Injection monitoring module with magnetic spin sensing

Abstract

An injection monitoring module is removably mounted on the proximal end of an injection pen comprising a pen body, a dose setting wheel located on the proximal end, and an injection initiator. The dose setting wheel rotates about the central longitudinal axis of the pen during dose setting. The injection monitoring module comprises a hollow body coaxially mounted on and co-rotatingly engaged with the dose setting wheel. The body comprises a longitudinal bore having a proximal end, a distal end, and a central longitudinal axis; one or more magnets located on or within the body. The injection monitoring system comprises at least one magnetic field sensor that moves along the central axis within the bore from a first monitoring position to a second monitoring position. The injection monitoring module further comprises a rotational stop for preventing rotational movement of the monitoring system about the central axis during dose selection.

Description

Technical Field

[0001] This invention generally relates to a monitoring system for injectable drug delivery devices, and particularly to injection monitoring for pen systems. Background Technology

[0002] As is well known, the field of injection monitoring relates to drug delivery devices, particularly infusion systems. Over time, this monitoring has shifted towards pen injection systems, enabling users of these systems and healthcare professionals involved in the treatment and follow-up of such patients to more closely monitor their own injection methods, and in many cases, the actual dosage administered, in an attempt to achieve better healthcare outcomes. These developments have been accompanied by the increasing use of related software and portable communication devices, such as tablets or smartphones, which have been programmed to receive and interact with the monitoring system to provide information to users or healthcare professionals in real-time or periodically via appropriate communication units included in the monitoring system.

[0003] For example, regarding injection pen systems, one challenge is providing an easy-to-use, reliable, and reasonably safe monitoring system that can accommodate various variants of such commercially available injection pen systems, which often have numerous monitoring systems. Previous attempts to provide such monitoring systems typically involved tweaking the body of the injection pen system, including the electronics and one or more sensors. However, one of the main drawbacks of such systems is that once all the electronics are integrated, they tend to make the final product rather large and bulky, thus more difficult to use from the user's perspective. Furthermore, such improved systems tend to be highly brand- or manufacturer-specific, thus rarely using injection pen devices from other manufacturers. Additionally, there is a trend to try to reduce the overall size of the injection pen body as much as possible through the miniaturization of complex electronics, which in turn introduces its own problems, particularly electromagnetic interference between various components due to the proximity of circuitry providing the required or desired integrated functionality. Moving the sensors in the monitoring system away from sources of electromagnetic interference only complicates the problem, potentially leading to erroneous readings or requiring further systems to compensate for the physical separation between the sensors and other electronic components, such as microcontrollers designed to control and direct the various components and manage their interactions.

[0004] Injection pen systems are well-known and typically feature a dose-setting wheel and injection trigger at the proximal end, with the dose-setting wheel rotating about the pen's central longitudinal axis. The user selects the dosage by rotating the wheel. The pen is usually mechanically or electromechanically configured to produce an injection effect upon activation of the injection trigger. This injection trigger is typically a simple press or push button that has mechanical or electrical contact with the dispensing mechanism located within the pen system; pressing it causes the injection mechanism to eject and expel the medication from the pen system. In some pen systems, the dose-setting wheel rotates not only during dose setting but also during injection. This is usually achieved by incorporating one or more metal components, such as a helically wound drive spring located within the pen system housing and physically connected to the dose-setting wheel. Because these metal components are relatively large compared to the electronic systems contained in many current pen systems, they can further interfere with the sensors designed to capture or receive signals in those electronic systems, potentially making the system less accurate and / or requiring complex correction mechanisms to avoid calculation errors.

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

[0006] For example, published PCT patent application WO2014128156A1 relates to a sensor assembly having: a first rotating sensor portion having a plurality of individually conductive sensor regions arranged in a pattern; and a second rotating sensor portion rotatably arranged relative to the first portion, including a plurality of contact structures adapted to contact the conductive sensor regions on the rotating portion of the first sensor. The contact structures are configured to engage and connect different sensor regions as the first and second portions of the rotating sensor rotate relative to each other, the created connection representing the rotational position between the first and second portions. One of the contact structures is an actuable contact structure that is axially movable relative to the first portion and has a connected position for the actuable contact structure to contact the sensor regions and a non-connected position not to contact the sensor regions. The system is mounted within the body of an injection pen, at least partially within a volume within a dose setting wheel. The system also includes a visual display, such as an LCD display located in or replacing the injection initiator button.

[0007] In contrast, published PCT application WO2018013419A1 relates to a dose detection system comprising a drug delivery component connected to an actuator and rotatable and axially movable relative to a connection component connected to a dose setting component, and including a module with an electronic sensor operable to detect the relative rotation of the connection component and the drug delivery component to detect a dose delivered by a drug delivery device. The dose detection module is detachably connected to the proximal end of an injection pen system and is designed as a device to detect the amount of drug dispensed by the injection pen system, while simultaneously being connected thereto, storing the detected dose in memory, and transmitting a signal representing the detected dose to a remote communication device. The system includes a pair of rotatable and translational cylinders that interact via electrical contacts provided on the surfaces of the cylinders to indicate various states or positions of the injection drug delivery process (including dose setting), the electrical contacts being connected to an assembly of electronic components on a flexible printed circuit board, arranged in an accordion-like folded arrangement within the detachable connection body, and isolated between overlapping layers of the circuit board by electrically insulating non-conductive spacers to prevent potential electrical, electronic, and electromagnetic interference.

[0008] A direct observation of the above structure is that, although folded flexible printed circuit boards are used to provide multiple surfaces for placing electronic components, their relative spatial density and positioning relative to each other require non-conductive spacing between the electronic component layers. The direct consequence of this is an increase in module height, and inevitably an increase in the complexity of the clip-on dose detection module within it.

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

[0010] Therefore, one object of the present invention is to provide an injection monitoring module adapted to be detachably connected to the proximal end of an injection pen system for drug delivery. The injection pen system has a dose setting wheel that can rotate about the central longitudinal axis of the injection pen system to set the dose of drug to be injected; and can optionally be fixed during injection, while avoiding complex shielding or protection solutions against any unwanted electrical, electronic, or electromagnetic effects caused by the relatively high density of electronic components within the monitoring module.

[0011] Another object of the present invention is to provide an injection monitoring module as described above, wherein the monitoring module is adjusted and configured to determine a set dose and injection initiation point. For the purposes of this invention, "injection initiation point" as used herein refers to the point at which the injection mechanism within the pen is activated. This is typically achieved by moving the injection initiator distally (such as a button located proximally on the injection pen system).

[0012] However, another object of the present invention is to provide an injection monitoring module as described above, wherein the module is adjusted and configured to detect or calculate the user-set dose or amount of the injectable substance contained in the injection pen system, as well as the injection start point or initiation point and the injection end point in the injection pen system, thereby determining whether all doses or amounts of the injectable substance set by the user of the injection pen system have been discharged from the pen system.

[0013] These and other objectives of the present invention will be readily apparent from a full reading of the present specification.

[0014] Therefore, according to any of the above objectives, this application provides an injection monitoring module adapted to be detachably mounted to the proximal end of an injection pen system for drug delivery; the injection pen system has a pen body, a dose setting wheel located proximally connected to the pen body, and an injection initiator, the dose setting wheel being rotatable about the central longitudinal axis of the injection pen system during dose setting, wherein the injection monitoring module includes:

[0015] A hollow body adapted to be coaxially mounted on a dose setting wheel at the proximal end of an injection pen system and to co-rotate with the dose setting wheel at the proximal end of the injection pen system; the hollow body includes a central longitudinal hole having a proximal end, a distal end, and a central longitudinal axis;

[0016] A magnetic field generating device, wherein the magnetic field generating device is located on or inside the hollow body; the magnetic field generating device is located near the end of the central longitudinal hole;

[0017] An injection monitoring system includes at least one or more magnetic field sensors; the injection monitoring system is located at the proximal end of a hollow body, and the injection monitoring system is movable from a first monitoring position to a second monitoring position along the central longitudinal axis within the hole of the hollow body; the injection monitoring system is not in adjacent contact with the proximal surface of the injection initiator at the first monitoring position, and the injection monitoring system is in adjacent contact with the proximal surface of the injection initiator at the second monitoring position.

[0018] The injection monitoring module also includes a rotation stop device configured to prevent the injection monitoring system from rotating about the central longitudinal axis during dose selection.

[0019] As used herein, the terms "pen injection system" and "injection pen system" are used interchangeably to refer to a general handheld pen-shaped injection system that is readily recognized and commercially available for treating many different medical instructions. These systems are also typically designed for users requiring treatment to self-inject medication according to specific medical instructions. For example, insulin for treating diabetes is available in various forms, such as the brand name FlexPen commercialized by Novo Nordisk. ⑧ The pen injection system, commercialized by Eli Lilly, is branded as Kwikpen. ⑧ The pen injection system and the brand name Lantus Solostar, commercialized by Sanofi. ⑧ These are just three of the most well-known brands of pen-injection systems. Other medications are also used with these medical devices, for example, to address potentially life-threatening situations requiring immediate emergency injections of medications such as those for anaphylactic shock, anticoagulants, opioid receptor agonists, and antagonists. It has become common for patients with or susceptible to such conditions to carry these devices with them.

[0020] The injection monitoring module according to the invention is adapted to be configured as a detachable accessory for an injection pen system, equipped with a dose setting wheel and an injection initiator at the proximal end of the injection pen system. The dose setting wheel rotates about the central longitudinal axis of the pen injection system to allow the user to set the dose of the injected drug. During the dose setting or dose “dialling” step, the dose setting wheel is typically rotatable clockwise and counterclockwise, which typically correspond to an increase and a decrease in the selected dose, respectively, and vice versa, depending on the manufacturer. The injection initiator is typically represented by a button and is usually located at the proximal end of the dose setting wheel, and in most injection pen systems, at the proximal end of the injection pen system. After the dose is set or “dialled” (this term is well known in the art), when the user of the injection system then presses the injection initiator distally, a piston drive is connected to the plunger, and in order to drive the drug from the cavity of the injection pen through a needle, the user inserts the needle into the appropriate injection site, such as skin, adipose tissue, or muscle, depending on the type of drug to be administered. The dosage setting wheel is sometimes (but not always) connected to the injection drive mechanism, so that, depending on the pen manufacturer and model, it can also rotate as the drug is injected. This functionality of the injection system is well known in the art. The monitoring module contemplated according to the invention is intended to be mounted on the pen injection system, wherein the dosage setting wheel can be configured to rotate during the spray / injection phase of the pen injection system, or conversely, not rotate during the spray / injection phase of the pen injection system. For example, the Kwikpen mentioned above... ⑧The injection pen's dosage setting wheel does not rotate during injection, unlike the Lantus Solostar. ⑧ and FlexPen ⑧ The dosage setting wheel of the injection pen rotates during the injection process.

[0021] Therefore, the injection monitoring module according to the invention is adjusted and configured to be detachably connected to the proximal end of such an injection pen system. The expressions “detachably attached,” “detachably connected,” “detachably mounted,” or “detachably installable” that may be used in this specification should be understood to mean that the injection monitoring module has the characteristic of being connected or mounted and subsequently detached when transferred to another pen injection system, or, for example, when the monitoring module is damaged and needs to be replaced. This connection and subsequent detachability can be achieved by providing a connection device on the monitoring module that engages releasably with the proximal end of the pen injection system, for example by friction or elastic engagement, or by other releasable fastening devices, such as clips, belts, threads, and corresponding fastening rings, which engage with the dose setting wheel or injection initiator and / or even the pen body of the pen injection system.

[0022] The aforementioned rotation stop device should be understood as a device that can physically prevent the injection monitoring system from rotating around the central longitudinal axis during the dose setting / dose dispensing process, optionally when the injection monitoring system is moved from the first injection monitoring position to the second injection monitoring position, and vice versa, that is, when the injection monitoring system is moved from the second monitoring position back to the first injection monitoring position.

[0023] The advantage of providing such a rotation stop device in the injection monitoring module contemplated by this invention is that the injection monitoring system will recognize the dose setting or "dialing" at the first injection monitoring position as the selected dose, whereas if the injection monitoring system is allowed to rotate for any reason while dialing out the dose by rotating the dose setting wheel, this recognition of the measured dose as the selected dose may not be accurate. Another advantage of this rotation-stop or stop-type monitoring module provided by this invention is that whether the injection monitoring system rotates during subsequent injections, whether accidentally or by design, is practically irrelevant during the selection of the dose to be dispensed, thus eliminating the need for any other corrective measures to determine the correctness of the selected dose, which might otherwise be necessary.

[0024] Therefore, for one purpose, the rotation stop device includes a rotary retaining connector arranged parallel to the central longitudinal axis, which connects the injection monitoring system to the pen body of the pen injection system. The rotary retaining connector is configured to prevent the injection monitoring system from rotating about the central longitudinal axis during dose setting or dispensing, more generally and more advantageously, to prevent the injection monitoring system from translating from a first monitoring position to a second monitoring position, and even more advantageously, to prevent the injection monitoring system from translating from the second monitoring position back to the first monitoring position. In this way, it can be ensured that the injection monitoring system will not rotate, whether accidentally or intentionally, particularly during dose selection or dispensing, and during the injection of the dispensing dose, or after injection when the user releases digital pressure on the cap of the injection initiator of the injection monitoring system.

[0025] For another purpose, the rotation stop device is also configured and adjusted to allow the injection monitoring system to translate from the first injection monitoring position to the second injection monitoring position during injection, and vice versa, that is, to allow translation from the second injection monitoring position to the first injection monitoring position.

[0026] Therefore, for another purpose, the rotary fixed connector includes:

[0027] At least one or more extension rod members, extending parallel to the longitudinal axis from the injection monitoring system distally and across the outer surface of the hollow body; and

[0028] A sheath member is mounted on the pen body of the injection pen system. The sheath member is adapted to receive at least one or more extension rod members in a sliding engagement manner during translational movement of the injection monitoring system from a first monitoring position to a second monitoring position.

[0029] As can be seen from the above, when the injection monitoring system moves from the first injection monitoring position to the second injection monitoring position (and vice versa, from the second injection monitoring position back to the first injection monitoring position), the extension rod component and the corresponding sheath component cooperate with each other, so that the extension rod component slides within the sheath component. The sliding engagement between the extension rod component and the sheath component is substantially parallel to the central longitudinal axis.

[0030] As described above, at least one or more extension rod members extend distally from the injection monitoring system (i.e., proximally away from the pen system and injection monitoring module, and parallel to the central longitudinal axis). These rod members are further located outside the outer surface of the hollow body and are shaped and sized to extend beyond the hollow body, thus not interfering with the dose-setting function of the hollow body. The hollow body needs to rotate to allow the dose on the pen injection system to be set via unidirectional rotational contact with the dose-setting wheel. Similarly, the shape and size of the extension rod members are configured and adjusted so that they do not interfere with any optional rotation of the dose-setting wheel during injection. Whether the pen injection system manufacturer has configured the pen to function in this way, for example with Sanofi Solostar... ⑧ or Flexpen ⑧ Pen injection system.

[0031] For another purpose, the extension rod member has a proximal end located within or fixed to a portion of the support body or housing of the injection monitoring system. For example, the extension rod member is prevented from being pulled out of the housing by providing an enlarged proximal cross-section at its proximal end and a groove of a corresponding shape with a reduced cross-sectional outlet diameter in the body or housing of the injection monitoring system.

[0032] Alternatively, for another purpose, at least one or more extension rod components are integrally formed with the injection monitoring system support.

[0033] Advantageously, according to another objective, at least one or more extension rod members are integrally formed with the activation cover of the injection monitoring system holder. The injection monitoring system is provided with a cover that the user presses to initiate injection. The cover encloses the magnetic field sensor within the body or housing of the injection monitoring system holder. Thus, according to this objective, one or more rod members extend from the cover in a distal direction parallel to the central longitudinal axis and also across the hollow body that contacts the dose setting wheel on the pen.

[0034] According to another purpose, at least one or more extension rod members include at least a portion of the extension rod member that defines an elliptical spline extending distally from the injection monitoring system parallel to the central longitudinal axis. With respect to this "elliptical spline," it should be understood that, according to the other purpose, the extension along the length of the rod towards the pen body of the pen injection system, when the extension rod member extends substantially parallel to the central longitudinal axis, is at least partially defined by an elliptical spline curve (i.e., a curve resembling an elliptical arc). Typically, when the injection monitoring system moves from a first monitoring position to a second monitoring position and then back, the spline curve portion of the extension rod member will be configured to maintain a sufficient distance between the extension rod member and the pen body such that the extension rod member never contacts the outer surface of the pen body of the injection pen system.

[0035] The dimensions and thickness of the corresponding material of the telescopic rod member are appropriately configured, for example, such that the telescopic rod member is semi-rigid along its length. Suitable materials for the telescopic rod member are, for example, semi-rigid plastic materials, such as mixtures of polycarbonate (PC) and acrylonitrile-butadiene-styrene (ABS) copolymers, commonly referred to as PC / ABS mixtures, although those skilled in the art are generally aware of other suitable polymers and polymer mixtures that provide appropriate rigidity, and the telescopic rod member can accordingly be made or constructed from any such suitable rigid material.

[0036] As described above, the rotary fixed connector also includes a sheath member having at least one or more flow channels configured to receive at least one or more extension rod members in a sliding engagement manner. Thus, for another purpose, the at least one or more flow channels extend parallel to a central longitudinal axis. The flow channels of the sheath member are aligned with the extension rod members such that the rod members are inserted into and received by the flow channels during the mounting of the injection monitoring module onto the pen injection system. The shape and dimensions of the one or more flow channels are typically configured as grooves having sidewalls, a base, and an opening. The base and sidewalls of the groove are located on the lower surface of the sheath member, and when the sheath member is mounted on the injection pen, the opening of the groove faces the pen body of the injection pen system.

[0037] As can be clearly seen from the preceding paragraph, the sheath member is mounted on the pen body of the injection pen system. Therefore, for another purpose, the sheath member also includes a pen body mounting portion configured to allow the sheath member to be detachably mounted to the pen body of the injection pen system. The pen body mounting portion of the sheath member may include a material wall, including, for example, a plastic or polymeric material such as polycarbonate (PC), acrylonitrile-butadiene-styrene (ABS) copolymer, or a mixture referred to as a PC / ABS blend, wherein the wall extends circumferentially around the pen body of the injection pen system, and is sized to allow the pen body to be inserted into a hole formed by the circumferentially extending wall, while simultaneously engaging with the outer surface of the pen body through a suitable size of the hole in the sheath member through elastic frictional engagement. Optionally and advantageously, the circumferentially extending wall has a softer, more elastic wall portion, for example, made of elastic SEBS or a similar elastic polymer, to engage and hold with the corresponding surface portion of the pen body, preventing any undesirable axial sliding movement of the pen within the hole of the circumferentially extending wall of the sheath member. Suitable elastomeric materials for achieving this function are known in the art.

[0038] According to another purpose, the sheath member also includes a retaining bridge configured to secure corresponding at least one or more extension rod members in corresponding flow channels. When the injection monitoring module is mounted on the injection pen, the retaining bridge is generally located on the underside of the sheath member, in contact with the outer surface of the pen body of the pen injection system. The retaining bridge serves to hold the extension rod member in the corresponding flow channel as the injection monitoring system moves from a first monitoring position to a second monitoring position and then back. The retaining bridge may be integrally formed as part of the sheath member, or alternatively, may be provided as an insertable block, for example, by snap-fit ​​mounting or ultrasonic welding in a corresponding position configured to receive the retaining bridge and located on the underside of the sheath member relative to the corresponding flow channel opening. In such a configuration, the sheath member will allow the lower surface of the extension rod member to slide against the upper surface of the sheath member, securing the rod within the corresponding flow channel of the sheath member. Alternatively, the retaining bridge may be formed by appropriate shaping of the flow channel, for example by providing one or more mutually positioned protrusions or shoulders extending from a first inner wall of the flow channel toward an opposing second inner wall of the flow channel, and optionally extending along at least a portion of the length of the flow channel. When the injection monitoring system moves from the first position to the second position, and vice versa, the extension rod component slides along the flow channel parallel to the central longitudinal axis. This forms a fixed bridge that prevents the extension rod component from accidentally falling out of the flow channel.

[0039] According to another purpose, the rotary fixed connector also includes a detachable link configured to temporarily position the sheath member and at least one or more extension rod members at predetermined intervals along an axis parallel to the central longitudinal axis during the mounting of the injection monitoring module on the pen body of the injection pen system. When the monitoring module is mounted on the pen injection system, the detachable link, as a single mounting unit, connects the injection monitoring system, with its protruding extension rod members and sheath members, to the hollow body and maintains this connection at a predetermined spatial relationship to prevent unintended axial displacement of the monitoring module when mounted on the dose setting wheel of the pen injection system. Accordingly, the detachable link is configured to engage and secure with a portion of the housing or support body of the injection monitoring system and a portion of the sheath member.

[0040] Therefore, for another purpose, the sheath component and the injection monitoring system each include a groove configured to receive a portion of the removable link and engage with a portion of the removable link in a temporary positioning relationship.

[0041] Therefore, for example, the sheath member and support body or housing of the injection monitoring system are provided with appropriately shaped grooves to receive corresponding complementary shaped protrusions of the detachable link. For example, a suitable complementary shape engaging with the corresponding grooves provided on the sheath member and the injection monitoring system housing can take the form of butterfly wings, with wings extending to either side of a central body that defines and extends into a predetermined space required to hold the sheath member and the injection monitoring system in their respective positions when the injection monitoring module is mounted on the injection pen system. The butterfly body can also extend circumferentially around the support body or housing of the injection monitoring system and elastically engage with it in a clamping manner (or, for example, more generally, a spring clamp). The elastic engagement with the support body of the injection monitoring system, and the butterfly wings engaging with the corresponding grooves in the sheath member and the pen body of the injection monitoring system respectively, prevent accidental axial movement of the support body of the injection monitoring system, thereby avoiding accidental triggering of erroneous readings in the injection monitoring system. Once the injection monitoring system is mounted and the hollow body is correctly positioned on the dose setting wheel of the injection pen system, the detachable link is detached. For example, to facilitate its reuse, when the injection monitoring module is removed from the injection pen system, the detachable link is conveniently stored in a corresponding groove provided at another location on the sheath member, which has a diameter sufficient to hold the link in place but allows it to be removed when needed.

[0042] The hollow body of the injection monitoring module includes a central longitudinal hole with proximal and distal ends, the hole being sized to allow the hollow body to be coaxially mounted on and around the pen body of the pen injection system. The hollow body is suitably made of any suitable material, such as durable polymers or plastics like high-density or high-impact polypropylene, or alternatively, polycarbonate. Advantageously, the hollow body is made of transparent, translucent, or opaque materials so that the user can understand and identify any visual cues, such as light-emitting diodes, which may also be provided or integrated into the injection monitoring module, where these cues can be selectively used to indicate various operational states of the injection monitoring system.

[0043] Therefore, according to another objective, the hollow body also includes a translational stop, configured to prevent axial translational movement of the hollow body along its central longitudinal axis when the injection monitoring module is in its mounting position on the pen system. The translational stop defines the limit of axial translational movement of the hollow body relative to the pen system's start button along its central longitudinal axis during the mounting of the injection monitoring module on the pen system. Advantageously, according to another objective, the translational stop of the hollow body includes an annular flange extending into the bore from the inner surface of the hollow body facing the central longitudinal axis. During the mounting of the injection monitoring module on the pen system, the distal surface of the annular flange contacts the proximal surface of the pen start button, thereby preventing any further translational movement of the hollow body along its central longitudinal axis.

[0044] According to another purpose, the hollow body also includes a distal body portion that extends around and triboelectrically engages with the outer surface of the dose setting wheel. Such a distal body portion may extend substantially from the annular flange described in the preceding paragraphs; or it may be, for example, represented as a hollow distal portion of a connectable hollow body, connected to the hollow body, for example, via a socket and bayonet, or screw-fit or snap-fit, sized to have a hole with dimensions suitable for the dose setting wheel of the pen system. For example, triboelectric engagement can be provided by a suitable elastomeric coating or deposition on the inner circumferential surface of the distal portion of the hollow body, for example, in one or more areas, or as a continuous, connected, or semi-continuous / connected coating deposited on the inner circumferential surface of the distal portion of the hollow body. The purpose of such a triboelectric coating or deposition is to provide friction between the distal body portion and the dose setting wheel in order to maintain the proper positioning of the hollow distal body portion to the dose setting wheel. Suitable types of elastomeric materials capable of providing such triboelectric engagement are known in the art; for example, a suitable elastomeric material is SEBS.

[0045] As described elsewhere in this specification, the injection monitoring module includes an injection monitoring system. Such a system includes at least one or more magnetic field sensors, and the injection monitoring system is substantially located near or near the proximal end of the opening in the hollow body. The injection monitoring system will be described in further detail below, but in essence, it includes many different components and devices for monitoring the injection status, such as:

[0046] - The start of the injection procedure;

[0047] - Termination or end of the injection procedure, wherein termination of the injection procedure shall be understood to include both complete administration of the selected dose of the substance to be injected and discrete injection procedures in which the user injects only a portion of the dose or causes a portion of the selected dose to be ejected from the pen injection system.

[0048] Furthermore, according to another objective of the invention, the injection monitoring system is moved along the central longitudinal axis from a first monitoring position where the injection monitoring system is not in adjacent contact with the proximal surface of the injection initiator, to a second monitoring position where the injection monitoring system is in adjacent contact with the proximal surface of the injection initiator. The injection monitoring system is advantageously mounted proximal to the hole in the hollow body, and preferably completely covers, or at least substantially covers, said proximal end of the hole.

[0049] As described above, the injection monitoring system can move from a first position where there is no physical contact between the injection monitoring system and the pen injection system's initiator button to a second position where physical contact is established between the monitoring system and the proximal surface of the pen injection system's initiator. This movement is generally a translation of the monitoring system along its central longitudinal axis from the first position to the second position. The configuration of the injection monitoring module ensures that rotation of the hollow body and the correspondingly connected dose setting wheel results in the determination that the set dose or dialed dose is the selected dose, as the rotational movement of the injection monitoring system around its central axis is locked during dose setting. The start of injection is also determined by detecting an increase in the magnetic norm when the injection monitoring system begins to translate along its central longitudinal axis from the first monitoring position to the second monitoring position. When the monitoring system translates proximally, i.e., from the second monitoring position to the first monitoring position, thereby eliminating physical contact between the pen injection system's initiator button and the monitoring system, the injection monitoring system is configured to detect the injection or spray endpoint of the injectable substance. One way to achieve this is to configure a reference point corresponding to the first monitoring position and detect when the injection monitoring system moves back to that reference point from any other point, for example, using a suitably configured sensor.

[0050] A translational movement opposite to the injection direction, i.e., a translation of the monitoring system proximally towards the user's hand or thumb, can be provided by the recoil energy of a bias spring. This bias spring is compressed during injection initiation and released when the start button is released. The bias spring can also be appropriately provided within the orifice and form part of the injection monitoring system. For example, after the user releases the start cap, by directly or indirectly removing the pressure of the thumb or finger on the start cap, the recoil force of the bias spring compressed within the orifice will move the injection monitoring system away from the pen's start button, biasing the injection monitoring system back to the first monitoring position.

[0051] According to another object of the invention, the monitoring module of the invention includes a magnetic field generating device located on or inside a hollow body, adjacent to or near the proximal end of a central longitudinal hole. The phrase "located on or inside a hollow body" implies that, for example, the magnetic field generating device may be mounted on the proximal surface of the hollow body, near the proximal end of the central hole. Alternatively, and preferably, the magnetic field generating device may be mounted within a cavity or recess provided in the hollow body, located near or adjacent to the proximal end of the central hole.

[0052] Various devices for generating magnetic fields are known, such as classical magnets, electromagnets, and hybrid material magnets. These magnets are typically made of magnetizable materials and possess magnetic or paramagnetic properties, whether naturally occurring or generated when an electric or other excitation current passes through or influences the material to produce or induce a magnetic field within it. Suitable materials can be appropriately selected from the following:

[0053] - Ferrite magnets, especially sintered ferrite magnets, for example, crystalline compounds comprising iron, oxygen and strontium;

[0054] -A composite material consisting of a thermoplastic matrix and isotropic neodymium-iron-boron powder;

[0055] - A composite material consisting of a thermoplastic matrix and strontium-based hard ferrite powder, the resulting magnet may contain isotropic, i.e., non-oriented, or anisotropic, i.e., oriented ferrite particles.

[0056] - A composite material of thermosetting plastic matrix and isotropic NdFeB powder;

[0057] - Magnetic elastomers, such as highly charged strontium ferrite powder, are mixed with synthetic rubber or PVC and then extruded into the desired shape or calendered into sheets;

[0058] - Flexible calendered composite materials, generally with a brown flake appearance, have elasticity levels that depend on their thickness and composition. These composites are not as elastic as rubber, and their Shore hardness ranges from approximately 40 to approximately 70 HSD (ANSI). Such composites are typically formed by combining synthetic elastomers with charged strontium ferrite particles.

[0059] The resulting magnets can be anisotropic or isotropic; due to rolling, thin sheet varieties typically have magnetic particle arrangement.

[0060] -Laminated composite materials, generally including the above-mentioned flexible composite materials, are co-laminated with soft iron plates;

[0061] Neodymium-iron-boron magnets;

[0062] - AlNiCo alloy magnetized steel;

[0063] - An alloy of samarium and cobalt.

[0064] In the list of magnetic field generating devices applicable to the present invention, the preferred selection is from the group consisting of neodymium-iron-boron permanent magnets, magnetic elastomers, composite materials composed of thermoplastic matrices and strontium-based hard ferrite powders, and composite materials composed of thermosetting plastic matrices and isotropic neodymium-iron-boron powders. Such magnets are known for their ability to maintain relatively high magnetic field strength while remaining relatively small in size. While the magnetic field generating device can be of any suitable general shape, such as a disk shape, including circular, ellipsoidal, or any other suitable polygonal shape, it preferably has only one dipole with a pair of diametrically opposed north and south magnetic poles. Although the magnetic field generating device can also be substantially disk-shaped, such a disk shape can preferably include a magnet with a hole substantially at the center of the disk to form a ring or annular magnet. Such a ring or annular magnet can be effectively mounted on the peripheral annular and proximal-facing surfaces of the hollow body. Advantageously, in the configuration of the currently envisioned injection monitoring module, the dipole magnets are rod-shaped or cylindrical dipole magnets, one of which is in opposite polarity orientation relative to the other, for example, NS and SN aligned. Thus, the magnets are positioned along their own longitudinal axis, across a horizontal plane that runs through and is orthogonal to the central longitudinal axis, on which the magnets are positioned relative to each other, for example, one of which is positioned relative to the other at a position 180° rotated about the central longitudinal axis.

[0065] A magnetic field generating device is provided so that the magnetic field sensor detects any changes in the magnetic field during dose setting, for example, due to the rotational movement of the hollow body relative to the magnetic field sensor, thereby determining the dose setting dialed by the dose setting wheel.

[0066] A magnetic field sensor is used to measure the magnetic field generated by a magnetic field generating device. As the dosing wheel rotates, the hollow body and magnetic field generating device move about a central longitudinal axis relative to the rotating, fixed magnetic field sensor. This movement is used to calculate or determine the dosage of the injectable substance in the injection pen system, which has been dialed or set by the user. Once the dosage is set, activating the proximal trigger cap causes a translational movement of the injection monitoring system housing, and the corresponding magnetic field sensor, along the central longitudinal axis, determines or calculates whether injection has begun. Conversely, and correspondingly, when finger or thumb pressure on the proximal trigger cap is released, the recoil energy in the bias spring within the injection monitoring system housing, located at the distal end of the housing, causes the injection monitoring system to recoil, inducing a proximal translational movement of the injection monitoring system housing along the central longitudinal axis towards the user's thumb or finger. This, in turn, causes the magnetic field sensor within the injection monitoring system to move proximally.

[0067] As described above, during the injection process, when digital pressure is applied to the injection monitoring system housing in the distal direction along the central longitudinal axis, the magnetic field sensor will detect the change in magnetic field caused by the sensor translating toward the magnetic field generating device in the distal direction along the longitudinal axis, and then translate in the opposite proximal direction as the digital pressure is released from the injection monitoring system.

[0068] Furthermore, the compression characteristics of the bias spring, and the degree of resistance it provides to distal movement of the injection monitoring system, can be appropriately used to improve the sensitivity of the monitoring system in detecting the injection initiation point. For example, in the event of uncontrolled distal directional movement, a user might suddenly push down the activation cover of the monitoring module, potentially inducing an error in the injection monitoring system regarding the injection initiation due to a sudden increase in the magnetic norm detected by the magnetic field sensor. Due to the compression characteristics of the bias spring, this rapid distal movement of the injection monitoring system, and the corresponding increase in the magnetic norm, is suppressed to a level that the magnetic field sensor can easily and accurately handle, thus making the determination of the injection point more secure and reliable. To this extent, the bias spring can be seen as a more general suppression mechanism to help correctly determine the injection initiation event.

[0069] Regarding general magnetic field sensors, devices for measuring and determining magnetic fields are known in the art. For example, magnetoresistive (MR) is a well-known device. Such magnetoresistive devices are often represented by their abbreviations, such as AMR sensors, GMR sensors, and TMR sensors, which indicate the physical mechanism upon which the function of these sensor components depends. Giant magnetoresistive (GMR) is a quantum mechanical magnetoresistance effect observed in thin-film structures composed of alternating ferromagnetic and non-magnetically conductive layers. Anisotropic magnetoresistive (AMR) is considered to exist in materials where resistance is observed to depend on the angle between the current direction and the magnetization direction. Tunnel magnetoresistive (TMR) is a magnetoresistance effect occurring in magnetic tunnel junctions (MTJs), which are components composed of two ferromagnetic materials separated by a thin insulator. Resistors using these different properties are known in themselves.

[0070] Based on the above, the injection monitoring module and / or system of the present invention preferably uses one or more magnetometers as one or more magnetic field sensors. This magnetometer differs from GMR, AMR, or TMR sensors because it directly measures the magnetic field strength. There are two main methods for measuring magnetic fields: vector magnetometers measure the vector components of the magnetic field, and full-field magnetometers or scalar magnetometers measure the magnitude of the vector magnetic field.

[0071] Another type of magnetometer is the absolute magnetometer, which uses the internal calibration of a magnetic field sensor or known physical constants to measure the absolute magnitude or vector magnetic field. A relative magnetometer measures the magnitude or vector of the magnetic field relative to a fixed but uncalibrated baseline; also known as a variometer, it is used to measure changes in the magnetic field.

[0072] Therefore, according to the present invention, the preferred type of magnetometer for the injection monitoring module is an ultra-low power, high-performance triaxial Hall effect magnetometer. While the magnetometer can be configured to measure magnetic fields on three mutually perpendicular or orthogonal axes, in this example, the magnetic field sensor is configured to measure only two of the three orthogonal axes, such as the X-axis and Z-axis.

[0073] As can be understood from the preceding paragraphs, for another purpose, the injection monitoring module also includes an injection start determination device. For example, the injection start determination device is suitably represented by a magnetic field sensor, such as one or more magnetometers located in the injection monitoring system, and discussed elsewhere in this specification. Thus, in order to detect the start of injection, the injection monitoring system is configured to detect an increase in the magnetic norm, i.e., to determine the magnetic field vector along an axis parallel to or coaxial with the central longitudinal axis, without any accompanying effect on the magnetic field vector due to rotation of the injection monitoring system, by means of values ​​measured and reported by one or more magnetometers present in the injection monitoring system, as the injection monitoring system begins to move from a first monitoring position to a second monitoring position.

[0074] Advantageously, for another purpose, the injection monitoring module includes an injection end determination device. The determination of injection end can be based on contact, i.e., requiring physical or electrical contact between two surfaces or eliminating such contact, for example, by means of a mechanical or electrical switch; or it can be based on a non-contact device, such as any number of known non-contact detection devices, such as wave-based sensors, like sound or light sensors or any other sensors that apply the principle of propagating waveforms, and involves transmitters, receivers and optional reflective surfaces, chemical or biological reaction sensors, quantum effect sensors, etc., all of which are generally known in the art.

[0075] Advantageously, and for another purpose, the injection start and / or end determination device includes an optical sensor and a corresponding reflective surface.

[0076] According to another purpose, the optical sensor is located on the injection monitoring system, adjacent to at least one or more extension rod members. The optical sensor may be suitably mounted in the start-up cover, for example, or alternatively, in the support body or housing of the injection monitoring system. Advantageously, the optical sensor is located within the cover and / or housing of the injection monitoring system so that it can receive reflected light from a reflective surface at a corresponding and appropriate location.

[0077] Accordingly, for another purpose, the reflective surface of the optical sensor is located on a sheath member opposite to and optically aligned with the optical sensor on the injection monitoring module.

[0078] Therefore, the optical sensor and the reflective surface are positioned such that reflected light from the reflective surface propagates to the optical sensor. The optical sensor is suitably configured to determine, for example, the intensity of the reflected light and / or the time it takes for the reflected light to travel along a path between the reflective surface and the optical sensor, and thus the distance by which a predetermined reference position in the injection monitoring system is moved parallel to or along the central longitudinal axis. Therefore, the optical sensor is suitably equipped with a light source, for example, that can be provided by a light-emitting diode (LED). The optical sensor may also be equipped with a known focusing or diffusing system for such a light source, and with a power supply known in the art, depending on the characteristics of the reflective surface.

[0079] In an injection pen system where the dosage setting wheel rotates during injection, the end of the injection can be determined using the magnetic field vector value provided by the magnetic field sensor of the injection monitoring system. This is because the magnetic field vector value recorded by the magnetic field sensor will depend on, for example, how many times the hollow body including the magnet has rotated around the central longitudinal axis, and the relative change of the magnetic field vector is related to the distance from the magnetic field sensor to the magnet. In this case, such a configuration allows the injection end event to be displayed using only a magnetometer.

[0080] However, in the case of an injection pen system in which the dosage setting wheel does not rotate, for example during injection, it is particularly advantageous for the injection monitoring system to be configured to use such a non-contact sensor, such as an optical sensor, to signal when the injection monitoring device returns from the second injection monitoring position to the first injection monitoring position by axial translation along the central longitudinal axis, thereby determining the injection end event at this return position.

[0081] According to another object of the invention, the injection monitoring system includes an electronic component board.

[0082] Advantageously, and according to another object of the invention, one or more magnetic field sensors are electrically connected to the electronic component board. One or more magnetic field sensors may advantageously be located on the electronic component board, their positions opposite to or otherwise radially distributed along the central longitudinal axis of the electronic component board, and preferably, a single magnetic field sensor is located on the central longitudinal axis.

[0083] More advantageously, the electronic component board includes 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. Therefore, the electronic component board can suitably be, for example, a printed circuit board of a correspondingly suitable size. In the configuration contemplated in this invention, such a printed circuit board is advantageously disk-shaped, with its center corresponding to the intersection with the central longitudinal axis.

[0084] As described above, the injection monitoring system includes an optical sensor. For another purpose, the optical sensor is electrically connected to the at least one microcontroller. The microcontroller controls the operation of the optical sensor and processes signals and / or data received from the optical sensor to calculate, for example, the end of an injection event as described elsewhere in this specification, and additionally, how far the injection monitoring system has translated along its central longitudinal axis. This information is used to calculate whether the injection has been completed.

[0085] The electronic component board is advantageously mounted within an injection monitoring system housing or support body located mostly proximal to the hollow body and typically extending beyond the central bore. The distal portion of the injection monitoring system housing lies within the bore. The injection monitoring housing can move freely within the bore of the hollow body; however, rotation is prevented by a definite rotation-stopping device, such as a sheath member and an extension rod member.

[0086] Advantageously, the electronic component board is held such that its horizontal plane lies in a plane substantially orthogonal to the central longitudinal axis. Therefore, during dose setting, the electronic component board is in a first injection monitoring position relative to the hollow body with a fixed rotational relationship, such that rotation of the hollow body does not cause a corresponding rotation of the electronic component board. This means that when the hollow body rotates to "pull out" or sets the dose for injection, rotation about the central longitudinal axis is prevented of at least one or more magnetometers located on the electronic component board.

[0087] According to another object of the invention, the electronic component board includes a communication unit electrically connected to at least one microcontroller. Such a communication unit can be one or more of any number of communication units known per se, such as a wireless communication unit, like Bluetooth. ⑧ Bluetooth ⑧ Bluetooth Low Energy ⑧ (Bluetooth LE ⑧ or any other short-range or long-range wireless communication technology.

[0088] According to another objective of the invention, the electronic component board includes an autonomous, optionally rechargeable power source, such as a lithium-ion battery, which can be easily swapped out when depleted; or alternatively includes a rechargeable battery, such as a rechargeable lithium-ion battery. When a rechargeable battery is provided, it can be recharged via a corresponding charging port (such as a USB charging port) connected to the rechargeable battery, provided in the injection monitoring module, when the rechargeable battery is depleted. Non-rechargeable batteries (i.e., disposable batteries) and rechargeable batteries are generally known to those skilled in the art. Advances in charging technology today have also made wireless charging a reality, and according to the objectives of the invention, such a wirelessly charging battery, for example using an inductive charging system, is also considered potentially usable.

[0089] The integrated control and data processing unit, including at least one microcontroller, handles all electrical communication and signals between different electronic components on the electronic component board, including magnetic field sensors and optical sensors. It is also responsible for performing calculations, enabling it to calculate and determine the precise position of the magnetic field sensors, and processing signals from autonomous power supplies and communication devices integrated into the injection monitoring system. Furthermore, it communicates with local or remote data processing systems (e.g., on a smartphone). Such integrated control and data processing units are known in their own right, typically integrating a central processing unit, a real-time clock, one or more memory storage systems, and optional communication systems or subsystems, as well as other necessary components.

[0090] These and other objects of the invention will become apparent from the following more detailed description of the monitoring module in the accompanying drawings and examples. Attached Figure Description

[0091] For purposes of illustration and example, the present invention will now be described in more detail with reference to the accompanying drawings, in which:

[0092] Figure 1 An exploded perspective view of the injection monitoring module installed on a handheld pen injection system is shown.

[0093] Figure 2 It shows the installation on the handheld injection pen system Figure 1 A schematic cross-section of the injection monitoring module before use;

[0094] Figure 3 It shows Figure 1 or Figure 2 A detailed schematic perspective view of the injection monitoring module;

[0095] Figure 4 It shows Figure 1 or Figure 2 A schematic perspective view of another detail of the injection monitoring module;

[0096] Figure 5A and Figure 5B Showing observations from different angles Figure 4 A schematic perspective view obtained from the details;

[0097] Figure 6 It shows Figure 1 or Figure 2 A schematic perspective view of another detail of the injection monitoring module. Detailed Implementation

[0098] Now for reference Figure 1 and Figure 2A schematic diagram of an injection monitoring module (1) according to the invention is shown. The injection monitoring module (1) is mounted on a handheld injection pen system (2), comprising an injection pen system body (3) having an outer peripheral surface (4), a pen cap (5) covering the distal end of the injection pen system, a dose setting wheel or dialing wheel (6) located at the proximal end of the injection pen system body (3), and a dialed dose display window (7) located at the distal end of the dose setting wheel (6) and displaying the dose dialed by the user of the injection pen system. The injection monitoring module (1) according to the invention is mounted on, covers, and surrounds the proximal end (8) of the injection pen system (2), and in particular is also mounted on the pen body (3) to at least partially cover and contact the outer peripheral surface (4). The injection monitoring module (1) extends in a proximal direction beyond the proximal end (8) of the pen body (3), and in particular extends beyond the dose setting wheel (6). A central longitudinal axis (9) is also shown, which passes through the longitudinal axis of the injection monitoring module (1) and the injection pen system pen body (3). The injection pen system (2) has an activation button (10), which can be found in several commercially available injection pen systems, located near the end of the dose setting wheel or dial wheel (6). Figure 1 and Figure 2 In the injection pen system (2) shown, the dose setting wheel (6) rotates around the central longitudinal axis (9) when the dose is set, but is fixed against rotation when the injection is performed, that is, the dose setting wheel does not rotate around the central longitudinal axis (9) when the injection is performed.

[0099] The injection monitoring module (1) includes a hollow body (11) sized and sized to be coaxially mounted around the pen body (3) of the injection pen system (2). For this purpose, the hollow body (11) includes a central longitudinal hole (12) having a proximal end (13) and a distal end (14) and a central longitudinal axis coinciding with a central longitudinal axis (9). The hollow body (11) also includes a distal body portion (15) that extends around and frictionally engages with the outer surface of the dose setting wheel (6). Frictional engagement between the hollow body (11) and the outer surface (4) of the dose setting wheel (6) can be achieved, for example, by making the distal body portion with an elastomeric friction material (16), or by providing a coating of such an elastomeric friction material on the inner circumferential surface (17) of the hollow body, such elastomeric friction engagement materials are readily known in the art, so that the distal portion (15) can engage with the outer surface (4) of the pen body (3) in a push-fit or sliding-fit manner. The suitable elastomeric friction material (16) for the distal body portion (15) can be a thermoplastic elastomer, such as SEBS or polystyrene-poly(ethylene butene)-polystyrene block copolymer.

[0100] exist Figure 6The hollow body (11) is shown in more detail in the proximal direction, extending beyond the limit of the starter button (10) of the injection pen system (2), such that the orifice (12) accommodates both the dose setting wheel (6) and the starter button (10), and is also shown within the distal body portion (15) of the hollow body (11). The hollow body (11) also includes orifices located on or as shown in the orifice (12) of the hollow body (11). Figure 6 The magnetic field generating device (18, 19) is shown located within a hole (12) in the hollow body (11). The magnetic field generating device (18, 19) is suitably provided by a pair of dipole magnets (18, 19) that are completely opposite to each other, each magnet having a north (N) pole and a south (S) pole, and each pair of magnetic poles is preferably aligned along the central longitudinal axis with opposite polarities, i.e., NS / SN, wherein the first magnet with the N pole is located on a horizontal plane orthogonal to the central longitudinal axis, while the completely opposite magnet is located on the same plane orthogonal to the central longitudinal axis, with its S pole facing the same plane direction as the N pole of the first magnet. The dipole magnets may suitably be formed in the shape of rods or bricks, or alternatively as disks or rings, or any other suitable shape. The magnets are located in appropriately sized recesses (20, 21) provided in the hollow body (11), the recesses (20, 21) being located near the proximal end (13) of the body (11) or adjacent to the proximal end (13) of the body (11). Alternatively, the magnetic field generating device may be a single dipole annular magnet located on the surface surrounding the proximal end (13) of the hollow body or within a corresponding annular groove in the hollow body (11). It can be understood from the above that the magnetic field generating device is freely rotatable about a central longitudinal axis because the hollow body (11) containing the magnet is itself mounted on and frictionally engaged with a dose setting wheel around the central longitudinal axis (9).

[0101] The hollow body (11) also includes an inner guide sleeve (22) located within a central longitudinal bore (12) and extending from the inner surface (17) of the hollow body (11) to the bore (12) via an annular flange portion (23), the sleeve (22) extending from the inner end of the flange (23) in a proximal direction to the proximal end (13) of the hollow body (11). As will be described in more detail, when the injection monitoring system translates within the bore (12) from a first monitoring position to a second monitoring position, the inner guide sleeve (23) receives and guides the injection monitoring system.

[0102] The hollow body (11) also includes a translation stop device (24), which is adjusted and configured to prevent the hollow body (11) from axially translating along the central longitudinal axis (9) when the injection monitoring module (1) is in its mounting position on the injection pen system (2). Figure 2As shown, the translation stop device may include an annular flange (24) extending inwardly into the bore from the inner surface (17) of the hollow body along the central longitudinal axis. The annular flange (24) may be advantageously configured to abut against the proximal facing surface of the distal body portion (15), thereby forming a distal facing surface on the annular flange that, when the injection monitoring module is coaxially mounted on the pen, engages with the proximal facing surface of the start button (10) of the injection pen system (2), preventing axial movement of the injection monitoring module in the distal direction.

[0103] like Figure 1 , Figure 2 and Figure 3As shown, the injection monitoring system (25) is at least partially located within the orifice (12) and can be translated within the orifice (12) from a first monitoring position to a second monitoring position. The injection monitoring system (25) includes several components, including an injection monitoring system housing (26). The injection monitoring system housing (26) is configured in a shape similar to a cup with a rod, with a base wall (27) extending to cover a diameter substantially the same as or similar to that of the hollow body and substantially perpendicular to the central longitudinal axis (9). A first wall (28) extends from the periphery of the base wall (27) in a proximal direction away from the base wall (27), thereby forming a cup-shaped component with an internal volume closed by a proximal cap (29) forming an activator button, which engages or pushes to fit or adheres to the proximal end of the first wall (28), or is otherwise attached to the proximal end of the first wall (28). The base wall (27) also includes a second annular wall (30) extending distally from the base wall (27) at a position radially spaced from the central longitudinal axis (9), with a diameter smaller than the diameter of the hole (12) in the hollow body, allowing the housing (26) to translate within the sleeve (24) and hole (12) of the hollow body (11). The second annular wall (30) is closed at its distal end by a flexible cross wall (31) to form the stem of the cup. The flexible cross wall may be made of, for example, a flexible membrane material, and is deformable upon contact with the starter button (10) of the injection pen system (2). The stem of the cup is located within the hole (12) of the hollow body (11). The injection monitoring system housing (26), as defined by the cup-shaped internal volume, receives and accommodates the electronic component board (32). The inner volume of the rod formed by the second annular wall (30) and the cross wall (31) receives an autonomous power source (33), such as a disposable or rechargeable battery, for example a lithium-ion battery electrically connected to the electronic component board (32) to provide power thereto. The electronic component board (32) is suitably and typically a properly sized printed circuit board located within the cup-shaped inner volume formed by the base wall (27) and extends from the proximal end of the first wall (28). The injection monitoring housing (26) optionally includes a light guide window integrated into or part of the first wall (28), for example, formed of a translucent, opaque, or transparent material, and having crystalline properties, for example, crystalline properties selected to guide light waves generated by optional light-emitting diodes or other light-generating components from the inner volume of the cup to the outside of the injection monitoring system housing (26).

[0104] The electronic component board (32) also includes at least one magnetometer (34), which is advantageously located on the central longitudinal axis (9). In the case of a substantially circular component board, the magnetometer is substantially centered, such that it is coaxially aligned with the central longitudinal axis (9). In addition to the magnetometer (34), the injection monitoring system (25) also includes 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 signals between the different electronic components of the injection monitoring system. It is also responsible for performing dose management system and calculations, enabling the calculation and determination of the precise position of the magnet, and processing signals from the autonomous power supply (33). The electronic component board can also be connected to a USB port (35), which can be configured as a power charging port for a rechargeable battery (33) and / or configured to allow basic settings of any programmable memory on the electronic component board, or to configure the data processing unit. The integrated control and data processing unit typically also includes a communication device, such as a wireless communication circuit, like Bluetooth, for communicating with local or remote data processing systems (e.g., on a smartphone). ⑧ Or Bluetooth Low Energy ⑧ Wireless communication systems, to name only two of the many types of suitable communication devices. An integrated control and data processing unit can be appropriately programmed remotely upon first use, or receive information and updates in a manner similar to other electronic devices today that incorporate integrated control and data processing units, for example, wirelessly or via any other suitable link, such as a USB port. Such integrated control and data processing units are known in themselves and typically integrate a central processing unit, a real-time clock, one or more memory storage systems, and optional communication systems or subsystems, as well as other necessary components. An electronic component board (32) is housed within or located within a cup-shaped structure formed by the base wall (27) and the first wall (28) of the injection monitoring system housing (26), arranged substantially along the horizontal plane of the board, i.e., generally orthogonal and perpendicular to the central longitudinal axis (9).

[0105] The second annular wall (30) further defines a chamber housing (36) via a cross wall (31) for a biasing device (37) (e.g., a compression spring) that pushes the cross wall (31) located proximal to the second annular wall (30) and is constrained by a retaining block (38) located proximal to the chamber (36). Compression of the biasing device (37) causes the cross wall to bend distally. The cross wall (31) is positioned distally to the second annular wall (30) by a snap-fit ​​or snap-fit ​​protrusion that inserts into a corresponding groove provided in the second annular wall (30). The biasing device (37) also serves as a damper for the injection monitoring system (25), preventing movement from the first monitoring position under digital pressure of the start button on the cap after dose selection. The interaction of the compression spring (optionally assisted by a flexible cross wall) suppresses the initial acceleration of the injection monitoring system (25) upon contact with the start button (10) on the injection pen (2). Given that the distance between the first injection monitoring position and the second injection monitoring position can be very small, for example, only a few tenths of a millimeter to a few millimeters depending on the size of the injection pen, the biasing device can not only adapt to the changes in axial geometry and molding tolerances of various components of various pens, but also help to detect the increase in magnetic norm when the magnetometer (34) in the injection monitoring system (25) moves along the central longitudinal axis (9) toward the magnet (18, 19) as the magnetic norm increases.

[0106] The injection monitoring housing (26) also includes a third annular wall (39) extending from the base wall (27) toward the distal end of the hollow body (11). The third annular base wall (36) provides further axial stability to the injection monitoring housing (26), particularly in the first monitoring position and during activation of the starter button (10), in other words, during the injection and / or discharge of material from the injection pen system (2), and during the return of the injection monitoring housing (26) from the second position to the first position, and is sized to be surrounded and guided by the inner circumference at the proximal end (13) of the hollow body (11).

[0107] Figure 3 and Figure 4The various components of the rotation stop device are shown, configured to prevent the injection monitoring system from rotating about the central longitudinal axis (9) during dose setting. The rotation stop device includes a rotation-fixed connector disposed parallel to the central longitudinal axis (9). The rotation-fixed connector connects the injection monitoring system (25) to the pen body (3) of the injection pen system (2), as described below. The rotation-fixed connector prevents the injection monitoring system (25) from rotating about the central longitudinal axis (9) not only during dose setting or dispensing, but more generally during the translation of the injection monitoring system (25) from a first monitoring position to a second monitoring position and then back from the second monitoring position. In this way, it is ensured that the injection monitoring system (25) will not rotate, whether accidentally or intentionally, especially during dose selection or dispensing, as such rotation is a source of incorrect dose determination. The rotation stop device is also configured to allow the injection monitoring system to move from a first injection monitoring position to a second injection monitoring position and vice versa during injection, i.e., a translational movement from the second injection monitoring position to the first injection monitoring position, while being adapted to hold the rotating block. As can be clearly seen from the foregoing description, the rotation stop device thus physically prevents the injection monitoring system (25) from rotating about the central longitudinal axis (9), while providing a translational guide system corresponding to the injection monitoring system (25) that allows translation in both distal and proximal directions.

[0108] The rotary fixed connector includes at least one extension rod member (40, 41) or multiple extension rod members (40, 41), such as Figure 3 , Figure 4 As shown in Figure 5, it extends distally from the injection monitoring system, parallel to the longitudinal axis and across the outer surface of the hollow body (11). Although the presence of two extension rod members is shown in the figure, the rotary fixed connector may also include only one extension rod member in place.

[0109] The rotary fixed connector also includes a sheath member (42), which is, for example, coaxially mounted on the pen body (3) of the injection pen system (2) about the pen body (3), for example, by sliding the sheath member (42) onto the pen body (3) and mounting it along the pen body (3). During the translational movement of the injection monitoring system (25) from a first monitoring position to a second monitoring position, the sheath member (42) is adapted to be configured to receive at least one (or a plurality of extension rod members (40, 41) that are slidably engaged with the sheath member (42).

[0110] Therefore, when the injection monitoring system (25) moves from the first injection monitoring position to the second injection monitoring position, and vice versa, that is, when it moves back from the second injection monitoring position to the first injection monitoring position, the extension rod member (40, 41) and the corresponding sheath (42) cooperate with each other, such that the extension rod member (40, 41) slides into the sheath member (42). The sliding engagement between the extension rod member (40, 41) and the sheath member (42) occurs substantially parallel to the central longitudinal axis (9).

[0111] At least one or more extension rod members (40, 41) extend distally from the injection monitoring system (25), i.e., proximally away from the pen system (25) and the injection monitoring module (1), and parallel to the central longitudinal axis (9). The rod member (40) or the rod members (40, 41) are further located outside the outer surface of the hollow body (11) and are shaped and sized to extend beyond the hollow body (11) so as not to interfere with the dose setting function of the hollow body (11). This means that the hollow body (11) can rotate without obstruction by the extension rod members (40, 41), thereby allowing the hollow body (11) to rotate and the dose setting wheel (6) to rotate in the same direction, thus enabling dose setting on the pen system. Similarly, if the manufacturer of the injection pen system has configured the pen to work in this manner, the shape and size of the extension rod member (40) or extension rod member (40, 41) are configured to be adjusted such that one or more rod members do not interfere with any optional rotation of the dose setting wheel during injection.

[0112] The extension rod members (40, 41) have a proximal end located or fixed within a portion of the injection monitoring system housing (26), for example, by providing an enlarged proximal cross-section at the proximal end of the extension rod members (40, 41) and by having a correspondingly shaped groove that provides a reduced cross-sectional outlet diameter in the injection monitoring system housing (26), thereby preventing the extension rod members (40, 41) from being pulled out of the housing (26). Alternatively, at least one or more extension rod members (40, 41) are preferably integrally formed with the injection monitoring system housing (26), particularly with the activation cover (29) of the injection monitoring system housing (26). The cover (29) is correspondingly configured and sized such that it extends beyond the nominal diameter of the hollow body (11). In this way, the extension rod members (40, 41) can extend freely from the cover (29) toward the distal end parallel to the central longitudinal axis (9) and pass over the hollow body (11) without touching or contacting it.

[0113] At least one or more extendable rod members (40, 41) also include at least one portion that defines an elliptic spline parallel to the central longitudinal axis (9) extending distally from the cap (29). The “elliptic spline” shape of the extendable rod member facilitates the rod’s contactless passage around the relatively increased diameter of the hollow body, while reducing the need to increase the diameter of the injection monitoring system housing (26). Thus, when the injection monitoring system (25) moves from the first monitoring position to the second monitoring position and then back again, the spline portion of the extendable rod member (40, 41) is configured to maintain a sufficient distance between the extendable rod member (40, 41) and the hollow body (11) and the pen body (3), so that the extendable rod member (40, 41) preferably never comes into contact with the outer surface (4) of the pen body of the injection pen system.

[0114] The extension rod members (40, 41) are further dimensioned with appropriate thicknesses, for example, of a corresponding material, such that the extension rod members (40, 41) are semi-rigid along their length. Suitable materials for the extension rod members are, for example, semi-rigid plastic materials, such as mixtures of polycarbonate (PC) and acrylonitrile-butadiene-styrene (ABS) copolymers, commonly referred to as PC / ABS mixtures. Other suitable polymers and polymer mixtures providing appropriate rigidity are generally known to those skilled in the art; therefore, the extension rod members can be made or constructed from any such suitable rigid material.

[0115] The sheath member (42) includes a generally elongated and flat body (43) that extends parallel to and generally surrounds the outer surface (4) of the pen body (3). The sheath member (42) also includes at least one flow channel (44) or multiple flow channels (44, 45) configured and adapted to receive at least one or more extension rod members (40, 41) in a sliding engagement manner. The at least one or more flow channels (44, 45) also extend parallel to the central longitudinal axis (9). The flow channels (44, 45) of the sheath member (42) are axially aligned with the extension rod members (40, 41) such that the rod members (40, 41) are inserted into the flow channels and received by the flow channels (44, 45) during the mounting of the injection monitoring module (1) onto the injection pen system (2). The flow channel (44) or flow channels (44, 45) are typically shaped and sized as grooves having sidewalls (46, 47), a base (48), and forming an opening. The base (48) and sidewalls (46, 47) of the groove are located on the lower surface (49) of the sheath member (42). When the sheath member (42) is mounted on the injection pen body (3), the opening of the flow channel (44, 45) faces the pen body (3) of the injection pen system (2).

[0116] To properly position the sheath member (42) on the outer surface (4) of the pen body (3) of the injection pen (2), the sheath member also includes a pen body mounting portion (50) configured to allow the sheath member to be detachably mounted to the pen body (3) of the injection pen system (2). The pen body mounting portion (50) thus includes a material wall (51), the material being, for example, a plastic or polymeric material, such as polycarbonate (PC), acrylonitrile-butadiene-styrene (ABS) copolymer, or a mixture referred to as a PC / ABS mixture. Thus, the wall (51) extends circumferentially around the pen body (3) of the injection pen system (2) and is sized to allow the pen body to be inserted into a hole (52) formed by the circumferentially extending wall (51), while simultaneously engaging with the outer surface (4) of the pen body (3) through the appropriate size of the hole (52). Advantageously, the circumferential extension wall (51) has a softer, more elastic wall portion (53), for example made of elastic SEBS or a similar elastic polymer, for engaging and securing with the corresponding surface portion (4) of the pen body (3) of the pen (2) to prevent any unwanted axial sliding movement of the pen within the hole (52) of the circumferential extension wall (51).

[0117] The sheath component may also be configured with a fixing bridge (54) configured and adapted to secure at least one or more extension rod components (40, 41) respectively in at least one or more corresponding flow channels (44, 45). When the injection monitoring module (1) is mounted on the injection pen (2), the fixing bridge (54) is typically located on the underside of the body (43) of the sheath component (42) in contact with the outer surface (4) of the pen body (3) of the injection pen system (2). When the injection monitoring system (25) moves from a first monitoring position to a second monitoring position and then returns, the fixing bridge (54) serves to hold the extension rod components (40, 41) in the corresponding flow channels (44, 45). The fixing bridge (54) may be integrally formed as part of the body (43) of the sheath component (42), or alternatively, may be provided as an insertable fixing block, for example by snap-fit ​​mounting or ultrasonic welding at a corresponding position on the lower surface (49) of the sheath relative to the opening of the corresponding flow channel (44, 45) configured to receive the fixing bridge. In such a configuration, the fixed sheath (54) will allow the lower surfaces (55, 56) of the extension rod members (40, 41) to slide onto the upper surfaces (57, 58) of the fixed bridge (54), and secure the rods (40, 41) within the corresponding channels (44, 45) of the sheath member (42). Alternatively, the fixed bridge (54) can be formed by suitable shaping of the channels (44, 45), for example by providing one or more mutually positioned protrusions or shoulders to the channels (44, 45) extending from a first inner wall surface (46) of the channel toward an opposing second inner wall surface (47) of the channel, and optionally extending along at least a portion of the length of the channels (44, 45). When the injection monitoring system (25) moves from the first position to the second position, and vice versa, when the extension rod members (40, 41) slide along the flow channel (44, 45) parallel to the central longitudinal axis (9), the fixed bridge (54) prevents the extension rod members (40, 41) from accidentally falling out of the flow channel (44, 45).

[0118] The rotary fixed connector also includes a detachable link (59) configured to temporarily position the sheath member (52) and at least one or more extension rod members (40, 41) at predetermined intervals along an axis parallel to the central longitudinal axis (9) during the mounting of the injection monitoring module (1) on the pen body (3) of the injection pen system (2). During the mounting of the monitoring module (1) on the injection pen system (2), the detachable link, as a single mountable unit, connects the injection monitoring system (25) with the protruding extension rod members (40, 41) and sheath member (42) to the hollow body (11) and maintains it in a predetermined spatial relationship to prevent accidental and undesirable axial displacement of the monitoring module (1) when the hollow body (11) is mounted on the dose setting wheel (6) of the injection pen system (2). Accordingly, the detachable link is configured to engage and secure with a portion of the injection monitoring system housing (26) and a portion of the sheath member (42).

[0119] Accordingly, the sheath member (42) and the injection monitoring system (25) each include grooves (60, 61) configured to receive a portion of the removable link and engage with it in a temporary positioning relationship. The groove (60) of the injection monitoring system is located in the peripheral region of the cap (29), while the groove of the sheath member is located in the proximal end of the body (43) of the sheath member (42). When the removable link (59) is inserted into the grooves (60, 61), the two grooves are parallel to the central longitudinal axis (9) and axially aligned with each other.

[0120] The detachable connecting rod (59) includes corresponding complementary shaped protrusions (62, 63), for example, to engage with corresponding grooves (60, 61) provided on the sheath member (42) and the injection monitoring system housing (26). Suitable complementary shapes may take the form of butterfly wings, with the wings (62, 63) extending to either side of a central body (64), which defines and extends into a predetermined space required to maintain the sheath member (42) and the injection monitoring system housing (26) in their respective positions when the injection monitoring module (1) is mounted on the injection pen system (2). The butterfly body (64) may also extend circumferentially around the injection monitoring housing (26) and elastically engage it with it in the manner of a clamp (or, for example, a spring clamp). The elastic engagement with the injection monitoring system housing (26), and the butterfly wings (62, 63) engaging with the corresponding grooves (60, 61) of the sheath member (42) and the housing (26) respectively, prevent accidental axial movement of the housing (26), thereby avoiding any accidental erroneous readings triggered in the injection monitoring system (25). Once the injection monitoring module (1) is mounted on the pen (2) and the hollow body (11) is correctly positioned on the dose setting wheel (6), the removable link (59) is detached. For example, for ease of reuse, when the injection monitoring module (1) is removed from the injection pen system (2), the removable link (59) is conveniently stored in a corresponding groove (65, 66, 67) at another location on the sheath member (42), for example on or near the mounting portion (51) of the sheath member (42), wherein the groove (65) will have a diameter sufficient to retain the removable link (59) but allows it to be removed when needed.

[0121] Figure 3 , Figure 5A , Figure 5B Another specific aspect of the injection monitoring module (1) is shown, in which an optical sensor (68) is present, serving as a suitable example of a non-contact sensor. The optical sensor (68) is located on the injection monitoring system housing (26), adjacent to at least one or more extension rod members (40, 41), and as shown... Figure 3As shown, the optical sensor is suitably located in the activation cover (29) portion of the housing (26). In this embodiment, the optical sensor (68) is located between the two extension rod members (40, 41) so as to receive reflected light from a corresponding and suitable reflective surface (69) located near the proximal end of the body (43) of the sheath member (42). Thus, the positioning of the optical sensor (68) and the reflective surface (69) allows reflected light from the reflective surface (69) to propagate to the optical sensor (68). The optical sensor (68) is suitably configured, for example, to determine the distance that the optical sensor (68) and thus the predetermined reference position in the injection monitoring system (25) has moved parallel to and along the central longitudinal axis, based on the intensity of the reflected light and / or the time it takes for the reflected light to travel along a path between the reflective surface (69) and the optical sensor (68). Therefore, the optical sensor (68) is suitably equipped with a light source, for example, that can be provided by a light-emitting diode. Regarding the function and operation of such an optical sensor, the optical sensor (68) may also be equipped with a focusing or diffusing system for such a light source, as is known in the art; and a power supply for the light source, as is known in the art, depending on the characteristics of the reflective surface (69).

[0122] In operation, after the monitoring module (1) is mounted on and correctly positioned on the body (1) of the injection pen, the monitoring module (1) operates as briefly described below. The detachable connecting rod (59), which initially holds the hollow body, injection monitoring system, extension rod components (40, 41), and sheath component (42) together, is removed and optionally placed in the corresponding recesses (65, 66, 67). The dose is set by rotating the hollow body, causing the dose setting wheel to rotate. Since the extension rod components (40, 41) are already engaged in the flow channel of the sheath component (42), the injection monitoring housing (26) is prevented from rotating within the hole (12) of the hollow body. The monitoring system (25) then receives only the signal from the magnetometer corresponding to the actual dose selected by rotating the dose setting wheel (6). Without the rotation lock provided in the injection monitoring module of this invention, unintentional relative rotation could lead to errors in these readings, requiring supplemental corrective measures to attempt to determine whether the dose dispensed is the actual dose selected. The set or dispensed dose has been verified by the processing unit as the selected dose. The monitoring system now determines whether the injection operation has begun, i.e., whether the injection monitoring system has begun to translate along the central longitudinal axis (9) from the first monitoring position to the second monitoring position. This is achieved by the magnetometer sending a signal of increasing magnetic norm to the processing unit, as the increase in magnetic norm is closely related to the movement of the magnetometer toward the magnet. In this way, the monitoring system knows that the injection operation has begun. In an injection pen that rotates the dose wheel during injection, the magnetic field vector value captured by the magnetometer can be similarly used to calculate the injection endpoint.

[0123] However, in pens where the dosage setting wheel does not rotate, it is typically impossible to know when the injection has ended, as the user may allow the injection monitoring system (25) to contact the injection start button (10) of the pen (2) for an indeterminate period of time, or barely touch the start button (10). Therefore, measuring time at the second monitoring position could potentially be riddled with errors requiring correction. Thus, in such a configuration, an optical sensor is used to provide a reference point for the injection monitoring system, thereby determining when the injection monitoring system returns from the second monitoring position to the reference point of the first monitoring position, thus emitting an injection endpoint signal.

[0124] Therefore, as can be understood from the preceding content, the current injection monitoring module is able to determine, in a significantly more efficient manner than before, whether the dose dispensed is indeed the selected dose, the start point of injection, and the end point of injection.

Claims

1. An injection monitoring module adapted to be detachably mounted to the proximal end of an injection pen system for drug delivery, the injection pen system having a pen body, a dose setting wheel located proximally connected to the pen body, and an injection initiator, the dose setting wheel rotating about a central longitudinal axis of the injection pen system during dose setting, wherein the injection monitoring module includes: A hollow body adapted to be coaxially mounted on the dose setting wheel at the proximal end of the injection pen system and configured to co-rotate with the dose setting wheel at the proximal end of the injection pen system, the hollow body including a central longitudinal hole having a proximal end, a distal end, and a central longitudinal axis; A magnetic field generating device, the magnetic field generating device being located on or inside the hollow body, the magnetic field generating device being located near the proximal end of the central longitudinal hole; An injection monitoring system includes at least one or more magnetic field sensors. The injection monitoring system is located at the proximal end of the hollow body and moves from a first monitoring position to a second monitoring position along the central longitudinal axis within the hole of the hollow body. The injection monitoring system is not in adjacent contact with the proximal surface of the injection initiator at the first monitoring position, and is in adjacent contact with the proximal surface of the injection initiator at the second monitoring position. The injection monitoring module further includes a rotation stop device configured to prevent the injection monitoring system from rotating about the central longitudinal axis during dose selection. The rotation stop device includes a rotation fixing connector arranged parallel to the central longitudinal axis, which connects the injection monitoring system to the pen body of the injection pen system. The rotary fixed connector includes: At least one or more extension rod members, said at least one or more extension rod members being parallel to the longitudinal axis, extending distally from the injection monitoring system and crossing the outer surface of the hollow body; and A sheath member, mounted on the pen body of the injection pen system, the sheath member being adapted to receive the at least one or more extension rod members in a sliding engagement manner during translational movement of the injection monitoring system from the first monitoring position to the second monitoring position.

2. The injection monitoring module according to claim 1, wherein, The rotation stop device is also configured to allow the injection monitoring system to move from the first monitoring position to the second monitoring position during injection, and vice versa, to move from the second monitoring position to the first monitoring position after injection is completed.

3. The injection monitoring module according to claim 1, wherein, The at least one or more extension rod components are integrally formed with the support of the injection monitoring system.

4. The injection monitoring module according to claim 3, wherein, The at least one or more extension rod components are integrally formed with the cover of the injection monitoring system bracket.

5. The injection monitoring module according to any one of claims 3-4, wherein, The at least one or more extension rod components include at least a portion of the extension rod component, the at least a portion defining an elliptical spline parallel to the central longitudinal axis and extending distally from the injection monitoring system.

6. The injection monitoring module according to any one of claims 3-4, wherein, The sheath member includes at least one or more flow channels configured to receive the at least one or more extension rod members in a sliding engagement manner.

7. The injection monitoring module according to claim 6, wherein, The at least one or more flow channels extend parallel to the central longitudinal axis.

8. The injection monitoring module according to claim 6, wherein, The sheath component also includes a pen body mounting portion configured to allow the sheath component to be detachably mounted to the pen body of the injection pen system.

9. The injection monitoring module according to claim 6, wherein, The sheath member further includes a fixing bridge configured to fix at least one or more corresponding extension rod members in at least one or more corresponding flow channels.

10. The injection monitoring module according to claim 1, wherein, The rotary fixed connector also includes a detachable link configured to temporarily position the sheath member and the at least one or more extension rod members at predetermined intervals along an axis parallel to the central longitudinal axis during the installation of the injection monitoring module on the pen body of the injection pen system.

11. The injection monitoring module according to claim 10, wherein, The sheath component and the injection monitoring system each further include a groove configured to receive a portion of the detachable link and engage with a portion of the detachable link in a temporary positioning relationship.

12. The injection monitoring module according to claim 1, wherein, The hollow body also includes a translation stop device, which is configured to prevent the hollow body from axially translating along the central longitudinal axis when the injection monitoring module is located at the installation position on the injection pen system.

13. The injection monitoring module according to claim 12, wherein, The translational stop device of the hollow body includes an annular flange that extends longitudinally from the inner surface of the hollow body into the hole.

14. The injection monitoring module according to claim 13, wherein, The hollow body also includes a distal body portion, which extends around the outer surface of the dose setting wheel and frictionally engages with the dose setting wheel.

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

16. The injection monitoring module according to claim 1, wherein, The injection monitoring module also includes an injection completion determination device.

17. The injection monitoring module according to claim 15, wherein, The injection start determination device includes an optical sensor and a corresponding reflective surface.

18. The injection monitoring module according to claim 16, wherein, The injection completion determination device includes an optical sensor and a corresponding reflective surface.

19. The injection monitoring module according to claim 17 or 18, wherein, An optical sensor is located on the injection monitoring system and is adjacent to the at least one or more extension rod components.

20. The injection monitoring module according to claim 17 or 18, wherein, The reflective surface for the optical sensor is located on the sheath member and is opposite to and aligned with the optical sensor on the injection monitoring module.

21. The injection monitoring module according to claim 17 or 18, wherein the injection monitoring system further comprises an electronic component board and at least one microcontroller, the at least one microcontroller being electrically connected to the one or more magnetic field sensors.

22. The injection monitoring module according to claim 21, wherein, The at least one microcontroller is electrically connected to the optical sensor.

23. The injection monitoring module according to claim 22, wherein, The electronic component board includes a communication unit electrically connected to the at least one microcontroller.

24. The injection monitoring module according to claim 22, wherein the electronic component board includes an autonomous power supply.

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