Medicament delivery device and dose measurement system

Abstract

The present invention relates to a medicament delivery device and a dose measurement system comprising a rotation sensor as part of a medicament injection device or adapted as part of a medicament injection device, thereby measuring the amount of dose dispensed by the medicament injection device.

Description

[0001] This divisional application of the present invention is based on the invention patent application with the application date of November 19, 2020, application number 202080081348.1 (international application number PCT / EP2020 / 082610), and title "Drug Delivery Device and Dose Measurement System". Technical Field

[0002] The present disclosure relates to a drug delivery device and a dose measurement system for a drug delivery device. Background Art

[0003] There are many diseases that require regular treatment by delivering a drug using a drug delivery device. Such delivery can be performed by using an injection device, applied by medical staff or by the patient themselves. For example, type 1 and type 2 diabetes can be treated by the patient themselves by injecting insulin doses, for example, once or several 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 empty drug cartridge to be replaced with a new one. Either pen can have a set of single-use needles, which are replaced before each use. The insulin dose to be injected can then be manually selected, for example, at the insulin pen by turning a dose knob and observing the actual dose through a dose window or display of the insulin pen. The dose is then injected by inserting the needle into a suitable part of the skin and pressing an injection button of the insulin pen. In order to be able to monitor insulin injections, for example, to prevent incorrect manipulation of the insulin pen or to record the administered dose, it is desirable to measure information related to the condition and / or use of the injection device, such as information about the insulin dose injected. Summary of the Invention

[0004] An object of the present disclosure is to provide an improved drug delivery device and a dose measurement system for a drug delivery device.

[0005] According to the present disclosure, there is provided a drug delivery device, the drug delivery device comprising:

[0006] a drug reservoir; a dispensing mechanism operable to dispense the drug from the reservoir, the dispensing mechanism including a sleeve configured to rotate during drug dispensing and having a plurality of configurations at an end of the sleeve; and

[0007] a dose measurement system including a processor and at least one mechanically actuated sensor configured such that in use, rotation of the sleeve causes engagement of the sensor with each configuration one by one, such that the sensor detects the rotation of the sleeve, and the processor is configured to determine the dose dispensed from the drug reservoir based on the detected rotation of the sleeve.

[0008] Using a mechanical sensor engaged with a sleeve provides a compact system for determining the dose dispensed from a medicament reservoir. Mechanical sensors are generally more energy efficient than other types of sensors (e.g., optical gates) and can thus use a smaller battery. Due to the construction of the mechanical sensor on the sleeve of the dispensing mechanism, the system can be more portable compared to the case of external components of the sensor detection device.

[0009] In some embodiments, the plurality of configurations includes a plurality of teeth.

[0010] In some embodiments, the configuration is formed on the proximal end of the sleeve.

[0011] The configuration located on the proximal end of the sleeve allows the sensor to be axially aligned with the sleeve. The sensor can be disposed proximal to the sleeve.

[0012] In some embodiments, the sleeve is a dialing sleeve or a drive sleeve.

[0013] In some embodiments, the sensor includes a sensing member configured to move from a non-actuated state to an actuated state when the sensing member engages one of the configurations during rotation of the sleeve, wherein the sensor detects the movement of the sensing member between the non-actuated state and the actuated state.

[0014] In some embodiments, each configuration includes a leading edge, and wherein during rotation of the sleeve, the engagement of the sensor with the leading edge of a first configuration among the configurations to the engagement of the sensor with the leading edge of an adjacent second configuration among the configurations represents one coding cycle, and wherein the sensor is actuated for between 40% and 60% of the coding cycle, and preferably, the sensor is actuated for approximately 50% of the coding cycle. This configuration produces a symmetric scheme, which can contribute to the robustness of tolerances since tolerances are symmetrically distributed in many cases.

[0015] In some embodiments, the medicament delivery device further includes a dose dial and a housing, wherein the dose dial is configured to rotate relative to the housing to set the dose of the medicament to be delivered by the dispensing mechanism, and wherein the sensor is mounted to the dose dial.

[0016] The sensor mounted to the dose dial allows for a compact medicament delivery device. In some embodiments, the sensor is mounted inside the dose dial such that the dose measurement system is small and compact.

[0017] In some embodiments, the medicament delivery device includes a torque limiter, wherein the sensor is mounted to the dose dial via the torque limiter such that rotation of the dose dial relative to the housing with a torque greater than a predetermined limit causes the torque limiter to move to an open state such that the dose dial can rotate relative to the sensor, and preferably, the torque limiter includes an overload clutch.

[0018] In the case where a user applies a large torque to the dose dial during setting of the dose to be delivered by the measuring delivery device, the torque limiter prevents damage to the sensor.

[0019] In some embodiments, the medicament delivery device further includes a one-way mechanism, wherein the sensor is mounted to the dose dial via the one-way mechanism such that the sensor is impeded from rotating in the direction in which the sleeve rotates during medicament dispensing relative to the dose dial and is permitted to rotate in the opposite direction relative to the dose dial in which the sleeve rotates during medicament dispensing.

[0020] In the case where a user urges the sleeve to rotate in a direction opposite to the direction in which the sleeve rotates during medicament dispensing, the one-way mechanism prevents damage to the sensor since the sensor will rotate with the sleeve in the opposite direction.

[0021] According to another aspect, there is provided a dose measurement system for a medicament delivery device, wherein the medicament delivery device includes: a housing that contains a reservoir for a medicament; and a dispensing mechanism that is operable to dispense the medicament from the reservoir and includes a component configured to rotate during medicament dispensing, the component including a plurality of configurations; and an actuator configured to be movable relative to the housing upon actuation to operate the dispensing mechanism to dispense the medicament from the reservoir, the dose measurement system includes: a sensor that is movable from an idle position to a detection position, wherein rotation of the component causes each configuration to be detected by the sensor such that the sensor detects rotation of the component; a processor configured to determine a dose dispensed from the medicament reservoir based on the detected rotation of the component; and

[0022] a start switch that is movable from an initial off state to an on state to start the dose measurement system upon actuation of the actuator, the sensor being configured to be mounted to the actuator such that actuation of the actuator causes the sensor to move relative to the housing to reach the detection position, wherein the start switch reaches the on state before the sensor reaches the detection position.

[0023] The configuration of the sensor and the start switch ensures that the dose measurement system is started before the sensor reaches the detection position. This helps to ensure that the sensor is not in the detection position before the dose measurement system is powered on.

[0024] In some embodiments, the actuator may slide relative to the housing. The sliding movement of the actuator may be easier for the patient, especially in cases where the patient is old or frail.

[0025] In some embodiments, the activation switch includes a pivoting member that pivots from a closed state to an open state to activate the dose measurement system.

[0026] In some embodiments, the medicament delivery device includes a stop, and wherein the activation switch is configured to rest on the stop when the activation switch is in the closed state.

[0027] In some embodiments, the activation switch is configured to engage a portion of the medicament delivery device when the actuator moves to operate the dispensing mechanism, such that the activation switch is urged to the open state, and preferably, the portion includes a part of the dispensing mechanism.

[0028] This configuration allows actuation of the activation switch without the need for additional components. In some embodiments, the portion includes a drive sleeve of the dispensing mechanism.

[0029] In some embodiments, the activation switch is configured such that the activation switch moves a first distance from the closed state to the open state, and the sensor is configured such that the sensor moves a second distance from the idle position to the detection position, where the second distance is greater than the first distance. This helps to ensure that the activation switch reaches the open position before the sensor reaches the detection position.

[0030] In some embodiments, the dose measurement system includes a first radial support and a second radial support, wherein the actuator is rotatably mounted to a portion of the device via the first support and the second support, and the first support and the second support are axially spaced apart. The portion of the device may be, for example, a rotatable sleeve of the device (e.g., a dialing sleeve) or may be the housing.

[0031] In some embodiments, the dose measurement system includes a support member and a coupling member, wherein the dose setting dial is fixed relative to the support member, and wherein the support member is coupled to the coupling member, and preferably, the support member is coupled to the coupling member via a pivot.

[0032] In some embodiments, the support member is rotatably coupled to the coupling member via at least one radial support and preferably via a first radial support and a second radial support. Optionally, the second radial support is axially spaced from the first radial support in the direction of the actuating movement of the actuator.

[0033] In some embodiments, the dose measurement system has any of the features discussed above. In some embodiments, a medicament delivery device is provided, the medicament delivery device including a dose measurement system having any of the features discussed above.

[0034] According to another aspect, there is provided a dose measurement system for a medicament delivery device, wherein the medicament delivery device includes a reservoir for a medicament and a dispensing mechanism operable to dispense the medicament from the reservoir, the dispensing mechanism including a component configured to rotate during medicament dispensing, the component including a plurality of first encoder regions and a plurality of second encoder regions, the dose measurement system including: a first sensor and a second sensor, the first sensor and the second sensor being offset such that in use, rotation of the component causes one of the first encoder regions in the first encoder regions to align with the first sensor while one of the second encoder regions in the second encoder regions aligns with the second sensor, and then one of the second encoder regions in the second encoder regions aligns with the first sensor while one of the first encoder regions in the first encoder regions aligns with the second sensor, the first sensor and the second sensor being configured to distinguish the first encoder regions and the second encoder regions to detect rotation of the component; and

[0035] a processor configured to determine a dose dispensed from the medicament reservoir based on the detected rotation of the component.

[0036] The arrangement of the offset first sensor and second sensor increases the resolution of the measurement of the rotation of the component for a given size of encoding region, thereby allowing a more accurate determination of the dose dispensed from the medicament reservoir.

[0037] In some embodiments, the component includes a plurality of configurations, wherein each first encoding region includes at least a portion of a corresponding configuration detectable by the first sensor and the second sensor as the component rotates, and wherein the second encoder regions are disposed between adjacent first encoder regions.

[0038] In some embodiments, each configuration includes a tooth, wherein each first encoding region includes at least a portion of a corresponding tooth detectable by the first sensor and the second sensor as the component rotates, and wherein each second encoder includes at least a gap between adjacent teeth.

[0039] In some embodiments, the first sensor and the second sensor are arranged such that for all rotational positions of the component in which the first sensor aligns with one of the first encoder regions, the second sensor aligns with one of the second encoder regions.

[0040] This helps to ensure that for a given number and size of coded regions, the maximum resolution of the component rotation measurement can be achieved. Also, it can be determined that the initial axial movement will cause the first coded region to align with one of the first and second sensors, and thus the false readings due to the initial axial movement can be ignored.

[0041] In some embodiments, the component includes a plurality of coding cycles, where each coding cycle includes a first coding region in the first coding regions and an adjacent second coding region, and for a given rotational position of the component, the first sensor is aligned with a portion of one of the coding cycles, and the second sensor is aligned with a different portion of one of the coding cycles.

[0042] In some embodiments, the dose measurement system further includes a third sensor that, when the component is in the given rotational position, is aligned with a portion of one of the coding cycles that is different from the first and second sensors.

[0043] The processor is thus able to determine the rotational direction of the component.

[0044] In some embodiments, the dose measurement system further includes a fourth sensor that, when the component is in the given rotational position, is aligned with a portion of one of the coding cycles that is different from the first, second, and third sensors. The processor is thus able to determine the rotational direction of the component.

[0045] In some embodiments, the dose measurement system further includes a third sensor that is configured such that in use, when the component rotates, the third sensor is aligned with a first coding region in the first coding regions while the first sensor is aligned with a first coding region in the first coding regions.

[0046] If the first sensor fails to detect the coding region due to a detection error, the third sensor provides redundancy and also allows filtering of impossible detection events. Thus, there is paired redundancy that allows detection and compensation for false switch state detections.

[0047] In some embodiments, the dose measurement system further includes a fourth sensor that is configured such that in use, when the component rotates, the fourth sensor is aligned with a first coding region in the first coding regions while the second sensor is aligned with a first coding region in the first coding regions.

[0048] If the second sensor fails to detect the coding region due to a detection error, the fourth sensor provides redundancy and also allows filtering of impossible detection events. Thus, there is paired redundancy that allows detection and compensation for false switch state detections.

[0049] In some embodiments, when the first sensor is aligned with the transition between the first encoding region and the second encoding region, the third sensor is also aligned with the transition between the first encoding region and the second encoding region. In some embodiments, when the second sensor is aligned with the transition between the first encoding region and the second encoding region, the fourth sensor is also aligned with the transition between the first encoding region and the second encoding region.

[0050] In some embodiments, each of the first encoding region and the second encoding region extends the same predetermined angle about the axis of rotation of the component.

[0051] In some embodiments: the predetermined angle is about 15 degrees or 30 degrees.

[0052] In some embodiments, the amount by which the second sensor is offset from the first sensor about the axis of rotation in the first direction is an odd integer multiple of the angle subtended by each first encoding region about the axis of rotation.

[0053] In some embodiments, the second sensor is offset 165 degrees from the first sensor about the axis of rotation in the first direction.

[0054] In some embodiments, each of the first encoding region and the second encoding region includes a length extending in the rotational direction of the component, wherein the dose measurement system includes a third sensor that is offset from the first sensor and the second sensor such that in use when the first sensor is aligned with a first encoding region in the first encoding region and the second sensor is aligned with a second encoding region in the second encoding region, the third sensor is aligned with a different portion along the length of one of the first encoding region and the second encoding region.

[0055] In some embodiments, the processor is configured to determine the dose dispensed from the medicament reservoir by a process that includes counting the number of transitions between the first encoding region and the second encoding region detected by the first sensor and the second sensor.

[0056] In some embodiments, the first sensor and the second sensor are configured to move from an idle position to a detection position, wherein the movement of the sensors to the detection position causes one of the first region and the second region to be aligned with a first encoding region in the first encoding region, and wherein the processor is configured such that when determining the dispensed dose, the processor compensates for the alignment when the sensors move to the detection position.

[0057] This allows for improved accuracy in embodiments where the sensor axially moves to a detection position. This is because, in some embodiments, such axial movement will cause one of the first sensor and the second sensor to align with the first encoding region, which will manifest as an incorrect reading of the transition to the first encoding region. The processor can ignore this incorrect reading to more accurately determine the dispensed dose.

[0058] In some embodiments, the processor is configured to determine the dose dispensed from the medicament reservoir based on a signal from one of the first sensor and the second sensor and an anti-phase signal from the other of the first sensor and the second sensor.

[0059] In some embodiments, the processor is configured to determine the dose dispensed from the medicament reservoir based on the superposition of a signal from one of the first sensor and the second sensor and an anti-phase signal from the other of the first sensor and the second sensor.

[0060] In some embodiments, the processor is configured to determine the dose dispensed from the medicament reservoir by comparing the superposition with a first threshold and a second threshold greater than the first threshold, and preferably counting the number of times the superposition changes from a value below the first threshold to a value greater than the second threshold and / or from a value above the second threshold to a value below the first threshold.

[0061] This helps to improve the accuracy of dose determination by helping to filter out errors such as sensor noise and switch bounce. Additionally, having four sensors can further improve accuracy as two simultaneous errors can be ignored.

[0062] In some embodiments, the dose measurement system has any of the features discussed above.

[0063] In some embodiments, a medicament delivery system is provided that includes a dose measurement system.

[0064] These and other aspects of the present disclosure will become apparent and be elucidated with reference to the embodiments described hereinafter.

[0065] Specifically, the present invention includes but is not limited to the following:

[0066] 1. A medicament delivery device (100) comprising:

[0067] A reservoir for the medicament;

[0068] A dispensing mechanism (104) operable to dispense a medicament from the reservoir, the dispensing mechanism (104) including a sleeve (106, 107, 206, 306, 406) configured to rotate during medicament dispensing and having a plurality of formations (112, 212, 312, 412) at an end of the sleeve (106, 107, 206, 306, 406); and

[0069] A dose measurement system (101, 201, 301, 401) including a processor (115) and at least one mechanically actuated sensor (114, 214A, 214C, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D), the at least one mechanically actuated sensor being configured such that in use, rotation of the sleeve (106, 107, 206, 306, 406) causes successive formations (112, 212, 312, 412) to engage the sensor such that the sensor detects rotation of the sleeve, the processor being configured to determine a dose dispensed from the medicament reservoir based on the detected rotation of the sleeve.

[0070] 2. The medicament delivery device (100) according to item 1, wherein the plurality of formations (112, 212, 312, 412) includes a plurality of teeth.

[0071] 3. The medicament delivery device (100) according to item 1 or item 2, wherein the formations (112, 212, 312, 412) are formed on a proximal end of the sleeve (106, 107, 206, 306, 406).

[0072] 4. The medicament delivery device (100) according to any one of items 1 to 3, wherein the sleeve (106, 107, 206, 306, 406) is a dialing sleeve (106, 206, 306, 406) or a drive sleeve (107).

[0073] 5. The medicament delivery device (100) according to any one of items 1 to 4, wherein the sensor (114, 214A, 214C, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D) comprises a sensing member (118, 218A, 218C, 318A, 318B, 318C, 318D, 418A, 418B, 418C, 418D) configured to move from an unactuated state to an actuated state when the sensing member is engaged by one of the configurations (112, 212, 312, 412) during rotation of the sleeve (106, 107, 206, 306, 406), and wherein the sensor detects movement of the sensing member between the unactuated state and the actuated state.

[0074] 6. The medicament delivery device (100) according to item 5, wherein each configuration (112, 212, 312, 412) comprises a leading edge (112A), and wherein during rotation of the sleeve (106, 107, 206, 306, 406), the engagement of the sensor (114, 214A, 214C, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D) with the leading edge of a first configuration among the configurations to the engagement of the sensor with the leading edge of an adjacent second configuration among the configurations represents one coding cycle, and wherein the sensor is actuated for between 40% and 60% of the coding cycle, and preferably, the sensor is actuated for approximately 50% of the coding cycle.

[0075] 7. The medicament delivery device (100) according to any one of items 1 to 6, comprising a dose dial (108) and a housing (102), wherein the dose dial is configured to rotate relative to the housing to set the dose of medicament to be delivered by the dispensing mechanism (104), and wherein the sensor (114, 214A, 214C, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D) is mounted to the dose dial.

[0076] 8. The medicament delivery device (100) according to item 7, which includes a torque limiter, wherein the sensor (114, 214A, 214C, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D) is mounted to the dose dial (108) via the torque limiter, such that rotation of the dose dial (108) relative to the housing (102) with a torque greater than a predetermined limit causes the torque limiter to move to an open state, such that the dose dial (108) is capable of rotating relative to the sensor, and preferably, the torque limiter includes an overload clutch.

[0077] 9. The medicament delivery device (100) according to item 7 or item 8, which includes a one-way mechanism, wherein the sensor (114, 214A, 214C, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D) is mounted to the dose dial (108) via the one-way mechanism, such that the sensor is impeded from rotating relative to the dose dial (108) in the direction in which the sleeve (106, 107, 206, 306, 406) rotates during medicament dispensing, and is allowed to rotate relative to the dose dial (108) in the opposite direction to the direction in which the sleeve rotates during medicament dispensing.

[0078] 10. A dose measurement system (101, 201, 301, 401, 501) for a medicament delivery device (100), wherein the medicament delivery device includes: a housing (102) that contains a reservoir for the medicament; and a dispensing mechanism (104) that is operable to dispense the medicament from the reservoir and includes a component configured to rotate during medicament dispensing, the component including a plurality of configurations (112, 212, 312, 412, 512); and an actuator (108) that is configured to move relative to the housing (102) upon actuation to operate the dispensing mechanism (104) to dispense the medicament from the reservoir, the dose measurement system (101, 201, 301, 401, 501) includes:

[0079] a sensor (114, 214A, 214C, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D, 514) that is movable from an idle position to a detection position, wherein rotation of the component causes each configuration (112, 212, 312, 412, 512) to be detected by the sensor, such that the sensor detects rotation of the component;

[0080] A processor (115) configured to determine a dose dispensed from the medicament reservoir based on the detected rotation of the component; and

[0081] An activation switch (119, 332, 432) movable from an initial off state to an on state to activate the dose measurement system (101, 201, 301, 401, 501) when the actuator (108) is actuated. The sensors (114, 214A, 214C, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D, 514) are configured to be mounted to the actuator (108) such that actuation of the actuator (108) causes the sensor to move relative to the housing (102) to reach the detection position, wherein the activation switch (119, 332, 432) reaches the on state before the sensor reaches the detection position.

[0082] 11. The dose measurement system (101, 201, 301, 401, 501) according to item 10, wherein the actuator (108) is slidable relative to the housing (102).

[0083] 12. The dose measurement system (101, 201, 301, 401, 501) according to item 10 or item 11, wherein the activation switch (119, 332, 432) includes a pivot member (120) that pivots from the off state to the on state to activate the dose measurement system.

[0084] 13. The dose measurement system (101, 201, 301, 401, 501) according to any one of items 10 to 12, wherein the medicament delivery device (100) includes a stop (122), and wherein the activation switch (119, 332, 432) is configured to rest on the stop (122) when the activation switch (119, 332, 432) is in the off state.

[0085] 14. The dose measurement system (101, 201, 301, 401, 501) according to any one of items 10 to 13, wherein the activation switch (119, 332, 432) is configured to engage a part of the medicament delivery device (100) when the actuator (108) moves to operate the dispensing mechanism (104), such that the activation switch (119, 332, 432) is pushed to the on state, and preferably, the part includes a part of the dispensing mechanism (104).

[0086] 15. The dose measurement system (101, 201, 301, 401, 501) according to any one of items 10 to 14, wherein the activation switch (119, 332, 432) is configured such that the activation switch (119, 332, 432) moves a first distance from the off state to the on state, and the sensor (114, 214A, 214C, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D, 514) is configured such that the sensor moves a second distance from the idle position to the detection position, wherein the second distance is greater than the first distance.

[0087] 16. The dose measurement system (101, 201, 301, 401, 501) according to any one of items 10 to 15, comprising: a first radial support and a second radial support (125, 126), wherein the actuator (108) is rotatably mounted to a part of the device via the first support and the second support (125, 126), and the first support and the second support (125, 126) are axially spaced apart.

[0088] 17. The dose measurement system (101, 201, 301, 401, 501) according to any one of items 10 to 16, comprising a support member (121) and a coupling member (127), wherein the actuator (108) is fixed relative to the support member (121), and wherein the support member (121) is coupled to the coupling member (127).

[0089] 18. The dose measurement system (101, 201, 301, 401, 501) according to any one of items 10 to 17, comprising any feature of the dose measurement system (101, 201, 301, 401) of the medicament delivery device (100) according to any one of items 1 to 9.

[0090] 19. A dose measurement system (201, 301, 401) for a medicament delivery device (100), wherein the medicament delivery device comprises a reservoir for a medicament and a dispensing mechanism (104) operable to dispense the medicament from the reservoir, the dispensing mechanism (104) comprising a component configured to rotate during medicament dispensing, the component comprising a plurality of first encoder regions and a plurality of second encoder regions (223, 323, 423, 224, 324, 424), the dose measurement system comprising:

[0091] A first sensor and a second sensor (214A, 314A, 414A, 214C, 314C, 414C), the first sensor and the second sensor being offset such that in use, rotation of the component causes one of the first encoder regions (223, 323, 423) to align with the first sensor (214A, 314A, 414A) while one of the second encoder regions (224, 324, 424) aligns with the second sensor (214C, 314C, 414C), and then one of the second encoder regions (224, 324, 424) aligns with the first sensor (214A, 314A, 414A) while one of the first encoder regions (223, 323, 423) aligns with the second sensor (214C, 314C, 414C), the first sensor and the second sensor being configured to distinguish the first encoder region and the second encoder region to detect rotation of the component; and

[0092] A processor (115), the processor being configured to determine a dose dispensed from the medicament reservoir based on the detected rotation of the component.

[0093] 20. The dose measurement system (201, 301, 401) according to item 19, wherein the component includes a plurality of configurations (212, 312, 412), wherein each first coding region (223, 323, 423) includes at least a portion of a corresponding configuration that can be detected by the first sensor and the second sensor (214A, 314A, 414A, 214C, 314C, 414C) when the component rotates, and wherein the second encoder region (224, 324, 424) is disposed between adjacent first encoder regions (223, 323, 423).

[0094] 21. The dose measurement system (201, 301, 401) according to item 20, wherein each configuration (212, 312, 412) includes teeth, wherein each first coding region (223, 323, 423) includes at least a portion of a corresponding tooth that can be detected by the first sensor and the second sensor (214A, 314A, 414A, 214C, 314C, 414C) when the component rotates, and wherein each second encoder region (224, 324, 424) includes at least a gap between adjacent teeth.

[0095] 22. The dose measurement system (201, 301, 401) according to any one of items 19 to 21, wherein the first sensor and the second sensor (214A, 314A, 414A, 214C, 314C, 414C) are arranged such that for all rotational positions of the component where the first sensor (214A, 314A, 414A) is aligned with one of the first coding regions (223, 323, 423), the second sensor (214C, 314C, 414C) is aligned with one of the second coding regions (224, 324, 424).

[0096] 23. The dose measurement system (201, 301, 401) according to any one of items 19 to 22, wherein the component includes a plurality of coding cycles (225, 325, 425), each coding cycle including one of the first coding regions (223, 323, 423) and an adjacent second coding region (224, 324, 424), and for a given rotational position of the component, the first sensor (214A, 314A, 414A) is aligned with a part of one of the coding cycles, and the second sensor (214C, 314C, 414C) is aligned with a different part of one of the coding cycles.

[0097] 24. The dose measurement system (401) according to item 23, further comprising a third sensor (414B) which, when the component is in the given rotational position, is aligned with a part of one of the coding cycles (225, 325, 425) that is different from the first sensor and the second sensor (414A, 414C).

[0098] 25. The dose measurement system (401) according to item 24, further comprising a fourth sensor (414D) which, when the component is in the given rotational position, is aligned with a part of one of the coding cycles (225, 325, 425) that is different from the first sensor, the second sensor, and the third sensor (414A, 414C, 414B).

[0099] 26. The dose measurement system (301) according to any one of items 19 to 23, further comprising a third sensor (314B), the third sensor being configured such that in use, when the component rotates, while the first sensor (314A) is aligned with one of the first encoding regions (223, 323, 423), the third sensor (314B) is aligned with one of the first encoding regions (223, 323, 423).

[0100] 27. The dose measurement system (301) according to item 26, further comprising a fourth sensor (314D), the fourth sensor being configured such that in use, when the component rotates, while the second sensor (314C) is aligned with one of the first encoding regions (223, 323, 423), the fourth sensor (314D) is aligned with one of the first encoding regions (223, 323, 423).

[0101] 28. The dose measurement system (201, 301, 401) according to any one of items 19 to 27, wherein each of the first encoding region and the second encoding region (223, 323, 423, 224, 324, 424) extends the same predetermined angle around the rotation axis of the component.

[0102] 29. The dose measurement system (201, 301, 401) according to item 28, wherein the amount by which the second sensor (214C, 314C, 414C) is offset from the first sensor (214A, 314A, 414A) in a first direction around the rotation axis is an odd integer multiple of the angle subtended by each first encoding region (223, 323, 423, 224, 324, 424) around the rotation axis.

[0103] 30. The dose measurement system (201, 301, 401) according to any one of items 19 to 29, wherein the processor (115) is configured to determine the dose dispensed from the medicament reservoir by a process that includes counting the number of transitions between the first encoding region and the second encoding region (223, 323, 423, 224, 324, 424) detected by the first sensor and the second sensor (214A, 314A, 414A, 214C, 314C, 414C).

[0104] 31. The dose measurement system (201, 301, 401) according to any one of items 19 to 30, wherein the first sensor and the second sensor (214A, 314A, 414A, 214C, 314C, 414C) are configured to move from an idle position to a detection position, and the movement of the sensor to the detection position causes one of the first sensor and the second sensor (214A, 314A, 414A, 214C, 314C, 414C) to align with one of the first encoding regions (223, 323, 423, 224, 324, 424), and wherein the processor (115) is configured such that when determining the dispensed dose, the processor (115) compensates for the alignment when the sensor moves to the detection position.

[0105] 32. The dose measurement system (201, 301, 401) according to any one of items 19 to 31, wherein the processor (115) is configured to determine the dose dispensed from the medicament reservoir based on a signal from one of the first sensor and the second sensor (214A, 314A, 414A, 214C, 314C, 414C) and an anti-phase signal from the other of the first sensor and the second sensor (214A, 314A, 414A, 214C, 314C, 414C).

[0106] 33. The dose measurement system (201, 301, 401) according to item 32, wherein the processor (115) is configured to determine the dose dispensed from the medicament reservoir based on a superposition of the signal from one of the first sensor and the second sensor (214A, 314A, 414A, 214C, 314C, 414C) and the anti-phase signal from the other of the first sensor and the second sensor (214A, 314A, 414A, 214C, 314C, 414C).

[0107] 34. The dose measurement system (201, 301, 401) according to item 33, wherein the processor (115) is configured to determine the dose dispensed from the medicament reservoir by comparing the superposition with a first threshold and a second threshold greater than the first threshold, and preferably by counting the number of times the superposition changes from a value below the first threshold to a value greater than the second threshold and / or from a value above the second threshold to a value below the first threshold.

[0108] 35. The dose measurement system (201, 301, 401) according to any one of items 19 to 34, comprising any feature according to any one of items 10 to 18.

[0109] 36. A dose measurement system (101, 201, 301, 401) according to any one of items 1 to 9, comprising a dose measurement system (101, 201, 301, 401, 501), said dose measurement system comprising any feature according to any one of items 10 to 35. BRIEF DESCRIPTION OF THE DRAWINGS

[0110] Embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings, in which:

[0111] Figure 1 is an exploded view of a medicament delivery device;

[0112] Figure 2 is a cross-sectional side view of a part of a medicament delivery device comprising a dose measurement system according to an embodiment;

[0113] Figure 3 is of the medicament delivery device before the actuator has been actuated by a user Figure 2 cross-sectional side view;

[0114] Figure 4 is once the actuator has been actuated by the user Figure 2 cross-sectional side view of the device;

[0115] Figure 5 is Figure 2 perspective view of the coding ring of the device;

[0116] Figure 6 is Figure 2 perspective view of the dialing sleeve of the device;

[0117] Figure 7 is Figure 2 perspective view of a part of the dialing sleeve and the sensor of the device;

[0118] Figure 8 is Figure 2 side view of a part of the dialing sleeve and the sensor of the device, wherein the sensing member is in an unactuated state;

[0119] Figure 9 is Figure 2 perspective view of a part of the dialing sleeve and the sensor of the device, wherein the sensing member is in an actuated state;

[0120] Figure 10 is Figure 2 schematic side view of the sensor of the device, showing the sensing member being actuated;

[0121] Figure 11 is Figure 2Schematic side view of the first and second coding regions of the dialing sleeve of the device;

[0122] Figure 12 is actuating Figure 2 Schematic side view of the first and second coding regions of the sensor of the device;

[0123] Figure 13 is Figure 2 Cross-sectional side view of a part of the device, showing a part of the support member and the coupling member;

[0124] Figure 14 is Figure 2 Cross-sectional side view of a part of the device, showing a part of the coupling member;

[0125] Figure 15 is Figure 2 Schematic block diagram of the dose measurement system of the device;

[0126] Figure 16A Schematic diagram of the sensor of another embodiment of the dose measurement system;

[0127] Figure 16B Schematic diagram of the sensor of another embodiment of the dose measurement system;

[0128] Figure 16C Schematic diagram of the sensor of another embodiment of the dose measurement system;

[0129] Figure 17 shows the signal output from the sensor of the embodiment of Figure 16A ;

[0130] Figure 18 shows the signal output from the sensor of the embodiment of Figure 16A and the superimposed signal;

[0131] Figure 19 is Figure 16B Top view of the sensor and the start switch of the embodiment of

[0132] Figure 20 shows the signal output from the sensor and the start switch of the embodiment of Figure 16B and the superimposed signal;

[0133] Figure 21 is Figure 16C Top view of the sensor and the start switch of the embodiment of

[0134] Figure 22 Perspective view of a part of the dialing sleeve and the sensor of another embodiment; and

[0135] Figure 23 This is a circuit diagram of an embodiment of a dose measurement system. Detailed Description

[0136] In the following disclosure, embodiments will be described with reference to an insulin injection device. However, the present disclosure is not limited to such applications and can be deployed equally well with a medicament delivery device for ejecting other medicaments.

[0137] The term "distal" refers to a position relatively closer to the medicament delivery site (e.g., the injection site in the case of an injection device), and the term "proximal" refers to a position relatively farther from the medicament delivery site.

[0138] Figure 1 This is an exploded view of the medicament delivery device 1. In this example, the medicament delivery device 1 is an injection device 1, such as an insulin injection pen of Sanofi or an insulin injection pen of Sanofi. However, the present disclosure is also compatible with other types and makes of injection pens as described below. The present disclosure is also compatible with other types of medicament delivery devices (such as needle-free injectors). insulin injection pen or an insulin injection pen of Sanofi. However, the present disclosure is also compatible with other types and makes of injection pens as described below. The present disclosure is also compatible with other types of medicament delivery devices (such as needle-free injectors). The injection device 1 is a pre-filled injection pen that includes a housing 2 and contains a reservoir 14 for the medicament, which in this embodiment is an insulin container 14. A needle 15 can be attached to the reservoir 14. The injection device 1 can be disposable or reusable. The needle 15 is protected by an inner needle cap 16 and an outer needle cap 17 and / or an alternative cap 18.

[0139] Figure 1 The insulin dose to be ejected from the injection device 1 can be programmed by moving a dose setting member 12, which in this embodiment is a dose setting dial 12 that can be rotated relative to the housing 2 to allow "dialing in" of the dose. The currently programmed dose is then displayed via a dose window 13, for example, in multiples of units. For example, in the case where the injection device 1 is configured to administer human insulin, the dose can be displayed in so-called international units (IU), where one IU is the biological equivalent of approximately 45.5 micrograms of pure crystalline insulin (1 / 22 mg). Other units can be employed in the medicament delivery device to deliver analogue insulin or other medicaments.

[0140] The dose window 13 can be in the form of an aperture in the housing 2 that allows the user to observe a limited portion of a digital sleeve 10 that is configured to move when the dose setting dial 12 is rotated to provide a visual indication of the currently programmed dose. It should be noted that the selected dose can be equally well with

[0141] The dose window 13 can be in the form of an aperture in the housing 2 that allows the user to observe a limited portion of a digital sleeve 10 that is configured to move when the dose setting dial 12 is rotated to provide a visual indication of the currently programmed dose. It should be noted that the selected dose can be equally well with Figure 1are displayed differently as shown in dose window 13. For example, due to space limitations of the digital sleeve 10, only every other dose unit may be shown. The unnumbered dose units may be represented by tick marks between the displayed numbers. Alternatively, the digital sleeve 10 may remain stationary during the dose dialing phase, and the dose window 13 may move as doses are dialed in to reveal the numbers corresponding to the dialed dose. In either case, the digital sleeve 10 may be a rotating component when a dose is dispensed from the injection device 1.

[0142] In this example, the dose setting dial 12 includes one or more configurations 12a, 12b, 12c that facilitate programming as they improve the grip that the user feels when holding the dose setting dial 12. In another example (not shown), the dose setting dial does not include a configuration.

[0143] The injection device 1 may be configured such that turning the dose setting dial 12 causes a mechanical click to provide acoustic feedback to the user. The digital sleeve 10 interacts mechanically with the piston in the insulin container 14. When the needle 15 is inserted into the skin portion of the patient and then the dose setting dial 12 is axially pushed relative to the housing 2, the insulin dose displayed in the display window 13 will be ejected from the injection device 1. Thus, the dose setting dial 12 forms an actuator that can be actuated by the user to dispense the medicament. When the needle 15 of the injection device 1 remains in the skin portion for a certain time after the dose setting dial 12 has been pushed, a higher percentage of the dose is actually injected into the patient. The ejection of the insulin dose may also cause a mechanical click, however, the mechanical click is different from the sound generated when the dose setting dial 12 is rotated to set the dose to be delivered. [[ID=৮]]

[0144] [[ID=৯]]The injection device 1 includes a dialing sleeve 10 which, in the present embodiment, is the same component as the digital sleeve 10. In other embodiments (not shown), the dialing sleeve 10 may be fixed to the proximal end of the digital sleeve 10.

[0145] The dialing sleeve 10 has a proximal end close to the dose setting dial 12. The dialing sleeve 10 (and the digital sleeve 10 which is the same component) rotates relative to the dose setting dial 12 during dose ejection, rather than during dose dialing. During dose dialing, the user rotates the dose setting dial 12 relative to the housing ๒, which causes the dialing sleeve 10 to rotate correspondingly relative to the housing ๒.

[0146] To operate the injection device 1 to dispense a medicament from the container 14, the dose setting dial 12 is configured to move axially a short distance relative to the housing 2 and the selection sleeve 10 of the injection device 1. This movement occurs when the user applies a force on the end of the dose setting dial 12. For example, the user axially pushes the dose setting dial 12 towards the injection site. This movement disengages a clutch (not shown) and allows the selection sleeve 10 and other internal components of the injection device 1 to rotate relative to the dose setting dial 12. Alternatively, the injection device 1 may include a separate injection button ( Figure 1 not shown in) that is mounted to the dose setting dial 12 and moves axially relative to the housing 2 so that the medicament is dispensed. The injection button may be located at the proximal end of the dose setting dial 12.

[0147] In various embodiments, during the delivery of an insulin dose, the dose setting dial 12 moves axially to its initial position (i.e., without rotation), while the digital sleeve 10 rotates to return to its initial position, for example, to display a dose of zero units.

[0148] The injection device 1 can be used for a number of injection procedures until the insulin container 14 is emptied or the medicament in the injection device 1 reaches its expiration date (e.g., 28 days after first use).

[0149] Before the first use of the injection device 1, 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 two units of insulin and pressing the dose setting dial 12 while keeping the needle 15 of the injection device 1 pointing upwards. For the sake of presentation, hereinafter, it will be assumed that the ejected dose substantially corresponds to the injection dose, such that, for example, the number of dose units of the medicament ejected from the injection device 1 is equal to the number of dose units of the medicament received by the user. However, in some applications of the device, it may be necessary to consider the difference (e.g., loss) between the ejected volume and the injection dose.

[0150] Now referring to Figures 2 to 15 , an embodiment of a medicament delivery device 100 is shown. The medicament delivery device 100 is similar to the medicament delivery device 1 described with respect to Figure 1 and therefore the detailed description of the common features of the medicament delivery device 100 will not be repeated hereinafter. The difference is that the medicament delivery device 100 includes a dose measurement system 101.

[0151] The medicament delivery device 100 includes a housing 102 that contains a reservoir (not shown) for the medicament. The medicament delivery device 100 further includes a dispensing mechanism 104 that is operable to dispense the medicament from the reservoir.

[0152] The dispensing mechanism 104 includes a clutch 105, a selector sleeve 106, a drive sleeve 107, a drive member (not shown), a plunger rod (not shown), and a piston (not shown). The drive member may include a biasing member (not shown, such as a spring) and is configured to bias the drive sleeve 107 to rotate relative to the housing 102.

[0153] The drive sleeve 107 is coupled to the plunger rod such that rotation of the drive sleeve 107 in a first rotational direction (shown by the arrow “X” in Figures 7 to 11 causes the plunger rod to axially move in a distal direction to dispense a medicament from the reservoir. More specifically, a piston (not shown) is mounted to the distal end of the plunger rod such that during rotation of the drive sleeve 107 in the first rotational direction X, the axial movement of the plunger rod in the distal direction causes the piston to slide distally within the reservoir to dispense the medicament therefrom.

[0154] In one embodiment, the drive sleeve 107 and the plunger rod include corresponding threads (not shown) that are engaged such that rotation of the drive sleeve 107 causes axial movement of the plunger rod. In other embodiments (not shown), the drive sleeve 107 is coupled to the plunger rod via one or more intermediate members (not shown).

[0155] The clutch 105 is initially in an engaged position in which the clutch 105 prevents the drive sleeve 107 from rotating in the first rotational direction X under the force of the drive member. In some embodiments, the clutch 105 has one or more splines (not shown) or other engagement elements that engage the drive sleeve 107 or another component when the clutch 105 is in the engaged position to prevent the drive sleeve 107 from rotating relative to the housing 102.

[0156] The medicament delivery device 100 further includes a dose setting member 108, which in the present embodiment is a dose setting dial 108 mounted to the proximal end of the housing 102. The dose of medicament to be dispensed from the medicament delivery device 100 can be programmed or “dialed in” by rotating the dose setting dial 108, and the currently programmed dose is then displayed, for example, in multiples of units, via a dose window (not shown). In some embodiments, the dose setting dial 108 rotates relative to the housing 102 in a second rotational direction opposite to the first rotational direction X such that the selector sleeve 106 also rotates relative to the housing 102 in the second rotational direction from an initial position (representing “zero” dose) until the desired dose is selected.

[0157] The dialing sleeve 106 has a proximal end near the dose setting dial 108. The dialing sleeve 106 (and the digital sleeve 106 which is the same component) rotates relative to the dose setting dial 108 during dose ejection, rather than during dose dialing. In other embodiments (e.g., embodiments where the dose setting dial 108 includes a separate actuator (such as a button)), the dialing sleeve 106 does not rotate relative to the dose setting dial 108 during dose ejection, but rather the dose setting dial 108 rotates with the dose sleeve 106, and optionally, both the dose setting dial 108 and the dialing sleeve 106 rotate relative to the actuator.

[0158] During dose dialing, the user rotates the dose setting dial 108 relative to the housing 102 in a second rotational direction, which causes a corresponding rotation of the dialing sleeve 106 relative to the housing 102.

[0159] The dispensing mechanism 104 further includes a digital sleeve 106, which is the same component as the dialing sleeve 106 in this embodiment. In other embodiments (not shown), the dialing sleeve may be fixed to the digital sleeve.

[0160] The user will be able to determine that the desired dose has been selected by observing the digital sleeve 106 through an observation window (not shown) in the housing 102.

[0161] The dose setting dial 108 forms an actuator that can be actuated by the user to dispense the medicament. More specifically, the dose setting dial 108 is axially slidable relative to the housing 102 to operate the dispensing mechanism 104 to dispense the medicament from the reservoir. In some embodiments, rotation of the dose setting dial 108 in the second rotational direction during dose dialing causes the dose setting dial to move axially in the proximal direction. In other embodiments, rotation of the dose setting dial 108 in the second rotational direction during dose dialing does not cause the dose setting dial 108 to move axially.

[0162] In operation, the dose setting dial 108 is configured to axially move a short distance relative to the housing 102. This movement occurs when a user applies a force to the dose setting dial 108 (e.g., the user axially pushes the dose setting dial 108 in the distal direction toward the injection site). This axial movement of the dose setting dial 108 disengages the clutch 105 such that the clutch 105 moves to a disengaged position. For example, the distal movement of the dose setting dial 108 may cause a corresponding distal movement of the clutch 105 which disengages the clutch 105, e.g., disengages splines or other engagement elements (not shown). Disengaging the clutch 105 allows the selector sleeve 106 and the drive sleeve 107 to rotate relative to the housing 102 and the dose setting dial 108 in a first rotational direction X under the force of the drive member to dispense a medicament from the reservoir.

[0163] As long as the dose setting dial 108 remains depressed by the user, the clutch 105 will remain in the disengaged position and thus the selector sleeve 106 and the drive sleeve 107 will continue to rotate in the first rotational direction X under the force of the drive member to deliver the medicament to the user until the selector sleeve 106 reaches the initial position. The dose setting dial 108 may be biased proximally by a dial biasing member (not shown).

[0164] The selector sleeve 106 includes a cylindrical body 110 and an encoder ring 111 disposed at the proximal end of the body 110. In the present embodiment, the encoder ring 111 is attached to the body 110, but in other embodiments, the encoder ring 111 may be integrally formed with the body 110 (e.g., the encoder ring 111 and the body 110 are molded or cast from a single piece of material).

[0165] The encoding ring 111 includes a plurality of formations 112 which are teeth 112 in the present embodiment, with gaps 113 therebetween. The teeth 112 extend proximally.

[0166] The dose measurement system 101 further includes a mechanically actuated sensor 114 which is configured such that in use, rotation of the selector sleeve 106 in the first rotational direction X causes successive formations 112 to engage the sensor 114 such that the sensor 114 detects rotation of the selector sleeve 106.

[0167] The dose measurement system 101 further includes one or more processors 115 which are configured to determine the dose dispensed from the medicament reservoir based on the detected rotation of the selector sleeve 106. The processor 115 may include, for example, a microprocessor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), etc.

[0168] The dose measurement system 101 further includes one or more computer-readable storage media. In this embodiment, the computer-readable storage media includes memory units 116A, 116B, which include a program memory 116A and a main memory 116B, and can store software executed by the processor 115.

[0169] The dose measurement system 101 further includes a battery 109 configured to power the dose measurement system 101.

[0170] The dose measurement system 100 further includes an output 117. The output 117 can be a wireless communication interface for communicating with another device via a wireless network (such as Wi-Fi or ) or an interface for a wired communication link, such as a socket for receiving a Universal Serial Bus (USB), Mini-USB, or Micro-USB connector.

[0171] In this embodiment, the sensor 114 is a mechanically actuated switch 114. In a specific embodiment, the sensor 114 is a C&K(TM) HDT0001 switch.

[0172] In some embodiments, when the structure 112 engages the switch 114 during rotation of the dial sleeve 106, the switch 114 moves from one of an open state or a closed state to the other of the open state or the closed state.

[0173] The sensor 114 includes a sensing member 118 configured to move from an unactuated state to an actuated state when the sensing member 118 is engaged by one of the structures 112 during rotation of the dial sleeve 106. The sensor 114 is configured to detect the movement of the sensing member 118 between the unactuated state and the actuated state. The sensing member 118 can be a pivot member 118 that rotates when the sensing member 118 is engaged by one of the structures 112 during rotation of the dial sleeve 106.

[0174] In some embodiments, each structure 112 includes a leading edge 112A arranged such that when the dial sleeve 106 rotates in a first rotational direction X, the leading edge 112A of each structure 112 sequentially abuts the sensor 114. In some embodiments, during rotation of the dial sleeve 106, the engagement of the sensor 114 with the leading edge 112A of the first structure in the structures 112 to the engagement of the sensor 114 with the leading edge 112A of the adjacent second structure in the structures 112 represents one coding cycle.

[0175] In some embodiments, the sensor 114 is actuated for between 40% and 60% of the coding cycle. Preferably, the sensor 114 is actuated for approximately 50% of the coding cycle. When the dialing sleeve 106 rotates in the first rotational direction X during the medicament dispensing process, the sensor 114 is actuated for 50% of the angular position of the dialing sleeve 106 during one complete rotation, and the sensor 114 is not actuated for the remaining 50% of the angular position of the dialing sleeve 106.

[0176] In some embodiments, the medicament delivery device 100 includes a torque limiter (not shown). The sensor 114 is mounted to the dose setting dial 108 via the torque limiter such that rotation of the dose dial 108 relative to the housing 102 with a torque greater than a predetermined limit causes the torque limiter to move to an open state such that the dose setting dial 108 rotates relative to the sensor 114. Optionally, the torque limiter includes an overload clutch (not shown).

[0177] As explained above, in some embodiments, axially pressing the dose setting dial 108 relative to the housing 102 disengages the clutch 105 to allow the dialing sleeve 106 and the drive sleeve 107 to rotate relative to the housing 102 and the dose setting dial 108. In some embodiments, with the dose setting dial 108 depressed and the clutch 105 in the disengaged state, a user can grasp the dialing sleeve 106 and overcome the force of the drive mechanism to rotate the dialing sleeve relative to the dose setting dial 108 in the second rotational direction. Such an unintended operation of the device 100 may cause damage to the device 100. In particular, the sensing member 118 of the sensor 114 can be shaped and arranged to detect rotation of the dialing sleeve 106 relative to the dose setting dial 108 in the first rotational direction, i.e., such that the sensing member 118 moves unobstructed over the structure 112. Conversely, if the dialing sleeve 106 is forced relative to the dose setting dial 108 in the second rotational direction, this may cause the structure 112 of the dialing sleeve 106 to obstruct the sensing member 118 of the sensor 114, which may cause damage to the sensing member 118 or misalignment of the sensing member 118 relative to the structure 112.

[0178] In some embodiments, the medicament delivery device 100 includes a one-way mechanism (not shown). The one-way mechanism can be configured to mitigate the above situation.

[0179] In one embodiment, the sensor 114 is mounted to the dose setting dial 108 via a one-way mechanism such that rotation of the sensor 114 relative to the dose setting dial 108 is impeded by the one-way mechanism. Thus, in normal operating conditions, when the clutch 105 is disengaged and the selector sleeve 106 rotates in the first rotational direction X during drug dispensing, the structure 112 moves on the sensing member 114 and the sensing member 114 remains stationary via the one-way mechanism such that relative rotation between the structure 112 and the sensing member 114 can be detected.

[0180] The one-way mechanism is configured to allow the sensor 114 to rotate relative to the dose setting dial 108 in a second rotational direction. Thus, in the non-intended operating scenario discussed above in which the user disengages the clutch 105 and then forces the selector sleeve 106 in the second rotational direction, the structure 112 will be urged against the sensing member 118 and will urge the sensor 114 to also rotate in the second rotational direction. The one-way mechanism allows the sensor 114 to rotate in the second rotational direction, and thus the sensor 114 will rotate relative to the dose setting dial 108 in the second rotational direction together with the selector sleeve 106, and thus will not force the structure 112 past the sensing member 118, and thus will prevent damage to the sensing member 118 and / or the structure 112. In some embodiments, the one-way mechanism may include ratchet teeth on one or both of the dose setting dial 108 and the sensor 114.

[0181] The sensor 114 is mounted to the dose setting dial 108 such that axial movement of the dose setting dial 108 relative to the housing 102 to operate the dispensing mechanism 104 to dispense a drug also causes the sensor 114 to move axially. More specifically, the sensor 114 moves from an idle position ( Figure 3 as shown) to a detection position ( Figure 4 as shown), in which idle position the sensor 114 is spaced apart from the structure 112 in the axial direction of the drug delivery device 100, and in which detection position the sensor 114 moves distally such that rotation of the selector sleeve 106 causes the structure 112 to be detected by the sensor 114 one by one, such that the sensor 114 detects rotation of the selector sleeve 106. In the present embodiment in which the sensor 114 includes a mechanical switch 114, when the sensor 114 is in the detection position, as the selector sleeve 106 rotates in the first rotational direction X, the structure 112 physically engages the sensor 114.

[0182] The drug delivery device 100 further includes an activation switch 119, which can be moved from an initial off state ( Figure 3is moved to an ON state to activate the dose measurement system 101 when the dose setting dial 108 is actuated. For example, the movement of the start switch 119 to the ON state can wake up or power on one or more of the sensors 114, processors 115, or other components of the dose measurement system 101.

[0183] In the present embodiment, the start switch 119 is mounted to the dose setting dial 108 such that the start switch 119 moves with the dose setting dial 108 such that the start switch 119 is urged against a component of the medicament delivery device 100 (e.g., the drive sleeve 107) to move the start switch 119 to the ON state.

[0184] In another embodiment (not shown), the start switch 119 is mounted to a component of the medicament device 100 other than the dose setting dial 108, wherein the sliding movement of the dose setting dial 108 during actuation causes the dose setting dial 108 or a portion connected to the dose setting dial 108 to be urged against the start switch 119 to move the start switch 119 to the ON state. For example, the start switch 119 can be mounted to the proximal end of the drive sleeve 107.

[0185] The sensor 114 and the start switch 119 are configured such that when the user actuates the dose setting dial 108 by sliding the dose setting dial 108 in the distal direction, the start switch 119 reaches the ON state before the sensor 114 reaches the detection position. This helps to ensure that the dose measurement system 101 has time to power on before the sensor 114 reaches the detection position to detect the rotation of the selection sleeve 106. Thereby, the measurement accuracy of the dose dispensed by the dispensing mechanism 104 is increased.

[0186] Those skilled in the art will recognize that many different types of start switches 119 can be used, e.g., relays, analog switches, pressure sensors, push switches, or flick switches. In one embodiment, the start switch 119 includes a Panasonic (TM) ESE13 switch.

[0187] In the present embodiment, the start switch 119 includes a pivot member 120 that pivots from a closed state to an open state to activate the dose measurement system 101. The pivot member 120 is pivotally connected to the dose setting dial 108.

[0188] The activation switch 119 is configured to engage a portion of the medicament delivery device 100 when the dose setting dial 108 is axially moved to operate the dispensing mechanism 104, such that the activation switch 119 is urged to an ON state. In some embodiments, the portion includes a part of the dispensing mechanism 104, for example, the drive sleeve 107. In some embodiments where the activation switch 119 includes a pivot member 120, the pivot member 120 engages the portion of the medicament delivery device 100 when the dose setting dial 108 is axially moved, such that the pivot member 120 rotates from an OFF state to an ON state relative to the dose setting dial 108.

[0189] In some embodiments, the medicament delivery device 100 includes a stop 122, and wherein the activation switch 119 is configured to rest on the stop 122 when the activation switch 119 is in the OFF state.

[0190] In some embodiments, the medicament delivery device 100 includes a support member 121. The support member 121 projects axially from the dose setting dial 108 in a distal direction. The support member 121 is generally cylindrical and is configured to be received within a bore of the drive sleeve 107. When the dose setting dial 108 is actuated, the support member 121 moves into the drive sleeve 107. The support member 121 may be attached to the dose setting dial 108 or integrally formed with the dose setting dial. In one embodiment, the support member 121 is mounted to the activation switch 119.

[0191] Optionally, the support member 121 includes a stop 122 against which the activation switch 119 abuts when the activation switch 119 is in the OFF state. The stop 122 may be in the form of a stop surface 122 of the support member 121. In this embodiment, the pivot member 120 abuts the stop surface 122 when the activation switch is in the OFF state. During actuation of the actuator 109, when the pivot member 120 is urged against the drive sleeve 107, the pivot member 120 rotates away from the stop surface 122. Once the activation switch 119 reaches the ON state, the pivot member 120 may further rotate to accommodate additional axial movement of the dose setting dial 108 relative to the housing 102 in the distal direction, such that the dose measurement system 101 remains powered on. In other embodiments, the activation switch 119 only needs to be briefly moved to the ON state to power on the dose measurement system 101, after which time the dose measurement system 101 will remain powered on until the battery is depleted or for a set period of time, regardless of the subsequent position of the activation switch 119.

[0192] In some embodiments, the activation switch 119 is configured such that the activation switch 119 moves a first distance D from the OFF state to the ON state (as Figure 3(as shown), and the sensor 114 is configured such that the sensor 114 moves a second distance D2 from the idle position to the detection position (as Figure 3 (as shown). The second distance D2 is greater than the first distance D1 such that the activation switch 119 reaches the on state before the sensor 114 reaches the detection position. The dose setting dial 108 must be axially moved a first distance D1 to move the activation switch 119 to the on state and must be axially moved a second distance D2 to move the sensor 114 to the detection position. Both the first distance D1 and the second distance D2 may extend in the axial direction of the medicament delivery device 100.

[0193] In Figure 3 , once the pivot member 120 is urged against the selector sleeve 107, the activation switch 119 moves from the off state to the on state to power the processor. However, it should be appreciated that in alternative embodiments (not shown), the pivot member 120 rotates partially or fully after abutting the selector sleeve 107 before the activation switch 119 moves to the on state and the processor is powered on. The point at which the activation switch 119 moves to the on state is the switching point of the activation switch 119.

[0194] Similarly, in Figure 3 , when the sensing member 118 overlaps one of the structures 112 in the axial direction of the device 100, the sensor 114 moves from the idle position to the detection position such that if the sensor 114 is aligned with the structure 112 in the rotational direction, the sensing member 118 will start to rotate and this is detected by the processor. However, it should be appreciated that in alternative embodiments (not shown), the sensing member 118 rotates partially or fully after abutting the structure 112 before this movement is detected, and this position of the sensing member 118 is the switching point of the sensing member 118. In other words, the detection position of the sensor 114 may be the position where the switching point of the sensing member 118 is axially aligned with the structure 112.

[0195] When the dose setting dial 108 is axially moved, the switching point of the activation switch 119 is reached before the switching point of the sensor 114.

[0196] In some embodiments, the dose setting dial 108 must be axially moved a third distance D3 (as Figure 3 shown) to operate the dispensing mechanism 104 to dispense the medicament, for example, to disengage the clutch 105. The third distance D3 may be greater than the first distance D1 and the second distance D2 to help ensure that the medicament is not dispensed from the reservoir until the activation switch 119 has moved to the on state and the sensor 114 has moved to the detection position.

[0197] In some embodiments, the support member 121 is rotatably coupled to a component of the medicament delivery device 100 via a first support member 125 and a second support member 126. The first support member 125 and the second support member 126 may be radial support members. However, it should be appreciated that one of the first radial support member 125 and the second radial support member 126 may be omitted.

[0198] In this embodiment, the support member 121 is rotatably coupled to the coupling member 127 via the first support member 125 and the second support member 126. However, it should be appreciated that in other embodiments, the coupling member 127 is omitted.

[0199] The first support member 125 includes a curved inner surface 121A of the support member 121 and a curved outer surface 127A of the coupling member 127. The inner surface 121A and the outer surface 127A may be cylindrical. The inner surface 121A and the outer surface 127A may extend circumferentially about the longitudinal axis of the medicament delivery device 100.

[0200] The inner surface 121A and the outer surface 127A engage to form the first radial support member 125 such that the support member 121 can rotate relative to the coupling member 127, wherein the inner surface 121A of the support member 121 slides on the outer surface 127A of the coupling member 127.

[0201] The second support member 126 includes a circumferentially extending groove 121B of the support member 121 and a rib 127B of the coupling member 127. The rib 127B is received within the groove 121B. The rib 127B and the groove 121B form the second radial support member 126 such that the support member 121 can rotate relative to the coupling member 127, wherein the rib 127B rotates within the groove 121B. In some embodiments, the engagement of the rib 127B and the groove 121B axially secures the support member 121 and the coupling member 127 relative to each other.

[0202] It should be appreciated that in alternative embodiments (not shown), the support member 121 may include a groove that receives a rib of the coupling member 127 to form the second support member 126.

[0203] The coupling member 127 is fixed in the rotational direction relative to the selection sleeve 106. The coupling member 127 may be slidably mounted to the sleeve 106 such that the coupling member 127 can axially move together with the dose setting dial 108 during actuation. For example, the coupling member 127 may be slidably mounted on a longitudinal member that extends distally from the coupling member 127 and is connected to an internal portion of the medicament delivery device 100. In another embodiment, the coupling member 127 is mounted to the clutch 105 such that actuation of the dose setting dial 108 axially urges the coupling member 127, which in turn axially urges the clutch 105 to disengage.

[0204] Optionally, the device 100 further includes a pivot 128. In Figure 14 FIG., the pivot 128 is shown in the form of a pivot point 128A, including a rounded protrusion 128A that extends proximally from the proximal end of the coupling member 127 (the pivot point 128A is not shown in Figure 13 FIG.). The protrusion 128A abuts a generally flat distally facing surface of the support member 121. In an alternative embodiment (not shown), the rounded protrusion is provided on the distally facing surface of the support member 121 and abuts the proximally facing surface of the coupling member 127.

[0205] The pivot 128 is configured to allow rotation of the dose setting dial 108 relative to the coupling member 127 (e.g., due to rotation of the coupling member 127 relative to the dose setting dial 108 during medicament dispensing). The pivot 128 helps to minimize the contact surface area between the support member 121 and the coupling member 127 and thus reduce the friction therebetween.

[0206] The pivot 128 is configured such that if a user applies a force on the dose setting dial 108 that urges the dose setting dial 108 to tilt relative to the housing 102, e.g., by applying an off-center force at the peripheral edge of the dose setting dial 108, the dose setting dial 108 will be urged to tilt about the pivot 128. However, the first radial support 125 and the second radial support 126 are configured to resist the tilting of the dose setting dial 108, and thus the radial supports 125, 126 help to maintain alignment of the dose setting dial 108 with the housing 102.

[0207] More specifically, it is desirable to prevent the dosing dial 108 from tilting relative to the housing 102, as such tilting could otherwise result in misalignment of the sensor 114 relative to the structure 112. For example, if the user presses on the edge of the dosing dial 108 during actuation, this could cause the dosing dial 108 to be urged to tilt relative to the longitudinal axis of the medicament delivery device 100 such that the proximal end of the dosing dial 108 is no longer perpendicular to the longitudinal axis and is now instead angled thereto. To help prevent this, the second support member 126 is located distally of the first support member 125. Thus, if the user applies a force to the dosing dial 108 that causes the dosing dial 108 to tilt, the second support member 126 will provide a reaction force that prevents the dosing dial 108 from tilting. The spacing of the second support member 126 from the pivot 128 means that the reaction force required for the second support member 126 to stabilize the dosing dial 108 and prevent tilting is less than the reaction force when the second support member 126 is positioned closer to the pivot 128.

[0208] The second support member 126 may be located radially outside of the first support member 125, in other words, further from the longitudinal axis of the medicament delivery device 100 than the first support member 125. That is, the second support member 126 may have a greater diameter than the first support member 125. Thus, compared to the first support member 125 having a greater diameter, if the dosing dial 108 rotates while tilting, the reaction torque applied by the first support member 125 is reduced. This reduces the friction that impedes the rotation of the dosing dial 108. The second support member 126 has a greater diameter than the first support member 125 to provide support when the dosing dial setting 108 tilts about the pivot 128.

[0209] Optionally, the support member 121 or another component may include the aforementioned stop 122 against which the activation switch 119 abuts when in the closed state.

[0210] The operation of the medicament delivery device 100 will now be described. The user dials in the dose to be delivered by rotating the dosing dial 108 relative to the housing 102 in a second rotational direction, which causes the selection sleeve 106 to rotate correspondingly relative to the housing 102 in the second rotational direction until the desired dose is displayed in a dose window (not shown). A needle (not shown) is inserted into the injection site of the patient.

[0211] To deliver a dose of medicament, the user axially pushes the dose setting dial 108 in the distal direction into the housing 102. This causes the sensor 114 and the activation switch 119 mounted to the dose setting dial 108 to axially move in the distal direction. The axial movement of the dose setting dial 108 first causes the activation switch 119 to abut against the drive sleeve 107, such that the activation switch 119 moves to the on state and thus the processor 115 of the dose measurement system 101 is powered on.

[0212] The continued movement of the dose setting dial 108 in the distal direction causes the sensor 114 to move to a detection position, where the sensor 114 overlaps with the structure 112 in the axial direction of the medicament delivery device 100, and then operates the dispensing mechanism 104 to expel the medicament from the reservoir for delivery via the needle. For example, the medicament delivery device 100 may include a release mechanism that is activated to release the drive member when the dose setting dial 108 has been moved distally to an axial position where the sensor 114 is in the detection position, or in other embodiments, when the dose setting dial 108 has been further moved distally to an axial position (e.g., moved a third distance D3).

[0213] In the present embodiment, the movement of the dose setting dial 108 relative to the housing 102 by the third distance D3 causes the clutch 105 to disengage, such that the clutch 105 moves to the disengaged position. Accordingly, the selection sleeve 106 and the drive sleeve 107 are allowed to rotate relative to the housing 102 and the dose setting dial 108 in the first rotational direction X under the force of the drive member to dispense the medicament from the reservoir. In another embodiment (not shown), the clutch 105 disengages when the dose setting dial 108 has been moved relative to the housing 102 by a second distance D2 while the sensor 114 reaches the detection position.

[0214] The sensor 114 detects the rotation of the selection sleeve 106 relative to the housing 102 in the first rotational direction X during the medicament dispensing process, such that the processor 115 can determine the dose delivered by the medicament delivery device 100. In particular, the rotation of the selection sleeve 106 causes each structure 112 to be pushed against the sensing member 118, such that the sensing member 118 repeatedly moves between the unactuated state ( Figure 8 as shown) and the actuated state ( Figure 9 as shown).

[0215] The processor 115 is configured to determine the delivered dose based on the movement of the sensing member 118. For example, the processor 115 may be configured to count the number of times the sensing member 118 transitions from an unactuated state to an actuated state and / or the number of times the sensing member 118 transitions from an actuated state to an unactuated state. The memories 116A, 116B may be programmed with information or instructions that allow the processor 115 to convert the number of transitions into the delivered dose.

[0216] When the dial sleeve 106 rotates in the first rotational direction X, a portion of the leading edge 112A of the first configuration 112 will abut the sensing member 118 and urge the sensing member 118 from an unactuated state to an actuated state, such that the sensor 114 transitions from outputting a low (LOW) signal to outputting a high (HIGH) signal. This indicates the start of the first encoding region 123 and the end of the second encoding region 124. As the dial sleeve 106 continues to rotate in the first rotational direction X, the configuration 112 will remain engaged with the sensing member 118 such that the sensing member 118 remains in the actuated state. When the configuration 112 begins to pass by the sensor 114, the sensing member 118 will begin to move back toward the unactuated state while still being engaged with the configuration 112. In some embodiments, the sensing member 118 is biased into the unactuated state by a biasing member (not shown, such as a spring).

[0217] As the dial sleeve 106 further rotates in the first rotational direction X, the sensing member 118 will reach the unactuated state, and thus the sensor 114 will transition from outputting a high signal to outputting a low signal. This indicates the end of the first encoding region 123 and the start of the second encoding region 124. The sensor 114 will then align with the gap 113 adjacent to the configuration 112, and thus, the sensing member 118 will remain in the unactuated state, and thus, the sensor 114 will output a low signal until the dial sleeve 106 rotates to a position in which a portion of the leading edge 112A of the second configuration 112 adjacent to the first configuration 112 abuts the sensing member 118 and urges the sensing member 118 from the unactuated state to the actuated state, such that the sensor 114 again transitions from outputting a low signal to outputting a high signal.

[0218] Rotation of the dial sleeve 106 in the first rotational direction X thus causes the sensor 114 to generate an oscillating signal, e.g., a square wave signal. The signal is input to the processor 115. The processor 115 can then use edge detection to determine the angular displacement of the dial sleeve 106 and thereby determine the dose dispensed from the medicament reservoir.

[0219] Figure 10 and Figure 12 depicts the movement of the sensing member 118 between the unactuated and actuated states, which shows a schematic illustration of the sensor 114 and the configuration 112.

[0220] The dialing sleeve 106 includes a plurality of first coding regions 123 and a plurality of second coding regions 124 that are alternately arranged around the rotation axis of the dialing sleeve 106. Each first coding region 123 starts when the sensing member 118 is urged to the actuated state by the corresponding structure 112 adjacent to the sensing member 118, causing the sensor 114 to transition to output a high signal; and ends when the structure 112 passes by the sensor 114, causing the sensing member 118 to move back to the unactuated state and the sensor 114 to transition to output a low signal. Each second coding region 124 starts at a rotational position of the dialing sleeve 106 where the sensing member 118 reaches the actuated state in which the sensor 114 outputs a low signal; and ends when the sensing member 118 is pushed to the unactuated state by an adjacent structure 112 adjacent to the sensing member 118, causing the sensor 114 to output a high signal.

[0221] The sensor 114 is thus able to distinguish between the first coding region 123 and the second coding region 124 because when the sensor 114 is aligned with the first coding region 123, the sensing member 118 is in the unactuated state and the sensor 114 outputs a high signal (or in an alternative embodiment, a low signal), and when the sensor 114 is aligned with the second coding region 124, the sensing member 118 is in the actuated state and the sensor 114 outputs a low signal (or in the alternative embodiment, a high signal).

[0222] Each first coding region 123 faces a predetermined angle about the axis of rotation of the dialing sleeve 106, and each second coding region 124 faces the same predetermined angle about the axis of rotation of the dialing sleeve 106. This does not necessarily mean that the structure 112 faces the same angle as the gap 113 between the structures 112 about the axis of rotation of the dialing sleeve 106. This is because the sensing member 118 and the structure 112 are arranged such that even when the vertex 112B of the structure 112 passes through the vertex 118A of the sensing member 118, the sensing member 118 remains in the actuated state. For example, the trailing edge 112C of the structure 112, which normally faces the circumferential direction opposite to the leading edge 112A, can still be adjacent to the sensing member 118 to prevent the sensing member 118 from returning to the unactuated state. This is called "ON drag" and refers to the relative movement required between the engaged structure 112 and the sensor 114 before the sensing member 118 can be turned back into the unactuated state once the sensing member 118 has been turned into the actuated state. In one embodiment, the structure 112 and the sensing member 118 are arranged such that the engaged structure 112 must move 1 mm relative to the sensing member 118 before the sensing member 118 can be turned back into the unactuated state. Once engaged and moved into the actuated state by the structure 112, the sensing member 118 remains in the actuated state for 1 mm of travel of the structure 112.

[0223] In some embodiments, the size and / or shape of each structure 112 is adjusted to account for the ON drag such that the sizes of the first coding region 123 and the second coding region 124 remain equal. For example, the angle at which each structure 112 faces about the axis of rotation of the dialing sleeve 106 can reduce the magnitude of the ON drag (shown by arrow D4 in Figure 11 and Figure 12 ).

[0224] In some alternative embodiments (not shown), the sensor 114 outputs a high signal when the sensing member 118 is in the unactuated state and a low signal when in the actuated state. In yet other embodiments, the sensor 114 outputs an analog signal that depends on the position of the sensing member 118, e.g., a signal that is below a predetermined value when the sensing member 118 is in the unactuated state and above the predetermined value when in the actuated state. In some embodiments, the signal is generally sinusoidal when the dialing sleeve 106 rotates in the first rotational direction X.

[0225] In one embodiment, the processor 115 is configured to determine the dose dispensed from the reservoir by counting the number of low-to-high transitions and high-to-low transitions of the signal output by the sensor 114. In some embodiments, this involves edge counting of the signal generated by the sensor 114, e.g., positive and / or negative edge counting.

[0226] Processor 115 can thus determine the rotational displacement of the dialing sleeve 106 during the medicament delivery, the resolution of which is equal to the angle subtended by each of the first coding region 123 and the second coding region 124 around the rotational axis of the dialing sleeve 106. Based on this rotational displacement, processor 115 can determine the amount of medicament dispensed from the reservoir. The smaller the angle subtended by each of the first coding region 123 and the second coding region 124 around the rotational axis, the greater the resolution of the dose determination measurement.

[0227] Processor 115 can be configured to transmit the determined medicament dose and, where determined, the timestamp information to another device, such as a computer (not shown). As described above, the output terminal 117 can be configured to transmit information using a wireless communication link. Alternatively, the dose measurement system 101 can be connected to a computer (not shown) using a wired connection (not shown) to allow uploading of the information to the computer. Processor 115 can be configured to transmit information to the computer periodically. In some embodiments, the dose measurement system 115 can be used to monitor compliance with a particular dosing regimen.

[0228] In the present embodiment, the dialing sleeve 106 includes twenty-four configurations 112. Accordingly, twenty-four first coding regions 123 and twenty-four second coding regions 124 are provided. Each coding region 123, 124 subtends an angle of 7.5 degrees around the rotational axis of the dialing sleeve 106.

[0229] Now referring Figures 16A to 18 to, another embodiment of a dose measurement system 201 is shown. The dose measurement system 201 is similar to the dose measurement system 101 described above with respect to the Figures 2 to 15 embodiment, where like features bear the same reference numerals and is part of a medicament delivery device (not shown) having the same features as the Figures 2 to 15 dose measurement system 201 is different in that it has a first sensor 214A and a second sensor 214C. The dialing sleeve 206 includes a plurality of configurations 212 separated by a gap 213, where the configurations 212 are configured to engage the first sensor 214A and the second sensor 214C as the dialing sleeve 206 rotates.

[0230] Each of the first sensor 214A and the second sensor 214C can be of the same type as the sensor 114 of the Figure 2 and Figure 15 embodiments described above, having sensing members 218A, 218C movable between an unactuated state and an actuated state, and will not be described in detail again hereinafter.

[0231] With Figure 2 and Figure 15Like the embodiments, the selection sleeve 206 includes a plurality of first coding regions 223 and a plurality of second coding regions 224 that are alternately arranged about the axis of rotation of the selection sleeve 206. The first coding regions 223 are formed by a portion of the respective structure 212 that, when aligned with the sensing members 218A, 218C, urges the sensing members into an actuated state. The second coding regions 224 are formed between the first coding regions 223.

[0232] Each of the first sensor 214A and the second sensor 214C generates a high signal when the sensors 214A, 214C are aligned with one of the first coding regions 223 and generates a low signal when aligned with one of the second coding regions 224. Thus, each of the sensors 214A, 214C is capable of distinguishing between the first coding regions 223 and the second coding regions 224 and generating signals accordingly.

[0233] The first sensor 214A and the second sensor 214C are offset such that, in use, rotation of the selection sleeve 206 in the first rotational direction X causes one of the first encoder regions 223 to align with the first sensor 214A while one of the second encoder regions 224 aligns with the second sensor 214C. Further rotation of the selection sleeve 206 in the first rotational direction X causes one of the second encoder regions 224 to align with the first sensor 214A while one of the first encoder regions 223 aligns with the second sensor 214C. Thus, when the first sensor 214A detects one of the first coding regions 223, the second sensor 214C will be aligned with one of the second coding regions 224, and when the second sensor 214C detects one of the first coding regions 223, the first sensor 214A will be aligned with one of the second coding regions 224.

[0234] In Figure 16A the schematic diagram depicts the relative positions of the first sensor 214A and the second sensor 214C with respect to the first coding regions 223 and the second coding regions 224. In Figure 16A it, the first sensor 214A is aligned with the first coding region 223, and thus the first sensing member 218A will be in an actuated state, but this is not shown in order to give a clearer indication of the respective positions of the sensors 214A, 214C with respect to the coding regions 223, 224.

[0235] In Figure 16A it, the structure 212 and the gap 213 are schematically shown for illustrative purposes, Figure 16Ais provided to show the arrangement of the first coding region 223 and the second coding region 224 relative to the sensors 214A, 214C.

[0236] The first sensor 214A and the second sensor 214C may be arranged such that for all rotational positions of the dialing sleeve 206 in which the first sensor 214A is aligned with one of the first coding regions in the first coding region 223, the second sensor 214C is aligned with one of the second coding regions in the second coding region 224. Thus, during rotation of the dialing sleeve 206, when the sensing member 218A of the first sensor 214A changes from the unactuated state to the actuated state, the sensing member 218C of the second sensor 214C changes from the actuated state to the unactuated state.

[0237] In some embodiments, the first sensor 214A and the second sensor 214C are offset 165 degrees about the axis of rotation of the drive sleeve 206 in the first rotational direction X.

[0238] The first sensor 214A and the second sensor 214C may be arranged such that for all rotational positions of the dialing sleeve 206 in which the first sensor 214A is aligned with one of the second coding regions in the second coding region 224, the second sensor 214C is aligned with one of the first coding regions in the first coding region 223. Thus, during rotation of the dialing sleeve 206, when the sensing member 218A of the first sensor 214A changes from the actuated state to the unactuated state, the sensing member 218C of the second sensor 214C changes from the unactuated state to the actuated state.

[0239] A processor (not shown) is configured to determine the delivered dose based on the movement of the first sensing member 218A and the second sensing member 218C. For example, the processor may be configured to count the number of times the sensing members 218A, 218C change from the unactuated state to the actuated state and / or the number of times the sensing members 218A, 218C change from the actuated state to the unactuated state. The processor may be pre-programmed with information that allows the processor to convert the number of transitions into a determination of the dose delivered by the medicament delivery device.

[0240] In one embodiment, the processor is configured to determine the delivered dose based on one of the following: counting the transitions of the sensing members 218A, 218C from the unactuated state to the actuated state; or counting the transitions of the sensing members 218A, 218C from the second position to the unactuated state. Figure 17Shows an example where the processor is configured to count the number of times the signals 219A, 219C output from the first sensor 214A and the second sensor 214C transition from low to high, respectively. This can be referred to as positive edge counting. In another example, the processor is configured to count the number of times the signals 219A, 219C output from the first sensor 214A and the second sensor 214C transition from high to low. This can be referred to as negative edge counting.

[0241] Providing the first sensor 214A and the second sensor 214C offset in the first rotational direction X advantageously means that the resolution of dose determination is increased compared to an embodiment having only a single sensor. In the present embodiment, the resolution for a given size of the structure 212 is doubled compared to an embodiment having only a single sensor. Thus, the size of the structure 212 can be increased, and thus the angle of each of the first coding region 223 and the second coding region 224 can be increased, resulting in a larger edge tolerance as explained below, while achieving the same resolution as a single sensor configuration. For example, if the first sensor 214A and the second sensor 214C are used, the number of structures 212 can be reduced to twelve, while achieving the same measurement resolution as Figures 2 to 15 the twenty-four structure 112 embodiment.

[0242] Providing twelve structures 212 means that each of the first coding region 223 and the second coding region 224 subtends an angle of 15 degrees about the axis of rotation of the dialing sleeve 206. If only a single sensor 114 is utilized and the processor counts only one of the negative or positive edges, the resolution of the measurement will be 30 degrees, which is the angle by which the dialing sleeve 206 needs to rotate for successive transitions of the signal output from the sensor from high to low (or low to high in a negative edge counting embodiment). However, due to the use of the first sensor 214A and the second sensor 214C, the resolution is doubled, such that it is the same as a single sensor embodiment having twenty-four structures. However, the advantage of using fewer, larger structures 212 (e.g., twelve structures 212 in the present embodiment, although one skilled in the art will recognize that different numbers of structures 212 can be used) is to achieve a larger edge tolerance.

[0243] The edge tolerance is the maximum distance that the dialing sleeve 206 must rotate (in either the first rotation direction X or the second rotation direction Y) to align the transition between one of the first coding regions in the first coding regions 223 and one of the second coding regions in the second coding regions 224 with the sensors 214A, 214C. Thus, in the present embodiment, in the case of twelve configurations 212, the maximum edge tolerance is 7.5 degrees. For comparison, in an embodiment having a single sensor 114 and twenty-four configurations 112, the edge tolerance is 3.75 degrees.

[0244] A larger edge tolerance is advantageous because it reduces the likelihood of false edge detection by the sensors 214A, 214C, which could otherwise occur due to mechanical tolerances. This is because for an embodiment with a larger edge tolerance, the sensing members 218A, 218C of the sensors 214A, 214C are less likely to transition from one of the unactuated state and the actuated state to the other of the first position and the second position for a given rotational displacement of the dialing sleeve 206. Thus, for example, a small amount of "play" or accidental rotation of the dialing sleeve 206 relative to the housing 202 is less likely to cause the first sensor 214A and the second sensor 214C to transition between outputting low / high signals, which would otherwise result in an error edge detection by the processor and thus a measurement error.

[0245] In some embodiments, the edge tolerance is at least 5 degrees, at least 7 degrees, and preferably, the edge tolerance is at least 7.5 degrees.

[0246] In some embodiments, the first sensor 214A and the second sensor 214C are mounted to a dose setting dial (not shown) such that the sensors 214A, 214C can be moved from an idle position to a detection position in a manner similar to that described for the Figures 2 to 15 embodiment.

[0247] The first sensor 214A and the second sensor 214C can be arranged such that for all rotational positions of the dialing sleeve 206, one of the first sensor 214A and the second sensor 214C is aligned with the first coding region 223, and the other of the first sensor 214A and the second sensor 214C is aligned with the second coding region 224. This means that when the user actuates the dose setting dial 208 (not shown) such that the first sensor 214A and the second sensor 214C are moved to the detection position, one of the first sensor 214A and the second sensor 214C will engage one of the configurations 212 such that the sensing members 218A, 218C of the sensors 214A, 214C are moved to the actuated state, and thus the signal output from the sensors 214A, 214C changes from low to high (or in an embodiment where the sensors output inverted signals, the other sensor outputs such a change).

[0248] If such transitions are counted and used to determine the dose dispensed from the reservoir, the determined dose will be greater than the actual dose dispensed. To compensate for this, in some embodiments, the processor is configured to ignore the first detected low-to-high transitions output from sensors 214A, 214C because these are caused by the axial movement of one of sensors 214A, 214C to the detection location. The processor considers the remaining low-to-high transitions to determine the dispensed dose because these transitions are the result of the rotation of the dialing sleeve 206 during the medicament dispensing process and not due to the axial movement of sensors 214A, 214C.

[0249] In some embodiments, the dialing sleeve 206 includes a plurality of coding cycles 225, where each coding cycle 225 includes a first coding region 223 and an adjacent second coding region 224 in the first coding region 223. In some embodiments, for a given rotational position of the dialing sleeve 206, the first sensor 214A aligns with a portion of one of the coding cycles 225, and the second sensor 214C aligns with a different portion of one of the coding cycles 225. If each coding cycle 225 is considered to have an imaginary cycle of 360 degrees, i.e., the structure 212 repeats every 360 degrees, the first sensor 214A and the second sensor 214C may be offset by 180 degrees of the coding cycle 225.

[0250] In some embodiments, the offset angle of the first sensor 214A and the second sensor 214C about the axis of rotation of the dialing sleeve 206 is an odd integer multiple of the angle subtended by each first coding region 223 about the axis of rotation of the drive sleeve 206. For example, if the first coding region 223 subtends 15 degrees about the axis of rotation, the offset angle may be 15 degrees, 45 degrees, 75 degrees, 105 degrees, 135 degrees, 165 degrees, 195 degrees, 225 degrees, 255 degrees, 285 degrees, 315 degrees, or 345 degrees.

[0251] In one such embodiment, the first sensor 214A and the second sensor 214C are offset by an angle that is eleven times the angle subtended by each first coding region 223 about the axis of rotation of the drive sleeve 206. The first sensor 214A and the second sensor 214C are offset by 165 degrees about the axis of rotation of the drive sleeve 206.

[0252] The processor may be configured to determine the dose dispensed from the medicament reservoir based on the signal output from one of the first sensor 214A and the second sensor 214C and the inversion of the signal output from the other of the first sensor 214A and the second sensor 214C. In Figure 18In one embodiment shown, the processor is configured to determine the dose dispensed from the medicament reservoir based on the superposition of a signal from one of the first sensor 214A and the second sensor 214C and an inverted signal from the other of the first sensor 214A and the second sensor 214C. In this particular embodiment, the superposition 220 of the signal 219A output from the first sensor 214A and the inverted signal 219C output from the second sensor 214C.

[0253] The superposition 220 can be calculated by adding the first signal 219A to the inverted second signal 219C.

[0254] The processor is configured to determine the dose dispensed from the medicament reservoir by comparing the superposition 220 with a first threshold 226 and a second threshold 227 greater than the first threshold 226. In one such embodiment, the processor counts the number of times the superposition 220 transitions from a value below the first threshold 226 to a value greater than the second threshold 227 and / or the number of times the superposition transitions from a value above the second threshold 227 to a value below the first threshold 226. This helps improve the accuracy of dose determination by helping to filter out errors such as sensor noise and switch bounce. This is because if one of the first sensor 214A and the second sensor 214C gives a false reading, this will not cause the superposition 220 to transition in a manner that is counted by the processor in the dose determination calculation.

[0255] In the present embodiment, the processor counts the number of times the superposition 220 transitions from a value below the first threshold 226 to a value greater than the second threshold 227 and the number of times the superposition transitions from a value above the second threshold 227 to a value below the first threshold 226. This count is used to determine the dose dispensed from the reservoir. As previously mentioned, in embodiments where the sensors 214A, 214C are axially moved on the actuator, the first count can be ignored.

[0256] The first threshold 226 can be such that when the first sensor 214A is aligned with the second coding portion 224 and the second sensor 214C is simultaneously aligned with the first coding portion 223, the superposition 220 is below the first threshold 226 and otherwise above the first threshold 226. That is, in order for the superposition 220 to be below the first threshold 226, both the inverted second signal 219C and the first signal 219A must be low.

[0257] The second threshold 227 can be such that when the first sensor 214A is aligned with the first coding portion 223 and the second sensor 214C is simultaneously aligned with the second coding portion 224, the superposition 220 is above the second threshold 227 and otherwise below the second threshold 227. That is, in order for the superposition 220 to be above the second threshold 227, both the inverted second signal 219C and the first signal 219A must be high.

[0258] In some embodiments, when the superposition 220 is equal to or lower than the first threshold 226, the superposition 220 is in the low state L, and when the superposition 220 is equal to or higher than the second threshold 227, the superposition 220 is in the high state H. When the superposition 220 is higher than the first threshold 226 but lower than the second threshold 227, the superposition 220 is in the UNDEFINED state. The processor can count the number of times the superposition 220 transitions from the low state to the high state and / or from the high state to the low state to determine the dispensed dose.

[0259] For example, for certain rotational positions of the dialing sleeve 206, the signal 219A output from the first sensor 214A should be high and the signal 219C output from the second sensor 214C should be low, such that the inverse of the signal 219C output from the second sensor 214C should be high, and thus two high signals mean that the superposition signal 220 should be higher than the second threshold 227 (the superposition 220 should be in the high state H). However, the mechanical switch of the first sensor 214A can momentarily "chatter", causing it to output a low reading. In such a case, the superposition 220 will be lower than the second threshold 227 but will still be greater than the first threshold 226 because the inverse signal is still high (the superposition will be in the undefined state). When both the signal 219A output from the first sensor 214A and the inverse of the signal 219C output from the second sensor 214C are low (at this time, the superposition 220 will transition to the low state L, and the total transition from high to low is counted as one increment by the processor in the dispensed dose determination), the superposition signal 220 will only transition to a value lower than the first threshold 226 and will thus be counted by the processor to determine the dispensed dose. Thus, in the dose dispensing calculation, switch chatter will not be counted by the processor and will thus not contribute to an incorrect dose determination value. Alternatively, if after the "chatter", the first sensor 214A instead outputs a high reading again, the superposition 220 will transition back to the high state H, and this will not be counted as an increment by the processor because the superposition was previously in the high state H before moving to the undefined state and has thus not transitioned from the low state L to the high state H.

[0260] In some embodiments, when the dialing sleeve 206 has reached the zero position and has completed rotation such that the programmed dose has been dispensed from the reservoir, the first sensor 214A and the second sensor 214B will each be aligned with specific coded regions 223, 224 for a longer duration than when the dialing sleeve 206 rotates and the first sensor 214A and the second sensor 214C are aligned with the respective coded regions 223, 224. This is in Figure 18shown, which shows the last transition between the first coding region 223 and the second coding region 224 detected by sensors 214A, 214C during the rotation of the dialing sleeve 206 (in Figure 18 example, the number of transitions 8), after which the signals 219A, 219C output from the first sensor 223 and the second sensor 224 remain in the high state and the low state (and thus the superposition 220 remains in the high state) for a relatively long period of time. In Figure 18 , the last transition after the number of transitions 8 is due to the actuator (in this case the dose setting dial 208) moving proximally away from its actuated position, causing the sensors 214A, 214C to move out of the detection position and return to the idle position, and thus no longer engaging the structure 212.

[0261] If the first sensor 214A and / or the second sensor 214C remains aligned with one of the first coding region 223 and the second coding region 224 for more than a predetermined amount of time, the processor can thus determine that the dialing sleeve 206 has stopped rotating, and thus the dose has been dispensed. The predetermined amount of time can be selected to be greater than the amount of time that either the first coding region 223 or the second coding region 224 will remain aligned with one of the first sensor 214A and the second sensor 214C during the rotation of the dialing sleeve 206 during the operation of the dispensing mechanism to dispense the medicament from the reservoir.

[0262] If the processor determines that the dose has been dispensed, the processor can perform one or more operations, such as: indicating to the user that the dose has been dispensed, for example, through a user interface such as an LED, a speaker, or a screen, or by transmitting a signal to display such information on a separate device; storing and / or transmitting data related to the dispensed dose; ignoring any additional transitions between the first coding region and the second coding region detected by the sensors, such that the additional transitions are not used for calculating the dispensed dose; and / or powering down the dose measurement system to save energy.

[0263] Now referring to Figure 16B 、 Figure 19 and Figure 20 shows another embodiment of the dose measurement system 301. The dose measurement system 301 is similar to the dose measurement system 201 described above with respect to the embodiments of Figure 16A and Figures 17 to 18 , where like features are given the same reference numerals and is part of a medicament delivery device (not shown) having the same features as Figures 2 to 15 . However, the dose measurement system 301 differs in that, in addition to including the first sensor 314A and the second sensor 314C, the dose measurement system 301 further includes a third sensor 314B and a fourth sensor 314D.

[0264] The dialing sleeve 306 includes a plurality of configurations 312 separated by a gap 313, wherein the configurations 312 are configured to engage the first sensor 314A, the second sensor 314C, the third sensor 314B, and the fourth sensor 314D when the dialing sleeve 306 rotates.

[0265] Each of the first sensor 314A, the second sensor 314C, the third sensor 314B, and the fourth sensor 314D may be of the same type as the first sensor 214A and the second sensor 214C of the embodiments described above with respect to Figure 16A and Figures 17 to 18 Accordingly, they each have a first sensing member 318A, a second sensing member 318C, a third sensing member 318B, and a fourth sensing member 318D that can each move between an unactuated state and an actuated state, and thus will not be described in detail again hereinafter.

[0266] With Figure 16A and Figures 17 to 18 As in the embodiments of

[0267] The dialing sleeve 306 includes a plurality of first coding regions 323 and a plurality of second coding regions 324 that are alternately arranged around the rotation axis of the dialing sleeve 306. The first coding regions 323 are formed by a part of the corresponding configuration 312 that pushes the sensing members 318A, 318C, 318B, 318D to the actuated state when aligned with the sensing members 318A, 318C, 318B, 318D. The second coding regions 324 are formed between the first coding regions 323.

[0268] With Figure 16A and Figures 17 to 18As in the embodiment of the dose measurement system 201, the first sensor 314A and the second sensor 314C are offset such that in use, rotation of the dialing sleeve 306 in the first rotational direction X causes one of the first encoder regions in the first encoder region 323 to align with the first sensor 314A, while one of the second encoder regions in the second encoder region 324 aligns with the second sensor 314C. Further rotation of the dialing sleeve 306 in the first rotational direction X causes one of the second encoder regions in the second encoder region 324 to align with the first sensor 314A, while one of the first encoder regions in the first encoder region 323 aligns with the second sensor 314C. Thus, when the first sensor 314A detects one of the first encoding regions in the first encoding region 323, the second sensor 314C will be aligned with one of the second encoding regions in the second encoding region 324, and when the second sensor 314C detects one of the first encoding regions in the first encoding region 323, the first sensor 314A will be aligned with one of the second encoding regions in the second encoding region 324.

[0269] The third sensor 314B and the fourth sensor 314D are offset from the first sensor 314A and the second sensor 314C in the rotational direction of the dialing sleeve 306.

[0270] In some embodiments, the first sensor 314A and the second sensor 314C are offset 165 degrees about the axis of rotation of the drive sleeve 306 in the first rotational direction X. In some embodiments, the third sensor 314B is offset 90 degrees about the axis of rotation from the first sensor 314A in the first rotational direction X, and wherein the fourth sensor 314D is offset 105 degrees about the axis of rotation from the first sensor 314A in the second rotational direction.

[0271] In Figure 16B For illustrative purposes, the structure 312 and the gap 313 are schematically shown, Figure 16B which is provided to show the arrangement of the first encoding region 323 and the second encoding region 324 relative to the sensors 314A, 314C, 314B, 314D.

[0272] The third sensor 314B is arranged such that in use, rotation of the dialing sleeve 306 in the first rotational direction X causes one of the first encoder regions in the first encoder region 323 to align with the first sensor 314A, while the other first encoder region in the first encoder region 323 aligns with the third sensor 314B. Additionally, further rotation of the dialing sleeve 306 in the first rotational direction X causes one of the second encoder regions in the second encoder region 324 to align with the first sensor 314A, while the other second encoder region in the second encoder region 323 aligns with the third sensor 314B. Thus, when the first sensor 314A detects one of the first encoding regions in the first encoding region 323, the third sensor 314B will align with the other first encoding region in the first encoding region 323, and when the first sensor 314A detects one of the second encoding regions in the second encoding region 324, the third sensor 314B will align with the other second encoding region in the second encoding region 324.

[0273] The third sensor 314B can be arranged such that for all rotational positions of the dialing sleeve 306 where the first sensor 314A aligns with one of the first encoding regions in the first encoding region 323, the third sensor 314B aligns with one of the first encoding regions in the first encoding region 323. Thus, during rotation of the dialing sleeve 306, when the sensing member 318A of the first sensor 314A transitions from the unactuated state to the actuated state, the sensing member 318B of the third sensor 314B transitions from the unactuated state to the actuated state. Similarly, the third sensor 314B can be arranged such that for all rotational positions of the dialing sleeve 306 where the first sensor 314A aligns with one of the second encoding regions in the second encoding region 324, the third sensor 314B aligns with one of the second encoding regions in the second encoding region 324. Thus, during rotation of the dialing sleeve 306, when the sensing member 318A of the first sensor 314A transitions from the actuated state to the unactuated state, the sensing member 318B of the third sensor 314B transitions from the actuated state to the unactuated state.

[0274] The fourth sensor 314D is arranged such that in use, rotation of the dialing sleeve 306 in the first rotational direction X causes one of the first encoder regions in the first encoder region 323 to align with the second sensor 314C, while the other first encoder region in the first encoder region 323 aligns with the fourth sensor 314D. Additionally, further rotation of the dialing sleeve 306 in the first rotational direction X causes one of the second encoder regions in the second encoder region 324 to align with the second sensor 314C, while the other second encoder region in the second encoder region 323 aligns with the fourth sensor 314D. Thus, when the second sensor 314C detects one of the first encoder regions in the first encoding region 323, the fourth sensor 314D will align with the other first encoder region in the first encoding region 323, and when the second sensor 314C detects one of the second encoder regions in the second encoding region 324, the fourth sensor 314D will align with the other second encoder region in the second encoding region 324.

[0275] The fourth sensor 314D can be arranged such that for all rotational positions of the dialing sleeve 306 in which the second sensor 314C aligns with one of the first encoder regions in the first encoder region 323, the fourth sensor 314D aligns with one of the first encoder regions in the first encoder region 323. Thus, during rotation of the dialing sleeve 306, when the sensing member 318C of the second sensor 314C changes from the unactuated state to the actuated state, the sensing member 318D of the fourth sensor 314D changes from the unactuated state to the actuated state. Similarly, the fourth sensor 314D can be arranged such that for all rotational positions of the dialing sleeve 306 in which the second sensor 314C aligns with one of the second encoder regions in the second encoder region 324, the fourth sensor 314D aligns with one of the second encoder regions in the second encoder region 324. Thus, during rotation of the dialing sleeve 306, when the sensing member 318C of the second sensor 314C changes from the actuated state to the unactuated state, the sensing member 318D of the fourth sensor 314D changes from the actuated state to the unactuated state.

[0276] In some embodiments, the dialing sleeve 306 includes a plurality of encoding cycles 325, where each encoding cycle 325 includes one first encoding region in the first encoding region 323 and an adjacent second encoding region 324. In some embodiments, for a given rotational position of the dialing sleeve 306, the first sensor 314A is aligned with a portion of one of the encoding cycles 325, and the second sensor 314C is aligned with a different portion of one of the encoding cycles 325. If each encoding cycle 325 is considered to have a 360-degree imaginary cycle, i.e., the structure 312 repeats every 360 degrees, then the first sensor 314A and the second sensor 314C can be offset by 180 degrees of the encoding cycle 325.

[0277] The third sensor 314B is in phase with the first sensor 314A such that the sensors 314B, 314A are aligned with the same portion of the corresponding encoding cycle 325, and thus are offset by zero degrees of the encoding cycle 325. The fourth sensor 314D is in phase with the second sensor 314C such that the sensors 314D, 314C are aligned with the same portion of the corresponding encoding cycle 325, and thus are offset by zero degrees of the encoding cycle 325.

[0278] If the first sensor 314A fails to detect the encoding regions 323, 324 due to a detection error, the third sensor 314B provides redundancy and also allows filtering of impossible detection events. If the second sensor 314C fails to detect the encoding regions 323, 324 due to a detection error, the fourth sensor 314D provides redundancy and also allows filtering of impossible detection events (please explain examples of such impossible detection events).

[0279] The processor can be configured to determine the dose dispensed from the medicament reservoir based on the superposition of the signals 319A, 319B output from the first sensor 314A and the third sensor 314B and the inversion of the signals 319C, 319D output from the second sensor 314C and the fourth sensor 314D, or the superposition of the signals 319C, 319D output from the second sensor 314C and the fourth sensor 314D and the inversion of the signals 319A, 319B output from the first sensor 314A and the third sensor 314B.

[0280] In Figure 20 the specific embodiment shown, the dose is determined based on the superposition 320 of the signals 319A, 319B output from the first sensor 314A and the third sensor 314B and the inversion of the signals 319C, 319D output from the second sensor 314C and the fourth sensor 314D.

[0281] The superposition 320 can be calculated by adding the first signal 219A and the third signal 219B in anti-phase to the second signal 219C and the fourth signal 219D.

[0282] The processor is configured to determine the dose dispensed from the medicament reservoir by comparing the superposition 320 with a first threshold 326 and a second threshold 327 greater than the first threshold 326.

[0283] In one such embodiment, the processor counts the number of times the superposition 320 transitions from a value below the first threshold 326 to a value greater than the second threshold 327 and / or the number of times the superposition transitions from a value above the second threshold 327 to a value below the first threshold 326. This helps improve the accuracy of dose determination by helping filter out errors such as sensor noise and switch bounce. This is because if one or both of the sensors 314A, 314B, 314C, 314D give an incorrect reading, this will not cause the superposition 320 to transition in a manner that is counted by the processor in the dose determination calculation.

[0284] In the present embodiment, the processor counts the number of times the superposition 220 transitions from a value below the first threshold 326 to a value greater than the second threshold 327 and the number of times the superposition transitions from a value above the second threshold 327 to a value below the first threshold 326. This count is used to determine the dose dispensed from the reservoir. As previously mentioned, in embodiments where the sensors 314A, 314B, 314C, 314D are axially moved on the actuator of the operation start switch 332, the first count can be ignored. In Figure 20 The signal 333 of the start switch 332 is shown.

[0285] The first threshold 326 can be such that, in order for the superposition 320 to be below the first threshold 326, at least three of the signals 319A, 319B output from the first sensor 314A and the third sensor 314B and the anti-phase of the signals 319C, 319D output from the second sensor 314C and the fourth sensor 314D must be low.

[0286] The second threshold 227 can be such that, in order for the superposition 320 to be above the second threshold 326, at least three of the signals 319A, 319B output from the first sensor 314A and the third sensor 314B and the anti-phase of the signals 319C, 319D output from the second sensor 314C and the fourth sensor 314D must be high.

[0287] In some embodiments, when the superposition 320 is equal to or lower than a first threshold 326, the superposition 320 is in a low state L, and when the superposition 320 is equal to or higher than a second threshold 327, the superposition 320 is in a high state H. When the superposition 320 is higher than the first threshold 326 but lower than the second threshold 327, the superposition 320 is in an undefined (UNDEFINED) state. The processor may count the number of times the superposition 320 transitions from the low state to the high state and / or from the high state to the low state to determine the dispensed dose.

[0288] For example, for certain rotational positions of the dialing sleeve 306, the signals 319A, 319B output from the first sensor 314A and the third sensor 314C should be high, and the inverses of the signals 319C, 319D output from the second sensor 314B and the fourth sensor 314D should be high, and thus four high signals mean that the superposition signal 320 should be equal to or higher than the second threshold 327 (the superposition 320 should be in the high state H). However, the mechanical switch of the first sensor 314A may momentarily "jitter" such that it outputs a low reading. In such a case, the superposition 320 is still equal to or higher than the second threshold 327, and thus the state of the superposition 320 will remain in the high state H. Therefore, the superposition 320 does not transition to the low state, and thus the processor does not count the calculated increment for the dispensed dose determination. In fact, if the mechanical switch of the fourth sensor 314D also "jitters" simultaneously such that it outputs a high reading and thus the inverse of the signal 319D is low, then the superposition 320 includes two low and two high signal inputs, and thus the superposition 320 will be greater than the first threshold 326 but less than the second threshold 327. The superposition 320 will thus be in the undefined state U.

[0289] The superposition signal 220 will transition to a value equal to or lower than the first threshold 226 and thus be counted by the processor to determine the dispensed dose only when at least three of the following occur: the first sensor 314A outputs a low signal 319A, the third sensor 314B outputs a low signal 319B, the second sensor 314C outputs a high signal 319C such that the inverse is low, and the fourth sensor 314D outputs a high signal 319D such that the inverse is low (at this time, the superposition 320 will transition to the low state L, and the total transition from high to low is counted by the processor as one increment in the dispensed dose determination).

[0290] Therefore, in the dose dispensing calculation, multiple switch jitters or other such errors will not be counted by the processor and thus will not contribute to an incorrect dose determination value.

[0291] Now referring to Figures 16C to 21 , another embodiment of the dose measurement system 401 is shown. Figure 16C The dose measurement system 401 of Figure 16B, Figure 19 and Figure 20 of the dose measurement system 301 of the embodiment, where similar features retain the same reference numerals. The difference is that the configuration 412 and the gap 413 of the dialing sleeve 406 have different sizes, and the first sensor 414A, the second sensor 414C, the third sensor 414B, and the fourth sensor 414D have different arrangements relative to the first coding region 423 and the second coding region 424.

[0292] The dialing sleeve 406 includes Figure 16B , Figure 19 and Figure 20 half of the configuration 412 and the gap 413 of the dialing sleeve 306 of . In this embodiment, the dialing sleeve 406 includes six configurations 412 and six gaps 413.

[0293] Similar to Figure 16A and Figures 17 to 18 of the embodiment and Figure 16B and Figures 19 to 20 of the embodiment, the dialing sleeve 406 includes a plurality of first coding regions 423 and a plurality of second coding regions 424 that are alternately arranged around the rotation axis of the dialing sleeve 406. The first coding region 423 is formed by a part of the corresponding configuration 412, and the part pushes the sensing members 418A, 418C, 418B, 418D into the actuated state when aligned with the sensing members 418A, 418C, 418B, 418D. The second coding region 424 is formed between the first coding regions 423.

[0294] Each of the first sensor 414A, the second sensor 414C, the third sensor 414B, and the fourth sensor 414D generates a high signal when the sensor 414A, 414C, 414B, 414D is aligned with one of the first coding regions 423 in the first coding region 423, and generates a low signal when aligned with one of the second coding regions 424 in the second coding region 424. Therefore, each sensor 414A, 414C, 414B, 414D can distinguish the first coding region 423 and the second coding region 424 and generate signals accordingly.

[0295] Similar to Figure 16A and Figures 17 to 18 of the dose measurement system 201 of the embodiment and Figure 16B and Figures 19 to 20As in the embodiments, the first sensor 414A and the second sensor 414C are offset such that in use, rotation of the dialing sleeve 406 in the first rotational direction X causes one of the first encoder regions in the first encoder region 423 to align with the first sensor 414A, while one of the second encoder regions in the second encoder region 424 aligns with the second sensor 414C. Further rotation of the dialing sleeve 406 in the first rotational direction X causes one of the second encoder regions in the second encoder region 424 to align with the first sensor 414A, while one of the first encoder regions in the first encoder region 423 aligns with the second sensor 414C. Thus, when the first sensor 414A detects one of the first encoding regions in the first encoding region 423, the second sensor 414C will align with one of the second encoding regions in the second encoding region 424, and when the second sensor 414C detects one of the first encoding regions in the first encoding region 423, the first sensor 414A will align with one of the second encoding regions in the second encoding region 424.

[0296] The third sensor 414B and the fourth sensor 414D are offset from the first sensor 414A and the second sensor 414C in the rotational direction of the dialing sleeve 406. In Figure 16C FIG., the structure 412 and the gap 413 are schematically shown for illustrative purposes, Figure 16C which are provided to show the arrangement of the first encoding region 423 and the second encoding region 424 relative to the sensors 414A, 414C, 414B, 414D.

[0297] In some embodiments, the first sensor 414A and the third sensor 414B are offset 165 degrees about the axis of rotation of the drive sleeve 406 in the first rotational direction X. In some embodiments, the second sensor 414C is offset 90 degrees about the axis of rotation from the first sensor 414A in the first rotational direction X, and wherein the fourth sensor 414D is offset 105 degrees about the axis of rotation from the first sensor 414A in the second rotational direction.

[0298] The third sensor 414B is arranged such that when the dialing sleeve 406 rotates, when the first sensor 414A aligns with the transition between the encoding regions 423, 424 and the second sensor 414C aligns with the transition between the encoding regions 423, 424, the third sensor 414B does not align with the transition between the encoding regions 423, 424 (i.e., the third sensor 414B only aligns with one of the first encoding region 423 or the second encoding region 424). In some embodiments, when the dialing sleeve 406 is in such a position, the third sensor 414B is equidistant from the two nearest transitions between the first encoding region 423 and the second encoding region 424.

[0299] The fourth sensor 414D is arranged such that when the dialing sleeve 406 rotates, when the first sensor 414A is aligned with the transition between the coding regions 423, 424 and the second sensor 414C is aligned with the transition between the coding regions 423, 424, the fourth sensor 414D is not aligned with the transition between the coding regions 423, 424 (i.e., the fourth sensor 414D is aligned with only one of the first coding region 423 or the second coding region 424). In some embodiments, when the dialing sleeve 406 is in such a position, the fourth sensor 414D is equidistant from the two nearest transitions between the first coding region 423 and the second coding region 424.

[0300] The third sensor 414B and the fourth sensor 414D are offset such that in use, rotation of the dialing sleeve 406 in the first rotational direction X causes one first encoder region in the first encoder region 423 to be aligned with the third sensor 414B, while one second encoder region in the second encoder region 424 is aligned with the fourth sensor 414D. Further rotation of the dialing sleeve 406 in the first rotational direction X causes one second encoder region in the second encoder region 424 to be aligned with the third sensor 414B, while one first encoder region in the first encoder region 423 is aligned with the fourth sensor 414D. Thus, when the third sensor 414B detects one first encoder region in the first coding region 423, the fourth sensor 414D will be aligned with one second encoder region in the second coding region 424, and when the fourth sensor 414D detects one first encoder region in the first coding region 423, the third sensor 414B will be aligned with one second encoder region in the second coding region 424.

[0301] In some embodiments, when the first sensor 414A is aligned with the transition between the coding regions 423, 424, the second sensor 414C is aligned with the transition between the coding regions 423, 424, and wherein when the third sensor 414B is aligned with the transition between the coding regions 423, 424, the fourth sensor 414D is aligned with the transition between the coding regions 423, 424.

[0302] In some embodiments, the dialing sleeve 306 includes a plurality of coding cycles 425, where each coding cycle 425 includes one first encoder region in the first encoder region 423 and an adjacent second encoder region 424. In some embodiments, for a given rotational position of the dialing sleeve 406, the first sensor 414A, the second sensor 414C, the third sensor 414B, and the fourth sensor 414D are each aligned with a different part of the corresponding coding cycle 425.

[0303] If each coding period 425 is considered to have an imaginary period of 360 degrees, i.e., the structure 412 repeats every 360 degrees, the first sensor 414A and the second sensor 414C can be offset by 180 degrees of the coding period 425. The third sensor 414B and the fourth sensor 414D can be offset by 180 degrees of the coding period 425.

[0304] In some embodiments, the third sensor 414B can be offset by 90 degrees relative to one of the first sensor 414A and the second sensor 414C and by 270 degrees relative to the other of the first sensor 414A and the second sensor 414C. The fourth sensor 414B can be offset by 270 degrees relative to the one of the first sensor 414A and the second sensor 414C and by 90 degrees relative to the other of the first sensor 414A and the second sensor 414C.

[0305] In the present embodiment, the third sensor 414B is offset by 270 degrees relative to the first sensor 414A and by 90 degrees relative to the second sensor 414C. The fourth sensor 414D is offset by 90 degrees relative to the first sensor 414A and by 270 degrees relative to the second sensor 414C.

[0306] Since the first sensor 414A, the second sensor 414C, the third sensor 414B, and the fourth sensor 414D are all out of phase with respect to each other, the processor can determine whether the dialing sleeve 406 is rotating in the first rotational direction or the second rotational direction. When the dialing sleeve 406 rotates, only one of the sensors 414A, 414C, 414B, 414D is aligned with the positive edge transition from the first coding region 423 to the second coding region 424.

[0307] For example, if the dialing sleeve 406 rotates in the first rotational direction X, the actuation will have the following sequence: the first sensor 414A, the third sensor 414B, the second sensor 414C, and then the fourth sensor 414D. That is, one of the structures 212 will abut the sensing member 418A of the first sensor 414A to move the sensing member 418A from the unactuated state to the actuated state; one of the structures 212 will abut the sensing member 418B of the third sensor 414B to move the sensing member 418B from the unactuated state to the actuated state; one of the structures 212 will abut the sensing member 418C of the second sensor 414C to move the sensing member 418C from the unactuated state to the actuated state; and then, one of the structures 212 will abut the sensing member 418D of the fourth sensor 414D to move the sensing member 418D from the unactuated state to the actuated state.

[0308] Conversely, if the dialing sleeve 406 is rotated in the second rotational direction, actuation will have the following sequence: first sensor 414A, fourth sensor 414D, second sensor 414C, and then third sensor 414B. That is, one of the configurations 212 will abut the sensing member 418A of the first sensor 414A to move the sensing member 418A from the unactuated state to the actuated state; one of the configurations 212 will abut the sensing member 418D of the fourth sensor 414D to move the sensing member 418D from the unactuated state to the actuated state; one of the configurations 212 will abut the sensing member 418C of the second sensor 414C to move the sensing member 418C from the unactuated state to the actuated state; and then, one of the configurations 212 will abut the sensing member 418B of the third sensor 414B to move the sensing member 418D from the unactuated state to the actuated state.

[0309] Accordingly, the processor can determine the rotational direction of the dialing sleeve 406 based on the actuation sequence of the sensors 414A, 414B, 414C, 414D. In some embodiments, the determination of the rotational direction can be made starting from any one of the sensors 414A, 414B, 414C, 414D. For example, if the second sensor 414C is actuated, the processor can determine that the dialing sleeve 406 is rotating in the first rotational direction X if the next actuation is the fourth sensor 414D, and can determine that the dialing sleeve 406 is rotating in the second rotational direction if the next actuation is the third sensor 414B.

[0310] The processor can be configured to disregard the detected rotation of the dialing sleeve 406 from the dispensed dose if it determines that the rotation is in the second rotational direction. For example, when the dialing sleeve 406 rotates in the first rotational direction X during a medicament dispensing process, once the dialing sleeve 406 has fully rotated in the first rotational direction X and all doses have been dispensed, the dialing sleeve 406 will reach the "zero" position. However, it has been found that once the dialing sleeve 406 reaches the "zero" position, the dialing sleeve 406 can slightly rotate past the "zero" position and then can rotate back in the second rotational direction (which can be referred to as "backspin"), which can cause another one of the sensors 414A, 414B, 414C, 414D to be actuated. If this further rotation is taken into account when calculating the dispensed dose, the measurement will be higher than the actual dose delivered. However, due to the rotation of the dialing sleeve in the second rotational direction, the rotation can be ignored in the calculation. During rotation of the dose setting dial 408, the dialing sleeve 406 can also move in the second rotational direction to "dial in" a dose.

[0311] Note that in an alternative embodiment (not shown), one of the third sensor 414B and the fourth sensor 414D is omitted. In such an arrangement, the processor is still able to determine the rotational direction of the dial sleeve 406 based on readings from the three remaining sensors.

[0312] In the above-described embodiment, the sensors 114, 214A, 214B, 214C, 214D, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D are mechanically actuated. However, it should be recognized that in some embodiments, different types of sensors are used. In Figure 22 the alternative embodiment shown, the dose measurement system includes one or more optical sensors 514. The or each optical sensor 514 may include a light gate. The dial sleeve 506 may include a plurality of configurations 512 separated by gaps 513. As the dial sleeve 506 rotates, the configurations 512 are aligned with the light gate one by one to interrupt the light beam of the light gate, such that the sensor 514 detects the rotation of the dial sleeve 506. In an embodiment having a plurality of sensors 514, the sensors 514 may be arranged as described in any of the above with reference to Figures 16A to 16C any one of them.

[0313] In other embodiments (not shown), the sensors 114, 214A, 214B, 214C, 214D, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D, 514 may be, for example, magnetic sensors or capacitive sensors. For example, in one embodiment (not shown), the first coding region may include a plurality of portions of magnetic material that are adhered to the proximal end of the dial sleeve and spaced apart around the rotational axis of the dial sleeve, and the second coding region is formed as the space between adjacent portions of magnetic material. The or each sensor includes a magnetic sensor that detects the presence of magnetic material, such as a Hall sensor. In yet another embodiment (not shown), the first coding region may include a plurality of portions of reflective material that are adhered to the proximal end of the dial sleeve and spaced apart around the rotational axis of the dial sleeve, and the second coding region is formed as the space between adjacent portions of reflective material, or alternatively is formed as a portion of a material having different optical properties (such as less reflectivity) from the first coding region. The or each sensor includes an optical sensor that can distinguish the optical characteristics of the first coding region and the second coding region.

[0314] In the above-described embodiments, the dose setting dial 108 forms an actuator that is axially movable relative to the housing to operate a dispensing mechanism to dispense medicament from a reservoir. However, in alternative embodiments (not shown), the actuator alternatively includes a component that is movable relative to the dose setting dial to dispense medicament. In one embodiment (not shown), the actuator includes a push button that is mounted to the dose setting dial and is axially slidable relative to the dose setting dial to operate the dispensing mechanism to dispense medicament from the reservoir. In operation, the push button is configured to axially move a short distance relative to the housing and the selector sleeve. This movement occurs when a user applies a force to the push button. For example, the user axially pushes the push button in the distal direction toward the injection site. This axial movement of the push button disengages the clutch such that the clutch moves to a disengaged position and thus allows the selector sleeve and the drive sleeve to rotate relative to the housing and the dose setting dial in a first rotational direction under the force of the drive member to dispense medicament from the reservoir. The push button may be located at the proximal end of the dose setting dial. The push button may be biased proximally. In some embodiments, sensors 114, 214A, 214B, 214C, 214D, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D, 514 are mounted to the push button to move relative to the housing and the dose setting dial. The sensor may move from a rest position to a detection position when the push button is actuated, which may also cause the activation switch to be actuated to an on state to power the dose measurement system, similar to that previously described. The activation switch may reach the on state before the sensor reaches the detection position.

[0315] In some alternative embodiments (not shown), sensors 114, 214A, 214B, 214C, 214D, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D, 514 do not move axially with the actuator. The sensor may be in the detection position prior to actuation of the actuator. In some embodiments (not shown), the sensor is fixed relative to the housing.

[0316] In the above-described embodiments, the encoding regions are provided on the dial sleeves 106, 206, 306, 406, 506, and the said or each sensor 114, 214A, 214B, 214C, 214D, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D, 514 is configured to detect rotation of the dial sleeves 106, 206, 306, 406, 506. However, in alternative embodiments (not shown), the encoding region (e.g., configuration and gaps) is provided on the drive sleeve 107, and the said or each sensor 114, 214A, 214B, 214C, 214D, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D, 514 is configured to detect rotation of the drive sleeve 107. In yet another alternative embodiment (not shown), the encoding region is provided on another component, and the said or each sensor 114, 214A, 214B, 214C, 214D, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D, 514 is configured to detect rotation of the component. In some embodiments (not shown), the component is a component of the dispensing mechanism.

[0317] In some embodiments (not shown), one or more of the signals 219A, 219C, 319A, 319B, 319C, 319D, 419A, 419B, 419C, 419D output from the sensors are filtered in order to improve measurement accuracy, for example, by filtering noise from the signals. In some embodiments, the signals are filtered by a low-pass filter. In some embodiments, the signals are filtered before being input to the processor. In other embodiments, the processor filters the signals.

[0318] The electromechanical switch includes electrical contacts that can swing for a short time after being opened or closed. This can result in several rapid signal pulses after the edge of the original signal, which are referred to as jitter. Jitter can be reduced by switches having a minimized oscillation contact design. Further, as described above, the signals can be filtered by electronics or software as long as the jitter duration is shorter than the duration of a conventional signal pulse. This filtering is referred to as debouncing.

[0319] It is advantageous to improve power management such that a smaller battery with a smaller capacity can be used, resulting in a smaller dosimetry system. Reducing the peak current is advantageous because small batteries are more sensitive to peak current.

[0320] Improved power management can include reducing energy consumption during storage. In one such embodiment (not shown), the battery is mechanically disconnected during storage by a strip (e.g., a paper or plastic strip). The user can pull the strip to activate the dose measurement system. In another embodiment (not shown), the battery is mechanically decoupled by a mechanism. When the actuator is pressed for the first time, components disconnect and enable a permanent connection between the electronics and the battery. In yet another embodiment (not shown), the battery is mechanically disconnected by a lifetime switch on the PCB. Such activation can be irreversible. In yet another embodiment, the electronics remain in a strong power-saving mode until the actuator is pressed for the first time. In yet another embodiment (not shown), the battery is inserted into the device only before first use. In some embodiments (not shown), the button can be replaced or recharged.

[0321] The processor can have a minimum sampling interval. In some embodiments, the shortest gap is about 700 μs. In such an embodiment, a sampling interval of 500 μs is sufficient to properly detect such a short gap. In such an embodiment, the minimum sampling frequency for detecting all signal edges is calculated as:

[0322]

[0323] In Equation 1, fmin is the minimum sampling frequency, and T is the sampling interval. Thus, for a sampling interval of 500 μs, the minimum sampling frequency is 2 kHz.

[0324] Using a mechanical switch instead of a light gate / light barrier reduces energy consumption because in some embodiments, the state of the mechanical switch can be detected with less than 100 μA per switch. If the signal has good quality, additional energy can be saved by detecting the edges of each interruption. This means that the switch can be connected to the interrupt port of the processor. The interrupt port can be selected to be triggered by rising / falling edges in the switch state, thereby allowing the processor to wait in a low-energy state instead of performing a permanent energy-expensive polling operation at a high sampling frequency.

[0325] In embodiments where a light gate / light barrier is used, during an estimated sampling period of 500 μs, the IR-LED can be turned on (rise time typically 10 μs @ ≤100 kΩ, fall the same), the ADC can acquire (2 μs) and convert (5 μs), and the IR-LED can be turned off for the rest of the time to save power.

[0326] This has been found to reduce power.

[0327] In some embodiments (not shown), the medicament delivery device includes a user interface, such as one or more LEDs that prompt or provide an indication to the user. The user interface can be optimized to reduce power consumption. For example, if multiple LEDs of one color are used for a particular prompt or indication, the number of LEDs of that color can be reduced. In some embodiments, the LED power is reduced. In some embodiments, the injection reminder function, e.g., the reminder alert, is removed. In some embodiments, the dwell time indication (e.g., the visual or audible indication of the amount of time the medicament delivery device should remain in place after an injection) is removed. In some embodiments, the end-of-life mode (e.g., an indicator that the dose measurement system and / or the medicament delivery device has reached the end of its operating life) is removed. In some embodiments, the user interface is omitted.

[0328] In some embodiments, the BLE (Bluetooth(TM) Low Energy) advertisement duration is reduced. The advertisement time defines the duration for which the medicament delivery device attempts to connect to a mobile phone or other device. This parameter is important when the phone is frequently out of reach (e.g., too far away or turned off). Experiments have shown that 5 seconds is sufficient when the mobile phone is within the appropriate reach radio range. Therefore, the advertisement time can be reduced from 15 seconds to about 5 seconds. This means that the advertisement energy can be increased by a factor of 3.

[0329] In some embodiments, the BLE communication timeout is reduced. After data transmission, the communication channel currently remains open for 3 seconds. This can be improved when the mobile phone or other device sends an explicit communication close command to the medicament delivery device and the timeout only remains as an inefficient operation.

[0330] In some embodiments, the number of daily communication attempts is reduced. Data can be transmitted to the mobile phone after an injection, but only if the last data transfer was more than a predetermined period of time (e.g., 12 hours) before that. In some embodiments, the startup log data is never transmitted separately. This helps save energy for users who have several injections and / or prefilled doses per day.

[0331] There may be use cases where the user wants to force an immediate data transfer. This can be initiated by a button press mode. One additional step is to transfer only after a specific button press mode (e.g., pressing the actuator or another button five times in quick succession, or long pressing the button a certain number of times). In some embodiments, data is transferred after a normal button release event, but only if the last data transfer was more than a predetermined time period (e.g., 12 hours) prior to this. In some embodiments, pre-charge data is not transferred separately. For example, if the user performs a pre-charge operation in which the processor detects one or two rotational increments, this is not transferred separately to the drug delivery data (in some embodiments, pre-charge (e.g., measurements equal to or less than two rotational increments) is ignored and not transferred).

[0332] It is advantageous to avoid or reduce current peaks because they reduce the available capacity of the battery. Therefore, it is advantageous to optimize the energy management for UI, sensor, and communication current peaks. In some embodiments, the current peaks of the electronic components are aligned continuously. In some embodiments, components with high current do not operate simultaneously with components having high peak current, or at least such simultaneous occurrences are minimized.

[0333] Visible LEDs may have high peak current, but the time is controllable. BLE communication may have high peak current, which may not be controllable or predictable. Therefore, in some embodiments, communication begins only after the potential user feedback of the LED has been completed.

[0334] The radio range can depend on the transmission power of the dose measurement system (e.g., a system-on-chip (SoC) component). Reducing the power will reduce the average current and the peak current. In some embodiments, the maximum output power is +0dBm and has a peak current of 5.3mA. If the maximum output power is alternatively +4dBm, the peak current will be 7.5mA, which may be too high for smaller battery types. Reducing the output power to -4dBm results in a peak current of 4.2mA.

[0335] In some embodiments, the battery is a CR1225 button cell with a nominal capacity of 48mAh.

[0336] Although the above embodiments have been described with respect to collecting data from an insulin injection pen, it should be noted that embodiments of the present invention can be used for other purposes, such as monitoring the injection of other drugs.

[0337] The injection device may comprise a cartridge containing a liquid medicament or pharmaceutical agent. In an example, by pressing an injection button, a portion thereof may be discharged from the cartridge according to a dialed or preset amount. The term "medicament" or "pharmaceutical agent" may refer to a pharmaceutical formulation comprising at least one pharmaceutically active compound. Further details regarding specific pharmaceutical formulations may be obtained from the disclosure of co-pending application PCT / EP2018 / 082640, Attorney Docket No. DE2017 / 081, the scope of which is incorporated herein by reference in its entirety.

[0338] Those skilled in the art will understand that various components of the substances, formulations, devices, methods, systems and embodiments described herein may be modified (added and / or removed) without departing from the full scope and spirit of the invention, and the invention encompasses such modifications and any and all equivalents thereof.

Claims

1. A medicament delivery device (100) comprising: a reservoir for a medicament; a dispensing mechanism (104) operable to dispense medicament from the reservoir, the dispensing mechanism (104) including a sleeve (106, 107, 206, 306, 406) configured to rotate during medicament dispensing and having a plurality of formations (112, 212, 312, 412) at an end of the sleeve (106, 107, 206, 306, 406); and a dose measuring system (101, 201, 301, 401) including at least one mechanically actuated sensor (114, 214A, 214C, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D), the at least one mechanically actuated sensor being configured such that in use rotation of the sleeve (106, 107, 206, 306, 406) causes the formations (112, 212, 312, 412) to engage the sensor one by one, such that the sensor detects rotation of the sleeve and a processor (115), the processor being configured to determine a dose dispensed from the medicament reservoir based on the detected rotation of the sleeve.

2. The medicament delivery device (100) according to claim 1, wherein the plurality of formations (112, 212, 312, 412) includes a plurality of teeth.

3. The medicament delivery device (100) according to claim 1 or claim 2, wherein the formations (112, 212, 312, 412) are formed on a proximal end of the sleeve (106, 107, 206, 306, 406).

4. The medicament delivery device (100) according to any one of claims 1 to 3, wherein the sleeve (106, 107, 206, 306, 406) is a dialing sleeve (106, 206, 306, 406) or a drive sleeve (107).

5. The medicament delivery device (100) according to any one of claims 1 to 4, wherein the sensor (114, 214A, 214C, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D) includes a sensing member (118, 218A, 218C, 318A, 318B, 318C, 318D, 418A, 418B, 418C, 418D) configured to move from a non-actuated state to an actuated state when the sensing member is engaged by one of the formations (112, 212, 312, 412) during rotation of the sleeve (106, 107, 206, 306, 406), wherein the sensor detects movement of the sensing member between the non-actuated state and the actuated state.

6. The medicament delivery device (100) according to claim 5, wherein each configuration (112, 212, 312, 412) includes a leading edge (112A), and wherein during rotation of the sleeve (106, 107, 206, 306, 406), the engagement of the sensor (114, 214A, 214C, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D) with the leading edge of the first configuration in the configuration until the engagement of the sensor with the leading edge of the adjacent second configuration in the configuration represents one coding cycle, and wherein the sensor is actuated for 40% to 60% of the coding cycle.

7. The medicament delivery device (100) according to claim 6, wherein the sensor is actuated for approximately 50% of the coding cycle.

8. The medicament delivery device (100) according to any one of claims 1 to 7, comprising a dose dial (108) and a housing (102), wherein the dose dial is configured to rotate relative to the housing to set the dose of the medicament to be delivered by the dispensing mechanism (104), and wherein the sensor (114, 214A, 214C, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D) is mounted to the dose dial.

9. The medicament delivery device (100) according to claim 8, wherein the sensor is mounted inside the dose dial.

10. The medicament delivery device (100) according to claim 8 or claim 9, comprising a torque limiter, wherein the sensor (114, 214A, 214C, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D) is mounted to the dose dial (108) via the torque limiter such that rotation of the dose dial (108) relative to the housing (102) with a torque greater than a predetermined limit causes the torque limiter to move to an open state such that the dose dial (108) can rotate relative to the sensor.

11. The medicament delivery device (100) according to claim 10, wherein the torque limiter includes an overload clutch.

12. The medicament delivery device (100) according to any one of claims 8 to 11, comprising a one-way mechanism, wherein the sensor (114, 214A, 214C, 314A, 314B, 314C, 314D, 414A, 414B, 414C, 414D) is mounted to the dose dial (108) via the one-way mechanism such that the sensor is impeded from rotating relative to the dose dial (108) in the direction in which the sleeve (106, 107, 206, 306, 406) rotates during medicament dispensing, and is allowed to rotate relative to the dose dial (108) in the opposite direction to the rotation of the sleeve during medicament dispensing.

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