WO2024134239A1

WO2024134239A1 - Injection monitoring module

Info

Publication number: WO2024134239A1
Application number: PCT/IB2022/000733
Authority: WO
Inventors: Alain MARCOZ
Original assignee: Biocorp Production S.A.S.
Priority date: 2022-12-21
Filing date: 2022-12-21
Publication date: 2024-06-27

Abstract

Injection monitoring module comprising a hollow main body for coaxial mounting on, and co-rotational engagement with, a dose setting wheel of an injection pen, and a rotational stop means for preventing rotational movement of an injection monitoring system of the monitoring module about a central longitudinal axis during dose setting and during injection. The rotational stop means is connected to the hollow main body via an articulation, and comprises at least one elongate rod member extending from the injection monitoring system in a distal direction in parallel to the central longitudinal axis and bypassing an outside surface of the hollow main body, and a sheath member, mountable on an outer surface of a body of the injection pen, the sheath member receiving the at least one elongate rod members in sliding engagement during translational movement of the injection monitoring system from a first monitoring position to a second monitoring position.

Description

DESCRIPTION

Title of Invention: Injection Monitoring Module

[0001] The present invention relates generally to monitoring systems for injectable drug deliveiy devices, and in particular to injection monitoring for injection pen systems.

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

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

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

[0005] Notwithstanding the above, there remain a number of challenges in providing an injection monitoring module which is both easy to use when mounted on a pen injection system, and easy to mount and dismount from the pen injection system.

[0006] For example, published PCT application WO2022079462A1 provides an injection monitoring module adapted and configured to be removably attached to a proximal extremity of an injection pen system for delivery of a drug, the injection pen system having a dose setting wheel that can be rotated about a central longitudinal axis of the pen injection system for setting a dose of drug to be injected, and optionally fixed against rotation during injection, the monitoring module being configured to obviate the need for complicated shielding or protecting solutions to counter any unwanted electrical, electronic, or electromagnetic effects caused by the relatively high density of the electronic components within the monitoring module. The injection monitoring module is adapted and configured to determine a dose that has been set, and an injection begin point. The expression “injection begin point” as used herein signifies the point at which the injection mechanism within the pen is activated. This usually occurs by moving an injection activator, such as a push button, located on the proximal extremity of the pen injection system, in a distal direction. The injection monitoring module can also be configured to detect or calculate a dose or amount of dose set by a user of an injectable substance contained within the pen injection system, an injection begin or start point, and an injection end point in said pen injection system, and therefrom determine whether, or not, all of the dose or amount of injectable substance set by the user of the pen injection system has been ejected from said pen system.

[0007] The injection monitoring module described and disclosed in WO2022079462A1 is adapted and configured to be removably mounted to a proximal extremity of an injection pen system for delivery of a drug, wherein the injection pen system has a pen body, a proximally located dose setting wheel connected to said body, and an injection activator, such as a proximally located injection activation button, and wherein the dose setting wheel is rotatable about a central longitudinal axis of the pen injection system during dose setting. This injection monitoring module comprises:

[0008] a hollow main body adapted and configured to be coaxially mounted on, and engage in co- rotation with, the dose setting wheel of the injection pen system, the hollow main body comprising a central longitudinal bore having a proximal extremity and a distal extremity, and a central longitudinal axis;

[0009] a magnetic field production means, located on or within the hollow main body, at the proximal extremity of the central longitudinal bore;

[00010] an injection monitoring system comprising at least one or a plurality of magnetic sensors, the injection monitoring system being located at the proximal extremity of, and movable in translation along, the central longitudinal axis within the bore of the hollow main body, from a first monitoring position in which the injection monitoring system, to at least a second monitoring position distant from the first monitoring position; [00011] a rotational stop means configured and adapted to prevent rotational movement of the injection monitoring system about the central longitudinal axis during dose setting and during injection.

[00012] As may be used in the present specification, the terms “pen injection system” and “injection pen system” are used interchangeably to designate a generally handheld penshaped injection system, such systems being readily well known per se and commercially available for use in the treatment of many various medical indications. These systems are also often generally designed for self -injection of a drug by the user in need of treatment for the given medical indication. This is for example the case with insulin, supplied in various forms for use in the treatment of diabetes, for example the pen injection systems commercialized under the brand names FlexPen®, as commercialized by Novo Nordisk, Kwikpen®, as commercialized Eli Lilly, or Lantus Solostar®, as commercialized by Sanofi, being but three of the most well known, but also with other hormones, such as growth hormone, or follicular stimulating hormones such as folli tropin delta, commercialized in a pen injection system called Rekovelle®. Other drugs are also used with this category of medical devices, and may be required, for example, to address a number of potentially life-threatening situations, enabling immediate emergency injection of a required drug, such as anaphylactic shock treatments, anti-coagulants, opioid receptor agonists and antagonists, and the like, to the extent that it has become a common occurrence for patients suffering from, or susceptible to, such ailments to cany these devices around with them.

[00013] Additionally, the terms “proximal”, “proximally”, “distal” and “distally”, where such terms may be used in the present specification, refer to relative positions with regard to any of an injection monitoring system, injection monitoring module, and pen injection system in general, wherein “proximal” relates to a point or position or direction that is generally oriented in the direction towards the holder of the injection monitoring system, injection monitoring module, or pen injection system, and “distal” relates to a point or position or direction that is generally oriented in the direction away from the holder of the injection monitoring system, injection monitoring module, or pen injection system, for example towards a target site for injection, whether that be another part of the user’s body, or a different person’s, or animal’s, body, or simply a target site for ejection of the substance contained within the pen injection system. [00014] The injection pen system, to which the injection monitoring module according to the invention is adapted and configured for removable attachment, is equipped with a proximally located dose setting wheel and an injection activator. The dose setting wheel rotates about a central longitudinal axis of the pen injection system to allow a user to set the dose of medicament for injection. During the dose setting, or dose “dialing” step, the dose setting wheel is generally rotatable in both a clockwise, and a counter-clockwise direction, these directions corresponding generally to an increase in the selected dose, and a decrease in the selected dose, to be administered, respectively, or vice-versa, depending on the manufacturer. The injection activator is often represented by a push-button, usually located proximally of the dose setting wheel, and in the majority of injection pens at the proximal extremity of the injection pen system. After a dose has been set, or “dialed”, as the term is commonly known in the art, when a user of the injection system then presses the injection activator in a distal direction, a piston is driven which is connected to a plunger in order to expel drug from a chamber within the injection pen body out through a needle that the user has inserted into an appropriate injection site, for example, the skin, fatty tissue, or muscle, depending on the type of drug to be administered. The dose setting wheel is sometimes, but not necessarily, also coupled to the injection drive mechanism so that it can, depending on the manufacturer and model of injection pen, also rotate as injection of the drug proceeds. The functioning of such injection systems is well known per se in the art. The monitoring module as envisaged according to the present invention is intended for mounting onto a pen injection system in which the dose setting wheel can be configured to either rotate during the eject! on/inj ection phase of operation, or, on the contrary, not rotate during the eject! on/inj ection phase of operation of the pen injection system. For example, the Kwikpen® injection pen mentioned above does not have a dose setting wheel that rotates during injection, whereas the dose setting wheel of the Lantus Solostar®, FlexPen® and Rekovelle® injection pens do rotate during injection.

[00015] The injection monitoring module according to the invention, therefore, is adapted and configured to be removably attached to a proximal extremity of such an injection pen system. The expressions “removably attached”, “removably attachable”, “removably mounted” or “removably mountable” as might be used in the present specification are to be understood as referring to the possibility of attaching, or mounting, and subsequently removing, the injection monitoring module, for example, in the case of transferring the injection monitoring module to another pen injection system, or for example, if the monitoring module is damaged during use and requires replacement. Such attachment and subsequent removability can be achieved by providing coupling means on the monitoring module which engage in a releasable manner with the proximal extremity of the pen injection system, for example via frictional or elastic engagement, or via other releasable fastening means, such as clips, straps, screw threads and corresponding tightening rings, and the like, which engage with either the dose setting wheel, or the injection activator, and/or even the body of the pen injection system.

[00016] The rotational stop means mentioned above are to be understood as means by which rotation of the injection monitoring system around the central longitudinal axis is physically prevented during dose setting / dose dialing, and also when the injection monitoring system is moved from the first injection monitoring position to the second injection monitoring position, and vice-versa, that is, when the injection monitoring system is moved from the second monitoring position back to the first injection monitoring position. As illustrated in WO2022079462A1, the rotational stop means comprises:

[00017] at least one elongate rod member, or a plurality of elongate rod members, extending from the injection monitoring system in a distal direction in parallel to the longitudinal axis and bypassing an outside surface of the hollow main body; and

[00018] a sheath member, mountable on the body of the injection pen system, which is adapted and configured to receive the at least one, or plurality of, elongate rod members in sliding engagement with said sheath member during translational movement of the injection monitoring system from the first monitoring position to the second monitoring position.

[00019] Despite the advances in usability with an injection monitoring module as described in WO2022079462A1, it would be desirable to provide even greater user security and functionality of such an injection monitoring module. According to one aspect, therefore, an improved device similar to that of WO2022079462A1 is provided.

[00020] Accordingly, the at least one elongate rod member of the rotational stop means is connected to the injection monitoring system via an articulation, for example, a hinge.

[00021] According to another aspect, the articulation, or respectively, the hinge, is configured to allow a rotational movement of the elongate rod member, together with the sheath, about a point of rotation of the hinge, from a first angular position in which the sheath and at least one elongate rod member are angled away from a longitudinal axis of the injection monitoring module, to a second angular position in which both the at least one elongated body, and sheath, are in parallel longitudinal axial alignment with the longitudinal axis of the injection monitoring module.

[00022] The provision of an articulation such as a hinge, configured to allow rotational movement of the elongate rod member and sheath from the first position, located at an angle, away from the central longitudinal axis of the injection monitoring module, to a second position in which the sheath and at least one elongate rod member are in parallel longitudinal axial alignment with the central longitudinal axis of the injection monitoring module, enables a user of the injection monitoring module to mount the injection monitoring module at a proximal end of an injection pen, and yet still allow, temporarily, the user to correct any potential axial misalignment of the injection monitoring module when mounting the latter on an injection pen, without being constrained by the fixed alignment of the sheath and at least one elongated rod member when the sheath is brought into elastically engaging contact with the body of an injection pen, such a fixed alignment being described in the injection monitoring module of WO2022079462A1. From a practical point of view, this temporaiy freedom to be able to rotate the injection monitoring system about the central longitudinal axis is most useful, and will significantly prevent or markedly reduce the occurrences of incorrect mounting of the injection monitoring system part of the injection monitoring module onto the injection pen. Similarly, an additional degree of freedom for the user is now permitted when dismounting the injection monitoring module from the injection pen, since, once the sheath has been removed from elastically engaging contact with an outer surface of the injection pen body, it now becomes easier to dismount the injection monitoring module by rotating the part of the injection monitoring module including the injection monitoring system, about the central longitudinal axis, and pulling the injection monitoring module in a proximal direction.

[00023] According to another aspect, the at least one elongate rod member extends in a proximal direction beyond the articulation and is configured to form a switch actuator. The extension of the elongate rod member in a proximal direction beyond the articulation can usefully be formed as an additional component, attached to the elongate rod member at a proximal end of the rod member, or alternatively, be formed as an integral part of the elongate rod member, according to which a proximal end of the elongate rod member would be suitably shaped and configured to form the switch actuator. Typically, the switch actuator can be formed as a spigot or a peg, having a diameter or dimensions that are usually smaller than those of the elongated rod member, and which spigot or peg projects in a proximal direction.

[00024] According to another aspect, the injection monitoring module comprises an actuatable switch, configured to selectively energize, and respectively, de-energize, the injection monitoring system when the switch actuator is brought into contact, and respectively, is moved out of contact, with the actuatable switch. The actuatable switch can typically included a contact surface, configured, or shaped and dimensioned, to come into surface engaging contact with the switch actuator, for example, a distally facing contact surface.

[00025] According to another aspect, the switch actuator and actuatable switch can be configured to function without surface engaging contact of one with respect to the other. For example, the actuatable switch can be formed as an optical sensor, which optical sensor is activated to energize or de-energize, the injection monitoring system, as a function of the position of the switch actuator relative to the optical sensor, for example, when the switch actutator blocks, or unblocks the passage of light to the optical sensor, depending on the orientation or angle of the switch actuator. Similarly, and alternatively, other switch actuator / actuatable switch configuration pairs can be provided, for example, a Hall effect sensor as the actuatable switch, and a magnetic field production means as a sensed element for the Hall sensor, the actuation of the switch being dependent, in a similar manner to that described above, on the relative positioning of the switch actuator in relation to the switch.

[00026] According to another aspect, the switch actuator is configured to actuate the actuatable switch when the at least one elongated body and sheath are in the second position. As indicated above, the switch actuator is advantageously configured, or shaped and dimensioned, to correspond to the dimensions of the actuatable switch, or to be shaped such that the switch actuator can be selectively brought into, and removed from, surface engaging contact with an exposed contact surface of the actuatable switch. For example, the actuatable switch can have a proximally facing contact surface, which in the first angled-away position, is not in contact with the actuatable switch, and in the second position, is brought into surface engaging contact with the contact surface of the actuatable switch, for example, via the distally facing contact surface of the actuatable switch.

[00027] According to another aspect, the injection monitoring system comprises a temporary axial positioning means. The temporaiy axial positioning means is configured to maintain, or hold, the injection monitoring system, at least partially within the bore of the hollow main body, in a predetermined axial position with respect to the hollow main body, pending completion of mounting of the injection monitoring module on the injection pen body.

[00028] Accordingly, the temporaiy axial positioning means of the injection monitoring system can usefully be provided by, for example, a magnetizable ring or one or more magnetizable plates, or similar, which is, or are, positioned coaxially and proximally to, and in magnetizable distance of, the magnetic field production means, which are located within or on the hollow main body, at or adjacent a proximal end of the hollow main body. By “magnetizable distance”, it is to be understood that the magnetic field production means located within, or on, the hollow body, provide a magnetic field which is sufficiently strong to induce an opposite magnetic filed in the magnetizable plates or magnetizable ring, at a predetermined and preconfigured distance, and thereby maintain a magnetic attraction between the magnetizable ring or plates. The magnetizable ring or plate of material can be suitably positioned for example, at or adjacent to, a distal end of the injection monitoring system, for example in a distal area of an injection monitoring system holder. In this way, the injection monitoring system is temporarily held in a position adjacent to a proximal end of the hollow main body, until the injection monitoring system comes into contact with a proximal end of the injection pen on mounting of the injection monitoring module onto the pen, at which point the proximally directed force caused by the pen activation button bearing against a distal surface area zone of the injection monitoring system, for example, a part of the injection monitoring system holder, will cause the injection monitoring system holder to be moved in a proximal direction, overcoming the magnetic attraction between the magnetic field production means, and the magnetizable ring or plates, and the corresponding temporaiy axial positioning, causing the injection monitoring system to be moved into a position ready for use. [00029] As may be used in the present specification, the expression “magnetic field production means” refers to materials which produce a magnetic field. Magnetic field production means are known per se, for example, classical magnets, electromagnets, and mixed material magnets. Such magnets are typically made from magnetizable materials, having magnetic or paramagnetic properties, whether naturally or when an electric or other energizing flow traverses or affects said material to produce or induce a magnetic field in said material. Suitable materials can be appropriately selected from:

[00030] ferrite magnets, especially sintered ferrite magnets, for example, comprising a ciystalline compound of iron, oxygen and strontium;

[00031] composite materials consisting of a thermoplastic matrix and isotropic neodymium-iron-boron powder;

[00032] composite materials made up of a thermoplastic matrix and strontium- based hard ferrite powder, whereby the resulting magnets can contain isotropic, i.e. nonoriented, or anisotropic, i.e. oriented ferrite particles;

[00033] composite materials made of a thermo-hardening plastic matrix and isotropic neodymium-iron- boron powder;

[00034] magnetic elastomers produced with, for example, heavily charged strontium ferrite powders mixed with synthetic rubber or PVC, and subsequently either extruded into the desired shape or calendered into fine sheets;

[00035] flexible calendered composites, generally having the appearance of a brown sheet, and more or less flexible depending on its thickness and its composition. These composites are never elastic like rubber, and tend to have a Shore Hardness in the range of about 40 to about 70 Shore D ANSI. Such composites are generally formed from a synthetic elastomer charged with strontium ferrite grains. The resulting magnets can be anisotropic or isotropic, the sheet varieties generally having a magnetic particle alignment due to calendering;

[00036] laminated composites, generally comprising a flexible composite as above, co-laminated with a soft iron-pole plate;

[00037] neodymium-iron-boron magnets; [00038] steels made of aluminium-nickel-cobalt alloy and magnetized;

[00039] alloys of samarium and cobalt.

[00040] Of the above list of magnetic field production means suitable for use in the present invention, those selected from the group consisting of neodymium-iron-boron permanent magnets, magnetic elastomers, composite materials made up of a thermoplastic matrix and strontium-based hard ferrite powder, and composite materials made of a thermohardening plastic matrix and isotropic neodymium-iron-boron powder, are preferred. Such magnets are known for their ability to be dimensioned at relatively small sizes whilst maintaining relatively high magnetic field strength.

[00041] According to another aspect, the hollow main body comprises a proximal body portion and a distal body portion, wherein the distal body portion is configured and shaped to fit around, and elastically engage with, a dose setting wheel of an injection pen. The distal body portion can therefore be provided in a shape and configuration adapted for each type and shape of injection pen.

[00042] According to another aspect, the rotational stop means comprises a displacement lock system configured to, in a first, locked position, prevent sliding axial movement of the at least one elongate rod within the sheath, and in a second, unlocked position, enable sliding axial movement of the at least one elongate rod within the sheath.

[00043] Accordingly, the displacement lock system can be suitably implemented by, for example, providing a first magnet on the at least one elongated rod member, and a second magnet on the sheath. In the first, locked position, the first and second magnets will be located one with respect to the other to present opposite facing magnetic poles, causing them to be mutually attracted to each other. This mutual attraction will prevent the at least one elongate member from sliding within the sheath, for example, in an unmounted configuration of the injection monitoring module.

[00044] According to another aspect, the second magnet is supported on a rotating locking arm, which is configured to be moved from the first, locked position, in which the second magnet and the first magnet are attracted to each other, thereby preventing axial displacement of the at least one elongate member with respect to the sheath, and vice-versa, into the second, unlocked position, in which rotation of the rotating locking arm causes the second magnet to disengage from the first magnet, thereby allowing relative axial displacement of the sheath with respect to the at least one elongate member, and vice-versa.

[00045] According to another aspect, the first, angular position of the rotational stop means, and the first, locked position of the displacement lock system are synchronized, meaning that when the rotational stop means is located in the first, angular position, the displacement lock system is in the first, locked position, and the sheath and at least one elongate rod member are not free to move axially relative to one another.

[00046] According to yet another aspect, and similarly, the second, angular position of the rotational stop means, and the second, unlocked position of the displacement lock system, are synchronized, meaning that when the rotational stop means is located in the second, angular position, the displacement lock system is in the second, unlocked position, and the sheath and at least one elongate rod member are free to move axially relative to one another.

[00047] The injection monitoring module will now be described in greater detail with regard to the figures in which:

[00048] Figure 1 is a schematic side representation of an injection monitoring module according to the invention;

[00049] Figure 2 is an exploded perspective representation of the injection monitoring module of Figure 1;

[00050] Figure 3 is a schematic side representation of the injection monitoring module of Figure 1, in a first position, and a second position, when mounting the injection monitoring module on a pen injection system;

[00051] Figure 4 is a schematic cross-sectional representation of a part of the injection monitoring module;

[00052] Figure 5 is a schematic perspective representation of a face of a circuit board forming part of an injection monitoring system within the injection monitoring module;

[00053] Figures 6A and 6B are, respectively, magnified schematic cross-sectional representations of a detail of the injection monitoring module in a first position, and in a second position; [00054] Figures 7A and 7B are, respectively, a schematic perspective representation of a body of the injection monitoring module, and a schematic cross-sectional representation of the body of injection monitoring module;

[00055] Figures 8A and 8B are, respectively, schematic cross-sectional representations of the injection monitoring module mounted on a pen injection system in a first position, and the injection monitoring module mounted on a pen injection system in a second position;

[00056] Figures 9A and 9B are, respectively, magnified schematic cross-sectional representations of another detail of the injection monitoring module in a first position, and in a second position.

DETAILED DESCRIPTION

[00057] Turning now to Figures 1 to 3, the injection monitoring module (1) comprises a hollow main body (2) adapted and configured to be coaxially mounted on, and engage in co- rotation with, a dose setting wheel (3), cf . Fig. 8A, 8B of an injection pen system (4), cf. Fig. 3, the hollow main body (2) comprising a central longitudinal bore (5) having a proximal extremity (6) and a distal extremity (7), and a central longitudinal axis (8). A magnetic field production means (9, 10) is located on or within the hollow main body (2), at the proximal extremity of the central longitudinal bore (5). Such a magnetic field producing means can usefully be a pair of diametrally located opposed dipole magnets, i.e. wherein a first magnet, such as a rod-shaped, rectangular, or flat disk magnet, is located with a proximally facing north pole, and a distally facing south pole, and the diametrally opposite located magnet, for example, also a rod-shaped, rectangular, or flat disk magnet, is located with a south pole facing in a proximal direction and a north pole facing in a distal direction.

[00058] The injection monitoring module also comprises an injection monitoring system (11), cf. Fig. 2, comprising at least one or a plurality of magnetic sensors (not shown), the injection monitoring system (11) being located in proximity to, or at, the proximal end (6) of the hollow main body (2). The injection monitoring system (11) is movable in translation along the central longitudinal axis (8) within the bore (5) of the hollow main body (2), from a first monitoring position, to at least a second monitoring position distant from the first monitoring position.

[00059] The injection monitoring module (1) also comprises a rotational stop means

(12) configured and adapted to prevent rotational movement of the injection monitoring system (11) about the central longitudinal axis (8), when the injection monitoring module is mounted on the injection pen system (4), during dose setting and during injection. The rotational stop means comprises at least one elongate rod member (13), or a plurality of elongate rod members, extending from the injection monitoring system (11) in a distal direction in parallel to the longitudinal axis (8) and bypassing an outside surface (14) of the hollow main body (2), and a sheath member (15), mountable on an outer surface (16) of a body (17) of the injection pen system (4), and adapted and configured to receive the at least one, or plurality of, elongate rod members

(13) in sliding engagement with said sheath member (15) during translational movement of the injection monitoring system (11) from a first monitoring position to a second monitoring position.

[00060] The above description corresponds in general to the injection monitoring module already disclosed in published PCT application WO2022079462A1.

[00061] A first significant difference with the device described in published PCT application WO2022079462A1 and the present invention is that the rotational stop means (11) is connected to the hollow main body via an articulation (18). The articulation (18) is illustrated in the figures as a hinge, although other suitable types of articulation could also be configured to function in the same or similar manner. The articulation (18), or respectively, the hinge, is configured to allow a rotational movement of the elongate rod member (13), together with the sheath (15), about a point of rotation (19), or a fulcrum, from a first angular position, 0i, in which the sheath (15) and at least one elongate rod member (13) are angled away from the central longitudinal axis (8) of the injection monitoring module (1), to a second angular position, 0₂, in which both the at least one elongated body (13), and sheath (15), are in parallel longitudinal axial alignment with the central longitudinal axis (8) of the injection monitoring module (1). In practical terms, it will be understood that, relative to the central longitudinal axis (8), in the first angular position, the angle 0i, is equal to greater than 5 degrees and less than 90 degrees, as measured from the central longitudinal axis (8), and in the second angular position, the angle 0₂, is equal to zero, or between 0 degrees and 5 degrees, as measured from the central longitudinal axis (8).

[00062] The provision of an articulation (18), such as a hinge, configured to allow rotational movement of the elongate rod member (13) and sheath (15) from the first angular position, at angle 0_1; to the second angular position, at angle 0₂, enables a user of the injection monitoring module (1) to mount the injection monitoring module (1) at a proximal end of an injection pen system (4), and yet still allows, temporarily at least, and for as long as the elongate rod member (13) and sheath (15) are in the first angular position, the user to correct any potential axial misalignment of the injection monitoring module (1) when mounting the latter on an injection pen system (4), without being constrained by the fixed alignment of the sheath (15) and at least one elongated rod member (13), when the sheath (15) is brought into elastically engaging contact with the outer surface (14) of the injection pen system (4). From a practical point of view, this temporaiy freedom to be able to rotate the injection monitoring system (11) about the central longitudinal axis (8) is most useful, and significantly prevents or markedly reduces the occurrence of incorrect mounting of the injection monitoring system (11) of the injection monitoring module (1) onto the injection pen system (4). Similarly, an additional degree of freedom for the user is now permitted when dismounting the injection monitoring module (1) from the injection pen system (4), since, once the sheath (15) has been angled away, via rotation about the rotation point (19) or fulcrum, from an elastically engaging contact with the outer surface (14) of the injection pen system (4), it now becomes easier to dismount the injection monitoring module (1) by rotating the part of the injection monitoring module including the injection monitoring system (11), about the central longitudinal axis (8), and pulling the injection monitoring module (1) in a proximal direction. [00063] As illustrated in more detail in Figure 2, the articulation (18) comprises several components. For example, the elongated rod member (13) can be suitably configured at a proximal end (20) of the elongate rod member (13) with a pair of spaced-apart hinge gates (21a, 21b), the hinge gates (21a, 21b) each comprising a rotation point (19) pin hole (22a, 22b) for receiving a corresponding connecting pin (23) which passes through pin holes (22a, 22b) of the hinge gates (21a, 21b).

[00064] The injection monitoring system (11) is similar to that described in published PCT application WO2022079462A1, i.e. comprising an injection monitoring system housing (24), shaped and configured to resemble a cup with a stem, with a base wall (25) extending over substantially the same, or similar diameter as the hollow main body (2), and substantially perpendicular to the central longitudinal axis (8), and a first wall (26) extending from an outer peripheiy of the base wall (25), in a proximal direction away from said base wall (25), thereby forming a cup shaped part with an inner volume that is closed by a proximal cap (27) forming an activator button, which is snap or push-fitted or adhered, or otherwise affixed onto said proximally extending first wall (26) at a proximal extremity of said first wall (26). The base wall (25) further comprises a second annular wall (28) extending from the base wall (25) in a distal direction from a location radially spaced apart from the central longitudinal axis (8), and having a diameter smaller than the diameter of the bore (5) of the hollow main body (2), enabling the injection monitoring system housing (24) to move in translation within the bore (5) of the hollow main body (2). The injection monitoring system housing (24) is closed at its distal extremity by a a further cylindrical body (29) which is configured to mate, or otherwise engage, with an inside surface of the second annular wall, for example via twist-fit or snap-fit engagement, to form the stem of the cup. The further cylindrical body (29) is closed at its respective distal extremity by a flexible cross wall (30), and can be made of, for example, a flexible membrane material, which is capable of deforming on contact with an injection activator button (31) of the pen injection system (4). The stem of the cup sits within the bore (5) of the hollow main body (2). The injection monitoring system housing (24), as defined by the cup shaped inner volume, receives and seats an electronic component board (32). The internal volume of the stem formed by the second annular wall (28), further cylindrical body (29), and the cross wall (30) receives an autonomous power supply (33), such as a single use, or rechargeable, battery, for example, a lithium ion batteiy electrically connected to the electronic component board (32) to provide power thereto.

[00065] As can be seen from the figures, in particular from Figure 1, the injection monitoring system housing is also suitably provided with a hinge gate (34), which extends in a distal direction from the base wall (25), and which is configured and shaped to be surrounded by the respective hinge gates (21a, 21b) of the elongate rod member (13). Accordingly, the hinge gate (34) is provided with a rotation point (19) pin hole (35), for receiving the connecting pin (23). The connecting pin thus traverses both the hinge gates (21a, 21b) of the elongate rod member (13), and the hinge gate (34) of the injection monitoring system housing (24), via the respective pin holes (22a, 22b, 35).

[00066] Figure 3 illustrates, schematically, the movement of the injection monitoring module (1), during mounting of the injection monitoring module (1) onto an injection pen system (4), and showing the injection monitoring system housing (24) mounted on, and surrounding the proximal end of the injection pen system (4). In such an arrangement, the injection monitoring system housing (24) surrounds and engages with, via the hollow main body (2), an injection activation button (31) of the injection pen system (4), which injection activation button also serves as the dose setting wheel, against which an inside surface of the hollow body (2) engages, such that rotation of the hollow body (2) causes the dose setting wheel to rotate to the same extent, and thereby enable a dose to be dialed, or selected. Other injection pen manufacturers provide separate dose setting wheels and injection activator buttons, and the hollow body is configured to engage with these dose setting wheels in a similar manner, even though there may not be, in those particular configurations, any contact between the hollow main body (2) and the injection activator button. To that end, the hollow main body (2) comprises a proximal body portion and a distal body portion (36), with the distal body portion (36) being configured and shaped to fit around, and elastically engage with, such a dose setting wheel of the injection pen system (4). Figure 3 thus illustrates not only how the injection monitoring module (1) is mounted to an injection pen system (4), but also the relative positions of the rotational stop (12), during the corresponding phases of mounting to the injection pen system. In a first step, the injection monitoring system housing (24) is located onto, and around the proximal end of the injection pen system (4) to engage with either the dose setting wheel alone, or as illustrated here, with the dose setting wheel and injection activator button, which are one and the same. The rotational stop, comprising the elongate rod member (13) and sheath (15), are located at the first angular position, i.e. at angle 0i, which is angularly removed away from the central longitudinal axis (8). Rotation of the elongate rod member (13) and sheath (15) via the articulation (18) about the rotation point (19) cause a reduction in the angle separating said rod and sheath from the central longitudinal axis (8), and as the sheath (15) begins to engage with an outside surface of the pen system, thereby gripping the injection pen, so the rotational stop means reach the second angular position, angle 0!, which is then aligned, or substantially aligned with the central longitudinal axis (8). The rotational movement is represented in this figure by the arrow. When it is desired to remove the injection monitoring module from the injection pen, the system functions in reverse.

[00067] The at least one elongate rod member (13) extends in a proximal direction beyond the articulation and is configured to form a switch actuator (37). The switch actuator can usefully be shaped as a spigot, or peg, extending from an proximal end of the elongate rod member. The switch actuator (37) is designed to actuate an actuatable switch (38), which is suitably provided on the electronic component board, and is visible in greater detail in Figures 4 and 5. The actuatable switch (38) is configured to selectively energize, and respectively, de-energize, the injection monitoring system (11), and in particular allow power to flow, or respectively cut power, within the electronic component board, when the switch actuator (37) is brought into contact, and respectively, is moved out of contact, with the actuatable switch (38). Figures 6A and 6B illustrate the functioning of the switch actuator (37) and the actuatable switch (38).

[00068] Figure 6A represents a magnified view of the switch actuator (37) and actuatable switch (38) in the first angular position. As can be seen from the figure, the switch actuator (37) which extends beyond the proximal end of the elongated rod member (13) is inclined away from the actuatable switch in this first angular position. However, as the angle is closed between the rotational stop (12), comprising the elongate rod member (13) and sheath (15), when the rod member and sheath are rotated via the articulation (18) about the rotation point (19), and the central longitudinal axis (8), so the switch actuator (37) is moved into a position in which it comes into surface engaging contact with the acutatable switch (38). In the example illustrated by the figures, the surface engaging contact of the actuatable switch (38) can be provided by a distally facing surface (39), for example, made of an elastomeric material, which is provided with a proximally facing projection (40). The peg or spigot of the switch actuator (37) bears down on the elastomeric proximal facing surface (39), which in turn causes said surface to deform, pushing the proximally facing projection (40) onto the switch (38). Once the rod (13) and sheath (15) have reached the second angular position, the spigot of the actuator (37) is fully engaged in proximally directed contact with the distally facing surface (39) and the proximally directed projection (40) fully deformed in the proximal direction to cause the switch (38) to be actuated. This then allows power to be provided to the electronic component board (32). Similarly, when the injection monitoring module is being removed, the rod member (13) and sheath (15) are moved from the second angular position back to the first angular position, and in doing so, the spigot of the actuator (37) is moved away from the position in which it is in surface contact engagement with the proximal facing surface (39), and by extension the proximally directed projection (40), into a position in which it is no longer in said surface contact engagement, thereby releasing the proximally directed projection (40) from engagement with the switch (38), and cutting off power supply to the electronic component board (32). [00069] The electronic component board (32) is appropriately and generally a printed circuit board of suitable dimensions to be located within the internal volume of injection monitoring housing (24). The electronic component board (32) further comprises at least one magnetometer (41), advantageously located on the central longitudinal axis (8), and in the case of a substantially circular shaped component board, substantially in the center thereof so that it is coaxially aligned with the central longitudinal axis (8). In addition to the magnetometer (41), the injection monitoring system (11) also comprises an integrated control and data processing unit electrically connected to the magnetometer (41) for processing information received from the magnetometer. The integrated control and data processing unit handles all electrical communication and signalling between the different electronic components of the injection monitoring system. It is also responsible for execution of the dose management system and calculations enabling the precise positional location of the magnet to be calculated and determined, as well as handling signals from the autonomous power supply (33). The integrated control and data processing unit usually also comprises communication means which communicate with a local or remote data processing system, e.g. on a smartphone, such as a wireless communications circuit, for example, a Bluetooth® or BluetoothLE® wireless communications system, to name but two of many types of suitable communications means. The integrated control and data processing unit can suitably be programmed remotely, upon first use, or receive information and updates, in a similar way to other electronic devices today containing integrated control and data processing units, for example, wirelessly, or via any other suitable link, such as the USB port. Such integrated control and data processing units are known per se, and often integrate a central processing unit, a real time clock, one or more memoiy storage systems, and optionally communications systems or subsystems, along with other desired components. The electronic component board (32) is seated or located within the injection monitoring system housing (24), substantially along the horizontal plane of the circuit board, i.e. generally orthogonal and perpendicular to the central longitudinal axis (8). [00070] Another aspect of the injection monitoring module (1) is illustrated in Figures 7A and 7B, more particularly with regard to the hollow main body (2), and that is the inclusion a temporaiy axial positioning means. In particular, the temporary axial positioning means is configured to maintain a part of the injection monitoring system (11), at least partially within the bore (5) of the hollow main body (2) in a predetermined axial position with respect to the hollow main body (2), pending completion of the mounting of the injection monitoring module (1) onto an injection pen system (4). To that end, the temporary axial positioning means comprise a magnetizable ring (42), for example a split ring, as illustrated in Figure 2, or one or more magnetizable plates, or similar. The magnetizable ring (42), or plates, is or are positioned coaxially and proximally to, and in magnetizable distance of, the magnets (9, 10), located within or on the hollow main body (2), at, or adjacent, the proximal end (6) of the hollow main body (2). For example, the magnetizable ring (42) can be seated in an appropriately provided annular groove (43) or an annular shoulder, located on a distally facing surface of the annular wall (28). As can further be seen from Figures 7A and 7B, the hollow body is provided with seating nubs (44a, 44b, 45a, 45b (not shown)), which extend in a proximal direction adjacent to the locations where the magnets (9, 10) are seated within the hollow body (2). The proximally projecting nubs serve to maintain a physical distance between the magnetizable ring (42) and the magnets (9, 10), this physical separation distance, and the corresponding dimensions of the nubs, being configured according to the strength of the magnets (9, 10), in order to prevent the magnetizable ring (42) from becoming physically stuck to the magnets (9, 10) during mounting, whilst still enabling the magnets to exert a magnetizing effect on the ring (42). In this way, a relatively low separation force is required to overcome the induced magnetic attraction between the ring and the magnets (9, 10) located within the holder body. Such a low separation force can be provided, for example, via a coiled biasing spring (46), such as one suitably located within the further cylindrical body (29) of the injection monitoring system housing (24), the spring driving a movement of the hollow body (2) in a proximal direction, once the elongated rod member is free to move with respect to the sheath (15), as will be described below.

[00071] Another aspect of the injection monitoring module is illustrated in Figures 8A, 8B, and 9A and 9B. The rotational stop means (12) is provided with a displacement lock system (47) configured to, in a first, locked position, prevent sliding axial movement of the elongate rod (13) within the sheath (15), and in a second, unlocked position, enable sliding axial movement of the elongate rod (13) within the sheath (15). The displacement lock system (47) is designed to selectively prevent, or allow, movement of the sheath (15) and rod member (13) relative to one another when mounting the injection monitoring module onto an injection pen system (4). Accordingly, and as illustrated, the displacement lock system (47) includes a first magnet (48) located on the elongated rod member (13), for example, within a magnet housing or recess (49), and a second magnet (50), located on the sheath (15), cf. Fig. 9A. In the first, locked position, the first (48) and second (50) magnets are located one with respect to the other to present opposite facing magnetic poles, causing them to be mutually attracted to each other, and thereby preventing axial displacement of the at elongate rod member (13) with respect to the sheath (15), and vice-versa, cf. Fig. 9A. The second magnet (50) is supported, for example, in a rotatable locking arm (51), having a pivot point or fulcrum (52), suitably provided for, for example, by a pin (53) which traverses a correspondingly provided pair of pivot gates (not shown). The rotatable locking arm (51) is held by the pin (53) within the sheath (15), and is located within a correspondingly dimensioned recess (54) to allow the arm (51) to swing or rotate freely, in the absence of any magnetic attraction with the first magnet (48). The rotatable locking arm (51) is movable by rotation about the pivot point (52) from the first, locked position, in which the second magnet (50) and the first magnet (48) are attracted to each other, into the second, unlocked position, in which the magnets (48, 50) are separated, and the locking arm (51) has rotated to move the end (55) containing the magnet into the recess (54) of the sheath (15). The rotation of the locking arm (51) into the second, unlocked position can, for example, be the result of the effect of gravity, in which the weight of the magnet (50) containing end (55) of the locking arm (51) induces rotation in the locking arm (51) as the elongate rod member (13) and sheath (15) are moved from the first angular position to the second angular position. The rotatable locking arm (51) can also be forced to rotate the magnet (50) containing end (55) out of the rod member recess (49) and away from the first magnet (48) into the sheath recess (54), as the non-weighted, other end (56) of the rotatable locking arm (51) comes into contact with the injection pen system (4) in the second angular position. Once the second magnet (50) is removed from the first magnet (48) by such rotation, and withdrawn into the sheath recess (54), relative axial displacement of the sheath (15) with respect to the elongate rod member (13), and vice-versa, is once again allowed, cf. Fig 9B. As will be understood from the above, this means that the first, angular position of the rotational stop means (12), and the first, locked position of the displacement lock system (47) are synchronized. Similarly, the second, angular position of the rotational stop means (12), and the second, unlocked position of the displacement lock system (47), are also synchronized. Thus, in the first angular position, the rod member (13) and sheath (13) can not move one with respect to the other, as illustrated in Figure 9A, and in the second angular position, such relative movement between the rod member (13) and the sheath is permitted, as illustrated in Figure 9B.

Claims

[Claim 1] Injection monitoring module comprising a hollow main body adapted and configured to be coaxially mounted on, and engage in co- rotation with, the dose setting wheel of an injection pen system, the hollow main body comprising a central longitudinal bore having a proximal extremity and a distal extremity, and a central longitudinal axis; a magnetic field production means, located on or within the hollow main body, at the proximal extremity of the central longitudinal bore; an injection monitoring system comprising at least one or a plurality of magnetic sensors, the injection monitoring system being located at the proximal extremity of, and movable in translation along, the central longitudinal axis within the bore of the hollow main body, from a first monitoring position, to at least a second monitoring position distant from the first monitoring position; a rotational stop means configured and adapted to prevent rotational movement of the injection monitoring system about the central longitudinal axis during dose setting and during injection, wherein the rotational stop means comprises at least one elongate rod member, or a plurality of elongate rod members, extending from the injection monitoring system in a distal direction in parallel to the longitudinal axis and bypassing an outside surface of the hollow main body; and a sheath member, mountable on an outer surface of a body of an injection pen system, and adapted and configured to receive the at least one, or plurality of, elongate rod members in sliding engagement with said sheath member during translational movement of the injection monitoring system from a first monitoring position to a second monitoring position; wherein the rotational stop means is connected to the hollow main body via an articulation.

[Claim 2] Injection monitoring module according to claim 1, wherein the articulation is a hinge.

[Claim 3] Injection monitoring module according to claim 1 or claim 2, wherein the articulation is configured to allow a rotational movement of the elongate rod member, together with the sheath, about a point of rotation of the hinge, from a first angular position in which the sheath and at least one elongate rod member are angled away from the longitudinal axis of the injection monitoring module, to a second angular position in which both the at least one elongated body, and sheath, are in parallel longitudinal axial alignment with the longitudinal axis of the injection monitoring module.

[Claim 4] Injection monitoring module according to any one of claims 1, 2 or 3, wherein the at least one elongate rod member extends in a proximal direction beyond the articulation and is configured to form a switch actuator.

[Claim 5] Injection monitoring module according to any one of claims 1 to 4, wherein the injection monitoring module comprises an actuatable switch, configured to selectively energize, and respectively, de-energize, the injection monitoring system when the switch actuator is brought into contact, and respectively, is moved out of contact, with the actuatable switch.

[Claim 6] Injection monitoring module according to any one of claims 1 to 4, wherein the switch actuator is configured to actuate the actuatable switch when the at least one elongated body and sheath are in the second position of parallel longitudinal axial alignment with the longitudinal axis of the injection monitoring module.

[Claim 7] Injection monitoring module according to any one of claims 1 to 6, wherein the injection monitoring system comprises a temporaiy axial positioning means.

[Claim 8] Injection monitoring module according to claim 7, wherein the temporary axial positioning means is configured to maintain a part of the injection monitoring system, and thereby the injection monitoring system, at least partially within the bore of the hollow main body in a predetermined axial position with respect to the hollow main body, pending completion of mounting of the injection monitoring module on an injection pen body.

[Claim 9] Injection monitoring module according to claim 7 or claim 8, wherein the temporary axial positioning means comprise a magnetizable ring or one or more magnetizable plates, or similar, positioned co-axially and proximally to, and in magnetizable distance of, the magnetic field production means, which are located within or on the hollow main body, at or adjacent a proximal end of the hollow main body.

[Claim 10] Injection monitoring module according to claim 9, wherein the magnetizable ring or plate of material is positioned for example, at or adjacent to, a distal end of the injection monitoring system, for example in a distal area of an injection monitoring system holder.

[Claim 11] Injection monitoring module according to claim 1, wherein the hollow main body comprises a proximal body portion and a distal body portion, wherein the distal body portion is configured and shaped to fit around, and elastically engage with, a dose setting wheel of an injection pen.

[Claim 12] Injection monitoring module according to claim 1, wherein the rotational stop means comprises a displacement lock system configured to, in a first, locked position, prevent sliding axial movement of the at least one elongate rod within the sheath, and in a second, unlocked position, enable sliding axial movement of the at least one elongate rod within the sheath.

[Claim 13] Injection monitoring module according to claim 12, wherein the displacement lock system includes a first magnet on the at least one elongated rod member, and a second magnet on the sheath.

[Claim 14] Injection monitoring module according to claim 13, wherein, in the first, locked position, the first and second magnets are located one with respect to the other to present opposite facing magnetic poles, causing them to be mutually attracted to each other.

[Claim 15] Injection monitoring module according to any one of claims 13 or 14, wherein the second magnet is supported on a rotating locking arm, configured to be moved from the first, locked position, in which the second magnet and the first magnet are attracted to each other, to the second, unlocked position, in which rotation of the rotating locking arm causes the second magnet to disengage from the first magnet. 1

[Claim 16] Injection monitoring module according to claim 1 and any one of claims 12 to 15, wherein the first, angular position of the rotational stop means, and the first, locked position of the displacement lock system are synchronized.

[Claim 17] Injection monitoring module according to claim 1 and any one of claims 12 to 15, wherein the second, angular position of the rotational stop means, and the second, unlocked position of the displacement lock system, are synchronized.