Dose detection system module for drug delivery device

Abstract

To provide a dose detection system for a drug delivery device which is a module for removable installation to a dose button of the drug delivery device, and a device including the dose detection system.SOLUTION: A module includes: a processor; and multiple magnetic sensors, such as five or six sensors, operably coupled to the processor and configured to detect a position of a rotating dipole magnetic ring in a delivery device. A drug identification system is also provided.SELECTED DRAWING: Figure 5-6

Description

[Technical field]

[0001] The present disclosure relates to an electronic dose detection system for a drug delivery device, and in particular to a drug delivery an electronic dose detection module adapted for removably mounting to a proximal end portion of the device; The dose delivery detection system detects the dose of drug delivered by the drug delivery device and and / or operable to detect the type of drug contained in the drug delivery device. [Background technology]

[0002] Patients suffering from various illnesses often have to inject themselves with drugs. To allow humans to self-administer drugs conveniently and accurately, pen-type A variety of devices, commonly known as syringes or injection pens, have been developed. These pens are fitted with a cartridge that includes a piston and contains multiple doses of liquid medication. The drive member is movable forward to advance a piston within the cartridge. The contained drug is then dispensed from an outlet at the distal cartridge end, typically through a needle. In disposable or pre-filled pens, the pen uses a supply of medication in a cartridge. After the pen has been used, the user discards the entire pen and uses a new replacement pen. With reusable pens, the drug supply in the cartridge is depleted as the pen depletes. After use, the pen is disassembled and the used cartridge is replaced with a new one. The pen can then be reassembled for subsequent use.

[0003] Many pen injectors and other drug delivery devices have a variance in the dose delivered by actuation of the device. A mechanical system in which parts rotate and / or translate relative to one another in a proportional manner. Thus, in the art, drug delivery methods are used to assess the delivered dose. An effort has been made to provide a reliable system for accurately measuring the relative motion of equipment components. Such systems have been used to attach a first component of a drug delivery device to a second component of the device. It may include a sensor that detects relative movement of a sensed component fixed to the member.

[0004] Administration of an appropriate amount of drug requires that the dose delivered by the drug delivery device is accurate. Many pen injectors and other drug delivery devices require that the drug be delivered by the device during an injection event. It does not include functionality for automatically detecting and recording the amount of drug delivered. Without it, patients would have to manually track the amount and time of each injection. and operable to automatically detect a dose delivered by the drug delivery device during an injection event. Further, such a dose detection device is removable and has multiple In other embodiments, such a dose detection device may be reusable with the delivery device. The device needs to be integrated with a delivery device.

[0005] Delivering the right medication is also important. Patients may need different medications, or It may be necessary to choose between different forms of a given drug. Which drug is compatible with the drug delivery device? If the dose is not within the range specified, the patient will not be properly administered and the administration of the dose will be inaccurately recorded. The possibility of this happening is due to the use of a dose detector that automatically checks the type of drug contained in the drug delivery device. This is significantly reduced when an extraction device is used. Summary of the Invention

[0006] In one embodiment, a rotatable sensed element may be utilized as part of a dose detection system. The present invention discloses a drug delivery device including a ring-shaped sensing element such as a metal ring or a magnetic ring. The dose setting component is positioned on a proximal surface of the device body. , rotatable relative to the device body with respect to the amount of dose to be set and / or delivered. The carrier is capable of axially and rotationally fixing the sensed element to the dose setting component. The carrier contacts the annular sensing element opposite the proximal surface of the dose setting component. In some embodiments, the carrier comprises a dose setting support. It may also be comprised of elements that aid in its attachment to the component. In this embodiment, the sensed element is bonded to the dose setting member without adhesive.

[0007] Another disclosed embodiment couples the sensed element to a dose setting component of a drug delivery device. The method includes the steps of providing a carrier and an annular sensed element, The carrier has a tubular body sized to fit within the annular sensed element, and extends radially beyond the tubular body. a proximal lip extending toward the tubular body, and a distal end extending away from the proximal lip. and mounting the annular sensed element on the tubular body of the carrier. and contacting and mating the radial lip and the dose setting structure under the proximal lip. The carrier is then attached to the annular sensed element so as to sandwich the annular sensed element between the carrier and the proximal surface of the component. and coupling the carrier to the dose setting component, the coupling legs of the carrier coupling the carrier to the dose setting component. A sensing element is attached to the dose setting component so as to be rotatably engaged with the dose setting component. It is combined. [Brief description of the drawings]

[0008] The features and advantages of the present disclosure will become more readily apparent to those skilled in the art upon consideration of the following detailed description in conjunction with the accompanying drawings, in which: It will become clearer to those who [Figure 1] FIG. 1 is a perspective view of an exemplary drug delivery device in which the dose detection system of the present disclosure is operable. [Diagram 2] 2 is a cross-sectional perspective view of the exemplary drug delivery device of FIG. 1. [Diagram 3-4] Fig. 3 is a perspective view of a proximal portion of the exemplary drug delivery device of Fig. 1. Fig. 4 is a partially exploded perspective view of the proximal portion of the exemplary drug delivery device of Fig. 1 together with a dose detection system of the present disclosure. [Figure 5-6] 5 and 6 are schematic side cross-sectional views of a module of a dose detection system according to another exemplary embodiment mounted on a proximal portion of a drug delivery device, respectively. [Figure 7-8] Figure 7 is a top schematic view showing a rotation sensor arranged to detect a magnetic sensed element attached to a dose setting member according to an exemplary embodiment. Figure 8 is a perspective view of the dose setting member of Figure 7 including a magnetic sensed element. [Figure 9] FIG. 13 is a perspective view of an alternative embodiment of a magnetic dose detection system. [Figure 10A-10B] 13 illustrates yet another exemplary embodiment of a dose detection system utilizing magnetic sensing. [Figure 11A-11B] 13 illustrates yet another exemplary embodiment of a dose detection system utilizing magnetic sensing. [Figure 12] 13 is a cross-sectional view of a dose detection system according to another embodiment, in which the sensor and the sensed element are integrated into a drug delivery device. [Figure 13-14] Figure 13 is a side cross-sectional schematic view of a dose detection system module according to another exemplary embodiment mounted on a proximal portion of a drug delivery device. Figure 14 is a perspective view of an example of a dose button for a drug delivery device. [Figure 15] FIG. 14 is a perspective view of a module housing subassembly of the dose detection system module of FIG. 13 . [Figure 16-17] Fig. 16 is a proximal perspective view of the components of the subassembly of Fig. 15. Fig. 17 is a distal view of the components of Fig. 15. [Figure 18-19] Figures 18 and 19 are perspective views of another example of a dose button for a drug delivery device. [Figure 20-21] Figure 20 is a perspective view of a subassembly of a module housing of another example of a dose detection system module attached to another example of a dose button for a drug delivery device, and Figure 21 is a perspective view of a subassembly of a module housing of a dose detection system module detached from a dose button. [Figure 22-23] Fig. 22 is a perspective view of the dose button of Fig. 20. Fig. 23 is a cross-sectional view of a subassembly of the module housing of Fig. 20. [Figure 24-25] Figure 24 is a cross-sectional view of a subassembly of a module housing of a dose detection system module mounted on the dose button of Figure 20. Figure 25 is a side cross-sectional schematic view of a dose detection system module according to another exemplary embodiment mounted on a proximal portion of a drug delivery device. [Figure 26] FIG. 13 is a side cross-sectional schematic view of a dose detection system module according to another exemplary embodiment mounted to a proximal portion of a drug delivery device. [Figure 27-28] 27 is a proximal perspective view of an example electronics assembly of a dose detection system module. FIG. 28 is an axial cross-sectional view taken along line 28-28 of FIG. [Figure 29] FIG. 28 is a distal perspective view of the electronics assembly of FIG. 27. [Diagram 30] FIG. 2 is a perspective, partially exploded view of a subassembly of the proximal portion of the drug delivery device. [Figure 31-32]Fig. 31 is a side partial cross-sectional schematic view of the assembled proximal portion of the subassembly of Fig. 30. Fig. 32 is a proximal perspective view of the flange, carrier, and rotational sensor assembled together. [Figure 33-34] Figure 33 is a proximal perspective view of the flange, carrier, rotational sensor, and spring assembled together. Figure 34 is a proximal view of the flange, carrier, and rotational sensor assembled together. [Diagram 35] FIG. 13 is a cross-sectional view of another embodiment of a module of a dose delivery detection system mounted on a proximal portion of a drug delivery device. [Diagram 36] FIG. 36 is a proximal axial view of the module of FIG. 35 shown with the proximal wall assembly removed. [Figure 37-38] Fig. 37 is a proximal perspective view of the unit components of the module of Fig. 35. Fig. 38 is a distal partial perspective view of the module of Fig. 35, shown without the delivery device. [Figure 39] FIG. 36 is a perspective view of a light guide member component provided in the module of FIG. 35. [Figure 40-41] Figure 40 is an axial view of yet another exemplary embodiment of a dose delivery detection system utilizing magnetic sensing. Figure 41 is a cross-sectional view of a proximal portion of a drug delivery device and its relative position to a magnetic sensing system. [Figure 42-43] Figure 42 is a graph comparing the measured rotational flux waveform to a purely sinusoidal model of the flux waveform during rotational position sensing. Figure 43 is a graph comparing the results of dial / dose error contributed from magnetic non-uniformity and harmonic distortion from a sample number of N35 grade magnets made from conventional production means for four, five, and six sensor architectures. [Figure 44-45]Figure 44 is a graph comparing the results of dial / dose error contributed from magnetic non-uniformity and harmonic distortion from a sample number of N35 high grade magnets made from normal customized production of 4, 5, and 6 sensor architectures. Figure 45 is a graph showing different orders of harmonic percentage versus lot-to-lot variation of N35 grade magnets made from normal production means. [Figure 46] 1 shows a block diagram of a controller and its components. [Figure 47] FIG. 36 shows an exploded view of the module of FIG. 35, with its components axially displaced relative to one another. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] 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, in which: Certain language will be used to describe this, however without limiting the scope of the invention. It will be understood that this is not intended to define

[0010] The present disclosure relates to a detection system for a drug delivery device. based on detection of relative rotational movement between a dose setting member of the drug delivery device and an actuator. The relative angle is then measured to determine the dosage delivered by the drug delivery device. The position or movement is correlated with the delivered dose. , to determine the type of drug contained in the drug delivery device. Drug delivery devices have been described in the form of pen-type syringes. However, drug delivery devices are A device that delivers a set dose of medication, such as a pump, bolus syringe, or auto-injector The drug may be delivered by any device used for such a drug delivery device. The type of the ion exchange resin may be any of the types that can be used.

[0011] The devices described herein, such as device 10, may include, for example, a reservoir or cartridge 20. In another embodiment, the system includes the device 10. The term "drug" may include, but is not limited to, one or more devices and drugs. insulin, insulin analogues such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dalaglutide or liraglutide, Glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), G IP analogs, GIP derivatives, oxyntomodulin analogs, oxyntomodulin derivatives , one or more therapeutics, including therapeutic antibodies and any therapeutic agent capable of being delivered by the above-described device. Drugs such as those used in the device are formulated with one or more excipients. The device may be used by a patient, a caregiver or a medical professional to deliver a drug to a human. and operates generally in the manner described above.

[0012] The exemplary drug delivery device 10 is a pen configured to inject a drug into a patient through a needle. 1-4 as a pen-type injector. The pen-type injector 10 has a distal portion 14 and a proximal portion 15. The pen includes a main body 11 having an elongated pen-shaped housing 12 including a distal portion 16. The distal portion 14 is , which is received within a pen cap 18. Referring to FIG. 2, the distal portion 14 is a reservoir or a catheter adapted to hold a medicinal fluid to be dispensed through its distal outlet end. The outlet end of the distal portion 14 includes a removable cover 25. The needle assembly 22 includes a needle 24 surrounded by a needle hole 26. The injection mechanism disposed in the proximal portion 16 includes a piston 26 disposed within the reservoir 20. During a dose dispensing operation, the piston 26 is advanced towards the outlet of the reservoir 20 to dispense the contained The injection mechanism is operable to force an object through the needle end. A screw that is axially movable relative to the housing 12 to advance the tongs 26 is illustratively The drive member 28 is in the form of

[0013] The dose setting member 30 is a housing for setting the dose to be dispensed by the device 10. In the illustrated embodiment, the dose setting member 30 is coupled to the pump 12 during dose setting and During dose dispensing, the actuator 14 moves in a spiral motion (i.e., axially and rotationally synchronized) relative to the housing 12. 1 and 2 show the form of a screw element operable to move when the screw is in the home position. Alternatively, the dose setting member 30 is shown fully screwed into the housing 12 in the zero dose position. The dose setting member 30 is a full dose setting member that corresponds to the maximum dose that can be delivered by the device 10 in a single injection. 1, the distal end of the housing 12 is operable to thread proximally out of the housing 12 until it reaches a fully extended position. It is Noh.

[0014] 2 to 4, the dose setting member 30 moves in a spiral motion relative to the housing 12. The dose setting member 30 is adapted to engage with a correspondingly threaded inner surface of the housing 12 so as to enable The dose dial member 32 includes a cylindrical dose dial member 32 having a helically threaded outer surface that engages the dose die 32. The threaded member 32 has a helical thread that engages with the threaded exterior surface of a sleeve 34 (FIG. 2) of the device 10. The outer surface of the dial member 32 further includes a threaded inner surface to indicate the set dose to the user. , including dose indicator markings, such as numbers, viewable through the dose window 36. 30 is connected to the open proximal end of dial member 32 and fits within opening 41 of dial member 32. axially and rotationally locked to the dial member 32 by a detent 40 received in The dose setting member 30 further includes a tubular flange 38 at its proximal end. The material 32 may further include a collar or skirt 42 positioned around the periphery thereof. The skirt 42 is secured to the dial member 32 by tabs 44 which are received in slots 46. Further embodiments described below are suitable for use with skirtless mountings. An example of the placement is shown.

[0015] Thus, the dose dial member 32, the flange 38, and the skirt 42 all rotate. Since the dose setting member 30 is fixed together radially and axially, The dose dial member 32 controls the setting of the dose and the administration of the drug. The flange 38 is attached to the dose dial member 32 and is directly involved in driving the delivery. , which cooperates with a clutch to selectively couple dial member 32 to dose button 56, as described below. The skirt 42 allows the user to rotate the dial member 32 to set the dose. The exterior of the body 11 is provided with a surface so that the

[0016] The skirt 42 illustratively includes a plurality of surface features 48 formed on an exterior surface of the skirt 42. and an annular ridge 49. The surface features 48 illustratively extend around the outer surface of the skirt 42. The skirt is provided with circumferentially spaced longitudinally extending ribs and grooves that allow a user to grip the skirt. In an alternative embodiment, the skirt 42 may be removed or are integrated with the dial member 32, and the user presses the dose button 56 and and / or the dose dial member 32 can be grasped and rotated. To set a dose, the user presses the integrated dose button 56, which also includes a number of surface features. The radially outer surface can be grasped and rotated.

[0017] The delivery device 10 includes an actuator 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 includes a dose button 56 disposed proximal to the skirt 42 of the dose setting member 30. In an alternative embodiment, the dose setting member 30 may further include, for example, 19, and may include an integral dose button without a skirt, as shown in FIG. The dose button 56 is secured to a mounting collar 58 (FIG. 2). The collar 58 axially and rotatably couples the dose button 56 and the clutch 52 together. To secure the clutch 52 to the stem 54, such as by interference fit or ultrasonic welding, Can be attached to.

[0018] The dose button 56 has a disk-shaped proximal end surface or face 60 and a distally extending and an annular wall portion 62 spaced radially inwardly of the outer periphery thereof with an annular lip 64 therebetween. The proximal surface 60 of the dose button 56 defines a proximal surface 62 for pushing the actuator 50 distally. Acts as a pressure surface to which force can be applied manually, i.e. directly by the user Dose button 56 illustratively includes a recessed portion 66 centrally located on proximal face 60, but may be recessed at any position within proximal face 60. The surface 60 may alternatively be a flat surface. Similarly, the integrated dose button may be a or Alternatively, it may be a flat surface. A biasing member 68, illustratively a spring, biases the distal end of the button 56. 2 and 3. The actuator 50 and the proximal surface 72 of the tubular flange 38 are disposed between the surface 70 and the proximal surface 72 of the tubular flange 38. The dose button 56 biases the dose setting member 30 axially away from one another. It can be pressed by the user to start the action.

[0019] The delivery device 10 is operable in both a dose setting mode and a dose dispensing mode. In a set mode of operation, to set a desired dose to be delivered by the device 10, The dose setting member 30 is dialed (rotated) relative to the housing 12. The dial acts to increase the set dose, while the distal dial decreases the set dose. The dose setting member 30 functions to decrease the minimum increment of the set dose during the dose setting operation. Adjustable in rotational increments (e.g., clicks) that correspond to increases or decreases. For example, 1 Each increment or "click" can be equal to one-half or one unit of drug. The amount is visible to the user via dial index markings shown through a dosing window 36. The actuator 50, including the dose button 56 and the clutch 52, is in the dose setting mode. It moves axially and rotationally together with the dose setting member 30 during dialing at .

[0020] The dose dial member 32, the flange 38, and the skirt 42 are all rotationally fixed to one another. Due to the threaded connection between the dose dial member 32 and the housing 12, During this dose setting operation, the dose button 56 rotates to extend proximally of the drug delivery device 10. Complementary splices of flange 38 and clutch 52 are biased together by biasing member 68. The nozzle is rotationally fixed relative to the skirt 42 by the insulator 74 (FIG. 2). The cart 42 and dose button 56 move relative to the housing 12 from a “start” position to a “finish” position. This rotation relative to the housing is essential for operation of the drug delivery device 10. Therefore, it is proportional to the dose set.

[0021] Once the desired dose is set, the needle 24 is adjusted, for example, to properly penetrate the user's skin. The device 10 is operated in the dose dispense mode by pressing a button 60 on the proximal surface 60 of the dose button 56. The axial force is initiated in response to a distal axial force applied by the user pressing the dose button. This allows the actuator 50 to rotate axially relative to the housing 12. Move distally in the direction of the

[0022] The axial translational movement of the actuator 50 compresses the biasing member 68, causing the dose button 56 to engage. and the tubular flange 38. This relative axial The movement separates the clutch 52 and the complementary splines 74 on the flange 38, thereby The actuator 50, e.g. the dose button 56, is fixed to the dose setting member 30 by a rotational mechanism. Specifically, the dose setting member 30 is released from the actuator 50 in a rotational manner. After the dose setting member 30 is decoupled from the actuator 50 and the housing 12 Operation in dose dispense mode is also controlled by a separate switch or trigger. It may also be initiated by activating a mechanism.

[0023] The actuator 50 is continuously pushed axially without rotating relative to the housing 12. 5. When the dose button 56 is pressed against the dial member 32, the dose button 56 rotates relative to the dial member 32. 2 is screwed back into the housing 12. The quantity markings are visible through a window 36. The dose setting member 30 is screwed distally. Once inserted, the drive member 28 is advanced distally to push the piston 26 through the reservoir 20. The drug enters the blood vessel and is expelled through needle 24 (FIG. 2).

[0024] During a dose dispensing operation, the amount of drug released from the drug delivery device is controlled by the dial member 32. The rotational movement of the dose setting member 30 relative to the actuator 50 as it is screwed back into the housing 12. The injection, which is proportional to the amount of movement, occurs when the female threads of the dial member 32 match the corresponding male threads of the sleeve 34. The process is complete when the distal end is reached (FIG. 2). The device 10 is then The dispenser may then be repositioned to a ready or zero dose position.

[0025] The thus rotationally fixed flange of the dose dial member 32 to the dose button 56 38 and the start and end angular positions of the skirt 42 define the "absolute" angular position during dose delivery. There are several ways to determine whether the relative rotation has exceeded 360°. By way of example, a full rotation can be measured by a sensing system in any number of ways. The amount of time required for the dose setting member 30 to move can also be determined by taking into account the incremental movement of the dose setting member 30 that can be achieved.

[0026] Further details of the design and operation of the exemplary delivery device 10 are provided in Medication Dispensing App. U.S. Patent No. 7 entitled “paratus with Triple Screw Threads for Mechanical Advantage” No. 2,291,132, the entire disclosure of which is incorporated herein by reference. Another example of a delivery device is the "Au tomatic Injection Device With Delay Mechanism Including Dual Functioning Biasing No. 8,734,394, entitled "Member," which is incorporated herein by reference in its entirety. and such an apparatus is adapted to determine whether or not a drug delivery device is being used based on sensing of relative rotation within the drug delivery device. The present invention can be applied to one or more of the various sensor systems described herein to determine the amount of drug delivered from the It is modified using the stem.

[0027] The dose detection system described herein comprises a sensing arrangement attached to a member of the drug delivery device. The term "attached" refers to the fact that they are The position of the components may be adjusted to another structure of the drug delivery device so as to be operable as described herein. For example, the sensing component may be attached to a component or member in any manner. Directly disposed on, received within, integrated into, or otherwise associated with the member. The connection may be attached to a member of a drug delivery device by means of a friction Joints formed by frictional engagement, splines, snap or press fits, sonic welding or adhesives It may include a sequel.

[0028] The term "directly attached" refers to two components or one component application and one The members are physically fastened together without the use of intermediate members other than the mounting components. Used to describe installation. Mounting components are used to facilitate installation. Fasteners, adapters, or other parts of a fastening system that are placed between two components (compression "Direct attachment" can be, for example, a diamond membrane in FIG. Components / devices, such as the way in which the clutch member 32 is coupled to the dose button 56 by the clutch 52 It is distinguished from a connection in which members are linked by one or more intermediate functional members.

[0029] The term "fixed" refers to the fact that the indicated movement may or may not occur. For example, two parts are required to rotate and move together. When the first member is rotated relative to the second member, the first member is "rotationally locked" relative to the second member. A member may be "fixed" to another member not only physically but functionally. For example, When one member is pressed against another member such that the frictional engagement rotates them together However, the two members cannot be secured together without the pressure of the first member.

[0030] A variety of sensor systems are contemplated herein. In general, a sensor system detects The term "sensing component" includes the sensed component. The term "sensing component" refers to any component capable of detecting the relative position of a sensor or a detector. The term "sensor" includes a sensing element together with associated electrical components for operating the sensing element. The "sensing component" refers to the sensing component's position and / or location of the sensed component relative to the sensing component. In the case of a dose delivery detection system, The sensed component rotates relative to the sensing component, thereby changing the angular position of the sensed component. and / or rotational motion. In the case of a dose-type detection system, the detection The component detects the relative angular position of the sensed component. The sensing component comprises one or more sensing elements. A sensor may include a sensor element, and a sensed component may include one or more sensed elements. The system detects the position or movement of the sensed component(s) and An output may be provided that represents the position(s) or movement(s) of a plurality of sensors.

[0031] A sensor system typically involves the position of one or more sensed elements within a sensed area. The sensed element detects a characteristic of the sensed parameter that varies with the sensed parameter. The sensor may extend or otherwise enter the sensed area in a manner that directly or indirectly affects the characteristics of the sensor. The relative position of the sensor and the sensed element affects the characteristics of the sensed parameter. The microcontroller unit (MCU) of the sensor system detects different This allows the rotational position to be determined.

[0032] A suitable sensor system may include a combination of active and passive components. When the sensing component is operating as the active component, both components must be powered or It does not need to be connected to other system elements such as a CU.

[0033] It incorporates any of a variety of sensing technologies that can detect the relative position of two components. Such techniques may be based, for example, on tactile, optical, inductive or electrical measurements. Such techniques may include measurements of sensed parameters associated with fields such as magnetic fields. In one embodiment, the magnetic sensor detects a magnetic field when the magnetic component is moved relative to the sensor. In another embodiment, the object is placed in the magnetic field and a change in the sensed magnetic field is detected. The sensor system measures the characteristics of the magnetic field and / or when moved through the magnetic field. The field variations can be detected by the sensing elements in the sensing area. In such an embodiment, the characteristic of the sensed parameter is varied in relation to the position of the child. ,The sensed parameters are capacitance, conductance, resistance, impedance, voltage, For example, a magnetoresistive sensor may have a characteristic that the resistance of the sensor element is large. As another example, Hall effect sensors detect distortions of an applied magnetic field that result in a change in electrical conductivity. It detects changes in voltage resulting from distortions of the magnetic field.

[0034] In one aspect, the sensor system comprises a sensing element and, therefore, an associated member of a drug delivery device. The sensor system detects the relative position or movement of the sensed component. For example, the sensor system may generate an output representative of a dose setting during dose delivery. The sensor may be operable to generate an output from which the rotation of the member can be determined. An MCU is operatively connected to each sensor to receive drug A dose delivered by operation of the delivery device is configured to be determined from the output.

[0035] The dose delivery detection system involves detecting relative rotational motion between the two members. The degree of rotation, which has a known relationship to the amount of dose administered, determines whether the sensor system is capable of detecting the start of dose injection. The device operates to detect the amount of angular movement from the end of the dose injection to the end of the dose injection. A typical relationship is that an angular displacement of the dose setting member of 18° is equal to one unit dose. The sensor system may be coupled to the dose setting member during dose delivery. Thus, if the angular displacement is 90°, , 5 unit doses would have been delivered.

[0036] One approach to detect angular displacement is to count dose increments as the injection progresses. For example, the sensor system may provide a measure of the rotation angle for each iteration. A repeating pattern of sensed elements can be used so that The pattern is such that each repetition corresponds to the smallest increment of dose that can be set using the drug delivery device. It can be established so that

[0037] An alternative approach is to detect the start and stop positions of the relatively moving members and then calculate those positions. The approach is to determine the delivered dose as the difference between the dose Part of the determination can be to detect the number of full revolutions of the setting member. Various methods for this are sufficient. It is within the skill of the art to "count" the increments to assess the total number of revolutions. It may include.

[0038] The sensor system components are attached, either permanently or removably, to the drug delivery device. In an exemplary embodiment, at least some of the components of the dose detection system may be Either is provided in the form of a module that is removably attached to the drug delivery device. This allows these sensor components to be used in more than one pen-type injector. This has the advantage that

[0039] In some embodiments, the sensing component is attached to the actuator and the sensed configuration The element is attached to the dose setting member. The sensed component may also be attached to the dose setting member or The sensor system may include any of the following components during dose delivery: The relative rotation of the dose setting member is detected and the dose delivered by the drug delivery device is determined therefrom. In an exemplary embodiment, a rotation sensor is attached to the actuator and is rotationally locked. The actuator does not rotate relative to the body of the drug delivery device during dose delivery. In an embodiment, the sensed component is coupled to the actuator and device body during dose delivery. The sensed component is also attached to and rotationally fixed on a dose setting member which rotates about the dose setting member. In an exemplary embodiment, the rotation sensor may include a setting member or any portion thereof. It is not directly attached to a dose setting member that rotates relative to it during delivery.

[0040] Referring to FIG. 5, a module useful in combination with a drug delivery device such as device 10 is shown. A dose delivery detection system 80 is shown in schematic form, including an example of a module 82. The controller 82 includes a rotation sensor 86 and other associated components such as a processor, memory, and battery. The module 82 carries a sensor system, shown generally at 84, including an actuator. It is provided as a separate component that is removably attachable to the eta.

[0041] The dose detection module 82 includes a body 88 that is attached to the dose button 56. 8 illustratively includes a cylindrical side wall 90 and a top wall 91 extending over and sealing the side wall 90. 2. For example, in FIG. 5 , the upper wall 90 may include a top wall 92 that supports the module 82 and the dose button 56. 1. The dose detection module is shown diagrammatically as having inwardly extending tabs 94 that attach to the dose detection module. The module 82 may alternatively be any suitable fastener such as a snap or press fit, threaded interface, etc. The dose button 56 may be attached via any suitable fastening means, however, in one embodiment, the module The rod 82 is removed from the first drug delivery device and then attached to the second drug delivery device. The attachment may be anywhere on the dose button 56, but However, as discussed herein, the dose button 56 may be axially moved relative to the dose setting member 30 at any angle. Alternative mounting elements for module 82 Examples are shown in Figures 15, 23 and 37 below.

[0042] During dose delivery, the dose setting member 30 is free to move relative to the dose button 56 and the module 82. In the exemplary embodiment, the module 82 is rotationally secured to the dose button 56. and does not rotate during dose delivery. This can be done, for example, by using tab 94 in FIG. When the module 82 moves axially relative to the amount button 56, the module body 88 and and engaging opposing splines or other surface features on the dose button 56. In another embodiment, the distal pushing of the module may be provided by: Provide sufficient frictional engagement between the module 82 and the dose button 56 to prevent the module from moving during dose delivery. The module 82 and the dose button 56 together remain rotationally fixed.

[0043] The top wall 92 is spaced from the face 60 of the dose button 56 to allow for easy access to the rotation sensor and other The cavity 96 may include some or all of the components of the cavity. 96 may be open at the bottom or may be enclosed by a bottom wall 98 or the like. The bottom wall 98 can be positioned to directly abut the face 60 of the dose button 56. Specifically, if a bottom wall 98 is present, it may be spaced from the dose button 56 and the module Other contact between the module 82 and the dose button 56 occurs when an axial force is applied to the module 82. The amount of the volume of the volume can be transmitted to the volume button 56. In another embodiment, the module 82 can be It may be rotationally fixed in an integrated dose button configuration as shown in FIG.

[0044] In an alternative embodiment, the dose setting module 82 is instead connected to the dose setting member 30. For example, side wall 90 engages skirt 42 at a location below ridge 49. 1. The casing 100 may include a lower wall portion 100 having an inward projection 102. In this approach, the tab 94 is omitted. 5, the module 82 may be attached to the proximal face 60 of the dose button 56 and the distal face 62 of the annular ridge 49. In this configuration, the surface features of the skirt 42 engage the module. Bottom wall portion 100 may be provided with surface features that rotationally secure screw 82 to skirt 42 . Rotational forces applied to the housing 82 during dose setting thereby cause the lower wall portion 100 and the This is transmitted to the skirt 42 by connection with the cart 42.

[0045] To continue dose delivery, the module 82 is rotationally released from the skirt 42 . The connection between the lower wall portion 100 and the skirt 42 is configured to decouple upon axial movement, thereby preventing scarring during dose delivery. This allows the mount 42 to rotate relative to the module 82.

[0046] Similarly, the module 82 interacts with both the dose button 56 and the skirt 42 during dose setting. This provides an additional interface during rotation of the module in dose setting. Secondly, the module 42 is attached to the skirt 42 when dose delivery is initiated. The connection of the module 82 to the skirt 42 is changed by, for example, the axial movement of the module 82. Released prior to injection, so that the dose setting member 30 is released relative to the module 82 during dose delivery. This allows the device to rotate.

[0047] In a particular embodiment, a rotation sensor 86 is mounted on the side wall 90 to detect the sensed component. The lower wall portion 100 also supports the dose setting member 30 against the module 82 and the and the user's hand may inadvertently exert a drag force on it as it rotates relative to the housing 12. Additionally, the dose button 56 serves to reduce the possibility of the dose setting member 30 being in contact with the dose setting member during dose setting. Since the side wall 90, including the bottom wall portion 100, is rotationally fixed to the The present invention provides a single continuous surface that can be easily grasped and manipulated.

[0048] When the injection process is initiated by pressing the dose detection module 82, the dose button The tongue 56 and the dose setting member 30 are rotationally fixed together. Moving the dose button 56 a short distance, e.g., less than 2 mm, releases the rotational engagement and the dose is Upon delivery, the dose setting member 30 rotates relative to the module 82. Regardless of the use of the dose button 56 or other trigger mechanism, the dose button 56 and the dose setting The dose detection system is activated before the member 30 has moved a sufficient distance to release the rotational lock. do.

[0049] Illustratively, the dose delivery detection system may include a sensor system as described herein. The electronics assembly includes one or more rotation sensors. The electronics assembly is operatively connected to the sensor system to receive an output from the sensor system. The module may be, for example, a process chamber contained within a cavity 96 defined by the module body 88. The device may include conventional components such as a processor, a power supply, a memory, a microcontroller, etc. Alternatively, at least some of the components may be implemented as a computer, smartphone, or other The information may then be provided separately by an external device, such as a wired or wireless connection. operatively connecting an external controller component to the sensor system at appropriate times, such as by A means is provided for detecting the presence of

[0050] The exemplary electronics assembly 120 is a flexible printed circuit board having multiple electronic components. The FPCB includes an electronics assembly that transmits a signal representative of the sensed relative rotation. one or more rotation sensors 86 in operative communication with the processor for receiving signals from the sensors; The electronics assembly includes a sensor system including at least one processing core and It further includes an MCU with internal memory. An example of a schematic of the electronics assembly is shown in FIG. The system includes a battery, illustratively a coin-type battery, for powering the components. The MCU determines whether or not the dose setting member is rotated relative to the actuator based on the detected rotation of the dose setting member. The present invention relates to a method for detecting a dose delivered by the drug delivery device 10 using the method described herein, including detecting a dose delivered by the drug delivery device 10 using the method described herein. In one embodiment, the control logic is operable to perform an action according to the detected The rotation is between the skirt 42 and the dose button 56 of the pen injector.

[0051] The MCU stores the detected dose in a local memory (e.g., internal flash memory or The MCU is operable to store the detected dose in The signal representing the The system communicates with a remote electronic device, such as a user's smartphone, via a long-distance wireless communication protocol. The BL The E control logic and the MCU are integrated on the same circuit. The explanation will be given in more detail below.

[0052] Much of the sensing electronics is contained within cavity 96. However, the rotation sensor The sensing components may be positioned in various locations to sense relative movement, e.g., rotation. The sensor may be located within the cavity 96, within the body 88 but outside the cavity 96, or on the bottom wall. The only requirement is that the rotation sensor must be located at the same time as the dose delivery. The object is to effectively detect rotational movement of the sensed component during the rotation. In some embodiments, the rotation sensor is integrated into the device 10 .

[0053] One or more sensed elements are attached to the dose setting member 30. In one embodiment, the sensed elements The sensing element is attached directly to the skirt 42 of the dose setting member. Alternatively, the sensing element may be a diamond. Any of the dose setting components, including the valve member, flange, and / or skirt. The only requirement is that the sensing element(s) detect the presence of The relative rotational movement is detected by a rotation sensor. In some configurations, the sensed component includes the dose setting member 30 or any part thereof.

[0054] Further exemplary embodiments of a dose delivery detection system 80 are provided in Figures 6-13. The embodiment is shown somewhat diagrammatically since common details have already been provided with respect to FIGS. Generally, each embodiment includes a body 88 having a cylindrical upper wall 90 and a top wall 92. Each embodiment also includes similar components of the dose detection module 82, including a lower wall 100. However, variations of these components, including the absence of bottom wall 100, are within the scope of this disclosure. It will be understood that the present invention is not limited to the above-described embodiment. The article includes an electronics assembly 120 contained within the cavity 96 of the module body 88. The amount button 56, the dose setting member 32 and the device housing 12. 2, the dose detection module 82 is attached to the annular side wall 62 of the dose button 56. Although shown generally as such, alternative mounting configurations and locations may be used. For example, a dose detection module 82 may be attached to the dose button 56, In some embodiments, it may be releasably attached to the skirt 42. The dispense module 82 is attached to the integrated dose button as shown in Figures 22 and 35. It can be done.

[0055] Each embodiment also illustrates the use of a particular type of sensor system. In an embodiment, the dose detection system includes multiple detection devices using the same or different detection technologies. system, which provides redundancy in case one of the detection systems fails. It also requires periodic checks to ensure the primary detection system is functioning properly. Provides the ability to use a second detection system.

[0056] In a particular embodiment, the top wall 92 of the module 82 may include fingers, as shown in FIG. The finger pad 110 is connected to the top wall 92 and Wall 92 is attached to upper wall 90. Finger pads 110 extend radially inward. 1 and includes a ridge 114 that is received within a circumferential groove 116 in the wall component 92. 6 allows for slight axial movement between the finger pad 110 and the wall component 92. A spring (not shown) normally holds the finger pad 110 away from the wall component 92. The finger pad 110 may be rotationally fixed to the wall component 92. The finger pads in the distal direction toward the module body 88 as the firing process begins. Axial movement of the fin 110 can be used to trigger a selected event. One use of the guide pad 110 is to provide a contact with the module body 88 when a dose injection is initiated. The electronics of the drug delivery device during the initial compression and axial movement of the finger pad 110 For example, this initial axial movement may be the actuation of the device, in particular the dose detection system. In one example, a module may be used to "wake up" a component associated with the module. The display 82 includes a display for presenting information to a user. The MCU can be integrated with the sensor 110. The MCU receives and processes the sensed data. For example, dose setting, dose dispensed, injection status, injection completion, date and / or time a display operable to display information on said display such as the time between injections or the time until the next injection. The controller includes a software module and control logic for driving the controller.

[0057] If the finger pad is not present, the system electronics may be powered up in a variety of other ways. For example, the initial axial movement of the module 82 at the start of dose delivery can be The fault may be detected directly, such as by the closure of a contact or the physical engagement of a switch. Various actions, such as removing the pen cap, detecting the movement of the pen using the accelerometer, Alternatively, it is known to activate a drug delivery device based on a dose setting. In, the dose detection system is activated before the start of dose delivery.

[0058] 6-8, the dose detection module 82 operates using a magnetic sensing system 84. Two magnetic sensors 130 are mounted on the opposite lower wall of the skirt 42 of the dose setting member 30. In all embodiments, the inner surface of the lower wall portion 100 is disposed on the inner surface of the lower wall portion 100. Therefore, the number and location of the rotation sensor(s) and sensed element(s) may vary. For example, the embodiment of FIGS. 6-8 may instead be configured with even or uneven distribution around the skirt 42. The magnetic sensor 130 may include any number of magnetic sensors 130 spaced apart, such as at least one of the first and second magnetic sensors 130. 7 and 8) are illustratively shown inside the skirt 42, and are fixed to the skirt 42. The magnetic strips 134 are arranged in a magnetic field. In the exemplary embodiment, the strips are arranged in a five-pair north-south magnetic configuration. 136 and 138, so that each magnetic portion extends over 36°. The magnetic sensors 130 are spaced at 18° intervals (FIG. 7) and the magnetic strips 132 , thus reading the digital position of the skirt 42 in a 2-bit Gray code format. For example, when the sensor detects the passage of the N-S magnetic pair, it indicates that the skirt 42 has rotated 36°. is detected, which corresponds to, for example, an added (or subtracted) dose of 2 units.

[0059] Other magnetic patterns containing different numbers or positions of magnetic elements may also be used. In an alternative embodiment, as shown in FIG. 9, the detected component 133 is a dose setting unit. The flange 38 of the member 30 is attached to or integral with the flange 38 .

[0060] As previously described, the sensing system 84 detects the amount of rotation of the sensing element relative to the magnetic sensor 130. The amount of rotation directly correlates to the dose delivered by the device. The relative rotation can, for example, identify the difference between the start and stop positions of the skirt 42. and "counting" the number of incremental movements of the skirt 42 during drug delivery. by detecting movement of the skirt 42 during dose delivery.

[0061] 10A, 10B, 11A, and 11B, the north pole 154 and the south pole An exemplary magnetic sensor includes an annular ring-shaped dipole magnet 152 having a diameter of 156 as a sensed element. The sensor system 150 is shown. The magnets described herein are diametrically magnetized. The magnet 152 is attached to the flange 38 and is also called a ring. 31-33. As shown, the magnet 152 is attached to the flange 38 with a mounting carrier. Alternatively, the dose dial 32 or other member may be attached to a dose setting member that is rotationally fixed thereto. The magnets 152 may be, for example, rare earth magnets such as neodymium, and other magnets such as those described below. It may be constructed from a variety of materials.

[0062] The sensor system 150 includes sensor electronics (not shown) contained within a module 82. It further includes a measurement sensor 158 that includes one or more sensing elements 160 operably connected thereto. The sensing element 160 of the sensor 158 is mounted on a printed circuit board 162 in FIG. 1, the circuit board 162 is shown attached to the module 82. The module 82 is rotationally secured to the dose button 56. As a result, during dose delivery, the magnet The magnet 152 rotates relative to the sensing element 160. The sensing element 160 detects the relative angular position of the magnet 152. The sensing element 160 is operable to detect the position of the ring 152 when the ring 152 is a metal ring. When used in conjunction with a sensor, the sensor may include an inductive, capacitive, or other non-contact sensor. Thus, the magnetic sensor system 150 detects the full rotation of the flange 38 relative to the dose button 56, and Thus, it operates to detect rotation relative to the housing 12 during dose delivery. , a magnetic sensor system 15 including a sensor 158 having a magnet 152 and a sensing element 160 0 may be arranged in the modules shown in Figures 13, 25, and 35.

[0063] In one embodiment, the magnetic sensor system 150 may be configured to generate a ring pattern as shown. The module 82 includes four detector elements 160 spaced at equal radiuses within the module 82 to define the Alternative numbers and locations of sensing elements may be used. For example, the alternative embodiment shown in FIG. In the embodiment, a single sensing element 160 is used. Additionally, the sensing element 16 in FIG. Although 0 is shown to be centered within module 82, other locations may be used. In another embodiment shown in FIG. 33 and FIG. 40, for example, the same circumferential direction is and five equal-radius spaced sensing elements 906. In the embodiment described above, sensing elements 160 is shown mounted within module 82. Alternatively, components may be The sensing element 160 is rotationally secured to the dose button 56 so as not to rotate relative to the housing 12. The mounting may be attached to any part of the component for which it is provided.

[0064] For purposes of illustration, magnet 152 may be considered as a single annular bipolar magnet attached to flange 38. However, alternative configurations and locations of magnets 152 are contemplated. For example, the magnet may have multiple poles, such as alternating north and south poles. The stone includes a number of pole pairs equal to the number of distinct rotational dose setting positions of the flange 38. 152 may also include several separate magnet members. In addition, the magnet components may be 3. A dose dial member 32 or other suitable member that is rotationally fixed to the flange 38 during dose delivery. It can be attached to any part of the member.

[0065] Alternatively, the sensor system may be an inductive or capacitive sensor system. This type of sensor system can be used in conjunction with the magnetic ring attachment described herein. The sensor system utilizes a sensed element that includes a metal strip attached to a flange. Four, five, or more equiangularly spaced apart along the distal wall of the ball or pen housing. One or more sensing elements, such as six or more independent antennas or armatures These antennas may be spaced apart by 180 degrees or other angles. The tensor pairs are paired to provide a ratiometric measurement of the angular position of the metal rings proportional to the delivered dose. Provide a definition.

[0066] The metal band ring can detect one or more different rotational positions of the metal ring relative to the module. The metal band is shaped so that it can be rotated relative to the antenna. The antenna is operatively connected to the electronics assembly and configured to generate a signal. so that the antenna is in direct contact with the sensor, and therefore the housing of the pen 10, during dose delivery. The metal band serves to detect the position of the metal ring relative to the flange 12. However, alternative configurations of metal bands may be used. Any composition and location is contemplated. For example, a metal band may include multiple different metal elements. In an embodiment, the metal band has a number of elements equal to the number of distinct rotational dose setting positions of the flange. An alternative metal band may be rotatably attached to the flange 38 during dose delivery, such as the dial member 32. The metal band may be attached to any part of the component that is fixed to the inside of the member. Alternatively, it may include a metal element attached to the rotating member externally, or may be attached to the component. Overmolding components with embedded metal particles or with metal strips The MCU may be integrated into such a component by detecting the metal ring with a sensor. The device is operable to determine a position of the

[0067] The MCU samples 160 sensing elements at the maximum sampling rate according to standard quadrature differential signal calculations. The starting position of the magnet 152 is determined by averaging a number of (for example, four) During dose delivery mode, the MCU is configured to detect the number of rotations of the magnet 152. At the end of dose delivery, the MCU The number of sensing elements 160 (e.g. 4) to determine the final position of the magnet 152. The MCU calculates the total rotation angle from the determined starting position, number of rotations, and final position. The MCU is operable to determine the total rotation angle in correlation with the device and drug design. The dosage step is calculated by dividing by a predetermined number (10, 15, 18, 20, 24, etc.) The device is operable to determine the number of units.

[0068] In one aspect, a modular dose detection system is disclosed. The use of a mounted module allows both the actuator and the dose setting member to be attached to the drug device. It is particularly suited for use with drug delivery devices that include a portion that is external to the housing. These external portions may be connected to actuators such as dose buttons as described herein. Direct attachment of sensing components and dose skirts, flanges, or dial members This allows for direct attachment of the sensed component to a dose setting member such as "Dose button" refers to a component of a drug delivery device that includes a portion that is located on the outside of the device housing. More generally, it refers to a substance available for use by the user to deliver a set dose. Similarly, the dose "skirt" is located on the outside of the device housing and includes an exposed surface. The exposure allows the user to grasp and rotate the component to set the dose. More generally, it refers to a component of a drug delivery device having a portion. The dose skirt rotates relative to the dose button during dose delivery. during dose setting so that you can set the dose by rotating any of the dose buttons. The dose skirt may be rotationally fixed to the dose button. The device may not include a dose skirt and the user must use an actuator (e.g. In some embodiments, the dose detection module may be grasped and rotated. With the dose detection module attached to the actuator and / or dose skirt, Rotating the module and thereby rotating the dose setting member of the delivery device causes the dose to be delivered. The dosage can be set.

[0069] A further feature of the present disclosure is to configure the sensing system of the dose detection system 80 as an additional module. can be integrated into drug delivery devices from the start, rather than as a single unit That is what it means.

[0070] The above provides a method for detecting the relative rotation of the dose setting member with respect to the actuator during dose delivery. In certain embodiments of the drug delivery device, , the actuator moves helically relative to the pen body during dose setting. In particular, the present disclosure relates to a dose detection system for such a helical actuator. However, the principles and physical operation of the disclosed dose detection system are It may also be used in combination with an actuator that rotates but does not translate during dose delivery. As will be appreciated by those skilled in the art, the dose detection system detects the dose setting member while the device is injecting the dose. With other configurations of medical delivery devices, provided that the actuator includes an actuator that rotates relative to the It will also be appreciated that this is operational.

[0071] The detection system is also adapted to identify a characteristic of a drug to be administered by the pen injection. The pen injector may be used with a wide variety of medications, and is used with various types of given drugs as mentioned above. For example, insulin is It is available in different forms depending on the intended purpose. Types of insulin include fast acting, These include short-acting, intermediate-acting and long-acting. The group will consider which drugs are involved, e.g. insulin vs. non-insulin drugs, and / or refers to the concentration of a drug. Do not mix drug types as the results may be severe. It is important not to confuse the two.

[0072] It is possible to correlate certain parameters based on the type of drug. For example, insulin When used as a marker, it is possible to determine which type of insulin is involved and which type of insulin is administered. The appropriate dose should be determined based on factors such as how it correlates with the timing of administration. Another aspect is that there are known limitations to accurately monitor and evaluate treatment regimens. In one embodiment, it is necessary to know what type of drug has been administered. A sensor system is provided that can identify the type of drug being administered.

[0073] To determine the type of drug, for example, the drug delivery device may be A module is provided for detecting a unique identification of a type of drug, such as any of the drugs When the module is attached to a drug delivery device, such as a pen-type syringe, the module delivers a dose of the drug. The module then detects the type of medication in the pen and stores it in memory. , as well as previous administration history and other information to evaluate the setting or delivery of the drug. An example of detecting the type of medication is described below in the identification sensor 680 of FIG. Another example is given below.

[0074] The detection of this drug type is achieved by detecting a predetermined angular position of the sensed element relative to the alignment feature. These sensor systems are useful in a variety of sensor systems that are operable to emit The drug type determination may include those previously disclosed herein. It is a further aspect that the device can be easily combined with a sensor system to measure the temperature. The systems may operate independently or in coordination with one another.

[0075] In certain embodiments, the sensor system used to detect dose delivery also includes a drug tag. For example, the same is used to identify the type of the 1B, and associated text, describes a sensing element 160 and and a magnet 152. The magnet 152 is a sensor so that the system can detect the specific angular position of the magnet 152 relative to the sensing element. It has a unique configuration.

[0076] The exemplary sensor system 230 may also be provided as a removable module. Rather, it is useful as an integrated system in a drug delivery device. See Figure 12. 1 shows a drug delivery device 310 which is substantially similar to device 10 of FIGS. The device 310 comprises a device body 11, a dose dial member 32, a flange 38, and a skirt. and a dose setting member 30 having a nozzle 42. These components are arranged to function as previously described. The actuator 50 is configured as follows: During dose setting, the dose button 56 is rotationally fixed to the dose setting member 30. To deliver a dose, this rotational fixation is released and the dose setting member 30 rotates to the position to be delivered. The dose detection system described herein rotates relative to the dose button 56 in proportion to the dose received. Other embodiments of the system may be integrally incorporated into device 310.

[0077] 13-15 show a cylindrical side wall 404 and a cylindrical housing 406 arranged coaxially around the axis AA of the device. A module (402) attachable to a drug delivery device having a dose button 402 including a top wall 406. 4 shows another example of a dose button 402 (referred to herein as module 400). The top wall 406 of the dose button 402 is Used to deliver a dose when the module 400 is not attached to the dose button 402. The top wall 406 includes a top or proximal axial surface 408 that is directly pressed by the user. 404 extends radially outwardly, thereby forming a lip 410. , extending between the upper surface 408 and the distal end, as shown in FIG.

[0078] The module 400 includes a housing 41 generally including a proximal wall 412 and a distal wall 414. The module 400 extends between a proximal wall 412 and a distal wall 414. When attached to the dose button, The distally facing axial surface 413 of the distal wall 414 illustratively coincides with the top surface 414 of the dose button 402. 08. Although the walls of module 400 are shown in a particular configuration, the walls may be The formation of the compartments 418 may be of any desired configuration. In one example, the compartments 418 are In another example, compartment 41 may be configured to resist the ingress of moisture and particulate matter. 8 is constructed to resist dust and debris but not to resist direct ingress of moisture. Industry standards provide guidance on different standards for moisture and dust protection. There are.

[0079] A compartment 418 having components similar to those of module 82 of FIGS. 5-6 is shown in FIG. As such, various desired components for use with the drug delivery device may be included. Such components may include, for example, a measurement sensor or other sensors, one or more batteries, an MC U, a clock timer, a memory, and a communication assembly. may also include various switches for use as described below.

[0080] Any of the modules described herein may include an attachment portion coupled to the module housing 411. Attachment element 419 can be removably attached to any of the dose buttons described herein. The attachment element 419 may include a plurality of distally extending arms 420. As shown generally in FIG. 13, the module 400 is mounted in a housing 411. Attached to the dose button 402 by an arm 420 which is attached to and extends distally therefrom. In an exemplary embodiment, the arms 420 are spaced at equal radii around the dose button 402. The arm 420 is attached to the distal wall 414 at an attachment location 422. Alternatively, the arm 420 may be attached to the module at other locations, such as the side wall 416. 400. The sidewall 416 is disposed radially outward of the arm 420. 416 and extends distally from side wall 416 a distance greater than the distal-most extension of arm 420. and when attached to the device, the arm is secured to prevent tampering or access. The arm 420 may include a distal portion 424 that at least partially or completely covers the arm 420 . The distal portion 424 may include an inwardly extending portion 426 that further surrounds the arm 420. Alternatively, the distal portion 424 may be provided as a slidable member relative to the side wall 416. may be provided.

[0081] The arm 420 travels over the lip 410 of the dose button 402 and radially outwards from the side wall 404. The arm 420 is configured to provide frictional engagement with an outwardly facing surface 421. The first portion 428 extends axially and is configured to extend beyond the lip 410. The arms 420 extend radially inwardly from the first portion 428 and engage the dose button 402. It further includes a support portion 430 that is received against the radially outwardly facing side wall 404. The parts 428, 430 are joined by a round base 429 joined between them, forming a "J " shape, with the first portion 428 forming the staff portion and the base and support forming the hook end. The support portion 430 forms an axial support portion that is received against the underside of the lip 410. 432, which allows the module 400 to However, the underside of lip 410 and the axial support portion 420 provide additional resistance to proximal displacement. The mating surfaces of portion 432 may include a mating surface 436 for ease of removal of module 400 if desired. In one example, each of the arms 420 includes an attachment to a dose button. The lip 410 is radially movable to displace the lip 410 during disengagement therefrom. In one example, both portions 428, 430 bend outward, and in some examples, the first portion Only one of the support portions 428 or 430 flexes outward to move over the lip. The arms 420 may be biased in a radially inward configuration and extend around the periphery of the mounting location 422. In the biased configuration, the arms 420 may be biased or pivoted outwardly. Axial retention on button 402 and torque during dose setting and / or dose dispensing of the sidewall 404, suitable for transmission (with little or no acceptable slippage); Adapted and adapted to apply radial normal forces to several engagement spots along the surface. The size is determined.

[0082] An assembly 434 (molded or fabricated) including an arm 420 attached to a distal wall 414. The components shown are shown in FIG. 15. For manufacturing purposes, The arm 420 and other components are attached to the distal wall 414 (as the radially outwardly facing surface of the wall 414). 414 is then attached to the remainder of the module 400. 16 and 17 show the distal wall 414 and some of its component parts. The distal wall 414 is configured to allow an identification sensor, described below, to view the top surface 408 of the dose button 402. The light guide includes a hole 436 formed therein to allow for light guide 436 to be inserted into the light guide 436. The opening may have various shapes, including a "D" shape, such as: 38 determines when the module 400 is attached to the dose button 402, which will be described later. In one example, the opening 438 is in the distal wall 4 The sensor receiving recessed location 440 may be, for example, a magnetic, inductive, The four measurement sensors, such as inductive or capacitive sensing elements, are spaced radially apart. The depth of the recess 440 is determined to provide structural support for the sensor during manufacture and use. Place the sensor close to the component being sensed while leaving enough material thickness to allow The recess 440 allows for secure fixation of the sensor and Therefore, the sensors maintain their respective positions for more consistent sensing. The sensors are arranged at equal angles to the object (four sensors spaced 90 degrees apart (as shown) and four sensors spaced 72 degrees apart). 5 sensors spaced at 60 degrees, 6 sensors spaced at 60 degrees, etc.) and evenly spaced from the longitudinal axis of the module. The recesses 440 are arranged so as to be radially disposed. The walls defining the recesses 440 are also The sensor is arranged along the passage plane. A mounting hole may be provided to connect the distal wall 414 to a complementary mounting feature on the module housing. For this purpose, mounting axial wings 441 may be provided.

[0083] The number of arms 420 may vary depending on the desired axial retention and / or torque transmission, e.g. The arm 420 may range from 3 to 36. 4. The distal wall 414 is shown attached at location 422 and is secured to the post as shown. The post may be a single post or a pair of posts 442, 444. Sixteen arms 42 Assembly 434 is shown including a periphery of distal wall 414. 3. The mounting post 442, 444 is shown to include four pairs of mounting posts 442, 444 spaced circumferentially therearound. Each pair of mounting posts is a circumferential segment having multiple arms, such as four arms. Each segment 445 is configured to support a mounting post 442, When received in place, the mounting posts 442, 4 44 is a heat stake that forms the arm segment to the distal wall 414 in a fixed manner. It is used to

[0084] The attachment of the arm 420 to the housing allows for the manufacture of the arm from a variety of materials. The materials may be selected to obtain desired characteristics such as strength, resilience, durability, etc. For example, it has been found that beryllium copper has advantageous properties for use as an arm. The separate attachment also allows flexibility in terms of placement of the arm relative to the dose button. For example, the arm may include a distal wall 414, a side wall 416, or a distal portion 424. The modules may be mounted on various walls, including the walls of the module.

[0085] The arm 420 may be adapted to different configurations of the surface 421 of the dose button 402. It is shown that the surface 421 has a smoothness (without ribs or grooves or planar variations). The button surface 421 includes surface features that enhance torque transmission with the arm 420. Other embodiments may use an interaction between the arm and the surrounding wall of the dose button. FIG. 18, for example, shows a cross-section of a tubular member having spaced apart, axially extending ridges 474, which Another portion of the dose button 470 of the device includes side walls 472 that form a series of recesses 476 therebetween. In this embodiment, a portion of the arm 420 may be receivable within the recess 476. The arm 420 may be suitable for other configurations of the protuberances than those shown in FIG. The circumferential width of 476 is sized to accommodate the circumferential width of arm 420. This sizing may allow for a snug fit or may be a little too tight around the wrist. The presence of adjacent ridges may allow some freedom of movement in the circumferential direction. It further ensures that the module does not rotate relative to the dose button during use. The dose button 480 includes a side wall 482 that is provided with a polygonal shape, thereby allowing the module to be 4 shows an alternative design that defines a series of flat surfaces 484 for receiving the arms. Separating the flat surfaces 484 is a round axial joint 485. The use of a cylindrical surface eliminates any issues regarding the orientation of the module relative to the dose button. While the concave and polygonal design avoids additional contact between the arm and the side wall of the dose button, A frictional engagement is provided.

[0086] 20-24 show the present invention when part of a module via mounting element 519. A unitary dose button configured to be removably coupled to any of the dose buttons described herein. 5 shows another example of a modular mounting subassembly called module 500. 519 is coupled to the tubular mounting housing 511 (other parts of the module housing). Although some parts are omitted, aspects of those parts that define the complete module housing are shown in the figure. 13 and 25). Mounting housing 5 with mounting element 519 11 may form part of a module 600 as described below. The motor includes a plurality of distally extending arms 520. As shown generally in FIG. A portion of the module is attached to the housing 511 and extends distally therefrom, particularly distally. The annular housing portion 517 of the housing 511 is in a recessed area defined by the side wall 514. Attached to another embodiment of the dose button 502 by an arm 520 extending distally from the The unit 500 when it is attached to the annular housing may, for example, at least partially house the electronics In an exemplary embodiment, the arm 520 defines a cavity for receiving the dose. The arms 520 are spaced at equal radii around the button 502. 5 and is shown as being coupled to and depending from a distal wall 514 of the

[0087] FIG. 21 shows the movement of the lip 510 of the dose button 502 over the side wall 50 of the dose button 502. 4. The resilient structure 521 of the first embodiment is configured to provide frictional engagement with the radially outwardly facing surface 521 of the second embodiment. 23, the arm 520 is shown having a shaft 520a. The guiding body has a radially inwardly extending and radially outwardly facing side wall 504 that is received against the guiding body's radially inwardly extending and radially outwardly facing side wall 504. The support portion 530 extends radially inward from the inner surface of the arm 520. The protrusion 531 may include a protruding body 531 extending from the lip 532 shown in FIG. An axial support 532 is received against or disposed adjacent to the underside 533 of the support 510. 532, which may be used to position the dose button 502 when installed. The protrusions 531 of the support portion 530 provide additional resistance to proximal displacement of the module. The surface 532 and / or the distally facing end 53 may include a distal end 537. 7 may be angled at any angle to give the protrusion 531 a tapered profile. The protrusion 531 has an axial length extending between the surface 532 and the end 537. The engagement surface 538 may include a radially facing engagement surface 538 having a flat The face may be rounded (as shown), tapered, or V-shaped. As such, the protrusion 531 may have a width that is less than the width of the arm 520. The arms are formed from a plurality of protrusions arranged to fit within adjacent or alternating ridges. It may include the output.

[0088] FIG. 22 illustrates that the side wall 504 of the dose button 502 is formed with a plurality of spaced, axially extending ridges. 5 includes a series of recesses 547 formed therebetween. 02 also includes a proximal wall with a proximal upper surface 508. At least one of the proximal surfaces 508 Some may have colors that correspond to unique types of drugs and / or doses. 502 may be used interchangeably with all other buttons described herein, as other buttons may have similar color schemes. To this end, any of the modules described in this document can be used It can be attached to different kinds of pens and using color detection, the module can detect the identification information The module and / or the external device can communicate with the pen to determine if it is a given The same total amount of rotation due to having a unique rotation profile for the drug and dose In one example, the button 50 may determine a different number of units of drug to be delivered. The entire top surface 508 of the button 2 is a single color. A surface feature or region 507A, such as a center, may have a first color, and the surface feature or region The region 507B adjacent to the certain region may have a second color different from the first color. The drug discrimination detection described herein targets either a first color or a second color depending on the module configuration. In this embodiment, at least one of the support portions 530 of the arm 520 may be The support portion is receivable within the recess 547. In one example, the circumferential width of each of the recesses 547 is 530 , and may be sized to accommodate the circumferential width of engagement surface 538 of portion 530 , or in other embodiments. In some embodiments, the recess 547 may be located at the end of an arm as described herein, for example as shown in FIG. Each support portion may be sized to receive a distal end of the engagement surface of either end. The circumferential width of portion 530 is sized large enough to cover recess 547 and In one embodiment, the proximal extent 549 of the recess 547 engages the adjacent ridge without entering the recess. may extend into the radial lip 510. The depth D1 of the recess 547 shown in FIG. In other examples, the depth of the recess 547 may be constant along the axial extent of the recess. For example, the recess 547 may be sized to be deeper toward the proximal end than toward the distal end. The arm 520 may also vary along the axial range, e.g., as shown in FIG. 4, 18, and 19. Distal wall 514 The protruding axial direction of the axial bearing surface 532 of the arm 520 relative to the distally facing axial surface 513 of the arm 520 The axial distance O may be greater than the axial depth D of the radial lip 502 .

[0089] 24, the length of the extension of the arm 520 is such that the length of the extension of the arm 520 is the length of the distally facing axis of the distal wall 506. The dose button 502 extends beyond a plane defined by the directional surface 505 and perpendicular to the axis AA. A support portion 530 is sized to be disposed along the radially outward surface 521 of the side wall 504. In one example, the length of the extension portion may be such that the distal lower portion of the side wall 504 does not extend beyond any of the arms. only along the proximal upper portion 509 of the sidewall 504 so as to remain unengaged by the The dose button shown in FIG. The axial direction measured between the top surface 508 of the dose button 502 and the distal end 511 of the dose button 502 The distal end 513 of the support portion 530, i.e., the side wall 50 of the arm 520, includes a height H in the direction of the support portion 530. The distal-most portion of support portion 530 that directly engages surface 54 of sidewall 504 at an axial distance HL. 21, thereby adjusting the engagement position of the radial lip 510 and distal end 513 relative to the sidewall. The support portion 530 is disposed between the rim 510 and the surface-engaging portion 538 of the support portion 530. Axial between the underside and the engagement location of distal end 513 located along the upper half of sidewall 504. The axial distance HL can extend from the dose button 502 as shown in FIG. The surface 505 abutting the upper surface 508 of the distal end 513 and the position of such engagement are defined by the surface 505 abutting the upper surface 508 of the distal end 513. In one example, the axial distance HL is measured between the proximal portion of the side wall 504 and the plane of the side wall 504. In order to position the support portion 530 along 509, the maximum axial height H of the dose button 502 is This position may be determined by the attached module that contains the button. The engagement surface 538 of the support portion 530 is more Due to the greater radial force, the radial lip 510 is axially larger than its axial thickness. As shown, the more axially compact configuration The support portion 530 of the arm 520 generates a force on the support portion surface 538 along the rim 510. Reduces the amount of axial movement and friction that causes the user to install and / or The more axially compact configuration of the arm support portion also reduces the separation force. The duration of module installation and / or removal can be shortened, thereby This leaves the user in no doubt as to whether the installation was successful.

[0090] FIG. 21 shows that each of the arms 520 has an attachment to (or a coupling to) a dose button. During the movement of the module in the proximal direction P) and during the removal from the dose button (or during the removal from the dose button 5, the lip 510 is removed during the movement of the module in the distal direction DD relative to the arrow 535. The arm 520 is radially movable in the direction of 535. The arms may be biased in an inward configuration and outwardly biased about where they depend from the distal wall 514. In the biased configuration, the arm 520 may be biased or pivoted when the dose button 5 02 and torque transmission (permitted) during dose setting and / or dose dispensing. along the surface of the sidewall 504, which is suitable for Adapted and sized to apply radial normal force to several engagement spots. In other words, during dose setting, the unit 500 coupled to the button 502 Rotate in a first direction that moves the module / button further away from the device housing .

[0091] Any of the attachment elements described herein, such as elements 419 and 519, may be used to attach the The attachment force applied by the user in the distal direction DD is less than the detachment force applied by the user in the proximal direction P. The detachment force may be in the range of 4N to 30N. The release force is at least 1.5 times the attachment force to prevent inadvertent removal of the module. In one example, the force is configured to be at least twice as large as the attachment force so that the The separation force is greater than 20 N and the attachment force is less than 11 N. In another example, the module When attached to the dose button, torque from setting the dose can cause small deformations of the support along the dose button. Small amounts of slippage can cause excessive torque and potential damage to components of the dose setting device. may be permitted to avoid.

[0092] The arm 520 and the housing 511 are made of acetal thermoplastic (e.g., Delrin (registered trademark) or polycarbonate materials (e.g., Makrolon (registered trademark)). It may be formed as an integral unit, such as by molding a plastic material. A molded unit 561 is shown in Figure 23. Plastic materials provide strength, elasticity and durability. Alternatively, the arm 520 may be attached to the housing 510 in order to obtain desired characteristics such as Alternatively, the arm 52 may be fabricated separately from the arm 52 and later attached by adhesive or welding. The number of zeros may vary. In the example shown, four equally spaced circumferentially positioned In some instances, three arms may be provided, and in other instances, five arms. , six, seven or eight arms may be provided.

[0093] The arms, such as arm 420 or 520, described herein may be modular to a dose button. The module provides convenient and effective attachment of the drug to multiple drug delivery devices. The purpose of the module is to prevent the module from being attached to the dose button. This allows quick installation and removal of modules. The present invention relates to a method for removing a detachable member comprising the steps of: The arms described herein are also derived from repeating arms on a drug delivery device. The mounting must be durable enough to be attached to the bearing and must be provided with a radial compressive force along the outside. The button is fitted with a suitable retaining element without the use of a separate retaining element such as a coil spring or ring. It is configured to have a resilience that provides fixation and retention.

[0094] For example, by using one of the attachment elements 419 or 519. When installed in the drug delivery device, the module frictionally engages the dose button. The module can be used to set the dose bottle when necessary, such as during dose setting for some drug delivery devices. The surface engagement of the support portion of the arm described herein allows the tongue to rotate. The frictional engagement can be controlled via various parameters. The applied radial force depends on the force applied and the coefficient of friction applicable to the contact surfaces. , among other things, the size and shape of the arms, the elasticity and resilience of the arms, and other The disclosed mounting elements allow the module to be attached to the dose button for rotation. These parameters and other factors must be considered to provide the desired balance for friction locking at Allows you to select from parameters and easy attachment of the module to the dose button This allows for attachment and detachment.

[0095] The following description refers to module 600, but may be modified in any way to suit any of the modules described herein. Each module may also include one or more switches to facilitate ease of use. As mentioned, the module is removably attached to the drug delivery device. The module can be removed from one drug delivery device and then combined with another drug delivery device as needed. Those skilled in the art will appreciate that the various attachment elements described herein are useful in conjunction with It will be understood that the present invention can be used for such coupling to the The module 600 includes a proximal wall assembly 602, a side wall 604, and a distal wall 606. The walls 602, 604, 606 of the module 600 thereby The wall 602 defines an interior compartment 608 configured to house a LED 610. A transparent or translucent material around the top edge to provide a light guide when the It can include.

[0096] Mounting element 607 is illustratively shown as mounting element 419 in FIG. Module 600 may also be provided with any other mounting unit described herein. In such a configuration, the tubular mounting housing 511 The proximal end opening of the is friction-fitted or otherwise secured to the periphery of the distal wall 606. 609. In this configuration, posts 442, 444 and and the block protrusion disposed between posts 442, 444 is omitted, thereby A smooth outer surface 606A of the distal wall 606 that is sized and shaped to receive the socket 500. Except for providing the openings 438, 436, the distal wall 606 has the same structure as the distal wall 414 (e.g., 16 and 17 as examples of the characteristic portions 440, 441, etc. It is being done.

[0097] 25, 26, 27, and 29 are schematic diagrams of a module according to any of the embodiments described herein. An example of an electronics assembly 610 that can be used is shown. The assembly 610 includes a first remote a distal segment 612, a second proximal segment 614, and a third intermediate segment therebetween. 616, each connected to power by connections and leads generally designated 618A-B. Segments 612, 614, 616 are coaxially connected to one another in an "S" pattern. The battery 621 may be disposed and coupled to the first segment 612 and the third segment. The second connector 616 is shown axially disposed between the first connector 616 and captured by the resilient arms. The second segment 614 is for receiving a measurement sensor, such as the sensing element 160. The module may include a sensor pocket 623 defined therein. The pocket 623 may include a The pocket 440 is aligned and inserted into the recessed portion 440 in the distal wall of the housing. Instead of the pocket 623, the measurement sensor is directly coupled to the second segment circuit without a pocket. This may be done.

[0098] In FIG. 27, a first segment 612 includes a proximally facing surface 615 having a Included in the figure is an example of a switch 622 in a wake-up switch system 620. The modules are equipped with indicators such as LEDs that show the operator status of the device and / or modules. In one example, the indicator element 624 may include a first segment The wake-up switch 622 is operably attached to the surface 615 of the monitor 612. Used to turn on associated electronics such as those associated with dose delivery For example, the wake-up switch 622 may be generated by the rotation of the sensed element. 2. Turning on a measurement sensor, such as sensing element 160, that is involved in measuring the dose delivery to be LEDs or other indicators such as audible speakers and / or vibration generators. The data elements may be used to inform the user of the progression of the system through completion of dose delivery, or The user may be notified during the duration of dose delivery, such as a battery charge indication. The ED is attached to the side of the switch 622. The wake-up switch system It may be configured to increase power to the device from a low power state to a fully operational state.

[0099] Any of the modules described herein may include a wake-up switch system 620. The provision of such a wake-up switch by the module is optional. In one example, the module 600 shown in FIGS. 25-26 may include a proximal wall An axially movable segment disposed within a recess defined in an upper surface of the assembly 602. 626. The wake-up switch system 620 includes a wake-up segment 626 can be moved distally into the module 600 and biased as shown. The wake-up segment 626 may be, for example, a segment that is normally located in the proximal position. Alternatively, the proximal end may be biased by a spring (not shown) or the like. The material of the wake-up segment may be a material that is biased toward the segment 62. 6. The present invention may allow for some deflection of the center 627 of the segment 626 relative to the circumferential edge 629 of the segment 626. Segment 626 is a wall that defines a recess in proximal portion 602 of the module housing. The segment 626 may be a rigid member slidably disposed along the a fixed segment (not shown) movably coupled to the module housing, such that When segment 626 is in its biased proximal position, the segment exits the module. The wall 630 of the proximal wall assembly 602 is biased against the A physical stop or its most distal portion for distal movement of segment 626 from a designated proximal position. a shape defining a proximally facing axial surface 631 configured to define a position The wall 630 may have a through hole 63 extending axially along the axis AA through the proximal wall 602. Define two smaller sized portions.

[0100] When a user actuates the wake-up segment 626 in a distal direction, the axial force is Overcoming the biasing force of a spring (not shown) and directly or indirectly actuating the switch system 620 It is sufficient to allow distal movement of segment 626 until actuation. This axial force actuating the pump causes actuation of the delivery device for dose delivery. In one example, segment 626 engages axial surface 631. While the wall 630 defining the through hole 632 may be moved distally to 26 to continue axially deflecting in a distal direction beyond axial surface 630. 620. The switches shown include mechanical switches or rubber dome switches. However, other switches, such as electrical contacts, are contemplated. The switches described herein may be configured in different ways. It can be mechanically actuated or triggered by engagement with an element.

[0101] In one example, switch system 620 switches segments 62 when pressed by a user. 6 to limit the distal deflection of the wake-up switch 620 to prevent damage to the wake-up switch 620. The shroud 635 may further include a flexible shroud 635 configured as follows: The switch 622 may be disposed axially between the segment 626 and the switch 622. The force in the direction is transmitted to the shroud 635 through the segment 626, and the shroud 63 A central portion 638 of the shroud 5 is deflected axially to engage the trigger of the switch 622. The guide 635 may be configured to have a maximum distal range of deflection. The switch does not allow the trigger to be engaged, but does not allow the switch to be moved to a position that could damage it. The shroud may be sized to fit various Includes various sizes and shapes.

[0102] FIG. 28 shows an example of a shroud 635 having a hub 636 surrounding a central portion 638 of the shroud. A plurality of radial legs 64 extending from a center point of 42 and disposed circumferentially relative to one another. 0. The center point of the hub is coaxial with the axis AA. The hub 642 and the central portion 63 8 may have any shape, and may be rectangular, oval, or circular as shown. The central portion 642 may be radially outwardly of the recessed region and distally relative to the surrounding hub region. The end of the first set of legs 640A may include a recessed area that extends the hub toward the end of the first set of legs 640A. End 643 may be sized and shaped to receive the size and shape of tip 643, for example. 4. The anchor portion 644 may have a distal surface having a slotted region of The anchor portion 644 may be coupled distally from the axially movable segment 626. 643. The anchor portion 644 extends from the distal end 642 to the distal end 643. 644 is configured to move together with segment 626 within through hole 632 when a user applies axial force. The anchor portion 644 is integrally formed with the segment 626, such as by molding. Alternatively, portion 644 may be formed separately and attached to the distal surface of segment 626. The tips 646 of the second set of legs 640B may be fixedly secured. or may remain unengaged with segment 626. The arms are spaced apart at equal angular positions to distribute axial force and deflection to each of the legs 640. In one example, the first set of legs 640A may contact the car portion 644. The first set of legs 640A has a shorter radial length than the second set of legs 640B. may extend directly radially between adjacent legs of the second set 640B. All of the legs 40 may provide flexibility to the shroud 635, but the free leg 640B may provide flexibility to the shroud 635. The force can be reduced by the segment 62 while the tine 636 can be prevented from having a maximum distal deflection. 6 to the tip 643 via the anchor portion 644, and penetrates the tip 643. 6. In the example shown, there are eight total legs 640, each with a The short fixed legs are spaced 90 degrees apart. the long legs are disposed 90 degrees apart and radially offset relative to the short fixed legs. Other numbers of legs and their relative positions may be used. The assembly 610 may, for example, be configured to align any distal end of the module and / or the dose button. Without any movement, the user may move the switch 622 to the point where it touches the axial trigger. The axial movement of the segments 626 and the shroud 635 caused by Alternatively, the wake-up switch may be 6 is biased away from contact with a corresponding contact pad mounted on the segment, One or more leaf springs movable from the transmission of force via 26 to contact the contact pads In some examples, powering on the electronics assembly may include contact elements. It occurs due to the simultaneous contact of each element.

[0103] Any of the modules described herein may include a presence switch system 650. The provision of such presence switches and modules is optional. According to Figs. 25, 26 and 27, the module 600 may be A method for detecting when the drug delivery device is attached to or detached from the drug delivery device. The system 650 includes a presence switch system 650 mounted to the distal wall 606 at a The presence switch 652 of the second segment 614 of the electronic device assembly 610 The switch 652 is operably connected to the proximal surface 617. The switch 652 is defined by the distal wall 606. 16.) to at least partially overlap opening 657 (see opening 438 in FIG. 16) that is to be The distal wall 606 includes a pivot switch arm 654 positioned in the distal direction as shown in, for example, FIG. The same levels of features such as openings 438, 436 and features 440, 441 shown in FIG. The switch 652 may include a layout (or a layout substantially the same). The arm 654 can be positioned in a biased position (shown in FIG. 27) and a distal position (shown in dashed lines). As shown in Figures 25-26, the switch system indicates the absence of a drug device. From the biased distal position of the skirt (as shown in FIG. 26), the module 600 is 25) indicating that the catheter is attached to the catheter.

[0104] The presence switch system 650 includes a switch actuator mounted on the distal wall 606. The actuator 660 includes a first member 662 that is nested within a second member 664. The second member 664 includes a cylindrical member for receiving the first member 662. The second member 664 has a cup configuration that defines a cavity. The second member 664 has an outer radial lip 666 formed along its proximal end. 63 and housed within the module to enhance the inhibition of ingress of particulates and / or water. Although a radial lip 663 is shown in FIG. 25 disposed away from the distal wall, ,When the module is mounted on the device, the radial lip, as shown in FIG. 663 may remain engaged with the distal wall. The second member 664 may be elastomeric for flexibility. The second member 664 may be made of a plastic or soft plastic material. When the device is attached to the device, the device is directly engaged with the proximal The first member 662 is movable into a cavity defined by a second member 664. The first member 662 is shaped and sized to fit within the proximal axial The distal end includes a cylindrical body 666 extending axially between the distal end and a distal axial end. 4. The actuator spring 672 is configured to receive a distal end of the actuator segment 670. As shown, an outer radial rim 668 is shown extending from an intermediate segment of the first member body 666. The actuator spring 672 is secured at its proximal end to the interior structure of the module housing. The actuator spring is secured to the component, the distal end of the actuator spring bearing against the rim 668, Rim 668 is movable with distal support 668. Rim 668 has a distal support depending from a distal surface of rim 668. In one example, the distal skirt 674 extends radially outward from the rim. The rim 668 is diametrically disposed instead of being a continuous circumferential element. The radial element may be provided with a radial groove.

[0105] Under the bias of the actuator spring 672, the first member 662 rotates within the second member 664. 6, the rim 668 of the first member 662 contacts the switch arm 654. and is biased to a distal position when the module is removed from the device. The switch system 650 in its distal position is configured to place the system in the distal position. Electronically indicates that the module is not installed in the device and performs minimal functions. A power limit can be programmed into the processor to limit the power consumption. 606 against the inner surface of lip 663 of the second member to provide radial pressure, particularly When the module is coupled to the device, the first member 6 The outer end of the second member 664 with 62 is in a nested position and contacts the dose button of the device. However, a force is transmitted through the body of the first member to the rim, overcoming the force of the spring 672 and to move the first and second members proximally within the module housing, and This allows the switch system to return to the proximal position. The system 650 electronically indicates that the module is installed in the device and all functions are The processor can be programmed with full power to perform the function.

[0106] The actuator 660 is biased distally by a spring 672, which biases the actuator 660 in the distal direction. When 600 is not attached to a drug delivery device, it typically extends distally from opening 657. As shown somewhat diagrammatically in FIG. 25, a module 600 may be used to When one of the buttons, typically 601, is attached to the top surface of the dose button 601 The force pushes the actuator 660 in a proximal direction, which in turn moves the switch arm proximally. The MCU of the electronic assembly 610 then triggers the presence switch 652. As a confirmation that the device 500 is attached to the drug delivery device, the switch arm 654 In response, the MCU automatically configures the electronics to prepare the drug delivery device for use. Wake up or provide power to associated components of the assembly 610 When module 600 is subsequently removed, spring 672 biases actuator 660 distally. 6, the switch arm 654 returns to its distal position, and the module 600 Then, the MCU detects that the module is not attached to the drug delivery device. The drug delivery device may be shut down, for example by turning off the device or setting it to sleep mode. Return to non-use state. An example of an electronic assembly 610 is shown diagrammatically in FIG.

[0107] By way of illustration, any of the modules described herein, such as module 600, may also be A security device to identify the type of drug delivery device or the type of drug contained in the drug delivery device. 29, the identification sensor 680 may also include an identification sensor 680. 10 is operably connected to a distal surface 617 of a third segment 616 of the second segment. The port 614 includes a window opening 682 defined therein. The identification sensor 680 is 682 and hole 684 in distal wall 606 (the hole configuration and layout of hole 436 in FIGS. 16-17 6A) and allows the exposed surface of the dose button 601 to be seen. Recess 6 may be formed along a distal surface of distal wall 606 that overlaps hole 684. 86 can receive an internally bonded lens or shield to keep out debris. The dose button 601 may have indicia visible to the type sensor 680 through a hole 684. Indicia may be provided to identify the drug delivery device, such as the type of device or the drug contained in the device. The identification sensor 680 reads the indicia, and the MCU The indicia are recognized as indicating delivery device information. The light guide member 685 is placed in the hole 684. The optical path for the identification sensor can be provided by snap-fitting or adhesive. The light guide member 685 is secured to the distal wall 606, such as by ultrasonic welding. This prevents optical and sensor distortion caused by relative motion or vibration of the guide members. It can be made from transparent or translucent materials, for example polycarbonate. The light guide member 685 is arranged to extend axially between the top surface of the button 601 and the opening 682. Recess 686 is also shown to receive the enlarged base portion of light-guiding member 685. The device may be configured to:

[0108] As an example, the identification sensor 680 may be an RGB color sensor for detecting the color reflected from a dose button. The indicia may include a source(s) and a sensor, and the indicia may include different colors, each color representing a drug. The RGB light source is axially guided to the button, which is associated with specific information about the object delivery device. , a shielding element may be provided to inhibit premature reading of the light forming sensor. Alternatively, the indicia may be a grayscale, pattern, or other optically discernible material. In addition, multiple types of drugs may be used to enhance detection of information related to the drug delivery device. In one embodiment, the identification sensor 680 is connected to the dose button 60. The indicia are positioned to detect the near center or center of the proximal superior surface of the 1. Patters positioned symmetrically around the center of the dose button 601, such as concentric color rings When the type sensor 680 is so positioned, it acts as a presence switch. 652 is positioned off-center of the module 600 .

[0109] In use, the identification sensor 680 is activated by the module 600 mounted on the drug delivery device. In one example, the presence switch 652 indicates whether the unit 500 is attached to a drug delivery device. Each time a drug delivery device is detected, the identification sensor 680 is activated. The detected information may then be stored and / or transmitted. may be moved to a low power mode until reactivated during dose delivery, such as after a predetermined period of time. good.

[0110] As shown diagrammatically in FIG. 27, light indicator elements 624 (shown as LEDs); or other signaling devices may be used to indicate various states of the module 600, as well as the drug delivery device itself. For example, the light signal may notify the user of other components, including the drug delivery device or drug delivery system. It may be used to indicate the type of drug contained by the device. Another signal may be provided to confirm proper placement of the module. , the transition of module 600 between various states, such as a wake-up state or a sleep state. The indicator element may indicate an attachment between the module and the dose button of the device. to indicate successful installation (e.g. green) in one form or unsuccessful installation (e.g. yellow) in another form. It may be operable in the

[0111] The assembly of the modules can be configured for mass production. 25 and 27, any of the modules described herein may be may also be applied in a sequential order other than that described below. The positioning wall 606 is provided in the orientation and arrangement shown in FIG. The switch actuator 660 is inserted through the opening 657 and engages the rim of the first element. 668 is an axial slot formed by an upstanding wall surrounding the edge of the opening and extending therefrom. The actuator spring is sized to fit within the actuator (as shown in Figure 16). 672 is disposed on the top of the actuator as shown in FIG. 14, the interior of the distal wall component is formed with various features and Axial spacer components 675 (shown in FIG. 25) are aligned around the opening. A spacer 675 is disposed on the second segment 614 and on the upper portion of the distal wall. , which includes alignment features for positioning the segments at a predetermined relative distance. To position the third segment 616 proximal to the top of the spacer 675, the segments are The battery 621 is folded over along the connecting portion 618A of the third segment 616. and configured to operatively provide power to all of the segments. Then, in order to place the first segment 612 proximal to the top of the battery 621, The bearing portion 612 is then folded over along the connecting portion 618B. The unit 500 may be slid over the distal wall 606 with the arm 520 or as described above. Attach the attachment element to the arm of the attachment element 419 as shown in FIG. The proximal wall portion component 602 is located on a first segment 612. 16. The mounting axial wings 606 are secured to the distal wall 606, including the mounting axial wings shown in FIG. The proximal wall portion 602 includes an attachment feature for attachment to form a pre-assembly. The shafts are assembled together as described herein prior to attachment to the side wall 604. The tubular structure may include a segment 626 that is movable in the direction and a shroud 635. The sidewall component 604 formed thereon radially surrounds and slides around the pre-assembly and its proximal end. The distal skirt portion 677 is movably disposed and fixedly secured to the proximal wall portion 606. 604, and is secured to the distal end of side wall 604, thereby forming a fully assembled module. Form a loop.

[0112] Referring to FIG. 35, another embodiment of a module, referred to herein as module 800. The module 8 includes a proximal wall 802, a side wall 804, and a distal wall 806. Walls 802, 804, 806 of the housing 800 are configured to house an electronics assembly 810. The proximal wall 802 has a disk shape and defines an inner compartment 808 for device manipulation. The module may form a finger pad that the user presses on the module, as shown in FIG. Around the top edge to provide radial light guidance when light sources such as LEDs are used The light source may include a ring 812 of transparent or translucent material. The light guide ring 8 may be located on a proximal surface of the circuit board 809 of the assembly 810. 12. The phosphor is positioned to emit light through an opening 813 defined by the phosphor The opposing surfaces of the groove 812 and the proximal wall 802 are aligned with the proximal wall assembly of the module housing. The positive attachment may be secured to one another to define an assembly. The secure attachment may be by adhesion, glue, ultrasonic welding, etc. In another example, the secure attachment may be by The proximal wall assembly may be a double-sided adhesive tape 860. The proximal wall assembly may be discharged through an opening 813. 8. Covering the opening 813 for improved radial light transmission within the optical ring 812. The distal surface of the proximal wall may include a white or reflective surface disposed such that In one example, the distal surface 862 of the tape 860 may be white or or a reflective surface, and in other examples, disk elements with white or reflective surfaces are used. The proximal wall assembly described herein refers only to the proximal wall without the light ring. Ring 812 may be a mounting element for attachment to another modular component. For example, ring 812 may include a plurality of retention devices depending from a distal surface of ring 812. The arm 812A may include a snap arm 812A that is adapted to pivot the proximal wall relative to the housing. 8. The ring 812 may be configured to allow directional movement and prevent removal of the ring 812 in a particular position. The button gasket 811 having a ring shape includes a tip configured to be fixed to the ring. 812A and is disposed radially outwardly relative to arm 812A. FIG. 47 shows a module 800 separated into individual components along a common axis. 1 shows an exploded view of one embodiment of a module such as

[0113] The module has a ring shape and is attached to a circumference defined by snap arms 812A. The spacer includes a first spacer element 815 defining an inner radial surface 817 disposed along the For wake-up capability, surface 817 may be positioned at a proximal location of the proximal wall assembly. to a distal position. The distal surface of the spacer element 815 along the directional surface 817 is adapted to allow the proximal wall assembly to receive the biasing force. Provides an area for snap arm 812A to engage for retention when lowered back to proximal position In some embodiments, the light ring is omitted and the proximal wall engages surface 817. The spacer elements 815 include snap arms for snapping the spacer elements radially outward. The flange 819A may include a proximal flange 819A disposed along the length of the flange 819A. The upper end can provide a physical stop to limit distal movement of the proximal wall 802. The spacer elements 815 are disposed radially outwardly of the spacer elements and extend along the proximal flaps. The flange 819A may include a distal flange 819B that is concave radially inwardly relative to the flange 819A. The recess is formed by recessing the side wall 819B when the upper end of the side wall engages the radially outer surface of the distal flange 819B. The device may be sized to accommodate a thickness of 04.

[0114] The button gasket 811 is made up of a proximal wall 802 and a ring 812, and a spacer element 815. In one example, a button gasket is disposed axially between the housing portion and the housing portion. 811 is engaged between the ring 812, or if there is no ring, the proximal wall and element 815. The gasket 811 is axially compressible from its natural state. Gasket materials, such as Retan foam, may be configured to provide compressibility. The material of the skirting board 811 may also provide a seal against liquid spills, but allow ventilation. In embodiments, the gasket material may provide a seal against liquid and air escape. In this embodiment, gasket 811 is provided to maintain the proximal wall assembly in its extended proximal position. To achieve this, biasing force and support can be provided along the periphery of the proximal wall assembly. When the user presses down on the proximal wall to use the device, the button gasket 811 is in a fixed position. As the ring / proximal wall unit moves distally relative to the spacer element 815 in its position, The gasket 811 may be stretched to compress the proximal wall assembly axially. Helps return the device to its original position and provides the user with consistent haptic feedback throughout the movement Instead of a compressible gasket, a lining or other sealing means may be provided. A spring sheath may also be used.

[0115] The module is configured to have a first spacer element 815 between the element 815 and the distal wall 806. The second spacer element 821 may be disposed distally from the first spacer element 821. The second spacer elements 821 have a ring shape. The second spacer elements 821 may each be bondable, for example. The first spacer element 815 may have an axially extending feature that enables A battery 861 is shown disposed between elements 815 and 821. A battery support element 864 (not shown) may be coupled to a proximal surface of the second spatial element. and one of the circuit boards of the electronics assembly, in frictional contact with the battery, The battery may be prevented from moving within the module. In one example, the battery support element 864 may be a free-standing Element 864 may include a ring of axially compressible material such as cellular foam. The sidewalls 804 may have a cross-sectional area smaller than the cross-sectional area of ​​the battery. A first spacer element 815 is disposed radially outwardly of the side wall 804 and is connected to a distal end of the side wall 804. The base ring 82 is shown extending axially between the base ring 82 and the base ring 823. 3 is optional. Side walls 804 secure the base plate 802 in a manner that secures the components together. 823. A plurality of distally extending recesses engage correspondingly shaped recesses formed along the inner surface of the recess 823. The snap arm 804A may include an extending retaining snap arm 804A. Disposed radially inwardly from the general outer periphery of the sidewall 804 is a top end of a base ring 823 The seating surface 80 may define a recess sized to receive the overall thickness of the seating surface 80. 4B is formed along the inner surface of the sidewall 804 and extends further radially inward of the surface. The seating surface 804B is configured to receive the distal gasket 825.

[0116] The distal gasket 825 has a ring shape and is disposed between the inner surface of the side wall 804 and the outer periphery of the distal wall 802. and a seat defined by a radial flange 827 extending from the distal wall 802. The gas is radially disposed between surface 804B and seating surface 827A. The gasket 825 is sealably engaged between the side wall 804 and the distal wall 802. 825 may be made from a gasket material such as, for example, porous urethane foam. It may be configured to provide compressibility.

[0117] Module 800 is shown without a presence switch, but may be implemented, for example, as in the systems described above. A presence switch system such as system 650 may be constructed in modules as will be understood by those skilled in the art. You can put it in.

[0118] 8, a module 800 is shown that includes another embodiment of a wake-up switch system. This is referred to herein as the wake-up switch system 820. A switch system 820 is shown as an example, but the module 800 does not include a wake-up switch. The present invention is not limited to the above, since a switch system 620 may also be provided. Other modules described herein may include a wake-up switch system 820. .

[0119] With further reference to FIG. 36, the wake-up switch system 820 includes an electronic device assembly. A flexible printed circuit board (FPCB) that electrically communicates with the assembly 810 and the MCU ) or one axially movable contact arm 82 coupled to a circuit board 809. 2 and corresponding contact pad 824. The contact arm 822 is biased as shown. The contact arms 822 can be moved distally from their natural non-contact configuration, The feeler arm 822 and the contact pad 824 are arranged such that there is electrical communication between the two. (Thus, power to the electronic device is increased to a fully operational state) axially away from the contact pad 824 so that there is no electrical communication (and therefore no electronics in a low power state) The contact arms 822 are spaced apart along different axial positions of the movable proximal wall. It may have a preload to maintain contact with the proximal wall 802. The bias may be a separate Alternatively, the contact arm 822 may be provided by a leaf spring configuration as shown. The composition may be the same as that of the first embodiment.

[0120] In one embodiment, the contact arm 822 is a base that is firmly attached to the circuit board 809. 830, a movable arm length coupled to the base 830 via a joint 834 832. Arm length 832 is attached to base 830 about joint 834. The biasing force from the contact arm 822 moves the upper proximal wall 802 closer to the The actuation of the proximal wall 802 in the distal direction by the user may be sufficient to maintain the proximal wall 802 in the distal first position. When the contact arm 822 is pulled up, the axial force overcomes the biasing force of the contact arm 822 and and contact pads 824 for controlling the switch system and / or the way of the control system. from its first location on the proximal wall 802 to a distal second portion thereof in contact for the The movement of the proximal wall 802 is sufficient to allow distal movement of the This occurs with the module housing in place and applies an actuation force to the actuator. The system can be powered on without any need for a power supply. The movement of the proximal wall 802 is is in the process of moving to a final distal position during an applied actuation force to effect dose delivery. The switch system 820 may also be a mechanical Alternative switch configurations such as switches or rubber dome switches may be included.

[0121] The contact length arm portion 832 is at an acute angle to the plane defined by the base 830. The arm portion may extend from the base 830 at a right angle to the base or at an angle to the base. From a radial perspective, the contact arm may have a V-shaped body. In one example, any portion of the arm portion 832 can be in contact with the contact pad 824. In one embodiment shown, the arm portion 832 may include a tip 835 In another embodiment, the contact portion is disposed at an intermediate body of the arm portion 832. The contact portion of the arm portion 832 may, for example, have a polished or smoothed surface and / or or rounded surfaces or hook-shaped and / or domed surfaces (see Figures 35-36) The contact pad 824 may be configured to enhance contact with the contact pad 824, such as by including a recess (as shown).

[0122] Any applied force to the proximal wall 802 will move the contact arms from their natural state to their contact configuration. In one embodiment, arm portion 832 can be moved from a first proximally extending The bearing joint is configured to define a first portion 840A and a distally extending second portion 840B. The first portion 840A can be angled along its body at joint 837. The base 830 and the joint 834 extend between the bearing joint 837. The second portion 840B extends between the bearing joint 837 and the tip 835. The length and angle of the extension of the first portion 840A is determined by the angle of the inner surface 802A of the proximal wall or the optical ring. Alternatively, the bearing joint 837 may be located in a position to maintain contact with the first When moving between the first position and the second position, the surface 802A of the proximal upper wall 802 is The first boss 802B is configured to extend in the distal direction. The length and angle of the extension of the second portion 840B are such that when the proximal wall 802 is in the first position, The tip 835 is disposed in spaced relation to the contact pad 824 and the proximal wall 802 is in the second position. When the tip 835 is pressed against the proximal wall 802, the tip 835 is pressed against the proximal wall 802 at a distance sufficient to contact the contact pad 824. In an alternative embodiment, the contact arm 82 is configured to allow movement in a distal direction. The second bearing portion 837 is located closer to the tip 835 of the arm portion than the location of the contact portion. For this purpose, the contact portion may be formed along a valley or recess in the arm portion. In some contact arm embodiments, the bearing portion of the contact arm may be a contact portion is disposed at a location more proximal than

[0123] From an axial perspective, the configuration of the arm portion 832 of the contact arm 822 is linear, angular, FIG. 36 shows an example of an arch-shaped arm portion 832. The wake-up function of the module includes one contact arm and contact pad system. 36 shows three sets of contact arms 822 and contact pads (not shown in the figure), while one contact arm 822 is sufficient. The figure shows a system including three contact arms (not explicitly shown). The arms 822 may be radially disposed at approximately the same distance from the longitudinal axis. , for example, to allow for a 20-40 degree separation between adjacent ends of the contact arms, etc. The circumferentially spaced apart distances may be 2, 3, 4, 5, or more. Such multiple sets more evenly distribute the biasing force from the contact arms 822 to the upper wall 802. Even with multiple sets, the control device can be connected to the Only one set of the feeler arms 822 and contact pads 824 or more than all of the total sets may be used. The total number of contacts required for activation may be reduced. The user can press any part of the proximal wall, rather than requiring precise finger placement. To assist with accidental start-up, the controller may: For example, three sections of contact arms 822 and contact pads 824 are provided for actuation contact. The method may be configured to require more than two sets, such as all of the sets.

[0124] The base 830 and the contact arm portion 832 are made of the same material, such as a conductive material, such as a metal. The contact pad 824 may be integrally formed with the contact arm. The base and arm portions may be separately formed from the same or different materials. If formed separately, the base and arm portions may be joined together by, for example, welding, metal-to-epoxy bonding, or the like. The components may be bonded together, such as by welding, brazing, or other means depending on the material of the components. The base and arm portions are made of a conductive material impregnated with plastic material at least at the tip portion. The wire is made of a plastic material having a conductive material coating along its tip. In one example, the base and arm portions are integrally formed from a conductive metallic material. , the contact arms are coupled to each other at a living hinge joint such that they have a leaf spring configuration. do.

[0125] FIG. 37 illustrates a module mounting support referred to herein as spacer unit 839. 8 shows another example of a subassembly. When unit 839 is part of a module, The module 800 can be attached to any of the dose buttons described herein via the mounting element 807. The distal wall 806 is configured to be removably coupled to, for example, the distal wall 806 shown in FIG. A light guide member 849 for receiving an identification sensor such as the identification sensor 680 is provided therein. The distal wall 806 includes an opening 836 defined therein. A vent opening 841 may be defined in the distal wall 806. The sensor receiving recessed location 842 can accommodate, for example, five magnetic, inductive, , or capacitive sensing elements or magnetic sensors 906, etc., spaced apart in equal radial directions, and A recess 842 is defined in the proximal surface of the distal wall 806 for placement of an angle measurement sensor. , may be located on the distal surface of the distal wall 806. The distal wall 806 and / or unit 83 9 to complementary mounting features on the module housing. 3 can be provided.

[0126] Referring to FIG. 39, a light guide includes a light guide post 853 extending from a base 855. The light guide member 849 is shown. The light guide member is made of optically transparent polycarbonate or the like. material, and the identification sensor emits light that is reflected from a colored portion of the proximal surface of the button. and allows at least some light transmission for sensing. 38, the distal wall 806 is sized to fit within the distal end 836. A recessed area 857 defined in the positioning surface 806A can surround the opening 836. Region 857 may have a depth and shape that corresponds to the thickness and shape of base 855 . The opening 836 and recessed area 857 are adapted to receive the light guide member 849 in a fixed manner. The axial length of the extension may be such that it is in direct contact with the sensor. The distal surface of the distal wall 806 abuts against the colored surface feature of the device button proximally to It is possible to provide a light guide path for the identification sensor from the surface, or as shown, There may be an axially spaced gap between the end of the post 853 and the light color sensor. The Dopost 853 can be made in any of a variety of geometric shapes such as round, oval or rectangular. In one example, the post 853 has an elliptical cross-sectional shape. More mounting posts 859 (two shown) also extend proximally from base 855. Each mounting post 859 may be radially spaced from the light guide post 853. To this end, the base 855 may include a mounting post for receiving the mounting post. A corresponding number of post openings 863 may be defined in distal wall 806. , which can receive mounting posts 859 during manufacturing. Once the material is in place, it is heated (for example, by ultrasonic welding) and the material fills the gaps in each post opening. and enhances consistent detection capability for secure installation.

[0127] The module 800 includes another embodiment of a mounting element 807. 8 is shown as an example, the mounting unit 500 or mounting Element 419 may also be provided, and is not intended to be limiting. The other modules may include mounting elements 807 .

[0128] The mounting element 807 with the distal wall 806 forms a unit part of the module 800. The attachment element 807 can include a plurality of distally extending arms 850. In one exemplary embodiment, the arms 850 are equiangularly spaced about the dose button. The shaft 850 is coupled to the distal wall 806 and depends distally from the distal wall 806. When the module is attached to the device, the arm 850 is The arm 850 is positioned to contact the radially outwardly facing surface. The body 854 includes a protrusion extending radially inwardly of the body 854. The arm 850 may include a protruding bearing portion 852. The body 854 of the arm 850 may include a W-shaped body. The legs 856A-B extending in the distal direction outward from the arm body have two mounting Extending from distal wall 806 at the mounting location is proximally extending inner arm 858 . The surfaces of the protruding body of the bearing portion 852 may be right-angled, curved, and / or angled. Alternatively, body 854 may have a portion defining a proximally extending arm. The shape may include a J-shape.

[0129] With further reference to FIG. 35, the battery 861 provides shielding properties to the magnetic sensor and the magnetic ring. In one example, the battery 861 is a coin cell battery with a ferromagnetic nickel coating. The placement of the battery 861 is axially proximal to the magnetic sensor and provides shielding for the sensor. and providing shielding along its proximal side to block the effects of magnetic fields from the proximal direction; and / or provide shielding along its distal side to direct magnetic fields from the magnetic ring towards the sensor. In one example, the battery 861 is attached to a sensor, such as from a ring of the rotation sensor 706. Redirection of magnetic flux lines toward and away from the location of a sensor, such as sensor 906. It can help redirect magnetic flux lines away from unwanted external interference. In this example The size of the cell, such as radius, may correspond to the radial location of the sensor from the axis. Another example is the composition of the battery 861, which can be made of iron (most series), cobalt or The battery 861 may provide other shielding properties, such as a battery containing nickel or other nickel alloys. The sensors may have a cross-sectional size relative to the radial arrangement of the sensors and / or may have a magnetic sensor. Such shielding may be provided axially spaced from the sensor.

[0130] For example, any of the modules described herein, such as module 800, may include a magnetic sensor The sensing elements may include five (as shown) or six sensing elements such as 8. The circuit board 809 of the electronics assembly 810 is disposed within the compartment 808 and is thus In one example, the sensing element is disposed within the distal wall 806, as shown in FIG. Five or six magnetic sensors disposed within corresponding sensor receiving recessed locations 842 defined in The sensor includes a sensing element located on top of the distal wall 806 (i.e., not recessed), and may be disposed proximally by distal wall 806 within the modular compartment.

[0131] 40-41 show examples of sensor arrangements relative to the magnetic ring, and are described in the present specification. FIG. 40 illustrates the N pole 903 and all other magnetic capacitance detection systems described above. The current embodiment includes a diametrically magnetized ring 902 having a north pole 905 and a south pole 906 as a sensing element. 9 shows another example of a magnetic sensor system, referred to as system 900. A magnetized ring 902 is attached to a dose setting member, such as a flange, as previously described. A radial direction of a magnetic sensor 906, e.g., a Hall effect sensor, relative to the ring 902. The arrangement of the ribs may be equiangular with respect to one another in a ring pattern. As shown in FIG. 1, the magnetic sensor 906 is located on the magnetized ring 902. and the remainder is outside the magnetized ring 902. The overlapping arrangement is radially disposed in overlapping relationship with the outer peripheral edge 902A of the high Placing the sensor within the range of magnetic flux capability, thereby providing more consistent magnetic flux sensing FIG. 41 shows the determined radial distance from the center of the magnetic sensor 906 to the AA axis. The radial distance 907 is at least the outer radius 902 of the magnetized ring 902. 08. In one example, the radial distance 907 is 0.1 to 20% larger than the outer radius of the ring 902, and in another example, the radial distance 9 07 is at least 10% greater than the outer radius of the magnetized ring 902. Can provide enhanced peak magnetic flux for sensing beyond other radial positions It was surprising that the magnetic field was so small ... FIG. 11B shows another example of a radial arrangement in which the inner entire opening formed by the ring is 4 shows another example of an associated radial arrangement of magnetic sensors disposed on the body.

[0132] FIG. 41 illustrates the axial and radial placement of the magnetic sensor 906 relative to the magnetized ring 902. The sensor 906 is aligned along a common plane substantially perpendicular to the AA axis. The electronics assembly of the module (module components omitted for clarity) is The magnetic ring 902 having a thickness 913 may be disposed along the circuit board 903 of the sensor. The ring 902 may be arranged in a plane parallel to the plane of the device 720. The sensor 906 may be mounted on a module that is removably mountable to the device. In an alternative example, the components of the module that includes the sensor 906 can be: Permanently integrated into the device is a magnetized ring 902 such as that shown in FIG. It is possible.

[0133] The ring must be dimensioned within the constraints of the available space to meet the flux performance requirements of the sensor selected. The shape can be changed. Figure 41 shows the state when the dose button is not compressed, such as during dose setting. The relative axial position 911 of the magnetic sensor 906 on the magnetized ring 902 when During dose delivery, the dose button and sensor 906 are rotated by an axially stationary magnetized After being distally displaced toward the magnetized ring 902 by a distance indicated by arrow 909, The relative axial position of the magnetic sensor 906 on the rotating ring 902 changes. The distal movement of the magnetized ring 902 is in the range of 1 mm to 3 mm. In one example, during use, when a user applies pressure to the top of the module, the button / spring releases the The assembly is subjected to axial compression to reduce the interaction between the sensor 906 and the magnetized ring 902. In the dose delivery position, the sensor is moved in a direction away from the center of the sensor by a distance of 1.7 mm. The magnetic flux of the magnetized ring 902 available for reading by the sensor 906 is It should be at least twice as high as when it is in the amount setting position.

[0134] The magnetic material of the diametrically magnetized ring 902 is utilized at the dial distance and the dispense distance. The available magnetic flux should be selected to be acceptable for reliable detection. In the example, the magnetic ring used in the sensed component has, for example, a nickel coating. Neodymium magnets (NdFeB, NIB, or also known as Neo magnets, are a mixture of neodymium, iron, and boron. It is a rare earth permanent magnet made of gold. Other sintered neodymium magnets such as N42, N45, and N50 Neodymium magnet grades and similar or bonded neodymium grades (thermoplastic or thermal Injection or compression molded with a hardenable resin) ensures adequate magnetic flux availability at the magnetic sensor. The magnet material selected may be a plastic carrier such as carrier 708. Meets mechanical strength requirements for a tight fit to the rear and ensures operation and handling without cracking or failure. It is expected that the size will be determined so that it can withstand the impact of hand-on and hand-off. The magnetized ring is fixed firmly to the dose setting member so that it does not rotate. It rotates with the dose setting member during dialing or dispensing.

[0135] The axial movement of the sensor relative to the magnetized ring during dose delivery, as well as this axial Changes in magnetic flux due to changes in position and rotation of the ring can make dose detection difficult. Also, the more cost-effective diametrically magnetized phosphorus of sintered N35Neo magnets is The guiding provides non-uniform magnetic field characteristics, leading to more inconsistent detection and dialing errors. Dial errors in the dose detection module may occur due to magnetic rings or other devices. The actual physical rotational position of the dosage component (the "dial position") and the The difference in degree of rotational position between the detected rotational position ("detected position") detected by the For example, if a user desires the device to deliver a particular number of units of a drug, the user may , the device button on which the module is attached is moved to the housing of the device by 10 units, etc. Rotate by the amount indicated by the dosing dial or 18 degrees ±X% per unit The dose detection system will rotate approximately 180 degrees based on the button press to start the delivery operation. The system is capable of tracking the initial and final positions upon completion of dose delivery, The difference between the final position corresponds to several rotation angles and a correlated amount of delivered dosage units. is.

[0136] A dialing error can be illustrated by the following example: The initial position dialed is The dose / dial member, and therefore the magnetic ring, is set to the nominal zero initial value after the dose setting has been made. The position of the ring after the actual rotation of 90 degrees correlates to 5 units during dose delivery. In case of dial error, the diameter of the normal production The dose detection system of the four sensor system with magnetized rings is the nominal Detect -10 degrees at zero initial position and 100 degrees at final position delivered, totaling 110 degrees This may result in a rotation of the detected ring of 5 units greater than the 5 units actually delivered. would correspond to a detectable dose of more than 6 units being delivered.

[0137] Dial errors can be introduced into the system from magnetic sensors and other factors. The first spatial harmonic waveform (main waveform / signal) is the magnetization May be susceptible to phase, gain, or offset errors during rotation of the attached ring. They may be equally spaced circumferentially from each other and equally spaced axially from the magnet. The number of sensors used will represent the number of times the sine wave is sampled. Calibration can greatly reduce these errors. However, Other error contributions range from higher harmonics such as the 3rd or 4th harmonics down to the 1st harmonic. Consistent radial arrangement of the magnet sensors from the module shaft, as well as the Consistent circumferential spacing between the sensors, substantially perpendicular to the module axis and flat against the magnetic ring The reduction in the inclination of the plane of the sensors positioned together in a row, and the calibration of the system Bracing can reduce some of the errors.

[0138] Use a high grade source of magnetic material, for example N50 grade neodymium magnets, or or by tightening manufacturing controls, the magnetic properties of the diametrically magnetized rings By improving the uniformity of the magnetic flux in the dial, dial errors can be reduced. Such improved magnetic components would be more expensive and would limit magnet supply capabilities. By providing an additional magnet sensor (one or two more) that already exhibits non-uniform characteristics, It was uncertain whether rotation during dose delivery would improve detection. The diametrically magnetized ring 902 is fitted with five or six magnet sensors 906. This effectively eliminates the offset second and third harmonic signal distortions typically present in normally produced magnets. Filtering improves the position signal used for dose determination, which It was found that such filtering reduces the number of errors. For this purpose, the dose detection system Improvements to ensure that the detected amount of units delivered corresponds to the actual amount of units delivered. Goodness has been discovered.

[0139] Regular production N35Neo sintered diametrically magnetized rings were tested for secondary, tertiary, quaternary, and The harmonic distortion of the sensor signal was determined for the percentage amplitude of the first and fifth harmonics versus the first harmonic. The results are shown in Figure 4. A customized magnetic test fixture was constructed to perform the measurements described herein. The described modular arrangement of magnet sensor subsystem functions was emulated. The fixture was designed to test different configurations as well as the axial and The relative radial and circular alignment of the sensor and magnetic ring is then performed to reproduce the radial alignment. It is configured to adjust the circumferential position as well as the axial (out-of-plane tilt) position. Analyze the sensor results to measure magnetic inhomogeneity for harmonic distortion and dial / dosage errors Understand the impact of normal production (more cost-effective) and customer satisfaction. 4 vs 5 of N35 grade magnets made from shrunk production (less cost effective) methods The dial errors due to the three and six sensor architectures are shown in Figures 3-4, respectively. 4. Figure 45 shows the results of three typical production N35Neo sintered diametrically magnetized rings. The sensitivity of the four sensor architectures to harmonics is shown, with the dial error being 6 The 3D high-temperature properties of the normally produced N35Neo sintered diametrically magnetized ring are easily increased beyond the Five sensor architecture immunity to harmonics, reducing dial error to less than 2 degrees Significantly reduce.

[0140] Figure 42 shows the schematic diagram of the four sensor architectures used in a typical production N35 magnetic ring. The four sensor architectures affect the reliability of the position signal. It has been demonstrated that this increases the unwanted error contribution due to the third harmonic. The radially equidistant sensor configuration eliminates the small amplitude variations due to the magnetic flux of the rotating magnetized ring. It was thought that the magnets would be resistant to vibration. Numerical simulation of a six-sensor architecture, equally spaced around the circumference Adding a sensor reduces the higher harmonics in the angle measurement, thereby reducing the It was shown that the variation in the dosing error was reduced. shows non-uniform properties), sintered N35 magnets with customized production methods (more We have carried out various tests with strict controls, and sintered N50Neo high grade magnets. to compare sensor architecture effects with each other and with numerical modeling simulations. It was found that the third harmonic has the greatest effect on the angle measurement. In addition, the five-sensor architecture achieves better third-harmonic performance than the four-sensor architecture. The six sensor architecture was able to eliminate the wave distortion, but it also eliminated up to the fourth harmonic. I was able to delete it.

[0141] In FIG. 42, the rotational position detection (line 1010) is performed based on the shape and characteristics of the magnet. ) of the four sensor architectures compared to the calculated desired mathematical model of the magnetic flux waveform. Deviation of the rotating magnetic flux waveform measured (at line 1000) during rotational position sensing along 360 degrees The effect of error contributions from higher harmonics leading to the two lines 1000 and 101 Such deviations between 0 and 1 can contribute to dial error in a four sensor system. There is.

[0142] From the test data, modules with five or six magnetic sensors reduce distortion errors. In one embodiment, the sensor / ring array is configured to substantially reduce the magnet This is likely to produce an acceptable dial error contribution of less than 2 degrees from the distortion of the For example, in Figure 43, for a number of commonly produced magnets, four sensor architectures are used. The average dial error was 6.5 degrees (at line 1100). The dial error of the five sensor architectures is an average of 1.2 degrees (line 1110), and an average of 0.5 degrees (line 11 20. Five sensors or six sensors with standard production N35 magnetic rings. The sensor architecture reduces dial error by more than five times compared to the four sensor architecture. It has been shown that the magnets can be custom manufactured to reduce the noise generated by 5 sensors or 6 sensors. The new sensor architecture reduces errors by more than three times compared to the four sensor architecture. In Figure 44, the diamond was used for the customized production magnet. The error is from a four sensor (at line 1200) to a five sensor architecture (at line The average temperature decreased from 1.4 degrees to 0.4 degrees for the 1210 and 1220 sensors, respectively, and the 6 sensors The architecture (at line 1220) showed an average decrease of 0.4 degrees.

[0143] Figure 45 shows the four sensor and five sensor systems produced by conventional production methods. From three lots (1301, 1302, 1303) of N35 grade sintered magnetic rings The percentage of harmonic variation in the four sensor architectures (at line 1310) is summarized. The 3rd harmonic averaged 3.8 percent maximum and was The 1320 model showed approximately 0 percent at the third harmonic. (at line 1320) shows an average maximum of 0.8 percent fourth harmonic, with four sensor arrays. The architecture (at line 1340) showed approximately 0 percent at the 4th harmonic. The third harmonic contribution is shown in Figure 43, dialing in the four sensor architecture. The error is 6 degrees or more, and the five sensors or six sensor architecture The addition of the sensor reduces the third harmonic and improves the main waveform, as shown in Figure 43. Thus, the dial error is reduced to less than 2 degrees.

[0144] Further exemplary embodiments of dose delivery detection systems are provided in Figures 30-34. The embodiment is shown somewhat diagrammatically since common details have already been provided with respect to FIGS. Several examples of drug delivery devices that utilize magnetic sensing of dose delivery are described herein. Exemplary embodiments are described. For example, a ring-shaped element, such as a magnet or a metal ring, The device can be attached to the dosing device by a variety of attachment means, such as adhesives, welding, or mechanical attachment. The ferrule can be fixed firmly to the bearing and / or flange. In some cases, attachment means may be beneficial. In Figures 30 to 34, a FIG. 30 shows an exemplary manner in which a ring-shaped element is attached to a flange that is An integral single unit that rotates and moves axially as a unit (as shown in Figure 31) FIG. 1 shows axially aligned components bonded together as a die A gear member 700, an exemplary clutch 702, a rotation sensor 706, e.g., a flag A dose setting component, such as a flange 704, a rotation sensor 706 is securely attached to the flange 704. A mating carrier 708 includes a button spring 710 for biasing a dose button 712. Instead of the flange, other dose setting components as described herein may be used. Button 712 may have any of the configurations of buttons described herein. 1-4, the drug delivery device 720 includes a device body 722. The dose dial member 700 includes a dial member 700 attached to the dose dial member 700. A flange 704 is provided within the dose dial member 700. and clutch 702 is disposed within flange 704. 700, flange 704 are rotatably secured together and may also be used to set the dose and / or or rotates during dose delivery which is directly related to the amount of dose delivered. The spring 710 includes a stem 724 on which the dose button 712 is mounted. 704 to urge dose button 712 proximally away from flange 704. As previously mentioned, the drug delivery device further includes a rotation sensor attached to the flange. For example, the sensor is entirely contained within the dose button. None of the sensors detects rotation of the rotation sensor 706 during dose setting and / or delivery. The device includes an electronics assembly and sensing element that determines the amount of dose involved.

[0145] The flange 704 is generally cylindrical in shape and has a proximal axial surface 73 at the end of the side wall 734. 2. Flange 704 defines a central opening 736 within proximal surface 732. As shown in FIG. 32, the rotation sensor 706 may be an annular magnet, a metal ring, or or a magnetized or metallized polymer ring, and the proximal surface of the flange 704 The carrier 708 is disposed on a surface 732 opposite the proximal surface 732 of the rotation sensor 70. 6 and arranged to sandwich the sensor 706 therebetween. The support 742 includes a mating proximal lip or support 742. The support 742 has a generally ring-shaped configuration. Although shown as an element, it may alternatively be a segmented ring or rotation sensor 70 6. The support may include a plurality of supports spaced apart about 6.

[0146] In this configuration, the carrier 708 positions the support 742 distally relative to the sensor 706. The sensor 706 is held in place on top of the flange 704 by contacting it with the This is achieved by axially fixing the carrier 708 to the flange 704. In this embodiment, the carrier 708 is attached directly to the flange 704, for example at a location distal to the sensor 706. In another exemplary embodiment, the carrier 704 is attached to the carrier 708. A spring 710 biases the carrier 704 away from the button 712 or the carrier 704 is flipped. A spring biased distally, such as by a spring acting to pull toward the lunge 704 will be done.

[0147] Referring again to FIG. 30, the carrier 708 includes a generally axially extending The axially extending legs 752 are spaced apart circumferentially about the bore 754. The flange 706 is configured to capture the rotation sensor 706. The body 750 includes a support 742 that is sized to fit within the inner diameter or cross-section of the sensor 706. As shown in FIG. 31, the support 742 is sized to accommodate the The portion of the body 750 extends radially outward beyond the size of the body 750. The support 742 has depending legs 772 that are sized to the axial thickness of the sensor 706. a snap radial rib disposed distally away from the sensor 706 and engaging a distal face of the sensor 706 As shown in FIG. 34, each of the legs 772 may include a flange. Inserted into a corresponding suitably sized axial slot 760 formed in the side wall 734. The slot includes radially inwardly projecting elements 756 sized and shaped to The set is a frictional engagement that rotatably locks two components together and transmits torque between them. The size can be determined to closely accommodate element 756 so that do.

[0148] The radial end of element 756 is secured to flange 704 as shown in FIGS. In one approach, the carrier may be engaged with a central hub of the carrier, as shown in FIG. When the legs 752 of the flange 708 are inserted into the openings 736 of the flange 704, the flange 704 along the cylindrical inner surface 759. In one example, the legs 752 extend into the central opening 736 and define a cross-sectional span of In this technique, the spring 71 is attached directly to the flange 704 at a location distal to the sensor 706. The relative arrangement of 0 is shown in Figures 31 and 33. Flange 704 is The axial surface 732 may include a radial slot 762 formed therein. The slot 760 may include As shown in FIG. 31, the inner surface of the leg 752 is in contact with the outer wall defining a radial slot 762. The flange is formed in such a manner that it closely aligns with the inner surface of the spring 710. The distal end is disposed within the radial slot 762. The wall supports the distal end of the spring 710 and allows it to abut against the dose button at the mounting collar. , thereby urging the carrier 708 distally away from the dose button.

[0149] The various components of the carrier 708 may comprise either partial or complete circumferential members. For example, the body of the carrier 708 may extend completely around the flange or can be formed as spaced apart segments. Advantageously, the use of a carrier allows the rotation sensor to This means that it is held securely in place without the use of adhesives. However, adhesives can complicate the manufacturing process.

[0150] The electronics assembly 610 includes a battery 621 for power and associated contacts, a program an MCU for executing the instructions stored in the MCU; a memory for storing programs and data; A communication assembly for transmitting and / or receiving data, a timer for tracking time The modules 600 include the meter, as well as the various switches and sensors described. and various operative connections for any of the other modules described herein. For example, modules 82, 232, 400, or 600 may be included. Any of the modules described herein may be used with the sensor system 150 described above. The electrical wiring diagram of the present invention includes a wiring diagram of a sensing element 160 for detecting an electrical potential of the sensor. The device may be configured to accommodate any of the following child device assemblies:

[0151] FIG. 46 illustrates a block diagram of a module designated 1400 that may be included in any of the modules described herein. The figure shows an example of an electronics assembly that can be used in a variety of applications. The MCU is responsible for implementing the electronic functions of the module. The MCU is programmed to detect the dose delivery member relative to the actuator. A data set used to determine the dose delivered by the drug delivery device based on the rotation of the device. and control logic operable to perform the operations described herein, including obtaining the data. The MCU collects data by determining the amount of rotation of a rotation sensor fixed to the flange. The system may be operable to obtain data, for example from measurements of the system, such as Hall effect sensors. The rotational speed is determined by detecting the magnetic field of the rotational sensor with the sensing element of the stationary sensor.

[0152] The assembly includes dosage sensors 1402A-E, a memory 1408, an identification sensor 1404, counter 1414, light driver 1411 and light indicator 1412, power-on module 1406, a communication module 1410, a display driver / display 1416, a power supply 1418, and an MC that may be operatively coupled to one or more of the presence modules 1420. The assembly 1400 includes, for example, five magnetic sensors 1402A-E (shown) or The MCU determines the total rotation units. The MCU is configured to receive the presence switch system triggers. In this embodiment, to determine whether the module is coupled to a button on the device, is configured via a presence module 1420, which is shown as optional in dashed lines. The MCU may be configured to determine the color of the dose button via the identification sensor 1404. In some cases, there are on-board or off-board decisions that correspond to specific drugs. The MCU associates the color data set with the external device. to power up the electronics assembly for use. In one example, the full rotation is determined based on the database, communicating with an external device including a memory having a lookup table or other data stored in the memory; The total turnover units can be correlated to the amount of drug delivered for a given drug identified. In another example, the MCU may be configured to determine the amount of drug to be delivered. The device stores the detected dose in a local memory 1408 (e.g., an internal flash memory or The MCU may be further operable to store the , rotation unit (any one or any combination of them), drug identification (e.g., color) Data, timestamp, time since last dose, battery charge status, module identification number, Module insertion and removal times, inactivity times, and / or other errors (e.g., amount detection and / or transmission errors, drug identification detection and / or transmission errors, etc. A signal representing device data may be transmitted via Bluetooth Low Energy (BLE) or other suitable A short-range or long-range wireless communication protocol module 1410 (e.g., short-range wireless communication (NFC), WIFI, or cellular network) on the user's smartphone, etc. Illustratively, the BLE control The logic and the MCU are integrated on the same circuit. Any of the modules described herein may be implemented to display information to a user. In some embodiments, a display module 1420, shown in dashed lines as optional, may be included. Such displays may be LEDs, LCDs, or other digital or analog displays. The MCU may be a part of the finger pad or may be integrated with the finger pad of the proximal portion. Receive and process, for example, dose settings, dispensed dose, injection status, injection completion, date and / or to display information such as time or time until the next injection on the display. The display driver software module and control logic may be operable as follows: Then the MCU will check whether the data was sent successfully and whether the battery charge is high or low. or other clinical communication, by on / off sequences and different colors For example, an RGB LED, an orange LED, and a green LED are used to communicate with The LED driver 1411 is coupled to one or more LEDs 1412, such as LEDs. The counter 1414 is electronically coupled to the MCU to track time, e.g., administration time. The counter 1414 is shown as a real-time clock (RTC) that is connected to the power It can also be a time counter that tracks seconds from zero based on the time or count value. can be communicated to an external device.

[0153] The dose detection system may be implemented using a specific design of the drug delivery device, e.g., a pen-type injection device. However, the exemplary dose detection system may also be implemented as described herein. may be used with alternative drug delivery devices and with other sensing configurations that are operable in For example, any one or more of a variety of sensing and switching systems may be included in the module. It may be omitted from the rule.

[0154] The present invention has been shown and described in detail in the drawings and foregoing description, which It should be considered as illustrative and not limiting in nature. The sensing module is in conjunction with a device portion having suitable components that undergo relative rotation during dose setting. When the device is adapted to function in accordance with the present invention, it is possible to detect the dose setting amount. This application is intended to cover any variations, uses, or adaptations of the invention using its general principles. Further, this application is intended to provide a method and system for the preparation of a method for the preparation of a compound according to the invention. It is intended to cover such departures from the present disclosure as come within conventional or customary practice. Within the spirit and scope of the present invention as defined by the claims contained herein. All such alterations, equivalents, and modifications are desired to be protected.

[0155] Various aspects are described in this disclosure, including but not limited to the following aspects: do.

[0156] 1. A dose detection module for removable attachment to a dose button of a drug delivery device, the dose button having a cylindrical button sidewall, the device including a sensed component ring rotatable during dose dispensing, the module including a housing about a module longitudinal axis including a proximal wall assembly for defining an internal compartment, a distal wall, and a module sidewall extending therebetween, the module sidewall extending distally beyond the distal wall, the distal wall defining a plurality of recesses disposed at equal angles relative to one another, the housing being configured to couple around the button sidewall, and an electronics assembly including a processor and a plurality of sensors operably coupled to the processor, each of the sensors fixedly disposed within a corresponding recess, the sensors configured to detect rotational movement of the sensed component ring to generate position signals, the processor configured to receive the position signals to determine data indicative of an amount of dose dispensed based on the position signals. 2. The module of aspect 1, wherein the sensed component ring includes a bipolar magnetic ring and the sensor includes a magnetic sensor arranged in an overlapping arrangement with the outer periphery of the bipolar magnetic ring. 3. The module of aspect 2, wherein the magnetic sensor includes five or six magnetic sensors. 4. The module of any one of aspects 1-3, wherein the housing includes a light guide member and a distal wall defining a post opening, the light guide member includes a light guide post extending proximally through the post opening past the magnetic sensor, and the electronics assembly includes a color sensor disposed on and axially spaced from the light guide post, the color sensor operably coupled to the processor and configured to emit and / or detect a color of the dose button. 5. The module of embodiment 4, wherein the light guide member is fixedly secured to the distal wall. 6. The module of embodiment 5, wherein the light guide member includes one or more mounting posts radially spaced from the light guide posts, and the distal wall includes a light guide hole that receives the light guide post, and one or more mounting holes that receive a corresponding number of mounting posts. 7. The module of any one of aspects 1-6, wherein the electronics assembly further includes a battery operably coupled to the processor and an axially compressible battery support element in frictional contact with a proximal side of the battery. 8. The module of aspect 7, wherein the battery has a cross-sectional area relative to the radial location of the sensor and is axially spaced from the sensor so as to provide shielding for the sensor. 9. The module of any one of aspects 1-8, further comprising a switch system configured to increase power to the electronics assembly, wherein the proximal wall assembly is axially movable relative to the module side wall and distal wall to actuate the switch system with a force less than that required for dose delivery from actuation of the device. 10. The module of aspect 9, wherein the switch system includes at least one set of biased contact arms extending between the electronics assembly and the proximal wall assembly and corresponding contact pads operably coupled to the processor, the proximal wall assembly being axially movable relative to the housing between a first proximal position in which the contact arms and contact pads are not in contact with each other and a second distal position in which the contact arms and contact pads are in a contacting relationship enabling an increase in power to the electronics assembly. 11. The module of aspect 10, wherein the switch system includes multiple sets of contact arms and corresponding contact pads, each of the sets being equally spaced and circumferentially disposed relative to one another, and one of the sets in contact relationship is configured to enable increased power to the electronic device assembly. 12. The module of embodiment 9, wherein the housing further includes an axially compressible member coupled between the proximal wall assembly and the housing portion to bias the proximal wall assembly to a proximal position. 13. The module of any one of aspects 1-12, wherein the proximal wall assembly includes a light guide ring and a white or reflective surface disposed over an opening defined by the light guide ring, the light guide ring includes a retaining arm coupled to a housing portion of the housing, and the electronics assembly includes a light indicator element operably coupled to the processor to emit light at the light guide ring. 14. The module of any one of aspects 1-13, wherein the housing includes a plurality of radially bendable arms extending from a distal wall and angularly spaced apart from one another, each of the arms having a support portion extending in a proximal direction. 15. A dose detection system comprising: a drug delivery device having a magnetic ring rigidly coupled to a dosing member and rotatable during dose setting and dose dispensing; a processor; and an electronics assembly including a plurality of magnetic sensors operably coupled to the processor, wherein the magnetic sensors are in overlapping positions relative to an outer periphery of the magnetic ring, the magnetic sensors are rigidly fixed relative to the processor, the magnetic sensors are axially and rotatably locked to the magnetic ring during dose setting and are axially and rotatably free relative to the magnetic ring during dose dispensing, the magnetic sensors are disposed at equal angles relative to each other to define a ring pattern, and during dose dispensing the magnetic sensors move distally closer to the magnetic ring and remain stationary relative to the rotating magnetic ring to detect rotational movement of the magnetic ring and generate a position signal, and the processor is configured to receive the position signal to determine data indicative of a dispensed dose based on the position signal. 16. The system of aspect 15, wherein the plurality of magnetic sensors includes five or six magnetic sensors and the magnetic ring includes a bipolar magnetic ring. 17. A system as described in any one of aspects 15 and 16, wherein each of the magnetic sensors is equiradially spaced at a radial distance defined from the center of the magnetic sensor to the axis of the module, and the radial distance is sized to be equal to the distance of the outer radius of the magnetic ring. 18. The system of any one of aspects 15-17, further comprising a module housing including a proximal wall assembly, a distal wall, and a side wall coupled therebetween for defining an internal compartment in which the electronics assembly is disposed, the distal wall defining a plurality of recesses in which the magnetic sensors are disposed. 19. The system of aspect 18, wherein the module housing includes a light guide member and a distal wall defining a post opening, the light guide member including a light guide post extending proximally through the post opening and past the magnetic sensor, the light guide member being securely secured to the distal wall. 20. The system of any one of aspects 18-19, wherein the electronics assembly further comprises a battery disposed proximate the magnetic sensor and operably coupled to the processor. 21. The system of aspect 20, further comprising an axially compressible battery support element in frictional contact with a proximal side of the battery. 22. The system of any one of aspects 18-21, further comprising a switch system configured to increase power to the electronics assembly, wherein the proximal wall assembly is axially movable relative to the side wall and the distal wall to actuate the switch system. 23. The system of aspect 22, wherein the switch system includes at least one set of biased contact arms and corresponding contact pads, the biased contact arms extend between the electronics assembly and the proximal wall assembly to bias the proximal wall assembly to a proximal position, the contact arms include angled joints that engage the proximal wall assembly and distally extending tips, the contact pads are coupled to the electronics assembly and operably coupled to the processor, and the proximal wall is axially movable relative to the module housing to a distal position such that the tips and contact pads are in a contacting relationship enabling an increase in power to the electronics assembly. 24. A system described in any one of aspects 18 to 23, wherein the proximal wall assembly includes a light guide ring and the electronics assembly includes a light indicator element operably coupled to the processor to emit light at the light guide ring. 25. The system of embodiment 24, wherein the light guide ring includes a retaining snap arm coupled to the housing portion, and the module housing further includes a compressible gasket coupled between the light guide ring and the first spacer element to bias the proximal wall assembly to a proximal position. 26. The system of embodiment 24, wherein the proximal wall assembly includes an element having a white or reflective surface disposed over the opening defined by the light guide ring. 27. A system described in any one of embodiments 18 to 26, wherein the module housing includes a plurality of radially bendable arms extending from a distal wall, the arms having a proximally extending portion configured to enable attachment and detachment of the module housing from the device. 28. The system of any one of aspects 15 to 27, wherein the magnetic ring includes a bipolar magnetic ring, the contribution to the dial error from the magnetic sensor and the bipolar magnetic ring arrangement is less than or equal to 2 degrees, and the dial error is the difference between a dial position corresponding to the physical rotational position of the bipolar magnetic ring and a detected position corresponding to the detected rotational position of the bipolar magnetic ring detected by the magnetic sensor. 29. A module for removable attachment to a dose button of a drug delivery device, the dose button having a cylindrical sidewall and a top wall having an upper surface, the dose button further including a radial lip extending outwardly at the top wall beyond the cylindrical sidewall, the module comprising a housing including a proximal wall, a distal wall, and a peripheral sidewall extending between and forming a compartment with the proximal and distal walls, an electronics assembly received within the housing compartment, the electronics assembly including a processor and a measurement sensor operably coupled to the processor, and a plurality of arms coupled to the housing and extending distally therefrom, each of the arms extending in a radial direction of the arm. a module comprising a plurality of arms including an inwardly extending support portion, each of the arms extending distally beyond the radial lip of the dose button and sized to position the support portion to engage a cylindrical sidewall of the dose button at an engagement position distal to the radial lip of the dose button when the module is attached, each of the arms configured to flex radially outwardly to remove the radial lip when the module is attached to or detached from a device, each of the arms configured to apply a radially inward force against the cylindrical sidewall at the engagement position when the module is attached. 30. The module of aspect 29, wherein the distal wall has a distal surface configured to be received against the top surface of the dose button when the module is attached. 31. The module of any one of aspects 29 and 30, wherein the arms are spaced apart from each other at equal radii. 32. The module of embodiment 31, wherein the arm is attached to a wall of the housing. 33. The module of embodiment 32, wherein the arms are formed to have a J shape. 34. The module of aspect 31, wherein the support portion of the arm includes a surface configured to be received against or in close proximity to the underside of the radial lip of the dose button when the module is attached. 35. The module of embodiment 31, wherein the arm is integrally formed with the distal wall. 36. A module described in any one of aspects 29 to 35, wherein the arm is configured such that a detachment force for removing the module from the dose button is at least twice the attachment force for attaching the module to the dose button. 37. The module of any one of aspects 29-36, further comprising a wake-up switch system including a movable segment disposed within the proximal wall of the housing and axially movable relative thereto, and a wake-up switch operably coupled to the processor. 38. The module of aspect 37, wherein the wake-up switch system includes a bendable shroud disposed between the movable segment and the wake-up switch, the shroud including a plurality of radially extending legs. 39. The module of embodiment 38, wherein the legs include a first set of fixed legs and a second set of free legs. 40. The module of any one of aspects 29-39, further comprising a presence switch system including a presence switch and a biased axial actuator slidably disposed within an opening defined by the distal wall of the housing. 41. The module of aspect 40, wherein the axial actuator includes an outer radial rim positioned to trigger a switch arm of the presence switch when the module is disengaged from the dose button. 42. The module of any one of aspects 29 to 41, further comprising a drug identification system configured to detect data indicative of a type of drug of the device. 43. The module of aspect 42, wherein the drug identification system includes an RGB sensor operably coupled to the processor, and wherein the distal wall of the housing includes a hole defined therein, the hole being axially positioned over the RGB sensor to enable color detection of the top surface of the dial button when the module is attached. 44. The module of any one of aspects 29 to 43, wherein the electronics assembly includes a first segment, a second segment, and a third segment electrically coupled to each other, the third segment being disposed between the first and second segments. 45. The module of embodiment 44, wherein the first segment of the electronics assembly includes a wake-up switch operably mounted thereon, and the third segment includes a drug discrimination sensor operably mounted thereon. 46. ​​The module of any one of aspects 29 to 45, further comprising a sensor recess defined in a distal wall of the housing, the measurement sensor including a plurality of magnet sensors spaced apart from one another at equal angles, each magnet sensor disposed within a corresponding sensor recess. 47. A drug delivery system comprising: a device body; and a dose button disposed on a proximal portion of the device body, the dose button including a cylindrical sidewall and a top wall having an upper surface, the dose button further including a lip formed by an extension of the top wall radially outward of the cylindrical sidewall, the dose button including a rotation sensor and a carrier coupled to the rotation sensor; and a module mounted on the drug delivery device, the module including a housing including a proximal wall, a distal wall, and a peripheral sidewall extending between and forming a compartment with the proximal and distal walls, a sensor assembly received within the housing compartment, the sensor assembly including a measurement sensor configured to detect movement of the rotation sensor, a battery, a memory, a processor, and a communication assembly. and a module including a sensor assembly including an electronics assembly including a housing including a sensor member and a module including a plurality of arms coupled to the housing and extending distally therefrom, each including a support portion extending radially inward of the arm, wherein when the module is attached to the dose button, each of the arms extends distally beyond the radial lip of the dose button to position the support portion engaging a cylindrical side wall of the dose button at an engagement position distal to the radial lip of the dose button, each of the arms is configured to apply a radially inward force against the cylindrical side wall at the engagement position, and each of the arms is configured to bend radially outward to remove the radial lip when the module is removed from the device. 48. The system of aspect 47, wherein the axial extension of the arm extends beyond the distal wall to position the support portion along the proximal portion of the side wall of the dose button. 49. The system of any one of aspects 47-48, wherein the engagement surface of the support portion is sized axially larger than the axial thickness of the radial lip. It is further noted that the present invention may include the following aspects. [Aspect 1] 1. A dose detection module for removable attachment to a dose button of a drug delivery device, said dose button having a button sidewall, said device including a sensed component ring rotatable during dose dispensing, said module comprising: a housing including a proximal wall for defining an interior compartment, a distal wall distal to said proximal wall, and a modular side wall extending therebetween about a module longitudinal axis, said distal wall defining a plurality of recesses disposed at equal angles relative to one another, said housing configured to fit around said button side wall; the module comprising: an electronics assembly including a processor and a plurality of sensors operably coupled to the processor, each of the sensors fixedly disposed within a corresponding recess, the sensors configured to detect rotational movement of the sensed component ring and generate a position signal, the processor configured to receive the position signal to determine data indicative of an amount of a dose dispensed based on the position signal, the sensors including magnetic sensors disposed in an array overlapping an outer periphery of the sensed component ring. [Aspect 2] 2. The module of embodiment 1, wherein the sensed component ring comprises a magnetic ring. [Aspect 3] 2. The module of embodiment 1, wherein the magnetic sensor includes five or six magnetic sensors. [Aspect 4] The module of aspect 1, wherein the housing includes a light guide member and a distal wall defining a post opening, the light guide member extending through the post opening, and the electronics assembly includes a color discrimination sensor disposed on the light guide member, the color discrimination sensor operably coupled to the processor and configured to emit and / or detect a color of the dose button after reflection of light from the dose button. [Aspect 5] The module of embodiment 4, wherein the light guide member includes a light guide post extending through the post opening and beyond the magnetic sensor. [Aspect 6] 6. The module of claim 5, wherein the color discrimination sensor is disposed on and axially spaced from the light guide post. [Aspect 7] The module of any one of claims 5 to 6, wherein the light guide member is fixedly secured to the distal wall. [Aspect 8] The module of embodiment 7, wherein the light guide member includes one or more mounting posts radially spaced from the light guide posts, and the distal wall includes a light guide hole that receives the light guide post and one or more mounting holes that receive a corresponding number of mounting posts. [Aspect 9] 2. The module of embodiment 1, wherein the electronics assembly further includes a battery operably coupled to the processor and an axially compressible battery support element in contact with a proximal side of the battery. [Aspect 10] 10. The module of embodiment 9, wherein the battery has a cross-sectional area relative to a radial location of the sensor and is axially spaced from the sensor to provide shielding for the sensor. [Aspect 11] The module of embodiment 1, further comprising a switch system configured to increase power to the electronics assembly, the proximal wall being axially movable relative to the module side wall and the distal wall to actuate the switch system with a force less than that required for dose delivery from actuation of the device. [Aspect 12] the switch system including at least one set of biased contact arms extending between the electronics assembly and the proximal wall and corresponding contact pads operably coupled to the processor; The module of embodiment 11, wherein the proximal wall is axially movable relative to the housing between a first proximal position in which the contact arm and the contact pad are not in contact with each other and a second distal position in which the contact arm and the contact pad are in a contacting relationship enabling the increase of the power to the electronic assembly. [Aspect 13] the switch system including a plurality of sets of the contact arms and the corresponding contact pads; each of the sets being equally spaced circumferentially disposed relative to one another; 13. The module of claim 12, wherein one of the sets in contact is configured to enable the increase in power to the electronics assembly. [Aspect 14] 12. The module of embodiment 11, wherein the housing further includes an axially compressible member coupled between the proximal wall and the housing portion to bias the proximal wall to a proximal position. [Aspect 15] the proximal wall includes a light guide ring and a white or reflective surface disposed over an opening defined by the light guide ring; the light guide ring including a retention arm depending from a distal surface of the light guide ring; 2. The module of embodiment 1, wherein the electronics assembly includes a light indicator element operably coupled to the processor to emit light at the light guide ring. [Aspect 16] The module of embodiment 1, wherein the button side wall is cylindrical and the housing includes a plurality of radially bendable arms extending from the distal wall and angularly spaced from one another, each of the arms having a support portion extending in a proximal direction. [Aspect 17] the magnetic sensor is axially and rotatably locked to the magnetic ring during dose setting and is axially and rotatably free relative to the magnetic ring during dose dispensing; The module of aspect 2, wherein the magnetic sensors are arranged at equal angles relative to each other to define a ring pattern, and during dose dispensing the magnetic sensor moves distally closer to the magnetic ring which remains axially stationary to detect rotational movement of the magnetic ring and generate a position signal. [Aspect 18] 18. The module of embodiment 17, wherein the magnetic sensor includes five or six magnetic sensors. [Aspect 19] The module of embodiment 17, wherein each of the magnetic sensors is equally spaced apart at a radial distance defined from a center of the magnetic sensor to an axis of the module, the radial distance being sized to be equal to the distance of the outer radius of the magnetic ring. [Aspect 20] The module of embodiment 17, wherein the housing includes a light guide member and the distal wall defining a post opening, the light guide member including a light guide post extending proximally through the post opening and beyond the magnetic sensor, the light guide member being securely fixed to the distal wall. [Aspect 21] 20. The module of embodiment 17, wherein the electronics assembly further includes a battery disposed proximate to the magnetic sensor and operably coupled to the processor. [Aspect 22] 22. The module of embodiment 21, further comprising an axially compressible battery support element in contact with a proximal side of the battery. [Aspect 23] a switch system configured to increase power to the electronics assembly; 18. The module of embodiment 17, wherein the proximal wall is axially movable relative to the module side wall and the distal wall to actuate the switch system. [Aspect 24] the switch system including at least one set of biased contact arms and corresponding contact pads; the biased contact arm extends between the electronics assembly and the proximal wall to bias the proximal wall to a proximal position, the contact arm includes an angled joint that engages the proximal wall with a distally extending tip, the contact pad is coupled to the electronics assembly and operably coupled to the processor; The module of embodiment 23, wherein the proximal wall is axially movable relative to the housing to a distal position such that the tip and the contact pad are in a contacting relationship that enables the increase of the power to the electronics assembly. [Aspect 25] The module of embodiment 17, wherein the proximal wall includes a light guide ring and the electronics assembly includes a light indicator element operably coupled to the processor to emit light at the light guide ring. [Aspect 26] The module of embodiment 25, wherein the light guide ring includes a retaining snap arm depending from a distal surface of the light guide ring, and the housing further includes a compressible gasket coupled between the light guide ring and a first spacer element to bias the proximal wall to a proximal position. [Aspect 27] The module of embodiment 25, wherein the proximal wall includes an element having a white or reflective surface disposed over an opening defined by the light guide ring. [Aspect 28] 2. The module of embodiment 1, wherein the button side wall is cylindrical and the housing includes a plurality of radially bendable arms extending from the distal wall. [Aspect 29] The module of embodiment 17, wherein the contribution to dial error from the arrangement of the magnetic sensor and the magnetic ring is less than or equal to 2 degrees, and the dial error is the difference between a dial position corresponding to the physical rotational position of the magnetic ring and a detected position corresponding to the detected rotational position of the magnetic ring detected by the magnetic sensor.

Claims

1. 1. A dose detection module for attachment to a dose button of a medication delivery device, comprising: the dose button having a cylindrical button sidewall; The module comprises: Housing and a plurality of attachment arms configured to couple to the dose button; an electronics assembly contained within the housing, the electronics assembly comprising a processor and a presence switch system attached to a distal wall of the housing, the presence switch system comprising a switch operatively connected to the processor, the presence switch system being movable between an actuated distal position and a proximal position, the processor configured to recognize that the module is attached to the dose button when the presence switch system is in the proximal position, and to recognize that the module is not attached to the dose button when the presence switch system is in the actuated distal position; the presence switch system comprising: a switch actuator attached to the distal wall and extending through an opening in the distal wall; and an actuator spring biasing the switch actuator to a distal position, the switch actuator being movable into contact with the switch; the switch actuator comprises a first member and a second member having a cup configuration configured to receive the first member, the second member comprising a flexible material, and the first member comprising a skirt configured to provide radial pressure along a lip of the second member to inhibit ingress of particulates. The dose detection module.

2. 11. The module of claim 1, wherein when the processor recognizes that the module is attached to the dose button, the processor is configured to wake up the electronics assembly or enable the electronics assembly to be provided with power.

3. The module of claim 1 , wherein the processor is configured to place the electronics assembly in an out-of-service state when the processor recognizes that the module is not attached to the dose button.

4. The module of claim 1, wherein the switch has a switch arm extending laterally into the opening and is contactable with the switch arm when the switch actuator is moved away from the distal position.

5. The module of claim 4 , wherein the switch actuator is movable into contact with a switch arm of the switch.

6. The module of claim 1, wherein the electronics assembly further comprises at least one measurement sensor operably coupled to the processor, the at least one measurement sensor responsive to a sensed parameter of a rotatable sensed component of the drug delivery device, the sensed parameter being from an angular position and / or rotational movement of the rotatable sensed component.

7. The module of claim 6, wherein the at least one measurement sensor is axially and rotatably engaged with the sensed component during dose setting and is rotatably free relative to the sensed component which rotates during dose dispensing.

8. The module of claim 1, wherein the electronics assembly further comprises an identification sensor operably coupled to the processor, and when the dose detection module is attached to the dose button, a light guide member is disposed between the identification sensor and an axial surface of the dose button, the light guide member configured to provide an optical path for the identification sensor, and the light guide member is attached to a housing wall of the housing.

9. The module of claim 8 , wherein the identification sensor is configured to emit light and / or detect a color of the dose button after reflection of light from the dose button.

10. The module of claim 8 , wherein the light guide member comprises a light guide post extending proximally through an opening in a housing wall of the housing.

11. 2. The module of claim 1, wherein a plurality of mounting arms extend beyond the distal wall of the housing, the mounting arms being angularly spaced from one another, each of the arms having a bearing portion received within a corresponding recess formed in the cylindrical button side wall of the dose button.

12. The module of claim 1 , wherein the electronics assembly further comprises a plurality of magnetic sensors operatively coupled to the processor, the plurality of magnetic sensors responsive to a magnetic field of a rotatable magnetic component of the drug delivery device, the magnetic field from an angular position and / or rotational movement of the rotatable magnetic component.

13. 1. A dose delivery system comprising: a drug delivery device comprising a dose button coupled to a device body, a container containing a drug, and an end of the body configured to receive a needle, the dose button having a cylindrical button sidewall; The dose detection module according to any one of claims 1 to 12, removably attached to the dose button; A dose delivery system comprising:

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