Injection monitoring module with position locking 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 generally relates to a monitoring system for an injectable drug delivery device, and more particularly to injection monitoring for an injection pen system.

Background Art

[0002] Injection monitoring is a well-known field related to injectable drug delivery devices, for example particularly related to infusion systems. Over time, more recently such monitoring systems have migrated to injection pen systems for delivering drugs, and users of such pen injection systems as well as medical professionals involved in the treatment and follow-up of such patients, intend to bring about better health management outcomes and enable more detailed monitoring of the patient's injection regimen and often the actual dosage administered. These developments have been accompanied by an increase in the related use of software and portable communication devices such as tablets or smartphones, which are programmed to receive information from the monitoring system and interact with it in order to provide information to the user or medical professional on the fly or at regular intervals via a suitable communication unit included in the monitoring system.

[0003] For example, particularly with regard to pen injection systems, one long-standing challenge has been to provide an easy-to-use, reliable, and reasonably fail-safe monitoring system that can adapt to the various different variations of the numerous commercially available pen injection systems. Attempts to provide such monitoring systems to date have typically involved adapting the pen injection system body by incorporating electronic components, along with one or more sensors. However, one of the main drawbacks of such systems is that, when all the electronic components are incorporated, the final product becomes quite bulky and cumbersome, and therefore more difficult to use from the user's perspective. Furthermore, such modified systems tend to be specific to a given brand or manufacturer and therefore little to no use for pen injection devices from other manufacturers. Moreover, there has long been a tendency to try to reduce the overall volume of the injection pen body as much as possible through miniaturization of complex electronic components, but this results in its own problems, particularly regarding electromagnetic interference between various components, due to the close proximity of multiple circuits that provide the necessary or desired integrated functionality. Moving sensors within such monitoring systems further away from sources of electromagnetic interference only complicates matters, potentially leading to reading errors or requiring additional systems to compensate for the physical isolation of the sensors from other electronic components, such as microcontrollers designed to control and command various components and manage their interactions.

[0004] The injection pen system in question is a well-known one, generally comprising a dosage setting wheel and an injection actuation mechanism located proximal to the system, with the dosage setting wheel rotatable around the longitudinal axis of the pen injection system. The user rotates the wheel to select the dosage of the drug to be administered. The pen is generally configured to perform an injection either mechanically or electromechanically when the injection actuation mechanism is activated. 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, and pressing this button causes the injection mechanism to dispense and inject the drug contained within the pen injection system. In some pen injection systems, the dosage setting wheel is configured to rotate not only during dosage setting but also during injection. This is generally achieved by including one or more metal components, such as a helical drive spring located within the housing body of the injection pen system and physically connected to the dosage setting wheel. Since such metal elements are relatively large compared to the electronic component systems found in many pen injection systems today, these large metal objects can further disrupt signals designed to be captured or picked up by sensors within such electronic component systems, potentially reducing the accuracy of the system and / or requiring the placement of complex compensation mechanisms to avoid calculation errors.

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

[0006] For example, International Publication No. 2014 / 128156 relates to a sensor assembly having a first rotational sensor portion having a plurality of individual conductive sensor areas arranged in a pattern, and a second rotational sensor portion having a plurality of contact structures arranged to rotate relative to the first portion and adapted to contact the conductive sensor areas on the rotational portion of the first sensor. The contact structures are configured to engage and connect to different sensor areas when the first and second portions of the rotational sensor rotate relative to each other, and the formed connections indicate the rotational positional relationship between the first portion and the second portion. One of the contact structures is an axially movable operable contact structure relative to the first portion, having a connected position in which the operable contact structure contacts a sensor area, and a disconnected position in which the operable contact structure does not contact a sensor area. The system is housed within the pen syringe body, at least in part within the volume inside the dosage setting wheel. The system also includes a visual display, such as an LCD display, located on or instead of the injection action mechanism button.

[0007] In contrast, International Publication No. 2018 / 013419 relates to a dosage detection system comprising a module including a dosage component that is rotatable and axially movable relative to a coupling component attached to an actuator and a dosage setting member, and an electronic sensor operable to detect the relative rotation of the coupling component and the dosage component in order to detect the dosage delivered by a drug delivery device. The dosage detection module is detachably coupled to the proximal end of a pen injection system and is intended to function as a means for detecting the amount of drug dispensed by the pen injection system while it is attached thereto, storing the detected dosage in memory, and transmitting a signal representing the detected dosage to a remote communication device. The system comprises a pair of rotatable and translatable cylinders that interact with each other via electrical contacts provided on the cylinder surfaces to indicate various states or positions of injection administration operations, including dosage setting. The electrical contacts are arranged in an accordion configuration with overlapping folding sections within a removablely connected 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 any resulting electrical, electronic, and electromagnetic interference.

[0008] One thing that becomes immediately apparent from observing the above configuration is that, despite using a folded flexible printed circuit board to provide multiple surfaces for positioning electronic components, their relative spatial density and positioning relative to each other necessitate the placement of non-conductive spacers between layers of electronic components. As a direct consequence of this, the module height increases, inevitably increasing the complexity of the clip-on dosage detection module described in the specification.

[0009] Furthermore, various other injection monitoring modules for injection pen systems are also known from International Publication Nos. 2019 / 175790, 2019 / 175615, 2018 / 138542, 2017 / 013464, and 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 [Overview of the project] [Means for solving the problem]

[0011] Accordingly, one aspect of the present invention provides an injection monitoring module adapted and configured to be detachably attached to the proximal tip of an injection pen system for delivering a drug, wherein the injection pen system has a dosage setting wheel that is rotatable about the longitudinal central axis of the pen injection system for setting the dosage of the drug to be injected, and which can be optionally fixed so as not to rotate during injection, thereby eliminating the need for complex shielding or protective solutions to address any unwanted electrical, electronic, or electromagnetic effects caused by the relatively high density of electronic components within the monitoring module.

[0012] Another aspect of the present invention is to provide an injection monitoring module as described above, which is adapted and configured to determine a set dose and an injection initiation point. For the purposes of the present invention, the expression “injection initiation point” as used herein means the moment when the injection mechanism in the pen is activated. This is typically caused by moving an injection activation mechanism, such as a push button located at the proximal tip of the pen injection system, distally.

[0013] A further aspect of the present invention is to provide an injection monitoring module as described above, wherein the module is adapted and configured to detect or calculate the dose of an injectable substance contained in a pen injection system or a user-defined amount, the injection start or start point in the pen injection system, and the injection end point, and to determine whether the entire dose of the injectable substance or the user-defined amount of the pen injection system has been dispensed from the pen system.

[0014] A further aspect of the present invention is to provide an injection monitoring module as described above, wherein the module comprises relative positioning means for selectively positioning the components of the injection monitoring module into one or more predetermined spatial relationships during mounting of the injection monitoring module onto a pen injection system, after mounting onto the pen injection system for preparation for normal operation, and during removal or unmounting from the pen injection system.

[0015] These and other aspects of the present invention will be readily apparent upon reading this specification in its entirety.

[0016] Therefore, according to any of the above embodiments, an injection monitoring module is fitted and configured to be detachably attached to the proximal tip of an injection pen system for delivering a drug, wherein the injection pen system comprises a pen body, a dose setting wheel located proximal to and connected to the body, and an injection operating mechanism, the dose setting wheel being rotatable about the longitudinal central axis of the pen injection system during dose setting, and the injection monitoring module is A hollow main body is fitted and configured to be coaxially mounted on the dosage setting wheel at the proximal tip of an injection pen system and to engage with it in a manner that it rotates together with the wheel, and has a longitudinal central hole with a proximal tip and a distal tip, and a longitudinal central axis, A magnetic field generating means is disposed on or inside the surface of the hollow main body at the proximal tip of the longitudinal central hole, An injection monitoring system comprising at least one or more magnetic sensors, positioned at the proximal end of a hollow main body, and movable along the longitudinal central axis within a hole in the hollow main body from a first monitoring position in which the injection monitoring system is not in contact with the proximal surface of the injection actuation mechanism to a second monitoring position in which the injection monitoring system is in 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 longitudinal central axis during dose selection, The rotation stopping mechanism includes a rotatably fixed coupling member arranged parallel to the longitudinal central axis, the rotatably fixed coupling member connecting the injection monitoring system to the main body of the pen injection system. The rotation stopping means is configured and adapted to allow translational movement of the injection monitoring system from a first injection monitoring position to a second injection monitoring position during injection, and vice versa, from the second injection monitoring position to the first injection monitoring position after injection is complete. An injection monitoring system is provided, comprising a rotation stop means also comprising relative positioning means configured to prevent the injection monitoring system from moving proximal away from the first collapsed position in a first collapsed mounting position, and to allow the injection monitoring system to move proximal away from the collapsed position to a second deployed mounting position in a second deployed position.

[0017] The relative positioning means referred to herein are configured to prevent any unwanted movement of the injection monitoring module during attachment to and / or removal from the pen injection system. It will be further understood that such a relative positioning system is intended to prevent the detection of any unwanted or undesirable translational movement events of the injection monitoring module along its longitudinal central axis during attachment to or removal from the pen injection system. More advantageously, the relative positioning means are configured to prevent proximal translational movement of the injection monitoring system away from the first pressed-in attachment position, and to allow proximal translational movement of the injection monitoring system away from the pressed-in position to the second deployed-in attachment position, in the second deployed position. What this means is that, during mounting onto the pen injection system, the injection monitoring module adopts a compressed mounting configuration in which the relative components of the injection monitoring module, particularly the hollow main body and the injection monitoring system, are in close surface contact with each other along the longitudinal central axis so that the combined overall length of these two components is as short as possible, or the hollow main body and the injection monitoring system are maintained in a configuration that is shorter in length compared to the deployed mounting position, which takes these respective normal operating positions and corresponding combined overall lengths along the longitudinal central axis. Furthermore, in the compressed mounting configuration, the hollow main body and the injection monitoring system are prevented from translating relative to each other along the longitudinal central axis, preferably in the proximal direction. In the deployed mounting configuration, the injection monitoring system is positioned relative to the hollow main body in its normally expected operating position by selective movement of relative positioning means that allows for translational movement of the injection monitoring system in the proximal direction along the longitudinal central axis.

[0018] As used herein, the terms “pen injection system” and “injection pen system” are interchangeable to generally refer to a pen-shaped injection system that is typically held in one hand, but such systems are well known on their own, commercially available, and used in a wide variety of medical applications. These systems are also often designed as a whole for the self-injection of drugs by the user when a treatment for a given medical application is required. This is the case, for example, with insulin supplied in various forms for the treatment of diabetes, and the pen injection systems marketed under brand names such as FlexPen® by Novo Nordisk, Kwikpen® by Eli Lilly, or Lantus Solostar® by Sanofi are just three of the most well known. Other drugs are also used in conjunction with this category of medical devices to enable the immediate emergency injection of necessary drugs, such as anaphylactic shock treatments, anticoagulants, opioid receptor agonists and antagonists, which are needed to deal with potentially life-threatening situations. This corresponds to the fact that it has become common for patients suffering from or susceptible to such illnesses to carry these devices with them.

[0019] The injection pen system comprises a dose setting wheel disposed proximally and an injection actuation mechanism, and the injection monitoring module according to the present invention is adapted and configured to be removably attached to this injection pen system. The dose setting wheel rotates about the longitudinal central axis of the pen injection system, whereby the user can set the dose of the drug for injection. During dose setting or "dialling" of the dose, the dose setting wheel is generally rotatable in both the clockwise and counterclockwise directions, and these directions generally correspond, depending on the manufacturer, to an increase in the selected dose to be administered and a decrease in the selected dose to be administered, or vice versa, respectively. The injection actuation mechanism is often represented by a push button, usually disposed proximally to 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" (this term is generally known in the art), when the user of the injection system then presses the injection actuation mechanism in the distal direction, the piston connected to the plunger is driven, and the drug is discharged out through a needle inserted into an appropriate injection site, such as the skin, adipose tissue, or muscle, corresponding to the type of drug the user is to administer, from the chamber within the injection pen body. The dose setting wheel may also, although not necessarily, be connected to the injection drive mechanism such that it can rotate as the drug injection progresses, depending on the manufacturer and the model of the injection pen. The functional mode of such an injection system is well known per se in the art. The monitoring module envisaged by the present invention is intended to be mounted on the pen injection system, in which case the dose setting wheel can be configured to rotate during the dispensing / injection operating phase of the pen injection system or, conversely, not to rotate during the dispensing / injection operating phase. For example, the above-mentioned Kwikpen® injection pen does not have a dose setting wheel that rotates during injection, while the dose setting wheels of the Lantus Solostar® injection pen and the FlexPen® injection pen rotate during injection.

[0020] The injection monitoring module according to the present invention is thus adapted and configured to be removably attached to the proximal tip of such an injection pen system. As used herein, the expressions "removably attached", "removably attachable", "removably mounted" or "removably mountable" mean that, for example, when transferring the injection monitoring module to another pen injection system, or, for example, when the monitoring module is damaged during use and needs to be replaced, the injection monitoring module can be attached or mounted and then removed. Such attachment and subsequent removal can be achieved by providing coupling means on the monitoring module that engage in a releasable manner with the proximal tip of the pen injection system, and this engagement can be via, for example, frictional or elastic engagement, or via other releasable fastening means, such as clips, straps, threads and corresponding clamping rings, that engage with either the dose setting wheel or the injection actuating mechanism and / or the body of the pen injection system.

[0021] The rotational stop means referred to herein is understood to be means that physically prevent rotation of the injection monitoring system about its longitudinal central axis during dose setting / dosing dialing and, optionally and advantageously also, when the injection monitoring system is moved from a first injection monitoring position to a second injection monitoring position and vice versa, i.e., when the injection monitoring system is moved from the second monitoring position back to the first injection monitoring position.

[0022] The advantage of providing such a rotation-stopping mechanism in an injection monitoring module as envisioned by the present invention is that while the dose setting, or "dialing," at the first injection monitoring position is identified by the injection monitoring system as the selected dose, if the injection monitoring system becomes able to rotate for any reason during the dialing of the dose by rotating the dose setting wheel, such identification as the dialed dose being the selected dose would not necessarily be appropriate. A further advantage of a monitoring module whose rotation is prevented or stopped during the selection of the dose to be injected, as provided by the present invention, is that, with respect to the subsequent injection, whether or not the injection monitoring system rotates, whether accidental or by design, is not actually relevant, thereby eliminating the need for any other corrective measures for determining the selected dose that might otherwise be necessary.

[0023] The rotatably fixed connecting member is configured and adapted to prevent rotation of the injection monitoring system about its longitudinal central axis not only during dose setting or dialing, but more generally and advantageously, when the injection monitoring system translates from a first monitoring position to a second monitoring position, and even more advantageously, when the injection monitoring system translates back from the second monitoring position to the first monitoring position. In this way, it can be ensured that rotation of the injection monitoring system does not occur, whether accidental or intentional, particularly during dose selection or dose dial operation, advantageously not during injection of the dialed dose, and furthermore, not when the user releases finger pressure on the injection operating mechanism cap of the injection monitoring system after the injection is complete.

[0024] In another embodiment, the rotatably fixed connecting member comprises: An elongated rod member extends distally from the injection monitoring system parallel to the longitudinal axis and bypasses the outer surface of the hollow main body, and A sheath member that can be attached to the body of an injection pen system and is fitted and configured to slide-engage with the sheath member to receive an elongated rod 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 understood that the elongated rod member and the corresponding sheath member cooperate with each other so that the elongated rod member can slide into place within the sheath member when the injection monitoring system moves from the first injection monitoring position to the second injection monitoring position, and vice versa. The sliding engagement between the elongated rod member and the sheath member is performed substantially parallel to the longitudinal central axis.

[0026] As described above, the elongated rod member extends distally from the injection monitoring system, i.e., away from the proximal tip of both the injection pen system and the injection monitoring module, parallel to the longitudinal central axis. The elongated rod member is further positioned outside the outer surface of the hollow main body and has a shape and dimensions that bypass the hollow body on its outside, and therefore does not interfere with the dosage setting function of the hollow body, which is necessary for rotation by co-rotational contact with the dosage setting wheel so that the dosage can be set in the pen injection system. Similarly, the shape and dimensions of the elongated rod member are configured and adapted so that the elongated rod member does not interfere with any optional rotation of the dosage setting wheel during injection, if the manufacturer of the pen injection system has configured the pen to function in that way, such as in the case of pen injection systems such as Sanofi's Solostar® or Flexpen®.

[0027] In another embodiment, the elongated rod member has a proximal end portion, which is installed or fixed within a part of the holder body or housing of the injection monitoring system, for example by providing an enlarged proximal cross-section at the proximal end portion of such an elongated rod member, and the body or housing of the injection monitoring system is provided with a recess of a corresponding shape having a reduced cross-sectional outlet diameter to prevent the housing from being pulled out from the elongated rod member.

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

[0029] Advantageously, according to yet another embodiment, the elongated rod member is formed integrally with the operating cap of the injection monitoring system holder. The injection monitoring system includes a cap which the user presses to activate the injection, and this cap encloses a magnetic field sensor within the holder body or housing of the injection monitoring system. Thus, according to this embodiment, the rod member extends distally from the cap parallel to the longitudinal central axis and further bypasses a hollow main body that contacts the dosage setting wheel on the pen.

[0030] In another further embodiment, the elongated rod member comprises at least one portion of the elongated rod member that defines an elliptical spline extending distally from the injection monitoring system parallel to the longitudinal central axis. It should be understood that the “elliptical spline” means that, while extending substantially parallel to the longitudinal central axis, the elongated rod member is defined, in the above further embodiment, at least partially along the length of the rod by an elliptical spline curve, i.e., a curve extending toward the body of the pen injection system similar to the curve of an elliptical arc. Generally, the spline curve portion of the elongated rod member is configured to maintain a sufficient distance between the elongated rod member and the body of the pen so that the elongated rod member never comes into contact with 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 then back.

[0031] The elongated rod members are of appropriate dimensions, for example, having a corresponding thickness of material such that the elongated rod members are semi-rigid along their length. Suitable materials for elongated rod members are semi-rigid plastic materials such as a mixture of polycarbonate (PC) and acrylonitrile butadiene styrene (ABS) copolymer, commonly known as PC / ABS mixture, but other suitable polymers and polymer mixtures that provide suitable rigidity are generally known to those skilled in the art, and the elongated rod members can be made or constructed accordingly from any such suitable rigid material.

[0032] In yet another embodiment, the elongated rod member is provided with a spigot, which protrudes outward from the outward-facing surface of the elongated 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 elongated rod member and comprises a shaft portion extending from the outward-facing surface of the elongated rod member, the shaft portion of the spigot terminating with a flat head, the diameter of which is greater than the diameter of the shaft portion of the spigot. The functional modes of the spigot and head will be further understood in relation to the sheath, which will be detailed below.

[0033] As described above, the rotatably fixed connecting member also includes a sheath member having runnels configured and adapted to receive elongated rod members in sliding engagement. Thus, according to another embodiment, the runnels extend parallel to the longitudinal central axis. The runnels of the sheath member are aligned with the elongated rod members so that the elongated rod members are inserted into and received by the runnels before the injection monitoring module is mounted on the pen injection system. The runnels are generally configured and sized as open grooves, each having a side wall with corresponding longitudinally oriented openings, the longitudinally oriented openings being parallel to the longitudinal central axis. The longitudinally oriented openings are sized to receive the shaft portion of the spigot, and as a result, the degree of lateral movement of the shaft portion of the spigot is limited to the dimensions of the longitudinally oriented openings. The dimensions of the longitudinally oriented opening are configured to allow the spigot shaft to move proximal and distally along the opening during the operation of the injection monitoring module and when moving from a retracted to an unretracted position.

[0034] In yet another embodiment, the longitudinally oriented opening in the sheath also comprises a distal end and a proximal end, the distal and proximal ends of the longitudinally oriented opening being configured and sized 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 sized proximal and / or distal ends of the longitudinally oriented opening. Such interaction ensures reliable axial tracking of the elongated rod member within the sheath member and prevents the elongated rod member from being accidentally pulled out if the user of the injection monitoring module applies an inappropriate lateral force to the elongated rod member or sheath member while attempting to remove the rod member from or from the sheath.

[0035] It will be understood from this specification that the sheath member is mounted on the body of the injection pen system. Therefore, to yet another purpose, the sheath member further comprises a body mounting portion configured and adapted to allow the sheath member to be detachably mounted onto the body of the pen injection system. The body mounting portion of the sheath member comprises a wall of a plastic or polymer material, such as polycarbonate (PC), acrylonitrile butadiene styrene (ABS) copolymer, or a mixture thereof known as a PC / ABS mixture, in which case the wall extends circumferentially around the body of the pen injection system and allows insertion of the pen body into a hole formed by this circumferentially extending wall, and at the same time is sized to engage with the outer surface of the pen body by elastic friction engagement through appropriate sizing of the hole in the sheath member. Optionally, the circumferentially extending wall may include a wall portion made of a softer, more elastic material, such as elastomer SEBS or a similar elastomer polymer, for engaging with and gripping the corresponding surface portion of the pen body, thereby preventing any unwanted axial sliding of the pen within the circumferentially extending wall of the sheath member. Suitable elastomer materials for performing this function are known in the art.

[0036] As described elsewhere in this specification, the rotation stop means includes relative positioning means configured to prevent the injection monitoring system from moving proximal to a first retracted mounting position, and to allow the injection monitoring system to move proximal to a second deployed mounting position, moving from the retracted position to a second deployed mounting position, in a second deployed position. For example, the relative positioning means includes a locking system configured to engage with the sheath and / or elongated rod member in a selectively operable manner, allowing the user to lock and unlock the relative axial movement of the elongated rod relative to the sheath, thereby enabling proximal movement of the injection monitoring system from the retracted position to the deployed position. Similarly, after the injection monitoring module has been used by the user, or, for example, if the user wishes to move the injection monitoring module to a new pen injection system, the injection monitoring system can be moved distally along its axis and the selectively operable locking system can be engaged, thereby returning the injection monitoring module to its re-pressed position, ready for removal or detachment from the pen injection system.

[0037] From the above, it will be understood that the relative positioning means interacts with the elongated rod member and / or sheath member to maintain the hollow body and injection monitoring system in a compressed position while the injection monitoring module is mounted on the pen injection system. The relative positioning means thus plays a role in maintaining the hollow body, injection monitoring system, elongated rod member, and sheath member in a predetermined packed or compressed spatial relationship as a single mountable unit during mounting of the monitoring module on the pen injection system, in order to avoid any accidental or undesirable axial displacement of the monitoring module when mounting the hollow main body on the dosage setting wheel of the pen injection system. As can be understood from the above, it is generally considered that the selective locking of the injection monitoring module in the compressed position via the operation of the relative positioning means is performed before mounting the injection monitoring module on the pen injection system, which is why this position is referred to as the compressed mounting position, although selective locking is also performed when removing the injection monitoring device from the pen injection system. In this retracted position, the injection monitoring system is physically prevented from accidental axial movement, thereby avoiding any undesirable triggers for erroneous readings in the injection monitoring system. Once the injection monitoring module is mounted and the hollow main body is correctly positioned on the dosage setting wheel of the injection pen system, the relative positioning means can be activated, for example, unlocked, to allow the injection monitoring module to move proximal to the deployed mounting position. By unlocking the relative positioning means, the injection monitoring system can be moved to a ready-to-operate position, also known as the deployed mounting position.In the unlocked position, the spigot of the elongated rod member can be moved axially within the groove of the sheath, thereby allowing the injection monitoring system to be moved proximal. This is done, for example, by the kinetic force of the reaction energy of the proximal actuation button of the pen injection system, or alternatively, via a biasing spring located at the distal end of the injection monitoring system, which is compressed in the pressed-in locked position and decompressed in the unlocked position, resulting in the injection monitoring system being moved proximal and taking an deployed mounting position.

[0038] Therefore, in another embodiment, the relative positioning means comprises a rotatably selectable lock, which is positioned on a sheath and configured to rotate from a first locked position to a second unlocked position about an axis perpendicular to the longitudinal central axis. The rotatably selectable lock appropriately comprises, for example, a lock head. The selectable lock is appropriately configured and dimensionally determined to lock into the shaft portion and / or preferably the flat head of the spigot of an elongated rod member in the first locked position to prevent longitudinal axial movement of the flat head and / or shaft portion of the spigot within the sheath, and to disengage the lock in the second unlocked position to allow longitudinal axial movement of the shaft portion and / or flat head of the spigot within the sheath, particularly within the groove. The rotary selectable lock can be appropriately operated, for example, by rotation of the user's fingers other than the thumb or the thumb on a corresponding shaped surface located on the outward-facing surface of the sheath, and can also be configured, for example, to allow a quarter turn around a vertical axis of rotation to move the locking system from the locked position to the unlocked position.

[0039] The hollow main body of the injection monitoring module has a longitudinal central hole having a proximal tip and a distal tip, and this hole is dimensioned to allow coaxial mounting of the hollow main body so as to cover the body of the pen injection system. The hollow main body is appropriately fabricated from any suitable material, for example, a highly durable polymer or plastic material, such as high-density or high-impact polypropylene, or alternatively, polycarbonate. Advantageously, the hollow main body is fabricated from a transparent, translucent, or opaque material so that the user can grasp and recognize some visual cues, such as light-emitting diodes, which may be provided on or incorporated into the injection monitoring module and may be optionally used to indicate various states of operation of the injection monitoring system.

[0040] Therefore, according to another purpose, the hollow main body further comprises translational contact means adapted and configured to prevent axial translational movement of the hollow main body along the longitudinal central axis when the injection monitoring module is in a mounted position on the injection pen system. The translational contact means sets a limit to the axial translational movement of the hollow main body along the longitudinal central axis relative to the activation button of the pen injection system while the injection monitoring module is mounted on the pen injection system. Advantageously, according to yet another purpose, the translational contact means of the hollow main body comprises an annular flange extending inward into the hole toward the longitudinal central axis from the inner surface of the hollow main body. While the injection monitoring module is mounted on the injection pen system, the annular flange has a distal surface that contacts the surface facing the proximal side of the pen's activation button, thereby preventing further translational movement of the hollow main body along the longitudinal central axis.

[0041] To another further objective, the hollow main body further comprises a distal body portion extending around the outer surface of the dosage setting wheel and engaging with it elastically and frictionally. Such a distal body portion may, for example, extend substantially from the annular flange described in the preceding paragraph, or may be represented by a separately attachable hollow distal portion of the hollow main body, which is connectable to the hollow main body via, for example, a socket and bayonet mount, or a screw-fit mount or snap-lock mount, and is configured and sized to have a hole that fits the dimensions of the dosage setting wheel of the injection pen system. The frictional elastic engagement may be provided, for example, located on the inner circumferential surface of the distal portion of the hollow main body, for example, in one or more areas, or alternatively, by a suitable elastomer coating or deposit as a continuous, continuous, or somewhat continuous / continuous coating deposited on the aforementioned 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 portion and the dosage setting wheel in order to maintain proper positioning of the hollow distal body portion relative to the dosage setting wheel. Suitable types of elastomer materials capable of providing the corresponding frictional engagement are known in the art, and a preferred elastomer material is, for example, SEBS.

[0042] As described elsewhere in this specification, the injection monitoring module comprises an injection monitoring system. Such a system comprises at least one or more magnetic sensors, and the injection monitoring system is substantially located at or next to the proximal tip of the hole in the hollow main body. The injection monitoring system will be described in more detail below, but basically, the injection monitoring system comprises several different components and means that provide monitoring of the injection status, such as the following: - Initiation of injection procedure, The completion or termination of an injection action, in this case, the completion of an injection action should be understood to include both the complete administration of the selected dose of the substance to be injected, or separate injection actions in which the user injects only a portion of the dose or dispenses a portion of the selected dose from the pen injection system.

[0043] Furthermore, according to another object of the present invention, the injection monitoring system is movable along the longitudinal central axis from a first monitoring position in which the injection monitoring system is not in contact with the proximal surface of the injection actuation mechanism to a second monitoring position in which the injection monitoring system is in contact with the proximal surface of the injection actuation mechanism. The injection monitoring system is advantageously mounted on the proximal tip of the hole in the hollow main body, preferably completely covering, or at least substantially covering, the proximal tip of the hole.

[0044] From the above, it will be understood 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 operating mechanism button of the pen injection system to a second position where physical contact is established between the monitoring system and the proximal surface of the injection operating mechanism of the pen injection system. Such movement generally constitutes a translational movement of the monitoring system along the longitudinal central axis from the first position to the second position. The injection monitoring module is configured such that, as a result of the rotation of the hollow main body and the correspondingly connected dose setting wheel, it is determined that the set dose or dialed dose is the selected dose, because the injection monitoring system is locked against rotational movement about the central axis during dose setting. Determination of injection initiation is also performed by detecting an increase in the magnetic norm when the injection monitoring system begins to translate along the longitudinal central axis from the first monitoring position to the second monitoring position. The injection monitoring system is configured to detect the end point of injection or dispensing of the injectable substance when the monitoring system translates proximally, i.e., from a second monitoring position to a first monitoring position, thereby releasing physical contact between the operating 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, for example, use a appropriately configured sensor to detect the point in time when the injection monitoring system has moved from any other point and returned to that reference point.

[0045] Translational movement in the opposite direction to the injection direction, i.e., proximal translation of the monitoring system toward the user's hand or thumb, can be suitably achieved by utilizing the reaction energy of a biasing spring that is compressed during injection and released when the activation button is released, and this biasing spring can also be suitably provided within a hole to form part of the injection monitoring system. After the user releases the activation cap, either directly or indirectly, for example by removing pressure from the thumb or other fingers against the activation cap, the reaction energy of the compressed biasing spring within the hole will move the injection monitoring system toward the activation button on the pen, biasing the injection monitoring system toward the first monitoring position.

[0046] According to another object of the present invention, the monitoring module of the present invention comprises a magnetic field generating means disposed adjacent to or within the proximal end of the longitudinal central hole of a hollow main body. The expression "disposed on or within the hollow main body" will be understood to mean that the magnetic field generating means can be installed, for example, on opposing proximal surfaces at the proximal end of the central hole of the hollow main body. Alternatively, it is preferable that the magnetic field generating means be installed in or within a cavity or recess provided adjacent to the proximal end of the central hole of the hollow main body.

[0047] Various means of generating magnetic fields are known, including conventional magnets, electromagnets, and magnets made of mixed materials. Such magnets can typically be made from magnetizable materials that are magnetic or paramagnetic, whether naturally occurring or those through which a magnetic field is generated or induced when an electric current or other energy-giving flow passes. Suitable materials can be appropriately selected from the following: - Ferrite magnets, especially sintered ferrite magnets, such as crystalline compounds of iron, oxygen, and strontium, - A composite material consisting of a thermoplastic matrix and isotropic neodymium-iron-boron powder. - A composite material composed of a thermoplastic matrix and strontium-based hard ferrite powder; in this case, the resulting magnet may contain isotropic (i.e., non-oriented) or anisotropic (i.e., oriented) ferrite particles. - A composite material composed of a thermosetting plastic matrix and isotropic neodymium-iron-boron powder. - For example, a magnetic elastomer manufactured from heavily charged strontium ferrite powder mixed with synthetic rubber or PVC, which is then extruded into a desired shape or calendered into a fine sheet. - Calendrized flexible composites generally having the appearance of brown sheets and possessing more or less flexibility depending on their thickness and composition. These composites never have rubber-like elasticity and tend to have a Shore hardness in the range of approximately 40-70 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 an alignment of magnetic particles due to the calendrization process. - Laminated composite materials generally containing the above-mentioned flexible composite materials, which are laminated with soft iron electrode plates. -Neodymium-iron-boron magnet, -Magnified steel made from 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, composite materials composed of a thermoplastic matrix and strontium-based hard ferrite powder, and composite materials made of a thermosetting plastic matrix and isotropic neodymium-iron-boron powder are preferred. Such magnets are known to be sized to relatively small sizes while maintaining relatively high magnetic field strength.

[0049] The magnetic field generating means may be a disc shape including any preferred overall shape, such as circular, elliptical, or any other preferred polygonal shape, but it is preferable to have only a single dipole having a single pair of north and south magnetic poles opposite each other in the diametrical direction. The magnetic field generating means may also be optionally substantially disc-shaped, and such a disc shape preferably also includes a magnet having an opening substantially at the center of the disc to form a ring or annular magnet. Such a ring or annular magnet can be usefully mounted on the annular outer surface facing the proximal end of the hollow main body. Advantageously, for the purposes of the currently envisioned configuration of the injection monitoring module, the dipole magnets are rod-shaped or cylindrical dipole magnets, with one pole positioned facing the opposite pole to the other, for example, NS aligned with SN, in which case the magnets are positioned to extend flat along their own longitudinal axes, bisecting the longitudinal central axis and extending along a horizontal plane perpendicular to the longitudinal central axis, with each magnet positioned so that one is on the opposite side of the longitudinal central axis from the other, for example, rotated 180° around the longitudinal central axis.

[0050] A magnetic field generating means is provided, which allows the magnetic field sensor to detect any change in the magnetic field caused by the rotational movement of the hollow body relative to the magnetic field sensor during dosage setting, thereby enabling the determination of the dialed dosage set via the dosage 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 when the dosage wheel is rotated is used to calculate or determine the dosage of the injectable substance in the injection pen system, which is dialed or set by the user. Once the dosage is set, the operation 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 started. Conversely, when the pressure of a finger other than the thumb or the thumb is released from the proximal actuation mechanism cap, the reaction energy of a biasing spring located distal to the housing of the injection monitoring system causes a reaction in the injection monitoring system, inducing a proximal translational movement towards the user's thumb or other finger along the longitudinal central axis of the housing of the injection monitoring system, thereby moving the magnetic field sensor housed within the injection monitoring system proximal as well.

[0052] As shown above, during injection, when finger pressure is applied distally along the longitudinal central axis to the housing of the injection monitoring system, the magnetic field sensor detects a change in the magnetic field due to the translation of the sensor along the longitudinal axis distally toward the magnetic field generating means, and then proximal in the opposite direction when the finger pressure is released from the injection monitoring system.

[0053] Furthermore, the compression characteristics of the biasing spring, and the degree of resistance to distal movement of the injection monitoring system provided by these compression characteristics, can be advantageously and suitably used as a means to enhance the sensitivity of the injection initiation point detection by the monitoring system. For example, in the case of uncontrolled distal movement, such as when a user suddenly pushes down the operating cap of the monitoring module, an error may be induced in the injection monitoring system regarding injection initiation 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 attenuated to a level that the magnetic sensor can easily and accurately process, thereby making the determination of injection point initiation safer and more reliable. To this extent, the biasing spring can be seen more generally as representing a damping means to assist in the proper determination of injection initiation events.

[0054] Regarding general magnetic sensors, methods for measuring the magnetic field to be determined are generally known in the art. For example, magnetoresistive sensors are a well-known method. Such magnetoresistive sensors are often represented by their abbreviations, such as AMR, GMR, and TMR sensors, which describe the physical mechanism by which their 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 where the 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 that occurs in a magnetic tunnel junction (MTJ), which is a component consisting of two ferromagnetic materials separated by a thin insulator. Resistors that utilize these various properties are known themselves.

[0055] In light of the above, the injection monitoring module and / or system according to the present invention preferably uses one or more or more magnetometers as one or more or more magnetic field sensors. Such magnetometers differ from GMR, AMR, or TMR sensors in that they directly measure magnetic field strength. Magnetometers measure magnetic fields in two main ways: namely, vector magnetometers measure the vector component of the magnetic field, and total magnetic field magnetometers 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 the internal calibration of the magnetic sensor or known physical constants. Relative magnetometers measure the magnitude or vector magnetic field relative to a fixed but uncalibrated baseline, and are also called geomagnetic variation meters, and are used to measure variations in the magnetic field.

[0056] The preferred type of magnetometer for use in the injection monitoring module according to the present invention is, in this case, an ultra-low-power, high-performance three-axis Hall effect magnetometer. While it is possible to configure the magnetometer to measure magnetic fields along three mutually perpendicular or orthogonal axes, in this application, it is preferable that the magnetic field sensor be configured to measure magnetic fields along only two of the three orthogonal axes, for example, the X-axis and the Z-axis.

[0057] As can be understood from the preceding paragraph, for yet another purpose, the injection monitoring module further comprises an injection start determination means. For example, the injection start determination means is appropriately represented by a magnetic field sensor, such as one or more magnetometers, located within the injection monitoring system, as discussed elsewhere in this specification. Thus, in order to detect the start of an injection, the injection monitoring system is configured to detect an increase in the magnetic norm, i.e., the magnetic field vector determined along an axis substantially parallel or coaxial with the longitudinal central axis, in the absence of any accompanying effects on the magnetic field vector due to the rotation of the injection monitoring system, via values ​​measured and reported by one or more magnetometers present within the injection monitoring system, as the injection monitoring system begins to move from a first monitoring position to a second monitoring position.

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

[0059] Advantageously, according to yet another purpose, the injection start and / or end determination means comprises an optical sensor and a corresponding reflective surface.

[0060] For yet another purpose, the optical sensor is positioned on the injection monitoring system adjacent to at least one or more elongated rod members. The optical sensor can be appropriately positioned, for example, within the operating cap, or alternatively, within the holder body or housing of the injection monitoring system. Advantageously, the optical sensor is positioned within the cap and / or housing of the injection monitoring system so as to receive reflected light from a correspondingly and appropriately positioned reflective surface.

[0061] Accordingly, for yet another purpose, the reflective surface for the optical sensor is positioned on the sheath member, facing the optical sensor on the injection monitoring module and aligned with its optical axis.

[0062] The optical sensor and reflective surface are therefore positioned so that reflected light coming from the reflective surface travels to the optical sensor. The optical sensor is appropriately configured to determine, for example, the distance that the optical sensor, and therefore a predetermined reference position in the injection monitoring system, has traveled parallel to and along the longitudinal central axis, 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 optical sensor preferably comprises a light source, which may be provided in this case, for example by a light-emitting diode. The optical sensor may further comprise a focusing or diffusing system for such a light source, as is known in the art, depending on the characteristics of the reflective surface, the output of the light source, etc.

[0063] In an injection pen system where the dosage setting wheel rotates during injection, the end of the injection can be determined using a magnetic field vector value provided by a magnetic field sensor in the injection monitoring system. This is due to a combination of factors: the magnetic field vector value registered by the magnetic sensor changes, for example, depending on how many times the hollow main body containing the magnet has rotated around its longitudinal central axis, and the distance of the magnetic sensor from the magnet is linked to the relative change in the magnetic field vector. With this configuration, it becomes possible to register the event of the end of the injection using only a magnetometer in this case.

[0064] However, in the case of injection pen systems where the dosage setting wheel does not rotate, for example, during injection, non-contact sensors, such as optical sensors, are particularly advantageous. This is because the injection monitoring system is configured to use such non-contact sensors to notify when the injection monitoring device returns from a second injection monitoring position back to the first injection monitoring position via axial translation along the longitudinal central axis, and thus assign the injection completion event to such a return position.

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

[0066] Advantageously, and according to further objects of the present invention, one or more magnetic field sensors are electrically connected to an electronic component substrate. It is useful that one or more magnetic field sensors be positioned on the electronic component substrate at a position diametrically opposed to the electronic component substrate, or otherwise dispersed radially, with a single magnetic field sensor positioned on the longitudinal central axis.

[0067] More advantageously, the electronic component board comprises an integrated control and data processing unit, such as at least one microcontroller, electrically connected to one or more magnetic field sensors for processing information received from the magnetic field sensors. The electronic component board is therefore preferably, for example, a printed circuit board of appropriate dimensions. In the configuration intended in the present invention, it is advantageous that such a printed circuit board is disc-shaped, with its center coinciding with the intersection of the longitudinal central axis.

[0068] As described above, the injection monitoring system includes an optical sensor. The optical sensor is electrically connected to at least one microcontroller, for yet another purpose. The microcontroller controls the mode of operation of the optical sensor 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 in this specification, and further, the distance the injection monitoring system has traveled along its longitudinal central axis. This information is used to calculate whether the injection is complete.

[0069] The electronic component substrate is mostly located proximal to the hollow main body and is advantageously housed within the housing or holder body of the injection monitoring system, generally extending beyond the proximal tip of the central hole. The distal portion of the injection monitoring system housing is located within the hole. The injection monitoring housing is free to translate within the hole of the hollow main body, but rotation is prevented by a rotation-stopping mechanism, such as one embodied by a sheath member and an elongated rod member.

[0070] Advantageously, the electronic component substrate is held such that its horizontal plane lies in a plane substantially perpendicular to the longitudinal central axis. The electronic component substrate is thus positioned relative to the hollow main body in a rotationally fixed relationship with respect to the first injection monitoring position during dose setting, so that rotation of the hollow main body does not cause a corresponding rotation of the electronic component substrate. This means that when the hollow main body is rotated to "dial" or set the injection dose, rotation of at least one or more magnetometers located on the electronic component substrate about the longitudinal central axis is prevented.

[0071] For yet another purpose, the electronic component board comprises a communication unit electrically connected to at least one microcontroller. Such a communication unit may be one or more of any number of self-known communication units, such as wireless communication units, for example, Bluetooth®, Bluetooth LE®, or any other short-range or long-range wireless communication technology.

[0072] According to another further object of the present invention, the electronic component board may optionally include a rechargeable self-contained power source, such as a lithium-ion battery that is easily replaceable when depleted, or alternatively, a rechargeable battery such as a rechargeable lithium-ion battery. Where a rechargeable battery is provided, when the rechargeable battery is depleted, it can be charged via a corresponding charging port provided on the injection monitoring module and connected to the rechargeable battery, such as a USB charging port. Non-rechargeable, i.e., single-use batteries and rechargeable batteries are generally known to those skilled in the art. Advances in charging technology have also made wireless charging possible today, and such wirelessly rechargeable batteries using, for example, an inductive charging system are also foreseen as a possibility within the object of the present invention.

[0073] An integrated control and data processing unit comprising at least one microcontroller handles all electrical communications and signal transmission between various electronic components on an electronic component board, including magnetic field sensors and optical sensors. This unit also performs calculations that enable the precise calculation and determination of the magnetic field sensor's position, and handles signals from self-contained power supplies and communication means integrated into the injection monitoring system, communicating with a local or remote data processing system, for example, on a smartphone. Such integrated control and data processing units are known in themselves and often incorporate a central processing unit, a real-time clock, one or more memory storage systems, and optionally a communication system or subsystem, along 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 descriptions relating to each figure and illustrative monitoring module.

[0075] The present invention will now be described in more detail with reference to the accompanying figures provided for illustrative and explanatory purposes. [Brief explanation of the drawing]

[0076] [Figure 1] This is a schematic exploded perspective view of the injection monitoring module that will be mounted on a one-handed pen injection system. [Figure 2A] This is a schematic perspective view of the injection monitoring module shown in Figure 1, before use, before being mounted on the pen injection system, or ready to be mounted, in the pressed-in locked position (Figure 2A). [Figure 2B] This is a schematic perspective view of the injection monitoring module of Figure 1 in its deployed, unlocked position (Figure 2B), before use, before being mounted on or ready to be mounted on the pen injection system. [Figure 3A] This is a schematic perspective view of the injection monitoring module shown in Figure 1 or Figure 2, in the pressed-in locked position (Figure 3A) after being mounted on the pen injection system. [Figure 3B] This is a schematic perspective view of the injection monitoring module shown in Figure 1 or Figure 2, in the deployed unlocked position (Figure 3B) after being mounted on the pen injection system. [Figure 4A] This is a schematic cross-sectional representation of the injection monitoring module mounted on a pen injection system in the pressed-in locked position. [Figure 4B] This is a schematic cross-sectional representation of the injection monitoring module mounted on the pen injection system in the deployed and unlocked position. [Figure 5A] This is a perspective view (A) of a side-by-side schematic representation of the details of the relative positioning means of the injection monitoring module in the pressed-locked position. [Figure 5B] This is a partial section (B) of a side-by-side schematic representation of the details of the relative positioning means of the injection monitoring module in the pressed-locked position. [Figure 5C] This is a perspective view (C) of a side-by-side schematic representation of the details of the relative positioning means of the injection monitoring module in the deployed unlocked position. [Figure 5D] This is a partial section (D) of a side-by-side schematic representation of the details of the relative positioning means of the injection monitoring module in the deployed unlocked position. [Figure 6A] This is a schematic perspective view of another detail of the relative positioning means of the injection monitoring module. [Figure 6B] This is a schematic perspective view of another detail of the relative positioning means of the injection monitoring module. [Figure 7] This is a schematic representation of the sequence for attaching the injection monitoring module to the pen injection system, and the relative pressed-in locked position of the monitoring module while it is attached to the pen injection system. [Figure 8] This is a schematic representation of the sequence for attaching the injection monitoring module to the pen injection system, and the relative pressed-in locked position of the monitoring module after attachment to the pen injection system. [Figure 9] This is a schematic representation of the sequence for attaching the injection monitoring module to the pen injection system, and the relative deployed and unlocked position of the monitoring module after attachment to the pen injection system. [Modes for carrying out the invention]

[0077] The figure here shows various schematic representations of the injection monitoring module (1). As shown in Figure 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 the distal tip of the pen injection system, a dose setting or dialing wheel (6) located on the proximal tip of the pen injection system body (3), and a dialed dose visualization window (7) located distal to the dose setting wheel (6) that displays the dose dialed by the user of the pen injection system. The injection monitoring module (1) according to the present invention is mounted on the proximal tip (8) of the injection pen system (2), covering and surrounding it, and in particular also mounted on the pen body (3), at least partially covering and in contact with its peripheral outer surface (4). The injection monitoring module (1) extends proximal to the pen body (3), beyond the proximal tip (8), and particularly beyond the dose setting wheel (6). See also Figure 7. A longitudinal central axis (9) is also shown, passing through the longitudinal axis center of both the injection monitoring module (1) and the injection pen system body (3). The injection pen system (2) is equipped with an actuation mechanism button (10, Figure 7) located proximal to the dose setting or dialing wheel (6), as can be found in some commercially available injection pen systems. In the type of pen injection system (2) shown in Figure 3, the dose setting wheel (6) rotates around the longitudinal central axis (9) during dose setting, but is fixed so as not to rotate during injection; that is, the dose setting wheel does not rotate around the longitudinal central 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 main body (3) of the pen injection system (2). For this purpose, 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 the outer surface of the dose setting wheel (6) and frictionally engages with it. The frictional engagement between the hollow main body (11) and the outer surface (4) of the dosage setting wheel (6) can be achieved, for example, by fabricating the distal body portion from an elastomer friction material (16), or alternatively, by providing a coating of such a frictional elastomer engagement material on the inner circumferential surface (17) of the hollow main body. However, such elastomer friction materials are readily known in the art for achieving press-fit or slide-fit engagement between the distal portion (15) and the outer surface (4) of the pen body (3). Suitable elastomer friction materials (16) for the distal body portion (15) may be thermoplastic elastomers such as SEBS or polystyrene-poly(ethylenebutylene)-polystyrene block copolymer.

[0079] The hollow main body (11), shown in detail in Figures 1 and 4, extends proximal to the boundary of the operating mechanism button (10) of the pen injection system (2). At this time, as shown in the figures, a hole (12) located within the distal body portion (15) of the hollow main body (11) houses both the dosage setting wheel (6) and the operating mechanism button (10). The hollow main body (11) further comprises magnetic field generating means (18, 19) located on or within the hole (12). The magnetic field generating means (18, 19) is preferably provided by a pair of single-dipole magnets (18, 19) arranged opposite each other in the diametrical direction, each magnet having a north (N) pole and a south (S) pole, and each pair of poles is preferably oriented so that the poles are in opposite positions, i.e., NS / SN, across the longitudinal central axis, in which case the first magnet is placed with its N pole along a horizontal plane perpendicular to the longitudinal central axis, and the magnets arranged opposite each other in the diametrical direction are placed on the same plane perpendicular to the longitudinal central axis, with their S poles oriented in the same plane as the N pole of the first magnet. The dipole magnets can preferably be formed in the shape of a rod or brick, or alternatively as a disc or ring, or in any other suitable shape. The magnets are positioned within suitably sized recesses (20, 21) provided in the hollow main body (11), and the recesses (20, 21) are located at or next to the proximal tip (13) of the main body (11). Alternatively, the magnetic field generating means can be a ring-shaped single-dipole magnet, which is installed at the proximal tip (13) of the hollow main body (11) on the proximal circumferential surface of the hollow main body or in the corresponding annular recess. From the above, it can be understood that the magnetic field generating means rotates freely about the longitudinal central axis, since the hollow main body (11) itself, in which the magnets are positioned, is mounted on a dosage setting wheel centered on the longitudinal central axis (9) and frictionally engaged with it.

[0080] The hollow main body (11) further includes a guide sleeve (22) extending along the hole (12) and an annular flange portion (23, Figure 4) extending inward from the guide sleeve into the hole (12) and defining a second hole smaller in diameter than the hole in the hollow main body (11). The guide sleeve (22) also extends proximal from the annular flange portion (23) toward the proximal tip (13) of the hollow main body (11). The guide sleeve (22) receives and guides the injection monitoring system as it translates from a first monitoring position to a second monitoring position within the hole (12), a matter that will be described in more detail later in this specification.

[0081] The hollow main body (11) also includes a translational contact means (24) fitted and configured to prevent axial translational movement of the hollow main body (11) along its longitudinal central axis (9) when the injection monitoring module (1) is mounted on the injection pen system (2). As shown in Figure 4, the translational contact means may include an annular shoulder portion (24) extending inward into the hole from the inner surface (17) of the hollow main body toward the longitudinal central axis. This annular shoulder portion (24) may be advantageously configured to have a distal surface that contacts the proximal surface of the operating button (10) of the pen injection system (2) when the injection monitoring module is coaxially mounted on the pen, thereby preventing distal axial movement of the hollow body.

[0082] As shown in Figures 1 and 4, the injection monitoring system (25) is at least partially located within the hole (12) and is translationally movable within the hole (12) from a first monitoring position to a second monitoring position. The injection monitoring system (25) comprises several components, among which is the housing (26) of the injection monitoring system. The housing (26) of the injection monitoring system is shaped and constructed to resemble a cup with legs, with a base wall (27) extending substantially perpendicular to the longitudinal central axis (9) over a diameter substantially the same as or similar to that of the hollow main body, and a first wall (28) extending from the outer circumference of the base wall (27) toward the proximal end of the base wall (27) to form a cup-shaped portion having an internal volume that is closed by a proximal cap (29) which forms an operating mechanism button, and the proximal cap (29) is fixed to the proximal-extending first wall (28) by snap-fit, press-fit, adhesive or otherwise at the proximal end of the first wall (28). The base wall (27) further comprises a second annular wall (30) that extends distally from the base wall (27) at a point radially spaced from the longitudinal central axis (9) and has a diameter smaller than the diameter of the hole (12) in the hollow main body (11), allowing translational movement of the housing (26) within the sleeve (24) and the hole (12) in the hollow main body (11). The second annular wall (30) is closed at its distal end by a transverse wall (31) to form the legs of a cup. The transverse wall (31) can be made of a flexible film material that is deformable by contact with the operating mechanism button (10) of the pen injection system (2). The legs of the cup fit into the hole (12) of the hollow main body (11). The housing (26) of the injection monitoring system, defined by its cup-shaped internal volume, receives and fixes an electronic component substrate (32). The internal volume of the leg formed by the second annular wall (30) and the transverse wall (31) can accommodate a self-contained power source (33), such as a single-use or rechargeable battery, for example, a lithium-ion battery that is electrically connected to and supplies power to an electronic component board (32).The electronic component substrate (32) is generally a printed circuit board of suitable dimensions for placement within the internal volume of a cup, which is appropriately formed by a base wall (27) and a first wall (28) extending proximal. The injection monitoring housing (26) optionally further comprises a molded translucent, opaque, or transparent material having crystalline properties selected to guide light waves from the internal volume of the cup, such as those generated by an optionally present light-emitting diode or other light-wave generating component, to the outside of the housing (26) of the injection monitoring system, which may be incorporated into or part of the first wall (28).

[0083] The electronic component board (32) further comprises at least one magnetometer (34) advantageously positioned on its longitudinal central axis (9), and substantially at its center so as to be coaxial with the longitudinal central axis (9) in the case of a substantially circular component board. 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 communications and signal transmissions between the various electronic components of the injection monitoring system. The unit is also responsible for performing calculations that enable the calculation and determination of the precise position of the dosage management system and the magnet, and for handling signals from a self-contained power supply (33). The electronic component board is further connectable to a USB port (35), which can be configured as a power recharge port for a rechargeable battery (33) and / or to enable the basic setup of any programmable memory on the electronic component board, or to configure the data processing unit. Integrated control and data processing units (ICUs) typically also include communication means, such as wireless communication circuits, for communicating with local or remote data processing systems on smartphones. Two of the many types of suitable communication means are, for example, Bluetooth® or Bluetooth LE® wireless communication systems. ICUs can be suitably programmed remotely at first use, or they can receive and update information in a manner similar to other electronic devices today, including integrated control and data processing units, for example, wirelessly or via any other suitable link such as a USB port. Such ICUs are known in themselves and often incorporate a central processing unit, a real-time clock, one or more memory / storage systems, and optionally a communication system or subsystem, along with other desired components.The electronic component board (32) is installed 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., perpendicular to the longitudinal central 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 the transverse wall (31) at the proximal end of the second annular wall (30) and is constrained by contact with one or a pair of seating nubs (38) at the proximal end of the chamber (36). The compression of the biasing means (37) causes the transverse wall to flex distally. The transverse wall (31) is positioned at the distal end of the second annular wall (30) via a snap-fit ​​or clip-fit ​​projection that engages with a corresponding recess provided in the second annular wall (30). The biasing means (37) also functions as an attenuator for the injection monitoring system (25) when, after a dosage has been selected, the injection monitoring system receives finger pressure on the cap activation button and begins to move from the first monitoring position. The interaction of the compression spring is optionally assisted by the flexible transverse wall to attenuate the initial acceleration of the injection monitoring system (25) when it comes into contact with the activation button (10) on the injection pen (2). If the distance moved between the first injection monitoring position and the second injection monitoring position is very small, for example, depending on the dimensions of the injection pen, it is only a matter of a few tenths of a millimeter to at most a few millimeters, then the biasing means can not only accommodate variations in the axial geometry and molding tolerances of various components of various pens, but also facilitate the detection of the increase in magnetic norm as the magnetometer (34) in the injection monitoring system (25) moves toward the magnets (18, 19) along the longitudinal central axis (9).

[0085] The injection monitoring housing (26) further comprises a third annular wall (39) radially spaced apart from the first annular wall (28) and the second annular wall (30), and located radially between them. The third annular wall extends distally from the base wall (27) toward the hollow main body (11). This third annular base wall (36) provides further axial stability to the injection monitoring system housing (26) insofar as it is sized to surround and guide the inner circumference of the proximal tip (13) of the hollow main body (11).

[0086] Figures 1, 2, 3, and 4 also show various components of the rotation-stopping mechanism, which are configured and adapted to prevent rotational movement of the injection monitoring system about the longitudinal central axis (9) during dosage setting. The rotation-stopping mechanism comprises a rotatably fixed connecting member disposed parallel to the longitudinal central axis (9). The rotatably fixed connecting member connects the injection monitoring system (25) to the body (3) of the pen injection system (2), as described below. The rotatably fixed connecting member prevents rotation of the injection monitoring system (25) about the longitudinal central axis (9) not only during dosage setting or dialing, but more generally, during translation of the injection monitoring system (25) from a first monitoring position to a second monitoring position, and then translation back from the second monitoring position to the first monitoring position. In this way, it is possible to ensure that the injection monitoring system (25) does not rotate, whether accidentally or intentionally, and in particular, that such rotation does not occur during dose selection or dose dialing, which would cause errors in determining the selected or dialed dose. The rotation stopping 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 and vice versa, while maintaining the prevention of rotation. As will be apparent from the preceding description, the rotation stopping means in this case physically prevents rotation of the injection monitoring system (25) about the longitudinal central axis (9), while simultaneously providing a translational guide system for the injection monitoring system (25) in both the distal and proximal directions.

[0087] The rotatably fixed connecting member includes an elongated rod member (40), as shown in Figures 1 and 4, which extends distally from the injection monitoring system parallel to the longitudinal axis and bypasses the outer surface of the hollow main body (11). The elongated rod member includes a spigot (41) having an axial portion (42) projecting outward from the outer surface (43) of the elongated rod member (40) away from the longitudinal central axis (9) at or near its distal end. The axial portion (42) of the spigot (41) terminates at its outermost point with a flat head (44). The diameter of the flat head (44) is greater than the diameter of the axial portion (42) of the spigot (41).

[0088] The rotatably fixed connecting member also includes a sheath member (45), which is attached to the body (3) of the injection pen system (2) by, for example, sliding the sheath member (45) along the pen body (3) onto the pen body (3), thereby being mounted coaxially around the pen body (3). The sheath member (45) is fitted and configured to receive the elongated rod member (40) through sliding engagement with the sheath member (45) during the translational movement of the injection monitoring system (25) from a first monitoring position to a second monitoring position.

[0089] The elongated rod member (40) and the corresponding sheath member (45) cooperate in this case to enable sliding engagement of the elongated rod member (40) within the sheath member (45) when the injection monitoring system (25) 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 elongated rod member (40) and the sheath member (45) is performed substantially parallel to the longitudinal central axis (9).

[0090] The elongated rod member (40) extends distally from the injection monitoring system (25), that is, away from the proximal tip of both the injection pen system (25) and the injection monitoring module (1), parallel to the longitudinal central axis (9). The rod member (40) is further positioned outside the outer surface of the hollow main body (11) and has a shape and dimensions that bypass the hollow main body (11) on its outside, and therefore does not interfere with the dosage setting function of the hollow main body (11). This means that the hollow main body (11) can rotate without being obstructed by the elongated rod member (40), thereby allowing the hollow main body (11) to rotate and co-rotate the dosage setting wheel (6) to set the dosage of the pen injection system. Similarly, the shape and dimensions of the elongated rod member (40) are configured and fitted such that, if the manufacturer of the pen injection system configures the pen to function in that manner, the rod member does not obstruct any optional rotation of the dosage setting wheel during injection.

[0091] One or more elongated rod members (40) have a proximal end portion, which is installed or fixed within a portion of the housing (26) of the injection monitoring system, for example by providing an enlarged proximal cross-section at the proximal end portion of the elongated rod member (40), and the housing (26) of the injection monitoring system is provided with a corresponding recess having a reduced cross-sectional outlet diameter, thereby preventing the elongated rod member (40) from being pulled out of the housing (26). Alternatively, the elongated rod member (40) is preferably formed integrally with the housing (26) of the injection monitoring system, and in particular integrally with the operating cap (29) of the housing (26) of the injection monitoring system. The cap (29) is configured and dimensionally determined accordingly to extend beyond the nominal diameter of the hollow main body (11). Thus, the elongated rod member (40) extends distally from the cap (29) parallel to the longitudinal central axis (9), bypassing the hollow main body (11) without touching or contacting it.

[0092] The elongated rod member (40) is advantageously provided with at least one portion defining an elliptical spline that extends distally from the cap (29) parallel to the longitudinal central axis (9). The “elliptical spline” shape of the elongated rod member facilitates the rod member’s non-contact passage around the relatively enlarged diameter of the hollow main body while simultaneously reducing the need to increase the diameter of the injection monitoring system housing (26). The spline curve portion of the elongated rod member (40) is configured in this case to maintain a sufficient distance between the elongated rod member (40) and both the hollow main body (11) and the pen body (3) so that the elongated rod member (40) preferably never comes into contact with the outer surface (4) of the body of the injection pen system when the injection monitoring system (25) is moved from a first monitoring position to a second monitoring position and back again.

[0093] The elongated rod member (40) is further made to an appropriate size, for example, 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 a mixture of polycarbonate (PC) and acrylonitrile butadiene styrene (ABS) copolymer, commonly known as PC / ABS mixture, but other suitable polymers and polymer mixtures that provide suitable rigidity are generally known to those skilled in the art, and the elongated rod member can be made or constructed accordingly from any such suitable rigid material.

[0094] The sheath member (45) comprises an elongated, flat body that extends parallel to and generally conforms to the shape of the outer surface (4) of the pen body (3). The sheath member (45) further comprises grooves (46) configured and fitted to receive the elongated rod members (40) by sliding engagement. The grooves (46) also extend parallel to the longitudinal central axis (9). The grooves (46) of the sheath member (45) are axially aligned with the elongated rod members (40) so that the rod members (40) are inserted into and received by the grooves (46) before the injection monitoring module (1) is mounted onto the pen injection system (2). The groove (46) has side walls (48, 49) projecting inward from the inner surface of the sheath member (45), and includes an open groove (47) that defines a longitudinally oriented opening (50) extending parallel to the longitudinal central axis (9). The longitudinally oriented opening (50) is configured and sized to receive the shaft portion (42) of the spigot (41), and to allow the shaft portion (42) to move distally and / or proximal along the longitudinally oriented opening (50) when the elongated rod moves, but not to allow lateral movement of the spigot and the corresponding shaft portion outside the dimensional constraints of the longitudinally oriented opening (50). The longitudinally oriented opening (50) further comprises a proximal end portion (51) and a distal end portion (52), which are configured and sized to receive the flat head (44) of a spigot (41) for assembling an elongated rod member (40) into a sheath member (45). When assembled, the flat head (44) of the spigot (41) is positioned on the outward-facing side of the longitudinally oriented opening (50) of the groove (46), while the elongated rod member is positioned on the inward-facing side of the longitudinally oriented opening (50) of the groove (46), and the shaft portion (42) of the spigot (41) extends through the longitudinally oriented opening (50) of the groove (46) and can translate along the longitudinally oriented opening (50).

[0095] 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 the sheath member to be detachably attached to the body (3) of the pen-type injection device (2). The body mounting portion (53) in this case comprises a wall of a plastic or polymer material, such as polycarbonate (PC), acrylonitrile butadiene styrene (ABS) copolymer, or a mixture thereof known as a PC / ABS mixture, wherein the wall extends circumferentially around the body (3) of the pen injection system (2) and allows insertion of the pen body into a hole (54) formed by this circumferentially extending wall, and is sized to engage with the outer surface (4) of the pen body (3) by elastic friction engagement through appropriate dimensional setting of the hole (54). The circumferentially extending wall is advantageously provided with a wall portion (55) made of a softer, more elastic material, such as elastomer SEBS or a similar elastomer polymer, for engaging with and gripping the corresponding surface portion (4) of the body (3) of the pen (2) to prevent any unwanted axial sliding of the pen within the circumferentially extending wall (54).

[0096] Figures 1, 5, and 6 illustrate specific features of the sheath and relative positioning system of the injection monitoring module. Figures 5A and 5C are schematic perspective views of the sheath member (45) showing a position locking system located within the sheath member and configured to selectively engage with or disengage from a locking contact with the flat head (44) of the spigot (41). With respect to the relative positioning system, Figure 5A shows the locked configuration and Figure 5C shows the unlocked configuration. Figures 5B and 5D show the sheath (45) and positioning system with the upper part 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 from Figures 5A to 5D, but also in Figure 1, and more specifically in Figures 6A and 6B, the locking system comprises a rotatably operated locking head (56), a rotatable button that can be operated with a finger other than the thumb or the thumb, and the locking head optionally comprises one or more friction members (57) constructed as a dial mechanism along the periphery of the locking head button (56) to facilitate engagement by the user's finger other than the thumb or the thumb. The locking head button (56) also comprises a pair of legs (58A, 58B) extending from the underside of the locking head (56) into a groove (46) and a corresponding distal end opening (52) of a longitudinally oriented opening (50). The legs (58A, 58B) are terminated by a pair of opposing feet (59A, 59B). The locking head (56) is rotatable, for example, by a quarter turn around an axis (60, Figure 6A) that extends perpendicular to the longitudinal central axis. The legs (58A, 58B) and feet (59A, 59B) are configured and shaped to selectively lock into the flat head (44) of the spigot (41) depending on the rotational position of the locking head (56) around the rotation axis (60).In the first locked position, as shown in Figures 5A and 5B, the legs and feet are oriented laterally or perpendicularly 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 longitudinal central axis (9). For example, the lock head (56) rotates when the user presses the lock head button with a finger other than the thumb or with the thumb, or when the friction member is pushed clockwise to perform, for example, a quarter turn. This rotation causes the legs (58A, 58B) and feet (59A, 59B) to rotate 90 degrees, resulting in the legs and feet aligning with the longitudinally oriented opening (50). This releases the lock engagement between the legs and feet and the flat head, allowing the flat head (44) and attached shaft portion (42) of the spigot to move freely in the axial direction along and parallel to the longitudinal central axis (9). This unlocked position is shown in Figures 5C and 5D. To facilitate the user's recognition of the locked position and the corresponding unlocked position, the lock head can be advantageously provided with corresponding markings, a contact stopper to prevent over-rotation of the lock head button (56), and the like. The lock head button (56) is also preferably housed within a suitably provided cover (61) for the sheath, which may be, for example, removable, or otherwise welded or otherwise fixed 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 longitudinal central axis (9), which, in combination with optional markings on the lock head, allow the user of the injection monitoring module to recognize whether the lock head button (56) is set in the locked position or the 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 pressed-in position while the injection monitoring module is being mounted onto the pen injection system, as described below with respect to Figures 2A, 4A, 7, and 8. Figure 2A shows the injection monitoring module (1) in the first pressed-in position, in which case the injection monitoring system has its distal-facing surface in contact with the proximal-facing surface of the end (13) of the hollow main body, in preparation for mounting onto the proximal end of the injection pen system, for example, as shown in Figure 7. On the other hand, Figure 2B shows the same injection monitoring system in an unfolded unlocked position before any mounting onto the injection pen, or, for example, after unmounting 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 in the pressed-in position when the user rotates the lock head button (56) to the locked position, thereby creating a lock surface engagement between the lock head and the flat head (44) of the spigot (41). As a result, neither the head, the shaft portion (42) of the spigot, nor the elongated rod member (40) are allowed to move axially in the proximal or distal direction. In the pressed-in position, this allows the user of the injection monitoring module to attach the module to the 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 could be interpreted by the processing system of the injection monitoring system as the start or end of an injection process. Figure 8 shows the injection monitoring module attached to the injection pen system, with the lock head still set in the locked position. This diagram shows that the rod member (40) is still in a pushed-in position, and that most of it is not visible to the user from the outside.By rotating the locking head (56) by the user, for example, 90 degrees around the pivot axis (60), to move the locking head (56) to the unlocked position, the flat head (44) and shaft portion (42) of the spigot (41) are moved to align parallel to the longitudinal direction with the legs (58A, 58B) and feet (59A, 59B) and the longitudinally oriented opening (50), thus releasing them from lock engagement. The elongated rod member (40) is now able to move axially proximal, for example, by the kinetic force of some reaction energy transmitted via the injection actuation mechanism button (10), or alternatively, by the kinetic force of the biasing spring (36) that was pressed against and compressed by the actuation mechanism (10) of the pen injection system while the injection monitoring module was attached to 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 mounted and deployed position as shown in Figures 4B and 9.

[0098] Figures 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 positioned adjacent to an elongated rod member (40) on the housing (26) of the injection monitoring system, preferably on the portion of the operating cap (29) of the housing (26). In such embodiments, the optical sensor (62) is positioned so that it can receive reflected light from a correspondingly appropriately positioned reflective surface (63) which is located at the proximal end of the body of the sheath member (45). The optical sensor (62) and the reflective surface (63) are therefore positioned so that reflected light coming from the reflective surface (63) travels to the optical sensor (62). The optical sensor (62) is appropriately configured to determine, for example, the distance that the optical sensor (62), and therefore a predetermined reference position in the injection monitoring system (25), has traveled parallel to and along the longitudinal central axis, based on the intensity of the reflected light and / or the time it takes for the reflected light to travel along the path between the reflective surface (63) and the optical sensor (62). The optical sensor (62) preferably comprises a light source, which may be provided by, for example, a light-emitting diode. The optical sensor (62) may further comprise a focusing or diffusing system for such a light source, as is known in the art with respect to the mode of function and operation of such an optical sensor, depending on the characteristics of the reflective surface (63), the output of the light source, etc.

[0099] Once installed and positioned in the deployed position after unlocking, the injection monitoring module functions according to the following brief description:

[0100] The dosage is set by rotating the hollow main body, thereby co-rotating the dosage setting wheel. Since the elongated rod member (40) is already engaged in the groove of the sheath member (45), the injection monitoring housing (26) is prevented from rotating within the hole (12) of the hollow main body. In this case, the monitoring system (25) receives only the signal from the magnetometer corresponding to the actual dosage selected by the rotation of the dosage setting wheel (6). Without the rotation lock provided in the injection monitoring module of the present invention, errors may occur in these readings due to unintended relative rotation, in which case supplementary corrective measures would be necessary to determine whether the dialed dosage was actually the selected dosage. Once the processing unit verifies that the set or dialed dosage is the selected dosage, the monitoring system then determines whether the injection process has started, i.e., whether the injection monitoring system has begun to translate along the longitudinal central axis (9) from the first monitoring position to the second monitoring position. This is achieved by the magnetometer notifying the processing unit of an increase in the magnetic norm, because an increase in the magnetic norm is equivalent to the movement of the magnetometer toward the magnet. In this way, the monitoring system knows that the injection process has started. In injection pens where the dosage wheel rotates during injection, the injection end point can be similarly calculated using the magnetic field vector value captured by the magnetometer. However, in pens where the dosage setting wheel does not rotate, it is usually impossible to know when the injection has ended. This is because the user may keep the injection monitoring system (25) in contact with the injection activation button (10) of the pen (2) for an indeterminate period of time, or may not be in contact with the activation button (10) at all. Therefore, it is considered that the measurement of elapsed time at the second monitoring position may be subject to errors that require correction.In this configuration, the optical sensor is therefore used to provide a reference point to the injection monitoring system, which then determines when the injection monitoring system has returned from the second monitoring position to the reference point at the first monitoring position, thereby providing notification of the injection completion point.

[0101] Thus, as can be understood from the preceding information, the injection monitoring module described herein makes it possible to reliably determine, in a significantly more efficient manner than conventional methods, that the dialed dose is the actual selected dose, the point at which the injection begins, and the point at which the injection ends. Furthermore, the injection monitoring module includes means for actively preventing any unwanted axial translation along the longitudinal central axis of the injection monitoring system during the attachment and / or detachment of the injection monitoring module to the pen injection system, which would normally lead to the injection monitoring system generating and processing erroneous signals.

Claims

1. An injection monitoring module is fitted and configured to be detachably attached to the proximal tip of an injection pen system for delivering a drug, wherein the injection pen system comprises a pen body, a dose setting wheel located proximal to and connected to the body, and an injection operating mechanism, wherein the dose setting wheel is rotatable about the longitudinal central axis of the pen injection system during dose setting, and the injection monitoring module is, The hollow main body is fitted and configured to be coaxially mounted on the dosage setting wheel at the proximal tip of the injection pen system and to engage with it so as to rotate together, and has a longitudinal central hole having a proximal tip and a distal tip, and a longitudinal central axis, A magnetic field generating means is disposed on or inside the surface of the hollow main body at the proximal tip of the longitudinal central hole, An injection monitoring system comprising at least one or more magnetic sensors, the injection monitoring system being positioned at the proximal end of the hollow main body, and being movable along the longitudinal central axis within the hole of the hollow main body from a first monitoring position in which the injection monitoring system is not in contact with the proximal surface of the injection operating mechanism to a second monitoring position in which the injection monitoring system is in contact with the proximal surface of the injection operating 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 longitudinal central axis during dose selection, The rotation stopping means comprises a rotatably fixed connecting member arranged parallel to the longitudinal central axis, and the rotatably fixed connecting member connects the injection monitoring system to the main body of the pen injection system. The rotation stopping means is 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 injection, and vice versa, from the second injection monitoring position to the first injection monitoring position after the injection is completed. The injection monitoring module also includes relative positioning means configured to prevent the injection monitoring system from moving proximal away from the first pressed-in mounting position when in a first pressed-in mounting position, and to allow the injection monitoring system to move proximal away from the first pressed-in position to the second deployed mounting position when in a second deployed position.

2. The rotatably fixed connecting member is An elongated rod member extends distally from the injection monitoring system parallel to the longitudinal axis and bypasses the outer surface of the hollow main body, The injection monitoring module according to claim 1, comprising a sheath member which is attachable to the body of the injection pen system and is fitted and configured to slide-engage with the sheath member to receive the elongated rod member during translational movement of the injection monitoring system from a first monitoring position to a second monitoring position.

3. The injection monitoring module according to claim 2, comprising a locking system configured to selectively engage with the sheath and / or the elongated rod member to position the injection monitoring module in the first retracted mounting position or the second deployed mounting position, respectively.

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

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

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

7. The injection monitoring module according to claim 2, wherein the elongated rod member comprises a spigot projecting outward from a surface facing the outside of the elongated rod member, and the spigot is located at or near the distal end of the elongated rod member.

8. The injection monitoring module according to claim 6, wherein the spigot comprises a shaft portion extending from the outer surface of the elongated rod member, and the shaft portion of the spigot terminates with a flat head.

9. The injection monitoring module according to any one of claims 2 to 6, wherein the elongated rod member comprises at least one portion of the elongated rod member that defines an elliptical spline extending distally from the injection monitoring system parallel to the longitudinal central axis.

10. The injection monitoring module according to any one of claims 2 to 7, wherein the sheath member comprises grooves configured and adapted to receive the elongated rod members by sliding engagement.

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

12. The injection monitoring module according to claim 8, wherein the groove is provided with an open groove, and the open groove has a side wall having corresponding openings oriented in their respective longitudinal directions.

13. The injection monitoring module according to claim 6 and any one of claims 10 to 12, wherein the longitudinally oriented opening of the groove comprises a distal end and a proximal end, and the distal and proximal ends of the longitudinally oriented opening are configured and sized to receive the flat head of the spigot therein, and to allow insertion or withdrawal of the flat head into or out of each of the proximal and / or distal ends of the longitudinally oriented opening.

14. The injection monitoring module according to claim 2 and any one of claims 10 to 13, wherein the sheath member comprises a body mounting portion configured and adapted to allow the sheath member to be detachably attached to the body of the pen injection system.

15. The injection monitoring module according to any one of claims 4, 6, 7, and 8, wherein the rotatably selectable lock is configured and sized such that, in the first locked position, it locks and engages with the shaft portion and / or the flat head of the spigot of the elongated rod member to prevent longitudinal axial movement of the head and / or the shaft portion of the spigot within the sheath, and in the second unlocked position, it disengages the lock to allow longitudinal axial movement of the head and / or the shaft portion of the spigot within the sheath.

16. The injection monitoring module according to claim 1, wherein the hollow main body comprises translational contact means fitted and configured to prevent axial translational movement of the hollow main body along the longitudinal central axis when the injection monitoring module is in the mounting position on the injection pen system.

17. The injection monitoring module according to claim 16, wherein the translational contact means of the hollow main body comprises an annular shoulder portion extending inward into the hole from the inner surface of the hollow main body toward the longitudinal central axis.

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

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

20. The injection monitoring module according to claim 1, further comprising an injection start determination means.

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

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

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

24. The injection monitoring module according to claim 1, comprising an electronic component substrate and at least one microcontroller electrically connected to the one or more magnetic field sensors.

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

26. The injection monitoring module according to claim 24, wherein the electronic component board comprises a communication unit that is electrically connected to the at least one microcontroller.

27. The injection monitoring module according to claim 24, wherein the electronic component board is equipped with an autonomous power supply.

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