Injection monitoring module with position locking system

Abstract

An injection monitoring module includes a body, a central bore, a central axis, and a magnetic field generating device located on the body. An injection monitoring system including at least one magnetic sensor is translatable along the central axis and located within the bore. The monitoring module includes a rotational stop device that prevents rotational movement of the monitoring system about the central axis during dose selection. The stop device comprises a rotationally fixed coupling parallel to the central axis connecting the monitoring system to the body of the injection pen and allowing the monitoring system to translate from the first monitoring position to the second monitoring position during the injection and from the second monitoring position to the first monitoring position after the injection. The stop device includes a relative positioning device that selectively prevents or permits proximal translation of the monitoring system from the first retracted position to the second deployed position.

Description

Technical Field

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

[0002] Injection monitoring is a well-known area associated with injectable drug delivery devices, particularly, for example, with regard to infusion systems. Over time, such monitoring systems have recently been transferred to injection pen systems for delivering medications, enabling users of such pen injection systems and healthcare professionals involved in the treatment and tracking of such patients to more closely monitor their own injection regimens and, in many cases, the actual doses administered, in an attempt to produce better healthcare outcomes. These developments have been accompanied by an increased associated use of software and portable communication devices, such as tablet computers 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 either instantly or at regular intervals via an appropriate communication unit included in the monitoring system.

[0003] In particular, with respect to pen injection systems, for example, one of the challenges is to provide an easy-to-use, reliable and reasonably safe monitoring system that is adaptable to the various different variants of commercially available pen injection systems, of which there are many. Previous attempts to provide such monitoring systems have generally involved adapting the body of the pen injection system by including electronic components and one or more sensors therein. However, one of the main drawbacks of such systems is that, once all the electronic components are integrated, they tend to make the final product a rather bulky and awkward object, and therefore more difficult to use from the user's perspective. In addition, such modified systems tend to be dedicated to a given brand or manufacturer and therefore rarely or not be used with pen injection devices from other manufacturers. Furthermore, there is a trend to try to reduce the overall volume of the injection pen body as much as possible through miniaturization of complex electronic components, which in turn brings its own problems, particularly with respect to electromagnetic interference between the various components due to the close proximity of the circuits that provide the required or desired integrated functions. Moving the sensors in such a monitoring system further away from the source of electromagnetic interference would only complicate 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 the various components and manage their interactions.

[0004] The injection pen system in question is known per se and is typically equipped with a proximally located dose setting wheel and an injection activator, the dose setting wheel being 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 to mechanically or electromechanically effect an injection when the injection activator is activated. Such an injection activator is typically a simple key or button that is in mechanical or electrical contact with a dispensing mechanism located within the pen injection system, pressing the button causing the injection mechanism to fire and inject the medication contained within the pen injection system. In some pen-type 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 elements, such as a helically wound drive spring located within the housing of the injection pen system and physically coupled to the dose setting wheel. Because these metal components are relatively large objects compared to the electronic component systems included in many of today's pen injection systems, these large metal objects can further interfere with the signals that the sensors in such electronic component systems are designed to capture or pick up, causing the system to be potentially less accurate and / or requiring complex correction mechanisms to be placed in place to avoid calculation errors.

[0005] Some attempts to overcome the difficulties of electronic component integration have been described in the patent literature.

[0006] For example, published PCT patent application WO2014128156A1 relates to a sensor assembly having a first rotating sensor component and a second rotating sensor component, the first rotating sensor component having a plurality of separate electrically conductive sensor areas arranged in a pattern, the second rotating sensor component being arranged rotationally relative to the first component and comprising a plurality of contact structures adapted to contact the conductive sensor areas on the first sensor rotating part. The contact structures are configured to engage and connect different sensor areas when the first and second components of the rotating sensor rotate relative to each other, the created connection indicating the rotational position between the first and second parts. One of the contact structures is an actuable contact structure that is axially movable relative to the first part and has a connected position and a disconnected position, in which the actuable contact structure contacts the sensor area and in which the actuable contact structure does not contact the sensor area. The system is housed in a pen injector body, at least partially in a volume within a dose setting wheel. The system also includes a visual display, such as an LCD display located on or in place of an injection activator button.

[0007] In contrast, published PCT application WO2018013419A1 relates to a dose detection system comprising a dosing element attached to an actuator and rotatable and axially movable relative to a coupling element attached to a dose setting member, and comprising a module comprising an electronic sensor operable to detect relative rotation of the coupling element and the dosing element to detect a dose delivered by a drug delivery device. The dose detection module is removably coupled to a proximal end of a pen injection system and is intended to be used as a means for detecting an amount of drug dispensed by the pen injection system when attached thereto, storing the detected dose in a memory, and transmitting a signal representative of the detected dose to a remote communication device. The system includes a pair of rotatable and translatable cylinders that interact with each other via electrical contacts disposed on the surfaces of the cylinders to indicate various states or positions of an injection administration process including dose setting, the electrical contacts being connected to a collection of electronic components housed on a flexible printed circuit board that is disposed in an overlapping, folded, accordion-like arrangement within a detachably coupled body, and the flexible printed circuit board being insulated between overlapping layers of the circuit board by a non-conductive isolation layer to prevent potential electrical, electronic, and electromagnetic interference.

[0008] One direct observation of the above configuration is that, despite the use of a folded flexible printed circuit board to provide multiple surfaces on which to position electronic components, the relative spatial density and positioning of the electronic components to one another requires the provision of non-conductive spacers between the layers of electronic components. A direct consequence of this is the increased height in the module and the consequent increased complexity of the clip-on dose detection module described therein.

[0009] In addition, various other injection monitoring modules for injection pen systems are also known from published PCT applications WO2019 / 175790, WO2019175615, WO2018138542, WO2017013464 and WO2017013463. Summary of the invention

[0010] Accordingly, one aspect of the present invention is to provide an injection monitoring module adapted and configured to be removably attached to a proximal end of an injection pen system for delivering a drug, the injection pen system having a dose setting wheel rotatable about a central longitudinal axis of the pen injection system to set a dose of the drug to be injected and optionally secured to prevent rotation during injection, while eliminating the need for complex shielding or protection solutions to counteract any undesirable electrical, electronic or electromagnetic effects caused by the relatively high density of electronic components within the monitoring module.

[0011] Another aspect of the present invention is to provide an injection monitoring module as described above, wherein the monitoring module is adapted and configured to determine the dose that has been set and the injection start point. For the purposes of the present invention, the expression "injection start point" as used herein refers to the moment when the injection mechanism in the pen is activated. This is usually achieved by moving an injection activator, such as a button located on the proximal end of the pen injection system, in a distal direction.

[0012] Another aspect of the present invention is to provide an injection monitoring module as described above, wherein the module is adapted and configured to detect or calculate the dose or quantity of injectable substance contained in the pen injection system set by the user, the injection start or starting point in the pen injection system, and the injection endpoint, and thereby determine whether all doses or quantities of injectable substance set by the user of the pen injection system have been expelled from the pen system.

[0013] Another aspect of the present invention is to provide an injection monitoring module as described above, wherein the module is equipped with a relative positioning device for selectively positioning components of the injection monitoring module in one or more preset spatial relationships during installation, after installation in preparation for normal operation, and during removal or uninstallation of the injection monitoring module from the pen-type injection system and from the pen-type injection system, respectively.

[0014] These and other aspects of the present invention will become apparent from a complete reading of this specification.

[0015] According to any of the above aspects, there is thus provided an injection monitoring module adapted and configured to be removably mounted to a proximal end of an injection pen system for delivering a drug, the injection pen system having a pen body, a proximally located dose setting wheel connected to the body, the dose setting wheel being rotatable about a central longitudinal axis of the pen injection system during dose setting, and an injection activator, wherein the injection monitoring module comprises:

[0016] a hollow body adapted and configured to be coaxially mounted on and co-rotatably engaged with the dose setting wheel at a proximal end of the injection pen system, the hollow body comprising a central longitudinal bore having a proximal end and a distal end and a central longitudinal axis;

[0017] a magnetic field generating device located on or within the hollow body at a proximal end of the central longitudinal bore;

[0018] an injection monitoring system including at least one or more magnetic sensors, the injection monitoring system being located at the proximal end of the hollow body and being capable of translationally moving within the bore of the hollow body along the central longitudinal axis from a first monitoring position in which the injection monitoring system is not in abutting contact with the proximal surface of the injection activator to a second monitoring position in which the injection monitoring system is in abutting contact with the proximal surface of the injection activator;

[0019] an injection monitoring module, the injection monitoring module further comprising a rotation stop constructed and adapted to prevent rotational movement of the injection monitoring system about the central longitudinal axis during dose selection;

[0020] wherein the rotation stop device comprises a rotationally fixed coupling member arranged parallel to the central longitudinal axis, the rotationally fixed coupling member connecting the injection monitoring system to the main body of the pen-type injection system;

[0021] wherein the rotation stop is constructed and adapted to allow the injection monitoring system to translate from the first injection monitoring position to the second injection monitoring position during injection, and vice versa, from the second injection monitoring position to the first injection monitoring position after injection is completed; and

[0022] In which, the rotation stop device also includes a relative positioning device, which is configured to prevent the injection monitoring system from moving translationally in the proximal direction and leaving the retracted position in a first retracted installation position, and to allow the injection monitoring system to move translationally in the proximal direction and leave the retracted position to reach a second expanded installation position in a second expanded position.

[0023] The relative positioning device referred to in this specification is configured to prevent any undesired movement of the injection monitoring module during installation and / or removal relative to the pen-type injection system. It should also be understood that such a relative positioning system is intended to prevent the injection monitoring module from detecting a potentially undesirable or unintended translational movement event of the injection monitoring module along the central longitudinal axis when the injection monitoring module is installed on or removed from the pen-type injection system. More advantageously, the relative positioning device is configured to prevent the injection monitoring system from translating in the proximal direction and leaving the retracted position in a first retracted mounting position, and to allow the injection monitoring system to translate in the proximal direction from the retracted position to a second deployed mounting position in a second deployed position. This means that, during installation on the pen-type injection system, the injection monitoring module assumes a retracted mounting configuration, wherein the relevant elements of the injection monitoring module, in particular the hollow body and the injection monitoring system, are either in close surface contact with each other along the central longitudinal axis to minimize the total combined length of these two elements, or are otherwise maintained in a reduced length configuration compared to the deployed mounting position, in which the hollow body and the injection monitoring system assume their respective normal operating positions and corresponding total combined lengths along the central longitudinal axis. In addition, in the retracted mounting configuration, the hollow body and the injection monitoring system are prevented from translational movement relative to each other along the central longitudinal axis and preferably in the proximal direction. In the deployed, mounted configuration, the injection monitoring system is positioned relative to the hollow body in its normal and intended operating position by selectively operating the relative positioning device to allow translational movement of the injection monitoring system in the proximal direction along the central longitudinal axis.

[0024] As used herein, the terms "pen injection system" and "injection pen system" are used interchangeably to refer to generally handheld pen injection systems that are themselves well known and commercially available for the treatment of many various medical indications. These systems are also generally designed for self-injection of medication by a user who needs treatment for a given medical indication. For example, various forms of insulin for the treatment of diabetes, such as Novo Nordisk's commercially available Insulin®, are available for the treatment of diabetes. Pen injection system, Eli Lilly's Pen injection system or Lantus from Sanofi Pen injection systems are just three of the most well-known. Other drugs are also used with such medical devices and are needed, for example, to address potentially life-threatening situations, allowing for immediate emergency injection of needed medications, such as anaphylactic shock treatment, anticoagulants, opioid receptor agonists and antagonists, etc., to the extent that it has become common for patients suffering from or susceptible to such conditions to carry these devices with them.

[0025] The injection pen system to which the injection monitoring module according to the present invention is adapted and configured to be removably attached is equipped with a dose setting wheel and an injection activator located proximally. The dose setting wheel rotates around the central longitudinal axis of the pen injection system to allow the user to set the dose of the drug for injection. During the dose setting or dose "dialing" step, the dose setting wheel can usually be rotated in clockwise and counterclockwise directions, which usually correspond to the increase of the selected dose to be administered and the decrease of the selected dose, or vice versa, respectively, depending on the manufacturer. The injection activator is usually represented by a button, usually located proximally of the dose setting wheel, and in most injection pens at the proximal end of the injection pen system. After the dose has been set or "dialed", as the term is generally known in the art, when the user of the injection system then presses the injection activator in the distal direction, the piston connected to the plunger is driven so that the drug is discharged from the chamber in the injection pen body through the needle, which the user has inserted into the appropriate injection site, such as 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 the injection pen, also rotate as the injection of the drug proceeds. The functioning of such injection systems is known per se in the art. The monitoring module envisaged according to the present invention is intended to be mounted on a pen-type injection system, wherein the dose setting wheel can be configured to rotate during the ejection / injection phase of operation, or, conversely, not to rotate during the ejection / injection phase of operation of the pen-type injection system. For example, the above-mentioned The injection pen does not have a dose setting wheel that rotates during injection, and the Lantus and The dose setting wheel of the injection pen rotates during injection.

[0026] Therefore, the injection monitoring module according to the present invention is adapted and configured to be removably attached to the proximal end of such an injection pen system. The expressions "removably attachable", "removably attachable", "removably mounted" or "removably mountable" that may be used in the present specification should be understood to refer to the possibility of attaching or mounting the injection monitoring module 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 needs to be replaced. Such attachment and subsequent removability can be achieved by providing a coupling device on the monitoring module, which coupler device engages with the proximal end of the pen injection system in a releasable manner, for example via friction or elastic engagement, or via other releasable fastening means, such as a clip, a strip, a thread and a corresponding fastening ring, etc., which engage with the dose setting wheel or the injection actuator and / or even the body of the pen injection system.

[0027] Reference in this specification to rotation stop means is to be understood as means by which the injection monitoring system is physically prevented from rotating about the central longitudinal axis during dose setting / dose dialing and optionally and advantageously also when the injection monitoring system is moved from a first injection monitoring position to a second injection monitoring position and vice versa, i.e. when the injection monitoring system is moved from the second monitoring position back to the first injection monitoring position.

[0028] An advantage of providing such a rotation stop in the injection monitoring module envisaged by the present invention is that the setting or "dialing" of a dose in the first injection monitoring position will be recognised by the injection monitoring system as a selected dose, whereas if the injection monitoring system is allowed to rotate for any reason during dialling of a dose by rotation of the dose setting wheel, such recognition of the dialled dose as the selected dose will not necessarily be correct. A further advantage of such a rotationally arrested or stopped monitoring module provided by the present invention during selection of a dose to be injected is that in subsequent injections it does not matter whether the injection monitoring system rotates, either accidentally or by design, thereby eliminating the need for any other corrective measures for determining the selected dose which might otherwise be necessary.

[0029] The rotationally fixed coupling is constructed and adapted to prevent the injection monitoring system from rotating about the central longitudinal axis during dose setting or dialing, and more generally and advantageously when the injection monitoring system is translated from the first monitoring position to the second monitoring position, and further advantageously when the injection monitoring system is translated from the second monitoring position back to the first monitoring position. In this way, when the user releases the digital pressure on the injection activator cap of the injection monitoring system, one can ensure that the injection monitoring system does not rotate, whether accidentally or intentionally, but in particular not during dose selection or dose dialing, and advantageously also not during injection of the dialed dose, but after the injection is completed.

[0030] According to another aspect, the rotationally fixed coupling comprises:

[0031] an elongated rod member extending from the injection monitoring system in a distal direction parallel to the longitudinal axis and passing around an outer surface of the hollow body; and

[0032] A sheath member mounted on the body of the injection pen system is adapted and configured to receive the elongated shaft member in sliding engagement therewith during translational movement of the injection monitoring system from the first monitoring position to the second monitoring position.

[0033] It will be appreciated from the above that the elongated rod member and the corresponding sheath member cooperate with each other to allow the elongated rod member to slide in engagement within the sheath member when the injection monitoring system is moved from the first injection monitoring position to the second injection monitoring position, but vice versa, that is, from the second injection monitoring position back to the first injection monitoring position. The sliding engagement between the elongated rod member and the sheath member occurs substantially parallel to the central longitudinal axis.

[0034] As described above, the slender rod member extends from the injection monitoring system in a distal direction, that is, in a direction away from the proximal end of the injection pen system and the injection monitoring module, and extends parallel to the central longitudinal axis. The slender rod member is also located outside the outer surface of the hollow body and is shaped and sized to bypass the hollow body outside thereof and therefore not interfere with the dose setting function of the hollow body, which requires rotation in order to be able to set a dose on the pen injection system through co-rotational contact with the dose setting wheel. Similarly, the shape and size of the slender rod member are constructed and adapted so that the slender rod member also does not interfere with any optional rotation of the dose setting wheel during injection. The manufacturer of the pen injection system should have configured the pen to, for example, be compatible with Sanofi. or The pen injection system works the same way.

[0035] According to another aspect, a slender rod member is provided with a proximal end, which is arranged or fixed in a part of a retainer body or shell of an injection monitoring system, for example by providing an enlarged proximal cross-section at the proximal end of such slender rod member, and a correspondingly formed recess with a reduced cross-sectional outlet diameter is provided in the body or shell of the injection monitoring system to prevent the slender rod member from being pulled out of the shell.

[0036] Alternatively, and according to yet another aspect, the elongate rod member is integrally formed with the injection monitoring system holder.

[0037] Advantageously, and according to a further aspect, the elongated rod member is integrally formed with an activation cap of the injection monitoring system holder. The injection monitoring system is provided with a cap which the user presses to activate the injection, the cap enclosing the magnetic field sensor within the injection monitoring system holder body or housing. Thus, according to this aspect, the rod member extends from the cap in a distal direction parallel to the central longitudinal axis and also passes around the hollow body contacting the dose setting wheel on the pen.

[0038] According to yet another aspect, the elongated rod member comprises at least one portion of the elongated rod member defining an elliptical spline extending in a distal direction from the injection monitoring system parallel to the central longitudinal axis. By "elliptical spline", it is to be understood that, although the elongated rod member extends in a direction substantially parallel to the central longitudinal axis, according to the said another aspect, it is at least partially defined along the length of the rod by an elliptical spline curve, that is, a curve similar to an arc of an ellipse, which extends towards the body of the pen-type injection system. Typically, the spline curve portion of the elongated rod member will be configured to maintain a sufficient distance between the elongated rod member and the body of the pen when the injection monitoring system is moved from a first monitoring position to a second monitoring position and back again, so that the elongated rod member never contacts an outer surface of the body of the injection pen-type system.

[0039] The elongated rod member is appropriately sized, for example having a thickness of a corresponding material that makes the elongated rod member semi-rigid along the length of the elongated rod member. Suitable suitable materials for the elongated rod member are, for example, semi-rigid plastic materials, such as a mixture of polycarbonate (PC) and acrylonitrile-butadiene-styrene (ABS) copolymer, commonly referred to as PC / ABS mixtures, but other suitable polymers and polymer mixtures that provide suitable rigidity are generally known to those skilled in the art, and the elongated rod member can therefore be made or composed of any such suitable rigid material.

[0040] According to yet another aspect, the elongated shaft member includes a spigot that projects outwardly from an outwardly facing surface of the elongated shaft member and away from a body of the pen injection system when the injection monitoring module is mounted on the pen injection system. The spigot is advantageously located at or near a distal end of the elongated shaft member and includes a shaft portion extending from the outwardly facing surface of the elongated shaft member, the shaft portion of the spigot terminating in a flat head having a diameter greater than a diameter of the shaft portion of the spigot. The function of the spigot and the head will be further understood with respect to the sheath, details of which will be provided below.

[0041] As described above, the rotationally fixed coupling also includes a sheath member including a runnel, which is constructed and adapted to receive the elongated rod member in a sliding engagement, respectively. Therefore, according to another aspect, the funnel extends parallel to the central longitudinal axis. The funnel of the sheath member is aligned with the elongated rod member so that the elongated rod member is inserted into and received by the funnel before the injection monitoring module is mounted on the pen injection system. The funnel is generally constructed and dimensioned as an open slot having a sidewall having a corresponding and corresponding longitudinally oriented opening, which is parallel to the central longitudinal axis. The size of the longitudinally oriented opening is designed to receive the shaft portion of the plug, so that the extent of any lateral movement of the shaft portion of the plug is limited to the size of the longitudinally oriented opening. The size of the longitudinally oriented opening is configured to allow the shaft portion of the plug to move in the proximal and distal directions along the opening during the operation of the injection monitoring module and when moving from the retracted mounting position to the expanded mounting position.

[0042] According to yet another aspect, the longitudinal opening disposed within the sheath further comprises a distal end and a proximal end, wherein the distal end and the proximal end of the longitudinal opening are configured and sized to receive a flat head of the plug therein and to allow the flat head of the plug to be inserted into or withdrawn from the appropriately sized proximal and / or distal ends of the longitudinal opening. This interaction provides secure axial tracking of the elongated rod member within the sheath member and prevents accidental retraction of the elongated rod member if an undue lateral force is exerted on the elongated rod member or the sheath member by a user of the injection monitoring module attempting to separate the rod member from the sheath, or vice versa.

[0043] As will be appreciated from this specification, the sheath member is mounted on the body of the injection pen system. Therefore, according to a further object, the sheath member further comprises a body mounting portion, which is configured and adapted to enable the sheath member to be removably mounted to the body of the pen injection system. The body mounting portion of the sheath member may comprise a wall made of, for example, a plastic or polymer material, such as polycarbonate (PC), acrylonitrile-butadiene-styrene (ABS) copolymer or a mixture thereof, referred to as PC / ABS blend, whereby the wall extends circumferentially around the body of the pen injection system and is dimensioned to allow the pen body to be inserted into the hole formed by the circumferentially extending wall by an appropriate size of the hole of the sheath member and simultaneously engage with the outer surface of the pen body in a resilient friction engagement. Optionally, and advantageously, the circumferentially extending wall is provided with a softer, more resilient wall portion, such as made of elastomer SEBS or a similar elastomeric polymer, to engage and clamp a corresponding surface portion of the body of the pen, thereby preventing any undesired axial sliding movement of the pen within the hole of the circumferentially extending wall of the sheath member. Suitable elastomeric materials to fulfil this function are known per se in the art.

[0044] As already mentioned elsewhere in this specification, the rotation stop means comprises a relative positioning means configured to prevent the injection monitoring system from translational movement in the proximal direction and leaving the retracted position in a first retracted mounting position and to allow the injection monitoring system to translationally move in the proximal direction from the retracted position to the second deployed mounting position in a second deployed position. For example, the relative positioning means comprises a locking system configured to engage with either the sheath and / or the elongated rod member in a selectively actuatable manner, such that a user can lock and respectively unlock the relative axial movement of the elongated rod relative to the sheath, thereby allowing the injection monitoring system to move in the proximal direction from the retracted position to the deployed position. Similarly, after the user has achieved use of the injection monitoring module, or, for example, if the user wishes to move the injection monitoring module to a new pen-type injection system, the injection monitoring system can be moved axially in the distal direction and the selectively actuatable locking system is engaged, whereby the injection monitoring module will again assume the retracted position, ready to be removed or unloaded from the pen-type injection system.

[0045] As will be appreciated from the above, the relative positioning device interacts with the elongated rod member and / or the sheath member to maintain the hollow body and the injection monitoring system in a retracted position during installation of the injection monitoring module on the pen-type injection system. Thus, the relative positioning device is used to maintain the hollow body, the injection monitoring system, the elongated rod member and the sheath member as a single mountable unit in a predetermined compressed or folded spatial relationship during installation of the monitoring module on the pen-type injection system, so as to avoid any accidental, undesirable axial displacement of the monitoring module when the hollow body is installed on the dose setting wheel of the pen-type injection system. As will be appreciated from the above, selectively locking the injection monitoring module via actuation of the relative positioning device in a retracted position typically occurs prior to installation of the injection monitoring module on the pen-type injection system, which is why this position is designated as the retracted installation position, but also when the injection monitoring device is removed from the pen-type injection system. In this retracted position, the injection monitoring system is physically prevented from accidentally moving axially, thereby avoiding any adverse triggering of erroneous readings in the injection monitoring system. Once the injection monitoring module has been installed and the hollow body is correctly positioned on the dose setting wheel of the injection pen system, the relative positioning device can be actuated, e.g. unlocked, to allow the injection monitoring module to be moved in the proximal direction to the deployed installation position. Unlocking of the relative positioning device allows the injection monitoring system to be moved to an operationally ready position, also referred to as the deployed, installation position. Since the unlocked position allows the plug of the elongated rod member to move axially within the funnel of the sheath, the injection monitoring system can be moved in the proximal direction, e.g. under the impetus of the recoil energy of a proximal activator button of the pen injection system or alternatively via a biasing spring located at the distal end of the injection monitoring system, which is compressed in the locked and retracted position and can be decompressed in the unlocked position to move the injection monitoring system in the proximal direction to assume the deployed installation position.

[0046] Therefore, according to another aspect, the relative positioning device includes a rotatable selectable lock located on the sheath, which is configured to rotate from a first locked position to a second unlocked position around an axis perpendicular to the central longitudinal axis. The rotatable selectable lock may suitably include, for example, a locking head. The selectable lock is appropriately configured and dimensioned to engage with the shaft portion and / or advantageously the flat head of the protruding portion of the elongated rod member in a first locked position, thereby preventing the flat head and / or shaft portion of the plug from longitudinal axial movement in the sheath, and in the second unlocked position, allowing the shaft portion and / or flat head of the plug to move longitudinally axially in the sheath (and in particular in the funnel). The rotatable selectable lock may be suitably actuated, for example, via the rotation of a user's finger or thumb on a correspondingly shaped surface located on the outwardly facing surface of the sheath, and may, for example, be configured to allow a quarter rotation around the vertical rotation axis to move the locking system from the locked position to the unlocked position.

[0047] The hollow body of the injection monitoring module comprises a central longitudinal bore having proximal and distal ends, the bore being sized to allow the hollow body to be coaxially mounted onto and about the body of a pen-type injection system. The hollow body is suitably made of any suitable material, such as a durable polymer or plastic material, such as high density or high impact polypropylene, or alternatively, polycarbonate. Advantageously, the hollow body is made of a transparent, translucent or opaque material so as to enable the user to understand and identify any visual cues, such as light emitting diodes, which may also be provided or integrated into the injection monitoring module, wherein such cues may optionally be used to indicate various operating states of the injection monitoring system.

[0048] Therefore, according to another object, the hollow body also includes a translational abutment device adapted and configured to prevent an axial translational movement of the hollow body along the central longitudinal axis when the injection monitoring module is in the installed position on the injection pen system. During installation of the injection monitoring module on the pen injection system, the translational abutment device defines the limit of the axial translational movement of the hollow body along the central longitudinal axis relative to the activation button of the pen injection system. Advantageously, and according to yet another object, the translational abutment device of the hollow body includes an annular flange extending inwardly into the hole from the inner surface of the hollow body towards the central longitudinal axis. During installation of the injection monitoring module on the injection pen system, the annular flange has a distal surface that contacts the proximally facing surface of the activation button of the pen, thereby preventing any further translational movement of the hollow body along the central longitudinal axis.

[0049] According to a further object, the hollow body further comprises a distal body portion extending around the outer surface of the dose setting wheel and frictionally and elastically engaging with the outer surface of the dose setting wheel. Such a distal body portion may, for example, extend substantially from the annular flange described in the preceding paragraph, or may be represented by a separately attachable hollow distal portion of the hollow body, which may, for example, be connected to the hollow body via a socket and bayonet mount or a threaded fit or snap-lock mount, and which is constructed and dimensioned to have a hole of a size that matches the dose setting wheel of an injection pen system. The frictional elastic engagement may, for example, be provided via a suitable elastomeric coating or deposit on the inner circumferential surface of the distal portion of the hollow body, for example in one or more areas, or alternatively as a continuous, contiguous, or semi-continuous / continuous coating deposited on the inner circumferential surface of the distal portion of the hollow body. The purpose of such a frictional elastic coating or deposit is to provide a friction clamp between the distal body portion and the dose setting wheel so as to maintain the correct positioning of the hollow distal body portion with the dose setting wheel. Suitable types of elastomeric materials which may provide a corresponding frictional engagement are known per se in the art, a suitable elastomeric material being for example SEBS.

[0050] As already mentioned elsewhere in this specification, the injection monitoring module comprises an injection monitoring system. Such a system comprises at least one or more magnetic sensors, the injection monitoring system being substantially located at or adjacent to the proximal end of the hole of the hollow body. The injection monitoring system will be described in more detail below, but in principle, the injection monitoring system comprises a number of different elements and means for providing injection status monitoring, such as:

[0051] Start of injection procedure;

[0052] Termination or end of an injection operation, whereby termination of an injection operation should be understood to cover the complete administration of a selected dose of the substance to be injected, or a discrete injection operation in which the user only injects a portion of the dose or causes a portion of the selected dose to be expelled from the pen injection system.

[0053] Furthermore, according to another object of the present invention, the injection monitoring system is movable along the central longitudinal axis from a first monitoring position in which the injection monitoring system is not in abutting contact with the proximal surface of the injection actuator to a second monitoring position in which the injection monitoring system is in abutting contact with the proximal surface of the injection actuator. The injection monitoring system is advantageously mounted at the proximal end of the hole of the hollow body and preferably completely covers or at least substantially covers the proximal end of the hole.

[0054] It will be appreciated from the above that the injection monitoring system can be moved from a first position, in which there is no physical contact between the injection monitoring system and the activator button of the pen-type injection system, to a second position, in which physical contact is established between the monitoring system and the proximal surface of the injection activator of the pen-type injection system. Such movement is typically a translational movement of the monitoring system from the first position to the second position along the central longitudinal axis. The injection monitoring module is configured such that rotation of the hollow body and the correspondingly coupled dose setting wheel will result in a determination that the set dose or the dialed dose is the dose that has been selected, because the injection monitoring system is locked from rotational movement about the central axis during dose setting. When the injection monitoring system begins to translate along the central longitudinal axis from the first monitoring position toward the second monitoring position, a determination of the start of injection will also be achieved by detecting an increase in the magnetic norm. When the monitoring system translates in the proximal direction, i.e., from the second monitoring position to the first monitoring position, thereby removing the physical contact between the activator button of the pen-type injection system and the monitoring system, the injection monitoring system is configured to detect the end point of the injection or ejection of the injectable substance. One way to achieve this is to construct a reference point corresponding to the first monitoring position, and use, for example, a suitably constructed sensor to detect when the injection monitoring system is moved back to that reference point from any other point.

[0055] The translational movement in the direction opposite to the injection direction, i.e. the translational movement of the monitoring system in the proximal direction rearwardly towards the hand or thumb of the user, can be suitably provided by utilizing the recoil energy of a biasing spring which is compressed during injection activation and relaxes when the activation button is released, and which biasing spring may also be suitably arranged in the aperture and form part of the injection monitoring system. After the activation cap has been released by the user, for example by removing thumb or finger pressure on the activation cap directly or indirectly, the recoil energy of the compressed biasing spring in the aperture will cause the injection monitoring system to move away from the activation button of the pen, thereby biasing the injection monitoring system back to the first monitoring position.

[0056] According to another object of the present invention, the monitoring module of the present invention comprises a magnetic field generating device, which is located on or in the hollow body, adjacent to the proximal end of the central longitudinal hole or at the proximal end of the central longitudinal hole. By stating "located on or in the hollow body", it should be understood that the magnetic field generating device can be located on the proximal surface of the hollow body, for example, at the proximal end of the central hole. Alternatively, and preferably, the magnetic field generating device can be located in a cavity or recess, which is arranged in the hollow body at or near the proximal end of the central hole.

[0057] Various devices for generating magnetic fields are known, for example, conventional magnets, electromagnets and hybrid material magnets. Such magnets are usually made of magnetizable materials, having magnetic or paramagnetic properties, either naturally or when an electric or other energy flow traverses or affects the material to generate or induce a magnetic field in the material. Suitable materials may be suitably selected from:

[0058] - ferrite magnets, in particular sintered ferrite magnets, such as crystalline compounds containing iron, oxygen and strontium;

[0059] - Composite materials consisting of a thermoplastic matrix and isotropic NdFeB powder;

[0060] - composite materials made of a thermoplastic matrix and strontium-based hard ferrite powder, whereby the resulting magnets may contain either isotropic, ie non-oriented, ferrite particles, or anisotropic, ie oriented, ferrite particles;

[0061] - Composite materials made of a thermosetting plastic matrix and isotropic NdFeB powder;

[0062] - magnetic elastomers made of large quantities of charged strontium ferrite powder, for example mixed with synthetic rubber or PVC, and subsequently either extruded into the desired shape or calendered into fine sheets;

[0063] - Flexible calendered composites, which usually have the appearance of brown sheets and are more or less flexible depending on their thickness and their composition. These composites are never as elastic as rubber and tend to have a Shore hardness in the range of about 40 Shore D ANSI to about 70 Shore D ANSI. Such composites are usually formed from a synthetic elastomer filled with strontium ferrite particles. The resulting magnets can be anisotropic or isotropic, the sheet variety usually having a magnetic particle alignment due to calendering;

[0064] - a laminated composite material, typically comprising a flexible composite material as described above laminated together with a soft iron plate;

[0065] - Neodymium-Iron-Boron magnets;

[0066] - steel made of aluminum-nickel-cobalt alloy and magnetized;

[0067] - Alloy of samarium and cobalt.

[0068] In the above list of magnetic field generating means suitable for the present invention, preference is given to those selected from the group consisting of neodymium-iron-boron permanent magnets, magnetic elastomers, composite materials made of a thermoplastic matrix and strontium-based hard ferrite powder, and composite materials made of a thermosetting plastic matrix and isotropic neodymium-iron-boron powder. Such magnets are known to be able to be dimensioned in relatively small dimensions while maintaining a relatively high magnetic field strength.

[0069] Although the magnetic field generating device can be of any suitable general shape, such as a disk including a circular, elliptical or any other suitable polygonal shape, it is preferred that it has only a single dipole, with a single pair of diametrically opposed north and south magnetic poles. Although the magnetic field generating device can also optionally be substantially disk-shaped, such a disk shape also preferably includes a magnet having a hole substantially in the center of the disk to form an annular or ring-shaped magnet. Such an annular or ring-shaped magnet can be usefully placed on the peripheral annular and proximally facing surface of the hollow body at its proximal end. Advantageously, and for the purposes of the currently envisioned construction of the injection monitoring module, the dipole magnets are rod-shaped or cylindrical dipole magnets, one positioned relative to the other in an orientation facing opposite poles, such as NS is aligned with SN, whereby the magnets are positioned to lie flat along their own longitudinal axis, across a horizontal plane that bisects the central longitudinal axis and is orthogonal to the central longitudinal axis, each magnet being positioned on opposite sides of the central longitudinal axis, such as rotated 180° around the central longitudinal axis, one relative to the other.

[0070] The magnetic field generating means is arranged such that the magnetic field sensor will detect any changes in the magnetic field, eg due to rotational movement of the hollow body relative to the magnetic sensor during dose setting, thereby enabling determination of the adjusted dose set via the dose setting wheel.

[0071] The magnetic field sensor is used to measure the magnetic field generated by the magnetic field generating device. When the dose wheel rotates, the movement of the hollow body and the magnetic field generating device relative to the rotationally fixed magnetic field sensor about the central longitudinal axis is used to calculate or determine the dose of the injectable substance in the injection pen system, which dose has been dialed or set by the user. Once the dose has been set, actuation of the proximal actuator cap causes the injection monitoring system housing and the correspondingly accommodated magnetic field sensor provided therewith to move in translation along the central longitudinal axis for determining or calculating whether the injection has been started. Conversely, and correspondingly, when the finger or thumb pressure on the proximal actuator cap is released, the recoil energy in the biasing spring at the distal position of the housing located within the injection monitoring system housing causes the injection monitoring system to recoil, thereby causing the injection monitoring system housing to move in translation along the central longitudinal axis in the proximal direction towards the user's thumb or finger, thereby also causing the magnetic field sensor accommodated in the injection monitoring system to move in the proximal direction.

[0072] As described above, during an injection, when digital pressure is applied to the housing of the injection monitoring system in a distal direction along the central longitudinal axis, the magnetic field sensor will detect changes in the magnetic field caused by the sensor translating in the distal direction along the longitudinal axis toward the magnetic field generating device and then in the opposite proximal direction as the digital pressure is released from the injection monitoring system.

[0073] Furthermore, the compression characteristics of the biasing spring and the degree of resistance provided by said compression characteristics against distal movement of the injection monitoring system can advantageously and appropriately be used as a means for increasing the sensitivity of the monitoring system for the detection of the injection start point. For example, in the event of an uncontrolled distal directed movement, in which a user may suddenly push downwards on a start cap of the monitoring module, an error may be caused in the injection monitoring system regarding the start of an injection due to the sudden increase in the magnetic norm that will be detected by the magnetic field sensor. Due to the compression characteristics of the biasing spring, such rapid distal movement of the injection monitoring system and the corresponding increase in the magnetic norm are suppressed to a level that the magnetic sensor can easily and without error handle, thereby making the determination of the injection start point safer and more certain. In this sense, it can be seen that the biasing spring more broadly represents a damping device for assisting in the correct determination of the injection start event.

[0074] Generally with respect to magnetic sensors, devices for measuring magnetic fields to determine are well known in the art. For example, magnetoresistance is a well-known device. Such magnetoresistance is often referred to by their abbreviations, such as AMR, GMR, TMR sensors, which represent the physical mechanism by which these sensor elements function. Giant magnetoresistance (GMR) is a quantum mechanical magnetoresistance effect observed in thin film structures consisting of alternating ferromagnetic and non-magnetic conductive layers. Anisotropic magnetoresistance or AMR is believed to exist in materials where a dependence of resistance on the angle between the direction of current and the direction of magnetization is observed. Funnel magnetoresistance (TMR) is a magnetoresistance effect that occurs in a magnetic funnel junction (MTJ), which is an assembly consisting of two ferromagnets separated by a thin insulator. Resistors using these various properties are known per se.

[0075] In view of the above, the injection monitoring module and / or system according to the present invention preferably uses one or more magnetometers as one, more or more magnetic field sensors. This magnetometer is different from a GMR, AMR or TMR sensor in that it directly measures the magnetic field strength. Magnetometers measure magnetic fields in two main ways: vector magnetometers measure the vector component of the magnetic field, and total field magnetometers or scalar magnetometers measure the amplitude of the vector magnetic field. Another type of magnetometer is an absolute magnetometer, which uses the internal calibration of the magnetic sensor or known physical constants to measure the absolute amplitude or vector magnetic field. Relative magnetometers measure the amplitude or vector magnetic field relative to a fixed but uncalibrated baseline, and are also referred to as variable meters, for measuring changes in magnetic fields.

[0076] Therefore, the preferred type of magnetometer for use in an injection monitoring module according to the present invention is an ultra-low power high performance three-axis Hall effect magnetometer. Although it is possible for a magnetometer to be configured to measure the magnetic field on three mutually perpendicular or orthogonal axes, it is preferred in the present case that the magnetic field sensor is configured to measure the magnetic field on only two of the three orthogonal axes, such as the X-axis and the Z-axis.

[0077] As will be understood from the previous paragraphs, and in accordance with yet another purpose, the injection monitoring module also includes an injection start determination device. For example, the injection start determination device is appropriately represented by a magnetic field sensor, such as one or more magnetometers located in the injection monitoring system and discussed elsewhere in this specification. Therefore, in order to detect the start of an injection, the injection monitoring system, via the values ​​measured and reported by one or more magnetometers present in the injection monitoring system, is configured to detect an increase in the magnetic norm, i.e., an increase in the magnetic field vector determined along an axis extending substantially parallel to or coaxially with the central longitudinal axis, when the injection monitoring system begins to move from a first monitoring position toward a second monitoring position, in the absence of any accompanying effects on the magnetic field vector due to rotation of the injection monitoring system.

[0078] Advantageously, and according to another object, the injection monitoring module comprises an end-of-injection determination device. The end-of-injection determination may be contact-based, i.e. requiring physical or electrical contact between two surfaces or removal of such contact, for example in the form of a mechanical or electrical switch, or may be based on non-contact means, such as any number of known non-contact detection means, such as wave-based sensors, such as acoustic or optical sensors or any other sensor applying the principle of propagating waveforms, and involving a transmitter, a receiver and optionally a reflecting surface, a chemical or biological reaction sensor, a quantum effect sensor, etc., all of which are generally known per se in the art.

[0079] Advantageously, and according to yet another object, the injection start and / or end determination means comprise an optical sensor and a corresponding reflective surface.

[0080] According to yet another object, an optical sensor is located on the injection monitoring system adjacent to at least one or more elongated rod members. The optical sensor may be suitably positioned in a starter cap, for example, or alternatively, in a retainer body or housing of the injection monitoring system. Advantageously, the optical sensor is positioned within the cap and / or housing of the injection monitoring system such that it can receive reflected light from a correspondingly and appropriately positioned reflective surface.

[0081] Thus, and further to another object, a reflective surface for the optical sensor is located on a sheath member that faces the optical sensor on the injection monitoring module and is optically axially aligned with the optical sensor on the injection monitoring module.

[0082] Therefore, the optical sensor and the reflective surface are positioned so that reflected light from the reflective surface travels to the optical sensor. The optical sensor is suitably configured to determine, for example based on the intensity of the reflected light and / or the time it takes for the reflected light to travel the path between the reflective surface and the optical sensor, the distance the optical sensor has moved parallel to and along the central longitudinal axis, and thus the distance a predetermined reference position in the injection monitoring system has moved. Therefore, the optical sensor is suitably equipped with, for example, a light source, such as a light source that can be provided by a light emitting diode. The optical sensor can also be equipped with a focusing or diffusion system for such a light source, as known per se, and depending on the characteristics of the reflective surface, the power of the light source, etc., as known per se in the art.

[0083] In an injection pen system where the dose setting wheel rotates during an injection, the magnetic field vector value provided by the magnetic field sensor of the injection monitoring system can be used to determine the end of an injection, since the magnetic field vector value recorded by the magnetic sensor will change depending on, for example, how many times the hollow body including the magnet has rotated around the central longitudinal axis, combined with the relative change of the magnetic field vector related to the distance of the magnetic sensor from the magnet. In this case, this configuration enables the end of injection events to be registered using only the magnetometer.

[0084] However, in the case of an injection pen system in which the dose setting wheel does not rotate during injection, for example, a contactless sensor, such as an optical sensor, as described above is particularly advantageous, since the injection monitoring system is configured to use such a contactless sensor to signal when the injection monitoring device has returned from the second injection monitoring position to the first injection monitoring position via an axial translation along the central longitudinal axis, and thus assign an end-of-injection event to such returned position.

[0085] According to yet another object of the present invention, an infusion monitoring system includes an electronics board.

[0086] Advantageously, and according to another object of the invention, one or more magnetic field sensors are electrically connected to the electronics board. One or more magnetic field sensors may advantageously be located in diametrically opposed positions on the electronics board, or otherwise radially distributed on the electronics board around a central longitudinal axis, and preferably a single magnetic field sensor is located on the central longitudinal axis.

[0087] More advantageously, the electronic component board comprises an integrated control and data processing unit, such as at least one microcontroller, which is electrically connected to one or more magnetic field sensors for processing information received from the magnetic field sensors. Thus, the electronic component board can suitably be, for example, a printed circuit board of correspondingly appropriate dimensions. In the configuration envisaged by the invention, such a printed circuit board is advantageously disc-shaped, the center of which corresponds to the intersection with the central longitudinal axis.

[0088] As described above, the injection monitoring system includes an optical sensor. According to yet another object, the optical sensor is electrically connected to at least one microcontroller. The microcontroller controls the functions of the optical sensor and processes the signals and / or data received from the optical sensor to calculate, for example, the end of the injection sequence as described elsewhere in this specification, and in addition, how far the injection monitoring system has translated along the central longitudinal axis. This information is used to calculate whether the injection has been completed.

[0089] The electronics board is advantageously housed within an injection monitoring system housing or holder body positioned proximal to the hollow body and typically beyond the proximal end of the central bore. A distal portion of the injection monitoring system housing is located within the bore. The injection monitoring housing is free to translate within the bore of the hollow body, however, rotation is prevented due to a rotation stop such as embodied by a sheath member and an elongated rod member.

[0090] Advantageously, the electronics board is held such that a horizontal plane of the electronics board lies in a plane substantially perpendicular to said central longitudinal axis. Thus, during dose setting, the electronics board is positioned in a fixed rotational relationship relative to the hollow body in the first injection monitoring position such that rotation of the hollow body does not cause a corresponding rotation of the electronics board. This means that when the hollow body is rotated to "dial" or set an injection dose, at least one or more magnetometers located on the electronics board are prevented from rotating about the central longitudinal axis.

[0091] According to a further object of the invention, the electronic component board comprises a communication unit electrically connected to the at least one microcontroller. Such a communication unit may be one or more of any number of communication units known per se, such as wireless communication units, for example Bluetooth or any other short or long range wireless communication technology.

[0092] According to a further object of the invention, the electronic component board comprises an independent and optionally rechargeable power source, such as a lithium-ion battery, which can be easily replaced when exhausted, or comprises a rechargeable battery, such as a rechargeable lithium-ion battery. In the case of a rechargeable battery, the rechargeable battery can be charged when exhausted via a corresponding charging port, such as a USB charging port, which is provided in the injection monitoring module and connected to the rechargeable battery. Non-rechargeable, i.e. disposable, batteries and rechargeable batteries are known per se to those skilled in the art. Advances in charging technology now also make wireless charging a reality, and such wireless rechargeable batteries, for example using an inductive charging system, are also foreseen as a possibility within the objects of the present invention.

[0093] An integrated control and data processing unit comprising at least one microcontroller handles all electrical communications and signaling between the different electronic components of the electronic component board, including the magnetic field sensor and the optical sensor. It is also responsible for performing calculations so that the precise position location of the magnetic field sensor can be calculated and determined, as well as processing signals from an autonomous power supply and communication device integrated into the injection monitoring system, and which communicates with a local or remote data processing system (e.g. on a smartphone). Such integrated control and data processing units are known per se and typically integrate a central processing unit, a real-time clock, one or more memory storage systems, and optionally a communication system or subsystem, together with other desired components.

[0094] These and other objects of the present invention will become apparent and described in more detail in the following description of the accompanying drawings and exemplary monitoring modules. BRIEF DESCRIPTION OF THE DRAWINGS

[0095] The present invention will now be described in more detail with reference to the accompanying drawings, which are provided for the purpose of illustration and example, in which:

[0096] Figure 1 is a schematic exploded perspective view of an injection monitoring module to be installed on a handheld pen injection system;

[0097] Figure 2A and Figure 2B yes Figure 1 The injection monitoring module is in the retracted and locked positions before use before being installed or prepared to be installed on the pen-type injection system ( Figure 2A ) and the expanded, unlocked position ( Figure 2B ) is a schematic perspective view of

[0098] Figure 3A and Figure 3B Figure 1 Or the injection monitoring module of FIG. 2 is installed on the pen-type injection system, and is in the locked and retracted positions ( Figure 3A ) and the expanded and unlocked positions ( Figure 3B ) is a schematic perspective view of

[0099] Figure 4A and Figure 4B are schematic cross-sectional views of an injection monitoring module mounted on a pen-type injection system in a locked and retracted position and an unlocked and deployed position, respectively;

[0100] Figure 5A , Figure 5B , Figure 5C and Figure 5D schematic side-by-side representations of details of the relative positioning device of the injection monitoring module in a locked and retracted position and an unlocked and deployed position, respectively;

[0101] Fig. 6A and Figure 6B is a schematic perspective view of another detail of the relative positioning device of the injection monitoring module;

[0102] Figure 7 , Figure 8 and Fig. 9 is a schematic diagram of a sequence for installing an injection monitoring module onto a pen injection system, and the relative retracted and locked, deployed and unlocked positions of the monitoring module when installed and when installed on a pen injection system. DETAILED DESCRIPTION

[0103] Turning now to the drawings, various schematic diagrams of an injection monitoring module 1 according to the present invention are shown. The injection monitoring module 1 is intended to be mounted on a handheld injection pen system 2, as shown in Figure 3. The injection pen system 2 comprises a pen injection system body 3 having a peripheral surface 4, a pen cap 5 covering the distal end of the pen injection system, a dose setting or dial wheel 6 located at the proximal end of the pen injection system body 3, and a dialed dose visualization window 7 located distal to the dose setting wheel 6 and displaying the dose that has been dialed by a user of the pen injection system. The injection monitoring module 1 according to the present invention is mounted to the proximal end 8 of the injection pen system 2, covers and surrounds the proximal end 8, and is in particular also mounted on the pen body 3 to at least partially cover the peripheral outer surface 4 and be in contact therewith. The injection monitoring module 1 extends in the proximal direction beyond the proximal end 8 of the pen body 3, and in particular beyond the dose setting wheel 6, see also Figure 7 Also shown is a central longitudinal axis 9 which passes through the longitudinal axial centers of both the injection monitoring module 1 and the injection pen system body 3. The injection pen system 2 is provided with an activator button 10 ( Figure 7 ), as can be found in several commercially available injection pen systems. In the pen injection system 2 shown in FIG. 3 , the dose setting wheel 6 rotates about the central longitudinal axis 9 during dose setting, but is fixed against rotation during injection, i.e., the dose setting wheel does not rotate about the central longitudinal axis 9 during injection.

[0104] The injection monitoring module 1 comprises a hollow body 11 which is sized and dimensioned to be mounted coaxially around a body 3 of a pen injection system 2. To this end, the hollow body 11 comprises a central longitudinal bore 12 having a proximal end 13 and a distal end 14, and a central longitudinal axis coinciding with the central longitudinal axis 9. The hollow body 11 further comprises a distal body portion 15 which extends around and frictionally engages with an outer surface of a dose setting wheel 6. The frictional engagement of the hollow body 11 with the outer surface 4 of the dose setting wheel 6 may be achieved, for example, by making the distal body portion from an elastomeric friction material 16, or alternatively by providing a coating of such an elastomeric friction material on an inner peripheral surface 17 of the hollow body, such elastomeric friction engagement materials being per se readily known in the art, to provide a push-fit or slide-fit engagement of the distal body portion 15 with the outer surface 4 of the pen body 3. A suitable resilient friction material 16 for the distal body portion 15 may be a thermoplastic elastomer, such as SEBS or polystyrene-poly(ethylene butylene)-polystyrene block copolymer.

[0105] exist Figure 1 4 extends in a proximal direction above and beyond the limit of the activation button 10 of the pen injection system 2, such that the aperture 12 is within the distal body portion 15 of the hollow body 11 to accommodate the dose setting wheel 6 and the activation button 10, and as shown in the figure. The hollow body 11 also includes magnetic field generating means 18, 19 located on or in the aperture 12 of the hollow body 11. The magnetic field generating means 18, 19 are suitably provided by a pair of mono-dipole magnets 18, 19 diametrically opposed to each other, each magnet having a north pole N and a south pole S, respectively, each pair of magnetic poles preferably arranged in reverse polarity on the central longitudinal axis, i.e. NS / SN, wherein the first magnet is across a horizontal plane orthogonal to the central longitudinal axis with the N pole, and the diametrically opposed magnet is located in the same plane orthogonal to the central longitudinal axis, wherein the S pole faces in the same plane orientation as the N pole of the first magnet. The dipole magnet may be suitably formed in the shape of a rod or block, or alternatively in the shape of a disk or ring, or any other suitable shape. The magnet is located in a recess 20, 21 of suitable size provided in the hollow body 11, the recess 20, 21 being located at or adjacent the proximal end 13 of the body 11. Alternatively, the magnetic field generating means may be a single dipole annular magnet disposed on the peripheral proximal surface of the hollow body 11 at the proximal end 13 of the hollow body or in a corresponding annular recess. It will be appreciated from the above that the magnetic field generating means can rotate freely about the central longitudinal axis, since the hollow body 11 in which the magnet is located is itself mounted on the dose setting wheel about the central longitudinal axis 9 and frictionally engaged with the dose setting wheel.

[0106] The hollow body 11 also includes a guide sleeve 22 extending along the bore 12 and an annular flange portion 23 (FIG. 4) extending inwardly from the guide sleeve into the bore 12 to define a second bore having a smaller diameter than the bore of the hollow body 11. The guide sleeve 22 also extends from the annular flange portion 23 in a proximal direction toward the proximal end 13 of the hollow body 11. The guide sleeve 22 receives and guides the injection monitoring system as it translates within the bore 12 from a first monitoring position to a second monitoring position, as will be described in more detail herein.

[0107] The hollow body 11 further comprises a translational abutment 24 adapted and configured to prevent axial translational movement of the hollow body 11 along the central longitudinal axis 9 when the injection monitoring module 1 is in the installed position on the injection pen system 2. As shown in Fig. 4, the translational abutment may comprise an annular shoulder 24 extending inwardly into the bore from the inner surface 17 of the hollow body towards the central longitudinal axis. The annular shoulder 24 may advantageously be configured to have a distally facing surface which abuts against a proximally facing surface of the activation button 10 of the pen injection system 2 when the injection monitoring module is coaxially mounted on the pen, thereby preventing axial movement of the hollow body in the distal direction.

[0108] like Figure 1As shown in FIG4 , an injection monitoring system 25 is at least partially located in the bore 12 and is movably translatable from a first monitoring position to a second monitoring position in the bore 12. The injection monitoring system 25 includes a plurality of components, among which there is an injection monitoring system housing 26. The injection monitoring system housing 26 is shaped and configured to resemble a cup with a cup handle, having a bottom wall 27 extending on a diameter substantially the same or similar to that of the hollow body and substantially perpendicular to the central longitudinal axis 9, and a first wall 28 extending from the periphery of the bottom wall 27 in a proximal direction away from the bottom wall 27, thereby forming a cup-shaped component having an internal volume, the internal volume being closed by a proximal cap 29 forming an actuator button, which is snap-fitted or push-fitted or adhered or otherwise fixed to the proximally extending first wall 28 at the proximal end of the first wall 28. The bottom wall 27 further comprises a second annular wall 30 extending from the bottom wall 27 in a direction away from a position radially spaced from the central longitudinal axis 9 and having a diameter smaller than the bore 12 of the hollow body, so that the housing 26 can move in translation within the sleeve 24 and the bore 12 of the hollow body 11. The second annular wall 30 is closed at its distal end by a transverse wall 31 to form a cup handle. The transverse wall 31 can be made of, for example, a flexible film material that can be deformed when in contact with the activator button 10 of the pen-type injection system 2. The cup handle is located within the bore 12 of the hollow body 11. The injection monitoring system housing 26, defined by a cup-shaped internal volume, receives and houses an electronics board 32. The internal volume of the cup handle formed by the second annular wall 30 and the transverse wall 31 houses an autonomous power source 33, such as a single-use or rechargeable battery, such as a lithium-ion battery electrically connected to the electronics board 32 to provide power thereto. The electronics board 32 is suitably and typically a printed circuit board of suitable dimensions to be located within the interior volume of the cup formed by the bottom wall 27 and the proximally extending first wall 28. The injection monitoring housing 26 optionally also includes a light-conducting window that is integrated into or is a part of the first wall 28, such as a translucent, opaque or transparent material that is shaped and has crystalline properties selected to direct light waves from the interior volume of the cup to the exterior of the injection monitoring system housing 26, for example, the light waves are generated by an optionally present light emitting diode or other light wave generating element.

[0109] The electronics board 32 further comprises at least one magnetometer 34, advantageously located on the central longitudinal axis 9 and, in the case of a substantially circular element board, substantially in its centre, so that it is coaxially aligned with the central longitudinal axis 9. In addition to the magnetometer 34, the injection monitoring system 25 further comprises an integrated control and data processing unit electrically connected to the magnetometer 34 for processing the information received from the magnetometer. The integrated control and data processing unit handles all electrical communications and signalling between the different electronic elements of the injection monitoring system. It is also responsible for the execution and calculations of the dose management system, so that the precise position positioning of the magnet can be calculated and determined, as well as for processing the signals from the autonomous power supply 33. The electronics board may also be connected to a USB port 35, which may be constructed as a power recharging port for the rechargeable battery 33 and / or configured to enable substantially setting of any programmable memory on the electronics board, or to configure the data processing unit. The integrated control and data processing unit typically also comprises communication means, such as wireless communication circuitry, for communicating with a local or remote data processing system, for example on a smartphone, for example or Bluetooth Wireless communication systems, to name just two of many types of suitable communication devices. The integrated control and data processing unit may be suitably programmed remotely upon first use, or receive information and updates in a manner similar to other electronic devices currently incorporating integrated control and data processing units, for example wirelessly or via any other suitable link, such as a USB port. Such integrated control and data processing units are known per se, and typically integrate a central processing unit, a real time clock, one or more memory storage systems, and optionally a communication system or subsystem, together with other desired components. The electronics board 32 is disposed or positioned within the cup formed by the bottom wall 27 and the first wall 28 of the injection monitoring system housing 26 substantially along a horizontal plane of the circuit board, i.e., approximately orthogonal to and perpendicular to the central longitudinal axis 9.

[0110] The second annular wall 30 together with the transverse wall 31 also defines a chamber housing 36 for a biasing means 37, such as a compression spring, which pushes against the transverse wall 31 at the proximal end of the second annular wall 30 and which is constrained against one or a pair of seating projections 38 at the proximal end of the chamber 36. Compression of the biasing means 37 causes the transverse wall to flex in the distal direction. The transverse wall 31 is located at the distal end of the second annular wall 30 via snap or clip fitting projections which engage in corresponding recesses provided in the second annular wall 30. The biasing means 37 also acts as a damper for the injection monitoring system 25 when the injection monitoring system starts to move from the first monitoring position under digital pressure on the cap activation button after a dose has been selected. The interaction of the compression spring, optionally assisted by the flexible transverse wall, dampens the initial acceleration of the injection monitoring system 25 when it comes into contact with the activation button 10 on the injection pen 2. Given that the distance traveled between the first injection monitoring position and the second injection monitoring position can be very small, for example only a few tenths of a millimeter to a few millimeters at most, depending on the size of the injection pen, the biasing device not only accommodates variations in the axial geometry and molding tolerances of various elements of various pens, but also facilitates detection of an increase in the magnetic norm as the magnetometer 34 in the injection monitoring system 25 moves along the central longitudinal axis 9 towards the magnets 18, 19.

[0111] The injection monitoring housing 26 further comprises a third annular wall 39 which is radially spaced apart from the first annular wall 28 and the second annular wall 30 and radially located between the first annular wall and the second annular wall. The third annular wall extends from the bottom wall 27 in a distal direction towards the hollow body 11. The third annular bottom wall 36 provides another axial stabilization for the injection monitoring system housing 26, so that it is sized to be surrounded and guided by the inner periphery of the hollow body 11 at its proximal end 13.

[0112] Figure 12, 3 and 4 also show various elements of a rotation stop device, which is constructed and adapted to prevent rotational movement of the injection monitoring system about the central longitudinal axis 9 during dose setting. The rotation stop device comprises a rotationally fixed coupling arranged parallel to the central longitudinal axis 9. The rotationally fixed coupling connects the injection monitoring system 25 to the body 3 of the pen injection system 2, as will be described below. The rotationally fixed coupling prevents the injection monitoring system 25 from rotating about the central longitudinal axis 9 not only during dose setting or dialing, but more generally during translation of the injection monitoring system 25 from a first monitoring position to a second monitoring position and then from the second monitoring position back to the first monitoring position. In this way, it can be ensured that no rotation of the injection monitoring system 25 occurs, whether accidentally or intentionally, and in particular during dose selection or dose dialing, where such rotation is a source of error in determining the selected or dialed dose. The rotation stop is also constructed and adapted to allow the injection monitoring system to move in translation from the first injection monitoring position to the second injection monitoring position and vice versa, that is, from the second injection monitoring position to the first injection monitoring position during an injection, while maintaining the rotation block. As can be clearly seen from the foregoing description, the rotation stop thus physically prevents the injection monitoring system 25 from rotating about the central longitudinal axis 9, while providing a translation guide system for the injection monitoring system 25 in the distal and proximal directions.

[0113] Rotationally fixed couplings include Figure 1 4, the elongated rod member 40 extends from the injection monitoring system in a distal direction parallel to the longitudinal axis and the elongated rod member 40 bypasses the outer surface of the hollow body 11. The elongated rod member includes a plug 41 having a shaft portion 42 at or near its distal end, the shaft portion 42 protruding outwardly from an outwardly facing surface 43 of the elongated rod member 40 and away from the central longitudinal axis 9. The shaft portion 42 of the plug 41 terminates at its outermost point in a flat head 44. The diameter of the flat head 44 is greater than the diameter of the shaft portion 42 of the plug 41.

[0114] The rotationally fixed coupling also comprises a sheath member 45 which is mounted on the body 3 of the injection pen system 2, for example via coaxial mounting around the pen body 3, for example by sliding the sheath member 45 onto and along the pen body 3. The sheath member 45 is adapted and configured to receive the elongated rod member 40 in sliding engagement with said sheath member 45 during translational movement of the injection monitoring system 25 from the first monitoring position to the second monitoring position.

[0115] Thus, when the injection monitoring system 25 is moved from the first injection monitoring position to the second injection monitoring position, the elongated rod member 40 and the corresponding sheath member 45 cooperate with each other to allow the elongated rod member 40 to slide in the sheath member 45, but vice versa, that is, from the second injection monitoring position back to the first injection monitoring position. The sliding engagement between the elongated rod member 40 and the sheath member 45 occurs substantially parallel to the central longitudinal axis 9.

[0116] The elongated rod member 40 extends from the injection monitoring system 25 in a distal direction, that is, in a direction away from the proximal ends of both the injection pen system 25 and the injection monitoring module 1, and parallel to the central longitudinal axis 9. The rod member 40 is also located outside the outer surface of the hollow body 11 and is shaped and dimensioned to pass around the hollow body 11 outside thereof, so as not to interfere with the dose setting function of the hollow body 11. This means that the hollow body 11 can rotate without being hindered by the elongated rod member 40, thereby allowing the hollow body 11 to rotate and cause the dose setting wheel 6 to rotate together to enable setting of a dose on the pen injection system. Similarly, the shape and size of the elongated rod member 40 is constructed and adapted so that if the manufacturer of the pen injection system has configured the pen to function in this way, the rod member also does not interfere with any optional rotation of the dose setting wheel during injection.

[0117] The elongated rod member 40 is provided with a proximal end which is housed or fixed in a portion of the injection monitoring system housing 26, for example by providing an enlarged proximal cross section at the proximal end of the elongated rod member 40, and a correspondingly shaped recess with a reduced cross-sectional outlet diameter is provided in said injection monitoring system housing 26, thereby preventing the elongated rod member 40 from being withdrawn from said housing 26. Alternatively, the elongated rod member 40 is preferably formed integrally with the injection monitoring system housing 26, and in particular, integrally with a starter cap 29 of the injection monitoring system housing 26. Therefore, the cap 29 is structured and dimensioned so that it extends beyond the nominal diameter of the hollow body 11. In this way, the elongated rod member 40 extends freely from the cap 29 in a distal direction parallel to the central longitudinal axis 9 and bypasses the hollow body 11 without contacting or coming into contact with it.

[0118] The elongated rod member 40 advantageously comprises at least one portion defining an elliptical spline extending in a distal direction from the cap 29 parallel to the central longitudinal axis 9. The "elliptical spline" shape of the elongated rod member facilitates contact-free passage of the rod member around the relatively enlarged diameter of the hollow body, while reducing the need to increase the diameter of the injection monitoring system housing 26. Thus, the spline portion of the elongated rod member 40 is configured to maintain a sufficient distance between the elongated rod member 40 and the hollow body 11 and the body of the pen 3 when the injection monitoring system 25 is moved from the first monitoring position to the second monitoring position and back again, so that the elongated rod members 40, 41 preferably never come into contact with the outer surface 4 of the body of the injection pen system.

[0119] Furthermore, the elongated rod member 40 is appropriately dimensioned, for example having a thickness of a corresponding material that makes the rod member 40 semi-rigid along the length of the elongated rod member 40. An appropriate suitable material for the elongated rod member is, for example, a semi-rigid plastic material, such as a mixture of polycarbonate PC and acrylonitrile-butadiene-styrene ABS copolymer, commonly referred to as a PC / ABS mixture, although other suitable polymers and polymer mixtures that provide suitable rigidity are generally known to those skilled in the art, and the elongated rod member can therefore be made or constructed of any such suitable rigid material.

[0120] The sheath member 45 includes a generally elongated and flat body extending parallel to and generally conforming to the shape of the outer surface 4 of the pen body 3. The sheath member 45 also includes a funnel 46 configured and adapted to receive the elongated rod member 40 in a sliding engagement, respectively. The funnel 46 also extends parallel to the central longitudinal axis 9. The funnel 46 of the sheath member 45 is axially aligned with the elongated rod member 40 so that the rod member 40 is inserted into and received by the funnel 46 before the injection monitoring module 1 is installed on the pen injection system 2. The funnel 46 includes an open slot 47 having sidewalls 48, 49 protruding inwardly from the inwardly facing surface of the sheath member 45 and defining a longitudinally oriented opening 50 extending parallel to the central longitudinal axis 9. The longitudinally oriented opening 50 is constructed and dimensioned to receive the shaft portion 42 of the plug 41 and allow the shaft portion 42 to move along the longitudinally oriented opening 50 in the distal and / or proximal direction as the elongated shaft moves, but does not allow the plug and the corresponding shaft portion to move laterally outside the dimensional constraints of the longitudinally oriented opening 50. The longitudinally oriented opening 50 also includes a proximal portion 51 and a distal portion 52, which are constructed and dimensioned to receive the flat head 44 of the plug 41 for assembling the elongated shaft member 40 into the sheath member 45. Once assembled together, the flat head 44 of the plug 41 is located outward of the longitudinally oriented opening 50 of the funnel 46, while the elongated shaft member is located inward of the longitudinally oriented opening 50 of the funnel 46, and the shaft portion 42 of the plug 41 extends through the longitudinally oriented opening 50 of the funnel 46 and is able to translate along the longitudinally oriented opening 50.

[0121] In order to properly position the sheath member 45 on the outer surface 4 of the body 3 of the injection pen 2, the sheath member further comprises a body mounting portion 53 which is configured and adapted to enable the sheath member to be removably mounted to the body 3 of the pen injection system 2. The body mounting portion 53 thus comprises a wall made of, for example, a plastic or polymer material, such as polycarbonate PC, acrylonitrile-butadiene-styrene ABS copolymer or a mixture thereof, i.e. a PC / ABS mixture, whereby the wall extends circumferentially around the body 3 of the pen injection system 2 and is dimensioned to allow the pen body to be inserted into the hole 54 formed by the circumferentially extending wall and at the same time to be elastically frictionally engaged with the outer surface 4 of said pen body 3 by appropriately dimensioning the hole 54. The circumferentially extending wall is advantageously provided with a softer, more resilient wall portion 55, for example made of resilient SEBS or a similar resilient polymer, so as to engage and grip with a corresponding surface portion 4 of the body 3 of the pen 2, thereby preventing any undesired axial sliding movement of the pen within the hole 54 of the circumferentially extending wall.

[0122] Figure 15 and 6 show specific features of the sheath and relative positioning system equipped with the injection monitoring module. Figure 5A and Figure 5C A schematic perspective view of a sheath member 45 is provided showing a positioning locking system located within the sheath member and configured to selectively engage or disengage locking contact with the flat head 44 of the plug 41, wherein Figure 5A shows a locked configuration of the relative positioning system, and Figure 5C The unlocked configuration of the relative positioning system is shown. Figure 5B and Figure 5D The sheath 45 and positioning system are shown with the upper portion of the sheath and positioning system removed or cut away, and Figure 5B The locked configuration is shown respectively, and Figure 5D The unlocked configuration is shown. FIG. 5A to FIG. 5D As shown, but also Figure 1 shown, and in Fig. 6A and Figure 6B As shown in more detail in , the locking system includes a rotationally actuated locking head 56, such as a finger or thumb actuable and rotatable button, which is optionally provided with one or more friction members 57, such as arranged in a dial configuration around the periphery of the locking head button 56 to facilitate engagement by the user's fingers or thumb. The locking head button 56 also includes a pair of legs 58A, 58B extending from the underside of the locking head 56 into the corresponding distal opening portions 52 of the funnel 46 and the longitudinally oriented opening 50. The legs 58A, 58B terminate in a corresponding pair of mutually opposed feet 59A, 59B. The locking head 56 can be rotated about an axis 60 ( Fig. 6A ) is rotated, for example, a quarter turn. The legs 58A, 58B and feet 59A, 59B are constructed and shaped to selectively and lockingly engage the flat head 44 of the plug 41 depending on the rotational position of the locking head 56 about the rotational axis 60. In the first locking position, as Figure 5A and Figure 5B As shown, the legs and feet are transverse or orthogonal to the longitudinal axis of the longitudinally oriented opening 50, thereby preventing any axial movement of the flat head 44 and shaft portion 42 of the plug 41 parallel to the central longitudinal axis 9. The locking head 56 is rotated, for example by the user pressing the locking head button with a finger or thumb or by pushing the friction member in a clockwise direction, and for example a quarter turn is achieved, which causes the legs 58A, 58B and feet 59A, 59B to rotate 90 degrees so that the legs and feet are aligned with the longitudinally oriented opening 50, and thereby remove the locking engagement of the legs and feet with the flat head and release the flat head 44 and the attached shaft portion 42 of the plug to move axially along and parallel to the central longitudinal axis 9. This unlocked position is Figure 5C and Figure 5D . In order to facilitate the user to identify the locked and unlocked positions, respectively, the locking head may advantageously be provided with corresponding markings, abutment stops to prevent excessive rotation of the locking head button 56, etc. The locking head button 56 is also advantageously arranged in a properly provided cover 61 for the sheath, which cover 61 may be removable, for example, or adhered to the body of the sheath 45 by ultrasonic welding or other means, and the cover 61 may be provided with indicator marks aligned parallel to the central longitudinal axis 9, and the user of the injection monitoring module may identify whether the locking head button 56 has been set to the locked position or the unlocked position in combination with the optional markings on the locking head.

[0123] The locking head 56 is also used to hold the injection monitoring system 25 of the injection monitoring module in the first retracted position during installation of the injection monitoring module on the pen injection system, as will be described below with respect to Figure 2A , Figure 4A , Figure 7 and Figure 8 Described. Figure 2A The injection monitoring module 1 is shown in a first retracted position, wherein the injection monitoring system has been brought into contact with the distally facing surface of the proximally facing surface of the end 13 of the hollow body, in preparation for installation on the proximal end of an injection pen system, e.g. Figure 7 shown. Figure 2B 4 shows the same injection monitoring system in an unlocked and deployed position before installation on an injection pen or after the injection monitoring module has been removed from the injection pen and unlocked from the locked position. The rod member elongated rod member 40 and the latch 41 are locked into the collapsed position by the user rotating the locking head button 56 to the locked position, thereby causing the locking head to engage the locking surface of the flat head 44 of the latch 41. As a result, the head, the shaft portion 42 of the plug and the elongated rod member 40 are not allowed to move axially in the proximal or distal direction. Therefore, this collapsed position enables the user of the injection monitoring module to install the module to the injection pen system without having to worry about accidentally causing axial distal or proximal movement of the injection monitoring system 25 relative to the hollow body 11, which axial distal or proximal movement may be interpreted by the processing system of the injection monitoring system as the beginning or end of an injection operation. Figure 8The injection monitoring module is shown mounted on an injection pen system, but with the locking head still disposed in the locked position. In this view, it is also still in the folded position, and it can be seen that the elongated rod member 40 is generally not visible to the user from the outside. The user rotates the locking head 56 about the rotational axis 60, for example 90 degrees, to move the locking head 56 to the unlocked position, which will release the flat head 44 and shaft portion 42 of the plug 41 from the locked engagement with the legs 58A, 58B and feet 59A, 59B when the legs 58A, 58B and feet 59A, 59B are moved into longitudinal alignment parallel to the longitudinally oriented opening 50. For example, under the impetus of any recoil energy transmitted by the injection activator button 10, or alternatively, under the impetus of the biasing spring 36 that has been compressed against the activator 10 of the pen injection system during the process of installing the injection monitoring module on the proximal end of the pen injection system, the slender rod member 40 is now able to move axially in the proximal direction. This biasing force moves the injection monitoring system 25 of the injection monitoring module 1 to the installed and deployed position, as shown in FIG. Figure 4B and Fig. 9 shown.

[0124] Figure 1 4 shows another aspect of the injection monitoring module 1, in which there is an optical sensor 62 as a suitable example of a non-contact sensor. The optical sensor 62 is located on the injection monitoring system housing 26 adjacent to the elongated rod member 40, and is suitably located in the starter cap 29 portion of the housing 26. In such an embodiment, the optical sensor 62 is positioned so that it can receive reflected light from a corresponding and appropriately positioned reflective surface 63 located at the proximal end of the body of the sheath member 45. Therefore, the optical sensor 62 and the reflective surface 63 are positioned so that the reflected light from the reflective surface 63 travels to the optical sensor 62. The optical sensor 62 is suitably configured to determine, for example, based on the intensity of the reflected light and / or the time taken for the reflected light to travel on the path between the reflective surface 63 and the optical sensor 62, the distance that the optical sensor 62 and therefore the predetermined reference position in the injection monitoring system 25 has moved parallel to and along the central longitudinal axis. Therefore, the optical sensor 62 is suitably equipped with a light emitting source, such as a light emitting source that can be provided by a light emitting diode. The optical sensor 62 may also be equipped with a focusing or diffusing system for such a light source, as known per se, and depending on the characteristics of the reflecting surface 63, the power of the light emitting source etc., as known per se in the art, regarding the functionality and operation of such an optical sensor.

[0125] Once installed and positioned in the unlocked, deployed position, the injection monitoring module functions as briefly described below:

[0126] By rotating the hollow body, this causes the dose setting wheel to rotate synchronously, thereby setting the dose. Since the elongated rod member 40 is already engaged in the funnel of the sheath member 45, the injection monitoring housing 26 is prevented from rotating within the hole 12 of the hollow body. The monitoring system 25 then receives only signals from the magnetometer corresponding to the actual dose selected by the rotation of the dose setting wheel 6. In the absence of a rotation lock provided in the injection monitoring module of the present invention, unintentional relative rotation may lead to errors in these readings, which would require supplementary corrective measures to try to determine whether the dose dialed is actually the selected dose. The dose setting or dialing has been verified as a selected dose by the processing unit, and the monitoring system now determines whether the injection operation has begun, that is, whether the injection monitoring system has begun to translate from the first monitoring position to the second monitoring position along the central longitudinal axis 9. This is achieved when the magnetometer signals the processing unit an increase in the magnetic norm, because an increase in the magnetic norm is synonymous with the movement of the magnetometer towards the magnet. In this way, the monitoring system knows that the injection operation has begun. In an injection pen that rotates the dose wheel during injection, the magnetic field vector value captured by the magnetometer can be similarly used to calculate the injection endpoint. However, in pens where the dose setting wheel does not rotate, it is often impossible to know when the injection has ended, as the user may leave the injection monitoring system 25 in contact with the injection activator button 10 of the pen 2 for an indeterminate period of time, or barely in contact with the activator button 10. Measuring the time elapsed in the second monitoring position would therefore be potentially fraught with errors that would need to be corrected. Therefore, in this configuration, the optical sensor is used to provide a reference point for the injection monitoring system, and the optical sensor can therefore determine when the injection monitoring system has returned from the second monitoring position to the reference point of the first monitoring position, thereby signaling the end of injection.

[0127] Thus, as will be appreciated from the foregoing description, the injection monitoring module as described herein enables unambiguous determination that the dialed dose is indeed the selected dose, the point at which an injection is started and the point at which an injection is ended, in a manner significantly more efficient than previously possible. Furthermore, the injection monitoring module is provided with means for actively preventing any undesired axial translation of the injection monitoring system along the central longitudinal axis during installation and / or removal of the injection monitoring module from the pen injection system, which could otherwise result in erroneous signals being generated and processed by the injection monitoring system.

Claims

1. An injection monitoring module adapted and configured to be removably mounted to a proximal end of an injection pen system for delivering a drug, the injection pen system having a pen body, a proximally located dose setting wheel connected to the body, and an injection activator, the dose setting wheel being rotatable about a central longitudinal axis of the pen injection system during dose setting, wherein The injection monitoring module comprises: a hollow body adapted and configured to be coaxially mounted on and co-rotatably engaged with the dose setting wheel at a proximal end of the injection pen system, the hollow body comprising a central longitudinal bore having a proximal end and a distal end and a central longitudinal axis; a magnetic field generating device located on or within the hollow body at a proximal end of the central longitudinal bore; an injection monitoring system, the injection monitoring system comprising at least one or more magnetic sensors, the injection monitoring system being located at the proximal end of the hollow body and being capable of translationally moving within the bore of the hollow body along the central longitudinal axis from a first monitoring position in which the injection monitoring system is not in abutting contact with the proximal surface of the injection activator to a second monitoring position in which the injection monitoring system is in abutting contact with the proximal surface of the injection activator; The injection monitoring module further comprises a rotation stop configured and adapted to prevent rotational movement of the injection monitoring system about the central longitudinal axis during dose selection; wherein the rotation stop device comprises a rotationally fixed coupling disposed parallel to the central longitudinal axis, the rotationally fixed coupling connecting the injection monitoring system to the main body of the pen-type injection system; wherein the rotation stop is constructed and adapted to allow the injection monitoring system to translate from a first injection monitoring position to a second injection monitoring position during an injection, and vice versa, from the second injection monitoring position to the first injection monitoring position after an injection is completed; and In which, the rotation stop device includes a relative positioning device, which is configured to prevent the injection monitoring system from moving translationally in a proximal direction and leaving the retracted position in a first retracted installation position, and to allow the injection monitoring system to move translationally in a proximal direction and leave the first retracted position to a second expanded installation position in a second expanded position.

2. The injection monitoring module according to claim 1, wherein: The rotating fixed connection member comprises: an elongated rod member extending from the injection monitoring system in a distal direction parallel to the longitudinal axis and around an outer surface of the hollow body; and A sheath member, mountable on a body of the injection pen system, is adapted and configured to receive the elongated shaft member in sliding engagement therewith during translational movement of the injection monitoring system from the first monitoring position to the second monitoring position.

3. The injection monitoring module according to claim 2, wherein: The relative positioning arrangement comprises a locking system configured to selectively engage with the sheath and / or the elongated rod member to place the injection monitoring module in the first retracted installation position or in the second deployed installation position, respectively.

4. The injection monitoring module according to claim 3, wherein: The locking system includes a rotationally selectable lock located on the sheath and configured to rotate about an axis perpendicular to the central longitudinal axis from a first locked position to a second unlocked position.

5. The injection monitoring module according to claim 2, wherein: The elongated rod member is integrally formed with the injection monitoring system holder.

6. The injection monitoring module according to claim 2, wherein: The elongated rod member is integrally formed with the cap of the injection monitoring system holder.

7. The injection monitoring module according to claim 2, wherein: The elongated rod member includes a plug projecting outwardly from an outwardly facing surface of the elongated rod member, and wherein the plug is located at or near a distal end of the elongated rod member.

8. The injection monitoring module according to claim 6, wherein: The plug includes a shaft portion extending from an outwardly facing surface of the elongated rod member, the shaft portion of the plug terminating in a flat head.

9. The injection monitoring module according to any one of claims 2 to 6, wherein: The elongated rod member includes at least one portion of the elongated rod member defining an elliptical spline extending in a distal direction from the injection monitoring system parallel to the central longitudinal axis.

10. The injection monitoring module according to any one of claims 2 to 7, wherein: The sheath members include funnels configured and adapted to receive the elongated rod members, respectively, in sliding engagement.

11. The injection monitoring module according to claim 8, wherein: The funnel extends parallel to the central longitudinal axis.

12. The injection monitoring module according to claim 8, wherein: The funnel includes an open trough having side walls with respective and corresponding longitudinally oriented openings.

13. The injection monitoring module according to claim 6 and any one of claims 10 to 12, wherein: The longitudinally oriented opening of the funnel includes a distal end and a proximal end, wherein the distal end and the proximal end of the longitudinally oriented opening are constructed and dimensioned to receive the flat head of the plug therein and allow the flat head of the plug to be inserted into or withdrawn from the corresponding proximal end and / or distal end of the longitudinally oriented opening.

14. The injection monitoring module according to any one of claims 2 and claims 10 to 13, wherein: The sheath member includes a body mounting portion configured and adapted to enable the sheath member to be removably mounted to a body of the pen injection system.

15. An injection monitoring module according to claims 4, 6, 7 and 8, and wherein: The rotatably selectable lock is constructed and dimensioned to, in a first locked position, be lockingly engaged with the shaft portion and / or the flat head of the plug of the elongated rod member to prevent longitudinal axial movement of the head of the plug and / or the shaft portion within the sheath, and to disengage from the lock in a second unlocked position to allow longitudinal axial movement of the head and / or the shaft portion of the plug within the sheath.

16. The injection monitoring module according to claim 1, wherein: The hollow body comprises a translational abutment device adapted and configured to prevent axial translational movement of the hollow body along the central longitudinal axis when the injection monitoring module is in an installed position on the injection pen system.

17. The injection monitoring module according to claim 16, wherein: The translational abutment means of the hollow body comprises an annular shoulder extending inwardly into the bore from an inner surface of the hollow body towards the central longitudinal axis.

18. The injection monitoring module according to claim 1, wherein: The hollow body includes a distal body portion that extends around and frictionally engages an outer surface of the dose setting wheel.

19. The injection monitoring module according to claim 2, wherein: An optical sensor is located on the injection monitoring system adjacent the elongated shaft member.

20. The injection monitoring module according to claim 1, wherein: The injection monitoring module also includes an injection start determination device.

21. The injection monitoring module according to claim 1, wherein: The injection monitoring module also includes an injection end determination device.

22. The injection monitoring module according to claim 20 or 21, wherein: The injection start determination device and / or the injection end determination device comprises an optical sensor and a corresponding reflective surface.

23. The injection monitoring module according to claim 22, wherein: A reflective surface for the optical sensor is located on the sheath member, the sheath member facing the optical sensor on the injection monitoring module and optically axially aligned with the optical sensor.

24. The injection monitoring module according to claim 1, wherein: The injection monitoring system includes an electronics board and at least one microcontroller electrically connected to the one or more magnetic field sensors.

25. The injection monitoring module according to claim 24, wherein: The at least one microcontroller is electrically connected to the optical sensor.

26. The injection monitoring module of claim 24, wherein: The electronics board includes a communication unit electrically connected to the at least one microcontroller.

27. The injection monitoring module of claim 24, wherein: The electronics board includes an autonomous power supply.

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