Injection monitoring module with position lock system

Abstract

The injection monitoring module comprises a main body, a central bore, a central axis, and a magnetic field generating means disposed on the main body. An injection monitoring system comprising at least one magnetic sensor is translatable along the central axis and disposed within the bore. The monitoring module comprises a rotation stop means for preventing rotational movement of the monitoring system about the central axis during dose selection. The stop means comprises a rotatably fixed coupling member parallel to the central axis for connecting the monitoring system to the body of the injection pen and for allowing translational movement of the monitoring system from a first monitoring position to a second monitoring position during injection and vice versa after injection. The stop means comprises a relative positioning means for selectively preventing or allowing translation of the monitoring system in a proximal direction from a first retracted position to a second deployed position.

Description

[Technical field]

[0001] The present invention relates generally to monitoring systems for injectable drug delivery devices, and more particularly to injection monitoring for injection pen systems. [Background technology]

[0002] Injection monitoring is a well-known field related to injectable drug delivery devices, for example in particular infusion systems. Over time, and more recently, such monitoring systems have migrated to injection pen systems for delivering drugs, allowing users of such pen injection systems, as well as medical professionals involved in the treatment and follow-up of such patients, to monitor more closely the patient's injection regime and often the actual dose administered, with the intention of providing better healthcare outcomes. These developments have been accompanied by an associated increase in the use of software and portable communication devices, such as tablets or smartphones, that are programmed to receive information from and interact with the monitoring system in order to provide the user or medical professional with information on the fly or at regular intervals via a suitable communication unit included in the monitoring system.

[0003] For example, with particular reference to pen injection systems, one of the challenges has been to provide an easy to use, reliable and reasonably fail-safe monitoring system that can be adapted to the many different variations of such pen injection systems available on the market. Previous attempts to provide such monitoring systems have typically involved adapting the body of the pen injection system by including electronic components therein along with one or more sensors. However, one of the main drawbacks of such systems is that when incorporating all electronic components, they make the end product a rather bulky and unwieldy object, and therefore less usable from the user's point of view. Moreover, such modified systems tend to be specific to a given brand or manufacturer and therefore of little or no use with pen injection devices from other manufacturers. Furthermore, there has been a long-standing trend to try to make the overall volume of the injection pen body as small as possible through miniaturization of complex electronic components, but this brings its own problems, particularly with regard to electromagnetic interference between the various components, due to the close proximity of multiple circuits providing the necessary or desired integrated functionality. Moving the sensors in such monitoring systems further away from the source of electromagnetic interference only complicates things further, possibly leading to erroneous readings, or requiring additional systems to compensate for the physical separation of the sensor from other electronic components, such as microcontrollers that are designed to control and command the various components and manage their interactions.

[0004] The injection pen systems in question are well known per se and generally comprise a proximally located dose setting wheel and an injection actuation mechanism, 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 generally configured to perform an injection, either mechanically or electromechanically, upon actuation of the injection actuation mechanism. Such an injection actuation mechanism is very commonly a simple press or push button that is in mechanical or electrical contact with a dispensing mechanism located within the pen injection system, the depression of which causes the injection mechanism to fire and inject the medication contained within the pen injection system. In some pen injector systems, the dose setting wheel is configured to rotate not only during dose setting but also during injection. This is generally achieved by including one or more metallic components, such as a helically wound drive spring, that is located within the housing body of the injection pen system and is physically connected to the dose setting wheel. Because such metal elements are relatively large objects compared to the electronic component systems included in many pen injection systems today, these large metal objects can further disturb the signals that are designed to be captured or picked up by sensors in such electronic component systems, potentially reducing the accuracy of the system and / or requiring complex compensation mechanisms to be put in place to avoid calculation errors.

[0005] There have already been several attempts in the patent literature to overcome the difficulties of integrating electronic components.

[0006] For example, WO 2014 / 128156 relates to a sensor assembly having a first rotating sensor part with a plurality of individual conductive sensor areas arranged in a pattern, and a second rotating sensor part with a plurality of contact structures arranged to rotate relative to the first part and adapted to contact the conductive sensor areas on the rotating part of the first sensor. The contact structures are configured to engage and connect to the different sensor areas as the first and second parts of the rotating sensor rotate relative to each other, the connection formed being indicative of a rotational position relationship between the first and second parts. One of the contact structures is an actuatable contact structure axially movable relative to the first part, having a connected position in which the actuatable contact structure contacts the sensor area and a disconnected position in which the actuatable contact structure is not in contact with the sensor area. The system is contained within the pen injector body, at least partially within a volume inside the dose setting wheel. The system also includes a visual display, such as an LCD display, located on or in place of the injection actuation mechanism button.

[0007] In contrast, WO 2018 / 013419 relates to a dose detection system including a dosing component rotatably and axially movable relative to a connecting component attached to an actuator and attached to a dose setting member, with a module including an electronic sensor operable to detect relative rotation of the connecting component and the dosing component to detect a dose delivered by the medicine delivery device. The dose detection module is removably coupled to a proximal end of the pen injection system and is intended to function as a means for detecting the amount of medicine dispensed by the pen injection system while attached thereto, storing the detected dose in memory and transmitting a signal representative of the detected dose to a remote communication device. The system comprises a pair of rotatable and translatable cylinders which interact with each other via electrical contacts provided on the cylinder surfaces to indicate various states or positions of the injection administration operation including dose setting, and the electrical contacts are arranged in an accordion-like configuration of overlapping folds within a releasably coupled body and are connected to a collection of electronic components housed on a flexible printed circuit board which is insulated by non-conductive spacer layers between overlapping layers of the circuit board to prevent possible electrical, electronic, and electromagnetic interference.

[0008] One immediate observation of the above configuration is that, despite the use of folded flexible printed circuit boards to provide multiple surfaces for positioning the electronic components, their relative spatial density and positioning relative to one another necessitates the provision of non-conductive spacers between layers of electronic components, which directly results in an increased module height and necessarily increased complexity of the clip-on dose detection module described therein.

[0009] Furthermore, various other injection monitoring modules for injection pen systems are also known from WO 2019 / 175790, WO 2019 / 175615, WO 2018 / 138542, WO 2017 / 013464 and WO 2017 / 013463. [Prior art documents] [Patent documents]

[0010] [Patent Document 1] International Publication No. 2014 / 128156 [Patent Document 2] International Publication No. 2018 / 013419 [Patent Document 3] International Publication No. 2019 / 175790 [Patent Document 4] International Publication No. 2019 / 175615 [Patent Document 5] International Publication No. 2018 / 138542 [Patent Document 6] International Publication No. 2017 / 013464 [Patent Document 7] International Publication No. 2017 / 013463 Summary of the Invention [Means for solving the problem]

[0011] Thus, one aspect of the present invention is to provide an injection monitoring module adapted and configured to be removably attached to the proximal tip 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 the dose of drug to be injected, and optionally fixed against rotation during injection, thereby eliminating the need for complex shielding or protection solutions to address any unwanted electrical, electronic or electromagnetic effects caused by the relatively high density of electronic components in the monitoring module.

[0012] Another aspect of the present invention is to provide an injection monitoring module as described above, said monitoring module being adapted and configured to determine a set dose and an injection trigger point. For the purposes of the present invention, the expression "injection trigger point" as used herein means the moment when an injection mechanism in the pen is actuated. This occurs by distally displacing an injection actuation mechanism, such as a push button, which is typically located at the proximal tip of the pen injection system.

[0013] Yet 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 a dose or user set amount of injectable substance contained within a pen injection system, an injection initiation or start point in said pen injection system, and an injection end point, and therefrom to determine whether the entire dose or user set amount of injectable substance has been dispensed from said pen injection system.

[0014] Yet another aspect of the present invention is to provide an injection monitoring module as described above, said module comprising relative positioning means for selectively positioning components of the injection monitoring module in one or more pre-defined spatial relationships during mounting of the injection monitoring module onto the pen injection system, after mounting on the pen injection system in preparation for normal operation, and during removal or dismounting from the pen injection system.

[0015] These and other aspects of the present invention will become readily apparent from a complete reading of this specification.

[0016] Thus, according to any of the above aspects, there is provided an injection monitoring module adapted and configured to be removably mounted to a proximal tip of an injection pen system for delivering a medicament, the injection pen system having a pen body, a dose setting wheel located proximally and connected to said body, and an injection actuation mechanism, the dose setting wheel being rotatable about a central longitudinal axis of the pen injection system during dose setting, the injection monitoring module comprising: a hollow main body adapted and configured to be coaxially mounted on and co-rotatably engaged with a dose setting wheel at a proximal tip of an injection pen system, the hollow main body having a longitudinal central bore and a longitudinal central axis with a proximal tip and a distal tip; a magnetic field generating means disposed on or within the hollow main body at the proximal end of the longitudinal central bore; an injection monitoring system comprising at least one or more magnetic sensors disposed at a proximal end of the hollow main body and movable within the bore of the hollow main body along said central longitudinal axis from a first monitoring position in which the injection monitoring system is not in abutting contact with a proximal surface of the injection actuation mechanism to a second monitoring position in which the injection monitoring system is in abutting contact with a proximal surface of the injection actuation mechanism; the injection monitoring module further comprising a rotation stop means configured and adapted to prevent rotational movement of the injection monitoring system about said central longitudinal axis during dose selection; the rotation stopping means comprises a rotatably fixed coupling disposed parallel to the central longitudinal axis, the rotatably fixed coupling connecting the injection monitoring system to a body of the pen injection system; the rotation stop means is configured and adapted to permit translational movement of the injection monitoring system from the first injection monitoring position to the 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; An injection monitoring system is also provided, wherein the rotation stop means is configured, in the first collapsed mounting position, to prevent translational movement of the injection monitoring system in a proximal direction out of the first collapsed position, and, in the second deployed position, to allow translational movement of the injection monitoring system in a proximal direction out of the collapsed position to the second deployed mounting position.

[0017] The relative positioning means referred to herein are configured to prevent any unwanted movement of the injection monitoring module during mounting and / or removal from the pen injection system. It will be further understood that such a relative positioning system is intended to prevent detection of potentially unwanted or undesired translational events of the injection monitoring module along the central longitudinal axis by the injection monitoring module during mounting or removal from the pen injection system. Even more advantageously, the relative positioning means is configured in the first retracted mounting position to prevent translational movement of the injection monitoring system in the proximal direction out of the retracted position, and in the second deployed position to allow translational movement of the injection monitoring system in the proximal direction out of the retracted position to the second deployed mounting position. This means that during mounting on the pen injection system, the injection monitoring module adopts a retracted mounting configuration in which the relative components of the injection monitoring module, in particular the hollow main body and the injection monitoring system, are either in intimate surface contact with one another along the central longitudinal axis such that the combined overall length of these two components is as short as possible, or are otherwise maintained in a configuration of reduced length compared to the deployed mounting position in which the hollow main body and the injection monitoring system adopt their respective normal operating positions and corresponding combined overall lengths along the central longitudinal axis. Furthermore, in the retracted mounting configuration, the hollow main body and the injection monitoring system are prevented from translational movement relative to one another along the central longitudinal axis, preferably in the proximal direction. In the deployed mounting configuration, the injection monitoring system is positioned in its normal expected operating position relative to the hollow main body by selective operation of the relative positioning means which allows translational movement of the injection monitoring system in the proximal direction along the central longitudinal axis.

[0018] As used herein, the terms "pen injection system" and "injection pen system" are used interchangeably to designate an injection system in the form of a pen that is generally held in one hand, but which is well known as such, commercially available and used in the treatment of many different medical applications. These systems are also often entirely designed for the self-injection of the drug by the user when treatment for a given medical application is required. This is the case, for example, of insulin, which is supplied in various forms for the treatment of diabetes, for example pen injection systems marketed under the brand names FlexPen® marketed by Novo Nordisk, Kwikpen® marketed by Eli Lilly, or Lantus Solostar® marketed by Sanofi, are just three of the best known. Other drugs are also used with this category of medical devices, allowing immediate emergency injection of needed drugs such as anaphylactic shock medications, blood thinners, opioid receptor agonists and antagonists, etc., required to deal with potentially life-threatening situations, to the extent that it has become common for patients suffering from or susceptible to such diseases to carry these devices around with them.

[0019] The injection monitoring module according to the present invention is adapted and configured to be removably attached to an injection pen system comprising a proximally located dose setting wheel and an injection actuation mechanism. The dose setting wheel rotates about the central longitudinal axis of the pen injection system, allowing the user to set a dose of medication for injection. During dose setting or "dialling" a dose, the dose setting wheel can generally be rotated in both clockwise and counterclockwise directions, which generally correspond to an increase in the selected dose to be administered and a decrease in the selected dose, or vice versa, respectively, depending on the manufacturer. The injection actuation mechanism is often represented by a push button, which is usually located proximally of the dose setting wheel and, in most injection pens, at the proximal tip of the injection pen system. After the dose has been set or "dialled" (as this term is commonly known in the art), the user of the injection system then presses the injection actuation mechanism distally, which drives a piston connected to the plunger, expelling the drug from a chamber in the injection pen body and out through a needle inserted into an appropriate injection site, e.g., skin, fatty tissue, or muscle, depending on the type of drug the user wishes to administer. The dose setting wheel may also, but not necessarily, be coupled to the injection actuation mechanism such that it can also rotate as the injection of the drug progresses, depending on the manufacturer and the model of the injection pen. The manner of functioning of such injection systems is per se well known in the art. The monitoring module envisaged by the present invention is intended to be mounted on a pen injection system, in which case the dose setting wheel may be configured to rotate during the delivery / injection phase of operation of the pen injection system, or conversely not rotate during the delivery / injection phase of operation. For example, the Kwikpen® injection pen mentioned above does not have a dose setting wheel that rotates during injection, whereas the dose setting wheels on the Lantus Solostar® injection pen and the FlexPen® injection pen do rotate during injection.

[0020] The injection monitoring module according to the present invention is therefore adapted and configured to be removably attached to the proximal tip of such an injection pen system. The expressions "removably attached", "removably attachable", "removably mounted" or "removably mountable" as may be used herein should be understood to refer to the ability to attach or mount and subsequently remove the injection monitoring module, for example when transferring the injection monitoring module to another pen injection system or, for example, if the monitoring module becomes damaged during use and requires replacement. Such attachment and subsequent removal can be achieved by providing coupling means on the monitoring module which releasably engage with the proximal tip of the pen injection system, for example via frictional or elastic engagement or via other releasable fastening means, such as clips, straps, screw threads and corresponding tightening rings, which engage either the dose setting wheel or the injection actuation mechanism and / or even the body of the pen injection system.

[0021] The rotation stopping means referred to in this specification should be understood to be means by which rotation of the injection monitoring system about its central longitudinal axis is physically prevented during dose setting / dose dialing, and optionally and advantageously also when the injection monitoring system is moved from the first injection monitoring position to the 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.

[0022] The advantage of providing such rotation stopping means in an injection monitoring module as envisaged by the present invention is that while setting or "dialling" a dose in a first injection monitoring position will be identified by the injection monitoring system as being the selected dose, if for whatever reason rotation of the injection monitoring system is allowed during dialing of a dose by rotation of the dose setting wheel, such identification of the dialed dose as being the selected dose will not necessarily be correct. A further advantage of a monitoring module whose rotation is prevented or stopped as provided by the present invention during selection of the dose to be injected is that for a subsequent injection it does not really matter whether the injection monitoring system rotates, whether by accident or by design, thereby eliminating the need for any other corrective action for the determination of the selected dose that may otherwise be necessary.

[0023] The rotatably fixed coupling member is configured and adapted to prevent rotation of the injection monitoring system about the central longitudinal axis not only during dose setting or dialing, but more generally and advantageously also when the injection monitoring system translates from the first monitoring position to the second monitoring position, and even more advantageously also when the injection monitoring system translates 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, whether accidental or intentional, occurs in particular during dose selection or dose dialing, advantageously also during injection of the dialed dose, and even moreover when the user releases finger pressure on the injection actuation mechanism cap of the injection monitoring system after completion of the injection.

[0024] According to another aspect, the rotatably fixed coupling member comprises: an elongated rod member extending distally from the injection monitoring system parallel to the longitudinal axis and circumventing an outer surface of the hollow main body; and A sheath member mountable to a body of the injection pen system and adapted and configured to receive the elongated rod member in sliding engagement with the sheath member during translational movement of the injection monitoring system from a first monitoring position to a second monitoring position.

[0025] From the above, it will be appreciated that the elongate rod member and the corresponding sheath member cooperate with one another to allow sliding engagement of the elongate rod member within the sheath member as the injection monitoring system moves from a first injection monitoring position to a second injection monitoring position and vice versa, i.e., from the second injection monitoring position back to the first injection monitoring position. The sliding engagement between the elongate rod member and the sheath member is substantially parallel to the central longitudinal axis.

[0026] As mentioned above, the elongated rod member extends parallel to the central longitudinal axis in a distal direction from the injection monitoring system, i.e., away from the proximal tip of both the injection pen system and the injection monitoring module. The elongated rod member is further arranged outside the outer surface of the main hollow body and is shaped and dimensioned to circumvent the hollow body outside thereof, and thus does not interfere with the dose setting function of the hollow body, which is necessary for rotation in co-rotating contact with the dose setting wheel so that a dose can be set in the pen injection system. Similarly, the shape and dimensions of the elongated rod member are configured and adapted such that it does not interfere with any optional rotation of the dose setting wheel during an injection, if the pen injection system manufacturer configures the pen to function in this way, as is the case for pen injection systems such as, for example, Sanofi's Solostar® or Flexpen®.

[0027] According to another aspect, the elongate rod member has a proximal tip that is mounted or secured within a portion of a holder body or housing of the injection monitoring system, for example by providing an enlarged proximal cross-section at the proximal tip of the elongate rod member, the body or housing of the injection monitoring system being provided with a correspondingly shaped recess having a reduced cross-sectional exit diameter that prevents withdrawal of the housing from the elongate rod member.

[0028] Alternatively, according to yet another aspect, the elongated rod member is integrally formed with the holder of the injection monitoring system.

[0029] Advantageously, according to yet another aspect, the elongate rod member is integrally formed with an actuation cap of a holder of an injection monitoring system, the injection monitoring system comprising a cap which a user presses to actuate an injection, the cap confining the magnetic field sensor within a holder body or housing of the injection monitoring system. Thus, according to this aspect, the rod member extends from the cap in a distal direction parallel to the central longitudinal axis and further bypasses the hollow main body which contacts a dose setting wheel on the pen.

[0030] According to another further aspect, the elongated rod member comprises at least one portion of the elongated rod member that defines an elliptical spline that extends parallel to the central longitudinal axis in a distal direction from the injection monitoring system. By "elliptical spline", it is understood that the elongated rod member extends in a direction substantially parallel to the central longitudinal axis, but according to the further aspect, is defined at least partially along the length of the rod by an elliptical spline curve, i.e., a curve that extends toward the body of the pen injection system that resembles the curve of an arc of an ellipse. In general, 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 such that the elongated rod member never contacts the outer surface of the body of the injection pen system when the injection monitoring system is moved from a first monitoring position to a second monitoring position and back again.

[0031] The elongated rod member is suitably dimensioned, e.g., having a corresponding thickness of material such that the elongated rod member is semi-rigid along the length of the elongated rod member. Suitable materials for the elongated rod member are semi-rigid plastic materials such as, for example, blends of polycarbonate (PC) and acrylonitrile-butadiene-styrene (ABS) copolymers, commonly known as PC / ABS blends, although other suitable polymers and polymer blends providing suitable stiffness are commonly known to those skilled in the art, and the elongated rod member may be fabricated or constructed of any such suitable rigid material accordingly.

[0032] According to yet another aspect, the elongate rod member includes a spigot that projects outwardly from an outwardly facing surface of the elongate rod member and away from the 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 the distal end of the elongate rod member and includes a shaft portion extending from the outwardly facing surface of the elongate rod member, the shaft portion of the spigot terminating in a flat head, the diameter of the head being greater than the diameter of the shaft portion of the spigot. The manner in which the spigot and head function will be further understood in relation to the sheath, details of which are provided below.

[0033] As mentioned above, the rotatably fixed coupling member also includes a sheath member including runnels configured and adapted to receive the elongated rod members, respectively, in sliding engagement. Thus, according to another aspect, the runnels extend parallel to the central longitudinal axis. The runnels of the sheath member are aligned with the elongated rod members such that the elongated rod members are inserted into and received by the runnels prior to mounting of the injection monitoring module onto the pen injection system. The runnels are generally configured and dimensioned as open runnels having side walls with corresponding respective longitudinally oriented openings, the longitudinally oriented openings being parallel to the central longitudinal axis. The longitudinally oriented openings are dimensioned to receive the shaft portions of the spigots, such that the extent of lateral movement of the shaft portions of the spigots is limited to the dimensions of the longitudinally oriented openings. The dimensions of the longitudinally oriented opening are configured to allow the shaft portion of the spigot to move proximally and distally along the opening during operation of the injection monitoring module and when moving from a retracted mounting position to a deployed mounting position.

[0034] According to yet another aspect, the longitudinally oriented opening in the sheath also includes a distal end and a proximal end that are configured and dimensioned to receive the flat head of the spigot therein and to allow insertion or withdrawal of the flat head into or out of the appropriately dimensioned proximal and / or distal ends of the longitudinally oriented opening. Such interaction provides positive axial tracking of the elongated rod member within the sheath member and prevents accidental withdrawal of the elongated rod member if a user of the injection monitoring module applies inappropriate lateral forces to the elongated rod member or sheath member in an attempt to remove the rod member from the sheath.

[0035] From this description it will be understood that the sheath member is mounted on the body of the injection pen system. Thus, according to yet another object, the sheath member further comprises a body mounting portion configured and adapted to allow removable mounting of the sheath member to the body of the pen injection system. The body mounting portion of the sheath member comprises a wall of a material, for example a plastic or polymeric material, such as polycarbonate (PC), acrylonitrile butadiene styrene (ABS) copolymer, or mixtures thereof known as PC / ABS mixtures, which extends circumferentially around the body of the pen injection system and is dimensioned to allow insertion of the pen body into a hole formed by said circumferentially extending wall, while engaging in elastic frictional engagement with the outer surface of said pen body by appropriate dimensioning of the hole of the sheath member. Optionally, but advantageously, the circumferentially extending wall comprises a wall portion made of a softer and more elastic material, for example the elastomer SEBS or a similar elastomeric polymer, for engaging and gripping a corresponding surface portion of the body of the pen so as to prevent any undesired axial sliding of the pen within the bore of the circumferentially extending wall of the sheath member. Suitable elastomeric materials for performing this function are known per se in the art.

[0036] As discussed elsewhere herein, the rotational stop means may comprise relative positioning means configured to prevent translational movement of the injection monitoring system in a proximal direction out of the retracted position in the first retracted mounting position, and to allow translational movement of the injection monitoring system in a proximal direction out of the retracted position to the second deployed mounting position in the second deployed mounting position. For example, the relative positioning means may comprise a locking system configured to engage the sheath and / or the elongate rod member in a selectively actuatable manner to allow a user to lock and unlock, respectively, relative axial movement of the elongate rod with respect to the sheath, thereby allowing proximal movement of the injection monitoring system from the retracted position to the deployed position. Similarly, after use of the injection monitoring module has been performed by the user, or if, for example, the user desires to move the injection monitoring module to a new pen injection system, the injection monitoring system can be moved distally along the axis and the selectively actuable locking system can be engaged, causing the injection monitoring module to again assume the pushed-in position and be ready for removal or detachment from the pen injection system.

[0037] From the above, it will be appreciated that the relative positioning means interacts with the elongate rod member and / or the sheath member to maintain the hollow body and the injection monitoring system in a pushed position while the injection monitoring module is mounted on the pen injection system. The relative positioning means thereby serves to maintain the hollow body, the injection monitoring system, the elongate rod member and the sheath member in a predefined tucked or pushed spatial relationship as a single mountable unit during mounting of the monitoring module onto the pen injection system to avoid any accidental undesired axial displacement of the monitoring module when mounting the hollow main body onto the dose setting wheel of the pen injection system. As can be seen from the above, the selective locking of the injection monitoring module via actuation of the relative positioning means in the pushed position will generally be performed prior to mounting of the injection monitoring module onto the pen injection system, which is why this position is referred to as the pushed mounting position, although the selective locking also occurs when removing the injection monitoring device from the pen injection system. In this depressed position, the injection monitoring system is physically prevented from inadvertent axial movement, thereby avoiding any undesired triggering of an erroneous reading in the injection monitoring system. Once the injection monitoring module is mounted and the hollow main body is properly positioned on the dose setting wheel of the injection pen system, the relative positioning means can be actuated, e.g. unlocked, to allow the injection monitoring module to be moved proximally to the deployed, mounted position. Unlocking the relative positioning means allows the injection monitoring system to be moved to its ready-to-operate position, also known as the deployed, mounted position.In the unlocked position, the spigot of the elongate rod member can be moved axially within the channel of the sheath, thereby allowing the injection monitoring system to be moved proximally, for example under the motive force of the recoil energy of a proximal actuator button of a pen injection system, or alternatively via a biasing spring disposed at the distal end of the injection monitoring system which is compressed in the depressed, locked position and can be decompressed in the unlocked position, thereby causing the injection monitoring system to be moved proximally to assume a deployed, mounted position.

[0038] Thus, according to another aspect, the relative positioning means of the locking system comprises a rotationally selectable lock arranged 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. The rotationally selectable lock suitably comprises, for example, a lock head. The selectable lock is suitably configured and dimensioned such that in the first locked position, the selectable lock is in locking engagement with a shaft portion and / or advantageously a flat head of the spigot of the elongate rod member to prevent longitudinal movement of the flat head and / or shaft portion of the spigot within the sheath, and in the second unlocked position, the selectable lock is disengaged to allow said longitudinal movement of the shaft portion and / or flat head of the spigot within the sheath, in particular within the channel. The rotationally selectable lock may, for example, be suitably actuated via rotation of a user's finger or thumb over a correspondingly shaped surface disposed on the outwardly facing surface of the sheath, and may be configured to permit, for example, a quarter turn about a vertical axis of rotation to move the locking system from a locked position to an unlocked position.

[0039] The hollow main body of the injection monitoring module has a longitudinal central bore with a proximal tip and a distal tip, the bore being dimensioned to allow for coaxial mounting of the hollow main body over the body of the pen injection system. The hollow main body is suitably made of any suitable material, for example a durable polymeric or plastic material, for example high density or high impact polypropylene, or alternatively polycarbonate. Advantageously, the hollow main body is made of a transparent, translucent or opaque material to allow the user to grasp and recognize any visual cues, such as light emitting diodes, which may be provided or incorporated into the injection monitoring module and which may optionally be used to indicate various states of operation of the injection monitoring system.

[0040] Thus, according to another object, the hollow main body further comprises translational abutment means adapted and configured to prevent axial translational movement of the hollow main body along the central longitudinal axis when the injection monitoring module is in a mounted position on the injection pen system. The translational abutment means defines a limit of axial translational movement of the hollow main body along the central longitudinal axis relative to the actuation button of the pen injection system during mounting of the injection monitoring module on the pen injection system. Advantageously, according to yet another object, the translational abutment means of the hollow main body comprises an annular flange extending inwardly into the bore from an inner surface of the hollow main body towards the central longitudinal axis. During mounting of the injection monitoring module on the injection pen system, the annular flange has a distal surface which contacts a proximally facing surface of the actuation button of the pen, thereby preventing further translational movement of the hollow main body along the central longitudinal axis.

[0041] According to another further object, the hollow main body further comprises a distal body portion extending around and in elastic frictional engagement with the outer surface of the dose setting wheel. Such a distal body portion may, for example, extend from an annular flange substantially as described in the previous paragraph, or may be represented by a separately attachable hollow distal portion of the hollow main body, for example connectable to the hollow main body via a socket and bayonet mount, or a screw-fit mount or a snap-lock mount, and configured and dimensioned to have a hole matching the dimensions of the dose setting wheel of the injection pen system. The frictional elastic engagement may, for example, be provided by a suitable elastomeric coating or deposit, for example in one or more zones, disposed on the inner circumferential surface of the distal portion of the hollow main body, or alternatively as a continuous, continuous or semi-continuous / continuous coating, deposited on said inner circumferential surface of the distal portion of the hollow main body. The purpose of such a frictional elastic coating or deposit is to provide a frictional gripping force between the distal body part and the dose setting wheel in order to maintain a proper positioning of the hollow distal body part relative to the dose setting wheel. Suitable types of elastomeric materials capable of providing a corresponding frictional engagement are known per se in the art, a suitable elastomeric material is for example SEBS.

[0042] As described elsewhere herein, the injection monitoring module comprises an injection monitoring system, such system comprising at least one or more magnetic sensors, the injection monitoring system being located substantially at or adjacent the proximal tip of the bore of the hollow main body. The injection monitoring system is described in more detail below, but essentially the injection monitoring system comprises a number of different components and means that provide monitoring of the injection status, such as, for example: - the start of the injection movement, Completion or termination of an injection operation, where completion of an injection operation should be understood to include both the complete administration of a selected dose of the substance to be injected, or a separate injection operation in which the user injects only a portion of the dose or causes a portion of the selected dose to be expelled from the pen injection system.

[0043] Still further, in accordance with 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 a proximal surface of the injection actuation mechanism to a second monitoring position in which the injection monitoring system is in abutting contact with a proximal surface of the injection actuation mechanism. The injection monitoring system is advantageously mounted at a proximal tip of the bore in the hollow main body, preferably completely covering or at least substantially covering said proximal tip of the bore.

[0044] From the above, it will be appreciated that the injection monitoring system can be moved from a first position, where there is no physical contact between the injection monitoring system and the actuation mechanism button of the pen injection system, to a second position, where physical contact is established between the monitoring system and a proximal surface of the injection actuation mechanism of the pen injection system. Such movement generally results in translational movement of the monitoring system along the central longitudinal axis from the first position to the second position. The injection monitoring module is configured such that rotation of the hollow main body and the correspondingly coupled dose setting wheel results in a determination that the set or dialed dose is the selected dose, since the injection monitoring system is locked against rotational movement about the central axis during dose setting. The determination of the start of the injection is also made by detection of an increase in the magnetic norm as the injection monitoring system starts to translate along the central longitudinal axis from the first monitoring position towards the second monitoring position. The injection monitoring system is configured to detect an end point of injection or expulsion of the injectable substance when the monitoring system translates in a proximal direction, i.e., from the second monitoring position to the first monitoring position, thereby releasing physical contact between the actuation mechanism button of the pen injection system and the monitoring system. One way to achieve this is to configure a reference point corresponding to the first monitoring position and detect, for example using a suitably configured sensor, when the injection monitoring system has moved from any other point and returned to that reference point.

[0045] Translational movement opposite to the direction of injection, i.e., translational movement of the monitoring system in a proximal direction back towards the user's hand or thumb, may be conveniently achieved by utilizing the recoil energy of a biasing spring that is compressed during injection actuation and relaxed upon release of the actuation button, which may also be conveniently provided within the bore and form part of the injection monitoring system. After the user releases the actuation cap, either directly or indirectly, for example by removing pressure of the thumb or other finger on the actuation cap, the recoil energy of the compressed biasing spring within the bore will move the injection monitoring system away from the pen's actuation button and urge the injection monitoring system back to the first monitoring position.

[0046] According to another object of the invention, the monitoring module of the invention comprises a magnetic field generating means arranged on or in the hollow main body adjacent or at the proximal end of the longitudinal central bore. By the expression "arranged on or in the hollow main body" it is understood that the magnetic field generating means can be arranged for example on a proximal facing surface at the proximal end of the central bore of the hollow main body. Alternatively, the magnetic field generating means can preferably be arranged in a cavity or recess arranged at or adjacent to the proximal end of the central bore of the hollow main body.

[0047] Various means for generating a magnetic field are known, including conventional magnets, electromagnets, and mixed-material magnets. Such magnets can typically be made from magnetizable materials that have magnetic or paramagnetic properties, whether natural or in which a magnetic field is generated or induced in the material when an electric current or other energizing current passes through the material. Suitable materials can be suitably selected from: ferrite magnets, in particular sintered ferrite magnets, such as crystalline compounds of iron, oxygen and strontium; - a composite material consisting of a thermoplastic matrix and an isotropic neodymium-iron-boron powder; - a composite material consisting of a thermoplastic matrix and a strontium-based hard ferrite powder, in which case the resulting magnet may contain isotropic, i.e. non-oriented, or anisotropic, i.e. oriented, ferrite particles; - a composite material consisting of a thermosetting plastic matrix and an isotropic neodymium-iron-boron powder; - Magnetic elastomers, for example made of heavily charged strontium ferrite powder mixed with synthetic rubber or PVC and then extruded into the desired shape or calendered into fine sheets; - A calendered flexible composite that generally has the appearance of a brown sheet and is more or less flexible depending on its thickness and its composition. These composites are never rubber-like and tend to have a Shore hardness in the range of about 40 to 70 Shore D ANSI. Such composites are generally formed from synthetic elastomers filled with strontium ferrite particles. The resulting magnets can be anisotropic or isotropic, and the various sheets generally have alignment of the magnetic particles resulting from the calendering process. - laminated composites, generally including flexible composites as described above, laminated with soft iron plates, -Neodymium-iron-boron magnets, - magnetized steel made of an aluminum-nickel-cobalt alloy, -An alloy of samarium and cobalt.

[0048] Of the above list of magnetic field generating means suitable for use in the present invention, those selected from the group consisting of neodymium-iron-boron permanent magnets, magnetic elastomers, composites consisting of a thermoplastic matrix and strontium-based hard ferrite powder, and composites made of a thermosetting plastic matrix and isotropic neodymium-iron-boron powder are preferred. Such magnets are known for their ability to be sized to relatively small sizes while maintaining relatively high magnetic field strengths.

[0049] The magnetic field generating means may be of any suitable overall shape, for example disk-shaped, including circular, elliptical, or any other suitable polygonal shape, but preferably has only a single dipole with a single pair of diametrically opposed north and south magnetic poles. The magnetic field generating means may also optionally be substantially disk-shaped, but such a disk shape preferably also includes a magnet with an opening substantially in the center of the disk to form a ring or annular shaped magnet. Such a ring or annular shaped magnet may be usefully placed at the proximal tip of the hollow main body, on its proximally facing annular outer circumferential surface. Advantageously, for purposes of the presently envisaged configuration of the injection monitoring module, the bipolar magnets are rod-shaped or cylindrical bipolar magnets, positioned one with opposite pole facing relative to the other, e.g. NS aligned with SN, in which case the magnets are positioned to extend flat along their own longitudinal axes along a horizontal plane that bisects and is perpendicular to the longitudinal central axis, with each magnet positioned on the opposite side of said longitudinal central axis, e.g. rotated 180° around said longitudinal central axis, one with respect to the other.

[0050] A magnetic field generating means is provided which enables a magnetic field sensor, during dose setting, to detect any change in the magnetic field due to rotational movement of the hollow main body relative to the magnetic field sensor and thereby determine the dialled dose set via the dose setting wheel.

[0051] The magnetic field sensor is used to measure the magnetic field generated by the magnetic field generating means. The movement of the hollow body and the magnetic field generating means about the longitudinal central axis relative to the rotatably fixed magnetic field sensor during the rotation of the dose wheel is used to calculate or determine the dose of the injectable substance in the injection pen system that is dialed or set by the user. Once the dose is set, the actuation of the proximal actuation mechanism cap, which causes translational movement along the longitudinal central axis of the housing of the injection monitoring system and the correspondingly housed magnetic field sensor provided therewith, is used to determine or calculate whether the injection has been triggered. Conversely, correspondingly, the release of pressure of the finger or thumb on the proximal actuation mechanism cap causes a recoil in the injection monitoring system due to the recoil energy of a biasing spring located within the housing of the injection monitoring system at a location distal to said housing, inducing a proximal translational movement of the injection monitoring system toward the user's thumb or finger along the longitudinal central axis of the housing, thereby also moving the magnetic field sensor housed within the injection monitoring system in the proximal direction.

[0052] As indicated above, during an injection, when finger pressure is applied in a distal direction along the central longitudinal axis against the housing of the injection monitoring system, the magnetic field sensor will detect a change in the magnetic field due to the sensor translating along the longitudinal axis in a distal direction towards the magnetic field generating means and then in the opposite proximal direction when finger pressure is released from the injection monitoring system.

[0053] Furthermore, the compression characteristics of the biasing spring and the degree of resistance it provides to the distal movement of the injection monitoring system can be advantageously used as a means to increase the sensitivity of the detection of the injection triggering point by the monitoring system. In the case of an uncontrolled distal movement, for example when the user suddenly presses down on the actuation cap of the monitoring module, an error may be induced in the injection monitoring system regarding the injection triggering due to a sudden increase in the magnetic norm that would be detected by the magnetic field sensor. Due to the compression characteristics of the biasing spring, such a sudden distal movement of the injection monitoring system and the corresponding induced increase in the magnetic norm are damped to a level that the magnetic sensor can easily and without error process, making the determination of the injection point triggering much safer and more reliable. To this extent, the biasing spring can be seen more generally as representing a damping means to assist in the correct determination of the injection triggering event.

[0054] Regarding magnetic sensors in general, means for measuring the magnetic field to be determined are generally known in the art. For example, magnetoresistance is a well-known means. Such magnetoresistance is often represented by their abbreviations, e.g. AMR, GMR, TMR sensors, which represent the physical mechanism by which these sensor components function. Giant magnetoresistance (GMR) is a quantum mechanical magnetoresistance effect observed in thin film structures composed of alternating ferromagnetic and non-magnetic conductive layers. Anisotropic magnetoresistance, or AMR, is said to exist in materials in which a dependence of electrical resistance on the angle between the direction of current and the direction of magnetization is observed. Tunnel magnetoresistance (TMR) is a magnetoresistance effect occurring in magnetic tunnel junctions (MTJs), which are components made of two ferromagnetic materials separated by a thin insulator. Resistors using these various properties are known per se.

[0055] In light of the above, the injection monitoring module and / or system according to the present invention preferably uses one or more or a plurality of magnetometers as one or more or a plurality of magnetic field sensors. Such a magnetometer differs from a GMR, AMR or TMR sensor in that it directly measures the magnetic field strength. Magnetometers measure the magnetic field in two main ways: vector magnetometers measure the vector components of the magnetic field, and total field or scalar magnetometers measure the magnitude of the vector magnetic field. Another type of magnetometer is the absolute magnetometer, which measures the absolute magnitude or vector magnetic field using an internal calibration of the magnetic sensor or known physical constants. Relative magnetometers, which measure the magnitude or vector magnetic field relative to a fixed but uncalibrated baseline, are also called geomagnetic variance meters and are used to measure magnetic field variations.

[0056] A preferred type of magnetometer for use in the injection monitoring module of the present invention is, in this case, an ultra-low power, high performance, three-axis Hall effect magnetometer. Although it is possible to configure the magnetometer to measure the magnetic field about three mutually perpendicular or orthogonal axes, in the present case it is preferred that the magnetic field sensor is configured to measure the magnetic field about only two of the three orthogonal axes, e.g., the X-axis and the Z-axis.

[0057] As will be appreciated from the previous paragraph, according to yet another object, the injection monitoring module further comprises an injection initiation determination means, which for example are suitably represented by a magnetic field sensor, such as one or more magnetometers, as discussed elsewhere herein, arranged in the injection monitoring system. Thus, in order to detect the initiation of an injection, the injection monitoring system is configured to detect, via values ​​measured and reported by one or more magnetometers present in the injection monitoring system, an increase in the magnetic norm, i.e. the magnetic field vector determined along an axis extending substantially parallel or coaxial with the central longitudinal axis, in the absence of any concomitant effect on the magnetic field vector due to the rotation of the injection monitoring system, when said injection monitoring system starts to move from a first monitoring position towards a second monitoring position.

[0058] Advantageously, according to a further object, the injection monitoring module comprises an end of injection determination means, which may be contact-based, i.e. requiring physical or electrical contact between two surfaces or removal of such contact, e.g. in the form of a mechanical or electrical switch, or alternatively non-contact means, e.g. based on any number of known non-contact detection means, e.g. wave-based sensors, such as sound or light sensors, or any other sensor applying the principle of propagating waves including an emitter, a receiver and optionally a reflective surface, chemical or biological reaction sensors, quantum effect sensors, etc., all of which are generally known per se in the art.

[0059] Advantageously, according to yet another object, the means for determining injection initiation and / or completion comprises an optical sensor and a corresponding reflective surface.

[0060] According to yet another object, an optical sensor is arranged on the injection monitoring system adjacent to at least one or more elongate rod members. The optical sensor may be suitably arranged, for example, in an actuation cap or, alternatively, in a holder body or a housing of the injection monitoring system. Advantageously, the optical sensor is positioned in the cap and / or in the housing of the injection monitoring system such that it can receive reflected light from a correspondingly suitably arranged reflective surface.

[0061] Accordingly, and in yet another aspect, a reflective surface for an optical sensor is disposed on the sheath member facing and aligned with the optical sensor on the injection monitoring module.

[0062] The optical sensor and the reflective surface are thus positioned such that the reflected light coming from the reflective surface passes to the optical sensor. The optical sensor is suitably configured to determine, for example, from 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 that the optical sensor, and thus the predetermined reference position in the injection monitoring system, has traveled parallel to and along the central longitudinal axis. The optical sensor preferably comprises a light emitting source, which in this case can be provided, for example, by a light emitting diode. The optical sensor can further comprise a focusing or diffusing system for such a light source, as known per se, depending on the properties of the reflective surface, the power of the light emitting source, etc., as known per se in the art.

[0063] In an injection pen system where the dose setting wheel rotates during the injection, the end of injection can be determined using the magnetic field vector value provided by the magnetic field sensor of the injection monitoring system, in combination with the magnetic field vector value registered by the magnetic sensor changing depending on, for example, how many revolutions the hollow main body carrying the magnet has made about its central longitudinal axis, and the distance of the magnetic sensor from the magnet being linked to the relative change in the magnetic field vector. Such an arrangement allows the event of end of injection to be registered, in this case using only the magnetometer.

[0064] However, in the case of an injection pen system in which the dose setting wheel does not rotate, e.g. during injection, a non-contact sensor as described above, e.g. an optical sensor, is particularly advantageous, since the injection monitoring system is configured to use such a non-contact sensor to notify when the injection monitoring device returns from the second injection monitoring position back to the first injection monitoring position again via axial translation along the central longitudinal axis, and thus to assign an end of injection event to such return position.

[0065] According to yet another object of the present invention, an injection monitoring system includes an electronic component board.

[0066] Advantageously, and according to a further object of the invention, one or more magnetic field sensors are electrically connected to the electronic component board, the one or more magnetic field sensors being usefully arranged on the electronic component board at diametrically opposed positions about the central longitudinal axis or otherwise radially distributed, with a single magnetic field sensor being preferably arranged on the central longitudinal axis.

[0067] Even more advantageously, the electronic component board comprises an integrated control and data processing unit, for example at least one microcontroller, electrically connected to the one or more or a plurality of magnetic field sensors for processing information received from the magnetic field sensors. The electronic component board is thus advantageously, for example, a printed circuit board of correspondingly suitable dimensions. In the configuration envisaged by the present invention, such a printed circuit board is advantageously disk-shaped, the centre of which coincides with the intersection with the longitudinal central axis.

[0068] As mentioned above, the injection monitoring system comprises an optical sensor, which, according to yet another object, is electrically connected to at least one microcontroller, which controls the manner in which the optical sensor functions and processes the signals and / or data received from the optical sensor to calculate, for example, the completion of an injection sequence as described elsewhere herein, and further, the distance that the injection monitoring system has translated along the central longitudinal axis. This information is used to calculate whether the injection is complete or not.

[0069] The electronic component board is advantageously contained within an injection monitoring system housing or holder body that is located mostly proximally from the hollow main body and generally beyond the proximal tip 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 hollow main body bore but is prevented from rotating by rotational stop means, for example embodied by a sheath member and an elongated rod member.

[0070] Advantageously, the electronic component board is held such that a horizontal surface of the component board is disposed in a plane substantially perpendicular to said central longitudinal axis. The electronic component board is thus disposed in a rotationally fixed relationship with respect to the hollow main body in a first injection monitoring position during dose setting, such that rotation of the hollow main body does not cause a corresponding rotation of the electronic component board. This means that rotation of the hollow main body to "dial" or set the injection dose prevents rotation of at least one or more or a plurality of magnetometers disposed on the electronic component board about the central longitudinal axis.

[0071] According to yet another object, the electronic component board comprises a communication unit in electrical connection with the at least one micro-controller, such communication unit may be one or more of any number of communication units known per se, such as a wireless communication unit, for example Bluetooth®, Bluetooth LE® or any other short or long range wireless communication technology.

[0072] According to another further object of the present invention, the electronic component board is optionally provided with a rechargeable independent power source, for example a lithium ion battery that can be easily replaced when depleted, or alternatively a rechargeable battery, such as a rechargeable lithium ion battery. If a rechargeable battery is provided, said rechargeable battery, when depleted, can be recharged via a corresponding charging port, for example a USB charging port, provided in the injection monitoring module and connected to the rechargeable battery. Non-rechargeable, i.e. single-use batteries, as well as rechargeable batteries are generally known per se to those skilled in the art. Advances in charging technology have nowadays made wireless charging possible as well, and such wirelessly rechargeable batteries, for example using an inductive charging system, are also foreseen as a possibility within the scope of the present invention.

[0073] An integrated control and data processing unit, comprising at least one microcontroller, takes care of all electrical communication and signal transfer between the various electronic components of the electronic component board, including the magnetic field sensor and the optical sensor. This unit is also responsible for carrying out the calculations that allow the calculation and determination of the precise position of the magnetic field sensor, as well as for handling signals from the autonomous power supply and communication means integrated into the injection monitoring system, which communicate with a local or remote data processing system, for example on a smartphone. Such integrated control and data processing units are known per se and often incorporate 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.

[0074] These and other objects of the present invention will become apparent and will be described in more detail in the following description of the figures and exemplary monitoring modules.

[0075] The invention will now be described in more detail with reference to the accompanying figures, which are provided for purposes of illustration and description. [Brief description of the drawings]

[0076] [Figure 1] 1 is a schematic exploded perspective representation of an injection monitoring module as it would be mounted on a one-handed pen injection system. [Figure 2A] 2A is a schematic perspective representation of the injection monitoring module of FIG. 1 in a pushed-in, locked position (FIG. 2A) prior to use, prior to or ready for mounting onto a pen injection system. [Figure 2B] 2B is a schematic perspective representation of the injection monitoring module of FIG. 1 in a deployed, unlocked position (FIG. 2B) prior to use, prior to or ready for mounting onto a pen injection system. [Figure 3A] 3A is a schematic perspective representation of the injection monitoring module of FIG. 1 or FIG. 2 in a pushed, locked position (FIG. 3A) after mounting onto a pen injection system. [Figure 3B] 3B is a schematic perspective representation of the injection monitoring module of FIG. 1 or FIG. 2 in a deployed, unlocked position (FIG. 3B) after mounting onto a pen injection system. [Figure 4A] 1 is a schematic cross-sectional representation of an injection monitoring module mounted on a pen injection system in a pushed, locked position. [Figure 4B] 1 is a schematic cross-sectional representation of an injection monitoring module mounted on a pen injection system in a deployed, unlocked position. [Figure 5A] FIG. 1A is a perspective view of a side-by-side schematic representation of details of the relative positioning means of the injection monitoring module in the pressed, locked position. [Figure 5B] FIG. 1B is a partial cutaway view of a side-by-side schematic representation of details of the relative positioning means of the injection monitoring module in the pressed, locked position. [Figure 5C] FIG. 1C is a perspective view of a side-by-side schematic representation of details of the relative positioning means of the injection monitoring module in the deployed unlocked position. [Figure 5D] FIG. 1D is a partial cutaway view of a side-by-side schematic representation of details of the relative positioning means of the injection monitoring module in the deployed unlocked position. [Figure 6A] 13 is a schematic perspective representation of another detail of the relative positioning means of the injection monitoring module. [Figure 6B] 13 is a schematic perspective representation of another detail of the relative positioning means of the injection monitoring module. [Figure 7] 1 is a schematic representation of a sequence for mounting an injection monitoring module onto a pen injection system and the relative depressed and locked position of the monitoring module during mounting to the pen injection system. [Figure 8] 1 is a schematic representation of the sequence for mounting the injection monitoring module onto the pen injection system and the relative depressed and locked position of the monitoring module after mounting to the pen injection system. [Figure 9] 1 is a schematic representation of a sequence for mounting an injection monitoring module onto a pen injection system and the relative deployed, unlocked position of the monitoring module after mounting onto the pen injection system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0077] Turning now to the figures, various schematic representations of an injection monitoring module (1) are shown. As shown in FIG. 3, the injection monitoring module (1) is intended to be mounted on a one-handed injection pen system (2). The injection pen system (2) comprises a pen injection system body (3) having an outer peripheral surface (4), a pen cap (5) covering a distal tip of the pen injection system, a dose setting or dialing wheel (6) located at a proximal tip of the body (3) of the pen injection system, and a dialed dose visualization window (7) located distal to the dose setting wheel (6) for indicating the dose dialed by a user of the pen injection system. The injection monitoring module (1) according to the present invention is mounted on, covering and surrounding the proximal tip (8) of the injection pen system (2), and in particular is also mounted on the pen body (3) so as to at least partially cover and contact the peripheral outer surface (4). The injection monitoring module (1) extends proximally beyond the proximal tip (8) of the pen body (3), and in particular beyond the dose setting wheel (6). See also FIG. 7. A central longitudinal axis (9) is also shown passing through the longitudinal centers of both the injection monitoring module (1) and the injection pen system body (3). The injection pen system (2) includes an actuation button (10, FIG. 7) located proximally from the dose setting or dialing wheel (6), as can be found in some commercially available injection pen systems. In a pen injection system (2) of the type shown in FIG. 3, the dose setting wheel (6) is rotated 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.

[0078] The injection monitoring module (1) comprises a hollow main body (11) that is dimensioned and sized to be coaxially mounted around the body (3) of the pen injection system (2). To this end, the hollow main body (11) comprises a longitudinal central bore (12) having a proximal tip (13) and a distal tip (14) and a longitudinal central axis that coincides with the longitudinal central axis (9). The hollow main body (11) further comprises a distal body portion (15) that extends around and frictionally engages the outer surface of the dose setting wheel (6). The frictional engagement between the hollow main body (11) and the outer surface (4) of the dose setting wheel (6) can be achieved, for example, by fabricating the distal body portion from an elastomeric friction material (16) or, alternatively, by providing a coating of such a frictional elastomeric engagement material on the inner circumferential surface (17) of the hollow main body, although such elastomeric friction materials are readily known per se in the art for achieving a push-fit or sliding-fit engagement between the distal portion (15) and the outer surface (4) of the pen body (3). A suitable elastomeric friction material (16) for the distal body portion (15) can be, for example, a thermoplastic elastomer, such as SEBS or polystyrene-poly(ethylenebutylene)-polystyrene block copolymer.

[0079] 1 and 4, extends proximally above and beyond the confines of the actuation mechanism button (10) of the pen injection system (2), with both the dose setting wheel (6) and the actuation mechanism button (10) housed in a bore (12), which is in the distal body portion (15) of the hollow main body (11) as shown in the figures. The hollow main body (11) further comprises magnetic field generating means (18, 19) disposed on the hollow main body (11) or within the bore (12) thereof. The magnetic field generating means (18, 19) is preferably provided by a pair of single dipole magnets (18, 19) arranged diametrically opposed to one another, each magnet having a respective north (N) and south (S) pole, each pair of poles preferably oriented such that the poles are aligned opposite one another across the central longitudinal axis, i.e. NS / SN, with the first magnet lying with its north pole along a horizontal plane perpendicular to the central longitudinal axis and the diametrically opposed magnet lying in the same plane perpendicular to the central longitudinal axis with its south pole oriented in the same plane as the north pole of the first magnet. The dipole magnets may preferably be formed in the shape of a rod or brick, or alternatively as a disk or ring, or any other suitable shape. The magnets are located in suitably dimensioned recesses (20, 21) in the hollow main body (11), which are located at or adjacent to the proximal tip (13) of the body (11). Alternatively, the magnetic field generating means can be a ring-shaped single bipolar magnet, which is mounted on the proximal periphery of the hollow main body (11) or in a corresponding annular recess at the proximal tip (13) of the hollow main body (11). From the above, it will be understood that the hollow main body (11) in which the magnet is positioned is itself mounted on and frictionally engaged with a dose setting wheel centered on said central longitudinal axis (9), so that the magnetic field generating means is free to rotate about the central longitudinal axis.

[0080] The hollow main body (11) further comprises 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 in the hollow main body (11). The guide sleeve (22) also extends proximally from the annular flange portion (23) towards the proximal tip (13) of the hollow main 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 hereinafter.

[0081] The hollow main body (11) also comprises a translation abutment means (24) adapted and configured to prevent axial translational movement of the hollow main body (11) along the central longitudinal axis (9) when the injection monitoring module (1) is in a mounted position on the injection pen system (2). As shown in FIG. 4, the translation abutment means may comprise an annular shoulder portion (24) extending inwardly into the bore from the inner surface (17) of the hollow main body towards the central longitudinal axis. The annular shoulder portion (24) may be advantageously configured to present a distally facing surface that abuts against a proximally facing surface of the actuator 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.

[0082] 1 and 4, injection monitoring system (25) is at least partially disposed within bore (12) and is translatable from a first monitoring position to a second monitoring position within bore (12). Injection monitoring system (25) includes several components, among which is injection monitoring system housing (26). The housing (26) of the injection monitoring system is shaped and configured like a cup having legs, with a base wall (27) extending substantially perpendicular to the central longitudinal axis (9) over substantially the same or similar diameter as the hollow main body, and a first wall (28) extending from the outer periphery of the base wall (27) proximally away from said base wall (27) thereby forming a cup-shaped portion having an interior volume closed by a proximal cap (29) forming an actuation mechanism button, the proximal cap (29) being snap-fitted or press-fitted or adhesively or otherwise secured to said proximally extending first wall (28) at a proximal tip of said first wall (28). The base wall (27) further comprises a second annular wall (30) extending distally from the base wall (27) at a location radially spaced from the central longitudinal axis (9) and having a diameter smaller than the diameter of the bore (12) of the hollow main body (11) to allow translational movement of the sleeve (24) and the housing (26) within the bore (12) of the hollow main body (11). The second annular wall (30) is closed at its distal tip by a transverse wall (31) to form a leg of a cup. The transverse wall (31) can be made of, for example, a flexible membrane material that is deformable upon contact with the actuation mechanism button (10) of the pen injection system (2). The leg of the cup fits within the bore (12) of the hollow main body (11). The injection monitoring system housing (26) is defined by a cup-shaped interior volume to receive and seat an electronic component board (32). The interior volume of the leg, defined by the second annular wall (30) and the transverse wall (31), receives an independent power source (33), such as a single-use or rechargeable battery, e.g., a lithium-ion battery, electrically connected to and powering the electronic component board (32).The electronic component board (32) is generally a printed circuit board suitably sized for placement within the interior volume of the cup formed by the base wall (27) and the proximally extending first wall (28). The injection monitoring housing (26) optionally further comprises a light guiding window incorporated into or part of the first wall (28), e.g., a molded translucent, opaque, or transparent material with crystalline properties selected to guide light waves from the interior volume of the cup, such as those generated by an optionally present light emitting diode or other light wave generating component, to the exterior of the injection monitoring system housing (26).

[0083] The electronic component board (32) further comprises at least one magnetometer (34), advantageously arranged on the longitudinal central axis (9) and, in the case of a substantially circular component board, substantially at its center so as to be coaxially aligned with the longitudinal central axis (9). In addition to the magnetometer (34), the injection monitoring system (25) also comprises an integrated control and data processing unit, electrically connected to the magnetometer (34), for processing information received from the magnetometer. The integrated control and data processing unit handles all electrical communication and signal transfer between the various electronic components of the injection monitoring system. This unit is also responsible for performing calculations that allow for the calculation and determination of the precise position of the dosage management system and the magnet, as well as handling signals from the independent power source (33). The electronic component board is further connectable to a USB port (35), which can be configured as a power recharging port for the rechargeable battery (33) and / or can be configured to allow for the basic setup of any programmable memory on the electronic component board or to configure the data processing unit. The integrated control and data processing unit is also typically equipped with communication means, such as wireless communication circuitry, for communicating with a local or remote data processing system on the smartphone, e.g. Bluetooth® or Bluetooth LE® wireless communication systems, to name just two of the many types of suitable communication means. The integrated control and data processing unit may be suitably programmed remotely upon first use, or may receive and update information, e.g. wirelessly or via any other suitable link, such as a USB port, in a manner similar to other electronic devices today that include an integrated control and data processing unit. Such integrated control and data processing units are known per se, and often incorporate 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 electronic component board (32) is mounted or positioned within a cup formed by the base wall (27) and the first wall (28) of the injection monitoring system housing (26) substantially along the horizontal plane of the circuit board, i.e., vertically and generally perpendicular to the central longitudinal axis (9).

[0084] The second annular wall (30) together with the transverse wall (31) further defines a chamber housing (36) for a biasing means (37), such as a compression spring, which presses against the transverse wall (31) at the proximal end of the second annular wall (30) and is constrained against one or a pair of seating nubs (38) at the proximal end of the chamber (36). Compression of the biasing means (37) causes the transverse wall to flex distally. The transverse wall (31) is located at the distal tip of the second annular wall (30) via a snap-fit ​​or clip-fit ​​protrusion which fits into a corresponding recess in the second annular wall (30). The biasing means (37) also serves as a damper for the injection monitoring system (25) when it starts to move from the first monitoring position under finger pressure on the cap activation button after the dose has been selected. The interaction of the compression spring, optionally assisted by a 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 and second injection monitoring positions is very small, for example only a matter of a few tenths of a millimeter to only a few millimeters at most, depending on the dimensions of the injection pen, the biasing means not only accommodates the variations in axial geometry and molding tolerances of the various components of the various pens, but also facilitates the detection of the increase in the magnetic norm as the magnetometer (34) in the injection monitoring system (25) is moved towards the magnets (18, 19) along the central longitudinal axis (9).

[0085] The injection monitoring housing (26) further comprises a third annular wall (39) radially spaced from and radially between the first annular wall (28) and the second annular wall (30). The third annular wall extends distally from the base wall (27) towards the hollow main body (11). This third annular base wall (36) provides further axial stabilization of the injection monitoring system housing (26) insofar as it is dimensioned to be surrounded and guided by the inner circumference of the proximal tip (13) of the hollow main body (11).

[0086] 1, 2, 3 and 4 also show various components of a rotation stop means, which are configured and adapted to prevent rotational movement of the injection monitoring system about the central longitudinal axis (9) during dose setting. The rotation stop means comprises a rotatably fixed coupling member disposed parallel to the central longitudinal axis (9). The rotatably fixed coupling member connects the injection monitoring system (25) to the body (3) of the pen injection system (2), as described below. The rotatably fixed coupling member prevents rotation of the injection monitoring system (25) about the central longitudinal axis (9) not only during dose setting or dialing, but more generally also during translation of the injection monitoring system (25) from a first monitoring position to a second monitoring position, and then translation back from the second monitoring position to the first monitoring position. In this way, it can be ensured that no rotation, whether accidental or intentional, of the injection monitoring system (25) occurs, in particular that such rotation does not occur during dose selection or dose dialing that would cause an error in determining the selected or dialed dose. The rotation stop means is further configured and adapted to allow translational movement of the injection monitoring system from the first injection monitoring position to the second injection monitoring position during an injection and vice versa, i.e. from the second injection monitoring position to the first injection monitoring position, while maintaining the prevention of rotation. As will become clear from the preceding description, the rotation stop means in this case physically prevents rotation of the injection monitoring system (25) about the central longitudinal axis (9) while at the same time providing a translational guide system for the injection monitoring system (25) in both distal and proximal directions.

[0087] The rotatably fixed coupling member comprises an elongate rod member (40), as shown in Figures 1 and 4, extending distally from the injection monitoring system parallel to the longitudinal axis and circumventing the outer surface of the hollow main body (11). The elongate rod member comprises a spigot (41) at or near its distal end, having a shaft portion (42) projecting outwardly from an outer-facing surface (43) of the elongate rod member (40) away from the central longitudinal axis (9). The shaft portion (42) of the spigot (41) terminates at its outermost point in a flattened head (44). The diameter of the flattened head (44) is greater than the diameter of the shaft portion (42) of the spigot (41).

[0088] The rotatably fixed coupling member also includes a sheath member (45) that is mounted to the body (3) of the injection pen system (2), e.g., by being coaxially mounted around the pen body (3), e.g., by sliding the sheath member (45) onto and along the pen body (3), and the sheath member (45) is adapted and configured to receive the elongated rod member (40) in sliding engagement therewith during translational movement of the injection monitoring system (25) from the first monitoring position to the second monitoring position.

[0089] The elongated rod member (40) and the corresponding sheath member (45) in this case cooperate with each other to allow sliding engagement of the elongated rod member (40) within the sheath member (45) when the injection monitoring system (25) moves from the first injection monitoring position to the second injection monitoring position and vice versa, i.e. 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) is substantially parallel to the central longitudinal axis (9).

[0090] The elongated rod member (40) extends parallel to the central longitudinal axis (9) in a distal direction from the injection monitoring system (25), i.e., away from the proximal tip of both the injection pen system (25) and the injection monitoring module (1). The rod member (40) is further disposed outside the outer surface of the hollow main body (11) and is shaped and dimensioned to circumvent the hollow main body (11) outside thereof, and therefore does not interfere with the dose setting function of said hollow main body (11). This means that the hollow main body (11) can rotate without being hindered by the elongated rod member (40), which allows the hollow main body (11) to rotate and co-rotate the dose setting wheel (6) to set the dose of the pen injection system. Similarly, the shape and dimensions of the elongated rod member (40) are configured and adapted so that the rod member does not interfere with any optional rotation of the dose setting wheel during injection, if the pen injection system manufacturer configures the pen to function in that manner.

[0091] The elongated rod member or members (40) have a proximal tip that is mounted or fixed in a portion of the housing (26) of the injection monitoring system, for example by providing the proximal tip of the elongated rod member (40) with an enlarged proximal cross section, the housing (26) of the injection monitoring system being provided with a correspondingly shaped recess with a reduced cross-sectional exit diameter, thereby preventing withdrawal of the elongated rod member (40) from said housing (26). Alternatively, the elongated rod member (40) is preferably formed integrally with the housing (26) of the injection monitoring system, in particular with an actuation cap (29) of the housing (26) of the injection monitoring system, the cap (29) being accordingly configured and dimensioned to extend beyond the nominal diameter of the hollow main body (11). Thus, elongated rod member (40) extends distally from cap (29) parallel to central longitudinal axis (9) and bypasses hollow main body (11) without touching or contacting it.

[0092] The elongated rod member (40) advantageously comprises at least one portion that defines an elliptical spline, extending distally from the cap (29) and parallel to the central longitudinal axis (9). The "elliptical spline" shape of the elongated rod member facilitates contactless passage of the rod member around the relatively enlarged diameter of the hollow main body while reducing the need to enlarge the diameter of the injection monitoring system housing (26). The spline curved portion of the elongated rod member (40) is in this case configured to maintain a sufficient distance between the elongated rod member (40) and both the hollow main body (11) and the pen body (3) such that the elongated rod member (40) preferably never comes into contact with the outer surface (4) of the injection pen system body as the injection monitoring system (25) is moved from the first monitoring position to the second monitoring position and back again.

[0093] The elongated rod member 40 is further suitably dimensioned, e.g., having a corresponding thickness of material such that the rod member 40 is semi-rigid along the length of the elongated rod member 40. Suitable materials for the elongated rod member are semi-rigid plastic materials such as, for example, blends of polycarbonate (PC) and acrylonitrile-butadiene-styrene (ABS) copolymers, commonly known as PC / ABS blends, although other suitable polymers and polymer blends that provide suitable stiffness are commonly known to those skilled in the art, and the elongated rod member may be fabricated or constructed of any such suitable rigid material accordingly.

[0094] The sheath member (45) comprises a generally elongated, 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) further comprises channels (46) configured and adapted to respectively receive the elongated rod members (40) in sliding engagement. The channels (46) also extend parallel to the central longitudinal axis (9). The channels (46) of the sheath member (45) are axially aligned with the elongated rod members (40) such that the rod members (40) are inserted into and received by the channels (46) prior to mounting of the injection monitoring module (1) onto the pen injection system (2). Channel (46) has sidewalls (48, 49) projecting inwardly from an inner-facing surface of sheath member (45) and comprises an open channel (47) defining a longitudinally oriented opening (50) extending parallel to central longitudinal axis (9). Longitudinal opening (50) is configured and dimensioned to receive shaft portion (42) of spigot (41) and to permit distal and / or proximal movement of shaft portion (42) along longitudinal opening (50) as elongate rod is moved, but not to permit lateral movement of the spigot and corresponding shaft portion outside the dimensional constraints of longitudinal opening (50). The longitudinally oriented opening (50) further comprises a proximal end portion (51) and a distal end portion (52) configured and dimensioned to receive the flat head (44) of the spigot (41) for assembly of the elongated rod member (40) within the sheath member (45). When assembled together, the flat head (44) of the spigot (41) is disposed on an outwardly facing side of the longitudinally oriented opening (50) of the channel (46), while the elongated rod member is disposed on an inwardly facing side of the longitudinally oriented opening (50) of the channel (46), such that the shaft portion (42) of the spigot (41) extends through and can translate along the longitudinally oriented opening (50) of the channel (46).

[0095] 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) configured and adapted to allow for a removably mounting of the sheath member to the body (3) of the pen injection device (2). The body mounting portion (53) in this case comprises a wall of a material, for example a plastic or polymeric material, such as polycarbonate (PC), acrylonitrile butadiene styrene (ABS) copolymer, or a mixture thereof known as a PC / ABS mixture, which wall extends circumferentially around the body (3) of the pen injection system (2) and is dimensioned to allow the insertion of the pen body into a hole (54) formed by said circumferentially extending wall and at the same time engage in elastic frictional engagement with the outer surface (4) of said pen body (3) by appropriate dimensioning of the hole (54). The circumferentially extending wall advantageously comprises a wall portion (55) made of a softer and more elastic material, e.g., elastomer SEBS or a similar elastomeric polymer, for engaging and gripping a corresponding surface portion (4) of the body (3) of the pen (2) so as to prevent any undesired axial sliding of the pen within the hole (54) of the circumferentially extending wall.

[0096] Figures 1, 5, and 6 show certain features of the sheath and relative positioning system included in the injection monitoring module. Figures 5A and 5C are schematic perspective representations of a sheath member (45) showing a position locking system disposed within the sheath member and configured to selectively engage or disengage from a locking contact with the flat head (44) of the spigot (41), with Figure 5A showing a locked configuration and Figure 5C showing an unlocked configuration with respect to the relative positioning system. Figures 5B and 5D show the sheath (45) and positioning system with the top of the sheath and the positioning system removed or detached, with Figure 5B showing the locked configuration and Figure 5D showing the unlocked configuration, respectively. As can be seen in Figures 5A-5D, but also in Figure 1 and more particularly in Figures 6A and 6B, the lock system comprises a rotationally actuated lock head (56), e.g., a rotatable button operable by a finger or thumb, which optionally comprises one or more friction members (57), e.g., constructed as a dial mechanism along the periphery of the lock head button (56), to facilitate engagement by a user's finger or thumb. The lock head button (56) also comprises a pair of legs (58A, 58B) extending from an underside of the lock head (56) into the channel (46) and into a corresponding distal end opening (52) of the longitudinally oriented opening (50). The legs (58A, 58B) terminate in a pair of opposing feet (59A, 59B). The locking head (56) is rotatable, for example, by a quarter turn, about an axis (60, FIG. 6A) that extends perpendicular to the central longitudinal axis. The legs (58A, 58B) and feet (59A, 59B) are configured and shaped to selectively lockingly engage the flat head (44) of the spigot (41) depending on the rotational position of the locking head (56) about the axis of rotation (60).In a first locked position, as depicted in Figures 5A and 5B, the legs and feet are oriented transversely or perpendicular to the longitudinal axis of the longitudinally oriented opening (50), thereby preventing axial movement of the flat head (44) and shaft portion (42) of the spigot (41) parallel to the central longitudinal axis (9). Rotation of the lock head (56), for example by a user pressing the lock head button with a finger or thumb, or by pressing the friction member in a clockwise direction to perform, for example, a quarter turn, rotates the legs (58A, 58B) and feet (59A, 59B) 90 degrees, such that the legs and feet are aligned with the longitudinally oriented opening (50), thereby removing the locking engagement of the legs and feet with the flat head, and allowing the spigot flat head (44) and attached shaft portion (42) to move freely axially along and parallel to the central longitudinal axis (9). This unlocked position is depicted in Figures 5C and 5D. To facilitate the user's recognition of the locked and corresponding unlocked positions, the lock head may advantageously be provided with corresponding markings, abutment stops preventing over-rotation of the lock head button (56), etc. The lock head button (56) may also be advantageously mounted within a suitably provided cover (61) for the sheath, which may for example be either removable or alternatively welded or otherwise secured to the body of the sheath (45), for example by ultrasonic welding, and the cover (61) may be provided with index markings aligned parallel to the central longitudinal axis (9) which, in combination with optional markings on the lock head, enable a user of the injection monitoring module to know whether the lock head button (56) is set in the locked or unlocked position.

[0097] The locking head (56) is also used to maintain the injection monitoring system (25) of the injection monitoring module in a first, retracted position during mounting of the injection monitoring module onto a pen injection system, as described below with respect to Figures 2A, 4A, 7, and 8. Figure 2A shows the injection monitoring module (1) in a first, retracted position, with the injection monitoring system in contact with a proximal facing surface of the hollow main body end (13) in preparation for mounting onto the proximal end of an injection pen system, as shown, for example, in Figure 7. Meanwhile, Figure 2B shows the same injection monitoring system in an expanded, unlocked position, either prior to any mounting onto an injection pen, or after, for example, unloading the injection monitoring module from the injection pen and unlocking it from the locked position. The elongated rod member (40) and spigot (41) are locked into the depressed position by the user by rotating the lock head button (56) into the locked position, thereby causing a locking surface engagement between the lock head and the flat head (44) of the spigot (41). As a result, neither the head, nor the shaft portion (42) of the spigot, nor the elongated rod member (40) are permitted to move axially in the proximal or distal directions. In the depressed position, this allows a user of the injection monitoring module to mount the module onto an injection pen system without having to worry about accidentally causing distal or proximal axial movement of the injection monitoring system (25) relative to the hollow body (11), which may be interpreted by the injection monitoring system's processing system as the start or end of an injection process. Figure 8 shows the injection monitoring module mounted onto an injection pen system, but with the lock head still set in the locked position. In this view, it can be seen that it is still in the retracted position and that the elongated rod member (40) is largely externally invisible to the user.Rotation of the locking head (56) by a user, e.g., 90 degrees about the axis of rotation (60), to move the locking head (56) to an unlocked position will move the flat head (44) and shaft portion (42) of the spigot (41) into longitudinal parallel alignment with the legs (58A, 58B) and feet (59A, 59B) and the longitudinally oriented opening (50), thereby releasing them from locking engagement therewith. The elongated rod member (40) may now move axially proximally, e.g., under the motive force of any recoil energy transmitted via the injection actuation mechanism button (10), or alternatively, under the motive force of the biasing spring (36) that was compressed against the pen injection system actuation mechanism (10) during mounting of the injection monitoring module onto the proximal end of the pen injection system. This biasing force moves the injection monitoring system (25) of the injection monitoring module (1) to the attached, deployed position as shown in Figures 4B and 9.

[0098] 1 and 4 show another embodiment of the injection monitoring module (1) in which an optical sensor (62) is present as a suitable example of a non-contact sensor. The optical sensor (62) is disposed adjacent to the elongated rod member (40) on the housing (26) of the injection monitoring system, preferably in the actuation cap (29) portion of the housing (26). In such an embodiment, the optical sensor (62) is positioned such that it can receive reflected light from a correspondingly appropriately positioned reflective surface (63) disposed on the proximal tip of the body of the sheath member (45). The optical sensor (62) and the reflective surface (63) are thus positioned such that the reflected light coming from the reflective surface (63) passes to the optical sensor (62). The optical sensor (62) is suitably configured to determine the distance traveled parallel to and along the central longitudinal axis of the optical sensor (62) and thus the predetermined reference position in the injection monitoring system (25), for example from the intensity of the reflected light and / or the time it takes for the reflected light to travel the path between the reflecting surface (63) and the optical sensor (62). The optical sensor (62) preferably comprises a light emitting source, which in this case can be provided for example by a light emitting diode. The optical sensor (62) can further comprise a focusing or diffusing system for such a light source, as known per se, depending on the characteristics of the reflecting surface (63), the output of the light emitting source, etc., as known per se in the art for the manner of functioning and operation of such optical sensors.

[0099] Once attached and positioned in the unlocked deployed position, the injection monitoring module functions according to the following simple description:

[0100] The dose is set by rotating the hollow main body and thus co-rotating the dose setting wheel. Since the elongated rod member (40) is already engaged in the channel of the sheath member (45), the injection monitoring housing (26) is prevented from rotating in the bore (12) of the hollow main body. The monitoring system (25) then receives only a signal from the magnetometer corresponding to the actual dose selected by the rotation of the dose setting wheel (6). Without the rotation lock provided in the injection monitoring module of the present invention, these readings may be inaccurate due to unintended relative rotation, in which case an auxiliary corrective action would be required to determine whether the dialed dose was actually the selected dose. Once the processing unit has verified that the set or dialed dose is the selected dose, the monitoring system now determines whether the injection process has been initiated, i.e., whether the injection monitoring system has started to translate along the central longitudinal axis (9) from the first monitoring position to the second monitoring position. This is achieved by the magnetometer reporting an increase in the magnetic norm to the processing unit, since this is synonymous with a movement of the magnetometer towards the magnet. In this way, the monitoring system knows that the injection process has started. In injection pens in which a dose wheel is rotated during injection, the magnetic field vector values ​​captured by the magnetometer can be used to calculate the injection end point as well. However, in pens without a rotating dose setting wheel, it is usually not possible to know when the injection has ended, since the user may leave the injection monitoring system (25) in contact with the injection activation button (10) of the pen (2) for an indeterminate period of time, or barely in contact with the activation button (10). It is therefore considered that the measurement of the time elapsed at the second monitoring position may involve errors that require correction.In such a configuration, the optical sensor is therefore used to provide a reference point for the injection monitoring system, and the optical sensor therefore determines when the injection monitoring system returns from the second monitoring position to the reference point of the first monitoring position, thereby notifying the end point of the injection.

[0101] Thus, as can be seen from the foregoing, the injection monitoring module described herein makes it possible to reliably determine that the dialed dose is in fact the selected dose, the point at which the injection starts, and the point at which the injection ends in a significantly more efficient manner than has been possible in the past. Furthermore, the injection monitoring module includes means for actively preventing any undesired axial translation along the central longitudinal axis of the injection monitoring system during attachment and / or detachment of the injection monitoring module from the pen injection system, which may otherwise lead to the injection monitoring system generating and processing erroneous signals.

Claims

1. 1. An injection monitoring module adapted and configured to be removably mounted to a proximal tip of an injection pen system for delivering a medication, the injection pen system having a pen body, a dose setting wheel located proximally and connected to the body, and an injection actuation mechanism, the dose setting wheel being rotatable about a central longitudinal axis of the pen injection system during dose setting, the injection monitoring module comprising: a hollow main body adapted and configured to be coaxially mounted on and co-rotatably engaged with the dose setting wheel at the proximal tip of the injection pen system, the hollow main body having a longitudinal central bore and a longitudinal central axis with proximal and distal tips; a magnetic field generating means disposed on or within the hollow main body at the proximal tip of the longitudinal central bore; an injection monitoring system comprising at least one or more magnetic sensors disposed at the proximal end of the hollow main body and movable within the bore of the hollow main body along the central longitudinal axis from a first monitoring position in which the injection monitoring system is not in abutting contact with a proximal surface of the injection actuation mechanism to a second monitoring position in which the injection monitoring system is in abutting contact with the proximal surface of the injection actuation mechanism, the injection monitoring module further comprises a rotation stop means configured and adapted to prevent rotational movement of the injection monitoring system about the central longitudinal axis during dose selection; the rotation stopping means comprises a rotatably fixed coupling member disposed parallel to the central longitudinal axis, the rotatably fixed coupling member connecting the injection monitoring system to the body of the pen injection system; said rotation stopping means being configured and adapted to allow translational movement of said injection monitoring system from said first injection monitoring position to said second injection monitoring position during an injection and vice versa from said second injection monitoring position to said first injection monitoring position after an injection is completed; The injection monitoring module also comprises relative positioning means configured to prevent translational movement of the injection monitoring system in a proximal direction out of a retracted position in a first retracted mounting position, and to allow translational movement of the injection monitoring system in a proximal direction out of the first retracted position to a second deployed mounting position in a second deployed position.

2. The rotatably fixed coupling member includes: an elongated rod member extending distally from the injection monitoring system parallel to the longitudinal axis and circumventing an outer surface of the hollow main body; 2. The injection monitoring module of claim 1, comprising: a sheath member mountable to the body of the injection pen system and adapted and configured to receive the elongated rod member in sliding engagement with the sheath member during translational movement of the injection monitoring system from the first monitoring position to the second monitoring position.

3. 3. The injection monitoring module of claim 2, wherein the relative positioning means comprises a locking system configured to selectively engage with the sheath and / or the elongate rod member to position the injection monitoring module in the first retracted mounting position or the second deployed mounting position, respectively.

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

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

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

7. 3. The injection monitoring module of claim 2, wherein the elongated rod member comprises a spigot protruding outwardly from an outer-facing surface of the elongated rod member, the spigot being located at or near a distal end of the elongated rod member.

8. The injection monitoring module of claim 6 , wherein the spigot comprises a shaft portion extending from the outwardly facing surface of the elongate rod member, the spigot shaft portion terminating in a flattened head.

9. 7. The injection monitoring module of claim 2, wherein the elongated rod member comprises at least one portion thereof defining an elliptical spline extending distally from the injection monitoring system and parallel to the central longitudinal axis.

10. 8. The injection monitoring module of claim 2, wherein the sheath members include channels configured and adapted to respectively receive the elongate rod members in sliding engagement.

11. The injection monitoring module of claim 8 , wherein the channel extends parallel to the central longitudinal axis.

12. 9. The injection monitoring module of claim 8, wherein the channel comprises an open channel having side walls with corresponding respective longitudinally oriented openings.

13. 13. An injection monitoring module according to claim 6 and any one of claims 10 to 12, wherein the longitudinally oriented opening of the channel has a distal end and a proximal end, the distal end and the proximal end of the longitudinally oriented opening being configured and dimensioned to receive the flat head of the spigot therein and to enable insertion or withdrawal of the flat head into or out of the proximal and / or distal ends, respectively, of the longitudinally oriented opening.

14. The injection monitoring module of claim 2 and any one of claims 10 to 13, wherein the sheath member comprises a body attachment portion configured and adapted to enable removable attachment of the sheath member to the body of the pen injection system.

15. 9. The injection monitoring module of claims 4, 6, 7 and 8, wherein the rotationally selectable lock is configured and dimensioned to lockingly engage the shaft portion and / or the flat head of the spigot of the elongate rod member to prevent longitudinal movement of the head and / or the shaft portion of the spigot within the sheath in the first locked position and to disengage the lock to allow longitudinal movement of the head and / or the shaft portion of the spigot within the sheath in the second unlocked position.

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

17. 17. The injection monitoring module of claim 16, wherein the translation abutment means of the hollow main body comprises an annular shoulder extending inwardly from an inner surface of the hollow main body toward the central longitudinal axis and into the bore.

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

19. The injection monitoring module of claim 2 , wherein an optical sensor is disposed on the injection monitoring system adjacent to the elongated rod member.

20. The injection monitoring module of claim 1 , further comprising an injection initiation determining means.

21. The injection monitoring module of claim 1 , further comprising an injection completion determination means.

22. 22. The injection monitoring module of claim 20 or 21, wherein the injection initiation and / or end determination means comprises an optical sensor and a corresponding reflective surface.

23. 23. The injection monitoring module of claim 22, wherein the reflective surface for the optical sensor is positioned on the sheath member facing and aligned with the optical sensor on the injection monitoring module.

24. The injection monitoring module of claim 1 , wherein the injection monitoring system comprises an electronic components board and at least one microcontroller in electrical communication with the one or more magnetic field sensors.

25. 25. The injection monitoring module of claim 24, wherein the at least one microcontroller is in electrical communication with the optical sensor.

26. 25. The injection monitoring module of claim 24, wherein the electronic component board comprises a communication unit in electrical communication with the at least one microcontroller.

27. 25. The injection monitoring module of claim 24, wherein the electronic component board comprises an autonomous power source.

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