation comprising on a first axis data relating to patient’s adherence to a prescribed treatment regimen and on a second axis data related to therapy outcome. The data relating to patient’s adherence to the prescribed treatment regimen may for example be the percentage of injections that were actually made by a user compared to intended injections that a user should have made. The computing device can be configured to display on the screen a graphical representation comprising on the first axis data relating to patient’s adherence to a prescribed treatment regimen, such as data relating to patient’s adherence to a prescribed treatment regimen with a medicament, such as human growth hormone, and on the second axis a therapy related outcome data in particular marker concentration such as IGF-1 levels, body weight, body height and/or growth rate.

In some embodiments, the autoinjector 5013 may be configured to administer the complete content and thus the whole dose 5017 of the medicament to the patient in one administration in response to an activation of the autoinjector 5013 by a user, which may be the patient or another person who administers the dose 5017 to the patient. The autoinjector may be driven by electrical power, in particular from a battery, such as a rechargeable battery, and it might be activated by pressing the autoinjector against an injection site or by pressing a button after a needle of the autoinjector 5013 has been placed at the intended injection site of the patient. At least in some embodiments, by pressing the autoinjector against an injection site, the contact member is pressed into the interior of the autoinjector, blocking a light barrier, in particular the contact member protruding part covers the first and the second contact member sensor and thereby starting the injection. It is therefore not necessary to press an extra button at least in some embodiments.

At least in some embodiments, the computing device 5023 may store the received code 5019 together with a time stamp 5033 in the local storage 5025. The code 5019 and the time stamp 5033 may also be stored externally on the server system 5027. The time stamp 5033 may be determined by the computing device 5023, in particular in response to the reception of the code 5019 from the autoinjector 5013. The time stamp 5033 may also be determined by the autoinjector 5013. Therefore, in some embodiments, the autoinjector 5013 may have an internal clock. The time stamp 5033 may include time and date information of the administering of the medicament. In some embodiments, the time stamp 5033 may also record a time zone where a user performed the injection.

When the autoinjector 5013 determines the time stamp 5033, it may be sent together with the code 5019 to the computing device 5023, for example via a wired or wireless connection, such as an USB or a Bluetooth connection. The storing of the code 5019 and the time stamp 5033 makes it possible to track the injections of the medicament over time, and it may be used to check whether a prescribed plan has been adhered to.

The autoinjector 5013 can be used with single-chamber cartridges (such as cartridge 5015’), dual-chamber cartridges (such as cartridge 5015) or multiple-chamber cartridges. In some embodiments, the cartridge code feature indicates the type of cartridge.

As described before, for the administering of the medicament in one administration, the cartridge 5015 may be a dual chamber cartridge, for example as cartridge 700 described before in particular with regard to Fig. 11. Such a dual chamber cartridge 5015 is also shown in Figs. 42 and 43.

The cartridge 5015 comprises a first stopper 5035, for example corresponding to first stopper 708 shown in Fig. 11, which is movable by a plunger rod 5039 of the autoinjector 5013.

Fig. 42 (I)corresponds to a configuration, wherein the plunger rod has moved the first stopper 5035 and the second stopper 5037 to a prime plunger rod position, wherein air in the cartridge is reduced, such as minimized and/or reduced to an amount appropriate for injection. Ill

In another embodiment the cartridge may be a single chamber cartridge 5015’ in particular with regard to Figs. 44 and 45. The single chamber cartridge 5015’ comprises only a first stopper 5035’, which is movable by a plunger rod 5039 of the autoinjector 5013. Fig 44 (I) corresponds to a configuration, wherein the plunger rod has moved the first stopper 5035’ to a prime plunger rod position, wherein air in the cartridge is reduced, such as minimized and/or reduced to an amount appropriate for injection.

During an administering process, the plunger rod 5039 moves the first stopper 5035, 5035’ from an initial start position, such as the prime plunger rod position (see position C, C’ in Fig. 42(1) and Fig. 44(1)) to a final position (see position B, B’ in Fig. 42 (II) and 44 (II)), in which the first stopper 5035 is in abutment with the second stopper 5037 which is in abutment with a distal end 5041 of the cartridge 5015 (Fig. 42 (II)) or the first stopper 5035’ is in abutment with a distal end 5041 ’ of the cartridge 5015’ (Fig. 44 (II)) in order to move the complete content of the medicament in one administration out of the cartridge 5015, 5015’. The medicament can thus be pressed out of the cartridge 5015, 5015’ by a movement of the first stopper 5035, 5035’ from its initial position C, C’ to its final position B, B’. A corresponding movement is carried out by the plunger rod 5039.

As described before, the autoinjector 5013 may be configured to detect the position of the first stopper 5035, 5035’ when the first stopper 5035, 5035’ is in the initial position C, C’ and/or the final position B, B’. The autoinjector 5013 may further be configured to communicate a signal, which is indicative of the position of the plunger rod 5039 or the first stopper 5035, 5035’. In particular, the signal may indicate that the first stopper 5039 is at position C, C’ and/or at position B, B’. If the signal indicates that the first stopper 5035, 5035’ is at position B, B’ it may be assumed that the complete dose was administered.

In some embodiments, the autoinjector 5013 may be configured to determine whether the dose 5017 has been administered completely, in particular by use of the signal that indicates position B, B’ for the first stopper 5035, 5035’. The autoinjector 5013 sends then a confirmation, which is indicative that the dose has been administered completely, to the computing device 5023. The computing device 5023 may be configured to store the code 5019 and the timestamp 5033 in conjunction with the received confirmation and/or to provide the confirmation together with the code 5019 and the timestamp 5033 to the server system 5027.

The autoinjector 5013 may be configured to determine whether the dose 5017 has been administered completely based on a start position of the plunger rod 5039, which may correspond to position C, C’ of the first stopper 5035, 5035’ and an end position of the plunger rod, which may correspond to position B, B’ of the first stopper 5035, 5035’. Alternatively or additionally, the autoinjector 5013 may be configured to determine whether the dose 5017 has been administered completely based on the start position of the plunger rod 5039, which may correspond to position C, C’, and a resistance signal, which is indicative of a resistance against a movement of the plunger rod 5039 from the start position C, C’ to the end position B; B’.

Figs. 42 to 45 show in a respective graphs the resistance over the position of the first stopper 5035, 5035’. As may be seen, the resistance increases abruptly to larger values once the end position B; B’ has been reached. A threshold value Re2, Re2’ for the resistance may be defined such that, when the measured resistance exceeds the threshold value Re2, Re2’, it is indicative that the end position B; B’ has been reached. The autoinjector 5013 may further be configured to communicate signals to the computing device 5023, wherein the signals are indicative of the start position C, C’, the end position B, B’ and/or the resistance signal, such as resistance against movement above the threshold value Re2, Re2’.

The autoinjector 5013 can be configured to determine and optionally to communicate to the computing device a position of a plunger rod 5039 of the autoinjector 5013, in particular positions A, A’, B, B’ and/or C, C’. The autoinjector 5013 can be configured to determine and optionally to communicate to the computing device a resistance signal indicative of a resistance of a plunger rod 5039 against movement. The position and /or the resistance signal can be used to validate, for example, that a dose has been expelled completely. For example, if the resistance signal indicative of resistance against movement of the plunger rod is above a high resistance threshold Re2, Re2’ before the plunger rod reaches the plunger rod threshold B, B’ the movement of the plunger rod can be decreased and/or the injection process can be cancelled. In this case an error message is transmitted together with a dose that was expelled until the injection process was interrupted. This can be done at a later point in time as the information can be stored either locally and/or externally. Furthermore, the autoinjector 5013 can determine and optionally communicate to the computing device a status of the cartridge 5015, in particular whether full, not-full (such as partially full) or empty, for example by determining a cartridge parameter based on a resistance signal and a present plunger rod position. The cartridge parameter may be indicative of the cartridge 5015, 5015’ being not full and/or empty if the present plunger rod position has reached a plunger rod threshold A, A’, such as a predetermined threshold A, A’ and the resistance signal being indicative of resistance against movement below a predefined low resistance threshold Rel, Rel’. In case that a single chamber cartridge 5015’ is used with the autoinjector 5013 the start position C’ and the plunger rod threshold A’ may be the same or the start position C’ is between the distal end of the cartridge and the plunger rod threshold A’.

The computing device 5023 can also inform a user to replace the cartridge 5015. Therefore, the autoinjector 5013 can determine whether an inserted cartridge is full, not-full or empty and it can send a corresponding message to the computing device 5023 that the cartridge 5015 is full, not-full or empty. No dose administration is recorded in this case. The computing device 5023 can thus support the patient to ensure that the correct dose will be applied.

The autoinjector 5013 may be configured to generate and/or determine and optionally to communicate a contact member signal obtainable from a contact member (see contact member described before) of the autoinjector when the autoinjector 5013 is pressed against an injection site. The contact member signal may also be used to verify that a needle cover has been removed from the cartridge prior to the administration of the dose. The contact member may also be used to start the injection process into the injection site of the patient. The injection process may in particular be triggered by use of the contact member signal.

The autoinjector 5013 may be configured to determine and optionally to communicate a status information of the medicament, in particular a status of a medicament solution. The autoinjector 5013 may comprise one or more sensors that may detect whether the autoinjector 5013 has been shaken or inverted. In particular, the sensor signals may allow a determination of a number of inversions of the autoinjector 5013. The number of inversions may provide an indication how well the medicament has been mixed. In particular, the sensor signals may allow a determination of a number of shaking operations of the autoinjector 5013. The number of shaking operations may provide an indication how well the medicament has been mixed. In particular, the sensor signals may allow a determination of a number of inversions and a number of shaking operations of the autoinjector 5013. The number of inversions and shaking operations may provide an indication how well the medicament has been mixed. The sensor may include one or more of the following: accelerometer sensors, inertial sensors, vibration sensors, shake sensors, rotation sensors or a combination thereof.

In some embodiments, the computing device 5023 may determine whether the dose 5017 is in accordance with an intended dose according to a predefined dosage regime which may be stored on the computing device. The dosage regime may be stored on the server system 5027 from which it could be obtained by the computing device 5023. The computing device 5023 may confirm whether the dose 5017 corresponds to the intended dose prior to the injection of the dose 5017 and in response to receiving the code 5019, which is indicative of the dose 5017, from the autoinjector 5013. The computing device 5023 may also inform the user that the dose 5017 in the autoinjector 5013 corresponds to the intended dose, for example by providing a message to the user via screen 5031 and/or by outputting of an acoustic signal. If the dose 5017 does not correspond to the intended dose, an alert might be output.

The computing device 5023 may store the code 5019 in conjunction with validation information 5043 locally and/or externally on the server system 5027. The validation information 5043 may indicate whether the dose 5017 is or is not in accordance with the predefined dosage regime. It may for example be a simple text information stating “OK” or “NOT OK”. The validation information 5043 may indicate the deviation from the administered dose and the intended dose. The validation information 5043 might be useful in order to track back if a dose was applied in line with the dosage regime.

In some embodiments, the computing device 5023 may determine whether the time at which a cartridge is installed into the autoinjector is in accordance with an intended time of administration which may be stored on the computing device. The intended time of administration may be stored on the server system 5027 from which it could be obtained by the computing device 5023. The computing device 5023 may confirm whether the time at which a cartridge is installed into the autoinjector corresponds to the intended time of administration prior to the injection of the dose 5017 and in response to receiving the code 5019, which is indicative of the dose 5017, from the autoinjector 5013. The computing device 5023 may also inform the user that the time at which a cartridge is installed into the autoinjector corresponds to the intended time of administration, for example by providing a message to the user via screen 5031 and/or by outputting of an acoustic signal. If the time at which a cartridge is installed into the autoinjector does not correspond to the intended time of administration, an alert might be output.

The computing device 5023 may store the code 5019 in conjunction with validation information 5043 locally and/or externally on the server system 5027. The validation information 5043 may indicate whether the time of administration is or is not in accordance with the intended time of administration. It may for example be a simple text information stating “OK” or “NOT OK”. The validation information 5043 may indicate the deviation from the time of administration and the intended time of administration. The validation information 5043 might be useful in order to track back whether a dose was administered at the correct time.

The computing device 5023 and/or the server system 5027 may inform the user and/or a third party, such as a doctor, when the validation information 5043 indicates that the dose is not in accordance with the predefined dosage regime. When the computing device 5023 and/or the server system 5027 inform a third party, a message or signal, such as an email or another form of message, such as a text message, may be sent to the third person. If the validation information 5043 is provided to the user prior to injection, misapplication of the medicament may be prevented. In addition, the validation information 5043 may be stored, in particular after the dose is injected, which later could be helpful in identifying any problems the patient may have encountered.

For the communication between the autoinjector 5013 and the computing device 5023, a pairing process may be used in order to establish a wireless or wired connection, for example a secured wireless connection. The pairing process may require the manual entry of a registration code at the computing device 5023. The registration code may be based on the serial number of the autoinjector 5013, which may be printed on the casing of the autoinjector 5013, for example. The registration code can be or a part of the serial number, such as the last 7 digits of the serial number, such as the last 6 digits of the serial number, such as the last 5 digits of the serial number, such as the last 4 digits of the serial number, such as the last 3 digits of the serial number, such as the last 2 digits of the serial number, such as the last digit of the serial number, which can be printed on the casing of the autoinjector 5013. The registration code may also be stored, for example together with the code 5019 on the cartridge 5015. The registration code may be stored such that it may be read manually by a user of the autoinjector 5013. Using a registration code might raise the awareness of the user and the user may easily identify the autoinjector 5013 which is linked with the computing device. This may in particular be of relevance when the user owns more than one autoinjector or for a health care professional supporting several patients. A use of the serial number of the autoinjector 5013 as registration code may further simplify the pairing process and ensure the exact assignment to an autoinjector 5013.

In some embodiments, the wireless connection is a Bluetooth connection or the wired connection is an USB connection. Any other, in particular short-range, wireless or wired technology standard for exchanging data between electronic devices may also be used, such as a 5G or 4G/LTE mobile radio network connection in particular, a Narrowband Intemet-of- Things connection, NB-IoT or another suitable connection, such as LoRa, Sigfox or satellitebased communication.

The screen 5031 may be a touch screen. The computing device 5023 may display on the screen 5031 a plurality of injection sites, which may be suitable sites for the administering of the dose 5017.

FIGS. 47A and 47B show exemplary injection sites on a human body as displayed on a display of the computing device 5023. Previously used injection sites may be stored and the previously used injection sites may be displayed differently than other suitable injection sites. Thereby, a previously used injection site may be left out for the administration of a dose. For example, as shown in FIG. 47B, a previously used injection site 6001 is shown in black while suitable injection sites 6003 are shown in grey. In the embodiment of FIG. 47 A, all injection sites 6005 are shown in the same colour.

The user may specify an injection site that was used for administering the dose 5017, in particular by use of a touch input on the corresponding injection site, for example on injection site 6001 in FIG. 47B, which is displayed on the screen. The user may therefrom input manually the injection site that was used for administering of the dose 5017. The injection site may be stored on the computing device 5023 and/or on the external server system 5027. It may be displayed as a previously used injection site 6001 also in a next session. The computing device 5023 may also categorize injection sites of a plurality of injection sites into at least two different categories, for example with regard to a frequency of use of the injection sites. The categories of injection sites may be displayed differently on the screen 5031. Thereby, guidance may be provided to the user, when the user wishes to select an injection site for administering the dose 5017.

In some embodiments, the computing device 5023 is configured to enable a user to select or unselect or block an injection site of a displayed plurality of injection sites. This may be done by use of a touch input, provided by the user, on the displayed injection site. The user is therefore enabled to configure the display of the injection sites. For example, by blocking an injection site, it might not be displayed any more or differently than the unblocked injection sites.

In some embodiments, the computing device 5023 is configured to output a reminder, in particular a visual or an acoustic reminder, in accordance with a predefined schedule for the administering of the medicament. Thus, the computing device 5023 may provide support to the patient so that the patient may stick to the predefined schedule.

The computing device 5023 may also inform a user to replace the cartridge 5015. Therefore, the autoinjector 5013 may determine whether an inserted cartridge is full or empty and it may send a corresponding message to the computing device 5023 that the cartridge 5015 is full or empty. The computing device 5023 may thus support the patient to ensure that the correct dose will be applied.

In the example described above, the cartridge was a dual-chamber cartridge or a single chamber cartridge. However, the cartridge may also be of another type. For example, the cartridge may have several chambers.

An exemplary method of monitoring injections carried out on a patient and/or a patient’s adherence to a prescribed treatment regimen of administering a medicament to a patient using a patient care system as described before is described with regard to Fig. 46. In step 10011 the autoinjector having a cartridge with a medicament is provided, wherein the cartridge comprises a code which is indicative of the dose of the medicament in the cartridge, and wherein the dose of the medicament corresponds to a complete content of the medicament in the cartridge. In step 10013, the complete content of the medicament in the cartridge is administered in one administration to the patient. In step 10015 the autoinjector identifies the code and sends the code via a wireless or wired connection to a computing device, in particular in response to or prior to the administering of the medicament. In step 10017, the computing device stores the code on a storage device or it initiates the storing of the code on an external server system, such as a cloud system. The method may also include the steps of determining a time stamp and storing the code in conjunction with the time stamp. The time stamp may be indicative of the time and/or the date of the administering of the medicament and/or of a time zone where a user performed the injection.

In a further exemplary method, the autoinjector, in particular additionally, determines if the full content of the cartridge has been administered and if the auto injector determines that the full content of the cartridge has been administered, it sends the code signal together with a confirmation signal that is indicative that the full cartridge content has been administered. In such an embodiment, if only a part of the cartridge content has been administered, the autoinjector sends the code signal together with an error message that only a part of the cartridge content was administered. In this case only the part of the dose that was administered will be recorded by the patient care system.

Fig. 48 discloses a patient care system of the present disclosure that involves several computing devices 5023’, 5023”, 5023’” operated by different users. For example, the computing device 5023’ may be operated by one or more of a healthcare professional 5045, such as a nurse or doctor. The computing device 5023” may be operated by a patient 5047 and/or a caregiver of the patient 5047, such as a parent, in particular when the patient is a child. The computing device 5023’” may be operated by a manufacturer 5049. In some embodiments a cartridge code reader 5021 of an autoinjector 5013 reads a cartridge code 5019 of a cartridge 5015 (A) and transmits the cartridge code 5019, a timestamp indicative of a date and time of performing an injection and optionally a confirmation signal indicative of a confirmation that a full content of a dose has been administered to one or more of the computing devices 5023’, 5023” and/or 5023 ” ’ (B, C, D). In case that only a part of the intended dose was administered, the autoinj ector 5013 sends a confirmation signal indicative of the part of the dose that has been administered.

In some embodiments, the patient 5047 may report (Fig. 48, see “G”) errors in the operation of the autoinjector 5013 to the manufacturer 5049 and/or the manufacturer 5049 can inform (G) the patient about problems of the autoinjector 5013 and/or about updates of an app that is used on the computing device 5023” and/or the end of lifetime of the autoinjector 5013. For safety reasons the autoinjector 5013 may be automatically inactivated after a certain usage time, such as 2 years, such as 3 years, such as 4 years, such as 5 years, such as 6 years, such as 7 years.

In some embodiments, the patient 5047 may share (Fig. 48, see “F”) data such as full dose, part of a dose, time and date of injections performed, and/or adherence to prescribed treatment regimen and/or data related to therapy outcome, such as body height, body weight, growth rate and/or marker concentrations such as IGF-1 levels with a healthcare professional 5045. The healthcare professional 5045 can report (Fig. 48, see “F”) data related to therapy outcome, such as body height, body weight, growth rate and/or marker concentrations such as IGF-1 levels to the patient 5047. Furthermore, the healthcare professional 5045 may instruct the patient 5047 to stop injecting the medicament and/or to use a different dose. The healthcare professional 5045 may also be able to program the injection device that certain types of cartridges 5015 are not allowed to be used with the autoinjector 5013. The healthcare provider 5045 may also be able to input the intended dosage regimen that is used as reference in adherence monitoring. The healthcare provider may also be able to block certain injections sites to be displayed.

In some embodiments, the healthcare professional 5045 can report (Fig. 48, see “E”) operation errors to the manufacturer 5049. The manufacturer 5049 can inform the healthcare professional 5045 about problems of the autoinjector 5013 and/or updates of an app that is used on the remote device 5023’ and/or the end of lifetime of the autoinjector 5013. For safety reasons the autoinjector 5013 may be automatically inactivated after a certain usage time, such as 2 years, such as 3 years, such as 4 years, such as 5 years, such as 6 years, such as 7 years.

In some embodiments the autoinjector 5013 is further configured to transmit injection device performance data to the manufacturer 5049’, e.g. any error messages that occur during device usage. In some embodiments the manufacturer can provide a remote real-time help for a user. For example, a user having problems to perform an injection can get into contact with the manufacturer. The manufacturer has in real-time access to the performance data of the autoinjector 5013, such as usage data, installed cartridge, used cartridges, orientation signals, resistance signals indicative of resistance against movement of the plunger rod, plunger rod position signals etc. For example, if the autoinjector 5013 is not performing an inj ection because the detected cartridge parameter is indicative of the installed cartridge 5015 being not new/used, the manufacturer can instruct the user to replace the cartridge 5015. If the autoinjector 5013 is not starting an injection because the autoinjector 5013 didn’t perform an air-shot, the manufacturer can instruct the user to place the autoinjector 5013 upright and wait if the autoinjector 5013 automatically performs an air-shot. If the autoinjector 5013 is not starting an injection because the onset signal is not indicative that the autoinjector 5013 was sufficiently inverted and/or shaken, the manufacturer can instruct the user to perform additional inversions and/or shaking movements.

In some embodiments a manufacturer 5049” can access injection data, therapy adherence data and/or therapy related outcome data of several remote devices 5023’, 5023” of a plurality of different healthcare professionals 5045 and/or patients 5047. This has the advantage that the manufacturer can analyse usage and therapy outcome data and use these data for improving therapy.

In some embodiments a manufacturer 5049’” can access injection data, usage data, frequency of usage of the autoinjector and relating signals that were recorded by the autoinjector for each injection process, such as a code signal, a temperature signal, orientation signals, resistance signal indicative of resistance against movement of the plunger rod, plunger rod position signals. This has the advantage that a manufacturer 5049’” can analyse injection performance data of a plurality of autoinjectors, which can be used to improve the autoinjector.

The patient care system of FIG. 48 comprises an autoinjector 5013 with a code reader 5021, a cartridge 5015 with a code 5019 that may be read by the code reader 5021 as explained before, and three computing devices 5023’, 5023”, and 5023’” that may communicate with each other over the internet, for example.

The computing device 5023’ may be a device of a healthcare professional, such as a physician. The computing device 5023 ’ ’ may be a device of a user, and the computing device 5023 ’ ’ ’ may be the device of a manufacturer of the medicament and/or the autoinjector.

As indicated by arrow A, in particular by use of the code reader 5021 and the code 5019, information may be obtained from the autoinjector 5013 about the cartridge 5015. More generally, a transfer of usage data may take place between autoinjector 5013 and cartridge 5015. Moreover, usage data may be generated by the autoinjector 5013 in response to receiving the code 5019. The usage data may include a date, time, dose, injection device performance data, etc.

As indicated by arrows B, C, and D, data in the autoinjector 5013 may be selectively sent to at least one of the computing devices 5023’, 5023”, 5023’”.

As indicated by arrow E, the computing device 5023’ of the healthcare professional may report errors to the manufacturer’s device 5023’”, which may inform the computing device 5023’ for example about problems with the autoinjector or about a software update, and an end of lifetime of the autoinjector 5013. For safety reasons, the autoinjector 5013 may be shut down after a certain usage time, for example 2, 3, 4, or 5 years. The autoinjector 5013 may have a corresponding shut down mechanism implemented in the autoinjector.

As indicated by arrow F, the user’s computing device 5023 may share data with the computing device 5023’ of the healthcare professional 5023’ and vice versa. Such data may include information about injections, adherence, therapy outcome, adherence versus height/growth rate. Information provided by the healthcare professional may indicate to stop injections or use a different dosage.

As indicated by arrow G, the user’s computing device 5023” may report errors to the manufacturer’s device 5023’”. Moreover, a manufacturer’s device 5023’” may inform the user’s device 5023”, for example about problems or an update, end of lifetime of the autoinjector, etc.

Fig. 49 shows a block diagram of a patient care system for monitoring injections carried out on a patient and/or a patient’s adherence to a prescribed treatment regimen. The patient care system comprises an autoinjector 6011 for administering a medicament, such as a growth hormone, to a patient. The autoinjector 6011 is configured to receive a cartridge 6013 with the medicament. The patient care system further comprises a computing device 6015, such as a mobile and/or a handheld computing device.

At least in some embodiments, the cartridge 6013 is a dual chamber cartridge having different components of the medicament in two chambers of the cartridge 6013 as described before. The autoinjector 6011 is configured to mix the different components prior to the application of the medicament to a patient as described before. A dose of the medicament corresponds preferably to a complete content of the medicament in the cartridge, and the autoinjector 6011 is configured to administer the complete content in one administration. The autoinjector 6011 may be configured to determine and communicate that the complete dose has been administered.

The use of a dual chamber cartridge and the administering of the complete content of the cartridge in a single shot is to be seen as an example. In some embodiments, the autoinjector is configured to administer a predefined dose of a medicament stored in the cartridge, which may optionally have two chambers. The autoinjector may then be configured to determine and to communicate that the predefined dose has been administered.

The autoinjector 6011 is configured to generate and send information to the computing device 6015. The information is related to the preparing and/or administering of the medicament to the patient. The autoinjector 6011 is configured to use at least a first data stream 6017 and a second data stream 6019 to provide the information to the computing device 6015. The first data stream 6017 is sent independently from the second data stream 6019.

The information is transmitted via one or more wireless connections, such as a Bluetooth connection or a Wifi connection, or one or more wired connections, such as an USB connection. However, in order to keep the first data stream and the second data stream separate from each other, preferably different communication schemes are used to send the first data stream 6017 and the second data stream 6019 from the autoinjector 6011 to the computing device 6015.

The autoinjector 6011 is further configured to encrypt the information by use of an end-to-end encryption prior to the sending of the information to the computing device 6015. In some embodiments, the first data stream 6017 is encrypted, for example by using an encryption scheme provided by the communication protocol used to send the data, such as an encryption provided by Bluetooth.

In some embodiments, the second data stream 6019 is encrypted, but in a different way than the first data stream 6017. In some embodiments, the second data stream 6019 is encrypted using a two-step encryption scheme as will be described further below. The information sent in the first data stream 6017 is of a different type of information than the information sent in the second data stream 6019. The first data stream 6017 is preferably used to provide status messages from the autoinjector 6011 to the computing device 6015.

A status message 6021 may be selected from a predefined set of status messages 6023. Each status message 6021 of the set of status messages 6023 includes information about a specific state of the autoinjector and/or the cartridge.

An example of a set of status messages 6023 which consists of 19 statues messages is shown in the table of Fig. 51. Such a set of status messages 6023 may be stored in the autoinjector 6011 and in the computing device 6015. As indicated in the first column of the table in Fig. 51, a number may be associated with each status message. For providing a status message to the computing device 6015, the autoinjector 6011 may be configured to include a representation of the respective number for the status message into the first data stream 6017.

The computing device 6015 may further be configured to identify the status message 6021 based on the received representation of the number. Furthermore, the computing device 6015 may be configured to output, in particular to a screen of the computing device 6015, a notification 6025 which is associated with the received status message 6021. Thereby, in essence real time information may be provided to the user of the computing device 6015.

The notification 6025 may be obtained from a predefined set of notifications 6027 made available to the computing device 6015. Each notification of the set of notifications 6027 may be associated with one status message of the set of status messages 6023. A notification could be a text messages as illustrated in the second or third column of the table of Fig. 51. Alternatively, the notification may be output in form of one or more pictures or in form of an audio message.

In some embodiments, the autoinjector 6011 does not send any response to requests obtained from the computing device via the first data stream 6017. More specifically, in the communication scheme used to provide the first data stream 6017 to the computing device 6015, it is not intended that the computing device 6015 sends requests to the autoinjector 6011. The first data stream 6017 may thus be regarded as a unidirectional data stream which is only transmitted from the autoinjector 6011 to the computing device 6015. The first data stream 6017 is permanently active between the autoinjector 6011 and the computing device 6015. This means that information may be sent via the first data stream 6017 in the time between the start and the end of the connection, in particular Bluetooth connection, and in particular while the medicament is administered.

In some embodiments, as the information obtained via the first data stream 6017 corresponds to status messages of the autoinjector 6011 and/or the dose, the received status messages are usually only stored temporarily on the computing device 6015.

At least in some embodiments, the second data stream 6019 is configured to provide information related to the administering of the medicament from the autoinjector 6011 to the computing device 6015. For example, the information in the second data stream 6019 may include at least one of the following: a dose log history, technical parameter in the dose log history, medical data, such as the current time and/or the size of the dose, and data related to earlier injection events, information related to the cartridge, such as a cartridge code.

At least in some embodiments, the second data stream 6019 is a unidirectional data stream from the autoinjector 6011 to the computing device 6015, so that the autoinjector 6011 does not receive any message from the computing device 6015 via the second data stream 6019. Alternatively, the computing device 6015 is configured to send messages, such as confirmation messages, to the autoinjector 6011 in response to receiving information in the second data stream 6019. The autoinjector 6011 may be configured to not respond to the messages from the computing device 6015.

In some embodiments, the autoinjector 6011 is configured to set the second data stream 6019 temporally inactive, in particular during the administering of the medicament. Thus, the second data stream 6019 may only be active before and after the preparing and/or administering of the medicament. In some embodiments, the autoinjector 6011 is configured to set the second data stream 6019 temporally inactive, in particular during preparing and administering of the medicament. Thus, the second data stream 6019 may only be active before and after the preparing and administering of the medicament. The information received via the second data stream 6019 may be stored, in particular permanently, on the computing device and/or further provided, in particular using encryption, to a server system. When the second data stream 6019 is inactive, the autoinjector 6011 may be configured to not respond to requests received from the computing device 6015. A time window during which the autoinjector 6011 is inactive in view of a transmission of the second data stream 6019 may start at the occurrence of a first event and the time window may end at the occurrence of a second event, where the autoinjector 6011 is configured to detect the first and second events. The first event may be indicative of a start of the preparation and/or administration and the second event may be indicative of an end of the preparation and/or administration of the medicament. The first event may be indicative of a start of the preparation and the second event may be indicative of an end of the administration of the medicament. The first event may be indicative of a cartridge is being installed within the autoinjector and the second event may be indicative of an end of the administration of the medicament. The first event may be indicative of a cartridge is being installed within the autoinjector and the second event may be indicative of a cartridge being removed from the autoinjector.

As mentioned before, at least in some embodiments, the second data stream 6019 is encrypted, in particular by use of a two-step encryption scheme. In some embodiments, the information in the second data stream 6019 is encrypted in a first step by use of a first encryption scheme and afterwards in a second step by use of a second encryption scheme.

Fig. 50 shows in a block diagram an example of a two-step encryption scheme. The autoinjector 6011 of Fig. 50 comprises amain processing unit 6029 and the autoinjector 6011 is configured to carry out a first encryption scheme of the two-step encryption scheme on the main processing unit 6029. Furthermore, the autoinjector 6011 comprises a communication module 6031, such as a Bluetooth chip or a Bluetooth Low Energy Chip, for establishing a link between the autoinjector 6011 and the computing device 6015, and the autoinjector 6011 is configured to carry out the second encryption scheme on the communication module 6031.

The first encryption scheme is a proprietary encryption scheme, which is provided on the autoinjector 6011. The first encryption scheme may use a symmetric encryption. Using a symmetric encryption may be advantageous from a manufacturability perspective, while a high level of security can be achieved. The symmetric encryption involves using a single key 6033 to encrypt and decrypt data. The key may have been provided by the computing device 6015 or a server system (not shown in Fig. 50), such as a cloud computing system, in a secured way to the autoinjector 6011. Alternatively, it could have been implemented in the autoinjector 6011 before delivery by the manufacturer. Furthermore, it may be updated during an update of an operating system of the autoinjector 6011.

In some embodiments, the key for symmetric encryption may be generated, in particular on the computing device 6015 or on a server system, by taking account of a unique specification of the autoinjector, such as a serial number. The key may therefore be assigned to a specific autoinjector.

As shown in Fig. 50, the computing device 6015 may be configured to decrypt the received information by use of a corresponding two-step decryption process. The computing device 6015 may comprises a main processing unit 6035 which may be configured to carry out a corresponding first decryption scheme on the main processing unit. The computing device 6015 may further comprises a communication module 6037, such as a Bluetooth chip or a Bluetooth Low Energy Chip, for carrying out a corresponding second decryption scheme on the communication module 6037. The received encrypted information is at first decrypted using the second decryption scheme and subsequently by use of the first decryption scheme.

At least in some embodiments, Bluetooth is managed on the level of the operational system of the computing device 6015, whereas the first encryption/ decry ption is carried out on an application executed on the computing device 6015.

The embodiment of Fig. 50 is an example. More generally, the computing device 6015 can be configured to execute one or more computer programs, for example in form of apps or applications, in order to carry out the first and second decryption scheme on the received data stream from the autoinjector.

The computing device 6035 may be configured to provide the received encrypted information to the server system, which may also be configured to decrypt the received information.

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

LIST OF REFERENCE SIGNS

2 system

4 autoinjector

6 housing

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 needle sensor

32 temperature sensor

34 resistance sensor

40 battery calculation module

100, 100’ blocking member

102 first blocking coupling member

104 first blocking member stop

106 the second blocking member stop

200 ejector

202 ejector member

204 ejector abutment face

206 end portion

207 angle retaining guide

208 second blocking coupling member

212 ejector lock

214 bottom portion

216 ejector lock guide pin

218 ejector resilient member

222 ejector rod bore

224 ejector collar

226 ejector cog ejector cut-out ejector lock cut-out ejector lock cog end portion ejector spring ejector lock bore stop position extreme position cartridge receiver cartridge receiver opening cartridge receiver compartment receiving direction first section first guide members first guide member angle passage passage angle second guide members first face second face retention portion second section retention angle slope portion slope angle eject face first riser portions second riser portion first section second section retention face bore opening base 400 plunger rod

402 inner plunger rod

404 outer plunger rod

406 plunger rod track

408 plunger rod groove

410 plunger rod front end

424 plunger rod distal rim

428 first track portion

430 third track portion

432 second track portion

500 drive module

502 motor

504 transmission

600 cartridge assembly

700 cartridge

701 dual chamber cartridge

702 cartridge component

704 first cartridge subcomponent

706 second cartridge subcomponent

708 first stopper

710 second stopper

712 bypass section

714 cartridge outlet

716 cartridge back face

718 first end

720 second end

722 first stopper direction

790 medicament

792 first medicament component

794 second medicament component

800 cartridge holder

806 cartridge assembly outlet opening

808 cartridge retention member

812 needle assembly coupling portion 814 cartridge holder slot

900 needle assembly

902 needle

904 needle hub

906 cartridge holder coupling portion

908 needle cover

910 needle cover abutment face

1000 cartridge code feature

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 part

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 third high resistance threshold

1206 first slope

1208 second slope

1210 third slope

1220 first plunger rod position

1222 second plunger rod position

1223 third plunger rod position

1224 fourth plunger rod position

1226 fifth 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 as a function of the plunger rod position

1300 speed graph

1300X position axis

1300Y speed axis

3000 method

3001 receiving

3002 moving

3004 determining

3006 receiving

3010 adjusting

3100 method

3102 move plunger rod at first speed

3104 first resistance criteria

3106 stop movement of plunger rod

3108 first position criteria

3110 move plunger rod at second speed

3112 second resistance criteria

3114 stop movement of plunger rod

3200 method

3202 move plunger rod at first speed

3204 resistance criteria

3206 increase speed

3208 speed criteria

3210 decrease speed

3212 stop movement of plunger rod

3300 method

3302 move plunger rod at first speed

3304 first resistance criteria

3306 stop movement of plunger rod

3308 second resistance criteria

3310 first position criteria

3312 stop movement of plunger rod 3400 method

3402 move plunger rod at first speed

3404 first resistance criteria

3406 increase speed

3408 first position criteria

3410 decrease speed

3412 second resistance criteria

3414 speed criteria

3416 stop movement of plunger rod

4000, 4000’ method

4002 measure the temperature of the autoinjector

4004 measure the battery voltage level

4010, 4010’ temperature above a predetermined threshold temperature

4012 sufficient electrical voltage to perform an autoinjector process

4014 autoinjector is ready for use

4016 battery recharging needed

4022 sufficient electrical voltage to perform two autoinjector processes

5011 patient care system

5013 autoinjector

5015 cartridge

5017 dose

5019 code

5021 code reader

5023, 5023’, 5023”, 5023’” computing device

5025 storage device

5027 server system

5029 app

5031 screen or touch screen

5033 time stamp

5035 first stopper

5037 second stopper

5039 plunger rod

5041 distal end 5043 validation information

5045 health care professional (HCP)

5047 patient

5049 manufacturer

6001 injection site

6003 injection site

6005 injection site

A, A’ start position

B, B’ final position

C, C’ start position

6011 autoinjector

6013 cartridge

6015 computing device

6017 first data stream

6019 second data stream

6021 status message

6023 set of status messages

6025 notification

6027 set of notifications

6029, 6035 main processing unit

6031, 6037 communication module

6033 key

Examples, embodiments and features in accordance with the present disclosure are described in the following by use of a list of items. A feature mentioned above or below in conjunction with one embodiment may also be implemented in another embodiment, even if this is not disclosed explicitly.

LIST OF ITEMS

1. A patient care system for monitoring injections and/or a patient’s adherence to a prescribed treatment regimen, the patient care system comprising: an autoinjector configured to administer a medicament, such as a growth hormone, in particular to a patient, wherein the autoinjector is configured to receive a cartridge, in particular a dual chamber cartridge, with the medicament, wherein a dose of the medicament corresponds to a complete content of the medicament in the cartridge, wherein the cartridge comprises a code which is indicative of the dose, and wherein the autoinjector comprises a code reader configured to determine the code, wherein the autoinjector is further configured to administer at least approximately the complete content of the medicament in one administration, wherein, optionally, determining the code includes reading the code and/or detecting data represented by the code; a computing device, in particular a mobile and/or a handheld computing device, wherein the autoinjector is configured to send the code which is indicative of the dose of the medicament to the computing device via a wireless or wired connection, in particular in response to or prior to the administering of the medicament, wherein, optionally, sending the code includes sending data represented by the code, and wherein the computing device is configured to store the code on a storage device, which is internal to the computing device and/or on an external server system.

2. The patient care system of item 1, wherein the autoinjector is configured to administer the complete content of the medicament in one administration in response to an activation of the autoinjector by a user, and/or wherein the autoinjector comprises a drive module connected to a battery, the drive module comprising a motor, the drive module being coupled to move a plunger rod between a retracted plunger rod position and an extended plunger rod position. 3. The patient care system of item 1 or 2, wherein, for administering the complete content of the medicament in one administration, the autoinjector comprises a plunger rod and the cartridge comprises a stopper which is movable by the plunger rod, when the cartridge is inserted in the autoinjector, wherein during an administering process the plunger rod is configured to move the stopper from an initial start position to a final position, in which the stopper is in contact with a distal end of the cartridge in order to remove the complete content of the medicament in one administration from the cartridge.

4. The patient care system of any one of the preceding items, wherein the code is at least one of the following: a colour code, a code comprising a sequence of colours, a bar code, a QR code, an identification number of the cartridge, a letter and/or number code, a RFID tag, a NFC tag.

5. The patient care system of any one of the preceding items, wherein the computing device is connected or connectable to the external server system via a communications network, such as the internet, wherein, optionally, the external server system is a cloud computing system.

6. The patient care system of any one of the preceding items, wherein the computing device is configured to store the code in conjunction with a time stamp that is either determined by the computing device or sent together with the code by the autoinjector, wherein the time stamp is indicative of the time and/or the date of the administering of the medicament.

7. The patient care system of any one of the preceding items, wherein the autoinjector is configured to determine whether the dose has been administered completely and to send a confirmation, which is indicative that the dose has been administered completely, wherein the computing device is configured to store the code in conjunction with the confirmation.

8. The patient care system of any one of the preceding items, wherein the autoinjector is configured to determine whether the dose is administered completely based on a start position of a plunger rod of the autoinjector for moving a stopper, in particular a first stopper, of the cartridge and an end position of the plunger rod and/or a start position of the plunger rod and a resistance signal indicative of a resistance against a movement of the plunger rod from the start position to the end position, wherein the autoinjector is configured to determine the start position, the end position and/or the resistance signal and, optionally, to communicate the start position, the end position and/or the resistance signal to the computing device, wherein, further optionally, the start position is a position at which air in the cartridge is removed to an amount appropriate for injection.

9. The patient care system of any one of the preceding items, wherein the autoinjector is configured to determine and optionally to communicate at least one of the following: a status of the cartridge, in particular whether full, not-full or empty, a position of a plunger rod of the autoinjector, a resistance signal indicative of a resistance of a plunger rod against movement, a contact member signal obtainable from a contact member of the autoinjector, in particular when the contact member is pressed against an injection site, wherein, optionally, the contact member signal is indicative of a start of the administering of the medicament and/or wherein, optionally, the time stamp corresponds to the point in time when the contact member signal is generated or detected in the autoinjector; status information of the medicament, in particular a status of a medicament solution, wherein, optionally the status information comprises a number of inversions of the autoinjector.

10. The patient care system of any one of the preceding items, wherein the autoinjector is configured to determine and optionally to communicate, in particular in one or more confirmation signals, at least one of the following: whether a needle cover is removed from the autoinjector prior to an injection and/or whether the device is pressed against an injection site during an injection, in particular based on a contact member signal obtained from pressing a contact member of the autoinjector against the injection site and/or by moving the contact member along a longitudinal axis; whether a dwell time, which is indicative of a time period during which the autoinjector is pressed against the injection site, exceeds a predefined threshold value; whether the complete content of the cartridge was administered; whether air was expelled from the cartridge; whether the content of the cartridge was homogeneously mixed prior to the administering of the cartridge; whether a reconstitution time exceeds a predefined threshold value prior to the administering of the medicament, wherein the reconstitution time is indicative of a time period between a mixing of the content of the cartridge and the injection of the medicament into the injection site, or whether a reconstitution time has elapsed since moving the plunger rod to a predefined plunger rod position.

11. The patient care system of any one of the preceding items, wherein the autoinjector is configured to measure, by use of at least one sensor, an acceleration or orientation signal and to determine, based on the acceleration or orientation signal, that a cartridge inserted into the autoinjector was shaken sufficiently for mixing the medicament in the cartridge.

12. The patient care system of any one of the preceding items, wherein the computing device is configured to determine whether the dose is in accordance with an intended dose in accordance with a predefined dosage regime stored on the computing device and/or the server system.

13. The patient care system of item 12, wherein the computing device is configured to inform the user, in particular by use of a visual message displayed on a display of the computing device and/or an acoustic signal output by a loudspeaker of the computing device, that the dose is or is not in accordance with the predefined dosage regime.

14. The patient care system of item 12 or 13, wherein the computing device is configured to store the code in conjunction with validation information which indicates whether the dose is or is not in accordance with the predefined dosage regime.

15. The patient care system of item 14, wherein the computing device and/or the server system is configured to inform the user and/or a third person when the validation information indicates that the dose is not in accordance with the predefined dosage regime. 16. The patient care system of any one of the preceding items, wherein the autoinjector and the computing device are configured to be linked together in order to communicate with each other via the wireless or wired connection by use of a pairing process, such as a Bluetooth pairing process, wherein, optionally, the pairing process requires the manual entry of a registration code at the computing device, wherein, further optionally, the registration code is based on the serial number of the autoinjector and/or a key printed on the autoinjector.

17. The patient care system of any one of the preceding items, wherein the wireless connection is a Bluetooth connection, 5G or 4G/LTE mobile radio network connection in particular, a Narrowband Intemet-of-Things connection, NB-IoT or another suitable connection, such as LoRa, Sigfox or satellite-based communication or wherein the wired connection is an USB connection.

18. The patient care system of any one of the preceding items, wherein the computing device comprises a screen, in particular a touch screen, and wherein the computing device is configured to display on the screen a plurality of injection sites for the administering of the dose.

19. The patient care system of item 18, wherein the computing device is configured to store previously used injection sites and to display the previously used injection sites, and/or wherein the computing device is configured to enable a user to input an injection site used for administering the dose, in particular by enabling the user to provide a touch input on the corresponding injection site displayed on the screen.

20. The patient care system of item 18 or 19, wherein the computing device is configured to categorize the injection sites of the plurality of injection sites into at least two different categories, for example with regard to a frequency of use of the injection sites, and to display differently the at least two different categories of injection sites.

21. The patient care system of any one of items 18 to 20, wherein the computing device is configured to enable a user to select or unselect or block an injection site, in particular by use of a touch input on the displayed injection site.

22. The patient care system of any one of the preceding items, wherein the computing device is configured to output a reminder, in particular a visual or an acoustic reminder, in accordance with a predefined schedule for the administering of the medicament.

23. The patient care system of any one of the preceding items, wherein the computing device is configured to inform the user to replace the cartridge, wherein, optionally, the autoinjector is configured to determine whether an inserted cartridge is full, not-full or empty and to send a message to the computing device that the cartridge is full, not-full or empty.

24. The patient care system of any one of the preceding items, wherein the cartridge is a dual chamber cartridge, wherein the medicament comprises at least two components or consists of two components, which are kept separated from each other in two chambers of the cartridge prior to the administering of the medicament, wherein, optionally, during operation, the at least two components are mixed in the cartridge so that the medicament is formed in the cartridge prior to the injection of the medicament.

25. The patient care system of any one of the preceding items, wherein the computing device is a first computing device, for example of a patient, and wherein the system further comprises a second computing device, for example of a healthcare professional, and a third computing device, for example of a manufacturer of the autoinjector and/or the medicament, wherein the autoinjector is configured to send selectively data to the first, second or third computing device and/or wherein data is exchangeable between any two of the first, second and third computing device.

26. A patient care system for monitoring injections and/or a patient’s adherence to a prescribed treatment regimen, in particular a patient care system in accordance with any one of the preceding items, wherein the patient care system comprises: an autoinjector configured to administer a medicament, such as a growth hormone, in particular to a patient, wherein the autoinjector is configured to receive a cartridge with the medicament, and a computing device, in particular a mobile and/or a handheld computing device, wherein the autoinjector is configured to send information to the computing device, wherein the information is related to the preparing and/or administering of the medicament, and wherein the autoinjector is configured to use at least a first data stream and a second data stream to provide the information to the computing device, wherein the first data stream is independent from the second data stream.

27. The patient care system of item 26, wherein the cartridge is a dual chamber cartridge having different components of the medicament in the two chambers of the cartridge, wherein the autoinjector is configured to mix the different components prior to the administration of the medicament.

28. The patient care system of item 26 or 27, wherein a dose of the medicament corresponds to a complete content of the medicament in the cartridge, and the autoinjector is configured to administer the complete content in one administration, or wherein the dose of the medicament corresponds to a defined portion of the content of the medicament in the cartridge, and the autoinjector is configured to administer the defined portion in one administration.

29. The patient care system of item 28, wherein the information includes the size of the dose and/or a confirmation that the dose has been administered.

30. The patient care system of any one of the items 26 to 29, wherein the information is transmitted via at least one wireless connection, such as a Bluetooth connection, or at least one wired connection, such as an USB connection.

31. The patient care system of item 26 to 30, wherein different communication schemes are used to provide the first data stream and the second data stream to the computing device.

32. The patient care system of any one of the items 26 to 31, wherein the information sent in the first data stream is of a different type of information than the information sent in the second data stream.

33. The patient care system of any one of the items 26 to 32, wherein the first data stream is configured to provide one or more status messages from the autoinjector and/or the cartridge to the computing device.

34. The patient care system of item 33, wherein a status message is a status message from a predefined set of status messages, wherein, optionally, each status message of the set of status messages includes information about a state of the autoinjector and/or the cartridge.

35. The patient care system of item 33 or 34, wherein a symbol, such as a number, is defined for each status message and wherein for providing a status message to the computing device, the autoinjector is configured to include the symbol of the status message into the first data stream, wherein the computing device is further configured to identify the status message based on the received symbol.

36. The patient care system of any one of the items 33 to 35, wherein, after reception of a status message, the computing device is configured to output, in particular to the user, a notification which is associated with the received status message.

37. The patient care system of any one of the item 36, wherein the notification is obtained from a predefined set of notifications provided on the computing device, wherein each notification of the set of notifications is associated with one of the status messages.

38. The patient care system of item 36 or 37, wherein the notification is output in form of at least one picture and/or animation or a text message on a display of the computing device or in form of an audio message.

39. The patient care system of any one of the items 26 to 38, wherein the autoinjector does not send any response to requests obtained from the computing device via the first data stream.

40. The patient care system of any one of the items 26 to 39, wherein the first data stream is permanently active between the autoinjector and the computing device in the time between the start and the end of the connection, in particular Bluetooth connection.

41. The patient care system of any one of the items 26 to 40, wherein the first data stream is encrypted, preferably using an encryption provided by a communication protocol, such as an encryption provided by Bluetooth.

42. The patient care system of any one of the items 26 to 41, wherein the autoinjector comprises a communication module configured to transmit the data streams, and wherein at least the first data stream is encrypted in the communication module.

43. The patient care system of item 42, wherein the communication module is or comprises a Bluetooth chip.

44. The patient care system of any one of the items 26 to 43, wherein the first data stream includes one or more Bluetooth status messages, in particular Bluetooth unacknowledged status messages.

45. The patient care system of any one of the items 26 to 44, wherein the information received via the first data stream is only stored, in particular temporarily, on the computing device.

46. The patient care system of any one of the items 26 to 45, wherein the second data stream is configured to provide information related to the preparing and/or administering of the medicament from the autoinjector to the computing device.

47. The patient care system of any one of the items 26 to 46, wherein the information in the second data stream includes at least one of the following: a dose log history, preferably including technical parameters in the dose log history, medical data, such as the time stamp and/or the size of the dose, information related to the cartridge, such as cartridge code, data related to one or more earlier injection events, wherein the data optionally includes confirmation or validation information of one or more earlier injection events, used injection sites.

48. The patient care system of any one of the items 26 to 47, wherein the autoinjector does not send any response to requests obtained from the computing device via the second data stream.

49. The patient care system of any one of the items 26 to 48, wherein the computing device is configured to send data, such as confirmation messages, to the autoinjector in response to receiving information in the second data stream.

50. The patient care system of any one of the items 26 to 49, wherein the autoinjector is configured to set the second data stream temporally inactive, in particular during the preparing and/ or administering of the medicament.

51. The patient care system of any one of the items 26 to 50, wherein the second data stream is only active before and after the preparing and/or administering of the medicament.

52. The patient care system of any one of the items 26 to 51, wherein the second data stream is encrypted, in particular by use of a two-step encryption scheme. 53. The patient care system of any one of the items 26 to 52, wherein the second data stream is transmitted via Bluetooth.

54. The patient care system of any one of the items 26 to 53, wherein the information received via the second data stream is stored on the computing device.

55. The patient care system of any one of the items 26 to 54, wherein the computing device is further configured to send at least some of the received information to an external server system, such as a cloud computing system.

56. A patient care system for monitoring injections and/or a patient’s adherence to a prescribed treatment regimen, in particular a patient care system in accordance with any one of the preceding items, wherein the patient care system comprises: an autoinjector configured to administer a medicament, such as a growth hormone, in particular to a patient, wherein the autoinjector is configured to receive a cartridge, optionally a dual chamber cartridge, with the medicament, wherein, further optionally, a dose of the medicament corresponds to a complete content of the medicament in the cartridge, and a computing device, in particular a mobile and/or a handheld computing device, wherein the autoinjector is configured to send information to the computing device, wherein the information is related to the administering of the medicament, and wherein the autoinjector is configured to encrypt at least a portion of the information by use of an end-to-end encryption prior to the sending of the information to the computing device.

57. The patient care system of item 56, wherein the computing device is configured to decrypt the end-to-end encrypted information, in particular by use of one or more applications stored on and/or executed by the computing device.

58. The patient care system of item 56 or 57, wherein the autoinjector is configured to use at least a first data stream and a second data stream to provide the information to the computing device, wherein at least one of the first data stream and the second data stream is encrypted. 59. The patient care system of any one of the items 56 to 58, wherein the encryption includes a two-step encryption process, wherein the information is encrypted in a first step by use of a first encryption scheme and afterwards in a second step by use of a second encryption scheme.

60. The patient care system of item 59, wherein the first encryption scheme is a proprietary encryption scheme.

61. The patient care system of item 59 or 60, wherein the second encryption scheme is a standard encryption scheme, such as an encryption scheme provided by Bluetooth.

62. The patient care system of any one of the items 59 to 61, wherein the first encryption scheme uses a symmetric encryption.

63. The patient care system of item 62, wherein the symmetric encryption uses an encryption key which is provided by the computing device or a server system, such as a cloud computing system, wherein the computing device is configured to connect to the server system.

64. The patient care system of item 62 or 63, wherein the symmetric encryption uses an encryption key which is generated, in particular on the computing device or on a server system, by taking account of a unique specification of the autoinjector, such as a serial number.

65. The patient care system of any one of items 62 to 64, wherein a server system comprises a database in which data which is indicative of reported lost autoinjectors and/or lost computing devices is stored, wherein the server system is configured to provide the encryption key to the computing device only if the autoinjector and/or the computing device are/is not included in the database.

66. The patient care system of any one of the items 62 to 65, wherein an encryption key for symmetric encryption is incorporated, in particular by coding, in the autoinjector and/or the computing device.

67. The patient care system of any one of the items 59 to 66, wherein the autoinjector comprises a main processing unit and wherein the autoinjector is configured to carry out the first encryption scheme on the main processing unit.

68. The patient care system of any one of the items 59 to 67, wherein the autoinjector comprises a communication module, such as a Bluetooth chip or a Bluetooth Low Energy Chip, configured to transmit the information from the autoinjector to the computing device, and wherein the autoinjector is configured to carry out the second encryption scheme on the communication module, wherein, optionally, the second encryption scheme is provided by Bluetooth.

69. The patient care system of any one of the items 59 to 68, wherein the computing device is configured to decrypt the received information by use of a corresponding two-step decryption process.

70. The patient care system of any one of the items 59 to 69, wherein the computing device comprises a main processing unit and wherein the autoinjector is configured to carry out a corresponding first decryption scheme on the main processing unit.

71. The patient care system of any one of the items 59 to 70, wherein the computing device comprises a communication module, such as a Bluetooth chip or a Bluetooth Low Energy Chip, configured to receive the information from the autoinjector, and wherein the computing device is configured to carry out a corresponding second decryption scheme on the communication module.

72. The patient care system of any one of the items 59 to 71, wherein the computing device is configured to provide the encrypted information to the server system, wherein the server system is configured to decrypt the received information. 73. Use of a patient care system as in any of the preceding items for monitoring injections and/or for monitoring a patient’s adherence to a prescribed treatment regimen.

74. A method of monitoring injections and/or a patient’s adherence to a prescribed treatment regimen of administering a medicament using a patient care system, which comprises an autoinjector configured to administer the medicament and a computing device, in particular a patient care system in accordance with any one of the items 1 to 72, the method comprising: identifying, by the autoinjector, the code and sending the code via a wireless or wired connection to the computing device, in particular in response to or prior to the administering of the medicament, and storing, by the computing device, the code on a storage device, which is internal to the computing device and/or on an external server system.

75. The method of item 74, further comprising determining a time stamp and storing the code in conjunction with the time stamp, wherein the time stamp is indicative of the time and/or the date of the administering of the medicament.

76. The method of item 74 or 75, wherein the computing device is a first computing device, for example of a patient, and wherein the system further comprises a second computing device, for example of a healthcare professional, and a third computing device, for example of a manufacturer of the autoinjector and/or the medicament, wherein the autoinjector sends selectively data to the first, second or third computing device, and/or wherein the first computing device sends data, such as data about injections, adherence, therapy outcome, adherence versus height/growth rate, to the second computing device and/or sends data, such as error messages, to the third computing device, and/or wherein the second computing device sends data, such as instructions to stop injections or use a different dose, to the first computing device and/or sends data, such as error messages, to the third computing device, and/or wherein the third computing device sends data, such as information about probl ems/updates or information about the autoinjector, to the first computing device and/or the second computing device. 77. A method of monitoring injections and/or a patient’s adherence to a prescribed treatment regimen of administering a medicament using a patient care system, which comprises an autoinjector configured to administer the medicament and a computing device, in particular a patient care system in accordance with any one of the items 1 to 72, the method comprising: providing the autoinjector such that it comprises a cartridge with the medicament, sending, by the autoinjector, information to the computing device, wherein the information is related to the administering of the medicament, and wherein the information includes first and second information and wherein the first information is sent in a first data stream and the second information is sent in a second data stream to the computing device, wherein the first data stream is independent from the second data stream.

78. A method of monitoring injections carried and/or a patient’s adherence to a prescribed treatment regimen using a patient care system which comprises an autoinjector configured to administer the medicament and a computing device, in particular a patient care system in accordance with any one of the items 1 to 72, the method comprising: providing the autoinjector such that it comprises a cartridge with the medicament, sending, by the autoinjector, information to the computing device, wherein the information is related to the administering of the medicament, and encrypting at least a portion of the information by use of an end-to-end encryption prior to the sending of the information to the computing device.

79. Autoinjector for use in a patient care system in accordance with any one of the items 1 to 72.

80. Use of an autoinjector in a patient care system in accordance with any one of the items 1 to

72.

Claims

2. The patient care system of claim 1, wherein the autoinjector is configured to administer the complete content of the medicament in one administration in response to an activation of the autoinjector by a user, and/or wherein the autoinjector comprises a drive module connected to a battery, the drive module comprising a motor, the drive module being coupled to move a plunger rod between a retracted plunger rod position and an extended plunger rod position.

3. The patient care system of claim 1 or 2, wherein, for administering the complete content of the medicament in one administration, the autoinjector comprises a plunger rod and the cartridge comprises a stopper which is movable by the plunger rod, when the cartridge is inserted in the autoinjector, wherein during an administering process the plunger rod is configured to move the stopper from an initial start position to a final position, in which the stopper is in contact with a distal end of the cartridge in order to remove the complete content of the medicament in one administration from the cartridge.

4. The patient care system of any one of the preceding claims, wherein the code is at least one of the following: a colour code, a code comprising a sequence of colours, a bar code, a QR code, an identification number of the cartridge, a letter and/or number code, a RFID tag, a NFC tag.

5. The patient care system of any one of the preceding claims, wherein the computing device is connected or connectable to the external server system via a communications network, such as the internet, wherein, optionally, the external server system is a cloud computing system.

6. The patient care system of any one of the preceding claims, wherein the computing device is configured to store the code in conjunction with a time stamp that is either determined by the computing device or sent together with the code by the autoinjector, wherein the time stamp is indicative of the time and/or the date of the administering of the medicament.

7. The patient care system of any one of the preceding claims, wherein the autoinjector is configured to determine whether the dose has been administered completely and to send a confirmation, which is indicative that the dose has been administered completely, wherein the computing device is configured to store the code in conjunction with the confirmation.

8. The patient care system of any one of the preceding claims, wherein the autoinjector is configured to determine whether the dose is administered completely based on a start position of a plunger rod of the autoinjector for moving a stopper, in particular a first stopper, of the cartridge and an end position of the plunger rod and/or a start position of the plunger rod and a resistance signal indicative of a resistance against a movement of the plunger rod from the start position to the end position, wherein the autoinjector is configured to determine the start position, the end position and/or the resistance signal and, optionally, to communicate the start position, the end position and/or the resistance signal to the computing device, wherein, further optionally, the start position is a position at which air in the cartridge is removed to an amount appropriate for injection.

9. The patient care system of any one of the preceding claims, wherein the autoinjector is configured to determine and optionally to communicate at least one of the following: a status of the cartridge, in particular whether full, not-full or empty, a position of a plunger rod of the autoinjector, a resistance signal indicative of a resistance of a plunger rod against movement, a contact member signal obtainable from a contact member of the autoinjector, in particular when the contact member is pressed against an injection site, wherein, optionally, the contact member signal is indicative of a start of the administering of the medicament and/or wherein, optionally, the time stamp corresponds to the point in time when the contact member signal is generated or detected in the autoinjector; status information of the medicament, in particular a status of a medicament solution, wherein, optionally the status information comprises a number of inversions of the autoinjector.

10. The patient care system of any one of the preceding claims, wherein the autoinjector is configured to determine and optionally to communicate, in particular in one or more confirmation signals, at least one of the following: whether a needle cover is removed from the autoinjector prior to an injection and/or whether the device is pressed against an injection site during an injection, in particular based on a contact member signal obtained from pressing a contact member of the autoinjector against the injection site and/or by moving the contact member along a longitudinal axis; whether a dwell time, which is indicative of a time period during which the autoinjector is pressed against the injection site, exceeds a predefined threshold value; whether the complete content of the cartridge was administered; whether air was expelled from the cartridge; whether the content of the cartridge was homogeneously mixed prior to the administering of the cartridge; whether a reconstitution time exceeds a predefined threshold value prior to the administering of the medicament, wherein the reconstitution time is indicative of a time period between a mixing of the content of the cartridge and the injection of the medicament into the injection site, or whether a reconstitution time has elapsed since moving the plunger rod to a predefined plunger rod position.

11. The patient care system of any one of the preceding claims, wherein the autoinjector is configured to measure, by use of at least one sensor, an acceleration or orientation signal and to determine, based on the acceleration or orientation signal, that a cartridge inserted into the autoinjector was shaken sufficiently for mixing the medicament in the cartridge.

12. The patient care system of any one of the preceding claims, wherein the computing device is configured to determine whether the dose is in accordance with an intended dose in accordance with a predefined dosage regime stored on the computing device and/or the server system.

13. The patient care system of claim 12, wherein the computing device is configured to inform the user, in particular by use of a visual message displayed on a display of the computing device and/or an acoustic signal output by a loudspeaker of the computing device, that the dose is or is not in accordance with the predefined dosage regime.

14. The patient care system of claim 12 or 13, wherein the computing device is configured to store the code in conjunction with validation information which indicates whether the dose is or is not in accordance with the predefined dosage regime.

15. The patient care system of claim 14, wherein the computing device and/or the server system is configured to inform the user and/or a third person when the validation information indicates that the dose is not in accordance with the predefined dosage regime.

16. The patient care system of any one of the preceding claims, wherein the autoinjector and the computing device are configured to be linked together in order to communicate with each other via the wireless or wired connection by use of a pairing process, such as a Bluetooth pairing process, wherein, optionally, the pairing process requires the manual entry of a registration code at the computing device, wherein, further optionally, the registration code is based on the serial number of the autoinjector and/or a key printed on the autoinjector.

17. The patient care system of any one of the preceding claims, wherein the wireless connection is a Bluetooth connection, 5G or 4G/LTE mobile radio network connection in particular, a Narrowband Intemet-of-Things connection, NB-IoT or another suitable connection, such as LoRa, Sigfox or satellite-based communication or wherein the wired connection is an USB connection.

18. The patient care system of any one of the preceding claims, wherein the computing device comprises a screen, in particular a touch screen, and wherein the computing device is configured to display on the screen a plurality of injection sites for the administering of the dose.

19. The patient care system of claim 18, wherein the computing device is configured to store previously used injection sites and to display the previously used injection sites, and/or wherein the computing device is configured to enable a user to input an injection site used for administering the dose, in particular by enabling the user to provide a touch input on the corresponding injection site displayed on the screen.

20. The patient care system of claim 18 or 19, wherein the computing device is configured to categorize the injection sites of the plurality of injection sites into at least two different categories, for example with regard to a frequency of use of the injection sites, and to display differently the at least two different categories of injection sites.

21. The patient care system of any one of claims 18 to 20, wherein the computing device is configured to enable a user to select or unselect or block an injection site, in particular by use of a touch input on the displayed injection site.

22. The patient care system of any one of the preceding claims, wherein the computing device is configured to output a reminder, in particular a visual or an acoustic reminder, in accordance with a predefined schedule for the administering of the medicament.

23. The patient care system of any one of the preceding claims, wherein the computing device is configured to inform the user to replace the cartridge, wherein, optionally, the autoinjector is configured to determine whether an inserted cartridge is full, not-full or empty and to send a message to the computing device that the cartridge is full, not-full or empty.

24. The patient care system of any one of the preceding claims, wherein the cartridge is a dual chamber cartridge, wherein the medicament comprises at least two components or consists of two components, which are kept separated from each other in two chambers of the cartridge prior to the administering of the medicament, wherein, optionally, during operation, the at least two components are mixed in the cartridge so that the medicament is formed in the cartridge prior to the injection of the medicament.

25. The patient care system of any one of the preceding claims, wherein the computing device is a first computing device, for example of a patient, and wherein the system further comprises a second computing device, for example of a healthcare professional, and a third computing device, for example of a manufacturer of the autoinjector and/or the medicament, wherein the autoinjector is configured to send selectively data to the first, second or third computing device and/or wherein data is exchangeable between any two of the first, second and third computing device.

26. A patient care system for monitoring injections and/or a patient’s adherence to a prescribed treatment regimen, in particular a patient care system in accordance with any one of the preceding claims, wherein the patient care system comprises: an autoinjector configured to administer a medicament, such as a growth hormone, in particular to a patient, wherein the autoinjector is configured to receive a cartridge with the medicament, and a computing device, in particular a mobile and/or a handheld computing device, wherein the autoinjector is configured to send information to the computing device, wherein the information is related to the preparing and/or administering of the medicament, and wherein the autoinjector is configured to use at least a first data stream and a second data stream to provide the information to the computing device, wherein the first data stream is independent from the second data stream.

27. The patient care system of claim 26, wherein the cartridge is a dual chamber cartridge having different components of the medicament in the two chambers of the cartridge, wherein the autoinjector is configured to mix the different components prior to the administration of the medicament.

28. The patient care system of claim 26 or 27, wherein a dose of the medicament corresponds to a complete content of the medicament in the cartridge, and the autoinjector is configured to administer the complete content in one administration, or wherein the dose of the medicament corresponds to a defined portion of the content of the medicament in the cartridge, and the autoinjector is configured to administer the defined portion in one administration.

29. The patient care system of claim 28, wherein the information includes the size of the dose and/or a confirmation that the dose has been administered.

30. The patient care system of any one of the claims 26 to 29, wherein the information is transmitted via at least one wireless connection, such as a Bluetooth connection, or at least one wired connection, such as an USB connection.

31. The patient care system of any one of claims 26 to 30, wherein different communication schemes are used to provide the first data stream and the second data stream to the computing device.

32. The patient care system of any one of the claims 26 to 31, wherein the information sent in the first data stream is of a different type of information than the information sent in the second data stream.

33. The patient care system of any one of the claims 26 to 32, wherein the first data stream is configured to provide one or more status messages from the autoinjector and/or the cartridge to the computing device.

34. The patient care system of claim 33, wherein a status message is a status message from a predefined set of status messages, wherein, optionally, each status message of the set of status messages includes information about a state of the autoinjector and/or the cartridge.

35. The patient care system of claim 33 or 34, wherein a symbol, such as a number, is defined for each status message and wherein for providing a status message to the computing device, the autoinjector is configured to include the symbol of the status message into the first data stream, wherein the computing device is further configured to identify the status message based on the received symbol.

36. The patient care system of any one of the claims 33 to 35, wherein, after reception of a status message, the computing device is configured to output, in particular to the user, a notification which is associated with the received status message.

37. The patient care system of any one of the claim 36, wherein the notification is obtained from a predefined set of notifications provided on the computing device, wherein each notification of the set of notifications is associated with one of the status messages.

38. The patient care system of claim 36 or 37, wherein the notification is output in form of at least one picture and/or animation or a text message on a display of the computing device or in form of an audio message.

39. The patient care system of any one of the claims 26 to 38, wherein the autoinjector does not send any response to requests obtained from the computing device via the first data stream.

40. The patient care system of any one of the claims 26 to 39, wherein the first data stream is permanently active between the autoinjector and the computing device in the time between the start and the end of the connection, in particular Bluetooth connection.

41. The patient care system of any one of the claims 26 to 40, wherein the first data stream is encrypted, preferably using an encryption provided by a communication protocol, such as an encryption provided by Bluetooth.

42. The patient care system of any one of the claims 26 to 41, wherein the autoinjector comprises a communication module configured to transmit the data streams, and wherein at least the first data stream is encrypted in the communication module.

43. The patient care system of claim 42, wherein the communication module is or comprises a Bluetooth chip.

44. The patient care system of any one of the claims 26 to 43, wherein the first data stream includes one or more Bluetooth status messages, in particular Bluetooth unacknowledged status messages.

45. The patient care system of any one of the claims 26 to 44, wherein the information received via the first data stream is only stored, in particular temporarily, on the computing device.

46. The patient care system of any one of the claims 26 to 45, wherein the second data stream is configured to provide information related to the preparing and/or administering of the medicament from the autoinjector to the computing device.

47. The patient care system of any one of the claims 26 to 46, wherein the information in the second data stream includes at least one of the following: a dose log history, preferably including technical parameters in the dose log history, medical data, such as the time stamp and/or the size of the dose, information related to the cartridge, such as cartridge code, data related to one or more earlier injection events, wherein the data optionally includes confirmation or validation information of one or more earlier injection events, used injection sites.

48. The patient care system of any one of the claims 26 to 47, wherein the autoinjector does not send any response to requests obtained from the computing device via the second data stream.

49. The patient care system of any one of the claims 26 to 48, wherein the computing device is configured to send data, such as confirmation messages, to the autoinjector in response to receiving information in the second data stream.

50. The patient care system of any one of the claims 26 to 49, wherein the autoinjector is configured to set the second data stream temporally inactive, in particular during the preparing and/ or administering of the medicament.

51. The patient care system of any one of the claims 26 to 50, wherein the second data stream is only active before and after the preparing and/or administering of the medicament.

52. The patient care system of any one of the claims 26 to 51, wherein the second data stream is encrypted, in particular by use of a two-step encryption scheme.

53. The patient care system of any one of the claims 26 to 52, wherein the second data stream is transmitted via Bluetooth.

54. The patient care system of any one of the claims 26 to 53, wherein the information received via the second data stream is stored on the computing device.

55. The patient care system of any one of the claims 26 to 54, wherein the computing device is further configured to send at least some of the received information to an external server system, such as a cloud computing system.

56. A patient care system for monitoring injections and/or a patient’s adherence to a prescribed treatment regimen, in particular a patient care system in accordance with any one of the preceding claims, wherein the patient care system comprises: an autoinjector configured to administer a medicament, such as a growth hormone, in particular to a patient, wherein the autoinjector is configured to receive a cartridge, optionally a dual chamber cartridge, with the medicament, wherein, further optionally, a dose of the medicament corresponds to a complete content of the medicament in the cartridge, and a computing device, in particular a mobile and/or a handheld computing device, wherein the autoinjector is configured to send information to the computing device, wherein the information is related to the administering of the medicament, and wherein the autoinjector is configured to encrypt at least a portion of the information by use of an end-to-end encryption prior to the sending of the information to the computing device.

57. The patient care system of claim 56, wherein the computing device is configured to decrypt the end-to-end encrypted information, in particular by use of one or more applications stored on and/or executed by the computing device.

58. The patient care system of claim 56 or 57, wherein the autoinjector is configured to use at least a first data stream and a second data stream to provide the information to the computing device, wherein at least one of the first data stream and the second data stream is encrypted.

59. The patient care system of any one of the claims 56 to 58, wherein the encryption includes a two-step encryption process, wherein the information is encrypted in a first step by use of a first encryption scheme and afterwards in a second step by use of a second encryption scheme.

60. The patient care system of claim 59, wherein the first encryption scheme is a proprietary encryption scheme.

61. The patient care system of claim 59 or 60, wherein the second encryption scheme is a standard encryption scheme, such as an encryption scheme provided by Bluetooth.

62. The patient care system of any one of the claims 59 to 61, wherein the first encryption scheme uses a symmetric encryption.

63. The patient care system of claim 62, wherein the symmetric encryption uses an encryption key which is provided by the computing device or a server system, such as a cloud computing system, wherein the computing device is configured to connect to the server system.

64. The patient care system of claim 62 or 63, wherein the symmetric encryption uses an encryption key which is generated, in particular on the computing device or on a server system, by taking account of a unique specification of the autoinjector, such as a serial number.

65. The patient care system of any one of claims 62 to 64, wherein a server system comprises a database in which data which is indicative of reported lost autoinjectors and/or lost computing devices is stored, wherein the server system is configured to provide the encryption key to the computing device only if the autoinjector and/or the computing device are/is not included in the database.

66. The patient care system of any one of the claims 62 to 65, wherein an encryption key for symmetric encryption is incorporated, in particular by coding, in the autoinjector and/or the computing device.

67. The patient care system of any one of the claims 59 to 66, wherein the autoinjector comprises a main processing unit and wherein the autoinjector is configured to carry out the first encryption scheme on the main processing unit.

68. The patient care system of any one of the claims 59 to 67, wherein the autoinjector comprises a communication module, such as a Bluetooth chip or a Bluetooth Low Energy Chip, configured to transmit the information from the autoinjector to the computing device, and wherein the autoinjector is configured to carry out the second encryption scheme on the communication module, wherein, optionally, the second encryption scheme is provided by Bluetooth.

69. The patient care system of any one of the claims 59 to 68, wherein the computing device is configured to decrypt the received information by use of a corresponding two-step decryption process.

70. The patient care system of any one of the claims 59 to 69, wherein the computing device comprises a main processing unit and wherein the autoinjector is configured to carry out a corresponding first decryption scheme on the main processing unit.

71. The patient care system of any one of the claims 59 to 70, wherein the computing device comprises a communication module, such as a Bluetooth chip or a Bluetooth Low Energy Chip, configured to receive the information from the autoinjector, and wherein the computing device is configured to carry out a corresponding second decryption scheme on the communication module.

72. The patient care system of any one of the claims 59 to 71, wherein the computing device is configured to provide the encrypted information to the server system, wherein the server system is configured to decrypt the received information.

73. Use of a patient care system as in any of the preceding claims for monitoring injections and/or for monitoring a patient’s adherence to a prescribed treatment regimen.

74. A method of monitoring injections and/or a patient’s adherence to a prescribed treatment regimen of administering a medicament using a patient care system, which comprises an autoinjector configured to administer the medicament and a computing device, in particular a patient care system in accordance with any one of the claims 1 to 72, the method comprising: identifying, by the autoinjector, the code and sending the code via a wireless or wired connection to the computing device, in particular in response to or prior to the administering of the medicament, and storing, by the computing device, the code on a storage device, which is internal to the computing device and/or on an external server system.

75. The method of claim 74, further comprising determining a time stamp and storing the code in conjunction with the time stamp, wherein the time stamp is indicative of the time and/or the date of the administering of the medicament.

76. The method of claim 74 or 75, wherein the computing device is a first computing device, for example of a patient, and wherein the system further comprises a second computing device, for example of a healthcare professional, and a third computing device, for example of a manufacturer of the autoinjector and/or the medicament, wherein the autoinjector sends selectively data to the first, second or third computing device, and/or wherein the first computing device sends data, such as data about injections, adherence, therapy outcome, adherence versus height/growth rate, to the second computing device and/or sends data, such as error messages, to the third computing device, and/or wherein the second computing device sends data, such as instructions to stop injections or use a different dose, to the first computing device and/or sends data, such as error messages, to the third computing device, and/or wherein the third computing device sends data, such as information about probl ems/updates or information about the autoinjector, to the first computing device and/or the second computing device.

77. A method of monitoring injections and/or a patient’s adherence to a prescribed treatment regimen of administering a medicament using a patient care system, which comprises an autoinjector configured to administer the medicament and a computing device, in particular a patient care system in accordance with any one of the claims 1 to 72, the method comprising: providing the autoinjector such that it comprises a cartridge with the medicament, sending, by the autoinjector, information to the computing device, wherein the information is related to the administering of the medicament, and wherein the information includes first and second information and wherein the first information is sent in a first data stream and the second information is sent in a second data stream to the computing device, wherein the first data stream is independent from the second data stream.

78. A method of monitoring injections carried and/or a patient’s adherence to a prescribed treatment regimen using a patient care system which comprises an autoinjector configured to administer the medicament and a computing device, in particular a patient care system in accordance with any one of the claims 1 to 72, the method comprising: providing the autoinjector such that it comprises a cartridge with the medicament, sending, by the autoinjector, information to the computing device, wherein the information is related to the administering of the medicament, and encrypting at least a portion of the information by use of an end-to-end encryption prior to the sending of the information to the computing device.

79. Autoinjector for use in a patient care system in accordance with any one of the claims 1 to 72.

80. Use of an autoinjector in a patient care system in accordance with any one of the claims 1 to 72.