Medication delivery device with sensing system

Abstract

To provide medication delivery devices having a dose delivery sensing capability.SOLUTION: A sensed element is attached to a dose setting member of the device. The sensed element includes surface features radially-spaced from one another. A rotational sensor is attached to an actuator of the device. The rotational sensor includes a movable element that is contactable against the surface features. The rotational sensor is configured to generate a signal in response to the movement of the movable element over the surface features during their rotation. A controller is operatively coupled to the rotational sensor, and in response to receiving the generated signal, the controller is configured to determine the number of the surface features passing the movable element of the rotational sensor during dose delivery. The number can be associated with an amount of dose delivered. Sensing can be provided in a module or integrated in the device.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present disclosure relates to an electronic dose detection system for a drug delivery device and / or a module adapted to be removably attachable to a proximal end portion of a drug delivery device. The dose delivery detection system is operable to detect data for determining the dose of drug delivered by the drug delivery device.

Background Art

[0002] Patients suffering from various illnesses often have to inject themselves with drugs. To enable humans to conveniently and accurately self-administer drugs, various devices widely known as pen-type syringes or injection pens have been developed. Generally, these pens contain a piston and are loaded with a cartridge containing multiple doses of a liquid drug. The drive member is movable forward to advance the piston in the cartridge and dispense the contained drug from the outlet at the distal end of the cartridge, typically through a needle. In disposable or pre-filled pens, after the pen has been used up the supply of drug in the cartridge, the user discards the entire pen and starts using a new replacement pen. In reusable pens, after the pen has been used up the supply of drug in the cartridge, the pen can be disassembled to replace the used cartridge with a new cartridge, and then the pen is reassembled for subsequent use.

[0003] Many pen-type syringes and other drug delivery devices do not provide information on the dose delivered by the operation of the device ​​​​​​​​​​​​A mechanical system in which members rotate and / or translate relative to each other in a proportional manner is utilized. To evaluate the delivered dose, a system has been developed for measuring the relative movement of the members of a drug delivery device However, a system integrated into a device or module to achieve mass production and reproducible accuracy throughout the product life cycle is difficult to design Appropriate dosing requires that the dose delivered by a drug delivery device be accurate Many pen-type syringes and other drug delivery devices do not include a function for automatically detecting and recording the amount of drug delivered by the device during an injection event Without an automated system, the patient must manually track the amount and time of each injection Accordingly, there is a need for a device that can automatically detect the dose delivered by a drug delivery device during an infusion event and / or operate to overcome one or more of these and other disadvantages of the prior art SUMMARY OF THE INVENTION

[0004] In one embodiment, a drug delivery device is provided that includes a device body and a dose setting member attached to the device body and rotatable relative to the device body about a rotation axis during dose delivery The dose setting member includes a sensed element that includes surface features spaced radially apart from each other about the rotation axis of the dose setting member An actuator or dose button is attached to the device body The sensed element is rotatable relative to the dose button during dose delivery in relation to the delivered dose A rotation sensor includes a movable element that can contact the surface features of the sensed element The dose button can be configured to house the rotation sensor The movable ​​​​The element moves over the surface features during rotation of the sensed element relative to the dose button during dose delivery. It is arranged so that. The rotation sensor is configured to generate a signal in response to movement of the movable element over the surface features during rotation of the dose setting member. The controller is operably coupled to the rotation sensor and may be housed by the dose button or module. In response to receiving the generated signal from the rotation sensor, the controller is configured to determine the number of surface features that passed the movable element of the rotation sensor during dose delivery.

[0005] In another embodiment of the drug delivery device, the actuator has a first position where the movable element of the rotation sensor is disengaged from the axially extending surface features and a second position where the movable element of the rotation sensor is in contact with the axially extending surface features. The actuator may be at the dose button. When the actuator is in the second position, the controller is configured to activate the controller to a full power state upon receiving a signal indicating contact with the first of the axially extending surface features, and the controller, after the first of the axially extending surface features, is configured to determine the number of axially extending surface features that passed the movable element of the rotation sensor during dose delivery upon receiving a signal indicating contact with a subsequent one of the axially extending surface features.

Brief Description of the Drawings

[0006] Further embodiments of the present disclosure, as well as their features and advantages, will become more apparent by reference to the description in this specification in conjunction with the accompanying drawings. The components in the figures are not necessarily to scale. Further, in the drawings, like reference numerals correspond throughout the different figures. ​ Shows the part to be processed.

[0007]

Figure 1

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[0008] To facilitate understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings and this will be described using specific language. However, it will be understood that this is not intended to limit the scope of the invention. It will be understood that this is not intended to limit the scope of the invention. It will be understood that this is not intended to limit the scope of the invention.

[0009] The present disclosure relates to a sensing system for a drug delivery device. In one aspect, the sensing system is for sensing relative rotational movement between a dose setting member and an actuator of a drug delivery device to determine a dose delivered by the drug delivery device. The sensed relative rotational movement correlates with the dose delivered. By way of example, the drug delivery device is described in the form of a pen-type injector. However, the drug delivery device may be a pen-type syringe, an infusion device, etc. relative rotational movement between a dose setting member and an actuator of a drug delivery device to determine a dose delivered by the drug delivery device. The sensed relative rotational movement correlates with the dose delivered. By way of example, the drug delivery device is described in the form of a pen-type injector. However, the drug delivery device may be a pen-type syringe, an infusion device, etc. device, etc. Any device that can be used to set and deliver a certain dose of a drug, such as a pump and a syringe, etc. can be. The drug can be any of the types that can be delivered by such a drug delivery device.

[0010] Devices described herein, such as device 10, 210, 410, 610 or 810, for example, may further contain a drug, such as in reservoir or cartridge 20. In another embodiment, the system may include one or more devices including device 10 and a drug. The term "drug" (medication) refers to one or more therapeutic agents including, but not limited to, insulin, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies, and any therapeutic agent that can be delivered by the above devices. The drug as used in the device may be formulated with one or more excipients. The device is generally operated by a patient, caregiver or healthcare professional in the manner generally described above for delivering the drug to a human.

[0011] The exemplary drug delivery device 10 is shown in FIGS. 1-4 as a pen-type syringe configured to inject a drug into a patient through a needle. Device 10 includes a body 11 having an elongated pen-shaped housing 12 including a distal portion 14 and a proximal portion 16. The distal portion 14 is received within pen cap 18. Referring to FIG. 2, the distal portion 14 is during the dispensing operation ​​​​​A reservoir configured to hold a chemical solution to be dispensed through its distal outlet end, or includes a cartridge 20. The outlet end of the distal portion 14 is equipped with a removable needle assembly 22 that includes a syringe needle 24 surrounded by a removable cover 25. The piston 26 is disposed within the reservoir 20. The injection mechanism disposed within the proximal portion 16 is operable to advance the piston 26 toward the outlet of the reservoir 20 during a metered dispensing operation to force the contained drug through the needle tip. The injection mechanism includes a drive member 28, illustratively in the form of a screw that is axially movable relative to the housing 12 to advance the

[0012] piston 26 through the reservoir 20. The dose setting member 30 is coupled to the housing 12 to set the dose to be dispensed by the device 10. In the illustrated embodiment, the dose setting member 30 operates to move in a helical motion (i.e., axially and rotationally simultaneously) about the longitudinal axis AA relative to the housing 12 during dose setting and metered dispensing. FIGS. 1-2 show the dose setting member 30 fully screwed into the housing 12 in its home or zero dose position. The dose setting member 30 is operable to unscrew proximally from the housing 12 until it reaches a fully extended position corresponding to the maximum dose deliverable by the device 10 in one injection. The extended position is between a position corresponding to an incremental extended position (such as a 0.5 or 1 unit dose setting) and the fully It can be screwed in and set to any position.

[0013] Referring to FIGS. 2-4, the dose setting member 30 is helically movable relative to the housing 12. To enable this, the dose setting member 30 includes a cylindrical dose dial member 32 having an outer helical thread that engages the corresponding threaded inner surface of the housing 12. The dose dial member 32 further includes an inner helical thread that engages the threaded outer surface of the sleeve 34 (FIG. 2) of the device 10. The outer surface of the dial member 32 includes dose indicator markings, such as numbers, visible through the dose window 36 to indicate the set dose to the user. The dose setting member 30 is connected to the open proximal end of the dial member 32 and is axially and rotationally locked to the dose dial member 32 by a detent 40 received within the opening 41 of the dial member 32. The dose setting member 30 further includes an optional collar or skirt 42 disposed on the outer periphery of the proximal end of the dial member 32. The skirt 42 is axially and rotationally locked to the dial member 32 by tabs 44 received in slots 46. Accordingly, since the dose dial member 32, the flange 38, and the skirt 42 are all rotationally and axially fixed together, the dose setting member 30 can be considered to include any or all of them. The dose dial member 32 is directly involved in setting the dose and advancing the delivery of the medicament. The flange 38 is attached to the dial member 32 and, as described below, cooperates with a clutch to selectively couple the dial member 32 to the dose button. The dose setting member 30 further includes an optional collar or skirt 42 disposed on the outer periphery of the proximal end of the dial member 32. The skirt 42 is axially and rotationally locked to the dial member 32 by tabs 44 received in slots 46. Accordingly, since the dose dial member 32, the flange 38, and the skirt 42 are all rotationally and axially fixed together, the dose setting member 30 can be considered to include any or all of them.

[0014] Accordingly, since the dose dial member 32, the flange 38, and the skirt 42 are all rotationally and axially fixed together, the dose setting member 30 can be considered to include any or all of them. The dose dial member 32 is directly involved in setting the dose and advancing the delivery of the medicament. The flange 38 is attached to the dial member 32 and, as described below, cooperates with a clutch to selectively couple the dial member 32 to the dose button. The dose dial member 32 is directly involved in setting the dose and advancing the delivery of the medicament. The flange 38 is attached to the dial member 32 and, as described below, cooperates with a clutch to selectively couple the dial member 32 to the dose button. As shown, skirt 42 provides a surface outside the body 11 so that the user can rotate the dose dial member 32 to set the dose.

[0015] In the embodiment shown in FIG. 18, the dose button of the illustrated device 10 is an integrated component that combines both the skirt 42 and the dose button 56 of FIGS. 1-4. In this embodiment, the flange is attached to the dial member and cooperates with a clutch described below to selectively couple the dial member to an integrated dose button shown as button 656. The radially outer surface of the integrated dose button 656 provides a surface outside the device body 11 for rotating the dial member. 11.

[0016] Skirt 42 illustratively includes a plurality of surface contours 48 and an annular ridge 49 formed on the outer surface of skirt 42. Surface contours 48 are illustratively longitudinal ribs and grooves circumferentially spaced around the outer surface of skirt 42 to facilitate the user's gripping and rotating of the skirt. In an alternative embodiment, skirt 42 is removable or integrated with the dial member, and the user can grip and rotate the dose dial member 32 to set the dose. 32.

[0017] Delivery device 10 includes an actuator 50 having a clutch 52 received within dose dial member 32. Clutch 52 includes a stem 54 that extends axially at its proximal end. Actuator 50 further includes a dose button 56 disposed proximal to skirt 42 of dose setting member 30 as shown. Dose button 56 is within the distal face of dose button 56 It includes a mounting collar 58 (Figure 2) located centrally. The collar 58 is interference - fitted or ultrasonically welded or the like to the stem 54 of the clutch 52 to axially and rotatably fix the dose button 56 and the clutch 52 together. It is attached to the stem 54 of the clutch 52 by such means as interference - fitting or ultrasonic welding.

[0018] The dose button 56 includes a disc - shaped proximal end surface or face 60 and an annular wall portion 62 that extends distally and is spaced radially inward of the outer peripheral edge of the face 60, with an annular lip 64 formed therebetween. The face 60 of the dose button 56 functions as a pressing surface that can be manually, i.e., directly by the user, forced to push the actuator 50 in the distal direction. It forms an annular lip 64 therebetween. The face 60 of the dose button 56 functions as a pressing surface that can be manually, i.e., directly by the user, forced to push the actuator 50 in the distal direction. The dose button 56 illustratively includes a concave portion 66 located at the center of the proximal face 60, but the proximal face 60 may alternatively be a flat surface. A biasing member 68, illustratively a spring, is disposed between the distal surface 70 of the button 56 and the proximal surface 72 of the tubular flange 38 to bias the actuator 50 and the dose setting member 30 axially apart from each other. The dose button 56 can be depressed by the user to initiate a dose dispensing operation. In an alternative embodiment, the skirt 42 is omitted from the device, and the annular wall portion 62 of the dose button 56 extends distally to a position reaching approximately the distal side limit of the skirt relative to the dial member as shown in the figure.

[0019] The delivery device 10 is operable in both a dose - setting mode and a dose - dispensing mode. In the operation of the dose - setting mode, the dose setting member 30 is dialed (rotated) relative to the housing 12 to set the desired dose to be delivered by the device 10. Dialing in the proximal direction functions to increase the set dose, and dialing in the distal direction functions to decrease the set dose. functions to decrease. The dose setting member 30 has a minimum increment of the set dose during the dose setting operation is adjustable in rotational increments (e.g., clicks) corresponding to increases or decreases. For example, 1 increment or "click" can be equal to 1 / 2 or 1 unit of the drug. The set dose is visible to the user via the dial indicator markings shown through the dosing window 36 There is. The actuator 50 including the dose button 56 and the clutch 52 moves axially and rotationally with the dose setting member 30 during the dose setting mode movement.

[0020] The dose dial member 32, the flange 38 and the skirt 42 (if employed) are all are rotationally fixed to each other, and for the threaded connection between the dose dial member 32 and the housing 12 rotates during dose setting and extends proximally to the drug delivery device 10. This dose setting operation During, the dose button 56 is rotationally fixed to the skirt 42 by the complementary splines 74 (FIG. 2) of the flange 38 and the clutch 52 that are biased together by the biasing member 68 . During dose setting, the skirt 42 and the dose button 56 move helically relative to the housing 12 from the "start" position to the "end" position. This rotation relative to the housing is proportional to the dose set by the operation of the drug delivery device 10. After the desired dose is set, the injection needle 24 is operated, for example, to properly penetrate the user's skin of the device 10. The operation of the dose dispensing mode is initiated in response to an axial distal force applied to the proximal surface 60 of the dose button 56

[0021] . The axial force is applied directly to the dose button 56 by the user. This moves the actuator 50 distally axially relative to the housing 12 . .​​

[0022] The axial movement of the actuator 50 compresses the biasing member 68 and reduces or closes the gap between the dose button 56 and the tubular flange 38. This relative axial movement disengages the complementary splines 74 on the clutch 52 and the flange 38, thereby releasing the actuator 50, e.g., the dose button 56, from its rotationally fixed state relative to the dose setting member 30. Specifically, the dose setting member 30 is rotationally disconnected from the actuator 50, allowing the dose setting member 30 to be driven rotationally rearward relative to the actuator 50 and the housing 12. Also, since the dose setting member 30 and the actuator 50 are free to rotate relative to each other, engagement of the user with the dose button 56 by pushing it causes the actuator 50 to be held against rotation relative to the device housing 12. continue to be axially pushed in while the actuator 50 is held against rotation relative to the housing 12, the dial member 32 rotates relative to the dose button 56 and the dial member 3 2 is screwed back into the housing 12. The dose markings indicating that an amount of the drug to be injected remains are visible through the window 36. When the dose setting member 30 is screwed distally

[0023] secured, the drive member 28 is advanced distally to push the piston 26 through the reservoir 20 and release the drug through the needle 24 (FIG. 2). During the dose dispensing operation, the amount of drug released from the drug delivery device is based on the rotational movement of the dose setting member 30 relative to the actuator 50 as the dial member 32 is screwed back into the housing 12. into the piston 26 and release the drug through the needle 24 (FIG. 2).

[0024] During the dose dispensing operation, the amount of drug released from the drug delivery device is based on the rotational movement of the dose setting member 30 relative to the actuator 50 as the dial member 32 is screwed back into the housing 12. ment 30 relative to the actuator 50 as the dial member 32 is screwed back into the housing 12. ​​​is proportional to the amount of movement. The injection is completed when the female thread of the dial member 32 reaches the corresponding male thread of the sleeve 34 (Figure 2). Next, the device 10 is repositioned to a ready state or zero dose position as shown in Figures 2 and 3. The dose to be delivered can be derived based on the rotation of the dose setting member 30 relative to the actuator 50 during dose delivery. This rotation can be determined by detecting the incremental movement of the dose setting member that is "counted" as the dose setting member rotates during dose delivery. Further details of the design and operation of the exemplary delivery device 10 can be found in U.S. Patent No. 7,291,132 entitled Medication D

[0025] ispensing Apparatus with Triple Screw Th reads for Mechanical Advantage, the entire disclosure of which is incorporated herein by reference. Another example of a delivery device can be found in U.S. Patent No. 8,734,394 entitled " Automatic Injection Device With Delay Me

[0026] chanism Including Dual Functioning Biasi ng Member", the entire disclosure of which is incorporated herein by reference, and such a device is modified to determine the amount of drug delivered from the drug delivery device based on the sensing of relative rotation within the drug delivery device using one or more of the various sensor systems described herein. Another example of a delivery device can be found in "Medication Injector Apparat automatic injection device, the entire disclosure of which is incorporated herein by reference, and such a device is modified to determine the amount of drug delivered from the drug delivery device based on the sensing of relative rotation within the drug delivery device using one or more of the various sensor systems described herein. Another example of a delivery device can be found in "Medication Injector Apparat us with Drive Assembly that Facilitates It can be found in U.S. Patent No. 7,195,616 entitled "Reset", which is a reusable pen-type device. Such a device is modified herein using one or more of the various sensor systems described to determine the amount of drug delivered from the drug delivery device based on the perception of relative rotation within the drug delivery device. The dosage detection system uses a sensing component and a sensed component attached to a member of the drug delivery device. The term "attached" encompasses any manner of fixing the position of the components to another component or member of the drug delivery device such that they are operable as described herein. For example, the sensing component can be attached to a member of the drug delivery device by being directly disposed on the member, received within the member, integrated with the member, or otherwise connected to the member. The connection can include, for example, a connection formed by frictional engagement, splines, snap or press fit, sonic welding, or an adhesive.

[0027] The dosage detection system uses a sensing component and a sensed component attached to a member of the drug delivery device. The term "attached" encompasses any manner of fixing the position of the components to another component or member of the drug delivery device such that they are operable as described herein. For example, the sensing component can be attached to a member of the drug delivery device by being directly disposed on the member, received within the member, integrated with the member, or otherwise connected to the member. The connection can include, for example, a connection formed by frictional engagement, splines, snap or press fit, sonic welding, or an adhesive. The term "attached" encompasses any manner of fixing the position of the components to another component or member of the drug delivery device such that they are operable as described herein. For example, the sensing component can be attached to a member of the drug delivery device by being directly disposed on the member, received within the member, integrated with the member, or otherwise connected to the member. The connection can include, for example, a connection formed by frictional engagement, splines, snap or press fit, sonic welding, or an adhesive. The term "attached" encompasses any manner of fixing the position of the components to another component or member of the drug delivery device such that they are operable as described herein. For example, the sensing component can be attached to a member of the drug delivery device by being directly disposed on the member, received within the member, integrated with the member, or otherwise connected to the member. The connection can include, for example, a connection formed by frictional engagement, splines, snap or press fit, sonic welding, or an adhesive. The term "attached" encompasses any manner of fixing the position of the components to another component or member of the drug delivery device such that they are operable as described herein. For example, the sensing component can be attached to a member of the drug delivery device by being directly disposed on the member, received within the member, integrated with the member, or otherwise connected to the member. The connection can include, for example, a connection formed by frictional engagement, splines, snap or press fit, sonic welding, or an adhesive. The term "attached" encompasses any manner of fixing the position of the components to another component or member of the drug delivery device such that they are operable as described herein. For example, the sensing component can be attached to a member of the drug delivery device by being directly disposed on the member, received within the member, integrated with the member, or otherwise connected to the member. The connection can include, for example, a connection formed by frictional engagement, splines, snap or press fit, sonic welding, or an adhesive. The term "attached" encompasses any manner of fixing the position of the components to another component or member of the drug delivery device such that they are operable as described herein. For example, the sensing component can be attached to a member of the drug delivery device by being directly disposed on the member, received within the member, integrated with the member, or otherwise connected to the member. The connection can include, for example, a connection formed by frictional engagement, splines, snap or press fit, sonic welding, or an adhesive. The term "attached" encompasses any manner of fixing the position of the components to another component or member of the drug delivery device such that they are operable as described herein. For example, the sensing component can be attached to a member of the drug delivery device by being directly disposed on the member, received within the member, integrated with the member, or otherwise connected to the member. The connection can include, for example, a connection formed by frictional engagement, splines, snap or press fit, sonic welding, or an adhesive. The term "attached" encompasses any manner of fixing the position of the components to another component or member of the drug delivery device such that they are operable as described herein. For example, the sensing component can be attached to a member of the drug delivery device by being directly disposed on the member, received within the member, integrated with the member, or otherwise connected to the member. The connection can include, for example, a connection formed by frictional engagement, splines, snap or press fit, sonic welding, or an adhesive.

[0028] The term "directly attached" is used to describe an attachment where two components, or one component and one member, are physically fixed together without using an intermediate member other than the attachment component. The attachment component can include fasteners, adapters, or other parts of the fastening system (such as a compression membrane) that intervene between the two components to facilitate the attachment. "Direct attachment" is for dosage The term "directly attached" is used to describe an attachment where two components, or one component and one member, are physically fixed together without using an intermediate member other than the attachment component. The attachment component can include fasteners, adapters, or other parts of the fastening system (such as a compression membrane) that intervene between the two components to facilitate the attachment. "Direct attachment" is for dosage The term "directly attached" is used to describe an attachment where two components, or one component and one member, are physically fixed together without using an intermediate member other than the attachment component. The attachment component can include fasteners, adapters, or other parts of the fastening system (such as a compression membrane) that intervene between the two components to facilitate the attachment. "Direct attachment" is for dosage The term "directly attached" is used to describe an attachment where two components, or one component and one member, are physically fixed together without using an intermediate member other than the attachment component. The attachment component can include fasteners, adapters, or other parts of the fastening system (such as a compression membrane) that intervene between the two components to facilitate the attachment. "Direct attachment" is for dosage The term "directly attached" is used to describe an attachment where two components, or one component and one member, are physically fixed together without using an intermediate member other than the attachment component. The attachment component can include fasteners, adapters, or other parts of the fastening system (such as a compression membrane) that intervene between the two components to facilitate the attachment. "Direct attachment" is for dosage The manner in which the dial member 32 is coupled to the dose button 56 by the clutch 52 in FIG. 2 is distinct from attachments in which components / members are coupled by one or more intermediate functional members such as

[0029] The term "fixed" is used to indicate that the indicated movement may or may not occur. For example, if two members are required to rotate and move together then the first member is "fixed rotationally" to the second member In one aspect, a member may be "fixed" functionally rather than structurally to another member. For example, a frictional engagement between two members may be such that they are rotationally fixed together and one member may be pressed against another, but the two members may not be fixed together without the pressing of the first member

[0030] A variety of sensor systems are contemplated herein. Generally, a sensor system includes a sensing component and a sensed component. The term "sensing component" refers to any component that can detect the relative position or movement of a sensed component The sensing component includes a sensing element or "sensor" together with associated electrical components for operating the sensing element The "sensed component" is any component that the sensing component can detect the position and / or movement of the sensed component relative to the sensing component In the case of a dose detection system, the sensed component rotates relative to the sensing component, thereby detecting the rotational movement of the sensed component ​​​​​​The element can include one or more sensing elements, and the sensed component can include one or more sensed elements. The sensor system detects the movement of the sensed component and provides an output representing the movement of the sensed component.

[0031] Exemplarily, the dose detection system includes a suitable electronic device assembly as described herein for the operation of the sensor system. A controller is operably connected to the sensor system and receives the output from the rotation sensor. The controller receives a generated signal from a rotation sensor indicating the count from the first to the last with respect to the total number of counts used to determine the total angular displacement. The controller can be configured to receive data indicating the angular movement of a dose setting member that can be used to determine the dose delivered by the operation of the drug delivery device from the output. The controller can be configured to determine the dose delivered by the operation of the drug delivery device from the output. The controller can include conventional components such as a processor, a power source, a memory, a microcontroller, etc. Alternatively, at least some of the components can be provided separately by a computer, a smartphone, or other device, etc. Next, means are provided for operably connecting an external controller component to the sensor system when appropriate, such as by a wired or wireless connection.

[0032] An exemplary electronic device assembly 76 is shown in FIG. 5 and can include a flexible printed circuit board (FPCB) having a plurality of electronic components. The electronic device assembly operably communicates with one or more sensors to receive signals from the sensors representing the sensed rotation. The electronics assembly 76 includes a circuit board having at least one The microcontroller unit acts as a controller with two processing cores and internal memory. The system further includes a battery for powering the components; The controller of the electronics assembly 76 controls the actuator. and determining whether or not a dose is to be delivered based on the detected rotation of the dose setting member relative to the dose delivery device. Detecting the angular movement of the dose setting component during delivery and / or the drug delivery device 1 0. Many of the components in the electronics assembly include the dose button. 56. The catheter 52 may be contained in a compartment 78 located proximal to the catheter 56.

[0033] The controller of the electronics assembly 76 determines the total angle used to determine dose delivery. Record the exercise and / or detected dose delivery in a local memory (e.g., internal flash memory). The controller also stores the total count in a The sensor then transmits signals representing the detected dose, total angular motion, and / or detected dose to the user's smartphone. The wireless communication device 100 operates to wirelessly transmit to a paired remote electronic device, such as a Bluetooth Low Energy (BLE) or other suitable short or long range wireless This can be done through a communication protocol. For example, BLE control logic and The controllers are integrated on the same circuit.

[0034] The dose detection system includes detecting relative rotational motion between the two members. Based on the degree of rotation having a known relationship with the dosage, the sensor system operates to detect the angular displacement from the start to the end of the dosage injection. For example, in a pen-type syringe, a typical relationship is that an angular displacement of 18° of the dosage setting member is equal to 1 unit dosage. However, other angular relationships are also appropriate. For example, 9, 10, 15, 20, 24, or 36 degrees can be used as 1 unit or 0.5 unit. The sensor system is operable to determine the total angular displacement of the dosage setting member during dosage delivery. Thus, if the angular displacement is 90°, it means that 5 units of dosage have been delivered. The angular displacement is determined by counting the dosage increments as the injection progresses. For example, the sensing system can use the repetitive pattern of the sensed element such that each repetition serves as an indicator of a predetermined degree of rotational angle. Conveniently, the pattern can be established to correspond to the minimum increment of dosage that can be set using the drug delivery device. The components of the sensor system can be permanently or removably attached to the drug delivery device. In an exemplary embodiment, at least some of the components of the dosage detection system are provided in the form of a module that is removably attached to the drug delivery device. This has the advantage of allowing these sensor components to be used with more than one pen-type syringe. During dosage delivery, the sensor system detects the relative rotation of the sensed component, and thus the dosage setting member, and then determines the dosage delivered by the drug delivery device. For example, a typical relationship is that an angular displacement of 18° of the dosage setting member is equal to 1 unit dosage, but other angular relationships are also appropriate, such as 9, 10, 15, 20, 24, or 36 degrees being used as 1 unit or 0.5 unit. The sensor system is operable to determine the total angular displacement of the dosage setting member during dosage delivery. Thus, if the angular displacement is 90°, it means that 5 units of dosage have been delivered. The angular displacement is determined by counting the dosage increments as the injection progresses. For example, the sensing system can use the repetitive pattern of the sensed element such that each repetition serves as an indicator of a predetermined degree of rotational angle.

[0035] Conveniently, the pattern can be established to correspond to the minimum increment of dosage that can be set using the drug delivery device. The components of the sensor system can be permanently or removably attached to the drug delivery device. In an exemplary embodiment, at least some of the components of the dosage detection system are provided in the form of a module that is removably attached to the drug delivery device. This has the advantage of allowing these sensor components to be used with more than one pen-type syringe. During dosage delivery, the sensor system detects the relative rotation of the sensed component, and thus the dosage setting member, and then determines the dosage delivered by the drug delivery device.

[0036] The components of the sensor system can be permanently or removably attached to the drug delivery device. In an exemplary embodiment, at least some of the components of the dosage detection system are provided in the form of a module that is removably attached to the drug delivery device. This has the advantage of allowing these sensor components to be used with more than one pen-type syringe. The sensor system detects the relative rotation of the sensed component, and thus the dosage setting member, during dosage delivery, and then determines the dosage delivered by the drug delivery device. For example, a typical relationship is that an angular displacement of 18° of the dosage setting member is equal to 1 unit dosage, but other angular relationships are also appropriate, such as 9, 10, 15, 20, 24, or 36 degrees being used as 1 unit or 0.5 unit. The sensor system is operable to determine the total angular displacement of the dosage setting member during dosage delivery. Thus, if the angular displacement is 90°, it means that 5 units of dosage have been delivered.

[0037] The angular displacement is determined by counting the dosage increments as the injection progresses. For example, the sensing system can use the repetitive pattern of the sensed element such that each repetition serves as an indicator of a predetermined degree of rotational angle. In an embodiment, the rotation sensor is attached to and rotationally fixed to the actuator. The actuator does not rotate relative to the body of the drug delivery device during dose delivery. In this embodiment, the sensed component is attached to and rotationally fixed to a dose setting member that rotates relative to the actuator and the device body during dose delivery. In some of the embodiments described herein, the sensed component includes a ring structure having a plurality of proximally extending protrusions circumferentially disposed relative to each other. The protrusions are shaped and sized to deflect the movable element of the rotation sensor. The embodiments described herein can be removably attachable to the dose button of the delivery device or provided for a module integrated within the dose button of the delivery device as shown in FIGS. 10-11. Referring to FIG. 5, a dose delivery detection system 80 including a module 82 useful in combination with a drug delivery device such as device 10 is shown in schematic form. The module 82 includes a rotation sensor 86 and carries a sensor system 84, shown generally at 84, including other associated components such as a processor, memory, battery, etc. The module 82 is provided as a separate component that can be removably attached to the actuator. The dose detection module 82 includes a body 88 attached to the dose button 56. The body 88 illustratively includes a cylindrical sidewall 90 and a top wall 92 extending across and sealing the sidewall 90. By way of example, in FIG. 5, the sidewall 90 attaches the module 82 to the dose button 56.

[0038]

[0039] ​​​​​​​​​​​​​​​It is schematically shown to have an inwardly extending tab 94 to be attached. Thereby, the module 82 is attached to the dose button 56 such that when the module is pushed, a set dose is delivered.

[0040] The dose detection module 82 can alternatively be attached to the dose button 56 via any suitable fastening means such as snap or press-fit, screw interface, etc., provided that in one aspect the module 82 can be removed from the first drug delivery device and then attached to the second drug delivery device. The attachment can be at any position on the dose button 56, provided that, as discussed herein, the dose button 56 can be axially moved by any required amount relative to the dose setting member 30.

[0041] During dose delivery, the dose setting member 30 can rotate freely relative to the dose button 56 and the module 82. In an exemplary embodiment, the module 82 is rotationally fixed to the dose button 56 and does not rotate during dose delivery. This can be structurally provided, for example, by using the tab 94 of FIG. 5 or by engaging mating splines or other surface features on the module body 88 and the dose button 56 when the module 82 is axially moved relative to the dose button 56. In another embodiment, pressing the module distally provides sufficient frictional engagement between the module 82 and the dose button 56 to keep them rotationally fixed together during dose delivery.

[0042] The top wall 92 is spaced from the face 60 of the dose button 56, thereby ​​​​​​​​​​​​Provide a compartment 78 that includes some or all of the 76. Compartment 78 defines a chamber 96 and may have an open bottom or be enclosed by a bottom wall 98 or the like The bottom wall 98 can be arranged to directly abut the surface 60 of the dosage button 56 Alternatively, if the bottom wall 98 is present, it may be spaced apart from the dosage button 56, and other contacts between the module 82 and the dosage button 56 can be used such that the axial force applied to the module 82 is transmitted to the dosage button 56

[0043] Also disclosed herein is a dosage detection system operable to determine the delivered dosage based on the relative rotation between the dosage setting member and the device body The dosage detection system utilizes a dosage setting member that is attached to the device body and rotatable relative to the device body about a rotation axis during dosage delivery. The sensed element is attached to the dosage setting member and rotationally fixed The actuator is attached to the device body and held so as not to rotate relative to the device body during dosage delivery. Thereby, the sensed element rotates relative to the actuator during dosage delivery in relation to the amount of dosage delivered

[0044] The dosage detection system comprises a sensor system including a rotational sensor attached to the actuator The sensed element includes surface feature portions radially spaced around the rotation axis of the dosage setting member The surface feature portions can be configured to correlate to the equivalent of one unit of dosage, but other angular relationships are also suitable, for example, 9, 10, 15, 18, 20, 24 or 36 degrees can be used for one unit or 0.5 unit The rotational sensor is attached to the actuator and senses ​​​​​​​A movable element having a contact portion that can rest and be spring-biased in the direction of the surface feature portion of the known element is included. Thereby, the contact surface is positioned to move across the surface feature portion during rotation of the sensed element relative to the actuator during dose delivery. The rotation sensor responds to the movement of the contact portion on the surface feature portion and generates a signal corresponding to the rotation of the dose setting member. The controller determines the dose count to determine the amount of dose delivery based on the detected rotation of the dose setting member relative to the actuator in response to the signal generated by the rotation sensor. on the surface feature portion and generates a signal corresponding to the rotation of the dose setting member. The controller determines the dose count to determine the amount of dose delivery based on the detected rotation of the dose setting member relative to the actuator in response to the signal generated by the rotation sensor. on the surface feature portion and generates a signal corresponding to the rotation of the dose setting member. The controller determines the dose count to determine the amount of dose delivery based on the detected rotation of the dose setting member relative to the actuator in response to the signal generated by the rotation sensor.

[0045] The surface feature portion can include anything detectable by the rotation sensor. As described above , the sensor system can be based on various sensed characteristics including, for example, tactile, optical, electrical, and magnetic properties. In one aspect, the surface feature portion is a physical feature that enables detection of incremental movement as the dose setting member rotates relative to the actuator. on the surface feature portion and generates a signal corresponding to the rotation of the dose setting member. The controller detects incremental movement as the dose setting member rotates relative to the actuator.

[0046] The contact surface is biased against the physical feature to ensure proper contact between the contact surface and the physical feature during rotation. In one embodiment, the movable member is an elastic member having one portion attached to the actuator at a position displaced from the contact surface. In one example, the movable member is a follower member having a beam attached to the actuator at one end and having a contact surface at the other end. The beam is bent to bias the contact surface in the direction of the surface feature portion. Alternatively, the movable member can be biased in any of various other ways. In addition to the use of an elastic beam, for example, biasing can be provided by the use of a spring component. Such spring components, for example member is a follower member having a beam attached to the actuator at one end and having a contact surface at the other end. The beam is bent to bias the contact surface in the direction of the surface feature portion. Alternatively, the movable member can be biased in any of various other ways. In addition to the use of an elastic beam, for example, biasing can be provided by the use of a spring component. Such spring components, for example the movable member can be biased in any of various other ways. In addition to the use of an elastic beam, for example, biasing can be provided by the use of a spring component. Such spring components, for example the movable member can be biased in any of various other ways. In addition to the use of an elastic beam, for example, biasing can be provided by the use of a spring component. Such spring components, for example For example, it may include a compression, tension, or torsion coil spring. In yet other embodiments, the movable member may be biased against the surface features of the sensed element by a separate elastic member or spring component that supports the movable element thereof.

[0047] In one embodiment, the surface features are uniformly spaced intermittently around the axis of rotation of the sensed element and are elements. In certain aspects, the surface features are equi-radius projections spaced in a direction separated by intervening recesses. The contact surface of the movable element is arranged to straddle the projections and move inwardly with respect to the intervening recesses. The movable element can be, for example, an elastic beam that bends outwardly along the projections or a translational member that rides over the projections.

[0048] In one aspect, the projections are inclined upwardly in a direction opposite to the rotation of the sensed element during dose delivery to facilitate movement of the contact surface on the projection along the projection. In other aspects, the projections have different profiles in opposite angular directions to provide detection of the direction of rotation of the sensed element with respect to the actuator. The projections can extend in any direction detectable by the movable element. For example, the projections may extend axially or radially. Axial projections may extend proximally or distally. Radial projections may extend inwardly or outwardly.

[0049] The sensed element is attached to the dose setting member. Depending on the drug delivery device, the sensed element may be attached to a skirt, flange or dose dial, or any other component that rotates relative to the device body during dose delivery in relation to the delivered dose.

[0050] In one aspect, the sensing system of the dosage detection system 80 is originally integrated as a drug delivery device. In other aspects, a modular form of the dosage detection system is disclosed . The use of a removably attached module is particularly suitable for use with a drug delivery device that includes a portion of an actuator and / or a dosage setting member that is external to the drug device housing. These external portions are particularly suitable for use with a drug delivery device that includes a portion of an actuator and / or a dosage setting member that is external to the drug device housing. As described herein, these external portions enable direct attachment of the module to an actuator such as a dosage button and / or attachment of a sensed element to a dosage setting member such as a skirt , flange, or dosage dial member. Alternatively, the sensed element is integral with the drug delivery device and the module is removably attached. This has the advantage that more complex and expensive electronics, including a rotational sensor and a controller, can be reused with different drug delivery devices. In comparison, the sensed element may use relatively simple features, such as radially spaced protrusions, which do not significantly increase the cost of the drug delivery device. Exemplary drug delivery devices incorporating an exemplary dosage detection system are shown in FIGS. 5-9. The device includes a sensor system 84 of the dosage detection system 80 that includes a rotational sensor 8 6 and a sensed element 99 having surface features. Examples of the position and configuration of the surface features include, by way of illustration, axial surface features of the flange (e.g., FIG. 6), axial surface features of the dosage dial member

[0051] . The device includes a sensor system that detects surface features of a sensed element extending from one or more of the components of a dosage setting device 30, such as a dosage dial member 32 and / or a flange 38. In particular, the sensor system 84 of the dosage detection system 80 includes a rotational sensor 8 6 and a sensed element 99 having surface features. Examples of the position and configuration of the surface features include, by way of illustration, axial surface features of the flange (e.g., FIG. 6), axial surface features of the dosage dial member direction surface features of the dosage dial member (e.g., FIG. 7), etc. The directional surface feature portion (e.g., FIG. 10), the radially outer surface feature portion of the dosage dial member (e.g., FIG. 20), and the radially inner surface feature portion of the flange (e.g., FIG. 23) are shown.

[0052] In one example shown in FIG. 6, the sensed element 99 includes a ring 100 connected to the flange 38. The ring 100 can be permanently fixed to the flange 38 (shown) or the dosage dial member 32 with an adhesive and / or fasteners, or can be configured to be removably attached to the flange 38 or the dosage dial member using, for example, mechanical fasteners or retaining components. It will be understood that the ring may be omitted, and the surface feature portion may be integrally formed from the flange 38 or the dial member 32 as a single member (e.g., as shown in FIGS. 17 or 23) by, for example, molding or additive manufacturing. As shown in FIGS. 6 and 7, the surface feature portion 101 includes a series of ramped protrusions 102. The rotation sensor 86 includes one or more movable elements 103 (FIG. 5), and in this example, is received through a button opening 105 defined by the face 60 of the dosage button

[0053] 56, and is arranged with a follower member pin 104 having a distal contact surface 111 that can rest on the surface feature portion shown as the protrusion 102 when the flange 38 rotates relative to the dosage button 56. The pin 104 is shown extending through a module opening 107 that is coaxially aligned with the button opening 105 defined by the distal bottom wall 98. The inner surfaces defining the module opening and the button opening respectively are configured such that during axial movement, the pin rests at two positions along the inner surfaces. has a distal contact surface 111 that can rest on the surface feature portion shown as the protrusion 102 when the flange 38 rotates relative to the dosage button 56, and is provided with a follower member pin 104 arranged so as to have The pin 104 is shown extending through a module opening 107 that is coaxially aligned with the button opening 105 defined by the distal bottom wall 98. The inner surfaces defining the module opening and the button opening respectively are shown to extend through a module opening 107 that is coaxially aligned with the button opening 105 defined by the distal bottom wall 98 and is defined by the distal bottom wall 98. The inner surfaces defining the module opening and the button opening respectively are such that during axial movement, the pin ​configured to provide bearing support to the plunger. Such openings 105, 107 by their size and configuration enhance the linear axial movement of the pin to reduce spurious readings from the sensors or switches employed. For redundant sensing to reduce spurious readings, more than one pin and corresponding openings defined by respective components may be utilized.

[0054] Pin 104 may include a pin flange 106 received between contact surface 111 and dose button 56. Coil spring 108 is disposed between pin flange 106 and dose button 56 and biases pin 104 in the distal direction of projection 102. When flange 38 rotates during dose delivery, the pin and dose button maintain their relative positions and contact surface 111 of pin 104 rides up on each surface feature shown as projection 102 against the biasing force of coil spring 108. Pin 104 then drops into each recess 110 between adjacent projections. Thereby, pin 104 operates as a follower member that follows the contour of the projections and recesses.

[0055] Rotary sensor 86 further includes a sensing element 114 arranged to detect the movement of pin 104 as it rides over projection 102 and drops into recess 110. Sensing element 114 may be provided in various forms operable to detect the translational movement of pin 104. By way of example, sensing element 114 is shown in FIG. 5 as including a microswitch that operates to detect the axial movement of pin 104 in the proximal direction each time pin 104 rides over projection 102. By this operation, each time the projection / recess pair of ring 100 is traversed, ​​​​​​​​​​​​​The on / off or off / on setting of the microswitch will be changed continuously.

[0056] In the manner described above, the rotation sensor 86 detects the angular movement of the dose setting member by counting the number of protrusions that trigger the sensing element 114 during dose delivery. The rotation sensor 86 generates signals indicative of this angular movement, and these signals can be used by the controller to determine the total rotation of the dose setting member during dose delivery, which can be used to determine the amount of dose delivered. In one example, the rotation sensor 86 generates a signal indicative of the count number, and the controller receives the generated signal. The controller may store the count number in an internal memory and / or may electronically transmit the count number to an external device. The controller may compare the count number with an internal database that correlates the count number to the total angular movement and thus the dose delivered. The determined angular movement and / or the dose delivered may be displayed (such as numerically) on a local display or indicator system as part of the electronic device assembly, and / or may be electronically transmitted to an external device. The determined angular movement and / or the dose delivered may be displayed (such as numerically) on a local display or indicator system as part of the electronic device assembly, and / or may be electronically transmitted to an external device.

[0057] FIG. 8 shows an alternative dose detection system that similarly uses radially spaced protrusions 102 and a movable member 103 with pins 104 that ride along successive protrusions and recesses. As shown in FIG. 8, each movable member 103 includes a contact surface 116 that moves over a surface feature 101, such as protrusions 102, that are radially spaced about the axis of rotation. The contact surface 11 6 of the pin 104 includes an enlarged end portion 118 that desirably is made of a durable low friction material that allows the pin 104 to slide easily across the protrusions 102 in FIG. 8. is shown. An enlarged end portion 118 having a cross-sectional area larger than the cross-sectional area of the pin. Also, FIG. 8 As shown in, the protrusion 102 may be formed with a surface 120 that slopes upward in a direction opposite to the rotational direction indicated by the arrow 122 of the dose setting member. This makes it even easier for the follower member on the protrusion to move.

[0058] In another aspect, the opposite side of the protrusion 102 can be tilted to allow rotation of the dose setting member in the opposite direction. Furthermore, different tilt angles can be provided on both sides of the protrusion to allow the dose detection system to detect the direction of rotation. On the other hand, the opposite side of the protrusion can be at a steeper angle to prevent rotation in the other direction.

[0059] Described herein are embodiments in which the actuator is moved distally relative to the device body to transition from a dose setting mode or a rest position to a dose delivery mode. In a proximally displaced state, one way to allow the sensed element to rotate in a direction opposite to dose delivery relative to the actuator is to separate the follower member from the protrusion. However, as also described, in certain embodiments, the actuator is rotationally fixed to the dose setting member during dose setting.

[0060] FIG. 8 shows an alternative dose detection system that operates by detecting vibrations associated with the rotation of the sensed element relative to the actuator during dose delivery. When the sensed element 99 rotates in the direction 122 relative to the movable member 103, the contact surface 116 moves the pin 104 away from the dose setting member and presses it against a biasing member, such as a spring 108. Once the contact surface 116 reaches the protrusion member and presses it against a biasing member, such as a spring 108. Once the contact surface 116 reaches the protrusion ​​​​​​Once past the apex, the biasing member quickly urges the compliant member down into the subsequent recess 110. 1, as the sensed element 99 moves further in the direction 122, the spring 108 pushes the pin 104 124, where it is suddenly stopped by contact with the bottom of the next recess 124. This sudden stop is accompanied by a vibration that is detected by the rotation sensor.

[0061] For example, FIG. 8 shows a rotational accelerometer 128 mounted on the proximal end of the pin 104. A support 126 is shown supporting the sensor. A rotational accelerometer 128 is primarily indicative of the rotation of the sensed element. During operation of the system, the accelerometer 128 detects the vibration of the protrusion. Each vibration associated with the passage of the pin 104 over the top and dropping into the next recess is detected. The gauge 128 can be of any type capable of detecting vibrations, and may be of any type capable of detecting vibrations. In an embodiment, a three-axis accelerometer is included. As used herein, the accelerometer is a specific It does not imply a type of accelerometer, but rather refers to the accelerometer used to detect rotation of the sensed element. To distinguish it as a speedometer, it is called a "rotational accelerometer." It can detect rotational vibrations. Other sensors may also be used.

[0062] Also shown in FIG. 8 is a second support 130 and a second support 132 useful in conjunction with the rotational accelerometer 128. Optional sensor components are shown including an accelerometer 132. In this case, the second accelerometer is used as a background accelerometer rather than suggesting a specific type of accelerometer. To distinguish it from the accelerometer used to detect hand vibration, The background accelerometer 132 is primarily used to measure the Provided to detect background vibrations such as those caused by the movement of the entire chair caused, and the vibration does not indicate rotation of the sensed element. For this purpose, the background The accelerometer 132, the pin 104 is slidably received within the opening of the dose button 56 etc., is relatively isolated from the pin 104.

[0063] A significant axial movement of the pin 104 relative to the dose button 56 is sensed more strongly by the rotational accelerometer 128 than by the background accelerometer 132. If the vibration sensed by the rotational accelerometer is substantially the same as that sensed by the background accelerometer, rotation of the sensed element is not indicated. In contrast, if, over a given time, the amount of vibration detected by the rotational accelerometer is substantially greater than that detected by the background accelerometer, rotation of the sensed element is indicated. The controller compares the detected rotational vibration with the background vibration to identify vibrations indicating rotation of the sensed element relative to the actuator during dose delivery. The movement of the follower member during rotation of the sensed element can also be associated with a related sound. In particular, when the pin 1 04 strikes the bottom of the recess 124, a distinct sound is produced. An alternative dose detection system utilizes this sound to detect rotation of the sensed element 99 relative to the dose button 56. As an example

[0064] and, as shown in FIG. 8, a microphone 134 forming a component of the alternative sensing system is also shown. When a pre-determined sound that serves as an indicator of rotation of the sensed element is detected, the rotation sensor generates a signal identifying rotation of the sensed element associated with dose delivery. To distinguish the rotational sound from other sounds, an additional background sound microphone may be used. is used to detect rotation of the sensed element 99 relative to the dose button 56. As an example and, as shown in FIG. 8, a microphone 134 forming a component of the alternative sensing system is also shown. When a pre-determined sound that serves as an indicator of rotation of the sensed element is detected, the rotation sensor generates a signal identifying rotation of the sensed element associated with dose delivery. To distinguish the rotational sound from other sounds, an additional background sound microphone may be used. generates a signal identifying rotation of the sensed element associated with dose delivery. To distinguish the rotational sound from other sounds, an additional background sound microphone may be used. because the rotational sound can be distinguished from other sounds, an additional background sound microphone may be used.

[0065] As shown in FIG. 8, the follower member can be biased, for example, by a coil spring. Alternatively , the follower member can be biased against the surface feature in a variety of other ways. For example, an elastic member can be used to bias pin 104 against protrusion 102. As shown in FIG. 9, elastic member 136 is attached at one end to the lower surface 138 of the dose button 56. Elastic member 136 includes, at the opposite end, a portion 140 that rests on the enlarged end portion of the contact surface 116 of the pin 104. Movement of the contact surface 116 over the protrusion causes the pin to translate upward against the downward bias of the elastic member 136, thereby maintaining the contact surface 116 in a position relative to the surface feature. Exemplarily , instead of pin 104, the follower member may comprise an elastic member 136 and the contact surface may be disposed at the end portion 140.

[0066] Referring now to FIGS. 1-2, a drug delivery device equipped with a sensing system is further shown as being used to determine the dose of administration set by the operation of the device. Such an amount is determined based on sensing relative rotational movement during dose setting between members of the drug delivery device, and the sensed movement correlates as being applicable to the set dose of administration. In different embodiments, the sensing system is configured to determine at least one of the dose set by the operation of the device and the dose delivered, or alternatively to determine both the dose set by the operation of the device and the dose of administration delivered.

[0067] FIGS. 10-11 show a rotational sensor disposed not in a module but within the dose button 256 ​​​​​Having a dose detection sensor system 284 that includes 286, herein referred to as 210, shows the proximal portion of the device. Device 210 includes at least a portion of the electronic components within the electronic device assembly and includes many of the same components that operate for dose setting and dose dispensing as described with reference to device 10, and such components will have the same corresponding description. Device 210 is shown as a device within an integrated dose detection sensing system, and such a sensing system can be incorporated within a module for removably attaching to a dose button. The dose setting member 230 is connected to the device housing 212 to set the dose to be dispensed by device 210. The dose setting member 230 is operable to screw in a proximal direction until it reaches a fully extended position corresponding to the maximum dose deliverable by device 210 in a single injection. The cylindrical dose dial member 232 of the dose setting member 230 includes a helical outer surface with threads that engages a corresponding threaded inner surface of the housing 212, and the dose setting member 230 is capable of a helical movement relative to the housing 212. The dose dial member 232 includes a helical inner surface with threads that engages the threaded outer surface of a sleeve of device 210, such as sleeve 34 of FIG. 2. The outer surface of the dial member 232 includes dose indicator markings visible through a dose window 236 to show the user the set dose. The tubular flange 238 of the dose setting member 230 is connected within the open proximal end of the dial member 232 and is retained within the opening of the dial member 232, for example, by a detent as shown in FIG. 2, to prevent the dose dial member 23 from rotating relative to the dose setting member 230. from rotating relative to the dose setting member 230. from rotating relative to the dose setting member 230. from rotating relative to the dose setting member 230. from rotating relative to the dose setting member 230.

[0068] The dose setting member 230 is connected to the device housing 212 to set the dose to be dispensed by device 210. The dose setting member 230 is operable to screw in a proximal direction until it reaches a fully extended position corresponding to the maximum dose deliverable by device 210 in a single injection. The cylindrical dose dial member 232 of the dose setting member 230 includes a helical outer surface with threads that engages a corresponding threaded inner surface of the housing 212, and the dose setting member 230 is capable of a helical movement relative to the housing 212. The dose dial member 232 includes a helical inner surface with threads that engages the threaded outer surface of a sleeve of device 210, such as sleeve 34 of FIG. 2. The outer surface of the dial member 232 includes dose indicator markings visible through a dose window 236 to show the user the set dose. The tubular flange 238 of the dose setting member 230 is connected within the open proximal end of the dial member 232 and is retained within the opening of the dial member 232, for example, by a detent as shown in FIG. 2, to prevent the dose dial member 23 from rotating relative to the dose setting member 230. from rotating relative to the dose setting member 230. from rotating relative to the dose setting member 230. from rotating relative to the dose setting member 230. from rotating relative to the dose setting member 230. from rotating relative to the dose setting member 230. from rotating relative to the dose setting member 230. from rotating relative to the dose setting member 230. from rotating relative to the dose setting member 230. from rotating relative to the dose setting member 230. from rotating relative to the dose setting member 230. is axially and rotationally locked to 2.

[0069] The actuator 250 of the delivery device 210 includes a clutch 252 received within the dose dial member 232. The proximal end of the clutch 252 includes a stem 254 that extends axially therefrom. The dose button 256 of the actuator 250 is disposed proximal to the dose setting member 230 as shown. The mounting collar 258 of the dose button 256 is attached to the stem 254 of the clutch 252 by interference fit or ultrasonic welding or the like, axially and rotatably fixing the dose button 256 and the clutch 252 together. The biasing member 268, which is illustratively a spring, is disposed between the distal face of the mounting collar 258 of the dose button and the proximal face of the tubular flange 238 of the dose setting member, axially spacing the actuator 250 and the dose setting member 230 apart from each other. The dose button 256 is depressible by the user to initiate a dose dispensing operation. The biasing member 268 biases the dose button 256 to a proximal first position (as shown in FIG. 10), and the dose button 256 remains there until the user applies an axial force large enough to overcome the biasing force of the member 268 and move the dose button 256 to a distal second position (as shown in FIG. 11) for a dose setting operation.

[0070] The dose button 256 includes an upper proximal wall 261 having a disc-shaped proximal end face 260 and an annular wall portion 262 extending distally from the proximal wall 261 to define a button housing lumen 265. The face 260 of the dose button 256 is for pushing the actuator 250 in the distal direction. The force functions as a pressing surface that can be applied manually, i.e., directly by the user. The dose button 256 includes a distal wall 263 that is axially spaced from the proximal wall 261. The distal wall 263 can at least partially divide the inner cavity 265 into two inner cavity portions, a proximal and a distal one. The mounting collar 258 of the dose button 256 is shown as extending distally from an intermediate position of the distal wall 263 for attachment to the stem 254 of the clutch 252. In one example the surface feature 301 is disposed radially outside the biasing member 268 within the inner cavity 265. As shown, the rotation sensor and the controller are disposed within the inner cavity 265. As shown, the rotation sensor and the controller are disposed within the inner cavity 265. As shown, the rotation sensor and the controller are disposed within the inner cavity 265. are disposed within the inner cavity 265.

[0071] The distal wall 263 can be configured to allow a portion of the sensor system to extend distally beyond the distal wall 263. The distal wall 263 may include a separate opening or, as shown in FIGS. 10 - 11, extend partially across the inner cavity 265 from a portion of the annular wall portion 262 and stop in front of the opposite end of the annular wall portion to define an axial opening 269. The distal wall 263 can be configured to allow a portion of the sensor system to extend distally beyond the distal wall 263. The distal wall 263 may include a separate opening or, as shown in FIGS. 10 - 11, extend partially across the inner cavity 265 from a portion of the annular wall portion 262 and stop in front of the opposite end of the annular wall portion to define an axial opening 269. As shown in FIGS. 10 - 11, extend partially across the inner cavity 265 from a portion of the annular wall portion 262 and stop in front of the opposite end of the annular wall portion to define an axial opening 269. The axial opening 269 can be radially spaced from the axis AA towards the outer end and a rotation sensor extending through the opening 269 is disposed on the radially spaced surface features 301 around the axis of rotation AA. The electronic device assembly 276 is shown as being received within the dose button 256. The axial opening 269 can be radially spaced from the axis AA towards the outer end and a rotation sensor extending through the opening 269 is disposed on the radially spaced surface features 301 around the axis of rotation AA. The electronic device assembly 276 is shown as being received within the dose button 256. The axial opening 269 can be radially spaced from the axis AA towards the outer end and a rotation sensor extending through the opening 269 is disposed on the radially spaced surface features 301 around the axis of rotation AA. The electronic device assembly 276 is shown as being received within the dose button 256. The electronic device assembly 276 is shown as being received within the dose button 256. The circuit board 325 includes a plurality of electronic components and is shown as being attached to the proximal surface of the distal wall 263. The circuit board 325 includes a plurality of electronic components and is shown as being attached to the proximal surface of the distal wall 263. The sensor system 284 includes a rotation sensor 286 that is operably communicable with the processor of the controller on the circuit board to receive a signal from the sensor representative of the sensed rotation. The rotation sensor 286 is attached to the distal surface of the circuit board. is shown. The controller of the electronic device assembly 276 includes at least one processing core that communicates electrically with the rotation sensor 286 and an internal memory. The assembly 276 includes a battery B, illustratively a coin cell, for powering the electronic components. The controller includes control logic that operates to perform the operations described herein, including detecting the dose delivered by the drug delivery device based on the detected rotation of the dose setting member with respect to the actuator. Some of the components within the electronic device assembly 276 are shown as unconnected for illustrative purposes only and, in actuality, are electrically connected to each other by connectors, wires, or conductors, as understood in the art, as shown at 297 in FIG. 10 and as shown in other drawings. The sensor system 284 having the rotation sensor 286 is configured to detect a surface feature 301 extending from one or more of the components of the dose setting device 230, such as the dose dial member 232 (shown) and / or the flange 238. For example, referring to FIG. 14, the axial end face 233 of the dose dial member 232 of the ring-shaped dose setting device 230 defines a surface feature 301 shown as protrusions 302 radially spaced from each other along the axial end face, and the protrusions are separated by intervening recesses 310. In the illustrated example, there are 18 protrusions, each spaced 20 degrees from an adjacent one. The dose button 256 is movable relative to the device housing 212 between two positions. In FIG. 10, the dose button 256 is in the proximal position, where the device is configured such that the dose button

[0072] The sensor system 284 having the rotation sensor 286 is configured to detect a surface feature 301 extending from one or more of the components of the dose setting device 230, such as the dose dial member 232 (shown) and / or the flange 238. For example, referring to FIG. 14, the axial end face 233 of the dose dial member 232 of the ring-shaped dose setting device 230 defines a surface feature 301 shown as protrusions 302 radially spaced from each other along the axial end face, and the protrusions are separated by intervening recesses 310. In the illustrated example, there are 18 protrusions, each spaced 20 degrees from an adjacent one. The sensor system 284 having the rotation sensor 286 is configured to detect a surface feature 301 extending from one or more of the components of the dose setting device 230, such as the dose dial member 232 (shown) and / or the flange 238. For example, referring to FIG. 14, the axial end face 233 of the dose dial member 232 of the ring-shaped dose setting device 230 defines a surface feature 301 shown as protrusions 302 radially spaced from each other along the axial end face, and the protrusions are separated by intervening recesses 310. In the illustrated example, there are 18 protrusions, each spaced 20 degrees from an adjacent one. The axial end face 233 of the dose dial member 232 of the ring-shaped dose setting device 230 defines a surface feature 301 shown as protrusions 302 radially spaced from each other along the axial end face, and the protrusions are separated by intervening recesses 310. In the illustrated example, there are 18 protrusions, each spaced 20 degrees from an adjacent one. The axial end face 233 of the dose dial member 232 of the ring-shaped dose setting device 230 defines a surface feature 301 shown as protrusions 302 radially spaced from each other along the axial end face, and the protrusions are separated by intervening recesses 310. In the illustrated example, there are 18 protrusions, each spaced 20 degrees from an adjacent one. In the illustrated example, there are 18 protrusions, each spaced 20 degrees from an adjacent one.

[0073] The dose button 256 is movable relative to the device housing 212 between two positions. In FIG. 10, the dose button 256 is in the proximal position, where the device is configured such that the dose button It is in a dose setting mode of a first operation that can set a dose using it. In FIG. 11 , the dose button 256 is in the distal position, where the device is in a dose delivery mode of a second operation that can deliver a dose using the dose button. In a particular embodiment , the dose button 256 is rotationally fixed to the dose setting member in the dose setting mode, and the dose can be set by rotating the dose button 256 . In this position, the rotation sensor 286 is axially displaced from the surface feature portion 301. In the dose setting mode, the rotation sensor 286 may remain inoperable, and the electronic device assembly may remain powered off or in a low power state . . . .

[0074] When the proximal wall 261 is pushed, the dose button 256 advances distally relative to the housing 212 as shown in FIG. 11, compressing the spring 268. Continuing to push the dose button 256 distally will cause the dose dial 232 to be driven in a helical reverse direction relative to the housing 212 . As a result, the dose dial 232 and the flange 238 are driven and rotated by the axially moving dose button. The dose detection system may be operable only to count when the dose button is pressed. The electronic device assembly includes a clock or timer to determine the elapsed time between counts triggered by the rotation sensor by the surface features of the sensed element . . . . . When the trigger arm is not actuated for a certain period, that is, , when no count is detected by the controller, this can be used to indicate that the dose is complete .

[0075] When the first one of the surface feature portions 301 is sensed, the controller is the electronic device assembly configured to activate or operate the plunger 276 in a more powerful or full-power state The activation trigger characteristics minimize inadvertent power loss or usage when a dose dispensing event is not occurring and enable power transmission from a power source ( illustrated as a battery) to power the dose sensing electronics. In other embodiments a separate activation switch is installed and configured within the dose button housing and can be triggered when the dose button 256 is in its distal position. In this case, the activation switch can be disposed, for example along the upper end of the flange. After activation of the electronic device assembly, the controller begins receiving the generated signal from the rotation sensor indicating the counts from the first through the last of the total count used to determine the total angular displacement and thus the dose delivered.

[0076] FIGS. 12-13 illustrate an example of a rotation sensor 286 provided in the device 210. For example the rotation sensor 286 includes a sensor body 320 and a movable element having a pair of contacts 324, 326. The contacts 324, 326 are elastic, i.e., have a natural configuration in one state and move or flex to another state when a force is applied and can return to the natural configuration when the force is removed. The sensor body 320 is shown attached to a circuit board 325 and is operably coupled to the controller of the electronic device assembly to transmit a sensor signal of an electronic characteristic (voltage, resistance, current signal) defined by the contact or separation of the contacts 324, 326 to the controller. The contacts 324, 326 operate by flexing at least one of the contacts (shown as contact 326) during engagement with a surface feature 301 such that the contacts 324, 326 are operably coupled to the controller of the electronic device assembly to transmit a sensor signal of an electronic characteristic (voltage, resistance, current signal) defined by the contact or separation of the contacts 324, 326 to the controller. The contacts 324, 326 are configured to transmit a sensor signal of an electronic characteristic (voltage, resistance, current signal) defined by the contact or separation of the contacts 324, 326 to the controller. The contacts 324, 326 are configured to transmit a sensor signal of an electronic characteristic (voltage, resistance, current signal) defined by the contact or separation of the contacts 324, 326 to the controller. The contacts 324, 326 are configured to transmit a sensor signal of an electronic characteristic (voltage, resistance, current signal) defined by the contact They may remain spaced apart in their natural state until they come into contact with each other. Alternatively, both the contact portions 32 4 and 326 may be configured to flex when engaging with the surface feature portion and to contact each other due to the flexure. After the contact portion 326 engages with the surface feature portion 301, the contact portion 326 may return to its natural state in which it is spaced apart from the contact portion 3 24. Alternatively, the contact portions 324 and 326 may remain in contact with each other in their natural state, separate from the contact relationship due to the engagement with the surface feature portion 301, and be configured to return to the natural state in the contact relationship after passing through the surface feature portion. According to FIG. 12 when the dosing button 256 is at the proximal position where the device is in the dosing setting mode of its first operation, the rotation sensor 286 is at the proximal position. According to FIG. 13, when the dosing button 256 is at the distal position where the device is in the dosing delivery mode of its second operation, the rotation sensor 28 6 is at the distal position. FIGS. 12 to 13 show an exemplary configuration of the contact portions 324 and 326, but other configurations of the contact portions may be utilized. The first contact portion 324 is shown extending axially from the sensor body 320 The first contact portion 324 includes a first segment 3 30 connected to the sensor body 320 and a second segment 332 extending from the first segment 330. The first segment 330 is shown extending axially from the sensor body 320, and the second segment 332 is shown extending radially from the first segment 330 at an elbow connection. The second contact portion 326 includes a first segment 340 connected to the sensor body 320 and a second segment 342 extending from the first

[0077] segment 340. The first segment 340 is shown extending axially from the sensor body 320. The second segment 34 The first segment 340 is shown extending axially from the sensor body 320. The second segment 342 extends radially from the first segment 340 at an elbow connection. segment 330. The first segment 330 is shown extending axially from the sensor body 320, and the second segment 332 is shown extending radially from the first segment 330 at an elbow connection. The second contact portion 326 includes a first segment 340 connected to the sensor body 320 and a second segment 342 extending from the first segment 340. The first segment 340 is shown extending axially from the sensor body 320. The second segment 34 is shown extending radially from the first segment 340 at an elbow connection. segment 340. The first segment 340 is shown extending axially from the sensor body 320. The second segment 342 extends radially from the first segment 340 at an elbow connection. 1 segment 340 and a second segment 342 extending from the first segment 340. The first segment 340 is shown extending axially from the sensor body 320. The second segment 34 2 is shown as extending substantially radially from the first segment 340 at the elbow connection . The second segment 342 includes an arm portion 344, a transition engagement portion 346, and a tip contact portion 348, which are sequentially connected from the first segment 340. The arm portion 344 is sized and shaped to place the tip contact portion 348 below the second segment 332 of the first contact portion. The arm portion 344 is shown as extending axially and radially inclined from the first segment 342. The transition engagement portion 346 is configured to directly engage the surface feature 3 01. The transition engagement portion 346 may have a U-shape, a V-shape, or an inclined shape to transition the second segment 3 42 from the distal direction to the proximal direction. The tip contact portion 348 extends radially and, in its natural state, may be substantially parallel and spaced from the second segment 332 of the first contact portion 324 . The shape of the transition engagement portion 346 may enable the contact portion to slide along the surface feature 301 without allowing the rotating dose dial member to be grasped. The depth of the shape of the transition engagement portion 346 is such that when its distal surface engages the surface feature 301, the second contact portion 326 flexes proximally at the elbow with the first segment and the proximal surface of the tip contact portion 348 contacts the distal surface of the second segment 332 of the first contact portion 324 . Such a contact portion is sufficient to generate a sensor signal of certain electronic characteristics. Alternatively, one of the contacts, such as the contact 326, may be employed, and the surface feature has conductivity, such as being coated with a metallic material, and can enable a rotational sensor to generate a signal when the contact and the surface feature engage as described herein .

[0078] Figures 15-16 show the proximal portion of the device, here referred to as 410. Device 410 includes at least a portion of the electronic components within the electronic device assembly for the dosage detection system, and includes many of the same components that operate for dosage setting and dosage dispensing as described with reference to device 10 or 210, and such components are given the same corresponding explanation. Device 410 is shown as a device within the integrated sensing system, although such a sensing system may be incorporated into a module for removable attachment to the dosage button. Device 410 has, for example, the same device components as device 210, such as device housing 41 2, dosage dial member 432, flange 438, and electronic device assembly 476, although, as will be described later, it differs with respect to the rotational sensor configuration and the dosage setting member having surface features used for sensing. As shown in the illustration, the rotational sensor and the controller are disposed within the lumen of the button. Another example of a rotational sensor of the dosage detection sensor system 484, which is referred to as 486 in its entirety, that can be used with any of the modules and / or devices described herein. For example,

[0079] rotational sensor 486 is a microswitch that includes a sensor body 490 and a movable element including a trigger arm 492. Referring to the previous figure, the dosage button housing is configured to include an axial opening that is radially spaced from the axis AA toward the outer end in order to be disposed on the radially spaced surface features 501 around the axis of rotation AA. The trigger arm 492 of the rotational sensor 486 penetrates through, and, for placement on the surface features 501 that are radially spaced around the axis of rotation AA, the trigger arm 492 of the rotational sensor 486 penetrates through, The lever 492 is overcome by a pressing force until it moves from the natural state position to an operating state position. Until then, it is biased to the natural state by an internal spring. The sensor body 490 is attached to the circuit board 52 5 and is operably connected to the controller of the electronic device assembly, and transmits a sensor signal of an electronic characteristic (voltage, resistance, current signal) defined by the movement of the trigger arm to the controller. The trigger arm 492 can remain in the natural state until it engages with the surface feature 501. After the trigger arm 492 engages with the surface feature 501 it can return to the natural state. According to FIG. 15, when the dose button 456 can be biased to the proximal position when the device 410 is in the dose setting mode of its first operation the rotational sensor 486 is in the proximal position. The biasing member (not shown) can be axially disposed between the dose button and the dose setting member, and the surface feature 501 is disposed radially outside the biasing member as shown in FIGS. 10-11. According to FIG. 16, when the device has the dose button 456 at the distal position in the dose delivery mode of its second operation the rotational sensor 48 6 is in the distal position. The biasing member (not shown) can be axially disposed between the dose button and the dose setting member, and the surface feature 501 is disposed radially outside the biasing member as shown in FIGS. 10-11. According to FIG. 16, when the device has the dose button 456 at the distal position in the dose delivery mode of its second operation the rotational sensor 486 is in the distal position. According to FIG. 16, when the device has the dose button 456 at the distal position in the dose delivery mode of its second operation the rotational sensor 48 6 is in the distal position.

[0080] FIG. 17 shows an example of a dose setting member having a surface feature 501. In one example, the axial surface 437 of the proximal end of the flange 438 can be integrally defined with a surface feature shown as a protrusion 502 with an intervening recess 510, such as a molded part or a part made by additive manufacturing. In another example, a ring component having a surface feature defined along one of its surfaces can be connected to the axial surface of the flange. It will be understood that the ring can be permanently or temporarily fixed to the flange with an adhesive and / or fastener. In another example, the surface feature In another example, a ring component having a surface feature defined along one of its surfaces can be connected to the axial surface of the flange. The ring can be permanently or temporarily fixed to the flange with an adhesive and / or fastener. In another example, the surface feature can be connected to the axial surface of the flange. The ring can be permanently or temporarily fixed to the flange with an adhesive and / or fastener. In another example, the surface feature It will be understood that the ring can be permanently or temporarily fixed to the flange with an adhesive and / or fastener. In another example, the surface feature is formed on or otherwise coupled to the dose dial member.

[0081] As shown in FIGS. 15 to 17, the surface feature 501 is a series of surfaces each having a slope shape. The protrusion 502 rotates the flange 438 in the direction indicated by arrow 511. The projection 502 may be formed with a surface that slopes upward in the opposite direction to the projection 502. In another embodiment, the protrusion 502 may be The opposite side can be tilted to allow the dose setting member to rotate in the opposite direction. By providing different inclination angles on both sides of the raised portion 502, the dose detection system can detect the direction of rotation. Meanwhile, the opposite side of the protrusion 502 may be at a steeper angle to allow for a more responsive force in the other direction. Rotation can be prevented.

[0082] The following embodiments show different configurations of rotation sensors and surface features along the radial direction. 18-21 show a radially outwardly disposed surface feature relative to the radially outwardly extending surface feature. FIG. 1 shows a rotation sensor of a dose detection system of a device, referred to herein as 610. The device 610 is an electronic device in an electronics assembly for a dose detection system. The device 10, 210, or 410 may include at least a portion of the component. It includes many of the same components that operate for dose setting and dose dispensing as described above, and The same corresponding description is given to the various components of the device 610 in the integrated sensing system. Although shown as a device, such sensing system may be removable from the dose button. The rotation sensor may be incorporated into a module for easy mounting. Although shown as a microswitch similar to those that exist, the rotation sensor can be any of the sensors described herein. Device 610 can have the same device components as device 210, such as, for example, device housing 61 2, dose dial member 632, flange 638, and electronic device assembly 676, etc., but, as will be described later, it is different for the dose setting member having the rotation sensor configuration and surface features used for sensing. The rotation sensor 686 of the sensor system 684 is shown disposed along the annular wall portion 662 of the dose button 656. The sensor body 690 of the rotation sensor 686 may be within the opening 695 defined by the annular wall portion 6 62, or in an alternative embodiment, the sensor body 690 may be disposed along the inner surface of the wall portion 662. The movable element includes a trigger arm 692 that extends radially inwardly toward the longitudinal axis AA. Although not shown

[0083] The rotation sensor 686 is operably coupled to the controller of the electronic device assembly, such as via a conductor connected between the sensor 686 and a circuit board extending along the inner surface of the dose button housing. The rotation sensor 686 is configured to transmit a sensor signal of an electronic characteristic (voltage, resistance, current signal) defined by the movement of the trigger arm of the rotation sensor 686 to the controller. The rotation sensor 686 is shown disposed along the annular wall portion 662 of the dose button 656. The sensor body 690 of the rotation sensor 686 may be within the opening 695 defined by the annular wall portion 6 62, or in an alternative embodiment, the sensor body 690 may be disposed along the inner surface of the wall portion 662. The movable element includes a trigger arm 692 that extends radially inwardly toward the longitudinal axis AA. Although not shown The rotation sensor 686 is shown disposed along the annular wall portion 662 of the dose button 656. The sensor body 690 of the rotation sensor 686 may be within the opening 695 defined by the annular wall portion 6 62, or in an alternative embodiment, the sensor body 690 may be disposed along the inner surface of the wall portion 662. The movable element includes a trigger arm 692 that extends radially inwardly toward the longitudinal axis AA. Although not shown The rotation sensor 686 is shown disposed along the annular wall portion 662 of the dose button 656. The sensor body 690 of the rotation sensor 686 may be within the opening 695 defined by the annular wall portion 6 62, or in an alternative embodiment, the sensor body 690 may be disposed along the inner surface of the wall portion 662. The movable element includes a trigger arm 692 that extends radially inwardly toward the longitudinal axis AA. Although not shown The rotation sensor 686 is shown disposed along the annular wall portion 662 of the dose button 656. The sensor body 690 of the rotation sensor 686 may be within the opening 695 defined by the annular wall portion 6 62, or in an alternative embodiment, the sensor body 690 may be disposed along the inner surface of the wall portion 662. The movable element includes a trigger arm 692 that extends radially inwardly toward the longitudinal axis AA. Although not shown The rotation sensor 686 is shown disposed along the annular wall portion 662 of the dose button 656. The sensor body 690 of the rotation sensor 686 may be within the opening 695 defined by the annular wall portion 6

[0084] Figures 19 - 21 show a flange having surface features. In one example, the radially outer surface 639 of the proximal annular end 641 of the flange 638 is shown as a radially projecting portion 702 with intervening recesses 710, such as made of a molded part or a part made by additive manufacturing, around the axis of rotation. The rotation sensor 686 is shown disposed along the annular wall portion 662 of the dose button 656. The sensor body 690 of the rotation sensor 686 may be within the opening 695 defined by the annular wall portion 6 62, or in an alternative embodiment, the sensor body 690 may be disposed along the inner surface of the wall portion 662. The movable element includes a trigger arm 692 that extends radially inwardly toward the longitudinal axis AA. Although not shown It may be defined integrally with the radially spaced surface features 701. In another example, a ring component having surface features 701 defined along a radially outer side surface may be coupled to the axial surface of the flange. It will be appreciated that the ring may be permanently or temporarily fixed to the flange with an adhesive and / or fastener. In another example, the surface features 701 are formed on or otherwise coupled to the dosage dial member. The surface features may include a series of ramped protrusions as described above. The radial protrusions 702 may extend between a proximal end and a distal end to define an axial ridge. FIGS. 18-19 show a rotary sensor in a proximal position when the device 610 is in a dosage setting mode of its first operation and there is a dosage button 656 in the proximal position. The dosage button 656 can move to its distal position (see FIGS. 20-21), placing the rotary sensor in a distal position where the device is in a dosage delivery mode of its second operation. In one example, the trigger arm 692 can enter one of the recesses 710 from the proximal end when the dosage button is moved to its distal position and the trigger arm is engageable with the surface features. The controller can count the number of times the trigger arm has moved between the first trigger and the last trigger, and such data is used to determine dosage delivery. FIG. 22 shows a proximal portion of a device, referred to herein as 810, showing a rotary sensor disposed radially inwardly of a surface feature extending radially inwardly. Device 810 includes at least a portion of the electronics within the electronics assembly for the dosage detection system 844. It may be defined integrally with the radially spaced surface features 701. In another example, a ring component having surface features 701 defined along a radially outer side surface may be coupled to the axial surface of the flange. It will be appreciated that the ring may be permanently or temporarily fixed to the flange with an adhesive and / or fastener. In another example, the surface features 701 are formed on or otherwise coupled to the dosage dial member. The surface features may include a series of ramped protrusions as described above. The radial protrusions 702 may extend between a proximal end and a distal end to define an axial ridge. It may be defined integrally with the radially spaced surface features 701. In another example, a ring component having surface features 701 defined along a radially outer side surface may be coupled to the axial surface of the flange. It will be appreciated that the ring may be permanently or temporarily fixed to the flange with an adhesive and / or fastener. In another example, the surface features 701 are formed on or otherwise coupled to the dosage dial member. The surface features may include a series of ramped protrusions as described above. The radial protrusions 702 may extend between a proximal end and a distal end to define an axial ridge. It may be defined integrally with the radially spaced surface features 701. In another example, a ring component having surface features 701 defined along a radially outer side surface may be coupled to the axial surface of the flange. It will be appreciated that the ring may be permanently or temporarily fixed to the flange with an adhesive and / or fastener. In another example, the surface features 701 are formed on or otherwise coupled to the dosage dial member. The surface features may include a series of ramped protrusions as described above. The radial protrusions 702 may extend between a proximal end and a distal end to define an axial ridge. It may be defined integrally with the radially spaced surface features 701. In another example, a ring component having surface features 701 defined along a radially outer side surface may be coupled to the axial surface of the flange. It will be appreciated that the ring may be permanently or temporarily fixed to the flange with an adhesive and / or fastener. In another example, the surface features 701 are formed on or otherwise coupled to the dosage dial member. The surface features may include a series of ramped protrusions as described above. The radial protrusions 702 may extend between a proximal end and a distal end to define an axial ridge.

[0085] FIGS. 18-19 show a rotary sensor in a proximal position when the device 610 is in a dosage setting mode of its first operation and there is a dosage button 656 in the proximal position. The dosage button 656 can move to its distal position (see FIGS. 20-21), placing the rotary sensor in a distal position where the device is in a dosage delivery mode of its second operation. In one example, the trigger arm 692 can enter one of the recesses 710 from the proximal end when the dosage button is moved to its distal position and the trigger arm is engageable with the surface features. The controller can count the number of times the trigger arm has moved between the first trigger and the last trigger, and such data is used to determine dosage delivery. FIGS. 18-19 show a rotary sensor in a proximal position when the device 610 is in a dosage setting mode of its first operation and there is a dosage button 656 in the proximal position. The dosage button 656 can move to its distal position (see FIGS. 20-21), placing the rotary sensor in a distal position where the device is in a dosage delivery mode of its second operation. In one example, the trigger arm 692 can enter one of the recesses 710 from the proximal end when the dosage button is moved to its distal position and the trigger arm is engageable with the surface features. The controller can count the number of times the trigger arm has moved between the first trigger and the last trigger, and such data is used to determine dosage delivery. FIGS. 18-19 show a rotary sensor in a proximal position when the device 610 is in a dosage setting mode of its first operation and there is a dosage button 656 in the proximal position. The dosage button 656 can move to its distal position (see FIGS. 20-21), placing the rotary sensor in a distal position where the device is in a dosage delivery mode of its second operation. In one example, the trigger arm 692 can enter one of the recesses 710 from the proximal end when the dosage button is moved to its distal position and the trigger arm is engageable with the surface features. The controller can count the number of times the trigger arm has moved between the first trigger and the last trigger, and such data is used to determine dosage delivery. FIGS. 18-19 show a rotary sensor in a proximal position when the device 610 is in a dosage setting mode of its first operation and there is a dosage button 656 in the proximal position. The dosage button 656 can move to its distal position (see FIGS. 20-21), placing the rotary sensor in a distal position where the device is in a dosage delivery mode of its second operation. In one example, the trigger arm 692 can enter one of the recesses 710 from the proximal end when the dosage button is moved to its distal position and the trigger arm is engageable with the surface features. The controller can count the number of times the trigger arm has moved between the first trigger and the last trigger, and such data is used to determine dosage delivery. FIGS. 18-19 show a rotary sensor in a proximal position when the device 610 is in a dosage setting mode of its first operation and there is a dosage button 656 in the proximal position. The dosage button 656 can move to its distal position (see FIGS. 20-21), placing the rotary sensor in a distal position where the device is in a dosage delivery mode of its second operation. In one example, the trigger arm 692 can enter one of the recesses 710 from the proximal end when the dosage button is moved to its distal position and the trigger arm is engageable with the surface features. The controller can count the number of times the trigger arm has moved between the first trigger and the last trigger, and such data is used to determine dosage delivery. FIGS. 18-19 show a rotary sensor in a proximal position when the device 610 is in a dosage setting mode of its first operation and there is a dosage button 656 in the proximal position. The dosage button 656 can move to its distal position (see FIGS. 20-21), placing the rotary sensor in a distal position where the device is in a dosage delivery mode of its second operation. In one example, the trigger arm 692 can enter one of the recesses 710 from the proximal end when the dosage button is moved to its distal position and the trigger arm is engageable with the surface features. The controller can count the number of times the trigger arm has moved between the first trigger and the last trigger, and such data is used to determine dosage delivery. FIGS. 18-19 show a rotary sensor in a proximal position when the device 610 is in a dosage setting mode of its first operation and there is a dosage button 656 in the proximal position. The dosage button 656 can move to its distal position (see FIGS. 20-21), placing the rotary sensor in a distal position where the device is in a dosage delivery mode of its second operation. In one example, the trigger arm 692 can enter one of the recesses 710 from the proximal end when the dosage button is moved to its distal position and the trigger arm is engageable with the surface features. The controller can count the number of times the trigger arm has moved between the first trigger and the last trigger, and such data is used to determine dosage delivery. FIGS. 18-19 show a rotary sensor in a proximal position when the device 610 is in a dosage setting mode of its first operation and there is a dosage button 656 in the proximal position. The dosage button 656 can move to its distal position (see FIGS. 20-21), placing the rotary sensor in a distal position where the device is in a dosage delivery mode of its second operation. In one example, the trigger arm 692 can enter one of the recesses 710 from the proximal end when the dosage button is moved to its distal position and the trigger arm is engageable with the surface features. The controller can count the number of times the trigger arm has moved between the first trigger and the last trigger, and such data is used to determine dosage delivery.

[0086] FIG. 22 shows a proximal portion of a device, referred to herein as 810, showing a rotary sensor disposed radially inwardly of a surface feature extending radially inwardly. Device 810 includes at least a portion of the electronics within the electronics assembly for the dosage detection system 844. FIG. 22 shows a proximal portion of a device, referred to herein as 810, showing a rotary sensor disposed radially inwardly of a surface feature extending radially inwardly. Device 810 includes at least a portion of the electronics within the electronics assembly for the dosage detection system 844. FIG. 22 shows a proximal portion of a device, referred to herein as 810, showing a rotary sensor disposed radially inwardly of a surface feature extending radially inwardly. Device 810 includes at least a portion of the electronics within the electronics assembly for the dosage detection system 844. A dosage as described with reference to devices 10, 210, 410, or 610, including minutes Many of the same components that operate for setting and dosage dispensing are included, and for such components The same corresponding description is made. Device 810 is shown as a device within an integrated sensing system, but such a sensing system can be incorporated within a module for removable attachment to a dosage button. Device 810 can have the same device components as device 210, such as, for example, device housing 812, dosage dial member 832, flange 838, dosage button 856, and electronic device assembly 876, provided that as described later, the dosage setting member having a rotational sensor configuration and surface features used for sensing is different. Similar to the configuration of rotational sensor 286, rotational sensor 886 is shown as extending axially through aperture 869 from the distal surface of the circuit board. The sensor body of rotational sensor 886 is attached to the circuit board and operably coupled to the controller of electronic device assembly 876 to transmit a sensor signal of an electronic characteristic (voltage, resistance, current signal) defined by the movement of a movable element that forms the trigger arm of rotational sensor 886 to the controller. The attachment of rotational sensor 886 is configured to direct its trigger arm radially outward within the periphery of proximal annular end 841 of flange 838 for engagement with surface feature 901.

[0087] attached to the circuit board and operably coupled to the controller of the electronic device assembly 876, and is configured to transmit a sensor signal of an electronic characteristic (voltage, resistance, current signal) defined by the movement of a movable element that forms the trigger arm of the rotational sensor 886 to the controller. The attachment of the rotational sensor 886 is configured to arrange its trigger arm radially outward within the periphery of the proximal annular end 841 of the flange 838 for engagement with the surface feature 901.

[0088] Figures 23 - 24 show flange 838 having surface features. In one example, the radially inner surface 839 of proximal annular end 841 of flange 838 is made by a molded part or additive manufacturing ​​​​​​​​​Shown are a projection 902 with an intervening recess 910, such as a component, radially around the axis of rotation and may be defined integrally with a surface feature 901 spaced apart in the radial direction. In another example, a ring component having a surface feature defined along a radially outer surface can be coupled to the axial surface of the flange It will be appreciated that the ring can be permanently or temporarily fixed to the flange with an adhesive and / or fastener In another example, the surface feature 901 is formed on or otherwise coupled to the dosage dial member. The surface feature 901 may include a series of ramped projections The surface feature may extend between a proximal end and a distal end and define an axial ridge

[0089] FIG. 25 shows a rotational sensor as a piezoelectric sensor 1000 that can be used with any of the devices 10, 210, 410, 610, or 810 The piezoelectric sensor 1000 can be oriented in the same manner as the rotational sensors described above, such as axially, radially outwardly, or radially inwardly. In one example the trigger arm 1002 of the piezoelectric sensor 1000 is defined as a film of a bendable piezoelectric material The film extends from the sensor body 1004, and the sensor body 1004 includes a first electrode 1006 and a second electrode 1008. The sensor body may include, for example, a polymer injection molded housing such as a fluoropolymer (e.g., polyvinylidene fluoride) or polyurethane The piezoelectric sensor 1000 is a transducer that converts mechanical energy into electrical energy. More specifically, the piezoelectric sensor 1000 converts the mechanical deformation of the trigger arm 1002 into a proportional electrical signal (charge or voltage). Thus, when the trigger arm 1002 of the piezoelectric sensor is subjected to mechanical force and undergoes deformation or strain, the piezoelectric sensor 1000 ​​​​​is configured to generate a proportional electrical signal between a first electrode 1006 and a second electrode 1008 for detection by an analog voltage detector of an electronic device assembly. The mechanical deformation of the trigger arm 1002 of the piezoelectric sensor 1000 is elastic, and the trigger arm 1002 can return to its original natural shape when the force is removed. The controller of the electronic device assembly can be configured to receive an analog piezoelectric signal, which can be a substantially ring-shaped signal, from the voltage detector of each piezoelectric sensor 1000. The controller of the electronic device assembly can be programmed to convert the analog piezoelectric signal into a digital signal, such as an intermediate digital signal, which can be a high-frequency signal representing the time of a "click" or deformation event. The controller of the electronic device assembly can be further programmed to convert the intermediate digital signal into an adjusted digital signal, which can be a single-step / square wave having a predetermined width W representing a predetermined time, as further described below. The mechanical deformation of the trigger arm 1002 of the piezoelectric sensor 1000 is elastic, and the trigger arm 1002 can return to its original natural shape when the force is removed. The mechanical deformation of the trigger arm 1002 of the piezoelectric sensor 1000 is elastic, and the trigger arm 1002 can return to its original natural shape when the force is removed.

[0090] The controller of the electronic device assembly can be configured to receive an analog piezoelectric signal, which can be a substantially ring-shaped signal, from the voltage detector of each piezoelectric sensor 1000. The controller of the electronic device assembly can be configured to receive an analog piezoelectric signal, which can be a substantially ring-shaped signal, from the voltage detector of each piezoelectric sensor 1000. The controller of the electronic device assembly can be programmed to convert the analog piezoelectric signal into a digital signal, such as an intermediate digital signal, which can be a high-frequency signal representing the time of a "click" or deformation event. The controller of the electronic device assembly can be programmed to convert the analog piezoelectric signal into a digital signal, such as an intermediate digital signal, which can be a high-frequency signal representing the time of a "click" or deformation event. The controller of the electronic device assembly can be programmed to convert the analog piezoelectric signal into a digital signal, such as an intermediate digital signal, which can be a high-frequency signal representing the time of a "click" or deformation event. The controller of the electronic device assembly can be programmed to convert the analog piezoelectric signal into a digital signal, such as an intermediate digital signal, which can be a high-frequency signal representing the time of a "click" or deformation event. The controller of the electronic device assembly can be further programmed to convert the intermediate digital signal into an adjusted digital signal, which can be a single-step / square wave having a predetermined width W representing a predetermined time, as further described below. The controller of the electronic device assembly can be further programmed to convert the intermediate digital signal into an adjusted digital signal, which can be a single-step / square wave having a predetermined width W representing a predetermined time, as further described below. The controller of the electronic device assembly can be further programmed to convert the intermediate digital signal into an adjusted digital signal, which can be a single-step / square wave having a predetermined width W representing a predetermined time, as further described below.

[0091] The signal processing logic used by the control system. The logic performs a DC voltage offset step using a resistor on the analog piezoelectric signal, then an amplification step using an amplifier, and then an analog-to-digital conversion step using a comparator to generate an intermediate digital signal. The signal can be generated when the input voltage is above a predetermined voltage (e.g., 1.3V). Alternatively, when the input voltage is lower than the predetermined voltage, the signal can be ignored. The intermediate digital signal turns the signal "on" when starting the timer in the timer start step and turns the signal "off" when the timer expires after a predetermined time in the timer expiration step. The signal processing logic used by the control system. The logic performs a DC voltage offset step using a resistor on the analog piezoelectric signal, then an amplification step using an amplifier, and then an analog-to-digital conversion step using a comparator to generate an intermediate digital signal. The signal processing logic used by the control system. The logic performs a DC voltage offset step using a resistor on the analog piezoelectric signal, then an amplification step using an amplifier, and then an analog-to-digital conversion step using a comparator to generate an intermediate digital signal. The signal processing logic used by the control system. The logic performs a DC voltage offset step using a resistor on the analog piezoelectric signal, then an amplification step using an amplifier, and then an analog-to-digital conversion step using a comparator to generate an intermediate digital signal. The signal can be generated when the input voltage is above a predetermined voltage (e.g., 1.3V). The signal processing logic used by the control system. The logic performs a DC voltage offset step using a resistor on the analog piezoelectric signal, then an amplification step using an amplifier, and then an analog-to-digital conversion step using a comparator to generate an intermediate digital signal. The intermediate digital signal turns the signal "on" when starting the timer in the timer start step and turns the signal "off" when the timer expires after a predetermined time in the timer expiration step.​ and can be converted into an adjusted digital signal. The timing step can be performed using a resistor-capacitor (RC) timing loop. The predetermined time associated with the timing step controls the width W of the adjusted digital signal and can be adjusted to align the time of each rotation and deformation event to minimize errors. The logic may output a number corresponding to the number of digital signals counted over a certain period of time. For example, devices described herein such as device 210, 410, 610, or 810 may include a dosage detection system that includes detecting relative rotational movement between two members. The degree of rotation having a known relationship with the delivered dosage causes the sensor system in any of the embodiments described herein to operate to detect the angular momentum from the start to the end of dosage injection. The angular displacement is determined by counting increments of the dosage as the injection progresses. For example, the sensing system can use a repeating pattern of the sensed element such that each repeat is an indicator of a predetermined degree of rotational angle. Conveniently, the pattern can be established such that each repeat corresponds to the minimum increment of dosage that can be set using the drug delivery device. The controller is configured to count the number of generated signals. The count can be electronically transmitted to an external device. The external devices described herein can refer to a server, a mobile phone, or other well-known computer systems. The count can be correlated with the absolute rotational angle, which is then used by a processor of the external device to determine the delivered dosage. Contact portion

[0092] ​​​​​​​​​​​​​​​​The signal generated by the first contact among them activates the controller as described above. Or may be operable to actuate.

[0093] In the above-described method, the rotation sensors 286, 486, 686, 886, etc. described herein Any of the rotation sensors may be used to measure the number of surface features that trigger actuation of the trigger arm during dose delivery. Each rotation sensor detects the angular movement of the dose setting member by counting. The system generates signals indicative of the movement of the sample, and those generated signals are used to determine the total number of counts or units. Such total count is used by the controller of the electronics assembly to The number has a corresponding total rotation of the dose setting member during dose delivery, thereby In one example, each rotation sensor generates a signal indicative of the number of counts, and the controller The controller receives the generated signal and stores the count in its internal memory on the board. The controller can then read and / or transmit the count to an external device. may compare the counts to an on-board database that correlates the counts with total angular motion. The determined angular motion may be displayed on a local display and / or transmitted to an external device. may be transmitted to

[0094] For example, a device described herein, such as device 210, 410, 610, or 810. The device may include an activation feature as described herein, which activates the dose button in its distal position during the first dose delivery. You can activate the controller by pressing the Upon sensing the first of these features, the electronics assembly controller The start-up trigger characteristic is configured to activate the assembly to a start-up or full power state. minimizes inadvertent power loss or usage when a dose dispensing event is not occurring and is configured to enable power transmission from a power source (illustrated as a battery) for powering electronic components for dose sensing In other embodiments, a separate activation switch is installed and configured within the dose button housing of any one of the devices described herein and can be triggered when the dose button is in its distal position. In this case, the activation switch can be disposed, for example, along the upper end of the flange

[0095] In some embodiments, a single sensing system can be used for both dose detection sensing and activation operation For example, devices described herein, such as devices 210, 410, 610, or 810, can have a controller configured to enable activation or operation to a full power state of the electronic device assembly when a first first surface feature is sensed Subsequently, when the controller senses a first surface feature after the first first surface feature (or the second in order), it is configured to count the total number of surface features until rotation of the dose setting member is stopped at the completion of the dose dispensing phase One advantage of this single system with its rich functionality is that it can reduce the number of electronic components within the device and the manufacturing complexity including additional sensors

[0096] The illustrated device is a generally referred to reusable pen-type drug injection device in which a user manually handles to selectively set a dose and then injects the set dose This type of injection device is well known, and the sensing system is configured differently ​​​​​​​​Constructed pen-type drug injection devices, injection devices of other shapes, and infusion pump de Including vices, can be adapted for use in variously configured drug delivery devices, so The description of the device is merely exemplary. The drug can be of any of the types that can be delivered by such a drug delivery device. The sensing system described further below can be used in other differently configured devices, so the device is exemplary and is not intended to be limiting.

[0097] To clarify its usage and notify the public by this specification, " 、 , ... and <n>at least one of」 or 「「< / n> 、 、... <n>at least one of, or a combination thereof」 or 「< / n> 、 ,... and / or <n>" is defined in the broadest sense by the applicant and, unless otherwise expressly stated by the applicant, takes precedence over any other implicit definition above or below and means one or more elements selected from the group including A, B,... and N. In other words, the expression means any combination of one or more of the elements A, B,... or N, including that one element in combination with one or more of the other elements that may include only that one element or additional elements not listed. , prior to any other implicit definition above or below, and means one or more elements selected from the group including A, B,... and N. , B,... and N. In other words, the expression means any combination of one or more of the elements A, B,... or N, including that one element in combination with one or more of the other elements that may include only that one element or additional elements not listed. , or in combination with one or more of the other elements that may include only that one element or additional elements not listed, and means any combination of one or more of the elements A, B,... or N. , or in combination with one or more of the other elements that may include only that one element or additional elements not listed, and means any combination of one or more of the elements A, B,... or N. , B,... or N.

[0098] Although various embodiments have been described, it will be apparent to those skilled in the art that many more embodiments and implementations are possible. Accordingly, the embodiments described herein are examples and not the only possible embodiments and implementations. Further, the advantages described above are not necessarily the only advantages, and it is not necessarily expected that all of the advantages described will be achieved in each embodiment. , and it is not necessarily expected that all of the advantages described will be achieved in each embodiment. , and it is not necessarily expected that all of the advantages described will be achieved in each embodiment. Further, the advantages described above are not necessarily the only advantages, and it is not necessarily expected that all of the advantages described will be achieved in each embodiment.

[0099] Various aspects including but not limited to the following aspects are described in this disclosure. 1. A drug delivery device comprising a device body, a dose setting member attached to the device body and rotatable relative to the device body about a rotation axis during dose delivery, a sensed element attached to the dose setting member and rotationally fixed, the sensed element including axially extending surface features radially spaced from each other around the rotation axis of the dose setting member, an actuator attached to the device body, the sensed element being rotatable relative to the actuator during dose delivery in relation to the delivered dose, and a rotation sensor attached to the actuator. and rotatable relative to the device body about a rotation axis during dose delivery, a sensed element attached to the dose setting member and rotationally fixed, the sensed element including axially extending surface features radially spaced from each other around the rotation axis of the dose setting member, an actuator attached to the device body, the sensed element being rotatable relative to the actuator during dose delivery in relation to the delivered dose, and a rotation sensor attached to the actuator. and rotationally fixed, the sensed element including axially extending surface features radially spaced from each other around the rotation axis of the dose setting member, an actuator attached to the device body, the sensed element being rotatable relative to the actuator during dose delivery in relation to the delivered dose, and a rotation sensor attached to the actuator. member and including axially extending surface features radially spaced from each other around the rotation axis of the dose setting member, an actuator attached to the device body, the sensed element being rotatable relative to the actuator during dose delivery in relation to the delivered dose, and a rotation sensor attached to the actuator. g surface features), an actuator attached to the device body, the sensed element being rotatable relative to the actuator during dose delivery in relation to the delivered dose, and a rotation sensor attached to the actuator. dose delivery, and a rotation sensor attached to the actuator. and a rotation sensor attached to the actuator. A rotation sensor, comprising a movable element that can be arranged to slidably contact an axially extending surface feature during rotation of a sensed element relative to an actuator during dose delivery, and a controller operably coupled to the rotation sensor, the controller being configured to determine the number of axially extending surface features passed by the movable element of the rotation sensor during dose delivery in response to receiving a generated signal from the rotation sensor. A drug delivery device comprising the rotation sensor and the controller. The axially extending surface feature includes alternating protrusions and recesses, and the movable element straddles the protrusions and recesses during rotation of the sensed element relative to the actuator during dose delivery. The drug delivery device according to aspect 1. The protrusions extend proximally from the dose setting member. The drug delivery device according to aspect 2. The dose setting member is a flange or a dose dial member. The drug delivery device according to any one of aspects 1 to 3. The rotation sensor includes a switch, and the movable element that alternately engages or disengages with the axially extending surface feature is operable to trigger the switch to generate a signal. The drug delivery device according to any one of aspects 1 to 4. The actuator has a first position where the movable element of the rotation sensor is disengaged from the axially extending surface feature. The drug delivery device according to any one of aspects 1 to 5. The actuator has a second position where the movable element of the rotation sensor can contact the axially extending surface feature. The drug delivery device according to aspect 6. 2. The axially extending surface feature includes alternating protrusions and recesses, and the movable element straddles the protrusions and recesses during rotation of the sensed element relative to the actuator during dose delivery. The drug delivery device according to aspect 1. 3. The protrusions extend proximally from the dose setting member. The drug delivery device according to aspect 2. 4. The dose setting member is a flange or a dose dial member. The drug delivery device according to any one of aspects 1 to 3. 5. The rotation sensor includes a switch, and the movable element that alternately engages or disengages with the axially extending surface feature is operable to trigger the switch to generate a signal. The drug delivery device according to any one of aspects 1 to 4. 6. The actuator has a first position where the movable element of the rotation sensor is disengaged from the axially extending surface feature. The drug delivery device according to any one of aspects 1 to 5. 7. The actuator has a second position where the movable element of the rotation sensor can contact the axially extending surface feature. The drug delivery device according to aspect 6. 1. A drug delivery device, comprising a rotation sensor and a controller operably coupled to the rotation sensor, the rotation sensor including a movable element that can be arranged to slidably contact an axially extending surface feature during rotation of a sensed element relative to an actuator during dose delivery, and being configured to generate a signal in response to triggering of the movable element on the axially extending surface feature during rotation of the dose setting member, and the controller being configured to determine the number of axially extending surface features passed by the movable element of the rotation sensor during dose delivery in response to receiving a generated signal from the rotation sensor. 2. The axially extending surface feature includes alternating protrusions and recesses, and the movable element straddles the protrusions and recesses during rotation of the sensed element relative to the actuator during dose delivery. The drug delivery device according to claim 1. 3. The protrusions extend proximally from the dose setting member. The drug delivery device according to claim 2. 4. The dose setting member is a flange or a dose dial member. The drug delivery device according to any one of claims 1 to 3. 5. The rotation sensor includes a switch, and the movable element that alternately engages or disengages with the axially extending surface feature is operable to trigger the switch to generate a signal. The drug delivery device according to any one of claims 1 to 4. 6. The actuator has a first position where the movable element of the rotation sensor is disengaged from the axially extending surface feature. The drug delivery device according to any one of claims 1 to 5. 7. The actuator has a second position where the movable element of the rotation sensor can contact the axially extending surface feature. The drug delivery device according to claim 6. 1. A drug delivery device comprising a rotation sensor and a controller operably coupled to the rotation sensor, the rotation sensor including a movable element that can be arranged to slidably contact an axially extending surface feature during rotation of a sensed element relative to an actuator during dose delivery, and being configured to generate a signal in response to triggering of the movable element on the axially extending surface feature during rotation of the dose setting member, and the controller being configured to determine the number of axially extending surface features passed by the movable element of the rotation sensor during dose delivery in response to receiving a generated signal from the rotation sensor. 8. When the actuator is in the second position, upon receiving a signal indicating contact with the first of the axially extending surface features , the controller is configured to operate the controller in a full-power state, and after the first first feature, when the controller receives a signal indicating contact with a subsequent feature of the axially extending surface features, the controller is configured to determine the number of axially extending surface features that have passed through the movable element of the rotational sensor during dose delivery . The drug delivery device according to aspect 7. 9. The movable element includes at least one contact portion that is operable to generate a signal when engaged with an axially extending surface feature . The drug delivery device according to any one of aspects 1 to 8. 10. The at least one contact portion includes a pair of contact portions, and when one of the pair of contact portions engages with an axially extending surface, the other of the pair of contact portions moves into contact to generate a signal . The drug delivery device according to aspect 9. 11. The movement of the movable element relative to the axially extending surface feature is configured to generate a rotational vibration, and the rotational sensor is configured to generate a signal in response to detecting the rotational vibration . The drug delivery device according to any one of aspects 1 to 8. 12. The rotational sensor includes a rotational accelerometer operable to detect rotational vibration. The drug delivery device according to aspect 11. 13. The rotational sensor further includes a ground accelerometer operable to detect ground vibration, and the controller is configured to compare the rotational vibration and the ground vibration , and from the comparison, determine the vibration indicating rotation of the sensed element relative to the actuator during dose delivery . The drug delivery device according to aspect 12. 14. Movement of the movable element relative to the axially extending surface feature is configured to generate a rotational sound. and the rotation sensor is configured to generate a signal in response to detection of the rotation sound. A drug delivery device according to any one of aspects 1 to 8. 15. The actuator further includes a module removably attached to the actuator, The module engages with a sensible element of a dose setting member of the device body on the outside of the module. 15. The drug delivery device according to any one of aspects 1 to 14, comprising a movable element for 16. The drug delivery device according to any one of aspects 1 to 8, wherein the rotation sensor comprises a piezoelectric sensor. device. 17. A drug delivery device, comprising: a device body; and a device for use attached to the device body. a dose setting member rotatable relative to the device body about an axis of rotation during dose delivery, the sensing elements being radially spaced apart from one another around the axis of rotation of the dose setting member. a dose setting member including a surface feature; and a dose button attached to the device body. The sensed element is rotatable relative to the dose button during dose delivery in relation to the dose delivered. and the dose button houses a rotation sensor, the rotation sensor detecting a rotation of the dose button during dose delivery. a movable element positionable to slidably contact the surface feature during rotation of the sensed element relative to the surface feature; and a rotation sensor adapted to detect movement of the movable element over the surface features during rotation of the dose setting member. In response, the dose button is configured to generate a signal, the movable element of the rotation sensor being configured to rotate relative to the surface of the dose button. a first position disengaged from the feature and a movable element of the rotation sensor capable of contacting the surface feature; a dose button having a first position being a first position and a second position being a second position; and a dose button operably coupled to the rotation sensor, a controller housed by the tongue for receiving the generated signal from the rotation sensor; configured to determine the number of surface features that have passed through the movable element of the rotation sensor during dose delivery in response to such that when the dose button is in the second position, upon receiving a signal indicating contact with the first of the surface features, the controller is configured to operate in a full power state and, after the first of the first features, upon receiving a signal indicating contact with a subsequent one of the surface features, is configured to determine the number of axially extending surface features that have passed through the movable element of the rotation sensor during dose delivery, a controller, and a drug delivery device comprising. device. 12. 18. The rotation sensor is the drug delivery device according to aspect 17, including a switch. 19. The rotation sensor is the drug delivery device according to aspect 17, including at least one contact portion. 18. 20. The rotation sensor is the drug delivery device according to aspect 17, including a piezoelectric sensor. 21. The surface feature is the drug delivery device according to aspect 17, axially extending from the dose setting member. 24. 22. Further comprising a biasing member axially disposed between the dose button and the dose setting member, the rotation sensor and the controller being disposed within the lumen of the dose button, and the surface feature being disposed radially outside the biasing member within the lumen, the drug delivery device according to any one of aspects 1 to 21. 32. device. 23. The device body includes a reservoir containing the drug, the drug delivery device according to any one of aspects 1 to 22. 36.< / n>

Claims

1. 1. An apparatus for detecting operation of an injection device, comprising: A sensed element configured to be rotatable relative to the tracking part; a resilient member arranged to bias the compliant part into contact with the sensed element such that rotation of the sensed element relative to the compliant part causes reciprocating movement of the compliant part; an accelerometer configured to detect vibrations indicative of reciprocating motion of the compliant component; a background accelerometer configured to detect background vibrations caused by movement of the entire device; and a controller configured to compare vibrations detected by the accelerometer with background vibrations detected by the background accelerometer and identify vibrations indicative of rotation of the sensed element.

2. The apparatus of claim 1 , wherein the compliant part is configured to reciprocate in an axial direction of the injection device.

3. The apparatus of claim 1 , wherein the sensed element is disposed adjacent to the compliant component and has an axially varying profile configured to cause reciprocating motion of the compliant component.

4. The apparatus of claim 3 , wherein the axially varying profile is a sawtooth profile.

5. The apparatus of claim 4 , wherein the sawtooth profile comprises a plurality of teeth, each tooth corresponding to a fixed dose of the injection device.

6. The apparatus of claim 1 , wherein the elastic member comprises a linear coil spring configured to expand and contract along a direction parallel to an axial direction of the injection device.

7. The apparatus of claim 1 , wherein the controller is configured to identify a vibration indicative of a rotation of the sensed element when the accelerometer detects a vibration substantially greater than the background accelerometer.

8. 2. The apparatus of claim 1, wherein the controller is configured to not identify vibrations indicative of rotation of the sensed element when the accelerometer does not detect vibrations substantially greater than the background accelerometer.

9. The apparatus of claim 1 , wherein the background accelerometer is vibrationally isolated from the compliant component.

10. The apparatus of claim 1 , wherein the compliant component is a pin.

11. The device of claim 10 , wherein the pin includes an enlarged end portion made of a durable, low-friction material that allows the pin to slide easily over the sensed element.

12. The apparatus of claim 1 , wherein the accelerometer is attached to the compliant component.

13. An apparatus according to claim 1; and the injection device containing a medicament.

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