Injection Monitoring Module

Abstract

To provide an injection monitoring module which is adapted and configured to be removably fitted to a proximal end of an injection pen system for delivering medicine.SOLUTION: A monitoring module includes: a hollow body which is coaxially fitted to a dosage setting wheel of a pen-type injection system and rotates and engages with the same; a longitudinal direction central cavity having a proximal end and a distal end; and an injection monitoring system located at the proximal end in the cavity. The injection monitoring system is movable inside the cavity along a central axis in the longitudinal direction from a first monitoring location where an injection monitoring system does not contact a proximal surface of an injection operation device of the injection pen system to a second monitoring location where the injection monitoring system contacts the proximal surface of the injection operation device.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] FIELD OF THE INVENTION The present invention relates generally to monitoring systems for injectable drug delivery devices, and more particularly to injection monitoring for injection pen systems.

[0002] Injection monitoring is a well-known field in the context of injectable drug delivery devices, particularly with regard to injection systems, for example. Over time, such monitoring systems have recently been introduced into injection pen systems for delivering drugs in an attempt to enable users of such pen injection systems and healthcare professionals involved in the treatment and follow-up of such patients to monitor their injection regimes and, in many cases, the actual dose administered, in a more detailed manner, leading to better medical outcomes. These developments have been accompanied by the increasing use of associated software and portable communication devices, such as tablets or smartphones, that are programmed to receive information from and interact with the monitoring system in order to provide information to users and healthcare professionals, either on the fly or at regular intervals, via a suitable communication unit included in the monitoring system.

[0003] One challenge, particularly with regard to pen injectors, is to provide an easy-to-use, reliable, and highly fail-safe system that can be adapted to the various different variations of such commercially available pen injectors (of which there are many). Previous attempts to provide such monitoring systems have typically required adapting the pen injector body by incorporating electronic components along with one or more sensors. However, one major drawback of such systems is that the final product, which integrates all the electronic components at once, tends to be very bulky and cumbersome, and therefore more difficult to use from the user's perspective. Additionally, such conversion systems tend to be highly specific to a particular brand or manufacturer, and therefore have little or no usability with other manufacturers. Furthermore, to address the bulkiness and cumbersomeness of modified pen injectors, there is a tendency to attempt to minimize the overall volume of the injection pen body as much as possible by miniaturizing complex electronic components, but doing so presents its own problems, particularly issues related to electromagnetic interference between the various components due to the proximity of circuits providing the required or desired integrated functionality. In such monitoring systems, moving the sensor further away from sources of electromagnetic interference only complicates the problem, potentially leading to erroneous measurements, or requiring additional systems to compensate for the sensor's physical separation from other electronic components (e.g., microcontrollers designed to control, command, and manage the interactions between the various components).

[0004] The pen injectors discussed are well known and typically include a proximally located dose setting wheel and an injection actuator, the latter rotatable about the pen injector's central longitudinal axis. The wheel is rotated by the user to select a dose of medication to be administered. The pen is typically configured mechanically or electromechanically to perform an injection upon activation of the injection actuator. Such an injection actuator is typically a simple press or push button that is in mechanical or electrical contact with a discharge mechanism located within the pen injection system. Pressing this button activates the injection mechanism, injecting the medication contained within the pen injection system. In some pen injector systems, the dose setting wheel is configured to rotate not only during dose setting but also during injection. This is achieved by including one or more metal components, such as a helically wound drive spring, located within the injection pen system housing and physically coupled to the dose setting wheel. Because such metallic elements are relatively large objects compared to the electronic systems found in many pen injectors today, such large metallic objects can further disrupt the signals that the sensors in such electronic systems are designed to capture and pick up, potentially reducing the accuracy of the system and / or requiring the implementation of complex correction mechanisms to avoid calculation errors.

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

[0006] For example, published PCT patent application WO2014128156A1 relates to a sensor assembly having a first rotary sensor component having a plurality of discrete conductive sensor regions arranged in a pattern and a second rotary sensor component rotatably disposed relative to the first component, the sensor assembly including a plurality of contact structures adapted to contact the conductive sensor regions on the first rotary sensor component. The contact structures are configured to engage and connect with different sensor regions as the first and second components of the rotary sensor rotate relative to each other, with the formed connection indicating a rotational position between the first and second components. One of the contact structures is an actuatable contact structure axially movable relative to the first component, and has a connected position in which the actuatable contact structure contacts the sensor regions and a disconnected position in which the actuatable contact structure does not contact the sensor regions. The system is housed within the pen injector body and at least partially housed within the space within the dose setting wheel. The system also includes a visual display, such as an LCD display, located on or in place of the injection activation button.

[0007] In comparison, published PCT application WO2018013419A1 relates to a dose detection system including a dispensing member attached to an actuator and rotationally and axially movable relative to a coupling member attached to a dose setting member, the dose detection system comprising a module including an electronic sensor operative to detect relative rotation between the coupling member and the dispensing member and to detect a dose delivered by the drug delivery device. The dose detection module is removably coupled to the proximal end of the pen injection system and, while attached to the pen injection system, is intended to serve as a means for detecting the amount of drug dispensed by the pen injection system, 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 translatable cylinders that interact with each other via electrical contacts on the cylinder surfaces to indicate various states or positions of the injection administration process, including dose setting, the electrical contacts being connected to a collection of electronic components housed on a flexible printed circuit board. The printed circuit boards are arranged in an accordion-style configuration with overlapping folds within the removable assembly, with electrically non-conductive spacer layers insulating the overlapping layers of the circuit boards to prevent potential electrical, electronic, and electromagnetic interference.

[0008] It is readily apparent from the above-described configuration that, despite the use of a folded flexible printed circuit board to provide multiple surfaces on which the electronic components are located, their relative spatial density and position relative to one another necessitates the use of non-conductive spacers between layers of electronic components, which directly results in an increased height of the module and necessarily increases the complexity of the clip-on dose detection module described therein.

[0009] It is therefore one object of the present invention to provide an injection monitoring module adapted and configured to be removably attached to the proximal end of an injection pen system for delivering a drug, the injection pen system having a rotatable dose setting wheel for setting the dose of drug to be injected, said dose setting wheel also rotating during injection, said injection monitoring module being of a much simpler configuration while at the same time eliminating the need for complex shielding or protection solutions to counteract unwanted electrical, electronic or electromagnetic effects caused by the relatively high density of electronic components within the monitoring module.

[0010] Another object of the present invention is to provide an injection monitoring module as above, said module being adapted and configured to detect an injection endpoint in a pen system having a rotary dose setting wheel that rotates during injection. For the purposes of the present invention, the expression "injection end point" as used herein does not only mean the completion of injection of a dose of an injectable substance, such as a drug (when the user injects the required dose of the injectable substance in one actuation), but also includes any amount of drug actually released by the pen injection system when the injection monitoring module is attached to the pen injection system. This means that when a user performs a series of small, repeated injection acts, for example by successively repeating actuations of the injection actuator, a corresponding end point is registered for each injection step, and a corresponding amount of injectable substance calculated to have been injected or released from the pen injection system is registered.

[0011] These and other objects of the present invention will become readily apparent from a complete reading of this specification.

[0012] Therefore, in accordance with any of the above objects, there is provided an injection monitoring module adapted and configured to be removably attached to a proximal end of an injection pen system for drug delivery, the injection pen system comprising a proximally disposed dose setting wheel and an injection actuator, the dose setting wheel being rotatable about a central longitudinal axis of the pen injection system during dose setting and during injection, the injection monitoring module comprising a hollow body and an injection monitoring system; the hollow body is adapted and configured to be coaxially mounted to, and to rotate and engage with, the dose setting wheel at the proximal end of the pen injection system; the hollow body includes a longitudinal central lumen having a proximal end and a distal end; the injection monitoring system is disposed within a central longitudinal cavity of the body at a proximal end thereof and extends proximally along the longitudinal axis beyond the proximal end; The injection monitoring system is movable within the longitudinal central cavity of the body along the longitudinal central axis from a first monitoring position to a second monitoring position, wherein in the first monitoring position the injection monitoring system is not in contact with the proximal surface of the injection actuator, and in the second monitoring position the injection monitoring system is in contact with the proximal surface of the injection actuator.

[0013] As used herein, the terms "pen injection system" and "injection pen system" are used interchangeably to refer to a typical handheld pen injection system, which is readily familiar and commercially available for use in treating many different medical indications. These systems are typically designed for self-injection of medication by a user in need of treatment for a given medical indication. This is the case, for example, with insulin for the treatment of diabetes, such as the Lantus® and SoloSTAR® brand injectors from Sanofi-Aventis. However, other medications also fall into this category, and it is common for patients suffering from or susceptible to such conditions to carry these devices to provide immediate emergency injection of necessary medications (e.g., anaphylactic shock medications, anticoagulants, opioid receptor agonists and antagonists, etc.) in potentially life-threatening situations.

[0014] An injection pen system adapted for and configured to removably mount an injection monitoring module according to the present invention includes a proximally disposed dose setting wheel and an injection actuator. The dose setting wheel rotates about the central longitudinal axis of the pen injector, allowing the user to set the dose of medication to be injected. The dose setting wheel is typically rotatable both clockwise and counterclockwise, which typically correspond to increasing and decreasing the selected dose to be administered, respectively. The injection actuator is often a push button. When a user of the injection system presses the injection actuator distally, a piston connected to a plunger is actuated to expel medication from a chamber in the injection pen body through a needle inserted by the user into an appropriate injection site (e.g., skin, fatty tissue, muscle, etc., depending on the type of medication to be administered). The dose setting wheel is coupled to an injection drive mechanism, which causes the dose setting wheel to also rotate as the medication is injected. The function of such injection systems is per se well known in the art.

[0015] The injection monitoring module according to the present invention is therefore adapted and configured to be removably attached to the proximal end of such an injection pen system. The terms "removably attached" or "removably attachable" as may be used herein should be understood to refer to the possibility of attaching and subsequently detaching the injection monitoring module, for example, when transferring the injection monitoring module to another pen injection system, or, for example, if the monitoring module is damaged during use and requires replacement. Such attachment and subsequent detachment may be achieved by providing the monitoring module with coupling means for releasably engaging the proximal end of the pen injection system, for example, via frictional or elastic engagement or other releasable fastening means such as a clip, strap, screw thread and corresponding fastening ring, with either the dose setting wheel or the injection actuator, or both.

[0016] In view of the above, therefore, the removably attached injection monitoring module comprises a hollow body adapted and configured to be coaxially mounted to, rotate with and engage a dose setting wheel at the proximal end of the pen injection system.

[0017] The hollow body of the injection monitoring module comprises a longitudinal central lumen having a proximal end and a distal end. The distal end of the lumen is preferably configured and dimensioned to resiliently engage, e.g., via friction, and surround the outer surface of the dose setting wheel of the pen injection system, such that rotation of the hollow body in turn rotates the dose setting wheel in the same direction and to substantially the same or identical degrees of rotation, and conversely, rotation of the dose setting wheel also rotates the hollow body. In this manner, the hollow body is said to rotate together with the dose setting wheel. The hollow body is suitably made of any suitable material, such as a durable polymer or plastic material. Advantageously, the hollow body is made of a transparent, translucent, or opaque material, so that the user can grasp and recognize any visual cues, such as light-emitting diodes, that can optionally be used to indicate various operating states of the injection monitoring system.

[0018] The injection monitoring module also includes an injection monitoring system disposed within the central longitudinal lumen of the body at its proximal end and extending proximally along the longitudinal axis beyond the proximal end. The injection monitoring system is described in more detail below, but essentially includes a number of different components and means for providing monitoring of the injection status, for example: -Start of injection procedure. - Completion of an injection operation (wherein completion of an injection operation is understood to include both the administration of the entire selected dose of the substance to be injected, or a discontinuous injection operation in which the user injects only a portion of the dose or causes a portion of the selected dose to be expelled from the pen injection system).

[0019] Further in accordance with the present subject matter, the injection monitoring system is movable within the central longitudinal cavity of the body along the central longitudinal axis from a first monitoring position in which the injection monitoring system is not in contact with the proximal surface of the injection actuator to a second monitoring position in which the injection monitoring system is in contact with the proximal surface of the injection actuator.

[0020] From the foregoing, it will be appreciated that the injection monitoring system is movable from an initial position in which there is no physical contact between the monitoring system and the actuator button to a different position in which physical contact is established between the monitoring system and the proximal face of the injection actuator, such movement generally being a translational movement of the monitoring system from a first position to a second position along the central longitudinal axis within the lumen of the hollow body.

[0021] According to another object of the present invention, the monitoring module of the present invention comprises a magnetic field generating means, of which various means are known, such as classical magnets, electromagnets, mixed material magnets, etc. Such magnets are usually made from magnetizable materials with magnetic or paramagnetic properties, which generate or induce a magnetic field in the material either naturally or when an electric or other current is passed through or acts on the material. Suitable materials can be selected from the following: - Ferrite magnets, especially sintered ferrite magnets containing a crystalline compound of iron, oxygen and strontium. -A composite material consisting of a thermoplastic matrix and isotropic neodymium-iron-boron powder. - A composite material made of a thermoplastic resin matrix and strontium-based hard ferrite powder, where the resulting magnet can contain isotropic, i.e., non-oriented ferrite particles, and anisotropic, i.e., oriented ferrite particles. -A composite material made of a thermosetting plastic matrix and isotropic neodymium-iron-boron powder. - Magnetic elastomers, for example, produced by highly filling strontium ferrite powder and mixing it with synthetic rubber or PVC, followed by extrusion into the desired shape or calendering into fine sheets. -A flexible, calendered composite material, generally appearing as a brown sheet, with more or less flexibility depending on its thickness and composition. These composites are not rubber-like in elasticity and tend to have a Shore hardness in the ANSI Shore D range of 60-65. Such composites are typically formed from synthetic elastomers filled with strontium ferrite particles. The resulting magnets can be anisotropic or isotropic, with the various sheets typically having magnetic particle alignment dependent on the calendering process. - A laminated composite material, typically comprising a flexible composite material as described above, with soft iron plates laminated together. -Neodymium-iron-boron magnets. -Made from an aluminum-nickel-cobalt alloy and magnetized steel. -An alloy of samarium and cobalt.

[0022] Of the above list of magnetic field generating means suitable for use in the present invention, those selected from the group consisting of neodymium-iron-boron permanent magnets, magnetic elastomers, composites made from a thermoplastic matrix and a strontium-based hard ferrite powder, and composites made from a thermosetting plastic matrix and an isotropic neodymium-iron-boron powder are preferred. Such magnets are known for their ability to be sized to relatively small sizes while maintaining relatively high magnetic field strengths.

[0023] The magnetic field generating means may be of any suitable general shape, for example a disk shape including a circle, an ellipse or any other suitable polygon, but preferably has only a single dipole, with a pair of diametrically opposed north and south magnetic poles. The magnetic field generating means may be substantially disk shaped, but such a disk shape may include a magnet having an orifice substantially in the center of the disk, forming a ring or annular magnet.

[0024] According to one advantageous aspect of the present invention, the magnetic field generating means comprises two diametrically aligned single dipole magnets that cross the diameter of the hollow cavity at opposite positions on the diameter and are aligned substantially along the circumference of the cavity. As used herein, the terms "alignment" or "aligned" mean that the poles of the magnets are aligned along the longitudinal axis of each magnet. Such a configuration can be achieved, for example, by using a rod-shaped or cylindrical magnet having first and second ends, with the first pole located substantially at the first end and the second and opposite pole located at the second end of the rod-shaped magnet. Furthermore, each magnet is positioned at opposite positions on the circumference of the hollow cavity, such that the rod is longitudinally aligned with one end relative to the other end. The magnetic poles of each magnet may be arranged end to end in opposition to the other, for example in a NS / SN arrangement or an SN / NS arrangement, but preferably and advantageously the magnetic poles are arranged in a repeating configuration, with the poles aligned in a NS / NS arrangement or an SN / SN arrangement.

[0025] In a further object of the present invention, the magnetic field generating means is accommodated in the cavity of the hollow body so as to be immovable about the central longitudinal axis. Here, the term "immovable" may be understood to mean that the magnetic field generating means is arranged in a fixed position along the central longitudinal axis relative to the cavity of the hollow body, which also means that the magnetic field generating means does not undergo any longitudinal translational movement within the injection monitoring module. For example, the magnetic field generating means may be arranged in or incorporated into the material forming the hollow body, having the effect of generating a magnetic field that extends at least partially within the cavity of said hollow body.

[0026] Alternatively, and advantageously according to yet another object of the present invention, the magnetic field generating means is integrated into, inserted into or otherwise introduced into a separate magnetic field generating means support, which support is advantageously configured and dimensioned to form a disk or annular disk (i.e. a disk configured to form a disk with a hole substantially in its center). The annular disk is introduced into the cavity of the hollow body and positioned therein, coaxially aligned with the longitudinal central axis and in a fixed longitudinal position. When formed as an annular disk, the disk advantageously protrudes radially inwardly into the cavity from the inner circumferential surface of the cavity, forming a narrowing of the cavity diameter at the radially innermost end of such protrusion.

[0027] It will be appreciated that when the magnetic field generating means is immovably arranged (i.e. immovable in terms of longitudinal translation) within the lumen of the hollow body, for example in the manner and configuration described above, the magnetic field generating means nevertheless maintains a degree of freedom relative to the hollow body and its central longitudinal axis, allowing it to rotate together with said hollow body, albeit about a fixed longitudinal position. This means that when either the dose setting wheel or the hollow body rotates, the magnetic field generating means also rotates to the same extent about its central longitudinal axis.

[0028] According to another object of the present invention, the injection monitoring system is mounted in a selectively engageable and disengageable clutch assembly. As used herein, the term "clutch assembly" refers to an assembly configured to selectively move the injection monitoring system from a first engaged position to a second disengaged position, which in the context of the present invention correspond to the first monitoring position in which the injection monitoring system is not in contact with the proximal surface of the injection actuator and the second monitoring position in which the injection monitoring system is in contact with the proximal surface of the injection actuator, respectively. The concepts of "engagement," "engageable," "disengagement," and "disengageable" used herein are provided to facilitate understanding of how the clutch assembly functions with respect to the injection monitoring system mounted thereto and will be described in further detail below. One purpose of the clutch assembly is to provide a method or means by which longitudinal translation of the injection monitoring system along its central longitudinal axis can be achieved.

[0029] In accordance with yet another object of the present invention, a clutch assembly includes a first distal body and a second proximal body, and further includes a biasing member located between the first distal body and the second proximal body. The first and second bodies are physically connected or coupled to one another at appropriate locations on the first distal body and the second proximal body, for example, by ultrasonic welding. The first and second bodies are advantageously sized and configured to fit within the hollow cavity of the body and to be capable of translational movement therein along a central longitudinal axis.

[0030] According to yet another object of the present invention, a first distal body and a second proximal body of a clutch assembly are connected together along a central longitudinal axis via an elongated, hollow connecting member. In this configuration, the elongated, hollow connecting member forms a tube between the first distal body and the second proximal body. The connecting member can be integrally formed with either the first distal body or the second proximal body, or alternatively, can be partially integrally formed with both the first distal body and the second proximal body and be formed as a separate, hollow, elongated connecting member bonded to both the proximal end of the first distal body and the distal end of the second proximal body. Such a connection can be achieved, for example, by ultrasonically welding the distal body and the proximal body together, or, if the connecting member is not integrally formed with either the first or second body, by assembling and welding the distal body and the proximal body together.

[0031] According to yet another object of the present invention, the first distal body of the clutch assembly is disposed distal to the magnetic field generating means.

[0032] According to yet another object of the present invention, a second proximal body is arranged proximal to the magnetic field generating means.

[0033] From the above, it will be appreciated that the first distal body and the second proximal body are optimally disposed on either side of the magnetic field generating means and are also connected to each other via elongated hollow connecting members, such that there is a fixed distance between said first distal body and said second proximal body. As mentioned above, the magnetic field generating means is disposed in a fixed relationship within the hollow body of the injection monitoring module, and the first and second bodies are disposed on either side thereof, which means that the first and second bodies can only translate longitudinally either distally or proximally along said longitudinal central axis from a first position to a second position a predetermined travel distance before one or the other contacts the radially inwardly projecting surface of the annular disc of the magnetic field generating means.

[0034] The bias member is disposed between the first distal body and the second proximal body, and is preferably and advantageously disposed proximal to the magnetic field generating means and distal to the second proximal body. The bias member is typically a pre-compressed bias member, such as a spring, and an appropriate selection can be made by one skilled in the art for a desired application. However, for purposes of the present invention, it has been found advantageous for such pre-compressed bias member to be a flat compression wire spring or a wave spring. Such compression wire springs and wave springs are commonly known in the art and are available, for example, from Smalley Steel Ring Company, sold under the CM and CMS designations (CM for plain end wave springs and CMS for shimmer end wave springs). Such springs are typically made of carbon steel or stainless steel.

[0035] The biasing member is designed to bias the second proximal body to an engaged position, i.e., the position when the injection monitoring module is at rest after attachment to the pen injection system and / or the dose setting position when the dose setting wheel is rotated to set the amount of medication to be administered, wherein the biasing member adopts a relatively uncompressed configuration, which is considered to be the engaged position because the biasing member presses against the distal surface of the proximal body and the corresponding proximal surface of the first distal body is in contact and surface abutment with the distal surface of the magnetic field generating means.

[0036] When the bias member is compressed in the distal direction (e.g., when the distal surface of the second proximal body is moved or displaced longitudinally and distally), this pushes down on the bias member, transitioning it to a compressed configuration, and due to the rigid connecting member between the second proximal body and the first distal body, the first distal body moves in unison, and due to the fixed relationship between the two, the first distal body moves to a disengaged position (where the proximal surface of the first distal body is no longer in contact with the distal surface of the magnetic field generating means).

[0037] In accordance with yet another object of the present invention, an injection monitoring system includes a single magnetic field sensor.

[0038] In accordance with another object of the present invention, a single magnetic field sensor is disposed on a central longitudinal axis and is movable along said axis from a first proximal position to a second distal position.

[0039] According to yet another object of the present invention, the single magnetic field sensor is arranged on or in a first distal body, which, as will be readily apparent from the above description of said first distal body, second proximal body, biasing means and magnetic field generating means, means that the magnetic field sensor is longitudinally movable along a central longitudinal axis from a first proximal position adjacent to the magnetic field generating means to a second distal position located away from said first position.

[0040] In accordance with yet another object of the present invention, a clutch assembly is provided comprising a first distal body and a second proximal body, the clutch assembly having no biasing member, the first and second bodies being directly physically connected or coupled to one another about and along a central longitudinal axis, e.g., via a suitable adhesive or ultrasonic welding, at appropriate locations on the first distal body and the second proximal body, for example, when the injection monitoring system is assembled into the hollow body of the injection monitoring module. The first and second bodies are advantageously sized and configured to fit within the hollow cavity of the body and to be movable therein as a single unit along the central longitudinal axis.

[0041] According to yet another object of the present invention, both the first distal body and the second proximal body of the clutch assembly are located proximal to the magnetic field generating means. For example, a proximally facing engagement portion of the first distal body can engage a distally facing engagement portion of a radially inwardly projecting surface of the hollow body, which extends into the cavity from the inner surface of the hollow body and defines an opening therein aligned with the longitudinal central axis, through which at least a portion of the first distal body extends distally.

[0042] According to yet another object of the present invention, the magnetic field generating means is disposed within a hollow body of the injection monitoring module adjacent to an activation button located at the proximal end of the pen-type injection system. Consequently, in such an embodiment, the first and second bodies of the clutch assembly are initially disposed proximal to the magnetic field generating means in the first monitoring position. In the second monitoring position, the first distal body is located substantially at the level of the magnetic field generating means. Furthermore, in such an embodiment, the magnetic sensor is preferably disposed on the second proximal body of the clutch assembly. This arrangement allows for a particularly compact injection monitoring system to be provided within the hollow body, with a total longitudinal movement or translation distance along the longitudinal central axis of the distal end of the first distal body being between about 0.4 mm and about 1 mm. This configuration also allows for a shorter hollow body, and the overall compact injection monitoring module is less likely to adversely affect user behavior and psychology toward the injection monitoring module, further providing a system whose use is familiar to both children and adults.

[0043] A magnetic field sensor is used to measure the magnetic field generated by the magnetic field generating means, and movement of the sensor along the central longitudinal axis relative to the fixed magnetic field generating means is used to calculate the translational position of a reference point along said central longitudinal axis, which can be used to correlate to a zero point, an initialization point, an injection start point, an injection end point of the injection monitoring system according to the present invention, and / or a point corresponding to any administered amount of an injectable substance, such as a drug.

[0044] Means for measuring and determining magnetic fields are generally known in the art. For example, magnetoresistors are well-known. Such magnetoresistors are often referred to by abbreviations such as AMR, GMR, or TMR sensors, which describe the physical mechanisms by which these sensor components function. Giant magnetoresistance (GMR) is a quantum mechanical magnetoresistance effect observed in thin-film structures composed of alternating ferromagnetic and non-magnetic conductive layers. Anisotropic magnetoresistance, or AMR, exists in materials where a dependence of electrical resistance on the angle between the direction of current flow and the direction of magnetization is observed. Tunneling magnetoresistance (TMR) is the magnetoresistance effect that occurs in magnetic tunnel junctions (MTJs), which are components composed of two ferromagnetic materials separated by a thin insulator. Resistors utilizing various of these properties are known per se.

[0045] In view of the above, the injection monitoring module and / or system according to the present invention preferably uses a magnetometer as the magnetic field sensor. Such magnetometers differ from GMR, AMR, or TMR sensors in that they directly measure magnetic field strength. Magnetometers measure magnetic fields in two main ways: vector magnetometers measure the vector component of a magnetic field, and total or scalar magnetometers measure the magnitude of a vector field. Another type of magnetometer is the absolute magnetometer, which measures the absolute magnitude or vector field using internal calibration and known physical constants of the magnetic sensor. Relative magnetometers, which measure the magnitude or vector of a magnetic field relative to a fixed but uncalibrated baseline, are also called variometers and are used to measure magnetic field fluctuations.

[0046] Therefore, a preferred magnetometer for use in the injection monitoring module of the present invention is an ultra-low power, high performance, three-axis Hall effect magnetometer. The magnetometer can be configured to measure the magnetic field about three mutually perpendicular or orthogonal axes, and in the present case the magnetic field sensor is preferably configured to measure the magnetic field about only two of the three orthogonal axes (e.g., the X-axis and the Z-axis), where the Y-axis is coaxial with the longitudinal central axis, so that distance measurements for translational movements of the magnetic field sensor along the longitudinal axis, corresponding to the normal, can be calculated relative to the position of a reference point on said axis, as described above.

[0047] According to yet another object of the present invention, the injection monitoring system further comprises a rotational movement measuring means configured to detect and / or measure rotational movement of the injection monitoring system caused by a user upon actuation of the injection actuation device from a first monitoring position, in which the injection monitoring system is not in contact with the proximal surface of the injection actuation device, to a second monitoring position, in which the injection monitoring system is in contact with the proximal surface of the injection actuation device. The rotational movement means is distinct from the magnetic field sensor. By the expression "user-induced rotation of the magnetic field sensor," it is understood that the magnetic field sensor typically does not rotate when moving from the first monitoring position to the second monitoring position, since injection monitoring systems are typically designed to measure only translational movement along the central longitudinal axis using the magnetic field sensor. However, in some circumstances, a user of a pen injection system may slightly rotate the injection monitoring system by pressing or relaxing the pressure of a finger or thumb on the activation button (e.g., when the user rotates their thumb or finger when depressing or relaxing the pressure of such finger on the activation button). Thus, the purpose of providing the rotational movement measuring means is to detect and measure any user-induced rotation of the magnetic sensor when actuating the activation button and moving the injection monitoring system from the first monitoring position to the second monitoring position, thereby allowing a corrected injection dose to be determined that takes into account any such measured rotational movement that might otherwise lead to an inaccurate or imprecise determination of the injection dose.

[0048] Advantageously, the means for measuring such user-induced rotational movement is a gyroscope, which is normally arranged to be in a sleep mode, ie inactive, until an activation button is pressed.

[0049] In accordance with yet another object of the present invention, an injection monitoring system includes an electronics board.

[0050] Advantageously, according to a further object of the invention, the single magnetic field sensor is electrically connected to the electronics board.

[0051] Furthermore, the electronics board preferably comprises an integrated control and data processing unit, such as at least one microcontroller, electrically connected to the magnetic field sensor for processing the information received from the magnetic field sensor. The electronics board may therefore preferably be, for example, a printed circuit board of correspondingly suitable dimensions. In the configuration envisaged by the present invention, such a printed circuit board is advantageously disk-shaped.

[0052] The electronics board is advantageously located on, integrated into, or housed within the first distal body of the clutch assembly. In another embodiment, the electronics board is advantageously located on, integrated into, or housed within the second proximal body. An integrated control and data processing unit, including at least one microcontroller, handles all electrical communications and signals between the various electronic components of the electronics board and the magnetic field sensor. The electronics board is also responsible for performing calculations, allowing it to calculate and determine the exact placement position of the magnetic field sensor, and for processing signals from the autonomous power source and communication means integrated into the injection monitoring system and communicating with a local or remote data processing system (e.g., a smartphone). The electronics board can be remotely programmed upon first use or receive information and updates, and, like other electronic devices today, includes an integrated control and data processing unit. Such integrated control and data processing units are known per se and often integrate a central processing unit, a real-time clock, one or more memory storage systems, and optionally a communication system or subsystem, along with other desired components.

[0053] According to yet another object of the present invention, the magnetic field sensor is disposed on the proximal surface of the electronics board. In this aspect and configuration, according to a first arrangement of the injection monitoring system, when the injection monitoring module is initially attached to the pen injection system, the magnetic field sensor is substantially in contact with the magnetic field generating means. In a second alternative arrangement, as described above, the magnetic field sensor is disposed proximal to the magnetic field generating means, and in this second arrangement, the magnetic field sensor is disposed at a distance at least equal to the length of the first distal body, considering that the magnetic field sensor is disposed on an electronics board disposed on the second proximal body.

[0054] Furthermore, advantageously, the magnetic field sensor is arranged on the proximal face of the electronics board as close to the central longitudinal axis as physically possible, preferably on said central longitudinal axis, the purpose of such positioning being to try to avoid as much as possible the need for correction calculations to be performed by the integrated control and data processing unit due to the radial displacement of the magnetic field sensor from the central longitudinal axis, thereby increasing the accuracy of the corresponding calculations and of the determination of the translation reference point along said axis.

[0055] As can be gathered from the above, another subject of the present invention is an injection monitoring module, in which the first distal body is an electronics board support, and the electronics board is consequently arranged in the board support, and in an alternative configuration, as mentioned above, the second proximal body is an electronics board support, and the electronics board is consequently arranged in this proximally arranged support.

[0056] As briefly mentioned above, the electronics board is powered by a stand-alone power source. Thus, according to one object of the present invention, the injection monitoring system comprises a removable and / or rechargeable power source. Such a removable stand-alone power source may be, for example, a lithium-ion battery that can be easily replaced when depleted, or may be, for example, a rechargeable battery that can be recharged when depleted by connecting it to a rechargeable battery, for example, via a corresponding charging port provided on the injection monitoring module; both types of batteries are generally known to those skilled in the art.

[0057] Thus, advantageously, according to yet another object of the present invention, the second proximal body is a power supply support, the power supply being preferably arranged within the power supply support, or even more advantageously, according to yet another object of the present invention, the first distal body is a power supply support, the power supply being preferably arranged within the power supply support.

[0058] The second proximal body is usefully and advantageously closed at its proximal end by a removable cap configured and dimensioned to be pressed by a user's thumb or finger to activate the injection monitoring system. The cap usefully covers the power source if the power source is located in the second proximal body, or more advantageously, can cover the electronics board if the electronics board is located in the second proximal body and the power source is located in the first distal body. The cap can prevent the ingress of dust and / or water or moisture and is configured to be press-fit or resiliently engageable with the second proximal body, yet also removable as needed to provide access to the components housed in the second proximal body (electronics board and power source) depending on the desired configuration and arrangement.

[0059] It will be apparent from the previous paragraphs above that the power source can be in the second proximal body and the electronics board in the first distal body, or alternatively, and more advantageously, the electronics board can be in the second proximal body and the power source in the first distal body. In this alternative arrangement, the power source, e.g., a rechargeable lithium-ion battery, is housed in the first distal body disposed along the longitudinal central axis in an opening formed by a radially inwardly protruding surface of the hollow body, which extends into the cavity from the inner surface of the hollow body.

[0060] The two bodies of the clutch assembly can advantageously be electrically connected via an elongated, hollow connecting member, where the electrical connection (e.g., standard copper wiring) can be disposed within the hollow, elongated connecting member, or can be directly, e.g., by ultrasonically welding the first distal body and the second proximal body. In the first case, the electrical connection between the power source and the electronics board is configured and dimensioned within the elongated connecting member to avoid any disconnection or interruption of the electrical connection even when the injection monitoring system rotates coaxially with the dose setting wheel. Therefore, using the elongated connecting member as a conduit for said electrical connection is highly advantageous when said elongated connecting member is disposed along the longitudinal central axis, meaning that even when a user twists and turns the dose setting wheel and the corresponding attached injection monitoring system through various rotations, either alternately or sequentially, the electrical connection is protected from any substantial rotation, reducing the risk of breakage or disconnection. In a second arrangement, the power source can be usefully held in electrical contact with the cage, similar to a cage directly connected to the electronics board, with the power source (e.g., a rechargeable lithium-ion battery) located within the cage (itself located within the first distal body). In such a case, the only way to remove the battery would be to destroy the entire monitoring module; in this arrangement, the module is self-contained and cannot be altered.

[0061] In accordance with another object of the present invention, and as is apparent from the foregoing description of the relative movements and positions of the various components, the injection monitoring system has a first arrangement in which, when the clutch assembly is in a first engaged position, the magnetic field generating means has a distal surface in contact with a proximal surface of the electronics substrate body, and when the clutch assembly is in a second disengaged position, said proximal surface of the electronics substrate body is axially spaced along the longitudinal central axis from said distal surface of the magnetic field generating means.

[0062]

[0010] Furthermore, advantageously, the first monitoring position is a position where the proximal surface of the electronics substrate body abuts the distal surface of the magnetic field generating means, and the second monitoring position is a position where the distal surface of the injection monitoring system abuts the proximal surface of the injection actuator of the pen injection system. In such a configuration, when the biasing member is compressed distally along the longitudinal axis, the proximal surface of the electronics substrate body moves distally away from abutment with the distal surface of the magnetic field means, i.e., away from the first position, to a point where the distal surface of the electronics substrate body contacts and / or abuts the proximal surface of the injection actuator of the pen injection system. The magnetic sensor relays the measured magnetic field change to the integrated control and data processing unit when the sensor moves along the central longitudinal axis away from the magnetic field generating means until it abuts the injection actuator, a distance of a few millimeters, for example about 15 millimeters. Thus, the entire injection monitoring module can be manufactured to have a total length of several tens of millimeters, for example, approximately 20-30 millimeters, from the distal end of the hollow body to the proximal end of the push cap cover.

[0063] In an alternative, more advantageous arrangement, the magnetic field generating means is disposed within the hollow body of the injection monitoring module adjacent to the activation button of the pen injection system. Furthermore, in such an alternative arrangement, the first distal body and second proximal body of the clutch assembly are disposed proximal to the magnetic field generating means in the first monitoring position, and the first distal body is disposed substantially at the level of the magnetic field generating means in the second monitoring position. Again, the magnetic sensor relays measured changes in the magnetic field to the integrated control and data processing unit as the sensor moves along its central longitudinal axis toward the magnetic field generating means located distal to the magnetic sensor until the distal end of the first distal body abuts the injection actuator. The movement distance in this arrangement is typically less than 1 millimeter, e.g., between about 0.4 millimeters and about 1 millimeter. Thus, the entire injection monitoring module can be manufactured so that the overall length from the distal end of the hollow body to the proximal end of the push cap cover is about 20 millimeters, e.g., about 15 millimeters to about 20 millimeters.

[0064] In accordance with yet another object of the present invention, there is provided a process for calculating an actual amount of medication released or injected from a pen injection system, comprising the steps of attaching an injection monitoring module, setting a dose, actuating an injector, and determining the injected dose. the step of attaching an injection monitoring module comprising attaching an injection monitoring module comprising an injection monitoring system substantially as described herein to a proximal end of a pen injection system for delivering a drug; the pen injection system includes a proximally disposed dose setting wheel and an injection actuator, the dose setting wheel being rotatable about a central longitudinal axis of the pen injection system during dose setting and during injection; In the step of setting the dose, the dose is set by rotating the dose setting wheel; The step of activating the syringe includes activating the syringe to perform an injection; In the step of determining the injected dose, the injected dose is determined from translational movement of the injection monitoring system caused by actuation of the injection actuator from a first monitoring position where the injection monitoring system is not abutting a proximal surface of the injection actuator to a second monitoring position where the injection monitoring system abuts a proximal surface of the injection actuator.

[0065] According to another object of the present invention, there is provided a method for calculating the actual amount of drug released or injected from such a pen injection system, the process comprising the steps of detecting rotational movement of the injection monitoring system caused by the user and determining a corrected injection dose. the step of detecting rotational movement includes detecting rotational movement of the injection monitoring system caused by a user upon actuation of the injection actuation device from a first monitoring position in which the injection monitoring system is not abutting a proximal surface of the injection actuation device to a second monitoring position in which the injection monitoring system is abutting a proximal surface of the injection actuation device using a rotational movement measuring means, the rotational movement measuring means being configured to measure any rotational movement caused by the user of the injection monitoring system; In the step of determining a corrected injection dose, the corrected injection dose is determined from a translational movement of the injection monitoring system caused by actuation of the injection actuator from the first monitoring position to the second monitoring position, and said step of determining the corrected dose takes into account any measurements made by the rotational movement measuring means. [Brief explanation of the drawings]

[0066] The invention will now be described in more detail with reference to the accompanying figures, which are provided for purposes of explanation and example.

[0067] [Figure 1] FIG. 1 is a schematic perspective view of an injection monitoring module according to the present invention for a handheld pen injection system.

[0068] [Figure 2] FIG. 2 is a schematic end view of the injection monitoring module of FIG. 1, viewed from its distal end.

[0069] [Figure 3] 3 is a schematic cross-sectional view of the injection monitoring module of FIG. 1 in a first monitoring position.

[0070] [Figure 4] 4 is a schematic cross-sectional view of the injection monitoring module of FIG. 1 rotated 90 degrees in a first monitoring position.

[0071] [Figure 5] FIG. 5 is a schematic exploded view of an injection monitoring module according to the present invention, taken along a line from the proximal end of the module to the distal end of the module.

[0072] [Figure 6] FIG. 6 is a schematic exploded view of an injection monitoring module according to the present invention, taken along a line from the distal end of the module to the proximal end of the module.

[0073] [Figure 7] 7A and 7B are schematic cross-sectional views of an injection monitoring module according to the present invention, showing the module in a first monitoring position (7A) and a second monitoring position (7B), respectively.

[0074] [Figure 8] FIG. 8 is a schematic cross-sectional view of an injection monitoring module according to the present invention, showing the module in a second monitoring position.

[0075] FIG. 9 is a schematic exploded view of an alternative embodiment of an injection monitoring module according to the present invention, taken along a line of sight from the proximal end of the module on the left to the distal end of the module on the right.

[0076] FIG. 10 is a schematic exploded view of an alternative embodiment of an injection monitoring module according to the present invention shown in FIG. 9, taken along a line of sight from the proximal end of the module on the right to the distal end of the module on the left.

[0077] Figures 11A and 11B are schematic cross-sectional views of an alternative embodiment of the injection monitoring module of the present invention shown in Figures 8, 9 or 10, the difference between Figures 11A and 11B being that the monitoring module is rotated 90° around its longitudinal central axis of rotation to show other elements of the monitoring module.

[0078] FIG. 12 is a schematic cross-sectional view of an alternative embodiment of the injection monitoring module of the present invention shown in FIG. 8, 9, 10 or 11, attached to an injection pen system in a first monitoring position.

[0079] FIG. 13 is a schematic cross-sectional view of an alternative embodiment of the injection monitoring module of the present invention shown in FIG. 8, 9, 10 or 11, attached to an injection pen system in a second monitoring position.

[0080] Detailed Description of the Embodiments Referring now to FIG. 1, a schematic perspective view of an injection monitoring module (1) according to the present invention is shown. The injection monitoring module comprises a hollow body (2) having a distal end (3) and a proximal end (4). The hollow body (2) has a peripheral wall (5) having an inner surface (6) and an outer surface (7), thereby defining a central cavity (8) of the hollow body (2) extending from the distal end (3) to the proximal end (4). The distal end (3) is open, allowing the injection monitoring module (1) to be inserted over and surround the proximal end (9) of a pen injection system (10) having a dose setting wheel (11) and an injection activation button (12). The hollow body (2) comprises an index shoulder (13) on its outer surface (7) to facilitate alignment of the body (2) with a corresponding zero point on the dose setting wheel (11) of the pen injection system (10), corresponding to the zero dose setting. Indicating shoulder (13) comprises a raised area of ​​material comprising body (2) and extends in a slope (14) where the thickness of said body material increases from proximal end (15) to distal end (16). At proximal end (4) of body (2), cavity (8) is substantially closed by clutch assembly (17), of which only proximal body (18) and covering cap (19), which form part of injection monitoring system (20), are visible.

[0081] 2 is an end view of the injection monitoring module, as viewed from the distal end (3) of the body (2). A raised indicator shoulder (13) of the body material is visible, projecting upward from the outer surface (7) of the peripheral wall (5) of the body (2). An annular flange (21) projects radially inward from the inner surface (6) of the body (2), thereby narrowing the diameter of the cavity (8) and providing a means for limiting any proximal movement of the injection monitoring module (1) as the body slides over and around the proximal end (9) of the pen injection system (10), since the protruding annular flange (21) has a distal surface (22) that abuts and engages at least a portion of the proximal surface (23) of the dose setting wheel (11). As can be seen in both Figures 1 and 2, the body 2 includes a series of radially spaced, raised, sloped shoulders 24 of body material that project inward from the inner surface 6 into the cavity 8 and extend distally along the inner surface 6 in a decreasing thickness from a location distal to the protruding annular flange 21 to the distal end 3 of the body 2. The alternating projecting shoulders form a corresponding series of alternating valleys 25. These inwardly projecting, sloped shoulders 24 and corresponding valleys 25 enable the body 2 to resiliently or frictionally engage with the dose setting wheel 11 of a pen injection system, particularly since the dose setting wheel of such a pen injection system often includes corresponding outwardly projecting shoulders and corresponding alternating valleys on its outer surface. The two sets of protruding shoulders and valleys can thus frictionally engage with each other, ensuring that rotation of the dose setting wheel (11), or alternatively the main body (2), rotates the other to the same extent and in the same direction of rotation. In another mounting arrangement, the inner surface (6) of the cavity can have, in a suitably positioned location adjacent the distal end (3) of the main body (2), an elastomer layer covering said surface, said elastomer layer frictionally or elastically engaging with the outer surface of the dose setting wheel upon rotation of a threaded or slide-fit clamping ring attached to and positioned around the outer surface (7) of the distal end (3) of the main body (2).

[0082] 3 and 4 are schematic cross-sectional views of the injection monitoring module taken along lines A-A' and B-B', respectively, showing the injection monitoring module in more detail, with FIG. 4 taken along line B-B' rotated 90° about the central longitudinal axis 26 of the body (2). FIGS. 3 and 4 show the injection monitoring module with its various components in a first position, immediately after attachment of the various components to the pen injection system or, for example, during dose setting. This relative arrangement of the various components of the injection monitoring module also corresponds to the first monitoring position, which also corresponds to the "engaged" position described herein. The first monitoring position relates to the first monitoring position of the injection monitoring system, which will be described in more detail hereinafter, and the "engaged" position relates to the clutch assembly, which will also be described in more detail hereinafter.

[0083] 3 and 4, a magnetic field generating means (27) is disposed within the cavity (8) around its circumference and in contact with the inner surface (6) of the body. The magnetic field generating means (27) can be, for example, a plastic magnet formed as a substantially annular-shaped disk, or alternatively, preferably, a molded plastic annular disk into which a pair of single-pole permanent magnets (28, FIG. 4) are introduced or encapsulated during molding of the annular-shaped disk. The magnets (28, FIG. 4) are preferably arranged within the annular-shaped disk in a diametrically opposed NS / NS pole configuration, whereby the poles are aligned across the annular-shaped disk. The disk also includes a central hole (29) with a diameter smaller than the diameter of the cavity (8). The annular shaped disk of the magnetic field generating means 27 is received within the body 2 adjacent to the annular flange 12 of the body 2 and may be held in place by a variety of different means, such as one or more inner proximal portion 30 protrusions formed on the inner surface 6 of the body 2, which protrude radially from said inner surface 6 at least partially into the cavity 8 along the length of the cavity 8 to form a proximal angled shoulder 30a and a distal flange portion 30b extending on either side of the protruding shoulder 30a. The annular disk 27 is provided with corresponding recesses 31 a, 31 b, 31 c, 31 d located on the periphery 32 of the disk 27 that resiliently or frictionally engage when the disk 27 is inserted coaxially with the central longitudinal axis 26 into the cavity 8 during manufacturing and assembly of the injection monitoring module 1. The recesses 31 a, 31 b, 31 c, 31 d cooperate with the inner angled shoulders such that at least a portion of the distal surface 33 of the disk 27 rests against the flange 30 b of the proximal angled shoulder 30 a. Due to the frictional contact between the recesses (31a, 31b, 31c, 31d) and the angled shoulder (30a) on the one hand, and the frictional contact between the distal face (33) and the flange (30b) on the other hand, the annular disc (27) cannot move in any direction along the longitudinal axis and is, for all intents and purposes, immovably contained within the cavity (8) of the body (2).

[0084] Also shown in Figures 3 and 4 is a clutch assembly 17 located within the cavity 8 of the body 2, extending along the longitudinal axis 26 at least partially beyond the proximal end 4 of the body and outside the cavity 8. The clutch assembly includes a first distal body 34 and a second proximal body 18. Both the first distal body 34 and the second proximal body 18 are connected to one another in a fixed spatial relationship along the central longitudinal axis 26 and are dimensioned to allow the first and second bodies to slide or move longitudinally within the cavity 8 along the central longitudinal axis. The first distal body 34 and the second proximal body 18 each have a general goblet shape with protruding legs 35, 37 and cups 36, 38, respectively, with the first distal body being inverted relative to the second proximal body 18. The legs 35, 37 are substantially hollow and are each formed as at least one annular wall projecting away from the corresponding bases 39, 40 of the cups 36, 38. In the case of the second proximal body 18, the legs are formed by a pair of concentric annular walls 37, 37' that form an annular channel into which the legs 35 of the first distal body are inserted. The legs 35, 37 are held together in a fixed relationship, for example, by adhesive or ultrasonic welding. As can be seen in Figures 3 and 4, the legs thereby form an elongated, hollow connecting member between the first distal body 34 and the second proximal body 18, with the distal end of the elongated connecting member opening into the base 39 of the cup 36 and the proximal end of the elongated connecting member opening into the base 40 of the cup 38. The elongated connecting member formed by the legs (35, 37) traverses the central bore (29) of the magnetic field generating means (27) such that the first distal body (34) is located distal to the magnetic field generating means (27) and the second proximal body (18) is located proximal to said magnetic field generating means (27). The elongated connecting member formed by the legs (35, 37) is dimensioned to allow sliding or translational movement of the first distal body (34) and the second proximal body (18) along the central longitudinal axis (26), the maximum predetermined length of such possible longitudinal translation being, for example, approximately 15 millimeters in total.

[0085] A biasing member 41, e.g., a flat wire spring, is disposed distal to the base 40 of the cup 38 of the second proximal body 18 but proximal to the magnetic field generating means 27. The magnetic field generating means includes a receiving protrusion 42 for receiving the biasing member 41, e.g., extending proximally along the cavity 8 from the proximal face of the disk 27. The biasing member 41 is selected to be capable of adopting a relatively compressed or compressed configuration and a relatively uncompressed, relaxed, or expanded configuration. By default, and also when the injection monitoring module is initially attached to the pen injection system, the biasing member is in the relatively uncompressed or relaxed configuration. When the biasing member 41 is received on the receiving projection 42 on the proximal surface of the magnetic disk 27, immovably blocking the disk within the cavity 8 of the hollow body 2, the biasing member naturally exerts a pressing force against and tends to engage the distal surface 43 of the base 40 of the cup 38 of the second proximal body. This is to be understood in this specification as the "engaged" position. This position also corresponds to the first monitoring position of the injection monitoring module. Corresponding to the biasing member 41 adopting a relatively unpressured, expanded, or relaxed configuration, the biasing effect of the biasing member 41 also causes the base 39 of the cup 36 of the first distal body 34 to move proximally along the central longitudinal axis 26 via the fixed length elongated connecting member formed by the legs 35, 37. As a result, the proximal surface (44) of the base (39) of the first distal body comes into contact with the distal surface (33) of the disk of the magnetic field generating means (27).

[0086] Also shown in Figures 3 and 4 is an injection monitoring system, substantially housed within the various components of the clutch assembly. The first distal body 34 functions as an electronics board support, with an electronics board 45, such as a printed circuit board, disposed substantially within the cup 36. The electronics board has several electrically connected components, including a microcontroller 46 disposed on the distal surface of the electronics board and a magnetometer 47 disposed substantially centrally on the proximal surface of the electronics board 45, thereby aligned with the longitudinal central axis 26. In each of the component positions shown in Figures 3 and 4, the magnetometer 47 senses and measures the magnetic field generated by the permanent magnet 28 disposed within the disk 27 and sends a corresponding electrical signal to the microcontroller 46, which is responsible for calculating a series of reference points and deriving the relative and absolute position of the magnetometer with respect to the magnetic field generating means 27, which is located in a fixed position within the hollow body 2. The electronics board 45 also includes a communications unit 48, such as a Bluetooth® Low Energy circuit, that allows data to be transmitted and received between the electronics board and a remote terminal device, such as an appropriately equipped smartphone, remote computing system, or distributed computing system. The second proximal body 18 serves as a power support for the injection monitoring system and, to that end, accommodates and arranges within its cup 38 an autonomous power source 49, such as a replaceable lithium-ion battery or a removable rechargeable battery, as shown. The power source 49 is connected via electrical connectors 50, 50′ (e.g., appropriately positioned connection plates for the positive and negative terminals of the battery) arranged within the cup 38 to a series of further flexible electrical connectors 51, 51′ (e.g., plastic-coated copper wiring or ribbon connectors), which extend from the connection plates 50, 50′ to the electronics board 45 via elongated connecting members formed by the legs 35, 37.The flexible electrical connectors 51, 51' are designed to allow any possible rotational movement of the clutch assembly about the longitudinal central axis 26 without being damaged or breaking the electrical connection between the electronic component board 45 and the power source 49. A removable covering cap 19 (e.g., a push-fit cap) engages with the open end of the cup 38 of the second proximal body 18. In Figures 3 and 4, this is shown as a radially inwardly projecting annular ridge 52 around the inner peripheral wall 53 of the cap 19, which resiliently and / or frictionally engages with a corresponding circumferential groove on the outer surface of the cup 38 of the second proximal body to seal the opening of the cup 38 and prevent the ingress of foreign matter into the cup, which could affect the delivery of power to the component board. Additionally, cap 19 provides an exterior proximal surface 55 that a user can depress or press with a finger (e.g., thumb or other finger) to activate the monitoring system and clutch assembly. First distal body 34 also includes a distal contact surface 56 that effects closure of cup 36, thereby enclosing electronics board 45 within first distal body 34. This distal surface 56 abuts against the proximal surface of the injection activation button during operation of the injection monitoring module.

[0087] 5 and 6 show schematic alternative views of the injection monitoring system, with various components arranged along or around a central longitudinal axis 26. Like numerals refer to features and components of the injection monitoring module already described with respect to the previous figures.

[0088] 7A and 7B show the injection monitoring module during operation and the relative positions of its various components, as described below.

[0089] 7A is a diagram of the injection monitoring module when attached to the proximal end (9) of the pen injection system (10). The hollow body (2) surrounds and engages the dose setting wheel (11) at the distal end (3) of the body. The body slides along its central longitudinal axis onto the proximal end (9) of the pen injection system (10) until the distal surface of the annular flange (21) of the body (2) abuts and makes surface contact with the proximal surface (57) of the dose setting wheel (11). In this position, it can be seen that the injection activation button (12) extends proximally through the narrowed diameter formed by the annular flange (21) of the body (2), but the proximal surface (58) of the injection activation button does not abut the distal surface (56) of the first distal body (34). In effect, the biasing element 41 positively urges the first distal body 34 away from the proximal surface 58 due to the fixed-length connection between the first distal body 34 and the second proximal body 18 of the clutch assembly 17. The body 2 rotates with the dose setting wheel 11 and is free to rotate about the longitudinal central axis 26, allowing the user to set the dose to be administered. In this position, the injection monitoring module is considered to be in the first monitoring position, which is registered by the microcontroller and stored in volatile or non-volatile memory storage located either within the microcontroller or on the electronics board, thereby subsequently communicating via the communication unit to a remote computing device, such as a suitably equipped smartphone, remote computer, or distributed computing system.

[0090] A user can actuate the injection by pushing the proximal surface 55 of the cap cover 19 distally. Because the cap cover 19 is coupled to the cup 38 of the second proximal body 18, any translational force is imparted to the cup 38 and, through abutment of the distal surface of the cup base 40, to the biasing member 41. In this manner, the second proximal body 18 moves distally, i.e., along the central longitudinal axis 26, until the compression limit of the biasing member is reached. This compression limit is configured such that the fixed length connection between the first distal body and the second proximal body allows the cup base (39) of the first distal body (34) to move away from abutment with the distal surface (33) of the magnetic field generating means and into abutment between the distal contact surface (56) of the cup (39) of the first distal body (34) and the proximal surface (58) of the injection actuation button (12), following said axial movement along the central longitudinal axis, allowing normal function of the injection actuation button (12) and accomplishing an injection of a medication from the pen injection system (10).

[0091] As a result of the displacement along the central longitudinal axis, the electronics board carrying the magnetometer (47) moves distally from a position closer to the magnetic field generating means to a position spaced therefrom. The displacement, or longitudinal movement, of the magnetometer along the central longitudinal axis affects the magnetic field values ​​sensed by the magnetometer and the signal sent to the microcontroller. However, because the magnetometer on the electronics board is centrally located (centered on the central longitudinal axis), the measurements do not require offset correction calculations by the microcontroller. Furthermore, the total distance traveled by the magnetometer, on the order of approximately 15 mm, is relatively small and is not susceptible to potential interfering magnetic fields that may otherwise be generated by other moving metal parts found in most typical pen-type syringes. As a result, a microcontroller programmed with appropriate logic and instructions for performing various calculations can calculate various reference points from the associated measured and reported magnetic fields and derive absolute and relative positions therefrom without the need for complex correction calculations, thereby indicating successful achievement of the desired injection endpoint (e.g., that the selected dose has been fully injected) via an appropriate signal (e.g., an illuminated LED appropriately located on the electronics board or an audible signal generated by appropriate circuitry also located on the electronics board). The microcontroller can also calculate any released or injected drug volume and notify the user thereof via an appropriate signal, such as the LED or audible signal system described above, even if the user releases pressure on the cap cover (19) and the biasing element moves the second proximal body (18) proximally back toward the engaged position of the clutch assembly. A communications unit can also be activated by the microcontroller at this time, or at any other appropriate time, to transmit corresponding information or calculation results to a remote device, as described above. In this way, the injection monitoring system provides a means to determine, at any given translational point along the central longitudinal axis, whether any drug has actually been injected, and if so, the actual and precise amount of drug injected or expelled.

[0092] 8 is a cross-sectional view of the injection monitoring module according to the present invention once it has reached the second monitoring position, where it can be seen that the cap cover (19) has been depressed, thereby moving the second proximal body (18) distally along the central longitudinal axis and compressing the biasing member (41) to a depressed configuration, thereby moving the cup base (39) of the first distal body (34) out of contact with the distal surface (33) of the magnetic field generating means (27) and into a clutch assembly disengaged position, in which the distal contact surface (56) of the cup (36) of the first distal body is in face-to-face contact with the proximal surface (58) of the injection activation button (12).

[0093] When the digital pressure on the cap is once again released by the user at the end of the injection, the biasing member 41 assumes a relatively unpressured or relaxed configuration, biasing the cup base 40 of the second proximal body 18 proximally along the central longitudinal axis 26 and moving the distal contact surface 56 of the cup 36 of the first distal body 34 away from abutting surface contact with the proximal surface 58 of the injection actuator until the cup base 39 of the first distal body again abuts the distal surface 33 of the disk of the magnetic field generating means 17. This return position can also be detected and calculated through the interaction of the magnetometer and microcontroller, providing the user with an appropriate signal, if desired (e.g., indicating that the system is once again ready for a new dose setting for the next injection operation).

[0094] Figures 9-13 illustrate an alternative embodiment of an injection monitoring module 101 according to the present invention. Figure 9 is a schematic, exploded perspective view of such an injection monitoring module 101, which includes a hollow body 102 having a distal end 103 and a proximal end 104. The hollow body 102 has a peripheral wall 105 having an inner surface 106 and an outer surface 107, thereby defining a central cavity 108 of the hollow body 102 extending from the distal end 103 to the proximal end 104. As shown in Figures 12 and 13, the distal end 103 is open, allowing the injection monitoring module 101 to be inserted over and surround the proximal end 109 of a pen injection system 110 having a dose setting wheel 111 and an injection activation button 112. The hollow body has an inner surface (106) around its distal end (103) that is provided with a resilient frictional engagement means (113) for engaging with the outer surface of a dose setting wheel (111) of the injection pen system (110). The resilient frictional engagement means (113) can be usefully configured, for example, as a series of alternating ridges and valleys that correspond to the series of alternating ridges and valleys on the outer surface of the dose setting wheel. The resilient frictional engagement means (113) can be configured, for example, from a suitable elastomer and covers a portion of the inner surface (106) of the hollow body (102) in the region of the distal end (103) and / or in a peripheral region thereof to provide for a press-fit insertion of the injection monitoring module onto and around the dose setting wheel (111), with the ridges mating with corresponding valleys on the dose setting wheel and the valleys mating with corresponding ridges on the dose setting wheel (111).Other means of removably securing the hollow body to and around the proximal end of the dose setting wheel are also envisioned, such as by providing a separate tightening ring that can be screwed or slidably engaged around a suitably contoured outer surface (107) of the circumferential wall (105) of the hollow body so that its inner surface (106) frictionally engages the dose setting wheel of the pen injection system (110), which can then be released as required by unscrewing the ring or sliding such tightening ring in a direction opposite to the tightening action. The hollow body (102) further comprises a radially inwardly protruding annular shoulder (114) located approximately midway between the proximal end (104) and the distal end (103) of the hollow body (101). An inwardly projecting annular shoulder 114 extends from the inner surface 106 of peripheral wall 105 into cavity 108 substantially perpendicular to the longitudinal axis of cavity 108, and then extends proximally, terminating just short of the proximal end 104 of body 102 to form a lip 115, i.e., a shoulder that projects radially inward again into cavity 108, thereby narrowing the diameter of cavity 108 at this point and forming opening 116. Where shoulder 114 extends substantially perpendicularly inward from inner surface 106 toward the proximally extending portion of shoulder 114, a pair of diametrically opposed recesses 117a, 117b are provided that are disposed substantially parallel to the central longitudinal axis of the hollow body of the monitoring module. Each recess (117a, 117b) houses a single dipole magnet (118) having a suitably configured magnetic field. Magnet (118) is preferably positioned within recess (117a, 117b) to form a diametrically opposed NS / SN pole configuration, e.g., whereby the respective poles are aligned substantially linearly across cavity (108) and substantially perpendicular to the central longitudinal axis.When the shoulder extends proximally at the end of the orthogonally protruding portion, it forms a distally facing support surface (119) whereby, as the body (102) slides over and around the proximal end (109) of the pen injection system (110), the distally facing support surface (119) abuts and engages with at least a portion of the proximally facing surface of the dose setting wheel (11), thereby providing a means to limit any proximal movement of the injection monitoring module (101).

[0095] At the proximal end 104 of the body 102, the cavity 108 and opening 116 are substantially closed by a clutch assembly 120, which includes a proximal body 121, a distal body 122, and a cover cap 123, forming part of an injection monitoring system, with the proximal body 121, the distal body 122, and the cover cap 123 sized to extend beyond the proximal end 104 of the hollow body 102. A light guide 124, comprising a layer of translucent or transparent material, can be inserted between the cap 123 and the proximal body 121 and configured to direct light from an emission source from within the clutch assembly to a point on the outer surface of the clutch assembly that is visible to a user of the injection monitoring module. Suitable materials for providing such a light guide are generally known in the art.

[0096] The proximal body 121 and the distal body 122 are configured and dimensioned such that the distal body 122 substantially traverses and fills the opening 116 of the cavity 108 and is maintained in a substantially longitudinal position by a peripheral lip 115 of the protruding annular shoulder 114. The distal body 122 is joined or welded at its proximal end to the proximal body 121 at a point on the distally-facing surface of the proximal body 121 about its central longitudinal axis, for example, by ultrasonic spot welding, whereby it will be understood that in such case the material comprising the proximal and distal bodies 121, 122 is suitable for such ultrasonic spot welding. It should also be understood that the proximal and distal bodies (121, 122) can therefore translate distally along their central longitudinal axes within translational limits defined by the lip (115) of the shoulder (114) on the one hand, and the distal-facing surface (125) of the proximal body (121) (e.g., the distally projecting protrusion or annular ridge (126)) on the other. In the proximal direction, for example, when an attempt is made by a user to withdraw the clutch assembly from the hollow body (102), the limit of translational movement of the proximal and distal bodies (121, 122) in that proximal direction is defined by the abutment interaction between the distal-facing surface (127) of the lip (115) and the proximal surface of the radially outwardly extending protrusion (128) extending from the distal end (129) of the distal body (122). It can be seen from the figure that the distal end of the distal body (122) is closed by a distally facing surface (130), thus forming an internal cavity (131) when the distal body (122) is mated with the proximal body (121).

[0097] The proximal body (121) is configured and dimensioned to accommodate and position the electronics board (132), which includes substantially the same types and kinds of components as described in the previously illustrated embodiments herein. The electronics board has a different configuration for an autonomous power source (e.g., a battery (133), in this case a rechargeable lithium-ion battery, rechargeable, e.g., via a compatible USB port (134)). In the embodiment shown in FIGS. 9 and 10, for example, the battery (133) is housed in a cage (135), which provides electrical connections, e.g., for the positive and negative terminals of the battery, and the cage (135) is in turn electrically connected to the distal surface (136) of the electronics board (132). Thus, the battery (133) and cage (135) are fully housed within the cavity (131), e.g., during assembly of the injection monitoring system.

[0098] In some circumstances, when a user presses the actuation cap (123) to move the monitoring system from the first monitoring position to the second monitoring position, the user may cause or impose a rotational movement on the clutch assembly on which the injection monitoring system is disposed, for example, by accidentally rotating the thumb or other fingers used to apply digital pressure to the cap (123). This accidental, i.e., user-induced, rotation of the clutch assembly and injection monitoring system may cause errors in the magnetic field values ​​detected, read, or signaled by the magnetic sensors present in the injection monitoring system, thereby leading to errors in the calculation of the dispensed volume. To accommodate such accidental behavior, the electronics board (132) further includes a rotational movement sensor means (137), such as a gyroscope. The rotational movement sensor means (137) is configured to activate, i.e., detect, and obtain a measurement corresponding to the rotational movement, only when the cap (123) is pressed to move the injection monitoring system along its central longitudinal axis from the first monitoring position to the second monitoring position. In this way, any accidental misreading of the magnetic field can be accommodated and a corrected value that takes into account any detected, measured or signaled rotational movement can be included in the determination of the emitted volume by the integrated control and data processing unit.

[0099] A further notable difference between the previous embodiments and this embodiment is the absence of a bias spring, as can be seen in Figures 9 to 13. In such an embodiment, the components of the injection monitoring module are configured and dimensioned to take into account changes in the position of the magnetic field generating means, as has been described above. While the magnets in the first embodiment illustrated and shown in FIGS. 1-8 were integrated into the annular disk, in the embodiment illustrated in FIGS. 9-13, the magnets are located in recesses (117a, 117b) in the protruding shoulder (114), thereby correspondingly reducing the overall length of the injection monitoring module. This is particularly suited to certain pen-type injection systems in which actuation of the injection activation button, upon completion of an injection, induces a recoil force acting proximally on the button. This recoil effect is used here to bias the clutch assembly and corresponding monitoring system from the second monitoring position back to the first monitoring position. In this configuration, when the cap (123) is pushed distally, the distal surface (130) at the distal end (129) of the distal second body (122) contacts the proximal surface of the injection activation button (112). Thus, the monitoring system translates along its central longitudinal axis from a first monitoring position, in which the distal surface 130 is not in contact with the button 112, to a second monitoring position, in which the distal surface 130 is in contact with the button 112, similar to the first illustrated embodiment. The primary difference is that the translation is significantly smaller, on the order of about 0.4 millimeters to about 1 millimeter, and further, the monitoring module uses the recoil force generated by the pen syringe, which is directed in the proximal direction, to move the clutch assembly from the second monitoring position back to the first monitoring position. An advantage of such an arrangement is an overall simplification of the number of components in the system, e.g., elimination of bias springs. Furthermore, since the magnets (118) are disposed within recesses (117a, 117b) formed in the hollow body (102) in the illustrated second embodiment, the annular disk containing the magnets as shown in the first embodiment is also eliminated, resulting in a monitoring module that is much shorter in overall length and thus making the module much more readily acceptable to end users.

[0100] 11A and 11B, which show schematic cross-sectional views of the embodiment of the injection monitoring module already shown in FIGS. 9 and 10 in an unattached state, i.e., prior to attachment to a pen injector. The main difference between FIGS. 11A and 11B is that FIG. 11B shows the injection module of FIG. 11A rotated 90° about its central longitudinal axis to show, for example, the presence of a USB port (134). In these figures, it can be seen that the distal body (122) extends into and traverses the opening (116) formed by the annular lip (115) of the protruding shoulder. In FIG. 11B, it can also be seen that the proximal surface of the radially outwardly extending protrusion (128) located at the distal end (129) of the distal body (122) engages with the distally facing surface (127) of the lip (115) to limit the proximal movement of the distal and proximal bodies (121, 122), thereby helping to prevent these bodies (121, 122) from being forcibly withdrawn by the user.

[0101] 11A and 11B, proximal body 121 is seen to also include an annular wall 138 extending distally from distal face 125 of proximal body 121, spaced radially outward from annular ridge 126, and extending into an annular space 139 in hollow body 102 defined by protruding annular shoulder 114 and the inner surface 106 of circumferential wall 105 of hollow body 102. Annular wall 138 at least partially occupies annular space 139, but is configured and dimensioned such that an outer surface 140 of annular wall 138 slidingly abuts inner surface 106 of hollow body 102 near proximal end 104 of hollow body 102. The sliding surface abutment between the outer surface (140) and the inner surface (106) of the annular wall (138) provides additional axial stability to the proximal body (121), but also allows the proximal body to be guided along its longitudinal central axis without any significant slowing or braking effect caused by the sliding abutment imposed on the proximal body.

[0102] Referring now to Figures 12 and 13, these figures are schematic cross-sectional views of an injection monitoring module according to a second embodiment, attached to a pen injection system (110) such as those typically found commercially, e.g., an insulin medication injection pen system. Figure 12 illustrates the relative positions of the components of the injection monitoring module during the first monitoring injection, prior to injection. As can be seen from Figure 12, the distal surface (130) of the distal body (122) is not in contact with the actuator button (112) of the pen injection system (110) in the first monitoring position. Contact between the distal-facing surface (127) of the lip (115) and the proximal-facing surface of the distal protrusion (128) of the distal body (122) can also be seen. Figure 13 shows the relative positional relationship of the components of the injection monitoring module for a second monitoring injection upon actuation of the injection activation button (112), which is achieved by depressing the cap (123) and moving the proximal and distal bodies (121, 122) in a distal translational motion until the distal surface (130) of the distal end of the distal body (122) contacts the proximally facing surface of the activation button (112).

[0103] Upon release of finger pressure from cap (123), i.e., when the user releases finger or thumb pressure from cap (123), the distal and proximal bodies are moved back to the first monitoring position by their internal spring-loaded and release mechanisms through the transmission of a recoil force, typically generated in some pen injection systems, which is directed through the injection activation button onto the distal face of distal body (122), thereby moving the distal and proximal bodies in a proximal translational movement along the central longitudinal axis. This return position can also be detected and calculated by interaction of the magnetometer and microcontroller, providing the user with an appropriate signal, if desired, indicating that the system is once again ready for a new dose setting in preparation for the next injection operation.

Claims

1. an injection monitoring module, the injection monitoring module is adapted and configured to be removably attached to a proximal end of a pen injection system for delivering a medication; The pen injection system includes a proximally disposed dose setting wheel and an injection actuator; the dose setting wheel is rotatable about a central longitudinal axis of the pen injection system during dose setting and during injection; the injection monitoring module comprises a hollow body, an injection monitoring system, and at least one dipole magnet; the hollow body includes a longitudinal central cavity having a proximal end and a distal end, and is adapted and configured to be coaxially mounted to, and to rotate and engage with, the dose setting wheel at the proximal end of the pen injection system; the injection monitoring system is movable within the central longitudinal lumen of the hollow body along a central longitudinal axis from a first monitoring position to a second monitoring position; In the first monitoring position, the injection monitoring system is not in contact with a proximal surface of the injection actuator; In the second monitoring position, the injection monitoring system abuts a proximal surface of the injection actuator; the injection monitoring system is mounted within a selectively engageable and respectively disengageable clutch assembly; the at least one dipole magnet is disposed within a recess in the hollow body about the longitudinal central axis; The injection monitoring system includes a single magnetic field sensor. the single magnetic field sensor is disposed on the central longitudinal axis, is translatable along the central longitudinal axis from a first proximal position to a second distal position, and is configured to measure variations in a magnetic field generated during the translation; the injection monitoring system further comprises a rotational movement measuring means configured to detect and / or measure a rotational movement of the injection monitoring system caused by a user upon actuation of the injection actuation device from the first monitoring position, in which the injection monitoring system is not in contact with a proximal surface of the injection actuation device, to a second monitoring position, in which the injection monitoring system is in contact with a proximal surface of the injection actuation device; the rotational movement measuring means is different from the magnetic field sensor; Injection monitoring module.

2. 2. The injection monitoring module of claim 1, wherein the rotational movement measuring means is a gyroscope.

3. 10. The injection monitoring module of claim 1, wherein the injection monitoring system is configured to correct the value of the magnetic field detected, read or signaled by the magnetic field sensor to take into account any rotational movement detected, measured or signaled by the rotational movement measuring means, and wherein the correction is included in the determination of the emitted dose.

4. 10. The injection monitoring module of claim 1, wherein the at least one dipole magnet comprises two diametrically aligned single dipole magnets.

5. 5. The injection monitoring module according to claim 1, wherein the injection monitoring system comprises an electronic component board; The injection monitoring module, wherein the electronics board comprises at least one microcontroller in electrical communication with the magnetic field sensor.

6. 6. The injection monitoring module of claim 5, wherein the magnetic field sensor is disposed on a proximal surface of the electronics board.

7. 6. The injection monitoring module of claim 5, wherein the electronics board comprises a communication unit electrically connected to at least one microcontroller.

8. 6. The injection monitoring module of claim 5, wherein the clutch assembly comprises a first distal body and a second proximal body.

9. 9. The injection monitoring module of claim 8, wherein the clutch assembly further comprises a biasing member disposed between the first distal body and the second proximal body.

10. 9. The injection monitoring module of claim 8, wherein the first distal body is an electronics board support.

11. 9. The injection monitoring module of claim 8, wherein the second proximal body is an electronics board support.

12. 12. The injection monitoring module according to claim 10 or 11, wherein the electronics board is disposed within the electronics board support.

13. 9. The injection monitoring module of claim 8, wherein the injection monitoring system comprises a removable and / or rechargeable power source.

14. 14. The injection monitoring module of claim 13, wherein the second proximal body is a power supply support.

15. 14. The injection monitoring module of claim 13, wherein the first distal body is a power supply support.

16. 16. The injection monitoring module according to claim 14 or 15, wherein the power supply is disposed within the power supply support.

17. 9. The injection monitoring module of claim 8, wherein the first distal body is disposed distal to the at least one dipole magnet.

18. 9. The injection monitoring module of claim 8, wherein the first distal body is positioned proximal to the at least one dipole magnet.

19. 9. The injection monitoring module of claim 8, wherein the second proximal body is positioned proximal to the at least one dipole magnet.

20. 10. The injection monitoring module of claim 9, wherein the biasing member is disposed proximal to the at least one dipole magnet and distal to the second proximal body.

21. 10. The injection monitoring module of claim 1, wherein the at least one dipole magnet is disposed within a hollow body of the injection monitoring module adjacent to an activation button of the pen injection system.

22. 9. The injection monitoring module of claim 8, wherein the first distal body and the second proximal body of the clutch assembly are positioned proximal to the at least one dipole magnet in the first monitoring position, and the first distal body is positioned substantially at the level of the at least one dipole magnet in the second monitoring position.

23. A method for calculating an actual amount of drug released or injected from a pen injection system using an injection monitoring module according to any one of claims 1 to 22, comprising: The method comprises detecting a rotational movement caused by a user and determining a corrected injection dose; the injection monitoring module is attached to a proximal end of a pen injection system for delivering a drug, the pen injection system including the injection monitoring system; the pen injection system includes a proximally disposed dose setting wheel and an injection actuator, the dose setting wheel being rotatable about a central longitudinal axis of the pen injection system during dose setting and during injection; the step of detecting a user-induced rotational movement comprises detecting a user-induced rotational movement of the injection monitoring system upon actuation of the injection activation device with a rotational movement measuring means, the rotational movement measuring means being configured to measure any such user-induced rotational movement of the injection monitoring system; determining the corrected injection dose from a translational movement of the injection monitoring system caused by actuation of the injection actuator from a first monitoring position to a second monitoring position, and determining the corrected injection dose takes into account any measurements made by the rotational movement measuring means. method.

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