Data collection device attached to the injection device

Abstract

The present invention relates to a data collection device attached to an injection device, and in particular, provides a data collection device, which includes an attachment assembly for attaching the data collection device to a dose setting dial of a drug administration device; a light source, which is configured to illuminate a portion of a surface of an internal component of the drug administration device, including a pattern of relatively reflective and non-reflective areas formed on the surface of the internal component; and an optical sensor, which is configured to receive light reflected by at least the relatively reflective area. The present invention also provides a system, which includes the data collection device and the drug administration device.

Description

[0001] This application is a divisional application based on an invention patent application with application date of September 8, 2017, application number 201780067362.4 (international application number PCT / EP2017 / 072618) and name “Data collection device attached to an injection device”. Technical Field

[0002] The present disclosure relates to a data collection device for attaching to and collecting medicament dosage information from an injection device. Background Art

[0003] There are multiple diseases that need to be treated conventionally by injecting medicaments. The injection can be carried out by using an injection device, which is applied by medical staff or by the patient himself. As an example, type 1 and type 2 diabetes can be treated by the patient himself by injecting insulin dosage, for example, injecting once or multiple times a day. For example, a pre-filled disposable insulin pen can be used as an injection device. Alternatively, a reusable pen can be used. The reusable pen allows the replacement of an empty cartridge with a new cartridge. Any pen can have a set of one-way needles, which are replaced before each use. The insulin dosage to be injected can then be manually selected, for example, on the insulin pen by turning the dosage knob and observing the actual dosage from the dosage window or display of the insulin pen. The dosage is then injected by inserting a needle into a suitable skin part and depressing the dosage knob or injection button of the insulin pen. In order to monitor insulin injection, for example, in order to prevent the false treatment of the insulin pen or in order to track the dosage applied, it may be necessary to measure the information related to the condition and / or use of the injection device, for example, information about the injected insulin dosage. Summary of the invention

[0004] A first aspect provides a data collection device, comprising:

[0005] an attachment assembly for attaching the data collection device to a dose setting dial of a medication administration device;

[0006] a light source configured to illuminate a portion of a surface of an interior component of the medication delivery device, including a pattern of relatively reflective and non-reflective areas formed on the surface of the interior component; and

[0007] An optical sensor is configured to receive light reflected from at least the reflective region.

[0008] A second aspect provides a system comprising:

[0009] A drug administration device, comprising:

[0010] a dose setting dial; and

[0011] an inner component that rotates about a longitudinal axis of the device when a dose of medicament is delivered from the device, wherein the inner component includes a pattern of relatively reflective and non-reflective areas formed on a surface thereof, and

[0012] A data collection device according to the first aspect.

[0013] A third aspect provides a system comprising:

[0014] A drug administration device, comprising:

[0015] a dose setting dial; and

[0016] an inner component that rotates about a longitudinal axis of the device when a dose of medicament is delivered from the device, wherein the inner component includes a pattern of relatively reflective and non-reflective areas formed on a surface thereof, and

[0017] A data collection device comprising:

[0018] an attachment assembly for attaching the data collection device to the dose setting dial;

[0019] a light source configured to illuminate a portion of a surface of an interior component including a pattern of relatively reflective and non-reflective areas; and

[0020] An optical sensor is configured to receive light reflected from at least the reflective region.

[0021] The light source and the optical sensor may be supported on a side of the data collection device that abuts a dose setting dial of the drug delivery device. The attachment assembly may be configured to releasably attach the data collection device to the dose setting dial of the medication administration device such that the dose setting dial of the medication administration device is disposed in a light path between the light source, a portion of the surface of the internal component, and the optical sensor.

[0022] When the data collection device is attached to the dose setting dial, the light source and the optical sensor may be positioned close to the dose setting dial so that the light path between the light source, the internal component and the optical sensor passes through the proximal surface of the dose setting dial. Alternatively, when the data collection device is attached to the dose setting dial, the light source and the optical sensor may be positioned between the attachment assembly and the dose setting dial so that the light path between the light source, the internal component and the optical sensor passes through the side surface of the dose setting dial.

[0023] The dose setting dial of the medication administration device may be at least partially transparent to the electromagnetic radiation emitted by the light source.The electromagnetic radiation may be infrared light.

[0024] The data collection device of the first or second aspect may include an electronic assembly including a light source and an optical sensor. The electronic assembly may be configured to move longitudinally relative to the attachment assembly. The dose setting dial of the medicament administration device may further include a dose delivery button. The electronic assembly may be configured to abut the dose delivery button when the data collection device is attached to the dose setting dial, and cause the dose delivery button to be pressed when the electronic assembly moves longitudinally in a distal direction relative to the attachment assembly.

[0025] When the data collection device is attached to the dose setting dial, the light source and optical sensor may be positioned proximate to the dose delivery button such that the light path between the light source, internal components and optical sensor passes through the dose delivery button.The light source and optical sensor may be positioned on the underside of the electronics assembly.

[0026] The pattern of relatively reflective and non-reflective areas may include evenly spaced relatively reflective and non-reflective areas formed on the proximal surface of the inner component.

[0027] When the data collection device is attached to the dose setting dial, the light source and the optical sensor may be positioned between the attachment assembly and the dose setting dial so that the light path between the light source, the internal components and the optical sensor passes through the dose setting dial. The light path between the light source, the internal components and the optical sensor may also pass through a portion of the dose delivery button.

[0028] The pattern of relatively reflective and non-reflective areas may include evenly spaced relatively reflective and non-reflective areas formed on the peripheral surface of the inner component.

[0029] The data collection device of the first or second aspect may comprise an electronic assembly including a light source and an optical sensor. The electronic assembly and the attachment assembly may be fixedly connected together. The electronic assembly may be configured to abut a proximal surface of the dose setting dial when the data collection device is attached to the dose setting dial. Alternatively or additionally, the electronic assembly may be configured to abut a circumferential surface of the dose setting dial when the data collection device is attached to the dose setting dial.

[0030] When the data collection device is attached to the dose setting dial, the light source and optical sensor may be positioned proximate to the dose setting dial such that the light path between the light source, internal components and optical sensor passes through the dose setting dial.The light source and optical sensor may be positioned on the underside of the electronics assembly.

[0031] Alternatively, when attaching the data collection device to the dose setting dial, the light source and optical sensor may be positioned between the attachment assembly and the dose setting dial such that the light path between the light source, internal components and optical sensor passes through the dose setting dial.

[0032] The data collection device of the first or second aspect may include a processor arrangement configured to receive a signal from the optical sensor and detect the occurrence of a medicament delivery from the medicament administration device. The processor arrangement may be configured to determine an amount of rotation of the internal component based on the signal received from the optical sensor.

[0033] The data collection device of the first or second aspect may further include a switch configured to be triggered by applying a force to the proximal end of the data collection device, and wherein the triggering of the switch may be configured to cause activation of at least the light source, the optical sensor, and the processor configuration. The switch may be a mechanical switch. Alternatively, the switch may be an optical wake-up sensor configured to sense the reflectivity and / or color of a base component of the medication administration device and provide a wake-up signal when a change in reflectivity and / or color is detected.

[0034] The data collection device of the first or second aspect may further include a timer, and wherein the switch may be further configured to trigger activation of the timer. The data collection device of the first or second aspect may be further configured to determine the elapsed time since the last time the timer was triggered, and generate an alarm if the elapsed time is inconsistent with a threshold condition.

[0035] The processor configuration may be configured to determine a timestamp of the administration of a dose of the medicament using the timer and store the determined dose of the medicament and the timestamp. The processor configuration may be configured to transmit a log of the determined internal component rotation angles and timestamp information to another device.

[0036] The medicament administration device may include a housing, and the dose setting dial does not rotate relative to the housing when the medicament dose is delivered from the device. The internal component may include a plurality of equally spaced serrations, and wherein the relatively reflective area may be formed on an upper surface of the serrations. The light source may be an infrared light source, and a component of the medicament administration device arranged in the light path between the light source and the optical sensor may fully or partially transmit infrared light. The processor configuration may be configured to detect the occurrence of two separate medicament deliveries and merge the two medicament deliveries when it is determined that the two deliveries occurred within a predetermined time of each other.

[0037] A fourth aspect provides a data collection device releasably attachable to a medication administration device, the data collection device comprising:

[0038] a sensor arrangement adapted to detect a signal related to a dose amount and generated from said medication administration device during dose dialling and / or dose expulsion; and

[0039] a processor adapted to determine a dosage amount or a rotation angle based on the detected signal;

[0040] The data collection device is designed to be attachable to a dose selection element of the medication administration device, and the sensor is configured to be supported on an inner surface of a mounting component of the data collection device facing the dose selection element when attached to the medication administration device.

[0041] Generally, any component that is positioned proximate to the dose setting dial and that rotates when a dose is dispensed from the injection device may be used as the inner component having a pattern of relatively reflective and non-reflective areas formed on its surface.

[0042] Certain embodiments describe a data collection device having a light source and sensor arrangement configured to abut a dose dial (including a release button if present) when attached to an injection device. The light source and sensor are configured to emit and detect radiation that can pass through a material without cutouts, apertures, etc., thereby preventing dust ingress. An example of suitable radiation is infrared light.

[0043] A fifth aspect provides a data collection device, comprising:

[0044] an attachment assembly for attaching the data collection device to a dose setting dial of a medication administration device; and

[0045] An electronic assembly includes a non-contact sensor configured to detect rotation of an internal component of a medication administration device, the internal component configured to rotate when a dose is delivered from the medication administration device.

[0046] The internal component of the medication administration device may include one or more magnets or magnetic regions, and the non-contact sensor may be a magnetic sensor configured to detect changes in the magnetic field when the internal component is rotated.

[0047] Specifically, the present invention relates to the following:

[0048] 1. A data collection device, comprising:

[0049] an attachment assembly for attaching the data collection device to a dose setting dial of a medication administration device;

[0050] a light source configured to illuminate a portion of a surface of an internal component of the medication administration device, including a pattern of relatively reflective and non-reflective areas formed on the surface of the internal component; and

[0051] An optical sensor is configured to receive light reflected from at least the relatively reflective region.

[0052] 2. The data collection device of claim 1, wherein the light source and the optical sensor are supported on a side of the data collection device that is adjacent to the dose setting dial of the drug delivery device.

[0053] 3. The data collection device of claim 1 or claim 2, wherein the attachment assembly is constructed to releasably attach the data collection device to the dose setting dial of the medication administration device such that the dose setting dial of the medication administration device is arranged in an optical path between the light source, a portion of the surface of the internal component, and the optical sensor.

[0054] 4. The data collection device of claim 3, wherein when the data collection device is attached to the dose setting dial, the light source and the optical sensor are positioned proximate to the dose setting dial such that the light path between the light source, the internal component and the optical sensor passes through the proximal surface of the dose setting dial.

[0055] 5. The data collection device of claim 3, wherein when the data collection device is attached to the dose setting dial, the light source and the optical sensor are positioned between the attachment assembly and the dose setting dial such that the light path between the light source, the internal component and the optical sensor passes through a side surface of the dose setting dial.

[0056] 6. The data collection device of any one of items 1 to 5, wherein the dose setting dial of the medication administration device is at least partially transmissive to the electromagnetic radiation emitted by the light source.

[0057] 7. The data collection device of item 6, wherein the electromagnetic radiation is infrared light.

[0058] 8. The data collection device of any one of items 1 to 7, wherein the data collection device comprises an electronic assembly including the light source and the optical sensor.

[0059] 9. The data collection device of claim 8, wherein the electronic assembly is constructed to move longitudinally relative to the attachment assembly.

[0060] 10. The data collection device of claim 9, wherein the electronic assembly is constructed to abut a dose delivery button of the dose setting dial when the data collection device is attached to the dose setting dial, and to cause depression of the dose delivery button when the electronic assembly is moved longitudinally in a distal direction relative to the attachment assembly, and wherein the light path between the light source, the internal component and the optical sensor passes through the dose delivery button.

[0061] 11. The data collection device of claim 8, wherein the electronic assembly and the attachment assembly are fixedly connected together.

[0062] 12. The data collection device of claim 11, wherein the electronics assembly is configured to abut a proximal surface of the dose setting dial when the data collection device is attached to the dose setting dial.

[0063] 13. The data collection device of any one of items 1 to 12, wherein the data collection device comprises a processor configuration constructed to receive signals from the optical sensor and detect the occurrence of drug delivery from the drug administration device.

[0064] 14. The data collection device of claim 13, wherein the processor configuration is constructed to detect the occurrence of two separate dose deliveries and to merge the two dose deliveries upon determining that the two deliveries occur within a predetermined time of each other.

[0065] 15. The data collection device of claim 13 or 14, wherein the processor configuration is constructed to determine the amount of rotation of the internal component based on the signal received from the optical sensor.

[0066] 16. The data collection device of any one of items 13 to 15, wherein the data collection device further comprises a switch, which is constructed to be triggered by applying a force to the proximal end of the data collection device, and wherein the triggering of the switch is constructed to cause activation of at least the light source, the optical sensor and the processor configuration.

[0067] 17. The data collection device of claim 16, wherein the switch is an optical wake-up sensor configured to sense the reflectivity and / or color of a base component of the medication administration device and to provide a wake-up signal upon detecting a change in reflectivity and / or color.

[0068] 18. A data collection device according to item 16 or item 17, wherein the data collection device further comprises a timer, the switch being constructed to trigger activation of the timer, and wherein the data collection device is further constructed to measure the elapsed time since the timer was last triggered and to generate an alarm if the elapsed time is inconsistent with a threshold condition.

[0069] 19. The data collection device of any one of items 16 to 18, wherein the processor configuration is constructed to:

[0070] determining a timestamp of administering a dose of medication using the timer and storing the determined dose of medication and the timestamp, and

[0071] The determined internal component rotation angle and timestamp information are transmitted to another device.

[0072] 20. A system comprising:

[0073] A drug administration device, comprising:

[0074] a dose setting dial; and

[0075] an inner component that rotates about a longitudinal axis of the device when a dose of medicament is delivered from the device, wherein the inner component includes a pattern of relatively reflective and non-reflective areas formed on a surface thereof, and

[0076] The data collection device of any one of items 1 to 19.

[0077] 21. A system comprising:

[0078] A drug administration device, comprising:

[0079] a dose setting dial; and

[0080] an inner component that rotates about a longitudinal axis of the device when a dose of medicament is delivered from the device, wherein the inner component includes a pattern of relatively reflective and non-reflective areas formed on a surface thereof, and

[0081] A data collection device comprising:

[0082] an attachment assembly for attaching the data collection device to the dose setting dial;

[0083] a light source configured to illuminate a portion of a surface of the interior component including the pattern of relatively reflective and non-reflective areas; and

[0084] An optical sensor is configured to receive light reflected from at least the relatively reflective region.

[0085] 22. The system of claim 21, wherein the light source and the optical sensor are supported on a side of the data collection device that is adjacent to the dose setting dial of the drug delivery device.

[0086] 23. The system of item 21 or item 22, wherein the pattern of relatively reflective and non-reflective areas comprises evenly spaced relatively reflective and non-reflective areas formed on the proximal surface of the internal component.

[0087] 24. The system of any one of items 21 to 23, wherein when the data collection device is attached to the dose setting dial, the light source and the optical sensor are located between the attachment assembly and the dose setting dial so that the light path between the light source, the internal component and the optical sensor passes through the dose setting dial.

[0088] 25. The system of claim 24, wherein the light path between the light source, the internal component and the optical sensor also passes through a portion of the dose delivery button.

[0089] 26. The system of item 24 or item 25, wherein the pattern of relatively reflective and non-reflective areas comprises evenly spaced relatively reflective and non-reflective areas formed on the peripheral surface of the internal component.

[0090] 27. The system of any one of items 21 to 26, wherein the medicament administration device comprises a housing, and wherein the dose setting dial does not rotate relative to the housing when a dose of medicament is delivered from the device.

[0091] 28. The system of any one of items 21 to 27, wherein the internal component includes a plurality of equally spaced serrations, and wherein the relatively reflective region is formed on an upper surface of the serrations.

[0092] 29. A data collection device, comprising:

[0093] an attachment assembly for attaching the data collection device to a dose setting dial of a medication administration device; and

[0094] An electronic assembly includes a non-contact sensor configured to detect rotation of an internal component of the medication administration device, the internal component configured to rotate when a dose is delivered from the medication administration device.

[0095] 30. The data collection device of claim 29, wherein the internal component of the drug administration device comprises one or more magnets or magnetic regions, and wherein the non-contact sensor is a magnetic sensor constructed to detect changes in the magnetic field when the internal component rotates. BRIEF DESCRIPTION OF THE DRAWINGS

[0096] Example embodiments will now be described with reference to the accompanying drawings, in which:

[0097] Figure 1 An exploded view showing an injection device for use with the data collection device;

[0098] Figure 2 Draw attached to Figure 1 a data collection device for an injection device;

[0099] Figure 3 is a cross-sectional view of the data collection device when attached to an injection device of a first type;

[0100] Figure 4 illustrates an alternative configuration of components of a data collection device;

[0101] Figure 5 illustrates another alternative configuration of components of a data collection device;

[0102] Figure 6 is a cross-sectional view of a second type of injection device to which a data collection device may be attached;

[0103] Figure 7 Displays the data collection device when attached to Figure 6A cross-sectional view of the injection device;

[0104] Figure 8 is a block diagram of a data collection device;

[0105] Fig. 9 display system, wherein the data collection device is connected to another device, such as a personal computer; and

[0106] Fig.10 Another alternative configuration of components of a data collection device is illustrated. DETAILED DESCRIPTION

[0107] In the following disclosure, embodiments will be described with reference to insulin injection devices. However, the present disclosure is not limited to said application and may be equally well applied to injection devices that discharge other medicaments.

[0108] Figure 1 is an exploded view of a drug administration device. In this example, the drug administration device is an injection device 1, such as Sanofi's Insulin injection pens, but the present invention is also compatible with other types and configurations of injection pens, as described below.

[0109] Figure 1 The injection device 1 is a prefilled injection pen comprising a housing 10 and containing an insulin container 14 to which a needle 15 can be attached. The injection device 1 can be disposable or reusable. The needle is protected by an inner needle cap 16 and an outer needle cap 17 or an alternative cap 18. The dose of insulin to be discharged from the injection device 1 can be programmed or 'dialed in' by turning a dose knob 12 (also referred to herein as a dose selection element 12), and the currently programmed dose is then displayed by a dose window 13, for example in multiples of units. For example, if the injection device 1 is constructed to administer human insulin, the dose can be displayed in so-called international units (IU), where 1 IU is the biological equivalent of approximately 45.5 micrograms of pure crystalline insulin (1 / 22 mg). Other units may be used in the injection device for delivering insulin analogs or other medicaments. It should be noted that the selected dose may be different from the dose selected by the injection device 1. Figure 1 The different approaches shown in the dosage window 13 in FIG. 1 are also well shown.

[0110] The dose window 13 may be in the form of an aperture in the housing 10 that allows the user to view a limited portion of a number sleeve 70 that is configured to move when the dose knob 12 is turned to provide a visual indication of the currently programmed dose. Alternatively, the number sleeve 70 may remain stationary during the dose dialing stage and the dose window 13 may move when a dose is dialed to reveal the numbers corresponding to the dialed dose. In either case, the number sleeve 70 may be a component that rotates when a dose is dispensed from the injection device 1.

[0111] In this example, the dose knob 12 comprises one or more formations 71a, 71b, 71c which facilitate programming by improving the grip felt by the user when gripping the dose knob 12. In another example (not shown), the dose knob comprises no formations.

[0112] Attaching the data collection device does not require the dose knob to have a formation. Having a tight fit and / or using a rubber-like material on the contact surface between the data collection device and the injection device may provide an attachment that, on the one hand, facilitates a stable connection in the sense that the two devices remain attached to each other, and on the other hand, allows the two devices to be separated when intended. The rubber-like material will ensure a proper fit even on smooth surfaces, such as a dose knob with a smooth surface, such that rotation of the data collection device causes rotation of the dose knob, and vice versa.

[0113] The injection device 1 can be constructed so that turning the dose knob 12 causes a mechanical click to provide an audible feedback to the user. The number sleeve 70 interacts mechanically with the piston in the insulin container 14. When the needle 15 is inserted into the skin portion of the patient and the injection button 11 is subsequently pushed, the insulin dose displayed in the display window 13 will be discharged from the injection device 1. When the needle 15 of the injection device 1 remains in the skin portion for a period of time after the injection button 11 is pushed, most of the dose is actually injected into the patient. The discharge of the insulin dose can also cause a mechanical click, but it is different from the sound produced when the dose knob 12 is used. In some other embodiments, the injection device 1 does not have a separate injection button 11, and the user presses the entire dose knob 12, which moves longitudinally relative to the housing 10 to allow the medicament to be dispensed.

[0114] In various embodiments, during insulin dose delivery, the dose knob 12 is rotated to its initial position in axial movement, ie, no rotation, while the number sleeve 70 is rotated to return to its initial position, eg, displaying a dose of zero units.

[0115] The injection device 1 can be used for several injection processes until the insulin container 14 is emptied or the medication in the injection device 1 reaches its expiration date (eg, 28 days after the first use).

[0116] In addition, before using the injection device 1 for the first time, it may be necessary to perform a so-called "prime shot" to remove air from the insulin container 14 and the needle 15, for example by selecting 2 units of insulin and pressing the injection button 11 while holding the needle 15 of the injection device 1 facing upwards. For ease of presentation, it will be assumed in the following that the amount expelled substantially corresponds to the injected dose, so that, for example, the amount of medicament expelled from the injection device 1 is equal to the dose received by the user. However, the difference (e.g., loss) between the expelled amount and the injected dose may need to be taken into account.

[0117] Figure 2 is a perspective view of one end of the injection device 1 when a data collection device 20 is attached according to an exemplary embodiment. The data collection device 20 includes a housing 21 having an end plate 22, which forms a user interaction surface. The housing 21 can support optical user feedback, such as one or more LEDs (not shown). In some optional embodiments, the data collection device 20 includes a display (not shown).

[0118] The data collection device 20 is compatible with a variety of existing injection devices 1. The data collection device 20 is compatible with injection devices having a separate dose delivery button or an integrated dial. The data collection device 20 is compatible with injection devices in which the dose setting dial does not rotate during dose administration, but in which an internal component near the dose setting dial rotates during dose administration. The data collection device 20 allows this internal component to rotate for detection and measurement.

[0119] Figure 3 is a cross-sectional view of a data collection device 20 when attached to an injection device 1 of a first type, according to some embodiments.

[0120] In these embodiments, the injection device 1 is of the type having a dose setting dial 12 and a depressible dose delivery button 11, which the user typically depresses to activate the dispensing mechanism. The dose setting dial 12 is configured to rotate to set the dose. In some injection devices, the rotation of the dose setting dial 12 causes an internal spring to tighten, or the device may have a pre-tensioned spring. The dose setting dial 12 does not move longitudinally during dose setting. The dose setting dial 12 remains stationary during dose dispensing. For some other injection devices, the rotation of the dose setting dial 12 also causes the dose setting dial to move proximally from the housing 10. When a dose is dispensed from the injection device 1, the dose setting dial moves back (distal) into the housing, but does not rotate. In either case, an internal component 70 (e.g., a number sleeve 70) rotates during dose dispensing. The data collection device 20 is configured to detect and measure the rotation of this internal component 70 when attached to the injection device 1.

[0121] The data collection device 20 includes a housing 21, an electronic assembly 24 disposed inside the housing 21, and a button 26 that protrudes from a proximal end of the housing 21 and is longitudinally movable relative to the housing 21. The housing 21 includes an attachment assembly 23 that is configured to secure the data collection device 20 to the dose setting dial 12. Formations 71a, 71b, 71c on the dose setting dial 12 may be used to facilitate attachment of the data collection device 20.

[0122] In this particular example, the attachment assembly 23 is a sleeve that is positioned on the dose setting dial 12 by a formation (not shown) that cooperates with the formations 71a, 71b, 71c on the dose setting dial 12 so that when the dose setting dial 12 is rotated during dose programming, the data collection device 20 is also rotated. Alternatively, or in addition, a resilient gasket, such as a sponge rubber gasket 44, may be provided within the formation on the attachment assembly 23 to allow for dimensional tolerances of the formations on the attachment assembly 23 and the formations 71a, 71b, 71c on the dose setting dial 12, and / or to provide engagement between the attachment assembly 23 and the dose setting dial 12 so that rotation of the attachment assembly 23 causes rotation of the dose setting dial 12 and vice versa. Alternatively, the attachment assembly 23 includes a resilient gasket of sufficient thickness to provide a formation that cooperates with the formations 71a, 71b and 71c on the dose setting dial. The shim is soft enough to conform to the surface of the dose setting dial 12. For example, the shim is soft enough to conform to formations on the surface of the dose setting dial 12.

[0123] The electronic assembly 24 is held within the housing 21 so that it can move longitudinally relative to the housing. When the data collection device 20 is attached to the injection device, the distal side of the electronic assembly 24 is constructed to abut against the dose delivery button 11. The proximal side of the electronic assembly 24 abuts against or is integrated with the button 26. The button 26 and the electronic assembly 24 can form a single subassembly. The attachment assembly 23 can form another subassembly. In this embodiment, the two subassemblies can move longitudinally relative to each other, but cannot rotate relative to each other. The button 26 provides a finger rest for the user and provides a push surface for transmitting a thrust to the dose delivery button 11 of the injection device. As a result of this configuration, when the button 26 of the data collection device 20 is pressed, the force is transferred to the dose delivery button 11 through the electronic assembly 24, causing it to be pressed.

[0124] The electronic assembly 24 includes a PCB 28 and a battery 30, for example in the form of a button cell. The PCB 28 can support a number of components, including a processor configuration 50, a light source 32, and an optical sensor 34. In these embodiments, the light source 32 is an infrared light source and the optical sensor 34 is an infrared optical sensor. Figure 3As shown in , in some embodiments, the light source 32 and the optical sensor 34 are supported on the side of the PCB adjacent to the dose delivery button 11. The dose delivery button 11 is transparent or substantially transparent to infrared radiation. Therefore, the light emitted by the light source 32 passes through the dose delivery button 11 and illuminates the internal components. Specifically, the number sleeve 70 is a hollow cylinder that extends to the proximal end of the housing 10 and is releasably fixed to the dose setting dial 12. The annular end surface of the number sleeve 70 is therefore located below the dose delivery button 11 and illuminated by infrared light. The number sleeve 70 is provided with a pattern of relatively reflective and non-reflective areas on the annular end surface. For example, equally spaced and equally sized reflective and non-reflective portions may be alternately configured.

[0125] During a dose dispensing operation, the light source 32 illuminates a portion of the number sleeve 70 that includes a pattern of relatively reflective and non-reflective areas; and the optical sensor 34 receives light reflected from at least the relatively reflective areas. When the dose delivery button 11 is pressed by the electronic assembly 24 during dose dispensing, the distance (optical path) between the light source 32 and the optical sensor 34 is shorter than during dialing. The output of the optical sensor 34 is relayed to the processor 50, which calculates the amount of rotation of the number sleeve 70 during the dose dispensing operation. Based on the amount of rotation, the delivered dose can be calculated. This can be done by the data collection device 20 or by another computing device. In general, any component that is located close to the dose setting dial and rotates when a dose is dispensed from the injection device 1 can be used as an internal component having a pattern of relatively reflective and non-reflective areas formed on its surface.

[0126] Figure 4 An alternative configuration of components of the data collection device 20 is illustrated. In this embodiment, the electronic assembly is integrated with or supported on the inner surface of the attachment assembly 23 and is configured to remain substantially stationary relative to the attachment assembly. The button 26 of the data collection device 20 has an elongated portion 27 that extends through an aperture 29 in the proximal face of the data collection device. The elongated portion 27 is configured to contact the dose delivery button 11 of the injection device 1 and transfer force from the button 26 to the dose delivery button 11. As in the previous embodiment, the light source 32 and the optical sensor 34 are configured to face the dose delivery button 11, which is partially or completely transparent to infrared radiation. The light path between the light source 32, the reflective area of ​​the number sleeve 70 and the optical sensor 34 can be extended in this embodiment, and suitable optical elements can be used to focus the light.

[0127] Figure 4The advantages of the embodiment of are simple mechanical design and construction, and the subassembly (button 26) that transmits the thrust for injection is minimized. This enhances user comfort because friction is reduced and the user needs to move less mass. Therefore, triggering the injection requires the user to apply a relatively small amount of additional force.

[0128] Figure 3 An advantage of the embodiment is that the optical path is minimized when performing dose detection because the electronics assembly 24 is directly adjacent to the dose delivery button 11. Figure 3 The optical path length in Figure 4 The optical path in the attachment assembly 23 (where the electronic assembly is integrated with or supported on the inner surface of the attachment assembly 23) is reduced. Figure 4 In embodiments of the present invention, certain enhancers may be used to improve the signal-to-noise ratio due to the longer optical path lengths between the light source, sensor, and reflective surface. For example, a stronger light source 32 or a more sensitive optical sensor 34 may be used. The enhancer may alternatively or additionally be implemented as one or more focusing lenses to focus the light beam and / or a baffle to block scattered light / radiation at the sensor 34. However, the enhancer is optional.

[0129] Figure 5 Another alternative configuration of components of the data collection device 20 is illustrated. In this embodiment, the light source 32 and optical sensor 34 are supported in a recess between the dose setting dial 12 and the inner surface of the attachment assembly 23. For example, the light source 32 and optical sensor 34 may be supported on a protrusion of the electronic assembly 24. The attachment assembly 23 may have a recess to allow space for this protrusion. In this embodiment, relatively reflective and non-reflective areas are arranged around the circumference on the outer surface of the number sleeve 70. The configuration may allow the reflective and non-reflective areas to be larger or spaced farther apart because more space is available on this surface of the number sleeve 70. In this embodiment, the light path between the light source 32, the reflective area of ​​the number sleeve 70, and the optical sensor 34 passes through the dose setting dial 12. Therefore, at least the annular side wall of the dose setting dial 12 is partially or completely transparent to infrared radiation. As shown from Figure 5 It will be appreciated that the light path may also pass through a portion of the dose delivery button 11 as the dose delivery button 11 may extend into the dose setting dial 12 to connect with a dispensing mechanism of the injection device 1. Thus, this portion of the dose delivery button 12 may also be transparent to IR radiation.

[0130] This embodiment allows the optical path to be minimized and remain constant when the dose delivery button 11 is pressed. This adds to the already improved dose detection reliability. This embodiment also has a simple mechanical design and construction. Figure 3 and Figure 4The attachment assembly 23 of this embodiment may have a wider diameter compared to the attachment assembly of the embodiment to allow space for the light source 32 and the optical sensor 34. This may reduce the force required by the user to rotate the dose setting dial 12 during dose dialing and therefore improve ease of use for users with poor dexterity.

[0131] See also Fig.10 , showing an alternative embodiment. In this embodiment, instead of having a light source and an optical sensor, the electronic assembly includes a non-contact magnetic sensor 80, such as a Hall sensor. In this embodiment, the rotatable component 70 includes a series of magnetic regions 82 and non-magnetic regions 84 that are alternately spaced around the circumference of the rotatable component 70. The magnetic regions 82 may be permanent magnets, such as regions containing magnetic particles or magnetic ink. As the magnetic regions 82 and non-magnetic regions 84 rotate past the magnetic sensor 80 during dose dispensing, the magnetic sensor 80 detects periodic changes in the strength and optionally the direction of the magnetic field. This information can then be used to determine the amount (angle) of rotation of the rotatable component 70. The dose setting dial 12 can transmit or partially project the magnetic field generated by the magnetic regions 82, allowing the magnetic sensor 80 to remotely detect the rotation of the rotatable component 70 and without the need for a cutout or aperture in the dose setting dial 12. Although Fig.10 The magnetic sensor 80 is shown to be arranged radially relative to the dose setting dial 12, but the magnetic sensor 80 may instead be positioned proximally of the dose setting dial 12 to be in contact with the dose setting dial 12. Figure 3 and Figure 4 The same way as shown in .

[0132] Figure 6 is a cross-sectional view of a second type of injection device 1 to which a data collection device 20 may be attached. In this embodiment, the injection device 1 has a dose setting dial 12 (also referred to herein as a dose selection element 12), but does not have a separate dose delivery button, e.g. the dose setting dial may also serve as a dose delivery member when pressed.

[0133] The dose setting dial 12 is configured to be rotated to set a dose. This causes the dose setting dial 12 to move proximally from the housing 10. When a dose is dispensed from the injection device 1, the dose setting dial 12 moves back (distal) into the housing, but does not rotate. Figures 3 to 5 As with the described embodiment, the internal component 70 (eg the number sleeve 70 ) rotates during dose dispensing. The data collection device 20 is configured to detect and measure the rotation of this internal component 70 when attached to the injection device 1 . Figure 6The injection device 1 shown in the figure may also have other components that rotate when dispensing a dose, such as a drive sleeve 72. In the illustrated embodiment, the drive sleeve 72 has a series of serrations at its proximal end. The relatively reflective area may be printed or otherwise deposited directly onto the upper surface of the serrations. In general, any component that is positioned close to the dose setting dial and rotates when dispensing a dose from the injection device 1 may be used as an internal component having a pattern of relatively reflective and non-reflective areas formed on its surface.

[0134] Figure 7 The data collection device 20 according to some embodiments is shown attached to Figure 6 1. The data collection device 20 includes an attachment assembly 23 and an electronic assembly 24, which may be integrated or otherwise fixedly fastened together. For example, the attachment assembly 23 may form part of a housing 21 of the data collection device 24, and the housing 21 may also hold the electronic assembly 24.

[0135] The attachment assembly 23 is configured to secure the data collection device 20 to the dose setting dial 12. As previously described, the data collection device 20 may employ a simple friction fit to releasably secure it to the dose setting dial 12, and formations 71a, 71b, 71c on the dose setting dial 12 may be used to facilitate attachment or angular alignment.

[0136] When the data collection device 20 and the injection device 1 are secured together, the electronics assembly 24 is configured to abut the dose setting dial 12. The data collection device 20 effectively replaces the dose setting dial in that the user interacts directly with the data collection device 20 in the same way that the user may interact with a dose setting dial to set and deliver a dose of medicament.

[0137] The electronic assembly 24 includes a number of components, including a PCB 28, a light source 32, an optical sensor 34, a processor arrangement, and a battery 30. Figure 7 In the embodiment shown in FIG, the light source 32 and optical sensor 34 are supported on the distal side of the electronics assembly 24 such that they are adjacent to the proximal face of the dose setting dial 12. The light source 32 and sensor 34 are thereby supported on the side of the data collection device that abuts the dose dial of the drug delivery device when attached to the drug delivery device.

[0138] In these embodiments, the light source 32 is an infrared light source and the optical sensor 34 is an infrared optical sensor. The dose setting dial is transparent or substantially transparent to infrared radiation. Therefore, the light emitted by the light source 32 passes through the dose setting dial and illuminates the internal components. Specifically, the number sleeve 70 is a hollow cylinder that extends to the proximal end of the housing 10 and moves longitudinally with the dose setting dial 12 when setting a dose. The number sleeve can be releasably fixed to the dose setting dial 12 so that the annular end surface of the number sleeve 70 is located below the dose delivery button 11 and illuminated by the infrared light of the light source 32. The number sleeve 70 is provided with a pattern of relatively reflective and non-reflective areas on the annular end surface. For example, equally spaced and equally sized reflective and non-reflective portions can be arranged alternately. Alternatively, the drive sleeve 72 or another internal component can be provided with a pattern of relatively reflective and non-reflective areas.

[0139] During a dose dispensing operation, the light source 32 illuminates a portion of the number sleeve 70 that includes a portion of a pattern of relatively reflective and non-reflective areas; and the optical sensor 34 receives light reflected from at least the relatively reflective areas as the light passes underneath. The output of the optical sensor 34 is relayed to the processor 50, which calculates the amount of rotation of the number sleeve 70 during the dose dispensing operation. From the amount of rotation, the delivered dose can be calculated. This can be done by a data collection device or by another computing device.

[0140] Typically, it is necessary to know the type of injection device 1 to which the data collection device 20 is attached to determine the dose of medicament that has been dispensed. Therefore, in some embodiments, the data collection device 20 only measures the amount of rotation (degrees) of the internal components. This information is saved in the memory of the data collection device 20 and can be communicated to an external computing device by the data collection device 20, where it is combined with information about the type of injection device 1 to record the dose of medicament delivered.

[0141] Reference to above Figure 5Similar to the embodiments described above, the light source 32 and optical sensor 34 may instead be supported in a recess between the dose setting dial 12 and the inner surface of the attachment assembly 23. For example, the light source 32 and optical sensor 34 may be supported on a protrusion of the electronic assembly 24. The attachment assembly 23 may have a recess to allow space for this protrusion. In the embodiments described, relatively reflective and non-reflective areas are arranged around the circumference on the outer surface of the number sleeve 70. This may have an advantage over the previously described embodiments: allowing the reflective and non-reflective areas to be larger or more spaced apart because more space is available on this surface of the number sleeve 70. In these embodiments, the light path between the light source, the reflective area of ​​the number sleeve and the optical sensor passes through the annular side wall of the dose setting dial 12, which is partially or completely transparent to infrared radiation. In all embodiments, the light source 32 and optical sensor 34 are supported on a portion of the data collection device that, when attached to the drug delivery device 1, radially or proximally abuts the dose dial 12 (which may include the dose delivery button 11) of the drug delivery device 1.

[0142] In another alternative embodiment (not shown), the electronic assembly is integrated with or supported on the inner surface of the attachment assembly 23 and is configured not to move relative to the attachment assembly. Figure 4 However, in this alternative embodiment, the light source 32 and optical sensor 34 may instead be supported on the side of the electronics assembly 24 so that it is adjacent to the radial end face of the dose setting dial 12. This embodiment provides the benefit of having a simple mechanical design and enabling reading of radial codes.

[0143] Figure 7 The fixed construction and design of an embodiment of the data collection device 20 has the advantage of simple mechanical construction (e.g., by minimizing relative movement), which according to this embodiment provides accurately defined positioning of the optical sensor 34 relative to the injection device housing and internal components (e.g., the dose dial 12) including a pattern of relatively reflective and non-reflective areas.

[0144] Another alternative (not shown) is Figure 7 , but the light source 32 and optical sensor 34 are instead supported on the side of the electronics assembly 24 so that it is adjacent to the radial end face of the dose setting dial 12. This embodiment also provides a simple mechanical design and enables reading of radial codes.

[0145] The data collection device of the present disclosure is directly attached to the dose setting dial of the medication administration device. Previously, data collection devices have been attached to the main housing of the medication administration device. This may hinder the user from using the medication administration device. Multiple such devices are attached to the dose indication window in the housing of the medication administration device. This obscures the dose indication window, making the user completely dependent on the data collection device to indicate the dialed dose, which may reduce the user's confidence in the medication administration device. Some other such devices require additional cutouts or apertures in the housing of the medication administration device to view or connect internal movable components. Cutting off a portion of the housing of the medication administration device makes it more likely that dirt and dust will enter the interior of the delivery mechanism. It may also present problems related to the sterility of the medication administration device.

[0146] The data collection device of the present disclosure enables remote monitoring of the amount of medicament dispensed from a medicament administration device without contacting or being fastened to the main housing of the medicament administration device. The data collection device is constructed to attach to and effectively replace the portion of the medicament administration device with which the user normally interacts. When the user wishes to dial a dose, he grasps and rotates the housing 21 of the data collection device 20, which in turn rotates the dose setting dial 12. The user can continue to observe the mechanical dose indication window 13 of the medicament administration device. When the user wishes to inject a dose, he applies a force to the proximal end of the data collection device. This in turn transmits the force to the dose setting dial. If the medicament administration device has a dose delivery button 11, then the button 26 of the data collection device is constructed to press relative to the housing 21 and thereby in turn press the dose delivery button 11. Therefore, the user will notice that there is no significant difference in the way he operates the medicament administration device due to the addition of the data collection device according to the present invention.

[0147] The data collection device of the present disclosure may use infrared light as a source of illumination. This allows the external components of the medication administration device to be made of plastic or other material that is opaque to optical wavelengths but transparent or partially transparent to infrared wavelengths. No additional cutouts, apertures, etc. are required, but only appropriate areas of the medication administration device may be made of IR transmissive material, effectively forming an infrared 'window'.

[0148] The relatively reflective and non-reflective areas of the pattern can be printed, deposited, etched or otherwise created directly onto the number sleeve 70 or other suitable internal component during manufacture of the component. In some examples, the internal component is positioned in close proximity to the dose setting dial. The medication administration device can then be assembled in the same manner as before using the same assembly methods and tools. Therefore, only minimal modifications to the medication administration device design and production are required to implement the present invention.

[0149] As mentioned above about Fig.10 As stated, Figure 7The light source 32 and the optical sensor 34 in the embodiment may be replaced by a magnetic sensor 80 instead. The relatively reflective and non-reflective areas of the pattern on the rotatable component 70 may be replaced by alternating magnetic areas 82 and non-magnetic areas 84, so that periodic changes in the magnetic field are detected by the magnetic sensor 80 when the rotatable component 70 rotates during the dose dispensing operation.

[0150] Figure 8 is a block diagram of a data collection device 20. The data collection device 20 includes a processor configuration 50, including one or more processors, such as a microprocessor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), etc.; and memory units 52a, 52b, including a program memory 52a and a main memory 52b, which can store software executed by the processor configuration 50. The data collection device includes an infrared light source 32 and an infrared optical sensor 34. The processor configuration 50 controls the operation of the light source 32 and the optical sensor 34 and receives signals from the optical sensor 34.

[0151] The data collection device 20 has a power source 54, which may be a battery, such as a button cell. The data collection device 20 may optionally include a switch 53, which is configured to be triggered when or shortly before the dose is dispensed. To this end, the switch 53 may include a pressure or touch sensitive area in the end plate 22 or button 26 of the data collection device 20, such as a piezoelectric switch. The switch 53 may control the application of power from the power source 54 to the processor configuration 50 and other components of the data collection device 20. In an embodiment in which the electronic assembly 24 and the attachment assembly 23 are configured to move longitudinally relative to each other, the switch 53 may be implemented mechanically. For example, electrodes may be arranged on the inner surface of the attachment assembly 23, and corresponding electrodes on the electronic assembly 24 may form contacts (and thus complete the circuit) when the button 26 is pressed. This may then trigger the awakening of other electronic components including the light source and the optical sensor.

[0152] Alternatively, the wake-up switch can be implemented optically as an "optical wake-up sensor". Specifically, the dose delivery button 11 of the injection device 1 can be colored, for example green, while the base rotatable component 70 can be white (or black). When the dose delivery button 11 is pressed, it moves in front of the optical wake-up sensor, and a reflectivity and / or color change can be detected, thereby providing a wake-up signal for other electronic components. This reflectivity or color change can also be used to determine the start and end time of the injection process. In this case, a switch as previously described can be used to wake up the electronic components, including a light source and an optical sensor, and the optical switch can use a change in reflectivity or color to determine the start and end time of the injection process. This can help determine whether the injection process has occurred or whether the start process has occurred. In addition, the color / reflectivity switch can be used to determine how long the button has been pressed and to observe whether the user complies with the dwell time.

[0153] A timer 55 is also included. The processor configuration 50 can use the timer 55 to monitor the length of time that has elapsed since the injection was completed, determined using the switch 53. Also optionally, the processor configuration 50 can compare the elapsed time with a predetermined threshold to determine whether the user may attempt to give another injection too quickly after the previous injection, and if so, generate an alarm, such as an audible signal, and / or generate an optical signal, such as flashing one or more LEDs. The data collection device 20 may include multiple LEDs or other light sources for providing optical feedback to the user. For example, the LEDs can use different colors and / or light patterns, such as flashing at a constant or varying cycle. On the other hand, if the elapsed time is extremely short, it may indicate that the user is administering the dose as a "split dose", and the processor configuration 50 may store information indicating that the dose is delivered in this manner. In the case, the elapsed time is compared to a predetermined threshold, which is in the range of a few seconds (e.g., 10 seconds) to up to a few minutes (e.g., 5 minutes). According to the example, the predetermined threshold is set to 2 minutes. If the time elapsed since the last injection is 2 minutes or less, the processor arrangement 50 stores information indicating that the dose is delivered as a "split dose." Another optional purpose of monitoring the elapsed time by the processor arrangement 50 is to determine when the elapsed time passes a predetermined threshold, indicating that the user may have forgotten to give another injection and to generate an alarm if so.

[0154] The processor is further configured to store data regarding date and / or time information, data regarding information from the optical sensor 34, or a combination thereof. Specifically, the memory is configured to store a combination of date and / or time information and internal component rotation information retrieved from the optical sensor 34 output data. In this manner, the memory can store a log that provides a history of information regarding the rotation of the number sleeve 70 (or other internal components). The data may be stored, for example, in the main memory 52b. Alternatively, the data may be stored in a separate data storage segment (not shown) of the memory.

[0155] Since the number sleeve or other internal components rotate as the medicament is expelled from the injection device 1, the rotation angle measured by the optical sensor 34 is proportional to the amount of medicament expelled. There is no need to determine a zero level or an absolute amount of medicament contained in the injection device 1. In this way, the sensor configuration is simpler than a sensor configuration configured for absolute position detection. In addition, since there is no need to monitor the numbers or scale markings on the number sleeve 70 displayed through the dose window 13, the data collection device 20 can be designed so that it does not obstruct the dose window 13.

[0156] An output 57 is provided which can be used to transmit data via a wireless network (e.g. Wi-Fi, or NFC) to communicate with another device, or an interface for a wired communication connection, such as a socket for receiving a Universal Serial Bus (USB), mini USB, or micro USB connector. Fig. 9 An example of a system is depicted in which the data collection device 20 is connected to another device, such as a personal computer 60, via a wireless connection 61 for data transfer. Alternatively or additionally, the data collection device 20 may be connected to another device via a wired connection. For example, the processor configuration 50 may store the determined number sleeve 70 rotation angle and time stamp (including date and / or time) for the injection when it is administered by the user, and then transfer the stored data to the computer 60. The computer 60 may be configured to calculate the administered dose based on further information input by the user or medical personnel regarding the type of injection device and the type of medicament. The computer 60 maintains a treatment log and / or transmits treatment history information to a remote location, such as for review by medical personnel.

[0157] According to some embodiments, the data collection device 20 may be constructed to store data for up to 35 injection events, such as the rotation angle and time stamp of the number sleeve 70. Based on a once-daily injection therapy, this may be sufficient to store about a month's worth of treatment history. Data storage is organized in a first-in-first-out manner to ensure that the latest injection event is always present in the memory of the data collection device 20. Once transferred to the computer 60, the injection event history in the data collection device 20 will be deleted. Alternatively, the data is retained in the data collection device 20 and the oldest data is automatically deleted immediately after the new data is stored. In this way, the log in the data collection device accumulates over time during use and will always contain the latest injection events. Alternatively, other configurations may include storage capacity for 70 (twice a day), 100 (3 months), or any other suitable number of injection events, depending on the user's treatment needs and / or preferences.

[0158] In another embodiment, the output 57 may be configured to transmit the information using a wireless communication link and / or the processor arrangement 23 may be configured to periodically transmit the information to the computer 60 .

[0159] The specific embodiments described in detail above are intended only as examples of how the invention may be implemented. Numerous variations of the configuration of the data collection device 20 and / or the injection device 1 are conceivable.

[0160] Specifically, while the above embodiments are described with respect to collecting data from an insulin injector pen, it should be noted that embodiments of the present disclosure may be used for other purposes, such as monitoring the injection of other medicaments. While the data collection device is primarily described as including a single infrared light source 32, the data collection device may include multiple light sources 32. The multiple light sources 32 may be supported at different locations on the electronic assembly 24 and / or the attachment assembly 23, and may be angled and / or focused to illuminate specific portions of the internal assembly 70 from specific angles when the data collection device is attached to a dose setting dial.

[0161] The data collection device 20 may optionally include a display (not shown), which may, for example, occupy an end panel 22 of the data collection device 20. Various information may be displayed, such as the length of time that has elapsed since the injection was completed, and a warning message if the user attempts to give another injection too soon after a previous injection.

Claims

1. A data collection device, comprising: an attachment assembly for attaching the data collection device to a dose setting dial of a medication administration device, the dose setting dial being disposed at a proximal end of the medication administration device; a light source configured to illuminate a portion of an internal component of the medication administration device, the internal component including a plurality of reflective regions formed on the internal component; and an optical sensor configured to receive light reflected by the reflective area, Wherein when the data collection device is attached to the dose setting dial, the light source and the optical sensor are positioned proximate to the dose setting dial such that a light path between the light source, the internal component and the optical sensor passes through a proximal surface of the dose setting dial.

2. The data collection device of claim 1, wherein the light source and the optical sensor are supported on a side of the data collection device adjacent to the dose setting dial of the medication administration device.

3. The data collection device of claim 1, wherein the attachment assembly is configured to releasably attach the data collection device to the dose setting dial of the medication administration device.

4. The data collection device of claim 1, wherein the dose setting dial of the medication administration device is at least partially transmissive to electromagnetic radiation emitted by the light source.

5. The data collection device of claim 4, wherein the electromagnetic radiation is infrared light.

6. The data collection device of claim 1, wherein the data collection device comprises an electronic assembly including the light source and the optical sensor.

7. The data collection device of claim 6, wherein the electronic assembly is configured to move longitudinally relative to the attachment assembly.

8. A data collection device according to claim 7, wherein the electronic assembly is configured to abut a dose delivery button of the dose setting dial when the data collection device is attached to the dose setting dial, and cause depression of the dose delivery button when the electronic assembly is moved longitudinally in a distal direction relative to the attachment assembly, and wherein the light path between the light source, the internal component and the optical sensor passes through the dose delivery button.

9. The data collection device of claim 6, wherein the electronic assembly and the attachment assembly are fixedly connected together.

10. The data collection device of claim 9, wherein the electronics assembly is configured to abut a proximal surface of the dose setting dial when the data collection device is attached to the dose setting dial.

11. The data collection device of claim 1, wherein the data collection device comprises a processor configuration structured to receive a signal from the optical sensor and detect the occurrence of medication delivery from the medication administration device.

12. The data collection device of claim 11, wherein the processor arrangement is configured to detect the occurrence of two separate medicament deliveries and merge the two medicament deliveries upon determining that the two deliveries occurred within a predetermined time of each other.

13. The data collection device of claim 11, wherein the processor arrangement is configured to determine an amount of rotation of the internal component based on the signal received from the optical sensor.

14. A data collection device according to claim 11, wherein the data collection device further comprises a switch, the switch being constructed to be triggered by applying a force to the proximal end of the data collection device, and wherein triggering of the switch is constructed to cause activation of at least the light source, the optical sensor and the processor configuration.

15. A data collection device according to claim 14, wherein the switch is an optical wake-up sensor, which is constructed to sense the reflectivity and / or color of the base component of the medication administration device and provide a wake-up signal when a change in reflectivity and / or color is detected.

16. A data collection device according to claim 14, wherein the data collection device further includes a timer, the switch is constructed to trigger activation of the timer, and wherein the data collection device is further constructed to measure the elapsed time since the timer was last triggered and generate an alarm if the elapsed time is inconsistent with a threshold condition.

17. The data collection device of claim 16, wherein the processor arrangement is configured to: determining a timestamp of when a dose of medication is administered using the timer and storing the dose of medication and the timestamp, and The determined internal component rotation angle and timestamp information are transmitted to another device.

18. A system for collecting data from a medication administration device, comprising: A drug administration device, comprising: a dose setting dial disposed at a proximal end of the medication administration device; and an inner component that rotates about a longitudinal axis of the device when a dose of medicament is delivered from the device, wherein the inner component includes a plurality of reflective regions, and A data collection device comprising: an attachment assembly for attaching the data collection device to the dose setting dial; a light source configured to illuminate a portion of the interior component including the plurality of reflective regions; and an optical sensor configured to receive light reflected by at least the plurality of reflective areas, wherein when the data collection device is attached to the dose setting dial, the light source and the optical sensor are positioned proximate to the dose setting dial such that a light path between the light source, the internal component and the optical sensor passes through a proximal surface of the dose setting dial.

19. The system of claim 18, wherein the light source and the optical sensor are supported on a side of the data collection device that abuts the dose setting dial of the medication administration device.

20. The system of claim 18, wherein the plurality of reflective regions comprises evenly spaced reflective regions formed on a proximal surface of the inner component.

21. The system of claim 18, wherein when the data collection device is attached to the dose setting dial, the light source and the optical sensor are located between the attachment assembly and the dose setting dial such that a light path between the light source, the internal component and the optical sensor passes through the dose setting dial.

22. The system of claim 21, wherein the light path between the light source, the internal component and the optical sensor also passes through a portion of a dose delivery button.

23. The system of claim 21, wherein the internal component comprises a pattern of relatively reflective and non-reflective areas, the pattern comprising evenly spaced relatively reflective and non-reflective areas formed on an outer peripheral surface of the internal component.

24. The system of claim 18, wherein the medicament administration device comprises a housing, and wherein the dose setting dial does not rotate relative to the housing when a dose of medicament is delivered from the device.

25. The system of claim 18, wherein the inner component comprises a plurality of equally spaced serrations, and wherein the reflective region is formed on an upper surface of the serrations.

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