Drug delivery device having a sensing system

Abstract

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

Description

[Technical Field]

[0001] The present disclosure provides a drug delivery device and / or a proximal end portion of the drug delivery device. Electronic dose detection system for modules adapted for possible attachment - Patents.com The dose delivery detection system detects the dose of a drug delivered by a drug delivery device. The system is operable to detect data for determining: [Background technology]

[0002] Patients suffering from various illnesses often have to inject themselves with medication. To enable people to self-administer medications conveniently and accurately, injection pens are often used. A variety of devices, commonly known as injectors or injection pens, have been developed. These pens are loaded 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. and dispensing the contained medication from an outlet at the distal cartridge end, typically through a needle. With disposable or pre-filled pens, the pen may run out of the supply of medication in the cartridge. After sufficient use, the user discards the entire pen and begins using a new replacement pen. Reusable pens are used to deplete the supply of medication in the cartridge. 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 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 The relative movement of the members of the drug delivery device is measured to assess the delivered dose. However, mass production and reproducibility throughout the product life cycle are key challenges. The system is designed to be integrated into a device or module to achieve a certain degree of accuracy. Administration of the correct amount of medication is difficult if the dose delivered by the medication delivery device is accurate. Many pen injectors and other drug delivery devices require the device to be equipped during the injection event. does not include functionality for automatically detecting and recording the amount of medication delivered by the device. Without a streamlined system, patients must manually track the amount and time of each injection. Thus, automatically detecting the dose delivered by the medication delivery device during an infusion event. and / or to overcome one or more of these and other drawbacks of the prior art. You need a device that can do this. Summary of the Invention

[0004] In one embodiment, the device includes a device body and a device attached to the device body and configured to rotate during dose delivery. and a dose setting member rotatable relative to the device body about the dose setting member. The dose setting members are arranged radially spaced apart from one another around the axis of rotation of the dose setting members. The actuator or dose button includes a sensed element that includes a surface feature that is configured to The sensed element is attached to the body and is used during dose delivery in relation to the dose delivered. The rotation sensor is rotatable relative to the amount button. The rotation sensor contacts the surface feature of the sensed element. The dose button may be configured to accommodate a rotation sensor. The element moves over the surface feature during rotation of the sensed element relative to the dose button during dose delivery. The rotation sensor is arranged to detect movement over the surface features during rotation of the dose setting member. The controller is configured to generate a signal in response to the movement of the rotating element. The sensor may be operably coupled to and housed by the dose button or module. In response to receiving a signal from the rotation sensor, the controller The sensor is configured to determine the number of surface features that have passed by the moving element of the sensor.

[0005] In another embodiment of the medication delivery device, the actuator is adapted to rotate the movable element of the rotation sensor along the axis. a first position in which the movable element of the rotation sensor is disengaged from the axially extending surface feature; and a second position where the actuator is contactable with the dose button. When the actuator is in the second position, the controller may a signal indicating contact with a first feature of the first of the features is received, the controller is fully configured to activate the power state, and the controller and upon receiving a signal indicating contact with a subsequent one of the axially extending surface features, configured to determine the number of axially extending surface features that pass the movable element of the rotation sensor during delivery. It has been completed. [Brief explanation of the drawings]

[0006] Further embodiments of the present disclosure, and its features and advantages, may be seen in the following detailed description taken in conjunction with the accompanying drawings. This will become more apparent by reference to the detailed description. Further, in the drawings, like reference numerals correspond throughout the different views. This shows the part that is being

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

[0008] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, in which: Certain language will be used to describe this, however, and should not be construed as limiting the scope of the invention. It will be understood that this is not intended to define

[0009] The present disclosure relates to a sensing system for a drug delivery device. a dose setting device for determining the dose delivered by the drug delivery device; for sensing relative rotational movement between the member and the actuator. The relative rotational movement correlates with the dose delivered. However, drug delivery devices have been described in the form of pen-type syringes, injection syringes, and the like. pumps and syringes, etc., used to set and deliver a dose of a medication The drug may be any device capable of being delivered by such a drug delivery device. It can be one of the following types:

[0010] Any device described herein, such as device 10, 210, 410, 610, or 810 The cartridge 20 may further include a drug, for example, in a reservoir or cartridge 20. In some embodiments, the system may include one or more devices, including device 10, and a drug. The term "medication" includes, but is not limited to, insulin, insulin lispro or Insulin analogues such as insulin glargine, insulin derivatives, dalaglutide or GLP-1 receptor agonists such as liraglutide, glucagon, glucagon analogues, and glucagon-like compounds are used. Lucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, oxy oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies and the above-mentioned devices refers to one or more therapeutic agents, including any therapeutic agent capable of being delivered by a device such as that used in The drug may be formulated with one or more excipients. The device is for delivering the drug to a human. and operated by the patient, caregiver, or medical professional generally in the manner described above.

[0011] The exemplary medication delivery device 10 is a pen configured to inject medication into a patient through a needle. 1-4 as a syringe-type syringe. The device 10 comprises a distal portion 14 and a proximal portion The distal portion 14 includes a main body 11 having an elongated pen-shaped housing 12 containing a portion 16. The distal portion 14 is received within the pen cap 18. Referring to FIG. 2, the distal portion 14 extends during a dispensing operation. a reservoir or a syringe configured to hold a medicinal solution to be dispensed through its distal outlet end; The distal portion 14 includes a cartridge 20. The outlet end of the distal portion 14 is protected by a removable cover 25. The syringe is equipped with a removable needle assembly 22 including a syringe needle 24 enclosed within a syringe. The injection mechanism 26 is disposed within the reservoir 20. The injection mechanism disposed within the proximal portion 16 is During a dispense operation, the piston 26 is advanced toward the outlet of the reservoir 20 to release the contained drug. The injection mechanism is operable to force the piston through the reservoir 20. Illustratively, a screw is axially movable relative to the housing 12 to advance the screw 26. The drive member 28 is in the form of a

[0012] The dose setting member 30 is mounted in the housing 12 for setting the dose to be dispensed by the device 10. In the illustrated embodiment, the dose setting member 30 is connected to the pump 12. During dispensing, the nozzle 14 moves in a spiral motion about the longitudinal axis of rotation AA relative to the housing 12 (i.e. axial and rotational movement simultaneously). is a dose setting member that is fully threaded into the housing 12 in its home or zero dose position. The dose setting member 30 indicates the maximum dose that can be delivered by the device 10 in a single injection. The screw threads extend proximally from the housing 12 until it reaches a fully extended position corresponding to The extension positions are operable to provide incremental extension positions (0.5 or 1 unit of dose setting). from a position corresponding to the maximum dose deliverable by the device 10 in a single injection. to a corresponding fully extended position, deliverable by device 10 in a single injection. Rotate the housing 12 distally until it reaches the home or zero position corresponding to the minimum dose. Screwed in, can be in any position.

[0013] 2 to 4, the dose setting member 30 moves in a spiral motion relative to the housing 12. The dose setting member 30 is threaded onto 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. The screw member 32 has a helical thread that engages with the threaded outer 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. , including dose indicator markings such as numbers visible through the dose window 36. 30 is connected to the open proximal end of the dial member 32 and fits within the opening 41 of the dial member 32. axially and rotationally relative to the dose dial member 32 by a detent 40 received in In one example, the dose setting member 30 includes a dial and further including an optional collar or skirt 42 disposed about the periphery of the proximal end of member 32. The skirt 42 is secured to the dial member 32 by tabs 44 received in slots 46. The shaft is axially and rotationally locked by the shaft.

[0014] Thus, the dose dial member 32, flange 38, and skirt 42 all rotate Since the dose setting member 30 is fixed together electrically and axially, The dose dial member 32 is used for setting the dose and dispensing the medication. A flange 38 is attached to the dial member 32 and is directly involved in driving the delivery. As will be described, in cooperation with the clutch, the dial member 32 is selectively coupled to the dose button. As shown, the skirt 42 is provided with a dose dial member for the user to set the dose. 32 provides a surface on the exterior of body 11 so that it can rotate.

[0015] In the embodiment shown in FIG. 18, the dose button of the illustrated device 10 is the same as that of FIGS. It is an integral component that combines both the cart 42 and the dose button 56. In this embodiment, the flange is attached to the dial member and cooperates with a clutch described later to rotate the dial. The valve member is selectively coupled to an integral dose button shown as button 656. The radially outer surface of the dose button 656 is in contact with the device body for rotating the dial member. 11 outer surfaces.

[0016] The skirt 42 illustratively has a plurality of surface contours formed on the outer surface of the skirt 42. The surface contour 48 illustratively includes an outer surface of the skirt 42. longitudinally extending ribs and grooves circumferentially spaced about the surface to allow the user to grip the skirt. In an alternative embodiment, the skirt 42 is removed. or is integrated with the dial member 32, allowing the user to turn the dose dial to set the dose. The handle member 32 can be gripped and rotated.

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

[0018] The dose button 56 has a disc-shaped proximal end surface or face 60 and a distally extending and annular wall portions 62 spaced apart radially inwardly of the outer periphery, with an annular lip 64 therebetween. The face 60 of the dose button 56 is formed by a hand to push the actuator 50 distally. It serves as a pressure surface to which force can be applied dynamically, i.e. directly by the user. The dose button 56 illustratively includes a recessed portion 66 centrally located on the proximal face 60, but Face 60 may alternatively be a flat surface. A biasing member 68, illustratively a spring, may be attached to the button. 56 and a proximal surface 72 of the tubular flange 38. The dose button 56 biases the dispenser 50 and the dose setting member 30 axially away from each other. It is depressible by the user to initiate a dose dispensing operation. The cart 42 is omitted from the device and the annular wall portion 62 of the dose button 56 is shown in the figures. The skirt extends distally relative to the dial member to a position approximately at the distal limit of the skirt. do.

[0019] The delivery device 10 is operable in both a dose setting mode and a dose dispensing mode. In the set mode of operation, to set the 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. It is 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 medication. The amount is visible to the user via dial index markings shown through the dosing window 36. The actuator 50, including the dose button 56 and clutch 52, is in the dose setting mode. It moves axially and rotationally together with the dose setting member 30 during dialing.

[0020] The dose dial member 32, flange 38 and skirt 42 (if employed) are all are rotationally fixed to one another and due to the threaded connection between the dose dial member 32 and the housing 12 , which rotates and extends proximally of the medication delivery device 10 during dose setting. During this time, the dose button 56 is secured to the flange 38 and clamp 56 which are biased together by a biasing member 68. 2) in the skirt 42. During the dose setting process, the skirt 42 and dose button 56 are " This rotation relative to the housing causes the drug to move in a spiral from a "start" position to a "end" position. The dosage is proportional to the dosage set by operation of the drug delivery device 10.

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

[0022] The axial movement of the actuator 50 compresses the biasing member 68, causing the dose button 56 and the tubular flange 38. This relative axial The movement separates the complementary splines 74 on the clutch 52 and 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 Also, the dose setting member 30 and the actuator 50 are freely Because of the relative rotation, user engagement of the dose button 56 by pressing it activates the The actuator 50 is held against rotation relative to the device housing 12.

[0023] The actuator 50 is continuously pushed axially without rotating relative to the housing 12. 3. When the dose button 56 is pressed, as the dial member 32 rotates relative to the dose button 56, the 2 is screwed back into the housing 12. The quantity markings are visible through the 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 needle 24 (FIG. 2) is inserted into the syringe and releases the drug through the needle 24.

[0024] During a dose dispensing operation, the amount of medication released from the medication 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 is performed by mating the female threads of the dial member 32 with the corresponding male threads of the sleeve 34. The process is completed when the distal end of the device 10 is reached (FIG. 2). The syringe may then be repositioned in the ready or zero dose position.

[0025] The dose delivered depends on the rotation of the dose setting member 30 relative to the actuator 50 during dose delivery. This rotation can be derived based on the "cylinder" when the dose setting member rotates during dose delivery. This can be determined by detecting the incremental movement of the dose setting member being "loaded".

[0026] Further details of the design and operation of the exemplary delivery device 10 are provided in Medication Delivery Device 10. ispensing Apparatus with Triple Screw Th reads for Mechanical Advantage No. 7,291,132, the entire disclosure of which is incorporated herein by reference. Another example of a delivery device is described in " Automatic Injection Device With Delay Me chanism Including Dual Functioning Biasi No. 8,734,394, entitled "Member of the NG" An automatic injection device, such device administering a drug based on sensing relative rotation within a drug delivery device. and one or more of the various methods described herein to determine the amount of drug delivered from the drug delivery device. Another example of a delivery device is incorporated herein by reference in its entirety. The Medication Injector Apparatus us with Drive Assembly that Facilitates Reusable resettable devices can be found in U.S. Patent No. 7,195,616 entitled "Reset" and a functional pen-type device, such as a drug delivery device that is sensitive to relative rotation. The present invention provides a method for determining the amount of drug delivered from a drug delivery device based on the above-described method. The sensor system may be modified using one or more of the various sensor systems described above.

[0027] The dose detection system comprises a sensing component and a sensed component attached to a member of the medication delivery device. The term "attached" means that they are and adjusting the position of the component to another component of the medication delivery device so that the medication delivery device is operable as described in For example, the sensing component may be directly attached to the element or member. disposed on, received within, integrated into, or otherwise connected to a member The connection may be, for example, by frictional engagement. Connections formed by splines, snap or press fits, sonic welding or adhesives It may include.

[0028] The term "directly attached" refers to two components, The term refers to a structure in which one component and one part are connected to an object without using intermediate parts other than the attachment components. Used to describe attachments that are physically fastened together. A fastener, adapter, or fastening system that is placed between two components to facilitate installation. Other parts of the stem (such as a compression membrane) may be included. The manner in which the dial member 32 is coupled to the dose button 56 by the clutch 52 in FIG. This is distinct from an attachment in which components / members are connected by one or more intermediate functional members, such as Be separated.

[0029] The term "fixed" refers to the state in which the indicated motion may or may not occur. It is used to indicate that two parts may rotate and move together. When required, the first member is "fixed rotationally" with the second member. In one aspect, a member is functionally, but not structurally, "fixed" to another member. For example, a frictional engagement between two members may be provided to rotationally lock them together. One member may be pressed against another member in this way, but the two members are held together by the pressing of the first member. Without it they cannot be fastened together.

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

[0031] Illustratively, the dose detection system may include a sensor system as described herein. A controller is operatively connected to the sensor system and includes a suitable electronics assembly. and receives the output from the rotation sensor, which the controller uses to determine the total angular displacement. Rotation sensor showing the count from first to last for the total number of counts The controller begins receiving the generated signal from the medication delivery device. Data indicative of the angular movement of the dose setting member that can be used to determine the dose achieved from the output. The controller may be configured to receive data transmitted by operation of the medication delivery device. The controller may be configured to determine the dose achieved from the output. It may include conventional components such as a power source, memory, a microcontroller, etc. Some components may be accessed by a computer, smartphone, or other device. , may be provided separately and then connected to an external controller at an appropriate time, such as by wired or wireless connection. Means are provided for operably connecting the roller component to the sensor system.

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

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

[0034] The dose detection system involves detecting relative rotational movement between two members. The degree of rotation, which has a known relationship to the dose, allows the sensor system to measure the dose from the start of the dose injection. It operates to detect the amount of angular movement to the end of dose injection. The typical relationship is that an angular displacement of the dose setting member of 18° is equal to one unit dose, Other angular relationships are also suitable, for example, 9, 10, 15, 20, 24 or 36 degrees. The sensor system may be used for measuring the fullness of the dose setting member during dose delivery. Operable to determine the angular displacement. Thus, if the angular displacement is 90°, then 5 A unit dose has been delivered.

[0035] Angular displacement is determined by counting dose increments as the injection progresses. For example, the sensing system may be configured to sense the rotation angle of the subject so that each repetition represents a predetermined degree of rotation. A repeating pattern of knowledge elements can be used. Advantageously, the pattern Establishing that the repetition corresponds to the smallest dose increment that can be set using the drug delivery device It is possible.

[0036] The sensor system components are permanently or removably attached to the drug delivery device. In an exemplary embodiment, at least some of the components of the dose detection system may The drug delivery device may be 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

[0037] The sensor system measures the relative rotation of the sensed component and therefore the dose setting member during dose delivery. The dose delivered by the drug delivery device is then determined. In an embodiment, a rotation sensor is attached to the actuator and rotationally fixed. The actuator does not rotate relative to the body of the medication delivery device during dose delivery. In this embodiment, the sensed component is attached to the actuator and device body during dose delivery. It is attached to and rotationally fixed to a dose setting member which rotates relative to it. In some of the embodiments described herein, the sensed components are circumferentially arranged relative to one another. The rotation sensor includes a ring structure having a plurality of proximally extending projections disposed thereon. The delivery element is shaped and sized to deflect the delivery element. Removably attachable to the dose button of the device or as shown in Figures 10-11. In the embodiment shown, a dose button is provided for the module to be integrated into the dose button of the delivery device. It can be provided.

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

[0039] The dose detection module 82 includes a body 88 attached to the dose button 56. 8 illustratively includes a cylindrical side wall 90 and a top wall 90 extending over and sealing the side wall 90. 2. For example, in FIG. 5, sidewall 90 attaches module 82 to dose button 56. 1. The module is shown schematically as having an inwardly extending tab 94 that attaches to the module. The module 82 is attached to the dose button 56 so that pressing the module will deliver the set dose. can be.

[0040] The dose detection module 82 may alternatively be a snap or press fit, threaded interface, etc. It may be attached to the dose button 56 via any suitable fastening means, although in one embodiment Now, remove the module 82 from the first drug delivery device and then remove it from the second drug delivery device. The attachment may be at any position on the dose button 56. provided that the dose button 56 is in contact with the dose setting member 30 as discussed herein. It is assumed that the shaft can be moved any required amount in the axial direction.

[0041] During dose delivery, the dose setting member 30 is free to move relative to the dose button 56 and module 82. In an exemplary embodiment, the module 82 is coupled to the dose button 56 and the rotation lock. tionally fixed) and does not rotate during dose delivery. This is shown, for example, in tab 9 of Figure 5. 4 or when the module 82 is moved axially relative to the dose button 56 Opposing splines or other features on the module body 88 and dose button 56 In another embodiment, the modular structure may be provided by mating surface features. Distal pressure on the valve provides sufficient frictional engagement between the module 82 and the dose button 56. 4, so that the module 82 and dose button 56 remain rotationally fixed together during dose delivery.

[0042] The top wall 92 is spaced from the face 60 of the dose button 56, thereby preventing the electronics assembly from Compartment 78 is provided to contain part or all of compartment 76. defines a chamber 96, which may be open at the bottom or may be enclosed by a bottom wall 98 or the like. The bottom wall 98 may be positioned to directly abut the face 60 of the dose button 56. Alternatively, if the bottom wall 98 is present, it may be spaced from the dose button 56. Other contact between the module 82 and the dose button 56 may be added to the module 82. The resulting axial force can be used to transmit to the dose button 56.

[0043] Further disclosed herein is a method for controlling the relative rotation between the dose setting member and the device body. and a dose detection system operable to determine a delivered dose based on the measured dose. The dose detection system is attached to the device body and rotates relative to the device body about the axis of rotation during dose delivery. The dose setting member is rotatable relative to the sensing element. The actuator is attached to the device body and moves against the device body during dose delivery. The sensed element is held against rotation relative to the amount of dose delivered. Associated with this is the rotation relative to the actuator during dose delivery.

[0044] The dose detection system is a sensor system that includes a rotation sensor attached to the actuator. The sensed element comprises surface features spaced radially around the axis of rotation of the dose setting member. The surface features may be configured to correlate to the equivalent of one unit of dosage, but may also include other Angular relationships are also appropriate, e.g., 9, 10, 15, 18, 20, 24 or 36 degrees per unit. The rotation sensor is attached to the actuator and can be used for 0.5 units. a movable element having a contact portion that can be rested and spring-loaded in the direction of a surface feature of the sensor element; whereby the contact surface is adapted to detect rotation of the sensed element relative to the actuator during dose delivery. The rotation sensor is positioned to move over the surface feature during rotation. The controller responds to movement of the contact portion on the dose setting member and generates a signal corresponding to rotation of the dose setting member. A roller responds to signals generated by the rotation sensor to activate the actuator during dose delivery. to determine the amount of dose delivery based on the detected rotation of the dose setting member relative to the Determine the volume count.

[0045] The surface features may include anything that can be detected by a rotation sensor. ,Sensor systems can detect a variety of sensed properties, including, for example, tactile, optical, electrical, and magnetic properties. In one aspect, the surface features may be based on the fact that the dose setting member is A physical feature that allows for the detection of incremental motion as the object rotates.

[0046] The contact surface must be physically aligned to ensure proper contact between the contact surface and the physical feature during rotation. In one embodiment, the movable member is biased against the feature in a position displaced from the contact surface. In one example, the movable elastic member has one portion attached to the actuator. The member comprises a beam attached to the actuator at one end and having a contact surface at the other end. The beam is bent to bias the contact surface toward the surface feature; The movable member may be biased in any of a variety of other ways. In addition to using a resilient beam, e.g. For example, the bias may be provided by the use of a spring element. For example, it may comprise a compression, tension, or torsion coil spring. The movable member is supported by a separate elastic member or spring component that supports the movable element. can be biased against the surface features.

[0047] In one embodiment, the surface features are uniformly spaced intermittently about the axis of rotation of the sensed element. In certain aspects, the surface features are of equal radius separated by intervening recesses. The contact surface of the movable element is adapted to overcome and intervene the protrusions. The movable element is arranged to move inward relative to the recess. The spring may be a resilient beam that bends smoothly, or a translational member that rides on a protrusion.

[0048] In one aspect, the protrusion tilts upward in a direction opposite to the rotation of the sensed element during dose delivery. In another aspect, the protrusions are arranged to facilitate movement of the contact surface on the protrusions along the protrusions. different in opposite angular directions to provide detection of the rotational direction of the sensed element relative to the eta The protrusions extend in any direction that can be detected by the moving element. For example, the protrusions may extend axially or radially. Axial protrusions may extend proximally. The radial projections may extend medially or laterally. stomach.

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

[0050] In one embodiment, the sensing system of the dose detection system 80 is originally configured to detect the drug In another aspect, a modular dose detection system is disclosed. The use of removably mounted modules is and / or with a medication delivery device in which the dose setting member includes a portion external to the medication device housing. These external moieties are particularly suitable for use in the administration of Direct attachment of the module to actuators such as buttons and / or The attachment of the sensed element to a dose setting member such as a tap, flange, or dose dial member Alternatively, the sensed element may be integral with the drug delivery device and the module may be attached. This is a more complex system that includes a rotation sensor and controller. This has the advantage that the expensive electronic equipment can be reused in different drug delivery devices. The sensed element can then be configured using relatively simple features, such as radially spaced protrusions. This does not significantly increase the cost of the drug delivery device.

[0051] An exemplary drug delivery device incorporating an exemplary dose detection system is shown in FIGS. 5-9. The device may include a dose setting device such as a dose dial member 32 and / or a flange 38. A sensor for detecting surface features of the sensed element extending from one or more of the components of the sensor 30. In particular, the sensor system 84 of the dose detection system 80 includes a rotation sensor 8 6 and a sensed element 99 having surface features. Examples of the location and configuration of the surface features are: Illustrative examples include the axial surface features of the flange (e.g., FIG. 6), the axial surface features of the dose dial member, and the directional surface features (e.g., FIG. 10), radially outer surface features of the dose dial member (e.g., 20), and radially inner surface features of the flange (e.g., FIG. 23). There are.

[0052] In one example shown in FIG. 6, the sensed element 99 includes a ring 100 coupled to the flange 38. The ring 100 is attached to the flange 38 (as shown) or the dose dial member 32 by adhesive and and / or may be permanently secured with fasteners, or may be secured by, for example, mechanical fasteners or supports. Removably attached to flange 38 or dose dial member using a retaining component. It will be appreciated that the ring may be omitted and the surface features may be configured as follows: For example, by molding or additive manufacturing, a single The member may be integrally formed from the flange 38 or dial member 32 .

[0053] As shown in FIGS. 6 and 7, the surface feature 101 includes a series of ramp-like protrusions 102. The rotation sensor 86 includes one or more moving elements 103 (FIG. 5), in this example a dose button. 56, through the button opening 105 defined by the face 60 of the flange 38. When rotated relative to the dose button 56, it rests on a surface feature shown as a protrusion 102. a follower pin 104 arranged to have a distal contact surface 111 that can The pin 104 is coaxially aligned with a button opening 105 defined by the distal bottom wall 98. The module opening 107 is shown extending through the module opening 107. The inner surfaces defining the pin and button openings, respectively, are pinned along two positions during axial movement. Such openings 105, 107 may be configured to provide bearing support for the bearings. The size and configuration enhance the linear axial movement of the pin to accommodate the sensor or sensor employed. This can reduce inconsistent readings from the switch. For redundant sensing, more than one pin and corresponding pins defined by each component An opening for the opening may be used.

[0054] The pin 104 is fitted with a pin flange 106 received between the contact surface 111 and the dose button 56. A coil spring 108 is disposed between the pin flange 106 and the dose button 56. This biases the pin 104 distal to the protrusion 102. The flange 38 rotates during dose delivery. The pin and dose button then maintain their relative positions, and the contact surface 111 of the pin 104 The coil spring 108 rests against the biasing force of the coil spring 108 on each surface feature, shown as a protrusion 102. The pins 104 then drop into the recesses 110 between the adjacent protrusions. This causes the pin 104 to act as a compliant member that follows the contours of the protrusions and recesses.

[0055] The rotation sensor 86 is rotated by the pin 10 when it passes over the protrusion 102 and falls into the recess 110. The sensor element 114 further includes a sensing element 114 positioned to detect movement of the sensor element 114. The pin 104 may be provided in a variety of forms operable to detect translational movement of the pin 104. For example: , the sensing element 114 moves in the proximal direction each time the pin 104 passes over the protrusion 102 in FIG. a microswitch operative to detect axial movement of the pin 104 in the This actuation causes the ring 100 to move past each projection / recess pair. This results in continuously changing the on / off or off / on setting of the microswitch.

[0056] In the manner previously described, the rotation sensor 86 has a protrusion that triggers the sensing element 114 during dose delivery. The rotation sensor 86 detects the angular movement of the dose setting member by counting the number of rotations. Signals indicative of this angular movement are generated and these signals are used by the controller to regulate the timing of dose delivery. Determine the total rotation of the dose setting member during dose delivery, which can be used to determine the amount. The rotation sensor 86 generates a signal indicating the number of counts, and the controller receives the generated signal. The controller may store the count in an internal memory and / or The controller may electronically transmit the counts to an external device. The data can be compared to an internal database that correlates the total angular motion and therefore the delivered dose. The determined angular motion and / or delivered dose may be determined by the robot as part of the electronics assembly. may be displayed (e.g., numerically) on a local display or indicator system, and / or may be transmitted electronically to an external device.

[0057] FIG. 8 shows a cross-sectional view of a vehicle with radially spaced projections 102 and a continuous projection and recess. 1 shows an alternative dose detection system that also uses a moving member 103 with a leading pin 104. As shown in FIG. 8, each movable member 103 has surface features spaced radially about the axis of rotation. The contact surface 116 of the pin 104 moves over the portion 101, e.g., the protrusion 102. 6 allows the pin 104 to slide easily across the protrusion 102 in FIG. including an enlarged end portion 118 preferably made of a durable, low-friction material. 8. The enlarged end portion 118 has a cross-sectional area greater than the cross-sectional area of ​​the pin. As shown, the protrusion 102 rotates in a direction opposite to the direction of rotation of the dose setting member indicated by arrow 122. 1. The protrusion 120 may be formed with a surface 120 that slopes upward in the direction of the arrow 120. This makes the movement of the follower member easier.

[0058] In another embodiment, the opposite side of the protrusion 102 may be angled to allow rotation of the dose setting member in the opposite direction. Furthermore, different tilt angles may be provided on either side of the protrusion to allow the dose detection system to rotate. On the other hand, the opposite side of the protrusion may be at a steeper angle. , rotation in the other direction can be prevented.

[0059] Described herein is a method for moving an actuator distally relative to a device body. , from a dose setting mode or a rest position to a dose delivery mode. In the side-displaced state, the sensed element moves relative to the actuator in the direction opposite to dose delivery. One way to allow rotation is to separate the follower member from the protrusion. However, as also described, in certain embodiments, the actuator may is rotatably fixed to the dose setting member.

[0060] Figure 8 shows the vibration associated with the rotation of the sensed element relative to the actuator during dose delivery. An alternative dose detection system is shown that operates by discharging a sensing element 99. When rotated in direction 122 relative to member 103, contact surface 116 engages pin 104 with dose setting portion 106. Once the contact surface 116 is pressed against the biasing member, e.g., spring 108, the protrusion Once past the apex, the biasing member quickly pushes the follower member down into the subsequent recess 110. 1, as sensed element 99 moves further in direction 122, spring 108 pushes pin 104 1. Push down into recess 124 where it is suddenly stopped by contact with the bottom of the next recess 124. This sudden stop is accompanied by vibrations that are detected by the rotation sensor.

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

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

[0063] Significant axial movement of the pin 104 relative to the dose button 56 is detected by the background accelerometer The rotational accelerometer 128 senses the rotational accelerometer 132 more strongly than the rotational accelerometer 132. vibrations sensed by the accelerometer are substantially the same as those sensed by the background accelerometer. If the rotation of the sensed element is equal to the rotation of the sensed element, then no rotation of the sensed element is indicated. The amount of vibration detected by the accelerometer is greater than the amount of vibration detected by the background accelerometer. If the detected rotation is substantially greater than the rotational speed of the sensed element, a rotation of the sensed element is indicated. The detected rotational vibration is compared to the background vibration to determine the effect on the actuator during dose delivery. The vibrations indicative of rotation of the sensed element are identified.

[0064] The movement of the follower member during rotation of the sensed element may also be associated with an associated sound. 04 hitting the bottom of the recess 124 produces a distinctive sound. uses this sound to detect the rotation of the sensed element 99 relative to the dose button 56. Also shown in FIG. 8 is a microphone 134 which forms a component of an alternative sensing system. Upon detecting a predetermined sound indicative of rotation of the sensed element, the rotation sensor generates a signal that identifies the rotation of the sensed element associated with dose delivery. To be able to distinguish, an additional background sound microphone may be used.

[0065] As shown in FIG. 8, the compliant member may be biased by, for example, a coil spring. The compliant member may be biased against the surface feature in a variety of other ways. For example, 9, a resilient portion 104 may be used to bias the pin 104 against the protrusion 102. A resilient member 136 is attached at one end to the underside 138 of the dose button 56. The resilient member 136 is At the opposite end, it includes a portion 140 that rests against the enlarged end portion of the contact surface 116 of the pin 104 . The movement of the contact surface 116 over the protrusion causes the pin to move upwards as opposed to downwards on the resilient member 136. The contact surface 116 is translated when the surface is moved, thereby maintaining the contact surface 116 in position relative to the surface features. Alternatively, instead of the pin 104, the compliant member may comprise a resilient member 136, the contact surface being at the end It may be located in portion 140.

[0066] Referring now to Figures 1-2, the amount of the dose set by the operation of the device is determined. 10. A drug delivery device equipped with a sensing system, further described as being used for Such amounts are shown to be relative values ​​during dose setting between the components of the drug delivery device. The determined rotational movement is based on sensing an appropriate rotational movement, the sensed movement being applicable to the set dose amount. In a different embodiment, the sensing system may be configured to detect the presence or absence of a signal by operating the device. the dose set and / or the dose delivered, or alternatively In essence, the device determines both the amount of dose set and the amount of dose delivered. The system is configured to determine the

[0067] 10-11 show a rotary sensor located within the dose button 256 rather than in a module. 286, herein referred to as 210. The device 210 shows a proximal portion of the device in use. at least in part, as described with reference to device 10. It contains many of the same components that operate for dispensing, and such components have the same corresponding The device 210 is shown as a device within an integrated dose detection sensing system. Such sensing system may be modular for removable attachment to the dose button. It can be incorporated into the rule.

[0068] The dose setting member 230 is configured to set the dose to be dispensed by the device 210. The dose setting member 230 is connected to the seat housing 212. proximally, to a fully extended position corresponding to the maximum dose deliverable by device 210 in a single injection. The cylinder of the dose setting member 230 is operable to thread off until it reaches the desired position. The dose dial member 232 engages a corresponding threaded inner surface of the housing 212. the dose setting member 230 includes a helically threaded outer surface that is threaded relative to the housing 212 The dose dial member 232 is adapted to be attached to a device such as the sleeve 34 of FIG. a helically threaded inner surface that engages with the threaded outer surface of the sleeve of device 210; The outer surface of the dial member 232 includes a dose window 23 to indicate the set dose to the user. 6. The tubular flange 2 of the dose setting member 230 includes a dose indicator marking visible through the 38 is coupled within the open proximal end of the dial member 232, for example, as shown in FIG. A detent received within an opening in dose dial member 232 allows dose dial member 23 2 is axially and rotationally locked to the

[0069] The actuator 250 of the delivery device 210 is received within the dose dial member 232. The proximal end of the clutch 252 includes a The dose button 256 of the actuator 250 includes a stem 254 that , located proximal to the dose setting member 230. The mounting collar 258 of the dose button 256 is attached to the stem 254 of the clutch 252, such as by interference fit or ultrasonic welding. , axially and rotatably securing the dose button 256 and the clutch 252 together. A biasing member 268, which is essentially a spring, engages the distal surface of the dose button mounting collar 258 and the dose setting portion. and the proximal surface of the tubular flange 238 of the actuator 250 and the dose setting member. The dose button 256 initiates the dose dispensing operation. The biasing member 268 can be pressed by a user to bias the dose button 256 (FIG. 10). The dose button 256 is biased in the proximal first position (as shown in FIG. 1) during the dose setting operation. , the user presses the dose button 256 to overcome the biasing force of the member 268 for a dose dispensing operation. axial force sufficient to move the distal end of the stent to a second position (as shown in FIG. 11). It will stay there until

[0070] The dose button 256 has an upper proximal wall 261 with a disk-shaped proximal end surface 260 and a proximal wall an annular wall portion 262 extending distally from 261 to define a button housing lumen 265; The face 260 of the dose button 256 is configured to push the actuator 250 distally. It serves as a pressure surface against which force can be applied manually, i.e. directly by the user. The dose button 256 includes a distal wall 263 axially spaced from a proximal wall 261. 263 may at least partially divide the lumen 265 into two lumen portions, proximal and distal. The mounting collar 258 of the dose button 256 is attached to the stem 254 of the clutch 252. For purposes of illustration, the distal wall 263 is shown extending distally from a midpoint of the distal wall 263. 2, surface feature 301 is disposed within bore 265, radially outward of biasing member 268. As shown, the rotation sensor and controller are located within lumen 265. It is being done.

[0071] The distal wall 263 is such that a portion of the sensor system extends distally beyond the distal wall 263. The distal wall 263 may include a separate opening, As shown in FIGS. 10 and 11, a portion of the annular wall portion 262 is cut across the lumen 265. and terminates short of the opposite end of the annular wall portion to define an axial opening 269. The axial openings 269 may be radially spaced apart from the axis AA toward the outer end, The rotation sensors extending through the openings 269 are arranged on the surface radially spaced apart about the axis of rotation AA. The electronics assembly 276 is located on top of the feature 301. The electronics assembly 276 is housed within the dose button 256. The circuit board 325 contains a number of electronic components and is shown mounted proximal to the distal wall 263. The sensor system 284 is shown mounted on a surface. and a circuit board controller processor in operative communication with the circuit board controller processor to receive a signal from the sensor. The rotation sensor 286 is mounted on the distal surface of the circuit board. The controller of the electronics assembly 276 is shown as a rotation sensor 286 and an internal The assembly 276 includes at least one processing core in electrical communication with an internal memory. The controller includes a battery B, illustratively a coin cell, for powering the device. based on the detected rotation of the dose setting member relative to the actuator, and detecting a dose delivered by the device. Some of the components within the electronics assembly 276 are shown in the are shown as disconnected for illustrative purposes only, and in reality, as shown at 297 in Figure 10, As shown in these and other figures, connectors, wires, Alternatively, they are electrically connected to each other by a conduit or the like.

[0072] A sensor system 284 having a rotation sensor 286 is connected to the dose dial member 232 (shown). and / or one or more of the components of the dose setting device 230, such as the flange 238. It is configured to detect surface features 301 extending from above. For example, see FIG. 2. When illuminated, the axial end face of the dose dial member 232 of the ring-shaped dose setting device 230 233 is a table shown as protrusions 302 radially spaced apart from one another along the axial end face. The protrusions define surface features 301 and are separated by intervening recesses 310. In the example, there are 18 protrusions, each spaced 20 degrees apart from its neighbors.

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

[0074] Pressing the proximal wall 261 causes the dose button 256 to extend from the housing 212 as shown in FIG. Advance dose button 256 distally to compress spring 268. Continue to press dose button 256 distally. This will drive the dose dial 232 back helically relative to the housing 212. As a result, the dose dial 232 and flange 238 are moved by the axially moving dose button. The dose detection system is driven by the dose button and rotates. The electronics assembly may be operable only to sense the surface features of the sensed element. To determine the elapsed time between counts caused by triggering of the rotation sensor by It may include a clock or timer. When the trigger arm is not actuated for a certain period of time, i.e. ,When no count is detected by the controller, this is used to indicate that the dose is complete. It can be shown that:

[0075] Upon sensing the first one of the surface features 301, the controller Configured to activate or activate the Bri 276 to a stronger or full power state The activation trigger feature prevents inadvertent power-on when no dose dispense event is occurring. To minimize losses or usage, a power supply ( The device is configured to allow power transfer from a battery (shown as a battery). In the dose button, a separate activation switch is located and configured within the dose button housing, and the dose button 256 in its distal position. In this case, the activation switch may be, for example, , may be disposed along the top edge of the flange. After operation of the electronics assembly, the controller , the first of the total counts used to determine the total angular displacement and therefore the delivered dose. The generated signal is received from the rotation sensor indicating a count from the beginning to the end.

[0076] 12 and 13 show an example of a rotation sensor 286 provided in the device 210. For example, the rotation sensor 286 may include a sensor body 320 and a pair of contacts 324, 326. The contacts 324, 326 are elastic, meaning they are naturally flexible in one state. It has a flexible configuration that moves or deflects to another state when a force is applied and then to its natural configuration when the force is removed. The sensor body 320 is shown attached to a circuit board 325, Operatively coupled to a controller of the electronics assembly, the contacts 324, 326 or control the sensor signals of the electronic characteristics (voltage, resistance, current signals) defined by the separation. The contacts 324, 326 are configured to transmit to the surface feature 301. During engagement, at least one of the contacts (shown as contact 326) deflects, thereby providing a Alternatively, the contact portions 32 may remain spaced apart in their natural state until they contact each other in a natural state. Both 4 and 326 are configured to deflect and deflect to contact each other upon engagement with the surface feature. After the contact portion 326 engages the surface feature 301, the contact portion 326 Alternatively, the contact portions 324, 326 may return to their natural state in a spaced apart relationship with the contact portions 324, 326. The surfaces remain in contact with each other in the natural state and are separated from the contacting relationship by engagement with the surface feature 301. and may be configured to return to a natural state of contact after passing over the surface feature. According to this, the dose button 256 is in a proximal position when the device is in its first dose setting mode of operation. 13, the rotation sensor 286 is in the proximal position when the device is in its second position. When the dose button 256 is in the distal position in the dose delivery mode of operation, the rotation sensor 28 6 is in the distal position.

[0077] 12-13 show exemplary configurations of the contact portions 324, 326, The first contact portion 324 extends axially from the sensor body 320. The first contact portion 324 is connected to the first segment 320. 30 and a second segment 332 extending from the first segment 330. Segment 330 is shown extending axially from sensor body 320, and second segment 332 is shown extending radially from the first segment 330 at the elbow connection. The second contact portion 326 has a first segment 340 connected to the sensor body 320 and a second segment 340 connected to the sensor body 320. and a second segment 342 extending from the first segment 340. 340 is shown extending axially from the sensor body 320. 2 is shown extending generally radially from the first segment 340 at the elbow connection. The second segment 342 is an arm portion connected in order from the first segment 340. Arm portion 344 includes a transition engagement portion 346 and a tip contact portion 348. , the tip contact portion 348 is positioned below the second segment 332 of the first contact portion. The arm portion 344 extends axially from the first segment 342. and extending radially at an angle. The transition engagement portion 346 is configured to directly engage the second segment 301. 42 may have a U-shape, V-shape, or angled shape to transition from distal to proximal. The tip contact portion 348 extends radially and, in its natural state, is in contact with the first contact portion 324. The shape of the transition engagement portion 346 may be substantially parallel to and spaced apart from the second segment 332. The shape allows the rotating dose dial member to contact along the surface features 301 without jamming. The depth of the shape of the transition engagement portion 346 may allow the distal surface of the transition engagement portion 346 to slide. When the second contact portion 326 engages the surface feature 301, the second contact portion 326 contacts the first segment at an elbow. flexes proximally at 348, bringing the proximal surface of the tip contact portion 348 into contact with the second segment of the first contact portion 324. The contact is sized to contact the distal surface of the electrode 332. Alternatively, the contacts, such as contact 326, may be sufficiently thick to generate a characteristic sensor signal. One of these methods can be used, and the surface feature portion can be made conductive, for example, by being coated with a metallic material. and, as described herein, the rotation sensor generates a signal upon engagement of the contact with the surface feature. This can be done to make it possible to achieve this.

[0078] 15-16 show the proximal portion of the device, referenced herein as 410. The device 410 is one of the electronic components in an electronics assembly for a dose detection system. and a dosing and administration device as described with reference to device 10 or 210, including at least a portion thereof. It contains many of the same components that operate for dose dispensing and dose administration, and such components have the same counterparts. The device 410 is shown as a device within an integrated sensing system. However, such sensing systems are not intended for removable attachment to the dose button. The device 410 may be incorporated into a module, for example, a device housing 41 2, the dose dial member 432, the flange 438, and the electronics assembly 476, etc. It may have the same device components as device 210, except that, as will be described below, The dose setting member with the rotation sensor configuration and surface features used is different. As noted above, the rotation sensor and controller are located within the bore of the button.

[0079] Dosages that may be used with any of the modules and / or devices described herein Another example of a rotation sensor, generally referenced 486, of the detection sensor system 484. For example, the rotation sensor 486 includes a sensor body 490 and a movable element including a trigger arm 492. Referring to the previous figure, the microswitch includes Trigger arm 492 of rotation sensor 486 to position it over the surface feature 501 The dose button housing is rotated radially from the axis AA towards the outer end so that the The trigger arm 492 is configured to include spaced apart axial openings. Forces that push the arm 492 away from its natural position into an operating position are overcome. The sensor body 490 is biased to its natural state by an internal spring until it is 5 and operably coupled to the controller of the electronics assembly, The sensor signals of the electronic characteristics (voltage, resistance, current signals) determined by the movement of the robot are controlled. The trigger arm 492 is configured to engage with the surface feature 501. The trigger arm 492 may remain in its natural state until it engages with the surface feature 501. After that, the trigger arm 492 can return to its natural state. When the dose button 456 can be actuated to a proximal position in a first dose setting mode of operation, A rotation sensor 486 is located in the proximal position. A biasing member (not shown) biases the dose button and the dose setting portion. The surface feature 501 can be disposed axially between the substrate and the surface as shown in FIGS. As shown in FIG. 16, the device is disposed radially outward of the biasing member. When the dose button 456 is in the distal position in the dose delivery mode of operation, the rotation sensor 48 6 is in the distal position.

[0080] Figure 17 shows an example of a dose setting member having surface features 501. In one example, the flange The axial surface 437 of the proximal end of 438 is formed of an intermediate part, such as a molded part or an additively manufactured part. The surface features shown as protrusions 502 with recesses 510 may be integrally defined. In another example, a ring component having surface features defined along one of its surfaces may be The ring may be connected to the axial surface of the flange with adhesive and / or fasteners. It will be appreciated that the surface features may be permanently or temporarily fixed to the surface. is formed on or otherwise coupled to the dose dial member.

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

[0082] The following embodiments illustrate different configurations of rotation sensors and surface features along the radial direction: 18-21 show a surface feature disposed radially outward relative to the radially outward extending surface feature. 6 shows the rotation sensor of the dose detection system of the device, referred to here as 610. The device 610 is an electronic device in an electronics assembly for a dose detection system. 10, 210, or 410, including at least a portion of the component. It contains many of the same components that operate for dose setting and dose dispensing, such as The same corresponding description applies to all other components of the device 610 within the integrated sensing system. Although shown as a device, such a sensing system may be detachable from the dose button. The rotation sensor can be incorporated into a module for easy installation. Although shown as a microswitch similar to those described herein, the rotation sensor is The device 610 may be, for example, a device housing 61 2, such as a dose dial member 632, a flange 638, and an electronics assembly 676; It may have the same device components as device 210, except that, as will be described below, The rotary sensor configuration and dose setting member having surface features used are different.

[0083] The rotation sensor 686 of the sensor system 684 is mounted on the annular wall portion 662 of the dose button 656. The sensor body 690 of the rotation sensor 686 is shown disposed along the annular wall portion 6 62, or in an alternative embodiment, the sensor itself may be positioned within an opening 695 defined by the sensor. The body 690 may be disposed along the inner surface of the wall portion 662. The movable element may extend longitudinally. A trigger arm 692 extends radially inward toward the axis AA. However, the rotation sensor 686 extends along the inner surface of the sensor 686 and dose button housing. to the controller of the electronics assembly, such as through electrical conductors connected between the The rotation sensor 686 is operatively connected to the trigger arm of the rotation sensor 686. The sensor signals of the electronic characteristics (voltage, resistance, current signals) specified by the is configured to send

[0084] 19-21 show flanges with surface features. In one example, flange 638 The radially outer surface 639 of the proximal annular end 641 is a molded or additively manufactured part. etc., around the axis of rotation, shown as radial projections 702 with intervening recesses 710 In another example, the radially outwardly spaced surface features 701 may be integrally defined. A ring component having surface features 701 defined along its side surface is axially aligned with the flange. The ring may be permanently or permanently attached to the flange with adhesive and / or fasteners. It will be appreciated that the surface features 701 may be temporarily fixed. The surface features may be formed on or otherwise coupled to the ear member. The radial projections 702 may include a series of ramp-like projections between the proximal and distal ends. It may extend to define an axial ridge.

[0085] 18-19 show the device 610 in its first dose setting mode of operation in a proximal position. 6 shows the rotation sensor in a proximal position with the dose button 656 in place. can be moved to its distal position (see FIGS. 20-21) and the rotation sensor can be moved to the device. In one example, the trigger arm is positioned in a distal position where the device is in its second dose delivery mode of operation. The dose button 692 is moved to its distal position and the trigger arm engages the surface feature. When engageable, it can enter one of the recesses 710 from the proximal end. counts the number of times the trigger arm moves between the first and last trigger. Such data can be used to determine dose delivery.

[0086] FIG. 22 illustrates a rotating surface disposed radially inward relative to a radially inward extending surface feature. The proximal portion of the device, referenced here as 810, shows the sensor. 10 is at least a portion of the electronic components in an electronics assembly for a dose detection system 844 doses as described with reference to the device 10, 210, 410, or 610 minutes Contains many of the same components that operate for setup and dose dispensing. The same corresponding description applies to the device 810 as a device in an integrated sensing system. While shown in Figure 1, such a sensing system may be a removable attachment to the dose button. The device 810 may be incorporated into a module for The dosing ring 812, the dose dial member 832, the flange 838, the dose button 856, and the electronics 8. The device may have the same device components as device 210, such as vessel assembly 876, except that: A dose setting portion having a rotational sensor configuration and surface features used for sensing, as described below. The materials are different.

[0087] Similar to the configuration of rotation sensor 286, rotation sensor 886 is configured to extend axially from the distal face of the circuit board. The sensor body of the rotation sensor 886 is shown extending through the opening 869. mounted on a circuit board and operably coupled to the controller of the electronics assembly 876 The electronic characteristic is determined by the movement of the movable element consisting of the trigger arm of the rotation sensor 886. It is configured to send sensor signals of various characteristics (voltage, resistance, current signals) to the controller. The rotation sensor 886 is mounted by attaching its trigger arm to the proximal annular end of the flange 838. 841 and arranged radially outwardly to engage surface feature 901. It is configured as follows.

[0088] 23-24 show a flange 838 having surface features. The radially inner surface 839 of the proximal annular end 841 of the 38 is made from a molded part or additively manufactured. 902 with intervening recesses 910. In another example, the radially outer surface may be integrally defined with the surface features 901 spaced apart. a ring component having surface features defined along the axial surface of the flange; The ring may be permanently or temporarily secured to the flange with adhesive and / or fasteners. It will be appreciated that in another example, the surface features 901 may be formed on a dose dial member. The surface feature 901 may be a series of ramp-like protrusions. The surface feature may extend between the proximal end and the distal end to define an axial ridge. do.

[0089] Figure 25 can be used with either Device 10, 210, 410, 610 or 810. The piezoelectric sensor 1000 is a rotation sensor that rotates in the axial direction, the radial direction, and the The orientation may be similar to the rotational sensors described above, such as radially outward or radially inward. The trigger arm 1002 of the piezoelectric sensor 1000 is made of a film of bendable piezoelectric material. The film extends from the sensor body 1004, which is a first The sensor body includes a first electrode 1006 and a second electrode 1008. The sensor body may be made of, for example, fluoropoly Polymer-cast housings such as polyvinylidene fluoride or polyurethane The piezoelectric sensor 1000 may include a transducer that converts mechanical energy into electrical energy. More specifically, the piezoelectric sensor 1000 is connected to a trigger arm 1002. converts the mechanical deformation of a piezoelectric sensor into a proportional electrical signal (charge or voltage). When the trigger arm 1002 is subjected to a mechanical force and undergoes deformation or distortion, the piezoelectric sensor 1000 connects the first electrode 1006 for detection by an analog voltage detector of the electronics assembly. and the second electrode 1008. The mechanical deformation of the trigger arm 1002 of the trigger arm 1000 is elastic. 2 can return to its original natural shape when the force is removed.

[0090] The controller of the electronics assembly receives, from the voltage detector of each piezoelectric sensor 1000, The electronic device may be configured to receive an analog piezoelectric signal, which may typically be a ring-shaped signal. The controller of the instrument assembly may convert the analog piezoelectric signal into a "click" or a variable The signal is converted into a digital signal, such as an intermediate digital signal, which may be a high frequency signal representing the time of a shape event. The controller of the electronics assembly may be programmed to As will be explained, the intermediate digital signal is divided into single steps having a predetermined width W representing a predetermined time. The digital signal may be further programmed to convert the digital signal into a conditioned digital signal, which may be a square wave. .

[0091] The signal processing logic used by the control system. The logic converts the analog piezoelectric signal into a resistor a direct current (DC) voltage offset step using , and then perform an analog-to-digital conversion step using a comparator to generate an intermediate digital signal. The signal is generated when the input voltage is equal to or greater than a predetermined voltage (for example, 1.3V). Alternatively, when the input voltage is below a predetermined voltage, the signal may be ignored. The digital signal turns the signal "on" when the timer starts in the timer start step, and In the timer expiration step, the signal is turned "off" when the timer expires after a predetermined time. The timing steps are performed using a resistance-capacitance (RC) timing loop. The predetermined time associated with the timing step may be performed using an adjusted digital The width W of the data signal is controlled to time-align each rotation and deformation event to minimize errors. The logic can be adjusted to calculate the digital signal counted over a period of time. The number corresponding to the number may be output.

[0092] For example, a device described herein, such as device 210, 410, 610, or 810 The device may include a dose detection system that includes detecting relative rotational motion between two members. The degree of rotation, which has a known relationship to the delivered dose, allows for the embodiments described herein to be The sensor system in either The angular displacement acts to count dose increments as the injection progresses. For example, the sensing system may rotate at a predetermined angle each time. A repeating pattern of sensed elements can be used to provide an indication of the degree of Advantageously, the pattern is such that each repetition corresponds to the smallest increment of the dose that can be set using the drug delivery device. The controller can count the number of signals generated. The count may be transmitted electronically to an external device. The external device described in the specification may be a server, a mobile phone, or other known computer. The counts may be correlated to an absolute rotation angle, which may then be calculated as: Used by the processor of the external device to determine the delivered dose. The signal generated by the first contact among these activates the controller, as previously mentioned. Or may be operable to actuate.

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

[0094] For example, a device described herein, such as device 210, 410, 610, or 810. The device may include an activation feature as described herein to activate the dose button in its distal position during first dose delivery. You can activate the controller by pressing the Upon sensing the first of these features, the electronics assembly controller The start-up trigger characteristic is configured to activate the assembly to a start or full power state. minimizes inadvertent power loss or usage when no dose dispensing events are occurring To do this, a power source (shown as a battery) is required to power the dose-sensing electronics. In other embodiments, a separate activation switch is configured to allow power transfer. , located within the dose button housing of any one of the devices described herein. and can be triggered when the dose button is in its distal position. The switch may be located, for example, along the top edge of the flange.

[0095] In some embodiments, a single sensing system may be used for both dose detection sensing and activation actuation. For example, devices 210, 410, 610, or 810 may be used in the The device according to claim 1, wherein upon sensing a first surface feature, the device activates an electronic device assembly. Or, it may have a controller configured to allow activation to a full power state. The controller then determines the first surface feature (or sequence) after the first surface feature. 2) until the dose setting member stops rotating at the completion of the dose dispensing phase , which is configured to count the total number of surface features. One advantage of this system is that it reduces the number of electronic components in the device and the manufacturing complexity of including additional sensors. The advantage is that it can reduce the risk of

[0096] The illustrated device is manually operated by the user to selectively set a dose and then A reusable drug injection pen, commonly referred to as a pen-type device, that injects a set dose. This type of injection device is well known and the sensing system is constructed differently. Constructed pen-type medication injection devices, alternatively shaped injection devices, and infusion pump devices The drug delivery device may be adapted for use with variously configured drug delivery devices, including The device descriptions are merely exemplary. Drugs may be delivered by such drug delivery devices. The sensing system described further below can be of any of the types that can be achieved. , may be used in other differently configured devices, so the devices are exemplary and not limiting. It is not intended to be.

[0097] In order to clarify its use and to inform the public hereby, 、 , ...and <n> At least one of the following" or "< / n> 、 、... <n> At least one of, or a combination thereof" or "< / n> 、 ,... and / or <n>" is defined by the applicant in the broadest sense and Unless expressly stated otherwise, A supersedes any other implied definition above or below. , B, ... and N. Thus, an expression can consist of any single element alone or in combination with additional elements not listed. Element A, including that element in combination with one or more of the other elements that may be included in combination. , B, ... or N in any combination.

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

[0099] Various aspects are described in this disclosure, including but not limited to the following aspects. 1. A drug delivery device, comprising: a device body; and a dose delivery device attached to the device body. a dose setting member rotatable relative to the device body about a rotation axis during delivery; A rotationally fixed sensed element attached to the dose setting section Axially extending surface features spaced apart radially about the axis of rotation of the member. The sensed elements, including the sensing surface features, and the actuators attached to the device body. the sensed element is related to the dose delivered and is actuated by the actuator during dose delivery. an actuator that is rotatable relative to the rotation sensor; and a rotation sensor attached to the actuator. during rotation of the sensed element relative to the actuator during dose delivery, a movable element positionable to slidably contact the surface feature, and generating a signal in response to triggering of the movable element over the axially extending surface feature. a rotation sensor and a controller operably coupled to the rotation sensor, and detecting the rotational speed of the rotation sensor during dose delivery in response to receiving a generated signal from the rotation sensor. a controller configured to determine a number of axially extending surface features that have passed the moving element; A drug delivery device comprising: 2. The axially extending surface features include alternating protrusions and recesses, and the movable element is During rotation of the sensed element relative to the actuator within, the protrusions and recesses are overcome. A drug delivery device as described in Example 1. 3. The medication delivery device of aspect 2, wherein the protrusion extends proximally from the dose setting member. Chair. 4. Any of aspects 1-3, wherein the dose setting member is a flange or a dose dial member. 1. A drug delivery device according to claim 1. 5. The rotation sensor includes a switch that alternately engages and disengages the axially extending surface feature. The moving element is operable to trigger the switch to generate a signal. A drug delivery device described in any one of claims 1 to 4. 6. The actuator disengages the movable element of the rotation sensor from the axially extending surface feature. 6. The medication delivery device according to any one of aspects 1 to 5, having a first position where the medication is administered. 7. The actuator is adapted to allow a movable element of the rotation sensor to contact the axially extending surface feature. 7. The medication delivery device according to embodiment 6, having a second position where 8. When the actuator is in the second position, the controller controls the axially extending surface feature. When a signal indicating contact with the first feature is received, the controller is fully powered. and the controller is configured to operate in the first state after the first feature. Upon receiving a signal indicating contact with a subsequent one of the directionally extending surface features, and determining a number of axially extending surface features that have passed the movable element of the rotation sensor during rotation. 8. The drug delivery device of embodiment 7, 9. The movable element is operable to generate a signal upon engagement with the axially extending surface feature. The drug delivery device according to any one of aspects 1 to 8, comprising at least one contact portion. vinegar. 10. At least one contact portion includes a pair of contact portions, and one of the pair of contact portions is axially Upon engagement with the extending surface, the contact moves into contact with the other of the pair of contacts to generate a signal. 10. The drug delivery device of embodiment 9, configured as follows: 11. The movement of the movable element relative to the axially extending surface feature is configured to generate rotational vibration. The rotation sensor is configured to generate a signal in response to detecting the rotational vibration. The drug delivery device according to any one of aspects 1 to 8, 12. The rotational sensor includes a rotational accelerometer operable to detect rotational vibrations. 12. The drug delivery device according to claim 11. 13. The rotation sensor is a ground accelerometer operable to detect ground vibrations and wherein the controller is configured to compare the rotational vibration and the ground vibration. and from the comparison, determine vibrations indicative of rotation of the sensed element relative to the actuator during dose delivery. 13. The medication delivery device according to embodiment 12, configured to: 14. Movement of the movable element relative to the axially extending surface feature is configured to generate rotational sound. and the rotation sensor is configured to generate a signal in response to detecting the rotation sound. A drug delivery device according to any one of aspects 1 to 8. 15. The method further comprising: The module engages with a sensed element of the dose setting member of the device body on the outside of the module. 15. The medication delivery device according to any one of aspects 1 to 14, comprising a movable element for 16. The drug delivery system of any one of aspects 1 to 8, wherein the rotation sensor comprises a piezoelectric sensor. device. 17. A drug delivery device, comprising: a device body; and a device body attached to the device body and used a dose setting member rotatable relative to the device body about an axis of rotation during dose delivery, the sensing elements being radially spaced apart from one another around the rotation axis of the dose setting member. a dose setting member including a surface feature; and a dose button attached to the device body. , the sensed element is rotatable relative to the dose button during dose delivery in relation to the dose delivered and the dose button houses a rotation sensor, the rotation sensor detecting a rotation of the dose button during dose delivery. a movable element positionable to slidably contact the surface feature during rotation of the sensed element relative to the surface feature; and a rotation sensor adapted to detect movement of the movable element over the surface feature during rotation of the dose setting member. The dose button is configured to generate a signal in response to a rotation of the movable element of the rotary sensor. a first position disengaged from the feature and allowing the movable element of the rotation sensor to contact the surface feature; a dose button having a rotation sensor operably coupled to the dose button and a second position where the rotation sensor is a controller housed by the tank receiving the generated signal from the rotation sensor; and determining the number of surface features that have passed the moving element of the rotation sensor during dose delivery in response to the and when the dose button is in the second position, a first one of the surface features When a signal indicating contact with a feature is received, the controller is activated to full power. and after the initial first feature, contact with a subsequent one of the surface features. Upon receiving a signal indicating that the axially extending surface has passed the movable element of the rotation sensor during dose delivery, a controller configured to determine a number of features. Chair. 18. The medication delivery device of aspect 17, wherein the rotation sensor comprises a switch. 19. The drug delivery device of aspect 17, wherein the rotation sensor includes at least one contact. Chair. 20. The medication delivery device of aspect 17, wherein the rotation sensor comprises a piezoelectric sensor. 21. The medicament of aspect 17, wherein the surface features extend axially from the dose setting member. Delivery device. 22. Further comprising a biasing member axially disposed between the dose button and the dose setting member; The rotation sensor and controller are disposed within a lumen of the dose button, and the surface features are 22. The method according to claim 1, wherein the biasing member is disposed radially outward of the biasing member. Drug delivery devices. 23. Any one of aspects 1-22, wherein the device body includes a reservoir having the agent. The drug delivery device described.< / n>

Claims

1. 1. An apparatus for detecting operation of an injection device, comprising: a sensed element configured to be rotatable relative to a pin having a proximal end and a distal end connected by a shaft, wherein the distal end of the pin has a contact surface and the proximal end of the pin has a support having a cross-sectional area greater than a cross-sectional area of ​​the shaft; a resilient member arranged to bias the contact surface of the pin into contact with the sensed element such that rotation of the sensed element relative to the pin causes reciprocating movement of the pin; an accelerometer disposed on the support at the proximal end of the pin and configured to detect vibrations indicative of reciprocating motion of the pin; a background accelerometer configured to detect background vibrations caused by movement of the entire device; a controller configured to compare vibrations detected by the accelerometer with background vibrations detected by the background accelerometer and identify vibrations indicative of rotation of the sensed element.

2. The apparatus of claim 1 , wherein the pin is configured to reciprocate axially in the injection device.

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

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

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

6. An apparatus according to claim 1; the injection device containing a medicament; A system having:

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

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

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

10. The apparatus of claim 1 , wherein the background accelerometer is vibrationally isolated from the pin.

11. 10. The device of claim 1, wherein the distal end of the pin comprises an enlarged end portion made of a durable, low-friction material that allows the distal end of the pin to easily slide over the sensed element.

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