Drug delivery system with drug identification function

Abstract

The present invention relates to a drug delivery system comprising essentially three main components: a housing structure (10), a reservoir structure (20) and a protective cap structure (30). The housing structure includes an electron dose size capture arrangement and a first communication device. The reservoir structure contains a liquid medicament and is releasably attached to the housing structure. The reservoir structure further includes an identifier encoded with information relating to the type of medicament contained in the reservoir structure. A protective cap mountable on the drug delivery device includes a sensor arrangement configured to perceive information encoded in the identifier, and a second communication device for communicating information about the type of drug contained in the reservoir structure.

Description

Technical Field

[0001] The present invention relates to a drug delivery system, which comprises a combination of a housing structure, a reservoir structure and a protective cap. The drug delivery system is suitable for discharging one or more doses of liquid drug, and preferably is of the type in which the liquid drug is contained in a replaceable container unit. More specifically, the present invention relates to such a drug delivery system that can identify or determine the type of drug contained in the replaceable container unit and transmit the information.

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

[0003] International Patent Application WO 2012 / 022771 discloses an injection device, in which a housing part is provided with one or more electronic sensors configured to detect and identify a code on a drug reservoir unit that can be inserted into the housing part of the injection device.

[0004] Another international patent application WO 2013 / 053695 discloses an injection device with a BGM cap, which is provided with a processor capable of calculating a dosage recommendation. The BGM cap is further provided with a detection device that can obtain information from an identifier provided on a separate injection device. In one embodiment, the identifier is interpreted as an RFID tag.

[0005] US Patent Application 2014 / 0194825 discloses a pen-shaped injection device, in which an additional unit containing a data capture device is physically connected to the pen-shaped injection device and is capable of transmitting injection-related data to a protective cap containing a display.

[0006] A similar method is disclosed in US11,318,251, which also discloses a pen-shaped device. The shown protective cap is also provided with a display, and data related to the dosage size can be transmitted from the pen-shaped injection device to the protective cap for display on the display.

[0007] When, as disclosed for example in WO 2012 / 022771, a sensor for reading information on a code on a reservoir unit is provided inside a housing part with a dose engine, a rather complex interface is required between the reservoir unit and the housing part. In addition, the presence of an identifier on the reservoir unit and a sensor on the inner surface of the housing part requires a part of the housing part to overlap with the reservoir unit, which limits the available design options for the injection device and also requires the diameter of the housing part to be significantly larger than the diameter of the reservoir unit.

[0008] In addition, in many known electronic dose capture systems, such as those disclosed in, for example, US11,318,251, a rotating part is involved, which makes such systems relatively complex. Feeding the information encoded on the cartridge into such a rotating dose capture system is particularly challenging. The rotating part can also be located at a certain position inside the injection device, which makes such data transmission even more complex. Summary of the Invention

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

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

[0011] Accordingly, in one aspect of the present invention, the drug delivery system comprises a housing structure, a reservoir structure and a protective cap structure:

[0012] · The housing structure includes a dose setting and delivery mechanism for setting and expelling a liquid drug dose, an electronic dose size capture arrangement for capturing the size of the expelled dose, and a first communication device for transmitting the size of the expelled dose.

[0013] · The reservoir structure contains the liquid drug and is releasably attached to the housing structure. The reservoir structure further includes an identifier encoded with information related to the type of drug contained in the reservoir structure.

[0014] · The protective cap structure is mountable on the drug delivery device and at least partially covers the reservoir structure when mounted.

[0015] Furthermore, the protective cap structure includes a sensor arrangement configured to sense the information encoded in the identifier, and the protective cap further includes a second communication device for transmitting information about the type of drug contained in the reservoir structure.

[0016] Thus, the housing structure includes an electronic dose size capture arrangement that is capable of recording the size of each expelled dose and transmitting this information. Preferably, the size of the expelled dose is collected when the liquid drug is actually administered. In addition, the sensor arrangement carried by the protective cap is capable of obtaining information about the type of liquid drug contained in the attached reservoir structure and transmitting this information.

[0017] Thus, the two information streams of dose size and drug type can be collected and transmitted separately. Therefore, it is not necessary for these two systems to be close to each other, which provides a high degree of flexibility in the physical design of the injection device.

[0018] In addition, a timer may be provided that records the actual time when the electronic dose capture arrangement captures the size of the expelled dose, such that each expelled dose is stored together with a time stamp. Further, a display may be provided, for example, in a protective cap, such that information about the type of drug contained in the reservoir structure can be displayed. Other stored data may also be displayed on the display.

[0019] In a further embodiment, a second communication device provided in the protective cap is configured to transmit information about the type of drug contained in the reservoir structure to an external data receiving unit, which is preferably a computer, a tablet computer, or a mobile phone, and preferably a smart phone running a dose application.

[0020] A first communication device provided in the housing structure is capable of transmitting the size of each expelled dose to an external data receiving unit, which in one example is the same external receiving unit that also receives information about the type of drug contained in the reservoir structure. The two information streams can then be processed in a program stored in the external data receiving unit, which is preferably a dose application uploaded on a tablet computer or a smart phone.

[0021] In a different arrangement, a second communication device provided in the protective cap is designed to transmit information about the type of drug contained in the reservoir structure to the electronic dose size capture arrangement provided in the housing structure, such that both information streams can be used in the electronic dose size capture arrangement.

[0022] A first communication device provided in the housing structure preferably transmits the size of the expelled dose and information about the drug type to an external data receiving unit, which can be any type of computer, tablet computer, or mobile phone, preferably a smart phone, such that the two information streams can be processed in a dose application.

[0023] In a further embodiment, the reservoir structure includes a container for containing a liquid drug, which is permanently fixed in a holder unit that can be attached to the housing structure. The container is preferably a glass cartridge, which is encapsulated in a suitable plastic housing made of any suitable polymer. The plastic housing is preferably made of two or more molded parts that are irreversibly joined to encapsulate the glass cartridge.

[0024] The holder unit preferably carries an identifier that is encoded with information related to the type of drug contained in a specific reservoir structure, such that each holder unit is encoded with information related to the liquid drug contained in the specific holder unit. The encoding is preferably an encoding that can be electronically recognized.

[0025] In one example, the identifier includes a plurality of individual regions, some of which are conductive and some of which are non-conductive, thereby forming a bit-code.

[0026] In a specific example, six such individual regions are provided such that a 6-bit code can be generated. Thus, each of these six regions can be either conductive or non-conductive. In a further example, the plurality of conductive and non-conductive regions can be replicated to provide further redundancy in the system.

[0027] Thus, the range of the bit-code can be a 6-bit code, ranging from 0-0-0-0-0-0 to 1-1-1-1-1-1. Thus, it is possible to obtain 64 different bit-codes, each specific bit-code representing a specific type of liquid drug.

[0028] In order to read information from the holder unit, the sensor arrangement in the protective cap includes an elastomeric connector that makes electrical contact with the conductive and non-conductive regions of the identifier carried by the holder unit when the protective cap is mounted on the drug delivery device to at least partially cover the reservoir structure.

[0029] The elastomeric connector is often referred to as a zebra connector and typically includes a plurality of alternating conductive and non-conductive segments. All or only some of the segments are made of a flexible material such as elastomer or silicone rubber, such that the zebra connector is compressible and thus suitable for pressing against a surface and maintaining electrical contact. In a specific example, the alternating conductive and non-conductive regions extend axially along the central axis (“X”) of the injection device.

[0030] Whenever the user replaces an empty holder unit with a new holder unit, when the protective cap is installed, the sensor arrangement in the protective cap will read the information about the type of liquid drug contained in the holder unit and transmit the information.

[0031] In order to read the information, a cap insert is provided in the protective cap, and the cap insert is provided with conductive strips that connect the elastomeric connector to the PCB. Thus, the processor on the PCB can determine the current transmitted to the identifier and the response received from the identifier.

[0032] In one example, the electronic dose size capture arrangement includes a rotating part and a non-rotating part, and their relative rotation generates a signal indicating the dose size. The non-rotating part is fixed to the housing of the injection device at least during drug administration, such that the relative rotation that occurs between the rotating part and the non-rotating part during drug administration is a representation of the volume dispensed.

[0033] In one example, the electronic dose size capture arrangement is provided proximal to 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 away from the injection device and easily integrated into the dose setting button in the housing structure during the assembly of the injection device. Thus, the electronic dose size capture arrangement is a separate component that has its own power source such as a battery and is thus at least electronically completely independent of the injection device operation.

[0034] Furthermore, the first and second communication devices are Bluetooth communication devices using the standard Bluetooth protocol to easily transmit information to an external data receiving unit such as a computer, a tablet computer or a smart phone.

[0035] In a second aspect of the invention, a protective cap provided in a drug delivery system includes a sensor arrangement. Thus, the protective cap includes an elastomeric connector electrically connected to a cap insert that carries a plurality of conductive strips connecting the elastomeric connector to a PCB also provided in the protective cap. Definitions:

[0036] An "injector pen" or "injecting pen" is generally an injection device having an oblong or elongated shape, somewhat like a pen for writing. Although such pens generally have a tubular cross-section, they can easily have different cross-sections such as triangular, rectangular or square or any variation based on these geometries.

[0037] The term "needle cannula" is used to describe the actual conduit that performs skin penetration during injection. The needle cannula is typically made of a metallic material such as, for example, stainless steel and is connected to a needle hub to form a complete injection needle, often also referred to as a "needle assembly". However, the needle cannula can also be made of polymeric or glass materials. The needle hub also carries connection means for connecting the needle assembly to the injection device and is typically molded from a suitable thermoplastic material. As an example, the "connection means" can be a Luer connection, a bayonet connection, a threaded connection or any combination thereof.

[0038] The term "needle unit" is used to describe a single needle assembly carried in a container. Such a container typically has a closed distal end and an open proximal end sealed by a removable seal. The interior of such a container is typically sterile so that the needle assembly is in a standby state. ISO standard No. 11608 part 2 defines a needle unit specifically designed for pen-type injection systems, often referred to as a "pen needle". A pen needle is typically double-pointed, having a front end for piercing the user's skin and a rear end for piercing into a cartridge containing a drug so that a liquid communication is established during injection.

[0039] As used herein, the term "liquid medicament" is intended to encompass any medicament-containing flowable agent that can pass through a delivery device, such as a hollow needle cannula, in a controlled manner, such as a liquid, solution, gel, or fine suspension. Representative medicaments include agents such as peptides, proteins (e.g., insulin, insulin analogs, and C-peptide), as well as hormones, bio-derived or active agents, hormonal agents, and gene-based agents, nutritional formulations, and other substances in solid (dispensed) or liquid form.

[0040] "Cartridge" is the term used to describe the container that actually holds the medicament, often referred to as the primary packaging. Cartridges are typically made of glass, but can also be molded from a 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 the needle cannula. Such septa are typically self-sealing, meaning that once the needle cannula is removed from the septum, the opening created during penetration automatically seals itself through inherent elasticity. The opposite end of the cartridge is typically closed by a movable "plunger", which is a piston-like element made of rubber or a suitable polymer. The plunger moves slidably inside the cartridge during use, preferably in the distal direction. The space between the pierceable membrane and the movable plunger contains the liquid medicament, which is forced out when the plunger reduces the volume of the space containing the liquid medicament. Cartridges for prefilled injection devices and durable injection devices are typically filled by the manufacturer at the factory with a predetermined volume of liquid medicament. A large number of currently available cartridges contain 1.5 ml or 3 ml of liquid medicament.

[0041] Since cartridges typically have a narrow distal neck into which the plunger cannot move, it is not actually possible to expel all of the liquid medicament contained within the cartridge. Thus, the term "initial amount" or "substantially used" refers to the injectable contents contained within the cartridge, and not necessarily to all of the contents.

[0042] The term "prefilled injection device" refers to an injection device in which a cartridge containing a liquid medicament is permanently embedded in the injection device such that it cannot be removed without permanently damaging the injection device. Once the prefilled amount of liquid medicament in the cartridge has been used, the user typically discards the entire injection device. Typically, a cartridge that has been filled by the manufacturer with a specific amount of liquid medicament is fixed in a cartridge holder, which is then permanently attached to the housing structure such that the cartridge cannot be replaced.

[0043] This is different from a "durable injection device" in which, whenever the cartridge is empty, the user can replace the cartridge containing the liquid medicament themselves. Prefilled injection devices are typically sold in packages containing more than one injection device, while durable injection devices are typically sold one at a time. When using a prefilled injection device, an average user may need up to 50 to 100 injection devices per year, while when using a durable injection device, one injection device can last for several years. However, an average user needs 50 to 100 new cartridges per year.

[0044] All references cited herein, including publications, patent applications, and patents, are incorporated by reference in their entirety to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

[0045] All headings and subheadings used herein are for convenience only and should not be construed as limiting the invention in any way.

[0046] The use of any and all examples or exemplary language (e.g., such as) provided herein is intended merely to better illustrate the invention and does not limit the scope of the invention unless otherwise stated. No language in the specification should be construed as indicating that any non-claimed element is essential to the practice of the invention.

[0047] The citation and incorporation of patent documents herein are for convenience only and do not reflect any opinion as to the validity, patentability, and / or enforceability of such patent documents.

[0048] The invention includes all modifications and equivalents of the subject matter recited in the appended claims as permitted by applicable law. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] The invention will be more fully explained below in connection with preferred embodiments and with reference to the accompanying drawings, in which:

[0050] Figure 1 A exploded view showing the main structure of an injection device according to the invention is shown.

[0051] Figure 2 A perspective view showing the reservoir structure is shown.

[0052] Figure 3 An exploded view showing the cap insert is shown.

[0053] Figure 4 Shows the elements shown in Figure 3 viewed from the distal position.

[0054] Figure 5A An injection device with a protective cap mounted thereon is shown.

[0055] Figure 5B shows an injection device with the protective cap visually removed.

[0056] Figure 5C shows an injection device with the protective cap and the cap insert visually removed.

[0057] Figure 5D shows an injection device with the protective cap removed.

[0058] Figures 6A - 6B shows two different views of the dose dial button and the electronic dose capture arrangement that can be inserted into the dose dial button.

[0059] These figures are schematic and simplified for clarity, and they only show the details necessary for understanding the present invention, while omitting other details. Throughout the text, the same reference numerals are used for the same or corresponding components. Detailed Description

[0060] When terms such as "upper" and "lower", "right" and "left", "horizontal" and "vertical", or similar relative expressions are used below, these terms only refer to the figures and not necessarily to the actual usage. The figures shown are schematic representations, so the construction of different structures and their relative dimensions are only for illustrative purposes.

[0061] In the context, it can be conveniently defined as follows: In the figures, the term "distal end" of the injection device means the end of the injection device that supports the injection needle, and the term "proximal end" means the opposite end with the injection button, as Figure 1 shown. Distal and proximal mean an axial orientation extending along the longitudinal axis (X) of the injection device, as also Figure 1 shown.

[0062] When clockwise and counterclockwise or anticlockwise are mentioned in the following examples, it should be understood that the injection device is observed from a position distal to the injection device. Thus, clockwise is the rotation following the hands on a common clock, and counterclockwise is the rotation in the opposite direction.

[0063] To explain the various movements occurring in the injection devices described in the examples, the following terms are used throughout the following detailed description:

[0064] "Translational movement" means a strictly linear movement without any rotation.

[0065] "Rotational movement" is any rotational movement around a center, which can be a central point, i.e., in a plane or on a central axis, i.e., having a longitudinal extension.

[0066] "Axial movement" means any movement in the axial direction. Such movement can be strictly translational or include rotational movement, which thus makes it a "helical movement" as it means a combination of axial movement and rotational movement.

[0067] "Telescopic" is intended to cover the case where a movable element moves out of and / or into a base element. The telescopic movement can be translational or include rotation, thus making the telescopic movement helical.

[0068] As Figure 1 shown, the injection device 1 according to the present invention comprises a housing structure 10, a reservoir structure 20 and a protective cap 30. The injection device is disclosed as a longitudinal pen-shaped injection device, but other shapes can also be considered.

[0069] Both the housing structure 10 and the reservoir structure include a Bluetooth transmitter, as Figure 1 indicated by "BT" therein. The usage of these two Bluetooth transmitters will be explained below.

[0070] The housing structure 10 contains a delivery mechanism commonly referred to as a dose engine. Such a dose engine can be a manual dose engine, where the force for expelling the dose is provided by the user of the injection device, or the dose engine can be spring-driven, such that the force for expelling the dose is provided 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 commercial injection device with a torsion spring-driven dose engine is from Novo Nordisk A / S, which is described in detail in WO 2022 / 013155 and is also depicted in Figures 1 to 3 WO 2022 / 013155.

[0071] The spring-driven dose engine is actuated by pressing an injection button 11 provided at the proximal end of the housing structure 10, thereby releasing 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 a dose setting button 12. When the dose is set and the torsion spring is tensioned, the size of the dose is displayed in a window 13. At the distal side of the housing structure 10, there are means for releasably engaging the reservoir structure 20. These means are typically screw or bayonet interfaces. However, other interfaces can be considered

[0072] To cover the reservoir structure 20 when not in use, a protective cap 30 is provided. The protective cap 20 is preferably snap-fitted onto the distal end of the injection device 1.

[0073] The reservoir structure 20 is Figure 2is disclosed and includes a container 21, which is preferably made of glass and contains a liquid medicament, permanently embedded in a holder unit 22 molded from a suitable polymer. The reservoir structure 20 is provided distally with a needle interface 23 for attaching a pen needle 25 to the reservoir structure 20. The proximal end of the needle cannula in the pen needle 25 pierces into the glass container 21, as is commonly known for such pen-shaped injection devices. Proximally, the reservoir structure 20 is provided with a bayonet track 24 that engages with an inwardly directed projection 14 provided on the inner surface of the housing structure 10. The inwardly directed projection 14 is shown in dashed lines in Figure 1 as shown.

[0074] In one example, the holder unit 22 encapsulating the glass container 21 is molded into two or more different parts that are assembled around the glass container 21 by gluing, welding, or other means, which can be simple mechanical assembly means such as a screw interlock connection or an irreversible snap-fit mechanism. In different examples, the holder unit 22 can be molded around the glass container 22. Thus, the holder unit 22 together with the glass container 21 constitutes the reservoir structure 20.

[0075] Thus, the reservoir structure 20 containing the liquid medicament is made as a separate unit, which is typically sold as such a separate unit. Thus, the same housing structure 10 can be used with a plurality of different reservoir structures 20, depending on which type of liquid medicament the user requires for a particular treatment.

[0076] The reservoir structure 20 also carries an identifier 40 that identifies the type of liquid medicament contained in the glass container 21 in a particular reservoir structure 20. The identifier 40 can be any type of electronic or non-electronic component that can be encoded with information regarding the type of liquid medicament contained in the glass container 21 in the reservoir structure 20. Encoding of the identifier 40 is preferably done as an integral part of production. Examples of suitable identifiers 40 will be provided below.

[0077] In one example, the identifier 40 includes a chip 41 or the like, as best shown in Figure 3 attached to the reservoir structure 20 as disclosed in Figure 2 and having a number of individual areas 42 that can be formed to be conductive or non-conductive. In the disclosed example, twelve (12) such areas 41 are provided. To provide sufficient redundancy, these areas are replicated such that two sets of areas are actually provided, each set having six (6) individual areas 42. Since each of these six areas 42 can be conductive or non-conductive, a 6-bit code can be provided.

[0078] Thus, six (6) conductive and non-conductive regions 42 can generate a 6-bit code ranging from 0-0-0-0-0-0 to 1-1-1-1-1-1. "0" represents no electrical connection and "1" represents electrical contact. Thus, a total of 2 6 ^6 = 64 different codes can be generated. Thus, each specific bit code is dedicated to a specific liquid drug, such that the identifier 40 is encoded with information regarding the type of liquid drug contained in the glass container 21 within the reservoir structure 20.

[0079] An example of such a bit code system based on conductive and non-conductive regions is provided in US2010 / 0161240, where in particular FIG. 7A shows how to identify these conductive and non-conductive regions by transmitting current to these regions and measuring whether the current returns. This is preferably controlled by a processor.

[0080] Figure 3 The sheet 41 including the conductive and non-conductive regions 42 disclosed in can be attached to the reservoir structure 20 in a variety of different ways, such as by soldering or gluing. Alternatively, the conductive and non-conductive regions 42 can be made an integral part of the reservoir structure 20. As Figure 2 best shown in, 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 engages with the housing structure 10.

[0081] Figure 3 A cap insert 50 is further disclosed, which has a printed circuit board (PCB) 55 on the distal side and an elastomeric connector 52 on the proximal side. The cap insert 50 is provided with a plurality of longitudinal conductive strips 51, such as made by 2K molding, on the inner surface, where these conductive strips 51 can be metallic or otherwise conductive. These conductive strips 51 connect the elastomeric connector 52 (commonly also referred to as a zebra connector) to the PCB 55. The PCB 55 carries a processor that controls the current applied to the conductive and non-conductive regions 42 on the reservoir structure 20 through the zebra connector 52, and further controls whether these regions 42 close the circuit to generate a bit code identifying the type of liquid drug contained in a specific reservoir structure 20.

[0082] A zebra connector typically includes a plurality of alternating conductive and non-conductive segments. These segments are made of a flexible material such as elastomer or silicone rubber, such that the zebra connector is compressible. In the disclosed example, the zebra connector 52 is circular in shape, following the circular contour of the protective cap 30, and the conductive segments in the zebra connector 52 are axially conductive.

[0083] Figure 4The cap insert 50 is disclosed as viewed from the proximal end. The PCB 55 is also provided with two (2) sets of six (6) regions 56 each, which identify the conductive and non-conductive regions 42 on the reservoir structure 20 via conductive strips 51 and zebra connectors 52 to generate a 6-bit code. The PCB 55 further includes a Bluetooth unit 57 capable of transmitting the bit code to another electronic unit. For better illustration, in Figure 3 the Bluetooth unit 57 and other components of the PCB are disclosed separately from the PCB 55, but in use, these parts including the Bluetooth unit 57 are part of the PCB. The bit code represents information related to the type of liquid drug contained in a specific reservoir structure 20, as described above.

[0084] Figure 5A An injection device attached with a protective cap 30 is disclosed, Figure 1 where the protective cap 30 covers the reservoir structure 20 and abuts against the housing structure 10. Additionally, as shown in Figure 5B where the protective cap 30 has been visually removed, the cap insert 50 is provided with a plurality of protrusions 53 on the distal side, and these protrusions 53 fix the cap insert 50 to the protective cap 30 to function as one element. However, the cap insert 50 can be fixed to the protective cap 30 in a variety of different ways, including being an integral part of the protective cap 30.

[0085] In Figure 5C both the protective cap 30 and the cap insert 50 have been visually removed, thus exposing the PCB 55, the battery 58, and the zebra connector 52 disposed inside the cap insert 50. A compression spring 59 inserted between the protective cap 30 and the battery 58 presses the battery 58 against the PCB 58. Figure 5D An injection device is disclosed where the protective cap 30 has been completely removed and the pen needle 25 is attached to the reservoir structure 20.

[0086] In Figures 5A to 5C the zebra connector 52 is pressed against the identifier 40 such that current can flow from the conductive strip 51 inside 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.

[0087] The said injection device is further provided with an electronic dose capture arrangement for capturing the magnitude of each discharged dose. The dose capture arrangement 60 is disclosed in Figures 6A - 6B and is encapsulated in a housing 61, which is connected to the injection button 11 proximally to form a single-dose unit 65 that can be produced at a location remote from the rest of the injection device.

[0088] As in Figure 6A and Figure 6BAs shown, the injection button 11 is provided with a plurality of pawl arms 15 extending distally, and these pawl arms 15 are connected to the housing 61 to form a single-dose unit 65. As Figure 6B best shown in Figure 6B , the shape and dimensions of this dose unit 65, which includes the housing 61, the dose capture arrangement 60, and the injection button 11, are such that it is adapted to be placed inside the dose setting button 12. A compression spring 66 is provided to push the dose unit 65 in the proximal direction when no dose is being injected. Flanges, tracks, etc. are provided to prevent the dose unit 65 from disengaging from the dose setting button 12. During drug administration, the user presses the injection button 11 in the distal direction, which also moves the entire dose unit 65 in the distal direction. This axial movement further rotates and locks the dose setting button 12 to the housing structure 10 through longitudinal ribs 67 provided on the dose unit 65. Thus, neither the dose dial button 12, nor the housing 61, nor the injection button 11 of the dose unit 65 rotates during drug administration.

[0089] The dose capture arrangement 60 is provided with a distal pin 62 distally, which projects through a distal opening in the housing 61 to connect to a rotating part inside the injection device. When using the dose engine disclosed in WO 2022 / 013155, which is incorporated herein by reference, the distal pin 62 is connected to a reset tube of a drug delivery mechanism that rotates during dose expulsion.

[0090] The dose capture arrangement 60 includes a rotating part and a stationary part, the rotating part being connected to the distal pin 62 to rotate therewith. The stationary part is non-rotatably fixed to the housing 61, and the housing 61 is non-rotatably fixed to the dose setting button 12, which is further rotationally locked to the housing structure 10 during drug administration, as described above.

[0091] In the dose engine disclosed in WO 2022 / 013155, the dose setting button is released from the rotating reset tube during dose expulsion. Thus, the stationary part of the dose capture arrangement 60 is stationary at least during dose expulsion, while the rotating part connected to the distal pin 62 rotates during dose expulsion. The dose capture arrangement 60 thereby captures a relative rotation, which is representative of the magnitude of the dose expelled.

[0092] The dose capture arrangement 60 is further provided with a first communication device, such as a first Bluetooth unit, such that the magnitude of the dose expelled can be transmitted to another electronic unit.

[0093] Thus, the protective cap 30 has a sensor arrangement, such as a zebra connector 52, which is capable of sensing information from the identifier 40 carried by the reservoir structure 20. The sensed information relates to the type of liquid drug contained in the reservoir structure 20. The protective cap 30 is further provided with a second communication device, such as a second Bluetooth unit 57, which is capable of transmitting this information to another electronic unit, which in one example can be a mobile phone running a drug administration application. In different examples, this other electronic unit can be an electronic dose capture arrangement 60 provided in the housing structure 10 of the injection device.

[0094] As described above, the electronic dose capture arrangement 60 also includes a first communication device, such as a first Bluetooth unit, which is capable of transmitting the dose size to another electronic unit, which in one example can be the same mobile phone that also receives information about the type of liquid drug contained in the reservoir structure 20. In different examples, the communication device in the protective cap 30 can transmit information about the type of liquid drug contained in the reservoir structure 20 to the dose capture arrangement 60, which can in turn transmit this drug type information together with the information about the dose size to an external unit, such as a mobile phone, for further processing in the application carried by the mobile phone. These two information flows can also be collected in the protective cap 30 and thus transmitted to the external unit. In Figure 1 which, the two communication flows originating from the housing structure 10 and from the protective cap 30 are represented by the "BT" character.

[0095] In a further embodiment, the information about the dose size and the information about the type of liquid drug can be stored together in the protective cap 30, which can be further provided with a display for displaying this information.

[0096] Some preferred embodiments have been shown above, but it should be emphasized that the present invention is not limited to these embodiments, but can be embodied in other ways within the subject matter defined by the appended claims.

[0097] List of reference numerals

[0098]

[0099]

Claims

1. A drug delivery system, comprising: a housing structure (10) having a dose setting and delivery mechanism for setting and expelling a liquid drug dose, wherein the housing structure (10) includes an electronic dose size capture arrangement (60) for capturing the size of each expelled dose and a first communication device for transmitting the size of each expelled dose, a reservoir structure (20) containing the liquid drug and releasably attached to the housing structure (10), wherein the reservoir structure (20) includes an identifier (40) encoded with information related to the type of drug contained in the reservoir structure (20), a protective cap (30) mountable on the drug delivery device and at least partially covering the reservoir structure (20) when mounted, characterized in that ， the protective cap (30) includes a sensor arrangement (50, 51, 52, 55) configured to sense the information encoded in the identifier (40), and wherein the protective cap (30) further includes a second communication device (57) for transmitting information about the type of drug contained in the reservoir structure (20).

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

3. The drug delivery system according to claim 1, wherein the first communication device provided in the housing structure (10) is configured to transmit the size of each expelled dose to an external data receiving unit.

4. The drug delivery system according to claim 1, wherein the second communication device (57) provided in the protective cap (30) is configured to transmit information about 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. The drug delivery system according to claim 4, wherein the first communication device provided in the housing structure (10) is configured to transmit the size of each expelled dose and information about the drug type to an external data receiving unit.

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

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

8. The drug delivery system according to any one of the preceding claims, wherein the identifier (40) includes a plurality of individual regions (42), some of the individual regions (42) being conductive and some of the individual regions (42) being non-conductive.

9. The drug delivery system according to any one of the preceding claims, wherein the sensor arrangement (50, 51, 52, 55) in the protective cap (30) comprises an elastomeric connector (52) which is in electrical contact with the conductive and non-conductive regions (42) of the identifier (40) when the protective cap (30) is mounted on the drug delivery device to at least partially cover the reservoir structure (20).

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

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

12. The drug delivery system according to any one of the preceding claims, wherein the electronic dose size capture arrangement (60) is provided proximal to the housing structure (10), preferably inside the dose setting button (12).

13. The drug delivery system according to any one of the preceding claims, wherein the first communication device and the second communication device are Bluetooth communication devices.

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

15. The protective cap according to claim 14, wherein the sensor arrangement comprises an elastomeric connector (52) electrically connected to a cap insert (50) which has a plurality of conductive strips (51) connecting the elastomeric connector (52) to a PCB (55) provided in the protective cap (30).

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