An injection device including a remote controller

Abstract

In one aspect, the present disclosure relates to an injection device configured to eject a dose of a medication, comprising: a housing (10) configured to accommodate a medication reservoir (6); a drive mechanism (30) configured to mechanically interact with the medication reservoir (6) and including an electric propulsion unit (32) configured to draw or eject a quantity of medication from the medication reservoir (6); and at least a first interface (50) directly or indirectly connected to the electric propulsion unit (32) and configured to connect to a second interface (150) of an auxiliary electronic device (100), wherein the electric propulsion unit (32) is controllable by the auxiliary electronic device (100) when the first interface (50) and the second interface (150) are interconnected. [Selection diagram] Figure 4

Description

Technical Field

[0001] The present disclosure relates to an injection device configured to dispense a dose of a medicament and an auxiliary electronic device configured to couple to such an injection device. In another aspect, the present disclosure relates to an injection system including an injection device and an auxiliary electronic device coupled to the injection device. In a further aspect, the present disclosure relates to a computer program comprising computer-readable instructions scheduled to be executed by a processor of an auxiliary electronic device configured to couple to an injection device.

Background Art

[0002] Drug delivery devices for setting and dispensing single or multiple doses of a liquid medicament are themselves well known in the art. Generally, such devices have substantially the same purpose as a conventional syringe.

[0003] Drug delivery devices such as pen-type syringes must meet many user-specific requirements. For example, if a patient suffers from a chronic disease such as diabetes, the patient may be physically weak and have reduced vision. Thus, a suitable drug delivery device, particularly one intended for home use, must be robust in construction and easy to use. Further, the operation and general handling of the device and its components must be clear and easily understandable. Such an injection device should provide for the setting and subsequent dispensing of variable-sized doses of a medicament. Further, the dose-setting and dose-dispensing procedures must be easy to operate and free of ambiguity.

[0004] Typically, such a device includes a housing or a specific cartridge holder adapted to receive a cartridge at least partially filled with the drug scheduled for administration. The device further includes a drive mechanism having a piston rod displaceable for operatively engaging, usually, the stopper or piston of the cartridge. By the drive mechanism and its piston rod, the stopper or piston of the cartridge is displaceable in the distal or dosing direction and, thus, can discharge a predetermined amount of drug through a piercing assembly, e.g., in the form of a hypodermic needle, which is to be releasably connected to the distal end of the housing of the drug delivery device.

[0005] The drug scheduled for administration by the drug delivery device is provided and contained within a multi-dose cartridge. Such a cartridge typically includes a glass barrel sealed in the distal direction by a pierceable seal and further sealed in the proximal direction by a piston. When using a reusable drug delivery device, the empty cartridge can be replaced with a new one. In contrast, a disposable type of drug delivery device is intended to be discarded entirely when the drug in the cartridge has been administered or depleted.

[0006] In some drug delivery devices, such as pen-type injection devices, the user has to set a variable-sized dose by rotating a dose dial and a dose dial sleeve clockwise or in the dose increment direction with respect to the body or housing of the injection device. To inject and discharge the dose of the liquid drug, the user has to push a trigger or dose button in the distal direction and thus towards the body or housing of the injection device. Typically, the user uses the thumb to apply distal pressure to the dose button located at the proximal end of the dose dial and the dose dial sleeve while holding the housing of the injection device with the remaining fingers of the same hand.

[0007] There are injection devices such as pen-type syringes configured as disposable devices. These injection devices are pre-filled with injectable drugs. When the drug is exhausted throughout the injection device, the injection device is intended to be discarded. There are also reusable injection devices equipped with a drug container or drug reservoir intended to be replaced after the drug contained therein is exhausted. Such reusable injection devices enable the replacement of a drug reservoir or a drug container such as a cartridge.

[0008] For injection devices, it is desirable to enable accurate and highly reliable semi-automatic monitoring and / or collection of injection-related data during use of the injection device. Such injection devices include an electronically implemented add-on device or data collection device configured to monitor user-induced operations of the injection device. A data collection device for attachment to an injection device should be fairly compact in terms of its geometric size. In the case of a data collection device configured to be attached to a mechanically implemented injection device, it is difficult to detect and / or quantitatively measure manual operations of the device performed by the user of the device, for example, when the user rotates the dial member of the injection device during dose setting or when a rotatable component of the injection device rotates during dose ejection. However, even for electronically implemented injection devices, it is desirable to provide accurate, reliable, and fail-safe quantitative measurements of rotatable components of the injection device.

[0009] In either type of injection device, it is desirable to monitor the operation of the injection device, for example, with respect to monitoring the size of the injected dose, the time at which the dose is injected, and other injection-related parameters. SUMMARY OF THE INVENTION PROBLEMS TO BE SOLVED BY THE INVENTION

[0010] In view of the above, a particular object is to provide an injection device, an auxiliary electronic device for connecting to the injection device, and an injection system including the injection device and the auxiliary electronic device that enables universal connection. The auxiliary electronic device should provide an extended function beyond mere monitoring of the operation of the injection device when connected or engaged with the injection device. Further, the injection device should include a fairly simple structure. The cost of manufacturing the injection device should be medium or at a fairly low level. The injection device should have a compact design and a compact geometry. Assuming that the injection device and the auxiliary electronic device have an interface that matches each other, the auxiliary electronic device should be connectable or configured to connect to various different injection devices.

Means for Solving the Problem

[0011] In one aspect, an injection device configured to discharge a dose of a drug is provided. The injection device includes a housing configured to accommodate a drug reservoir. The injection device further includes a drive mechanism. The drive mechanism includes an electric propulsion unit or an electric drive unit configured to mechanically interact with the drug reservoir. The drive mechanism and the electric propulsion unit are configured to draw or discharge an amount of the drug from the drug reservoir. That is, the drive mechanism and the electric propulsion unit should be configured to draw or discharge a dose of the drug of a predetermined or variable user-defined size.

[0012] The injection device further includes a first interface directly or indirectly connected to the electric propulsion unit. The first interface is configured to connect to a second interface of an auxiliary electronic device. The electric propulsion unit is controllable by the auxiliary electronic device when the first interface and the second interface are interconnected. The auxiliary electronic device is a separate device. The auxiliary electronic device does not coincide with the injection device and is different from the injection device. The auxiliary electronic device typically includes a user interface and a processor for controlling the electric propulsion unit of the injection device when the auxiliary electronic device and the injection device are coupled to each other via the first and second interfaces interconnected with each other. In this way, the injection device does not require its own processor or respective electronic control circuits. The operation of the drive mechanism is completely dominated by the auxiliary electronic device. If the auxiliary electronic device is not connected to the injection device, the injection device may become inoperable. In this way, the injection device cannot operate independently without connection to the auxiliary electronic device.

[0013] The auxiliary electronic device typically includes a memory and a communication interface connected to the processor of the auxiliary electronic device. In this way, the auxiliary electronic device and its electronic components are configured to monitor the operation of the injection device. The auxiliary electronic device is configured to record at least the dosage history of the injection device. The auxiliary electronic device is configured to track at least one of the number of dosages, the size of the dosage, and the time point when each dosage is set and discharged or injected.

[0014] Since the auxiliary electronic device is configured to control the electrical propulsion unit of the injection device, and since the injection device does not have its own electronic control circuit, it is essential to establish a connection or linkage between the injection device and the auxiliary electronic device in order to set and / or dispense the dosage of the drug. In this way, it is ensured in some form that any dispensing or ejection operation of the injection device can be monitored and is monitored by the auxiliary electronic device.

[0015] Since the injection device includes an electrical propulsion unit that can be controlled by the auxiliary electronic device, no additional sensors are required in the auxiliary electronic device to measure or detect the size of the dosage currently set or dispensed by the injection device. By controlling the electrical propulsion unit via the auxiliary electronic device and by controlling the drive mechanism, the auxiliary electronic device inherently provides information regarding the size of the dosage actually dispensed and / or the remaining available units / volume of the drug remaining in the drug container. The dosage size information is generated by the auxiliary electronic device and can be obtained directly from the electrical control signal configured to control the electrical propulsion unit of the injection device.

[0016] In a further example, the first interface of the injection device includes a first power connector configured to establish a power connection with a second power connector of the second interface. The second power connector belongs to the auxiliary electronic device. When the first power connector of the injection device and the second power connector of the auxiliary electronic device are interconnected, power can be transferred from the auxiliary electronic device to the injection device. Typically, the first power connector is directly or indirectly connected to the electrical propulsion unit. To that extent, the injection device does not have its own power source or power supply unit. The electrical propulsion unit of the injection device is powered by the auxiliary electronic device when the first power connector and the second power connector are interconnected. The electrical propulsion unit of the injection device is fully powered by the auxiliary electronic device when the respective power connectors are interconnected.

[0017] The first power connector is disposed on the first interface such that when the first and second interfaces are interconnected with each other, it automatically connects to the second power connector of the second interface. This eliminates the need for manual connection between the first power connector and the second power connector. The first and second power connectors are respectively disposed on the first interface and the second interface such that a power connection is established between the first and second power connectors when the first and second interfaces of the injection device and the auxiliary electronic device are interconnected.

[0018] In some examples, the injection device includes its own power source such as a battery or a rechargeable battery. Here, the power connection provided by the first and second power connectors functions to recharge the on-board power source of the injection device. In this way, the injection device also includes its own power source with limited capacity that can be recharged via the power connection with the auxiliary electronic device. Thus, the auxiliary electronic device provides a charging function to the injection device.

[0019] According to a further example, the first interface includes a first data connector configured to establish a data connection with the second data connector of the second interface. The second data connector belongs to the auxiliary electronic device. When interconnected with the first data connector of the first interface of the injection device, the second data connector is configured to transmit an electrical control signal to the electric propulsion unit. To that extent, the first data connector is directly or indirectly connected to the electric propulsion unit. Typically, the electrical control signal generated by the auxiliary electronic device and transferred to the injection device via the data connection is configured to trigger and / or control the operation of the electric propulsion unit.

[0020] The data connection established by the first and second data connectors interconnected with each other includes bidirectional transmission of electronic data between the injection device and the auxiliary electronic device. The data connection between the injection device and the auxiliary electronic device enables the configuration of an injection device without its own electronic control circuit. In this way, the processor of the auxiliary electronic device or each electronic control circuit can be directly connected to the electric propulsion unit of the injection device. Therefore, the injection device does not have its own electronic control circuit. In this way, the manufacturing cost related to the injection device can be reduced.

[0021] When the injection device does not have its own electronic control circuit, the first data connector is directly connected to the electric propulsion unit. In other examples, the injection device includes its own electronic control circuit. At this time, the first data connector is typically connected to the built-in electronic control circuit of the injection device. At this time, the electronic control circuit is connected to the electric propulsion unit of the injection device. However, the electronic control circuit of the injection device can be controlled or configured via the data connection with the auxiliary electronic device.

[0022] When the injection device is equipped with its own electronic control circuit, the data connection established between the first and second data connectors is of the bidirectional type. Here, the first data connector of the injection device is configured to receive an electronic control signal via the established data connection and transmit an electronic control signal or an electronic feedback signal to the auxiliary electronic device. In some examples, the injection device includes its own electronic control circuit and its own power source. This enables at least limited independent operation of the injection device, for example, to discharge at least a specific number of doses of a drug. When establishing a data connection with the auxiliary electronic device, injection-related data such as the size of the dose and the time when each dose is set and / or discharged can be transmitted to the auxiliary electronic device via the data connection.

[0023] The first data connector is positioned and arranged at the first interface of the injection device such that when the first interface and the second interface are interconnected with each other, a data connection with the second data connector is automatically established.

[0024] In some examples, the first power connector and the first data connector coincide or are implemented in a common plug or socket of the first interface. The same is true for the second power connector and the second data connector. When a power connection is established by interconnecting the first power connector and the second power connector, a data connection is also inherently established.

[0025] In a further example, the injection device includes a first mechanical connector configured to establish a mechanical connection with an auxiliary electronic device. The first mechanical connector is configured to provide a form-fitting mechanical interconnection to the auxiliary electronic device. For this purpose, the housing of the injection device comprises a male or female mechanical connector, which is configured to mechanically and releasably engage with a correspondingly shaped female or male connector of the housing of the auxiliary electronic device.

[0026] The first mechanical connector is configured to releasably engage with a second mechanical connector of complementary or corresponding shape of the auxiliary electronic device. In other examples, the first mechanical connector is configured to mechanically engage with the housing of the auxiliary electronic device. Here, the first mechanical connector is configured to receive a part of the housing of the auxiliary electronic device. The auxiliary electronic device does not require a specific second mechanical connector to establish a mechanical connection with the injection device.

[0027] In some examples, the first mechanical connector is consistent with, or includes, the first interface of the injection device. In this way, when establishing a mechanical connection between the injection device and the auxiliary electronic device, the first and second interfaces of the injection device and the auxiliary electronic device are inherently connected when the mechanical connection between the injection device and the auxiliary electronic device is established. For example, the male or female plug or socket of the first interface is located or integrated with the first mechanical connector such that when establishing a mechanical connection with the auxiliary electronic device, the male or female plug or socket of a complementary or corresponding shape of the injection device is connected to the respective plug or socket of the auxiliary electronic device. Typically, the first interface of the injection device includes a plug, and the second interface of the auxiliary electronic device includes a socket configured to receive the plug of the injection device.

[0028] According to another example, the injection device includes a first optical interface configured to establish a light transmitting optical coupling with the second optical interface of the auxiliary electronic device. The first optical interface of the injection device includes a dual function. The first optical interface enables an optical or visual inspection of the contents of the drug reservoir, and thus the drug. The first optical interface further functions to provide visual feedback to the user during the use and operation of the injection device. By the light transmitting optical coupling to the second optical interface of the auxiliary electronic device, the auxiliary electronic device is enabled to perform a visual inspection of the contents of the drug reservoir.

[0029] In a further aspect, the auxiliary electronic device uses optical transmission optical coupling to illuminate at least a specific part of the injection device when the injection device is connected to the auxiliary electronic device. In this way, the auxiliary electronic device is configured to generate a visual feedback signal that is directly identifiable at the first optical interface or other parts of the injection device. To that extent, the optical transmission optical coupling between the injection device and the auxiliary electronic device provides a visual inspection of the drug reservoir and enables the illumination effect of the injection device. Since the first and second optical interfaces enable and establish the optical transmission optical coupling, the injection device does not have a light source.

[0030] The light source is exclusively provided by the auxiliary electronic device. Generally, it is conceivable that the injection device includes its own light source, for example, to provide a visual optical feedback signal to the user, for example, indicating that the preparation of the injection device for performing the injection procedure is complete or that the injection procedure has ended. Here, the optical coupling between the injection device and the auxiliary electronic device is limited to the visual inspection of the contents of the drug reservoir. For example, the first optical interface overlaps or coincides with a window in the housing of the injection device. Through the window, at least a part of the drug reservoir is identifiable and thus visually inspectable.

[0031] The second optical interface of the auxiliary electronic device includes a light source and a light detector such as a camera. The second optical interface is configured to visually inspect the integrity of the drug located within the drug reservoir. For this purpose, the second optical interface, and thus the light source and detector of the auxiliary electronic device, are configured to quantitatively measure the light transmission or absorption coefficient of the drug located within the drug reservoir. The measurable absorption of the drug indicates the integrity of the drug located within the drug reservoir.

[0032] In another example, the injection device does not have at least one of an electronic control circuit, a power source, and a light source. The injection device may not have at least two of the above-described components, an electronic control circuit, a power source, and a light source. The injection device may not have an electronic control circuit, a power source, and a light source. In this way, the manufacturing cost and each expense can be further reduced. In other examples, the injection device includes at least one of an electronic control circuit, a power source, and a light source. In this way, the injection device has at least limited functions, and thus enables at least limited independent operation of the injection device when, for example, an auxiliary electronic device is not available or not connected to the injection device.

[0033] In another example, the injection device includes a drug reservoir at least partially filled with an injectable drug. The drug reservoir has a pierceable seal at its distal end and includes a glass barrel sealed by a displaceable stopper towards its proximal end.

[0034] In another aspect, the present disclosure relates to an auxiliary electronic device configured to be coupled to the injection device described above. The auxiliary electronic device includes a housing, a user interface, a processor, and a second interface configured to connect to a first interface of the injection device. Here, the processor is configured to control at least the electric propulsion unit of the injection device when the second interface and the first interface are interconnected. Thus, the auxiliary electronic device is configured to control the operation of the electric propulsion unit and the operation of the injection device. Through the user interface, the auxiliary electronic device provides an interaction with the user. In order to operate and control the injection procedure, the user can communicate and operate exclusively with the user interface of the auxiliary electronic device. User commands input to the user interface of the auxiliary electronic device are processed by the processor of the auxiliary electronic device and are further used to generate respective electrical control signals transmitted to the electric propulsion unit of the injection device via the connected first and second interfaces.

[0035] In this way, the auxiliary electronic device provides and realizes the remote controller of the injection device. In some examples, the injection device is inoperable alone. The injection device requires a connection to the auxiliary electronic device to operate or control the electric propulsion part of its drive mechanism.

[0036] According to another example, the second interface of the auxiliary electronic device includes a second power connector. Further, the auxiliary electronic device includes an electrical energy source connected to the second power connector. In this way, when properly connected to the injection device, the power or electrical energy provided by the electrical energy source of the auxiliary electronic device can be transferred to the injection device through the power connection established by the interconnection of the first and second power connectors. Typically, the second power connector is arranged on the second interface such that when the connection between the first interface and the second interface is established, the first power connector is also connected to the second power connector.

[0037] When establishing the connection between the first and second interfaces, the first power connector is connected to the electrical energy source of the auxiliary electronic device through the first and second power connectors connected to each other. In this way, the injection device does not have its own power source or electrical energy source. In an example where the injection device includes its own power source, the injection device includes a rechargeable battery that can be recharged by the power source of the auxiliary electronic device when the first and second power connectors are interconnected.

[0038] In a further example, the second interface includes a second data connector connected to the processor of the auxiliary electronic device. The second data connector is configured to establish a data connection with the first data connector of the injection device. Typically, the second data connector is located at the second interface such that the first and second data connectors interconnect with each other when the first and second interfaces are interconnected. In this way, when the connection between the first and second interfaces is established, the first and second data connectors are also interconnected with each other, and a data connection between the injection device and the auxiliary electronic device is established.

[0039] Via the data connection, the processor of the auxiliary electronic device can be electrically connected to the electric propulsion unit of the drive mechanism of the injection device. In this way, the processor of the auxiliary electronic device is enabled to control the operation of the electric propulsion unit. Here, the injection device does not have its own electronic control circuit or its own processor. In some examples, the injection device includes its own electronic control circuit that can be connected to the processor of the auxiliary electronic device via a data connection. In this way, the data connection is of a bidirectional type. The data connection can transmit an electronic control signal from the processor of the auxiliary electronic device to the electronic control circuit of the injection device. Similarly, the electronic data or electronically stored information provided by the electronic control circuit of the injection device can also be transferred and transmitted to the processor of the auxiliary electronic device via the data connection.

[0040] When the injection device is provided with its own electronic control circuit, the injection device is configured to perform or execute at least a limited number of injection procedures in an independent mode, i.e., without interconnection to the auxiliary electronic device. When properly connected to the auxiliary electronic device, the injection-related data collected and stored in the electronic control circuit of the injection device is transferred via the data connection to the processor of the auxiliary electronic device for further processing, or for reporting and transmitting to a further electronic device, such as a physician's computer, for example, to manage the patient's compliance with the prescribed pharmaceutical schedule.

[0041] According to another example, the auxiliary electronic device includes a second mechanical connector configured to establish a mechanical connection with the first mechanical connector of the injection device. The second mechanical connector comprises at least one of a male or female connector, which has a complementary or corresponding shape to the female or male first mechanical connector of the injection device. The corresponding first and second mechanical connectors of the injection device and the auxiliary electronic device enable a dedicated, well-defined, fail-safe, and releasable mutual mechanical interconnection between the injection device and the auxiliary electronic device. The first and second mechanical connectors include a pair of corresponding plug and socket. For example, the first mechanical connector includes a mechanical plug intended to be received in the female socket of the auxiliary electronic device.

[0042] The first and second mechanical connectors coincide with, or are integrated into, the respective first and second interfaces of the injection device and the auxiliary electronic device. For example, the first mechanical connector coincides with, or is integrated into, the first interface. The second mechanical connector coincides with, or is integrated into, the second interface. When the connection of the first and second interfaces is established, the injection device and the auxiliary electronic device are also mechanically interconnected. Therefore, when the mechanical connection between the injection device and the auxiliary electronic device is established by the corresponding first and second mechanical connectors, the first and second interfaces of the injection device and the auxiliary electronic device can be connected to each other.

[0043] In some examples, the first interface and / or the second interface is positioned offset from at least one of the first and second mechanical connectors. The first and second interfaces are considered to be exclusively configured to provide at least one of a power connection, a data connection, or an optical coupling without a mechanical connection between the injection device and the auxiliary electronic device.

[0044] In some examples, it is conceivable that the injection device and the auxiliary electronic device are interconnected by a cable or wirelessly interconnected without being mechanically linked or coupled. This provides a fairly free mechanical arrangement of the injection device and the auxiliary electronic device. Thus, it is not necessary to mechanically link the injection device to the auxiliary electronic device to perform the dose expulsion procedure. For example, the auxiliary electronic device is located on a table while being interconnected to the injection device via a cable.

[0045] According to another example, the auxiliary electronic device includes a second optical interface configured to establish an optical transmission optical coupling with a first optical interface of the injection device. Typically, the second optical interface includes at least a light source. Via the optical coupling, the optical signal generated by the second optical interface can be transferred to the injection device. In this way, the dedicated part of the injection device can be illuminated by the light source of the auxiliary electronic device. The injection device does not have its own light source.

[0046] Furthermore, the first and second optical interfaces enable and support a visual inspection of the drug in the drug reservoir. For this purpose, the second optical interface includes a camera configured to receive light reflected or transmitted through the drug reservoir and indicative of the integrity of the drug. For example, the second optical interface includes a light source and a camera configured to measure the light transmittance coefficient of the drug located in the drug reservoir.

[0047] In another example, the auxiliary electronic device is a portable electronic device. In that regard, the auxiliary electronic device is configured as a portable electronic device or a mobile electronic device. The portable electronic device is configured as a smartphone, a smartwatch, or a tablet computer. In that regard, existing portable electronic devices such as smartphones, smartwatches, or tablet computers can function as auxiliary electronic devices for an injection device.

[0048] Existing auxiliary electronic devices such as smartphones, smartwatches, or tablet computers are configured to act and operate as auxiliary electronic devices that enable control of at least the electric propulsion unit and thus the electric drive unit of the injection device. Widely available portable electronic devices such as smartphones, smartwatches, or tablet computers only need to be equipped with appropriate software or software applications, that is, only need to be equipped with applications that enable each portable electronic device to communicate with the injection device so as to control at least the electric propulsion unit of the injection device.

[0049] The second interface of the auxiliary device includes a standardized interface compliant with a predetermined standard widely used in portable electronic devices. In that regard, the second interface includes, for example, a Universal Serial Bus (USB) interface with respective connectors, a mini-USB or a micro-USB interface. The first interface includes connectors of corresponding or complementary shapes. Implementing the first and / or second interfaces of the injection device and the auxiliary electronic device according to a predetermined communication standard is beneficial in that existing auxiliary electronic devices such as smartphones, smartwatches, or tablet computers become auxiliary electronic devices configured to interact with the injection device as described above without the need for hardware changes.

[0050] For example, many existing portable electronic devices only need a software update or installation of a specific software application to provide control of the electrical propulsion unit of the injection device. In this way, the injection device provides a high degree of compatibility with many existing portable electronic devices such as smartphones, smartwatches, or tablet computers. The electronic components of the portable electronic device, particularly the computing power, user interface, and / or power source, become available to the injection device. Therefore, the injection device may not have to have at least one of an electronic control circuit, a power source, and a light source.

[0051] The existing user interface of the portable electronic device can be used to communicate with the injection device. The injection device is software-controlled via the software of the auxiliary device. This enables the implementation of many programmable functions implemented and provided by the portable electronic device. Individual device settings or user preferences are provided by the portable electronic device. The portable electronic device is individually programmed or individually configured to provide fairly intuitive operation and handling of the injection device and / or fairly intuitive and self-explanatory user feedback or user guidance before, during, and after the injection procedure.

[0052] According to a further example, the second optical interface includes at least one of a display, a light source, and a camera. Here, the display of a smartphone, smartwatch, or tablet computer provides a visual and tactile user interface for the injection device. The display includes a touch sensor type display. Further, the display of the portable electronic device is used as a light source for illuminating at least a part of the injection device when mechanically coupled to the auxiliary electronic device. In this way, the display of the auxiliary electronic device provides visual user feedback transmitted via the injection device.

[0053] The second optical interface may include a dedicated separate light source located outside the display of the auxiliary electronic device, for example, outside the display of a portable electronic device. The light source is implemented as a flashlight or as an auxiliary light, for example, implemented as a light-emitting diode on the back surface of the portable electronic device housing. The back surface is typically located on the opposite side of the front surface of the portable electronic device, and the front surface is provided with a graphical user interface including, for example, a touch-sensor type two-dimensional display. The second optical interface further includes a camera. For this purpose, a camera of an existing portable electronic device such as a smartphone, smartwatch, or tablet computer camera can be used. The camera can be used to perform an optical and visual inspection of, for example, the drug contained in the drug reservoir.

[0054] In some examples, the auxiliary electronic device is configured to attach the injection device to the front surface of the auxiliary electronic device. In other embodiments, the auxiliary electronic device is configured to attach the injection device to the back surface of the auxiliary electronic device. In a further example, the auxiliary electronic device is configured for variable connection of the injection device. Thus, the auxiliary electronic device is configured to selectively attach the injection device to either the front surface of the auxiliary electronic device or the back surface of the auxiliary electronic device.

[0055] In another aspect, the present disclosure further relates to an injection system including the injection device described above and further including the auxiliary electronic device described above. To that extent, all of the embodiments, examples, advantages, and effects described above in relation to the injection device and / or in relation to the auxiliary electronic device are equally applicable to the injection system.

[0056] According to a further aspect, the present disclosure is a computer program comprising computer-readable instructions which, when executed by a processor of the auxiliary electronic device described above, cause the auxiliary electronic device to control the electric propulsion unit or the electric drive unit of the injection device as described above when the injection device is connected, i.e., when connected to the electronic auxiliary device. Typically, the injection device, the auxiliary device, and the injection system, as well as the computer program, are configured to provide enhanced and improved control functions to the user interface of the auxiliary electronic device. Typically, a specific button or actuator that can be manually operated by a user of the injection device or the injection system is provided on the user interface of the auxiliary electronic device, such as the touch-sensor display of a portable electronic device, to trigger and / or control the injection procedure. The coupling and connection between the injection device and the auxiliary electronic device provide a software-implemented control function on the user interface of the auxiliary electronic device that enables the user to control, e.g., trigger, the injection device process.

[0057] All of the above-described functions, effects, and configurations described in relation to the injection device and described in relation to the auxiliary electronic device are equally valid for the computer program; and vice versa.

[0058] Furthermore, it should be noted that the first interface and the second interface of the injection device and the auxiliary electronic device, respectively, are configured as a wired connection for transmitting power, data, and / or optical signals between the auxiliary electronic device and the injection device. However, it is also conceivable to establish a wireless connection between the auxiliary electronic device and the injection device, at least with respect to the data connection. To that extent, the first data connector of the injection device is configured for wireless communication with the second data connector of the auxiliary electronic device. Here, the first and / or second data connectors are configured to exchange data based on one of a plurality of available wireless data transmission standards such as Wi-Fi, NFC, or RFID.

[0059] In other examples, it is also conceivable that the first power connector of the injection device and the second power connector of the auxiliary electronic device are configured for wireless power transmission, for example, by inductive electrical coupling. In a further example, the optical transmission optical coupling established by the first optical interface of the injection device and the second optical interface of the auxiliary electronic device is implemented by an optical fiber interconnecting the first optical interface and the second optical interface. To that extent, a mechanical interconnection between the injection device and the auxiliary electronic device is not essential or necessary to establish at least one or some of the power connection, the data connection, and the optical coupling between the injection device and the auxiliary electronic device.

[0060] In this context, the terms "distal" or "distal end" relate to the end of the injection device facing the injection site of a human or animal. The terms "proximal" or "proximal end" relate to the end of the injection device on the opposite side, furthest from the injection site of the human or animal.

[0061] The term "drug" or "agent", as used herein, means a pharmaceutical formulation comprising at least one pharmaceutically active compound, wherein, in one embodiment, the pharmaceutically active compound has a molecular weight of up to 1500 Da and / or is a peptide, protein, polysaccharide, vaccine, DNA, RNA, enzyme, antibody or fragment thereof, hormone, or oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compounds, wherein, in a further embodiment, the pharmaceutically active compound is useful for the treatment and / or prevention of diabetes or complications associated with diabetes, such as diabetic retinopathy, thromboembolic disorders, such as deep vein thrombosis or pulmonary embolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis, Here, in a further embodiment, the pharmaceutically active compound comprises at least one peptide for the treatment and / or prevention of diabetes or complications associated with diabetes, such as diabetic retinopathy. Here, in a further embodiment, the pharmaceutically active compound comprises at least one human insulin or human insulin analog or derivative, glucagon-like peptide (GLP-1) or its analog or derivative, or exendin-3 or exendin-4 or an analog or derivative of exendin-3 or exendin-4.

[0062] Insulin analogs are, for example, Gly(A21), Arg(B31), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin in which proline at position B28 may be replaced by Asp, Lys, Leu, Val or Ala and Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0063] Insulin derivatives include, for example, B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0064] Exendin-4 means, for example, exendin-4(1-39), which is a peptide of the sequence H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

[0065] Exendin-4 derivatives include, for example, the compounds in the following list: H-(Lys)4-desPro36,desPro37 exendin-4(1-39)-NH2, H-(Lys)5-desPro36,desPro37 exendin-4(1-39)-NH2, desPro36 exendin-4(1-39), desPro36[Asp28] exendin-4(1-39), desPro36[IsoAsp28] exendin-4(1-39), desPro36[Met(O)14,Asp28]exendin-4(1-39), desPro36[Met(O)14,IsoAsp28]exendin-4(1-39), desPro36[Trp(O2)25,Asp28]exendin-4(1-39), desPro36[Trp(O2)25,IsoAsp28]exendin-4(1-39), desPro36[Met(O)14 Trp(O2)25,Asp28]exendin-4(1-39), desPro36[Met(O)14 Trp(O2)25,IsoAsp28]exendin-4(1-39); or desPro36[Asp28]exendin-4(1-39), desPro36[IsoAsp28]exendin-4(1-39), desPro36[Met(O)14,Asp28]exendin-4(1-39), desPro36[Met(O)14,IsoAsp28]exendin-4(1-39), desPro36[Trp(O2)25,Asp28]exendin-4(1-39), desPro36[Trp(O2)25,IsoAsp28]exendin-4(1-39), desPro36[Met(O)14 Trp(O2)25,Asp28]exendin-4(1-39), desPro36[Met(O)14 Trp(O2)25,IsoAsp28]exendin-4(1-39), (wherein the group -Lys6-NH2 may be attached to the C-terminus of the exendin-4 derivative);

[0066] or, an exendin-4 derivative of the following sequence: desPro36 exendin-4(1-39)-Lys6-NH2 (AVE0010), H-(Lys)6-desPro36[Asp28]exendin-4(1-39)-Lys6-NH2, desAsp28Pro36,Pro37,Pro38 exendin-4(1-39)-NH2, H-(Lys)6-desPro36,Pro38[Asp28] exendin-4(1-39)-NH2, H-Asn-(Glu)5desPro36,Pro37,Pro38[Asp28] exendin-4(1-39)-NH2, desPro36,Pro37,Pro38[Asp28] exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-desPro36,Pro37,Pro38[Asp28] exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5-desPro36,Pro37,Pro38[Asp28] exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-desPro36[Trp(O2)25,Asp28] exendin-4(1-39)-Lys6-NH2, H-desAsp28Pro36,Pro37,Pro38[Trp(O2)25] exendin-4(1-39)-NH2, H-(Lys)6-desPro36,Pro37,Pro38[Trp(O2)25,Asp28] exendin-4(1-39)-NH2, H-Asn-(Glu)5-desPro36,Pro37,Pro38[Trp(O2)25,Asp28] exendin-4(1-39)-NH2, desPro36,Pro37,Pro38[Trp(O2)25,Asp28] exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-desPro36,Pro37,Pro38[Trp(O2)25,Asp28] exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5-desPro36,Pro37,Pro38[Trp(O2)25,Asp28] exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-desPro36[Met(O)14,Asp28]exendin-4(1-39)-Lys6-NH2, desMet(O)14 Asp28 Pro36,Pro37,Pro38 exendin-4(1-39)-NH2, H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Asp28]exendin-4(1-39)-NH2, H-Asn-(Glu)5-desPro36,Pro37,Pro38[Met(O)14,Asp28]exendin-4(1-39)-NH2, desPro36,Pro37,Pro38[Met(O)14,Asp28]exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Asp28]exendin-4(1-39)-(Lys)6-NH2, H-Asn-(Glu)5 desPro36,Pro37,Pro38[Met(O)14,Asp28]exendin-4(1-39)-(Lys)6-NH2, H-Lys6-desPro36[Met(O)14,Trp(O2)25,Asp28]exendin-4(1-39)-Lys6-NH2, H-desAsp28Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25]exendin-4(1-39)-NH2, H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Asp28]exendin-4(1-39)-NH2, H-Asn-(Glu)5-desPro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]exendin-4(1-39)-NH2, desPro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]exendin-4(S1-39)-(Lys)6-NH2, H-Asn-(Glu)5-desPro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]exendin-4(1-39)-(Lys)6-NH2; or a pharmaceutically acceptable salt or solvate of any one of the aforementioned exendin-4 derivatives selected therefrom.

[0067] The hormones are, for example, pituitary hormones or hypothalamic hormones or regulatory active peptides listed in chapter 50 of the Rote Liste, 2008 edition, and their antagonists, for example, gonadotropins (folitropin, lutropin, chorionic gonadotropin, menotropin), somatropin (Somatropine), desmopressin, terlipressin, gonadorelin, tryptorelin, leuprorelin, buserelin, nafarelin, goserelin.

[0068] The polysaccharides are, for example, glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or their derivatives, or sulfated forms such as polysulfated forms of the aforementioned polysaccharides, and / or their pharmaceutically acceptable salts. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium.

[0069] Antibodies are globular plasma proteins (about 150 kDa) also known as immunoglobulins that share a basic structure. Since they have sugar chains attached to amino acid residues, they are glycoproteins. The basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only Ig units), and secreted antibodies can also be dimers having two Ig units such as IgA, tetramers having four Ig units such as IgM of teleost fish, or pentamers having five Ig units such as mammalian IgM.

[0070] The Ig monomer is a "Y"-shaped molecule consisting of four polypeptide chains; two identical heavy chains and two identical light chains joined by disulfide bonds between cysteine residues. Each heavy chain is approximately 440 amino acids in length, and each light chain is approximately 220 amino acids in length. The heavy and light chains each contain intra-chain disulfide bonds that stabilize these folded structures. Each chain is composed of structural domains called Ig domains. These domains contain 70 - 110 amino acids and are classified into different categories (e.g., variable or V, and constant or C) according to their size and function. They have a characteristic immunoglobulin fold structure that creates a "sandwich" shape in which two β-sheets are held together by interactions between conserved cysteines and other charged amino acids.

[0071] There are five types of mammalian Ig heavy chains, represented by α, δ, ε, γ, and μ. The type of heavy chain present defines the antibody isotype, and these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.

[0072] The different heavy chains vary in size and composition, with α and γ containing approximately 450 amino acids, δ containing approximately 500 amino acids, and μ and ε having approximately 550 amino acids. Each heavy chain has two regions, namely the constant region (C H ) and the variable region (V H ). In one species, the constant region is essentially identical in all antibodies of the same isotype but different in antibodies of different isotypes. Heavy chains γ, α, and δ have a constant region composed of three tandem Ig domains and a hinge region for added flexibility, and heavy chains μ and ε have a constant region composed of four immunoglobulin domains. The variable region of the heavy chain varies between antibodies produced by different B cells but is the same for all antibodies produced by a single B cell or B cell clone. The variable region of each heavy chain is approximately 110 amino acids in length and is composed of a single Ig domain.

[0073] In mammals, there are two types of immunoglobulin light chains, designated λ and κ. The light chain has two consecutive domains, namely one constant domain (CL) and one variable domain (VL). The approximate length of the light chain is 211-217 amino acids. Each antibody always contains two identical light chains, and for each antibody in mammals, only one type of light chain, either κ or λ, is present.

[0074] The general structure of all antibodies is very similar, but the unique properties of a given antibody are determined by the variable (V) regions, as detailed above. More specifically, for each light chain (VL), three and for each heavy chain (HV) three variable loops are involved in binding to the antigen, i.e., its antigen specificity. These loops are called complementarity-determining regions (CDRs). Since the CDRs from both the VH domain and the VL domain contribute to the antigen-binding site, it is the combination of the heavy and light chains that determines the final antigen specificity, not either alone.

[0075] An "antibody fragment" contains at least one antigen-binding fragment as defined above and exhibits essentially the same function and specificity as the complete antibody from which the fragment is derived. Limited proteolytic digestion with papain cleaves the Ig prototype into three fragments. Two identical amino-terminal fragments, each containing one complete L chain and approximately half of the H chain, are the antigen-binding fragments (Fab). A third fragment containing the carboxyl terminus at the position of approximately half of both heavy chains, which are of equal size but have interchain disulfide bonds, is the crystallizable fragment (Fc). Fc contains carbohydrates, complement-binding sites, and FcR sites. Limited pepsin digestion yields a single F(ab’)2 fragment that contains both the Fab fragment and the hinge region including the H-H interchain disulfide bond. F(ab’)2 is divalent for antigen binding. The disulfide bond of F(ab’)2 can be cleaved to obtain Fab’. Furthermore, the variable regions of the heavy and light chains can be fused to form a single-chain variable fragment (scFv).

[0076] Pharmaceutically acceptable salts include, for example, acid addition salts and basic salts. Acid addition salts are, for example, HCl or HBr salts. Basic salts are, for example, cations selected from alkali or alkaline earth, such as Na+, or K+, or Ca2+, or ammonium ion N+(R1)(R2)(R3)(R4), (wherein R1 to R4 are independently of each other: hydrogen, optionally substituted C1-C6 alkyl group, optionally substituted C2-C6 alkenyl group, optionally substituted C6-C10 aryl group, or optionally substituted C6-C10 heteroaryl group). Further examples of pharmaceutically acceptable salts are described in "Remington’s Pharmaceutical Sciences" 17th edition, Alfonso R. Gennaro (ed.), Mark Publishing Company, Easton, Pa., U.S.A., 1985 and Encyclopedia of Pharmaceutical Technology.

[0077] Pharmaceutically acceptable solvates are, for example, hydrates.

[0078] It will be further apparent to those skilled in the art that various modifications and variations can be made to the present disclosure without departing from the spirit and scope of the present disclosure. Further, it should be noted that the reference numbers used in the appended claims should not be construed as limiting the scope of the present disclosure.

[0079] Hereinafter, many examples of containers and injection devices will be described in more detail with reference to the drawings.

Brief Description of the Drawings

[0080]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

[0081] The injection device 1 shown in FIGS. 1 and 2 is a pre-filled disposable injection device including a housing 10 to which a needle assembly 15 can be attached. The injection needle 15 is protected by an inner needle cap 16 and an outer needle cap 17 or a protective cap 18 configured to surround and protect the distal section of the housing 10 of the injection device 1. The housing 10 includes and forms a main housing member configured to accommodate a drive mechanism 30 as shown in FIG. 5. The injection device 1 further includes a distal housing component represented as a drug container holder 14. The drug container holder 14 is permanently or releasably connected to the main housing 10. The drug container holder 14 is typically configured to accommodate a drug container 6 filled with a liquid medicament. The drug container 6 includes a cartridge sealed towards the distal end by a pierceable seal such as a septum.

[0082] The injection device 1 shown in FIGS. 2 to 5 is slightly modified with respect to the injection device 1 shown in FIG. 1. The injection device 1 according to FIGS. 2 to 5 may not have a dose window 13. Also, the injection device 1 may not have a dose dial 12 and / or a dose trigger 11. Optionally, as shown in FIG. 5, the injection device 1 may include its own dose window 13, for example in the form of an electronic display. Also, the injection device 1 shown in FIGS. 2 to 5 may include a trigger 11 or a dose dial 12 for manual and independent operation and / or control of the injection device 1, if necessary.

[0083] As shown in FIG. 5, the injection device 1 includes a housing 10 and a container 6 filled with a liquid medicament. The container 6 provides a medicament reservoir. The container 6 includes a substantially tubular barrel or bottle filled with a liquid medicament. In the proximal direction 3, the medicament reservoir 6 is closed by a displaceable stopper 7 or piston. The stopper 7 is in mechanical contact with a piston rod 26, which is configured to be displaced stepwise in the distal direction to further bias the stopper 7 in the distal direction and thus towards the outlet 8 of the medicament reservoir 6. At or near the outlet 8, the medicament reservoir 6 includes a pierceable membrane 9. The needle assembly 15 includes a threaded needle hub 22 configured to threadedly connect with a threaded socket 20 provided at the distal end of the drug container holder 14. As shown in FIG. 2, the most distal end of the drug container holder 14 includes a through hole 21 for receiving the proximal tip section of the injection needle 24. In particular, the injection device needle 24 of the needle assembly 15 intersects the needle hub 22 and includes a double-tipped cannula.

[0084] The injection device 1 includes a drive mechanism 30. The drive mechanism 30 includes an electric propulsion unit 32 in the form of, for example, an electric drive part or an electric motor. The electric propulsion unit is mechanically engaged with the piston rod 26 to bias the piston rod in the distal direction 2 to discharge a dose of the drug from the drug reservoir 6. As shown in FIG. 5, the distal end of the piston rod 26 includes a pressure part piece 28 having a radially expanded structure compared to the elongated piston rod 26. The pressure part piece 28 directly mechanically contacts the proximal surface of the stopper 7 to displace the stopper 7 with respect to the side wall of the drug reservoir 6. The piston rod 26 includes a threaded rod that is threadedly engaged with the housing 10. The electric propulsion unit 32 is configured to induce or apply a driving torque to the piston rod 26. Optionally, a gear or a gearbox is provided, and the electric propulsion unit 32 is mechanically connected to the piston rod 26 by the gear or the gearbox.

[0085] In other examples, the injection device 1 includes a flexible reservoir 6 in the form of, for example, a flexible bag connected to a suction pump. Here, the drive mechanism 30 of the injection device 1 includes an electric suction pump instead of an electric drive part. The drive mechanism 30 and the suction pump are configured to draw a predetermined dose of the drug from the flexible reservoir. The injection device is configured as an infusion device configured to discharge or administer an amount of the drug at a predetermined rate or a user-definable rate over a period of time.

[0086] The injection device 1 further includes a first interface 50 that is directly or indirectly connected to the electric propulsion unit 32. As shown in FIGS. 3 to 5, the first interface is configured to connect to a second interface 150 of the auxiliary electronic device 100. The auxiliary electronic device 100 is here exemplified as a portable electronic device configured as a smartphone 101. Alternatively, the auxiliary electronic device is embodied as a smartwatch or as a portable tablet computer 102 as shown in FIG. 9. The corresponding interfaces 50, 150 enable the auxiliary electronic device to control the electric propulsion unit 32 of the injection device 1.

[0087] The assembly of the auxiliary electronic device 100 and the injection device 1 forms or constitutes an injection system 200 as shown in FIGS. 3 and 4.

[0088] As further shown in FIG. 6, the first interface 50 includes a first power connector 52, and the first power connector 52 is configured to establish a power connection with a corresponding or complementary-shaped second power connector 152 of the second interface 150. In this way, when the first interface 50 is interconnected with the second interface 152, a power connection is established between the injection device 1 and the auxiliary electronic device 100.

[0089] As further shown in FIG. 6, the first interface 50 also includes a first data connector 54 configured to establish a data connection with a second data connector 154 belonging to the second interface 150. In this way, when the connection between the first interface 50 and the second interface 150 is established, a data connection between the first data connector 54 and the second data connector 154 is also established. In this way, the injection device 1 and the auxiliary electronic device 100 exchange power as well as electronic data. When the first and second interfaces 50, 150 include or form a power connection, the injection device 1 may not have its own power source 44, as shown by the dashed line in FIG. 5.

[0090] In a further example, the injection device 1 further does not have an electronic control circuit 42. Such an electronic control circuit 42 is provided in the injection device 1 only in some cases, to equip the injection device 1 with at least basic or fallback functions, and to operate the electric propulsion unit 32 and / or the electrically implemented drive mechanism 30 in a situation or case where the interconnection with the auxiliary electronic device 100 is not available. Generally, the injection device 1 does not have its own electronic control circuit 42. This is particularly true when the first and second interfaces 50, 150 include first and second data connectors 54, 154 that correspond to each other.

[0091] Via the data connection established by the first and second data connectors 54, 154, pharmaceutical-related or injection-related information can be exchanged between the injection device 1 and the auxiliary electronic device 100. For example, the dose size and the time when the most recent dose or several most recent doses were dispensed can be transmitted to the auxiliary electronic device via the data connection.

[0092] As further shown in FIG. 5, the injection device optionally includes a first optical interface 60, which is configured to establish an optical transmission optical coupling with a second optical interface 160 of the auxiliary electronic device 100. In one implementation, the first optical interface 60 includes a window 19 in the housing 10 or the drug container holder 14 of the injection device 1. The window 19 can provide a visual inspection of the drug located in the drug reservoir 6. The side wall or at least a part of the side wall of the drug reservoir 6 is transparent or translucent. The second optical interface 160 typically includes at least one of a light source 161 and a camera 162. The second optical interface 160 is provided on the front surface 109 of the housing 110 of the auxiliary electronic device 100, or on the back surface 111 of the auxiliary electronic device 100 as shown in FIG. 4.

[0093] When the second optical interface 160 is provided on the back surface 111 of the auxiliary electronic device 100, the second optical interface 160 includes both a light source 161 such as a flashlight and a camera 162. The light source 161 and the camera 162 or their respective photodetectors are configured to emit a light beam or a light pulse through optical coupling to the first optical interface 60, and thus through the window 19, to illuminate the drug located in the drug reservoir 6.

[0094] Returning to the second optical interface 160, the light reflections and reflected light captured by the camera 162, the auxiliary electronic device, particularly its processor 114, are configured to determine whether the drug still meets the optical inspection criteria. For example, if the intensity or wavelength of the light detected by the detector or camera 162 is lower or higher than a given threshold, this indicates that the drug should no longer be used. Then, when such unacceptable optical properties of the drug are detected, the processor 114 of the auxiliary electronic device is typically configured to generate or issue an alert on the user interface 120 provided on the front surface 109 of the auxiliary electronic device.

[0095] The user interface 120 of the auxiliary electronic device 100 provides many visual sections or elements. In particular, the user interface 120 includes a touch sensor type display 122 on the front surface 109 of the auxiliary electronic device 100. On the user interface 120 or the display 122, many dedicated sections or parts are visually shown to the user of the auxiliary electronic device. For example, a control element 124, a feedback element 126, and an indication element 128 are provided. The shapes, positions, and appearances of these various graphically represented elements 124, 126, 128 are individually configured and are subject to dynamic changes in terms of their geometry, brightness, color, or any other optical properties.

[0096] The indication element 128 is configured to provide visual guidance to the user regarding various handling steps related to the injection device. For example, the indication element 128 includes readable instructions or instructions represented by pictures that can be intuitively understood by the user for proper handling of the injection device 1. The indication element 128 is configured to indicate to the user that at least one of the protective cap 18, the outer needle cap 17, or the inner needle cap 16 should be removed. The indication element 128 further indicates initiating the dose setting procedure and thus selecting or setting a dose of a predetermined size. The indication element 128 notifies the user of the size of the dose to be set or administered.

[0097] The control element 124 is of a touch sensor type. When contact with or activation of the control element 124 occurs, for example, by the user's thumb or other finger, the processor 114 of the auxiliary electronic device 100 is triggered to control the electric actuator 32 to dispense a predetermined amount of the drug from the drug reservoir 6. Further, the auxiliary electronic device 100 includes a mechanical actuating element 130 located, for example, on the outer frame of the housing 110 of the auxiliary electronic device 100. The actuating element 130 can be depressed to trigger the injection procedure or to trigger the electric actuator 32. A feedback element 126 is further provided to indicate to the user that the injection process is scheduled, the injection process is currently in progress, or the injection process has ended.

[0098] The second optical interface 160 geometrically overlaps with the drug container holder 14 or other parts of the housing 10 of the injection device. Since the drug container holder 14 includes at least one or several windows 19, the second optical interface 160 is configured to illuminate the drug container holder through the windows 19. Here, the windows 19 of the drug container holder 14 form the first optical interface. In this way, a part of the display 122 that overlaps with the windows 19 of the drug container holder is used to illuminate the drug container holder. The second optical interface 160 is configured to transmit optical signals of different wavelengths to the first optical interface, and thus to or through the windows 19 of the drug container holder 14.

[0099] In this way, various modes or states of the injection device or the injection process can be color-coded. For example, during the injection procedure, the second optical interface emits an optical signal in the red spectral range. After the injection procedure ends without problems, the second optical interface is configured to transmit an optical signal within another spectral range, for example, the green spectral range, to the first optical interface. In this way, the drug container holder 14 or some other part of the injection device 1 is illuminated in red or green. For this reason, and due to optical coupling, the injection device 1 does not require its own light source. However, such an independent light source 46 may be present in the injection device. This enables the operation of the injection device at least in a fallback mode, and thus the injection device 1 provides at least a minimum amount of user feedback when operating in an independent mode, for example, without interconnection with an auxiliary electronic device 100.

[0100] The auxiliary electronic device 100 typically includes a power source 112 such as a rechargeable battery. When a connection between the auxiliary electronic device 100 and the injection device 1 is established, the power for driving the electric propulsion unit 32 can be provided exclusively or at least in part by the power source 112 of the auxiliary electronic device 100. To that extent, the injection device 1 does not have its own power source 44. In some examples, such a power source 44 is present in the injection device to enable at least a fallback or emergency operation of the injection device when a connection to the auxiliary electronic device 100 is not possible or not available.

[0101] Typically, the auxiliary electronic device 100 includes a memory 116 connected to a processor 114. The memory 116 can store injection-related information obtained via a data connection between the first data connector 54 and the second data connector 154. Typically, the auxiliary electronic device 100 also includes a communication interface 118. The communication interface is configured for a wired or wireless connection to a further external electronic device, such as another portable or fixed electronic device, for example another smartphone, another smartwatch, another tablet computer, or another personal computer.

[0102] The communication interface 118 coincides with the second interface 150. Furthermore, the second interface 150 provides a communication interface 118 for connecting the auxiliary electronic device 100 to at least one further portable electronic device 300. In this way, the data stored in the memory 116 and obtained via the connections of the interfaces 50, 150 can be further transmitted to another electronic device 300 implemented as a portable or fixed electronic device.

[0103] The communication interface 118 is configured to communicate with at least one further electronic device 300 via a network such as the Internet.

[0104] As further shown in FIG. 5, the injection device includes a first mechanical connector 70 configured to establish a mechanical connection with the auxiliary electronic device 100. As shown in FIG. 5, a plurality of mechanical connectors 70 are provided on the housing 10 of the injection device 1. For example, one mechanical connector is provided at the proximal end of the housing 10 and another mechanical connector 70 is provided at the distal end of the injection device. This enables at least a double mechanical connection between the injection device 1 and the auxiliary electronic device 100.

[0105] The first mechanical connector is configured to establish at least one of a form fit or a force type connection, such as a friction fit, with the housing 110 of the auxiliary electronic device 100. The first mechanical connector 70 includes a clamp or clip configured to establish a clamp connection or a clip connection with the housing 110 of the auxiliary electronic device 100. The first mechanical connector further comprises at least one of a male or female mechanical connector, which has a shape corresponding to the female or male mating connector of the auxiliary electronic device 100. For example, the first mechanical connector 70 includes a plug having a shape complementary to the socket of the auxiliary electronic device. It is particularly beneficial when the first mechanical connector coincides with the first interface or a part thereof. The first mechanical connector may also be integrated into the first interface.

[0106] The mechanical connector of the corresponding shape of the auxiliary electronic device coincides with or is integrated into the second interface. Thus, the auxiliary electronic device optionally includes, for example, a second mechanical connector 170 as shown in FIG. 7. The second mechanical connector 170 is shaped and configured to receive the first mechanical connector 70 provided on the outer surface of the injection device 1. The second mechanical connector 170 includes a contact surface 171, and the contact surface 171 is configured to abut against the corresponding contact surface 71 of the first mechanical connector 70. The first power connector 51 and the first data connector 54 are provided on the contact surface 71, for example. The second power connector 152 and the second data connector 154 are provided on the corresponding contact surface 171 of the second mechanical connector 170.

[0107] For example, when a mechanical connection is established based on the first and second mechanical connectors 70 and 170 corresponding to each other by sliding the first mechanical connector 70 into the receptacle 172 of the second mechanical connector 170, and when the side edge 72 of the first mechanical connector 70 reaches the final assembled configuration surrounded by the receptacle 172, a power connection is formed between the first and second power connectors 52 and 152. In addition, a data connection can be established between the first data connector 54 and the second data connector 154, respectively.

[0108] FIG. 8 shows a further example of the first mechanical connector 270. Here, the first mechanical connector 270 includes or forms a receptacle 272 for receiving at least a part of the housing 110 of the auxiliary electronic device 100. For example, the receptacle 272 forms a hollow shaft configured to slidably receive the longitudinal end of the housing 110 of the auxiliary electronic device 100. The second interface 250 is provided at each longitudinal end of the housing 110 of the auxiliary electronic device 100 that can be received by the receptacle 272.

[0109] When the final assembly configuration is reached, i.e., when the auxiliary electronic device 100 is inserted into the receptacle 272 of the injection device 1, the first interface 50 is connected to the second interface 150, and there is no need for further manual interconnection of the first and second interfaces 50, 150. In this way, when the mechanical interconnection between the injection device 1 and the auxiliary electronic device 100 is established, the two devices 1, 100 are automatically connected with respect to at least one of power connection, data connection, and optical coupling.

[0110] The example of FIG. 9 further shows that the first and second interfaces 50, 150 are connected by a wire or cable 80. In this way, the first interface 50 and the second interface 150 can be interconnected regardless of the mechanical coupling between the housing 10 of the injection device and the housing 110 of the auxiliary electronic device 100.

Explanation of Reference Numerals

[0111] 1 Injection device 2 Distal direction 3 Proximal direction 4 Dose increment direction 5 Dose decrement direction 6 Drug container 7 Plug 8 Outlet 9 Membrane 10 Housing 11 Trigger 12 Dose dial 13 Dose window 14 Drug container holder 15 Needle assembly 16 Inner needle cap 17 Outer needle cap 18 Protective cap 19 Window 20 Threaded socket 21 Through hole 22 Needle hub 24 Injection needle 26 Piston rod 28 Pressure part piece 30 Driving mechanism 32 Electric propulsion unit 42 Electronic control circuit 44 Power source 46 Light source 50 Interface 52 Power connector 54 Data connector 60 Optical interface 70 Mechanical connector 71 Contact surface 80 Cable 100 Auxiliary electronic device 101 Smartphone 102 Tablet computer 109 Front surface 110 Housing 111 Back surface 112 Power source 114 Processor 116 Memory 118 Communication interface 120 User interface 122 Display 124 Control element 126 Feedback element 128 Indication element 130 Actuating element 150 Interface 152 Power connector 154 Data connector 160 Optical interface 161 Light source 162 Camera 170 Mechanical connector 171 Contact surface 172 Receptacle 200 Injection system 270 Mechanical connector 272 Receptacle 300 Electronic device

Claims

1. An injection device configured to discharge a dose of a medicament, comprising: a housing (10) configured to accommodate a medicament reservoir (6); a drive mechanism (30) configured to interact mechanically with the medicament reservoir (6) and comprising an electric propulsion unit (32) configured to draw or discharge a quantity of medicament from the medicament reservoir (6); a first interface (50) directly or indirectly connected to the electric propulsion unit (32) and configured to connect to a second interface (150) of an auxiliary electronic device (100), the first interface (50) comprising: i) a first power connector (52) configured to establish a power connection with a second power connector (152) of the second interface (150); and ii) a first data connector (54) configured to establish a data connection with a second data connector (154) of the second interface (150); at least one of which; a first mechanical connector (70; 270) configured to establish a mechanical coupling with a second mechanical connector (170) of corresponding shape of the auxiliary electronic device (100), the first mechanical connector (70; 270) being coincident with or including the first interface (50); a first optical interface (60) configured to establish an optical transmission optical coupling with a second optical interface (160) of the auxiliary electronic device (100), the first optical interface (60) enabling and providing an optical or visual inspection of the contents of the medicament reservoir (6) by illuminating the medicament located within the medicament reservoir (6); wherein the electric propulsion unit (32) is controllable by the auxiliary electronic device (100) when the first interface (50) and the second interface (150) are interconnected; the first interface (50) includes a male or female plug or socket located at or integrated with the first mechanical connector (70; 270) provided on the outer surface of the injection device, and further includes a contact surface (71) provided with at least one of the first power connector ( 52) and the first data connector (54). The injection device mentioned above.

2. The injection device according to claim 1, wherein the injection device (1) does not have at least one of an electronic control circuit (42), a power source (44), and a light source (46).

3. An auxiliary electronic device (100) configured to be connected to the injection device (1) according to claim 1 or 2, comprising: A housing (110), A user interface (120), A processor (114), A second interface (150) configured to connect to a first interface (50) of the injection device (1), the second interface (150) comprising: i) A second power connector (152) configured to establish a power connection with a first power connector (52) of the first interface (50), and ii) A second data connector (154) configured to establish a data connection with a first data connector (54) of the first interface (50), The second interface (150) including at least one of; A second mechanical connector (170) configured to establish a mechanical connection with a first mechanical connector (70; 270) of corresponding shape of the injection device (1), the second mechanical connector (170) being the second mechanical connector (170) that coincides with or includes the second interface (150), and A second optical interface (160) configured to establish an optical transmission optical coupling with a first optical interface (60) of the injection device (1) and enable and provide an optical or visual inspection of the contents of the drug reservoir (6) of the injection device (1) by illuminating the drug located in the drug reservoir (6), wherein the processor (114) is configured to control the electric propulsion unit (32) of the injection device (1) when the second interface (150) and the first interface (50) are interconnected. The second interface (150) includes a male or female plug or socket located in or integrated with the second mechanical connector (170), and further includes a corresponding contact surface (171) provided with at least one of the second power connector (152) and the second data connector (154). The auxiliary electronic device mentioned above.

4. The auxiliary device (100) is the auxiliary electronic device according to claim 3, including a portable electronic device configured as a smartphone (101), a smartwatch, or a tablet computer (102).

5. The second optical interface (160) is the auxiliary electronic device according to claim 3, including at least one of a display, a light source (161), and a camera (162).

6. An injection system (200) including the injection device (1) according to claim 1 or 2 and the auxiliary electronic device (100) according to any one of claims 3 to 5.

7. A computer program including computer-readable instructions, which, when executed by a processor (114) of an auxiliary electronic device (100), cause the auxiliary electronic device (100) to perform an electrical push of the injection device (1) according to claim 1 or 2 when the injection device (1) is connected to the electronic auxiliary device (100). The computer program for controlling the advancing part (32).

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