Drug delivery device having a sensing system - Patents.com

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 medication delivery device and / or a module adapted for removably mounting to a proximal end portion of a medication delivery device, the dose delivery detection system being operable to detect data for determining a dose of medication delivered by the medication delivery device. [Background technology]

[0002] Patients suffering from various ailments frequently must inject themselves with medication. To allow humans to conveniently and accurately self-administer medication, various devices, popularly known as pen-type injectors or injection pens, have been developed. Generally, these pens are loaded with a cartridge that includes a piston and contains multiple doses of liquid medication. A drive member is movable forward to advance the piston in the cartridge to dispense the contained medication from an outlet at the distal cartridge end, typically through a needle. In disposable or pre-filled pens, after the pen has been utilized to exhaust the supply of medication in the cartridge, the user discards the entire pen and begins using a new, alternative pen. In reusable pens, after the pen has been utilized to exhaust the supply of medication in the cartridge, the pen is disassembled to allow the used cartridge to be replaced with a new cartridge, and the pen is then reassembled for subsequent use.

[0003] Many pen injectors and other drug delivery devices utilize mechanical systems in which members rotate and / or translate relative to one another in a manner proportional to the dose delivered by the operation of the device. Systems have been developed to measure the relative motion of members of the drug delivery device to assess the delivered dose. However, systems that are integrated into devices or modules for mass production and reproducible accuracy throughout the product's lifecycle are difficult to design. Administration of an appropriate amount of drug requires that the dose delivered by the drug delivery device be accurate. Many pen injectors and other drug delivery devices do not include functionality for automatically detecting and recording the amount of drug delivered by the device during an injection event. In the absence of an automated system, patients must manually track the amount and time of each injection. Thus, there is a need for a device that is operable to automatically detect the dose delivered by a drug delivery device during an injection event and / or to overcome one or more of these and other shortcomings of the prior art. Summary of the Invention

[0004] In one embodiment, a medication 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 including surface features arranged radially spaced apart from one another 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. The rotation sensor includes a movable element contactable against the surface feature of the sensed element. The dose button may be configured to house the rotation sensor. The movable element is arranged to move over the surface feature during rotation of the sensed element relative to the dose button during dose delivery. The rotation sensor is configured to generate a signal in response to movement of the movable element over the surface feature during rotation of the dose setting member. A controller is operably coupled to the rotation sensor and may be housed by the dose button or the module. In response to receiving the generated signal from the rotation sensor, the controller is configured to determine the number of surface features that have passed the movable element of the rotation sensor during dose delivery.

[0005] In another embodiment of the medication delivery device, the actuator has a first position in which the movable element of the rotation sensor is disengaged from the axially extending surface features and a second position in which the movable element of the rotation sensor is contactable with the axially extending surface features. The actuator can be a 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 indicative of contact with a first one of the axially extending surface features, and the controller is configured to determine a number of axially extending surface features that have passed the movable element of the rotation sensor during dose delivery upon receiving a signal indicative of contact with a subsequent one of the axially extending surface features after the first one. [Brief description of the drawings]

[0006] Further embodiments of the present disclosure, as well as its features and advantages, will become more apparent by reference to the following description taken in conjunction with the accompanying drawings, in which components are not necessarily drawn to scale. Moreover, in the drawings, like reference numerals designate corresponding parts throughout the different views.

[0007] [Figure 1] FIG. 1 is a perspective view of an exemplary medication delivery device in which the dose detection system of the present disclosure is operable. [Diagram 2] 2 is a cross-sectional perspective view of the exemplary drug delivery device of FIG. 1. [Diagram 3-4] Figure 3 is a perspective view of a proximal portion of the exemplary drug delivery apparatus of Figure 1. Figure 4 is a partially exploded perspective view of the proximal portion of the exemplary drug delivery device of Figure 1 showing a dose detection module. [Figure 5-6] Figure 5 is a schematic partial cross-sectional side view of an exemplary embodiment of a dose detection system shown attached to a proximal portion of a medication delivery device. Figure 6 is a perspective view of a flange including a sensed element. [Figure 7-9] Figure 7 is a perspective view of one embodiment of a sensed element. Figure 8 is a schematic diagram of another exemplary embodiment of a dose detection system. Figure 9 is a schematic diagram showing an alternative form of a biasing member for a dose detection system. [Figure 10-13] Figure 10 is a schematic partial cross-sectional side view of a proximal portion of another embodiment of a drug delivery device having a dose detection system with a dose button in a proximal position. Figure 11 is a schematic partial cross-sectional side view of a proximal portion of the drug delivery device of Figure 10 with the dose button in a distal position. Figure 12 is an enlarged side view of an example of a rotation sensor provided on the drug delivery device of Figure 10 with the dose button in a proximal position. Figure 13 is an enlarged side view of the rotation sensor of Figure 12 with the dose button in a distal position. [Figure 14-15] Figure 14 is a top axial view of a dose setting member showing examples of surface features. Figure 15 is a schematic partial cross-sectional side view of a proximal portion of another embodiment of a medication delivery device having a dose detection system with a dose button in a proximal position. [Figure 16-17]Fig. 16 is a schematic partial cross-sectional side view of the proximal portion of the medication delivery device of Fig. 15 with the dose button in a distal position. Fig. 17 is a perspective view of an example flange having another example of surface features along an axial surface. [Figure 18-19] Figure 18 is a perspective view of a proximal portion of another embodiment of a drug delivery device having a dose detection system. Figure 19 is a schematic partial cross-sectional side view of the proximal portion of the drug delivery device of Figure 18 with the dose button in a proximal position. [Figure 20-21] Figure 20 is a perspective view of the proximal portion of the drug delivery device of Figure 18 showing the configuration of the rotational sensor and surface features. Figure 21 is a top axial view of the proximal portion of the drug delivery device of Figure 18 showing the configuration of the rotational sensor and surface features. [Figure 22-25] Figure 22 is a schematic partial cross-sectional side view of a proximal portion of another embodiment of a medication delivery device having a dose detection system with a dose button in a proximal position. Figure 23 is a perspective view of another example of a flange having another example of surface features along a radially inner surface. Figure 24 is an axial top view of the proximal portion of the medication delivery device of Figure 22 showing the configuration of the surface features. Figure 25 is a perspective view of another example of a rotational sensor shown as a piezoelectric sensor. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same, it being understood, however, that no limitation of the scope of the invention is intended.

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

[0010] The devices described herein, such as device 10, 210, 410, 610, or 810, may further include a medication, for example, in the reservoir or cartridge 20. In another embodiment, a system may include one or more devices, including device 10, and medication. The term "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 dalaglutide 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 capable of being delivered by the above-mentioned devices. Medication as used in the device may be formulated with one or more excipients. The device is operated by the patient, a caregiver, or a medical professional in a manner generally as described above to deliver the medication to a human.

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

[0012] The dose setting member 30 is coupled to the housing 12 for setting the dose to be dispensed by the device 10. In the illustrated embodiment, the dose setting member 30 is in the form of a threaded element that operates to helically (i.e., move axially and rotationally simultaneously) about a longitudinal axis of rotation AA relative to the housing 12 during dose setting and dose dispensing. FIGS. 1-2 show the dose setting member 30 fully threaded into the housing 12 at its home or zero dose position. The dose setting member 30 is operable to thread proximally out of the housing 12 until it reaches a fully extended position corresponding to the maximum dose deliverable by the device 10 in a single injection. The extended position can be any position between a position corresponding to an incremental extension position (such as a 0.5 or 1 unit dose setting) to a fully extended position corresponding to the maximum dose deliverable by the device 10 in a single injection, threading the housing 12 distally until it reaches a home or zero position corresponding to the minimum dose deliverable by the device 10 in a single injection.

[0013] 2-4, the dose setting member 30 includes a cylindrical dose dial member 32 having a helically threaded outer surface that engages a corresponding threaded inner surface of the housing 12 to allow the dose setting member 30 to helically move relative to the housing 12. The dose dial member 32 further includes a helically threaded inner surface that engages a threaded outer surface of a sleeve 34 (FIG. 2) of the device 10. The outer surface of the dial member 32 includes dose indicator markings, such as numbers, viewable through a dose window 36 to indicate the set dose to a user. The dose setting member 30 further includes a tubular flange 38 coupled to the open proximal end of the dial member 32 and axially and rotationally locked to the dose dial member 32 by a detent 40 received within an opening 41 of the dial member 32. In one example, the dose setting member 30 further includes an optional collar or skirt 42 disposed about 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 which are received in slots 46 .

[0014] Thus, the dose setting member 30 may be considered to include any or all of the dose dial member 32, the flange 38, and the skirt 42, as they are all rotationally and axially fixed together. The dose dial member 32 is directly involved in setting the dose and driving the delivery of the medication. The flange 38 is attached to the dial member 32 and cooperates with a clutch to selectively couple the dial member 32 to the dose button, as described below. As shown, the skirt 42 provides a surface on the exterior of the body 11 to allow a user to rotate the dose dial member 32 to set the dose.

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

[0016] The skirt 42 illustratively includes a plurality of surface contours 48 and annular ridges 49 formed on an outer surface of the skirt 42. The surface contours 48 illustratively are longitudinally extending ribs and grooves circumferentially spaced about the outer surface of the skirt 42 to facilitate a user's gripping and rotating the skirt. In an alternative embodiment, the skirt 42 is removed or integral with the dial member 32, allowing a user to grip and rotate the dose dial member 32 for dose setting.

[0017] The delivery device 10 includes an actuator 50 having a clutch 52 received within the dose dial member 32. The clutch 52 includes an axially extending stem 54 at its proximal end. The actuator 50 further includes a dose button 56 disposed proximally of the skirt 42 of the dose setting member 30, as shown. The dose button 56 includes a mounting collar 58 (FIG. 2) centrally located on a distal face of the dose button 56. The collar 58 is attached to the stem 54 of the clutch 52, such as by an interference fit or ultrasonic welding, to axially and rotatably secure the dose button 56 and clutch 52 together.

[0018] The dose button 56 includes a disk-shaped proximal end surface or face 60 and a distally extending annular wall portion 62 spaced radially inward of the outer periphery of the face 60 to form an annular lip 64 therebetween. The face 60 of the dose button 56 serves as a pressing surface against which a force may be applied manually, i.e., directly by a user, to push the actuator 50 distally. The dose button 56 illustratively includes a concave portion 66 centrally located on the proximal face 60, although the proximal face 60 may alternatively be a flat surface. A biasing member 68, illustratively a spring, is disposed between a distal surface 70 of the button 56 and a proximal surface 72 of the tubular flange 38 to bias the actuator 50 and the dose setting member 30 axially away from one another. The dose button 56 is depressible by a user to initiate a dose dispensing operation. In one alternative embodiment, the skirt 42 is omitted from the device and the annular wall portion 62 of the dose button 56 extends distally to approximately the distal 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 a dose setting mode of operation, the dose setting member 30 is dialed (rotated) relative to the housing 12 to set a 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. The dose setting member 30 is adjustable in rotational increments (e.g., clicks) that correspond to a minimum incremental increase or decrease in the set dose during a dose setting operation. For example, one increment or "click" may be equal to one-half or one unit of medication. The set dose is visible to the user via dial indicator markings shown through the dosing window 36. An actuator 50, including a dose button 56 and a clutch 52, moves axially and rotationally with the dose setting member 30 during dialing in the dose setting mode.

[0020] The dose dial member 32, flange 38 and skirt 42 (if employed) are all rotationally fixed to one another and rotate during dose setting to extend proximally of the medication delivery device 10 due to the threaded connection between the dose dial member 32 and the housing 12. During this dose setting operation, the dose button 56 is rotationally fixed relative to the skirt 42 by complementary splines 74 (FIG. 2) of the flange 38 and clutch 52 which are biased together by a biasing member 68. During the course of dose setting, the skirt 42 and dose button 56 move helically from a "start" position to an "end" position relative to the housing 12. This rotation relative to the housing is proportional to the dose being set by operation of the medication delivery device 10.

[0021] Once the desired dose is set, the device 10 is manipulated so that the injection needle 24 is properly inserted, for example, into the user's skin. Operation in the dose dispensing mode is initiated in response to a distal axial force applied to the proximal face 60 of the dose button 56. The axial force is applied directly to the dose button 56 by the user, which causes the actuator 50 to move axially distally relative to the housing 12.

[0022] The axial movement of the actuator 50 compresses the biasing member 68, reducing or closing the gap between the dose button 56 and the tubular flange 38. This relative axial movement separates the clutch 52 and the complementary splines 74 on the flange 38, thereby releasing the actuator 50, e.g., the dose button 56, from its rotationally fixed relationship to the dose setting member 30. Specifically, the dose setting member 30 is rotationally decoupled from the actuator 50, allowing rearward driven rotation of the dose setting member 30 relative to the actuator 50 and the housing 12. Additionally, because the dose setting member 30 and the actuator 50 are free to rotate relative to one another, user engagement of the dose button 56 by pressing it holds the actuator 50 against rotation relative to the device housing 12.

[0023] As the actuator 50 continues to be pushed axially without rotation relative to the housing 12, the dial member 32 screws back into the housing 12 as it rotates relative to the dose button 56. Dose markings are visible through the window 36, indicating the amount still remaining to be injected. As the dose setting member 30 is screwed distally, the drive member 28 is advanced distally to force the piston 26 through the reservoir 20 and expel the medication through the needle 24 (FIG. 2).

[0024] During a dose dispensing operation, the amount of medication released from the medication delivery device is proportional to the amount of 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. Injection is completed when the female threads of the dial member 32 reach the distal end of the corresponding male threads of the sleeve 34 (FIG. 2). The device 10 is then repositioned in the ready or zero dose position as shown in FIGS. 2 and 3.

[0025] The delivered dose may be derived based on the rotation of the dose setting member 30 relative to the actuator 50 during dose delivery. This rotation may be determined by detecting the incremental movement of the dose setting member which is "counted" as it rotates during dose delivery.

[0026] 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 Dispensing Apparatus with Triple Screw Threads for Mechanical Advantage, the entire disclosure of which is incorporated herein by reference. Another example of a delivery device is an automatic injection device that can be found in U.S. Patent No. 8,734,394, entitled "Automatic Injection Device With Delay Mechanism Including Dual Functioning Biasing Member," the entire disclosure of which is incorporated herein by reference, where such a device is modified with one or more of the various sensor systems described herein to determine the amount of drug delivered from the drug delivery device based on sensing relative rotation within the drug delivery device. Another example of a delivery device is a reusable pen-type device that can be found in U.S. Pat. No. 7,195,616, entitled "Medication Injector Apparatus with Drive Assembly that Facilitates Reset," which is incorporated herein by reference in its entirety, where such a device is modified with one or more of the various sensor systems described herein to determine the amount of medication delivered from the medication delivery device based on sensing relative rotation within the medication delivery device.

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

[0028] The term "directly attached" is used to describe an attachment where two components, or one construction application and one member, are physically secured together without the use of intermediate members other than the attachment component. The attachment component may comprise a fastener, adapter, or other part of the fastening system (such as a compression membrane) that is interposed between the two components to facilitate attachment. "Directly attached" is distinguished from an attachment where the components / members are connected by one or more intermediate functional members, such as the way dose dial member 32 is connected to dose button 56 in FIG. 2 by clutch 52.

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

[0030] Various sensor systems are contemplated herein. In general, a sensor system includes a sensing component and a sensed component. The term "sensing component" refers to any component capable of detecting the relative position or movement of the sensed component. The sensing component includes a sensing element or "sensor" along with associated electrical components for operating the sensing element. The "sensed component" is any component capable of detecting 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 allowing detection of the rotational movement of the sensed component. The sensing component 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 representative of the movement of the sensed component.

[0031] Illustratively, the dose detection system includes an electronics assembly suitable for operation of the sensor system as described herein. A controller is operably connected to the sensor system and receives the output from the rotation sensor. The controller begins to receive a generated signal from the rotation sensor indicative of a count from a first to a last for a total number of counts used to determine a total angular displacement. The controller may be configured to receive data indicative of an angular motion of the dose setting member that may be used to determine from the output a dose delivered by operation of the medication delivery device. The controller may be configured to determine from the output a dose delivered by operation of the medication delivery device. The controller may include conventional components such as a processor, a power supply, a memory, a microcontroller, etc. Alternatively, at least some components may be provided separately, such as by a computer, a smartphone, or other device. Means are then provided for operably connecting an external controller component to the sensor system at the appropriate time, such as by a wired or wireless connection.

[0032] An exemplary electronics assembly 76 is shown in FIG. 5 and may include a flexible printed circuit board (FPCB) having multiple electronic components. The electronics assembly includes a sensor system including one or more sensors in operative communication with a processor to receive signals from the sensors representative of sensed rotation. The circuit board of the electronics assembly 76 further includes a microcontroller unit (MCU) as a controller with at least one processing core and internal memory. The system includes a battery, illustratively a coin cell battery, for powering the components. The controller of the electronics assembly 76 includes control logic operative to perform the operations described herein, including detecting angular motion of the dose setting component during dose setting and / or dose delivery based on the detected rotation of the dose setting member relative to the actuator and / or detecting the dose delivered by the medication delivery device 10. Many of the components of the electronics assembly may be included in a compartment 78 located proximal to the dose button 56.

[0033] The controller of the electronics assembly 76 operates to store in a local memory (e.g., internal flash memory or on-board EEPROM) the total angular motion used to determine dose delivery and / or the detected dose delivery. The controller further operates to wirelessly transmit a signal representative of the total count, the total angular motion, and / or the detected dose to a paired remote electronic device, such as a user's smartphone. The transmission can be via, for example, Bluetooth Low Energy (BLE) or other suitable short-range or long-range wireless communication protocol. Illustratively, the BLE control logic and the controller are integrated on the same circuit.

[0034] The dose detection system includes detecting the relative rotational movement between the two members. The sensor system operates to detect the amount of angular movement from the start of dose injection to the end of dose injection, with the degree of rotation having a known relationship to the dose delivered. For example, a typical relationship in a pen injector is that an angular displacement of the dose setting member of 18° is equal to one unit dose, although other angular relationships are also suitable, for example 9, 10, 15, 20, 24 or 36 degrees may be used for 1 unit or 0.5 unit. The sensor system is operable to determine the total angular displacement of the dose setting member during dose delivery. Thus, an angular displacement of 90° would result in 5 units of dose being delivered.

[0035] The angular displacement is determined by counting dose increments as the injection progresses. For example, the sensing system may use a repeating pattern of sensed elements such that each repetition is indicative of a predefined degree of rotation angle. Conveniently, the pattern may be established such that each repetition corresponds to a minimum dose increment that can be set with the drug delivery device.

[0036] The sensor system components can be permanently or removably attached to the drug delivery device. In an exemplary embodiment, at least some of the components of the dose detection system are provided in the form of a module that is removably attached to the drug delivery device. This has the advantage that these sensor components can be used with more than one pen injector.

[0037] The sensor system detects the relative rotation of the sensed component, and thus the dose setting member, during dose delivery, from which the dose delivered by the drug delivery device is determined. In an exemplary embodiment, the rotation sensor is attached 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 and rotationally fixed to the dose setting member, which rotates relative to the actuator and 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 projections circumferentially arranged relative to one another. The projections are shaped and sized to deflect a movable element of the rotation sensor. The embodiments described herein may be provided for a module that is removably attachable to a dose button of the delivery device, or, in the embodiment shown in Figures 10-11, integrated within the dose button of the delivery device.

[0038] 5, there is shown in schematic form a dose delivery detection system 80 including a module 82 useful in combination with a medication delivery device such as device 10. The module 82 carries a sensor system, generally indicated at 84, including a rotation sensor 86 and other associated components such as a processor, memory, battery, etc. The module 82 is provided as a separate component that may be removably attached to the actuator.

[0039] The dose detection module 82 includes a body 88 that is attached to the dose button 56. The body 88 illustratively includes a cylindrical side wall 90 and a top wall 92 that extends over and seals the side wall 90. By way of example, in Figure 5 the side wall 90 is shown diagrammatically as having an inwardly extending tab 94 that attaches the module 82 to the dose button 56. The module 82 is thereby attached to the dose button 56 such that pressing the module delivers a set dose.

[0040] The dose detection module 82 may alternatively be attached to the dose button 56 via any suitable fastening means such as a snap or press fit, threaded interface, etc., provided that in one aspect the module 82 can be removed from a first drug delivery device and then attached to a second drug delivery device. Attachment may be anywhere on the dose button 56, provided that the dose button 56 can move axially any desired amount relative to the dose setting member 30, as discussed herein.

[0041] During dose delivery, the dose setting member 30 is free to rotate 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 may be provided structurally, for example, with tabs 94 in FIG. 5, or by engaging opposing splines or other surface features on the module body 88 and the dose button 56 upon axial movement of the module 82 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 providing a compartment 78 that contains some or all of the electronics assembly 76. The compartment 78 defines a chamber 96 and may be open at the bottom or may be enclosed by a bottom wall 98 or the like. The bottom wall 98 may be positioned to directly abut the face 60 of the dose button 56. Alternatively, if the bottom wall 98 is present, it may be spaced from the dose button 56 and another contact between the module 82 and the dose button 56 may be used such that axial forces applied to the module 82 are transmitted to the dose button 56.

[0043] Further disclosed herein is a dose detection system operable to determine a delivered dose based on relative rotation between a dose setting member and a device body. The dose detection system utilises a dose setting member attached to the device body and rotatable relative to the device body about an axis of rotation during dose delivery. A sensed element is attached to and rotationally fixed on the dose setting member. An actuator is attached to the device body and held against rotation relative to the device body during dose delivery. The sensed element thereby rotates relative to the actuator during dose delivery in relation to the amount of dose delivered.

[0044] The dose detection system comprises a sensor system including a rotation sensor attached to the actuator. The sensed element includes surface features spaced radially around the axis of rotation of the dose setting member. The surface features may be configured to correlate to the equivalent of one unit of dose, although other angular relationships are suitable, for example, 9, 10, 15, 18, 20, 24 or 36 degrees may be used for one or half unit. The rotation sensor includes a movable element attached to the actuator and having a contact portion that may be resting and spring-loaded in the direction of the surface features of the sensed element, such that the contact surface is positioned to move across the surface features during rotation of the sensed element relative to the actuator during dose delivery. The rotation sensor responds to movement of the contact portion over the surface features and generates a signal corresponding to rotation of the dose setting member. A controller determines a dose count in response to the signal generated by the rotation sensor to determine the amount of dose delivery based on the detected rotation of the dose setting member relative to the actuator during dose delivery.

[0045] The surface features may include anything detectable by a rotational sensor. As previously mentioned, the sensor system may be based on a variety of sensed properties including, for example, tactile, optical, electrical and magnetic properties. In one aspect, the surface features are physical features that allow for detection of 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 a resilient member having one portion attached to the actuator at a position displaced from the contact surface. In one example, the movable member is a compliant member comprising 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 toward the surface feature. Alternatively, the movable member may be biased in any of a variety of other ways. In addition to the use of a resilient beam, biasing may be provided, for example, by the use of a spring component. Such a spring component may comprise, for example, a compression, tension, or torsion coil spring. In yet other embodiments, the movable member may be biased against the surface feature of the sensed element by a separate resilient member or spring component that supports the movable element.

[0047] In one embodiment, the surface features are uniform elements spaced intermittently about the axis of rotation of the sensed element. In a particular aspect, the surface features are equi-radially spaced protrusions separated by intervening recesses. The contact surface of the movable element is arranged to ride over the protrusions and move inwardly relative to the intervening recesses. The movable element can be, for example, a resilient beam that bends outwardly along the protrusions, or a translational member that rides over the protrusions.

[0048] In one aspect, the protrusions are inclined upward in a direction opposite to the rotation of the sensed element during dose delivery to facilitate movement of the contact surface on the protrusion along the protrusion. In another aspect, the protrusions are provided with different profiles in opposite angular directions to provide detection of the rotational direction of the sensed element relative to the actuator. The protrusions may extend in any direction detectable by the movable element. For example, the protrusions may extend axially or radially. Axial protrusions may extend proximally or distally. Radial protrusions 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, a flange or a 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 embodiment, the sensing system of the dose detection system 80 is originally incorporated into the medication delivery device as an integrated system. In another embodiment, a modular form of dose detection system is disclosed. The use of a removably attached module is particularly suitable for use with medication delivery devices in which the actuator and / or the dose setting member includes portions that are external to the medication device housing. These external portions allow for direct attachment of the module to the actuator, such as a dose button, and / or attachment of the sensed element to a dose setting member, such as a skirt, flange, or dose dial member, as described herein. Alternatively, the sensed element is integral with the medication delivery device and the module is removably attached. This has the advantage that more complex and expensive electronics, including rotation sensors and controllers, can be reused in different medication 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 medication delivery device.

[0051] An exemplary medication delivery device incorporating an exemplary dose detection system is shown in Figures 5-9. The device includes a sensor system that detects surface features of a sensed element extending from one or more of the components of the dose setting device 30, such as the dose dial member 32 and / or the flange 38. In particular, the sensor system 84 of the dose detection system 80 includes a rotational sensor 86 and a sensed element 99 having surface features. As examples of the location and configuration of the surface features, the illustrated examples show axial surface features of the flange (e.g., Figure 6), axial surface features of the dose dial member (e.g., Figure 10), radially outer surface features of the dose dial member (e.g., Figure 20), and radially inner surface features of the flange (e.g., Figure 23).

[0052] In one example shown in Figure 6, the sensed element 99 includes a ring 100 coupled to the flange 38. It will be appreciated that the ring 100 may be permanently secured to the flange 38 (as shown) or dose dial member 32 with adhesive and / or fasteners, or may be configured to be removably attached to the flange 38 or dose dial member, for example, using mechanical fasteners or carrying components. The ring may be omitted and the surface features may be integrally formed from the flange 38 or dial member 32 as a unitary member (e.g., as shown in Figures 17 or 23), such as, for example, by molding or additive manufacturing.

[0053] As shown in Figures 6 and 7, the surface feature 101 includes a series of ramp-like protrusions 102. The rotation sensor 86 includes one or more movable elements 103 (Figure 5), in this example comprising a follower pin 104 arranged to be received through a button opening 105 defined by the face 60 of the dose button 56 and to have a distal contact surface 111 that can rest on the surface feature shown as protrusion 102 as the flange 38 rotates relative to the dose button 56. The pin 104 is shown extending through a module opening 107 defined by the distal bottom wall 98 and in coaxial alignment with the button opening 105. The inner surfaces defining the module opening and the button opening, respectively, may be configured to provide bearing support for the pin along two positions during axial movement. Such size and configuration of the openings 105, 107 may enhance linear axial movement of the pin to reduce inconsistent readings from the employed sensor or switch. More than one pin and corresponding openings defined by each component may be utilized for redundant sensing to reduce false readings.

[0054] The pin 104 may include a pin flange 106 received between a contact surface 111 and the dose button 56. A coil spring 108 is disposed between the pin flange 106 and the dose button 56 and biases the pin 104 distal to the protrusions 102. As the flange 38 rotates during dose delivery, the pin and dose button maintain their relative positions and the contact surface 111 of the pin 104 rides up onto each surface feature shown as protrusions 102 against the biasing force of the coil spring 108. The pin 104 then drops into each recess 110 between adjacent protrusions. The pin 104 thereby acts as a compliant member that follows the contours of the protrusions and recesses.

[0055] The rotational sensor 86 further includes a sensing element 114 positioned to detect movement of the pin 104 as it passes over the protrusion 102 and drops into the recess 110. The sensing element 114 may be provided in a variety of forms operable to detect translational movement of the pin 104. By way of example, the sensing element 114 is shown in FIG. 5 as including a microswitch operable to detect axial movement of the pin 104 in the proximal direction each time the pin 104 passes over the protrusion 102. This actuation results in the microswitch successively changing its on / off or off / on setting with each passing protrusion / recess pair of the ring 100.

[0056] In the manner described above, the rotation sensor 86 detects the angular motion 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 motion, which the controller uses to determine the total rotation of the dose setting member during dose delivery, which the controller may use to determine the amount of dose delivery. In one example, the rotation sensor 86 generates signals indicative of the count number, and the controller receives the generated signals. The controller may store the count number in an internal memory and / or may transmit the count number electronically to an external device. The controller may compare the count number to an internal database that correlates the count number to the total angular motion and therefore the delivered dose. The determined angular motion and / or the delivered dose may be displayed (such as a number) on a local display or indicator system as part of the electronics assembly and / or may be transmitted electronically to an external device.

[0057] FIG. 8 shows an alternative dose detection system that also uses a movable member 103 with radially spaced projections 102 and pins 104 that ride along successive projections and recesses. As shown in FIG. 8, each movable member 103 includes a contact surface 116 that rides over surface features 101, e.g., projections 102, that are radially spaced about the axis of rotation. The contact surface 116 of the pin 104 is shown in FIG. 8 as including an enlarged end portion 118, preferably made of a durable, low-friction material that allows the pin 104 to slide easily across the projections 102. The enlarged end portion 118 has a cross-sectional area that is larger than that of the pin. Also, as shown in FIG. 8, the projections 102 may be formed with a surface 120 that slopes upward in a direction opposite to the direction of rotation of the dose setting member, indicated by arrow 122. This further facilitates movement of the follower member over the projections.

[0058] In another embodiment, opposite sides of the protrusion 102 may be angled to allow rotation of the dose setting member in opposite directions. Additionally, different angles of inclination may be provided on either side of the protrusion to allow the dose detection system to detect the direction of rotation, while the opposite side of the protrusion may 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 resting position to a dose delivery mode. In the proximal displacement state, the follower member may be disengaged from the protrusion as one way to allow the sensed element to rotate in the opposite direction to dose delivery relative to the actuator. However, as also described, in certain embodiments, the actuator is rotationally fixed to the dose setting member during dose setting.

[0060] In Fig. 8 an alternative dose detection system is shown which operates by detecting vibrations associated with rotation of the sensed element relative to the actuator during dose delivery. As the sensed element 99 rotates in a direction 122 relative to the movable member 103, the contact surface 116 urges the pin 104 away from the dose setting member and against a biasing member, e.g., a spring 108. Once the contact surface 116 passes the top of the protrusion, the biasing member rapidly pushes the follower member down into the subsequent recess 110. Referring to Fig. 8, as the sensed element 99 moves further in the direction 122, the spring 108 pushes the pin 104 down into a recess 124 where it is abruptly stopped by contact with the bottom of the next recess 124. This abrupt stop is accompanied by vibrations which are detected by a rotation sensor.

[0061] For example, FIG. 8 shows a support 126 attached to the proximal end of the pin 104 and carrying a rotational accelerometer 128. The rotational accelerometer 128 is provided primarily to detect vibrations indicative of rotation of the sensed element. During operation of the system, the accelerometer 128 detects each vibration associated with the passage of the pin 104 over the top of a protrusion and dropping into the next recess. The accelerometer 128 can be of any type capable of detecting vibrations, and in a particular embodiment comprises a three-axis accelerometer. As used herein, this accelerometer is referred to as a "rotational accelerometer" not to suggest a particular type of accelerometer, but to distinguish it as an accelerometer used to detect rotation of the sensed element. Other sensors capable of detecting rotational vibrations may also be used.

[0062] Also shown in FIG. 8 are optional sensor components including a second support 130 and a second accelerometer 132 useful in conjunction with the rotational accelerometer 128. As used herein, the second accelerometer is referred to as a "background accelerometer" not to imply a particular type of accelerometer, but to distinguish it as an accelerometer used to detect background vibrations. The background accelerometer 132 is provided primarily to detect background vibrations, such as those caused by motion of the entire drug delivery device, where the vibrations are not indicative of rotation of the sensed element. To this end, the background accelerometer 132 is relatively isolated from the pin 104, such as by the pin 104 being slidably received within an opening in the dose button 56.

[0063] 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 vibrations sensed by the rotational accelerometer are substantially the same as those sensed by the background accelerometer, then no rotation of the sensed element is indicated. Conversely, if the amount of vibration detected by the rotational accelerometer at a given time is substantially greater than that detected by the background accelerometer, then rotation of the sensed element is indicated. The controller compares the detected rotational vibrations to the background vibrations to identify vibrations indicative of rotation of the sensed element relative to the actuator during dose delivery.

[0064] The movement of the follower member during rotation of the sensed element may also be associated with an associated sound. In particular, the impact of the pin 104 against the bottom of the recess 124 produces a distinctive sound. The alternative dose detection system utilizes this sound to detect rotation of the sensed element 99 relative to the dose button 56. By way of example, FIG. 8 also shows a microphone 134 which forms a component of the alternative sensing system. Upon detecting a sound predetermined to be indicative of rotation of the sensed element, the rotation sensor generates a signal which identifies the rotation of the sensed element as being associated with dose delivery. To be able to distinguish the rotation sound from other sounds, an additional background sound microphone may be used.

[0065] As shown in FIG. 8, the compliant member may be biased, for example, by a coil spring. Alternatively, the compliant member may be biased against the surface feature in a variety of other ways. For example, a resilient member may be used to bias the pin 104 against the protrusion 102. As shown in FIG. 9, a resilient member 136 is attached at one end to the underside 138 of the dose button 56. At the opposite end, the resilient member 136 includes a portion 140 that rests against 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 movement of the resilient member 136, thereby maintaining the contact surface 116 in position against the surface feature. Illustratively, instead of the pin 104, the compliant member may comprise the resilient member 136, and the contact surface may be located at the end portion 140.

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

[0067] 10-11 show a proximal portion of the device, referred to herein as 210, that is disposed within the dose button 256 rather than a module and has a dose detection sensor system 284 including a rotation sensor 286. Device 210 includes many of the same components that operate for dose setting and dose dispensing as described with reference to device 10, including at least a portion of the electronics within an electronics assembly, and such components are given the same corresponding description. Device 210 is shown as a device within an integrated dose detection sensing system, such sensing system may be incorporated within a module for removable attachment to the dose button.

[0068] The dose setting member 230 is coupled to the device housing 212 for setting the dose dispensed by the device 210. The dose setting member 230 is operable to thread proximally from the housing 212 until it reaches a fully extended position corresponding to the maximum dose deliverable by the device 210 in a single injection. A cylindrical dose dial member 232 of the dose setting member 230 includes a helically threaded outer surface that engages with a corresponding threaded inner surface of the housing 212, allowing the dose setting member 230 to helically move relative to the housing 212. The dose dial member 232 includes a helically threaded inner surface that engages with a threaded outer surface of a sleeve of the device 210, such as the sleeve 34 of FIG. 2. The outer surface of the dial member 232 includes dose indicator markings visible through a dose window 236 to indicate the set dose to a user. The tubular flange 238 of the dose setting member 230 is coupled within the open proximal end of the dial member 232 and is axially and rotationally locked to the dose dial member 232 by a detent received within an opening in the dial member 232, for example as shown in FIG. 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 extending axially therefrom. The dose button 256 of the actuator 250 is disposed proximal to the dose setting member 230 as shown. A mounting collar 258 of the dose button 256 is attached to the stem 254 of the clutch 252, such as by interference fit or ultrasonic welding, to axially and rotatably secure the dose button 256 and the clutch 252 together. A biasing member 268, illustratively a spring, is disposed between a distal face of the dose button mounting collar 258 and a proximal face of the dose setting member tubular flange 238 to axially urge the actuator 250 and the dose setting member 230 away from each other. The dose button 256 is depressible by a user to initiate a dose dispensing operation. The biasing member 268 biases the dose button 256 in a proximal first position (as shown in FIG. 10 ) where the dose button 256 remains during a dose setting operation until a user applies an axial force sufficient 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 dispensing operation.

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

[0071] The distal wall 263 may 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 may extend partially across the lumen 265 from a portion of the annular wall portion 262 and stop short of the opposite end of the annular wall portion to define an axial opening 269, as shown in FIGS. 10-11. The axial opening 269 may be radially spaced from the axis AA toward the outer end, with a rotation sensor extending through the opening 269 disposed on surface features 301 radially spaced about the axis of rotation AA. An electronics assembly 276 is shown housed within the dose button 256. A circuit board 325 includes a plurality of electronic components and is shown mounted on a proximal surface of the distal wall 263. The sensor system 284 includes a rotation sensor 286 in operative communication with a processor of a controller of the circuit board to receive a signal from the sensor representative of the sensed rotation. The rotation sensor 286 is shown mounted on the distal surface of the circuit board. The controller of the electronics assembly 276 includes at least one processing core in electrical communication with the rotation sensor 286 and an internal memory. The assembly 276 includes a battery B, illustratively a coin cell, for powering the electronics components. The controller includes control logic operative to perform the operations described herein, including detecting a dose delivered by the medication delivery device based on a detected rotation of the dose setting member relative to the actuator. Some of the components within the electronics assembly 276 are shown as unconnected for illustrative purposes only, and in fact would be electrically connected to one another, such as by connectors, wires, or conduits, as understood in the art, as shown at 297 in FIG. 10 and in other figures.

[0072] A sensor system 284 having a rotational sensor 286 is configured to detect surface features 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, with reference to Figure 14, the axial end face 233 of the dose dial member 232 of the ring-shaped dose setting device 230 defines surface features 301 shown as protrusions 302 that are radially spaced apart from one another along the axial end face, the protrusions being separated by intervening recesses 310. In the example shown, there are 18 protrusions, each spaced apart from an adjacent one by 20 degrees.

[0073] The dose button 256 is capable of being relative to the device housing 212 between two positions. In FIG. 10, the dose button 256 is in a proximal position, where the device is in a first dose setting mode of operation where the dose button can be used to set a dose. In FIG. 11, the dose button 256 is in a distal position, where the device is in a second dose delivery mode of operation where the dose button can be used to deliver a dose. In certain embodiments, the dose button 256 is rotationally fixed to the dose setting member in the dose setting mode, and the dose button 256 can be rotated to set a dose. In this position, the rotation sensor 286 is axially displaced from the surface feature 301. In the dose setting mode, the rotation sensor 286 can remain inoperable, and the electronics assembly can remain in a powered off or low power state.

[0074] Pressing the proximal wall 261 advances the dose button 256 distally relative to the housing 212, compressing the spring 268, as shown in FIG. 11. Continuing to press the dose button 256 distally will back-drive the dose dial 232 in a helical direction relative to the housing 212. This results in the dose dial 232 and flange 238 rotating, driven by the axially moving dose button. The dose detection system may only be operable to count when the dose button is pressed. The electronics assembly may include a clock or timer to determine the elapsed time between counts caused by the triggering of the rotational sensor by the surface features of the sensed element. When the trigger arm is not actuated for a period of time, i.e., when no counts are detected by the controller, this can be used to indicate that a dose is complete.

[0075] Upon sensing the first one of the surface features 301, the controller is configured to activate or actuate the electronics assembly 276 to a stronger or full power state. The activation trigger feature is configured to allow power transfer from a power source (shown as a battery) to power up the dose sensing electronics to minimize inadvertent power loss or use when no dose dispensing event is occurring. In other embodiments, a separate activation switch may be installed and configured within the dose button housing and triggered when the dose button 256 is in its distal position. In this case, the activation switch may be located, for example, along the top edge of the flange. After actuation of the electronics assembly, the controller begins to receive a generated signal from the rotation sensor indicative of the total angular displacement and thus the first to last count of the total number of counts used to determine the delivered dose.

[0076] 12-13 show an example of a rotation sensor 286 provided on the device 210. For example, the rotation sensor 286 includes a sensor body 320 and a movable element with a pair of contacts 324, 326. The contacts 324, 326 may be elastic, i.e., have a natural configuration in one state, move or deflect to another state when a force is applied, and return to the natural configuration when the force is removed. The sensor body 320 is shown mounted on a circuit board 325 and is operably coupled to a controller of the electronics assembly and configured to transmit a sensor signal to the controller of an electronic characteristic (voltage, resistance, current signal) defined by contact or separation of the contacts 324, 326. The contacts 324, 326 may remain spaced apart in the natural state until they contact each other in the operative state due to deflection of at least one of the contacts (shown as contact 326) during engagement with the surface feature 301. Alternatively, both of the contacts 324, 326 may be configured to deflect upon engagement with the surface feature and to contact each other due to the deflection. After the contacts 326 engage the surface feature 301, the contacts 326 may return to their natural state in a spaced relationship with the contacts 324. Alternatively, the contacts 324, 326 may be configured to remain in contact with each other in their natural state, to disengage from the contact relationship upon engagement with the surface feature 301, and to return to their natural state in a contact relationship after the surface feature has passed. According to FIG. 12, when the dose button 256 is in a proximal position while the device is in a dose setting mode of its first operation, the rotation sensor 286 is in a proximal position. According to FIG. 13, when the dose button 256 is in a distal position while the device is in a dose delivery mode of its second operation, the rotation sensor 286 is in a distal position.

[0077] 12-13 show exemplary configurations of the contacts 324, 326, other configurations of the contacts may be utilized. The first contact 324 is shown extending axially from the sensor body 320. The first contact 324 includes a first segment 330 coupled 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 326 includes a first segment 340 coupled 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 342 is shown extending generally 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 position the tip contact portion 348 below the second segment 332 of the first contact. The arm portion 344 is shown extending axially and radially at an angle from the first segment 342. The transition engagement portion 346 is configured to directly engage the surface feature 301. The transition engagement portion 346 may have a U-shaped, V-shaped, or angled shape to transition the second segment 342 from a distal to a proximal direction. The tip contact portion 348 extends radially and may be generally parallel and spaced apart from the second segment 332 of the first contact 324 in a natural state. The shape of the transition engagement portion 346 may allow the contact to slide along the surface feature 301 without binding the rotating dose dial member. The depth of the shape of the transition engagement portion 346 is sized such that when its distal surface engages the surface feature 301, the second contact portion 326 deflects proximally at the elbow with the first segment, bringing the proximal surface of the tip contact portion 348 into contact with the distal surface of the second segment 332 of the first contact portion 324. Such contact is sufficient to generate a sensor signal of some electronic nature.Alternatively, one of the contacts, such as contact 326, can be employed and the surface feature can be conductive, such as coated with a metallic material, to enable the rotational sensor to generate a signal upon engagement of the contact with the surface feature, as described herein.

[0078] 15-16 show a proximal portion of the device, referred to herein as 410. Device 410 includes many of the same components that operate for dose setting and dose dispensing as described with reference to devices 10 or 210, including at least a portion of the electronics in the electronics assembly for the dose detection system, and such components are given the same corresponding description. Although device 410 is shown as a device in an integrated sensing system, such sensing system may be incorporated into a module for removable attachment to a dose button. Device 410 may have the same device components as device 210, such as, for example, device housing 412, dose dial member 432, flange 438, and electronics assembly 476, except for the dose setting member having a rotational sensor configuration and surface features used for sensing, as described below. As shown, the rotational sensor and controller are disposed within the lumen of the button.

[0079] Another example of a rotation sensor, generally referenced as 486, of a dose detection sensor system 484 that may be used with any of the modules and / or devices described herein. For example, the rotation sensor 486 is a microswitch including a sensor body 490 and a movable element with a trigger arm 492. Referring to the previous figure, the dose button housing is configured to include an axial opening radially spaced from the axis AA toward the outer end for the trigger arm 492 of the rotation sensor 486 to pass through for placement over surface features 501 radially spaced about the axis of rotation AA. The trigger arm 492 is biased to a rest state by an internal spring until a force is overcome that urges the trigger arm 492 away from the rest state position to an operative state. The sensor body 490 is mounted on a circuit board 525 and operably coupled to a controller of the electronics assembly and configured to transmit 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 may remain in a rest state until it engages the surface feature 501. After the trigger arm 492 engages with the surface feature 501, the trigger arm 492 may return to its natural state. According to FIG. 15, when the dose button 456 may be biased to a proximal position in which the device 410 is in its first dose setting mode of operation, the rotation sensor 486 is in a proximal position. A biasing member (not shown) may be disposed axially between the dose button and the dose setting member, and the surface feature 501 is disposed radially outward of the biasing member, as shown in FIGS. 10-11. According to FIG. 16, when the dose button 456 is in a distal position in which the device is in its second dose delivery mode of operation, the rotation sensor 486 is in a distal position.

[0080] FIG. 17 shows one 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 may be integrally defined with the surface feature, shown as a protrusion 502 with an intervening recess 510, such as a molded or additively manufactured part. In another example, a ring component having a surface feature defined along one of its surfaces may be coupled to the axial surface of the flange. It will be appreciated that the ring may be permanently or temporarily secured to the flange with adhesive and / or fasteners. In another example, the surface feature is formed into or otherwise coupled to the dose dial member.

[0081] As shown in Figures 15-17, the surface feature 501 includes a series of protrusions 502, each having a ramp-like shape. The protrusions 502 may be formed with a surface that slopes upward in a direction opposite to the direction of rotation of the flange 438, indicated by arrow 511. This further facilitates movement of the trigger arm 492 over the protrusions 502. In another embodiment, the opposite side of the protrusions 502 may be sloped to allow the dose setting member to rotate in the opposite direction. Additionally, the two sides of the protrusions 502 may have different slope angles to allow the dose detection system to detect the direction of rotation, while the opposite side of the protrusions 502 may be steeper to prevent rotation in the other direction.

[0082] The following embodiments show different configurations of the rotation sensor and surface features along the radial direction. Figures 18-21 show a proximal portion of the device, referred to herein as 610, showing the rotation sensor of the dose detection system positioned radially outward relative to the radially outward extending surface features. Device 610 includes many of the same components that operate for dose setting and dose dispensing as described with reference to devices 10, 210, or 410, including at least a portion of the electronics in an electronics assembly for the dose detection system, and the same corresponding description is given to such components. Although device 610 is shown as a device within an integrated sensing system, such sensing systems may be incorporated within a module for removable attachment to a dose button. Although the rotation sensor is shown as a microswitch similar to that shown in Figure 15, the rotation sensor may be any of the sensors described herein. Device 610 may have the same device components as device 210, such as, for example, device housing 612, dose dial member 632, flange 638, and electronics assembly 676, except for the dose setting member having a rotational sensor configuration and surface features used for sensing, as described below.

[0083] A rotational sensor 686 of the sensor system 684 is shown disposed along the annular wall portion 662 of the dose button 656. A sensor body 690 of the rotational sensor 686 may be within an opening 695 defined by the annular wall portion 662, or in alternative embodiments, the sensor body 690 may be disposed along an inner surface of the wall portion 662. The movable element includes a trigger arm 692 extending radially inward toward the longitudinal axis AA. Although not shown, the rotational sensor 686 is operably coupled to a controller of the electronics assembly, such as via electrical conductors connected between the sensor 686 and a circuit board extending along an inner surface of the dose button housing. The rotational sensor 686 is configured to transmit a sensor signal to the controller of an electronic characteristic (voltage, resistance, current signal) defined by the movement of the trigger arm of the rotational sensor 686.

[0084] 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 may be integrally defined with surface features 701, shown as radial protrusions 702 with intervening recesses 710, radially spaced about the axis of rotation, such as a molded or additively manufactured part. In another example, a ring component having surface features 701 defined along its radially outer surface may be coupled to the axial surface of the flange. It will be appreciated that the ring may be permanently or temporarily secured to the flange with adhesive and / or fasteners. In another example, the surface features 701 are formed on or otherwise coupled to the dose dial member. The surface features may include a series of beveled protrusions as previously described. The radial protrusions 702 may extend between the proximal and distal ends to define axial ridges.

[0085] 18-19 show the rotation sensor in a proximal position when the dose button 656 is in a proximal position with the device 610 in its first dose setting mode of operation. The dose button 656 can be moved to its distal position (with reference to FIGS. 20-21 ) to place the rotation sensor in a distal position with the device in its second dose delivery mode of operation. In one example, the trigger arm 692 can enter one of the recesses 710 from the proximal end when the dose button is moved to its distal position and the trigger arm can engage the surface feature. The controller can count the number of times the trigger arm moves between the first and last trigger, and such data is used to determine dose delivery.

[0086] FIG. 22 illustrates a proximal portion of the device, referred to herein as 810, showing a rotational sensor disposed radially inward relative to the radially inward extending surface features. Device 810 includes many of the same components that operate for dose setting and dose dispensing as described with reference to devices 10, 210, 410, or 610, including at least a portion of the electronics in an electronics assembly for dose detection system 844, and the same corresponding description is given to such components. Although device 810 is illustrated as a device within an integrated sensing system, such a sensing system may be incorporated within a module for removable attachment to a dose button. Device 810 may have the same device components as device 210, such as, for example, device housing 812, dose dial member 832, flange 838, dose button 856, and electronics assembly 876, except for a dose setting member having a rotational sensor configuration and surface features used for sensing, as described below.

[0087] Similar to the configuration of rotation sensor 286, rotation sensor 886 is shown extending from a distal face of the circuit board through an axial opening 869. A sensor body of rotation sensor 886 is mounted to the circuit board and operably coupled to a controller of electronics assembly 876 and configured to transmit a sensor signal to the controller of an electronic characteristic (voltage, resistance, current signal) defined by movement of a movable element comprising a trigger arm of rotation sensor 886. Mounting of rotation sensor 886 is configured to position its trigger arm radially outward within the periphery of proximal annular end 841 of flange 838 for engagement with surface feature 901.

[0088] 23-24 show a flange 838 having surface features. In one example, the radially inner surface 839 of the proximal annular end 841 of the flange 838 may be integrally defined with surface features 901 radially spaced about the axis of rotation, such as a molded or additively manufactured part, shown as protrusions 902 with intervening recesses 910. In another example, a ring component having surface features defined along its radially outer surface may be coupled to the axial surface of the flange. It will be appreciated that the ring may be permanently or temporarily secured to the flange with adhesive and / or fasteners. In another example, the surface features 901 are formed on or otherwise coupled to the dose dial member. The surface features 901 may include a series of beveled protrusions. The surface features may extend between the proximal and distal ends to define axial ridges.

[0089] FIG. 25 illustrates the rotation 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 similarly to the rotation sensors described above, such as axially, radially outward, or radially inward. In one example, the trigger arm 1002 of the piezoelectric sensor 1000 is defined as a film of bendable piezoelectric material. The film extends from a sensor body 1004, which includes a first electrode 1006 and a second electrode 1008. The sensor body can include, for example, a polymer cast 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 undergoes a deformation or strain upon receiving a mechanical force, the piezoelectric sensor 1000 is configured to generate a proportional electrical signal between the first electrode 1006 and the second electrode 1008 for detection by an analog voltage detector of the electronics assembly. The mechanical deformation of the trigger arm 1002 of the piezoelectric sensor 1000 is elastic, allowing the trigger arm 1002 to return to its original natural shape once the force is removed.

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

[0091] The signal processing logic used by the control system. The logic performs a direct current (DC) voltage offset step using a resistor, then an amplification step using an amplifier, then an analog-to-digital conversion step using a comparator on the analog piezoelectric signal to generate an intermediate digital signal. The signal may be generated when the input voltage is equal to or greater than a predetermined voltage (e.g., 1.3V). Alternatively, the signal may be ignored when the input voltage is lower than the predetermined voltage. The intermediate digital signal may be converted to a conditioned digital signal by turning the signal "on" when starting a timer in a timer start step, and turning the signal "off" when the timer expires after a predetermined time in a timer expiration step. The timing step may be performed using a resistive-capacitive (RC) timing loop. The predetermined time associated with the timing step may be adjusted to control the width W of the conditioned digital signal and align the times 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 period of time.

[0092] For example, the devices described herein, such as devices 210, 410, 610, or 810, may include a dose detection system that includes detecting relative rotational motion between two members. With the degree of rotation having a known relationship to the delivered dose, the sensor system in any of the embodiments described herein operates to detect angular momentum from the start of dose injection to the end of dose injection. The angular displacement is determined by counting dose increments as the injection progresses. For example, the sensing system may use a repeating pattern of sensed elements such that each repetition is indicative of a predefined degree of rotation angle. Conveniently, the pattern may be established such that each repetition corresponds to a minimum dose increment that may be set with the drug delivery device. The controller is configured to count the number of signals generated. The count may be electronically transmitted to an external device. The external device described herein may refer to a server, a mobile phone, or other well-known computer system. The count may be correlated to an absolute rotation angle, which is then used by the processor of the external device to determine the delivered dose. The signal generated by a first of the contacts may be operable to activate or activate a controller, as previously described.

[0093] In the aforementioned method, any of the rotational sensors described herein, such as rotational sensors 286, 486, 686, 886, detects angular motion of the dose setting member by counting the number of surface features that trigger actuation of the trigger arm during dose delivery. Each rotational sensor generates a signal indicative of this angular motion, and the generated signals are used by a controller of the electronics assembly to determine a total number of counts or units. Such total counts have a corresponding total rotation of the dose setting member during dose delivery, and thereby the amount of dose delivery. In one example, each rotational sensor generates a signal indicative of the counts, and the controller receives the generated signals. The controller can store the counts in an internal memory on board and / or transmit the counts to an external device. The controller can compare the counts to an on-board database that correlates the counts to the total angular motion. The determined angular motion can be displayed on a local display and / or transmitted to an external device.

[0094] The devices described herein, such as devices 210, 410, 610, or 810, may include an activation feature as described herein, which allows the controller to be activated by pressing the dose button to its distal position during initial dose delivery. For example, upon sensing a first one of the surface features, the controller of the electronics assembly is configured to activate or actuate the electronics assembly to a full power state. The activation trigger feature is configured to allow power transfer from a power source (illustrated as a battery) to power up the dose sensing electronics to minimize inadvertent power loss or use when no dose dispensing event is occurring. In other embodiments, a separate activation switch may be installed and configured within the dose button housing of any one of the devices described herein and triggered when the dose button is in its distal position. In this case, the activation switch may be located, for example, along the top edge of the flange.

[0095] In some embodiments, a single sensing system may be used for both dose detection sensing and activation actuation. For example, devices described herein, such as devices 210, 410, 610 or 810, may have a controller configured to enable activation or actuation of the electronics assembly to a full power state upon sensing an initial first surface feature. The controller is then configured to count the total number of surface features upon sensing the first surface feature (or the second in sequence) after the initial first surface feature, until rotation of the dose setting member is stopped upon completion of the dose dispensing phase. One advantage of this feature-rich single system is that it may reduce the number of electronic components in the device and the manufacturing complexity of including additional sensors.

[0096] The illustrated device is what is commonly referred to as a reusable pen-type drug injection device that is manually operated by a user to selectively set a dose and then inject the set dose. This type of injection device is well known, and the description of the device is merely exemplary, since the sensing system can be adapted for use with variously configured drug delivery devices, including otherwise constructed pen-type drug injection devices, alternatively shaped injection devices, and infusion pump devices. The drug can be any of the types that can be delivered by such drug delivery devices. The device is intended to be exemplary and not limiting, since the sensing system described further below can be used with other otherwise configured devices.

[0097] In order to clarify its use and inform the public hereby, 、 , ...and <n> At least one of the following" or "< / n> 、 、... <n> At least one of, or a combination of,< / n> 、 , ...and / or <n>" is defined by the applicant in its broadest sense and means one or more elements selected from the group including A, B, ... and N, unless expressly stated otherwise by the applicant, in preference to any other implied definition above or below. In other words, the phrase means any combination of one or more of the elements A, B, ... or N, including any one element alone or in combination with one or more of the other elements, which may include additional unlisted elements in combination.

[0098] While various embodiments have been described, it will be apparent to those skilled in the art that many more embodiments and implementations are possible. Thus, the embodiments described herein are examples and are not the only possible embodiments and implementations. Moreover, 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 are described in this disclosure, including but not limited to the following aspects. 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 and rotationally fixed on the dose setting member, the sensed element comprising axially extending surface features spaced radially from one another about 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 a delivered dose; and a rotation sensor attached to the actuator, the rotation sensor comprising a movable element positionable in slidable contact with the axially extending surface features during rotation of the sensed element relative to the actuator during dose delivery, the rotation sensor being configured to generate a signal in response to triggering of the movable element over the axially extending surface features during rotation of the dose setting member; and a controller operably coupled to the rotation sensor, the controller being configured to determine a number of axially extending surface features that have passed the movable element of the rotation sensor during dose delivery in response to receiving the generated signal from the rotation sensor. 2. The medication delivery device of aspect 1, wherein the axially extending surface features include alternating protrusions and recesses, and the movable element overcomes the protrusions and recesses during rotation of the sensed element relative to the actuator during dose delivery. 3. The drug delivery device of aspect 2, wherein the protrusion extends proximally from the dose setting member. 4. The drug delivery device according to any one of aspects 1 to 3, wherein the dose setting member is a flange or a dose dial member. 5. A medication delivery device according to any one of aspects 1 to 4, wherein the rotational sensor includes a switch, and a movable element that alternately engages and disengages with the axially extending surface feature is operable to trigger the switch to generate a signal. 6. The medication delivery device of any one of aspects 1-5, wherein the actuator has a first position in which the movable element of the rotational sensor is disengaged from the axially extending surface feature. 7. The medication delivery device of aspect 6, wherein the actuator has a second position in which the movable element of the rotational sensor is contactable with the axially extending surface feature. 8. The drug delivery device of aspect 7, wherein when the actuator is in the second position, the controller is configured to actuate the controller to a full power state upon receiving a signal indicating contact with a first one of the axially extending surface features, and the controller is configured to determine a number of axially extending surface features that have passed the movable element of the rotational sensor during dose delivery upon receiving a signal indicating contact with a subsequent one of the axially extending surface features after the first one. 9. The medication delivery device of any one of aspects 1-8, wherein the movable element includes at least one contact portion operable to generate a signal upon engagement with the axially extending surface feature. 10. The drug delivery device of aspect 9, wherein the at least one contact comprises a pair of contacts, and is configured such that when one of the contact pair engages with the axially extending surface, it moves into contact with the other of the contact pair to generate a signal. 11. The drug delivery device of any one of aspects 1 to 8, wherein 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 detection of the rotational vibration. 12. The medication delivery device of aspect 11, wherein the rotational sensor comprises a rotational accelerometer operable to detect rotational vibrations. 13. The medication delivery device of aspect 12, wherein the rotational sensor further includes a ground accelerometer operable to detect ground vibrations, and the controller is configured to compare the rotational vibrations and the ground vibrations, and determine from the comparison a vibration indicative of a rotation of the sensed element relative to the actuator during dose delivery. 14. The drug delivery device of any one of aspects 1 to 8, wherein movement of the movable element relative to the axially extending surface feature is configured to generate a rotational sound, and the rotational sensor is configured to generate a signal in response to detection of the rotational sound. 15. A drug delivery device according to any one of aspects 1 to 14, further comprising a module removably attached to the actuator, the module comprising a movable element for engaging with a sensed element of a dose setting member of the device body outside the module. 16. The medication delivery device of any one of aspects 1-8, wherein the rotational sensor comprises a piezoelectric sensor. 17. A medication delivery device comprising: a device body; a dose setting member attached to the device body and rotatable relative to the device body about an axis of rotation during dose delivery, the dose setting member including a sensed element, the sensed element including surface features radially spaced apart from one another about the axis of rotation of the dose setting member; and a dose button attached to the device body, the sensed element being rotatable relative to the dose button during dose delivery in relation to a delivered dose, the dose button housing a rotation sensor, the rotation sensor including a movable element positionable to slidably contact the surface feature during rotation of the sensed element relative to the dose button during dose delivery, the rotation sensor configured to generate a signal in response to movement of the movable element over the surface feature during rotation of the dose setting member, the dose button being configured to detect when the movable element of the rotation sensor moves over the surface feature. 16. A medication delivery device comprising: a dose button having a first position in which the dose button is disengaged from a movable element of the rotation sensor and a second position in which the movable element of the rotation sensor is contactable with the surface feature; and a controller operatively coupled to the rotation sensor and housed by the dose button, configured to determine a number of surface features that have passed the movable element of the rotation sensor during dose delivery in response to receiving a generated signal from the rotation sensor, the controller being configured to actuate the controller to a full power state when the dose button is in the second position upon receiving a signal indicative of contact with a first one of the surface features, and configured to determine the number of axially extending surface features that have passed the movable element of the rotation sensor during dose delivery upon receiving a signal indicative of contact with a subsequent one of the surface features after the first first feature. 18. The medication delivery device of aspect 17, wherein the rotational sensor comprises a switch. 19. The medication delivery device of aspect 17, wherein the rotational sensor comprises at least one contact portion. 20. The medication delivery device of aspect 17, wherein the rotational sensor comprises a piezoelectric sensor. 21. The medication delivery device of aspect 17, wherein the surface feature extends axially from the dose setting member. 22. The drug delivery device of any one of aspects 1 to 21, further comprising a biasing member axially disposed between the dose button and the dose setting member, wherein the rotational sensor and controller are disposed within an inner cavity of the dose button, and the surface feature is disposed within the inner cavity, radially outward of the biasing member. 23. The drug delivery device of any one of aspects 1-22, wherein the device body comprises a reservoir having the drug.< / n>

Claims

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 tracking part is configured to reciprocate in the axial direction of the injection device.

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

4. The device described in claim 3, wherein the axially varying profile is a sawtooth profile.

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

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

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

8. The device of claim 1, wherein the controller is configured not to 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 tracking component.

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

11. The device described in claim 10, wherein the pin has an enlarged end portion made of a durable, low-friction material that enables the pin to slide easily across the sensed element.

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

13. An apparatus as claimed in claim 1, and the injection device containing a medicament.

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