Assistance device for an injection device

Abstract

An auxiliary device is configured to couple to an injection device, the auxiliary device comprising a sensor assembly and a processor assembly, wherein the processor assembly is configured to cause the auxiliary device to use the sensor assembly to sense an identifying feature of the injection device and determine a type of the injection device based on the sensed identifying feature.

Description

Technical Field

[0001] The present invention relates to an auxiliary device for attachment to an injection device. Background Technology

[0002] Many diseases require regular treatment via delivery, particularly injection. These injections can be administered using an injection device, either by healthcare professionals or by the patient themselves.

[0003] Drug injection devices specifically designed for patient self-use may be equipped with electronics for measuring and storing usage-related data. This usage-related data may also be transmitted wirelessly or via wired connection to external devices (such as smartphones, tablets, or laptops) or to the cloud. Summary of the Invention

[0004] According to one aspect of the invention, an auxiliary device is provided, configured to be coupled to an injection device. The auxiliary device includes a sensor assembly and a processor assembly, the processor assembly being configured to cause the auxiliary device to: use the sensor assembly to sense identifying features of the injection device; and determine the type of the injection device based on the sensed identifying features. This allows the auxiliary device to be used with more than one injection device of different types, wherein the auxiliary device is capable of distinguishing between the different types of injection devices to which it is attached. The operation of the auxiliary device can be modified based on the type of injection device determined by the auxiliary device. This allows the auxiliary device to be more versatile in its operation. In other words, the auxiliary device can determine the type of the injection device based on the sensed identifying features, thus enabling it to distinguish between different types of injection devices and modify its operation accordingly.

[0005] The auxiliary device may further include a dose determination unit; wherein the processor component is further configured to cause the auxiliary device to use the dose determination unit to determine a dose, wherein the dose is determined based on the type of injection device determined.

[0006] The auxiliary device may further include an alignment component, wherein the alignment component is configured to interact with a corresponding alignment feature of the injection device, such that the auxiliary device can be coupled to the injection device in a predetermined number of orientations relative to the injection device, wherein the predetermined number is preferably one or two, or three, four or more.

[0007] The auxiliary device may further include a communication interface, wherein the processor component is configured to transmit data indicating the type of the determined injection device to an external computing device via the communication interface.

[0008] The sensor assembly may include a light source and a color sensor, wherein the light source is arranged to illuminate a portion of the injection device when the auxiliary device is coupled to the injection device, wherein the color sensor is arranged to determine the color of the illuminated portion, and wherein the processor assembly is configured to determine the type of the injection device based on the determined color.

[0009] The sensor assembly may include a navigation switch movable between multiple locations, wherein the navigation switch is arranged to be biased to one of the multiple locations by a biasing feature of the injection device when the auxiliary device is coupled to the injection device, wherein each of the multiple locations corresponds to a type of injection device, and wherein the processor assembly is configured to determine the type of injection device based on the location of the navigation switch.

[0010] The sensor assembly may include a plurality of contacts arranged to contact conductive traces formed on the surface of the injection device when the auxiliary device is coupled to the injection device, wherein the conductive traces include one or more segments arranged to electrically connect two or more contacts, wherein the processor assembly is configured to determine the type of the injection device by polling each of the contacts.

[0011] The sensor assembly may include two pins arranged to contact a conductive trace formed on the surface of the injection device when the auxiliary device is coupled to the injection device, wherein the processor assembly is configured to determine the type of the injection device based on a determined resistance of the conductive trace.

[0012] The sensor assembly may include a magnetic field sensor arranged to detect a magnetic field generated by the injection device when the auxiliary device is coupled to the injection device, wherein the processor assembly is configured to determine the type of the injection device based on the detected magnetic field.

[0013] The sensor assembly may include at least one proximity sensor arranged to determine a distance between a corresponding identification feature of the auxiliary device and the injection device when the auxiliary device is coupled to the injection device, wherein the processor assembly is configured to determine the type of the injection device based on the determined distance.

[0014] The proximity sensor may include an infrared transceiver, wherein the infrared transceiver is arranged to determine the depth of a hole disposed on the surface of the injection device when the auxiliary device is coupled to the injection device, wherein the processor assembly is configured to determine the type of the injection device based on the determined depth of the hole.

[0015] The sensor assembly may include a first infrared sensor and a second infrared sensor, wherein both the first and second infrared sensors are arranged to read coded traces formed on the injection device as the auxiliary device moves relative to the injection device during the process of the auxiliary device being coupled to the injection device, wherein the processor assembly is configured to determine the type of the injection device based on the code read using the first and second infrared sensors.

[0016] The sensor assembly may include multiple pins configured to form an electrical connection with a non-volatile memory in the injection device when the auxiliary device is connected to the injection device, wherein the processor assembly is configured to read data from the non-volatile memory when the auxiliary device is connected to the injection device, and wherein the processor assembly is configured to determine the type of the injection device based on the data read from the non-volatile memory.

[0017] According to another aspect of the invention, a system is provided comprising an injection device and an auxiliary device according to any of the foregoing examples, wherein the injection device includes an identification feature, and wherein the processor component is configured to cause the auxiliary device to:

[0018] The sensor assembly is used to sense the identification features of the injection device; and the type of the injection device is determined based on the sensed identification features.

[0019] According to another aspect of the invention, a method is provided for identifying the type of an injection device using an auxiliary device coupled to the injection device, the auxiliary device including a sensor assembly and a processor assembly, the method comprising: causing the sensor assembly to sense identifying features of the injection device via the processor assembly; and

[0020] The processor component determines the type of the injection device based on the sensed identification features.

[0021] An aspect of the invention provides an auxiliary device that can be connected to up to one of different types of injection devices. The auxiliary device can distinguish between different types of injection devices and modify their operation accordingly. The auxiliary device can therefore have improved versatility. The identification features on the injection device provide a simple means of allowing the type of the injection device to be identified via the auxiliary device. These identification features can be provided with only minor modifications to the injection device. Attached Figure Description

[0022] Embodiments of the invention will now be described by way of example only with reference to the accompanying drawings, wherein:

[0023] Figure 1 shows an exploded view of an injection device used with an auxiliary device according to an embodiment of the present invention;

[0024] Figure 2 depicts an auxiliary device according to an embodiment of the present invention, which is attached to the injection device of Figure 1;

[0025] Figure 3 is a block diagram of the auxiliary device shown in Figure 2;

[0026] Figure 4A depicts a cross-sectional view of the auxiliary device shown in Figure 2 according to a first embodiment of the present invention;

[0027] Figure 4B depicts a bottom view of the auxiliary device in Figure 4A;

[0028] Figure 5A depicts a cross-sectional view of the auxiliary device shown in Figure 2 according to a second embodiment of the present invention;

[0029] Figure 5B depicts a bottom view of the auxiliary device in Figure 5A;

[0030] Figure 5C shows a portion of the injection device of Figure 1, to which the auxiliary device of Figure 5A will be connected;

[0031] Figure 6A depicts a cross-sectional view of the auxiliary device shown in Figure 2 according to a third embodiment of the present invention;

[0032] Figure 6B depicts a bottom view of the auxiliary device in Figure 6A;

[0033] Figure 6C shows a portion of the injection device of Figure 1, to which the auxiliary device of Figure 6A will be connected;

[0034] Figure 7A depicts a cross-sectional view of the auxiliary device shown in Figure 2 according to a fourth embodiment of the present invention;

[0035] Figure 7B depicts a bottom view of the auxiliary device in Figure 7A;

[0036] Figure 7C shows a portion of the injection device of Figure 1, to which the auxiliary device of Figure 7A will be connected;

[0037] Figure 8A depicts a cross-sectional view of the auxiliary device shown in Figure 2 according to a fifth embodiment of the present invention;

[0038] Figure 8B depicts a bottom view of the auxiliary device in Figure 8A;

[0039] Figure 8C shows a portion of the injection device of Figure 1, to which the auxiliary device of Figure 8A will be connected;

[0040] Figure 9A depicts a cross-sectional view of the auxiliary device shown in Figure 2 according to a sixth embodiment of the present invention;

[0041] Figure 9B depicts a bottom view of the auxiliary device in Figure 9A;

[0042] Figure 9C shows a portion of the injection device of Figure 1, to which the auxiliary device of Figure 9A will be connected;

[0043] Figure 9D is a schematic diagram showing the auxiliary device of Figure 9A connected to the injection device of Figure 9C;

[0044] Figure 10A depicts a cross-sectional view of the auxiliary device shown in Figure 2 according to a seventh embodiment of the present invention;

[0045] Figure 10B depicts a bottom view of the auxiliary device in Figure 10A;

[0046] Figure 10C is a schematic diagram of the operation of the auxiliary device in Figure 10A;

[0047] Figure 11A depicts a cross-sectional view of the auxiliary device shown in Figure 2 according to an eighth embodiment of the present invention;

[0048] Figure 11B depicts a bottom view of the auxiliary device in Figure 11A;

[0049] Figure 11C shows a portion of the injection device of Figure 1, to which the auxiliary device of Figure 11A will be connected; and Figure 12 is a flowchart illustrating the method according to the invention. Detailed Implementation

[0050] In the following description, embodiments of the invention may be referenced to insulin injection devices. However, the invention is not limited to such applications and can be equally well applied to injection devices that dispense other medications.

[0051] Figure 1 is an exploded view of a drug delivery device. In this example, the drug delivery device is an injection device 1, such as those from Sanofi. Insulin injection pen, but aspects of the present invention are applicable to other types of injection devices 1 and injection pens.

[0052] The injection device 1 in Figure 1 is a pre-filled disposable injection pen comprising a housing 10 and containing an insulin container 14 to which a needle 15 can be attached. The needle is protected by an inner needle cap 16 and an outer needle cap 17 or other cap 18. The dose of insulin to be dispensed from the injection device 1 can be programmed or “dialed in” by turning the dose knob 12, and the currently programmed dose is then displayed (e.g., in multiples of units) via a dose window 13. For example, when the injection device 1 is configured to administer human insulin, the dose can be displayed in so-called International Units (IU), one IU being the biological equivalent of approximately 45.5 micrograms of pure crystalline insulin (1 / 22 mg). Other units can be used in the injection device for the delivery of insulin analogs or other agents. It should be noted that the selected dose can be displayed just as well as in a manner different from that shown in the dose window 13 in Figure 1.

[0053] The dosage window 13 may take the form of an aperture in the housing 10, allowing the user to view a limited portion of the digital sleeve 70, which is configured to move when the dosage knob 12 is turned to provide a visual indication of the currently programmed dosage. When turned during programming, the dosage knob 12 rotates in a helical path relative to the housing 10.

[0054] In this example, the dosage knob 12 includes one or more configurations 71a, 71b, 71c to facilitate attachment of the auxiliary device described below.

[0055] The injection device 1 can be configured such that turning the dosage knob 12 produces a mechanical click to provide acoustic feedback to the user. The digital sleeve 70 interacts mechanically with a piston in the insulin container 14. When the needle 15 is inserted into the patient's skin and the injection button 11 is then pushed, the insulin dose displayed in the display window 13 is dispensed from the injection device 1. Most of the dose is actually injected into the patient while the needle 15 of the injection device 1 remains in the skin for a period of time after the injection button 11 is pushed. The dispensing of the insulin dose also produces a mechanical click, but it is different from the sound produced when the dosage knob 12 is used.

[0056] In this embodiment, during insulin dose delivery, the dose knob 12 moves to its initial position in axial motion, that is, it does not rotate, while the digital sleeve 70 rotates back to its initial position, for example, displaying a dose of zero units.

[0057] The injection device 1 can be used for several injections until the insulin container 14 is emptied or the medication in the injection device 1 reaches its expiration date (e.g., 28 days after the first use).

[0058] Furthermore, before using the injection device 1 for the first time, a so-called "preparation for injection" may be necessary to remove air from the insulin container 14 and needle 15, for example, by selecting two units of insulin and pressing the injection button 11 while keeping the needle 15 of the injection device 1 facing upwards. For ease of presentation, it will be assumed below that the ejected volume substantially corresponds to the injected dose, such that, for example, the dose of medication expelled from the injection device 1 is equal to the dose received by the user. However, the difference between the ejected volume and the injected dose (e.g., loss) may need to be considered.

[0059] Figure 2 is a perspective view of one end of the injection device 1 when the auxiliary device 20 according to an example embodiment is attached. In this example, the auxiliary device 20 is attached to the injection button 11 of the injection device 1. The auxiliary device 20 (such as a data collection device) includes a housing 21 and optionally a display 22 for presenting the user with dosage information 22a or other information related to the use of the auxiliary device 20 and / or the injection device 1.

[0060] The auxiliary device 20 has a coupling assembly (not shown) for connecting the auxiliary device 20 to the injection device 1. The coupling assembly may include any suitable coupling means, such as one or more clips, pins, ridges, protrusions, threads, magnets, adhesives, etc. The coupling assembly interacts with corresponding coupling features (not shown) of the injection device 1 to connect the auxiliary device 20 and the injection device 1 together.

[0061] The auxiliary device 20 may also have an alignment component (not shown) that interacts with a corresponding alignment feature of the injection device 1 when the auxiliary device 20 is coupled to the injection device 1. The alignment component and the alignment feature can interact to ensure that the auxiliary device 20 can be attached to the injection device 1 only in a discrete number of orientations relative to the injection device 1. As should be clear, the presence of the alignment component can be useful in some embodiments discussed below, where the auxiliary device 20 and the injection device 1 need to be coupled in a predetermined configuration. The discrete number of orientations is preferably one or two. If the discrete number is one, the auxiliary device 20 can be attached to the injection device 1 only in one orientation relative to the injection device 1, thus ensuring that the auxiliary device 20 is always coupled to the injection device 1 in the same relative position. If the discrete number is two, the auxiliary device 20 can be attached to the injection device 1 only in two different orientations relative to the injection device 1, thus ensuring that the auxiliary device 20 is always coupled to the injection device 1 in one of two possible orientations. If there are two discrete quantities, this could mean that the alignment assembly and the auxiliary device 20 are arranged with second-order rotational symmetry, such that the two possible orientations are separated by 180 degrees by rotating the auxiliary device 20 about the axis.

[0062] The discrete number of orientations can be three, four, or more than four. If the discrete number is three, the auxiliary device 20 can be attached to the injection device 1 only in three different orientations relative to the injection device 1. The alignment assembly and the auxiliary device 20 can be arranged with third-order rotational symmetry, such that the three possible orientations are separated by 120 degrees by rotation about the axis through the auxiliary device 20. If the discrete number is four, the auxiliary device 20 can be attached to the injection device 1 only in four different orientations relative to the injection device 1. The alignment assembly and the auxiliary device 20 can be arranged with fourth-order rotational symmetry, such that the four possible orientations are separated by 90 degrees by rotation about the axis through the auxiliary device 20.

[0063] Figure 3 is a schematic diagram of the components that may be included in the auxiliary device 20. As shown in Figure 3, the auxiliary device 20 includes a processor assembly 23, which includes one or more processors, such as a microprocessor, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), etc.; and memory units 24 and 25, which include a program memory 24 and a main memory 25, and the memory units can store software executed by the processor assembly 23.

[0064] A communication interface 27 may be provided, which may be for use via a wireless network (such as Wi-Fi or A wireless communication interface for communicating with another device; or an interface for a wired communication link, such as a socket for receiving a Universal Serial Bus (USB), mini-USB, or micro-USB connector. The other device may be a mobile computing device, such as a smartphone.

[0065] A power switch 28 and a battery 29 are provided. In one example, the power switch 28 is configured to respond to pressure applied to the display 22 by turning the auxiliary device 20 on or off. The battery 29 provides power to one or more components of the auxiliary device 20. In other examples, power can be supplied from sources other than the battery 29, such as wireless power transmission, solar panels, or a wired connection to a power source external to the auxiliary device 20. In some examples, the power switch 28 may be omitted.

[0066] A sensor assembly 30 is provided for sensing identifying features of the injection device 1. These identifying features are characteristics of the injection device 1 that indicate its type. The sensor assembly 30 can sense these identifying features to determine the type of the injection device 1. By sensing the identifying features, the sensor assembly 30 determines attributes associated with those features, which correspond to the type of the injection device 1. The sensor assembly 30 senses the identifying features when the auxiliary device 20 is connected to the injection device 1.

[0067] The type of injection device 1 can be related to the type of drug contained in the injection device 1. For example, the type can indicate the name or concentration of the drug contained in the injection device. In some examples, the type of injection device 1 can be related to the type of dose selection mechanism present in the injection device 1 or the type of dispensing mechanism used in the injection device 1. If the type of injection device 1 is related to the type of dose selection mechanism present in the injection device 1 or the type of dispensing mechanism used in the injection device 1, then the determined type of injection device 1 can be used to calibrate the dose determination unit 26.

[0068] The type of injection device 1 can provide a unique identifier for injection device 1 (such as a serial number), or there can be more than one injection device 1 of the same type.

[0069] The sensor assembly 30 can take various forms, as illustrated in the example embodiments discussed below. In each example, the processor assembly 23 can be configured to cause the auxiliary device 20 to use the sensor assembly 30 to sense the identifying features of the injection device 1 and determine the type of the injection device 1 based on the sensed identifying features, so that it can distinguish different types of injection devices 1 and modify their operation accordingly.

[0070] In any of the embodiments discussed below, a dose determination unit 26 including one or more sensors may be provided in the auxiliary device 20. The processor component 23 uses the dose determination unit 26 to determine the dose. For example, the processor component 23 may use the dose determination unit 26 to determine the dose selected into the injection device 1 and / or the dose dispensed by the injection device 1. In a specific example of FIG3, the dose determination unit 26 includes an optical encoder, including a light source 26a (such as a light-emitting diode (LED)) and a photosensor 26B (such as an optical transducer). However, the dose determination unit 26 may alternatively or additionally include other suitable dose determination means, such as a Hall effect sensor, a rotary encoder, etc.

[0071] In some examples, the dose can be determined by the processor component 23 based on the type of injection device 1 determined using the sensor component 30. In other words, the processor component 23 can determine the dose using the dose determination unit 26 and the determined type of injection device 1. For example, the type of injection device 1 can indicate the concentration of the drug contained in the injection device 1. The processor component 23 can then use the concentration to determine how many units of drug to dispense. In another example, the type can indicate the number of units dispensed per incremental movement of the dose delivery mechanism contained in the injection device 1. The processor component 23 can then combine this factor with multiple incremental movements detected by the dose determination unit 26 to calculate the dose. The auxiliary device 20 is therefore adaptable for use with various types of injection devices 1.

[0072] After determining the type of injection device 1 to which the auxiliary device 20 is connected, the processor component 23 can be configured to transmit data indicating the type of injection device 1 to an external computing device (such as a smartphone) via the communication interface 27. Alternatively, the processor component 23 can be configured to transmit the dose determined using the dose determination unit 26 to the external computing device.

[0073] Figure 4A shows a cross-sectional side view of an auxiliary device 20 according to a first embodiment of the invention. The auxiliary device 20 generally has the same structure as the auxiliary device 20 shown in Figure 2. In this embodiment, the sensor assembly 30 includes a light source 410, such as an LED, and a color sensor 420. The light source 410 is arranged on the auxiliary device 20 such that it illuminates a portion of the injection device 1 when the auxiliary device 20 is coupled to the injection device 1. The color sensor 420 is arranged such that it can detect light reflected from the illuminated portion of the injection device 1 when coupled to the injection device 1, and thus detect the color of said portion of the injection device 1.

[0074] In this embodiment, the identifying feature of the injection device 1 is the color portion of the injection device 1 detected by the color sensor 420. The color portion 1 may be part of the injection button 11 of the injection device 1, to which the auxiliary device 20 is connected.

[0075] Figure 4B shows the auxiliary device 20 of Figure 4A when viewed from below along the direction of the large arrow shown in Figure 4A.

[0076] The color of the portion of the injection device 1 indicates the type of the injection device 1. This provides a simple means of identifying the type of the injection device 1. Only minor changes need to be made to the manufacturing process of the injection device 1. The portion of the injection device 1 can be formed of a material with the desired color, or the color can be applied to the portion of the injection device 1 after it has been manufactured, for example, by printing or spraying the color onto the portion.

[0077] The processor component 23 of the auxiliary device 20 controls the light source 410 to illuminate the portion of the injection device 1. A color sensor 420 receives reflected light from the illuminated portion of the injection device 1 and outputs a signal corresponding to the light received from the illuminated portion, thereby outputting the color of the portion. The signal can be received by the processor component 23, which determines the color and thus the type of injection device 1 based on the signal, for example, by comparing the identified color with a lookup table stored in the memory 24 of the auxiliary device 20. The lookup table may contain a list of colors and the corresponding type of injection device indicated by each color.

[0078] As shown in Figure 5A, in a second embodiment, the sensor assembly 30 includes one or more switches to be activated by the injection device 1, wherein activation of the switches is used to determine the type of the injection device 1. Figure 5A shows the sensor assembly 30, which includes a navigation switch 510, sometimes referred to as a joystick switch. The navigation switch 510 is located on the lower surface 210 of the auxiliary device 20 such that when the auxiliary device 20 is coupled to the injection device 1, the navigation switch is facing the injection device 1.

[0079] Figure 5B shows the auxiliary device 20 of Figure 5A when viewed from below along the direction of the large arrow in Figure 5A.

[0080] Figure 5B illustrates that the navigation switch 510 can be switched between four positions, as indicated by the four small arrows in Figure 5B. However, in other examples, the navigation switch 510 may be able to switch between different numbers of positions (such as two positions, three positions, five positions, or more positions). Each position of the navigation switch 510 results in a different signal being sent to the processor component 23 via the navigation switch 510. Furthermore, each position and the signal thus sent to the processor component 23 corresponds to a specific type of injection device 1. The processor component 23 is able to determine the position of the navigation switch 510 based on the signals sent from the navigation switch 510, and thus determine the type of injection device 1.

[0081] As shown in Figure 5B, the navigation switch 510 can be in a neutral position before the auxiliary device 20 is attached to the injection device 10.

[0082] Figure 5C shows a portion of the injection device 1 to which the auxiliary device 20 will be attached, in this case, the injection button 11 of the injection device 1. Since the auxiliary device 20 is coupled to the injection device 1, the bias feature 530 on the injection device 1 biases the navigation switch 510 to one of its positions. In this embodiment, the identifying feature will be the bias feature 530.

[0083] Each different type of injection device 1 may use a different bias feature 530, each bias feature 530 causing the navigation switch 510 to move to a different position. The position to which the navigation switch 510 is moved thus indicates the type of injection device 1 and can be detected by the processor component 23.

[0084] Figure 5C shows a bias feature 530 located on the upper surface 110 of the injection button 11. The bias feature 530 includes a recess 531 formed in the upper surface 110 of the injection button 11. The recess 531 has an inclined lower surface 532. During attachment, when the auxiliary device 20 is brought toward the injection device 1, the inclined lower surface 532 of the recess 531 contacts the navigation switch 510. The navigation switch 510 is deflected to a position by the force exerted by the inclined lower surface 532. The position into which the navigation switch 510 is forced will depend on the slope direction relative to the navigation switch 510 and will be detected by the processor assembly 23.

[0085] The processor component 23 can determine the type of injection device 1 using the determined location of the navigation switch 510, for example, by comparing the location with a lookup table stored in the memory 24 of the auxiliary device 20. The lookup table may contain a list of locations of the navigation switches 510 and the corresponding injection device types they indicate.

[0086] As discussed above, the auxiliary device 20 may have an alignment assembly and the injection device 1 may have a corresponding alignment feature, which ensures that the auxiliary device 20 and the injection device 1 can only be connected in one alignment. This means that the same injection device 1 will always move the navigation switch 510 to the same position. The alignment assembly and / or feature may include one or more grooves, ridges, protrusions, clips, recesses, keys, etc.

[0087] In some examples, sensor assembly 30 may include more than one switch that can be activated when the auxiliary device 20 is attached to injection device 1. As discussed above, one or more of these switches may be navigation switches 510. In other examples, sensor assembly 30 may include multiple push switches, such as microswitches. Push switches may be arranged in auxiliary device 20 such that they interact with corresponding bias features on injection device 1, such as bias features on injection button 11.

[0088] Each push switch can be pressed or released depending on the presence of a corresponding bias feature on the injection device 1. In some examples, the bias feature may be a protrusion arranged to press the corresponding push switch when the auxiliary device 20 is connected to the injection device 1. In other examples, the bias feature may be a recess that prevents the corresponding push switch from being pressed when the auxiliary device 20 is connected to the injection device 1.

[0089] Processor component 23 is configured to determine which push switches have been pressed by the injection device 1. Processor component 23 can determine the type of injection device 1 using a specific combination of push switches detected by processor component 23, for example, by comparing the specific combination of push switches with a lookup table 24 stored in the memory of auxiliary device 20. The lookup table may contain a list of different combinations of push switches and the corresponding injection device 1 types they indicate.

[0090] A single push switch provides one bit of information, so n switches will provide resolution for 2n different types of devices.

[0091] According to the third embodiment shown in Figures 6A and 6B, the sensor assembly 30 may include a plurality of electrical contacts 610a to 610f. The contacts 610a to 610f are arranged to make electrical contact with a conductive trace 620 formed on the injection device 1 when the auxiliary device 20 is coupled to the injection device 1. In this particular embodiment, the identifying feature is the conductive trace 620 on the injection device 1.

[0092] Figure 6B shows the auxiliary device 20 of Figure 6A when viewed from below along the direction of the large arrow in Figure 6A. It can be seen that contacts 610a to 610f are arranged in a circular pattern. This provides a particularly compact assembly; however, contacts 610a to 610f are not limited to this assembly.

[0093] Figure 6C shows a portion of the injection device 1 to which the auxiliary device 20 will be attached, in this case, the injection button 11. A conductive trace 620 is formed on the surface of the injection device 1, in this case, on the upper surface 110 of the injection button 11. The conductive trace 620 is formed of a conductive material and can be applied to the injection device 1 by printing, spraying, transfer, or any other suitable application method.

[0094] As can be seen in Figure 6C, the conductive trace 620 forms a circular shape corresponding to the circular arrangement of contacts 610a to 610f; however, the conductive trace 620 is not limited to this circular shape. The conductive trace 620 includes one or more conductive trace segments 630a to 630d separated by non-conductive gaps. Figure 6C shows a conductive trace 620 including four segments 630a to 630d; however, this is merely an example, and any number of segments 630a to 630d can be used.

[0095] When the auxiliary device 20 is connected to the injection device 1, each segment 630a to 630d electrically connects two or more contacts 610a to 610f together. Each type of injection device 1 may have a unique arrangement of traces 620 and trace segments 630a to 630d.

[0096] The processor component 23 is configured to distinguish different types of injection devices 1 by using electrical contacts 610a to 610f to detect a specific arrangement of traces 620.

[0097] Processor component 23 is configured to poll each of contacts 610a to 610f by applying current to each of the contacts 610a to 610f. While polling a particular contact 610a to 610f, processor component 23 can simultaneously detect whether current flows through any of the other contacts 610a to 610f via segments 630a to 630d of trace 620. This occurs when the polled contact 610a to 610f is electrically connected to another contact among contacts 610a to 610f via segments 630a to 630d of conductive trace 620.

[0098] If current can flow between the two contacts 610a to 610f via the segments of conductive trace 620, this can be considered a binary signal "1" by processor component 23. However, if no current can flow between the two contacts 610a to 610f because there are no segments 630a to 630d of conductive trace 620 connecting the two contacts 610a to 610f, this can be considered a binary signal "0". Processor component 23 can identify the binary code in segments 630a to 630d of conductive trace 620 by polling each contact 610a to 610f. The binary code can then be used by processor component 23 to determine the type of injection device 1, for example, by comparing the binary code with a lookup table stored in memory 24, where each binary code corresponds to a type of injection device 1.

[0099] Figures 6A and 6B both show the use of six contacts 610a to 610f; however, any number of contacts 610a to 610f, more than two, can be used alternatively. For n contacts 610a to 610f, the processor assembly 23 can distinguish 2n different types of injection devices 1.

[0100] As discussed previously, the auxiliary device 20 may have an alignment assembly and the injection device 1 may have a corresponding alignment feature that ensures the auxiliary device 20 and the injection device 1 can only be connected in one relative orientation. This ensures that the contacts 610a to 610f and segments 630a to 630d of the conductive trace 620 are correctly aligned each time the auxiliary device 20 is connected to the injection device 1. In other examples, the auxiliary device 20 may have an alignment assembly and the injection device 1 may have a corresponding alignment feature that ensures the auxiliary device 20 can only be connected to the injection device 1 in two different orientations relative to the injection device 1. The contacts 610a to 610f and segments 630a to 630d of the conductive trace 620 may be arranged such that the auxiliary device 20 can determine the type of the injection device 1 when it is connected to the injection device 1 in both the first and second orientations. If the auxiliary device 20 can only be connected to the injection device 1 in different numbers (such as three, four or more) orientations, then the contacts 610a to 610f and the segments 630a to 630d of the conductive trace 620 can be arranged such that the auxiliary device 20 can determine the type of the injection device 1 when it is connected to the injection device 1 in each discrete orientation.

[0101] Figure 7A illustrates a fourth embodiment, similar to the embodiment shown in Figure 6A, wherein the sensor assembly 30 includes a pair of electrical contacts 710a to 710b, each contact 710a to 710b being arranged such that the auxiliary device 20 protrudes. Figure 7B shows the auxiliary device 20 of Figure 7A as viewed from below along the direction of the large arrow in Figure 7A.

[0102] Each contact 710a to 710b is arranged to make electrical contact with a different point on a conductive trace 720 formed on the surface of the injection device 1. In this embodiment, the identifying feature is the conductive trace 720. Figure 7C shows portions of two different injection devices 1 to which the auxiliary device 20 can be attached. In both cases, the portion is the injection button 11. The conductive trace 720 is formed on the surface of the injection device 1, in this case on the upper surface 110 of the injection button 11. The conductive trace 720 on the left injection button 11 in Figure 7C is shorter than the conductive trace on the right injection button 11 in Figure 7C.

[0103] The conductive traces 720 are formed of conductive material and can be applied to the injection device 1 by printing, spraying, transferring or any other suitable application method.

[0104] When the auxiliary device 20 is connected to the injection device 1, contacts 710a and 710b make electrical contact with two different points on the conductive trace 720. In this example, contact 710a of FIG. 7A will contact the point on the trace 720 near mark X of FIG. 7C, while contact 710b will contact the point on the trace 720 near mark Y of FIG. 7C. These two points X and Y can be at different ends of the conductive trace 720. The resistance of the conductive trace 720 between these two points X and Y is measured by the auxiliary device 20 transmitting current between the electrical contacts 710a and 710b via the conductive trace 720. The resistance measurement can be performed under the control of the processor component 23.

[0105] The measured resistance can correspond to the type of injection device 1. Different conductive traces 720 with different resistances can be applied to different injection devices 1. Each type of injection device can have a conductive trace 720 with a unique resistance, which can be detected by the auxiliary device 20 and used to determine the type of injection device 1. The processor component 23 can measure the resistance of the conductive trace 720 using contacts 710a to 710b, and then determine the type of injection device 1 based on the measured resistance. For example, the processor component 23 can compare the measured resistance with a value stored in a lookup table in memory 24 or elsewhere. The lookup table can contain resistance values ​​and associated injection device 1 types. The lookup table can contain resistance ranges rather than specific values ​​to compensate for slight variations in the measured resistance.

[0106] As previously mentioned, the conductive trace 720 shown on the injection device 1 on the left side of Figure 7C is shorter than the conductive trace 720 shown on the injection device 1 on the right side of Figure 7C. Assuming the conductive traces 720 have the same width and thickness and are made of the same material, a longer conductive trace 720 generally has a higher resistance. Therefore, changing the length of the conductive trace 720 provided on the injection device 1 provides a simple means to change the resistance of the trace 720 and thus distinguish the type of injection device 1. Alternatively or additionally, the resistance of the conductive trace 720 can be changed by varying one or more thicknesses of the trace 720, the width of the trace 720, or the material forming the trace 720.

[0107] The auxiliary device 20 of Figure 7A will be able to distinguish the two injection devices shown in Figure 7C based on the resistance of the corresponding traces 720 formed on each injection device 1.

[0108] In the fifth embodiment shown in Figure 8A, sensor assembly 30 may include a magnetic field sensor. The magnetic field sensor may be arranged to detect the magnetic field generated by injection device 1 when auxiliary device 20 is coupled to injection device 1. The magnetic field generated by injection device 1 may be a permanent magnetic field generated by a permanent magnet located in injection device 1, or it may be a temporary magnetic field generated by electromagnetic interaction between auxiliary device 20 and injection device 1. Processor assembly 23 may be configured to measure or detect the magnetic field using the magnetic field sensor, compare the obtained measurement result with a value stored in a lookup table to determine the type of injection device 1.

[0109] Figure 8A illustrates a specific example where sensor assembly 30 includes an inductor, such as coil 810 acting as a magnetic field sensor. Injection device 1 also includes an inductor, such as coil 820, as shown in Figure 8C. In this embodiment, the identifying feature is coil 820 in injection device 1.

[0110] Figure 8B shows the auxiliary device 20 of Figure 8A when viewed from below along the direction of the large arrow in Figure 8A. As can be seen in Figures 8A and 8B, the coil 810 of the auxiliary device is a circular coil extending from the lower surface of the auxiliary device 20.

[0111] Figure 8C also shows the coil 810 of the auxiliary device 20, illustrating how it surrounds the coil 820 of the injection device 1 when the auxiliary device 20 is connected to the injection device 1. The dashed line indicates how the coil 810 of the auxiliary device 20 is housed in the injection button 11 of the injection device 1 when the auxiliary device 20 is connected to the injection device 1. The coil 810 of the auxiliary device 20 is housed such that the coil 810 of the auxiliary device 20 and the coil 820 of the injection device 1 are concentric.

[0112] The coil 810 in the auxiliary device 20 and the coil 820 in the injection device 1 are arranged such that the coils are electromagnetically connected when the auxiliary device 20 is attached to the injection device 1. The coil 810 in the auxiliary device 20 has a known fixed inductance. Depending on the type of injection device 1, the coil 820 in the injection device 1 has an inductance that varies between injection devices 1. That is, each type of injection device can have a coil 820 with a unique inductance, such that the unique inductance corresponds to the type of injection device 1.

[0113] Processor component 23 can apply current to coil 810 in auxiliary device 20, thereby generating a magnetic field that interacts with coil 820 in injection device 1 through mutual inductance. Processor component 23 can be configured to measure the total inductance of the connected coils 810 and 820. This measurement result can then be used to determine the type of injection device 1, for example, by comparing the inductance value with values ​​stored, for example, in a lookup table in memory 24. Different inductance values ​​(or ranges of values) will correspond to different types of injection devices 1. Inductance can therefore be used to identify the type of injection device 1.

[0114] In some examples, the magnetic field sensor includes one or more Hall effect sensors arranged to detect one or more magnets in the injection device 1 when the auxiliary device 20 is connected to the injection device 1. For different types of injection devices 1, the one or more magnets will be configured such that they elicit different responses in the one or more Hall effect sensors. The processor component 23 is thus able to distinguish different types of injection devices 1 based on the detected responses output by the one or more Hall effect sensors.

[0115] Figure 9A illustrates a sixth embodiment, wherein the sensor assembly 30 includes three proximity sensors 910a to 910c that point towards the injection device 1 when the auxiliary device 20 is coupled to the injection device 1. In this example, each proximity sensor 910a to 910c is an infrared transceiver. Figure 9B shows the auxiliary device 20 of Figure 9A as viewed from below along the direction of the arrows in Figure 9A.

[0116] Proximity sensors 910a to 910c are used to determine the distance between the auxiliary device 20 and one or more corresponding features of the injection device 1. The distance between the auxiliary device 20 and one or more corresponding features of the injection device 1 may correspond to the type of the injection device 1. In this embodiment, the identifying feature is one or more corresponding features of the injection device 1, the one or more features whose distance is determined by the one or more proximity sensors 910a to 910c.

[0117] Figure 9C shows a portion of the injection device 1 to which the auxiliary device 20 will be attached, in this case, the injection button 11. Three holes 920a to 920c are formed on the surface of the injection device 1, in this case, on the upper surface 110 of the injection button 11. Each hole 920a to 920c corresponds to one of the proximity sensors 910a to 910c. As schematically shown in Figure 9D, the depth of each hole 920a to 920c may vary.

[0118] Figure 9D shows that each hole 920a to 920c has a corresponding bottom surface 930a to 930c. Each proximity sensor 910a to 910c is located above the corresponding hole 920a to 920c, such that the proximity sensor 910a to 910c can determine the distance 940a to 940c between itself and the corresponding bottom surface 930a to 930c of the corresponding hole 920a to 920c.

[0119] Each proximity sensor 910a to 910c can determine the value of a corresponding distance 940a to 940c, or simply determine whether the corresponding distance 940a to 940c meets or exceeds a threshold distance. When the proximity sensors 910a to 910c determine whether the corresponding distance 940a to 940c meets or exceeds the threshold distance, the proximity sensors 910a to 910c can be effectively used as binary switches. However, if the proximity sensors 910a to 910c can distinguish three or more distances 940a to 940c, each different distance can indicate a different type of injection device 1.

[0120] Different types of injection devices 1 can be distinguished by adjusting the depth / height of various features sensed by proximity sensors 910a to 910c, thereby adjusting the distance between the features and the corresponding proximity sensors 910a to 910c when the auxiliary device 20 is connected to the injection device 1. For example, the depths 940a to 940c of the three holes 920a to 920c can vary depending on the type of injection device. Processor component 23 will be able to distinguish different combinations of outputs from proximity sensors 910a to 910c. Each combination of outputs corresponds to a type of injection device 1. Processor component 23 can compare a specific combination of outputs with a value stored in a lookup table in memory 24 to determine the corresponding type of injection device 1.

[0121] Although Figure 9A shows three proximity sensors 910a to 910c, the invention is not limited to this number and there may be more or fewer proximity sensors 910a to 910c.

[0122] Figure 10A illustrates a seventh embodiment, in which sensor assembly 30 includes a pair of infrared sensors 1010a to 1010b. Infrared sensor 1010b is hidden behind infrared sensor 1010a in Figure 10A, but can be seen in Figure 10B. Figure 10B shows the auxiliary device 20 of Figure 10A when viewed from below along the direction of the arrow shown in Figure 10A. Infrared sensors 1010a to 1010b are arranged to read coded traces on injection device 1; the identifying feature is therefore the coded traces formed on injection device 1.

[0123] The coded trace can resemble the conductive trace 620 previously discussed with respect to Figure 6C and can be positioned in a similar location on the injection device 1, such as on the surface of the injection button 11. The trace consists of two types of segments: one type elicits a first-type response in the infrared sensors 1010a to 1010b, and the other type elicits a second-type response in the infrared sensors 1010a to 1010b. The trace can be formed by grooves in the surface of the injection device or by a material printed on the surface. When the trace is formed by grooves, the surface portion with the grooves can be considered a first-type segment eliciting the first-type response, while the surface portion without grooves can be considered a second-type segment eliciting the second-type response. When the trace is formed by a material printed on the surface, portions with relatively high infrared reflectivity can be considered first-type segments, while segments with relatively low infrared reflectivity can be considered second-type segments.

[0124] The segments can have two different lengths: a shorter length representing a "dot" and a longer length representing a "dash," as shown in Figure 10C. These segments can therefore be used to provide binary codes in the encoded trace.

[0125] Infrared sensors 1010a to 1010b are arranged to read the coded trace at close but different positions along the trace. The infrared sensors 1010a to 1010b and the coded trace are arranged such that both infrared sensors 1010a to 1010b scan along the length of the trace as the auxiliary device 20 is connected to the injection device 1. In other words, both infrared sensors 1010a to 1010b are arranged to read the coded trace as the auxiliary device 20 moves relative to the injection device 1 during its connection to the injection device 1. When the auxiliary device 20 is connected to the injection device 1, the first infrared sensor 1010a reads the trace before the second infrared sensor 1010b.

[0126] In the specific embodiments shown in Figures 10A and 10B, the auxiliary device 20 is configured to be attached to the injection device 1 using a bayonet coupling, the coupling involving rotation of the auxiliary device 20 relative to the injection device 1. At the start of the coupling, the pair of infrared sensors 1010a to 1010b may point at different but adjacent points on a trace. The trace will be circular, similar to trace 620 shown in Figure 6C. Since the auxiliary device 20 and the injection device 1 are coupled by rotating the auxiliary device 20 relative to the injection device 1, the pair of infrared sensors 1010a to 1010b rotate relative to the injection device 1 such that they both move along the length of the trace, thereby reading binary codes as they move.

[0127] Infrared sensors 1010a to 1010b and the trace segments are arranged such that only one infrared sensor 1010a to 1010b can read short "dot" segments at a time, while both infrared sensors 1010a to 1010b can simultaneously read longer "dash" trace segments, as shown in Figure 10C. As a result, the two infrared sensors 1010a to 1010b can read binary information, regardless of the speed at which the auxiliary device 20 and the injection device 1 are connected.

[0128] Processor component 23 can determine the type of injection device 1 using binary codes read from the encoded traces, for example, by comparing the binary codes with values ​​in a lookup table. The lookup table can list different binary codes and the corresponding types of injection device 1 they represent.

[0129] According to the eighth embodiment shown in Figure 11A, the sensor assembly 30 includes pins 1110a to 1110b, which are configured to make electrical contact with a non-volatile memory 1120 disposed in the injection device 1 when the auxiliary device 20 is coupled to the injection device 1. In this embodiment, the identifying feature is the non-volatile memory 1120.

[0130] Figure 11B shows the auxiliary device of Figure 11A when viewed from below along the direction indicated by the arrow in Figure 11A.

[0131] Figure 11C shows a portion of the injection device 1 to which the auxiliary device 20 will be attached, in this case, the injection button 11. A non-volatile memory 1120 is located in the injection device 1, in this case, within the injection button 11. The non-volatile memory 1120 may be, for example, an electrically erasable programmable read-only memory (EEPROM). The non-volatile memory 1120 stores data that can be used to identify the type of injection device. This data may include one or more serial numbers, batch dates, drug origin, etc.

[0132] When the auxiliary device 20 is connected to the injection device 1, pins 1110a to 1110b are electrically contacted with the non-volatile memory 1120. In some examples, pins 1110a to 1110b are directly electrically contacted with corresponding pins of the non-volatile memory, such as corresponding pins of an EEPROM chip. In such examples, power can be supplied from the auxiliary device 20 to the non-volatile memory 1120 via pins 1110a to 1110b, thus requiring a separate power supply for the EEPROM within the injection device 1. In this example, the non-volatile memory 1120 may be located on the upper surface 110 of the injection button 11. In other examples, pins 1110a to 1110b of the auxiliary device 20 are electrically contacted with the non-volatile memory 1120 via one or more electrical connectors (not shown) disposed in the injection device 1, which provide an electrical connection between pins 1110a to 1110b and pins 1120 of the non-volatile memory.

[0133] The processor component 23 of the auxiliary device 20 can read data from the non-volatile memory 1120 via pins 1110a to 1110b and determine the type of the injection device 1 based on the data.

[0134] Figures 11A to 11C show two pins 1110a to 1110b, however any number of pins can be used. In particular, a pin 1110 can be provided for each corresponding pin of the non-volatile memory 1120.

[0135] The invention also relates to a system including any of the auxiliary devices 20 discussed herein and a corresponding injection device 1 containing identification features, wherein the processor component 23 is configured to cause the auxiliary device 20 to use the sensor component 30 to sense the identification features of the injection device 1 and determine the type of the injection device 1 based on the sensed identification features.

[0136] The invention also relates to a method using the aforementioned auxiliary device 20 and the corresponding injection device 1. FIG12 is a flowchart illustrating a method for identifying the type of injection device 1 using an auxiliary device 20 coupled to the injection device 1, wherein the auxiliary device 20 includes a sensor assembly 30 and a processor assembly 23.

[0137] In step 1210, processor component 23 causes sensor component 30 to sense a marking feature of injection device 1. Sensing the marking feature may include sensor component 30 interacting with the marking feature and outputting a signal corresponding to the marking feature. The signal may represent a value associated with the marking feature.

[0138] In step 1220, the processor component 23 then determines the type of the injection device 1 based on the sensed identification features, enabling it to distinguish different types of injection devices and modify their operation accordingly. Specifically, the processor component 23 can determine the type of the injection device 1 based on a signal output by the sensor component 30. The processor component 23 can compare the signal or a value derived from the signal with a plurality of signals or values ​​stored in a lookup table, where each stored signal or value corresponds to a type of injection device. The processor component 23 can determine the type of the injection device 1 based on the comparison results.

[0139] The invention also relates to an injection device 1 including one or more identifying features disclosed herein, the identifying features indicating the type of the injection device 1, and wherein the injection device 1 is configured to be coupled to an auxiliary device 20, the identifying features 1 being arranged to be sensed by the auxiliary device 20 to determine the type of the injection device 1. For example, aspects of the invention include an injection device 1 including conductive traces on the surface of the injection device 1, as discussed with respect to FIG. 7C.

[0140] The terms “drug” or “pharmaceutical” are used as synonyms herein and describe pharmaceutical formulations comprising one or more active pharmaceutical ingredients or their pharmaceutically acceptable salts or solvates, and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient (“API”) is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or pharmaceutical agent is used to treat, cure, prevent, or diagnose a disease, or to otherwise enhance physical or mental health. Drugs or pharmaceutical agents may be used for a limited period of time or periodically for chronic diseases.

[0141] As described below, in various types of formulations, a drug or pharmaceutical agent used to treat one or more diseases may include at least one API or a combination thereof. Examples of APIs may include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids (such as antisense DNA and RNA), small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also considered.

[0142] A drug or pharmaceutical agent may be contained in a primary package or "drug container" suitable for use in a drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other robust or flexible vessel configured to provide a suitable chamber for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chamber may be designed to store the drug for at least one day (e.g., from 1 day to at least 30 days). In some cases, the chamber may be designed to store the drug for about one month to about two years. Storage may be carried out at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the drug container may be or may include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one component in each chamber.

[0143] In such cases, the two chambers of a dual-chamber cartridge can be configured to allow mixing between two or more components before and / or during administration to a human or animal. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., through a catheter between the two chambers), allowing the user to mix the two components as needed before administration. Alternatively or additionally, the two chambers can be configured to allow mixing during administration of the components to a human or animal.

[0144] The drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent many different types of medical conditions. Examples of conditions include, for example, diabetes or diabetes-related complications (such as diabetic retinopathy), thromboembolic diseases (such as deep vein or pulmonary thromboembolism). Further examples of conditions are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those described in the following manuals: such as Rote Liste 2014 (e.g., but not limited to, main group 12 (antidiabetic drugs) or 86 (oncology drugs)) and Merck Index, 15th edition.

[0145] Examples of APIs used to treat and / or prevent type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide-1 (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture thereof. As used herein, the terms “analyte” and “derivative” refer to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deletion and / or exchange of at least one amino acid residue present in a naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues may be encoding amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. Specifically, the term "derivative" refers to a polypeptide having a molecular structure that can be formally derived from the structure of a naturally occurring peptide, such as human insulin, wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in a naturally occurring peptide may have been omitted and / or substituted with other amino acids (including non-coding amino acids), or amino acids (including non-coding amino acids) may have been added to a naturally occurring peptide.

[0146] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (glargine insulin); Lys(B3), Glu(B29) human insulin (glutamate insulin); Lys(B28), Pro(B29) human insulin (lispro insulin); Asp(B28) human insulin (aspart insulin); human insulin wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala and wherein the Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0147] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (detemir 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-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (degludecinin, ); B29-N-(N-lithochyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecyl) human insulin.

[0148] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixilatin. Exenatide (Exendin-4, Liraglutide, a 39-amino acid peptide produced by the salivary glands of the Gila monster. Semaglutide, Taspoglutide, Albiglutide Dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langnatide / HM-11260C, CM-3, GLP-1Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, exenatide-XTEN, and glucagon-Xten.

[0149] Examples of oligonucleotides include: imipenem sodium. It is a cholesterol-reducing antisense agent used to treat familial hypercholesterolemia.

[0150] Examples of DPP4 inhibitors include vidagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0151] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, fertility-stimulating hormone), growth hormone (Somatropine), desmopressin, terlipressin, gosorelin, triptorelin, leuprorelin, buserorelin, nafarelin, and goserelin.

[0152] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or their derivatives, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and / or their pharmaceutically acceptable salts. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20. It is a type of sodium hyaluronate.

[0153] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigens. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized antibodies or humanized antibodies, fully human antibodies, non-human (e.g., murine) antibodies, or single-chain antibodies. In some embodiments, antibodies have effector function and can fix complement. In some embodiments, antibodies have reduced or no ability to bind Fc receptors. For example, antibodies can be isotypes or subtypes that do not support binding to Fc receptors, antibody fragments, or mutants, for example, having a mutagenic or missing Fc receptor-binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or bivariate antibody-like binding proteins (CODVs) with cross-binding region orientation.

[0154] The term "fragment" or "antibody fragment" refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy chain and / or light chain polypeptide), excluding full-length antibody polypeptides but still including at least a portion of a full-length antibody polypeptide capable of binding an antigen. An antibody fragment may comprise a cleaved portion of a full-length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that may be used in this disclosure include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (such as bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., double-chain, triple-chain, and quadruple-chain antibodies)), monovalent or multivalent antibody fragments (such as bivalent, trivalent, quadruvalent, and multivalent antibodies), microantibodies, chelated recombinant antibodies, tri- or bispecific antibodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelified antibodies, and antibodies containing VHH. Further examples of antigen-binding antibody fragments are known in the art.

[0155] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term "frame region" refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides; these are not CDR sequences and are primarily responsible for maintaining the correct positioning of the CDR sequence to allow antigen binding. Although frame regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the frame regions of some antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0156] Examples of antibodies are anti-PCSK-9 mAb (e.g., Alirocumab), anti-IL-6 mAb (e.g., Sarilumab), and anti-IL-4 mAb (e.g., Dupilumab).

[0157] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in drug delivery devices for drugs or pharmaceutical preparations. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0158] Those skilled in the art will understand that various components of the APIs, formulations, devices, methods, systems, and implementations described herein may be modified (added and / or removed) without departing from the full scope and spirit of this disclosure, which covers such modifications and any and all equivalents thereof.

Claims

1. An auxiliary device (20) configured to be connected to an injection device (1), the auxiliary device comprising: Sensor assembly (30); Dosage determination unit (26); as well as Processor component (23), which is configured to cause the auxiliary device: The sensor assembly is used to sense the identifying features of the injection device; The type of the injection device is determined based on the sensed identification features; and The dose determination unit is used to determine the dose. The dosage is determined based on the type of injection device identified. The type of the injection device is related to the type of dose selection mechanism present in the injection device or the type of dispensing mechanism used in the injection device, and the dose determination unit is calibrated using a specific type of injection device.

2. The auxiliary device according to claim 1, further comprising: Alignment components, The alignment component is configured to interact with a corresponding alignment feature of the injection device, such that the auxiliary device can be coupled to the injection device in a predetermined number of orientations relative to the injection device.

3. The auxiliary device according to claim 2, wherein the predetermined quantity is one or two, or three, four or more.

4. The auxiliary device according to any one of claims 1 to 3, further comprising: Communication interface, The processor component is configured to transmit data indicating the type of the determined injection device to an external computing device via the communication interface.

5. The auxiliary device according to any one of claims 1 to 3, wherein the sensor assembly comprises a light source (410) and a color sensor (420). The light source is arranged to illuminate a portion of the injection device when the auxiliary device is connected to it. The color sensor is arranged to determine the color of the illuminated portion, and The processor component is configured to determine the type of the injection device based on the determined color.

6. The auxiliary device according to any one of claims 1 to 3, wherein the sensor assembly includes a navigation switch (510) movable between multiple locations. The navigation switch is arranged such that when the auxiliary device is connected to the injection device, it is biased to one of the plurality of positions by the biasing characteristics of the injection device. Each of the plurality of locations corresponds to a type of injection device, and The processor component is configured to determine the type of the injection device based on the position of the navigation switch.

7. The auxiliary device according to any one of claims 1 to 3, wherein the sensor assembly includes a plurality of contacts (610a to 610f) arranged to contact conductive traces (620) formed on the surface of the injection device when the auxiliary device is coupled to the injection device. The conductive traces include one or more segments (630a to 630d) arranged to electrically connect two or more contacts. The processor component is configured to determine the type of the injection device by polling each of the contacts.

8. The auxiliary device according to any one of claims 1 to 3, wherein the sensor assembly includes two pins (710a, 710b) arranged to contact a conductive trace (720) formed on the surface of the injection device when the auxiliary device is coupled to the injection device. The processor component is configured to determine the type of the injection device based on the determined resistance of the conductive trace.

9. The auxiliary device according to any one of claims 1 to 3, wherein the sensor assembly includes a magnetic field sensor (810) arranged to detect a magnetic field generated by the injection device when the auxiliary device is coupled to the injection device. The processor component is configured to determine the type of the injection device based on the detected magnetic field.

10. The auxiliary device according to any one of claims 1 to 3, wherein the sensor assembly includes at least one proximity sensor (910a to 910c), the at least one proximity sensor being arranged to determine the distance between the auxiliary device and a corresponding identification feature of the injection device when the auxiliary device is coupled to the injection device. The processor component is configured to determine the type of the injection device based on the determined distance.

11. The auxiliary device according to claim 10, wherein the proximity sensor includes an infrared transceiver. The infrared transceiver is arranged to determine the depth of the holes (920a to 920c) disposed on the surface of the injection device when the auxiliary device is coupled to the injection device. The processor component is configured to determine the type of the injection device based on the determined depth of the orifice.

12. The auxiliary device according to any one of claims 1 to 3, wherein the sensor assembly comprises a first infrared sensor (1010a, 1010b) and a second infrared sensor (1010b, 1010a). Both the first infrared sensor and the second infrared sensor are arranged to read the coded traces formed on the injection device as the auxiliary device moves relative to the injection device during the process of the auxiliary device being connected to the injection device. The processor component is configured to determine the type of the injection device based on the coded traces read using the first infrared sensor and the second infrared sensor.

13. The auxiliary device according to any one of claims 1 to 3, wherein the sensor assembly includes a plurality of pins (1110a, 1110b) configured to form an electrical connection with a non-volatile memory (1120) in the injection device when the auxiliary device is coupled to the injection device. The processor component is configured to read data from the non-volatile memory when the auxiliary device is coupled to the injection device, and The processor component is configured to determine the type of the injection device based on the data read from the non-volatile memory.

14. The auxiliary device according to any one of claims 1 to 3, wherein the type of the injection device indicates at least one of the concentration of the agent contained in the injection device, or the number of units allocated for each incremental movement of the dose delivery mechanism contained in the injection device.

15. A system comprising an injection device (1) and an auxiliary device (20) according to any one of claims 1 to 14, wherein the injection device includes an identification feature, and wherein the processor component is configured to cause the auxiliary device to: The sensor assembly (30) is used to sense the identification features of the injection device; and The type of the injection device is determined based on the sensed identification features.

16. The system of claim 15, wherein the type of the injection device indicates at least one of the concentration of the agent contained in the injection device, or the number of units allocated for each incremental movement of the dose delivery mechanism contained in the injection device.

17. A method for identifying the type of an injection device using an auxiliary device coupled to the injection device, the auxiliary device including a sensor assembly, a processor assembly, and a dose determination unit, the method comprising: The processor component causes the sensor component to sense (1210) the identification features of the injection device; The processor component determines (1220) the type of the injection device based on the sensed identification features; as well as The processor component uses the dose determination unit to determine the dose, wherein the dose is determined based on the type of injection device. The type of the injection device is related to the type of dose selection mechanism present in the injection device or the type of dispensing mechanism used in the injection device, and the dose determination unit is calibrated using a specific type of injection device.

18. The method of claim 17, wherein the type of the injection device indicates at least one of the concentration of the drug contained in the injection device, or the number of units allocated for each incremental movement of the dose delivery mechanism contained in the injection device.

Images