Injection monitoring module

Abstract

An injection monitoring module having a central longitudinal axis, for releasable, coaxial mounting to an injection pen, comprising: - an electronics housing enclosing an electronics unit; - a base unit configured to releasably receive and directly couple the electronics housing to the base unit; - an interconnector unit, extending along, or in parallel to the central longitudinal axis; - an injection pen attachment unit, configured for releasably coupling the injection monitoring module to a proximal end of an injection pen, covering at least an activation button of the injection pen system when mounted on the injection pen; and wherein the interconnector unit extends between a distal region of the base unit and the injection pen attachment unit, and connects said distal region of the base unit to the injection pen attachment unit.

Description

DESCRIPTIONTitle of Invention: Injection Monitoring Module

[0001] The present invention relates generally to monitoring systems for injectable drug delivery devices, and in particular to an injection monitoring module for monitoring use of an injection pen system.

[0002] Injection monitoring is a well known field associated with injectable drug delivery devices, especially with regard to infusion systems, for example. Over time, such monitoring systems have been made available for injection pen systems for delivery of a drug, enabling users of such pen injection systems, and health care professionals involved in the treatment and follow-up of such patients, to monitor more closely the associated injection regimes, and in many cases, the doses actually administered, in an attempt to lead to better healthcare outcomes. These developments have been accompanied by the increased associated use of software and portable communications devices such as tablets or smartphones, which have been programmed to receive information from, and interact with, the monitoring systems in order to provide information to the user or healthcare professional on-the-fly, or at regular intervals via appropriate communications units included in the monitoring systems.

[0003] In regard to pen injection systems in particular, for example, one of the challenges has been to provide easy to use, reliable and fairly failsafe monitoring systems that can be adapted to the various different variants of such commercially available pen injection systems, of which there are many. Previous attempts at providing such monitoring systems have usually involved adapting the body of the pen injection system by including electronic components therein, along with one or more sensors. Such adapted pen injection systems tend to be very specific to a given brand or a manufacturer, and thus of little or no use with pen injection devices of other manufacturers. There has furthermore been a tendency to attempt to reduce the overall volume of the injection pen bodies as much as possible through miniaturization of the complex electronic components, which in turn has brought about its own problems, in particular with regard to electromagnetic interference between the various components due to the close proximities of the circuits providing the required or desired integrated functionality. Moving the sensors in such monitoring systems further away from the source of electromagnetic interference only further complicates matters, potentially leading to erroneous readings, or requiring further systems to compensate for the physical separation ofthe sensors from the other electronic components, such as a microcontroller designed to control and command the various components and manage their interactions.

[0004] The injection pen systems in question are well known per se and are commonly equipped with a proximally located dose setting wheel and injection activator, the dose setting wheel being rotatable about a central longitudinal axis of the pen injection system. The wheel is rotated by the user to select the dose of drug to be administered. The pen is generally configured, either mechanically or electromechanically to effect an injection upon activation of an injection activator. Such injection activators are quite commonly a simple press or pushbutton, in mechanical or electrical contact with the dispensing mechanism located within the pen injection system, the pressing of which causes the injection mechanism to fire and expel the drug contained within the pen injection system. In some pen injector systems, the dose setting wheel is configured to rotate not only during dose setting, but also during injection. This is generally achieved through the inclusion of one or more metallic components, such as a helically wound drive spring, or a ratchet system, located within a housing body of the injection pen system and physically coupled to the dose setting wheel. As such metallic elements are relatively large objects in comparison to the electronic component systems that are included in many pen injection systems today, these large metallic objects can further perturb signals that the sensors in such electronic component systems are designed to capture or pick up, rendering the systems potentially less accurate, and / or requiring that complex correction mechanisms be put in place to avoid calculation errors.

[0005] Commonly commercialized injection pen systems have a variety of pen body shapes and diameters, and as a general rule, each type of injection pen has a set of dimensions that are specifically tailored for that pen, or the medicament, drug or substance intended to be administered via such an injection pen system. Additionally, each pen manufacturer, for any given brand of pen, and / or associated injectable product, may have pen bodies which vary in dimensions, in particular, in outer diameter, i.e. the diameter of a virtual circle, following the circumference of an outer peripheral surface of the pen body, due to manufacturing tolerances. This variation in injection pen body outer diameters can be problematic for injection monitoring modules with fixed diameter inner bores because, even with the provision of volume-adaptive internal coatings, such as push-fit elastomers, it can be difficult to obtain a securely snug fit of the injection monitoring module onto and around the outer surface of the injection pen body, or a dose setting wheel of such an injection pen system. Additionally, thefrictional nature of the volume-adaptive elastomers provided on such injection monitoring modules and the thereby induced necessity for a certain degree of axial and rotational force to be applied by the user when mounting the injection monitoring module onto an injection pen, can make it difficult for many users to either simply mount the injection monitoring module onto the injection pen, or to position such injection monitoring modules precisely on the injection pen. Such a situation can potentially lead to incorrect subsequent usage, and / or incorrect readings, such as, for example, an unwanted rotation of one or more parts of the injection monitoring module during mounting of the monitoring module onto the injection pen, leading to an erroneous detection of a measurable indicator or signal, such as a magnetic field.

[0006] As a result of the above, there remains the need to provide an injection monitoring module which is both easy to mount, and precisely position, onto a pen injection system, and similarly easy to dismount from the pen injection system, for example with users who might, in addition to the pathology or disorder requiring the administration of a medicament via an injection pen system, suffer from a range of physical or other disabilities. In such cases, having an injection monitoring module that is difficult to mount, and / or position correctly, for example requiring the application of a one-handed axial force to push the injection monitoring module into the correct position along the outer surface of the injection pen body, and / or dismount the injection monitoring module from the injection pen body by applying a one- handed pulling force in an opposite axial direction, may only serve to deter, or reduce observance of the treatment regime by the disabled user.

[0007] The applicant has previously described a number of injection monitoring modules for injection pen systems, for example, such as those published as WO2017013463A1, WO2019175615A1, WO2019175790A1, W02020217076A1, WO2021140352A1, W02020217094A1, W02021260404A1, WO2022079462A1, WO2023 / 170437A1, WO2023 / 187434A1 and W02024 / 069202A1.

[0008] As may be used in the present specification, the terms “pen injection system” and “injection pen system” are used interchangeably to designate a generally handheld pen-shaped injection system, such systems being readily well known per se and commercially available for use in the treatment of many various medical indications. These systems are also often generally designed for self-inj ection of a drug by the user in need of treatment for the givenmedical indication. This is for example the case with insulin, supplied in various forms for use in the treatment of diabetes, for example the pen injection systems commercialized under the brand names FlexPen®, as commercialized by Novo Nordisk, Kwikpen®, as commercialized Eli Lilly, or Lantus Solostar®, as commercialized by Sanofi, being but three of the most well known, but also with other hormones, such as growth hormone, or follicular stimulating hormones such as folli tropin delta, commercialized in a pen injection system by Ferring, called Rekovelle®. Other drugs are also used with this category of medical devices, and may be required, for example, to address a number of potentially life-threatening situations or disorders, enabling immediate emergency, or even non-emergency regular, injection of a required drug, such as anaphylactic shock treatments, anti-coagulants, opioid receptor agonists and antagonists, weight loss medication, appetite suppressors, and the like.

[0009] Additionally, the terms “proximal”, “proximally”, “distal” and “distally”, where such terms may be used in the present specification, refer to relative positions with regard to any of an injection monitoring system, injection monitoring module, and pen injection system in general, wherein “proximal” relates to a point or position or direction that is generally oriented in the direction towards the holder of the injection monitoring system, injection monitoring module, or pen injection system, and “distal” relates to a point or position or direction that is generally oriented in the direction away from the holder of the injection monitoring system, injection monitoring module, or pen injection system, for example towards a target site for injection, whether that be another part of the user’s body, or a different person’s, or animal’s, body, or simply a target site for ejection of the substance contained within the pen injection system.

[0010] The injection pen system, to which the injection monitoring module according to the invention is adapted and configured for removable attachment, is generally equipped with a proximally located dose setting system, often a rotatable wheel or dial, and an injection actuator. The dose setting wheel or dial rotates about a central longitudinal axis of the pen injection system to allow a user to set the dose of medicament for injection. In some injection pens, the activation button may be rotatable and form part of, or be connected to, the dose setting wheel or dial. During the dose setting, or dose “dialing” step, the dose setting wheel or dial is generally rotatable in a clockwise, and optionally also, a counter-clockwise direction, these directions corresponding respectively to either an increase in the selected dose, or a decrease in the selected dose to be administered, or vice-versa, depending on themanufacturer. The injection actuator is often represented by a push-button, usually located proximally of the dose setting wheel, or forming part of the dose setting system, and in the majority of injection pens is located at the proximal extremity of the injection pen system. After a dose has been set, or “dialed”, as the term is commonly known in the art, when a user of the injection system then presses the injection actuator in a distal direction, a piston is driven which is connected to a plunger in order to expel drug from a chamber within the injection pen body out through a needle that the user may have inserted into an appropriate injection site, for example, the skin, fatty tissue, or muscle, depending on the type of drug to be administered, or alternatively as a purge, or air shot, operation in which a small volume of drug, e.g. a few units or milliletres, is expelled from the distal end of the needle, in order to push out any potential air bubbles that might be present. The dose setting wheel is sometimes, but not necessarily, also coupled to the injection drive mechanism so that it can, depending on the manufacturer and model of injection pen, also rotate as injection of the drug proceeds. The functioning of such injection systems is well known per se in the art. The monitoring module as envisaged according to the present invention is intended for mounting onto a pen injection system in which the dose setting wheel can be configured to either rotate during the ejection / injection phase of operation, or, on the contrary, not rotate during the ejection / injection phase of operation of the pen injection system. For example, the Kwikpen® injection pen mentioned above does not have a dose setting wheel that rotates during injection, whereas the dose setting wheel of the Lantus Solostar®, FlexPen® and Rekovelle® injection pens do rotate during injection.

[0011] Accordingly, one aspect of the present invention is to provide an injection monitoring module which is universally mountable to a wide range of different manufacturers’ injection pen systems, each with it’s own specific geometry.

[0012] Accordingly, there is provided an injection monitoring module, configured and adapted for releasable mounting to an injection pen system, having a length, extending from a first, proximal end, to a second, distal end, and a central longitudinal bore extending at least partially along the length of the injection monitoring module around a central longitudinal axis, between the first, proximal end, and the second, distal end, wherein the injection monitoring module comprises: an electronics housing enclosing an electronics unit; a base unit, located distally of the electronics housing, and configured and adapted toreleasably receive and directly couple the electronics housing to the base unit; an interconnector unit, extending along, or in parallel to, the central longitudinal axis; a distal, injection pen attachment unit, configured and adapted for releasably coupling the injection monitoring module to a proximal end of an injection pen system, covering at least an activation button of the injection pen system when mounted on the injection pen system; and wherein the interconnector unit extends between a distal region of the base unit and the distal, injection pen attachment unit, and connects said distal region of the base unit to the distal, injection pen attachment unit.

[0013] According to another aspect, the interconnector unit is an injection activation buffer unit, comprising a lengthwise axially movable surface, wherein the injection activation buffer unit is configured to be moved along at least part of the length of the injection monitoring module and the central longitudinal axis from a first, axially extended position, to at least a first, and a second, axially constrained positions.

[0014] According to another aspect, the injection activation buffer unit extends at least partially within the central longitudinal bore, and connects the base unit to the distal, releasable attachment unit, in the first, axially extended position.

[0015] According to another aspect, the injection activation unit comprises a biasing element, located against the axially movable surface of the injection activation buffer unit, and wherein the biasing element has a first, extended configuration, in which the biasing element maintains the axially movable surface of the injection activation unit in the first, axially extended position.

[0016] According to another aspect, the biasing element of the injection activation buffer unit has a first, constrained configuration, in which the axially movable surface of the injection activation buffer unit is in the first, constrained position.

[0017] According to another aspect, the biasing element of the injection activation buffer unit has a second, constrained configuration, in which the axially movable surface of the injection activation buffer unit is in the second, constrained position.

[0018] According to another aspect, the first and second constrained positions of the axially movable surface of the injection activation buffer unit, and respectively, of the biasingelement, are spaced apart along the length, and / or respectively, along the central longitudinal axis, of the injection monitoring module. For example, the first constrained position of the axially movable surface of the injection buffer unit may be located proximally of the second constrained position of the axially movable surface of the injection buffer unit. Such a configuration can be desirable, for example, in order to generate a signal which will enable the electronics unit to determine, for example, that the injection monitoring module has been woken up, or that initiation of what appears to be an injection activation has begun, without actually engaging the activation button of the injection pen system on which the injection monitoring module is mounted, for example, when the axially movable surface of the injection activation buffer unit is moved from the unconstrained position to the first constrained position. In other words, the provision of a first unconstrained position, and more than one pre-determined constrained position, with regard to the axially movable surface of the injection activation buffer unit, allows for the generation of different signals within the electronics unit, and the identification of separate events involved in the use of the injection monitoring module when mounted on an injection pen system. In such a configuration, the second constrained position of the axially movable surface of the injection activation buffer unit can correspond to the actual activation of the injection activation button of the injection pen system. Similarly, movement of the axially movable surface of the injection buffer activation unit from either of the first or second constrained positions to the first, unconstrained position allows for the generation of other signals within the electronics unit corresponding to events related to the use of the injection monitoring module when mounted on an injection pen system, for example, a return to a zero position of the injection monitoring module, or a determination of a resting position of the injection monitoring module, or a completion of an injection, or a determination that no injection has actually taken place, and the like.

[0019] According to another aspect, the electronics housing comprises a distal coupling arrangement. The distal coupling arrangement is located generally in a distal area, or at a distal end, of the electronics housing, and is designed and configured to enable the electronics housing to be coupled to, and released from, the base unit, which is located distally, along the central longitudinal axis of the injection monitoring module, relative to the electronics housing. The distal coupling arrangement can be configured and shaped to permit a variety of coupling mechanisms, for example, via sliding fit, snap fit or screw fitengagement, or any combination thereof, with the base unit, with the proviso that the coupling mechanism be releasable. In this way, the electronics housing containing the electronics unit can be replaced should that be necessary, or be re-used in a replacement injection monitoring module should the remainder of the injection monitoring module become inoperable, for example, due to damage or breakage, or simply out of user convenience. Another advantage of such a releasable coupling configuration is that the electronics housing can be removed while the remainder of the injection monitoring module remains mounted onto an injection pen, meaning that it becomes possible to change the electronics housing on the fly, should that be desired and / or necessary.

[0020] According to one aspect, the electronics housing comprises a distal coupling mechanism which involves a sliding or translational fit with the base unit, and wherein the electronic housing is coupled to the base unit via a sliding movement or translation which is orthogonal, or perpendicular, to the central longitudinal axis of the injection monitoring module. In such a configuration, the electronics housing can be slid, from a first disengaged position, in which the electronics housing is not coupled to the base unit, to a second, engaged position, in which the electronics housing is firmly attached to the base unit.

[0021] According to one aspect, the base unit comprises a proximal coupling arrangement. The proximal coupling arrangement of the base unit is configured to permit a secure, but releasable, mating of a proximal end of the base unit with a distal end of the electronics housing. Accordingly, the proximal coupling arrangement is advantageously designed and / or configured to function with the distal coupling of the electronics housing.

[0022] According to another advantageous aspect, the base unit comprises a distal facing surface configured to receive at least a proximal part of the buffer unit. The distal facing surface of the base unit is shaped and dimensioned to receive, and / or seat a proximal end of the buffer unit. For example, the distal facing surface can advantageously be provided with a distal recess, or for example an annular wall which extends in a distal direction from the distal facing surface of the base unit, and which annular wall defines an inner volume, or closed bore, for receiving the proximal part of the injection activation buffer unit. The configuration of the distal facing surface of the base unit is generally axially aligned with, around, or on, the central longitudinal axis of the injection monitoring module.

[0023] According to another advantageous aspect, the base unit comprises a distal end portion which is shaped and dimensioned to match an outer surface shape of a proximal end of the distal, releasable, injection pen attachment unit, when the injection monitoring module is in use, and mounted on an injection pen system. In essence, the thus shaped distal end portion of the base unit protects and prevents a user of the injection monitoring module from interfering with the proximal end of the distal, releasable, injection pen attachment unit. For example, the distal end portion of the base unit can have substantially similar dimensions and general, overall, configuration as the distal end of the electronics housing. In some cases, however, it may be desirable, for example with certain injection pens, that the distal end portion of the base unit be configured, for example, as a skirt, which flares radially outwardly from a proximal position towards a distal position, in order to take account of a correspondingly shaped and dimensioned proximal part of the distal, releasable, injection pen attachment unit. In this way, the flared portion, or skirt, of the base unit can serve as a protective shield preventing tampering of the proximal end of the distal, releasable, injection pen attachment unit.

[0024] As has been mentioned above, the injection monitoring module comprises a distal, releasable, injection pen attachment unit. Such an injection pen attachment unit is designed and / or configured, to enable the injection monitoring module to be mounted onto, and cover, and / or extend around, at least the proximal activation button of the injection pen, and optionally, but advantageously, at least a part of an injection pen body, for example the dose setting wheel of the injection pen. According to one aspect therefore, the distal, releasable, injection pen attachment unit comprises: a first, proximal, annular body having a length and a diameter, and an annular wall extending along the length from a first, proximal end to a second, distal end, the annular wall defining at least part of the central bore of the injection monitoring module, which bore extends along the length of the first annular body, and along the central longitudinal axis; and a second, distal, annular body mounted coaxially on, and around, the first, proximal, annular body, wherein the second, distal, annular body is configured to be movable relative to the first, proximal, annular body, from a first position to a second position; wherein, in the first position, the second, distal, annular body exerts no inward radial force on at least one portion of the annular wall of the first, proximal, annular body, wherein, in the second position, the second, distal, annular body exerts an inwardradial force on the at least one portion of the first, proximal, annular wall, wherein the inward radial force applied to the at least one portion of the first, proximal, annular wall operates a reduction in the diameter of the at least one portion of the first, proximal, annular wall.

[0025] It will be understood from the above that the first position and the second position of the distal, releasable, injection pen attachment unit, relate to two different positions of the first, proximal, annular body and the second, distal, annular body, one with respect to the other. In the first position, also known as the unlocked position, the second, distal, annular body is in direct or indirect physical, or surface-to-surface engaging, contact with the first, proximal, annular body, but exerts no radially inward force on the first, proximal, annular body. For example, in the first, or unlocked, position, the second, distal, annular body may be attached, or mounted, to the first, proximal, annular body in a manner that exerts no radially inwardly directed force, i.e. no force directed towards the central longitudinal axis. In the first, or unlocked, position, for example, the second, distal, annular body can be configured to rotate freely about the central longitudinal axis, whilst nonetheless being mounted onto, or attached to, and engaging with, a portion of the first, proximal, annular body.

[0026] It will also be understood from the above that second, distal, annular body exerts a radially inwardly directed force on the first, proximal, annular body when the second, distal, annular body is moved from the first position into the second position, also known as the locked position. The radially inwardly exerted force causes a reduction in diameter of the at least one portion of the first annular wall, the reduction in diameter enabling a precise and secure positioning of the attachment unit onto an injection pen, in particular, around a dose setting wheel portion of the injection pen.

[0027] The annular wall of the first, proximal, annular body may comprise a plurality of elastically radially deformable fingers extending towards the second end. For example, the annular wall of the first, proximal, annular body may comprise two or more elastically radially deformable fingers, such as three, four , five, six, seven, eight or more, elastically radially deformable fingers, extending towards the second end of the annular wall of the first, proximal, annular body. The fingers may extend from any suitable point along a length of the first annular wall towards the second end of the first annular wall.

[0028] The plurality of elastically radially deformable fingers may be advantageously distributed radially about the central longitudinal axis, and even more advantageously, may be distributed radially equally about the central longitudinal axis.

[0029] The elastically radially deformable fingers may be deformable radially inwardly toward the central longitudinal axis, when the second, distal, annular body exerts an inward radial force on the at least one portion of the first annular wall.

[0030] Each finger of the plurality of elastically radially deformable fingers may have a portion of inward-facing surface configured to provide surface-engaging contact with an outer peripheral surface of an injection pen body, for example, with a dose-setting wheel portion of the injection pen body, or for example with the body of the injection pen, when the injection pen attachment unit is mounted onto the injection pen, and the second, distal, annular body is in the second, or locked, position. It will be understood here that the surfaceengaging contact portion of the inward-facing surface of each elastically deformable finger may be appropriately configured, for example, by providing an appropriately shaped portion of inward-facing surface of the deformable finger so that it corresponds to, or matches with, a correspondingly shaped outer peripheral surface of an injection pen body, or for example, an outer peripheral surface portion of the dose-setting wheel surface. For example, the portion of inward-facing surface of the elastically radially deformable fingers may be moulded into an appropriate shape, such as a concave or arcuate shape, or alternatively, include one or more layers of additional material located on the portion of inward-facing surface of the deformable finger, such as an elastomer in an appropriate thickness, in which the elastomer is compressible so as to adapt to the shape of an outer peripheral surface of the injection pen body, and / or dose-setting wheel.

[0031] Each finger of the plurality of elastically radially deformable fingers may have a portion of inward-facing surface which is sloped from a proximal point to a distal point, along at least a portion of a length of the elastically radially deformable finger, to conform to an outer peripheral surface of an injection pen body and / or dose-setting wheel, when the injection pen attachment unit is mounted onto an injection pen, and the second, distal, annular body is in the second, or locked, position.

[0032] The second, distal, annular body may have at least a first portion of an inwardfacing surface which is configured to engage with an outward facing surface of the first,proximal, annular body. The use of the term “engagement” in this context should be understood to mean that the inward-facing surface of the at least first portion of the second, distal, annular body physically engages in surface-to-surface contact with the outward facing surface of the first, proximal, annular body, either directly or indirectly, but preferably directly. The at least first portion of inward-facing surface of the second, distal, annular body may be configured in a variety of ways to perform this function, for example, by shaping of one or more portions of the second, distal, annular body, such as by moulding, and / or by providing, on the second, distal, annular body, additional layers of material, whereby the moulding and / or provision of additional layers can be shaped to provide one or rims, ridges, grooves, projections, and the like.

[0033] The first portion of inward-facing surface of the second, distal, annular body, which is configured to engage with an outward facing surface of the first, proximal, annular body, may advantageously be, for example, an annular shoulder.

[0034] In the first, or unlocked, position, the annular shoulder may be configured, and / or shaped, to provide a distal facing surface which engages with a proximal facing surface of a nose portion located at the distal, or second, end of the first, proximal, annular body, and the distal facing surface of the annular shoulder is free to rotate about the central longitudinal axis and against the proximal facing surface of the nose portion.

[0035] The annular shoulder of the second, distal, annular body may be configured, and / or shaped, to provide an inward facing portion which engages with an outward facing and sloping surface of the first, proximal, annular body. Such an inward facing portion of the annular shoulder, could be, for example, a ridge, or a dihedral forming an apex facing radially inwardly towards the central longitudinal axis, or a rounded or convex and proximally facing surface provided on the annular shoulder. Conversely, the outward facing, and sloping, surface of the first, proximal, annular body will generally extend from a proximal area of each elastically deformable finger, in a distal direction, and be defined by a first outer diameter of the elastically deformable finger, and terminate at a distal location of the finger having a second outer diameter, which is smaller than the first outer diameter of the elastically deformable finger.

[0036] When moving from the first, unlocked, position to the second, locked, position, the annular shoulder of the second, distal, annular body may exert an inward facing radialforce onto the outward facing and sloped surface of the first, proximal, annular body, thereby causing an inward facing surface of the first, proximal, annular body to be moved inwardly toward the central longitudinal axis. In this way, relative movement of the second, distal, annular body with respect to the first, proximal, annular body, from the first, unlocked, position into the second, locked, position, for example, from a proximal position to a distal position, causes a reduction in the diameter of the inner central bore, as the annular shoulder of the second, distal, annular body engages with the outward facing and sloped surface of the first, proximal, annular body, for example moving from a relative distal position of the second, distal, annular body to a relative proximal position of the second, distal, annular body, with respect to the first, proximal, annular body.

[0037] The second, distal, annular body has at least a second portion of an inwardfacing surface which is configured, and / or shaped, to engage with an outward facing surface of the first, proximal, annular body. In a manner similar to the first portion of inward-facing surface of the second, distal, annular body, the second inward-facing surface of the second, distal, annular body may be generally spaced apart from the first portion of inward-facing surface of the second, distal, annular body, and may be configured to form as an abutting stop for movement of the second, distal, annular body against the first, proximal, annular body, in a proximal direction. The lengthwise separation along a longitudinal axis of the attachment unit, between the first inward-facing surface and the second inward-facing surface of the second, distal, annular body, may therefore be configured to limit the extent to which the second, distal, annular body may be moved in a proximal direction, and thereby define the extent of movement of the second, distal, annular body from the first, unlocked, position into the second, locked, position.

[0038] The second portion of inward-facing surface configured to engage with an outward facing surface of the first, proximal, annular body may be an annular ridge located proximally of the annular shoulder, and adjacent to a proximal end, of the second, distal, annular body.

[0039] When moving from the first, unlocked, position to the second, locked position, the annular ridge may engage with a helical trough provided on the outward facing surface of the first, proximal, annular body.

[0040] The helical trough may comprise at least one, or a plurality of spires or full revolutions about and along, the central longitudinal axis.

[0041] In the second, locked, position, a proximal end of the second, distal, annular body may abut a distal end of the first, proximal, annular body.

[0042] In the second, locked, position, the annular ridge of the second, distal, annular body may comprise a proximal facing and inward sloping surface in stopping abutment with a corresponding distal facing and sloping surface of the first, proximal, annular body.

[0043] According to yet another aspect, the interconnector unit comprises at least one releasable catch extending between a distal region of the base unit and the distal injection pen attachment unit, wherein the at least one releasable catch connects the base unit to the distal injection pen attachment unit.

[0044] According to yet another aspect, the at least one releasable catch is configured and adapted to be moved between: a first, unreleased, position in which the attachment unit is held in a fixed axial relationship with the base unit, and a translational movement of the base unit along the central longitudinal axis is prevented; and a second, released, position in which the base unit is released from the fixed axial relationship with the distal injection pen attachment unit, and is free to translate along the central longitudinal axis.

[0045] The first, unreleased, position relates to a fixed axial position of the base unit, and more particularly, relative to the first, proximal, annular body of the distal, injection pen attachment unit, along the central longitudinal axis. The first, unreleased, position of the releasable catch is a position in which the catch prevents the base unit from translating along the central longitudinal axis, and which advantageously also prevents the base unit from rotating around said central longitudinal axis independently of the first, proximal, annular body of the distal, injection pen attachment unit. The second, released, position relates to a position in which the base unit is released from the retaining effect of the releasable catch, and is free to translate along, and co-rotate about, the central longitudinal axis, for example, at the same time as a dose setting shaft and dose setting wheel portion of the injection pen, when the injection monitoring module is mounted onto the injection pen in a use situation. Thereleasable catch thus operates to selectively prevent, or allow, such movement of the base unit, depending on whether it is in the unreleased, or released, position.

[0046] According to another aspect, the at least one releasable catch has a catch body which extends along the bore of the first, proximal, annular body. The catch body is typically an elongated body, such as a shaft, or rod, of a moulded polymeric material, or a lightweight alloy. The catch body extends from a proximal end to a distal end, and is positioned along an inward facing wall of the first, proximal, annular body, the inward facing wall being appropriately shaped and configured to receive the catch body. For example, when the injection monitoring module is mounted onto an injection pen, the catch body may be located in a space between an inward facing wall of the first, proximal, annular body of the distal, injection pen attachment unit, and a body, and / or a dose setting component, of an injection pen.

[0047] According to another aspect, the at least one releasable catch comprises a pair of releasable catches, and each releasable catch of the pair of releasable catches is located diametrically opposite the other of the pair of releasable catches.

[0048] According to another aspect, the at least one releasable catch has a proximal end with a radially inward facing proximal hook portion. The proximal end and hook portion will typically extend beyond a proximal end of the first, proximal, annular body.

[0049] According to another aspect, the inward facing proximal hook portion engages with a distal end portion of the base unit in the first, unreleased, position, and disengages with the distal end portion of the base unit in the second, released, position. The base unit may comprise a radially outwardly extending projection or shaping, located at, or adjacent to, the distal end of the base unit, onto which the proximal hook portion will latch, in the unreleased position of the catch, and from which the proximal hook portion will disengage, in the released position of the catch. The proximal end hook portion may advantageously extend laterally from either side of the proximal end to form a respective pair of hook arms, which hook arms may be shaped to conform to a correspondingly shaped surface of a distal end of the base unit.

[0050] According to another aspect, the at least one releasable catch has a proximal end with an outward facing proximal abutment shoulder, configured to abut against aproximal facing surface of a proximal end of the first, proximal, annular body in the second, released, position. This abutting shoulder prevents the proximal end of the releasable catch body from being accidentally or deliberately moved in a distal direction into the central bore of the first, proximal, annular body when the catch is in the released position.

[0051] According to another aspect, the at least one releasable catch has a catch body which extends in a distal direction from the proximal end of the releasable catch, and beyond a distal end of the first, proximal, annular body of the distal, injection pen attachment unit, to be received within the second, distal, annular body of the distal, injection pen attachment unit, as described in more detail elsewhere in the present specification.

[0052] According to another aspect, the at least one releasable catch has at least a first, outward facing projection located along a length of the catch body, said projection forming a fulcrum point configured to permit rotational movement of the releasable catch about the fulcrum point when moving the releasable catch from the first, unreleased, position, to the second released, position. The fulcrum point provides for a point of rotation of the releasable catch body within the bore of the first, proximal, annular body of the distal, injection pen attachment unit, in which the outward facing projection bears against an inward facing surface of the first, proximal, annular body of the distal, injection pen attachment unit. The degree of rotational freedom about the fulcrum point of the releasable catch body is determined by the thickness of the releasable catch body, the shape and size of the outward facing projection, and the dimensions of the first, proximal, annular body through which the releasable catch body extends. These configurational elements are chosen to enable the releasable catch body to pivot about the fulcrum point as the releasable catch is moved from the first, unreleased, position, to the second, released, position, and vice-versa in a reverse pivot direction.

[0053] According to another aspect, the at least one releasable catch comprises a distal end, configured and adapted to be received in a guide portion of the second, distal, annular body of the attachment unit.

[0054] According to another aspect, the at least one releasable catch comprises a second, outward facing projection located along the length of the catch body, adjacent the distal end of the catch body. The second, outward facing projection functions as an abutting stop for the catch body, preventing the distal end of the catch body from being removed from the dista, injection pen attachment unit.

[0055] According to another aspect, the second, distal, annular body of the distal, injection pen attachment unit comprises a guide portion for receiving and guiding a distal end of a releasable catch.

[0056] According to another aspect, the guide portion of the second, distal, annular body of the distal, injection pen attachment unit comprises at least one radially outwardly sloping surface, extending from a proximal location to a distal location, and at least one radially inwardly sloping surface, extending from a distal location to a proximal location. These sloping surfaces enable the guide portion of the second, distal, annular body of the distal, injection pen attachment unit to guide the distal end, and / or the second, outward facing projection, of the catch body, and to apply an elastic deformation to the catch body in order to deform the catch body in a first radially inward direction, or conversely, in a second, radially outwardly direction. For example, the radially outwardly sloping surface receives the distal end of the catch body, causing a radially outwardly directed elastic deformation to be applied to the distal end of the catch body, thereby, due to rotation about the fulcrum, forcing the proximal hook end of the catch body onto the distal end of the base unit, and maintaining the axial connection between the distal, injection pen attachment unit and the base unit in a locked position. Conversely, as the second, distal annular body is moved in a distal direction, to lock the distal, injection pen attachment unit to the body and / or dose setting wheel of an injection pen system, the second outward facing projection of the catch body is moved towards, and abuts against, the radially inwardly sloping surface, which in turn causes an elastic deformation of the catch body about the fulcrum, causing the proximal hook end of the catch body to be moved radially outwardly, and thereby be released from locking attachment with the distal end of the base unit.

[0057] According to another aspect, in the first, unlocked, position of the attachment unit, the at least one guide portion of the second, distal, annular body, applies a radially outward elastic deformation to the distal end portion of the releasable catch body of the at least one releasable catch, said radially outward elastic deformation being transmitted along the body of the releasable catch, and causing the releasable catch body to pivot radially inwardly about the fulcrum point, thereby moving the proximal hook portion of the catch body radially inwardly to engage said hook with a distal end portion of the base unit, corresponding to the unreleased position of said releasable catch.

[0058] It will be understood from the preceding paragraphs that the at least one guide portion is configured in shape and size to apply a deformation constraint to a distal end portion of the body of the releasable catch. This can, for example, be achieved by appropriate shaping of the internal volume and surfaces of the guide portion. In the first, unlocked, position of the attachment unit, the at least one guide portion applies an outwardly oriented constraint or deforming force onto the distal end of body of the releasable catch. The rigidity, or flexibility, of the material from which the releasable catch body is made, such as a suitable polymer, or metal alloy, causes the deforming force to be transferred along the body of the releasable catch and the fulcrum point of the body in contact with an inward facing surface of the first, proximal, annular body. This in turn causes the catch body to rotate, or pivot, about the fulcrum point, thereby driving the proximal hook end portion into a catching engagement with an appropriately configured distal end portion of the base unit.

[0059] According to another aspect, in the second, locked, position of the attachment unit, the at least one guide portion of the second, distal, annular body, removes application of the radially outward elastic deformation of the distal end portion of the releasable catch body of the at least one releasable catch, the removal of the radially outward elastic deformation causing the releasable catch body to pivot radially outwardly about the fulcrum point, thereby moving the proximal hook portion of the catch body out of engagement with a distal end portion of the base unit, corresponding to the released position of said releasable catch.

[0060] From the preceding paragraph, it is to be understood that as the second, distal, annular body is moved in a distal direction from the unlocked, to the locked position, the corresponding distally directed movement of the at least one guide portions removes, or reduces, the outwardly oriented deformation from the body of the releasable catch, thereby relaxing said constraint applied along the catch body, and causing the proximal end hook portion of the catch body to pivot away from the unreleased engagement position of the hook portion with the distal end portion of the base unit. Once the second, distal, annular body has reached the second, locked, position, the hook end portion of the releasable catch has been totally released from engaging contact with the distal end portion of the base unit, and said base unit is now free to translate along, and / or around, the central longitudinal axis, for example, when setting a dose via a proximal dose setting wheel component of a corresponding injection pen, or, as the case may be, during injection.

[0061] According to another aspect, the electronics unit comprises one or more of: a microcontroller located on an electronic circuit board; an autonomous power supply connected to the electronic circuit board; an optional activation switch configured to selectively enable power to be supplied, or turned off, to the electronic circuit board from the autonomous power supply; one or more sensors, such as one or more magnetometers, accelerometers, gyroscopes, and the like, connected to the microcontroller, wherein the microcontroller is configured to process signals received from the one or more sensors to identify parameters and conditions associated with operation of the injection monitoring module, when mounted on, and used with an injection pen system, or removed from the injection pen system. As indicated above, the microcontroller is typically located on the electronic circuit board and typically comprises one or more subcomponents, such as a processor, an internal clock, one or more data registers, and / or a non-volatile memory, and is often programmable or otherwise capable of processing a set of instructions, excuting programmed code, and / or effecting calculations, in order to process information, and / or data and / or electrical signals from the other components connected to, or integrated into, the electronic component board. Such microcontrollers are generally well known per se.

[0062] The electronics unit may also comprise a data storage connected to the microcontroller, and the microcontroller may be configured to calculate, and / or store data relating to an operation condition or status of an injection pen system onto which the injection monitoring module is mounted via the distal, injection pen attachment unit. For the purposes of the present specification, the data storage can be one of many possibilities, including data registers integrated into the microcontroller described above, and / or volatile and / or nonvolatile memory, either integrated into the microcontroller or formed as a separate functional unit and connected to the microcontroller via the electronic component board.

[0063] The autonomous power supply may typically be, for example, a simple battery, such as a button or coin-shaped battery, for example a lithium ion battery, as known in the art. Alternatively, the battery can be rechargeable, again as known per se in the art, the charge being supplied over a USB port, for example, extending through an opening in the casing of the injection monitoring system.

[0064] The activation switch may be optional in the event that power may be continuously supplied to the microcontroller and one or more sensors as identified above, in alow power consumption, or sleep mode. In such a configuration, one or more of the sensors may be configured instead to switch the injection monitoring module from the low power consumption mode to a normal power consumption mode in the event that a change in sensor value or signal, is received by the microcontroller from the one or more sensors. For example, in the case of the sensor being a magnetometer, in which the microcontroller would constantly poll the magnetometer, the injection monitoring module could be configured to consume power in a low power mode until a change in magnetic context is received by the microcontroller, at which point the microcontroller could then direct the autonomous power supply to supply more power, moving from the low power consumption mode to the normal power consumption mode, and powering up the other components of the electronics unit when switching to the normal power consumption mode.

[0065] According to another aspect, when the injection monitoring module is mounted on an injection pen, the microcontroller of the electronics unit is configured to process signals received from the one or more of a magnetometer, accelerometer, and gyroscope, in order to determine one or more conditions of operation selected from: a correct mounting of the injection monitoring module on the injection pen; a wake-up of the injection monitoring system; a dialing of a dose amount through rotation of a dose setting mechanism of the injection pen via rotational contact between the injection monitoring module and the dose setting mechanism of the injection pen; an onset of an injection; a completion of an injection; a return to a zero position of the injection pen; and a dose amount administered by the injection pen.

[0066] According to another aspect, the electronics unit may further comprise a wireless communications unit, such as a Bluetooth BLE® circuit. The wireless communications unit is configured to communicate data stored, and / or processed, and / or calculated by the microcontroller to a remote device, such as a smartphone executing a corresponding treatment regime management application, or a remotely hosted computer service providing such a treatment regime management application.

[0067] According to another aspect, the first, proximal, annular body of the distal, injection pen attachment unit comprises a pair of diametrically positioned magnets. The use of pairs of magnets in injection monitoring modules such as those envisaged by the present application is known per se from the previously published applications made by the applicant.

[0068] According to another aspect, a first magnet of the pair of diametrically positioned magnets is positioned with a north pole oriented in a proximal direction, and a second magnet of the pair of diametrically positioned magnets is positioned with a north pole oriented in a distal direction.

[0069] According to another aspect, a first magnet of the pair of diametrically positioned magnets is positioned with a north pole oriented in a first direction which is orthogonal to the central longitudinal axis, and a second magnet of the pair of diametrically positioned magnets is positioned with a north pole oriented in a second direction direction which is orthogonal to the central longitudinal axis and opposite to the first direction of the first magnet. This can advantageously be the case, for example, when the pair of magnets are located facing outwards from the central longitudinal bore.

[0070] According to another aspect, the pair of diametrically positioned magnets are located at, or adjacent to, a proximal end of the first, proximal, annular body of the distal, injection pen attachment unit.

[0071] The pair of magnets can appropriately be positioned within corresponding recesses of the first, proximal, annular body of the distal, injection pen attachment unit, with the recesses being oriented either inwardly into the central longitudinal bore of the first, proximal, annular body of the distal, injection pen attachment unit, or alternatively, outwardly away from the central longitudinal bore of the first, proximal annular body of the distal, injection pen attachment unit.

[0072] Additionally, the pair of magnets can be located in a fixed, non-rotating configuration with respect to the first, proximal, annular body of the distal, injection pen attachment unit, for example, in a further body positioned coaxially outwardly of the first, proximal body, and mounted to the body of the injection pen, rather than onto a dose setting component of the injection pen. This can be the preferred configuration of the injectionmonitoring module, for example, when it is configured to be mounted onto a Flextouch® injection pen, as commercialised by Novo Nordisk.

[0073] The electronics housing of the injection monitoring module may comprise a housing body and a proximal cover. The housing body of the electronics housing typically may have an open proximal end and a closed distal end, in the manner of a cup or a bowl, and the proximal cover may present a substantially flat or planar surface, or alternatively a domed or convex shape, or alternatively again, an incurved or concave shape. The housing body of the electronics housing is shaped and configured to receive, and / or hold, the electronic circuit board within the housing body, or within an inner volume formed by the housing body and proximal cover when the housing body and cover are assembled together. The proximal cover and housing body are typically assembled together to form this innner volume, for example, by gluing, clipping, snap-fitting or welding the housing body and proximal cover together, typically at one or more points around an each respective circumference of the open housing body and the proximal cover. The proximal cover, and / or housing body, may comprise one or more portions of transparent or translucent material, for example formed as a window, light guide or light tunnel, and / or may sandwich a ring of such transparent or translucent material. Said window, light guide or light tunnel is usually configured to allow, and / or guide, the passage of visible light emanating from a visible light emission source connected to, and / or located in or on the electronic circuit board, such as a LED, to outside of the electronics housing, such that said emitted light becomes visible to the user. The emitted light is commonly used to indicate a particular status and / or a condition of the injection monitoring module, for example, correct mounting and or positioning of the injection monitoring module relative to the injection pen, ready to set a dose, ready to inject, injection completed, ready to dismount, and the like.

[0074] As mentioned above, the microcontroller is located on an electronic circuit board, the electronic circuit board being held within the electronics housing formed by the housing body and proximal cover. The microcontroller typically comprises one or more subcomponents, such as a processor, an internal clock, one or more data registers, and / or a non-volatile memory, and is usually programmable or capable of processing a set of instructions, excuting programmed code, and / or effecting calculations, in order to process information, and / or data and / or electrical signals from the other components connected to, orintegrated into, the electronic component board. Such microcontrollers are generally well known per se.

[0075] The injection monitoring module may comprise a data storage connected to the microcontroller, and the microcontroller may be configured to calculate, and / or store data relating to an operation condition or status of the injection onto which it is mounted via the attachment unit. For the purposes of the present, the data storage can be one of many possibilities, including data registers integrated into the microcontroller described above, and / or volatile and / or non-volatile memory, either integrated into the microcontroller or formed as a separate functional unit and connected to the microcontroller via the electronic component board.

[0076] As indicated above, the injection monitoring module may also comprise an autonomous power supply connected to the electronic circuit board. Typically, this can be, for example, a simple batteiy, such as a button or coin-shaped batteiy, for example a lithium ion battery, as known in the art. Alternatively, the battery can be rechargeable, again as known per se in the art.

[0077] The injection monitoring module will now be described in greater detail with regard to the figures.

[0078] Figure 1 is a schematic exploded perspective representation of a first injection monitoring module, configured to function with a first injection pen type such as a Solostar® insulin pen commercialised by Sanofi or a Flexpen® insulin pen commercialised by Novo Nordisk;

[0079] Figure 2 is a schematic cross-sectional view representation of the injection monitoring module of Figure 1;

[0080] Figure 3 is a schematic perspective view representation of a base unit of the injection monitoring module illustrating a proximal coupling arrangeement for coupling to a corresponding distal coupling configuration of an electronics housing of the injection monitoring module;

[0081] Figure 4 is a schematic perspective view representation of a distal end of an electronics housing of the injection monitoring module, and which is couplable to the proximal coupling illustrated in Figure 3;

[0082] Figure 5A illustrates a schematic cross-sectional view representation of the injection monitoring module of Figures 1 and 2 in an assembled, unlocked position about a proximal end of an injection pen;

[0083] Figure 5B illustrates a schematic cross-sectional view representation of the injection monitoring module illustrated in Figure 5A in an assembled, locked position about the proximal end of an injection pen;

[0084] Figure 6 illustrates a schematic exploded view representation of a second injection monitoring unit, configured to function with a second injection pen type such as a Flextouch® injection pen commercialised by Novo Nordisk;

[0085] Figure 7 illustrates a schematic cross-sectional view representation of the injection monitoring module of Figure 6 in an assembled, and mounted position on an injection pen;

[0086] Figure 8A illustrates a schematic cross-sectional view representation of the injection monitoring module of Figures 6 and 7 in an assembled, unlocked position about a proximal end of an injection pen;

[0087] Figure 8B illustrates a schematic cross-sectional view representation of the injection monitoring module of Figures 6 and 7 in an assembled, locked position about a proximal end of an injection pen;

[0088] Figure 9 illustrates a schematic exploded view representation of a third injection monitoring unit, configured to function with a third injection pen type such as a Kwikpen® injection pen, commercialised by Eli Lilly;

[0089] Figure 10 illustrates a schematic cross-sectional view representation of the injection monitoring module of Figure 9, in an assembled, and mounted position on an injection pen;

[0090] Figure 11 A illustrates a cross-sectional view representation of the injection monitoring module of Figures 9 and 10 in an assembled, unlocked and unreleased catch position about a proximal end of an injection pen;

[0091] Figure 11B illustrates a cross-sectional view representation of the injection monitoring module of Figures 9 and 10 in an assembled, unlocked and released catch position about a proximal end of an injection pen.DETAILED DESCRIPTION

[0092] Turning now to Figures 1 and 2, an injection monitoring module (1) is shown. The injection monitoring module has a length L, extending from a first, proximal end (2), to a second, distal end (3), and a central longitudinal bore (4) extending at least partially along the length L of the injection monitoring module (1) around a central longitudinal axis (5), between the first, proximal end (2), and the second, distal end (3). The injection monitoring module (1) comprises: an electronics housing (6) enclosing an electronics unit (7) and having a proximal cap or cover (8) and a distal coupling end (9); a base unit (10), located distally of the electronics housing (6), and having a proximal end (11) and a distal end (12), wherein the proximal end (11) of the base unit (10) is releasably coupled to the distal coupling end (9) of the electronics housing (6); an interconnector unit (13), extending along the central longitudinal axis (5); a distal, injection pen attachment unit (14), configured and adapted for releasably coupling the injection monitoring module (1) to a proximal end (15) of an injection pen system (16), covering at least an activation button (17) of the injection pen system (16) when mounted on the injection pen system (16). As can be seen from Figure 2, the central longitudinal bore (4) is adapted in size and diameter to receive the injection pen activation button (17) within the bore (4), and the distal, injection pen attachment unit (14) is configured to bear against an outward facing surface (16a) of a proximal part of the injection pen (16), for example as illustrated in Figures 1, 2, 5A and 5B, to bear against an injection pen proximal-end located dose setting wheel (18) of the injection pen (16). Such injection pens are known per se and may vary in body diameter, length and functioning, depending on the injection pen manufacturer.

[0093] In the injection monitoring module illustrated in Figures 1, 2, 5A and 5B, the interconnector unit (13) extends between a distal facing surface (19) of the base unit (10) and a proximal end (20) of the distal, injection pen attachment unit (14), and connects the distal facing surface (19) of the base unit (10) to the injection pen attachment unit (14). In this embodiment, the interconnector unit (13) is an injection activation buffer unit, and comprises a lengthwise axially movable surface (21). The injection activation buffer unit is configured to be moved along at least part of the length L of the injection monitoring module (1), and thecentral longitudinal axis (5) from a first, axially extended, or unconstrained, position, to at least a first, and a second, axially constrained positions, and at least partially within the central longitudinal bore (4). As illustrated in Figures 1, 2, 5A and 5B, the injection activation buffer unit forming the interconnector unit (13) comprises a biasing element (22), such as a coiled spring or other resiliendy deformable member, which can adopt an unconstrained, or extended, configuration. The biasing element has a proximal end (23) which is located against the axially movable surface (21), and in the first, extended, or unconstrained, configuration, the biasing element (22) engages with the axially movable surface (21) and maintains said axially movable surface (21) in the first, axially extended, or unconstrained, position. The axially movable surface (21) can form an annular wall (24) with a closed proximal end (25) and which forms a bore or inner volume extending in a distal direction . At a distal end (26) of the annular wall (24), a flange (27) is provided which extends circumferentially, and radially outwardly. In the first, unconstrained, or extended position, the flange (27) has a proximal facing surface (28) which bears against, a distal facing surface (29) of the proximal end (20) of the distal attachment unit (14), and which is maintained in this position for as long as the biasing element remains in the first, unconstrained, or extended, position. It should be noted that even in the unconstrained, or extended position, the flange (27) is capable of free rotational movement about the central longitudinal axis (5) vis-a-vis the proximal end (20) of the attachment unit (14). In other words, the base unit (10) and electronics housing (6) still remain free to rotate around said central longitudinal axis (5) should the user decide to rotate the base unit coupled to the electronic housing. Conversely, the base unit (10) and electronic housing (6) do not therefore rotate during either dose setting or dose injection, even if the dose setting wheel (18) rotates. The biaising element (22) is also responsible for allowing the axially movable surface (21) to be moved along the central longitudinal axis (5) from the first, unconstrained, or extended position, to one, or preferably two, constrained positions. The first constrained position and the second constrained positions are axially spaced apart along the central longitudinal axis, with the second constrained position being located distally of the first constrained position. The first constrained position can be used for example, to generate a signal, which signal is received by a microcontroller (30) present in the electronics unit (7). The signal can advantageously be generated in a known manner, for example via detection of an inertial movement when the axially movable surface (21) is moved from the unconstrained position to the first constrained position. The inertial movement may be detected by a suitablypositioned inertial sensor such as an accelerometer or a gyroscope, for example, located within the electronics unit (7). Alternatively, the signal can be generated via detection of a change in magnetic field context or a magnetic field environment of the injection monitoring module when the latter is equipped with one or more magnets, and which is detectable by a suitably located magnetometer (31), for example, located within the electronics unit (7) and positioned on the central longitudinal axis (4). The microcontroller (30) can be configured to recognise the change in position of the axially movable surface (21) as one of one or more events related to, or associated with, the use of the injection monitoring module (1) when mounted on an injection pen, for example: a departure from a zero, or initial, position of the injection pen, in which case the unconstrained, or extended position would be considered the zero, or initial position of the injection pen; a wake-up call for the electronic circuit to change a power supply mode to the electronic unit; a pre-initiation of an injection, e.g. preparation for an injection, or a priming operation; and the like. The second, constrained position, which requires further movement in a distal direction of the axially movable surface (21), and thus further axial compression of the biasing element (22) along the central longitudinal axis, can for example correspond to an injection activation position of the injection monitoring module. In such a second, constrained position, the axially movable surface (21) comes into contact with a distally located injection activation surface (32) of the buffer unit of the interconnector unit (13), and which is also in contact with a distal end of the biasing element (22). The injection activation surface (32) may have, as illustrated in the figures, an annular wall (32a), or a series of radially spaced wall portions, or fingers (32a, 32b, 32c, 32d, 32e, 32f), extending from the distal injection activation surface (32) in a proximal direction towards the axially movable distal facing surface (21). The diameter of the annular wall (32a), wall portions or fingers (32a, 32b, 32c, 32d, 32e, 32f) extending proximally from the distal injection activation surface (32) may be suitably dimensioned to receive and guide movement of the annular wall (24) of the axially movable surface (21), or of the distal facing surface (19), where the latter is directly shaped and dimensioned to form a distally extending annular wall (24), along the longitudinal axis (5). It should be understood that the annular wall (32a) or fingers (32a, 32b, 32c, 32d, 32e, 32f) form mutually cooperating surfaces which assisting in maintaining axial stability of the connector (13) within the monitoring module, whilst permitting, and defining, the degree and limits of axial movement along the longitudinal axis (5). In the second, constrained position, the surface to surface contact of the axially movable surface (21) bearingin a distal direction against the injection activation surface (32), combined with the pent-up kinetic energy stored by the biasing element (22) in the second, constrained position, will cause activation of the activation button (17) of the injection pen (16). As will be understood, the axial movement of the axially movable surface in the distal direction is generally initiated by a user of the injection monitoring module (1), when mounted on the injection pen (16), when the user exerts a downward, or distally oriented, pressure, e.g. via one or more fingers, or a thumb or other similarly actionable body part, onto the proximal end of the injection monitoring module, for example, pressing down on the proximal cap of the electronics housing. Similarly, any movement of the axially movable surface in a proximal direction along the central longitudinal axis will generally occur due to a user releasing digital pressure from the proximal cap, and the biasing element (22) moving back into the extended, or unconstrained position.

[0094] Turning now to Figures 3 and 4, these figures illustrate a manner in which the base unit (10) and electronics housing (6) may be coupled together. As illustrated in Figure 4, the electronics housing (6) comprises a distal coupling arrangement, located in a distal area, or at the distal coupling end (9), of the electronics housing (6). The distal coupling arrangement of the electronics housing (6) is a releasable coupling mechanism which may involve one or more of a sliding fit, a snap fit, a screw fit, or any combination thereof, with the base unit. As illustrated in Figure 4, the distal coupling arrangement involves a sliding or translational fit with the base unit (10), and particularly advantageously, wherein the sliding or translational fit with the base unit (10) is orthogonal, or perpendicular, to the central longitudinal axis (5) of the injection monitoring module. Coupling between the electronics housing (6) and the base unit (10) can thus be effected by sliding the electronics housing (6) in a direction orthogonal to the central longitudinal axis (5) of the injection monitoring module (1), and relative to the base unit (10), from a first disengaged position, to a second, engaged position, and in which second position the electronics housing (6) engages with the base unit (10) to lock the electronics housing (6) to the base unit (10), cf. For example the dashed lines represented in Figures 1, 6 and 9. This can be achieved for example, by providing a pair of opposing guide arms (33) extending from the distal end (9) of the electronics housing (6) to define a distal recess (34). The guide arms (33) and recess (34) are shaped and configured to match a correspondingly configured proximal coupling arrangement located on the base unit (10). As illustrated in Figure 3, this can be provided through a pair ofopposing sleeves (35), which are located on the proximal end (11) of the base unit (10), and which are configured and shaped to receive, and releasably lock, via a suitable release mechanism, the arms (33) of the coupling arrangement of the electronics housing (6) within the sleeves (35). Such a releasable lock might involve for example, an elastically deformable portion of material forming part of the arms (33), and which when pushed in a given, predetermined direction by a user, would cause the arms (33) to deform resiliendy and move out of their locked positions within the sleeves (35), thereby allowing separation of the electronics housing (6) from the base unit (10). The base unit (10) may also comprise, as illustrated in Figure 3, a proximally projecting knob (36), extending from the proximal end of the (11) base unit (10), for example, substantially along the central longitudinal axis (5), and configured and shaped to match the distally located recess (34) of the electronics housing (6).

[0095] The distal facing surface (19) of the base unit (10), as illustrated in Figures 2, 5A and 5B, is configured to receive at least a proximal part of the injection activation buffer unit, and in this instance, the axially movable surface (21). To that end, the distal facing surface (19) of the base unit is shaped and dimensioned to receive, and / or seat the closed, proximal end (25) of the annular wall (24) of the axially movable surface (21) of the injection activation buffer unit of the interconnector unit (13). The distal facing surface (19) of the base unit (10) is therefore provided with a distal recess (37), and an annular wall (38), cf . Fig. 5A, which extends in a distal direction from the distal facing surface (19) of the base unit. As will be understood from Figures 2, 5A and 5B, the distal recess (37) and annular wall (38) correspond in fact to the distal facing side of the proximally projecting knob (36).Accordingly, the distal recess (37) and annular wall (38), cf. Fig. 5A, are axially aligned with the central longitudinal axis (5) of the injection monitoring module (1).

[0096] As can be seen from Figures 2, 5A and 5B, the base unit (6) has a distal end (12) which is shaped and dimensioned to be able to overlap with an outer surface shape of the proximal end (20) of the distal, injection pen attachment unit (14), when the injection monitoring module (1) is mounted on the injection pen. Additionally, and / or alternatively, the distal end (12) of the base unit (10) is dimensioned and configured similarly to the distal end (9) of the electronics housing (6).

[0097] In other embodiments, however, such as those illustrated in Figures 6, 7, 8A and 8B, the distal end (12) of the base unit comprises a skirt (39), which flares radially outwardly from a proximal position towards a distal position.

[0098] The distal, injection pen attachment unit (14) comprises a first annular body(40) having a length and a diameter, and comprising a first annular wall (41) extending along the length from a first end (42) to a second end (43). The first annular wall (41) of the first annular body (40) substantially defines the inner central bore (4) of the injection monitoring module. Generally, the length of the annular wall (41) of the first annular body (40) will be dimensioned such that the central bore (4) extends in a proximal direction beyond the proximal end (15) of the injection pen when the attachment unit (14) is mounted on the pen, and defines a bore volume adapted to receive the activation button (17) of the injection pen (16), and yet still provide sufficient volume to allow for translational, and / or rotational, movement of relevant moving parts of the injection monitoring module within the central bore (4), around and / or along, the central longitudinal axis (5). As will be understood from the foregoing description, the central bore (4) may, in some embodiments, also receive at least another part of the injection monitoring module, for example, the buffer unit, which is mounted co-axially with the attachment unit, and is configured, with regard to the attachment unit, to enable, for example, a translational and / or rotational movement of the buffer unit within the bore (4) of the first annular body (40) of the attachment unit (14). As illustrated in Figures 1, 5A, 5B, 6, 7, 8A, 8B, the first annular body (40) also comprises a second annular wall (44), situated radially inwardly of the first annular wall (41), and connected to the first annular wall (41) by a shoulder (45) extending radially inwardly from the first annular wall(41). In these embodiments, the second annular wall (44), is radially spaced apart from the first annular wall (41), and extends from the shoulder (45) in a proximal direction from a first, or distal end, to a second, or proximal end. The first annular wall (41) and the second annular wall (44) define an inner radial volume, at least a part of which can appropriately be configured or shaped to form at least one or more recesses (46a, 46b) to receive one or more dipole magnets (47a, 47b), as illustrated for example in Figures 1, 5A, 5B, 6, 7, 8A, 8B, or a ring-shaped dipole ou multipolar magnet. Such magnet holder recesses (46a, 46b) are useful to receive the magnet or magnets (47a, 47b) and provide a magnetic field for the electronics unit of the injection monitoring module, for example, when the electronics unit comprises one or more magnetometers. If such magnet holder recesses (46a, 46b) are each provided with acorresponding dipole magnet (47a, 47b), each magnet can be located in its respective magnet holder housing (46a, 46b) in a respective head-to-tail configuration, i.e. a first dipole magnet (47a) would be located in a first housing (46a) with the N-pole facing in a proximal direction and the S-pole facing in distal direction, and a second dipole magnet (47b) would be located in a second housing (46b) with the N-pole facing in distal direction and the S-pole facing in a proximal direction.

[0099] The attachment unit also comprises a second annular body (48), mounted coaxially on, and around, the first annular body (40). The second annular body (48) is configured to be movable relative to the first annular body (40), from a first position to a second position. In the first position, the second annular body (48) exerts no inward radial force on at least one portion of the annular wall (41) of the first annular body (40), and in the second position, the second annular body (48) exerts an inward radial force on said at least one portion of the first annular wall (41). When moving the second annular body (48) from the first position to the second position, an inward radial force is applied to the at least one portion of the first annular wall (41) causing a reduction in the diameter of the at least one portion of the first annular wall (41). Figures 5A, 8A, and 11A , illustrate the relative positions of the second annular body (48) and the first annular body (40) of the attachment unit (14), in a first, or unlocked, position, whereas Figures 5B, 8B and 11B, illustrate the relative positions of the second annular body (48) with respect to the first annular body (40) in a second, or locked, position. To all intents and purposes, as illustrated herein, the first position is an unlocked position of the attachment unit (14). In the first, or unlocked position, the second annular body (48) is free to translate, and / or rotate, along, and / or about, the first annular body (40), without exerting any inwardly directed radial force or pressure onto the first annular body (40). As a result, the diameter of the central bore (4) is unchanged. To all intents and purposes, as illustrated herein, the second position is a locked position of the attachment unit (14). In the second, or locked position, the second annular body (48) is locked against translation, and / or rotation, in a direction counter to the direction in which an inwardly directed radial force or pressure is applied by the second annular body (48) to the first annular body (40). It will be understood that the second annular body (48) is also locked against movement relative to the first annular body (9) in a proximal direction. It follows, as a result of the application of radial inwardly-directed force, that in the second, or locked position, thediameter of the central bore (4) is reduced compared to the diameter of the central bore (4) when the second annular body (48) is in the first, unlocked position, cf. Figure 5A.[000100] Figures 1, 2, 5A, 5B, 6, 7, 8A, 8B, 9, 10, 11A, and 11B illustrate in more detail details of embodiments for achieving the reduction in diameter on application of a radially inwardly directed force to the first annular wall (41) of the first annular body (40) by the second annular body (48), when moving from the first, unlocked position to the second, locked position. Looking at Figures 5A and 5B, for example, in more detail, the components of the attachment unit are illustrated in a cross-sectional view. This view shows the first annular body (40) and the second annular body (48). The first annular wall (41) of the first annular body (40) is visible, and as are the first, or proximal (42), and second, or distal (43), ends of the first annular wall (41). The first annular wall (41) comprises a number of elastically and radially deformable fingers (49a, 49b, 49c, 49d, 49e, 49f, 49g) which extend towards the second, or distal end (43) of the first annular wall (41) from a shoulder (50). The number of radially deformable fingers (49a, 49b, 49c, 49d, 49e, 49f, 49g) can be adjusted when shaping or forming the first annular body (40) and first annular wall (41), e.g. via injection moulding or additive manufacturing, depending on the desired degree of deformation required, and / or the desired degree in reduction of diameter of the bore (4). The plurality of elastically radially deformable fingers (49a, 49b, 49c, 49d, 49e, 49f, 49g) is distributed radially about the central longitudinal axis (5), preferably in an equally spaced manner, one from its adjacent or neighbouring, deformable finger (49). Each finger (49) of the plurality of elastically radially deformable fingers (49a, 49b, 49c, 49d, 49e, 49f, 49g) has a portion of inward-facing surface (51a-51g) configured to provide surface-engaging contact with an outer peripheral surface of an injection pen body, such as, for example, the outer peripheral surface of the dose setting wheel (18), when the attachment unit (14) is mounted onto the injection pen (16), and the second annular body (48) is in the second, or locked, position. Each finger of the plurality of elastically radially deformable fingers (49a-49g) has a portion of inward-facing surface (51a-51g) which is sloped from an each respective proximal point (52) to an each respective distal point (53), along at least a portion of a length of the elastically radially deformable finger (49a-49g), to conform to the outer peripheral surface of the dose setting wheel (18), and / or a pen body, of the injection pen (16) when the attachment unit (14) is mounted onto the injection pen (16), and the second annular body (48) is in the second, or locked, position. The use of the word “sloped”, in this context, refers to a shapingor dimensioning of the elastic fingers to provide the inward-facing engagement, or contact, surfaces (51a-51g). The shaping or dimensioning of the elastically deformable fingers (49a- 49g) can be achieved, for example, by reducing the thickness of each finger from the proximal point (52) towards the distal point (53) of the finger (49). Alternatively, and / or additionally, the shaping or dimensioning of the elastically deformable fingers (49a-49g) can be achieved by adding a layer of friction increasing material, such as an elastomer, from the proximal point (52) to a distal point (53) of the finger (49). Irrespective of the particular mode of execution, the inward-facing engagement, or contact, surfaces (51a-51g) can advantageously be shaped to correspond to similarly shaped outer peripheral surfaces present on the dose setting wheel (18), and / or pen body of the injection pen (16). Each deformable finger (49a- 49g) of the first annular body (40) has an outward facing surface (54) which can be engaged by an inward facing surface (55) of the second annular body (48).[000101] The second annular body (48) has at least a first portion of an inward-facing surface, which is configured to engage with an outward facing surface (54) of the first annular body (40). The first portion of the inward-facing surface of the second annular body (48) is an annular shoulder (56), which is configured to engage, when the second annular body (48) is mounted to the first annular body (40), with the outward facing surface (54) of the fingers (49a-49g). In the first, or unlocked, position, the shoulder (56) of the second annular body (48) merely rests against the outward facing surface (54) of the fingers (49a-49g), without exerting any radially inwardly directed force or effort. In the first, or unlocked, position therefore, the second annular body (48) does not cause elastic deformation of the fingers (49a- 49g).[000102] The outward facing surface (54) of the elastically deformable fingers (49a-49g) presents an ever increasing surface contact obstacle to the annular shoulder (56), as the second annular body (48) is moved from the first, unlocked, position into the second, locked, position. Furthermore, when moving the second annular body (48) from the first, unlocked, position to the second, locked position, the annular shoulder (56) of the second annular body (48) exerts an inward facing radial force onto the outward facing surface (54) of the first annular wall (41), thereby causing an inward facing surface of the first annular wall (10) to be moved inwardly toward the central longitudinal axis (5), causing a reduction in diameter of the central bore (4), due to the elasticity of the elastically deformable fingers (49a-49g). When the second, locked position is reached, the annular shoulder (50) slots into a grooved track ortrough (57), thereby preventing further immediate movement of the second annular body (48) in a distal direction, cf. Figure 5B.[000103] In order to dismount the attachment unit (1) from an injection pen (4), a reverse sequence of operations as described for mounting is carried out.[000104] The remaining figures will now be described with references to any differences they illustrate over the embodiment illustrated in Figures 1 to 4, and 5A and 5B. Identical number numbering will be retained for those parts or elements which are common to all embodiments.[000105] Figures 6 through to 8B illustrate an embodiment of the injection monitoring module that is configured to be mounted onto, and function with an injection pen similar to the Flextouch® injection pen, commercialised by Novo Nordisk. When mounted on such a pen (16), the distal, attachment unit (14) engages with an outer surface of the body of the injection pen (16), cf. Figure 7, and is not in direct contact with the dose setting wheel (18). Instead, a further, inner annular body (58) is located rotatingly within the central bore (4), radially inwardly of the first annular body (40) of the attachment unit (14), and positioned to frictionally engage the dose setting wheel (18) in order to co-rotate therewith during dose setting. The further, inner annular body (58) is also locked in co-rotation with the electronic housing (6) coupled to the base unit (10), during dose setting. The first, proximal annular body (40) of the attachment unit carries two, diametrically opposed dipole magnets, located at the proximal end (20) of the first, proximal annular body (40), and which are thus rotationally fixed, i.e. they do not rotate around the central longitudinal axis, whether during dose setting or dose injection. This is one major difference between the injection monitoring module of Figures 1 through to 5B and Figures 6 through to 8B. Also clearly recognisable in Figures 6 through to 8B is the presence of a radially outwardly extending, or flared, skirt (39) located at the distal end (12) of the base unit (10), the flared skirt being shaped to conform to and overlap with an outward-facing surface of the first, proximal annular body (40) of the attachment unit (14). Figures 8A and 8B respectively illustrate the injection monitoring module in the first, unlocked position, and the second, locked position, for mounting the injeciton monitoring module an injection pen, which functions in a manner as described for Figures 5A and 5B.[000106] The interconnector unit (13) comprising the buffer unit is substantially the same as that described for the injection monitoring module illustrated in Figures 1 through to8B, except that the lengthwise axially movable surface (21) is integrated directly into the distal facing surface (19) of the base unit (10). This distal facing surface (19) is therefore directly in contact with the biasing element (22), and additionally is connected axially along the central longitudinal axis (5), via the distal end of the biasing element (22) to the distally located injection activation surface (32). In this representation, the annular wall (32a) or wall portions (32a, 32b, 32c, 32d, 32e, 32f) which extend proximally from the distally facing activation surface (32) are dimensioned to receive the annular wall (24) extending from the distal facing surface (19) of the base unit (10). The distally located activation surface (32) is in turn rotationally connecter to the further, inner annular body (58), for example, via mutually cooperating and shaped projections and / or recesses, such that rotation of the base unit and coupled electronic housing is transmitted to the further, inner annular body during dose setting.[000107] Turning now to Figures 9 through to 11B, the injection monitoring module illustrated here is configured to function with a injection pen such as a Kwikpen®, as commercialised by Eli Lilly. The main differences over the injection monitoring module illustrated in Figures 1 through to 8B are described below. The interconnector does not comprise a buffer unit with biasing element, but instead comprises a releasable catch. The attachment unit (14) mounts the first, proximal, annular body (40a, 40b), shown here in two complementary parts, to an outward facing surface (16a) of the body of the injection pen (16), rather than the dose setting wheel (18). The base unit (10) and coupled electronic housing (6), are mounted directly onto the injection activation button (17) of the injection pen, which also serves as the dose setting wheel (18) in this kind of injection pen . In such an injection pen (16), the dose setting wheel (18) and injection activation button (17) are rotated together as one, to set a dose. In doing so, the dose setting wheel (18) and injection activation button (17) are moved in a proximal direction when increasing the dose to be set, and in the opposite direction when reducing the dose to be set. On injection, the injection activation button (17) and dose setting wheel (18) do not rotate, but they do translate along the longitudinal axis of the injection pen (16) in a distal direction back towards the zero position. Thus, with regard to the injection monitoring module as illustrated in Figures 9 through to 11B, mounted on such a pen, any determination of the administered dose using magnetometry is based on a calculation of the difference in the angular position of the magnets at the start of dose selection, and the angular position of the magnets at the end of an injection, and by accounting for the numberof rotations of the magnets from that dose selection start. The first, proximal, annular body (40) is mounted onto, and engages frictionally with, an outward facing surface (16a) of the injection pen (16) body at a proximal end portion of said body. As mentioned briefly above, the injection monitoring module (1) illustrated in Figures 9 through to 11B varies from the other examples described herein in that the first, proximal, annular body (40) of the attachment unit comprises at least one releasable catch (59a, 59b) configured and adapted to be moved between a first, unreleased, position in which the base unit (10) and electronic housing (6) are held in a fixed axial, and predetermined spaced-apart relationship with the first, proximal, annular body (40), and in which said unreleased position a translational movement of the base unit (10) and coupled electronic housing (6) relative to the first, proximal, annular body (40) of the attachment unit, along the central longitudinal axis (5), is prevented; and a second, released, position in which the base unit (10) and coupled electronic housing (6) is released from the fixed axial relationship with the first, proximal, annular body (40), and is free to translate along the central longitudinal axis (5), along with the dose setting wheel (18) and injection activation button (17).[000108] The first, unreleased, position of the releasable catch (59a, 59b) is a position in which the catch (59a, 59b) prevents the base unit (10) and coupled electronic housing (6) from translating along the central longitudinal axis (5), and from rotating around said central longitudinal axis independently of the first, proximal, annular body (40) of the attachment unit. The second, released, position relates to a position in which the base unit (10) and coupled electronic housing (6) is released from the retaining effect of the releasable catch (59), and is free to translate along, and co-rotate about, the central longitudinal axis (5), for example, at the same time as a dose setting shaft and dose setting wheel (18) portion of the injection pen (16), when the injection monitoring module (1) is mounted onto the injection pen in a use situation. The releasable catch (59a, 59b) thus operates to selectively prevent, or allow, such movement of the base unit (10) and coupled electronic housing (6), depending on whether it is in the unreleased, or released, position.[000109] The at least one releasable catch (59) has a catch body (60) which extends along the bore (4) of the first, proximal, annular body (40) of the attachment unit (14). The catch body (60) is typically an elongated body, such as a shaft, or rod, of a moulded polymeric material or metal. The catch body (60) extends from a proximal end (61) to a distal end (62), and is positioned along an inward facing wall (63) of the first, proximal, annular body (40) ofthe attachment unit (14), the inward facing wall (63) being appropriately shaped and configured to receive the catch body (60). The catch body (60) is located in the central longitudinal bore (5) of the first, proximal, annular body (40), in a space between the inward facing wall (63) of the first, proximal, annular body (40), and the body of the injection pen (16). The at least one releasable catch (59) comprises a pair of releasable catches (59a, 59b), and each releasable catch of the pair of releasable catches (59a, 59b) is located diametrically opposite the other of the pair of releasable catches. At each proximal end (61a, 61b) of the elongated body (60a, 60b) of each catch (59a, 59b), there is an inward facing proximal hook portion (64a, 64b). The inward facing hook portion (64a, 64b) is provided with a pair of arms (65a, 65b, 65c, 65d), each arm extending from respective opposing sides of the hook portion (64a, 64b). The proximal ends (61a, 61b), and hook portions (64a, 64b), extend beyond the proximal end of the first, proximal annular body (40). The inward facing proximal hook portions (64a, 64b) engage with the distal end (12) of the base unit (10) in the first, unreleased, position, and disengages with the distal end (12) of the base unit in the second, released, position. The base unit (10) can accordingly comprise a radially outwardly extending projection (66) or shaping, located at, or adjacent to, the distal end (12) of the base unit (10), onto which the proximal hook portions (64a, 64b) will latch, in the unreleased position of the catches (59a, 59b), and from which the proximal hook portions (64a, 64b) will disengage, in the released position of the catches (59a, 59b). Each catch (59) also has an outward facing proximal abutment shoulder (67a, 67b), cf. Fig 11A, located at the proximal end of the catch body (60a, 60b), which is configured to abut against a proximal facing surface (68) of the proximal end of the first, proximal, annular body (40) in the second, released, position. This abutting shoulder (67a, 67b) prevents the proximal end (61a, 61b) of the releasable catch body (60) from being accidentally or deliberately moved in a distal direction into the central bore (4) of the first, proximal, annular body (40) when the catch (59a, 59b) is in the released position. The catch body (60a, 60b) extends in a distal direction from the proximal end (61a, 61b) of the catch body (60a, 60b), and is received by the second, distal, annular body (48) of the attachment system. The catch body (60a, 60b) is also provided with an outward facing projection (69a, 69b) located along the length of the catch body (60a, 60b), and forming a fulcrum point which permits rotational movement of the catch (59a, 59b) about the fulcrum point when moving the catch (59a, 59b) from the first, unreleased, position, to the second released, position. The fulcrum point (69a, 69b) provides a point of rotation ofthe catch body (60a, 60b) within the bore (4) of the first, proximal, annular body (40), in which the outward facing projection (69a, 69b) of the fulcrum point bears against the inward facing wall (63) of the first, proximal, annular body (40). The relative degree of rotational freedom about the fulcrum point (69a, 69b) of the catch body (59a, 59b) is determined by the thickness of the catch body (60a, 60b), the shape and size of the outward facing projection (69a, 69b) forming the fulcrum point, and the dimensions of a guide portion (70a, 70b) located in the second, distal, annular body (48) of the attachment unit. These configurational elements are chosen to enable the releasable catch body (59a, 59b) to pivot about the fulcrum point (69a, 69b) as the releasable catch (59a, 59b) is moved from the first, unreleased, position, to the second, released, position, and vice-versa in a reverse pivot direction. The distal end (62a, 62b) of the catch body (60a, 60b) is configured and adapted to be received in the guide portion (70a, 70b) of second, distal annular body (48) of the attachment unit (14). The guide portion (70a, 70b) comprises at least one radially outwardly sloping surface (71a, 71b), extending from a proximal location to a distal location, and at least one radially inwardly sloping surface (72a, 72b), extending from a distal location to a proximal location. In the first, unlocked, position of the attachment system (14), as illustrated more particularly in Figure 11 A, the radially outwardly sloping surface (71a, 71b) of the guide portion applies a radially outward elastic deformation to the distal end (62a, 62b) of the releasable catch body (59a, 59b), the latter being located, and received within the guide portion (70a, 70b) at a distal end of the guide portion. The radially outward elastic deformation of the catch body (59a, 59b), which is caused by the shape of the radially outwardly sloping surface (71a, 71b) of the guide portion (70a, 70b) bearing against the catch body (59a, 59b), is transmitted along the body (60a, 60b), and causes the catch body (60a, 60b) to pivot radially inwardly about the fulcrum point (69a, 69b), thereby moving the proximal hook portion (64a, 64b) of the catch body (60a, 60b) radially inwardly to engage said hook portion (64a, 64b) with the radially outwardly extending projection (66) or shaping of the distal end (12) of the base unit (10). The guide portion (70a, 70b) also comprises a radially inwardly sloping surface (72a, 72b) from a distal location towards a proximal location, which sloping surface provides a gradual sloped change against which the distal end, or a projection (73a, 73b) extending from the catch body (60a, 60b) adjacent the distal end (62a, 62b) of the catch body, engages as the second, distal, annular body (48) is moved into the locking position.. The sloped change is responsible for the application of an elastic constraint against the distal end (62a, 62b) of thecatch body (60a, 60b), as the second, distal, annular body (48) of the attachment unit is moved from the first, unlocked, position (cf. Fig 11A), to the second, locked position (cf. Fig. 11B) of the attachment means (14). At the proximal end (61a, 61b) of the catch body (60a, 60b), the catch body (60a, 60b) pivots radially outwardly about the fulcrum point (69a, 69b), which in turn moves the proximal hook portion (64a, 64b) of the catch body (60a, 60b) out of catching engagement with the distal end (12) of the base unit (10), thereby releasing the base unit (10) and coupled electronic housing (6) from the first, proximal, annular body (40), and leaving the base unit (10) free to rotate, and / or translate in replication of the movements of the dose setting wheel (18) of the injection pen (16) during dose setting, and dose injection.[000110] As illustrated in Figures 9 and 10, the first, proximal, annular body (40) also comprises a pair of diametrically positioned dipole magnets (47a, 47b), which are located in corresponding respective recesses (46a, 46b), oriented facing outwards from the first, proximal, annular body (40). Additionally, the magnets (47a, 47b) are oriented with their respective magnetic poles positioned orthogonally relative to the central longitudinal axis (5). The second, distal annular body (48) is also provided with a dose visualisation window (74), which, when the injection monitoring module (1) is in the final, mounted and locked position on the injection pen (16), is located directly over, or in correspondence with, the dose display window of the injection pen, so that the user can directly see any dose being dialled into the pen when manipulating the dose setting wheel (18).

Claims

CLAIMS

1. Injection monitoring module, configured and adapted for releasable mounting to an injection pen system, having a length, extending from a first, proximal end, to a second, distal end, and a central longitudinal bore extending at least partially along the length of the injection monitoring module around a central longitudinal axis, between the first, proximal end, and the second, distal end, wherein the injection monitoring module comprises: an electronics housing enclosing an electronics unit; a base unit, located distally of the electronics housing, and configured and adapted to releasably receive and directly couple the electronics housing to the base unit; an interconnector unit, extending along, or in parallel to, the central longitudinal axis; a distal, injection pen attachment unit, configured and adapted for releasably coupling the injection monitoring module to a proximal end of an injection pen system, covering at least an activation button of the injection pen system when mounted on the injection pen system; and wherein the interconnector unit extends between a distal region of the base unit and the distal, injection pen attachment unit, and connects said distal region of the base unit to the distal, injection pen attachment unit.

2. Injection monitoring module according to claim 1, wherein the interconnector unit is an injection activation buffer unit, comprising a lengthwise axially movable surface, wherein the injection activation buffer unit is configured to be moved along at least part of the length of the injection monitoring module and the central longitudinal axis from a first, axially extended, or unconstrained, position, to at least a first, and a second, axially constrained positions.

3. Injection monitoring module according to claim 1 or claim 2, wherein the injection activation buffer unit extends at least partially within the centrallongitudinal bore, and connects the base unit to the distal, releasable attachment unit, in a first, axially extended, or unconstrained, position.

4. Injection monitoring module according to claim 2 or claim 3, wherein the injection activation buffer unit comprises a biasing element, located against the axially movable surface of the injection activation buffer unit, and wherein the biasing element has a first, extended, or unconstrained, configuration, in which the biasing element maintains the axially movable surface of the injection activation buffer unit in the first, axially extended, or unconstrained, position.

5. Injection monitoring module according to claim 4, wherein the biasing element of the injection activation buffer unit has a first, constrained configuration, in which the axially movable surface of the injection activation buffer unit is in the first, constrained position.

6. Injection monitoring module according to claim 4, wherein the biasing element of the injection activation buffer unit has a second, constrained configuration, in which the axially movable surface of the injection activation buffer unit is in the second, constrained position.

7. Injection monitoring module according to claims 5 and 6, wherein the first and second constrained positions of the axially movable surface of the injection activation buffer unit, and respectively, of the biasing element, are spaced apart along the length, and / or respectively, along the central longitudinal axis, of the injection monitoring module.

8. Injection monitoring module according to claims 5, 6, and 7, wherein the first constrained position of the axially movable surface of the injection buffer unit is located proximally of the second constrained position of the axially movable surface of the injection buffer unit.

9. Injection monitoring module according to any one of claims 2 to 7, wherein the unconstrained position corresponds to a zero position of the injection monitoring module.

10. Injection monitoring module according to any one of claims 2 to 7, wherein the first, constrained position corresponds to an initiation of an injection activation position of the injection monitoring module.

11. Injection monitoring module according to any one of claims 2 to 7, wherein the second, constrained position corresponds to an injection activation position of the injection monitoring module.

12. Injection monitoring module according to claim 1, wherein the electronics housing comprises a distal coupling arrangement.

13. Injection monitoring module according to claim 1, wherein the electronics housing comprises a distal coupling arrangement, located in a distal area, or at a distal end, of the electronics housing.

14. Injection monitoring module according to claim 13, wherein the distal coupling arrangement of the electronics housing is configured to couple the electronics housing to, and be released from, the base unit.

15. Injection monitoring module according to claim 13, wherein the distal coupling arrangement of the electronics housing comprises a releasable coupling mechanism selected from one or more of a sliding fit, a snap fit, a screw fit, or any combination thereof, with the base unit.

16. Injection monitoring module according to claim 13, wherein the distal coupling arrangement involves a sliding or translational fit with the base unit.

17. Injection monitoring module according to claim 13, wherein the distal coupling arrangement involves a sliding or translational fit with the base unit, wherein the sliding or translational fit with the base unit is orthogonal, or perpendicular, to the central longitudinal axis of the injection monitoring module.

18. Injection monitoring module according to claim 16 or 17, wherein coupling between the electronics housing and the base unit is effected by sliding the electronics housing in a direction orthogonal to the central longitudinal axis of the injection monitoring module, and relative to the base unit, from a firstdisengaged position, to a second, engaged position, in which second position the electronics housing engages with the base unit.

19. Injection monitoring module according to claim 1, wherein the base unit comprises a proximal coupling arrangement.

20. Injection monitoring module according to claim 1, wherein the base unit comprises a proximal coupling arrangement, and the proximal coupling arrangement of the base unit is configured for a secure, but releasable, mating of a proximal end of the base unit with a distal end of the electronics housing.

21. Injection monitoring module according to claim 13, wherein the base unit comprises a proximal coupling arrangement configured to function with the distal coupling of the electronics housing.

22. Injection monitoring module according to claim 1, wherein the base unit comprises a distal facing surface configured to receive at least a proximal part of an injection activation buffer unit.

23. Injection monitoring module according to claim 22, wherein the distal facing surface of the base unit is shaped and dimensioned to receive, and / or seat a proximal end of the injection activation buffer unit.

24. Injection monitoring module according to claim 22 or claim 23, wherein the distal facing surface of the base unit comprises one or more of a distal recess, and an annular wall which extends in a distal direction from the distal facing surface of the base unit.

25. Injection monitoring module according to claim 24, wherein the annular wall defines an inner volume, or closed bore, for receiving a proximal part of the injection activation buffer unit.

26. Injection monitoring module according to claim 22, wherein the configuration of the distal facing surface of the base unit is axially aligned with, around, or on, the central longitudinal axis of the injection monitoring module.

27. Injection monitoring module according to claim 1, wherein the base unit comprises a distal end portion which is shaped and dimensioned to overlapwith an outer surface shape of a proximal end of the distal, injection pen attachment unit, when the injection monitoring module is mounted on an injection pen system.

28. Injection monitoring module according to claim 27, wherein the distal end portion of the base unit is dimensioned and configured similarly to the distal end of the electronics housing.

29. Injection monitoring module according to claim 27, wherein the distal end portion of the base unit comprises a skirt, which flares radially outwardly from a proximal position towards a distal position.

30. Injection monitoring module according to claim 1, wherein the distal, injection pen attachment unit comprises: a first, proximal, annular body having a length and a diameter, and an annular wall extending along the length from a first, proximal end to a second, distal end, the annular wall defining at least part of the central bore of the injection monitoring module, which bore extends along the length of the first annular body, and along the central longitudinal axis; and a second, distal, annular body mounted coaxially on, and around, the first, proximal, annular body, wherein the second, distal, annular body is configured to be movable relative to the first, proximal, annular body, from a first position to a second position; wherein, in the first position, the second, distal, annular body exerts no inward radial force on at least one portion of the annular wall of the first, proximal, annular body, wherein, in the second position, the second, distal, annular body exerts an inward radial force on the at least one portion of the first, proximal, annular wall, wherein the inward radial force applied to the at least one portion of the first, proximal, annular wall operates a reduction in the diameter of the at least one portion of the first, proximal, annular wall.

31. Injection monitoring module according to claim 30, wherein the first, proximal, annular body of the distal, injection pen attachment unit comprises a pair of diametrically positioned magnets.

32. Injection monitoring module according to claim 31, wherein a first magnet of the pair of diametrically positioned magnets is positioned with a north pole oriented in a proximal direction, and a second magnet of the pair of diametrically positioned magnets is positioned with a north pole oriented in a distal direction.

33. Injection monitoring module according to claim 31, wherein a first magnet of the pair of diametrically positioned magnets is positioned with a north pole oriented in a first direction which is orthogonal to the central longitudinal axis, and a second magnet of the pair of diametrically positioned magnets is positioned with a north pole oriented in a second direction direction which is orthogonal to the central longitudinal axis and opposite to the first direction of the first magnet.

34. Injection monitoring module according to claim 31, wherein the pair of diametrically positioned magnets are located at, or adjacent to, a proximal end of the first, proximal, annular body of the distal, injection pen attachment unit.

35. Injection monitoring module according to claim 31, wherein the pair of magnets is positioned within corresponding recesses of the first, proximal, annular body of the distal, injection pen attachment unit, the recesses being oriented either inwardly into the central longitudinal bore of the first, proximal, annular body of the distal, injection pen attachment unit, or alternatively, outwardly away from the central longitudinal bore of the first, proximal annular body of the distal, injection pen attachment unit.

36. Injection monitoring module according to claim 31, wherein the pair of magnets can be located in a fixed, non-rotating configuration with respect to the first, proximal, annular body of the distal, injection pen attachment unit.

37. Injection monitoring module according to claim 1, wherein the interconnector unit comprises at least one releasable catch extending, in parallel to the centrallongitudinal axis, between a distal region of the base unit and the distal injection pen attachment unit, wherein the at least one releasable catch releasably connects the base unit to the distal, injection pen attachment unit.

38. Injection monitoring module according to claim 37, wherein the at least one releasable catch is configured and adapted to be moved between: a first, unreleased, position in which the distal, injection pen attachment unit is held in a fixed axial relationship with the base unit, and a translational movement of the base unit relative to the distal, injection pen attachment unit, along the central longitudinal axis, is prevented; and a second, released, position in which the base unit is released from the fixed axial relationship with the distal, injection pen attachment unit, and is free to translate along the central longitudinal axis.

39. Injection monitoring module according to claim 37 or claim 38, wherein the at least one releasable catch comprises a pair of releasable catches, and each releasable catch of the pair of releasable catches is located diametrically opposite the other of the pair of releasable catches.

40. Injection monitoring module according to any one of claims 37 to 39, wherein the at least one releasable catch has a catch body which extends along a bore of a first, proximal, annular body of the distal, injection pen attachment unit.

41. Injection monitoring module according to any one of claims 37 to 40, wherein the catch body is an elongated body of a moulded polymeric material, or a lightweight alloy.

42. Injection monitoring module according to any one of claims 37 to 41, wherein the catch body extends from a proximal end to a distal end, and is positioned along an inward facing wall of the first, proximal, annular body.

43. Injection monitoring module according to any one of claims 37 to 42, wherein, when the injection monitoring module is mounted onto an injection pen, the catch body is located in a space between an inward facing wall of the first, proximal, annular body of the distal, injection pen attachment unit, and a body, and / or a dose setting component, of an injection pen.

44. Injection monitoring module according to any one of claims 37 to 43, wherein the at least one releasable catch has a proximal end with a radially inward facing proximal hook portion.

45. Injection monitoring module according to any one of claims 37 to 44, wherein the inward facing proximal hook portion engages with a distal end portion of the base unit in the first, unreleased, position, and disengages with the distal end portion of the base unit in the second, released, position.

46. Injection monitoring module according to any one of claims 37 to 45, the inward facing proximal hook portion extends laterally from a respective side of the proximal end to form a respective pair of hook arms.

47. Injection monitoring module according to any one of claims 37 to 46, wherein the at least one releasable catch has a proximal end with an outward facing proximal abutment shoulder, configured to abut against a proximal facing surface of a proximal end of the first, proximal, annular body of the distal, injection pen attachment unit, in the second, released, position.

48. Injection monitoring module according to any one of claims 37 to 47, wherein the catch body of the at least one releasable catch extends in a distal direction from the proximal end of the releasable catch, beyond a distal end of the first, proximal, annular body of the distal, injection pen attachment unit, and is received within the second, distal, annular body of the distal, injection pen attachment unit.

49. Injection monitoring module according to any one of claims 37 to 48, wherein the at least one releasable catch has at least a first, outward facing projection located along a length of the catch body, said at least first, outward facing projection forming a fulcrum point configured to permit rotational movement of the releasable catch about the fulcrum point when moving the releasable catch from the first, unreleased, position, to the second released, position.

50. Injection monitoring module according to any one of claims 37 to 49, wherein the at least one releasable catch has a distal end, configured and adapted to bereceived in a guide portion of a second, distal, annular body of the distal, injection pen attachment unit.

51. Injection monitoring module according to any one of claims 37 to 50, wherein the at least one releasable catch comprises a second, outward facing projection located along the length of the catch body, adjacent the distal end of the catch body.

52. Injection monitoring module according to claim 50, wherein the guide portion of the second, distal, annular body of the distal, injection pen attachment unit comprises at least one radially outwardly sloping surface, extending from a proximal location to a distal location, and at least one radially inwardly sloping surface, extending from a distal location to a proximal location.

53. Injection monitoring module according to claim 50, wherein in the first, unlocked, position of the distal, injection pen attachment unit, the at least one guide portion of the second, distal, annular body, applies a radially outward elastic deformation to the distal end portion of the releasable catch body of the at least one releasable catch, said radially outward elastic deformation being transmitted along the body of the releasable catch, and causing the releasable catch body to pivot radially inwardly about the fulcrum point, thereby moving the proximal hook portion of the catch body radially inwardly to engage said hook with a distal end portion of the base unit, corresponding to the unreleased position of said releasable catch.

54. Injection monitoring module according to claim 50, wherein in the second, locked, position of the attachment unit, the at least one guide portion of the second, distal, annular body, removes application of the radially outward elastic deformation of the distal end portion of the releasable catch body of the at least one releasable catch, the removal of the radially outward elastic deformation causing the releasable catch body to pivot radially outwardly about the fulcrum point, thereby moving the proximal hook portion of the catch body out of engagement with a distal end portion of the base unit, corresponding to the released position of said releasable catch.

55. Injection monitoring module according to claim 1, wherein the electronics unit comprises one or more of: a microcontroller located on an electronic circuit board; an autonomous power supply connected to the electronic circuit board; an optional activation switch configured to selectively enable power to be supplied, or turned off, to the electronic circuit board from the autonomous power supply; one or more sensors connected to the microcontroller; and wherein the microcontroller is configured to process signals received from the one or more sensors to identify parameters and conditions associated with operation of the injection monitoring module, when mounted on, and used with an injection pen system, or when removed from the injection pen system.

56. Injection monitoring module according to claim 55, wherein the one or more sensors of the electronics unit are one or more of a magnetometer, a gyroscope, and an accelerometer.

57. Injection monitoring module according to claim 55 or claim 56, wherein the electronics unit further comprises a wireless communications unit.

58. Injection monitoring module according to claim 55, wherein when the injection monitoring module is mounted on an injection pen, the microcontroller of the electronics unit is configured to process signals received from the one or more of a magnetometer, accelerometer, and gyroscope, in order to determine one or more conditions of operation selected from: a correct mounting of the injection monitoring module on the injection pen; a wake-up of the electronic components on the circuit board; a dialing of a dose amount through rotation of a dose setting mechanism of the injection pen via rotational contact between the injection monitoring module and the dose setting mechanism of the injection pen; an onset of an injection; a completion of an injection; a return to a zero position of the injection pen; and a dose amount administered by the injection pen.

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