Injection monitoring module

Abstract

The present invention provides an injection monitoring module having a central longitudinal axis for releasable coaxial mounting to an injection pen. The injection monitoring module includes: an electronic housing enclosing an electronic unit; a base unit configured to releasably house the electronic housing and directly couple the electronic housing to the base unit; an interconnect unit extending along or parallel to the central longitudinal axis; and an injection pen attachment unit configured to releasably couple the injection monitoring module to a proximal end of an injection pen, thereby covering at least one start button of the injection pen system when mounted on the injection pen; wherein the interconnect unit extends between a distal region of the base unit and the injection pen attachment unit, and connects the distal region of the base unit to the injection pen attachment unit.

Description

[Technical Field]

[0001] The present invention relates generally to a monitoring system for an injectable drug delivery device, and more particularly to an injection monitoring module for monitoring the use of an injection pen system. [Previous Technology]

[0002] Injection monitoring is a well-known field associated with injectable drug delivery devices, particularly in the context of infusion systems, for example. Over time, such monitoring systems have been made available for pen injection systems, enabling users of these systems and healthcare professionals involved in the treatment and follow-up of such patients to more closely monitor associated injection protocols and, in many cases, monitor the actual dose administered in an attempt to achieve better healthcare outcomes. These developments have been accompanied by the increased use of associated software and portable communication devices (such as tablets or smartphones) programmed to receive and interact with monitoring systems in order to provide information to users or healthcare professionals, either on-the-fly or at regular intervals, via appropriate communication units included in the monitoring system.

[0003] For example, particularly with respect to pen injection systems, one of the challenges is providing an easy-to-use, reliable, and fairly fail-safe monitoring system that can be adapted to various variations of such commercially available pen injection systems (many exist). Previous attempts to provide such monitoring systems have typically involved adapting the body of the pen injection system by incorporating electronic components along with one or more sensors. Such adapted pen injection systems tend to be very brand- or manufacturer-specific and therefore rarely or never used with pen injection devices from other manufacturers. Furthermore, there has been a trend to reduce the overall size of the injection pen body as much as possible through miniaturization of complex electronic components, which raises its own problems, particularly regarding electromagnetic interference between various components due to the close proximity of the circuitry required to provide or integrate functionality. Moving the sensors in such monitoring systems further away from sources of electromagnetic interference only complicates matters further, potentially leading to erroneous readings or requiring additional systems to compensate for the physical separation of the sensors from other electronic components, such as microcontrollers designed to control and command various components and manage their interactions.

[0004] The pen injection system discussed is well-known and typically includes a dose setting wheel and an injection trigger located proximally. The dose setting wheel is rotatable about the central longitudinal axis of the pen injection system. The user rotates the wheel to select the dose of medication to be administered. The pen is typically configured mechanically or electromechanically to deliver the medication when the injection trigger is activated. Such an injection trigger is usually a simple press / push-button that makes mechanical or electrical contact with a dispensing mechanism located within the pen injection system. Pressing the button causes the injection mechanism to eject and expel the medication 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 typically achieved by including one or more metal components (such as a helically wound drive spring or a ratchet system) located within the housing of the pen injection system and physically coupled to the dose setting wheel. Because such metal components are relatively large compared to the electronic component systems currently included in many pen injection systems, these large metal components may further interfere with the signals that sensors in such electronic component systems are designed to capture or pick up, making the system less accurate and / or requiring complex calibration mechanisms to avoid calculation errors.

[0005] Commercially available injection pen systems typically have various pen body shapes and diameters, and generally, each type of injection pen has a set of dimensions specifically tailored to the pen or the agent, drug, or substance intended to be administered via such injection pen system. Furthermore, for any given brand of pen and / or associated injectable product, each pen manufacturer may have pen bodies that, due to manufacturing tolerances, differ in size, particularly in their outer diameter (i.e., the diameter of a virtual circle along the circumference of the outer perimeter of the pen body). This variation in the outer diameter of the injection pen body can be problematic for injection monitoring modules with a fixed-diameter internal bore, as even with a volume-adaptive internal coating (such as a push-fit elastomer), it may be difficult to achieve a firm and tight fit between the injection monitoring module and the outer surface of the injection pen body or the dose setting wheel of such injection pen systems, and around that outer surface. Furthermore, the frictional properties of the volume-adaptive elastomers on such injection monitoring modules, and the resulting necessity for the user to apply a certain degree of axial and rotational force when installing the injection monitoring module onto the injection pen, can make it difficult for many users to easily install the injection monitoring module onto the injection pen or to accurately position such a module. This can potentially lead to incorrect subsequent use and / or incorrect readings, such as, for example, unintended rotation of one or more parts of the injection monitoring module during installation onto the injection pen, resulting in erroneous detection of measurable indicators or signals, such as magnetic fields.

[0006] Due to the above, there is still a need for an injection monitoring module that is easy to install and precisely position onto a pen injection system, and equally easy to remove from the pen injection system, for example, for users who may have a range of physical disabilities or other disabilities in addition to having a pathology or condition requiring medication administration via an injection pen system. In such cases, an injection monitoring module that is difficult to install and / or position correctly, such as requiring the application of a unilateral axial force to push the injection monitoring module into the correct position along the outer surface of the injection pen body and / or removing the injection monitoring module from the injection pen body by applying a unilateral pulling force in the opposite axial direction, may only prevent or reduce the disabled user's adherence to the treatment plan.

[0007] The applicant has previously described a large number of injection monitoring modules for injection pen systems, such as those published under WO2017013463A1, WO2019175615A1, WO2019175790A1, WO2020217076A1, WO2021140352A1, WO2020217094A1, WO2021260404A1, WO2022079462A1, WO2023 / 170437A1, WO2023 / 187434A1 and WO2024 / 069202A1.

[0008] Where applicable in this specification, the terms “pen injection system” and “injection pen system” are used interchangeably to refer to a typically handheld pen-shaped injection system that is readily known and commercially available for the treatment of a variety of medical indications. Such systems are also typically designed for self-injection by a user requiring treatment for a given medical indication. This is the case with insulin, which is available in various forms for the treatment of diabetes, such as pen injection systems commercially available under the brand name FlexPen® (e.g., by Novo Nordisk, Kwikpen®, Eli Lilly, or Lantus Solostar®, and by Sanofi, these being just three of the most well-known), but also with other hormones, such as growth hormone or follicle-stimulating hormones, such as follicle-stimulating hormone Δ (called Rekovelle®) commercially available in pen injection systems by Ferring. Other medications are also used with this class of medical devices and may be necessary to address various potentially life-threatening conditions or illnesses, enabling the immediate, emergency, or even non-emergency, regular administration of the required medications, such as anaphylactic shock treatment, anticoagulants, opioid receptor agonists and antagonists, weight-loss drugs, appetite suppressants, and the like.

[0009] In addition, the terms “proximal,” “in proximal,” “distal,” and “in distal” (which may be used in this specification) generally refer to a relative position with respect to any of the injection monitoring system, injection monitoring module, and pen injection system. “Proximal” refers to a point, location, or direction generally oriented toward the holder of the injection monitoring system, injection monitoring module, or pen injection system, and “distal” refers to a point, location, or direction generally oriented away from the holder of the injection monitoring system, injection monitoring module, or pen injection system, such as toward the target site of the injection, whether the target site is another part of the user’s body, or the body of a different person or animal, or simply the spray target site of the substance contained in the pen injection system.

[0010] The injection monitoring module according to the present invention, adapted and configured for removable attachment to an injection pen system, typically includes a proximal dose setting system (typically a rotatable wheel or dial) and an injection actuator. The dose setting wheel or dial rotates about the central longitudinal axis of the pen injection system to allow the user to set the dose of the drug to be injected. 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 "adjustment" step, the dose setting wheel or dial typically rotates clockwise and, if necessary, counterclockwise, corresponding to an increase in the selected dose or a decrease in the selected dose to be administered, or vice versa, depending on the manufacturer. The injection actuator is typically indicated by a button (typically located proximal to the dose setting wheel or forming part of the dose setting system) and, in most injection pens, is located at the proximal end of the injection pen system. After the dose has been set or "adjusted"—a term commonly known in this art—the user of the injection system then presses the injection actuator distally, actuating a piston connected to a plunger to expel the drug from a chamber within the pen body using a needle that the user may have inserted into an appropriate injection site (e.g., skin, adipose tissue, or muscle, depending on the type of drug to be administered), or alternatively as a flushing or air jet operation, in which a small volume of drug (e.g., a few units or milliliters) is expelled from the distal end of the needle to expel any potential air bubbles that may be present. The dose setting wheel is sometimes (but not always) also coupled to the injection drive mechanism so that, depending on the pen manufacturer and model, it can also rotate during drug injection. The function of such injection systems is well known in this art. The monitoring module contemplated according to the invention is intended for mounting on a pen injection system, wherein the dose setting wheel can be configured to rotate during the spray / injection phase of the pen injection system, or conversely, not rotate during the spray / injection phase. For example, the Kwikpen® pen mentioned above does not have a dose setting wheel that rotates during injection, while the Lantus Solostar®, FlexPen®, and Rekovelle® pens do have dose setting wheels that rotate during injection. [Summary of the Invention]

[0011] Therefore, one aspect of the present invention is to provide an injection monitoring module that can be universally installed in injection pen systems from various manufacturers, each injection pen system having its own specific geometry.

[0012] Therefore, an injection monitoring module is provided, which is configured and adapted for releasable installation into an injection pen system. The injection monitoring module has a length extending from a first proximal end to a second distal end and a central longitudinal hole extending at least partially along the length of the injection monitoring module between the first proximal end and the second distal end about a central longitudinal axis. The injection monitoring module includes: an electronic housing enclosing an electronic unit; a base unit located distal to the electronic housing and configured and adapted to releasably house the electronic housing and directly couple the electronic housing to the base unit; and an interconnect unit extending along or parallel to the central longitudinal axis. A distal pen attachment unit is configured and adapted to releasably couple an injection monitoring module to a proximal end of an injection pen system, thereby covering at least one start button of the injection pen system when mounted on the injection pen system; and wherein an interconnect unit extends between a distal region of a base unit and the distal pen attachment unit, and connects the distal region of the base unit to the distal pen attachment unit.

[0013] According to another embodiment, the interconnect unit is an injection start buffer unit, the injection start buffer unit includes a longitudinally movable surface, wherein the injection start buffer unit is configured to move along at least a portion of the length of the injection monitoring module and the central longitudinal axis from a first axially extended position to at least a first axially constrained position and a second axially constrained position.

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

[0015] According to another embodiment, the injection initiation buffer unit includes a biasing element positioned against the axially movable surface of the injection initiation buffer unit, and wherein the biasing element has a first extension configuration in which the biasing element maintains the axially movable surface of the injection initiation buffer unit in the first axially extended position.

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

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

[0018] According to another configuration, the axially movable surface of the injection activation buffer unit and the first and second constraint positions of the biasing element are spaced apart along the length of the injection monitoring module and / or respectively along the central longitudinal axis of the injection monitoring module. For example, the first constraint position of the axially movable surface of the injection buffer unit may be located near the second constraint position of the axially movable surface of the injection buffer unit. For example, such a configuration may be desirable to generate a signal that allows the electronic unit to determine, for example, that the injection monitoring module has been activated or that the start of injection activation appears to have begun, without actually engaging the start 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 moves from an unconstrained position to a first constraint position. In other words, providing a first unconstrained position and more than one predetermined constraint position relative to the axially movable surface of the injection activation buffer unit allows for the generation of different signals within the electronic unit and the identification of individual events related to the use of the injection monitoring module when mounted on the injection pen system. In this configuration, the second constrained position of the axially movable surface of the injection initiation buffer unit corresponds to the actual activation of the injection initiation button on the injection pen system. Similarly, the movement of the axially movable surface of the injection buffer initiation unit from the first constrained position or the second constrained position to the first unconstrained position allows the generation within the electronic unit of other signals corresponding to events related to the use of the injection monitoring module when it is installed on the injection pen system, such as returning to the zero position of the injection monitoring module, determining the stationary position of the injection monitoring module, completing an injection, or determining that no injection actually occurred, and similar events.

[0019] According to another embodiment, the electronic housing includes a distal coupling configuration. This distal coupling configuration is typically located in a distal region or at a distal end of the electronic housing and is designed and configured such that the electronic housing can be coupled to and released from the base unit, which is located distally relative to the electronic housing along the central longitudinal axis of the injection monitoring module. The distal coupling configuration can be configured and shaped to allow various coupling mechanisms (e.g., via sliding fit, snap-fit, or screw-fit engagement, or any combination thereof) to be with the base unit, provided that the coupling mechanism is releasable. In this way, the electronic housing containing the electronic unit can be replaced if necessary, or reused in replacing the injection monitoring module if the rest of the injection monitoring module becomes inoperable, for example, due to damage or breakage, or purely for user convenience. Another advantage of this releasable coupling configuration is that the electronic housing can be removed while the rest of the injection monitoring module remains mounted on the injection pen. This means that the electronic housing can be replaced immediately if needed and / or necessary.

[0020] According to one configuration, the electronic housing includes a distal coupling mechanism relating to a sliding or translating engagement with one of the base units, wherein the electronic housing is slidably or translatorily coupled to the base unit via a sliding movement or translational movement or perpendicularity to the central longitudinal axis of the injection monitoring module. In this configuration, the electronic housing is slidable from a first disengaged position to a second engaged position where the electronic housing is securely attached to one of the base units.

[0021] According to one configuration, the base unit includes a proximal coupling configuration. This proximal coupling configuration of the base unit is configured to allow a robust but releasable engagement between a proximal end of the base unit and a distal end of the electronic housing. Therefore, the proximal coupling configuration is advantageously designed and / or configured to function in conjunction with the distal coupling of the electronic housing.

[0022] According to another advantageous embodiment, the base unit includes a distal opposing surface configured to receive at least a proximal portion of the buffer unit. The distal opposing surface of the base unit is shaped and sized to receive and / or mount a proximal end of the buffer unit. For example, the distal opposing surface may advantageously have a distal groove or, for example, an annular wall extending distally from the distal opposing surface of the base unit, and the annular wall defines an internal volume or closure for receiving the proximal portion of the injection initiation buffer unit. This configuration of the distal opposing surface of the base unit is generally aligned with, around, or axially along, the central longitudinal axis of the injection monitoring module.

[0023] According to another advantageous embodiment, the base unit includes a distal portion that, when the injection monitoring module is in use and mounted on an injection pen system, is shaped and sized to match the outer surface shape of a proximal end of one of the distal releasable injection pen attachment units. Essentially, the thus shaped distal portion of the base unit protects and prevents the user of the injection monitoring module from interfering with the proximal end of the distal releasable injection pen attachment unit. For example, the distal portion of the base unit may have dimensions and a general overall configuration substantially similar to the distal end of the electronic housing. However, in some cases, such as for certain injection pens, the distal portion of the base unit may need to be configured, for example, as a skirt that flares radially outward from the proximal position toward the distal position to accommodate the corresponding shaped and sized proximal portion of the distal releasable injection pen attachment unit. In this way, the flared portion or skirt of the base unit can act as a protective shield, thereby preventing tampering with the proximal end of the distal releasable injection pen attachment unit.

[0024] As mentioned above, the injection monitoring module includes a distally releasable pen attachment unit. Such a pen attachment unit is designed and / or configured such that the injection monitoring module can be mounted on at least the proximal activation button of the pen (and, where necessary but advantageously, at least a portion of the pen body, such as the dose setting wheel of the pen) and covers and / or extends around the proximal activation button. Therefore, according to one configuration, the distally 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 a portion of the central aperture of the injection monitoring module, the aperture extending along the length of the first annular body and along the central longitudinal axis; and a second distal annular body coaxially mounted 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 does not exert an inward radial force on at least a portion of the annular wall of the first proximal annular body, and wherein, in the second position, the second distal annular body exerts an inward radial force on the at least a portion of the first proximal annular wall. The inward radial force applied to at least one portion of the first proximal annular wall causes a reduction in the diameter of at least one portion of the first proximal annular wall.

[0025] As should be understood from the above, the first and second positions of the distal releasable injection pen attachment unit refer to two different positions of the first proximal annular body and the second distal annular body, one position relative to the other. In the first position (also known as the unlocked position), the second distal annular body is in direct or indirect solid or surface-to-surface contact with the first proximal annular body, but no radial inward force is applied to the first proximal annular body. For example, in the first or unlocked position, the second distal annular body can be attached or mounted to the first proximal annular body without applying a radial inward guiding force (i.e., without guiding a force toward 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, but remains mounted to or attached to and engaged with a portion of the first proximal annular body.

[0026] As should also be understood from the above, when the second distal annular body moves from the first position to the second position (also known as the locked position), the second distal annular body applies a radially inward guiding force to the first proximal annular body. The radially inward force causes a reduction in the diameter of at least a portion of the first annular wall, which allows the attachment unit to be precisely and securely positioned on the injection pen, particularly around the dose setting wheel portion of the injection pen.

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

[0028] A plurality of elastic radially deformable fingers may be advantageously distributed radially around a central longitudinal axis, and even more advantageously, may be distributed radially equally around a central longitudinal axis.

[0029] When the second distal annular body applies an inward radial force to at least a portion of the first annular wall, the elastic radially deformable finger can deform radially inward toward the central longitudinal axis.

[0030] Each of the plurality of resilient radially deformable fingers may have an inner-surface portion configured to provide surface engagement contact with an outer peripheral surface of the pen body when the pen attachment unit is mounted to the pen and the second distal annular body is in a second or locked position, such as surface engagement contact with a dose setting wheel portion of the pen body, or surface engagement contact with the pen body itself. It should be understood here that the inner-surface surface engagement contact portion of each resilient deformable finger may be suitably configured, for example, by providing a suitably shaped portion of the inner-surface of the deformable finger such that it corresponds to or matches a corresponding shaped outer peripheral surface portion of the pen body, or, for example, the outer peripheral surface portion of the dose setting wheel surface. For example, the inner-facing portion of the elastic radially deformable finger can be molded into a suitable shape, such as a concave or arcuate shape, or alternatively, include one or more additional material layers, such as an elastomer of suitable thickness, on the inner-facing portion of the deformable finger, wherein the elastomer can be compressed to adapt to the shape of the peripheral surface outside the pen body and / or dosage setting wheel.

[0031] Each of the plurality of resilient radially deformable fingers may have a portion facing the inner surface, which, when the pen attachment unit is mounted on the pen and the second distal annular body is in the second or locked position, is inclined from the proximal point to the distal point along at least a portion of the length of the resilient radially deformable finger to conform to the peripheral surface outside the pen body and / or the dose setting wheel.

[0032] The second distal annular body may have at least a first portion facing an inner surface, configured to engage with the outer surface of the first proximal annular body. In this context, the term "engagement" should be understood to mean that the inner surface of at least a first portion of the second distal annular body engages directly or indirectly (but preferably directly) with the outer surface of the first proximal annular body in surface-to-surface contact. The at least first portion of the inner surface of the second distal annular body may be configured in various ways to perform this function, for example, by shaping one or more portions of the second distal annular body, such as by molding an additional layer of material and / or by providing an additional layer of material on the second distal annular body, wherein the molding and / or provision of this additional layer may be shaped to provide one or more rims, ridges, grooves, protrusions and the like.

[0033] The first portion of the inner surface of the second distal annular body (which is configured to engage with the outer 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 opposing surface that engages with the proximal opposing surface of the nose portion located at the distal end or second end of the first proximal annular body, and the distal opposing surface of the annular shoulder may rotate freely about the central longitudinal axis and abut against the proximal opposing surface of the nose portion.

[0035] The annular shoulder of the second distal annular body may be configured and / or shaped to provide an inwardly facing portion that engages with the outwardly facing and inclined surface of the first proximal annular body. Such an inwardly facing portion of the annular shoulder may be, for example, a ridge, or a dihedral forming a apex of a radially inwardly facing surface toward the central longitudinal axis, or a circular or convex surface and a proximal opposing surface disposed on the annular shoulder. Conversely, the outwardly facing and inclined surface of the first proximal annular body will generally extend in the distal direction from the proximal region of each resilient deformable finger and be defined by the first outer diameter of the resilient deformable finger, and terminate at a distal position of the finger having a second outer diameter smaller than the first outer diameter of the resilient deformable finger.

[0036] When moving from the first unlocked position to the second locked position, the annular shoulder of the second distal annular body can apply an inward radial force to the outward and inclined surface of the first proximal annular body, thereby causing the inward-facing surface of the first proximal annular body to move inward toward the central longitudinal axis. In this way, the relative movement of the second distal annular body relative to the first proximal annular body from the first unlocked position to the second locked position (e.g., from the proximal position to the distal position) reduces the diameter of the internal central hole because the annular shoulder of the second distal annular body engages with the outward and inclined surface of the first proximal annular body, for example, from the relatively distal position of the second distal annular body to the relatively proximal position of the second distal annular body relative to the first proximal annular body.

[0037] The second distal annular body has at least a second portion facing an inner surface, which is configured and / or shaped to engage with the outer surface of the first proximal annular body. Similar to the first portion facing an inner surface of the second distal annular body, the second inner surface of the second distal annular body can be substantially spaced from the first inner surface of the second distal annular body and can be configured to form an abutment stop for moving the second distal annular body against the first proximal annular body in the proximal direction. Therefore, the longitudinal separation between the first and second inner surfaces of the second distal annular body along the longitudinal axis of the attachment unit can be configured to limit the extent to which the second distal annular body can move in the proximal direction, and thus define the extent to which the second distal annular body moves from the first unlocked position to the second locked position.

[0038] The second part of the inner surface, configured to engage with the outer surface of the first proximal annular body, may be an annular ridge located on the proximal side of the annular shoulder and adjacent to the proximal end of the second distal annular body.

[0039] When moving from the first unlocked position to the second locked position, the annular ridge can engage with the spiral groove provided on the outward-facing surface of the first proximal annular body.

[0040] The spiral groove may contain at least one or more spires or full revolutions surrounding and along the central longitudinal axis.

[0041] In the second locked position, the proximal end of the second distal annular body may be adjacent to the distal end of the first proximal annular body.

[0042] In the second locked position, the annular ridge of the second distal annular body may include a proximal opposing and inwardly inclined surface to stop the abutment with the corresponding distal opposing and inclined surface of the first proximal annular body.

[0043] According to another embodiment, the interconnect unit includes at least one releasable latch extending between a distal region of one of the base units and the distal pen attachment unit, wherein the at least one releasable latch releasably connects the base unit to the distal pen attachment unit.

[0044] According to yet another configuration, the at least one releasable latch is configured and adapted to move between: a first unreleased position, wherein the attachment unit maintains a fixed axial relationship with the base unit and prevents the base unit from translating along one of the central longitudinal axes; and a second released position, wherein the base unit is released from the fixed axial relationship with the distal pen attachment unit and translates freely along the central longitudinal axis.

[0045] The first unreleased position refers to the fixed axial position of the base unit, and more specifically, along the central longitudinal axis relative to the first proximal annular body of the distal pen attachment unit. The first unreleased position of the releasable latch is such that the latch prevents the base unit from translating along the central longitudinal axis, and advantageously also prevents the base unit from rotating independently of the first proximal annular body of the distal pen attachment unit about the central longitudinal axis. The second release position refers to such that when the injection monitoring module is installed on the pen in use, the base unit is released from the holding effect of the releasable latch, and, for example, simultaneously translates freely along the central longitudinal axis and rotates about the central longitudinal axis, for example, along with the dose setting shaft and dose setting wheel portion of the pen. Thus, the releasable latch 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 embodiment, the at least one releasable latch has a latch body extending along a hole in the first proximal annular body. The latch body is typically an elongated body of a molded polymer or a lightweight alloy, such as a shaft or rod. The latch body extends from a proximal end to a distal end and is positioned along an inner-facing wall of the first proximal annular body, the inner-facing wall being suitably shaped and configured to receive the latch body. For example, when the injection monitoring module is mounted to an injection pen, the latch body may be located in a space between an inner-facing wall of the first proximal annular body of the distal injection pen attachment unit and a body of the injection pen and / or a dosage setting component.

[0047] According to another embodiment, the at least one releasable latch includes a pair of releasable latches, and each of the pair of releasable latches is positioned opposite to the other of the pair of releasable latches.

[0048] According to another embodiment, the at least one releasable latch has a proximal end with a radially inwardly facing proximal hook portion. The proximal end and hook portion typically extend beyond one of the proximal ends of the first proximal annular body.

[0049] According to another embodiment, the inwardly facing proximal hook portion engages with a distal portion of the base unit in the first unreleased position and disengages from the distal portion of the base unit in the second release position. The base unit may include a radially outwardly extending protrusion or shaping portion located at or adjacent to the distal end of the base unit, the proximal hook portion being locked onto the protrusion or shaping portion in the unreleased position of the latch, and the proximal hook portion disengaging from the protrusion or shaping portion in the release position of the latch. The proximal hook portion may advantageously extend laterally from either side of the proximal end to form a separate pair of hook arms, the hook arms being shaped to conform to corresponding shaped surfaces at the distal end of the base unit.

[0050] According to another embodiment, the at least one releasable latch has a proximal end with an outwardly facing proximal abutment shoulder configured to abut a proximal opposing surface of one proximal end of the first proximal annular body in the second release position. When the latch is in the release position, this abutment shoulder prevents the proximal end of the releasable latch body from accidentally or intentionally moving into the central hole of the first proximal annular body in the distal direction.

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

[0052] According to another embodiment, the at least one releasable latch has at least one first outwardly facing protrusion positioned along the length of one of the latch bodies, the protrusion forming a fulcrum configured to allow the releasable latch to rotate about the fulcrum when moved from the first unreleased position to the second released position. The fulcrum provides a point of rotation for the releasable latch body within a hole in the first proximal annular body of the distal pen attachment unit, wherein the outwardly facing protrusion abuts against the inwardly facing surface of the first proximal annular body of the distal pen attachment unit. The rotational freedom about the fulcrum of the releasable latch body is determined by the thickness of the releasable latch body, the shape and size of the outwardly facing protrusion, and the dimensions of the first proximal annular body through which the releasable latch body extends. These configuration elements are selected such that the releasable latch body can pivot about the fulcrum when the releasable latch moves from the first unreleased position to the second released position in a reverse pivoting direction and vice versa.

[0053] According to another embodiment, the at least one releasable latch includes a distal end that is configured and adapted to be housed in a guide portion of the second distal annular body of the attachment unit.

[0054] According to another embodiment, the at least one releasable latch includes a second outwardly facing protrusion positioned along the length of the latch body adjacent to the distal end of the latch body. The second outwardly facing protrusion acts as an abutment stop for the latch body, thereby preventing the distal end of the latch body from being removed from the distal injection pen attachment unit.

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

[0056] According to another embodiment, the guide portion of the second distal annular body of the distal pen attachment unit includes at least one radially outwardly inclined surface extending from a proximal position to a distal position, and at least one radially inwardly inclined surface extending from a distal position to a proximal position. These inclined surfaces allow the guide portion of the second distal annular body of the distal pen attachment unit to guide the distal end of the locking body and / or the second outwardly protruding portion, and to apply elastic deformation to the locking body to deform it in a first radially inward direction or conversely in a second radially outward direction. For example, the radially outwardly inclined surface receives the distal end of the locking body, thereby applying radially outwardly guided elastic deformation to the distal end of the locking body, whereby, due to rotation about a fulcrum, the proximal hook end of the locking body is forced onto the distal end of the base unit, and the axial connection between the distal pen attachment unit and the base unit is maintained in the locked position. Conversely, when the second distal annular body moves in the distal direction, in order to lock the distal pen attachment unit to the body of the pen system and / or the dose setting wheel, the second outward protrusion of the locking body moves toward and close to the radially inward inclined surface. This causes the locking body to elastically deform around the fulcrum, thereby causing the proximal hook end of the locking body to move radially outward and thus release from the locking attachment to the distal end of the base unit.

[0057] According to another embodiment, in the first unlocked position of the attachment unit, at least one guide portion of the second distal annular body applies a radially outward elastic deformation to the distal portion of the releasable latch body of the at least one releasable latch. The radially outward elastic deformation is transmitted along the body of the releasable latch, causing the releasable latch body to pivot radially inward about the fulcrum, thereby causing the proximal hook portion of the latch body to move radially inward to engage the hook with a distal portion of one of the base units, the engagement corresponding to the unreleased position of the releasable latch.

[0058] As should be understood from the foregoing paragraph, the at least one guide portion is configured in shape and size to apply a deformation constraint to a distal portion of the body of the releasable latch. This can be achieved, for example, by appropriately shaping the internal volume and surface 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 deformation force to the distal end of the body of the releasable latch. The rigidity or flexibility of the material (such as a suitable polymer or metal alloy) used to manufacture the body of the releasable latch causes the deformation force to transfer along the body of the releasable latch and the fulcrum of the body that contacts the inward-facing surface of the first proximal annular body. This, in turn, causes the latch body to rotate or pivot about the fulcrum, thereby driving the proximal hook portion into latching engagement with the appropriately configured distal portion of the base unit.

[0059] According to another embodiment, in the second locked position of the attachment unit, the at least one guide portion of the second distal annular body removes the application of radial outward elastic deformation of the distal portion of the releasable latch body of the at least one releasable latch, the removal of the radial outward elastic deformation causing the releasable latch body to pivot radially outward about the fulcrum, thereby moving the proximal hook portion of the latch body to disengage from one of the distal portions of the base unit, the disengagement corresponding to the release position of the releasable latch.

[0060] From the preceding paragraph, it should be understood that when the second distal annular body moves from the unlocked position to the locked position in the distal direction, the movement of the corresponding distal guide of at least one guide portion removes or reduces the outward directional deformation of the body of the releasable latch, thereby relaxing the restriction applied along the latch body and causing the proximal hook portion of the latch body to pivot away from the unreleased engagement position of the hook portion and the distal portion of the base unit. Once the second distal annular body reaches the second locked position, the hook portion of the releasable latch has been fully released from engagement contact with the distal portion of the base unit, and the base unit now translates freely along and / or about the central longitudinal axis, for example, when a dose is set via the proximal dose setting wheel assembly of the corresponding injection pen, or as appropriate during injection.

[0061] According to another embodiment, the electronic unit includes one or more of the following: a microcontroller located on an electronic circuit board; an autonomous power supply connected to the electronic circuit board; an optional start switch configured to selectively allow power to be supplied to or disconnected 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 the operation of the injection monitoring module when it is installed on and used with or from an injection pen system. As indicated above, a microcontroller typically resides on an electronic circuit board and typically includes one or more sub-components, such as a processor, an internal clock, one or more data registers and / or non-volatile memory, and is often programmable or otherwise capable of processing a set of instructions, executing programmed code and / or performing calculations to process information and / or data and / or electrical signals from other components connected to or integrated into the electronic component board. Such microcontrollers are generally well-known.

[0062] The electronic unit may also include a data storage device connected to the microcontroller, and the microcontroller may be configured to calculate and / or store data related to the operating conditions or status of the injection monitoring module mounted on the injection pen system via the distal injection pen attachment unit. For the purposes of this specification, the data storage device may be one of many possibilities, including a data buffer integrated into the microcontroller described above, and / or volatile and / or non-volatile memory integrated into the microcontroller or formed as a separate functional unit and connected to the microcontroller via an electronic component board.

[0063] As is known in this art, the self-powered source can typically be, for example, a simple battery, such as a button or coin-shaped battery, such as a lithium-ion battery. Alternatively, the battery can be rechargeable, as is known in this art itself, with the charge supplied via a USB port, for example, through an opening in the housing of the injection monitoring system.

[0064] In cases where power can be continuously supplied to the microcontroller and one or more sensors identified above in low power consumption or sleep mode, a start switch may be selected as needed. In such configurations, one or more of the sensors may alternatively be configured to switch the injection monitoring module from a low power consumption mode to a normal power consumption mode when a change in sensor value or signal is received by the microcontroller from one or more sensors. For example, in the case where the sensor is a magnetometer (in which the microcontroller will continuously poll the magnetometer), the injection monitoring module may be configured to consume power in a low power mode until the microcontroller receives a change in the magnetic environment, at which point the microcontroller may then direct the autonomous power supply to provide more power, moving from the low power consumption mode to the normal power consumption mode, and powering other components of the electronic unit when switching to the normal power consumption mode.

[0065] According to another embodiment, when the injection monitoring module is installed on an injection pen, the microcontroller of the electronic unit is configured to process signals received from one or more of a magnetometer, an accelerometer, and a gyroscope in order to determine one or more operating conditions selected from: the correct installation of the injection monitoring module on the injection pen; the wake-up of the injection monitoring system; an adjustment of a dose by rotation of a dose setting mechanism of the injection pen via a rotational contact between the injection monitoring module and a dose setting mechanism of the injection pen; the start of an injection; the completion of an injection; a return to a zero position of the injection pen; and a dose delivered by the injection pen.

[0066] According to another embodiment, the electronic unit may further include a wireless communication unit, such as a Bluetooth BLE® circuit. The wireless communication unit is configured to transmit data stored and / or processed and / or calculated by the microcontroller to a remote device, such as a smartphone running a corresponding treatment management application, or a remote managed computer service providing such a treatment management application.

[0067] According to another embodiment, the first proximal annular body of the distal injection pen attachment unit includes a pair of diametrically opposed positioning magnets. The use of magnet pairs in injection monitoring modules (such as those contemplated in this application) is known from previously published applications completed by the applicant.

[0068] According to another configuration, one of the first magnets in the pair of diametrically opposed positioning magnets is oriented to a north pole in a proximal direction, and one of the second magnets in the pair of diametrically opposed positioning magnets is oriented to a north pole in a distal direction.

[0069] According to another configuration, one of the pair of diaphragm positioning magnets, the first magnet, is positioned with its orientation at a north pole in a first direction orthogonal to the central longitudinal axis, and the second magnet is positioned with its orientation at a north pole in a second direction orthogonal to the central longitudinal axis and opposite to the first direction of the first magnet. This is advantageous, for example, when the magnets are positioned outwards from the central longitudinal aperture.

[0070] According to another configuration, the pair of diaphragm positioning magnets are located at or near the proximal end of one of the first proximal annular bodies of the distal injection pen attachment unit.

[0071] The pair of magnets can be properly positioned in the corresponding grooves of the first proximal annular body of the distal injection pen attachment unit, wherein the grooves are oriented inward toward the central longitudinal hole of the first proximal annular body of the distal injection pen attachment unit, or alternatively, oriented outward away from the central longitudinal hole of the first proximal annular body of the distal injection pen attachment unit.

[0072] Additionally, the magnet pair can be positioned in a fixed, non-rotational configuration relative to the first proximal annular body of the distal pen attachment unit, for example, in another body coaxially positioned outside the first proximal body, and mounted to the body of the pen rather than the dosage setting component of the pen. For example, this may be a preferred configuration for the injection monitoring module when configured for mounting on a FlexTouch® pen, such as those commercially available from Novo Nordisk.

[0073] The electronic housing of the injection monitoring module may include a housing body and a proximal cover. The housing body of the electronic housing typically has an open proximal end and a closed distal end in the manner of a cup or bowl, and the proximal cover may have a substantially flat or planar surface, or alternatively a domed or convex shape, or alternatively an inwardly curved or concave shape. The housing body of the electronic housing is shaped and configured to house and / or retain an electronic circuit board within the housing body, or to house and / or retain the electronic circuit board within an internal volume formed by the housing body and the cover when the housing body and the proximal cover are assembled together. The proximal cover and the housing body are typically assembled together to form this internal volume, for example by gluing, trimming, snap-fitting, or welding the housing body and the proximal cover together at one or more points typically around the respective circumferences 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, such as formed as a window, light guide, or light tunnel, and / or a ring that may enclose such transparent or translucent material. The window, light guide, or light tunnel is typically configured to allow and / or guide visible light from a visible light emitting source to the outside of the electronic housing, making the emitted light visible to the user. This visible light emitting source is connected to and / or located within or on an electronic circuit board (such as an LED). The emitted light is typically used to indicate specific states and / or conditions of the injection monitoring module, such as correct installation and / or positioning of the injection monitoring module relative to the injection pen, preparation for dose setting, preparation for injection, completion of injection, preparation for disassembly, and the like.

[0074] As mentioned above, the microcontroller is located on an electronic circuit board, which is housed within an electronic enclosure formed by the main body and a proximal cover. A microcontroller typically includes one or more sub-components, such as a processor, internal clock, one or more data registers and / or non-volatile memory, and is generally programmable or capable of processing a set of instructions, executing programmable code, and / or performing calculations to process information and / or data and / or electrical signals from other components connected to or integrated into the electronic component board. Such microcontrollers are generally well-known in themselves.

[0075] The injection monitoring module may include a data storage unit connected to a microcontroller, and the microcontroller may be configured to calculate and / or store data related to the operating conditions or status of an injection on which the injection monitoring module is mounted via an attachment unit. For the purposes of this invention, the data storage unit may be one of many possibilities, including a data register integrated into the microcontroller described above, and / or volatile and / or non-volatile memory integrated into the microcontroller or formed as a separate functional unit and connected to the microcontroller via an electronic component board.

[0076] As indicated above, the injection monitoring module may also include an independent power source connected to an electronic circuit board. Typically, as known in the art, this may be, for example, a simple battery, such as a button or coin-shaped battery, such as a lithium-ion battery; alternatively, the battery may be rechargeable, as also known in the art itself.

Implementation Method

[0078] Now turning to Figures 1 and 2, the 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 hole (4) extending at least partially along the length L of the injection monitoring module (1) between the first proximal end (2) and the second distal end (3) about a central longitudinal axis (5). The injection monitoring module (1) includes: an electronic housing (6) enclosing an electronic unit (7) and having a proximal cover or cover (8) and a distal coupling terminal (9); a base unit (10) located distal to the electronic 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 terminal (9) of the electronic housing (6); an interconnect unit (13) extending along a central longitudinal axis (5); and a distal injection pen attachment unit (14) configured and adapted to releasably couple the injection monitoring module (1) to the proximal end (15) of the injection pen system (16), thereby covering at least one start button (17) of the injection pen system (16) mounted on the injection pen system (16). As can be seen from Figure 2, the central longitudinal hole (4) is adjusted in size and diameter to house the pen activation button (17) within the hole (4), and the distal pen attachment unit (14) is configured to abut against the proximal portion of the pen (16) on its outward-facing surface (16a), as shown in Figures 1, 2, 5A, and 5B, against the dose setting wheel (18) located proximal to the pen (16). Such pens are known and their body diameter, length, and function can be varied depending on the pen manufacturer.

[0079] In the injection monitoring module shown in Figures 1, 2, 5A and 5B, the interconnect unit (13) extends between the distal opposing surface (19) of the base unit (10) and the proximal end (20) of the distal injection pen attachment unit (14), and connects the distal opposing surface (19) of the base unit (10) to the injection pen attachment unit (14). In this specific example, the interconnect unit (13) is an injection initiation buffer unit and includes a longitudinally movable surface (21). The injection initiation buffer unit is configured to move from a first axially extended or unconstrained position to at least a first axially constrained position and a second axially constrained position along at least a portion of the length L of the injection monitoring module (1) and the central longitudinal axis (5), and is at least partially within the central longitudinal hole (4). As shown in Figures 1, 2, 5A, and 5B, the injection-initiating buffer unit forming the interconnect unit (13) includes a biasing element (22), such as a coiled spring or other elastically deformable component, which may be in an unconstrained or extended configuration. The biasing element has a proximal end (23) positioned against an axially movable surface (21), and in the first extended or unconstrained configuration, the biasing element (22) engages with the axially movable surface (21) and holds the axially movable surface (21) in the first axially extended or unconstrained position. The axially movable surface (21) may form an annular wall (24) with a closed proximal end (25) and form a hole or internal volume extending in the distal direction. At the distal end (26) of the annular wall (24), a circumferentially and radially outwardly extending flange (27) is provided. In the first unconstrained or extended position, the flange (27) has a proximal opposing surface (28) that abuts against the distal opposing surface (29) of the proximal end (20) of the distal attachment unit (14), and this proximal opposing surface remains in this position 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 free to rotate about the central longitudinal axis (5) relative to the proximal end (20) of the attachment unit (14). In other words, if the user decides to rotate the base unit coupled to the electronic housing, the base unit (10) and the electronic housing (6) remain free to rotate about the central longitudinal axis (5). Conversely, even if the dose setting wheel (18) rotates, the base unit (10) and the electronic housing (6) do not rotate as a result during dose setting or dose injection. The bias element (22) also allows the axially movable surface (21) to move along the central longitudinal axis (5) from a first unconstrained or extended position to one or more constrained positions. The first constrained position and the second constrained position are axially spaced along the central longitudinal axis, wherein the second constrained position is located distal to the first constrained position. The first constrained position may, for example, be used to generate a signal that is received by a microcontroller (30) present in the electronic unit (7).The signal can advantageously be generated in a known manner, for example by detecting inertial movement as the axially movable surface (21) moves from an unconstrained position to a first constrained position. The inertial movement can be detected by, for example, an inertial sensor (such as an accelerometer or gyroscope) appropriately positioned within the electronic unit (7). Alternatively, when the injection monitoring module is equipped with one or more magnets, the signal can be generated by detecting changes in the magnetic field context or environment of the injection monitoring module, and this signal can be detected by, for example, a magnetometer (31) appropriately positioned within the electronic unit (7) and located on the central longitudinal axis (4). The microcontroller (30) can be configured to identify changes in the 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 the injection pen, such as: deviation from the zero or initial position of the injection pen, in which case an unconstrained or extended position would be considered the zero or initial position of the injection pen; waking up the electronic circuitry to change the power mode of the electronic unit; pre-injection, such as preparing for injection or initiating operation; and the like. A second constrained position may, for example, correspond to the injection initiation position of the injection monitoring module, which requires further movement of the axially movable surface (21) in the distal direction and therefore requires further axial compression of the bias element (22) along the central longitudinal axis. In such a second constrained position, the axially movable surface (21) contacts the injection initiation surface (32) located distally to the buffer unit of the interconnect unit (13) and also contacts the distal end of the bias element (22). As shown in the figure, the injection initiation surface (32) may have 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 initiation surface (32) toward the axially movable distal opposing surface (21) in the proximal direction. The diameter of the annular wall (32a), wall portions or fingers (32a, 32b, 32c, 32d, 32e, 32f) extending from the distal injection initiation surface (32) toward the proximal side may be appropriately sized to accommodate and guide the movement of the annular wall (24) or distal opposing surface (19) of the axially movable surface (21), wherein the distal opposing surface is directly shaped and sized to form the annular wall (24) extending distally along the longitudinal axis (5). It should be understood that the annular wall (32a) or the finger-shaped parts (32a, 32b, 32c, 32d, 32e, 32f) form mutually cooperating surfaces, which help maintain the axial stability of the connector (13) within the monitoring module, while allowing and defining the extent and limitation of axial movement along the longitudinal axis (5).In the second constrained position, the surface-to-surface contact of the axially movable surface (21) against the injection activation surface (32) in the distal direction, combined with the accumulated kinetic energy stored by the bias element (22) in the second constrained position, will cause the activation of the activation button (17) of the injection pen (16). It should be understood that when the injection monitoring module (1) is mounted on the injection pen (16), axial movement of the axially movable surface in the distal direction is generally initiated by the user of the injection monitoring module (1) when the user applies downward or distally oriented pressure to the proximal end of the injection monitoring module, for example via one or more fingers or thumbs or other similar operable body parts (e.g., pressing down on the proximal cover of the electronic housing). Similarly, any movement of the axially movable surface in the proximal direction along the central longitudinal axis will generally be attributed to the user releasing finger pressure from the proximal cover and the bias element (22) moving back to the extended or unconstrained position.

[0080] Turning now to Figures 3 and 4, these figures illustrate the manner in which the base unit (10) and the electronic housing (6) can be coupled together. As shown in Figure 4, the electronic housing (6) includes a remote coupling configuration located in the remote region of the electronic housing (6) or at the remote coupling end (9). The remote coupling configuration of the electronic housing (6) is a releasable coupling mechanism, which may involve one or more of a sliding engagement, a snap-fit ​​engagement, a screw engagement, or any combination thereof with the base unit. As shown in Figure 4, the remote coupling configuration involves a sliding or translational engagement with the base unit (10), and particularly advantageously, wherein the sliding or translational engagement with the base unit (10) is orthogonal or perpendicular to the central longitudinal axis (5) of the injection monitoring module. Therefore, the coupling between the electronic housing (6) and the base unit (10) can be achieved by sliding the electronic housing (6) from a first disengaged position to a second engaged position relative to the base unit (10) in a direction orthogonal to the central longitudinal axis (5) of the injection monitoring module (1), in which the electronic housing (6) engages with the base unit (10) to lock the electronic housing (6) to the base unit (10), see, for example, the dashed lines shown 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 electronic housing (6) to define a distal recess (34). The guide arms (33) and the recess (34) are shaped and configured to match a proximal coupling configuration of a corresponding configuration located on the base unit (10). As shown in Figure 3, this can be provided by a pair of opposing sleeves (35) located on the proximal end (11) of the base unit (10) and configured and shaped to house and releasably lock the arms (33) of the coupled configuration of the electronic housing (6) within the sleeves (35) via a suitable release mechanism. Such releasable locking may involve, for example, an elastically deformable portion of the material forming a portion of the arm (33), which, when pushed by a user in a given predetermined direction, causes the arm (33) to elastically deform and move out of its locked position within the sleeve (35), thereby allowing the electronic housing (6) to separate from the base unit (10). As shown in Figure 3, the base unit (10) may also include a proximal protruding knob (36) that extends substantially along the central longitudinal axis (5) from the proximal end (11) of the base unit (10) and is configured and shaped to match the groove (34) of the distal positioning of the electronic housing (6).

[0081] As shown in Figures 2, 5A and 5B, the distal opposing surface (19) of the base unit (10) is configured to receive at least one proximal portion of the injection start buffer unit, and in this case, to receive the axially movable surface (21). For this purpose, the distal opposing surface (19) of the base unit is shaped and sized to receive and / or place the closed proximal end (25) of the annular wall (24) of the axially movable surface (21) of the injection start buffer unit of the interconnect unit (13). Therefore, the distal opposing surface (19) of the base unit (10) has a distal groove (37) and an annular wall (38), as shown in Figure 5A, which extends from the distal opposing surface (19) of the base unit in the distal direction. As should be understood from Figures 2, 5A and 5B, the distal groove (37) and the annular wall (38) actually correspond to the distal opposing side of the proximal protruding knob (36). Therefore, the distal groove (37) and the annular wall (38) (see Figure 5A) are axially aligned with the central longitudinal axis (5) of the injection monitoring module (1).

[0082] As can be seen from Figures 2, 5A and 5B, the base unit (6) has a distal end (12) which is shaped and sized to overlap with the 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 sized and configured to resemble the distal end (9) of the electronic housing (6).

[0083] However, in other specific instances, such as those shown in FIG6, FIG7, FIG8A and FIG8B, the distal end (12) of the base unit includes a skirt (39) that flares out radially from the proximal position toward the distal position.

[0084] The distal injection pen attachment unit (14) includes a first annular body (40) having a length and a diameter and including 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 internal central hole (4) of the injection monitoring module. Typically, the length of the annular wall (41) of the first annular body (40) will be sized such that when the attachment unit (14) is mounted on the injection pen, the central hole (4) extends in the proximal direction beyond the proximal end (15) of the injection pen and defines the volume of the hole adapted to accommodate the activation button (17) of the injection pen (16), while still providing sufficient volume to allow the relevant moving parts of the injection monitoring module to translate and / or rotate within the central hole (4) around and / or along the central longitudinal axis (5). As should be understood from the foregoing description, in some specific instances, the central hole (4) may also accommodate at least another part of the injection monitoring module, such as a buffer unit, which is coaxially mounted with the attachment unit and configured relative to the attachment unit such that, for example, the buffer unit can translate and / or rotate within the hole (4) of the first annular body (40) of the attachment unit (14). As shown in Figures 1, 5A, 5B, 6, 7, 8A, and 8B, the first annular body (40) also includes a second annular wall (44) located radially inside the first annular wall (41) and connected to the first annular wall (41) by a shoulder (45) extending radially inward from the first annular wall (41). In these specific instances, the second annular wall (44) is radially spaced from the first annular wall (41) and extends from the shoulder (45) from a first end or distal end to a second end or proximal end in the proximal direction. The first annular wall (41) and the second annular wall (44) define an internal radial volume, at least a portion of which may be suitably configured or shaped to form at least one or more recesses (46a, 46b) to receive one or more dipole magnets (47a, 47b), as shown, for example, in Figures 1, 5A, 5B, 6, 7, 8A, and 8B, or to receive annular dipole or multipole magnets. Such magnet holder recesses (46a, 46b) are suitable for receiving one or more magnets (47a, 47b) and, for example, when the electronic unit includes one or more magnetometers, provide a magnetic field for the electronic unit of the injection monitoring module. If each of the grooves (46a, 46b) of such magnet holders has a corresponding dipole magnet (47a, 47b), then each magnet can be configured head-to-tail in its respective magnet holder housing (46a, 46b). That is, the first dipole magnet (47a) will be located in the first housing (46a), with the N pole facing in the proximal direction and the S pole facing in the distal direction, and the second dipole magnet (47b) will be located in the second housing (46b), with the N pole facing in the distal direction and the S pole facing in the proximal direction.

[0085] The attachment unit also includes a second annular body (48) coaxially mounted 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) does not apply an inward radial force to at least a portion of the annular wall (41) of the first annular body (40), and in the second position, the second annular body (48) applies an inward radial force to at least that portion of the first annular wall (41). When the second annular body (48) is moved from the first position to the second position, an inward radial force is applied to at least a portion of the first annular wall (41), thereby reducing the diameter of at least a portion of the first annular wall (41). Figures 5A, 8A, and 11A show the relative positions of the second annular body (48) and the first annular body (40) of the attachment unit (14) in the first or unlocked position, while Figures 5B, 8B, and 11B show the relative positions of the second annular body (48) relative to the first annular body (40) in the second or locked position. For all intents and purposes, as described herein, the first position is the unlocked position of the attachment unit (14). In the first or unlocked position, the second annular body (48) is freely translated and / or rotated along and / or around the first annular body (40) without applying any inwardly guiding radial force or pressure to the first annular body (40). Therefore, the diameter of the central hole (4) remains unchanged. For all intents and purposes, as described herein, the second position is the locked position of the attachment unit (14). In the second or locked position, the second annular body (48) is locked to prevent translation and / or rotation in a direction opposite to the direction of the inwardly guiding radial force or pressure applied by the second annular body (48) to the first annular body (40). It should be understood that the second annular body (48) is also locked to prevent movement relative to the first annular body (9) in the proximal direction. Therefore, as a result of the applied radially inwardly guiding force, the diameter of the central hole (4) is reduced in the second or locked position compared to the diameter when the second annular body (48) is in the first unlocked position, see FIG5A.

[0086] Figures 1, 2, 5A, 5B, 6, 7, 8A, 8B, 9, 10, 11A and 11B show in more detail specific examples of how a reduction in diameter is achieved when a radially inward guiding force is applied to the first annular wall (41) of the first annular body (40) as the second annular body (48) moves 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 shown 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 the first end or proximal end (42) and the second end or distal end (43) of the first annular wall (41) are also visible. The first annular wall (41) includes a plurality of resilient and radially deformable fingers (49a, 49b, 49c, 49d, 49e, 49f, 49g) extending from the shoulder (50) toward the second end or distal end (43) of the first annular wall (41). The number of radially deformable fingers (49a, 49b, 49c, 49d, 49e, 49f, 49g) can be adjusted during the forming or construction of the first annular body (40) and the first annular wall (41), for example by injection molding or lamination, depending on the desired degree of deformation and / or the desired reduction in the diameter of the hole (4). The plurality of resilient radially deformable fingers (49a, 49b, 49c, 49d, 49e, 49f, 49g) are preferably radially distributed around the central longitudinal axis (5) with each deformable finger equidistant from its adjacent or neighboring deformable fingers (49). Each of the plurality of resilient radially deformable fingers (49a, 49b, 49c, 49d, 49e, 49f, 49g) has a portion of an inner surface (51a to 51g) configured to provide surface engagement contact with a peripheral surface outside the pen body (such as, for example, the peripheral surface outside the dose setting wheel (18)) when the attachment unit (14) is mounted to the injection pen (16) and the second annular body (48) in a second or locked position. Each of the plurality of resilient radially deformable fingers (49a to 49g) has a portion of an inward-facing surface (51a to 51g) that, when the attachment unit (14) is mounted to the injection pen (16) and the second annular body (48) is in the second or locked position, is inclined from a respective proximal point (52) to a respective distal point (53) along at least a portion of the length of the resilient radially deformable fingers (49a to 49g) to conform to the dosage setting wheel (18) of the injection pen (16) and / or the outer peripheral surface of the pen body. In this context, the term "inclined" refers to the shaping or sizing of the resilient fingers to provide an inwardly facing engagement or contact surface (51a to 51g).The shaping or sizing of the elastically deformable fingers (49a to 49g) can be achieved, for example, by reducing the thickness of each finger from the proximal point (52) to the distal point (53) of the finger (49). Alternatively and / or additionally, the shaping or sizing of the elastically deformable fingers (49a to 49g) can be achieved by adding a layer of friction-increasing material (such as an elastomer) from the proximal point (52) to the distal point (53) of the finger (49). Regardless of the particular mode of execution, the inwardly engaging or contacting surfaces (51a to 51g) can be advantageously shaped to correspond to the peripheral surfaces of a similar shape present on the dosage setting wheel (18) of the injection pen (16) and / or the pen body. Each deformable finger (49a to 49g) of the first annular body (40) has an outwardly engaging surface (54), which can be engaged by the inwardly engaging surface (55) of the second annular body (48).

[0087] The second annular body (48) has at least a first portion facing an inner surface, configured to engage with the outer surface (54) of the first annular body (40). The first portion of the inner surface of the second annular body (48) is an annular shoulder (56), configured to engage with the outer surface (54) of the fingers (49a to 49g) when the second annular body (48) is mounted to the first annular body (40). In the first or unlocked position, the shoulder (56) of the second annular body (48) abuts only against the outer surface (54) of the fingers (49a to 49g) without applying any radially inward guiding force or action. Therefore, in the first or unlocked position, the second annular body (48) does not cause elastic deformation of the fingers (49a to 49g).

[0088] As the second annular body (48) moves from the first unlocked position to the second locked position, the outward-facing surface (54) of the elastically deformable fingers (49a to 49g) presents an increasing surface contact barrier to the annular shoulder (56). Furthermore, when the second annular body (48) is moved from the first unlocked position to the second locked position, the annular shoulder (56) of the second annular body (48) applies an inward radial force to the outward-facing surface (54) of the first annular wall (41), causing the inward-facing surface of the first annular wall (10) to move inward toward the central longitudinal axis (5), thereby reducing the diameter of the central hole (4) due to the elasticity of the elastically deformable fingers (49a to 49g). When the second locked position is reached, the annular shoulder (50) inserts into the groove track or slot (57), thereby preventing further immediate movement of the second annular body (48) in the distal direction, see FIG5B.

[0089] In order to remove the attachment unit (1) from the injection pen (4), the reverse operation sequence as described for installation is performed.

[0090] The remaining figures will now be described with reference to any differences shown in the specific examples illustrated in Figures 1 to 4 and Figures 5A and 5B. The same reference numerals will be retained for those parts or elements common to all specific examples.

[0091] Figures 6 to 8B show specific examples of an injection monitoring module configured to be mounted on and function with an injection pen similar to the FlexTouch® injection pen commercially available from Novo Nordisk. When mounted on such a pen (16), the distal attachment unit (14) engages with the outer surface of the body of the injection pen (16), see Figure 7, and does not directly contact the dose setting wheel (18). In fact, another inner annular body (58) is positioned to rotate within the central hole (4), radially inside the first annular body (40) of the attachment unit (14) and positioned to engage the dose setting wheel (18) in a frictional manner so as to rotate with it during dose setting. The other inner annular body (58) is also locked to rotate 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 radially opposed dipole magnets located at the proximal end (20) of the first proximal annular body (40) and is therefore rotatably fixed, i.e., it does not rotate about the central longitudinal axis, whether during dose setting or dose injection. This is a major difference between the injection monitoring modules of Figures 1 to 5B and Figures 6 to 8B. Also clearly identifiable in Figures 6 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 fit and overlap the outward-facing surface of the first proximal annular body (40) of the attachment unit (14). Figures 8A and 8B show the injection monitoring module in a first unlocked position and a second locked position for mounting the injection monitoring module to the injection pen, respectively, which operates as described with respect to Figures 5A and 5B.

[0092] Except for the longitudinally axially movable surface (21) being directly integrated into the distal opposing surface (19) of the base unit (10), the interconnect unit (13) containing the buffer unit is substantially the same as that described for the injection monitoring module shown in Figures 1 to 8B. Therefore, this distal opposing surface (19) is in direct contact with the biasing element (22) and is also axially connected to the distally positioned injection initiation surface (32) along the central longitudinal axis (5) via the distal end of the biasing element (22). In this representation, the annular wall (32a) or wall portions (32a, 32b, 32c, 32d, 32e, 32f) extending proximally from the distal opposing initiation surface (32) are sized to accommodate the annular wall (24) extending from the distal opposing surface (19) of the base unit (10). The remotely positioned activation surface (32) is rotatably connected to another inner annular body (58), for example via mutually cooperating and shaped protrusions and / or grooves, so that the rotation of the base unit and the coupled electronic housing is transmitted to the other inner annular body during dose setting.

[0093] Turning now to Figures 9 through 11B, the injection monitoring module shown herein is configured to function with injection pens such as Kwikpen®, commercially available by Eli Lilly. The main differences between the injection monitoring modules shown in Figures 1 through 8B are described below. The interconnect does not include a buffer unit with a bias element, but instead includes a releasable latch. The attachment unit (14) mounts the first proximal annular body (40a, 40b), shown here as two complementary parts, to the outer-facing surface (16a) of the body of the injection pen (16), rather than the dose setting wheel (18). The base unit (10) and the coupled electronic housing (6) are mounted directly to the injection start button (17) of the injection pen, which also serves as the dose setting wheel (18) of such injection pens. In such injection pens (16), the dose setting wheel (18) and the injection start button (17) rotate together as a whole to set the dose. In this case, the dose setting wheel (18) and the injection start button (17) move in the proximal direction when the dose to be set is increased, and in the opposite direction when the dose to be set is decreased. During injection, the injection start button (17) and the dose setting wheel (18) do not rotate, but they translate back to the zero position along the longitudinal axis of the injection pen (16) in the distal direction. Therefore, with respect to the injection monitoring module installed on such a pen as shown in Figures 9 to 11B, any determination of the administered dose using magnetometry is based on the calculation of the difference between the angular position of the magnet at the start of dose selection and the angular position of the magnet at the end of injection, taking into account the number of rotations of the magnet at the start of dose selection. The first proximal annular body (40) is mounted at the proximal end of the body onto the outward-facing surface (16a) of the injection pen (16) body and engages with the outward-facing surface in a frictional manner. As briefly mentioned above, the injection monitoring module (1) shown in Figures 9 to 11B differs from other examples described herein in that the first proximal annular body (40) of the attachment unit includes at least one releasable latch (59a, 59b) configured and adapted to move between a first unreleased position and a second released position. In the first unreleased position, the base unit (10) and the electronic housing (6) are maintained in a fixed axial and predetermined spaced relationship with the first proximal annular body (40), and in the unreleased position, translational movement of the base unit (10) and the coupled electronic housing (6) relative to the first proximal annular body (40) of the attachment unit along the central longitudinal axis (5) is prevented. In the second released position, the base unit (10) and the coupled electronic housing (6) are released from their fixed axial relationship with the first proximal annular body (40) and are freely translated along the central longitudinal axis (5) together with the dose setting wheel (18) and the injection start button (17).

[0094] The first unreleased position of the releasable latches (59a, 59b) is such that the latches (59a, 59b) prevent the base unit (10) and the coupled electronic housing (6) from translating along the central longitudinal axis (5) and from rotating around the central longitudinal axis independently of the first proximal annular body (40) of the attachment unit. The second release position is such that when the injection monitoring module (1) is installed on the injection pen in a usage scenario, the base unit (10) and the coupled electronic housing (6) are released from the holding effect of the releasable latches (59) and, for example, simultaneously translate freely along the central longitudinal axis (5) and rotate around the central longitudinal axis, for example, together with the dose setting shaft and dose setting wheel (18) of the injection pen (16). Therefore, the release latches (59a, 59b) can be operated to selectively prevent or allow such movement of the base unit (10) and the coupled electronic housing (6), depending on whether it is in the unreleased or released position.

[0095] At least one releasable latch (59) has a latch body (60) extending along a hole (4) in the first proximal annular body (40) of the attachment unit (14). The latch body (60) is typically an elongated body of molded polymeric material or metal, such as a shaft or rod. The latch body (60) extends from a proximal end (61) to a distal end (62) and is positioned along the facing inner wall (63) of the first proximal annular body (40) of the attachment unit (14), which is properly shaped and configured to receive the latch body (60). The latch body (60) is located in a central longitudinal hole (5) in the first proximal annular body (40), in the space between the facing inner wall (63) of the first proximal annular body (40) and the body of the injection pen (16). At least one releasable latch (59) comprises a pair of releasable latches (59a, 59b), and each of the releasable latches (59a, 59b) is positioned diametrically opposite to the other of the pair of releasable latches. At the proximal ends (61a, 61b) of the elongated bodies (60a, 60b) of each latch (59a, 59b), there are inwardly facing proximal hook portions (64a, 64b). The inwardly facing hook portions (64a, 64b) have a pair of arms (65a, 65b, 65c, 65d), each arm extending from a respective opposite side of the hook portions (64a, 64b). The proximal ends (61a, 61b) and the hook portions (64a, 64b) extend beyond the proximal end of the first proximal annular body (40). The inwardly facing proximal hook portions (64a, 64b) engage with the distal end (12) of the base unit (10) in a first unreleased position and disengage from the distal end (12) of the base unit in a second release position. Thus, the base unit (10) may include a radially outwardly extending protrusion (66) or a shaped portion located at or adjacent to the distal end (12) of the base unit (10), the proximal hook portions (64a, 64b) being locked to the protrusion or shaped portion in the unreleased position of the latches (59a, 59b), and the proximal hook portions (64a, 64b) disengaging from the protrusion or shaped portion in the release position of the latches (59a, 59b). Each latch (59) also has an outwardly facing proximal abutment shoulder (67a, 67b) located at the proximal end of the latch body (60a, 60b), see FIG11A. This outwardly facing proximal abutment shoulder is configured to abut against the proximal opposing surface (68) of the proximal end of the first proximal annular body (40) in the second release position. When the latches (59a, 59b) are in the release position, this abutment shoulder (67a, 67b) prevents the proximal end (61a, 61b) of the releasable latch body (60) from accidentally or intentionally moving in the distal direction into the central hole (4) of the first proximal annular body (40).The latching bodies (60a, 60b) extend distally from their proximal ends (61a, 61b) and are received by the second distal annular body (48) of the attachment system. The latching bodies (60a, 60b) also have outwardly facing protrusions (69a, 69b) positioned along the length of the latching bodies (60a, 60b) and forming a fulcrum that allows the latches (59a, 59b) to rotate about the fulcrum when the latches (59a, 59b) are moved from a first unreleased position to a second released position. The fulcrum (69a, 69b) provides a point of rotation for the latching bodies (60a, 60b) within a hole (4) in the first proximal annular body (40), wherein the outwardly facing protrusions (69a, 69b) of the fulcrum abut against the inner wall (63) of the first proximal annular body (40). The relative rotational degrees of freedom of the latch bodies (59a, 59b) around the fulcrum (69a, 69b) are determined by the thickness of the latch bodies (60a, 60b), the shape and size of the outwardly projecting portions (69a, 69b) forming the fulcrum, and the size of the guide portions (70a, 70b) located in the second distal annular body (48) of the attachment unit. These configuration elements are selected such that the releasable latch bodies (59a, 59b) can pivot around the fulcrum (69a, 69b) when the releasable latch (59a, 59b) moves from the first unreleased position to the second released position in the reverse pivoting direction and vice versa. The distal ends (62a, 62b) of the latch bodies (60a, 60b) are configured and adjusted to be housed in the guide portions (70a, 70b) of the second distal annular body (48) of the attachment unit (14). The guide portions (70a, 70b) include at least one radially outwardly inclined surface (71a, 71b) extending from a proximal position to a distal position and at least one radially inwardly inclined surface (72a, 72b) extending from a distal position to a proximal position. In the first unlocked position of the attachment system (14), as shown more specifically in FIG11A, the radially outwardly inclined surfaces (71a, 71b) of the guide portions apply radially outward elastic deformation to the distal ends (62a, 62b) of the releasable latch bodies (59a, 59b), which are positioned at the distal ends of the guide portions (70a, 70b) and housed within the guide portions. The radial outward elastic deformation of the latch body (59a, 59b) caused by the shape of the radially outward inclined surface (71a, 71b) of the guide portion (70a, 70b) of the latch body (59a, 59b) is transmitted along the body (60a, 60b) and causes the latch body (60a, 60b) to pivot radially inward around the fulcrum (69a, 69b), thereby moving the proximal hook portion (64a, 64b) of the latch body (60a, 60b) radially inward so that the hook portion (64a, 64b) engages with the radially outwardly extending protrusion (66) or forming portion of the distal end (12) of the base unit (10).The guide portions (70a, 70b) also include radially inwardly inclined surfaces (72a, 72b) from the distal position toward the proximal position, which provide a gradual tilt change. When the second distal annular body (48) moves into the locked position, the distal ends (62a, 62b) of the distal ends or adjacent latching bodies (60a, 60b) of the protrusions (73a, 73b) extending from the latching bodies engage under this gradual tilt change. When the second distal annular body (48) of the attachment unit moves from the first unlocked position (see FIG. 11A) of the attachment device (14) to the second locked position (see FIG. 11B), the tilt change is responsible for applying an elastic constraint to the distal ends (62a, 62b) of the latching bodies (60a, 60b). At the proximal ends (61a, 61b) of the locking bodies (60a, 60b), the locking bodies (60a, 60b) pivot radially outward about the fulcrum (69a, 69b), which in turn causes the proximal hook portions (64a, 64b) of the locking bodies (60a, 60b) to move out of the locking engagement with the distal end (12) of the base unit (10), thereby releasing the base unit (10) and the coupled electronic housing (6) from the first proximal annular body (40), and allowing the base unit (10) to rotate and / or translate freely to replicate the movement of the dose setting wheel (18) of the injection pen (16) during dose setting and dose injection.

[0096] As shown in Figures 9 and 10, the first proximal annular body (40) also includes a pair of diagonally positioned dipole magnets (47a, 47b), which are located in corresponding recesses (46a, 46b) and oriented outward from the first proximal annular body (40). In addition, the magnets (47a, 47b) are oriented such that their respective magnetic poles are orthogonally positioned relative to the central longitudinal axis (5). The second distal annular body (48) also has a dose visualization window (74), which is located directly above or corresponding to the dose display window of the injection pen when the injection monitoring module (1) is in the final installation and locking position on the injection pen (16), so that the user can directly see any dose adjusted to the pen when manipulating the dose setting wheel (18). [Simplified Explanation of the Diagram]

[0077] The injection monitoring module will now be described in more detail with respect to the diagrams. [Figure 1] is a schematic exploded perspective view of a first injection monitoring module configured to function with a first type of injection pen (such as the Solostar® insulin pen from Sanofi or the FlexPen® insulin pen commercialized by Novo Nordisk); [Figure 2] is a schematic cross-sectional view of the injection monitoring module of Figure 1; [Figure 3] is a schematic perspective view of the base unit of the injection monitoring module, showing a proximal coupling configuration for coupling to the electronic housing of the injection monitoring module with a corresponding distal coupling configuration; [Figure 4] is a schematic perspective view of the distal end of the electronic housing of the injection monitoring module, which can be coupled to the proximal coupling shown in Figure 3; [Figure 5A] shows a schematic cross-sectional view of the injection monitoring module of Figures 1 and 2 in the assembled unlocked position around the proximal end of the injection pen; [Figure 5B] shows a schematic cross-sectional view of the injection monitoring module shown in Figure 5A in the assembled locked position around the proximal end of the injection pen. [Figure 6] shows a schematic exploded view of a second injection monitoring unit configured to function with a second type of injection pen (such as the FlexTouch® injection pen commercialized by Novo Nordisk); [Figure 7] shows a schematic cross-sectional view of the injection monitoring module of Figure 6 in the assembled and installed position on the injection pen; [Figure 8A] shows a schematic cross-sectional view of the injection monitoring module of Figures 6 and 7 in the assembled unlocked position around the proximal end of the injection pen; [Figure 8B] shows a schematic cross-sectional view of the injection monitoring module of Figures 6 and 7 in the assembled locked position around the proximal end of the injection pen; [Figure 9] shows a schematic exploded view of a third injection monitoring unit configured to function with a third type of injection pen (such as the Kwikpen® injection pen commercialized by Eli Lilly); [Figure 10] shows a schematic cross-sectional view of the injection monitoring module of Figure 9 in the assembled and installed position on the injection pen. [Figure 11A] shows a cross-sectional view of the injection monitoring module of Figures 9 and 10 around the proximal end of the injection pen in the assembled unlocked and unlocked positions; [Figure 11B] shows a cross-sectional view of the injection monitoring module of Figures 9 and 10 around the proximal end of the injection pen in the assembled unlocked and unlocked positions.

Claims

1. An injection monitoring module configured and adapted for releasable mounting to an injection pen system, the injection monitoring module having a length extending from a first proximal end to a second distal end and a central longitudinal aperture extending at least partially along the length of the injection monitoring module between the first proximal end and the second distal end about a central longitudinal axis, wherein the injection monitoring module comprises: an electronic housing enclosing an electronic unit, wherein the electronic housing is a replaceable electronic housing; a base unit located distal to the electronic housing and configured and adapted to releasably house the electronic housing and directly couple the electronic housing to the base unit; and an interconnect unit extending along or parallel to the central longitudinal axis. A distal pen attachment unit is configured and adapted to releasably couple an injection monitoring module to a proximal end of an injection pen system, thereby covering at least one start button of the injection pen system when mounted on the injection pen system; and wherein an interconnect unit extends between a distal region of a base unit and the distal pen attachment unit, and connects the distal region of the base unit to the distal pen attachment unit.

2. The injection monitoring module of claim 1, wherein the interconnect unit is an injection start buffer unit, the injection start buffer unit includes a longitudinally axially movable surface, wherein the injection start buffer unit is configured to move along at least a portion 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 axially constrained position and a second axially constrained position.

3. The injection monitoring module of claim 2, wherein the injection initiation buffer unit extends at least partially within the central longitudinal hole and connects the base unit to the distal releasable attachment unit in a first axially extended or unrestrained position.

4. The injection monitoring module of claim 2, wherein the injection initiation buffer unit includes a biasing element positioned against the axially movable surface of the injection initiation 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 initiation buffer unit in the first axially extended or unconstrained position.

5. The injection monitoring module as claimed in claim 4, wherein the biasing element of the injection initiation buffer unit has a first constraint configuration in which the axially movable surface of the injection initiation buffer unit is in a first constraint position.

6. The injection monitoring module as claimed in claim 4, wherein the biasing element of the injection initiation buffer unit has a second constraint configuration in which the axially movable surface of the injection initiation buffer unit is in a second constraint position.

7. The injection monitoring module of claim 6, wherein the axially movable surface of the injection initiation buffer unit and the first constraint position and the second constraint position of the biasing element are spaced apart along the length of the injection monitoring module and / or along the central longitudinal axis of the injection monitoring module.

8. The injection monitoring module of claim 6, wherein the first constraint position of the axially movable surface of the injection initiation buffer unit is located near the second constraint position of the axially movable surface of the injection initiation buffer unit.

9. An injection monitoring module as requested in any of items 2 and 4 to 6, wherein the unconstrained position corresponds to a zero position of the injection monitoring module.

10. The injection monitoring module as requested in item 5, wherein the first constraint position corresponds to a start of an injection initiation position of the injection monitoring module.

11. The injection monitoring module as requested in item 6, wherein the second constraint position corresponds to one of the injection initiation positions of the injection monitoring module.

12. The injection monitoring module as requested in claim 1, wherein the electronic housing includes a remote coupling configuration.

13. The injection monitoring module of claim 1, wherein the electronic housing includes a distal coupling configuration located in a distal region or at a distal end of the electronic housing.

14. The injection monitoring module of claim 13, wherein the remote coupling configuration of the electronic housing is configured to couple the electronic housing to and release from the base unit.

15. The injection monitoring module of claim 13, wherein the distal coupling configuration of the electronic housing includes a releasable coupling mechanism selected from one or more of a sliding engagement with one of the base units, a snap engagement, a screw engagement, or any combination thereof.

16. The injection monitoring module as claimed in claim 13, wherein the remote coupling configuration involves sliding or translating engagement with one of the base units.

17. The injection monitoring module of claim 13, wherein the distal coupling configuration involves sliding or translating with one of the base units, wherein the sliding or translating with the base unit is orthogonal or perpendicular to the central longitudinal axis of the injection monitoring module.

18. The injection monitoring module of claim 16 or 17, wherein the coupling between the electronic housing and the base unit is achieved by sliding the electronic housing from a first disengaged position to a second engaged position relative to the base unit in a direction orthogonal to the central longitudinal axis of the injection monitoring module, in which the electronic housing is engaged with the base unit.

19. The injection monitoring module as requested in item 1, wherein the base unit includes a proximal coupling configuration.

20. The injection monitoring module of claim 1, wherein the base unit includes a proximal coupling configuration and the proximal coupling configuration of the base unit is configured for a robust but releasable engagement between a proximal end of the base unit and a distal end of the electronic housing.

21. The injection monitoring module of claim 13, wherein the base unit includes a near-side coupling configuration configured to function in conjunction with the far-side coupling of the electronic housing.

22. The injection monitoring module of claim 1, wherein the base unit includes a distal opposing surface configured to receive at least a proximal portion of an injection initiation buffer unit.

23. The injection monitoring module of claim 22, wherein the distal opposing surface of the base unit is shaped and sized to accommodate and / or house one proximal end of the injection initiation buffer unit.

24. The injection monitoring module of claim 22 or claim 23, wherein the distal opposing surface of the base unit includes one or more of a distal groove and an annular wall, the annular wall extending from the distal opposing surface of the base unit in a distal direction.

25. The injection monitoring module of claim 24, wherein the annular wall defines an internal volume or closed orifice for receiving a proximal portion of one of the injection initiation buffer units.

26. The injection monitoring module of claim 22, wherein the configuration of the distal opposing surface of the base unit is aligned with the central longitudinal axis of the injection monitoring module, about the central longitudinal axis, or axially on the central longitudinal axis.

27. The injection monitoring module of claim 1, wherein the base unit includes a distal portion that, when the injection monitoring module is mounted on an injection pen system, is shaped and sized to overlap with the shape of an outer surface of a proximal end of one of the distal injection pen attachment units.

28. The injection monitoring module of claim 27, wherein the distal portion of the base unit is sized and configured to resemble the distal portion of the electronic housing.

29. The injection monitoring module of claim 27, wherein the distal portion of the base unit includes a skirt that flares out radially outward from a proximal position toward a distal position.

30. The injection monitoring module of 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 a portion of a central aperture of the injection monitoring module, the central aperture extending along the length of the first proximal annular body and along a central longitudinal axis; and a second distal annular body coaxially mounted 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 does not apply an inward radial force to at least a portion of the annular wall of the first proximal annular body, wherein in the second position, the second distal annular body applies an inward radial force to the at least a portion of the annular wall, wherein the inward radial force applied to the at least a portion of the annular wall causes a reduction in the diameter of the at least a portion of the annular wall.

31. The injection monitoring module of claim 30, wherein the first proximal annular body of the distal injection pen attachment unit includes a pair of diametrically opposed positioning magnets.

32. The injection monitoring module of claim 31, wherein a first magnet of the pair of diametrically opposed positioning magnets is oriented to a north pole in a proximal direction, and a second magnet of the pair of diametrically opposed positioning magnets is oriented to a north pole in a distal direction.

33. The injection monitoring module of claim 31, wherein a first magnet of the pair of diametrically opposed positioning magnets is positioned as a north pole in a first direction orthogonal to the central longitudinal axis, and a second magnet of the pair of diametrically opposed positioning magnets is positioned as a north pole in a second direction orthogonal to the central longitudinal axis and opposite to the first direction of the first magnet.

34. The injection monitoring module of claim 31, wherein the pair of diaphragm positioning magnets are located at or near a proximal end of the first proximal annular body of the distal injection pen attachment unit.

35. The injection monitoring module of claim 31, wherein the pair of magnets are positioned in corresponding grooves in the first proximal annular body of the distal injection pen attachment unit, the grooves being oriented inward toward the central longitudinal hole of the first proximal annular body of the distal injection pen attachment unit, or alternatively, oriented outward away from the central longitudinal hole of the first proximal annular body of the distal injection pen attachment unit.

36. The injection monitoring module of claim 31, wherein the pair of magnets can be positioned in a fixed, non-rotational configuration relative to the first proximal annular body of the distal injection pen attachment unit.

37. The injection monitoring module of claim 1, wherein the interconnect unit includes at least one releasable latch extending parallel to the central longitudinal axis between a distal region of the base unit and the distal injection pen attachment unit, wherein the at least one releasable latch releasably connects the base unit to the distal injection pen attachment unit.

38. The injection monitoring module of claim 37, wherein the at least one releasable latch is configured and adapted to move between: a first unreleased position, wherein the distal injection pen attachment unit maintains a fixed axial relationship with the base unit and prevents the base unit from translating relative to the distal injection pen attachment unit along one of the central longitudinal axes; and a second released position, wherein the base unit is released from the fixed axial relationship with the distal injection pen attachment unit and is freely translatable along the central longitudinal axis.

39. The injection monitoring module of claim 37 or claim 38, wherein the at least one releasable latch comprises a pair of releasable latches, and each of the releasable latches in the pair is positioned opposite to the other of the pair of releasable latches.

40. The injection monitoring module of claim 37 or 38, wherein the at least one releasable latch has a latch body that extends along a hole in a first proximal annular body of one of the distal injection pen attachment units.

41. The injection monitoring module of claim 40, wherein the locking body is an elongated body of a molded polymer material or a lightweight alloy.

42. The injection monitoring module of claim 40, wherein the locking body extends from a proximal end to a distal end and is positioned along one of the faces of the first proximal annular body toward the inner wall.

43. The injection monitoring module of claim 40, wherein when the injection monitoring module is mounted on an injection pen, the locking body is located in a space between an inner wall of the first proximal annular body of the distal injection pen attachment unit and a body of an injection pen and / or a dose setting component.

44. The injection monitoring module of claim 37 or 38, wherein the at least one releasable latch has a proximal end having a radially inward proximal hook portion.

45. The injection monitoring module of claim 37 or 38, wherein the inwardly facing proximal hook portion engages with a distal portion of the base unit in the first unreleased position and disengages from the distal portion of the base unit in the second released position.

46. ​​As in the injection monitoring module of claim 37 or 38, the inwardly proximal hook portion extends laterally from one of the proximal sides to form a separate pair of hook arms.

47. The injection monitoring module of claim 37 or 38, wherein the at least one releasable latch has a proximal end having an outwardly proximal abutment shoulder configured to abut a proximal opposing surface of a proximal end of one of the proximal ends of the first proximal annular body of the distal injection pen attachment unit in the second release position.

48. The injection monitoring module of claim 40, wherein the latch body of the at least one releasable latch extends in a distal direction from the proximal end of the releasable latch beyond a distal end of the first proximal annular body of the distal injection pen attachment unit, and is housed within the second distal annular body of the distal injection pen attachment unit.

49. The injection monitoring module of claim 40, wherein the at least one releasable latch has at least one first outwardly projecting portion positioned along the length of one of the latch bodies, the at least one first outwardly projecting portion forming a fulcrum, the fulcrum being configured to allow the releasable latch to rotate about the fulcrum when the releasable latch is moved from the first unreleased position to the second released position.

50. The injection monitoring module of claim 37 or 38, wherein the at least one releasable latch has a distal end configured and adapted to be housed in a guide portion of a second distal annular body of one of the distal injection pen attachment units.

51. The injection monitoring module of claim 40, wherein the at least one releasable latch includes a second outwardly facing protrusion positioned along the length of the latch body adjacent to the distal end of the latch body.

52. The injection monitoring module of claim 50, wherein the guide portion of the second distal annular body of the distal injection pen attachment unit includes at least one radially outwardly inclined surface extending from a proximal position to a distal position, and at least one radially inwardly inclined surface extending from a distal position to a proximal position.

53. The injection monitoring module of 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 portion of the releasable latch body of the at least one releasable latch, the radially outward elastic deformation being transmitted along the body of the releasable latch and causing the releasable latch body to pivot radially inward about the pivot point, thereby causing the proximal hook portion of the latch body to move radially inward to engage the hook with a distal portion of the base unit, the engagement corresponding to the unreleased position of the releasable latch.

54. The injection monitoring module of 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 the application of radial outward elastic deformation of the distal portion of the releasable latch body of the at least one releasable latch, the removal of the radial outward elastic deformation causing the releasable latch body to pivot radially outward about the fulcrum, thereby moving the proximal hook portion of the latch body to disengage from a distal portion of the base unit, the disengagement corresponding to the release position of the releasable latch.

55. The injection monitoring module of claim 1, wherein the electronic unit comprises one or more of the following: a microcontroller located on an electronic circuit board; an autonomous power supply connected to the electronic circuit board; an optional start switch configured to selectively allow power to be supplied to or disconnected 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 the operation of the injection monitoring module when it is installed on and used with an injection pen system, or when it is removed from the injection pen system.

56. The injection monitoring module of claim 55, wherein the one or more sensors of the electronic unit are one or more of a magnetometer, a gyroscope and an accelerometer.

57. The injection monitoring module as claimed in claim 55 or claim 56, wherein the electronic unit further includes a wireless communication unit.

58. The injection monitoring module of claim 55, wherein when the injection monitoring module is mounted on an injection pen, the microcontroller of the electronic unit is configured to process signals received from one or more of a magnetometer, an accelerometer, and a gyroscope in order to determine one or more operating conditions selected from: proper mounting of the injection monitoring module on the injection pen; wake-up of the electronic components on the circuit board; adjustment of a dose by rotation of a dose setting mechanism of the injection pen via a rotational contact between the injection monitoring module and a dose setting mechanism of the injection pen; the start of an injection; the completion of an injection; a return to a zero position of the injection pen; and a dose delivered by the injection pen.

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