WO2025196180A1

WO2025196180A1 - Electronic system

Info

Publication number: WO2025196180A1
Application number: PCT/EP2025/057624
Authority: WO
Inventors: Michael Jugl; Stephan Riedel
Original assignee: Sanofi SA
Current assignee: Sanofi SA
Priority date: 2024-03-21
Filing date: 2025-03-20
Publication date: 2025-09-25
Anticipated expiration: 2026-09-21

Abstract

An electronic system (240) comprising an electronic measuring unit and a monitoring unit, wherein the electronic measuring unit is configured to generate measurement signals, wherein the generated measurement signals are suitable for determining a drug dose quantity of a drug dose based on the generated measurement signals, wherein the monitoring unit is configured to monitor the operation of the drug delivery device by a user regarding the occurrence of a predetermined situation during the operation, and wherein the electronic system is configured such that, in response to the occurrence of the predetermined situation, measurement signals generated by the measuring unit are not considered for determining the drug dose quantity or the measuring unit is instructed to temporarily interrupt or to permanently terminate the generation of measurement signals.

Description

Title

Electronic system

Background

The exact monitoring and adjustment of drug delivery devices is of great importance for the physical safety of the patient. To ensure this, drug delivery devices are known from the state of the art, which can measure, store and transmit information on the dose quantities delivered. Especially with hand-held delivery devices, measurement errors can occur when using the delivery devices due to different handling habits of the users.

Summary

It is an object of the present disclosure to facilitate improvements associated with drug delivery devices, particularly with respect to measuring the delivered dose quantity.

This object is achieved by subject-matter disclosed herein, for example by the subject-matter defined in the appended independent claims. Advantageous refinements and developments are subject to dependent claims and/or set forth in the description below.

One aspect of the present disclosure relates to an electronic system for a drug delivery device.

In an embodiment the electronic system is an add-on device or comprised by an add-on device suitable for attachment to the drug delivery device. The add-on device may be configured to be attachable to a proximal end of the drug delivery device. Alternatively, the electronic system may be comprised by the drug delivery device.

In an embodiment the electronic system comprises an electronic measuring unit. The electronic measuring unit may be configured to generate measurement signals. The measurement signals may be suitable for determining the drug dose quantity of a drug dose delivered during the operation of the drug delivery device performed by a user of the drug delivery device. The electronic measuring unit may comprise a sensor arrangement configured to detect a movement of two parts of the drug delivery device, and/or the add-on device attached to the drug delivery device, that are movable relative to each other during the dispensing process performed by the user of the drug delivery device. The dispensing process may be the dispensing process which is necessary to dispense the whole drug dose stored in the drug delivery device. The movement may be a rotational or translational movement.

In an embodiment the sensor arrangement comprises a transducer that varies its output due to variations in the magnetic field, based on the Hall Effect.

In an embodiment the sensor arrangement comprises a microelectromechanical (MEMS) device.

In an embodiment the sensor arrangement comprises an optical encoder. The sensor arrangement may comprise a light source, such as a light emitting diode (LED) and a light detector, such as an optical transducer.

In an embodiment the sensor arrangement comprises a potentiometer.

In an embodiment the sensor arrangement comprises mechanical sensors.

In an embodiment the electronic system comprises a processing unit operatively coupled to the measuring unit. The processing unit may be configured to, based on said detected movement of the electronic measuring unit, to determine a medicament amount expelled by the drug delivery device.

In an embodiment the electronic system comprises a monitoring unit configured to monitor the operation of the drug delivery device by the user regarding the occurrence of a predetermined situation during the operation of the drug delivery device by the user. The time period "during the operation of the drug delivery device by the user" may include the time during which the user applies force to the drug delivery device and/or add-on device to dispense the drug from the drug delivery device. The time period "during the operation of the drug delivery device by the user" may be the time during which the user holds the drug delivery device on the skin. The time period "during the operation of the drug delivery device by the user" may be the time during which the user pushes an injection button on the drug delivery device and/or the add-on device. The time period "during the operation of the drug delivery device by the user" may be the time during which the drug delivery device decreases in length in the course of a dispensing movement along its longitudinal axis. In an embodiment the processing unit is operatively coupled to the monitoring unit. The processing unit may be operatively coupled to the monitoring unit and the measurement unit.

In an embodiment, the monitoring unit comprises a sensor structure. The sensor structure may be configured to detect user-induced influences that act, directly or indirectly, on the drug delivery device during manipulation of the add-on device and/or the drug delivery device by the user of the drug delivery device. The influences may include a force that the user applies to the drug delivery device before, during and/or after the dispensing process. The force may be a force applied by the user to the proximal end of the drug delivery device and/or the proximal end of the add-on device before, during and/or after the dispensing process.

The predetermined situation might occur before, during and/or after the dispensing process. As mentioned above It may occur before the dispensing process, e.g. when a force is applied by a user on the drug delivery device, e.g. on its proximal end, and/or on the electronic system, before the dispensing process.

The predetermined situation may occur during a dispensing process, e.g. when a force is applied by a user on the drug delivery device, e.g. on its proximal end, and/or on the electronic system before the dispensing process.

The predetermined situation may occur after a dispensing process, e.g. when a moveable dosing element or dose delivery element reaches its end position.

In an embodiment the sensor structure comprises one or more sensors. One or more of the sensor may be a force sensor. The force sensor may, inter alia, be a strain gauge sensors, piezoelectric sensors or a capacitive sensor.

In an embodiment the one or more sensors can include a pressure sensor.

In an embodiment the electronic measuring unit is configured to start generate measurement signals as soon as the user applies force to the drug delivery device and/or the add-on device for the first time.

In an embodiment the electronic measuring unit is configured to start generate measurement signals as soon as the user pushes a delivery button of the drug delivery device and/or the addon device for the first time. In an embodiment the electronic system is configured such that, in response to the occurrence of the predetermined situation, measurement signals generated by the measuring unit are not considered for determining the drug dose quantity.

In an embodiment the electronic system is configured such that, in response to the occurrence of the predetermined situation, the measuring unit is instructed to temporarily interrupt the generation of signals.

In an embodiment the electronic system is configured such that, in response to the occurrence of the predetermined situation, the measuring unit is instructed to permanently terminate the generation of signals.

In an embodiment the electronic system is configured such that, in response to the occurrence of the predetermined situation, the processing unit instructs the measuring unit to temporarily interrupt the generation of signals and/or to permanently terminate the generation of signals.

In an embodiment the electronic system comprises an output. The output may be a wireless communications interface for communicating with another device via a wireless network such as Wi-Fi or Bluetooth®, or an interface for a wired communications link, such as a socket for receiving a Universal Series Bus (USB), mini-USB or micro-USB connector.

In an embodiment, the output is configured such that the output generates a warning signal in response to the occurrence of the predetermined situation. The warning signal may be indicative of an incorrect dose quantity being detected. The warning signal may be directly perceived by the user visually, acoustically and/or haptically. For this purpose, the electronic system may comprise a warning light, a loudspeaker and/or a vibration unit. The warning signal may be indirectly perceived by the user visually, acoustically and/or haptically by means of another device to which the output sends the warning signal in response to the occurrence of the predetermined situation. The other device may be a smart device, for example a smartphone or a smartwatch. The output may be connected to the electronic measuring unit and the monitoring unit via the processing unit.

In an embodiment, the output is configured to output information indicating the last detected drug dispensing amount calculated by the processor unit before the detection of the predetermined situation occurred. In an embodiment the predetermined situation is characterized by one or more predetermined events occurring during the operation of the drug delivery device by the user.

In an embodiment the monitoring unit is configured to monitor a value indicative of the force applied by the user to the electronic system and/or the drug delivery device during the operation of the drug delivery device. The value indicative of the force applied by the user may be a force value that is measured by the sensor structure.

In an embodiment the occurrence of the predetermined situation may be characterized by the monitored value being greater than a predefined upper threshold value. The predefined upper threshold value may be greater than or equal to 15 Newton, for example 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 or 25 Newton.

In an embodiment the occurrence of the predetermined situation may be characterized by the monitored value being less than a predefined lower threshold value. The predefined lower threshold value may be equal to or less than 5 Newton, such as 1, 2, 3, 4 or 5 Newton.

In an embodiment the occurrence of the predetermined situation may be characterized by the monitored value being greater than the predefined upper threshold value and by the monitored value being less than the predefined lower threshold value. The predetermined situation may thus be characterized by a detection of the monitored value outside a range of values, wherein the range of values extends between the upper and lower threshold value.

In an embodiment the electronic system comprises a monitoring timer which is configured to record the time from the beginning of the dispensing process. The monitoring timer may be configured to record the time from the beginning of the generation of measurement signals by the electronic measuring unit. The occurrence of the predetermined situation may be characterized by the monitored value being less than the predefined lower threshold value within a predetermined time after the electronic measuring unit starts to generate measurement signals. The predetermined time can be equal to or less than 6 seconds, such as 6, 5, 4, 3, 2 or 1 seconds. The occurrence of the predetermined situation may also be characterized by the monitored value being less than the predefined lower threshold value, optionally within the predetermined time, after the electronic measuring unit starts to generate measurement signals, and the subsequent absence of the monitored value being more than the predefined lower threshold value within a further predetermined time. The further predetermined time may be equal to or less than 6 seconds, such as 6, 5, 4, 3, 2 or 1 seconds. In an embodiment the monitoring unit comprises an end position detector. The end position detector may be configured to detect an end position of a movable dosing element or dose delivery element of the electronic system and/or the drug delivery device after a drug delivery process. The predetermined situation may by characterized by the detection of the end position of the movable dosing element or dose delivery element. The movable dosing element or dose delivery element may be a number sleeve. The number sleeve may display adjustable dose amounts and may rotate relative to the housing of the drug delivery device during the dispensing process. The movable dosing element or dose delivery element may be a dosage knob which is configured to move along the longitudinal axis of the drug delivery device relative to the housing of the drug delivery device during the dispensing process. The end position detector may be a switch. The end position detector may be configured such that the end position detector changes from a first state to a second state in response to a relative movement between at least two components comprised by the drug delivery device and/or the add-on device for the drug delivery device.

In an embodiment the occurrence of the predetermined situation is characterized by the change or switch of the end position detector from the first state to the second state. The predetermined situation may by characterized by the change from the first state to the second state after the electronic measuring unit starts to generate measurement signals.

In an embodiment the occurrence of the predetermined situation is characterized by the monitored value being greater than the predefined upper threshold value after the end position detector has changed from the first state to the second state.

In an embodiment the occurrence of the predetermined situation is characterized by the monitored value being less than the predefined lower threshold value before the end position detector has changed from the first state to the second state.

In an embodiment the occurrence of the predetermined situation is characterized by the monitored value being greater than the predefined upper threshold value after the end position detector has changed from the first state to the second state and by the monitored value being less than the predefined lower threshold value before the end position detector has changed from the first state to the second state.

In an embodiment the electronic system is configured to monitor the operation of the drug delivery device by the user regarding the occurrence of the predetermined situation when the electronic measuring unit is in a state configured to generate measurement signals. Another aspect of the present disclosure relates to a drug delivery device comprising the electronic system described above. In both cases, the drug delivery device may be configured to retain a drug container with a drug or may comprise a drug container with a drug. The drug delivery device may be a fully functional drug delivery device. The drug may be a medicament. The drug delivery device may not be an auto- injector, meaning that the user must apply force to push the drug out of the container. The dispensing device may be a dispensing device in which the dose quantity to be dispensed can be set manually by the user. The drug delivery device may be a dial extension pen, wherein the drug delivery device lengthens along its longitudinal axis as the dose is increasingly set and shortens along the longitudinal axis as the dose is delivered. The drug delivery device is may be a hand-held pen-type injection device with a manual dose setting function. Alternatively, the drug delivery device may be an autoinjector. In an autoinjector, the energy for the drug delivery operation may be prestored in an energy storage member. That is to say, the user does not have to provide the energy for the drug delivery operation, e.g. when preparing the drug delivery device for use. Rather, this energy may be preloaded into the drug delivery device by the manufacturer. For example, a drive spring, e.g. a spiral spring or flat spiral spring, may be pre-stressed or pre-biased to provide the energy for the drug delivery operation.

The invention also relates to the method for monitoring measured dose delivery quantities of the drug delivery device. The method may be a computer-implemented method. The method may comprise the provision of the electronic system and drug delivery device described above. The method may comprise the monitoring of the operation of the drug delivery device regarding the occurrence of the predetermined situation while the user applies force to the drug delivery device to deliver the drug dose. The method my further comprise in response to the occurrence of the predetermined situation, not considering measurement signals generated by the measuring unit, suitable for providing measurement signals, through which the dose quantity delivered can be determined, or instructing the measuring unit to temporarily interrupt or to permanently terminate the generation of measurement signals. Furthermore, the method may comprise the step of forwarding a warning signal to the user in response to the detection of the predetermined situation. The warning signal may indicate that the measured dose is incorrect. Alternatively or additionally, in response to the detection of the predetermined situation, the method may comprise the step of forwarding information to the user indicative of the last detected quantity of drug dispensed before the detection of the predetermined situation took place.

Another aspect of the present disclosure relates to a computer program product, e.g. a computer program or a computer readable storage medium, comprising instruction which when carried out by a processor cause the electronic system to perform the method described above. The computer readable storage medium may be hardware memory component. The processor may be different from the processing unit. Contrary to the processing unit, the processor may not be part of the electronic system. Alternatively the processor may be the processing unit.

In the present invention, singular expressions such as "a sensor", are used for ease of reading the description and claims. Since the assembly according to the invention "comprises" or "has" components or features, respectively, however, such a singular expression does not limit the number of components or features concerned. Rather, such a singular expression is intended to be understood as "at least one sensor" unless the context indicates otherwise.

The making and using of the presently preferred embodiments are discussed in detail below. It should be appreciated, however, that the present disclosure provides many applicable concepts that can be embodied in a wide variety of specific contexts. The specific embodiments discussed are merely illustrative of specific ways to make and use the disclosed concepts, and do not limit the scope of the claims.

Moreover, same reference numerals may refer to same technical features if not stated otherwise. As far as "may" is used in this application it means the possibility of doing so as well as the actual technical implementation. The present concepts of the present disclosure will be described with respect to preferred embodiments below in a more specific context namely drug delivery devices, especially drug delivery devices for humans or animals. The disclosed concepts may also be applied, however, to other situations and/or arrangements as well, e.g. for other injectors, spraying devices or inhalation devices.

The foregoing has outlined rather broadly the features and technical advantages of embodiments of the present disclosure. Additional features and advantages of embodiments of the present disclosure will be described hereinafter, e.g. of the subject-matter of dependent claims. It should be appreciated by those skilled in the art that the conception and specific embodiments disclosed may be readily utilized as a basis for modifying or designing other structures or processes for realizing concepts which have the same or similar purposes as the concepts specifically discussed herein. It should also be recognized by those skilled in the art that equivalent constructions do not depart from the spirit and scope of the disclosure, such as defined in the appended claims.

Brief description of the drawings For a more complete understanding of the presently disclosed concepts and the advantages thereof, reference is now made to the following description in conjunction with the accompanying drawings. The drawings are not drawn to scale. In the drawings the following is illustrated in:

Figure 1 an exploded view of an injection device for use with an electronic system according to an embodiment of the invention;

Figure 2 an electronic system according to exemplary embodiments, attached to the injection device of Figure 1;

Figure 3 a cross-sectional view of the electronic system shown in Figure 2 when attached to the injection device of Figure 1;

Figure 4a-4d schematic drawings of variations of a part of the electronic system of Figure 2 that engages with the injection device;

Figure 5 an isometric cutaway view of a first variation of the electronic system of

Figure 2;

Figure 6 a force time diagram during the dispensing process of the injection device;

Figure 7a is a distal end isometric view of a second variation of the electronic system of Figure 2;

Figure 7b a proximal end isometric view of the second variation of the electronic system of Figure 2 installed on the injection device of Figure 1;

Figure 7c a side view of the second variation of the electronic system of Figure 2;

Figure 7d a cutaway side view of the second variation of the electronic system of

Figure 2;

Figure 7e a side cross-section view of the second variation of the electronic system of Figure 2; Figure 8 a block diagram of the components of the electronic systems of Figure 2,

5 and 7;

Figure 9 a system in which data from the electronic system of Figures 2, 5 and 7 is transmitted to another device.

Description of exemplary embodiments

As a general note, “distal” is used herein to specify directions, ends or surfaces which are arranged or are to be arranged to face or point towards a dispensing end of the drug delivery device and/or point away from, are to be arranged to face away from or face away from the proximal end. On the other hand, “proximal” is used to specify directions, ends or surfaces which are arranged or are to be arranged to face away from or point away from the dispensing end and/or from the distal end of the drug delivery device or components thereof. The distal end may be the end closest to the dispensing end and/or furthest away from the proximal end and the proximal end may be the end furthest away from the dispensing end. A proximal surface may face away from the distal end and/or towards the proximal end. A distal surface may face towards the distal end and/or away from the proximal end. The dispensing end may be the needle end where a needle is arranged or a needle or needle unit is or is to be mounted to the device, for example. “Axial” may be used synonymously with “longitudinal”.

The present description describes an electronic system. The electronic system can be an addon device. Alternatively, the electronic system can be part of an add-on device. The electronic system or add-on device is also referred to below as a data collection device. In the embodiments of the Figures, the electronic system is comprised by the data collection device. However, it should be noted that the electronic system does not necessarily have to be comprised by the data collection device. It is also possible to arrange the electronic system as an integral part of a drug delivery device e.g. within the housing of a drug delivery device.

The data collection device is attachable to a proximal end of a drug delivery injection device, such as a pen injector, such as to fit the injector device like a cap. The drug delivery device is also referred to below as the injection device. The data collection device is configured such that it can be push-fitted over a dosage knob or dose dialing knob of the injection device. In particular, a first portion of the data collection device includes a cavity that receives the dosage knob, and includes a deformable inner surface such as to provide a tight fit over the dosage knob and/or has features that mate closely with external features of the dosage knob. Through the push-fit features, the data collection device can easily be installed on the injection device, and can easily be removed through application of a removal force between the data collection device and the injection device in an axial direction. When installed, the data collection device is manipulated by the user in order to effect operation of the injection device.

The data collection device when installed monitors quantities and times of medicament delivery from the injection pen. In order to assist the monitoring, the electronic system comprises an electronic measuring unit configured to generate measurement signals. The electronic measuring unit may comprise the sensor arrangement described below. The generated measurement signals are suitable for determining a drug dose quantity of a drug dose delivered during the operation of the injection device performed by a user of the injection device based on the generated signals. Medicament quantities can be transmitted, e.g. to a smartphone, and/or displayed on a display of the data collection device. By providing the data collection device with push-fit features, it can be located onto and used with a series of different injection devices and thus monitor a user's medicament treatment over multiple devices. Moreover, this can be achieved without impeding normal use of the injection device and without obscuring a dosage window of the injection device.

In the following, embodiments of the present invention will be described with reference to an insulin injection device. The present invention is however not limited to such application and may equally well be deployed with injection devices that eject other medicaments.

Figure 1 is an exploded view of a drug delivery device. In this example, the drug delivery device is an injection device 1. The injection device 1 of Figure 1 is a pre-filled, disposable injection pen that comprises a housing 10 and contains an insulin container 14, to which a needle 15 can be affixed. The needle is protected by an inner needle cap 16 and either an outer needle cap 17 or an alternative cap 18. An insulin dose to be ejected from injection device 1 can be programmed, or 'dialed in' by turning a dosage knob 12, and a currently programmed dose is then displayed via dosage window 13, for instance in multiples of units. For example, where the injection device 1 is configured to administer human insulin, the dosage may be displayed in so- called International Units (IU), wherein one IU is the biological equivalent of about 45.5 micrograms of pure crystalline insulin (1/22 mg). Other units may be employed in injection devices for delivering analogue insulin or other medicaments. It should be noted that the selected dose may equally well be displayed differently than as shown in the dosage window 13 in Figure 1. The dosage window 13 may be in the form of an aperture in the housing 10, which permits a user to view a limited portion of a number sleeve 70 that is configured to move when the dosage knob 12 is turned, to provide a visual indication of a currently programmed dose. The dosage knob 12 is rotated on a helical path with respect to the housing 10 when turned during programming.

In this example, the dosage knob 12 includes one or more formations 71a, 71b, 71c to facilitate attachment of a data collection device to be described herein below. The injection device 1 may be configured so that turning the dosage knob 12 causes a mechanical click sound to provide acoustical feedback to a user. The number sleeve 70 mechanically interacts with a piston in insulin container 14. When needle 15 is stuck into a skin portion of a patient, and then injection button 11 is pushed, the insulin dose displayed in display window 13 will be ejected from injection device 1. When the needle 15 of injection device 1 remains for a certain time in the skin portion after the injection button 11 is pushed, a high percentage of the dose is actually injected into the patient's body. Ejection of the insulin dose may also cause a mechanical click sound, which is however different from the sounds produced when using dosage knob 12.

In this embodiment, during delivery of the insulin dose, the dosage knob 12 is turned to its initial position in an axial movement, that is to say without rotation, while the number sleeve 70 is rotated to return to its initial position, e.g. to display a dose of zero units.

Injection device 1 may be used for several injection processes until either the insulin container 14 is empty or the expiration date of the medicament in the injection device 1 (e.g. 28 days after the first use) is reached.

Furthermore, before using injection device 1 for the first time, it may be necessary to perform a so-called "prime shot" to remove air from insulin container 14 and needle 15, for instance by selecting two units of insulin and pressing injection button 11 while holding injection device 1 with the needle 15 upwards. For simplicity of presentation, in the following, it will be assumed that the ejected amounts substantially correspond to the injected doses, so that, for instance the amount of medicament ejected from the injection device 1 is equal to the dose received by the user. Nevertheless, differences (e.g. losses) between the ejected amounts and the injected doses may need to be taken into account.

Figure 2 is a perspective view of one end of the injection device 1 when a data collection device

20 according to an example embodiment is attached. The data collection device 20 includes a housing 21 and an end plate 22 with an optional display 22a. The data collection device 20 may take one of a number of different forms, as described below and as shown in the drawings.

Figure 3 is a cross-sectional view of the data collection device 20 according to an embodiment, when attached to the injection device 1. The data collection device 20 includes a first portion 23 and a second portion 24, where the first portion 23 is capable of rotational movement relative to the second portion 24.

In this particular example, the first portion 23 is a sleeve that is positioned over the dosage knob 12. The first portion may have formations 19a, 19b, 19c that co-operate with the formations 71a, 71b, 71c on the dosage knob 12. Whether or not the formations 19a-c are provided on the first portion 23, the arrangement is such that, when the first portion 23 is rotated by a user during programming of the dosage, the dosage knob 12 also rotates and such that, when the dosage knob 12 rotates during expulsion of medicament, the first portion 23 also rotates.

Resilient padding, such as a foam rubber pad 44, may be provided within the formations 19a- c on the first portion 23, to allow for tolerances in the dimensions of the formations 19a-c on the first portion 23 and the formations 71a, 71b, 71c on the dosage knob 12 and/or to provide an engagement between the first portion 23 and the dosage knob 12 so that rotation of the first portion 23 causes rotation of the dosage knob 12 and vice versa. The resilient padding 44 may alternatively be made of another rubber or synthetic rubber material. The resilient padding 44 may be provided around the entire circumference of the first portion 23, or it may be provided at intermittent locations.

As shown in Figure 4b, the resilient padding 44 may be provided alternatively to formations 19a- c on the first portion 23. In these embodiments, the inner surface of the first portion 23 at the distal end 35 (lowermost in Figure 3) is substantially featureless. The inner surface may be generally cylindrical in shape. It may alternatively be generally conical, being wider at the distal end. It may alternatively be generally dome-shaped, being wider at the distal end.

Further alternatively, the first portion 23 comprises a resilient padding of sufficient thickness to render formations that co-operate with the formations 71a, 71b, and 71c on the dosage knob. The padding is soft enough to conform to the surface of the dosage knob 12. For example, the padding is soft enough to conform to the formations on the surface of the dosage knob 12. In the embodiments of Figures 4a, 4c and 4d, the resilient padding 44 may be provided in addition to formations on the inner surface of the first portion 23. The padding 44 described above performs multiple functions.

First, it assists in mounting the first portion 23 of the data collection device 20 over the dosage knob 12. In particular, the resilient padding 44 deforms to accommodate the dosage knob 12 within the cavity of the first portion. Friction provides a reactive force in response to insertion of the dosage knob 12 within the first portion 23. This provides tactile feedback to the user indicating that the data collection device 20 is being received over the dosage knob 12. Once the data collection device 20 is installed fully, further movement is prevented. This can be detected by the user through tactile feedback by providing the user with a step change from some relative movement to no relative movement as the proximal end of the dosage knob 12 abuts an abutting surface at the proximal end of the cavity in the first section 23 (see Figure 5 for instance). The friction between the data collection device 20 and the dosage knob 12 causes the data collection device 20 to remain installed on the injection device 1. This can be achieved without any further mechanism to secure the data collection device 20 to the injection device, although the use of a further mechanism is not precluded. To uninstall the data collection device 20 from the injection device, the friction force needs to be overcome. This can be achieved by applying a strong pulling force, for instance of 30 Newton or more, to the data collection device in the proximal direction.

The padding also provides sufficient engagement for transferring rotation force applied by the user between the first portion 23 and the dosage knob 12 during dose setting/programming. The force is communicated by friction between the first portion 23 and the dosage knob 12. The friction force acting between the first portion 23 and the dosage knob 12 in the rotational direction exceeds the force required to overcome the forces internal to the drug delivery device 1 by a factor of at least 5, or more advantageously at least a factor of 10, which helps to avoid slippage between the components.

As shown schematically in Figure 4a, the formations 19a-c on the inner surface may take the form of features that have a shape that mates with the shape of the formations 71a, 71b, and 71c on the dosage knob 12. For instance, the formations 19a-c on the inner surface may take the form of features that have a shape corresponding closely to the shape of the formations 71a, 71b, 71c on the dosage knob 12. Close correspondence in shape can allow good engagement between the first portion 23 and the dosage knob 12. Where the formations 19a-c on the inner surface have a shape that mates with the shape of the formations 71a, 71b, 71c on the dosage knob 12, the choice of a material with a relatively high friction coefficient to form the inner surface of the first portion 23 contributes to providing a fit between the data collection device 20 and the dosage knob 12 that results in retention of the data collection device 20 on the injection device 1. The optional use of a resilient material on the inner surface of the first portion 23 contributes further to retention of the data collection device 20 on the injection device 1. However, if the fit between the formations on the inner surface of the first portion 23 and the formations 71a, 71b, 71c on the dosage knob 12 is sufficiently close and the coefficient of friction between them is sufficiently high, the material of the inner surface of the first portion 23 need not be resilient.

As shown schematically in Figure 4c, the formations 19a-c on the resilient inner surface of the first portion 23 may take the form of ribs. The ribs may have a triangular cross-section, or they may have a domed cross-section. The ribs may be circumferential. Alternatively, they may be axially arranged. Axial ribs advantageously number at least four times the number of formations 71a, 71b, 71c on the dosage knob 12. This can help to ensure that the formations 71a, 71b, 71c on the dosage knob 12 can easily be received by the formations on the first portion 23 without requiring specific rotational alignment.

As shown in Figure 4d, the formations 19a, 19b may take the form of ribs. When the data collection device 20 is placed over the dosage knob 12, the formations 71a-c of the dosage knob fall between the formations/ribs 19a-c of the first portion 23. The formations 19a, 19b here are configured such as to grip the surface of dosage knob 12 between the formations 71 a-c when the data collection device 20 is installed fully onto the injection device 1. To this end, the ribs 19a, 19b have a height in the radial direction that is equal to or greater than the radial height of the formations 71 on the dosage knob 12. The ribs are spaced and numbered such that it is unlikely that a proximal end of the ribs will contact a distal end of the formations on the dosage knob 12 when the data collection device is being installed. In particular, the spacing between adjacent ribs may be equal to an integer multiple of the spacing between adjacent formations 71 on the dosage knob 12. The configuration and spacing of the ribs is such that if there is contact between a proximal end of a rib and a distal end of a formation on the dosage knob 12 when the data collection device is being installed, there is substantially identical contact between multiple ribs and multiple formations 71. When this happens, a small amount of rotational force, which may be provided by the ribs glancing off the formations, causes the ribs to be located between the formations 71 on the dosage knob 12.

The ribs may or may not be twisted with respect to the longitudinal axis of the data collection device 20. In particular, there may be a relative twist between different formations 19a-c, for instance one formation/rib 19a has a clockwise twist and the next formation/rib 19b has an anticlockwise twist. When the data collection device 20 is placed over the dosage knob 12, the formations 71 a-c of the dosage knob fall between the formations/ribs 19a-c of the first portion 23.

In all of these arrangements, the first portion 23 is shaped such that there is substantially even engagement between the first portion 23 and the dosage knob 12 for the whole of the axial length of the dosage knob 12. This helps to ensure correct axial orientation of the data collection device 20 with the injection device 1. Axial orientation is provided because the shapes of the components are such that any incorrect orientation results in a corrective force being applied radially between the dosage knob 12 and the first portion 23 as they are mated together. Correct axial alignment is useful because it provides a better transmission of rotation force from the first portion 23 to the dosage knob 12 and because it provides better feedback to the user when dose delivery is performed. It also generally improves the experience of the user.

In other embodiments, the first portion 23 may be formed with a rigid section surrounding at least part of the second portion 24 and a resilient section that surrounds at least part of the dosage knob 12, the rigid section providing a firm gripping surface for the user when mounting or removing the data collection device 20 onto or from the injection device 1 and the resilient section assisting in mounting the first portion 23 over the dosage knob 12 and providing sufficient engagement for transferring rotation between the first portion 23 and dosage knob 12 during programming and medicament expulsion. Optionally, the rigid section may be formed of a different material from the resilient section. Such a first portion 23 may, optionally, also include formations 19a-c configured to co-operate with the formations 71a, 71b, 71c on the dosage knob 12, as described above, and/or resilient padding 44.

In some embodiments, an indicator is provided on the data collection device. The indicator may for instance be a groove, a nose or a printed feature. The indicator facilitates alignment by the user of the data collection device with a nose of the injection device 1. However, in the embodiments shown in the drawings, no such alignment is needed.

The coupling between the first portion 23 and the dosage knob 12 does not include any moving parts. The first portion 23 is coupled with the dosage knob 12 solely through a close fit, through friction between surfaces of the components, optionally assisted by deformation of a resilient material forming the coupling surface of the first portion 23. To set a medicament dosage amount to be administered, the user may grip and rotate the first portion 23, since this will cause the dosage knob 12 of the injection device 1 to turn and, thereby, program the dosage amount.

Also, in this particular example, the second portion 24 is a body located within the first portion 23, to which it is rotatably attached using bearings 25. The second portion 24 includes an outer portion 26, which includes the endplate 22 and optionally a display 22a. The second portion 24 also includes an inner portion 27. When the data collection device 20 is attached to the injection device 1 , the inner portion 27 overlies the injection button 11. The outer portion 26 and the inner portion 27 are attached by a fixture 28 that prevents rotation relative to each other. However, in this embodiment, the outer portion 26 can be moved axially relative to the inner portion 27 and one or more resilient members, such as springs 29, may be provided to bias the outer portion 26 away from the inner portion 27.

The data collection device 20 is configured to detect axial movement of the outer portion 26 relative to the inner portion 27. Movement greater than a predetermined amount may be detected using a switch 53, for instance, as is described later in the specification.

In this particular arrangement, first electrical contacts 30 are provided on the outer portion 26, while corresponding second electrical contacts 31 are provided on the inner portion 27. When a user presses the endplate 22, the outer portion 26 moves axially towards the inner portion, establishing a connection between the first and second electrical contacts 30, 31. Further pressure on the endplate 22 causes the inner portion 27 to press against, and activate, the injection button 11. The first and second electrical contacts 30, 31 provide a data connection between the processor arrangement 50 and display 22a when engaged.

Figure 5 is an isometric cutaway view of a first alternative data collection device 240, which is a variation of the data collection device 20.

In these Figures, reference numerals are retained from Figure 2 for like elements. Unless otherwise stated or unless impossible, features of the Figure 2 device are present in the Figure 5 data collection device. Also, features of any one device may be present in all of the other devices.

The Figures 2 and 5 data collection devices have a common characteristic that the first portion 23 has a larger accessible surface area than does the second portion 24. The data collection device 240 of Figure 5 includes a capsule 244, which is contained within the body of the data collection device 240. The capsule 244 itself contains a power source 54 or battery, in the form of a coin cell in this example, and a printed circuit board (PCB) 242. Mounted on the PCB are a number of electronic components including a communications interface 243, for instance a Bluetooth TM Low Energy chip or a Near Field Communications (NFC) chip. It also supports a switch 53 for detecting axial movement of the second portion 24. The PCB 242 further supports a sensor arrangement 51 , which is configured to detect rotation of the first portion 23 relative to the second portion 24. In particular, the capsule 244 is fixed in rotation relative to the second portion 24 and rotates with the second portion 24 relative to the first portion 23 when the dose is being delivered.

The power source 54 provides power to the electronic components of the data collection device 240. The power source 54 is located distally to the PCB 242. The power source 54 is abutted by the distal end of the capsule 244 and by the PCB 242.

The first portion 23 has three key structural elements. The first portion 23 may be formed as one part, or it may be formed of multiple parts that are connected together. A first element 246 of the first portion 23 is configured to engage with the dialing knob 12. Aspects of the first element are described above, especially in relation to Figures 4a to 4d. A second element 247 is configured to engage with the dose delivery button 11. In particular, the second element 247 is configured to fit closely around the dose delivery button 11. The second element 247 helps to ensure correct axial alignment of the data collection device 240 on the injection device 1. The second element 247 may take the form of a ring. The second element 247 may have a low friction inner surface, so as not to impede movement of the dose delivery button 11 in the distal direction. The third element 248 is located at the proximal end of the first portion 23. The third element 248 extends radially inwardly. It also surrounds the second portion 24 in the radial direction.

The capsule 244 is movable in the axial direction within the cavity formed in the first portion 23. The capsule 244 is restrained in the proximal direction at the periphery of the capsule 244 by the third element 248 of the first portion 23. In the distal direction, the capsule 244 abuts the dose button 11.

The second portion 24 is connected at its periphery to a proximal end of the capsule 244. A pillar 245 is provided at the center of the second portion 24 and extends axially. The pillar 245 is coincident with the switch 53, and may or may not contact it when no force in the distal direction is applied to the second portion 24. The center of the second portion 24 is slightly deformable in the distal direction. The switch 53 is configured to be operated upon movement of at least part of the second portion 24 relative to the first portion 23. A force required to operate the switch 53 is lower than a force required to cause medicament delivery from the injection device 1. By using operation of the switch 53 to trigger powering of components of the data collection device, the components of the data collection device will thus be powered before dose delivery commences. For instance, the force required to operate the switch 53 may be about 2 Newton, or more generally between 1 and 5 Newton.

The exemplary embodiment shown in Figure 5, like all other exemplary embodiments shown in the Figures, comprises a monitoring unit configured to monitor the operation of the drug delivery device 1 by the user regarding the occurrence of a predetermined situation during the operation. In the context of the present disclosure, the term “operation” may include any operation performed by the user while handling the drug delivery device. In particular, the term "operation" includes the application of force to the drug delivery device 1 and/or to the data collection device 240 while the user intends to deliver a dose of drug, wherein the duration of the actual delivery is shorter than the duration assumed by the user to deliver the drug. The period during which the monitoring unit is used can therefore be longer than the actual dispensing process.

The predetermined situation might occur before, during and/or after the dispensing process. As mentioned above It may occur before the dispensing process, e.g. when a force is applied by a user on the drug delivery device, e.g. on its proximal end, e.g. on the injection button 11 , and/or on the electronic system, before the dispensing process.

The predetermined situation may occur during a dispensing process, e.g. when a force is applied by a user on the drug delivery device, e.g. on its proximal end, and/or on the electronic system during the dispensing process, e.g. by keeping the injection button 11 of the drug delivery device pressed.

The monitoring unit comprises a sensor structure 90 configured to detect forces applied to the drug delivery device 1 and/or to the data collection device 240 during manipulation of the drug delivery device by the user of the drug delivery device, e.g. before, during and/or after a dispensing process. The sensor structure comprises at least one sensor 90 that can measure the force applied by the user. In all embodiments of the present figures, one or more of these force sensors 90 can be arranged at any points in or on the data collection device 20 or the drug delivery device 1 that are along the flow of force applied to the data collection device or the drug delivery device by the user to perform the drug delivery. Preferably, one or more sensors 90 of the sensor structure can be arranged between two movable parts of the drug delivery device 1 and/or the data collection device, which perform a relative movement to each other in response to the force applied by the user. With reference to the exemplary embodiment according to Figure 3, the force sensor 90 can be positioned, for example, between the distal surface of the inner portion 27 and the proximal surface of the injection button 11. With reference to the exemplary embodiment according to Figure 7, the force sensor 90 can be positioned, for example, between the printed circuit board 242 and the power source 54 or the capsule 244.

The monitoring unit according to the exemplary embodiments depicted in the figures may comprise an end position detector 91. The end position detector 91 is a different feature than the switch 53 described above and is arranged separately form switch 53. The end position detector 91 is configured such that the end position detector 91 changes from a first state to a second state in response to the relative movement between at least two parts. The end position detector 91 may be arranged on one of two parts or on both of the two parts that move relative to each other during the dispensing process. The two parts moving relative to each other during the dispensing process can be comprised by the data collection device 20, 120, 240 and/or the drug delivery device 1. The movement of the two parts can comprise a rotational and/or translational movement. With reference to the exemplary embodiment according to Figure 7, the end position detector 91 can be positioned at the first element 246, for example, in such a way that the end position detector 91 changes from the first state to the second state as soon as first element 246 and/or the dialing knob 12 comes into contact with the edge of the proximal opening, receiving the sleeve, at the proximal end region of the housing 10 of the drug delivery device 1 at the end of the delivery process. Alternatively the end position detector 91 can be positioned at the number sleeve 70 or dosage window 13, such that the end position detector changes from the first state to the second state as soon as the dosage window 13 visually indicates a zero position engraving or printing on the number sleeve 70. The end position detector 91 can, for example, be designed as a switch that interrupts the power supply of the sensor 51 or the signal transmission from the sensor 51 to the processor arrangement 50 after the end position detector has switched from the first to the second state.

Alternatively, the end position detector can also be implemented as a switch for detecting the zero position as described in the embodiments of US10,744,269 B2 or US11 ,357, 923 B2. Figure 6 shows an exemplary force time curve as it occurs, for example, from the start of the dose delivery process until the injection device is removed from the skin. The curve shown in Figure 6 is subdivided into the time range t1 of the actual delivery of the medication and a subsequent dwell time t2 in which the injection device is held on the skin for a few seconds after the actual delivery until, for example, the user is notified by an optical indicator to remove the injection device from the skin.

If the force applied by the user to the device fluctuates greatly during the actual delivery time t1 and/or the dwell time t2, this has a negative effect on the accuracy of the detected dose quantity based on the signals from the electronic measuring unit.

Since the user wants to ensure that the set dose has been completely delivered, the user may unnecessarily press the injection device 1 or the data collection device 20, 120, 240 again after the actual delivery process t1, i.e. during the dwell time t2. As can be seen in Figure 6, the force applied to the data collection device by the user increases significantly again after the actual dispensing process t1. Without the use of the monitoring unit, this renewed increase causes the data collection device to perform an incorrect measurement, which results in the data collection device outputting an incorrect value for the dose delivered. Similarly, a force value that drops too sharply (not shown in Figure 6) during the actual dose delivery can lead to incorrect measurements that are prevented by the use of the monitoring unit.

With reference to Figure 5 operation of the electronic system, i.e. the data collection device, 240 will now be described. First, a user dials a dose into the injection device 1. This movement may transfer the end position detector 91, which is optionally available, from the second state to the first state. The dose dialing is achieved by the user rotating the first portion 23 of the data collection device 240. The rotational force is communicated to the dosage knob 12, which rotates also. The second portion 24 also rotates along with the first portion when the dose is being dialed. During dialing, the electronics on the PCB 242 are not powered. Once the user has dialed the desired dose, they press the second portion 24 in order to start delivery of the dose, i.e. to cause injection. Initially, the second portion 24 deforms slightly and the center of the second portion 24 moves in the distal direction more than the periphery of the second portion 24, or put another way the center of the second portion 24 moves axially relative to the periphery of the second portion and axially relative to the first portion. This causes the pillar 245 to activate the switch 53. This causes the electronics on the PCB 242 to be powered and thus activated. Further movement of the second portion 24 is communicated into movement of the capsule 244 within the first portion 23. This is communicated to movement of the dose button 11 in the distal direction. Once the dose button 11 has moved enough to permit dose delivery (which occurs by causing disengagement of a clutch, not shown, within the injection device 1 ), the dosage knob 12 begins to rotate relative to the dose button 11 as the dose delivery button is moved in the distal direction by action of the user. In particular, the dose delivery button 11 does not rotate relative to the housing 10 of the injection device 1, but the dosage button and the number sleeve 70 move helically (i.e. they move axially and rotate simultaneously). The first portion 23 thus rotates relative to the second portion 24. When the user ceases to press on the second portion 24, or when all of the dose is delivered, rotation of the first portion 23 relative to the second portion 24 ceases. The amount of rotation that occurred indicates the delivered dose. The amount of rotation is detected by the sensor 51. The detected rotations are used to calculate the delivered dose. If the user presses the device again after the actual dispensing process in the dwell time t2 (see Figure 6) or if the applied force drops significantly during the actual dispensing process t1 (not shown in Figure 6), the electronic measuring unit may send an unnecessary additional measurement signal or may fail to send essential measurement signals. The amount of dose delivered, which is then stored in memory and/or displayed to the user as described below, may therefore be incorrect.

The measurement, storage or output of an incorrect value representing the dispensed quantity of drug is prevented by the electronic system being configured such that, in response to the occurrence of the predetermined situation detected by the monitoring unit, measurement signals generated by the measuring unit are not considered for determining the drug dose quantity or the electronic measuring unit is instructed to temporarily interrupt or to permanently terminate the generation of signals.

The monitoring unit is configured to monitor a value indicative of the force applied by the user to the data collection device. The occurrence of the predetermined situation can be characterized by the monitored value being greater than a predefined upper threshold value, e.g. before, during and/or after a dispensing process. The predefined upper threshold value can be greater than or equal to 15 Newton, for example 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 or 25 Newton. According to the example depicted in Figure 6 the predefined upper threshold value is 15 Newton. Additionally or alternatively, the occurrence of the predetermined situation can be characterized by the monitored value being less than a predefined lower threshold value. The predefined lower threshold value can be equal to or less than 5 Newton, such as 1 , 2, 3, 4 or 5 Newton. According to the example depicted in Figure 6 the predefined lower threshold value is 5 Newton. The electronic systems 20, 120, 240 can be configured such that the monitoring units monitor the force values detected by the force sensors 90 during the entire time span t1 and t2. As described above, the predetermined situation can comprise a single event or several events. As a prerequisite for the fulfillment or occurrence of the predetermined situation, in addition to the detection of a value that is outside the range of values between 5 and 15 Newton, it may be necessary that the value is detected before, after or during the occurrence of an additional event. For example, it may be necessary to detect the exceeding of the upper threshold value in the dwell time t2. Alternatively, it may be necessary to detect that the value falls below the lower threshold value before the start of the dwell time t2, e.g. during the actual dispensing process t1. With reference to the exemplary embodiment of Figure 6, the predetermined situation can be fulfilled if no falling below the lower threshold value is measured within the first 2 seconds and no exceeding of the upper threshold value is measured after the first 2 seconds have passed. It should be noted in this context that the time ranges of t1 and/or t2 according to the present invention can also be designed to be shorter or longer as depicted in Figure 6. Moreover, the upper and lower threshold values can also have values other than 15 and 5 Newton. The data collection devices or electronic systems shown in the figures may implement this, for example, by determining that the transition from time interval t1 to time interval t2 is considered complete as soon as the end position detector 91 changes from the first to the second state. The devices or systems shown in the figures can also have a monitoring timer, which starts or ends a time recording when the end position detector 91 switches from the first state to the second state.

Alternatively or additionally, the time recording can also start when the electronic measuring unit starts to generate the measurement signals suitable for determining the drug dose quantity.

The monitoring unit may have its own power source and processor, so that this power source and processor are present in the data collection device in addition to the processor arrangement 50 and the power source 54 as depicted in Figure 8.

The Figure 5 data collection device is absent of a display, although a display for displaying a delivered dose may instead be provided. Instead of the display, the Figure 5 data collection device includes an optical indicator arrangement. For instance, the optical indicator arrangement may be one or two light sources, such as light emitting diodes (not shown). The optical indicator arrangement may be provided axially or peripherally on the proximal end face of the second portion 24, or on the circumference of the second portion 24 or the first portion 23, for instance.

The optical indicator arrangement is configured to provide feedback regarding the dwell period. When the injection finishes, which is detected by detecting the ceasing of rotation between the first and second portions 23, 24, the ceasing of operation of the switch 53, or the change of the end position detector 91 from the first to the second state, the optical indicator arrangement of the data collection device indicates that a dwell time period is in place. For instance, the optical indicator arrangement starts blinking, that is being activated intermittently. The frequency of blinking can change over the dwell period. For instance, at the start of the dwell period the frequency may be about 5Hz and at the end of the period the frequency may be about 1 Hz. When the dwell period is finished, the optical indicator arrangement may remain illuminated, to indicate the end of the sequence and the end of the dwell period.

The duration of the dwell period depends on the type of medicament. The type of medicament or the dwell time may be communication to the data collection device, for instance from a mobile phone running an application that is configured to operate in conjunction with the data collection device.

The optical indicator arrangement is configured to provide feedback regarding a medicament dose having already been taken recently. When the user presses the second portion 24 of the data collection device, the data collection device checks when the last dose was delivered. The user may press the second portion 24 of the data collection device in order to initiate delivery of medicament or specifically to request information about the time since the last dose delivery. The data collection device determines if the dose already taken notification is to be provided by observation of the switch 53, a current time and a time of the last dose delivery. If it is determined that no significant dose (e.g. larger than 2 units) was delivered in a certain time period, for instance the previous hour, the optical indicator arrangement indicates that delivery of medicament is permitted. For instance, the optical indicator arrangement may glow green for one second. If instead it is determined that a significant dose was delivered within the certain time period, the optical indicator arrangement may glow or flash an alert, for instance red in color.

The optical indicator arrangement is configured to provide feedback regarding end of life of the data collection device. When an error or another unsolvable issue as an empty battery is detected, the data collection device indicates this, for instance by operating the optical indicator arrangement to blinking in red for at least several hours.

Once the user removes the distally directed force from the second portion, spring force from within the injection device causes the dose button 11 to return the capsule 244 and the second portion 24 to the original position.

Figures 7a to 7e are different views of a second alternative data collection device 120, which is a variation of the data collection device 20. In these Figures, reference numerals are retained from Figures 2 and 5 for like elements. Unless otherwise stated or unless impossible, features of the Figures 2 and 5 data collection devices are present in the Figures 7 data collection devices. Also, features of any one device are present in all of the other devices unless otherwise stated.

The Figures 7 data collection devices have a common characteristic that the second portion 24 has a larger user-contactable external surface area than does the first portion 23.

The shape of the second element 247 of the first portion 23, which serves to guide the data collection device to correct axial alignment using the dose button 11, is clearly visible in Figures 7a and 7e. The dose button 11 is shown in a depressed state in Figure 7a so is not shown engaging the second element 247 of the first portion 23 in this Figure. Second element 247 is shaped such that it at least partly fits around a dose button of the injection device when the data collection device is coupled to the injection device.

In the Figure 7 data collection device 120, the second portion 24 is relatively large. Within the second portion 24, a spring 121 biases two power source (e.g. batteries) 54 against the distal face of the PCB 242. A conductor 122 forms an electrical circuit between the proximal face of the proximal power source 54 and the PCB 242. The switch 53 is formed on the proximal face of the PCB 242. The switch 53 may include a spring terminal, as shown in the Figure. The spring terminal is moved, thereby to operate the switch 53, upon movement of the second portion 24 in the distal direction relative to the first portion 23. A force required to operate the switch 53 is lower than the force required to cause medicament delivery from the injection device 1. By using operation of the switch 53 to trigger powering of components of the data collection device, the components of the data collection device will thus be powered before dose delivery commences. For instance, the force required to operate the switch 53 may be about 2 Newton, or more generally between 1 and 5 Newton.

A first collar 124 is directed in a distal direction from the distal end of the capsule 244. A second collar 125 extends distally from the distal end of the capsule 244. The second collar 125 is outside of the first collar 124, and they are concentric.

The second collar 125 and the second portion 24 have interoperating features that limit axial movement of the components relative to each other. In particular, one or more protrusions 228 fit into one or more indents 229. The movement of the second portion 24 relative to the capsule 244 is limited by the ends of the one or more indents 229 as regards the one or more protrusions 228. In this example, the protrusions 228 are provided on the second collar 125, and thus the capsule 244, and the indents 229 are provided on the second portion 24, but alternative arrangements will be envisaged by the skilled person.

The first collar 124 snugly fits the dose button 11 , to assist in axial alignment between the data collection device 120 and the injection device 1 during delivery. A washer (not shown) may be provided between the first collar 124 and the dose button 11 , to improve contact between the components. The first collar 124 does not contact the first portion 23 during installation of the data collection device 120 nor during dose delivery.

The first portion 23 is provided with grip features 123. These allow a user to grip the first portion so as to provide torque and thus rotate the first portion when setting a dose. The grip features 123 provide surfaces that extend generally radially, to which the user can provide force to cause rotation of the first portion 23.

As can be seen best from Figure 7e, the first portion 23 is coupled to the second portion 24 by a connector arrangement 230, 231, 228. In particular, the first portion 23 includes a first L section component 231, which has an abutting surface facing in the distal direction. This is formed as part of the first portion 23. A second L section component 230, forming part of the second portion 24, is coupled to a support 232, which is coupled to the PCB 242, the first collar 124 and other components of the second portion 24. The second L section component 230 has an abutting surface facing in the proximal direction. The second L section component 230, and the other components that are coupled to it, are attached to the first section 23 during manufacture by application of a force to cause a snap fit such that the abutting surfaces of the first and second L section components 231 , 230 are located together. The snap fitting of the second L section component 230 over the first L section component 231 is facilitated by a sloping face of the first L section component 231, which faces slightly in the proximal direction.

After the power source 54 has been included within the second section 24, the main body 234 of the second portion, with the third L section component 228 already fitted, is snap fitted over the second L section component 230. The snap fitting is facilitated by a sloping face of the third L section component 228, which faces slightly in the distal direction. A proximally facing abutting surface of the third L section component then abuts a distally facing abutting surface of the second L section component 228. This arrangement keeps the spring 121 in compression, thereby ensuring good electrical connection of the power source 54. It also allows for a simple manufacturing process and the use of low cost components.

Once the first portion 23 is fitted to the second portion 24, the two portions rotate relative to one another by a low friction contact between surfaces of the first and second L section components 230, 231. The low friction contact may be provided by suitable coating of the relevant surfaces, or by suitable material choice of the components themselves.

During installation of the data collection device 120 on the injection device 1 , force is applied in an axial direction. During installation, the user is likely to apply force to the second portion 24. In this case, the force is communicated to the first portion, to result in fitting of the first portion 23 over the dosage knob 12, by the distal end of the third L section component 228, or more generally the main body 234, against a proximally facing surface 235 of the first portion 23. A spring force provided by the data collection device 120 forces the second portion 24 in the proximal direction relative to the first portion 23, after installation. This spring force is greater than a reaction force that is provided by the injection device 1 during dose delivery (the reaction force results primarily from friction from movement of internal components and hydrodynamic force resulting from medicament expulsion through the needle). Thus, the distal end of the third L section component 228, or more generally the main body 234, does not contact the proximally facing surface 235 of the first portion 23 during dose delivery. If they were to be in contact during dose delivery, a friction force would oppose rotational movement between the first portion 23 and the second portion 24.

In addition, the data collection device shown in Figure 7 comprises the electronic measuring unit and the monitoring unit described above. Furthermore, the data collection device can comprise the end position detector 91. With reference to the exemplary embodiment according to Figure 7, the force sensor 90 can be positioned, for example, between the injection button 11 and a support 232, which is coupled to the PCB 242. The end position detector 91 can be positioned at the distal end surface of the first portion 23, for example, in such a way that the end position detector 91 changes from the first state to the second state as soon as distal surface of the first portion 23 and/or the dialing knob 12 comes into contact with the edge of the proximal opening, receiving the sleeve, at the proximal end region of the housing 10 of the drug delivery device 1 at the end of the delivery process. The Figure 7 data collection device 220 is absent of a display, although a display for displaying a delivered dose may instead be provided. Operation of the data collection device 220 of Figure 7 will now be described.

First, a user dials a dose into the injection device 1. This is achieved by the user rotating the first portion 23 of the data collection device 220. The rotational force is communicated to the dosage knob 12, which rotates also. The second portion 24 also rotates along with the first portion when the dose is being dialed. During dialing, the electronics on the PCB 242 are not powered. Once the user has dialed the desired dose, they press the second portion 24 in order to start delivery of the dose, i.e. to cause injection. Initially, the second portion 24 moves in the distal direction from one end to the other end of the distance permitted by interoperation of the one or more protrusions 228 and the one or more indents 229. At or close to the limit of travel, the location of the second portion 24 activates the switch 53. This causes the electronics on the PCB 242 to be powered and thus activated. Further movement of the second portion 24 is communicated into movement of the capsule 244 in the distal direction. This is communicated to movement of the dose button 11 in the distal direction. Once the dose 25 button 11 has moved enough to commence dose delivery, the dosage knob 12 begins to rotate relative to the rest of the injection device 1, including the dose button 11. The first portion 23 thus rotates relative to the second portion 24. When the user ceases to press on the second portion 24, or when all of the dose is delivered, rotation of the first portion 23 relative to the second portion 24 ceases. The amount of rotation that occurred indicates the delivered dose. The amount of rotation is detected by the sensor 51. The detected amount of rotation is used to calculate the delivered dose, wherein the electronic system, using the electronic measuring unit and the monitoring unit, prevents the output of an incorrect value or quantity as described above with respect to Figures 5 and 6 if necessary. The delivered dose may then be displayed on the display 22a.

Once the user removes the distally directed force from the second portion, spring force from within the injection device causes the dose button 11 to return the capsule 244 and the second portion 24 to the original position. Because the first portion 23 is relatively small and because no part of the first portion is near to the proximal face of the second portion 24, the user is easily able to avoid contacting the first portion 23 when using the second portion 24 to cause dose delivery. This is the same regardless of whether the user uses their thumb or their index finger to manipulate the second portion 24.

Additionally, the electronic system 20, 120, 240 according to figures 1 to 9 can comprise a monitoring timer which is configured to record the time from the beginning of the generation of measurement signals by the electronic measuring unit. The monitoring timer can be used in addition to the timer 55 present in the electronic system or be comprised by it.

Figure 8 is a block diagram of the data collection device 20, 120, 240. The data collection device 20 includes the processor arrangement 50 including one or more processors, such as a microprocessor, a Digital Signal Processor (DSP), Application Specific Integrated Circuit (ASIC), Field Programmable Gate Array (FPGA) or the like, together with memory units 52a, 52b, including program memory 52a and main memory 52b, which can store software for execution by the processor arrangement 50 and data generated during use of the data collection device such as counted pulses, derived dose size, time stamp, etc.. The switch 53 connects the power source 54 to the electronic components of the device, including the sensor arrangement 51, when operated. The display 22a may or may not be present. The electronic measuring unit configured to generate measurement signals, suitable for determining a drug dose quantity of the drug dose delivered during the operation of the drug delivery device performed by the user of the drug delivery device based on the generated signals, may comprise, inter alia, the processor arrangement 50, the sensor arrangement 51, and the power source 54. The monitoring unit or components thereof are not explicitly shown in Figure 8, but can be arranged in connection with processor arrangement 50.

The first and second electrical contacts 30, 31 may provide a data connection between the processor arrangement 50 and display 22a when engaged. The sensor arrangement 51 , comprising one or more sensors, is provided for detecting rotational movement between the first portion 23 and the second portion 24. The resolution of the sensing arrangement 51 is determined by the design of the injection device 1. A suitable angular resolution of the sensing arrangement 51 may be determined by Equation (1):

, . 360“ resolution = - (1 > units > per > rotation

For instance, if one full rotation of the dosage knob 12 corresponds to a medicament dosage amount of 24 III, then a suitable resolution for the sensing arrangement 51 would be not more than 15°.

In the Figure 2 embodiment, one or more first magnets 56a are provided around a circumference of the inner surface of the first portion 23 and one or more second magnets 56b are provided around a circumference of the outer surface of the second portion 24, as shown in Figures 3 and 8. The sensor arrangement 51 is a transducer that varies its output due to variations in the magnetic field, based on the Hall effect, as the first portion 23 and first magnets 56a rotate relative to the second portion 24 and second magnets 56b.

Since the first portion 23 rotates with the dosage knob 12 as medicament is expelled from the injection device 1 , the angle of rotation measured by the sensing arrangement 51 is proportional to the amount of medicament expelled. It is not necessary to determine a zero level or an absolute amount of medicament contained in the injection device 1. Moreover, since it is not necessary to monitor the numbers or tick marks on the number sleeve 70 displayed through the dosage window 13, the data collection device 20 may be designed so that it does not obscure the dosage window 13. The medicament amount delivered is determined by the data collection device 20 independent from the dosage that is programmed into the injection device 1. Determining the delivered medicament amount provides a direct and thus more reliable information about the amount of medicament that is injected compared to data collection devices that determine the amount of medicament that is set, thus being intended to be dispensed. It is also possible to detect an incorrectly measured medicament amount independent from the dosage that is programmed into the injection device 1.

However, in other embodiments, different types of sensor may be used. For example, instead of a transducer, the sensor arrangement may include a microelectromechanical (MEMS) device or other magnetic sensor for detecting changes in a magnetic field. Another example of an sensing arrangement is an optical encoder, including a light source, such as a light emitting diode (LED) and a light detector, such as an optical transducer, that monitors changes in light reflected from an inner surface of the first portion, where the inner surface first portion has one or regions of varying reflectivity around its circumference, such as tick marks or at least one shaped reflective region. Such a sensor arrangement is used in the second to fourth variations described above.

In other embodiments, the sensing arrangement 51 may be a potentiometer. In yet another embodiments, a capacitive sensing arrangement may be used, where elements provided on the first portion 23 affect the capacitance between two plates in the sensing arrangement. In further examples, mechanical sensors, with mechanical switches and/or tracks, may be used to detect the relative rotation between the first and second portions 23, 25. While the embodiments described in detail includes only certain types of sensor in the sensor arrangement 51 , other embodiments may be devised in which the sensor arrangement 26 includes multiple sensors of one or more types.

An output 57 is provided, which may be a wireless communications interface for communicating with another device via a wireless network such as Wi-Fi or Bluetooth®, or an interface for a wired communications link, such as a socket for receiving a Universal Series Bus (USB), mini-USB or micro-USB connector.

Figure 9 depicts an example of a system in which the data collection device 20 is connected to another device, such as a personal computer 60, via a wired connection 61 for data transfer.

For example, the processor arrangement 50 may store determined delivered medicament amounts and time stamps for the injections as they are administered by the user and subsequently, transfer that stored data to the computer 60. The computer 60 maintains a treatment log and/or forwards treatment history information to a remote location, for instance, for review by a medical professional.

According to this embodiment, the data collection device 20 is configured to store data such as delivered medicament amounts and time stamps of up to 35 injection events, According to a once-daily injection therapy this would be sufficient to store a treatment history of about one month. Data storage is organized in a first-in first-out manner ensuring that most recent injection events are always present in the memory of the data collection device 20. Once transferred to a computer 60 the injection event history in the data collection device 20 will be deleted. Alternatively, the data remains in the data collection device 20 and the oldest data is deleted automatically once new data is stored. This way the log in the data collection device is built up over time during usage and will always comprise the most recent injection events. Alternatively, other configuration could comprise a storage capacity of 70 (twice daily), 100 (three months) or any other suitable number of injection events depending on the therapy requirements and/or the preferences of the user.

In another embodiment, the output 57 may be configured to transmit information using a wireless communications link and/or the processor arrangement 23 may be configured to transmit such information to the computer 60 periodically.

The power source 54 may be a battery. In some embodiments, the endplate 22 may include a solar panel to recharge a rechargeable battery. The power source may be a coin cell, or multiple coin cells arranged in series or parallel. In another embodiment, the power source 54 may be a piezo-electric generator, which generates power when the endplate 22 is pressed by the user, potentially avoiding the need for a battery.

A timer 55 is also provided. In addition to, or instead of, switching the data collection device 20 on and off, the switch 53 or the first and second electrical contacts 30, 31 may be arranged to trigger the timer 55 when engaged and/or disengaged. For example, if the timer 55 is triggered on both engagement or disengagement of the first and second electrical contacts 30, 31 , or both operation and ceasing of operation of the switch 53, then the processor arrangement 50 may use the output from the timer to determine a length of time during which the injection button 11 was pressed, for example to determine the duration of an injection.

Alternatively, or additionally, the processor arrangement 50 may use the timer 55 to monitor a length of time that has elapsed since an injection was completed, as indicated by a time of disengagement of the first and second electrical contacts 30, 31 or ceasing of operation of the switch 53. Optionally, the elapsed time may be shown on the display 22a, as depicted in Figure 2. Also optionally, when the first and second contacts 30, 31 are next engaged or when the switch 53 is next operated, the processor arrangement 50 may compare the elapsed time with a predetermined threshold, to determine whether a user may be attempting to administer another injection too soon after a previous injection and, if so, generate an alert such as an audible signal and/or a warning message on the display 22a. On the other hand, if the elapsed time is very short, it may indicate that the user is administering a medicament amount as a "split dose", and the processor arrangement 50 may store information indicating that a dosage was delivered in that manner. In such a scenario the elapsed time is compared with a predetermined threshold in the range of a few seconds, e.g. 10 seconds up to a few minutes, e.g. 5 minutes. According to an example the predetermined threshold is set to 2 minutes. If the time elapsed since the last injection is two minutes or less, the processor arrangement 50 stores information indicating that the dosage was delivered as a "split dose". Another optional purpose for monitoring the elapsed time by the processor arrangement 50 is to determine when the elapsed time has passed a predetermined threshold, suggesting that the user might have forgotten to administer another injection and, if so, generate an alert.

The specific embodiments described in detail above are intended merely as examples of how the present invention may be implemented. Many variations in the configuration of the data collection device 20, 120, 240 and/or the injection device 1, may be conceived. Some such variations will now be described.

The switch 53 in the Figure 2 embodiment is formed of electrical contacts, and in the first to fourth variations of a switch. The switch may for instance be a lever switch, a dome switch, a slider switch, a rubber keypad switch. It may be a capacitive touch switch or a resistive touch switch. It may be a tactile micro switch. The switch 53 may be generally referred to as a microswitch. The first portion 23 may facilitate gripping by the user through radial features, as shown in Figure 7. Alternatively, the peripheral surface of the first portion 23 may be roughened, or provided with an adhesive or tactile coating, be made of or coated with a high friction material, or have some other gripable features.

In other embodiments, a spring element is coupled to a center of the distal end of the capsule 242 at a center, proximal portion and is coupled to the first portion 23 at a distal, peripheral portion. A feature, for instance a depression, is provided on the capsule 244 to receive the center part of the spring element. When the second portion 24 is not being pressed in the distal direction, the spring element may not contact the dose button 11. When the second portion 24 is being pressed in the distal direction, the spring element compresses and communicates the force to the dose button 11. This arrangement can provide a low-friction rotation center for rotation of the first portion 23 relative to the second portion 24, along with guidance for the location of the capsule 244. It can also provide good axial tolerance compensation. Furthermore, by choosing a spring that does not compress significantly upon application of a force that is sufficient to operate the switch 53, this can provide good serial activation of the switch prior to activation of the dose delivery mechanism of the injection device 1.

Also, while the embodiments above have been described in relation to collecting data from an insulin injector pen, it is noted that embodiments of the invention may be used for other purposes, such as monitoring of injections of other medicaments.

The injection device 1 is configured to inject or infuse a medicament into a patient. For example, delivery could be sub-cutaneous, intra-muscular, or intravenous. Delivery could be needleless. The injection device 1 could be operated by a patient or care-giver, such as a nurse or physician, and may be one of various types of safety syringe, pen-injector, or auto-injector. The injection device 1 can include a cartridge-based system that requires piercing a sealed ampule before use. Volumes of medicament delivered with these various devices can range from about 0.5 ml to about 2 mi. The injection device 1 may be a large volume device ("LVD") or patch pump, configured to adhere to a patient's skin for a period of time (e.g., about 5, 15, 30, 60, or 120 minutes) to deliver a "large" volume of medicament (typically about 2 ml to about 10 ml). In combination with a specific medicament, the injection device 1 may also be customized in order to operate within required specifications. For example, the injection device 1 may be customized to inject a medicament within a certain time period (e.g., about 3 to about 20 seconds for autoinjectors, and about 10 minutes to about 60 minutes for an LVD). Other specifications can include a low or minimal level of discomfort, or to certain conditions related to human factors, shelf-life, expiry, biocompatibility, environmental considerations, etc. Such variations can arise due to various factors, such as, for example, a drug ranging in viscosity from about 3 cP to about 50 cP. Consequently, the injection device 1 may include a hollow needle ranging from about 25 to about 31 Gauge in size. Common sizes are 27 and 29 Gauge.

The injection device 1 can also include one or more automated functions. For example, one or more of needle insertion, medicament injection, and needle retraction can be automated. Energy for one or more automation steps can be provided by one or more energy sources. Energy sources can include, for example, mechanical, pneumatic, chemical, or electrical energy. For example, mechanical energy sources can include springs, levers, elastomers, or other mechanical mechanisms to store or release energy. One or more energy sources can be combined into a single device. Devices can further include gears, valves, or other mechanisms to convert energy into movement of one or more components of a device.

The one or more automated functions of such an injection device 1 may each be activated via an activation mechanism. Such an activation mechanism can include one or more of a button, a lever, a needle sleeve, or other activation component. Activation of an automated function may be a one-step or multi-step process. That is, a user may need to activate one or more activation components in order to cause the automated function. For example, in a one-step process, a user may depress a needle sleeve against their body in order to allow injection of a medicament to be provided. The injection device 1 may require a multi-step activation of an automated function. For example, a user may be required to depress a button and retract a needle shield in order to cause injection.

In addition, activation of one automated function may activate one or more subsequent automated functions, thereby forming an activation sequence. For example, activation of a first automated function may activate at least two of needle insertion, medicament injection, and needle retraction. The injection device 1 may also require a specific sequence of steps to cause the one or more automated functions to occur. The injection device 1 may operate with a sequence of independent steps.

The injection device 1 can include one or more functions of a safety syringe, pen-injector, or auto-injector. For example, the injection device 1 may include a mechanical energy source configured to automatically inject a medicament (as typically found in an auto- injector) and a dose setting mechanism (as typically found in a pen-injector).

The injection device 1 may be disposable or it may be reusable. The injection device 1 may provide a fixed dose or a user-settable dose.

The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders. As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., shorter long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dualchamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and/or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and/or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition. Examples of APIs for the treatment and/or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and/or exchanging at least one amino acid residue occurring in the naturally occurring peptide and/or by adding at least one amino acid residue. The added and/or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and/or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega- carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(w- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin. Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC- 1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1 , ZYD-1, GSK-2374697, DA-3091 , MAR-701 , MAR709, ZP- 2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA- 15864, ARI-2651 , ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide- XTEN and Glucagon-Xten.

An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.

Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and/or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and/or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and immunoglobulin single variable domains. Additional examples of antigen-binding antibody fragments are known in the art.

The term “immunoglobulin single variable domain” (ISV), interchangeably used with “single variable domain”, defines immunoglobulin molecules wherein the antigen binding site is present on, and formed by, a single immunoglobulin domain. As such, immunoglobulin single variable domains are capable of specifically binding to an epitope of the antigen without pairing with an additional immunoglobulin variable domain. The binding site of an immunoglobulin single variable domain is formed by a single heavy chain variable domain (VH domain or VHH domain) or a single light chain variable domain (VL domain). Hence, the antigen binding site of an immunoglobulin single variable domain is formed by no more than three CDRs.

An immunoglobulin single variable domain (ISV) can be a heavy chain ISV, such as a VH (derived from a conventional four-chain antibody), or VHH (derived from a heavy-chain antibody), including a camelized VH or humanized VHH. For example, the immunoglobulin single variable domain may be a (single) domain antibody, a "dAb" or dAb or a Nanobody® ISV (such as a VHH, including a humanized VHH or camelized VH) or a suitable fragment thereof. [Note: Nanobody® is a registered trademark of Ablynx N.V.]; other single variable domains, or any suitable fragment of any one thereof.

“VHH domains”, also known as VHHs, VHH antibody fragments, and VHH antibodies, have originally been described as the antigen binding immunoglobulin variable domain of “heavy chain antibodies” (i.e. , of “antibodies devoid of light chains”; Hamers-Casterman et al. 1993 (Nature 363: 446-448). The term “VHH domain” has been chosen in order to distinguish these variable domains from the heavy chain variable domains that are present in conventional 4- chain antibodies (which are referred to herein as “VH domains”) and from the light chain variable domains that are present in conventional 4-chain antibodies (which are referred to herein as “VL domains”). For a further description of VHH’s, reference is made to the review article by Muyldermans 2001 (Reviews in Molecular Biotechnology 74: 277-302).

For the term “dAb’s” and “domain antibody”, reference is for example made to Ward et al. 1989 (Nature 341: 544), to Holt et al. 2003 (Trends Biotechnol. 21: 484); as well as to WO 2004/068820, WO 2006/030220, WO 2006/003388. It should also be noted that, although less preferred in the context of the present invention because they are not of mammalian origin, single variable domains can be derived from certain species of shark (for example, the so-called “IgNAR domains”, see for example WO 2005/18629).

The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

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

Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts. Those of skill in the art will understand that modifications (additions and/or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).

As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

Although embodiments of the present disclosure and their advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made therein without departing from the spirit and scope of the disclosure as defined by the appended claims. For example, it will be readily understood by those skilled in the art that many of the features, functions, processes and methods described herein may be varied while remaining within the scope of the present disclosure. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the system, process, manufacture, method or steps described in the present disclosure. As one of ordinary skill in the art will readily appreciate from the disclosure of the present disclosure, systems, processes, manufacture, methods or steps presently existing or to be developed later that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present disclosure. Accordingly, the appended claims are intended to include within their scope such systems, processes, methods or steps. The embodiments mentioned in the first part of the description may be combined with each other. The embodiments of the description of figures may also be combined with each other. Further, it is possible to combine embodiments mentioned in the first part of the description with examples of the second part of the description which relates to Figures 1 to 9.

Reference numerals

1 drug delivery device I injection device

10 housing

11 injection button

12 dosage knob

13 dosage window

14 container

15 needle

16 inner needle cap

17 outer needle cap

18 alternative cap

19a, 19b, 19c formations

20 data collection device

21 housing

22 endplate

22 display

23 first portion

24 second portion

26 outer portion

27 inner portion

28 fixture

29 spring

30 first electrical contacts

31 second electrical contacts

35 distal end

44 rubber pad I resilient padding

50 processor arrangement

51 sensor arrangement

52b program memory

52a main memory

53 switch

54 power source

55 timer

56a first magnets

56b second magnets

57 output 60 personal computer

61 wired connection

70 number sleeve

71a, 71b, 71c formations

90 force sensor

91 end position detector

121 spring

122 conductor

123 grip features

124 first collar

125 second collar

228 protrusions fit

229 indents

230 second L section component

231 fist L section component

232 support

234 main body

242 printed circuit board (PCB)

243 communications interface

244 capsule

245 pillar

246 first element

247 second element

248 third element

Claims

PAT24072-WO-PCT Claims

1. Electronic system (20, 120, 240) for a drug delivery device (1), the electronic system comprising: an electronic measuring unit configured to generate measurement signals, wherein the generated measurement signals are suitable for determining a drug dose quantity of a drug dose based on the generated measurement signals, wherein the drug dose is delivered during the operation of the drug delivery device performed by a user of the drug delivery device, a monitoring unit configured to monitor the operation of the drug delivery device by the user regarding the occurrence of a predetermined situation during the operation, wherein the electronic system is configured such that, in response to the occurrence of the predetermined situation, measurement signals generated by the measuring unit are not considered for determining the drug dose quantity or the measuring unit is instructed to temporarily interrupt or to permanently terminate the generation of measurement signals.

2. Electronic system (20, 120, 240) according to claim 1 , wherein the monitoring unit comprises a sensor structure (90), wherein the sensor structure is configured such that the sensor structure detects forces applied to the electronic system and/or drug delivery device (1) during operation of the drug delivery device by the user to deliver the drug dose, and wherein the sensor structure comprises a sensor along the flow of force in the electronic system and/or drug delivery device generated by the user during the dose delivery operation on the electronic system and/or the drug delivery device.

3. Electronic system (20, 120, 240) according to any one of the preceding claims, wherein the monitoring unit is configured to monitor a value indicative of the force applied by the user to the electronic system and/or the drug delivery device (1) during operation of the drug delivery device, and wherein the occurrence of the predetermined situation is characterized by the monitored value being greater than a predefined upper threshold value, and/or wherein the monitoring unit is configured to monitor a value indicative of the force applied by the user to the electronic system and/or the drug delivery device (1) during operation of the drug delivery device, and wherein the occurrence of the predetermined situation is characterized by the monitored value being less than a predefined lower threshold value.

4. Electronic system (20, 120, 240) according to claim 3, wherein the occurrence of the predetermined situation is characterized by the monitored value being greater than the predefined upper threshold value and by the monitored value being less than the predefined lower threshold value.

5. Electronic system (20, 120, 240) according to any one of claims 3 to 4, wherein the monitoring unit comprises an end position detector (91), configured to detect an end position of a movable dosing element or dose delivery element of the electronic system and/or the drug delivery device (1) after the delivery process, wherein the end position detector is configured such that the end position detector changes from a first state to a second state in response to a relative movement between at least two components comprised by the electronic system and/or the drug delivery device, and wherein the predetermined situation is characterized by the change from the first state to the second state.

6. Electronic system (20, 120, 240) according to claim 5, wherein the predetermined situation is characterized by the monitored value being greater than the predefined upper threshold value after the end position detector (91) has changed from the first state to the second state.

7. Electronic system (20, 120, 240) according to claim 5, wherein the predetermined situation is characterized by the monitored value being less than the predefined lower threshold value before the end position detector (91) has changed from the first state to the second state.

8. Electronic system (20, 120, 240) according to claim 5, wherein the predetermined situation is characterized by the monitored value being greater than the predefined upper threshold value after the end position detector (91) has changed from the first state to the second state and by the monitored value being less than the predefined lower threshold value before the end position detector has changed from the first state to the second state.

9. Electronic system (20, 120, 240) according to any one of the preceding claims, wherein the monitoring unit is configured to monitor the operation of the electronic system and/or the drug delivery device (1) by the user regarding the occurrence of a predetermined situation when the electronic measuring unit is in a state configured to generates measurement signals.

10. Electronic system (20, 120, 240) according to any one of the preceding claims, wherein the electronic measuring unit comprises a sensor arrangement (51) configured to detect a movement of two parts of the electronic system and/or drug delivery device (1), that are movable relative to each other during the dispensing process of the drug delivery device, and wherein the electronic measuring unit is configured to generate the measurement signals based on the detected movement.

11. Add-on device (20, 120, 240) suitable for attachment to a drug delivery device, wherein the add-on device comprises the electronic system according to any one of the preceding claims.

12. Drug delivery device (1) comprising the electronic system (20, 120, 240) according to any one of the claims 1 to 10, wherein the drug delivery device is a hand-held pen-type injection device with a manual dose setting function.

13. Method for monitoring dose delivery of a drug delivery device (1), comprising the following steps:

- monitoring the operation of the drug delivery device regarding the occurrence of a predetermined situation while a user applies force to the drug delivery device to deliver the drug dose, and

- in response to the occurrence of the predetermined situation, a) not considering measurement signals generated by a measuring unit, suitable for providing measurement signals through which the dose quantity delivered can be determined, or b) instructing the measuring unit to temporarily interrupt or to permanently terminate the generation of measurement signals.

14. Computer program product, e.g. a computer program or a computer readable storage medium, comprising instruction which when carried out by a processor cause the electronic system (20, 120, 240) according to any one of the claims 1 to 10 to perform the method according to claim 13.

15. Electronic system (20, 120, 240) for a drug delivery device (1), the electronic system comprising: an electronic measuring unit configured to generate measurement signals, wherein the generated measurement signals are suitable for determining a drug dose quantity of a drug dose based on the generated measurement signals, wherein the drug dose is delivered during the operation of the drug delivery device performed by a user of the drug delivery device, a monitoring unit configured to monitor the operation of the drug delivery device by the user regarding the occurrence of a predetermined situation during the operation, wherein the predetermined situation is characterized by more than one predetermined events occurring during the operation of the drug delivery device by the user, wherein the electronic system is configured such that, in response to the occurrence of the predetermined situation, measurement signals generated by the measuring unit are not considered for determining the drug dose quantity or the measuring unit is instructed to temporarily interrupt or to permanently terminate the generation of measurement.