Dose detection and drug identification for drug delivery devices

Abstract

The present disclosure relates to a dose detection system for use in conjunction with a drug delivery device. In one aspect, the system includes a module that is keyed to the device and includes a sensor that is operable to detect the relative angular position of a sensed element attached to the drug delivery device. The system determines the type of drug contained by the device and / or the type of device based on the detected angular position of the sensed element. In another aspect, the dose detection system is used in conjunction with a drug delivery device that includes a dose setting member that rotates relative to an actuator during dose delivery. The dose detection system includes a sensor and is operable to detect the relative angular position of a sensed element attached to the dose setting member during dose delivery and determine the amount of the dose delivered. Related methods are also disclosed.

Description

[0001] This application is a divisional application of the Chinese invention patent application with application number 201880014625.X, application date February 22, 2018, and titled “Dose detection and drug identification for drug delivery devices”. Technical Field

[0002] The present disclosure relates to an electronic dose detection system for a drug delivery device, and illustratively to an electronic dose detection module adapted to be removably attached to a proximal portion of a drug delivery device. Alternatively, the dose detection module may be integral to the drug delivery device. The dose delivery detection system is operable to detect the amount of a dose of a drug delivered by the drug delivery device and / or the type of drug contained in the drug delivery device. Background Art

[0003] Patients suffering from various diseases must frequently inject themselves with medication. In order to allow people to conveniently and accurately administer medications themselves, a variety of devices collectively referred to as pen injectors or injection pens have been developed. Typically, these pens are equipped with a cartridge that includes a piston and contains a number of liquid medication amounts that are dosed multiple times. A drive member can move forward to advance the piston in the cartridge to dispense the contained medication from an outlet at the distal end of the cartridge, usually through a needle. In a disposable or prefilled pen, after the medication supply in the cartridge has been discharged using the pen, the user discards the entire pen and begins using a new replacement pen. In a reusable pen, after the medication supply in the cartridge has been discharged using the pen, the pen is disassembled to allow the spent cartridge to be replaced with a new cartridge, and then the pen is reassembled for its subsequent use.

[0004] Many pen injectors and other drug delivery devices utilize mechanical systems in which components rotate and / or translate relative to each other in a manner proportional to the dose delivered by operation of the device. Accordingly, the art has been devoted to providing reliable systems that accurately measure the relative movement of components of a drug delivery device in order to estimate the delivered dose. Such systems may include a sensor that is secured to a first component of the drug delivery device and detects relative movement of a sensed component secured to a second component of the device.

[0005] The administration of the right amount of medication requires that the dose delivered by the medication delivery device is accurate. Many pen injectors and other medication delivery devices do not include functionality to automatically detect and record the amount of medication delivered by the device during an injection event. In the absence of an automated system, the patient must manually track the amount and time of each injection. Therefore, there is a need for a device that is operable to automatically detect the dose delivered by the medication delivery device during an injection event. In addition, it is desirable that such a dose detection device is removable and reusable with multiple delivery devices. In other embodiments, it is desirable that such a dose detection device is integrated with the delivery device.

[0006] It is also important to deliver the correct medication. Depending on the situation, the patient may need to select a different medication or a different form of a given medication. If an error is made as to what medication is in the medication delivery device, the patient will not be dosed properly and the record of the dosage administration will be inaccurate. The likelihood of this happening is greatly reduced if a dose detection device is used that automatically confirms the type of medication contained by the medication delivery device. Summary of the invention

[0007] The present disclosure relates to a drug delivery device having a dose detection system and an associated control system configured to determine the amount of drug delivered from the drug delivery device based on sensing of relative rotation within the drug delivery device. The relative rotation may occur between a dose setting member and an actuator and / or a housing of the drug delivery device. The dose delivery detection system includes an electronics assembly attached to the actuator and a sensed component attached to or including the dose setting member. The electronics assembly includes a rotation sensor that can operate with the sensed component to detect rotation of the dose setting member relative to the actuator during dose delivery. The electronics assembly may also include various additional components, such as one or more other sensors, memory, a processor, a controller, a battery, etc. The dose delivery detection system and the attached electronics assembly may be fully integrated with the pen.

[0008] In another aspect, a dose delivery detection system includes a module that can be removably attached to a drug delivery device. Among other advantages, the attachable and detachable dose delivery detection module operates to detect the amount of drug delivered without changing the function or operation of the drug delivery device to which it is attached. In some embodiments, redundant sensors are provided to increase the robustness of the dose sensing system. In some embodiments, the sensing system records the size of the delivered dose and communicates the information to an external device. One of ordinary skill in the art will recognize other advantages.

[0009] In a further aspect, a dose type detection system is provided that is operable to detect a type of drug delivery device and / or a type of drug contained in the drug delivery device. The dose type detection system comprises a module that can be removably attached to an actuator member. The module comprises a sensor component that can detect a sensed component attached to the drug delivery device. The module is keyed to be attached to the drug delivery device in a predetermined angular position. The sensor is operable to detect an angular position of the sensed component relative to the sensor to determine the type of drug contained by the drug delivery device.

[0010] In another aspect, the module includes both a drug delivery system and a drug type detection system to detect both the amount of drug delivered and the type of drug contained by the drug delivery device. Also included is a method for determining the amount of the delivered dose and / or the type of drug contained by the drug delivery device. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The features and advantages of the present disclosure will become more apparent to those skilled in the art upon consideration of the following detailed description taken in conjunction with the accompanying drawings.

[0012] Figure 1 is a perspective view of an exemplary drug delivery device with which the dose detection system of the present disclosure may operate.

[0013] Figure 2 yes Figure 1 A cross-sectional perspective view of an exemplary drug delivery device.

[0014] Figure 3 yes Figure 1 A perspective view of a proximal portion of an exemplary drug delivery device.

[0015] Figure 4 yes Figure 1 A partially exploded perspective view of a proximal portion of an exemplary drug delivery device of the present disclosure together with a dose delivery detection system.

[0016] Figure 5 is a side diagrammatic view, partially in cross-section, of a dose detection system module attached to a proximal portion of a drug delivery device according to another exemplary embodiment.

[0017] Figure 6 is a cross-sectional view of a module of a dose delivery detection system attached to a proximal portion of a drug delivery device according to an exemplary embodiment.

[0018] Figure 7 is a top diagrammatic view showing a rotation sensor positioned to detect a magnetic sensed element attached to a dose setting member according to an exemplary embodiment.

[0019] Figure 8 It includes a magnetic sensing element Figure 7 A perspective view of a dose setting member.

[0020] Fig. 9 is a perspective view of an alternative embodiment of a magnetic dose delivery detection system.

[0021] FIG. 10A to FIG. 10B as well as FIG. 11A to FIG. 11B Still other exemplary embodiments of dose delivery detection systems utilizing magnetic sensing are shown.

[0022] FIG. 12A to FIG. 12D as well as FIG. 13A to FIG. 13G An exemplary embodiment of a dose detection system utilizing inductive sensing is shown.

[0023] Figures 14 to 17 An exemplary embodiment of a keying system useful for a dose-type delivery system is shown.

[0024] Fig.18 is a cross-sectional view of a module of a dose detection system according to another embodiment, the module being shown attached to a proximal portion of a drug delivery device.

[0025] Fig.19 is a diagrammatic view showing the positioning of sensors and sensed components useful in an exemplary embodiment of a dose detection system.

[0026] Fig. 20 It is shown Fig.19 Schematic diagram of the dose detection system.

[0027] Fig.21 It is shown Fig.19 A graph of the output response of a dose detection system.

[0028] Fig. 22 is a cross-sectional view of a dose detection system according to another embodiment, wherein the sensor and sensed element are integrated into a drug delivery device.

[0029] FIG. 23A to FIG. 23C An exemplary embodiment of a dose detection system utilizing optical sensing of the rotation and / or position of the skirt relative to the sensor component is shown in a diagrammatic view.

[0030] FIG. 24A to FIG. 24B Another exemplary embodiment of a dose detection system utilizing optical sensing of the rotation and / or position of a flange relative to a sensor component is shown in a diagrammatic view.

[0031] FIG. 25A to FIG. 25C An exemplary embodiment of a dose detection system utilizing capacitive sensing is shown.

[0032] Fig.26 is a cross-sectional view of an additional exemplary drug delivery device of the present disclosure. DETAILED DESCRIPTION

[0033] 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 will however be understood that no limitation of the scope of the invention is thereby intended.

[0034] The present disclosure relates to a sensing system for a drug delivery device. In one aspect, the sensing system is used to determine the amount of a dose delivered by the drug delivery device based on sensing of relative rotational movement between a dose setting member and an actuator of the drug delivery device. The sensed relative angular position or movement is associated with the amount of the delivered dose. In a second aspect, the sensing system is used to determine the type of drug contained in the drug delivery device. By way of illustration, the drug delivery device is described as being in the form of a pen injector. However, the drug delivery device can be any device for setting and delivering a dose of a drug, such as an infusion pump, a pill injector, or an auto-injector device. The drug can be any drug of a type that can be delivered by such a drug delivery device.

[0035] The devices described herein (such as device 10) may also include a drug, such as, for example, in a reservoir or cartridge 20. In another embodiment, the system may include one or more devices, the device including device 10 and a drug. The term "drug" refers to one or more therapeutic agents, including but not limited to insulin, insulin analogs (such as, insulin lispro or insulin glargine), insulin derivatives, GLP-1 receptor agonists (such as, dulaglutide or liraglutide), glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory peptide (GIP), GIP analogs, GIP derivatives, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies, and any therapeutic agent that can be delivered by the above device. The drug used in the device may be formulated with one or more excipients. The device is operated by the patient, caregiver, or healthcare professional in a manner generally as described above to deliver the drug to a person.

[0036] The exemplary drug delivery device 10 is Figures 1 to 4 1 is shown as a pen-type injector, which is configured to inject a drug into a patient through a needle. The pen-type injector 10 includes a body 11, which includes an elongated pen-shaped housing 12, which includes a distal portion 14 and a proximal portion 16. The distal portion 14 is received in a pen cap 18. Figure 2, the distal portion 14 contains a reservoir or cartridge 20 configured to contain a medicament fluid to be dispensed through a distal outlet end of the distal portion 14 during a dispensing operation. The outlet end of the distal portion 14 is equipped with a removable needle assembly 22 comprising an injection needle 24 enclosed by a removable cap 25. A piston 26 is positioned in the reservoir 20. An injection mechanism positioned in the proximal portion 16 operates to advance the piston 26 toward the outlet of the reservoir 20 during a dose dispensing operation to force the contained medicament through the needle end. The injection mechanism includes a drive member 28 (illustratively in the form of a screw) that is axially movable relative to the housing 12 to advance the piston 26 through the reservoir 20.

[0037] A dose setting member 30 is coupled to the housing 12 for setting the amount of a dose to be dispensed by the device 10. In the illustrated embodiment, the dose setting member 30 is in the form of a screw element that operates to make a helical motion (i.e. to move axially and rotationally simultaneously) relative to the housing 12 during dose setting and dose dispensing. Figure 1 and Figure 2 The dose setting member 30 is illustrated in its home or zero dose position fully screwed into the housing 12. The dose setting member 30 operates to be screwed outwardly from the housing 12 in a proximal direction until it reaches a fully extended position corresponding to the maximum dose that can be delivered by the device 10 in a single injection.

[0038] refer to Figures 2 to 4 The dose setting member 30 comprises a cylindrical dose dial member 32 having a helically threaded outer surface which engages a correspondingly threaded inner surface of the housing 12 to allow helical movement of the dose setting member 30 relative to the housing 12. The dose dial member 32 also comprises a helically threaded inner surface which engages a sleeve 34 ( Figure 2 ). The outer surface of the dial member 32 includes dose indicator indicia, such as numbers visible through the dose window 36 to indicate to the user the amount of the set dose. The dose setting member 30 also includes a tubular flange 38 coupled in the open proximal end of the dial member 32 and axially and rotationally locked to the dial member 32 by a detent 40 received in an opening 41 in the dial member 32. The dose setting member 30 also includes a collar or skirt 42 positioned around the outer periphery of the dial member 32 at its proximal end. The skirt 42 is axially and rotationally locked to the dial member 32 by a tab 44 received in a slot 46.

[0039] Therefore, the dose setting member 30 can 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 drug. The flange 38 is attached to the dose dial member 32 and, as described later, cooperates with the clutch to selectively couple the dial member 32 with the dose button 56. The skirt 42 provides a surface on the outside of the body 11 to enable the user to rotate the dial member 32 to set the dose.

[0040] The skirt 42 illustratively includes an annular ridge 49 and a plurality of surface features 48 formed on the outer surface of the skirt 42. The surface features 48 are illustratively longitudinally extending ribs and grooves that are circumferentially spaced around the outer surface of the skirt 42 and facilitate the user to grasp and rotate the skirt. In alternative embodiments, the skirt 42 is removed or integral with the dial member 32, and the user can grasp and rotate the dose button 56 and / or the dose dial member 32 to set a dose. Figure 4 In the embodiment of FIG. 5 , a user may grasp and rotate the radially outer surface of the one-piece dose button 56 to set a dose, and the one-piece dose button also includes a plurality of surface features.

[0041] The delivery device 10 includes an actuator 50 having a clutch 52 received within the dial member 32. The clutch 52 includes an axially extending stem 54 at its proximal end. The actuator 50 also includes a dose button 56 positioned proximal to the skirt 42 of the dose setting member 30. In an alternative embodiment, the dose setting member 30 includes a one-piece dose button 56 as shown in FIG. 11a. The dose button 56 includes a mounting collar 58 ( Figure 2 ). A collar 58 is attached to the rod 54 of the clutch 52, such as by interference fit or ultrasonic welding, so as to axially and rotatably secure the dose button 56 and the clutch 52 together.

[0042] The dose button 56 includes a disc-shaped proximal surface or face 60 and an annular wall portion 62 extending distally and radially inwardly from the outer peripheral edge of the face 60 to form an annular lip 64 therebetween. The proximal side 60 of the dose button 56 serves as a push surface against which force can be applied manually (i.e., directly by the user) to push the actuator 50 in the distal direction. The dose button 56 illustratively includes a recessed portion 66 centrally located on the proximal side 60, although the proximal side 60 may alternatively be a flat surface. Similarly, the one-piece dose button 56 shown in FIG. 11a may include a recessed portion 66 centrally located on the proximal side 60, or may alternatively be a flat surface. A biasing member 68 (illustratively a spring) is disposed between the distal surface 70 of the button 56 and the proximal surface 72 of the tubular flange 38 to push the actuator 50 and the dose setting member 30 axially away from each other. The dose button 56 may be depressed by a user to initiate a dose dispensing operation.

[0043] The delivery device 10 can be operated in both a dose setting mode and a dose dispensing mode. In the dose setting mode of operation, the dose setting member 30 is dialed (rotated) relative to the housing 12 to set the desired dose to be delivered by the device 10. Dialing in the proximal direction is used to increase the set dose, and dialing in the distal direction is used to decrease the set dose. The dose setting member 30 can be adjusted during the dose setting operation in rotation increments (e.g., clicks) corresponding to the smallest incremental increase or decrease of the set dose. For example, one increment or "click" can be equal to half or one unit of drug. The amount of the set dose is visible to the user via the dial indicator markings shown through the dose window 36. During dialing in the dose setting mode, the actuator 50 including the dose button 56 and the clutch 52 moves axially and rotationally with the dose setting member 30.

[0044] Due to the threaded connection of the dose dial member 32 to the housing 12, the dose dial member 32, the flange 38 and the skirt 42 are all rotationally fixed to each other and rotate and extend toward the proximal side of the drug delivery device 10 during dose setting. During this dose setting movement, the dose button 56 is moved by the flange 38 and the clutch 52 ( Figure 2 ) and rotationally fixed relative to the skirt 42 by complementary splines 74 of the housing 12, which are urged together by the biasing member 68. During dose setting, the skirt 42 and the dose button 56 move in a spiral manner from a "start" position to an "end" position relative to the housing 12. This rotation relative to the housing is proportional to the amount of the dose set by operation of the drug delivery device 10.

[0045] Once the desired dose is set, the device 10 is manipulated so that the injection needle 24 appropriately pierces, for example, the skin of the user. The dose dispensing mode of operation is initiated in response to an axial distal 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. This causes the actuator 50 to move axially relative to the housing 12 in the distal direction.

[0046] The axial displacement movement of the actuator 50 compresses the biasing member 68 and reduces or closes the gap between the dose button 56 and the tubular flange 38. This relative axial movement disengages the clutch 52 and the complementary splines 74 on the flange 38 and thereby disengages the actuator 50 (e.g., the dose button 56) from being rotationally fixed to the dose setting member 30. In particular, the dose setting member 30 is rotationally decoupled from the actuator 50 to allow the dose setting member 30 to be back-driven in rotation relative to the actuator 50 and the housing 12. The dose dispensing mode of operation may also be initiated by activating a separate switch or trigger mechanism.

[0047] As the actuator 50 continues to be inserted axially without rotation relative to the housing 12, the dial member 32 is screwed back into the housing 12 as it rotates relative to the dose button 56. The dose indicia indicating the amount still remaining to be injected are visible through the window 36. As the dose setting member 30 is screwed distally downward, the drive member 28 is advanced distally to push the piston 26 through the reservoir 20 and through the needle 24 ( Figure 2 ) to excrete the drug.

[0048] During a dose dispensing operation, the amount of drug expelled from the drug delivery device is proportional to the amount of rotational movement of the dose setting member 30 relative to the actuator 50 when the dial member 32 is screwed back into the housing 12. When the internal thread of the dial member 32 has reached the sleeve 34 ( Figure 2 ) when the distal end of the corresponding external thread of the injection is completed. Then, the device 10 is arranged again in the Figure 2 and Figure 3 Ready or zero dose position as shown in .

[0049] During dose delivery, the starting and ending angular positions of the dose dial member 32 and thus the rotationally fixed flange 38 and skirt 42 relative to the starting and ending angular positions of the dose button 56 provide an "absolute" change in angular position. Determining whether the relative rotation exceeds 360° is determined in a number of ways. By way of example, the total rotation may be determined by also taking into account the incremental movement of the dose setting member 30, which may be measured in any number of ways by the sensing system.

[0050] Further details of the design and operation of an exemplary delivery device 10 may be found in U.S. Pat. No. 7,291,132, entitled "Medication Dispensing Apparatus with Triple Screw Threads for Mechanical Advantage," the entire disclosure of which is hereby incorporated herein by reference. Another example of a delivery device is an automatic injector device that may be found in U.S. Pat. No. 8,734,394, entitled "Automatic Injection Device With Delay Mechanism Including Dual Functioning Biasing member," which is hereby incorporated herein by reference in its entirety, wherein 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.

[0051] The dose detection system uses a sensing component and a sensed component attached to a component of a drug delivery device. The term "attachment" encompasses any means of fixing the position of a component to another component or to a component of a drug delivery device so that they can operate as described herein. For example, the sensing component can be attached to a component of a drug delivery device by being directly positioned on the component, received within the component, integral with the component, or otherwise connected to the component. The connection can include, for example, a connection formed by friction engagement, splines, snap fits or press fits, sonic welding, or adhesives.

[0052] The term "direct attachment" is used to describe an attachment in which two parts or parts and components are physically fixed together without an intermediate component other than the attachment component. The attachment component may include a fastener, adapter, or other part of a fastening system, such as a compressible membrane that is sandwiched between two parts to facilitate attachment. "Direct attachment" is distinguished from a connection in which the parts / components are connected through one or more intermediate functional components (such as the dial member 32 in the Figure 2 52 is coupled to the dosage button 56).

[0053] The term "fixed" is used to indicate that the indicated movement can or cannot occur. For example, a first component is "rotationally fixed" to a second component if the two components are required to move rotationally together. In one aspect, a component may be "fixed" relative to another component functionally rather than structurally. For example, a component may be pressed against another component so that frictional engagement between the two components rotationally fixes them together, while the two components may not be fixed together without pressing the first component.

[0054] 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 of a sensed component. A sensing component includes a sensing element or "sensor" together with associated electrical components for operating the sensing element. A "sensed component" is any component for which the sensing component is capable of detecting the position and / or movement of the sensed component relative to the sensing component. For a dose delivery detection system, the sensed component rotates relative to the sensing component, and the sensing component is capable of detecting the angular position and / or rotational movement of the sensed component. For a dose type detection system, the sensing component detects the relative angular position of the sensed component. The sensing component may include one or more sensing elements, and the sensed component may include one or more sensed elements. The sensor system is capable of detecting the position or movement of (one or more) sensed components and providing an output representing the position (one or more) or movement (one or more) of (one or more) sensed components.

[0055] The sensor system typically detects a characteristic of a sensed parameter that varies in relation to the position of one or more sensed elements within a sensed region. The sensed elements extend into the sensed region or otherwise affect the sensed region in a manner that directly or indirectly affects the characteristic of the sensed parameter. The relative position of the sensor and the sensed element affects the characteristic of the sensed parameter, thereby allowing a controller of the sensor system to determine different positions of the sensed elements.

[0056] Suitable sensor systems may include a combination of active and passive components. Where the sensing component operates as an active component, it is not necessary to connect both components to other system elements, such as a power source or controller.

[0057] Any of a variety of sensing technologies may be incorporated by which the relative position of two components can be detected. Such technologies may include, for example, technologies based on tactile, optical, inductive or electrical measurements.

[0058] Such techniques may include the measurement of a sensed parameter associated with a field, such as a magnetic field. In one form, the magnetic sensor senses changes in the sensed magnetic field as the magnetic component moves relative to the magnetic sensor. In another embodiment, the sensor system may sense characteristics and / or changes in the magnetic field as an object is positioned within and / or moves through the magnetic field. The change in the field changes the characteristics of the sensed parameter in a manner related to the position of the sensed element in the sensed area. In such an embodiment, the sensed parameter may be capacitance, conductance, resistance, impedance, voltage, inductance, etc. For example, a magnetoresistive sensor detects a distortion of an applied magnetic field that causes a characteristic change in the resistance of an element of the sensor. As another example, a Hall effect sensor detects a voltage change caused by a distortion of an applied magnetic field.

[0059] In one aspect, the sensor system detects the relative position or movement of the sensed element and thus the relative position or movement of the associated component of the drug delivery device. The sensor system generates an output representing the position or movement of the sensed component(s). For example, the sensor system may be operable to generate an output by which the rotation of the dose setting component during dose delivery can be determined. The controller is operably connected to each sensor to receive the output. In one aspect, the controller is configured to determine the amount of the dose delivered by the operation of the drug delivery device based on the output.

[0060] The dose delivery detection system involves detecting relative rotational movement between two members. Where the degree of rotation has a known relationship to the amount of dose delivered, the sensor system operates to detect the amount of angular movement from the start of dose injection to the end of dose injection. For example, for a pen injector, a typical relationship is that an angular displacement of 18° of the dose setting member is equivalent to one dose unit, although other angular relationships are also suitable. The sensor system is operable to determine the total angular displacement of the dose setting member during dose delivery. Thus, if the angular displacement is 90°, 5 dose units have been delivered.

[0061] One method for detecting angular displacement is to count the increments of the amount of the dose as the injection proceeds. For example, the sensor system may use a repeating pattern of the sensed element such that each repeat is indicative of a predetermined number of degrees of angular rotation. Advantageously, the pattern may be established such that each repeat corresponds to the smallest increment of the dose that can be set using the drug delivery device.

[0062] An alternative approach is to detect the start and stop positions of the relatively moving members and determine the amount of the delivered dose as the difference between these positions. In this approach, the sensor system detecting the number of complete rotations of the dose setting member may be part of this determination. Various methods for this are well within the ordinary skill in the art and may include "counting" the number of increments to estimate the number of complete rotations.

[0063] The sensor system components may be permanently or removably attached to the drug delivery device. In an illustrative embodiment, at least some of the dose detection system components are provided in the form of a module that is removably attached to the drug delivery device. This has the advantage of making these sensor components usable for use with more than one pen injector.

[0064] In some embodiments, the sensing component is mounted to the actuator and the sensed component is attached to the dose setting member. The sensed component may also include the dose setting member or any part thereof. The sensor system detects the relative rotation of the sensed component and thus the relative rotation of the dose setting member during dose delivery, from which the amount of the dose delivered by the drug delivery device is determined. In an illustrative 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 the device body during dose delivery. The sensed component may also include the dose setting member or any part thereof. In an illustrative embodiment, the rotation sensor is not directly attached to the dose setting member that rotates relatively during dose delivery.

[0065] refer to Figure 5 , a dose delivery detection system 80 is shown in diagrammatic form, which includes a module 82 useful in conjunction with a drug delivery device, such as device 10. Module 82 carries a sensor system (shown generally at 84) that includes a rotation sensor 86 and other associated components, such as a processor, memory, battery, etc. Module 82 is provided as a separate component that can be removably attached to an actuator.

[0066] The dose detection module 82 includes a body 88 attached to the dose button 56. The body 88 illustratively includes a cylindrical side wall 90 and a top wall 92 that spans over and seals the side wall 90. By way of example, Figure 5, the upper sidewall 90 is diagrammatically shown as having an inwardly extending tab 94 that attaches the module 82 to the dose button 56. The dose detection module 82 may alternatively be attached to the dose button 56 via any suitable fastening means, such as a snap fit or press fit, a threaded interface, etc., provided that in one aspect, the module 82 may be removed from a first drug delivery device and thereafter attached to a second drug delivery device. The attachment may be at any location on the dose button 56, provided that the dose button 56 is able to be axially moved any desired amount relative to the dose setting member 30, as discussed herein.

[0067] During dose delivery, the dose setting member 30 is free to rotate relative to the dose button 56 and the module 82. In the illustrated embodiment, the module 82 is rotationally fixed to the dose button 56 and does not rotate during dose delivery. This can be provided structurally by, for example, using Figure 5 The module 82 may be provided with a lug 94, or by engaging mutually facing splines or other surface features on the module body 88 and the dose button 56 when the module 82 is axially moved relative to the dose button 56. In another embodiment, pressing the module distally provides sufficient frictional engagement between the module 82 and the dose button 56 to functionally cause the module 82 and the dose button 56 to remain rotationally fixed together during dose delivery.

[0068] The top wall 92 is spaced apart from the face 60 of the dose button 56 and thereby provides a cavity 96 in which some or all of the rotation sensor and other components may be accommodated. The cavity 96 may be open at the bottom, or may be closed (such as by a bottom wall 98). The bottom wall 98 may be positioned so as to bear directly against the face 60 of the dose button 56. Alternatively, the bottom wall 98 (if present) may be spaced apart from the dose button 56, and other contacts between the module 82 and the dose button 56 may be used so that an axial force applied to the module 82 is transferred to the dose button 56. In another embodiment, the module 82 may be rotationally fixed to the one-piece dose button 56 shown in FIG. 11a.

[0069] In an alternative embodiment, the module 82 is instead attached to the dose setting member 30 during dose setting. For example, the side wall 90 may include a lower wall portion 100 having an inward protrusion 102 that engages the skirt 42 in a position below the ridge 49. In this approach, the tabs 94 may be eliminated and the module 82 effectively engages the proximal side 60 of the dose button 56 and the distal side of the annular ridge 49. In this configuration, the lower wall portion 100 may be provided with surface features that engage with surface features of the skirt 42 to rotationally secure the module 82 with the skirt 42. Thereby, rotational forces applied to the housing 82 during dose setting are transferred to the skirt 42 due to the coupling of the lower wall portion 100 with the skirt 42.

[0070] The module 82 is rotationally disengaged from the skirt 42 for dose delivery. The coupling of the lower wall portion 100 to the skirt 42 is configured to break when the module 82 is axially moved distally relative to the skirt 42, thereby allowing the skirt 42 to rotate relative to the module 82 during dose delivery.

[0071] In a similar manner, the module 82 may be coupled to both the dose button 56 and the skirt 42 during dose setting. This has the advantage of providing an additional coupling surface during rotation of the module in dose setting. The coupling of the module 82 to the skirt 42 is then released prior to dose injection, such as by axially moving the module 82 relative to the skirt 42 when dose delivery is initiated, thereby allowing the dose setting member 30 to rotate relative to the module 82 during dose delivery.

[0072] In certain embodiments, the rotation sensor 86 is coupled to the side wall 90 for detecting the sensed component. The lower wall portion 100 also serves to reduce the likelihood that a user's hand will inadvertently apply resistance to the dose setting member 30 as it rotates relative to the module 82 and the housing 12 during dose delivery. In addition, since the dose button 56 is rotationally fixed to the dose setting member 30 during dose setting, the side wall 90 (including the lower wall portion 100) provides a single continuous surface that can be easily grasped and manipulated by a user during dose setting.

[0073] When the injection process is initiated by pressing down on the dose detection module 82, the dose button 56 and the dose setting member 30 are rotationally fixed together. Movement of the module 82 and therefore the dose button 56 a short distance (e.g. less than 2 mm) releases the rotational engagement, and the dose setting member 30 rotates relative to the module 82 as the dose is delivered. Whether by using a finger pad or other trigger mechanism, the dose detection system is activated before the dose button 56 has moved a sufficient distance to disengage the rotational lock of the dose button 56 and the dose setting member 30.

[0074] Illustratively, the dose delivery detection system includes an electronic device assembly suitable for the operation of the sensor system as described herein. The controller is operably connected to the sensor system to receive output from one or more rotation sensors. The controller may include, for example, conventional components contained in a cavity 96 defined by the module body 88, such as a processor, a power supply, a memory, a microcontroller, etc. Alternatively, at least some components may be provided separately, such as by means of a computer, a smart phone, or other device. Then, a device is provided to operably connect the external controller components to the sensor system at an appropriate time, such as by a wired or wireless connection.

[0075] The exemplary electronics assembly 120 includes a flexible printed circuit board (FPCB) having a plurality of electronic components. The electronics assembly includes a sensor system including one or more rotation sensors 86 in operative communication with a processor for receiving signals from the sensors representing sensed relative rotation. The electronics assembly also includes a microcontroller unit (MCU) including at least one processing core and internal memory. The system includes a battery (illustratively a button cell) for powering the components. The MCU includes control logic that operates to perform the operations described herein, including detecting a dose delivered by the drug delivery device 10 based on a detected rotation of a dose setting member relative to an actuator. In one embodiment, the detected rotation is between the skirt 42 and the dose button 56 of the pen injector.

[0076] The MCU operates to store the detected dose in a local memory (e.g., internal flash memory or on-board EEPROM). The MCU also operates to wirelessly transmit a signal representing the detected dose to a paired remote electronic device (such as a user's smartphone) and / or receive the signal from the paired remote electronic device via Bluetooth Low Energy (BLE) or other suitable short-range or long-range wireless communication protocols. Illustratively, the BLE control logic and the MCU are integrated on the same circuit.

[0077] Many of the sensing electronics are housed in cavity 96. However, the rotation sensor may be positioned in a variety of locations to sense relative movement of the sensed component. For example, the rotation sensor may be located within cavity 96, within body 88 but outside of cavity 96, or in other locations of the body (such as on lower wall portion 100). The only requirement is that the rotation sensor is positioned to effectively detect rotational movement of the sensed component during dose delivery. In some embodiments, the rotation sensor is integral to device 10.

[0078] One or more sensed elements are attached to the dose setting member 30. In one aspect, the sensed element is attached directly to the skirt 42 of the dose setting member. Alternatively, the sensed element may be attached to any one or more of the dose setting components, including the dial member, the flange and / or the skirt. The only requirement is that the sensed element(s) are positioned to be sensed by the rotation sensor during the relative rotational movement performed during dose delivery. In other embodiments, the sensed component comprises the dose setting member 30 or any part thereof.

[0079] Figure 6 to Figure 1 Additional illustrative embodiments of a dose delivery detection system 80 are provided in FIG. 3. These embodiments are shown in a somewhat schematic manner because the Figures 1 to 5Common details are provided. In general, each embodiment includes similar components of the dose detection module 82, including a body 88 having a cylindrical upper wall 90 and a top wall 92. Each embodiment also includes a lower wall 100, but it will be appreciated that variations of these components (including the absence of the lower wall 100) are within the scope of the present disclosure. Other portions common to the earlier description herein include an electronic device assembly 120, a dose button 56, a dose setting member 32, and a device housing 12 housed within a cavity 96 of the module body 88. In addition, in each embodiment, the dose detection module 82 is diagrammatically shown as being attached to the annular sidewall 62 of the dose button 56, but alternative forms and locations of attachment may be used. For example, in some embodiments, the dose detection module 82 may be attached to the dose button 56 and releasably attached to the skirt 42. Moreover, the dose detection module 82 may be attached to a one-piece dose button 56 as shown in FIG. 11a.

[0080] Each example also demonstrates the use of a specific type of sensor system. However, in some embodiments, the dose detection system includes multiple sensing systems using the same or different sensing technologies. This provides redundancy in the event that one of the sensing systems fails. It also provides the ability to use a second sensing system to periodically verify that the first sensing system is performing properly.

[0081] In certain embodiments, such as Figure 6 Attached to the top wall 92 of the module 82 is a finger pad 110, as shown in FIG. The finger pad 110 is coupled to the top wall 92, which in turn is attached to the upper side wall 90. The finger pad 110 includes a ridge 114 that extends radially inward and is received within a circumferential groove 116 of the wall member 92. The groove 116 allows slight axial movement between the finger pad 110 and the wall member 92. A spring (not shown) generally pushes the finger pad 110 upward away from the wall member 92. The finger pad 110 may be rotationally fixed to the wall member 92. When the injection process is initiated, the axial movement of the finger pad 110 in the distal direction toward the module body 88 may be used to trigger a selected event. One use of the finger pad 110 may be that when a dose injection is initiated, upon initial depression of the finger pad 110 and its axial movement relative to the module body 88, the drug delivery device electronics are activated. For example, this initial axial movement may be used to "wake up" the device, and in particular, components associated with a dose detection system. In one example, module 82 includes a display for indicating information to the user. Such a display may be integrated with finger pad 110. The MCU includes a display driver software module and control logic that operates to receive and process sensed data and display information on the display, such as, for example, dose setting, dose dispensed, injection status, injection completed, date and / or time, or time for the next injection.

[0082] In the absence of a finger pad, the system electronics may be activated in a variety of other ways. For example, the initial axial movement of the module 82 at the start of dose delivery may be detected directly, such as by physical engagement of closed contacts or switches. It is also known to activate a drug delivery device based on a variety of other actions, such as removing a pen cap, using an accelerometer to detect pen movement, or setting a dose. In many approaches, the dose detection system is activated before dose delivery begins.

[0083] refer to Figures 6 to 8 , the dose detection module 82 operates using a magnetic sensing system 84. Two magnetic sensors 130 are positioned on the lower wall portion 100 (illustratively, the inner surface of the lower wall portion 100) opposite the skirt 42 of the dose setting member 30. For all embodiments, the number and position of the rotation sensor(s) and the sensed element(s) may vary. For example, Figures 6 to 8 Embodiments of the invention may alternatively include any number of magnetic sensors 130 spaced evenly or unevenly around the skirt 42. The sensed component 132 ( Figure 7 and Figure 8 ) includes a magnetic strip 134 secured to skirt 42 (illustratively, on the interior of skirt 42). In the illustrated embodiment, the strip includes 5 pairs of north-south magnetic components, such as 136 and 138, so that each magnetic portion extends up to 36°. The magnetic sensors 130 are positioned at 18° intervals ( Figure 7 ), and reads the digital position of the magnetic strip 132 and therefore the digital position of the skirt 42 in a 2-bit Gray code. For example, when the sensor detects the passage of one NS magnetic pair, it detects that the skirt 42 has rotated 36°, which corresponds to adding (or subtracting) a dose of, for example, 2 units.

[0084] Other magnetic patterns may also be used, including different numbers or positions of magnetic elements. Furthermore, in alternative embodiments, the sensed component 133 is attached to or integral with the flange 38 of the dose setting member 30, such as Fig. 9 as shown in .

[0085] As previously described, the sensing system 84 is configured to detect the amount of rotation of the sensed element relative to the magnetic sensor 130. The amount of rotation is directly correlated to the amount of dose delivered by the device. The relative rotation is determined by detecting the movement of the skirt 42 during dose delivery, for example, by identifying the difference between the starting position and the stopping position of the skirt 42, or by "counting" the number of incremental movements of the skirt 42 during drug delivery.

[0086] Referring to Figures 10-11, an exemplary magnetic sensor system 150 is shown, which includes an annular, ring-shaped bipolar magnet 152 as a sensed element, which has a north pole 154 and a south pole 156. The magnet 152 is attached to the flange 38 and thus rotates with the flange during dose delivery. The magnet 152 can alternatively be attached to the dose dial 32 or other member that is rotationally fixed to the dose setting member.

[0087] Sensor system 150 also includes a sensor 158 that includes one or more sensing elements 160 operatively connected to sensor electronics (not shown) housed within module 82. Sensing elements 160 of sensor 158 are Fig.11A 160 is shown attached to a printed circuit board 162 which in turn is attached to a module 82 which is rotationally fixed to the dose button 56. Thus, the magnet 152 rotates relative to the sensing element 160 during dose delivery. The sensing element 160 is operable to detect the relative angular position of the magnet 152. Thus, the magnetic sensor system 150 operates to detect the total rotation of the flange 38 relative to the dose button 56 and therefore relative to the housing 12 during dose delivery.

[0088] In one embodiment, magnetic sensor system 150 includes four sensing elements 160 spaced equi-radially within module 82. Alternative numbers and locations of sensing elements may be used. For example, in Fig. 11B In another embodiment shown in , a single sensing element 160 is used. In addition, Fig. 11B The sensing element 160 in FIG. 8 is shown as being centered within the module 82, although other locations may be used. In the foregoing embodiments, the sensing element 160 is shown as being attached within the module 82. Alternatively, the sensing element 160 may be attached to any portion of a component that is rotationally fixed to the dose button 56 such that the component does not rotate relative to the housing 12 during dose delivery.

[0089] For purposes of illustration, the magnet 152 is shown as a single annular bipolar magnet attached to the flange 38. However, alternative configurations and locations of the magnet 152 are also contemplated. For example, the magnet may include multiple poles, such as alternating north and south poles. In one embodiment, the magnet includes a plurality of pole pairs, the number of which is equal to the number of discrete rotational dose setting positions of the flange 38. The magnet 152 may also include a plurality of separate magnet components. In addition, the magnet component may be attached to any portion of a component that is rotationally fixed to the flange 38 during dose delivery, such as the skirt 42 or the dose dial component 32.

[0090] Alternatively, the sensor system is illustrated in FIGS. 12-13 as an inductive sensor system 170. The sensor system 170 utilizes a sensed element 171 comprising a metal strip 172 attached to the skirt 42 as the sensed element. The sensor system 170 also includes a sensor 174 that includes one or more sensing elements 176, such as four independent antennas 178 spaced equiradially along the perimeter of the skirt 42. These four antennas form two antenna pairs positioned 180 degrees apart and provide a ratio-metric measurement of the angular position of the skirt 42.

[0091] The metal strip 172 is shaped so as to detect one or more different rotational positions of the skirt 42 relative to the module 82. The metal strip 172 has a shape that produces a signal that changes when the skirt 42 rotates relative to the antenna 178. Illustratively, FIG. 13A to FIG. 13C shows a band mode where Fig. 13B Shows from Fig.13A 90° rotation of the position, and Fig. 13C An additional 90° rotation is shown. This mode produces a detected sinusoidal response when the skirt 42 rotates relative to the module 82, as shown in FIG. Fig.12D As shown schematically in FIG. , positions ad and Fig. 12A .

[0092] Fig.13D A schematic diagram is provided showing an inductive sensor system 170 incorporated into the module 82 and skirt 42 of the pen 10. A metal band 172 is shown attached to the skirt 42. An antenna 178 is operably connected to the electronics 120 such that the antenna functions to detect the position of the skirt 42 relative to the module 82 and therefore relative to the housing 12 of the pen 10 during dose delivery.

[0093] In the embodiment shown in Figures 12 to 13, the inductive sensor system 170 includes four sensing elements 176, which include antennas 178 spaced equiradially within the module 82. Alternative numbers and locations of sensing elements can be used. For example, another embodiment utilizes a single antenna. In the illustrated embodiment, the antenna 178 is shown as attached within the module 82. Alternatively, the antenna (one or more) may be attached to any part of such a component: the component is rotationally fixed to the dose button 56 so that the component does not rotate relative to the housing 12 during dose delivery.

[0094] For purposes of illustration, the metal band 172 is shown as a single cylindrical band attached to the exterior of the skirt 42. However, alternative configurations and locations of the metal band 172 are contemplated. For example, the metal band may include a plurality of discrete metal elements. In one embodiment, the metal band includes a plurality of elements, the number of which is equal to the number of discrete rotational dose setting positions of the skirt 42. In an alternative example, the metal band may be attached to any portion of a component that is rotationally fixed to the skirt 42 during dose delivery, such as the flange 38 or the dial member 32. The metal band may include a metal element that is attached to the rotating component on the inside or outside of the component, or it may be incorporated into such a component, such as by metal particles incorporated into the component, or by overmolding the component with the metal band.

[0095] Fig. 12A The antenna 178 is schematically shown in FIG. Fig.13D and Fig.13E The antenna is shown in FIG. 1 as being circular in structure. Fig.13F and Figure 13G An alternative configuration of an antenna is schematically shown in FIG. Fig.13F An “elongated antenna” 180 is shown having a rectangular midsection 182 and semicircular ends 184 . Fig.13F The position of the antenna 180 relative to the metal strip 186 is depicted. This position corresponds to the pen injector being at rest, without axial displacement of the module as in delivering a dose. Figure 13G , the antenna 180 is in a position corresponding to the module having been pressed to cause dose delivery. The module and therefore the antenna 180 have been displaced relative to the metal band 186 ( Figure 13G As will be apparent, the elongated antenna 180 may provide more uniform sensing of the metal strip 186 because there is a more constant area of ​​the mid-segment 182 that overlaps the metal strip.

[0096] In one aspect, a dose detection system in modular form is disclosed. The use of a removably attached module is particularly suitable for use with a drug delivery device in which both the actuator and the dose setting member include portions outside the housing of the drug device. These external portions allow the sensing component to be directly attached to the actuator (such as a dose button) and allow the sensed component to be directly attached to the dose setting member (such as a dose skirt, flange or dial member), as described herein. In this regard, a "dose button" is used to more generally refer to such a component of a drug delivery device: it includes a portion located outside the housing of the device and includes an exposed surface that can be used by a user to deliver a set dose. Similarly, a dose "skirt" more generally refers to such a component of a drug delivery device: it is located outside the housing of the device and thus has an exposed portion that can be used for a user to grasp and turn the component to set a dose. As disclosed herein, the dose skirt rotates relative to the dose button during dose delivery. Moreover, the dose skirt can be rotationally fixed to the dose button during dose setting, so that either the dose skirt or the dose button can be rotated to set the dose. In alternative embodiments, the delivery device may not include a dose skirt, and the user may grasp and rotate an actuator (e.g., a dose button) to set a dose. In some embodiments, with a dose detection module attached to the actuator and / or the dose skirt, the dose detection module may be rotated to thereby rotate a dose setting member of the delivery device to set a dose to be delivered.

[0097] It is an additional feature of the present disclosure that the sensing system of the dose detection system 80 may be initially incorporated into the drug delivery device as an integrated system rather than as an add-on module.

[0098] The foregoing provides a discussion of various structures and methods for sensing relative rotation of a dose setting member relative to an actuator during dose delivery. In certain embodiments of a drug delivery device, the actuator moves in a spiral manner relative to the pen body during dose setting. For illustrative purposes, the present disclosure describes the dose detection system with respect to such an actuator that moves in a spiral manner. However, it will be appreciated by those skilled in the art that the principles and physical operation of the disclosed dose detection system may also be used in conjunction with an actuator that rotates but does not translate during dose delivery. It will also be appreciated that the dose detection system may operate with other configurations of a medical delivery device, provided that the device includes an actuator that rotates relative to a dose setting member during dose injection.

[0099] The detection system can also be used with a module for identifying the characteristics of a drug to be administered by a pen injector. Pen injectors are used with a wide variety of drugs, and even with various types of a given drug. For example, insulin is available in different forms, depending on the intended purpose. Insulin types include rapid-acting, short-acting, intermediate-acting, and long-acting. In another aspect, the type of drug refers to which drug is involved (e.g., insulin versus non-insulin drugs) and / or to the concentration of the drug. It is important not to confuse the type of drug, as the consequences can have serious implications.

[0100] It is possible to correlate certain parameters based on the type of medication. Using insulin as an example, there are known limits on the appropriate amount of a delivered dose based on factors such as which type of insulin is involved, how the type of insulin relates to the timing of the delivered dose, etc. In another aspect, it is necessary to know which type of medication is being administered in order to accurately monitor and evaluate treatment methods. In one aspect, a sensor system is provided that is capable of distinguishing the type of medication to be administered.

[0101] To determine the type of medication, a module is provided that detects a unique identification of the type of medication contained in a medication delivery device. When the module is installed to a medication delivery device (e.g., a pen injector), the module detects the type of medication and stores it in a memory. Thereafter, the module is able to evaluate medication settings or delivery taking into account the type of medication in the pen as well as previous administration dosage history and other information.

[0102] refer to Fig.14 , the pen injector 10 includes a sensor system 200 including a sensed component 202 and a sensing component 204. The sensor system 200 is operable to identify different angular orientations of the sensed component 202 relative to the pen injector 10. The sensor system 200 may be of any type whereby it is capable of identifying a particular angular position (such as the types previously described).

[0103] exist Fig.14, a pen injector 10 is shown that includes a housing 12, a dose dial member 32, a flange 38, a clutch 52, a dose button 56, and a module 82. The sensed component 202 includes one or more sensed elements 206 attached to the pen injector 10 in a uniquely identifiable manner. By way of example, the sensed element 206 is shown attached to the skirt 42 and always has the same orientation relative to the skirt 42. The skirt 42 is rotatable relative to the housing 12, but has a unique, identifiable position relative to the housing 12 when in an "initial zero position" before any drug has been dispensed from the pen injector. Similarly, the sensed element 206 may be attached to other rotatable members of the pen that have a uniquely identifiable position at a relevant time (such as during installation of the module 82 to the pen injector 10). In this regard, the sensed element 206 may alternatively be attached to, for example, the flange 38 or the dial member 32.

[0104] The skirt 42 includes a slot 208 extending axially on the outside of the cylindrical skirt wall 210 ( Fig.15 ). The angular position of the slot 208 relative to the angular position of the sensed element 206 is predetermined to correspond to the selected type of drug. Fig.15 , slot 208 is shown in the 9 o'clock position, with skirt 42 in its initial zero dose position. This position of slot 208 is assigned to represent a particular type of medication. Alternatively, slot 208 is located in a different angular position for the initial zero dose position, such as at Fig.15 . This position is then assigned as representing the second type of drug. Therefore, detecting the position of the sensed element 206 relative to the slot 208 is useful for identifying the type of drug contained by the pen injector 10.

[0105] Module 82 includes a lower wall 212 including an inner surface 214 ( Fig.16 The tab 216 extends radially inward from the inner surface 214 and is configured to be received within the groove 208 . Fig.15 This state is illustrated diagrammatically in FIG. The tab 216 may be a simple protrusion of the inner surface, or may be provided as an arm that can flex radially outward. To mount the module 82 to the device 10, the tab 216 is aligned with the slot 208, and the module is then pushed in the direction of the device. The tab 216 is configured to ensure proper alignment with the slot 208 by having a blunt front end 218. This is provided to require that the tab 216 be received within the slot 208, rather than improperly riding on another position on the skirt.

[0106] Fig.14 The module is shown during installation with the tab 216 received within the slot 208. Fig.172, the module 82 has been advanced to its installed position, wherein the tab 216 has been moved out of the slot 208. In this position, the module 82 can be secured to the dose button 56, for example by the protrusion 220, as previously described. Positioning the tab 216 outside the slot 208 allows relative rotation between the skirt 42 and the module 82 after installation.

[0107] Identification of the drug type results from a predetermined orientation of the sensed element relative to slot 208. Figures 14 to 17 , which means that the sensed element is selectively positioned on the skirt 42 to represent the type of medicine. In this way, whenever the lug 216 is aligned with the slot 208, the sensor system is operable to identify the relative angular relationship of (one or more) sensed elements and the module and obtain the type of medicine therefrom. This detection can occur at any time when the lug and the slot are aligned. Since this alignment is required at the time when the module is installed to the skirt, it is advantageous to detect the position at this time. This can be caused by triggering the sensor system in any suitable manner, such as, by a proximity sensor, a sliding contact, a spring biased switch, or by manual activation when the module is initially installed.

[0108] Once the module has been installed and the type of drug has been identified, the pen injector is ready for use. When desired, the module 82 is removed from the pen injector and can be used on another pen injector. During operation, the delivery of the dose will cause the skirt 42 to rotate relative to the module 82, so that at the end of the dose delivery, the lug and the groove may not be aligned. This does not affect the operation of the pen injector because the lug is axially displaced relative to the groove 208 and can therefore be in any angular position relative to the skirt 42. However, in order to facilitate the removal of the module 82, the lug 216 includes a tapered rear end 222. This allows the lug 216 to easily ride over the outer surface 210 of the skirt 42, regardless of the angular position of the skirt. The identification of the drug type has been described using the lug and groove alignment mechanism. However, other alignment structures or systems are also contemplated.

[0109] The drug type detection is useful for a variety of sensor systems that are operable to detect a predetermined angular position of a sensed element relative to an alignment feature. These sensor systems include sensor systems previously disclosed herein. In a further aspect, the drug type determination is easily combined with a sensor system for detecting the amount of dose delivered. The two systems can operate independently or in concert with each other.

[0110] In certain aspects, the sensor system used to detect dose delivery is also used to identify the type of drug. For example, FIGS. 10-11 and the associated text describe a magnetic sensor system that includes a sensing element 160 and a magnet 152 to determine the amount of a delivered dose. The magnet 152 has a unique configuration that enables the sensor system to detect a specific angular position of the magnet 152 relative to the sensing element. Thus, this same sensor system can be used in conjunction with an alignment feature, such as with respect to Figures 14 to 17 As described, to identify the type of medication contained by a pen injector. The inductive sensor system of Figures 12-13 is another example of a sensor system useful for both determining medication type and dose delivery.

[0111] refer to Figures 18 to 21 , an alternative medicine and / or pen type detection system 230 is provided. In this embodiment, the sensor system 230 is provided to be connected to a module 232. The module 232 is connected to the Figures 14 to 17 The module 82 in the embodiment of the present invention is removably attached to the pen injector 10 in the same keying manner as described above. The sensor system 230 includes a sensed component 234 and a sensor 236. The sensor system 230 is operable to identify different angular orientations of the sensed component 234 relative to the pen injector 10. As previously described, the identification of the drug and / or pen type is caused by the predetermined orientation of the (one or more) sensed elements. The sensor system is operable to identify the relative angular relationship of the (one or more) sensed elements to the module and obtain the drug and / or pen type therefrom.

[0112] The angular position of the sensed component 234 is detected based on a unique angular profile of the sensed component. The term "unique angular profile" is used to identify a configuration of the sensed component in which one or more sensed elements 238 of the sensed component 234 are included so that the angular position of the sensed component can be uniquely identified for any predetermined angular position to be used by the system. Figures 19 to 21 A sensed component having such a unique angular profile is shown in FIG. Fig.19 Diagrammatically illustrated is the relationship between one embodiment of a sensed component 234 and a sensor 236. The sensed component 234 includes a single sensed element 238 formed in a generally circular pattern.

[0113] Sensor 236 Fig. 20 244 are shown as including opposing pairs of inductive coil antennas 246 and 248 that are equiradially positioned about the rotation axis 242 of the actuator 244. The antennas represent A+ / A- and B+ / B- pairs. Fig. 2024, which are configured to rotate about an axis of rotation 242. AC current flows through the pair of antennas 246 and 248, thereby generating four separate and independent AC magnetic fields.

[0114] As the sensed element 234 passes by the antenna pair, the magnetic field of each antenna induces circulating electric currents (eddy currents) on the surface of the metal in the sensed element 234. The eddy currents induce their own magnetic field that opposes the original magnetic field generated by the antenna. As the metal of the sensed element 234 moves closer to the antenna coil, a larger portion of the electromagnetic field generated by that coil is intercepted, and a smaller portion of the electromagnetic field of the other antenna is intercepted. This means that the eddy currents increase when more electromagnetic field flux lines are intercepted, and decrease when fewer flux lines of the other coils are intercepted. This change in eddy currents in each of the antennas changes the effective inductance of each individual antenna. The system is able to measure these changes in the inductance of each antenna 246 and 248 over time, and use this data from the opposing coils 246 and 248 to eliminate unwanted differences due to temperature or mechanical tolerances. The result is two continuously changing waveforms that are 90 degrees out of phase, such as Fig.21 as shown in .

[0115] Thus, the corresponding levels of the two output signals can be associated with various rotational positions of the sensed component 234 relative to the sensor 236, which allows for orthogonal rotational sensing. The system provides response data A and data B from the A and B antenna pairs 246 and 248, respectively. The sensor system 230 is Fig. 20 244 is shown in the “0 position”. It is apparent from the shape of the sensed component 234 and from the signal output that each relative rotational position of the sensed component 234 has a unique response characteristic, and therefore the sensed component has a unique angular profile about the rotational axis 242 of the actuator 244.

[0116] The output signal is processed and decoded to produce a unique signature for a given position of the sensed element 234. Such processing may include signal processing to repeatedly sample the output or to convert the output Fig.21 The analog signal shown in is converted into a separate digital square wave that is also 90 degrees out of phase. A lookup table can be used to compare the current position information with the previous position information to decode the direction of movement. For example, if the last decoded values ​​of output signals A and B are 00, respectively, and the current value is 01, it can be said that the sensed element has moved half a step in the clockwise direction. The degree for a given "step" is determined by the sampling rate of the analog signal. When smaller changes in angular position are detected, increasing the sampling rate results in increased rotational resolution. However, in order to detect the type of drug or device, it is sufficient for the sensed component to produce a unique signal output for any angular position associated with the drug or device type or any other information to be detected.

[0117] The sensor system 230 is configured to detect one or more angular positions of the sensed component 234 relative to the sensor 236. The controller 250 is responsive to the one or more detected angular positions and is operable to determine information about the drug delivery device 10 thereby.

[0118] In this illustrative embodiment, the module 232 is attached to the actuator 244 in a keyed relationship so as to place the module 232, and therefore the sensor 236, in a predetermined angular position relative to the actuator 244. For example, the module 232 may be provided by having the slot 208 of the skirt 42 receive the tab 216 of the module 232 ( Fig.18 ) to target Figures 14 to 17 The bonding relationship is provided in the same manner as in the embodiments.

[0119] The predetermined angular position of the module 232 is associated with the type of drug delivery device 10 and / or the type of drug contained by the drug delivery device 10. For example, Fig. 20 The 0° position shown in may indicate that the pen injector is a pen with a specific drug capacity, and the 90° position may indicate that the drug is a rapid-acting insulin. For example, the 180° position may indicate that the drug delivery device is a pen injector containing a certain volume of rapid-acting insulin. These associations may be stored in a memory carried by the module 232. The controller is configured to determine the angular position of the sensed component 234 relative to the sensor 236 contained by the module 232 and obtain associated information about the drug delivery device.

[0120] In another illustrative embodiment, the sensor system 230 is operable to determine the amount of drug delivered by the drug delivery device. According to this embodiment, the drug delivery device includes a dose setting member that rotates relative to the body of the drug delivery device during dose delivery. During dose setting, the actuator is axially and rotationally fixed with the dose setting member in a first operating mode. During dose delivery, the actuator is non-rotatable relative to the device body in a second operating mode. The sensor system 230 detects rotation of the sensed component relative to the module during dose delivery, and the controller obtains the amount of drug delivered.

[0121] In another embodiment, the sensor system of the drug delivery device is operable to determine both information about the drug delivery device itself and the amount of drug delivered by the drug delivery device. In this embodiment, the module 232 is attached to the drug delivery device, and the sensor system 230 detects the angular position of the sensed component 234 relative to the module 232. The position is associated with the type of drug delivery device, the type of drug contained by the drug delivery device, or any other desired information. The drug delivery device is then used to deliver the drug. During delivery, the sensor system 230 detects the rotation of the sensed component 234 relative to the sensor 236 as an indication of the amount of drug delivered.

[0122] refer to Fig.18 , further exemplary details of the drug delivery system 252 are provided. Fig.18 In the embodiment, the system 252 includes a drug delivery device 10, which includes a device body 11, a dose dial member 32, a flange 38, a skirt 42, a clutch 52, and a dose button 56. The module 232 can be attached to the dose button 56 by a protrusion 220 extending inwardly from the module 232. With initial attachment, the module 232 is oriented relative to the skirt 42 by the tab 216 being received within the slot 208. In this orientation, the position of the sensed component 234 relative to the sensor 236 is associated with the type of drug and / or the type of drug delivery device, as previously described.

[0123] To deliver a dose, the module 232 and the dose button 56 are advanced in the distal direction relative to the skirt 42 to Fig.21 In this position, the skirt 42, the dose dial member 32 and the flange 38 move rotationally together relative to the dose button 56 when a dose of the drug is delivered.

[0124] As shown, the sensed component 234 includes a single sensed element provided as a metal strip 254. Figures 19 to 21 As depicted, the metal band 254 has a unique angular profile surrounding the axis of rotation 242. By way of example, the sensed element 238 is shown attached to the dose dial member 32. The dose dial member 32 is rotatable relative to the device body 11, but has a unique, identifiable position relative to the device housing 11 when in an "initial zero position" before any drug has been dispensed from the drug delivery device. Similarly, the sensed element 238 may be attached to other rotatable members of the drug delivery device that have uniquely identifiable positions at relevant times (such as during installation of the module 232 to the drug delivery device 10). In this regard, the sensed component 234 may alternatively be attached to, for example, the flange 38 or the skirt 42.

[0125] The illustrative sensor system 230 is also useful as a system integrated into a drug delivery device rather than being provided as a removable module. Fig. 22 , showing the Figures 1 to 4 The present invention relates to a drug delivery device 310 which is substantially the same as the device 10 in FIG. The drug delivery device 310 comprises a device body 11 and a dose setting member 30 comprising a dose dial member 32, a flange 38 and a skirt 42. These components are configured to function as previously described. The actuator 50 comprises a clutch 52 and a dose button 56 attached thereto. During dose setting, the dose button 56 is rotationally fixed to the dose setting member 30. For dose delivery, the rotational fixation is disengaged and the dose setting member 30 is rotated relative to the dose button 56 in proportion to the amount of the dose delivered.

[0126] Drug delivery device 310 and Figures 1 to 4 The device 10 of is different in that a dose detection system 312 is included, which includes a sensed component 314 and a sensor 316. The sensor 316 is integrated into the dose button 56. The dose button 56 includes a base wall 318, a peripheral wall 320, and a top wall 322, and together they form a compartment 324. The sensor 316 includes one or more sensor elements 326 supported within the compartment 324. Similarly, Fig.26 The one-piece dose button 56 shown in FIG. 3 may include an integrated sensor 316 and compartment 324 .

[0127] An electronics assembly 328 is also received within compartment 324 and is operably connected to sensor element 326. Electronics assembly 328 also includes a controller 330. Controller 328 is coupled to sensor element 320 to receive sensor output and determine information therefrom about the drug delivery device and / or its contents.

[0128] The sensed component 314 is attached to the dose setting member 30. Figures 18 to 21 For the embodiment of the present invention, the sensed component 314 includes a metal strip or other sensed element having a unique angular profile. The sensed component 314 is shown as being attached to the dose dial member 32, but it can also be attached to other components of the dose setting member 30. The sensor 316 is positioned and configured to detect the relative angular position of the sensed component 314.

[0129] This embodiment and Figures 18 to 21310 in that the components of the dose detection system 312 are integrated into the drug delivery device 310. In other aspects, the sensing operations are performed as previously described, with the dose detection system operating to detect the type of drug delivery device, the type of drug, and / or the amount of the dose delivered by the drug delivery device, etc. In yet another alternative, the sensed component 314 is integrated into the drug delivery device 310, but the sensor 316 is contained by a removable module as previously described.

[0130] refer to FIG. 23A to FIG. 23C , an alternative embodiment employing optical sensing is shown. As previously described, the module 82 is attached to the drug delivery device 10, which includes the dose button 56 and the skirt 42. The sensed element includes one or more detectable marks 350 applied to the upper surface 352 of the skirt 42. These marks may include, for example, dots of visible or invisible ink attached to the skirt 42. The sensor system includes a camera assembly 354 mounted within the compartment 96. The camera assembly 354 is positioned and includes suitable optics to track the detectable mark(s) throughout the rotation of the skirt 42 relative to the module 82.

[0131] In the case of optical sensing FIG. 24A to FIG. 24B In a similar embodiment shown in FIG. 1 , a module 82 attached to a drug delivery device 10 is also provided. The sensed component includes one or more detectable marks 360 applied to an upper surface 368 of the flange 38. A camera assembly 364 is positioned and includes suitable optics to track the detectable mark(s) 360 throughout the rotation of the flange 38 relative to the module 82. For example, the camera assembly 364 may include: a lens 366 positioned to align with a window (not shown) of the dose button 56; and optionally a notch 370 formed in the tab 94 of the sidewall 90. The detectable marks 360 may be provided in various patterns to facilitate monitoring the rotation of the flange 38. It will be appreciated that any of the embodiments of FIGS. 23 and 24 may alternatively or additionally be used to detect the absolute relative position of the skirt or flange based on including a unique detectable mark around the perimeter of the skirt or flange.

[0132] Alternatively, FIG. 25A to FIG. 25C3, the sensor system is exemplified as a capacitive sensor system 380. The sensor system 380 utilizes a sensed element 382, ​​which includes a metal strip 384 attached to the skirt 42. The sensor system 380 also includes a sensor 386, which includes one or more sensing elements, such as an antenna or armature 388, mounted to the side wall 90 opposite the metal strip 384. The metal strip covers, for example, half of the circumference of the skirt 42 and creates a capacitive coupling between each pair of armatures as it rotates about the Z axis. Two armature pairs separated by 180° form two orthogonal sensors and provide a ratiometric measurement of the angular position of the skirt.

[0133] The metal strip 384 is shaped so that the rotational position of the skirt 42 relative to the module 82 can be detected. The metal strip 384 has a shape that produces a signal that changes when the skirt 42 rotates relative to the antenna 384. The shape of the metal strip 384 and the position of the armature produce a sinusoidal response when the skirt 42 rotates. The shield 390 on the outside of the module wall 90 is connected to the device ground 392 and provides isolation for the sensor during operation.

[0134] For purposes of illustration, the metal band 384 is shown as a single cylindrical band extending halfway around the interior of the skirt 42. However, alternative configurations and locations of the metal band 384 are also contemplated. For example, the metal band may include a plurality of discrete metal elements. In the alternative, the metal band may be attached to any portion of a component that is rotationally fixed to the skirt 42 during dose delivery, such as the flange 38 or the dial member 32. The metal band may include a metal element that is attached to the member on the inside or outside of the rotating member, or it may be incorporated into such a member, such as by metal particles incorporated into the member, or by overmolding the member with the metal band. Fig.26 In the embodiment illustrated in FIG. 1 , the dose button 56 of the illustrated device 10 is one-piece, which combines Figures 1 to 4 The skirt 42 and the dose button 56 of the body 11 are both attached to the dose dial member 32. In this embodiment, the flange 38 is attached to the dose dial member 32 and cooperates with the clutch 52 to selectively couple the dose dial member 32 with the one-piece dose button 56. The radially outer surface of the one-piece dose button 56 provides a surface outside the body 11 for rotating the dial member 32.

[0135] The dose detection system has been described by way of example in the context of a particular design of a drug delivery device, such as a pen injector. However, the illustrative dose detection system may also be used with alternative drug delivery devices, and with other sensing configurations that may operate in the manner described herein. Any of the devices described herein may include any one or more of the drugs described herein, such as, for example, within a cartridge of the device.

Claims

1. A dose detection system for a drug delivery device, the drug delivery device comprising a substantially elongated housing, an injectable drug being held by the housing, the housing having a proximal portion and a distal portion, wherein: The dose detection system comprises: a magnet ring having one or more dipoles configured to generate a magnetic field, wherein the magnet ring is fixedly coupled to a dose setting member located at or near a proximal portion of the drug delivery device and rotatable relative to the housing during dose setting and dose dispensing, and an electronics assembly including a processor and at least one magnetic sensor operably coupled to and fixedly secured relative to the processor to detect a rotational position of the magnet ring, in: In dose setting, the magnet ring rotates relative to the substantially elongated housing of the drug delivery device, and in dose dispensing, the at least one magnetic sensor moves distally closer to the magnet ring, the magnet ring being configured to rotate relative to the at least one magnetic sensor, the at least one magnetic sensor being configured to detect a rotational position and / or rotational movement of the magnet ring so as to generate a position signal, and the processor being configured to receive the position signal so as to determine data indicative of an amount of the dispensed dose based on the position signal.

2. The dose detection system according to claim 1, wherein: The drug delivery device further comprises a rotatable dose skirt or a one-piece button coupled to the dose setting member and adapted to allow a user to set the amount of a dose of the drug to be dispensed, and the electronic device assembly is adapted to engage the rotatable dose skirt or the one-piece button to allow the user to set the amount of the dose of the drug to be dispensed via the electronic device assembly.

3. The dose detection system according to claim 1, wherein: The magnet ring includes a single dipole magnet.

4. The dose detection system according to claim 1, wherein: The at least one magnetic sensor includes a plurality of magnetic sensors arranged such that a portion of each of the magnetic sensors is disposed to extend radially beyond an outer periphery of the magnet ring.

5. A dose detection system, comprising: an additional module adapted to be releasably mounted at or near the proximal end of the drug delivery device, The drug delivery device comprises: a substantially elongated housing; a reservoir containing a drug; an injection drive mechanism adapted to dispense a dose of the drug from the reservoir; a dose setting member; a magnet ring configured to generate a magnetic field, wherein the magnet ring is coupled to the dose setting member, the magnet ring is located at or near an end portion of the drug delivery device and is adapted to rotate relative to the housing during dispensing and / or setting of a dose of the drug, wherein an amount of movement of the dose setting member indicates the size of the dose amount set and / or the dose amount dispensed, the magnet ring comprising one or more dipoles, The additional module includes a sensor system, which includes: at least one magnetic sensor, which is configured to determine a magnetic field value from the magnet ring; and a processor, which is configured to determine a rotational position and / or rotational movement of the magnet ring based on the determined magnetic field value from the at least one magnetic sensor when the additional module is installed on the drug delivery device, and the rotational position and / or rotational movement of the magnet ring corresponds to the amount of the dose dispensed.

6. The dose detection system according to claim 5, wherein: The drug delivery device further comprises a rotatable dose skirt or an integral button coupled to the dose setting member and adapted to allow a user to set the amount of a set dose of a drug, and the additional module is adapted to engage the dose skirt or the one-piece button to allow the user to set the amount of the set dose of the drug via the additional module.

7. The dose detection system according to claim 5, wherein: The magnet ring includes a single dipole magnet.

8. The dose detection system according to claim 5, wherein: The at least one magnetic sensor includes a plurality of magnetic sensors arranged such that a portion of the magnetic sensors is disposed to extend radially beyond an outer periphery of the magnet ring.

9. A dose detection system for a drug delivery device, the drug delivery device comprising: an elongated housing extending about an axis between a proximal portion and a distal portion; and an actuator located at the proximal portion; a magnetic component located at a proximal portion of the elongated housing; and a clutch, wherein the dosage detection system comprises: a module body to be removably attached to an actuator, the module body being adapted to engage the actuator to allow a user to set the amount of a dose of drug to be dispensed via the module body, the module body being adapted to engage the actuator to allow a user to apply an axial force via a portion of the module body to release the clutch in the drug delivery device; and an electronics assembly including a processor and one or more magnetic sensors in communication with the processor; wherein, at an initial zero position when no axial force is applied to the portion of the module body, the one or more magnetic sensors and the magnetic component are at a first distance relative to each other, and wherein, at the initial zero position when an axial force is applied to the portion of the module body, the one or more magnetic sensors and the magnetic component are at a second distance relative to each other.

10. The dose detection system according to claim 9, wherein: The magnetic component includes a single dipole magnet.

11. The dose detection system according to claim 9, wherein: The second distance is smaller than the first distance.

12. The dose detection system according to claim 9, wherein: The module body is configured to be coaxially mounted on the actuator and to rotate together with the actuator.

13. The dose detection system according to claim 9, wherein: The module body defines a cavity that houses the electronic device assembly.

14. The dose detection system according to claim 9, wherein: The axis is centrally located along the drug delivery device and the one or more magnetic sensors include a single magnetic sensor, wherein the single magnetic sensor is located on the axis and is axially movable relative to the magnetic component along the axis during dose delivery.

15. The dose detection system according to claim 9, wherein: The actuator further comprises a rotatable dose skirt and a push-dose button positioned proximally of the rotatable dose skirt, wherein when the push-dose button is depressed, a clutch in the drug delivery device is released.

16. The dose detection system according to claim 9, wherein: The actuator further comprises a one-piece dose button, wherein when the rotatable one-piece dose button is depressed, a clutch in the drug delivery device is released.

17. A dose detection system, comprising a module adapted and configured to be removably attached to a proximal portion of a drug delivery device, the system comprising: a magnetic component located at a proximal portion of the drug delivery device, the magnetic component being rotatable during dose setting and dose delivery, The drug delivery device comprises a reservoir of a drug, an actuator at a proximal portion of the drug delivery device, the actuator being rotatable about an axis of the drug delivery device for dose setting and / or dose delivery, the axis being centrally located along the drug delivery device, The module includes a module body configured to be coaxially mounted on the actuator and to rotate with the actuator; the module is configured to be removably attached to the actuator, the module body defining a cavity; as well as An electronics assembly is located within the cavity of the module body, wherein the electronics assembly includes a single magnetic sensor, wherein the single magnetic sensor is located on the axis and is axially movable along the axis relative to the magnetic component during dose delivery.

18. The dose detection system according to claim 17, wherein: The drug delivery device comprises a clutch, wherein the module body is adapted to engage the actuator to allow a user to apply an axial force via a portion of the module body to release the clutch in the drug delivery device.

19. The dose detection system according to claim 18, wherein: The actuator further comprises a rotatable dose skirt and a push-dose button positioned proximally of the rotatable dose skirt, wherein when the push-dose button is depressed, a clutch in the drug delivery device is released.

20. The dose detection system according to claim 18, wherein: The actuator further comprises a one-piece dose button, wherein when the rotatable one-piece dose button is depressed, a clutch in the drug delivery device is released.

21. The dose detection system of claim 17, further comprising a clutch, the module body being adapted to engage the actuator to allow a user to apply an axial force via a portion of the module body to release the clutch, wherein The single magnetic sensor and the magnetic component are located at a first distance relative to each other at an axial position when no axial force is applied to the portion of the module body, and the single magnetic sensor and the magnetic component are located at a second distance relative to each other at an axial position when an axial force is applied to the portion of the module body.

22. The dose detection system according to claim 21, wherein: The actuator further comprises a rotatable dose skirt and a push-type dose button positioned proximally of the rotatable dose skirt, wherein the module body is configured to be coaxially mounted on and co-rotationally engaged with the rotatable dose skirt.

23. The dose detection system according to claim 22, wherein: During dose setting, the module body, the rotatable dose skirt and the push-dose button move together in a helical manner relative to the housing of the drug delivery device in proportion to the amount of the set dose.

24. The dose detection system according to claim 23, wherein: During dose delivery after dose setting, when a user applies an axial force via part of the module body, the push-dose button moves distally relative to the rotatable dose skirt to release the clutch.

25. A dose delivery measurement module for use with a drug delivery device comprising an actuator, a dose setting member, a magnetic ring having one or more dipoles, the magnetic ring being rotationally fixed to the dose setting member which rotates during dose setting and / or dose delivery, the module comprising: a module body adapted to be engageable with the actuator of the drug delivery device; a plurality of magnetic sensing elements attached to the module body, the magnetic sensing elements being equally radially spaced to define a ring pattern; as well as a controller operably attached to the magnetic sensing element, the magnetic sensing element being configured to detect an angular position and / or a rotational movement of the magnetic ring relative to the magnetic sensing element so as to generate a signal representative of the detected angular position and / or rotational movement, wherein the controller is configured to receive the signal so as to determine data indicative of an amount of a delivered dose based on the signal, wherein, when the module body is attached to the actuator, the magnetic sensing element is positioned axially above the magnetic ring, and the magnetic sensing element is arranged in an overlapping position relative to the outer periphery of the magnetic ring, wherein the actuator of the drug delivery device comprises a rotatable dose skirt, and a push-dose button positioned proximally of the rotatable dose skirt, and wherein a portion of the module body is engageable with at least one of the push-dose button and the rotatable dose skirt.

26. The module of claim 25, wherein the magnetic ring of the drug delivery device is a bipolar magnetic ring, wherein: The controller is configured to detect an angular position and / or rotational movement of the bipolar magnetic ring relative to the magnetic sensing element.

27. The module of claim 25, wherein the magnetic ring comprises a plurality of dipoles, wherein: The controller is configured to detect an angular position and / or rotational movement of the magnetic ring having the plurality of dipoles relative to the magnetic sensing element.

28. The module of claim 25, further comprising a circuit board attached to the module body, and the magnetic sensing element is attached to the circuit board and faces the axially facing surface of the magnetic ring, wherein The overlapping position is defined by the portion of the magnetic sensing element extending beyond the outer periphery of the magnetic ring and the remaining portion of the magnetic sensing element remaining within the outer periphery of the magnetic ring.

29. The module according to claim 25, wherein: The drug delivery device further comprises a housing, and wherein, during dose setting, the magnetic sensing element, the rotatable dose skirt and the dose setting member rotate relative to the housing.

30. The module according to claim 29, wherein During dose delivery, the magnetic sensing element and the push dose button do not rotate relative to the housing, and the dose setting member rotates relative to the housing.

31. The module according to claim 25, wherein: During dose delivery, the magnetic sensing element and the actuator are moved axially closer relative to the magnetic ring.

32. The module according to claim 25, wherein: The module body includes a cylindrical sidewall and a top pad that is axially movable relative to the module body.

33. The module of claim 32, wherein axial movement of the top pad is configured to activate the magnetic sensing element.

34. A drug delivery system, comprising: A drug delivery device, the drug delivery device having: a housing; a dose setting member attached to the housing and rotatable relative to the housing during dose setting and / or dose delivery; and a magnetic ring comprising one or more dipoles, the magnetic ring being rotationally fixed to the dose setting member; an electronics assembly comprising a processor and a plurality of magnetic sensing elements operably connected to the processor, the magnetic sensing elements being rotationally fixed with the magnetic ring so as to rotate therewith during dose setting, wherein the magnetic sensing elements are equally radially spaced and equally angularly spaced in a ring pattern, wherein during dose delivery, the magnetic sensing elements move closer to the magnetic ring, wherein the magnetic sensing element is configured to detect an angular position and / or rotational movement of the magnetic ring relative to the magnetic sensing element so as to generate a signal representative of the detected angular position and / or rotational movement, wherein the processor is configured to receive the signal so as to determine data indicative of an amount of a delivered dose based on the signal.

35. The system of claim 34, wherein: The magnetic sensing element is arranged such that a portion of the magnetic sensing element extends beyond an outer periphery of the magnetic ring.

36. The system of claim 34, wherein: The drug delivery device further comprises an actuator attached to the housing, the actuator being configured to set a dose to be delivered by rotation, to initiate dose delivery by axial movement, or both, and wherein the electronics assembly is adapted to be engageable with a portion of the actuator, wherein, when the electronics assembly is attached to a portion of the actuator, rotation of the electronics assembly during dose setting is configured to set a dose with the drug delivery device.

37. The system of claim 36, wherein: When the electronic device assembly is attached to a portion of the actuator, the magnetic sensing element is arranged in the electronic device assembly to face the magnetic ring.

38. The system of claim 37, wherein: The magnetic sensing element is arranged such that a portion of the magnetic sensing element extends beyond the outer periphery of the magnetic ring and a remaining portion of the magnetic sensing element remains within the outer periphery of the magnetic ring.

39. The system of claim 36, wherein: The actuator comprises a rotatable dose skirt or a rotatable one-piece dose button which is rotated during dose setting, and a part of the electronics assembly is engageable with the rotatable dose skirt or the rotatable one-piece dose button.

40. The system of claim 36, wherein: The actuator comprises a dose button, wherein during dose setting the magnetic sensing element and the dose setting member rotate together relative to the housing, and wherein during dose delivery the magnetic sensing element does not rotate relative to the housing, the dose setting member rotates relative to the housing, and the dose button is axially displaced relative to the housing.

41. The system of claim 34, wherein: The magnetic sensing elements are arranged in a plane perpendicular to the rotation axis of the magnetic ring.

42. The drug delivery system of claim 34, wherein: The electronics assembly is adapted to be removably attached to a portion of the drug delivery device.

43. The system of claim 34, wherein: The electronic device assembly includes a wall member and an axially movable wall attached to the wall member, wherein axial movement of the axially movable wall relative to the wall member is configured to activate the magnetic sensing element.

44. The system of claim 34, wherein the dose setting member comprises a dose dial member.

45. The system of claim 34, wherein the dose setting member comprises a flange.

46. ​​A dose delivery measurement module for use with a drug delivery device, the drug delivery device comprising: an actuator configured to at least one of set a dose to be delivered and initiate dose delivery; a dose setting member which rotates during dose setting and / or dose delivery; a magnetic ring, the magnetic ring comprising one or more dipoles; The magnetic ring is rotationally fixed to the dose setting member, the module comprising: a module body adapted to be engageable with the actuator of the drug delivery device; a plurality of magnetic sensing elements attached to the module body, the magnetic sensing elements being arranged to define a ring pattern, the magnetic sensing elements being positioned axially above the magnetic ring when the module body is attached to the actuator; and a controller attached to the module body and responsive to the magnetic sensing element when the module body is attached to the actuator to detect an angular position and / or rotational movement of the magnetic ring of the one or more dipoles relative to the magnetic sensing element during dose delivery, wherein each of the magnetic sensing elements is moved closer to the magnetic ring during dose delivery.

47. A module according to claim 46, wherein When the module body is attached to the actuator, the magnetic sensing element does not rotate relative to the drug delivery device during dose delivery, and the magnetic sensing element is arranged such that a portion of the magnetic sensing element extends beyond the outer periphery of the magnetic ring and a remaining portion of the magnetic sensing element remains within the outer periphery of the magnetic ring, and wherein the magnetic sensing element remains axially positioned above the magnetic ring during dose setting and dose delivery.

48. The module of claim 46, wherein: The actuator comprises (i) a rotatable dose skirt and a push-type dose button, or (ii) a rotatable one-piece dose button, wherein the module body is adapted to be engageable with the rotatable dose skirt and / or the push-type dose button or the rotatable one-piece dose button.

49. The module according to claim 46, wherein The module body includes a cylindrical sidewall and an axially movable top pad, wherein axial movement of the top pad relative to the cylindrical sidewall is configured to activate the magnetic sensing element.

50. The module of claim 46, wherein: The controller is configured to detect an identifier of a type of medication contained in the medication delivery device.

51. A dose delivery measurement module for use with a drug delivery device having an actuator, a dose setting member, a magnetic ring having one or more dipoles, the magnetic ring being rotationally fixed with the dose setting member which rotates during dose setting and / or dose delivery, the module comprising: a module body adapted to be engageable with the actuator of the drug delivery device; a plurality of magnetic sensing elements attached to the module body, the magnetic sensing elements being equally radially spaced to define a ring pattern; as well as a controller operably attached to the magnetic sensing element, the magnetic sensing element being configured to detect an angular position and / or a rotational movement of the magnetic ring relative to the magnetic sensing element so as to generate a signal representative of the detected angular position and / or rotational movement, wherein the controller is configured to receive the signal so as to determine data indicative of an amount of a delivered dose based on the signal, wherein, when the module body is attached to the actuator, the magnetic sensing element is positioned axially above the magnetic ring, and the magnetic sensing element is arranged in an overlapping position relative to the outer periphery of the magnetic ring, Wherein the actuator of the drug delivery device comprises a rotatable one-piece dose button, and wherein a portion of the module body is attachable to the rotatable one-piece dose button.

52. The module of claim 51, further comprising a circuit board attached to the module body, and the magnetic sensing element is attached to the circuit board and faces the magnetic ring.

53. The module of claim 51, wherein the magnetic ring of the drug delivery device is a bipolar magnetic ring, wherein: The controller is configured to detect an angular position and / or rotational movement of the bipolar magnetic ring relative to the magnetic sensing element.

54. The module of claim 51, wherein the magnetic ring comprises a plurality of dipoles, wherein: The controller is configured to detect an angular position and / or rotational movement of the magnetic ring having the plurality of dipoles relative to the magnetic sensing element.

55. The module of claim 51, wherein: The drug delivery device further comprises a housing, and wherein, during dose setting, the magnetic sensing element, the rotatable one-piece dose button and the dose setting member rotate relative to the housing.

56. A module according to claim 55, wherein During dose delivery, the magnetic sensing element and the rotatable one-piece dose button do not rotate relative to the housing, and the dose setting member rotates relative to the housing.

57. The module of claim 51, wherein: During dose delivery, the magnetic sensing element and the actuator are moved axially closer relative to the magnetic ring.

58. The module of claim 51, wherein: The module body includes a cylindrical sidewall and a top pad that is axially movable relative to the module body.

59. A module according to claim 58, wherein Axial movement of the top pad is configured to activate the magnetic sensing element.

60. A drug delivery system, comprising: A drug delivery device, the drug delivery device having: a housing; a dose setting member attached to the housing and rotatable relative to the housing during dose setting and / or dose delivery; and a sensed component comprising a unique angular profile, the sensed component being rotationally fixed with the dose setting member; an electronics assembly comprising a processor and a plurality of rotation sensors operatively connected to the processor, the rotation sensors being rotationally fixed with the sensed component during dose setting so as to rotate therewith about a rotation axis during dose setting, wherein the rotation sensors are equally radially spaced in a circular pattern about the rotation axis, wherein during dose delivery, the rotation sensors are moved closer to the sensed component, wherein the rotation sensor is configured to detect a sensed parameter of the sensed component to generate an output signal, the sensed parameter corresponding to an angular position and / or rotational movement of the sensed component relative to the rotation sensor, wherein the processor is configured to receive the output signal in order to determine data indicative of an amount of a delivered dose based on the signal.

61. The system of claim 60, wherein: The rotation sensor is a capacitive sensor.

62. The system of claim 60, wherein: The rotation sensor is an inductive sensor.

63. The system of claim 60, wherein: The rotation sensor is a magnetic sensor.

64. The system of claim 60, wherein: The rotation sensor is an optical sensor.

65. The system of claim 60, wherein: The sensed component includes one or more metal elements.

66. The system of claim 60, wherein: The sensed component is a metal strip.

67. The system of claim 66, wherein: The metal strip includes a varying width extending about the rotation axis.

68. The system of claim 66, wherein: The metal band is shaped to cover half of the circumference of the dose setting member's skirt.

Images