EA039601B1 - Dose detection system module for medication delivery device - Google Patents

Abstract

Dose detection systems for medication delivery devices are described. One is a module for removable attachment to a dose button of a medication delivery device. A device with a dose detection system is also disclosed. The module includes a processor and a plurality of magnetic sensors, such as, for example, five or six sensors, operably coupled to the processor and configured to detect the position of a rotating bipolar magnetic ring within the delivery device. A medication identification system is also described.

Description

The present invention relates to an electronic dose determination system for a drug delivery device and, by way of illustration, to an electronic dose determination module releasably attachable to the proximal end portion of the drug delivery device. The system for determining the delivered dose is configured to determine the amount of the drug dose delivered by the drug delivery device and/or the type of drug contained in the drug delivery device.

State of the art

Patients suffering from various diseases often need to administer a drug to themselves. In order to enable a person to conveniently and accurately self-medicate, a variety of devices have been developed, commonly known as a syringe pen or a syringe pen for injection. Typically, these pens are provided with a cartridge containing a plunger and containing a multi-dose amount of liquid medication. The drive member is movable forward to advance the piston in the cartridge to dispense the contained drug from an outlet at the distal end of the cartridge, typically through a needle. In disposable or pre-filled pens, after the pen has been used until the drug cartridge is depleted, the user discards the entire pen and begins using a new replacement pen. In reusable pens, after the pen has been used up to the end of the drug supply inside the cartridge, the pen is disassembled so that the used cartridge can be replaced with a new cartridge, and then the pen is reassembled for its subsequent use.

Many pens and other drug delivery devices use mechanical systems in which the elements rotate and/or move relative to each other in a manner proportional to the dose delivered by the device. Accordingly, the art seeks to provide reliable systems that accurately measure the relative movement of the elements of a drug delivery device in order to estimate the dose delivered. Such systems may include a sensor that is attached to the first element of the drug delivery device and which determines the relative movement of the measured component attached to the second element of the device.

In order to administer the correct amount of drug, the dose delivered by the drug delivery device must be accurate. Many pens and other drug delivery devices do not include a feature to automatically detect and record the amount of drug delivered by the device during an injection. In the absence of an automated system, the patient must manually track the amount and timing of each injection. Accordingly, there is a need for a device that can automatically determine the dose delivered by a drug delivery device at the time of injection. In addition, there is a need for such a dose determination device to be removable and reusable with a variety of delivery devices. In other embodiments of the invention, there is a need for such a dose determination device to be integrated with a delivery device.

It is also important for the delivery of the appropriate drug. Depending on the circumstances, the patient may need to choose either another drug or a different form of this drug. If an error is made as to which drug is in the drug delivery device, the patient will not receive the correct dose and the dose records will be inaccurate. The likelihood of such a situation is substantially reduced if a dose determination device is used that automatically confirms the type of drug contained in the drug delivery device.

The essence of the invention

In one embodiment, the invention describes a drug delivery device containing a rotating measurable element that can be used as part of a dose determination system. An annular measurable element, such as a metal ring, a magnetic ring, or others, is located on the proximal surface of the dose setting component. The dose setting component is attached to the body of the device and is rotatable in accordance with the amount of dose set and/or delivered. The carrier component can fix the element to be measured on the dose setting component in the axial and rotational direction. The carrier component includes a proximal overlapping support in contact opposite an annular measurable element opposite the proximal surface of the dose setting component. In some embodiments of the invention, the carrier component may be provided with elements to facilitate its attachment to the dose setting component. In some embodiments of the invention, the measurable element is attached to the element for setting the dose without the use of adhesive. Other

- 1 039601 The described embodiment of the invention is a method of attaching a measurable element to a dose setting component of a drug delivery device. The steps of the method include: providing a carrier component and an annular measurable element, wherein the carrier component comprises a tubular body sized to fit inside the annular measurable element, a proximal protrusion extending radially beyond the tubular body, and a plurality of connecting branches extending distally from the tubular body at a distance from the proximal ledge; attaching an annular measurement element above the tubular body of the support component and in contact below the proximal ridge; and attaching the carrier with the annular measurable to the dose setting component to position the annular measurable between the radial protrusion and the proximal surface of the dose setting component, wherein the connecting arms of the carrier component cooperate with the dose setting component to lock in the rotational direction of the carrier with the annular measurable element on the component for setting the dose.

Brief description of graphic materials

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

In FIG. 1 is a perspective view of an exemplary drug delivery device with which the dose determination system of this disclosure operates.

In FIG. 2 is a cross-sectional perspective view of the exemplary drug delivery device of FIG. one.

In FIG. 3 is a perspective view of the proximal portion of the exemplary drug delivery device of FIG. one.

In FIG. 4 is an exploded perspective view of the exemplary drug delivery device of FIG. 1, together with a dose determination system in accordance with this disclosure.

In FIG. 5 is a schematic side view, partly in cross section, of a dose determination system module in accordance with another exemplary embodiment of the invention attached to the proximal portion of a drug delivery device.

In FIG. 6 is a cross-sectional view of a dose determination system module in accordance with an exemplary embodiment of the invention attached to the proximal portion of a drug delivery device.

In FIG. 7 is a schematic plan view of rotation sensors positioned to detect magnetic sensing elements attached to a dose setting element in accordance with an exemplary embodiment of the invention.

In FIG. 8 is a perspective view of the dose setting element shown in FIG. 7 containing magnetic measurable elements.

In FIG. 9 is a perspective view of an alternative embodiment of a magnetic dose determination system.

In FIG. 10A-10B and 11A-11B show yet another exemplary embodiment of the invention for dose determination systems using magnetic measurement.

In FIG. 12 is a cross-sectional view of a dose determination system in accordance with another embodiment of the invention, in which the sensor and the measured element are integrated into the drug delivery device.

In FIG. 13 is a schematic side cross-sectional view of a dose determination system module, in accordance with another exemplary embodiment of the invention, attached to the proximal portion of a drug delivery device.

In FIG. 14 is a perspective view of an example of a dispense button of a drug delivery device.

In FIG. 15 is a perspective view of the shell assembly of the dose determination system module shown in FIG. thirteen.

In FIG. 16 is a proximal perspective view of the assembly component of FIG. fifteen.

In FIG. 17 is a distal view of the component shown in FIG. fifteen.

In FIG. 18 is a perspective view of another example of a dispense button on a drug delivery device.

In FIG. 19 is a perspective view of another exemplary dosing button of a drug delivery device.

In FIG. 20 is a perspective view of a module shell assembly of another exemplary dose determination system module mounted on another exemplary dispense button for a drug delivery device.

- 2 039601

In FIG. 21 is a perspective view of the dosing system module shell assembly removed from the dosing button.

In FIG. 22 is a perspective view of the dispense button shown in FIG. 20.

In FIG. 23 is a cross-sectional view of the module shell assembly of FIG. 20.

In FIG. 24 is a cross-sectional view of the shell assembly of the dose detection system module mounted on the dispense button shown in FIG. 20.

In FIG. 25-26 are schematic side cross-sectional views of a dose determination system module in accordance with another exemplary embodiment of the invention attached to the proximal portion of a drug delivery device.

In FIG. 27 is a proximal perspective view of an exemplary dose determination system module electronics unit.

In FIG. 28 is an axial cross-sectional view taken along lines 28-28 in FIG. 25.

In FIG. 29 is a perspective view of the electronics unit shown in FIG. 27.

In FIG. 30 is an exploded perspective view of the drug delivery device proximal end assembly.

In FIG. 31 is a schematic side view, partly in cross section, of the proximal portion of the assembled assembly shown in FIG. thirty.

In FIG. 32 is a proximal perspective view of the flange, carrier, and rotation sensor assembled together.

In FIG. 33 is a proximal perspective view of the assembled flange, carrier, rotation sensor, and spring.

In FIG. 34 is a proximal view of the assembled flange, carrier, and rotation sensor.

In FIG. 35 is a cross-sectional view of another embodiment of a delivered dose determination system module attached to the proximal portion of a drug delivery device.

In FIG. 36 is a proximal axial view of the module shown in FIG. 35 shown with the proximal wall assembly removed.

In FIG. 37 is a proximal perspective view of a component of the module block shown in FIG. 35.

In FIG. 38 is a partial distal perspective view of the module shown in FIG. 35 shown with the delivery device lowered.

In FIG. 39 is a perspective view of the light guide element provided in the module shown in FIG. 35.

In FIG. 40 is an axial view of yet another exemplary embodiment of a delivered dose determination system that uses magnetic measurement.

In FIG. 41 is a cross-sectional view of the proximal portion of the drug delivery device and its relative position with respect to the magnetic sensing system.

In FIG. 42 is a graph comparing the measured rotational magnetic flux waveform and a purely sinusoidal model of the magnetic flux waveform during rotational position measurement.

In FIG. 43 is a graph comparing the results of settling/dose errors caused by magnetic non-uniformity and harmonic distortion from a sample of N35 class magnets made by conventional manufacturing methods for 4, 5, and 6 sensor arrangements.

In FIG. 44 is a graph comparing the results of settling/dose errors caused by magnetic non-uniformity and harmonic distortion from higher grade N35 magnet samples produced by custom manufacturing methods for 4, 5, and 6 sensor arrangements.

In FIG. 45 is a graph illustrating various orders of harmonics in percent for the spread in product characteristics from batch to batch of N35 class magnets manufactured by conventional manufacturing methods.

In FIG. 46 is a block diagram of the controller and its components.

In FIG. 47 is an exploded view of the module shown in FIG. 35 with its components axially offset from each other.

Detailed description of the invention

In order to facilitate an understanding of the principles of this disclosure, reference will be made to embodiments of the invention illustrated in the drawings, and specific language will be used to describe them. However, it should be understood that the scope of the invention is thus not intended to be limited. This disclosure relates to measurement systems for a drug delivery device. In one aspect, the measuring system is for determining the amount of dose delivered by the drug delivery device based on measuring the relative rotational movement between the dose setting element and the drug delivery device actuator. Measured relative angular positions or displacements are adjusted to match the amount of dose delivered. In a second aspect, the measurement system is for determining the type of drug contained in the drug delivery device. By way of illustration, the drug delivery device is described in the form of a syringe pen. However, a drug delivery device can be any device that is used to set up and deliver a dose of a drug, such as an infusion pump, bolus syringe, or auto syringe device. The drug may be of any type that can be delivered by such a drug delivery device.

The devices described herein, such as device 10, may further contain a drug, such as, for example, within a reservoir or cartridge 20. In another embodiment, the system may contain one or more devices, including device 10 and a drug. The term drug refers to one or more therapeutic agents, including, but not limited to, insulins, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, analogs glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, oxyntomodulin analogs, oxyntomodulin derivatives, monoclonal antibody drugs, and any therapeutic agent that can be delivered using the above device. The drug used in the device may be formulated into a dosage form with one or more excipients. The device is actuated in the manner described above by a patient, caregiver, or healthcare professional to deliver a drug to a human.

An exemplary drug delivery device 10 is illustrated in FIG. 1-4 in the form of a syringe pen configured to administer a drug to a patient through a needle. The pen 10 includes a housing 11 containing an elongated pen-shaped shell 12, including a distal portion 14 and a proximal portion 16. The distal portion 14 is within the cap 18 of the pen. With reference to FIG. 2, the distal portion 14 includes a reservoir or cartridge 20 configured to hold a drug liquid to be dispensed through its distal outlet end during a dispensing operation. The outlet end of the distal portion 14 is provided with a removable needle assembly 22 which contains an injection needle 24 enclosed in a removable cap 25. The piston 26 is located in the reservoir 20. the time of the dose dispensing operation in order to push the medicinal substance contained therein through the end with the needle. The injection mechanism includes a drive element 28, for illustration, in the form of a screw with the ability to move in the axial direction relative to the shell 12 to move the piston 26 through the reservoir 20.

The dose setting element 30 is connected to the sheath 12 for setting the amount of dose to be dispensed by the device 10. In the illustrated embodiment of the invention, the dose setting element 30 is in the form of a screw element acting in a helical direction (i.e. simultaneously moving in the axial direction and rotationally) relative to the sheath 12 during dose setting and dose delivery. In FIG. 1 and 2 illustrate the dose setting element 30 fully screwed into the sheath 12 in its rest or zero position. The dose setting element 30 serves to screw proximally out of the sheath 12 until it reaches the fully extended position corresponding to the maximum dose delivered by the device 10 in a single injection.

With reference to FIG. 2-4, the dose setting element 30 comprises a cylindrical dose setting element 32 having a screw-threaded outer surface that engages with a corresponding threaded inner surface of the sheath 12 to allow the dose setting element 30 to helically rotate relative to the sheath 12. The adjusting element 32 further comprises a screw-threaded inner surface that engages with the threaded outer surface of the sleeve 34 (FIG. 2) of the device 10. The outer surface of the tuning element 32 contains dose indicator markings, such as numbers, that are visible through the dosage window 36 to indicate to the user the set dose amount. The dose setting element 30 further comprises a tubular flange 38 which is connected to the open proximal end of the setting element 32 and is locked in the axial and rotational direction on the setting element 32 by means of latches 40 received within holes 41 in the setting element 32. The dose setting element 30 may further comprise an optional ring or skirt 42 located around the outer periphery of the tuning

- 4 039601 element 32 at its proximal end. The skirt 42 is axially and rotationally locked on the tuning element 32 by the projections 44 received in the slots 46. In the following embodiments of the invention described below, examples of the device without a skirt are shown.

Therefore, the dose setting element 30 can be considered to comprise, in whole or in part, the dose setting element 32, the flange 38 and the skirt 42, since they are all fixed together in the rotational and axial direction. The dose tuner 32 is directly involved in dose setting and drug delivery control. The flange 38 is attached to the adjusting element 32 dose and, as described below, interacts with the sleeve for selective connection of the adjusting element 32 with the button 56 dosing. The skirt 42 provides a surface external to the body 11 to allow the user to rotate the setting element 32 to set the dose.

The skirt 42, by way of illustration, includes a plurality of surface features 48 and an annular rib 49 formed on the outer surface of the skirt 42. The surface features 48 are, by way of illustration, longitudinally extending ribs and notches that are arranged circumferentially around the outer surface of the skirt 42 and facilitate the user to grip and rotate the skirt. In an alternative embodiment of the invention, the skirt 42 is removed or integral to the setting element 32 and the user can grip and turn the dose button 56 and/or the dose setting element 32 to set the dose. In the embodiment of the invention in FIG. 4, the user can grip and rotate the radial outer surface of the integral dispense button 56, which also includes a plurality of surface features for setting the dose.

The delivery device 10 includes an actuator 50 comprising a sleeve 52 that is located within the tuning element 32. The sleeve 52 includes an axially extending stem 54 at its proximal end. The actuator 50 further comprises a dosing button 56 located proximal to the skirt 42 of the dose setting element 30 . In an alternative embodiment of the invention, the dose setting element 30 may comprise an unskirted dispense button, such as shown in FIG. 14, 18, 19, and 22. Dispense button 56 includes a support ring 58 (FIG. 2) centrally located on the distal surface of dispense button 56. The support ring 58 is connected to the stem 54 of the sleeve 52, for example by an interference fit or ultrasonic welding, so as to axially and rotationally lock the dispensing button 56 and the sleeve 52 together.

Dispense button 56 includes a disc-shaped proximal end surface or surface 60 and an annular wall portion 62 extending distally and radially inwardly from the outer peripheral edge of surface 60 to form an annular protrusion 64 therebetween. The proximal surface 60 of the dispensing button 56 serves as a push surface against which force can be applied manually, ie directly by the user, in order to push the actuator 50 in a distal direction. Dispense button 56 illustratively includes a recessed portion 66 centrally located on proximal surface 60, although proximal surface 60 may alternatively be a flat surface. Likewise, an alternative one-piece dispense button, such as that shown in FIG. 22 may include a recessed portion 66 centrally located on the proximal surface 60, or alternatively may be a flat surface. A biasing member 68, illustrated as a spring, is positioned between the distal surface 70 of the button 56 and the proximal surface 72 of the tubular flange 38 to press the actuator 50 and the dose setting member 30 axially apart. The dispense button 56 is pressed by the user to start the dispense operation.

The delivery device 10 is configured to operate in both a dose setting mode and a dose dispensing mode. In dose setting mode, dose setting element 30 adjusts (rotates) relative to sheath 12 to set the desired dose to be delivered by device 10. Proximal adjustment serves to increase the set dose, and distal adjustment serves to decrease the set dose. The dose setting element 30 is adjusted by a rotational step (eg clicks) corresponding to a minimum gradual increase or decrease in the set dose during the dose setting operation. For example, one zoom or click may equal half or one unit of drug. The set amount of dose is visible to the user through the setting indicator markings shown through the dosage window 36 . The actuator 50, including the dose button 56 and the clutch 52, moves in the axial and rotational direction with the dose setting member 30 during adjustment in the dose setting mode.

The dose adjuster 32, flange 38, and skirt 42 are all non-rotatable fixed to each other, and rotate and extend in the proximal direction of the drug delivery device 10 during dose setting due to the threaded connection of the dose adjuster 32 to the sheath 12. During of this movement, when setting the dose, the dosing button 56 is fixed without the possibility of rotation relative to the skirt 42 with the help of additional splines 74 of the flange 38 and the coupling 52 (Fig. 2), which are pressed together with the help of the biasing element 68. In the process of setting the dose, the skirt 42 and the dispensing button 56 move relative to the shell 12 in a spiral from the start position to the end position. This rotation relative to the sheath is proportional to the dose amount set during operation of the drug delivery device 10.

Once the desired dose has been set, the device 10 is manipulated so that the injection needle 24 correctly penetrates into, for example, the user's skin. The dose-dispensing mode of operation is initiated in response to an axial distal force applied to the proximal surface 60 of the dispense button 56 . The axial force is applied by the user directly to the dispense button 56 . This causes an axial movement of the actuator 50 in a distal direction relative to the sheath 12. The axial movement of the actuator 50 compresses the bias member 68 and reduces or closes the gap between the dispense button 56 and the tubular flange 38. This relative axial movement separates the mating splines 74 on the coupling 52 and flange 38, and thus releases the actuator 50, such as the dispense button 56, from non-rotatable fixation on the dose setting element 30. In particular, dose setting member 30 is rotatably detachable from actuator 50 to allow dose setting member 30 to reverse rotation relative to actuator 50 and sheath 12. The dose dispensing mode of operation can also be initiated by activating a separate switch or trigger. mechanism.

As the actuator 50 continues to descend axially without rotation relative to the sheath 12, the setting element 32 is screwed back into the sheath 12 as it rotates relative to the dispensing button 56. Dose markings, which indicate the amount still left to inject, are visible through window 36. As dose setting element 30 is screwed down distally, actuator 28 is advanced distally to push piston 26 through reservoir 20 and eject drug through the needle 24 (Fig. 2).

During a dose dispensing operation, the amount of drug ejected from the drug delivery device is proportional to the amount of rotational movement of the dose setting member 30 relative to the actuator 50 when the adjusting member 32 is screwed back into the sheath 12 again. Injection is completed when the internal thread of the adjusting member 32 has reached the distal end of the corresponding external thread of the sleeve 34 (FIG. 2). The device 10 is then set back to the ready state or zero dose position, as illustrated in FIG. 2 and 3.

The initial and final angular positions of the dose adjusting element 32 and, therefore, the non-rotatably fixed flange 38 and skirt 42 relative to the dosing button 56 provide an absolute change in the angular positions during dose delivery. Determining whether the relative rotation has exceeded 360° is determined in several ways. By way of example, total rotation can be determined in terms of incremental movements of dose setting element 30, which can be measured in any number of ways by a measurement system.

Additional details of the construction and operation of the exemplary delivery device 10 can be found in US Pat. Another example of a delivery device is the automatic syringe device found in US Pat. one or more of the various sensor systems described herein for determining the amount of drug being delivered from a drug delivery device based on a measurement of relative rotation within the drug delivery device. Dosing systems described herein use a metering component and a metering component attached to elements of a drug delivery device. The term attached encompasses any method of attaching the position of a component to another component or element of a drug delivery device so that they function as described herein. For example, a measurement component may be attached to a drug delivery device element by being placed directly on it, received within it, integrated with it, or otherwise connected to it. Connections may include, for example, connections formed by frictional interaction, splines, snap or press fit, ultrasonic welding or adhesive.

The term directly attached is used to describe an attachment in which two components, or a component and an element, are physically attached together without an intermediate element,

- 6 039601 except for connection components. The fastener component may include a fastener, adapter, or other part of the fastening system, such as a compressible membrane inserted between the two components to facilitate fastening. Direct attachment differs from attachment in which the components/elements are connected by one or more intermediate functional elements, such as the tuning element 32 attached in FIG. 2 to the dosing button 56 by the clutch 52.

The term fixed is used to indicate that a specified movement either can occur or cannot occur. For example, the first element is fixed in the circumferential direction with the second element if the two elements are required to move together during rotation. In one aspect, an element may be functionally fixed relative to another element rather than structurally. For example, an element may be pressed against another element in such a way that the frictional interaction between the two elements locks them together without the possibility of rotation, while the two elements cannot be locked together without pressing the first element.

Various sensor systems are provided for in this document. In general, sensor systems comprise a measurement component and a measurement component. The term measurement component refers to any component that is capable of determining the relative position of the component being measured. The term metering component includes a metering element or sensor along with associated electrical components for operating the metering element. A measurement component is any component for which the measurement component is capable of detecting the position and/or movement of the measurement component relative to the measurement component. For a delivered dose determination system, the measured component rotates relative to the measuring component, which is capable of determining the angular position and/or rotational movement of the measured component. For a dose type determination system, the measured component determines the relative angular position of the measured component. The measuring component may contain one or more measuring elements, and the measured component may contain one or more measuring elements. The sensor system is capable of detecting the position or movement of the measured component(s) to provide output signals representative of the position(s) or movement(s) of the measured component(s). The sensor system typically detects a characteristic of the measured parameter that changes depending on the position of one or more measured elements in the measured area. The measured elements pass into or otherwise affect the measured area in a manner that directly or indirectly affects the performance of the measured parameter. The relative positions of the sensor and the measured element affect the characteristics of the measured parameter, allowing the microcontroller unit (MCU, microcontroller unit) of the sensor system to determine the various positions of rotation of the measured elements.

A suitable sensor system may include a combination of an active component and a passive component. When using a measurement component acting as an active component, it is not necessary to connect both components to other system elements such as a power supply or an MCU.

Any of a variety of measurement technologies may be included by which the relative positions of two elements may be detected. Such technologies may include, for example, technologies based on tactile, optical, inductive, or electrical measurements. Such techniques may include the measurement of a field-related measurable parameter, such as a magnetic field. In one form, the magnetic sensor measures the change in the measured magnetic field as the magnetic component moves relative to the sensor. In another embodiment of the invention, the sensor system can detect the characteristics and/or changes of the magnetic field when an object is located within and/or moves through the magnetic field. Field changes change the characteristic of the measured parameter in relation to the position of the measured element in the measured area. In such embodiments, the measured parameter may be capacitance, conductance, resistance, impedance, voltage, inductance, and so on. For example, a magnetoresistive-type sensor detects a distortion of an applied magnetic field that results in a characteristic change in the resistance of the sensor element. As another example, Hall effect sensors detect voltage changes caused by distortions in an applied magnetic field.

In one aspect, the sensor system detects the relative positions or movements of the elements being measured, and therefore associated elements of the drug delivery device. The sensor system generates output signals representing the position(s) or amount of movement of the measured component. For example, the sensor system can be configured to generate output signals that can determine the rotation of the dose setting element during dose delivery. The MCU is operatively connected to each sensor to receive output signals. In one aspect, the MCU is configured to determine from the output signals the amount of dose delivered by the operation of the drug delivery device.

The system for determining the delivered dose provides for determining the relative rotational movement between the two elements. Whereas the degree of rotation has a known dependence on the amount of dose delivered, the sensor system functions to determine the amount of angular movement from the start of the dose to the end of the dose. For example, a typical pen dependency is that an 18° angular displacement of the dose setting element is equivalent to one dose unit, although other angular dependencies are also suitable. The sensor system is configured to determine the total angular displacement of the dose setting element during dose delivery. Thus, if the angular displacement is 90°, then this means that 5 dose units have been delivered.

One method for determining angular displacement is to count increments in the number of doses when performing injections. For example, the sensor system may use a repeating pattern of measured elements such that each repetition is an indication of a predetermined degree of angular rotation. For convenience, the structure may be set such that each repetition corresponds to the minimum dose increment that can be set by the drug delivery device.

An alternative approach is to define the start and end positions relative to the moving element and define the amount of delivered dose as the difference between these positions. In this approach, it may be part of the definition that the sensor system measures the number of complete revolutions of the element to set the dose. Various methods for doing this are well known to those skilled in the art and may include counting the number of increments to estimate the number of complete revolutions.

Components of the sensor system may be permanently attached to the drug delivery device or may be detachable later. In an exemplary embodiment of the invention, at least some of the components of the dose determination system are provided in the form of a module that is detachably attached to the drug delivery device. This has the advantage that these sensor components are available for use on more than one pen.

In some embodiments of the invention, the measuring component is installed on the actuator, and the measured component is attached to the element for setting the dose. The measurable component may also contain a dose setting element or any part thereof. The sensor system determines during dose delivery the relative rotation of the measured component and hence the dose setting element, from which the amount of dose delivered by the drug delivery device is determined. In an exemplary embodiment of the invention, the rotation sensor is attached and fixed without the possibility of rotation to the actuator. The actuator does not rotate relative to the body of the drug delivery device during dose delivery. In this embodiment, the component to be measured is attached and non-rotatably fixed to the dose setting element, which rotates relative to the actuator and device body during dose delivery. The measurable component may also contain a dose setting element or any part thereof. In an exemplary embodiment of the invention, during dose delivery, the rotation sensor is not directly attached to the relatively rotating dose setting element. With reference to FIG. 5 schematically illustrates a delivered dose determination system 80 that includes one example of a module 82 used in combination with a drug delivery device such as device 10. Module 82 includes a sensor system, illustrated generally at 84, including a rotation sensor 86 and other related components such as processor, memory, battery, etc. Module 82 is provided as a separate component, which can be attached to the actuator with the possibility of subsequent detachment.

Module 82 determine the dose includes a housing 88 attached to the button 56 dosing. Housing 88 illustratively includes a cylindrical side wall 90 and a top wall 92 enclosing and sealing side wall 90. As an example, FIG. 5 schematically illustrates an upper side wall 90 which has inwardly projecting projections 94 attaching the module 82 to the dispense button 56. Alternatively, dose determination module 82 may be attached to dispense button 56 by any suitable fastener such as a snap or press fit, threaded connection, etc., provided that in one aspect of the invention, module 82 can be removed from the first drug delivery device and then attached to the second drug delivery device. The attachment may be anywhere on the dispense button 56, provided that the dispense button 56 can move any desired amount axially relative to the dose setting element 30, as described herein.

Examples of alternative fasteners for module 82 are shown in FIG. 15, 23 and 37 are described below.

- 8 039601

During dose delivery, dose setting element 30 is free to rotate relative to dispense button 56 and module 82. In an exemplary embodiment of the invention, module 82 is non-rotatably fixed to dispense button 56 and does not rotate during dose delivery. This can be provided structurally, for example, with the help of projections 94 shown in FIG. 5, or by facing splines or other surface features on the module body 88, and the dispense button 56 engages upon axial movement of the module 82 relative to the dispense button 56. In another embodiment, distally pressing the module provides sufficient frictional engagement between module 82 and dispense button 56 to functionally cause module 82 and dispense button 56 to remain stationary together without being able to rotate during dose delivery.

The top wall 92 is spaced from the surface 60 of the dispense button 56 and thus provides a cavity 96 in which some or all of the rotation sensor and other components may be located. The cavity 96 may be open at the bottom, or may be closed, for example, by a bottom wall 98. The bottom wall 98 may be positioned to rest directly on the surface 60 of the dispensing button 56. Alternatively, the bottom wall 98, if present, may be located at a distance from the dispense button 56, and other contacts between the module 82 and the dispense button 56 may be used so that the axial force applied to the module 82 is transmitted to the button 56 dosing. In another embodiment, module 82 may be rotatably attached to a one-piece dispensing button configuration such as that shown in FIG. 22.

In an alternative embodiment of the invention, module 82 is instead attached to dose setting element 30 during dose setting. For example, sidewall 90 may include a bottom wall portion 100 having internal projections 102 that engage skirt 42 at a position under rib 49. In this approach, projections 94 can be eliminated while module 82 effectively engages proximal surface 60 of dose button 56 and the distal side of the annular rib 49. In this configuration, the lower wall portion 100 can be provided with surface features that engage with the surface features of the skirt 42 to lock the module 82 to the skirt 42 without allowing rotation. are thereby transferred to the skirt 42 by connecting the bottom wall portion 100 to the skirt 42.

Module 82 rotates out of contact with skirt 42 to deliver the dose. The connection of the lower wall portion 100 with the skirt 42 is made with the possibility of separation during the distal axial movement of the module 82 relative to the skirt 42, thereby allowing the skirt 42 to rotate relative to the module 82 during dose delivery.

Similarly, during dose setting, module 82 can be connected to both dose button 56 and skirt 42. This has the advantage of providing additional interfaces during dose setting rotation of the module. The connection of module 82 to skirt 42 is then released prior to dose administration, for example, by moving module 82 axially relative to skirt 42 when dose delivery begins, thereby allowing dose setting element 30 to rotate relative to module 82 during dose delivery.

In some embodiments of the invention, a rotation sensor 86 is connected to the side wall 90 to detect a measured component. The bottom wall portion 100 also serves to reduce the likelihood that the user's hand will inadvertently apply a pull force to the dose setting member 30 as it rotates relative to the module 82 and sheath 12 during dose delivery. In addition, because dose button 56 is non-rotatably fixed to dose setting member 30 during dose setting, side wall 90, including bottom wall portion 100, provides a single continuous surface that can be easily grasped and manipulated by a user during dose setting.

When the injection process is started by pressing the dose determining module 82, the dosing button 56 and the dose setting member 30 are fixed together without being able to rotate. Moving the module 82 and hence the dispense button 56 a short distance, eg less than 2 mm, releases the rotational interaction and the dose setting element 30 rotates relative to the module 82 when the dose is delivered. Regardless of whether a finger pad or other trigger mechanism is used, the dose detection system is activated before the dispense button 56 has moved a sufficient distance to disengage the rotation lock of the dispense button 56 and the dose setting element 30.

By way of illustration, a delivered dose determination system includes an electronics package suitable for operation of a sensor system as described herein. The electronic unit is operatively connected to the sensor system to receive output signals from one or more rotation sensors. The electronic unit may include conventional components such as a processor, power supply, memory, microcontrollers, etc. contained, for example, in cavity 96 defined by module housing 88. Alternatively, at least some of the components may be provided separately, for example via an external device such as a computer, smartphone, or other device. Means are then provided to functionally connect the components of the external controller to the sensor system at appropriate times, such as via a wired or wireless connection.

The exemplary electronics box 120 includes a flexible printed circuit board (FPCB) having a plurality of electronic components. The electronics assembly includes a sensor system comprising one or more rotation sensors 86 operatively coupled to the processor to receive signals from the sensor representing the measured relative rotation. The electronic unit further comprises an MCU containing at least one processing core and an internal memory. One example of an electronics unit is shown schematically in FIG. 46. The system contains a battery, such as a coin cell battery, to power the components. The MCU includes control logic that performs the operations described herein, including determining the dose delivered by the drug delivery device 10 based on the detected rotation of the dose setting member relative to the actuator. In one embodiment, the detected rotation occurs between the skirt 42 and the dosing button 56 of the pen.

The MCU is designed to store the detected dose in local memory (eg, internal flash memory or built-in electrically erasable programmable read-only memory EEPROM). The MCU is further adapted to wirelessly transmit and/or receive a signal representative of the detected dose to a paired remote electronic device, such as a user's smartphone, via Bluetooth low energy (BLE) or other suitable short or long range wireless communication protocol. actions. As an illustration, BLE and MCU control logic are integrated in the same circuit.

Further description of the electronic device is provided below.

Most of the meter electronics is located in the cavity 96. However, the rotation sensor can be located in a variety of places to determine the relative movement of the measured component. For example, the rotation sensor may be located inside the cavity 96, inside the housing 88 but outside the cavity 96, or elsewhere in the housing, such as on the bottom wall portion 100. The only requirement is that the rotation sensor be positioned to effectively detect rotational movement of the measurable component during dose delivery. In some embodiments of the invention, the rotation sensor is integrated into the device 10. One or more measuring elements are attached to the element 30 for setting the dose. In one aspect, the measurable elements are directly attached to the element skirt 42 for setting the dose. Alternatively, the measuring elements may be attached to any one or more dose setting components, including a tuning element, flange and/or skirt. The only requirement is that the element(s) to be measured be positioned so that it is detected by the rotation sensor during relative rotational movement during dose delivery. In other embodiments of the invention, the measured component contains a dose setting element 30 or any part thereof.

Additional exemplary embodiments of the dose delivery detection system 80 are shown in FIG. 6-13. Embodiments of the invention are shown in some schematic form, since the general details have already been presented in FIG. 1-5. In general, each embodiment of the invention contains similar components of the dose determination module 82, comprising a housing 88 having a cylindrical top wall 90 and a top wall 92. Each embodiment of the invention also contains a bottom wall 100, although it should be understood that changes in these components, including the absence of bottom wall 100 are within the scope of this disclosure. Other parts common to earlier descriptions herein include electronics 120 located in cavity 96 of module housing 88, dispense button 56, dose setting element 32, and device shell 12. In addition, in each embodiment, the dosage determination module 82 is schematically shown attached to the annular sidewall 62 of the dispense button 56, although alternative shapes and attachment locations may be used. For example, in some embodiments, dose determination module 82 may be attached to dispense button 56 and detachably attached to skirt 42. In addition, dose determination module 82 may be attached to a one-piece dispense button, as shown in FIG. 22 and 35. Each example also demonstrates the use of a particular type of sensor system. However, in some embodiments of the invention, the dose determination system includes a plurality of determination systems using the same or different measurement technologies. This provides redundancy in the event of failure of one of the sensor systems. This also makes it possible to use the second measuring system to check periodically that the first measuring system is working properly.

In some embodiments of the invention, as shown in FIG. 6, a finger pad 110 is attached to the top wall 92 of the module 82. Finger pad 110 is connected to top wall 92, which is in turn attached to top side wall 90. Finger pad 110 comprises

- 10 039601 protrusion 114, which extends in the radial direction inward and is placed in the circumferential groove 116 component 92 of the wall. Groove 116 allows for slight axial movement between finger pad 110 and wall component 92 . Springs (not shown) typically push the finger pad 110 upward away from the wall component 92 . The platform 110 for the finger can be attached without the possibility of rotation to the component 92 of the wall. When the injection process begins, the axial movement 110 of the finger pad in a distal direction to the module sheath 88 can be used to trigger selected events. One application of the finger pad 110 may be to activate the drug delivery device electronics upon initial depression and axial movement of the finger pad 110 relative to the module housing 88 when a dose is initiated. For example, this initial axial movement can be used to wake up the device, and in particular the components associated with the dose determination system. In one example, module 82 includes a display for displaying information to a user. Such a display may be integrated with the finger pad 110 . The MCU may include a display control software module and control logic for receiving and processing measured data and for displaying information on said display, such as, for example, dose setting, dispensing, injection status, injection completion, date and/or time or time until the next injection.

In the absence of a finger pad, the electronics of the system can be activated in various other ways. For example, the initial axial movement of module 82 at the start of dose delivery can be directly detected, such as by closing contacts or physically interacting with a switch. It is also known to trigger a drug delivery device based on various other actions, such as removing the pen cap, detecting pen movement with an accelerometer, or setting a dose. In many approaches, the dose determination system is activated prior to the start of dose delivery.

With reference to FIG. 6-8, the dose determination module 82 operates using a magnetic measurement system 84. Two magnetic sensors 130 are located on the bottom wall portion 100 (illustrated on the inner surface of the bottom wall portion 100) opposite the skirt 42 of the dose setting member 30. With respect to all embodiments of the invention, the number and location of the rotation sensor(s) and measured element(s) may vary. For example, the embodiment of the invention in FIG. 6-8 may instead comprise any number of magnetic sensors 130 evenly or unevenly spaced around skirt 42. Measurement component 132 (FIGS. 7 and 8) includes a magnetic strip 134 attached to skirt 42 as an illustration on the inside of skirt 42. In an illustrative embodiment of the invention, the strip contains 5 pairs of north-south magnetic components, for example 136 and 138, each of which, therefore, runs at an angle of 36°. The magnetic sensors 130 are spaced at an angle of 18° (FIG. 7) and read the digital positions of the magnetic stripe 132, and hence the skirt 42, in the form of a 2-bit Gray code. For example, when the sensor detects the passage of the N-S magnetic pair, skirt 42 is found to have rotated 36°, which corresponds to 2 units of, for example, added (or subtracted) dose.

Other magnetic structures may also be used, including varying numbers or arrangements of magnetic elements. In addition, in an alternative embodiment of the invention, the measurable component 133 is connected to or integrated with the flange 38 of the dose setting element 30, as shown in FIG. 9. As described above, the measuring system 84 is configured to determine the amount of rotation of the measured element relative to the magnetic sensors 130. This amount of rotation is directly related to the amount of dose delivered by the device. Relative rotation is determined by detecting movements of the skirt 42 during dose delivery, for example by determining the difference between the start and end positions of the skirt 42 or by counting the number of gradual movements of the skirt 42 during drug delivery.

With reference to FIG. 10A, 10B, 11A, and 11B show an exemplary magnetic pickup system 150 comprising, as a measurable element, an annular, annular bipolar magnet 152 having a north pole 154 and a south pole 156. The magnets described herein may also be referred to as diametrically magnetized rings. Magnet 152 is attached to flange 38 and therefore rotates with the flange during dose delivery. In one example, the magnet 152 is attached to the flange 38 with a mounting carrier, as shown in FIG. 31-33. Alternatively, the magnet 152 may be attached to the dose setting element 32 or other elements attached without the possibility of rotation to the dose setting element. Magnet 152 may be made from a variety of materials such as rare earth magnets such as neodymium and others as described below.

Sensor system 150 further comprises a sensor 158 including one or more sensor elements 160 operatively coupled to sensor electronics (not shown) located in module 82. Sensor elements 160 of sensor 158 are shown in FIG. 11A and attached to the printed circuit board 162, which is an attached rotation module 82, which is attached non-rotatably to the dispensing button 56. Therefore, during dose delivery, the magnet 152 rotates relative to the measurement elements 160.

- 11 039601 elements 160 may determine the relative angular position of the magnet 152. When the ring 152 is a metal ring, the measuring elements 160 may include inductive sensors, capacitive sensors, or other non-contact sensors. Thus, magnetic sensor system 150 functions to detect full rotation of flange 38 relative to dispense button 56, and therefore rotation relative to sheath 12 during dose delivery. In one example, magnetic sensor system 150, including magnet 152 and sensor 158 with measuring elements 160, may be located in the modules shown in FIG. 13, 25 and 35.

As shown, in one embodiment, magnetic sensor system 150 includes four sensing elements 160 spaced evenly radially within module 82 to form an annular shape. Alternative numbers and positions of measuring elements may be used. For example, in another embodiment of the invention shown in FIG. 11B, one measurement element 160 is used. In addition, the measurement element 160 in FIG. 11B is shown at the center of module 82, although other locations may also be used. In another embodiment of the invention shown in FIG. 33 and FIG. 40, for example, five sensing elements 906 are spaced evenly circumferentially and radially within the module. In the above embodiments of the invention, the measuring elements 160 are shown attached within the module 82. Alternatively, the measuring elements 160 may be attached to any part of the component attached without the possibility of rotation to the dispense button 56 so that the component does not rotate relative to the shell 12 during delivery. doses. For purposes of illustration, magnet 152 is shown as a single annular bipolar magnet attached to flange 38. Alternate configurations and locations of magnet 152 are provided. For example, a magnet may have multiple poles, such as alternating north and south poles. In one embodiment, the magnet comprises multiple pairs of poles equal to the number of individual rotational dose setting positions of flange 38. Also, magnet 152 may include multiple individual magnetic elements. In addition, the magnetic component may be attached to any part of a non-rotatably attached flange 38 during dose delivery, such as skirt 42 or dose adjuster 32.

Alternatively, the sensor system may be an inductive or capacitive sensor system. This type of sensor system uses a measuring element containing a metal band attached to a flange in a manner similar to the magnetic ring attachment described in this document. The sensor system additionally contains one or more measuring elements, such as four, five, six or more independent antennas or anchors spaced equally along the distal wall of the module shell or handle shell. These antennas form antenna pairs spaced 180° or other number of degrees apart and provide a metric measurement of the angular position of the metal ring proportional to the delivered dose.

The metal band ring is shaped such that one or more different rotational positions of the metal ring relative to the module can be detected. The metal strip has a shape that generates a changing signal as the metal ring rotates relative to the antennas. The antennas are operatively coupled to the electronics unit such that the antennas function to detect the positions of the metal ring relative to the sensors and hence relative to the sheath 12 of the handle 10 during dose delivery. The metal strip may be a single cylindrical strip attached to the outside of the flange. However, alternative configurations and locations of the metal strip are contemplated. For example, a metal strip may contain a plurality of individual metal elements. In one embodiment of the invention, the metal tape contains a number of elements equal to the number of individual rotational dose setting positions of the flange. The metal band may alternatively be attached to any part of the component that is non-rotatably attached to the flange 38 during dose delivery, such as the tuning element 32. The metal band may comprise a metal element attached to a rotating element inside or outside the element, or it may be incorporated into such an element, for example, by means of metal particles included in the component, or by pressing a metal strip into the component. The MCU is configured to determine the position of the metal ring using sensors. The MCU is configured to determine the initial position of magnet 152 by averaging the number of measurement elements 160 (eg, four) at the maximum sampling rate in accordance with standard quadrature differential signal calculation. During the dose delivery mode, the MCU samples at a predetermined frequency to determine the number of revolutions of the magnet 152. calculation of quadrature differential signals. The MCU is configured to determine from the calculation the total rotation angle of the movement from the determined start position of the number of revolutions and the end position. The MCU is configured to determine the number of steps or dose units by dividing the total rotation angle by a predetermined number (eg, 10, 15, 18, 20, 24) that is associated with device and drug design.

In one aspect of the invention, a modular form of a dose determination system is disclosed. The use of an attached, detachable module is particularly adapted for use with a drug delivery device in which both the actuator and the dose setting element comprise parts located outside the drug device sheath. These outer portions allow the sensing component to be directly attached to an actuator, such as a dispense button, and the component to be measured to a dose setting element, such as a dispense skirt, flange, or adjustment element, as described herein. In this regard, the term dosing button is used more generally to refer to a component of a drug delivery device that contains a portion located outside the shell of the device and contains an open surface available for use by the user to deliver a set dose. Similarly, a dispensing skirt refers more generally to the component of a drug delivery device that is located on the outside of the device sheath and which thus has an open portion available for the user to grasp and rotate the component to set a dose. As disclosed herein, the dispensing skirt rotates relative to the dispensing button during dose delivery. Also, the dose skirt may be non-rotatably attached to the dose button during dose setting, such that the dose skirt or dose button can be rotated to set the dose. In an alternative embodiment of the invention, the delivery device may not include a dispensing skirt and the user can grip and turn an actuator (eg, a dispensing button) to set a dose. In some embodiments with the dose determination module attached to the actuator and/or the dispensing skirt, the dose determination module can be rotated to thereby rotate the dose setting element of the delivery device to set the dose to be delivered.

Another feature of the present disclosure is that the measuring system of the dose determination system 80 may be initially built into the drug delivery device as an integrated system, rather than as an additional module.

The foregoing provides a discussion of various designs and methods for measuring the relative rotation of the dose setting element relative to the actuator during dose delivery. In certain embodiments of drug delivery devices, the actuator moves in a spiral relative to the handle body during dose setting. For illustrative purposes, this disclosure describes a dose determination system for such a helical actuator. However, those skilled in the art will appreciate that the principles and physical operation of the disclosed dose determination system can also be used in conjunction with an actuator that rotates, but does not move, during dose delivery. It should also be understood that the dose determination system functions with other configurations of medical delivery devices, provided that the device includes an actuator that rotates relative to the dose setting element during dose administration.

Dosing systems can also be used with a module to identify the characteristics of a drug to be administered with a pen. Pens are used with a wide range of drugs, and even with different types of a given drug, as already described. For example, insulin is available in various forms depending on the intended use. Types of insulin include fast-acting, short-acting, intermediate-acting, and long-acting. In another respect, drug type refers to which drug is involved, such as insulin versus non-insulin drug and/or drug concentration. It is important not to confuse the type of drug because the consequences can be serious.

You can correlate certain parameters depending on the type of drug. Using insulin as an example, there are known limitations as to the appropriate amount of dose based on factors such as the type of insulin, how the type of insulin relates to the time of dosing, and so on. In another respect, it is necessary to know what type of drug was administered in order to accurately monitor and evaluate the treatment. In one aspect, a sensor system is provided that is capable of differentiating the type of drug to be administered.

To determine the type of drug, a module is provided that detects a unique identification of the type of drug, such as, for example, any of the drugs described herein contained in a drug delivery device. After installing the module on a drug delivery device, such as a pen, the module determines the type of drug and stores it in memory. After that

- 13 039601 the module can evaluate the insertion or delivery of a drug based on the type of drug in the pen, as well as previous dosing history and other information. One example of drug type determination is described later with identification sensor 680 in FIG. 29. Another example is described below.

This drug type detection is useful when using a variety of sensor systems that are configured to detect a predetermined angular position of the measured elements relative to the alignment element. These sensor systems include those previously described. Yet another aspect is that this drug typing is easily combined with sensor systems to determine the amount of dose delivery. These two systems can work independently or in conjunction with each other.

In a specific aspect, the sensor system used to detect dose delivery is also used to identify the type of drug. For example, FIG. 10A-10B and FIG. 11A11B and associated text describe a magnetic sensor system that includes sensing elements 160 and a magnet 152 for determining the amount of delivered dose. Magnet 152 is uniquely configured such that the sensor system is able to detect specific angular positions of magnet 152 relative to the measurement elements.

The exemplary sensor system 230 is also useful as a system that is integrated into a drug delivery device rather than provided as a plug-in module. With reference to FIG. 12 shows a drug delivery device 310 substantially the same as device 10 in FIG. 1-4. The drug delivery device 310 includes a device body 11 and a dose setting member 30 comprising a dose setting member 32, a flange 38, and a skirt 42. These components are configured to operate as previously described. The actuator 50 includes a sleeve 52 and a dosing button 56 attached thereto. The dosing button 56 is fixed without being able to rotate together with the dose setting member 30 during dose setting. For dose delivery, this non-rotational lock is released and the dose setting element 30 rotates relative to the dose button 56 in proportion to the amount of dose being delivered. Other embodiments of the dose determination systems described herein may be incorporated into and integral with the device 310.

In FIG. 13-15 depict another example of a module, hereinafter referred to as module 400, that can be attached to a drug delivery device having a dispense button 402 comprising a cylindrical side wall 404 and a top wall 406 coaxially about the axis A-A of the device. The top wall 406 of the dispense button 402 includes an upper or proximal axial surface 408 that is directly pressed by the user to deliver a dose when the module 400 is not mounted on the dispense button 402. Top wall 406 extends radially outward from side wall 404, thereby defining projection 410. Side wall 404 extends between top surface 408 and the distal end, as shown in FIG. fourteen.

Module 400 includes a sheath 411, typically including a proximal wall 412 and a distal wall 414. Module 400 further includes a perimeter side wall 416 extending between and forming chamber 418 with proximal wall 412 and distal wall 414. distally, the axial surface 413 of the distal wall 414, by way of illustration, is placed against the top surface 408 of the dosing button 402. The walls of module 400 are shown in a particular configuration, but said walls may be of any desired configuration suitable for forming chamber 418. In one example, chamber 418 may be configured to prevent ingress of moisture and particulates. In another example, chamber 418 may be configured to prevent the ingress of dust and debris, but not to prevent direct ingress of moisture. Industry standards provide guidance on the various standards for moisture and dust protection. With similar components as in module 82 shown in FIG. 5-6, chamber 418 may contain various required components for use with the drug delivery device disclosed herein. Such components may include, for example, measuring or other sensors, one or more batteries, an MCU, a timer, a memory, and a communication unit. Camera 418 may also contain various switches for use, as described below.

Any of the modules described herein can be detachably attached to any of the dispensing buttons described herein via an attachment element 419 coupled to the module shell 411. The attachment member 419 includes a plurality of distally extending levers 420. As generally shown in FIG. 13, module 400 is attached to dispense button 402 by levers 420 that are attached to and extend distally from sheath 411. In an exemplary embodiment of the invention, the levers 420 are evenly spaced radially apart around the dispensing button 402. The levers 420 are shown attached to the distal wall 414 at the attachment site 422 . Alternatively, the levers 420 may be attached to the module 400 at other locations, such as on the side wall 416. The side wall 416 may include a distal portion 424 located radially outward from the levers 420, which extends distally from sidewall 416 some distance further than the distalmost extension of the levers 420, at least to partially or completely overlap the levers 420, to prevent tampering with the operation of the levers or access to the levers when mounted on the device. The distal portion 424 may include an inwardly extending portion 426 that further surrounds the levers 420. Alternatively, the distal portion 424 may be provided as an element that can slide relative to the side wall 416.

The levers 420 are movable over the projection 410 of the dispensing button 402 and provide frictional engagement with the radially outwardly facing surface 421 of the side wall 404. The levers 420 comprise a first portion 428 extending axially and configured to extend beyond the projection 410. The levers 420 further include a support portion 430 extending radially inward from the first portion 428 and mounted opposite the radially outward side wall 404 of the dispensing button 402. The portions 428, 430 may be connected by a rounded base 429 joined therebetween to form a J-shape, with the first portion 428 forming a patch portion and the base and support portion forming a hook. The support portion 430 may include an axial support portion 432 mounted against the underside of the protrusion 410. This provides additional resistance to proximal displacement of the module 400 relative to the dispensing button 402. However, the engagement surfaces on the underside of the protrusion 410 and the axial support portion 432 may be provided with sloped surfaces to facilitate removal of the module 400 when needed. In one example, each of the levers 420 is radially movable to release the lug 410 during attachment to and detachment from the dispense button. In one example, both portions 428, 430 flex outward, and in some examples, only one of the first portion 428 or base portion 430 flexes outward to move over the ledge. The levers 420 can be displaced in a radially inwardly extending pattern and can tilt or pivot outward about the attachment site 422 . In an offset configuration, the levers 420 are configured and sized to apply a radial normal force to a series of engagement points along the surface of the sidewall 404 that is suitable for holding axially to the dispense button 402 as well as transmitting torque (without acceptable slip or with small acceptable slip) during dose setting and/or dose delivery.

A block 434 containing arms 420 attached to distal wall 414 (shown as a cast or fabricated component) is shown in FIG. 15. For fabrication purposes, the levers 420 and other components are combined with a distal wall 414 (shown as the radially outward facing surface of the wall 414), which is then attached to other portions of the module 400. FIG. 16-17 show the distal wall 414 and some of its component parts. The distal wall 414 has an opening 436 formed therein to allow the identification sensor, described below, to view the top surface 408 of the dispense button 402. The light guide hole 436 may have various shapes, including, as shown, a D-shape. In another hole 438 formed therein, a presence switch, also described below, is located so that the module 400 can determine when it is installed on the dispense button 402. In one example, opening 438 is lowered into distal wall 414. Sensor receiving recesses 440 are provided in the distal wall to accommodate four radially spaced sensing sensors, such as magnetic, inductive, or capacitive sensing elements, as previously disclosed. The depth of the recesses 440 is designed to place the sensors in close proximity to the component being measured, while leaving sufficient material thickness to structurally support the sensors during manufacture and use. The dimples 440 secure the sensors so that the sensors maintain their respective locations for more consistent measurement capability. The recesses 440 are arranged so that the sensors are evenly spaced in the angular direction (four sensors at 90° from each other (as shown); five sensors at 72° from each other, six sensors at 60° from each other, etc.). relative to each other and were evenly spaced in the radial direction from the longitudinal axis of the module. The walls forming recesses 440 are also configured to accommodate sensors along a common plane. Other openings may be provided for ventilation of the module. Axial attachment tabs 441 may be provided to connect the distal wall 414 to an additional attachment element of the module shell.

The number of levers 420 may vary, for example, in the range from 3 to 36, depending on the required axial holding force and/or torque transmission. The levers 420 are shown attached to the distal wall 414 at an attachment site 422 formed by pins, which may be a single pin or a pair of pins 442, 444 as shown. Block 434 is shown to contain sixteen levers 420. As shown, block 434 contains four pairs of support pins.

- 15 039601

442, 444, which are located circumferentially around the perimeter of the distal wall 414. Each pair of support pins is configured to support a circumferential segment 445 containing a plurality of levers, such as four levers each. Each segment 445 includes mounting holes 446 that receive support pins 442, 444. Once in position, support pins 442, 444 are used to securely heat-attach the lever segments to the distal wall 414. Attaching the levers 420 to the sheath allows levers to be made from a variety of materials. These materials can be selected to obtain the desired characteristics of strength, elasticity, durability and the like. For example, beryllium copper has been found to have advantageous properties for use as levers. The separate attachment also provides flexibility in lever placement relative to the dispense button. For example, the levers may be mounted on various walls of the module, including the distal wall 414, the side wall 416, or the distal portion 424.

The levers 420 may be suitable for various configurations of the surface 421 of the dispensing button 402. In FIG. 14 illustrates a surface 421 that is smooth (no ribs or notches or uneven planes). The button surface 421 may include certain surface features to improve torque transmission by the levers 420. Other embodiments of the invention may be used to interact between the levers and the dispense button perimeter wall. In FIG. 18, for example, another example of a dispensing button 470 is shown for a device comprising a side wall 472 having axially spaced apart ribs 474 defining a series of depressions 476 therebetween. In this embodiment, portions of the levers 420 may be accommodated in recesses 476. The levers 420 may accommodate another fin configuration shown in FIG. 22. The circumferential width of the recesses 476 can be calculated to accommodate the circumferential width of the levers 420. These dimensions can provide a snug fit for the lever or some freedom of circumferential movement of the lever. The presence of adjacent ribs further ensures that the module will not rotate relative to the dispense button during use. In FIG. 19 shows an alternative design in which the dispense button 480 includes a polygonal sidewall 482 thereby defining a series of flat surfaces 484 for receiving the module's levers. The separation of adjacent flat surfaces 484 is a rounded axial connection 485. The use of a flat, smooth cylindrical surface avoids any problems associated with the orientation of the module relative to the dispense button, while the recessed and polygonal designs provide additional frictional interaction of the levers with the side wall of the dispense button .

In FIG. 20-24 illustrate another example of a module attachment assembly, hereinafter referred to as a block 500, releasably connected within the module to any of the dispensing buttons described herein via an attachment member 519. The attachment member 519 is connected to the tubular attachment shell 511 (although other parts of the module shell are omitted, aspects of these parts to form a complete module shell are shown in FIG. 13 and FIG. 25). Attachment shell 511 with attachment element 519 may form part of module 600, as will be described below. Attachment member 519 includes a plurality of distally extending levers 520. As generally shown in FIG. 20, a module unit 500 is attached to another example of a dispensing button 502 by levers 520 that are attached to and extend distally from the sheath 511, and in particular extend distally from the annular sheath portion 517 of said sheath 511 in recessed areas defined by the distal wall 514. The annular sheath defines a cavity to accommodate, for example, at least part of the electronics. In an exemplary embodiment, the levers 520 are evenly spaced radially apart around the dispense button 502. The levers 520 are shown to be connected to the distal wall 514 of the attachment sheath 511 and depend on said distal wall. In FIG. 21 shows levers 520 that are resiliently movable over protrusion 510 of dispense button 502 and provide frictional engagement with the radially outwardly facing surface 521 of side wall 504 of dispense button 502. With additional reference to FIG. 23, the levers 520 include a support portion 530 extending radially within the axial body of the levers 520 and mounted against a radially outwardly facing side wall 504. The support portion 530 may include a protruding body 531 extending radially inward from the inner surface of the lever 520. The protruding body 531 may include an axial bearing surface 532 that is to be placed opposite or placed in close proximity to the underside 533 of the protrusion 510 shown in FIG. 24. This provides additional resistance to proximal displacement of the module relative to the dispense button 502, if attached. The protruding body 531 of the support portion 530 may include a distal facing end portion 537. The surface 532 and/or the distal facing end portion 537 may be inclined at any angle to give the protruding body 531 a tapered profile. Protruding core

- 16 039601 pus 531 may include facing in the radial direction of the surface 538 interaction, having some axial length, passing between the surface 532 and the end part 537. Surface 538 interaction can be flat, rounded (as shown), conical or V-shaped. As shown in FIG. 23, the protruding body 531 may have a smaller width than the lever 520. In another example, the levers may comprise more than one protruding body positioned to fit within adjacent ribs or alternating ribs. In FIG. 22 shows a side wall 504 of a dispensing button 502 comprising a plurality of spaced apart and axially extending ribs 545 defining a series of recesses 547 therebetween. The button 502 also includes a proximal wall with a proximal top surface 508. At least a portion of the proximal surface 508 may be colored to match the unique drug type and/or dosage. The color button 502 represents all other buttons described herein, as these other buttons may have similar color schemes. To this end, any of the modules described in this document can be attached to different types of pens, and with the help of color detection, the module can transmit identification information to an external device. The module and/or external device may determine a different number of units of drug delivered for the same total rotation value because the pen has a unique rotation profile for a given drug and dosage. In one example, the entire top surface 508 of button 502 is one color. In another example, a surface feature or region 507A, such as a recess or ridge or center of a button surface, may have a first color, and an area 507B adjacent the surface feature or particular region may have a second color different from the first color. The drug identification definition described herein may be oriented to the first color or the second color, depending on the configuration of the module. In this embodiment, at least a portion of the foot portion 530 of the levers 520 may fit into the recesses 547. In one example, the circumferential width of each of the recesses 547 may be sized to accommodate the circumferential width of the engagement surface 538 of the foot portion 530, and in others Embodiments of the invention, recesses 547 may be sized to accommodate the end portion of the engagement surface tip of any of the lever tips described herein, such as shown in FIG. 20. The circumferential width of each support portion 530 may be too large to fit the recesses 547, engaging with adjacent ribs and not extending into the recesses. In one embodiment, the proximal portion 549 of the recesses 547 may extend within the radial projection 510. The depth D1 of the recesses 547 shown in FIG. 24 may be constant along the axial portion of the recess. In other examples, the depth of the recesses 547 may vary along the axial portion, having, for example, a dimension that should be deeper towards the proximal end than towards the distal end of the recess 547. The levers 520 may also be suitable for other button surfaces, such as those which are shown in Fig. 14, 18 and 19. The protruding axial distance O of the axial bearing surface 532 of the arms 520 with respect to the distally facing axial surface 513 of the distal wall 514 may be greater than the axial depth D of the radial projection 502. With reference to FIG. 24, the value of the length of the protruding part of the levers 520 beyond the plane formed by the distally facing axial surface 505 of the distal wall 506 and perpendicular to the axis A-A, can be calculated so as to place the support portion 530 along the radially outward facing surface 521 of the side wall 504 dosing buttons 502. In one example, the length of the projection is calculated so that the support portion 530 is located along only the proximal upper portion 509 of the side wall 504, so that the distal lower portion of the side wall 504 remains unengaged with any portion of the levers. The dosing button shown in Fig. 24 has an axial height H measured between the top surface 508 of the dispense button 502 and the distal end 511 of the dispense button 502. The distal end 513 of the base portion 530, that is, the most distal portion of the base portion 530 which is in direct engagement with the side wall 504 of the arms 520, engages with the surface 521 of the side wall 504 at an axial distance HL, thereby accommodating a portion of the engagement surface 538 of the bearing part 530 between the radial ledge 510 and the interaction of the distal end 513 against the side wall. The support portion may extend axially between the bottom side of the rim 510 and the interface of the distal end 513, which is located along the upper half of the side wall 504. The axial distance HL is measured between the specified plane formed by the surface 505, which is opposite the upper surface 508 of the dispensing button 502, and the site of interaction of the distal end 513, as shown in FIG. 24. In one example, the axial distance HL may be up to 50% of the axial height H of the dispensing button 502 to position the support portion 530 along the proximal portion 509 of the side wall 504. This position may reduce the spatial impact of the levers within the attached module placed on the button. The engagement surface 538 of the support portion 530 is axially larger than the axial thickness of the radial protrusion 510 to generate a greater radial force. Support part 530 levers 520 in more compact in axial on

- 17 039601 the configuration rule, as shown, can reduce the value of axial movement and friction, creating forces on the surface 538 of the support part around the circumference 510, and thus reduce the force of attachment and/or detachment for the user. An axially more compact support portion of the levers can also reduce the module attachment and/or detachment time value so that the user is not left wondering if the attachment was successful.

In FIG. 21 illustrates that each of the levers 520 is movable radially in the direction of arrow 535 to release the lug 510 during attachment to the dispense button (or movement of the module in the proximal direction P relative to the dispense button) and detachment from the dispense button (or movement of the module in distal direction D-D relative to the dosing button). The levers 520 can be displaced in a radially inward configuration and can deflect or rotate around where the levers depend on the distal wall 514. In an offset configuration, the levers 520 are configured and sized to apply a radial normal force to a number of interaction points. along the surface of the side wall 504 which is suitable for holding axially to the dispense button 502 as well as transmitting torque (with no or little acceptable slip) during dose setting and/or dose delivery. In other words, during dose setting, the block 500 that is associated with the button 502 rotates in the first direction, which moves the module/button away from the device shell. With any of the attachment elements described herein, such as elements 419 and 519, the attachment force that the user applies in the distal direction DD may be less than the detachment force that the user applies in the proximal direction P. The detachment force value may be in range from 4 N to 30 N. In one example, the levers are designed such that the release force is at least 1.5 times the attachment force and can be at least twice the attachment force to prevent inadvertent detachment of the module. In one example, the release force is more than 20 N and the attachment force is less than 11 N. In other examples, when the module is attached to the device, a small amount of slippage of the supporting parts along the dispensing button due to the torque due to the dose setting may be allowed to avoid excessive torque and possible damage to dose setting device components. The levers 520 and sheath 511 may be formed as a single unit, for example by molding a plastic material such as an acetal thermoplastic (eg Delrin®) or a polycarbonate material (eg Makrolon®). Such a single unit 561 is shown in FIG. 23. Plastic materials can be selected to obtain the required characteristics of strength, elasticity, durability, and the like. Alternatively, the levers 520 may be made separately from the shell and later attached by adhesive or welding. The number of levers 520 may vary. In the example shown, the four levers are arranged circumferentially at the same distance from each other. In some examples there may be three levers, and in other examples there may be 5, 6, 7 or 8 levers. The levers described herein, such as levers 420 or 520, provide a convenient and efficient attachment of the module to the dispense button.

Because the module is intended to be used on multiple drug delivery devices, attaching the module allows for easy attachment of the module to the dispense button and removal of the module from the dispense button. This is due to the levers described herein having suitable configurations and physical properties to set the amount of force needed to attach/detach the module. The levers described herein also have sufficient durability to be repeatedly attached to drug delivery devices and remain elastic to provide proper fastening and retention on the button without the use of a separate locking piece such as a helical spring or ring located outside to provide a radial compressive force.

Once installed on the drug delivery device, for example, using any of the attachment elements 419 or 519, the module enters into frictional engagement with the dosing button. This allows the module to be used to rotate the dosing button at will, such as during dose setting in the case of some drug delivery devices. The surface interaction of the bearing portions of the levers described herein can be controlled by various parameters. The frictional interaction depends on such factors as the force applied perpendicular to the surface of the module and the coefficient of friction applied to the contact surfaces. The radial force applied depends, among other things, on the size and shape of the levers, the elasticity and resilience of the levers, and other factors. The disclosed attachment elements allow you to choose from these and other options to provide the required balance to frictionally lock the module with the dispense button to rotate and allow easy attachment and detachment of the module relative to the dispense button.

- 18 039601

Any of the modules described herein may include one or more switches to facilitate the use of the module, although the following description applies to module 600. As previously described, the module is detachably attached to a drug delivery device. If necessary, the module is removed from one drug delivery device and can then be used in conjunction with another drug delivery device. One skilled in the art will appreciate that the various attachment elements described herein may be used for such connection to a device. With reference to FIG. 25-28, module 600 includes a proximal wall assembly 602, a side wall 604, and a distal wall 606. Walls 602, 604, 606 of module 600 thus define an internal chamber 608 capable of receiving electronics 610. Wall 602 may comprise a transparent or translucent material around the top edge to provide a light guide when using LEDs.

Although the attachment member 607 is shown for illustration purposes as the attachment member 419 shown in FIG. 15, it is not meant to be limiting, as module 600 could also be provided with any other attachment point described herein. In such a configuration, the opening at the proximal end of the attachment tubular 511 is sized to accept the circumferentially located outer surface 609 of the distal wall 606 in a friction fit or otherwise secured. In this configuration, the distal wall 606 is shown by way of illustration in FIG. 16-17, when the distal wall 414 (with elements such as holes 438, 436 and elements 440, 441) except for pins 442, 444 and the block protrusions located between pins 442, 444 are lowered, the thereby providing a smooth outer surface 606A of the distal wall 606 that is appropriately sized and shaped to accommodate the block 500. FIG. 25, 26, 27 and 29 show an example of an electronics unit 610 that can be used for any of the modules described in this document. Block 610 includes a first distal segment 612, a second proximal segment 614, and a third intermediate segment 616 therebetween, each of which is electronically connected via connectors and terminals, indicated generally at 618A-618B. The segments 612, 614, 616 can be connected coaxially and arranged one above the other in the shape of the letter S. The battery 621 is shown to be located axially between the first and third segments 612, 616 and is gripped by resilient levers. The second segment 614 may include sensor sleeves 623 formed therein to receive measurement sensors such as, for example, measurement elements 160. The sleeves 623 are aligned and inserted into recessed locations 440 of the distal wall of the module sheath. Alternatively, instead of sleeves 623, the measuring sensors can be connected directly to the circuit of the second segment without sleeves.

In FIG. 27, the first segment 612 includes a proximal facing surface 615 and contains an example of a switch 622 of a wake switch system 620 installed thereon. The module may include indicator elements 624 such as LEDs to indicate the status of the device and/or module operator. In one example, indicator elements 624 are operatively mounted on surface 615 of first segment 612. Actuation of a wake-up switch 622 may be used to turn on appropriate electronics, such as those associated with dose delivery. For example, the wake-up switch 622 may include a measurement sensor, such as, for example, measurement elements 160 involved in measuring dose delivery generated by rotation of the measurement element. LEDs or other indicator elements, such as acoustic speakers and/or oscillators, may be used to notify the user of the progress of the system by completing a dose delivery or to notify the user between dose delivery periods, such as an indication of battery charge. In one example, LEDs are provided on the sides of the switch 622. The wake-up switch system may be configured to power up the electronics from a low power state to a full power state.

Any of the modules described herein may comprise a wake switch system 620. It may be optional for the module to provide such a wake-up switch. In one example, the module 600 shown in FIG. 25-26 includes a wake switch system 620 that includes an axially movable segment 626 located in a recess formed in the upper surface of the proximal wall assembly 602. The awakening segment 626 can move distally into the module 600 and has an offset configuration as shown. The awakening segment 626 may, for example, comprise a flexible disc-shaped element that is typically in a proximal position, or it may be an element that is displaced in a proximal direction, such as by means of springs (not shown). The awakening segment material may provide some deflection of the center 627 of the segment 626 relative to the circumferential edge 629 of the segment 626. The segment 626 may be a rigid element that is slidably located along the walls forming a recess in the proximal portion 602 of the module shell. Segment 626 may include an anchor segment (not shown) movably connected to the shell.

- 19 039601 module in such a way that when the segment 626 is in a displaced proximal position, the segment remains inside the shell of the module without leaving the module. The walls 630 of the proximal wall assembly 602 may be appropriately shaped to form a proximally facing axial surface 631 configured to form a physical stop or distal end position for distally moving the segment 626 from its displaced proximal position. The walls 630 form a smaller portion of the through hole 632 extending axially along the A-A axis through the proximal wall 602. moving the segment 626 until it causes direct or indirect actuation of the switch system 620. This thrust to actuate the wake-up switch is less than the thrust to actuate the delivery device to deliver the dose. In one example, segment 626 can be moved distally to engage axial surface 631 while walls 630 defining through hole 632 can be sized and shaped to continuously axially deflect segment 626 distally beyond axial surface 630. , so that this is sufficient to actuate the switch system 620. The switch shown comprises a mechanical switch or a rubber dome switch while other switches such as electrical contacts are provided. The switches described herein may be mechanically actuated or actuated through interaction with another component.

In one example, the switch system 620 may further comprise a flexible protective sheath 635 configured to restrict movement of the segment 626 in the distal direction when pressed by the user to prevent damage to the wake switch 620. The containment shell 635 may be located axially between the segment 626 and the switch 622. An axial force from the user may be transmitted through the segment 626 to the containment shell 635 to cause the central portion 638 of the containment shell 635 to deflect in the axial direction to engage the actuating lever of the switch 622. The containment sheath 635 may be configured to have a maximum distal degree of deflection. Such a distal degree may be calculated so as to engage the actuating lever of the switch, but not beyond a position that would cause damage to the switch. The containment can be of various sizes and shapes for this functionality.

In FIG. 28 illustrates one example of a containment 635 comprising a plurality of radial arms 640 arranged circumferentially relative to each other extending from a center point of a sleeve 642 that surrounds a central portion 638 of the containment. The central point of the sleeve is located coaxially with the A-A axis. Sleeve 642 and center portion 638 may be of any shape and may be rectangular, oval, or round as shown. The central portion 642 may include a concave portion that extends the sleeve in a distal direction relative to an area surrounding the sleeve in a radial direction beyond the concavity. The end caps 643 from the first set of arms 640A can be connected to the anchor portions 644, such as, for example, the distal surface of the anchor portions 644 having a slotted area sized and shaped to match the size and shape of the tips 643. The anchor portion 644 extends distally. from an axially movable segment 626 that positions the anchor portions 644 over the tips 643. The anchor portions 644 move axially with the segment 626 within the through hole 632 when an axial force is applied to them by the user. The anchoring portions 644 may be integral with the segment 626, such as by casting, or the portions 644 may be separate and permanently attached to the distal surface of the segment 626. The tips 646 of the second set of arms 640B may be free or remain non-engaging with the segment 626 The first set of arms 640A may contact anchor portions 644 at positions evenly spaced in the angular direction to distribute thrust and deflection to each of the arms 640. In one example, the first set of arms 640A is shorter in radial length than the longer second set of arms 640V. The first set of branches 640A may extend radially directly between adjacent branches of the second set 640B. While all arms 640 may allow containment 635 to be flexible, free arms 640B may prevent containment 636 from having a maximum distal degree of deflection while force is transmitted axially from segment 626 to tips 643 through fixture portions 644 to move the tips. 643 inside the through hole 632. In the example shown, there are a total of eight branches 640, each of which is located in the radial direction from the center point at an angle of 45°. The shorter fixed arms may be positioned at 90° relative to each other, and the longer arms may be positioned at 90° relative to each other and offset radially from the shorter fixed arms.

- 20 039601 branches. Other numbers of branches and their relative positions may be used. In one example, the electronics unit 610 is activated from a sleep state by axial movement of the segment 626 and containment 635 caused by the user to such an extent that it contacts the axial actuation lever of the switch 622, for example, without any movement in the distal direction. module and/or dispensing button. Alternatively, the wake-up switch may comprise one or more electrical leaf spring contact elements that are deflected from contact by respective pads mounted on the first segment and are movable to contact the pads as a result of force being applied through the element 626. In some In examples, the electronic unit is switched on by means of simultaneous contact of each of the contact elements. Any of the modules described herein may comprise a presence switch system 650. It may not be necessary to provide the module with such a presence switch. According to FIG. 25, 26, and 27, module 600 includes a presence switch system 650 mounted on distal wall 606 so as to determine when module 600 has been installed on or removed from a drug delivery device. The presence switch 652 of the system 650 is operatively coupled to the proximal surface 617 of the second segment 614 of the electronics assembly 610. The switch 652 includes a rotary switch arm 654 at least partially covering the opening 657 (see opening 438 in FIG. 16) formed by the distal wall 606. Distal wall 606 may include the same arrangement (or substantially the same arrangement) of elements, such as openings 438, 436 and elements 440, 441 shown in FIG. 16-17. The switch lever 654 of said switch 652 is in an offset position (shown in FIG. 27) and a distal position (shown in dotted lines). As shown in FIG. 25-26, the switch system can move from its displaced distal position (as shown in FIG. 26), representing the absence of a drug delivery device, to its proximal position (shown in FIG. 25), indicating that the module 600 is mounted on the device. drug delivery. The presence switch system 650 includes a switch actuator 660 that is mounted on the distal wall 606. The actuator 660 includes a first element 662 in nested engagement with a second element 664. The second element 664 has a cup configuration that defines a cylindrical cavity to receive the first element 662. The second element 664 is slidably positioned through the opening 657. The second element 664 includes an outer radial ridge 663 along its proximal end and is positioned within the module to further impede the entry of particles and/or water. Although in FIG. 25 shows a radial protrusion 663 further from the distal wall, the radial protrusion 663 may remain engaged with the distal wall as shown in FIG. 26 when the module is attached to the device. The second element 664 may be made from an elastomer or a soft plastic material for greater flexibility. The second element 664 can move within the module shell to a proximal position by interacting directly with the device when the module is installed on the device. The first element 662 has a shape and dimensions suitable for the cavity formed by the second element 664. The first element 662 includes a cylindrical body 666 extending in the axial direction between its proximal and distal axial ends. The outer radial rim 668 is shown to extend from the intermediate segment of the first element housing 666 such that a distal cap segment 670 is formed for insertion into the distal end of the actuator spring 672. The actuator spring 672 is fixedly attached at its proximal end to the inner shell component of the module, and the distal end of the actuator spring rests on and can move with the bezel 668. The headband 668 may include a distal skirt 674 dependent on the distal surface of the headband 668. In one example, the distal skirt 674 is connected to the outer radial end of the headband. The rim 668 may include diametrically opposed radial elements instead of a continuous circumferential element.

Under the actuating force of the actuator spring 672, the first element 662 is in a nested position in the second element 664, and the rim 668 of the first element 662 is configured to contact and distally move the switch lever 654 to place the system in its displaced distal position when the module is removed from the device. The switching system 650 electronically indicates in its distal position that the module is not installed on the device and power limits can be programmed into the processor to perform minimal functions. The skirt 674 may exert radial pressure along the second element protrusion 663 against the inner surface of the distal wall 606 to further inhibit specific penetration. After the module is attached to the device, the outer end of the second element 664 with the first element 662 is in a nested position, contacting the dispensing button of the device, and the force is transmitted to the rim through the body of the first element to overcome the force of the spring 672, thereby causing the first and second elements to move in the proximal direction inside the shell of the module and thereby ensuring the return of the switch system to the proximal position. The switch system 650, in its proximal position, electronically indicates that the module is installed in the device and the processor can be programmed to full power to perform all functions.

Actuator 660 is biased distally by spring 672 and typically extends distally from opening 657 when module 600 is not mounted on a drug delivery device. As shown somewhat schematically in FIG. 25, placing the module 600 on any of the dispense buttons described herein, typically labeled 601, causes the top surface of the dispense button 601 to push the actuator 660 in the proximal direction, and this movement in turn moves the switch lever in the proximal direction. , actuating the presence switch 652 . The MCU of the electronic unit 610 recognizes the proximal position of the switch lever 654 to confirm that the unit 500 is mounted on a drug delivery device. In response, the MCU activates or energizes the appropriate components of the electronics unit 610 in preparation for use of the drug delivery device. When module 600 is subsequently removed, spring 672 moves actuator 660 back out of distal wall 606 and switch lever 654 returns to its distal position, identifying that module 600 is not mounted on a drug delivery device. The MCU then returns the drug delivery device to an unused state, such as by shutting down the module's systems or putting them to sleep. One example of electronics block 610 is shown schematically in FIG. 46. By way of illustration, any of the modules described herein, such as module 600, may also include a sensor to identify the type of drug delivery device or the type of drug contained in the drug delivery device. With reference to FIG. 29, the identification sensor 680 is operatively connected to the distal surface 617 of the third segment 616 of the electronics unit 610. The second segment 614 has a window opening 682 formed therein. The identification sensor 680 is positioned above the window opening 682 and the opening 684 of the distal wall 606 (see opening configuration and arrangement in opening 436 in FIGS. 16-17) to be able to view the exposed surface of the dispense button 601. Recess 686 may be formed along the distal surface of distal wall 606 that spans aperture 684. Recess 686 may accommodate the associated lens or lens shield to prevent debris from entering. The dosing button 601 is provided with indicia visible to the type sensor 680 through aperture 684. The indicia correspond to information regarding the drug delivery device, such as the type of device or drug contained in the device. The identification sensor 680 reads the indication characters, and the MCU recognizes the indication characters as indicating drug delivery device information. The light guide element 685 may be positioned within the aperture 684 to provide an optical path for the identification sensor. Attaching the light guide element 685 to the distal wall 606, such as with a snap-on connection, adhesive, or ultrasonic welding, can prevent distortion of light and measurements caused by relative movement or vibration of the light guide element. A light guide element 685, which may be made of a transparent or translucent material such as, for example, polycarbonate, is shown to extend axially between the top surface of the dispense button 601 and the opening 682. The recess 686 may also be configured to accommodate an enlarged portion of the base light guide element 685.

For example, identification sensor 680 may include an RGB source(s) and a sensor for detecting a color reflected from a dispense button, and the indicia may comprise different colors, with each color associated with specific information regarding the drug delivery device. Protective elements may be provided to direct the RGB light sources axially towards the button and to prevent the sensor from prematurely reading the shape of the light beam. Alternatively, the indicia may include grayscale, patterns, or other material that can be optically recognized. In addition, more than one type of sensor may be used to improve the determination of information regarding the drug delivery device. In one embodiment, the identification sensor 680 is configured to determine the proximal center or center of the proximal top surface of the dispense button 601. At the same time, the indication marks may comprise patterns arranged symmetrically around the center of the dispensing button 601, such as concentric colored rings. With this location of the sensor 680, the presence switch 652 is offset from the center of the module 600. In use, the identification sensor 680 is actuated by the module 600 mounted on the drug delivery device. In one example, the presence switch 652 determines the setting of the block 500 on the drug delivery device, at which time the identification sensor 680 is activated. Each time it is collected, certain information regarding the drug delivery device may be stored and/or transmitted. The module 600 may then be put into a low power mode, eg after a predetermined period of time, before being reactivated during dose delivery.

As shown schematically in FIG. 27, indicator lights 624 (shown as LEDs) or other signaling devices may notify the user of various states of the module 600 as well as other components, including the drug delivery device itself. For example, a light signal may be used to indicate the type of drug delivery device or drug contained in the drug delivery device. Another signal may be provided to confirm correct placement of the module on the drug delivery device. In addition, the signal may indicate the transition of the module 600 to or from various states, such as an awake state or a sleep state. The indicator elements may be configured to indicate in one form (eg green) a successful connection or in another form (eg amber) an unsuccessful connection between the module and the dispensing button of the device.

Module assembly can be configured for mass production. The following steps may apply to any of the modules described herein with general reference to FIG. 25 and 27, and in an alternate sequential order other than that described below. The distal wall 606 is provided as a component in the orientation and arrangement shown in FIG. 16. The switch actuator 660 with the first and second elements is inserted through the opening 657 with the first element rim 668 sized to match the dimensions of the axial slots formed by the vertical walls surrounding and extending from the edge of the opening (as shown in FIG. 16). The actuator spring 672 is placed on top of the actuator as shown in FIG. 25. The second segment 614 is aligned with the interior of the distal wall component around various features and openings formed along the distal component. An axial separation component 675 (shown in FIG. 25) is placed over the second segment 614 and the distal wall. Separating component 675 contains alignment elements for positioning segments at a predetermined relative distance. The segments are then folded along connection 618A to position third segment 616 proximally on top of spacer member 675. Battery 621 is positioned on top of third segment 616 and is configured to power all segments functionally. The first segment 612 is then folded along the connection 618B to position the first segment 612 proximally on top of the accumulator 621. The attachment elements are then connected to the distal wall 606 by either sliding along the distal wall 606 with the lever block 500 520 with the support portion as described above, or by attaching with the levers of the attachment element 419 as described above. The proximal wall portion component 602 is positioned over the first segment 612 and includes attachment features for secure attachment to the distal wall 606, including attachment to the axial attachment tabs shown in FIG. 16 to form a pre-assembly. The proximal wall portion 602 may include an axially movable segment 626 and a containment sheath 635 assembled together as described herein prior to attachment to the side wall 604. The configured tubular side wall component 604 is slidably positioned radially surrounding the pre-assembly, and its proximal end is fixedly attached to the proximal wall portion 606 . The distal skirt portion 677 is fixedly attached to the distal end of the side wall 604, thereby forming a fully assembled module. With reference to FIG. 35, another embodiment of the module, hereinafter referred to as module 800, comprises a proximal wall 802, a side wall 804, and a distal wall 806. The walls 802, 804, 806 of the module 800 thus form an internal chamber 808 configured to accommodate the electronics unit 810. The proximal wall 802 may be disc-shaped and form a finger pad that the user presses to turn on the device. The module may include a ring 812 of transparent or translucent material around the top edge to provide a radial light guide when a light source such as LEDs is used, as shown in FIG. 27. Such a light source may be located on the proximal surface of the circuit board 809 of the block 810 and configured to emit light through the hole 813 formed by the light guide ring 812. The opposite surfaces of the ring 812 and the proximal wall 802, respectively, can be securely attached to each other, to form a block of the proximal wall of the module shell. In one example, a secure connection can be made with adhesive, bonding, ultrasonic welding, or the like. In another example, the secure attachment may be double-sided adhesive tape 860. The proximal wall assembly may include a white surface or reflective surface positioned to cover aperture 813 to improve radial transmission of light within the light guide ring 812 that radiates through aperture 813. The distal surface of the proximal the walls may include a white or reflective surface. In one example, the distal surface 862 of the tape 860 includes a white or reflective surface, and in other examples, a disk element with a white or reflective surface may be used. The proximal wall unit described herein can only refer to the proximal wall without the light guide ring. Ring 812 may contain element

- 23 039601 Attachment for attaching to another module component. For example, ring 812 may include a plurality of retaining latches 812A depending on the distal surface of ring 812. Levers 812A are configured to allow axial movement of the proximal wall relative to the sheath and include tips configured to prevent ring 812 from moving into position. The ring-shaped button gasket 811 is shown to engage with the distal surface of the ring 812 and is positioned radially outward relative to the levers 812A. In FIG. 47 is an exploded view of one implementation of a module, such as module 800, divided into its individual components along a common axis. The module may include a first separating element 815, which is in the form of a ring and forms an inner radial surface 817 located around the circle formed by the retaining latches 812A. The surface 817 is configured to provide controlled axial movement of the proximal wall block from a proximal position to a distal position for the awakening function. The distal surface of the spacer 815 along the inner radial surface 817 provides a site for interaction of the retaining latches 812A for retention when the proximal wall assembly returns to the proximal position under the action of the preload force. In some embodiments, the light guide ring is omitted and the proximal wall includes retaining latches to engage with surface 817. The spacer 815 may include a proximal flange 819A along the radially outward portion of the spacer. The upper end of the flange 819A may provide a physical stop to limit distal movement of the proximal wall 802. The spacer 815 may include a distal flange 819B located along the radially outward portion of the spacer and recessed radially inward relative to the proximal flange 819A. The recess may be sized to match the thickness of the sidewall 804 when the upper end of the sidewall engages the radial outer surface of the distal flange 819B.

A button gasket 811 is placed axially between the proximal wall 802 and ring 812, and a part of the shell in the form of a spacer element 815. In one example, the button gasket 811 engages between the ring 812 or the proximal wall (in the absence of a ring) and the element 815. 811 can axially compress from its natural state. The gasket material, such as, for example, honeycomb urethane, may be configured to be compressible. The gasket material 811 can also provide a seal against fluid leakage while still providing ventilation. In other embodiments of the invention, the gasket material may provide a seal against the exit of liquid and air. In its natural state, the spacer 811 can provide compressive force and support along the outer circumference of the proximal wall block to hold the proximal wall block in its extended proximal position. When the user depresses the proximal wall to use the device, the button pad 811 can compress in the axial direction as the ring/block of the proximal wall moves distally relative to the spacer 815, which is in a fixed position. The spacer 811 may assist in returning the proximal wall assembly to its extended position and provide continuous tactile feedback to the user throughout its movement. A padded spring or other sealing means may be used instead of a compressible gasket. The module may include a second separating element 821 located distally relative to the first separating element 815 between the element 815 and the distal wall 806. The second separating element 821 is in the form of a ring. The second separating element 821 is connected to the first separating element 815, and, for example, each of them has elements extending in the axial direction, which provide a connection. As shown, the battery 861 is located between the elements 815, 821. A battery retaining element (not shown) may be attached to the proximal surface of the second spacer element. A battery support member 864 may be included between the proximal side of the battery and one of the electronics plug-in boards and be in frictional contact with the battery to prevent movement of the battery within the module. In one example, battery support member 864 may include a ring of axially compressible material such as closed cell foam. The cross-sectional area of cell 864 may be smaller than the cross-sectional area of the battery. The side wall 804 is shown to extend radially outward from the contents of the module and extend axially between the first spacer 815 and a base ring 823 that is connected to the distal end of the side wall 804. The base ring 823 may be optional. The side wall 804 may include a plurality of distally extending retention latches 804A for engagement with appropriately shaped recesses formed along the inner surface of the base ring 823 so as to securely lock the components together. Retaining latches 804A may be positioned radially inward from the overall outer circumference of sidewall 804 to form a recess sized to match the total thickness of the top end of base ring 823. seat

804B may be formed along the inner surface of the side wall 804 extending further radially inward from the surface. Seat 804B is configured to receive a distal spacer 825.

The distal spacer 825 is in the form of a ring and is positioned radially between the inner surface of the side wall 804 and the outer circumference of the distal wall 802 and axially between the seat 804B and the seat 827A defined by a radial flange 827 extending from the distal wall 802. In one example, gasket 825 is in tight engagement between sidewall 804 and distal wall 802. Gasket 825 may be made from a gasket material, such as honeycomb urethane, for example, and may be configured to be compressible.

Although module 800 is shown with the presence switch omitted, a presence switch system, such as, for example, system 650 described previously, may be included in the module, as will be appreciated by those skilled in the art. Module 800 is shown to include another embodiment of a wake switch system, hereinafter referred to as wake switch system 820. Although the wake-up switch system 820 is shown by way of illustration, it is not intended to be limiting, as the module 800 may also be provided with a wake-up switch system 620. Similarly, other modules described herein may include a wake switch system 820.

With additional reference to FIG. 36, the wake-up switch system 820 includes one or more axially movable contact levers 822 and a corresponding pad 824 connected to a circuit board 809, which may be a flexible printed circuit board (FPCB; flexible printed circuit board) of the electronic unit 810, and electrically associated with the MCU. The contact arm 822 can distally move from a displaced non-contact natural configuration as shown in the figures, where the contact lever 822 is axially spaced from the pad 824 such that there is no electrical connection (thus the electronics is in a low power state), in a contact configuration by which the contact lever 822 and the contact pad 824 are in a contact relationship such that there is an electrical connection between them (thereby increasing the power of the electronics to a state of operation at full power). The contact arm 822 may be preloaded to maintain contact with the proximal wall 802 along various axial positions of the movable proximal wall. The bias may be provided by a discrete spring, or the contact lever 822 may be configured as a leaf spring, as shown.

In one embodiment, the contact lever 822 includes a base 830 fixedly attached to the circuit board 809, a movable lever length portion 832 connected to the base 830 via a connection 834. The lever length portion 832 can perform a pivotal movement relative to the base 830 around the connection 834. on the side of the contact lever 822 may be sufficient to maintain the upper proximal wall 802 in the proximal first position. When the user distally actuates the proximal wall 802, the axial force is sufficient to overcome the pushing force of the contact lever 822 and causes the proximal wall 802 to move distally from its first position to the distal second position, in which the contact lever 822 and the contact pad 824 are in a contact to actuate the switch system and/or wake up the control system. Movement of the proximal wall 802 relative to the module shell, which is in a fixed position during this action, may occur to enable the system without actuating force being applied to the actuator. There may also be movement of the proximal wall 802 relative to the shell of the module that is in the process of being moved to its final distal position while the actuator is subjected to actuation force to deliver the dose. The switch system 820 may include alternative switch configurations such as, for example, a mechanical switch or a rubber dome switch.

The lever length contact portion 832 may extend from the base 830 at an acute angle to the plane defined by the base 830, although the extension angle of the lever portion may be perpendicular or acute with respect to the base. From the point of view of the radial view, the contact lever may have a V-shaped body. In one example, any portion of the lever portion 832 may include a contact portion that can contact pad 824. In the illustrated embodiment, the end portion 835 of the tip of the lever portion 832 forms the contact portion. In another embodiment of the invention, the contact portion extends along the intermediate body of the lever portion 832. The contact portion of the lever portion 832 may be configured to improve contact with the pad 824, such as, for example, incorporating a polished or

- 25 039601 smooth surface and/or rounded surface or hook-shaped and/or domed surface (as shown in Fig. 35-36).

Any application of force to the proximal wall 802 can move the contact lever from its natural state to its contact configuration. In one embodiment, the lever portion 832 may be tilted along its body on the support joint 837 to form a proximal first portion 840A and a distal second portion 840B. The first part 840A extends between the base 830 and the connection part 834 and the support connection 837. The second part 840B extends between the support connection 837 and the end part 835 of the tip. The length and angle of the protruding portion of the first portion 840A is configured to locate the support connection 837 in a specific location to maintain contact with the inner surface 802A of the proximal wall or light guide ring, or alternatively with corresponding contacts 802B extending distally from the surface 802A proximal upper wall 802 when moving between its first and second positions. The length and angle of extension of the second part 840B in the distal direction is configured to place the end part 835 of the tip at some distance from the contact area 824 when the proximal wall 802 is in the first position, and to provide distal movement of the end part 835 of the tip together with the proximal wall 802 for a sufficient the distance to contact pad 824 when proximal wall 802 is in the second position. In an alternative embodiment of the invention, the support portion 837 of the contact lever 822 may be positioned closer to the tip portion 835 of the lever portion than the contact portion. To this end, the contact portion may be formed along the groove or recess of the lever portion. In some embodiments of the contact lever, the support portion of the contact lever is located in a more proximal position than the contact portion. From an axial viewpoint, the configuration of the lever portion 832 of the contact lever 822 may be linear, angular, or curved. In FIG. 36 illustrates an example of a lever portion 832 having an arcuate shape. Although one contact lever and contact pad system may be sufficient for the module's wake-up function, in FIG. 36 shows a system containing three sets of 822 contact levers and pads (not shown clearly in the figure). As shown, the three contact levers 822 may be located radially from the longitudinal axis at approximately the same distance. The levers 822 may be equally spaced circumferentially apart, for example, with a separation of 20° to 40° between adjacent ends of the contact levers. Multiple sets, such as two, three, four, five or more, can more evenly distribute the pushing force from the contact levers 822 on the top wall 802. Even if there are multiple sets, the controls can be made to use only one set of contact lever 822 and pad 824 or less than the total number of all kits to establish a contact for activation. The need for fewer than the total number of contacts to activate may allow the user to depress any part of the proximal wall to induce awakening, rather than requiring the user to depress a specific location with a finger. To facilitate inadvertent activation, the controls may be configured to use more than one set, such as all three sets of contact levers 822 and pads 824, to establish contact for activation. The base 830 and the contact arm portion 832 may be integrally formed from the same material, such as an electrically conductive material such as metal. The pad 824 is made of a conductive material with a contact lever. The base and part of the lever can be made separately from the same or different materials. If they are made separately, the base and part of the lever can be connected to each other, for example, welding, epoxy metal welding compound, soldering or other means depending on the materials of the components. The base and part of the lever may be made of a plastic material containing a conductive material that impregnates the plastic material at least at the end of the tip or has a coating of conductive material along the end of the tip. In one example, the base and part of the lever are integrally formed from an electrically conductive metallic material and are connected to each other by means of a flexible hinge such that the contact lever has a leaf spring configuration.

In FIG. 37 shows another example of a module attachment assembly, hereinafter referred to as a separator block 839. The block 839 is configured, when included in the module, to provide a detachable connection of the module 800 with any of the dispensing buttons described herein, through the attachment element 807 . The distal wall 806 has an opening 836 formed therein for receiving a light guide member 849 for an identification sensor, such as, for example, the identification sensor 680 illustrated in FIG. 29. An air vent 841 may be formed in the distal wall 806. On the proximal surface of the distal wall 806, sensor receiving recesses 842 are formed to accommodate evenly spaced in the radial direction and evenly spaced in the angular direction of the measurement sensors, for example, five magnetic, inductive or capacitive measuring elements or magnetic sensors 906 disclosed in this document. Recesses 842 may be located on the distal surface of the distal wall 806. Attachment posts 843 may be provided to connect the distal wall 806 and/or block 839 to an additional module shell attachment.

With reference to FIG. 39, a light guide element 849 is shown with a light guide pin 853 extending from a base 855. The light guide element is made of a material such as optically clear polycarbonate that allows at least some light to pass through for the identification sensor to emit and measure light reflected from the colored part of the proximal surface of the button. Pin 853 is sized to match hole 836. As shown in FIG. 38, a recessed region 857 formed in the distal surface 806A of the distal wall 806 may surround the opening 836. The recessed region 857 may have a depth and shape corresponding to the thickness and shape of the base 855. and securely anchoring the light guide member 849. The axial length of the extension may provide a light guide path for the identification sensor from the distal surface of the distal wall 806, which will abut the device button colored surface member proximally to contact the sensor directly, or a gap may be formed axially spaced apart. direction, as shown, between the end of pin 853 and the color light sensor. The light guide pin 853 has a cross-sectional shape of any of a variety of geometric shapes such as round, elliptical, or rectangular. In one example, pin 853 has an elliptical cross-sectional shape. One or more locking pins 859 (two shown) may also extend proximally from base 855. Each locking pin 859 may be radially spaced apart from light guide pin 853. To this end, base 855 may include wing portions 855A to accommodate the locking pin. An appropriate number of pin holes 863 may be formed in the distal wall 806 to receive the locking pins 859 during manufacture. Once installed, the locking pins can be heated, for example by ultrasonic welding, to allow the material to fill the voids of the respective pin holes for secure attachment to improve consistent measurement capability.

Module 800 contains another implementation of the attachment element 807 . Although the attachment element 807 is shown by way of illustration, it should not be limiting, since the module 800 may also be provided with an attachment node 500 or an attachment element 419. Similarly, other modules described in this document may contain an attachment element 807. Attachment element 807 with distal wall 806 may form a block portion of module 800. Attachment element 807 may include a plurality of distally extending levers 850. In an exemplary embodiment, the levers 850 are evenly spaced angularly around the dispense button. As shown, the levers 850 are connected to and distally dependent on the distal wall 806. When the module is attached to the device, the levers 850 are positioned to contact the radially outward facing surface of the dispense button. The levers 850 include an axially extending body 854. The body 854 may include a protruding support portion 852 extending radially into the body 854. The body 854 of the levers 850 may comprise a W-shaped body, with the outer distal-extending arms 856A-856B of the lever body extend from the distal wall 806 at two attachment points, and the proximally extending inner arm 858 includes a protruding body 852. The surfaces of the protruding body of the support portion 852 may be perpendicular, curved, and/or inclined. Alternatively, the body 854 may have a J-shape containing a portion that forms a proximally extending lever.

With additional reference to FIG. 35, the battery 861 can provide shielding properties to the magnetic sensors and the magnetic ring. In one example, the battery 861 may be a coin cell battery with a ferromagnetic nickel coating. The battery 861 can be placed axially proximal to the magnetic sensors to provide shielding for the sensors, providing shielding along its proximal side to suppress magnetic field effects from the proximal direction, and/or providing shielding along its distal side by deflecting magnetic flux away from the magnetic ring. to the sensors. In one example, battery 861 can assist in redirecting the magnetic flux lines, for example, from a ring, such as rotation sensor 706, to the location of sensors, such as sensors 906, and redirecting the magnetic flux lines, due to unwanted external interference, away from the location of the sensors. In this example, the size of the accumulator, such as radius, can match the radial location of the sensors about the axis. In another example, the battery composition

- 27 039601

861 can provide other shielding properties, such as a battery containing iron (most series), cobalt, or other nickel alloys of appropriate thickness. Battery

The 861 may have a specific cross-sectional area dimension relative to the radial placement of the magnetic sensors and/or may be axially spaced from the magnetic sensors to provide such shielding.

Any of the modules described herein, such as, for example, module 800, may contain five (shown) or six measurement elements, such as magnetic sensors. The measuring elements may be located in the modular chamber 808 and connected to the circuit board 809 of the electronics unit 810 and hence to the MCU. In one example, the sensing elements comprise five or six magnetic sensors located in respective recessed locations 842 to receive sensors formed in the distal wall 806 as shown in FIG. 37, although the sensing elements may be located on top of the distal wall 806 (ie, not in the recesses) or more proximal to the distal wall 806 within the module chamber. In FIG. 40-41 illustrate an example of the location of the sensors relative to the magnetic ring and are illustrative of all other magnetic dose determination systems described herein. In FIG. 40 illustrates another example of a magnetic pickup system, hereinafter referred to as system 900, comprising as a measuring element a diametrically magnetized ring 902 having a north pole 903 and a south pole 905. The magnetized ring 902 is connected to a dose setting element, such as, for example, the flange described higher. The radial arrangement between magnetic sensors 906, such as, for example, Hall effect sensors, relative to the magnetized ring 902 may be uniform in the angular direction in the form of a ring. In one example, the magnetic sensors 906 are arranged radially in an overlapping relationship with the circumferential outer edge 902A of the magnetized ring 902 such that a portion of the magnetic sensor 906 is above the magnetized ring 902 and the remainder is outside the magnetized ring 902, as shown in FIG. 40. It has been found that with an overlapping arrangement, the sensors are placed in a range of high flux capability and thus a more consistent measurement of magnetic flux. In FIG. 41 shows the radial distance 907 measured from the center of the magnetic pickup 906 to axis A-A. The radial distance 907 may have a size equal to at least the outer radius 908 of the magnetized ring 902. In one example, the radial distance 907 is 0.1-20% greater than the outer radius of the magnetized ring 902, and in another example, the radial distance 907 is at least 10% larger than the outer radius of the magnetized ring 902. Surprisingly, it has been found that this position can provide enhanced maximum magnetic flux for measurement at other radial positions. In FIG. 11A shows another example of a suitable radial placement of magnetic pickups positioned entirely above the ring. In FIG. 11B shows another example of a suitable radial placement of magnetic pickups located entirely within the hole formed by the ring.

In FIG. 41 illustrates an example of axial placement and radial placement of magnetic sensors 906 relative to magnetized ring 902. Sensors 906 may be located along a module electronics circuit board 903 (module components omitted for clarity) that is located along a common plane that is substantially perpendicular to axis A-A. . Magnetic ring 902 of thickness 913 may be located in one plane parallel to the plane of sensors 906. Ring 902 may be located in device assembly 720, while sensor 906 may be located in a module that can be detachably attached to the device. In an alternative example, module components, including sensors 906, may be permanently integrated with magnetized ring device 902, as shown in FIG. 12.

The geometric configuration of the ring can be changed within the available space constraints to meet the magnetic flux performance requirements of the selected sensors. In FIG. 41 shows the relative axial position 911 of the magnetic sensors 906 above the magnetized ring 902 when the dosing button is not depressed, such as during dose setting. During dose delivery, the relative axial position of the magnetic sensors 906 above the magnetized ring 902 changes after distal displacement of the dispense button and sensors 906 by the distance indicated by arrow 909 towards the rotating magnetized ring 902, which remains axially stationary. The amount of distal movement of the magnetic sensors 906 can range from 1 mm to 3 mm relative to the magnetized ring 902. In one example, during use, when the user applies pressure to the top of the module, the button/spring accessory is subjected to axial compression and reduces the relative axial distance between sensor 906 and magnetized ring 902 for an axial distance of 1.7 mm. At the dose delivery position, the magnetic flux of the magnetized ring 902 available to be read by the sensors 906 is at least twice as high as when the sensors 906 are at the dose setting position. The magnetic material for the diametrically magnetized ring 902 should be chosen such that the flow available at the set-up and metering distances is acceptable for reliable measurement. For example, in one example, the magnetic ring for the component being measured may be made of grade N35 neodymium sintered material. Neodymium magnet (also known as NdFeB or NIB or Neo magnet) is a rare earth permanent magnet made from an alloy of neodymium, iron and boron. Other grades of sintered neodymium magnet such as N42, N45, N50 and similar or related grades of neodymium (injection molded or compression molded, thermoplastic or thermoset injection molded) may be considered for appropriate flux in magnetic sensors. The selected magnetic material is expected to meet the mechanical strength requirements for a snug fit to the plastic carrier component, such as the carrier component 708, and be appropriately sized to withstand service and impact without cracking or damage. The fixed magnetized ring is fixedly attached to the dose setting element so as not to rotate on its own, but it rotates with the dose setting element during adjustment or dispensing.

The axial movement of the sensors relative to the magnetized ring during dose delivery and the change in magnetic flux due to this change in axial position and due to the rotation of the ring can prevent accurate dose determination. In addition, the more cost-effective diametrically magnetized sintered N35 Neo rings can have variable magnetic field properties, resulting in less consistent measurement determination and tuning errors. The dose module setting error is the rotational position difference in degrees between the actual physical rotational position of the dispensing device components such as the magnetic ring (set position) and the measured rotational position determined by the magnetic sensor system (detected position). For example, when a user wishes to deliver a certain number of units of drug through the device, the user rotates the button of the device with the module attached to it relative to the shell of the device by the amount indicated by the dosing scale, for example 10 units or approximately 180° of rotation at a rate of 18°±X% for 1 unit. When a button is pressed to start a delivery operation, the dose determination system can track the start position and end position while performing dose delivery, with the difference between the start and end positions corresponding to the number of degrees of rotation and the correlated number of dose units delivered.

The setting error can be illustrated by the following example.

The adjusted home position can place the dispensing/adjusted device element, and therefore the magnetic ring, at a nominal zero initial physical position after the dose setting has occurred, and the final physical position of the ring upon delivery after a rotation of 90 actual degrees, with a correlation of up to five units. during dose delivery. In the presence of tuning errors, a dose determination system in a system of four sensors with conventional manufacturing diametrically magnetized rings can determine -10° for the nominal zero initial position of the ring and 100° for the final position upon delivery, resulting in a total of 110° of the determined rotation of the ring . This would correspond to a measured dose of more than six units delivered, which is more than five units actually delivered.

Tuning errors can be introduced into the system by magnetic pickups and other factors. The first space harmonic waveform (fundamental waveform/fundamental waveform) can be subject to phase, gain, or offset errors as the magnetized ring rotates relative to sensors that measure a sine wave, with a certain number of sensors evenly spaced from each other circumferentially and evenly spaced axially away from the magnet, will represent a certain number of times the sine wave is sampled. Appropriate sensor calibration can greatly reduce these errors. However, other errors may occur due to the effect of higher harmonics, such as the third harmonic or the fourth harmonic, on the first harmonic. A certain error can be reduced due to the coordinated radial arrangement of the magnetic sensors relative to the axis of the module, as well as due to the uniform distance along the circumference between all sensors with a decrease in the inclination of the plane of the combined sensors so that it is essentially perpendicular to the module axis and parallel to the magnetic ring, as well as calibration systems.

Increasing the flux uniformity with respect to the magnetic properties of the diametrically magnetized rings using higher grade magnetic material sources such as N50 grade neodymium magnet or more precise manufacturing controls can reduce tuning error. Such improved magnetic components would be more expensive and would limit the ability of the magnet source. In addition, there was uncertainty as to whether the presence of additional magnetic sensors (one or two) would improve the measuring ability, which already showed inhomogeneous properties. It was found that the use of five or six magnetic sensors 906 for the rotating diametrically magnetized ring 902 during dose delivery improved the positional signals used for

- 29 039601 dose determination by appropriately filtering out the second and third order harmonic distortion typically found in conventional manufacturing magnets, resulting in a reduction in tuning error. This filtering was not present in the 4-sensor arrangement. To this end, an improvement has been found to ensure that the number of units delivered as determined by the dose determination system matches the actual number of units delivered.

Tests were carried out on conventional commercial N35 Neo diametrically magnetized sintered rings to determine the harmonic distortion of the sensor signals in relation to the percentage amplitude of the second, third, fourth and fifth order harmonics compared to the first order harmonics. The results are shown in FIG. 42. A special request was made for a magnetic test fixture to simulate the function of the magnetic sensor subsystem provided in the modules described in this document. Said fixture is capable of adjusting the relative radial position, circumferential position, and axial position (out-of-plane tilt) of the sensors and magnetic rings so as not only to test different configurations, but also to reproduce the axial and radial positions shown in FIG. 40 and FIG. 41. Individual sensor readings can be analyzed to understand the effect of magnetic discontinuity on harmonic distortion and tuning/dosing errors. The tuning errors resulting from the operation of the 4 and 5 and 6 sensor arrangements for class N35 magnets manufactured by conventional manufacturing (more cost effective) and specialty manufacturing (less cost effective) methods are shown in FIGS. 43-44. In FIG. 45 illustrates the sensitivity of a 4-sensor arrangement with conventional N35 Neo manufacturing sintered diametrically magnetized rings to third harmonics, resulting in its susceptibility to increasing tuning errors by more than 6°, and the immunity of a 5-sensor arrangement with conventional manufacturing sintered diametrically magnetized N35 Neo rings. N35 Neo to the third harmonics, resulting in a significant reduction in tuning errors of less than 2°.

In FIG. 42 illustrates the setup error of a 4-sensor arrangement used with conventional N35 manufacturing magnetic rings. The 4-sensor arrangement has been shown to be more conducive to undesirable third harmonic errors affecting the reliability of position signals. It was assumed that the configuration of radially equidistant sensors would be immune to small changes in amplitude under the influence of the magnetic flux of a rotating magnetized ring. Numerical modeling of a 4, 5, and 6 sensor arrangement, taking into account the flow properties of a neodymium magnet, showed that the addition of sensors evenly spaced around the circumference reduces the higher harmonics in angular measurement, thereby reducing the variation in tuning and dosing errors. Various tests were carried out with sintered N35 Neo magnets obtained from conventional production (which initially showed inhomogeneous properties), sintered N35 magnets obtained by special production methods (with more precise control), and higher grade sintered N50 Neo magnets to compare the effects of arrangements. sensors with each other and numerical simulations, in which third harmonics were found to have the greatest effect on angular measurements. To this end, the five-sensor arrangement was more capable of eliminating distortion up to the third harmonic than the four-sensor arrangement, while the six-sensor arrangement can eliminate distortion up to the fourth harmonic.

In FIG. 42 shows the error contribution due to higher harmonics that cause the measured rotational flux waveform to deviate during a 360° rotation position measurement (along line 1000) in the case of a four-sensor arrangement compared to the computed mathematical required model. magnetic flux waveforms during rotational position measurement (along line 1010) based on the geometry of the magnet and its properties. This deviation between the two lines 1000, 1010 can contribute to tuning errors in systems with four sensors.

Based on the test data, the five or six magnetic pickup module is designed to significantly reduce the distortion error so that it is likely to make an acceptable contribution to the tuning error due to magnet distortion on the side of the pickup/ring arrangement, which would be 2° or less. In one example shown in FIG. 43, for many conventional manufacturing magnets, the alignment error for the 4-sensor arrangement averaged 6.5° (along line 1100). The tuning error for a 5-sensor arrangement with similar conventional manufacturing magnets averaged 1.2° (at line 1110), respectively, and an additional 0.5° on average for a 6-sensor arrangement (at line 1120). A 5- or 6-sensor arrangement with conventional N35 manufacturing magnetic rings has been shown to reduce tuning error by more than a factor of five compared to a 4-sensor arrangement. Shown

- 30 039601 that a 5- or 6-sensor arrangement with custom-made manufacturing magnets reduces error by more than three times compared to a 4-sensor arrangement. In FIG. 44 shows that for custom made production magnets, the alignment error decreased from an average of 1.4° to an average of 0.4° when moving from a 4-sensor arrangement (line 1200) to a 5-sensor arrangement (line 1210), respectively. ) and up to an average of 0.4° in the case of a 6-sensor arrangement (on line 1220).

In FIG. 45 summarizes the harmonic percentage change of three batches (1301, 1302, 1303) of N35 grade sintered magnetic rings made by conventional manufacturing for 4-sensor and 5-sensor systems. The 4-sensor arrangement (on the 1310 line) averaged up to 3.8% third harmonics, and the 5-sensor arrangement (on the 1320 line) showed approximately zero percent third harmonics. The 5-sensor arrangement (on the 1320 line) averaged up to 0.8% in fourth harmonics, and the 4-sensor arrangement (on the 1340 line) showed approximately zero percent on the fourth harmonics. The contribution of third harmonics to the fundamental waveform is the cause that resulted in the tuning error in the 4-sensor arrangement of more than 6°, as shown in FIG. 43, while improving the fundamental waveform by reducing third harmonics with the addition of sensors in a 5 or 6 sensor arrangement results in a reduction in tuning error to less than 2°, as shown in FIG. 43. Additional exemplary embodiments of a dose delivery determination system are shown in FIG. 30-34. Embodiments of the invention are shown in some schematic form, since the general details have already been presented in FIG. 1-5. This document describes several exemplary embodiments of drug delivery devices that use magnetic measurement of dose delivery. An annular element, such as, for example, a magnet or a metal ring, can be permanently attached to the dose adjustment element and/or device flange by various fixing means such as adhesives, welding or mechanical fastening. For mass production, a mount can be useful. In FIG. 30-34 show an exemplary method of mounting an annular member to a flange forming part of a drug delivery device. In FIG. 30 illustrates coaxially aligned components that are connected to each other into a single separate unit (as shown in FIG. 31) that rotates and moves axially as a single unit, containing: a tuning element 700, an exemplary sleeve 702, a component for dose setting, such as, for example, a flange 704 to receive the rotation sensor 706, a bearing component 708 to permanently connect the rotation sensor 706 to the flange 704, a button spring 710 to bias the dispense button 712. In place of the flange, other dose setting components described herein may be used. The dispense button 712 may be configured with any of the buttons described herein. With reference to FIG. 31 and as previously described with reference to FIG. 1-4, the drug delivery device 720 includes a tuning element 700 installed within the body 722 of the device. Flange 704 fits inside dose adjuster 700, and sleeve 702 is positioned within flange 704. Dose adjuster 700, flange 704 is rotatably locked together and rotates during dose setting and/or dose delivery in direct proportion to the amount of dose set or delivered. Clutch 702 includes a stem 724 on which a dosing button 712 is mounted. Spring 710 operates between dispense button 712 and flange 704 to bias dispense button 712 proximally away from flange 704. As described above, the drug delivery device is further provided with a rotation sensor coupled to the flange such that the sensor is entirely within the dispense button. Any of the modules described herein include electronics and sensing elements to determine the rotation of the rotation sensor 706 during dose setting and/or delivery to determine the amount of dose applied. Flange 704 is predominantly cylindrical and defines a proximal axial surface 732 at the end of sidewall 734. Flange 704 further defines a central opening 736 that is internal to proximal surface 732. As shown in FIG. 32, the rotation sensor 706 has an annular shape, such as a ring magnet, a metal ring, or a magnetized or metallized polymer ring located on the proximal surface 732 of the flange 704. opposite the proximal surface 732 to accommodate the sensor 706 between them. The support 742 is shown as a predominantly annular component, however, it may alternatively comprise a segmented ring or a plurality of supports spaced around the rotation sensor 706. In this configuration, the carrier component 708 holds the sensor 706 in position on top of the flange 704 by abutting the support 742 distally against the sensor 706. This is achieved in that the carrier component 708 is secured axially relative to the flange 704. attached directly to the flange 704, for example, at a location distal to the sensor 706. In another illustrative embodiment of the invention, the carrier component 704

- 31 039601 is spring-loaded in the distal direction, for example, by a spring 710 retracting the carrier component 708 from the dispensing button 712, or by a spring acting to pull the carrier component 704 to the flange 704.

Let us now turn to FIG. 30, the carrier component 708 includes a hollow body 750 with a plurality of axially extending arms 752 spaced circumferentially apart around a predominantly axial opening 754 that extends through the carrier component. The housing 750 includes a support 742 sized to grip the rotation sensor 706 against the flange. Housing 750 is sized to accommodate the inside diameter or cross-sectional area of sensor 706. As shown in FIG. 31, the support 742 extends radially outwardly beyond the dimension of the body 750. The portions of the body 750 with branches 772, depending on them, may include a snap-on radial protrusion 771 located distal to the support 742 up to the size of the axial thickness of the sensor 706 to cooperate with the distal surface of the sensor 706. Each of the arms 772 includes a radially inwardly protruding member 756 appropriately sized and shaped for insertion into appropriately sized axial slots 760 formed in the side wall 734 of the flange, as illustrated in FIG. 34. The slots may be appropriately sized to tightly accommodate member 756 so that, due to frictional interaction, both components are locked in rotational direction and torque is transmitted between them. The radial end portions of the member 756 may be engaged with the central hub of the flange 704 as shown in FIG. 31 and FIG. 33. As shown in FIG. 31, in accordance with one method, arms 752 of carrier component 708 form a circumferentially sized section of cross-section appropriately sized for secure frictional engagement along the cylindrical inner surface 759 of flange 704 when inserted into bore 736 of flange 704. In one example, arms 752 extend through the central hole 736 and, in one method, are directly attached to the flange 704 at a location distal to the sensor 706. A suitable placement of the spring 710 is shown in FIG. 31 and 33. The flange 704 may include a radial slot 762 formed in its proximal axial surface 732. The slots 760 are formed in the flange such that the inner surface of the arms 752 is carefully aligned with the inner surface of the outer wall, which forms the radial slot 762, as shown in fig. 31. In this configuration, the distal end of the spring 710 is located within the radial slot 762. Walls defining the radial slot 762 support the distal end of the spring 710 and abut against the dispense button on the support ring, thereby pulling the carrier 708 distally away from the dispense button.

The various components of the carrier component 708 may comprise either partially or completely circumferential elements. For example, carrier component housing 708 may extend entirely around the flange, or may be provided in spaced segments. Advantageously, the use of a carrier component means that the rotation sensor is securely held in place without the use of adhesives. Although it is possible to use adhesives, they can complicate the manufacturing process.

The electronics unit 610 contains a variety of operatively connected components for module 600, as well as any other modules described herein, including a battery 621 for power supply and associated contacts, an MCU for executing programmed instructions, memory for storing programs and data, a communications unit for transmitting and / or data reception, a timer for tracking time and various switches and sensors as described. Any of the modules described herein, such as, for example, modules 82, 232, 400, or 600, may be configured to accommodate any of the electronic components described herein, including configured to accommodate measurement elements 160 for use with the sensor system 150 described previously. In FIG. 46 illustrates an example of an electronics assembly, designated 1400, that may be included in any of the modules described herein. The MCU is programmed to achieve the module's electronic functions. The MCU contains control logic that performs the operations described herein, including obtaining data used to determine the dose delivered by the drug delivery device based on the detected rotation of the dose delivery element relative to the actuator. The MCU may be configured to acquire data by determining the amount of rotation of the flange-mounted rotation sensor, which is determined by determining the magnetic field of the rotation sensor using the measuring elements of the measurement sensor of the system, such as, for example, Hall effect sensors. The block contains an MCU that can be operatively associated with one or more dosing sensors 1402A-1402E, a memory 1408, an identification sensor 1404, a counter 1414, a light control unit 1411 and indicator lights 1412, a power-on module 1406, a communication module 1410, a control device display/display 1416, power supply 1418 and presence module 1420. Block 1400 may contain any number of dosage sensors, such as five magnetic sensors 1402A-1402E (shown) or six sensors. The MCU is configured to determine the total number of rotation units. MCU can be

- 32 039601 is configured to determine, using the presence module 1420, shown in this embodiment of the invention in dotted lines as optional, by operating the presence switch system, whether the module is associated with a button of the device. The MCU is configured to determine the color of the dispensing button via the identification sensor 1404 and in some examples associates color data determined on-site or off-site using an external device, with the color corresponding to a particular drug. The MCU is configured to detect actuation of a wake-up switch to turn on the electronics for use, shown as a power-on module 1406. In one example, full rotation data may be transmitted to an external device that contains a memory having a database, lookup table, or other data stored in memory to correlate the total number of rotation units with the amount of drug delivered in the event of one or another identified medicinal product. In another example, the MCUs may be configured to determine the amount of drug delivered. The MCU may be configured to store the determined dose data in local memory 1408 (eg, internal flash memory or embedded EEPROM memory). The MCU is further configured to wirelessly transmit a signal representing device data such as, for example (any or any combination), units of rotation, drug identification data (such as color), timestamp, time since last dose delivered, state of charge battery, module identification number, module attachment or detachment time, idle time and/or other errors (such as, for example, an error in determining and/or transferring a dose, an error in determining in the process of identifying and/or transferring a medicinal product), per paired a remote electronic device, such as a user's smartphone, via a Bluetooth low energy (BLE) module 1410 or other suitable short or long distance wireless protocol module, such as, for example, near-field communication (NFC) ), WIFI or cellular network. As an illustration, BLE and MCU control logic are integrated in the same circuit. In one example, any of the modules described herein, such as module 600, may include a display module 1420, shown as optional in this embodiment in dotted lines, to provide information to the user. Such a display, which may be LEDs, a liquid crystal monitor, or other digital or analog displays, may be integrated with the proximal finger pad. The MCU comprises a display control unit software module and control logic for receiving and processing measured data and for displaying information on said display, such as, for example, dose setting, dispensing, injection status, injection completion, date and/or time or time until the next injection. In another example, the MCU includes an LED control unit 1411 associated with one or more LEDs 1412, such as, for example, an RGB LED, an orange LED, and a green LED, used to inform the patient through on and off sequences, as well as various colors, whether data was successfully transferred, whether the battery is high or low, or other medical messages. The counter 1414 is shown as a real time clock (RTC) pulse generator that is electronically coupled to the MCU to keep track of time, such as, for example, dosing time. The counter 1414 may also be a time counter that tracks seconds from zero based on power up. Time data or counter readings can be transferred to an external device.

Dosing systems are described above by way of example with specific designs for a drug delivery device such as a pen. However, exemplary dose determination systems may also be used with alternative drug delivery devices and other meter configurations capable of operating in the manner described herein. For example, any one or more different measurement systems and switches may be omitted from the module. Although the invention has been illustrated and described in detail in the drawings and the foregoing description, it should be considered as illustrative and not restrictive in nature. For example, a measurement module of a device can measure dose setting values if it is adapted to work with a portion of the device having suitable parts that experience relative rotation during dose setting. Therefore, this application is intended to cover any variation, use, or modification of the invention using its general principles. In addition, this application is intended to cover such deviations from the present disclosure, which fall within the known or customary practice in the field of technology to which this invention pertains. All changes, equivalents and modifications that fall within the spirit of the inventions defined by the claims included in this document are to be protected.

This disclosure describes various aspects, which include, but are not limited to, the following aspects:

- 33 039601

1. A dose determination module for removably attaching a drug delivery device to a dosing button, the dosing button comprising a cylindrical side wall of the button, the device comprising a ring of the measured component rotatable during dosing, the module comprising: a shell containing a proximal wall, the distal wall and the side wall of the module passing between them around the longitudinal axis of the module, forming an internal chamber, and the side wall of the module extends in the distal direction behind the distal wall, and the distal wall forms a plurality of recesses, located evenly in the angular direction relative to each other, and the shell is configured to be connected around the side wall of the button; and an electronic unit containing a processor and a plurality of sensors operatively associated with the processor, each of the sensors is fixedly located inside the respective recesses, and the sensors are configured to determine the rotational movement of the ring of the measured component to generate position signals, and the processor is configured to receive position signals for determining data indicating a dose amount to be dispensed based on the position signal.

2. The module of aspect 1, wherein the ring of the measured component includes a bipolar magnetic ring, and the sensors include magnetic sensors arranged in a configuration to overlap the outer circumference of the bipolar magnetic ring.

3. The module according to aspect 2, characterized in that the magnetic sensors include five or six magnetic sensors.

4. The module according to any one of aspects 1-3, characterized in that the shell contains a light guide element, and the distal wall forms a hole for the pin, and the light guide element contains a light guide pin passing in the proximal direction through the hole for the pin behind the magnetic sensors, and the electronic unit contains a color detection sensor located above the light-conducting pin and spaced in the axial direction from it, wherein the color detection sensor is operatively connected to the processor and configured to emit and/or detect the color of the dispensing button.

5. The module according to aspect 4, characterized in that the light guide element is fixedly attached to the distal wall.

6. The module according to aspect 5, characterized in that the light guide element contains one or more locking pins spaced in the radial direction from the light guide pin, and the distal wall contains a light guide hole for accommodating the light guide pin and one or more locking holes for accommodating the corresponding number fixing pins.

7. The module according to any one of aspects 1-6, characterized in that the electronic unit further comprises a battery operatively associated with the processor and an axially compressible battery support member in frictional contact with the proximal side of the battery.

8. The module according to aspect 7, characterized in that the battery has a cross-sectional area relative to the radial placement of the sensors, which is axially spaced from the sensors to provide shielding of the sensors.

9. The module according to any one of aspects 1-8, further comprising a switch system configured to increase the power supplied to the electronic unit, wherein the proximal wall assembly is axially movable relative to the side wall of the module and the distal wall to activate the switch system with using a device activation force that is less than the force required to deliver the dose.

10. The module according to aspect 9, characterized in that the switch system comprises at least one set of deflected contact lever passing between the electronic unit and the proximal wall assembly, and the corresponding contact pad operatively associated with the processor, the proximal wall assembly being movable axially relative to the shell between a first proximal position where the contact lever and pad are not in contact with each other and a second distal position where the contact lever and pad are in a contact relationship to provide an increase in power supplied to the electronic block.

11. The module according to aspect 10, characterized in that the switch system contains a plurality of sets of a contact lever and a corresponding contact pad, each of the sets is located circumferentially relative to each other at an equal distance from each other, with one of the sets being in a contact mutual arrangement , is configured to provide an increase in power supplied to the electronic unit.

12. The module of aspect 9, wherein the shell further comprises an axially compressible element coupled between the proximal wall assembly and the shell portion to bias the proximal wall assembly to a proximal position.

13. The module according to any one of aspects 1-12, characterized in that the proximal wall assembly contains

- 34 039601 lives a light guide ring and a white or reflective surface located above the hole formed by the light guide ring, and the light guide ring contains holding levers connected to a part of the shell of the specified shell, and the electronic unit contains a light indicator element functionally associated with the processor for emitting light into the light guide ring.

14. The module according to any aspect of aspects 1-13, characterized in that the shell contains a plurality of radially flexible levers extending from the distal wall, spaced apart at an angle from each other, each of the levers having a support portion extending in the proximal direction.

15. A dose determination system, comprising: a drug delivery device containing a magnetic ring fixedly connected to the dosing element and rotatable during dose setting and dose delivery; and an electronic assembly comprising a processor and a plurality of magnetic sensors operatively coupled to the processor, the magnetic sensors being in an overlapping position relative to the outer circumference of the magnetic ring, the magnetic sensors being fixed relative to the processor, the magnetic sensors being axially and rotationally locked together with the magnetic ring during dose setting and move freely in the axial and rotational direction relative to the magnetic ring during dose delivery, and the magnetic sensors are located evenly in the angular direction relative to each other, forming an annular structure, and when issuing the dose, the magnetic sensors move in the distal direction to the magnetic ring and remain stationary relative to the rotating magnetic ring to determine the rotational movement of the magnetic ring to generate position signals, wherein the processor is configured to receive position signals for determining data indicating a dose amount to be dispensed based on the position signal.

16. The system of aspect 15, wherein the plurality of magnetic sensors includes five or six magnetic sensors, wherein the magnetic ring includes a bipolar magnetic ring.

17. The system according to any one of aspects 15-16, characterized in that each of the magnetic sensors is spaced evenly in the radial direction by a radial distance from the center of the magnetic sensor to the axis of the module, and the radial distance has a size equal to the distance along the outer radius of the magnetic ring.

18. The system of any one of aspects 15-17, further comprising a module shell comprising a proximal wall assembly, a distal wall, and a side wall coupled therebetween to form an internal chamber in which the electronic assembly is located, the distal wall forming a plurality of recesses in which magnetic sensors are located.

19. The system according to aspect 18, characterized in that the module shell contains a light guide element, and the distal wall forms a hole for the pin, and the light guide element contains a light guide pin passing in the proximal direction through the hole for the pin behind the magnetic sensors, and the light guide element is fixedly attached to distal wall.

20. The system of any of the aspects 18, 19, wherein the electronic unit further comprises a battery proximal to the magnetic sensors and operatively coupled to the processor.

21. The system of aspect 20 further comprising an axially compressible battery support member in frictional contact with the proximal side of the battery.

22. The system of any one of aspects 18-21, further comprising a switch system configured to increase the power supplied to the electronic unit, wherein the proximal wall assembly is axially movable relative to the side wall and distal wall to activate the switch system.

23. The system according to aspect 22, characterized in that the switch system comprises at least one set of a deflected contact lever and a corresponding contact pad, and the deflected contact lever passes between the electronic unit and the proximal wall assembly to move the proximal wall assembly to the proximal position, and the contact lever contains an inclined connection interacting with the proximal wall assembly, and a contact extending in the distal direction, the contact pad being connected to the electronic unit and functionally connected to the processor, the proximal wall being movable in the axial direction relative to the module shell to the distal position, so that the contact and pad are in a contact relationship to provide an increase in power supplied to the electronic unit.

24. The system of any one of aspects 18-23, wherein the proximal wall assembly comprises a light guide ring and the electronic assembly includes a light indicator element operably coupled to the processor to emit light into the light guide ring.

25. The system according to aspect 24, characterized in that the light guide ring contains a retaining

- 35 039601 latches connected to a part of the shell, and the module shell further comprises a compressible gasket mated between the light guide ring and the first spacer element to move the proximal wall assembly to the proximal position.

26. The system of aspect 24, wherein the proximal wall assembly comprises an element having a white or reflective surface located above the aperture formed by the light guide ring.

27. The system according to any one of aspects 18-26, characterized in that the module shell contains a plurality of radially flexible levers extending from the distal wall, and the levers have a portion extending in the proximal direction, configured to allow the module shell to be attached to and detached from the device .

28. The system according to any one of aspects 15-27, wherein the magnetic ring includes a bipolar magnetic ring, wherein the contribution to the tuning error from the location of the magnetic sensors and the bipolar magnetic ring is two degrees or less, and the tuning error is the difference between a set position corresponding to the physical position during rotation of the bipolar magnetic ring, and a certain position corresponding to the measured position during rotation of the bipolar magnetic ring measured by magnetic sensors.

29. A module for removably attaching a drug delivery device to a dosing button, the dosing button comprising a cylindrical side wall and a top wall having a top surface, the dosing button further comprising a radial protrusion extending outward near the top wall beyond the cylindrical side wall, the module comprising : a shell containing a proximal wall, a distal wall and a side wall located along the perimeter, passing between the proximal and distal walls and forming a chamber with them; an electronic unit located within the shell chamber, the electronic unit comprising a processor and a measurement sensor operatively associated with the processor; and a plurality of levers connected to and extending distally from the sheath, each lever comprising a support portion extending radially into the lever, each of the levers being sized to extend distally beyond a radial protrusion of a dispensing button for mounting the support portion. into a position of engagement with the cylindrical side wall of the dispense button at an engagement site that is distal to the radial protrusion of the dispense button when the module is attached thereto, wherein each of the levers is configured to flex radially outward to pass the radial protrusion when the module is attached or detached from the device, and each of the levers is made with the possibility of applying force in the radial direction inward at the point of interaction against the cylindrical side wall when the module is attached to it.

30. The module of aspect 29, wherein the distal wall has a distal surface configured to oppose the top surface of the dispensing button when the module is attached thereto.

31. The module of any one of aspects 29-30, wherein the levers are evenly spaced radially apart from each other.

32. The module of aspect 31 wherein the levers are attached to the shell wall.

33. The module of aspect 32 wherein the levers are J-shaped.

34. The module of aspect 31 wherein the lever support portions comprise a surface configured to oppose or in close proximity to the underside of the radial protrusion of the dispensing button when the module is attached thereto.

35. The module of aspect 31 wherein the levers are integrally formed with the distal wall.

36. The module as in any of the aspects 29-35, wherein the levers are configured such that the release force to remove the module from the dispense button is at least twice the attachment force to install the module on the dispense button.

37. The module of any one of aspects 29-36, further comprising a wake-up switch system comprising a movable segment located within and movable in an axial direction relative to the proximal wall of the shell, the wake-up switch being operatively coupled to the processor.

38. The module of aspect 37, wherein the wake switch system comprises a flexible containment located between the movable segment and the wake switch, the containment comprising a plurality of radially extending arms.

39. The module of aspect 38, wherein the branches include a first set of fixed branches and a second set of movable branches.

40. The module of any one of aspects 29-39, further comprising a presence switch system comprising a presence switch and an offset axial actuator slidably positioned within an opening defined by a distal wall of the enclosure.

- 36 039601 boxes.

41. The module of aspect 40, wherein the axial actuator comprises an outer radial rim disposed to actuate a switch lever of said presence switch when the module is disconnected from the dispense button.

42. The module of any one of aspects 29-41, further comprising a drug identification system configured to determine data indicative of the drug type of the device.

43. The module according to aspect 42, characterized in that the drug identification system contains an RGB sensor operatively associated with the processor, and the distal wall of the sheath contains a hole formed in it, and the hole is located axially above the RGB sensor to provide color determination of the upper surface of the setting button when the module is attached to it.

44. The module according to any one of aspects 29-43, characterized in that the electronic unit includes a first segment, a second segment and a third segment electrically connected to each other, and the third segment is located between the first and second segments. 45. The module of aspect 44, wherein the first segment of the electronic unit contains a wake-up switch operatively mounted thereon, and the third segment contains a drug identification sensor operatively mounted thereon.

46. The module of any one of aspects 29-45, further comprising sensor recesses formed in the distal wall of the sheath, wherein the measurement sensor comprises a plurality of magnetic sensors spaced uniformly angularly apart from each other, each magnetic sensor located within a respective sensor recess. .

47. A drug delivery system, comprising: a drug delivery device, comprising: a device body and a dosing button located in the proximal part of the device body, the dosing button comprising a cylindrical side wall and an upper wall having an upper surface, the dosing button further comprising a protrusion formed by extending the top wall in a radial direction outward from the cylindrical side wall, the dispensing button comprising a rotation sensor and a bearing component connected to the rotation sensor; and a module mounted on the drug delivery device, the module comprising a shell containing a proximal wall, a distal wall, and a perimeter side wall extending between and forming a chamber with the proximal and distal walls; a sensor unit comprising a measurement sensor configured to detect movement of the rotation sensor, a battery, a memory, a processor, and a communication unit; and a plurality of levers connected to and extending distally from the sheath, each lever comprising a support portion extending radially into the lever, wherein, when the module is mounted on a dispensing button, each of the levers extends distally beyond a radial protrusion of the dispensing button for placing the support part in a position of interaction with the cylindrical side wall of the dispensing button at the interaction site that is distal to the radial protrusion of the dispensing button, each of the levers being configured to apply force in a radial inward direction at the interaction site opposite the cylindrical side wall, each of the levers are configured to flex radially outward to pass the radial protrusion when the module is removed from the device.

48. The system according to aspect 47, characterized in that the axial extension of the levers behind the distal wall allows the support part to be located along the proximal part of the side wall of the dispensing button.

49. The system according to any one of aspects 47-48, characterized in that the interaction surface of the support part has an axial dimension greater than the axial thickness of the radial protrusion.

CLAIM

Claims (26)

CLAIM 1. A dose determination module for removably attaching to a dosing button of a drug delivery device, in which the dosing button comprises a side wall of the button, and the ring of the measured component is rotatable during the delivery of the dose, and the ring of the measured component includes a bipolar magnetic ring, and the specified module contains: shell containing the node of the proximal wall, the distal wall and the side wall of the module, passing between them around the longitudinal axis of the module, forming an internal chamber, and the side wall of the module extends in the distal direction beyond the distal wall, and the distal wall forms a plurality of recesses, located evenly in the angular direction relative to each other, and the shell is made with the possibility of coverage when attaching the specified side wall of the dispensing button; and - 37 039601 an electronic unit containing a processor and a plurality of sensors functionally associated with the processor, each of the sensors is fixedly located inside the respective recesses, and the sensors are configured to determine the rotational movement of the ring of the measured component to generate position signals, and the processor is configured to receive signals positions for determining data indicative of a dose amount to be dispensed based on the position signal, and the sensors include magnetic sensors arranged in a configuration to overlap an outer circumference of the bipolar magnetic ring of the drug delivery device. 2. The module according to claim 1, characterized in that said magnetic sensors include five or six magnetic sensors. 3. The module according to claim 1, characterized in that the shell contains a light-guiding element, and the distal wall forms a hole for the pin, and the specified light-guiding element contains a light-guiding pin passing in the proximal direction through the specified hole for the pin behind the magnetic sensors, and the electronic unit contains a color detection sensor positioned above and axially spaced from the light guide pin, said color detection sensor being operatively coupled to the processor and configured to emit and/or detect the color of said dispensing button after light is reflected from the dispensing button. 4. Module according to claim 3, characterized in that the light guide element is fixedly attached to the distal wall. 5. The module according to claim 4, characterized in that the light guide element contains one or more locking pins, spaced apart in the radial direction from the light guide pin, and the distal wall contains one or more locking holes, each of the one or more holes accommodating the corresponding one of the one or more locking pins. 6. The module according to claim 1, characterized in that the electronic unit further comprises a battery operably associated with the processor and an axially compressible battery support element in frictional contact with the proximal side of the battery. 7. The module according to claim 6, characterized in that said battery has a cross-sectional area relative to the radial placement of said sensors, which is axially spaced from said sensors to provide shielding of the sensors. 8. The module of claim 1, further comprising a switch system configured to increase the power supplied to the electronic unit, wherein the proximal wall assembly is axially movable relative to the side wall of the module and the distal wall to activate the switch system with a force from activating a device that is less than the force required to deliver a dose. 9. The module of claim 8, wherein the switch system comprises at least one set of deflected contact lever extending between the electronic unit and the proximal wall assembly, and a corresponding pad operably coupled to the processor, the proximal wall assembly being configured to movement in the axial direction relative to the shell between a first proximal position, in which the offset contact lever and the corresponding contact pad of at least one set are not in contact with each other, and a second distal position, in which the offset contact lever and the corresponding contact pad of at least of one set are in a contact mutual arrangement to provide an increase in the power supplied to the electronic unit. 10. The module according to claim 9, characterized in that at least one set of offset contact lever and the corresponding contact pad of the switch system contains a plurality of sets of offset contact lever and the corresponding contact pad, each of the sets is located circumferentially relative to each other at an equal distance from each other, and one of the sets located in the contact mutual arrangement is configured to provide an increase in the power supplied to the electronic unit. 11. The module of claim 8, wherein the shell further comprises an axially compressible element coupled between the proximal wall assembly and the shell portion to bias the proximal wall assembly to a proximal position. 12. The module according to claim 1, characterized in that the proximal wall assembly contains a light guide ring and a white or reflective surface located above the hole formed by the light guide ring, and the light guide ring contains holding levers dependent on the light guide ring and connected to a shell part of said shell wherein the electronic unit comprises a light indicator element operatively coupled to the processor for emitting light into the light guide ring. 13. The module according to claim 1, characterized in that the side wall of the button is cylindrical and the shell contains a plurality of radially flexible levers extending from the distal - 38 039601 walls spaced at an angle from each other, and each of the levers has a supporting part extending in the proximal direction. 14. The module according to claim 1, characterized in that the magnetic sensors are made with the possibility of blocking in the axial and rotational direction together with the bipolar magnetic ring during dose setting and free movement in the axial and rotational direction relative to the bipolar magnetic ring during the issuance of the dose, and the magnetic sensors are arranged evenly in the angular direction relative to each other, forming a ring-shaped structure, and when issuing a dose, the magnetic sensors are configured to move in the distal direction to the bipolar magnetic ring and the magnetic sensors are configured to remain stationary relative to the rotating bipolar magnetic ring to determine the rotational movement of the bipolar magnetic ring magnetic ring to generate position signals. 15. The module of claim 14, wherein the plurality of magnetic sensors includes five or six magnetic sensors. 16. The module according to claim 14, characterized in that each of the magnetic sensors is spaced uniformly in the radial direction by a radial distance from the center of the magnetic sensor to the axis of the module, and the radial distance has a size equal to the distance along the outer radius of the bipolar magnetic ring. 17. The module according to claim 14, characterized in that the module shell contains a light guide element, and the distal wall forms a hole for the pin, and the light guide element contains a light guide pin passing in the proximal direction through the specified hole for the pin behind the magnetic sensors, and the light guide element is stationary attached to the distal wall. 18. The module according to claim 14, characterized in that the electronic unit further comprises a battery located in the proximal direction to the magnetic sensors and functionally associated with the processor. 19. The module of claim 18 further comprising an axially compressible battery support member in contact with the proximal side of the battery. 20. The module of claim 14, further comprising a switch system configured to increase the power supplied to the electronic unit, wherein the proximal wall assembly is axially movable relative to the side wall of the module and the distal wall to activate the switch system. 21. The module according to claim 20, characterized in that the switch system comprises at least one set of a deflected contact lever and a corresponding contact pad, wherein the deflected contact lever extends between the electronic unit and the proximal wall assembly to move the proximal wall assembly to the proximal position, moreover, the contact lever contains an inclined connection interacting with the proximal wall assembly, and a contact extending in the distal direction, moreover, the contact pad is connected to the electronic unit and is functionally connected to the processor, and the proximal wall is movable in the axial direction relative to the module shell to the distal position , so that the specified contact and the pad are in a contact relative position to provide an increase in power supplied to the electronic unit. 22. The module according to claim 14, characterized in that the proximal wall assembly contains a light guide ring, and the electronic unit contains a light indicator element operatively connected to the processor for emitting light into the light guide ring. 23. The module according to claim 22, characterized in that the light guide ring comprises holding latches dependent on the distal surface of the light guide ring, connected to a part of the shell of said shell, the shell further comprising a compressible spacer mated between the light guide ring and the first spacer for displacement node of the proximal wall to the proximal position. 24. The module of claim 22, wherein the proximal wall assembly comprises an element having a white or reflective surface located above the aperture formed by the light guide ring. 25. The module according to claim 1, characterized in that the side wall of the button is cylindrical and the module shell contains a plurality of radially flexible levers extending from the distal wall. 26. The module according to claim 14, characterized in that the contribution to the adjustment error from the location of the magnetic sensors and the bipolar magnetic ring is two degrees or less, and the adjustment error is the difference between the adjusted position corresponding to the physical position during rotation of the bipolar magnetic ring, and a certain position corresponding to the measured position during rotation of the bipolar magnetic ring, measured by magnetic sensors.