Drug delivery system with drug recognition

Abstract

The present invention relates to a medication delivery system essentially comprising three main components: a housing structure (10), a reservoir structure (20), and a protective cap structure (30). The housing structure comprises an electronic dose size capture arrangement and a first communication means. The reservoir structure contains a liquid medication and is removably attachable to the housing structure. The reservoir structure further comprises an identifier encoded with information related to the type of medication contained within the reservoir structure. A protective cap attachable onto the medication delivery device comprises a sensor arrangement configured to sense the information encoded in the identifier and a second communication means for communicating information related to the type of medication contained within the reservoir structure.

Description

[Technical Field]

[0001] The present invention relates to a drug delivery system comprising a combination of a housing structure, a reservoir structure, and a protective cap. The drug delivery system is suitable for dispensing one or more doses of a liquid drug, preferably of the type where the liquid drug is contained in a replaceable container unit. More specifically, the present invention relates to such a drug delivery system that is capable of recognizing or determining the type of drug contained in the replaceable container unit and communicating this information.

[0002] The present invention further relates to a protective cap for such a drug delivery system. [Background technology]

[0003] International Patent Application No. 2012 / 022771 discloses an injection device, in which a housing part is provided with one or more electronic sensors configured to detect and identify coding on a medication reservoir unit insertable into the housing part of the injection device.

[0004] Another patent application WO 2013 / 053695 discloses an injection device having a BGM cap provided with a processor capable of calculating a dose recommendation. The BGM cap is further provided with detection means capable of obtaining information from an identifier provided on the respective injection device. The identifier is described in one embodiment as an RFID tag.

[0005] US Patent Application No. 2014 / 0194825 discloses a pen-shaped injection device in which an add-on unit including data capture means is physically connected to the pen-shaped injection device and is capable of communicating injection-related data to a protective cap equipped with a display.

[0006] A similar approach is disclosed in US 11,318,251 which discloses a pen-shaped device. The protective cap shown is also provided with a display, and data relating to dose size can be transferred from the pen-shaped injection device to the protective cap where it is displayed on the display.

[0007] For example, as disclosed in WO 2012 / 022771, if a sensor for reading information encoded on the reservoir unit is provided in a housing part carrying the dose engine, a somewhat complex interface between the reservoir unit and the housing part is required. Furthermore, the presence of an identifier on the reservoir unit and a sensor on the inner surface of the housing part requires that part of the housing part overlaps with the reservoir unit, which limits the design options available for the injection device and further requires that the housing part have a diameter substantially larger than that of the reservoir unit.

[0008] Furthermore, many known electronic dose capture systems, for example those disclosed in US 11,318,251, include rotating components that make such systems relatively complex. In such systems, it is particularly difficult to provide information encoded on the cartridge to such a rotating dose capture system. Rotating components may also be provided at locations within the injection device, further complicating the transfer of such data. Summary of the Invention

[0009] Henceforth, it is an object of the present invention to provide a solution in which the system for identifying drug type is separated from the electronic dose size capture system and does not depend on a specific physical infrastructure within the injection device.

[0010] The invention is further defined in claim 1. Advantageous embodiments are defined in the dependent claims.

[0011] Thus, in one aspect of the present invention, a drug delivery system comprises a housing structure, a reservoir structure, and a protective cap structure. The housing structure comprises a dose setting and delivery mechanism for setting and expelling a dose of the liquid medication, and an electronic dose size capture arrangement for capturing the size of the expelled dose together with a first communication means for communicating the size of the expelled dose. The reservoir structure contains a liquid medication and is removably attachable to the housing structure. The reservoir structure further includes an identifier encoded with information related to the type of medication contained within the reservoir structure. The protective cap structure is mountable onto the medication delivery device and, when mounted, at least partially covers the reservoir structure.

[0012] Additionally, the protective cap structure comprises a sensor arrangement configured to sense information encoded in the identifier, and the protective cap further comprises second communication means for communicating information regarding the type of medication contained within the reservoir structure.

[0013] The housing structure therefore comprises an electronic dose size capture arrangement which is able to register the size of each dispensed dose and transmit this information. The dispensed dose sizes are preferably collected during the actual administration of the liquid medication. Furthermore, a sensor arrangement carried by the protective cap is able to obtain information from the attached reservoir structures regarding the type of liquid medication contained in the respective reservoir structure and transmit this information.

[0014] Thus, the two streams of information, dose size and drug type, can be collected separately and communicated separately, thus eliminating the need for the two systems to be in close proximity to each other, providing a high degree of flexibility in the physical design of the injection device.

[0015] Additionally, a timer may be provided that registers the actual time that the electronic dose capture arrangement captures the size of the ejected dose, so that each ejected dose is stored with a timestamp. Additionally, a display may be provided within the protective cap, so that, for example, information regarding the type of medication contained within the reservoir structure may be displayed. Other stored data may also be presented on the display.

[0016] In a further embodiment, the second communication means provided in the protective cap is configured to communicate information regarding the type of medicament contained in the reservoir structure to an external data receiving unit, preferably a computer, tablet or mobile phone, and preferably a smartphone operating a dosage app.

[0017] A first communication means provided within the housing structure can communicate the size of each ejected dose to an external data receiving unit, which in one example is the same external receiving unit that also receives information regarding the type of medication contained within the reservoir structure. These two information streams can then be processed by a program stored on the external data receiving unit, which is preferably a dose app running on a tablet or smartphone.

[0018] In a different setup, a second communication means provided in the protective cap is designed to communicate information regarding the type of drug contained in the reservoir structure to an electronic dose size capture arrangement provided in the housing structure, so that both information streams are available to the electronic dose size capture arrangement.

[0019] A first communication means provided within the housing structure preferably communicates information regarding the ejected dose size and type of medication to an external data receiving unit, which may be any kind of computer, tablet or mobile phone, preferably a smartphone, so that the two streams of information can be processed by the dose app.

[0020] In a further embodiment, the reservoir structure comprises a container for containing the liquid agent, the container being permanently fixed in a holder unit that can be attached to the housing structure. The container is preferably a glass cartridge enclosed in a suitable plastic housing made from any suitable polymer. The plastic housing is preferably made from two or more molded parts that are irreversibly connected to thereby enclose the glass cartridge.

[0021] The holder units preferably carry an identifier coded with information regarding the type of medicament contained within a particular reservoir structure, such that each holder unit is coded with information referencing the liquid medicament contained within the particular holder unit, the coding preferably being an electronically identifiable coding.

[0022] In one example, the identifier includes several distinct regions, some of which are conductive and some of which are non-conductive, thereby forming a bit code.

[0023] In one particular example, six such separate regions are provided so that a 6-bit code may be generated. Thus, each of the six regions may be conductive or non-conductive. In a further example, the number of conductive and non-conductive regions may be duplicated to provide further redundancy within the system.

[0024] Thus, the bit code can range as a 6-bit code from 0-0-0-0-0-0 to 1-1-1-1-1-1. Thus, 64 different bit codes can be obtained, with each specific bit code representing a specific type of liquid drug.

[0025] To read information from the holder unit, the sensor arrangement in the protective cap comprises an elastic connector that is in galvanic contact with conductive and non-conductive areas of the identifier carried by the holder unit when the protective cap is mounted on the medication delivery device and at least partially covers the reservoir structure.

[0026] The elastic connector, often referred to as a zebra connector, typically includes multiple alternating current conductive and non-conductive segments. All of the segments, or alternatively, only some of the segments, are made of a flexible material, such as an elastomer or silicone rubber, that allows the zebra connector to be compressed and thus suitable for being pressed against a surface and maintaining electrical contact. In a specific example, the alternating current conductive and non-conductive regions extend axially along the central axis ("X") of the injection device.

[0027] Each time the user replaces the empty holder unit with a new one, the sensor arrangement in the protective cap reads and transmits information about the type of liquid agent contained in the holder unit when the protective cap is attached.

[0028] To read the information, a cap insert is provided in the protective cap, which is provided with conductive strips connecting the elastic connector with the PCB, so that a processor on the PCB can determine the current delivered to the identifier and the response received from the identifier.

[0029] In one example, the electronic dose size capture arrangement comprises a rotating component and a non-rotating component, the relative rotation of which generates a signal indicative of the dose size, the non-rotating component being fixed to the housing of the injection device such that the relative rotation occurring between the rotating component and the non-rotating component at least during administration is representative of the ejected volume.

[0030] In one example, the electronic dose size capture arrangement is provided proximally within the housing structure, preferably inside the dose setting button. In such an example, the electronic dose size capture arrangement is an electronic component that can be manufactured separately from the injection device and easily integrated into the dose setting button within the housing structure during assembly of the injection device. The electronic dose size capture arrangement is therefore a separate component with its own power backup, such as a battery, and therefore operates completely independently of the injection device, at least electronically.

[0031] Furthermore, the first and second communication means are Bluetooth communication means that use the standard Bluetooth protocol for easily transmitting information to an external data receiving unit such as a computer, tablet or smartphone.

[0032] In a second aspect of the invention, a protective cap provided in the drug delivery system comprises a sensor arrangement, the protective cap therefore comprising a resilient connector electrically connected to a cap insert, the insert carrying several conductive strips connecting the resilient connector with a PCB also provided in the protective cap.

[0033] Definition: An "injection pen" or "injector pen" is an injection device that typically has an oval or elongated shape somewhat resembling a writing pen. Such pens usually have a tubular cross section, but can easily have different cross sections, such as triangular, rectangular, or square, or any variation around these geometric shapes.

[0034] The term "needle cannula" is used to describe the actual conduit that penetrates the skin during injection. The needle cannula is typically made from a metallic material, such as stainless steel, and is connected to a hub to form the complete injection needle, often referred to as a "needle assembly." However, the needle cannula may also be made from a polymeric or glass material. The hub also carries a connecting means for connecting the needle assembly to the injection device, and is typically molded from a suitable thermoplastic material. The "connecting means" may be, by way of example, a luer coupling, a bayonet coupling, a threaded connection, or any combination thereof.

[0035] The term "needle unit" is used to describe one single needle assembly carried within a container. Such containers typically have a closed distal end and an open proximal end sealed by a removable seal. The interior of such containers is typically sterilized so that the needle assembly is ready for use. Needle units specifically designed for pen injection systems are defined in ISO Standard No. 11608, Part 2, and are often referred to as "pen needles." Pen needles are typically double-pointed, with a front end for piercing the user's skin and a rear end for piercing the medication-containing cartridge so that fluid communication is established during injection.

[0036] As used herein, the term "liquid formulation" is meant to encompass any drug-containing flowable pharmaceutical product that can be passed through a delivery means, such as a hollow needle cannula, in a controlled manner, such as a liquid, solution, gel, or fine suspension. Exemplary pharmaceutical products include pharmaceuticals such as peptides, proteins (e.g., insulin, insulin analogs, and C-peptide), and hormones, biologically derived or active agents, hormone- and gene-based drugs, nutritional formulas, and other substances in solid (preparation) or liquid form.

[0037] "Cartridge" is a term used to describe the container that actually holds the medication and is often referred to as primary packaging. Cartridges are typically made of glass but can be molded from any suitable polymer. The cartridge or ampoule is preferably sealed at one end by a pierceable membrane called a "septum," which can be pierced, for example, by the non-patient end of a needle cannula. Such septums are typically self-sealing, meaning that when the needle cannula is removed from the septum, the opening created during piercing automatically seals due to its inherent elasticity. The opposite end of the cartridge is typically closed by a movable "plunger," a piston-like element made of rubber or a suitable polymer. During use, the plunger is slidably moved within the cartridge, preferably distally. The space between the pierceable membrane and the movable plunger holds the liquid medication, which is expelled when the plunger reduces the amount of space holding the liquid medication. Cartridges used in both prefilled and durable injection devices are typically filled with a predetermined amount of liquid medication at the factory by the manufacturer. Many cartridges currently available contain 1.5 ml or 3 ml of liquid medication.

[0038] Because cartridges typically have a narrower distal neck portion into which the plunger cannot move, not all of the liquid contained within the cartridge can actually be expelled. Thus, the terms "initial amount" or "substantially used" refer to the injectable volume contained within the cartridge, and therefore not necessarily the total volume.

[0039] The term "prefilled injection device" refers to an injection device in which a cartridge containing a liquid medication is permanently embedded within the injection device so that it cannot be removed without permanently destroying the injection device. Once the prefilled amount of liquid medication in the cartridge is used, the user typically discards the entire injection device. Typically, the cartridge, filled by the manufacturer with a specific amount of liquid medication, is secured within a cartridge holder that is later permanently connected within the housing structure so that the cartridge cannot be replaced.

[0040] This is in contrast to "durable syringes," which allow users to replace the cartridge containing the liquid medication whenever it becomes empty. Prefilled syringes are typically sold in packages containing two or more syringes, while durable syringes are typically sold one at a time. When using prefilled syringes, the average user may need 50 to 100 syringes per year, whereas with durable syringes, one single syringe may last for several years, but the average user will need 50 to 100 new cartridges per year.

[0041] All references, including publications, patent applications, and patents, cited herein are incorporated by reference in their entireties to the same extent as if each reference was individually and specifically indicated to be incorporated by reference.

[0042] All headings and sub-headings are used herein for convenience only and should not be construed as limiting the invention in any way.

[0043] The use of any and all examples or exemplary language (e.g., as follows) provided herein is intended merely to clarify the present invention and does not limit the scope of the present invention unless otherwise specified. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.

[0044] Citation and incorporation of patent documents herein is done for convenience only and does not reflect any view on the validity, patentability and / or enforceability of such patent documents.

[0045] This invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law.

[0046] The invention will be explained in more detail below in connection with preferred embodiments and with reference to the drawings. [Brief explanation of the drawings]

[0047] [Figure 1] FIG. 1 shows an exploded view of the main structure of an injection device according to the invention. [Figure 2] FIG. 2 shows a perspective view of the reservoir structure. [Figure 3] FIG. 3 shows an exploded view of the cap insert. [Figure 4] FIG. 4 shows a view of the elements shown in FIG. 3 from a distal position. [Figure 5A] FIG. 5A shows the injection device with the protective cap attached. [Figure 5B] FIG. 5B shows the injection device with the protective cap visually removed. [Figure 5C] FIG. 5C shows the injection device with the protective cap and cap insert visually removed. [Figure 5D] FIG. 5D shows the injection device with the protective cap removed. [Figures 6A-6B] 6A-6B show two different views of the dose dial button and an electronic dose capture arrangement that can be inserted into the dose dial button.

[0048] The figures are schematic and simplified for clarity, showing only details essential to an understanding of the invention and omitting other details, and the same reference numerals are used throughout to refer to the same or corresponding parts. DETAILED DESCRIPTION OF THE INVENTION

[0049] When terms such as "top" and "bottom," "right" and "left," "horizontal" and "vertical," or similar relative expressions are used below, these merely refer to the accompanying drawings and do not necessarily represent actual usage situations. The drawings shown are schematic representations, so the configurations of different structures and their relative dimensions are intended to serve illustrative purposes only.

[0050] In that context, it may be convenient to define that the term "distal end" in the accompanying figures is meant to refer to the end of the injection device that supports the injection needle, and that the term "proximal end" is meant to refer to the opposite end that carries the injection button, as shown in Figure 1. Distal and proximal refer to the orientation of an axis that extends along the longitudinal axis (X) of the injection device, as also disclosed in Figure 1.

[0051] In the following examples, when clockwise and reverse or counterclockwise directions are referred to, it is understood that the injection device is viewed from a position distal to the injection device. Thus, a clockwise direction is a rotation following a normal clockwise arm, and a counterclockwise direction is a rotation in the opposite direction.

[0052] The following terms are used throughout the detailed description below to describe the various movements performed by the injection devices described in the examples.

[0053] "Translational motion" means strictly linear motion without any rotation.

[0054] "Rotational movement" is any rotational movement about a center, which may be the center point of a single planar axis or central axis, i.e., having a longitudinal extension.

[0055] "Axial motion" means any motion in an axial direction. Such motion can be strictly translational or can include rotational motion, thus resulting in "helical motion", which means a combination of axial and rotational motion.

[0056] "Telescopic" is meant to encompass situations where a movable element moves out of and / or into a base element. The telescopic movement can be translational or can include rotation, making the telescopic movement helical.

[0057] As can be seen in Figure 1, an injection device 1 according to the present invention comprises a housing structure 10, a reservoir structure 20, and a protective cap 30. Although the injection device is disclosed as a longitudinal pen-shaped injection device, other shapes may be contemplated.

[0058] Both the housing structure 10 and the reservoir structure are equipped with a Blue Tooth transmitter, as indicated by "BT" in Figure 1. The use of these two Blue Tooth transmitters is explained below.

[0059] The housing structure 10 contains a delivery mechanism, usually referred to as a dose engine. Such a dose engine can be a manual dose engine, in which the force to expel the dose is delivered by the user of the injection device, or the dose engine can be spring-driven, such that a force-driven dose is delivered by a spring. Alternatively, the dose engine can use an electric motor to dispense the dose. Numerous examples of these different dose engines can be found in the prior art. A well-known commercially available injection device based on a torsion spring-driven dose engine is the FlexTouch® from Novo Nordisk A / S, which is described in detail in WO 2022 / 013155 and is also illustrated in Figures 1 to 3 of WO 2022 / 013155.

[0060] The spring-driven dose engine is activated by pressing an injection button 11 provided at the proximal end of the housing structure 10, which releases the torque stored in the torsion spring during dose setting. Before pressing the injection button 11, the user sets the size of the dose to be expelled by rotating the dose setting button 12. Once the dose is set and the torsion spring is tensioned, the dose size is displayed in window 13. Distally, the housing structure 10 is provided with means for releasably engaging with the reservoir structure 20. These means are typically a screw or bayonet interface; however, other interfaces may be contemplated.

[0061] A protective cap 30 is provided to cover the reservoir structure 20 when not in use. This protective cap 20 is preferably clicked onto the distal end of the injection device 1.

[0062] The reservoir structure 20 is disclosed in Figure 2 and comprises a container 21 containing a liquid agent, preferably made from glass and permanently embedded in a holder unit 22 molded from a suitable polymer. Distally, the reservoir structure 20 is provided with a needle interface 23 for securing a pen needle 25 to the reservoir structure 20. The proximal end of a needle cannula in the pen needle 25 penetrates into the glass container 21, as is commonly known from such pen-shaped injection devices. Proximally, the reservoir structure 20 is provided with a bayonet track 24 that engages with an inwardly pointing protrusion 14 provided on the inner surface of the housing structure 10. The inwardly pointing protrusion 14 is also shown in dashed lines in Figure 1.

[0063] In one example, the holder unit 22 enclosing the glass container 21 is molded as two or more distinct parts that are assembled around the glass container 21 by adhesive bonding, welding, or other means, which may be simple mechanical assembly means such as threaded interlocking connections or irreversible click mechanisms. In a different example, the holder unit 22 may be molded around the glass container 22. Thus, the holder unit 22, together with the glass container 21, constitutes the reservoir structure 20.

[0064] Thus, the reservoir structures 20 containing the liquid medication are made as separate units and are typically sold as such individual units, and the same housing structure 10 can thus be used with multiple different reservoir structures 20 depending on which type of liquid medication the user requires for a particular treatment.

[0065] The reservoir structure 20 also carries an identifier 40 that identifies the type of liquid medication contained in the glass container 21 within the particular reservoir structure 20. The identifier 40 may be any type of electronic or non-electronic device that can be coded with information regarding the type of liquid medication contained within the glass container 21 within the reservoir structure 20. The coding of the identifier 40 is preferably done as an integral part of manufacture. Examples of suitable identifiers 40 are provided below.

[0066] In one example, the identifier 40 comprises a sheet 41, best seen in FIG. 3, or the like, which is attached to the reservoir structure 20 as disclosed in FIG. 2 and has several distinct regions 42 that can be formed to be either conductive or non-conductive. In the disclosed example 12, such a region 41 is provided. To provide redundancy, the region is replicated so that two sets of regions are actually provided, each having six distinct regions 42. Each of these six regions 42 can be either conductive or non-conductive, and thus a six-bit code can be provided.

[0067] Thus, the six conductive and non-conductive regions 42 can generate a six-bit code from 0-0-0-0-0-0 to 1-1-1-1-1-1. A "0" indicates no electrical connection, and a "1" indicates electrical contact. Thus, a total of 2 6 = 64 different codes can be generated. Each specific bit code is therefore dedicated to a specific liquid drug such that the identifier 40 is encoded with information about the type of liquid drug contained in the glass container 21 inside the reservoir structure 20.

[0068] An example of such a bit code system based on conductive and non-conductive regions is provided in US2010 / 0161240, in particular Figure 7A which shows how these conductive and non-conductive regions can be identified by passing a current through the region and measuring whether the current is returned, which is preferably controlled by a processor.

[0069] The sheet 41 including the conductive and non-conductive regions 42 disclosed in Figure 3 may be attached to the reservoir structure 20 in many different ways, such as, for example, by welding or adhesive. Alternatively, the conductive and non-conductive regions 42 may be made as an integral part of the reservoir structure 20. As best seen in Figure 2, the conductive and non-conductive regions 42 are preferably located at the distal end of the reservoir structure 20 pointing away from the bayonet track 24 that mates with the housing structure 10.

[0070] 3 further discloses a cap insert 50 carrying a printed circuit board (PCB) 55 distally and a resilient connector 52 proximally. The cap insert 50 is provided on its inner surface with a plurality of longitudinal conductive strips 51, fabricated, for example, by 2K molding, where the conductive strips 51 can be metallic or otherwise conductive. These conductive strips 51 connect the PCB 55 to a resilient connector 52, often referred to as a zebra connector. The PCB 55 carries a processor that controls the current applied through the zebra connector 52 to the conductive and non-conductive regions 42 on the reservoir structure 20, further controlling whether these regions 42 complete a circuit to generate a bit code that identifies the type of liquid agent contained within the particular reservoir structure 20.

[0071] Zebra connectors typically include multiple alternating current conductive and non-conductive segments. The segments are made of a flexible material, such as an elastomer or silicone rubber, that allows the zebra connector to be compressed. In the example of the present disclosure, the zebra connector 52 is shaped as a circle that follows the circular outline of the protective cap 30, and the conductive segments of the zebra connector 52 are axially conductive.

[0072] FIG. 4 discloses the cap insert 50 as viewed from the proximal end. The PCB 55 is also provided with two sets of six regions 56 that, through conductive strips 51 and zebra connectors 52, identify the conductive and non-conductive regions 42 on the reservoir structure 20 to generate a six-bit code. The PCB 55 further includes a Bluetooth unit 57 capable of communicating the bit code to another electronic unit. For better illustration, the Bluetooth unit 57 and other components of the PCB are shown as separate from the PCB 55 in FIG. 3; however, in use, these components, including the Bluetooth unit 57, are part of the PCB. The bit code, as will be described, represents information related to the type of liquid agent contained within a particular reservoir structure 20.

[0073] Figure 5A discloses the injection device of Figure 1 with a protective cap 30 attached, covering the reservoir structure 20 and adjacent to the housing structure 10. As can also be seen in Figure 5B, where the protective cap 30 is visually removed, the cap insert 50 is provided with a number of protrusions 53 distally that secure the cap insert 50 to the protective cap 30 so that they operate functionally as one element. However, the cap insert 50 can be secured to the protective cap 30 in a number of different ways, including being an integral part of the protective cap 30.

[0074] In Figure 5C, both the protective cap 30 and the cap insert 50 are visually removed, thereby disclosing the PCB 55, the battery 58, and the zebra connector 52 provided inside the cap insert 50. The battery 58 is pressed against the PCB 58 by a compression spring 59 inserted between the protective cap 30 and the battery 58. Figure 5D discloses the injection device with the protective cap 30 completely removed and the pen needle 25 attached to the reservoir structure 20.

[0075] In Figures 5A-5C, the zebra connector 52 is pressed against the identifier 40 so that electrical current can be directed from the conductive strip 51 in the cap insert 50 to the conductive and non-conductive regions 42 of the identifier carried by the reservoir structure 20 to generate a specific bit code.

[0076] The injection device is further provided with an electronic dose capture arrangement 60 for capturing the size of each dispensed dose. The dose capture arrangement 60 is disclosed in Figures 6A-6B and is enclosed within a shell 61 that is proximally connected to the injection button 11 to form a single dose unit 65 that can be manufactured separately from the rest of the injection device.

[0077] As seen in FIGS. 6A and 6B , the injection button 11 is provided with several distally extending click arms 15 that connect to the shell 61 to form a single dose unit 65. This dose unit 65, comprising the shell 61, the dose capture arrangement 60, and the injection button 11, is shaped and dimensioned to fit inside the dose set button 12, as best seen in FIG. 6B . A compression spring 66 is provided to urge the dose unit 65 proximally when a dose is not being injected. A flange, track, or the like is provided to prevent the dose unit 65 from falling off the dose set button 12. During administration, the user presses the injection button 11 distally, which also moves the entire dose unit 65 distally; the axial movement further secures the dose set button 12 rotationally to the housing structure 10 via longitudinal ribs 67 provided within the dose unit 65. Thus, both the dose dial button 12 and the shell 61, as well as the injection button 11 of the dose unit 65, do not rotate during administration.

[0078] The dose capture arrangement 60 is provided distally with a distal pin 62 which protrudes through a distal opening in the shell 61 for connection with a rotating part inside the injection device. When the dose engine disclosed in WO2022 / 013155, which is incorporated herein by reference, is used, the distal pin 62 connects to a reset tube of the dosing mechanism which rotates during dose ejection.

[0079] The dose capture arrangement 60 comprises a rotating portion connected for rotation with a distal pin 62 and a fixed portion which is non-rotationally fixed to a shell 61 which in turn is non-rotationally fixed to a dose set button 12 which is further rotationally locked to the housing structure 10 during administration as will be described.

[0080] In the dose engine disclosed in WO2022 / 013155, the dose set button is released from the rotation reset tube during dose ejection, and therefore the fixed part of the dose capture arrangement 60 remains stationary at least during dose ejection, while the rotating part connected to the distal pin 62 rotates during ejection. The dose capture arrangement 60 therefore captures a relative rotation that is representative of the size of the dose being ejected.

[0081] The dose capture arrangement 60 is further provided with first communication means, such as a first Bluetooth unit, so that the size of the ejected dose can be communicated to another electronic unit.

[0082] The protective cap 30 therefore has a sensor arrangement, e.g. a zebra connector 52, that is able to sense information from the identifier 40 carried by the reservoir structure 20. The sensed information relates to the type of liquid medication contained in the reservoir structure 20. The protective cap 30 is further provided with second communication means, such as a second Bluetooth unit 57, that is able to communicate this information to another electronic unit, which in one example may be a mobile phone operating a dosing app. In a different example, the other electronic unit may be an electronic dose capture arrangement 60 provided in the housing structure 10 of the injection device.

[0083] As mentioned above, the electronic dose capture arrangement 60 also comprises a first communication means, such as a first Bluetooth unit, capable of communicating the dose size to another electronic unit, which in one example may be the same mobile phone that also receives information regarding the type of liquid medication contained in the reservoir structure 20. In a different example, the communication means in the protective cap 30 may communicate information regarding the type of liquid medication contained in the reservoir structure 20 to the dose capture arrangement 60, which may again communicate this medication type information, together with information regarding the dose size, to an external unit, such as a mobile phone, for further processing in an app carried on the mobile phone. Two information streams may also be collected within the protective cap 30 and transmitted from there to the external unit. The two communication streams originating from the housing structure 10 and the protective cap 30 are indicated by the "BT" designation in FIG. 1.

[0084] In a further embodiment, information regarding the dose size and information regarding the type of liquid may be stored together within the protective cap 30, which may further be provided with a display for displaying this information.

[0085] Although certain preferred embodiments have been set forth above, it is emphasized that the present invention is not limited thereto and may be embodied in other ways within the scope of the subject matter defined in the following claims.

[0086] [Table 1]

Claims

1. 1. A drug delivery system comprising: a housing structure (10) having a dose setting and delivery mechanism for setting and dispensing a dose of a liquid medication, the housing structure (10) comprising an electronic dose size capture arrangement (60) for capturing the size of each dispensed dose, and a first communication means for communicating the size of each dispensed dose; a reservoir structure (20) containing the liquid medication and removably attachable to the housing structure (10), the reservoir structure (20) including an identifier (40) encoded with information relating to the type of medication contained within the reservoir structure (20); a protective cap (30) mountable onto the medication delivery device and at least partially covering said reservoir structure (20) when mounted; 10. A drug delivery system comprising: a protective cap (30) comprising a sensor arrangement (50, 51, 52, 55) configured to sense the information coded in the identifier (40); and wherein the protective cap (30) further comprises second communication means (57) for communicating the information relating to the type of drug contained in the reservoir structure (20).

2. 2. The drug delivery system of claim 1, wherein the second communication means (57) provided in the protective cap (30) is configured to communicate the information regarding the type of drug contained in the reservoir structure (20) to an external data receiving unit.

3. 2. The medication delivery system of claim 1, wherein the first communication means provided in the housing structure (10) is configured to communicate the size of each ejected dose to an external data receiving unit.

4. 2. The drug delivery system of claim 1, wherein the second communication means (57) provided in the protective cap (30) is configured to communicate the information regarding the type of drug contained in the reservoir structure (20) to the electronic dose size capture arrangement (60) provided in the housing structure (10).

5. 5. The medication delivery system of claim 4, wherein the first communication means provided in the housing structure (10) is configured to communicate the information regarding the size of each ejected dose and the type of medication to an external data receiving unit.

6. 6. A drug delivery system as claimed in any one of claims 1 to 5, wherein the reservoir structure (20) comprises a container (21) for containing the liquid drug, the container (21) being permanently fixed in a holder unit (22) attachable to the housing structure (10).

7. 7. The medication delivery system of claim 6, wherein the holder unit (22) carries the identifier (40) encoded with information related to the type of medication contained in a particular reservoir structure (20).

8. 8. The drug delivery system of claim 1, wherein the identifier (40) comprises several distinct regions (42), some of the distinct regions (42) being conductive and some of the distinct regions (42) being non-conductive.

9. 9. The medication delivery system of claim 1, wherein the sensor arrangement (50, 51, 52, 55) in the protective cap (30) comprises a resilient connector (52) that is in galvanic contact with the conductive and non-conductive areas (42) of the identifier (40) when the protective cap (30) is mounted on the medication delivery device and at least partially covers the reservoir structure (20).

10. 10. The drug delivery system of claim 9, wherein a cap insert (50) provided in the protective cap (30) is provided with conductive strips (51) connecting the elastic connector (52) with a PCB (55).

11. A medication delivery system according to any one of claims 1 to 10, wherein the electronic dose size capture arrangement (60) comprises a rotating part (62) and a non-rotating part, the relative rotation of which generates a signal indicative of the dose size.

12. A medication delivery system according to any one of claims 1 to 11, wherein the electronic dose size capture arrangement (60) is provided proximally within the housing structure (10), preferably inside the dose setting button (12).

13. The drug delivery system according to any one of claims 1 to 12, wherein the first communication means and the second communication means are Bluetooth communication means.

14. A protective cap for a drug delivery system according to any one of claims 1 to 13, comprising a sensor arrangement.

15. 15. The protective cap according to claim 14, wherein the sensor arrangement comprises a resilient connector (52) electrically connected to a cap insert (50) having several conductive strips (51) connecting the resilient connector (52) with a PCB (55) provided in the protective cap (30).

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