WO2024126133A1 - A drug delivery system with drug recognition - Google Patents

A drug delivery system with drug recognition Download PDF

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Publication number
WO2024126133A1
WO2024126133A1 PCT/EP2023/084128 EP2023084128W WO2024126133A1 WO 2024126133 A1 WO2024126133 A1 WO 2024126133A1 EP 2023084128 W EP2023084128 W EP 2023084128W WO 2024126133 A1 WO2024126133 A1 WO 2024126133A1
Authority
WO
WIPO (PCT)
Prior art keywords
drug delivery
dose
drug
protective cap
delivery system
Prior art date
Application number
PCT/EP2023/084128
Other languages
French (fr)
Inventor
Nikolaj Eusebius Jakobsen
Per Einar Pontus Holm
Jens Aage Munk
Original Assignee
Novo Nordisk A/S
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Novo Nordisk A/S filed Critical Novo Nordisk A/S
Publication of WO2024126133A1 publication Critical patent/WO2024126133A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566—Means improving security or handling thereof
    • A61M5/31568—Means keeping track of the total dose administered, e.g. since the cartridge was inserted
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2403—Ampoule inserted into the ampoule holder
    • A61M2005/2411—Ampoule inserted into the ampoule holder from the front
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3569—Range sublocal, e.g. between console and disposable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3584—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using modem, internet or bluetooth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means

Definitions

  • the invention relates to a drug delivery system comprising a housing structure, a reservoir structure and a protective cap in combination.
  • the drug delivery system is suitable for expelling one or more doses of a liquid drug and preferably of the type wherein the liquid drug is contained in an exchangeable container unit. More particular, the invention relates to such drug delivery system which is able to recognize or determine the type of drug contained in the exchangeable container unit and to communicate this information.
  • the invention further relates to a protective cap for such drug delivery system.
  • Another International patent application WO 2013/053695 discloses an injection device with a BGM cap which is provided with a processor which can calculate dose recommendations.
  • the BGM cap is further provided with detection means which can obtain information from an identifier provided on the individual injection device.
  • the identifier is in one embodiment explained as being an RFID tag.
  • the housing part carrying the dose engine As e.g. disclosed in WO 2012/022771 , a rather complicated interface between the reservoir unit and the housing part is required. Further the presence of an identifier on the reservoir unit and a sensor on an inner surface of the housing part requires that a part of the housing part overlaps with the reservoir unit which restricts the design options available for the injection device and further requires the housing part to have a diameter substantial larger than the diameter of the reservoir unit.
  • the housing structure comprises a dose setting and delivery mechanism for setting and expelling doses of a liquid drug and an electronic dose size capture arrangement for capturing the size of the expelled doses together with first communicating means for communicating the size of the expelled doses.
  • the sensor arrangement in the protective cap comprises an elastomeric connector which is in galvanic contact with the electric conductive and non-conductive areas of the identifier carried by the holder unit when the protective cap is mounted on the drug delivery device to at least partly cover the reservoir structure.
  • An elastomeric connector is often referred to a as a zebra connector and usually comprises a plurality of alternating conductive and non-conductive segments. All the segments or alternatively only some of the segments are made from a flexible material such as an elastomer or a silicone rubber making the zebra connector compressible and thus suitable to be pressed against a surface and maintain electric contact.
  • the alternating conductive and non-conductive areas extend in an axial direction along the centre axis (“X”) of the injection device.
  • Pre-filled injection device an injection device in which the cartridge containing the liquid drug is permanently embedded in the injection device such that it cannot be removed without permanent destruction of the injection device.
  • the user normally discards the entire injection device.
  • the cartridge which has been filled by the manufacturer with a specific amount of liquid drug is secured in a cartridge holder which is then permanently connected in a housing structure such that the cartridge cannot be exchanged.
  • Pre-filled injection devices are usually sold in packages containing more than one injection device whereas durable injection devices are usually sold one at a time.
  • pre-filled injection devices an average user might require as many as 50 to 100 injection devices per year whereas when using durable injection devices one single injection device could last for several years, however, the average user would require 50 to 100 new cartridges per year.
  • Figure 1 show an exploded view of the main structures of the injection device according to the invention.
  • Figure 2 show a perspective view of the reservoir structure.
  • Figure 3 show an exploded view of the cap insert.
  • Figure 4 show a view of the elements shown in figure 3 viewed from a distal position.
  • Figure 5B show the injection device with the protective cap visually removed.
  • Figure 5C show the injection device with the protective cap and the cap insert visually removed.
  • Figure 6A-B show two different views of the dose dial button and the electronic dose capture arrangement insertable into the dose dial button.
  • the figures are schematic and simplified for clarity, and they just show details, which are essential to the understanding of the invention, while other details are left out.
  • the same reference numerals are used for identical or corresponding parts.
  • distal end in the appended figures is meant to refer to the end of the injection device supporting the injection needle, whereas the term “proximal end” is meant to refer to the opposite end carrying the injection button as indicated in figure 1.
  • Distal and proximal is meant to be along an axial orientation extending along the longitudinal axis (X) of the injection device as also shown in figure 1.
  • Translational movement is meant to be a strictly linear movement without any rotation.
  • “Rotational movement” is any movement of rotation around a centre which centre can be a centre point i.e. in one planar or a centre axis i.e. having a longitudinal extension.
  • Axial movement means any movement in an axial direction. Such movement can be a strictly translational movement or include a rotational movement which thus makes it a “Helical movement” as this is meant to be an axial movement combined with a rotational movement.
  • Telescopic is meant to cover the situation in which a movable element moves out from, and/or into, a base element.
  • the telescopic movement can be either translational or include a rotation thus making the telescopic movement helical.
  • the injection device 1 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 could be contemplated.
  • Both the housing structure 10 and the reservoir structure comprises a Blue Tooth transmitter as indicated by the “BT” in figure 1.
  • the usage of these two Blue Tooth transmitters will be explained in the following.
  • the housing structure 10 contains a delivery mechanism usually referred to as the dose engine.
  • the dose engine can be a manual dose engine wherein the force for expelling the doses is delivered by the user of the injection device, or the dose engine can be spring driven such that the force driving out doses is delivered by a spring. Alternatively, the dose engine can use an electric motor to dispense the doses. Numerous examples of these different dose engines are to be found in the prior art.
  • a well-known commercial 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 also depicted in the figures 1 to 3 of WO 2022/013155.
  • the spring driven dose engine is actuated by the 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.
  • the user sets the size of the dose to be expelled by rotating the dose setting button 12.
  • the size of the dose is displayed in the window 13.
  • the housing structure 10 is provided with means for releasable engaging a reservoir structure 20. These means are typically a thread or a bayonet interface. However other interfaces could be contemplated
  • 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.
  • the reservoir structure 20 is disclosed in figure 2 and comprises a container 21 preferably made from glass and containing the liquid drug permanently embedded in a holder unit 22 which is moulded from a suitable polymer.
  • the reservoir structure 20 is distally provided with a needle interface 23 for securing a pen needle 25 to the reservoir structure 20.
  • the proximal end of the needle cannula in the pen needle 25 penetrates into the glass container 21 as it is generally known from such pen-shaped injection devices.
  • the reservoir structure 20 is provided with a bayonet track 24 which engages with an inwardly pointing protrusion 14 provided on an inner surface of the housing structure 10.
  • the inwardly pointing protrusion 14 is indicated with a broken line in figure 1.
  • the holder unit 22 encapsulating the glass container 21 is moulded as two or more different parts which are assembled around the glass container 21 by gluing, welding or by other means which could be a simple mechanical assembly means such as a threaded interlock connection or an irreversible click mechanism.
  • the holder unit 22 can be moulded around the glass container 22. The holder unit 22 together with the glass container 21 hence makes up the reservoir structure 20.
  • the reservoir structures 20 containing the liquid drug are thus made as separate units which are typically sold as such individual units.
  • the same housing structures 10 can thus be used together with a plurality of different reservoir structures 20 depending on which type of liquid drug the user require for the specific treatment.
  • the reservoir structure 20 also carries an identifier 40 which identifies the type of liquid drug contained in the glass container 21 in the specific reservoir structure 20.
  • the identifier 40 can be any kind of electronic of non-electronic element which can be coded with information regarding the type of liquid drug contained in the glass container 21 in the reservoir structure 20.
  • the coding of the identifier 40 is preferably done as an integral part of the production. An example of a suitable identifier 40 will be provided in the following.
  • the identifier 40 comprises a sheet 41 or the like as best seen in figure 3 which sheet 41 is attached to the reservoir structure 20 as disclosed in figure 2 and has a number of separate areas 42 which can be formed either conductive or non-conductive. In the disclosed example twelve (12) such areas 41 are provided. To provided able redundancy, the areas are duplicated such that there actually is provided two sets of areas each having six (6) separate areas 42. As each of these six areas 42 can be either conductive or non-conductive a 6-bit code can be provided.
  • bit-code system based on conductive and non-conductive areas are provided in US2010/0161240 wherein especially figure 7A shows how these conductive and non-conductive areas can be identified by passing an electric current to the areas and measuring if the current is returned or not. This is preferably controlled by a processor.
  • the sheet 41 comprising the conductive and the non-conductive areas 42 disclosed in figure 3 can be attached to the reservoir structure 20 in many different ways such as e.g. by welding or gluing.
  • the conductive and the non-conductive areas 42 can be made as integral parts of the reservoir structure 20.
  • the conductive and the non-conductive areas 42 are preferably located at the distal end of the reservoir structure 20 pointing away from the bayonet track 24 interfacing the housing structure 10.
  • Figure 3 further discloses a cap insert 50 which distally carries a Printed Circuit Board (PCB) 55 and proximally carries an elastomeric connector 52.
  • the cap insert 50 is on the inner surface provided with a plurality of longitudinal conductive strips 51 e.g. made by a 2K moulding in which the conductive strips 51 can be metallic or otherwise conductive. These conductive strips 51 connects the elastomeric connector 52, also often referred to as a Zebra connector, with the PCB 55.
  • a Zebra connector also often referred to as a Zebra connector
  • This PCB 55 carries the processor controlling the current which through the zebra connector 52 is applied to the conductive and non-conductive areas 42 on the reservoir structure 20 and further controls if these areas 42 closes the circuit to generate the bit-code identifying the type of liquid drug contained in the specific reservoir structure 20.
  • a zebra connector usually comprises a plurality of alternating conductive and non-conductive segments. The segments are made from a flexible material such as an elastomer or a silicone rubber making the zebra connector compressible.
  • the zebra connector 52 is shaped as a circle following the circular contour of the protective cap 30 and the conductive segments in the zebra connector 52 are conductive in the axial direction.
  • Figure 4 discloses the cap insert 50 viewed from a proximal end.
  • the PCB 55 is also provided with two (2) sets of six (6) areas 56 which through the conductive strips 51 and the zebra connector 52 identifies the conductive and the non-conductive areas 42 on the reservoir structure 20 to generate the 6 bit-code.
  • the PCB 55 further comprises a Bluetooth unit 57 able to communicate the bit-code to another electronic unit.
  • the Bluetooth unit 57 and the other components of the PCB are disclosed as separated from the PCB 55 in figure 3, however, in use, these parts including the Bluetooth unit 57 are part of the PCB.
  • the bit-code represents information relating to the type of liquid drug contained in the specific reservoir structure 20 as explained.
  • Figure 5A discloses the injection device of figure 1 with the protective cap 30 attached and covering the reservoir structure 20 and abutting the housing structure 10.
  • the cap insert 50 is distally provided with a number of protrusions 53 which secures the cap insert 50 to the protective cap 30 to functionally operate as one element.
  • 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.
  • FIG 5C both the protective cap 30 and the cap insert 50 has been visually removed thereby disclosing the PCB 55, a 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 fully removed and the pen-needle 25 attached the reservoir structure 20.
  • the zebra connector 52 is pressed against the identifier 40 such that a current can be lead from the conductive strips 51 inside the cap insert 50 and onto the conductive and non-conductive areas 42 of the identifier carried by the reservoir structure 20 to generate the specific bit code.
  • the injection device is further provided with an electronic dose capture arrangement for capturing the size of each expelled dose.
  • the dose capture arrangement 60 is disclosed in figure 6A-B and is encapsulated in a shell 61 which is proximally connected to the injection button 11 to form a single dose unit 65 which can be produced away from the remaining part of the injection device.
  • the injection button 11 is provided with a number of distally extending click arms 15 which connects to the shell 61 to form the single dose unit 65.
  • This dose unit 65 comprising the shell 61 , the dose capture arrangement 60 and the injection button 11 is, as best seen in figure 6B, shaped and dimensioned such that it fits inside the dose setting button 12.
  • a compression spring 66 is provided to urge the dose unit 65 in the proximal direction when a dose is not being injected.
  • a flange, a track or the like is provided to prevent the dose unit 65 from falling out from the dose setting button 12.
  • both the dose dial button 12 and the shell 61 and also the injection button 11 of the dose unit 65 do not rotate during dosing.
  • the dose capture arrangement 60 is distally provided with a distal pin 62 which protrudes through a distal opening in the shell 61 to connect with a rotational part inside the injection device.
  • the distal pin 62 connects to the reset tube of the dosing mechanism which rotates during dose expelling.
  • the dose capture arrangement 60 comprises a rotational part connected to rotate together with the distal pin 62 and a stationary part.
  • the stationary part is non-rotationally secured to the shell 61 and the shell 61 is non-rotational secured to the dose setting button 12 which is further rotationally locked to the housing structure 10 during dosing as explained.
  • the dose setting button is released from the rotational reset tube during dose expelling hence the stationary part of the dose capture arrangement 60 is stationary at least during dose expelling whereas the rotational part connected to the distal pin 62 is rotated during does expelling.
  • the dose capture arrangement 60 thus captures the relative rotation which is an expression of the size of the dose being expelled.
  • the dose capture arrangement 60 is further provided with a first communication means such as a first Bluetooth unit such that the size of the expelled dose can be communicated to another electronic unit.
  • a first communication means such as a first Bluetooth unit such that the size of the expelled dose can be communicated to another electronic unit.
  • the protective cap 30 thus has a sensor arrangement e.g. the zebra connector 52 which is able to sense information from the identifier 40 carried by the reservoir structure 20. The information sensed relates to the type of liquid drug contained in the reservoir structure 20.
  • the protective cap 30 is further provided with second communication means such as a second Bluetooth unit 57 which is able to communicate this information to another electronic unit which in one example could be a mobile phone operating a dosing app.
  • the other electronic unit could be the electronic dose capture arrangement 60 provided in the housing structure 10 of the injection device.
  • the electronic dose capture arrangement 60 also comprises a first communication means such as the first Bluetooth unit which is able to communicate the dose size to another electronic unit which in one example could be the same mobile phone also receiving information regarding the type of liquid drug contained in the reservoir structure 20.
  • the communication means in the protective cap 30 could communicate the information regarding the type of liquid drug contained in the reservoir structure 20 to the dose capture arrangement 60 which again could communicate this drug type information together with information regarding the dose size to an external unit such as a mobile phone to be further processed in an app carried on the mobile phone.
  • the two information streams could also be collected in the protective cap 30 and communicated therefrom to the external unit.
  • the two streams of communication arising from the housing structure 10 and from the protective cap 30 is indicated by the “BT” indication in figure 1.
  • the information regarding the size of the dose and the information regarding the type of liquid drug could be stored together in the protective cap 30 which could further be provided with a display to display this information.

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  • Health & Medical Sciences (AREA)
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  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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Abstract

The invention relates to a drug delivery system which essentially comprises three major 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 first communicating means. The reservoir structure contains the liquid drug and is releasable attachable to the housing structure. The reservoir structure further comprises an identifier which is coded with information relating to the type of drug contained in the reservoir structure. The protective cap, which is mountable on the drug delivery device comprises a sensor arrangement configured to sense the information coded in the identifier and second communication means for communicating the information regarding the type of drug contained in the reservoir structure.

Description

A Drug Delivery System with Drug Recognition
THE TECHNICAL FIELD OF THE INVENTION:
The invention relates to a drug delivery system comprising a housing structure, a reservoir structure and a protective cap in combination. The drug delivery system is suitable for expelling one or more doses of a liquid drug and preferably of the type wherein the liquid drug is contained in an exchangeable container unit. More particular, the invention relates to such drug delivery system which is able to recognize or determine the type of drug contained in the exchangeable container unit and to communicate this information.
The invention further relates to a protective cap for such drug delivery system.
DESCRIPTION OF RELATED ART:
International patent application WO 2012/022771 discloses an injection device wherein a housing part is provided with one or more electronic sensors which are configured to detect and identify a coding on a drug reservoir unit insertable into the housing part of the injection device.
Another International patent application WO 2013/053695 discloses an injection device with a BGM cap which is provided with a processor which can calculate dose recommendations. The BGM cap is further provided with detection means which can obtain information from an identifier provided on the individual injection device. The identifier is in one embodiment explained as being an RFID tag.
A US patent application 2014/0194825 discloses a pen-shaped injection device wherein an add-on unit containing data capture means are physically connected to the pen-shaped injection device and able to communicate data relating to the injection to the protective cap which comprises a display.
A similar approach is disclosed in US 11,318,251 which also discloses a pen-shaped device. The protective cap shown is also provided with a display and data relating to the dose size can be transferred from the pen-shaped injection device to the protective cap to be displayed on the display.
When the sensor for reading the information coded on the reservoir unit is provided inside the housing part carrying the dose engine as e.g. disclosed in WO 2012/022771 , a rather complicated interface between the reservoir unit and the housing part is required. Further the presence of an identifier on the reservoir unit and a sensor on an inner surface of the housing part requires that a part of the housing part overlaps with the reservoir unit which restricts the design options available for the injection device and further requires the housing part to have a diameter substantial larger than the diameter of the reservoir unit.
Further, in many known electronic dose capture systems as e.g. disclosed in US 11,318,251 rotational parts are involved which makes such system relatively complicated. In such systems it is especially challenging to feed the information coded on the cartridge into such rotational dose capture system. The rotational parts can also be provided in a position inside the injection device making such transfer of data even more complicated.
DESCRIPTION OF THE INVENTION:
It is henceforth an object of the present invention to provide a solution wherein the system for identifying the drug type is separated from the electronic dose size capturer system and not dependent on a specific physical infrastructure inside the injection device.
The invention is further defined in claim 1. Advantageous embodiments are defined in the dependent claims.
Accordingly in one aspect of the invention the 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 doses of a liquid drug and an electronic dose size capture arrangement for capturing the size of the expelled doses together with first communicating means for communicating the size of the expelled doses.
• The reservoir structure contains the liquid drug and is releasable attachable to the housing structure. The reservoir structure further comprises an identifier which is coded with information relating to the type of drug contained in the reservoir structure. The protective cap structure is mountable on the drug delivery device and covers, at least partly, the reservoir structure when mounted.
Further, the protective cap structure comprises a sensor arrangement configured to sense the information coded in the identifier and the protective cap further comprises second communication means for communicating the information regarding the type of drug contained in the reservoir structure.
Hence, the housing structure comprises an electronic dose size capture arrangement which is able to register the size of each dose being expelled and to transmit this information. The size of the dose expelled is preferably collected during the actual dosing of the liquid drug. Further, the sensor arrangement carried by the protective cap is able to obtain information from the attached reservoir structure regarding the type of liquid drug contained in the respective reservoir structure and to transmit this information.
The two streams of information; the dose size and the type of drug, can thus be collected separately and communicated separately. There is thus no requirement for the two systems to be in the near proximity of each other which provides a high degree of flexibility in the physical design of the injection device.
In addition, a timer can be provided which register the actual time 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 can be provided e.g. in the protective cap such that the information regarding the type of drug contained in the reservoir structure can be displayed. Other data stored could also be presented in the display.
In a further embodiment the second communication means provided in the protective cap is configured to communicate the information regarding the type of drug contained in the reservoir structure to an external data receiving unit which is preferably a computer, a tablet or a mobile phone and preferably a smart phone operating a dose app.
The first communication means provided in the housing structure is able to communicate the size of each expelled dose to an external data receiving unit which in one example is the same external receiving unit also receiving the information regarding the type of drug contained in the reservoir structure. These two information streams can then be processed in a program stored in the external data receiving unit, the program preferably being a dose app carried on a tablet or smart phone.
In a different set-up, the second communication means provided in the protective cap is designed to communicate the information regarding 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 are available in the electronic dose size capture arrangement.
The first communication means provided in the housing structure preferably communicates the size of the expelled doses and the information regarding the type of drug to an external data receiving unit which could be any kind a computer, tablet, or mobile phone, preferably a smart phone such that the two streams of information can be processed in a dose app.
In a further embodiment, the reservoir structure comprises a container containing the liquid drug which container is permanently secured in a holder unit attachable to the housing structure. The container is preferably a glass cartridge which is encapsulated in a suitable plastic housing made from any suitable polymer. The plastic housing is preferably made from two or more moulded parts which are irreversible connected to thereby encapsulate the glass cartridge.
The holder unit preferably carries the identifier coded with information relating to the type of drug contained in the specific reservoir structure such that each holder unit is coded with information referring to the liquid drug contained in the specific holder unit. The coding is preferably a coding which can be electronically identified.
In one example, the identifier comprises a number of separate areas where a number of the separate areas are electric conductive, and a number of the separate areas are electric non- conductive to thereby form a bit-code. In one specific example, six such separate areas are provided such that a 6 bit-code can be produced. Each of the six areas can thus be conductive or non-conductive. In a further example, the number of conductive and non-conductive areas can be duplicated to provided further redundancy in the system.
The bit-code could hence range as a 6 bit-code ranging from 0-0-0-0-0-0 to 1-1-1-1-1-1. It is thus possible to obtain 64 different bit-codes with each specific bit-code representing a specific type of liquid drug.
In order to read information from the holder unit, the sensor arrangement in the protective cap comprises an elastomeric connector which is in galvanic contact with the electric conductive and non-conductive areas of the identifier carried by the holder unit when the protective cap is mounted on the drug delivery device to at least partly cover the reservoir structure.
An elastomeric connector is often referred to a as a zebra connector and usually comprises a plurality of alternating conductive and non-conductive segments. All the segments or alternatively only some of the segments are made from a flexible material such as an elastomer or a silicone rubber making the zebra connector compressible and thus suitable to be pressed against a surface and maintain electric contact. In the specific example, the alternating conductive and non-conductive areas extend in an axial direction along the centre axis (“X”) of the injection device.
Whenever the user has replaced an empty holder unit with a new holder unit, the sensor arrangement in the protective cap will, when the protective cap is mounted, read the information regarding the type of liquid drug contained in the holder unit and transmit this information.
In order to read the information, a cap insert is provided in the protective cap which is provided with electric conductive strips connecting the elastomeric connector with a PCB. Hence, a processor on the PCB can determined the current delivered to the identifier and the response received from the identifier. In one example the electronic dose size capture arrangement comprises a rotational part and a non-rotational part and their relative rotation generates a signal indicative of the dose size. The non-rotational part is secured to the housing of the injection device at least during dosing such that the relative rotation occurring between the rotational part and the non-rotational part during dosing is an expression of the volume expelled.
In one example, the electronic dose size capture arrangement is provided proximally in the housing structure, preferably inside the dose setting button. In such example, the electronic dose size capture arrangement is an electronic component which can be produced away from the injection device and being easily integrated into the dose setting button in the housing structure during assembly of the injection device, The electronic dose size capture arrangement is thus an individual component having its own power supple such as a battery, and thus operate, at least electronically, fully independent of the injection device.
Further, the first and the second communication means are Bluetooth communication means using a standard Bluetooth protocol to easy transmit the information to an external data receiving unit such as a computer, a tablet or a smart phone.
In a second aspect of the invention, the protective cap provided in the drug delivery system comprises the sensor arrangement. The protective cap thus comprises an elastomeric connector electrically connected to a cap insert which insert carries a number of conductive strips connecting the elastomeric connector with a PCB also provided in the protective cap.
DEFINITIONS:
An “injection pen” or “pen for injection” is typically an injection apparatus having an oblong or elongated shape somewhat like a pen for writing. Although such pens usually have a tubular cross-section, they could easily have a different cross-section such as triangular, rectangular or square or any variation around these geometries.
The term “Needle Cannula” is used to describe the actual conduit performing the penetration of the skin during injection. A needle cannula is usually made from a metallic material such as e.g. stainless steel and connected to a hub to form a complete injection needle also often referred to as a “needle assembly”. A needle cannula could however also be made from a polymeric material or a glass material. The hub also carries the connecting means for connecting the needle assembly to an injection apparatus and is usually moulded from a suitable thermoplastic material. The “connection means” could as examples be a luer coupling, a bayonet coupling, a threaded connection or any combination thereof.
The term “Needle unit” is used to describe one single needle assembly carried in a container. Such container usually has a closed distal end and an open proximal end which is sealed by a removable seal. The interior of such container is usually sterile such that the needle assembly is ready to use. Needle units specially 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 usually double pointed having a front-end for penetrating through the skin of a user and a back-end for penetrating into the cartridge containing the drug such that liquid communication is established during injection.
As used herein, the term “Liquid drug” is meant to encompass any drug-containing flowable medicine capable of being passed through a delivery means such as a hollow needle cannula in a controlled manner, such as a liquid, solution, gel or fine suspension. Representative drugs include pharmaceuticals such as peptides, proteins (e.g. insulin, insulin analogues and C-peptide), and hormones, biologically derived or active agents, hormonal and gene-based agents, nutritional formulas and other substances in both solid (dispensed) or liquid form.
“Cartridge” is the term used to describe the container actually containing the drug which are often referred to as the primary packing. Cartridges are usually made from glass but could also be moulded from a suitable polymer. A cartridge or ampoule is preferably sealed at one end by a pierceable membrane referred to as the “septum” which can be pierced e.g. by the non-patient end of a needle cannula. Such septum is usually self-sealing which means that the opening created during penetration seals automatically by the inherent resiliency once the needle cannula is removed from the septum. The opposite end of the cartridge is typically closed by a movable “plunger” which is a piston-like element made from rubber or a suitable polymer. The plunger is during use slidable moved inside the cartridge preferably in a distal direction. The space between the pierceable membrane and the movable plunger holds the liquid drug which is pressed out as the plunger decreased the volume of the space holding the liquid drug. The cartridges used for both pre-filled injection devices and for durable injections devices are typically factory filled by the manufacturer with a predetermined volume of a liquid drug. A large number of the cartridges currently available contains either 1 ,5 ml or 3 ml of liquid drug.
Since a cartridge usually has a narrower distal neck portion into which the plunger cannot be moved not all of the liquid drug contained inside the cartridge can actually be expelled. The term “initial quantum” or “substantially used” therefore refers to the injectable content contained in the cartridge and thus not necessarily to the entire content.
By the term “Pre-filled injection device” is meant an injection device in which the cartridge containing the liquid drug is permanently embedded in the injection device such that it cannot be removed without permanent destruction of the injection device. Once the pre-filled amount of liquid drug in the cartridge is used, the user normally discards the entire injection device. Usually, the cartridge which has been filled by the manufacturer with a specific amount of liquid drug is secured in a cartridge holder which is then permanently connected in a housing structure such that the cartridge cannot be exchanged.
This is in opposition to a “Durable injection device” in which the user can himself change the cartridge containing the liquid drug whenever it is empty. Pre-filled injection devices are usually sold in packages containing more than one injection device whereas durable injection devices are usually sold one at a time. When using pre-filled injection devices an average user might require as many as 50 to 100 injection devices per year whereas when using durable injection devices one single injection device could last for several years, however, the average user would require 50 to 100 new cartridges per year.
All references, including publications, patent applications, and patents, cited herein are incorporated by reference in their entirety and 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.
All headings and sub-headings are used herein for convenience only and should not be constructed as limiting the invention in any way.
The use of any and all examples, or exemplary language (e.g. such as) provided herein, is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention. The citation and incorporation of patent documents herein is done for convenience only and does not reflect any view of the validity, patentability, and/or enforceability of such patent documents.
This invention includes all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law.
BRIEF DESCRIPTION OF THE DRAWINGS:
The invention will be explained more fully below in connection with a preferred embodiment and with reference to the drawings in which:
Figure 1 show an exploded view of the main structures of the injection device according to the invention.
Figure 2 show a perspective view of the reservoir structure.
Figure 3 show an exploded view of the cap insert.
Figure 4 show a view of the elements shown in figure 3 viewed from a distal position.
Figure 5A show the injection device with the protective cap mounted.
Figure 5B show the injection device with the protective cap visually removed.
Figure 5C show the injection device with the protective cap and the cap insert visually removed.
Figure 5D show the injection device with protective cap removed.
Figure 6A-B show two different views of the dose dial button and the electronic dose capture arrangement insertable into the dose dial button. The figures are schematic and simplified for clarity, and they just show details, which are essential to the understanding of the invention, while other details are left out. Throughout, the same reference numerals are used for identical or corresponding parts.
DETAILED DESCRIPTION OF EMBODIMENT:
When in the following terms as “upper” and “lower”, “right” and “left”, “horizontal” and “vertical” or similar relative expressions are used, these only refer to the appended figures and not necessarily to an actual situation of use. The shown figures are schematic representations for which reason the configuration of the different structures as well as their relative dimensions are intended to serve illustrative purposes only.
In that context it may be convenient to define that the term “distal end” in the appended figures is meant to refer to the end of the injection device supporting the injection needle, whereas the term “proximal end” is meant to refer to the opposite end carrying the injection button as indicated in figure 1. Distal and proximal is meant to be along an axial orientation extending along the longitudinal axis (X) of the injection device as also shown in figure 1.
When referring to clock-wise and anti or counter clock-wise in the following examples it is understood that the injection device is viewed from a position distal to the injection device. Clock-wise is thus a rotation following the arms on an ordinary clock and counter clock-wise is a rotation in the opposite direction.
To explain the various movements which take place in the injection device described in the example, the following terminology are used throughout the following detailed description.
“Translational movement” is meant to be a strictly linear movement without any rotation.
“Rotational movement” is any movement of rotation around a centre which centre can be a centre point i.e. in one planar or a centre axis i.e. having a longitudinal extension.
“Axial movement” means any movement in an axial direction. Such movement can be a strictly translational movement or include a rotational movement which thus makes it a “Helical movement” as this is meant to be an axial movement combined with a rotational movement.
“Telescopic” is meant to cover the situation in which a movable element moves out from, and/or into, a base element. The telescopic movement can be either translational or include a rotation thus making the telescopic movement helical.
As seen in Figure 1 , the injection device 1 according to the 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 could be contemplated.
Both the housing structure 10 and the reservoir structure comprises a Blue Tooth transmitter as indicated by the “BT” in figure 1. The usage of these two Blue Tooth transmitters will be explained in the following.
The housing structure 10 contains a delivery mechanism usually referred to as the dose engine. Such dose engine can be a manual dose engine wherein the force for expelling the doses is delivered by the user of the injection device, or the dose engine can be spring driven such that the force driving out doses is delivered by a spring. Alternatively, the dose engine can use an electric motor to dispense the doses. Numerous examples of these different dose engines are to be found in the prior art. A well-known commercial 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 also depicted in the figures 1 to 3 of WO 2022/013155.
The spring driven dose engine is actuated by the 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. As the dose is set and the torsion spring is strained, the size of the dose is displayed in the window 13. Distally the housing structure 10 is provided with means for releasable engaging a reservoir structure 20. These means are typically a thread or a bayonet interface. However other interfaces could be contemplated To cover the reservoir structure 20 when not in use a protective cap 30 is provided. This protective cap 20 is preferably clicked onto the distal end of the injection device 1.
The reservoir structure 20 is disclosed in figure 2 and comprises a container 21 preferably made from glass and containing the liquid drug permanently embedded in a holder unit 22 which is moulded from a suitable polymer. The reservoir structure 20 is distally provided with a needle interface 23 for securing a pen needle 25 to the reservoir structure 20. The proximal end of the needle cannula in the pen needle 25 penetrates into the glass container 21 as it is generally known from such pen-shaped injection devices. Proximally, the reservoir structure 20 is provided with a bayonet track 24 which engages with an inwardly pointing protrusion 14 provided on an inner surface of the housing structure 10. The inwardly pointing protrusion 14 is indicated with a broken line in figure 1.
In one example, the holder unit 22 encapsulating the glass container 21 is moulded as two or more different parts which are assembled around the glass container 21 by gluing, welding or by other means which could be a simple mechanical assembly means such as a threaded interlock connection or an irreversible click mechanism. In a different example, the holder unit 22 can be moulded around the glass container 22. The holder unit 22 together with the glass container 21 hence makes up the reservoir structure 20.
The reservoir structures 20 containing the liquid drug are thus made as separate units which are typically sold as such individual units. The same housing structures 10 can thus be used together with a plurality of different reservoir structures 20 depending on which type of liquid drug the user require for the specific treatment.
The reservoir structure 20 also carries an identifier 40 which identifies the type of liquid drug contained in the glass container 21 in the specific reservoir structure 20. The identifier 40 can be any kind of electronic of non-electronic element which can be coded with information regarding the type of liquid drug contained in the glass container 21 in the reservoir structure 20. The coding of the identifier 40 is preferably done as an integral part of the production. An example of a suitable identifier 40 will be provided in the following.
In one example, the identifier 40 comprises a sheet 41 or the like as best seen in figure 3 which sheet 41 is attached to the reservoir structure 20 as disclosed in figure 2 and has a number of separate areas 42 which can be formed either conductive or non-conductive. In the disclosed example twelve (12) such areas 41 are provided. To provided able redundancy, the areas are duplicated such that there actually is provided two sets of areas each having six (6) separate areas 42. As each of these six areas 42 can be either conductive or non-conductive a 6-bit code can be provided.
The six (6) conducting and non-conducting areas 42 could thus generate a 6 bit-code from 0- 0-0-0-0-0 to 1-1-1-1-1-1. “0” illustrating no electrical connection and “1” illustrating electric contact. Hence a total of 26 = 64 different codes can be generated. Each specific bit code is thus dedicated a specific liquid drug such that the identifier 40 is coded with information regarding the type of liquid drug contained in the glass container 21 inside the reservoir structure 20.
An example of such bit-code system based on conductive and non-conductive areas are provided in US2010/0161240 wherein especially figure 7A shows how these conductive and non-conductive areas can be identified by passing an electric current to the areas and measuring if the current is returned or not. This is preferably controlled by a processor.
The sheet 41 comprising the conductive and the non-conductive areas 42 disclosed in figure 3 can be attached to the reservoir structure 20 in many different ways such as e.g. by welding or gluing. Alternatively, the conductive and the non-conductive areas 42 can be made as integral parts of the reservoir structure 20. As best seen in figure 2, the conductive and the non-conductive areas 42 are preferably located at the distal end of the reservoir structure 20 pointing away from the bayonet track 24 interfacing the housing structure 10.
Figure 3 further discloses a cap insert 50 which distally carries a Printed Circuit Board (PCB) 55 and proximally carries an elastomeric connector 52. The cap insert 50 is on the inner surface provided with a plurality of longitudinal conductive strips 51 e.g. made by a 2K moulding in which the conductive strips 51 can be metallic or otherwise conductive. These conductive strips 51 connects the elastomeric connector 52, also often referred to as a Zebra connector, with the PCB 55. This PCB 55 carries the processor controlling the current which through the zebra connector 52 is applied to the conductive and non-conductive areas 42 on the reservoir structure 20 and further controls if these areas 42 closes the circuit to generate the bit-code identifying the type of liquid drug contained in the specific reservoir structure 20. A zebra connector usually comprises a plurality of alternating conductive and non-conductive segments. The segments are made from a flexible material such as an elastomer or a silicone rubber making the zebra connector compressible. In the disclosed example, the zebra connector 52 is shaped as a circle following the circular contour of the protective cap 30 and the conductive segments in the zebra connector 52 are conductive in the axial direction.
Figure 4 discloses the cap insert 50 viewed from a proximal end. The PCB 55 is also provided with two (2) sets of six (6) areas 56 which through the conductive strips 51 and the zebra connector 52 identifies the conductive and the non-conductive areas 42 on the reservoir structure 20 to generate the 6 bit-code. The PCB 55 further comprises a Bluetooth unit 57 able to communicate the bit-code to another electronic unit. For better illustration, the Bluetooth unit 57 and the other components of the PCB are disclosed as separated from the PCB 55 in figure 3, however, in use, these parts including the Bluetooth unit 57 are part of the PCB. The bit-code represents information relating to the type of liquid drug contained in the specific reservoir structure 20 as explained.
Figure 5A discloses the injection device of figure 1 with the protective cap 30 attached and covering the reservoir structure 20 and abutting the housing structure 10. As also seen in figure 5B wherein the protective cap 30 has been visually removed, the cap insert 50 is distally provided with a number of protrusions 53 which secures the cap insert 50 to the protective cap 30 to functionally operate 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.
In figure 5C, both the protective cap 30 and the cap insert 50 has been visually removed thereby disclosing the PCB 55, a 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 fully removed and the pen-needle 25 attached the reservoir structure 20.
In the figures 5A to 5C, the zebra connector 52 is pressed against the identifier 40 such that a current can be lead from the conductive strips 51 inside the cap insert 50 and onto the conductive and non-conductive areas 42 of the identifier carried by the reservoir structure 20 to generate the specific bit code.
The injection device is further provided with an electronic dose capture arrangement for capturing the size of each expelled dose. The dose capture arrangement 60 is disclosed in figure 6A-B and is encapsulated in a shell 61 which is proximally connected to the injection button 11 to form a single dose unit 65 which can be produced away from the remaining part of the injection device.
As seen in figure 6A and 6B, the injection button 11 is provided with a number of distally extending click arms 15 which connects to the shell 61 to form the single dose unit 65. This dose unit 65 comprising the shell 61 , the dose capture arrangement 60 and the injection button 11 is, as best seen in figure 6B, shaped and dimensioned such that it fits inside the dose setting button 12. A compression spring 66 is provided to urge the dose unit 65 in the proximal direction when a dose is not being injected. A flange, a track or the like is provided to prevent the dose unit 65 from falling out from the dose setting button 12. During dosing, the user presses the injection button 11 in the distal direction which also moves the entire dose unit 65 in the distal direction which axial movement further locks the dose setting button 12 rotational to the housing structure 10 via the longitudinal ribs 67 provided on in the dose unit 65. Hence, both the dose dial button 12 and the shell 61 and also the injection button 11 of the dose unit 65 do not rotate during dosing.
The dose capture arrangement 60 is distally provided with a distal pin 62 which protrudes through a distal opening in the shell 61 to connect with a rotational part inside the injection device. When the dose engine disclosed in WO 2022/013155, which is hereby incorporated by reference, is used, the distal pin 62 connects to the reset tube of the dosing mechanism which rotates during dose expelling.
The dose capture arrangement 60 comprises a rotational part connected to rotate together with the distal pin 62 and a stationary part. The stationary part is non-rotationally secured to the shell 61 and the shell 61 is non-rotational secured to the dose setting button 12 which is further rotationally locked to the housing structure 10 during dosing as explained.
In the dose engine disclosed in WO 2022/013155, the dose setting button is released from the rotational reset tube during dose expelling hence the stationary part of the dose capture arrangement 60 is stationary at least during dose expelling whereas the rotational part connected to the distal pin 62 is rotated during does expelling. The dose capture arrangement 60 thus captures the relative rotation which is an expression of the size of the dose being expelled.
The dose capture arrangement 60 is further provided with a first communication means such as a first Bluetooth unit such that the size of the expelled dose can be communicated to another electronic unit.
The protective cap 30 thus has a sensor arrangement e.g. the zebra connector 52 which is able to sense information from the identifier 40 carried by the reservoir structure 20. The information sensed relates to the type of liquid drug contained in the reservoir structure 20. The protective cap 30 is further provided with second communication means such as a second Bluetooth unit 57 which is able to communicate this information to another electronic unit which in one example could be a mobile phone operating a dosing app. In a different example, the other electronic unit could be the electronic dose capture arrangement 60 provided in the housing structure 10 of the injection device.
As mentioned, the electronic dose capture arrangement 60 also comprises a first communication means such as the first Bluetooth unit which is able to communicate the dose size to another electronic unit which in one example could be the same mobile phone also receiving information regarding the type of liquid drug contained in the reservoir structure 20. In a different example, the communication means in the protective cap 30 could communicate the information regarding the type of liquid drug contained in the reservoir structure 20 to the dose capture arrangement 60 which again could communicate this drug type information together with information regarding the dose size to an external unit such as a mobile phone to be further processed in an app carried on the mobile phone. The two information streams could also be collected in the protective cap 30 and communicated therefrom to the external unit. The two streams of communication arising from the housing structure 10 and from the protective cap 30 is indicated by the “BT” indication in figure 1.
In a further embodiment, the information regarding the size of the dose and the information regarding the type of liquid drug could be stored together in the protective cap 30 which could further be provided with a display to display this information. Some preferred embodiments have been shown in the foregoing, but it should be stressed that the invention is not limited to these but may be embodied in other ways within the subject matter defined in the following claims.
List of Reference Numerals
Figure imgf000020_0001

Claims

CLAIMS:
1. A drug delivery system, comprising:
A housing structure (10) with a dose setting and delivery mechanism for setting and expelling doses of a liquid drug, wherein the housing structure (10) comprises an electronic dose size capture arrangement (60) for capturing the size of each expelled dose and first communicating means for communicating the size of each expelled dose,
A reservoir structure (20) containing the liquid drug and releasable attachable to the housing structure (10), wherein the reservoir structure (20) comprises an identifier (40) which is coded with information relating to the type of drug contained in the reservoir structure (20),
A protective cap (30) mountable on the drug delivery device and at least partly covering the reservoir structure (20) when mounted,
Characterized in that the protective cap (30) comprises 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 regarding the type of drug contained in the reservoir structure (20).
2. A drug delivery system according to 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. A drug delivery system according to claim 1 , wherein the first communication means provided in the housing structure (10) is configured to communicate the size of each expelled dose to an external data receiving unit.
4. A drug delivery system according to 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. A drug delivery system according to claim 4, wherein the first communication means provided in the housing structure (10) is configured to communicate the size of each expelled dose and the information regarding the type of drug to an external data receiving unit.
6. A drug delivery system according to any of the claims 1 to 5, wherein the reservoir structure (20) comprises a container (21) containing the liquid drug which container (21) is permanently secured in a holder unit (22) attachable to the housing structure (10).
7. A drug delivery system according to claim 6, wherein the holder unit (22) carries the identifier (40) coded with information relating to the type of drug contained in the specific reservoir structure (20).
8. A drug delivery system according to any of the previous claims, wherein the identifier (40) comprises a number of separate areas (42) where a number of the separate areas (42) are electric conductive, and a number of the separate areas (42) are electric non-conductive.
9. A drug delivery system according to any of the previous claims, wherein the sensor arrangement (50, 51, 52, 55) in the protective cap (30) comprises an elastomeric connector (52) which is in galvanic contact with the electric conductive and non-conductive areas (42) of the identifier (40) when the protective cap (30) is mounted on the drug delivery device to at least partly cover the reservoir structure (20).
10. A drug delivery system according to claim 9, wherein a cap insert (50) provided in the protective cap (30) is provided with electric conductive strips (51) connecting the elastomeric connector (52) with a PCB (55).
11. A drug delivery system according to any of the previous claims, wherein the electronic dose size capture arrangement (60) comprises a rotational part (62) and a non-rotational part and wherein the relative rotation generates a signal indicative of the dose size.
12. A drug delivery system according to any of the previous claims, wherein the electronic dose size capture arrangement (60) is provided proximally in the housing structure (10), preferably inside the dose setting button (12).
13. A drug delivery system according to any of the previous claims, wherein the first and the second communication means are Bluetooth communication means.
14. The protective cap of the drug delivery system according to any of the 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) having a number of conductive strips (51) connecting the elastomeric connector (52) with a PCB (55) provided in the protective cap (30).
PCT/EP2023/084128 2022-12-14 2023-12-04 A drug delivery system with drug recognition WO2024126133A1 (en)

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