Injection monitoring module

Abstract

An injection monitoring module for mounting on the body of an injection pen system, the injection pen system including a rotatable dose setting wheel and an injection activator and having a central longitudinal axis, the injection monitoring module comprising: a hollow body including a central longitudinal bore; a magnetic field generating device located on the hollow body proximal to the bore; an injection monitoring system including at least one magnetic sensor; an inner sleeve located within the bore, the inner sleeve engaging an outer surface of the dose wheel and co-rotating therewith without axial translation during dose setting; the inner sleeve being coupled to the monitoring system so that the sleeve and monitoring system can co-rotate about the axis during dose setting and so that the monitoring system can translate along the axis without rotation during injection of medication from the pen.

Description

[0001] The present invention generally relates 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 area related to injectable drug delivery devices, for example, particularly with respect to infusion systems. Over time, such monitoring systems have recently migrated to pen systems for drug delivery, enabling users of such pen injection systems, as well as healthcare professionals involved in the treatment and follow-up of such patients, to more closely monitor their injection regimens and, in many cases, the actual dosage administered in an effort to achieve better healthcare outcomes. These developments have been accompanied by an associated increase in the use of software and portable communication devices (e.g., tablets or smartphones) that have been programmed to receive and interact with information from the monitoring systems in order to provide information to the user or healthcare professional in real time or periodically via an appropriate communication unit included in the monitoring system.

[0003] For example, with respect to pen-type injection systems in particular, one of the challenges is providing an easy-to-use, reliable, and relatively fail-safe system that is adaptable to the numerous and diverse variations of such commercially available pen-type injection systems. Previous attempts to provide such monitoring systems have typically involved adapting the body of the pen-type injection system by introducing electronic components and one or more sensors therein. However, one of the major drawbacks of such systems is that, once all the electronic components are integrated, the final product often becomes quite large and bulky, and therefore more difficult to use from a user's perspective. Furthermore, such modified systems are often very specific to a given brand or manufacturer, making them of little or no use to other manufacturers. Furthermore, to overcome the bulk and heaviness of modified pen-type injection systems, one trend has been to attempt to miniaturize the complex electronic components to minimize the overall volume of the injection pen body. This, in turn, presents its own problems, particularly electromagnetic interference between components due to the close proximity of the circuitry providing the required or desired integrated functionality. Removing the sensors in such monitoring systems from sources of electromagnetic interference only further complicates the problem, potentially leading to erroneous readings or requiring additional systems to compensate for the physical separation of the sensors from other electronic components, such as the microcontroller designed to control and direct the various components and manage their interactions.

[0004] The injection pen systems discussed are well known per se and are typically equipped with a proximally located dose setting wheel and an injection activator; the dose setting wheel is rotatable about the central longitudinal axis of the pen injection system. The user rotates the wheel to select the dose of medication to be administered. The pen is typically configured to mechanically or electromechanically effect an injection upon activation of the injection activator. This injection activator is typically a simple pushbutton or button that mechanically or electrically contacts a dispensing mechanism within the pen injection system, which activates the injection mechanism and injects the medication contained within the pen injection system. In some pen injection systems, the dose setting wheel is configured to rotate not only during dose setting but also during injection. This is typically achieved by including one or more metal components, such as a helically wound drive spring, within the housing of the pen injection system and physically connected to the dose setting wheel. Because such metal components are relatively large objects compared to the electronic components included in many current pen injection systems, these large metal objects can further disrupt the signals that the sensors within such electronic components are intended to capture or pick up, potentially making the system less accurate and / or requiring complex correction mechanisms to avoid miscalculations.

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

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

[0007] In contrast, published PCT application WO2018013419A1 relates to a dose detection system comprising a dose component attached to an activator and rotatable and axially movable relative to a coupling component attached to a dose setting member; and a module comprising an electronic sensor operable to detect relative rotation of the coupling component and the dose component to detect a dose delivered by a drug delivery device. The dose detection module is removably attachable to the proximal end of a pen-type injection system and is intended to detect a dose of medication dispensed by connecting the pen-type injection system thereto, store the detected dose in a memory, and transmit 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 through electrical contacts provided on the surfaces of the cylinders to indicate various states or positions of the injection administration process, including dose setting; the electrical contacts are connected to a collection of electronic components provided on a flexible printed circuit board, arranged in an accordion-like arrangement in overlapping folds within a removable coupling body, and insulated by non-conductive spacer layers between the overlapping layers of the circuit board to prevent potential electrical, electronic and electromagnetic interference.

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

[0009] It is therefore an 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 medication, the injection pen system having a dose setting wheel that is rotatable about a central longitudinal axis of the pen injection system to set a dose of medication to be injected and that is secured against rotation during injection; and wherein the injection monitoring module has a much simpler configuration while avoiding the need for complex shielding or protection schemes to counter any undesirable 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 described above, wherein the monitoring module is adapted and configured to determine an injection end point in a pen-type injection system, wherein the dose setting wheel is not rotated during the injection. For the purposes of the present invention, the term "injection end point" as used herein refers not only to the completion of the injection of a dose of an injectable substance (e.g., a drug), wherein the user has injected the desired dose of the injectable substance in a single operation, but also includes any amount of drug actually ejected by the pen-type injection system after a dose is selected or dialed via the dose setting wheel when the injection monitoring module is installed on the injection pen system. This means that if the user performs a series of small, repeated injection operations, for example, by repeatedly and successively activating an injection activator, the corresponding end point of each injection step will be registered, and the corresponding amount of injectable substance will be calculated as the amount injected or ejected from the pen-type injection system.

[0011] However, another object of the present invention is to provide an injection monitoring module as described above, wherein the module is adapted and configured to detect or calculate the dose or amount of injectable substance contained in the pen injection system set by the user, the injection start or starting point and the injection end point in the pen injection system, and thereby determine whether the dose or amount set by the user of the pen injection system has been completely ejected from the pen system.

[0012] These and other objects of the present invention will become apparent from a complete reading of this specification.

[0013] Therefore, in accordance with any of the above objects, an injection monitoring module is provided, the injection monitoring module being adapted and configured to be removably mounted to a proximal end of an injection pen system for delivering a drug, the injection pen system having a pen body, a proximally located dose setting wheel connected to the body, and an injection activator, the dose setting wheel being rotatable about a central longitudinal axis of the pen injection system during dose setting and being fixed against rotation during injection, wherein the injection monitoring module comprises:

[0014] a hollow body adapted and configured to be coaxially mounted about a body of the pen injection system, the hollow body including a central longitudinal bore having a proximal end and a distal end, and a central longitudinal axis;

[0015] a magnetic field generating device located on or within the hollow body proximal to the central longitudinal bore;

[0016] an injection monitoring system comprising at least one magnetic sensor or a plurality of magnetic sensors, the injection monitoring system being located proximal to the bore of the hollow body;

[0017] The hollow body further comprises an inner sleeve positioned within the central longitudinal bore and configured to frictionally engage an outer surface of the dose setting wheel to co-rotate with the dose setting wheel about the central longitudinal axis during dose setting without axially translating along the central longitudinal axis;

[0018] The inner sleeve is connected to the injection monitoring system; and

[0019] The connection between the inner sleeve and the injection monitoring system is adapted and configured to cause the inner sleeve and the injection monitoring system to rotate together about the central longitudinal axis during dose setting, and to cause the injection monitoring system to translate along the central longitudinal axis but not to rotate the injection monitoring system about the central longitudinal axis during injection and / or ejection of a drug from the pen injection system.

[0020] As used herein, the terms "pen injection system" and "injection pen system" are used interchangeably to refer to commonly used handheld pen injection systems, which are well known per se and commercially available for the treatment of a variety of different medical indications. These systems are also typically designed for self-injection of medication by a user who requires treatment for a given medical indication. This is the case, for example, with insulin intended to treat the consequences of diabetes, an example of which is the Novo Nordisk branded Penis. However, other medications also fall into this category of medical devices, for example, those used to respond to potentially life-threatening situations and enable immediate emergency administration of medications needed, such as anaphylactic shock treatment, anticoagulants, opioid agonists and antagonists, etc.; for patients suffering from or susceptible to such conditions, carrying these devices on their person has become a common practice.

[0021] The injection monitoring module according to the present invention is adapted and configured for removable connection to an injection pen system equipped with a proximal dose setting wheel and an injection activator. The dose setting wheel rotates about the central longitudinal axis of the pen injection system to allow the user to set the dose of the medication to be injected. The dose setting wheel can typically rotate in both clockwise and counterclockwise directions, which generally correspond to increasing and decreasing the selected dose, respectively. The injection activator, typically represented by a button, is typically located proximal to the dose setting wheel and, in most injection pens, is located proximal to the injection pen system. After setting the dose, the user of the injection system then presses the injection activator distally, actuating a piston, which is connected to a plunger, to expel medication from a chamber within the injection pen body through a needle that the user inserts into an appropriate injection site (e.g., skin, fatty tissue, or muscle), depending on the type of medication to be administered. The dose setting wheel is typically (but not necessarily) also connected to the injection drive mechanism, so that it rotates as the medication is injected. The functionality of such injection systems is well known in the art. However, the monitoring module according to the present invention is mounted on a pen injection system in which the dose setting wheel does not rotate during the ejection / injection phase of operation.

[0022] The injection monitoring module according to the present invention is therefore suitable and configured to be removably attached to the proximal end of such an injection pen system. The expressions "removably attached" (removably attachable) or "removably mounted" (removably mountable) or "removably mounted" (removably mountable) as may be used in this specification should be understood to refer to the possibility of attaching or mounting and subsequently removing the injection monitoring module, for example, in the case of transferring the injection monitoring module to another injection pen system, or for example if the monitoring module is damaged during use and needs to be replaced. Such attachment and subsequent removability can be achieved by providing a coupling device on the monitoring module, which couples with the proximal end of the pen injection system in a releasable manner, for example by friction or elastic engagement, or by other releasable fastening means, such as a clip, a strap, a thread and a corresponding fastening ring, etc., which engage with the dose setting wheel or the injection activator or both.

[0023] The hollow body of the injection monitoring module includes a central longitudinal bore having a proximal end and a distal end, the bore being sized to allow the hollow body to be coaxially mounted on and surround the body of the pen injection system.

[0024] The hollow body further comprises an inner sleeve located within the central longitudinal bore, the inner sleeve being configured to frictionally engage an outer surface of the dose setting wheel to co-rotate with the dose setting wheel about the central longitudinal axis during dose setting without axially translating along the central longitudinal axis, such that if the inner sleeve rotates, the dose setting wheel also rotates in the same direction and to substantially the same or the same extent. In this manner, the inner sleeve can be said to co-rotate with the dose setting wheel.

[0025] The hollow body is suitably made of any suitable material, such as a durable polymer or plastic material, such as high-density or high-impact polypropylene. Advantageously, the hollow body is made of a transparent, translucent, or opaque material to enable the user to understand and identify any visual cues, such as light-emitting diodes, which may also be provided or integrated into the injection monitoring module, wherein such cues can optionally be used to indicate various operating states of the injection monitoring system. Similarly, the inner sleeve is also suitably made of a suitable material, such as a durable polymer or high-impact plastic material, such as ABS.

[0026] Furthermore, the inner sleeve is connected or coupled to an injection monitoring system. The connection or coupling between the inner sleeve and the injection monitoring system is adapted and configured to co-rotate the inner sleeve and the injection monitoring system about the central longitudinal axis during dose setting, and to translate the injection monitoring system along the central longitudinal axis, but not to rotate the injection monitoring system about the central longitudinal axis, during injection and / or ejection of medicament from the pen injection system. To this end, the connection between the inner sleeve and the injection monitoring system is configured to selectively rotate about the central longitudinal axis and then selectively translate along the longitudinal axis, the two motions being mutually exclusive.

[0027] According to another aspect, the hollow body further comprises a distal body portion that extends around the outer surface of the main body of the injection pen system at a location distal to the dose setting wheel and frictionally engages with the outer surface of the main body of the injection pen system. In this way, the hollow body is retained in position on and around the main body of the pen injection system distal to the dose setting wheel, so that the dose setting wheel is free to rotate within the bore of the hollow body. For example, such a frictionally resilient configuration can be provided by a suitable elastomeric coating or deposit located on the inner circumferential surface of the hollow body, for example in one or more areas, or alternatively, as a continuous, contiguous, or semi-continuous / contiguous coating deposited on the inner circumferential surface of the hollow body. The purpose of such a frictionally resilient coating or deposit is to provide a frictional grip between the distal body portion and the injection pen body to maintain the correct positioning of the hollow distal body portion relative to the injection pen body. Suitable types of elastomeric materials capable of providing such frictional engagement are known in the art.

[0028] The injection monitoring module also includes an injection monitoring system, which includes at least one magnetic sensor or multiple magnetic sensors, and is located proximal to the bore of the hollow body. The injection monitoring system will be described in further detail below, but in general, the injection monitoring system includes a number of different components and devices for monitoring the injection status, such as:

[0029] Start of injection procedure;

[0030] Termination of an injection operation, wherein termination of an injection operation is understood to include both complete administration of a selected dose of the substance to be injected and discrete injection operations where the user injects only a partial dose, or causes a portion of the selected dose to be expelled from the pen injection system.

[0031] Furthermore, according to another object of the present invention, the injection monitoring system is movable along the central longitudinal axis from a first monitoring position in which the injection monitoring system is not in abutting contact with the proximal surface of the injection activator, to a second monitoring position in which the injection monitoring system is in abutting contact with the proximal surface of the injection activator. The injection monitoring system is advantageously mounted at the proximal end of the aperture and completely covers, or at least substantially covers, the proximal end of the aperture.

[0032] As will be appreciated from the above, the injection monitoring system can be moved from an initial position in which there is no physical contact between the monitoring system and the activator button, to a different position in which physical contact is established between the monitoring system and the proximal surface of the injection activator. This movement is typically a translational movement of the monitoring system along the central longitudinal axis from a first position to a second position. The injection monitoring module is further configured such that, after a dose is set by rotating the inner sleeve and the correspondingly coupled dose setting wheel, the aforementioned translational movement along the central longitudinal axis of the injection monitoring system is responsible for detecting or determining the start and / or end points of an injection. For example, when the monitoring system is translated in a distal direction, the monitoring module can be configured to detect the start point of an injection. Conversely, when the monitoring system is translated in a proximal direction, thereby eliminating physical contact between the activator button of the pen-type injection system and the monitoring system, the monitoring system can be configured to detect the end point of injection or ejection of the injectable substance. One way to achieve this is, for example, by determining the elapsed time that the injection monitoring system is in physical contact with the pen-type activator of the pen-type injection system. The translational movement in the direction opposite to the injection, i.e. the translation of the monitoring system in the proximal direction towards the user's hand or thumb, can be suitably utilized in such a pen-type injection system by the recoil energy of a retaining spring located inside the injection pen. For example, after the user releases the activator button, by directly or indirectly removing the pressure of the thumb or finger on the button, the recoil energy acts on any object that is in contact with the proximal surface of the activator button of the pen-type injection system and thereby moves the injection monitoring system away from the activator button of the pen so that the former is no longer in contact with the latter.

[0033] According to another aspect of the present invention, the monitoring module includes a magnetic field generating device located on or within the hollow body, proximal to the central longitudinal bore. The phrase "located on or within the hollow body" means that, for example, the magnetic field generating device may be mounted proximal to the central bore, on a proximal surface of the hollow body. Alternatively, the magnetic field generating device may be mounted proximal to the central bore, within a cavity or recess provided within the hollow body.

[0034] Various devices for generating magnetic fields are known, such as classical magnets, electromagnets, and hybrid magnets. Such magnets are generally made of magnetizable materials that have magnetic or paramagnetic properties, either naturally or when an electric current or other excitation flow passes through or affects the material to generate or induce a magnetic field. Suitable materials can be appropriately selected from:

[0035] - ferrite magnets, in particular sintered ferrite magnets, e.g. crystalline compounds comprising iron, oxygen and strontium;

[0036] - Composite materials consisting of a thermoplastic matrix and isotropic NdFeB powder;

[0037] - composite materials consisting of a thermoplastic matrix and strontium-based hard ferrite powder, the magnets produced from which may contain isotropic, i.e. non-oriented, or anisotropic, i.e. oriented, ferrite particles;

[0038] - Composite materials made of a thermosetting plastic matrix and isotropic NdFeB powder;

[0039] - magnetic elastomers, produced, for example, using highly charged strontium ferrite powder mixed with synthetic rubber or PVC and subsequently extruded into the desired shape or calendered into sheets;

[0040] Flexible calendered composites, typically appearing as brown flakes, are more or less flexible depending on their thickness and composition. These composites are never as elastic as rubber, with a Shore hardness ranging from approximately 40 to approximately 70 Shore DANSI. These composites are typically made from a synthetic elastomer filled with strontium ferrite particles. The resulting magnets can be anisotropic or isotropic; the flake varieties typically exhibit an alignment of the magnetic particles due to calendering.

[0041] - a laminated composite material, typically comprising a flexible composite material as described above, laminated together with a soft iron plate;

[0042] - Neodymium Iron Boron magnets;

[0043] -Magnetized steel made of aluminum-nickel-cobalt alloy;

[0044] - Alloy of samarium and cobalt.

[0045] Among the above-mentioned list of magnetic field generating devices suitable for the present invention, those selected from the group consisting of neodymium-iron-boron permanent magnets, magnetic elastomers, composite materials consisting of a thermoplastic matrix and strontium-based hard ferrite powder, and composite materials made of a thermosetting plastic matrix and isotropic neodymium iron boron powder are preferred. Such magnets are known for their ability to be dimensioned in relatively small dimensions while maintaining relatively high magnetic field strength.

[0046] While the magnetic field generating means may be of any suitable general shape, such as a disk, including circular, elliptical, or any other suitable polygonal shape, it preferably has only a single dipole having a pair of diametrically opposed north and south magnetic poles. While the magnetic field generating means may alternatively be substantially disk-shaped, such a disk shape may also preferably include a magnet having an aperture substantially in the center of the disk to form a ring-shaped or annular magnet. Such a ring-shaped or annular magnet may be operatively mounted on a peripheral annular and proximal-facing surface of the proximal end of the hollow body.

[0047] According to another object, the hollow body further comprises a translation support device adapted and configured to prevent axial translational movement of the inner sleeve along the central longitudinal axis when the injection monitoring module is in the installed position on the injection pen system. The translation support device is shaped and dimensioned to prevent axial translational movement of the inner sleeve along the central longitudinal axis beyond a predetermined point in at least the distal direction of the central longitudinal axis, but advantageously and preferably prevents axial translational movement of the inner sleeve along the central longitudinal axis in the proximal direction.

[0048] According to another object, the translational bearing means of the hollow body are formed as an annular groove or annular slot provided on the inner surface of the hollow body.

[0049] According to another object, the translational bearing means are formed by a distally directed surface provided on the hollow body and a corresponding proximally directed surface of the distal body portion, whereby the distally directed surface and said proximally directed surface together form a cooperating translational bearing surface for said inner sleeve.

[0050] According to another object, the inner sleeve further comprises a surface engagement device located near or substantially at the distal end of the inner sleeve, wherein the surface engagement device is configured to engage with at least an inner surface of the distal body portion of the hollow body, thereby preventing translational movement of the inner sleeve in a distal and / or proximal direction when the injection monitoring module is in an installed position on the injection pen system.

[0051] According to another object, the surface engaging means comprises at least one continuous protrusion or a plurality of separate protrusions extending radially outwardly from the outer surface of the inner sleeve.

[0052] Advantageously, according to another object, the surface engaging means comprises at least one distally directed surface, and said distally directed surface of the surface engaging means engages with a corresponding proximally directed surface of the translational support means provided on the inner surface of the hollow body.

[0053] According to another object, the surface engagement device includes at least one continuous protrusion, or multiple separate protrusions, extending radially outward from the outer surface of the inner sleeve, and the translation support device of the hollow body is formed as an annular groove or annular groove arranged on the inner surface of the hollow body, wherein the size of the annular groove or annular groove is suitable for engaging the at least one continuous protrusion or multiple separate protrusions extending radially outward from the outer surface of the inner sleeve in the mating proximal and distal surfaces.

[0054] In summary, the translational support means of the hollow body and the surface engagement means of the inner sleeve are provided with suitably shaped surfaces and areas which cooperate to prevent any translational movement in either the proximal or distal direction when the hollow body is mounted on the body of the pen injection system.

[0055] According to another object, the inner sleeve further comprises at least one elastically deformable surface or a plurality of elastically deformable surfaces extending inwardly from the inner sleeve towards the central longitudinal axis forming at least one frictional engagement surface or a plurality of frictional engagement surfaces for frictionally engaging with the outer surface of the dose setting wheel.

[0056] According to another aspect, the at least one elastically deformable surface or surfaces extending inwardly from the inner sleeve toward the central longitudinal axis is a ring of elastically deformable material, including a plurality of coaxially arranged, radially spaced teeth extending in the same direction from the ring, and the ring is mounted at the proximal end of the inner sleeve, with the teeth oriented to extend in a distal direction along the outer and / or inner surface of the sleeve. Advantageously, the elastically deformable material is a suitable elastomer, such as a SEBS elastomer.

[0057] According to another object, the inner sleeve further comprises a plurality of coaxially arranged, radially spaced openings extending across the inner sleeve from the outer surface to the inner surface of the inner sleeve.

[0058] Advantageously, and in accordance with another object, the at least one elastically deformable surface or surfaces extend through radially spaced openings that traverse the inner sleeve.

[0059] As will be readily appreciated from the preceding paragraphs, the elastically deformable surface advantageously extends from one side of the inner sleeve, such as the outer surface, through the bulk material of the inner sleeve and across to the other side, such as the inner surface of the inner sleeve.

[0060] According to another object, the inner sleeve further comprises at least one injection monitoring system connection surface extending from the inner surface of the sleeve and protruding inwardly toward the central longitudinal axis of the bore.

[0061] Advantageously, according to another object, at least one injection monitoring system connection surface extending from the inner surface of the sleeve and protruding inwardly towards the central longitudinal axis of the bore comprises at least one recess or a plurality of recesses provided on said inwardly protruding connection surface.

[0062] According to another object, an infusion monitoring system comprises a housing comprising at least one connection surface extending distally from the housing.

[0063] According to another object, at least one injection monitoring system connection surface and at least one injection system housing connection surface are adapted and configured to engage with each other in a first position, in which rotation of the injection monitoring system housing causes a joint rotation of the inner sleeve, and in a second position, in which the injection monitoring system only translates in a distal direction or a proximal direction along the central longitudinal axis, and the injection monitoring system housing does not rotate around the central longitudinal axis.

[0064] As can be readily appreciated from the above, at least one injection monitoring system connection surface and at least one injection system housing connection surface respectively engage one another. In a first position, the respective surfaces engage one another to rotate together about the central longitudinal axis, for example, when setting a dose, and in a second position, the at least one injection system housing connection surface translates relative to the at least one injection monitoring system connection surface in a distal or proximal direction, depending on whether the activator button is depressed or released, respectively.

[0065] According to another object, at least one connection surface extending from the injection monitoring system housing includes at least one distally extending protrusion or a plurality of distally extending protrusions extending from the distal end of the housing and aligned coaxially with the central longitudinal axis.

[0066] According to another object, in the first position, at least one distally extending protrusion or multiple distally extending protrusions of the injection monitoring housing each include an outwardly facing connecting surface, which frictionally engages with a corresponding inwardly facing surface on at least one recess or multiple recesses provided on the inwardly protruding connecting surface.

[0067] According to another object, in the second position, the at least one distally extending protrusion or multiple distally extending protrusions extending from the injection monitoring system housing further include at least one distally directed contact surface, and the at least one distally directed contact surface contacts the injection activator.

[0068] In another aspect, the injection monitoring system is further configured to determine an elapsed time during which the injection monitoring system is in physical contact with a pen activator (eg, a pen activator button) of the pen injection system.

[0069] The magnetic field generating means is arranged such that the magnetic field sensor will detect any changes in the magnetic field, for example, during dose setting, due to rotational movement of the inner sleeve relative to the magnetic field generating means, thereby enabling determination of the dialed dose set by the dose setting wheel. Furthermore, during an injection, when digital pressure in a distal direction along the central longitudinal axis is applied to the housing of the injection monitoring system, the magnetic field sensor will detect changes in the magnetic field resulting from translation of the sensor in a distal direction along the longitudinal axis toward the magnetic field generating means and then in an opposite proximal direction as the digital pressure is released from the injection monitoring system.

[0070] Thus, the magnetic field sensor is used to measure the magnetic field generated by the magnetic field generating device. As the dose wheel rotates, the movement of the magnetic field sensor about the central longitudinal axis relative to the proximal end of the fixed hollow body of the magnetic field generating device, through the inner sleeve in contact therewith, is used to calculate or determine the dose of injectable substance dialed or set by the user in the injection pen system. Once the dose is set, activation of the proximal activator button causes the injection monitoring system housing and the corresponding magnetic field sensor disposed therein to translate along the central longitudinal axis, which is used to determine or calculate whether the injection has begun. Conversely, and separately, when finger or thumb pressure on the proximal activator button is released, the inherent recoil energy in the injection pen causes the pen-type injection activator button to rebound, thereby causing the injection monitoring system housing to translate proximally along the central longitudinal axis toward the user's thumb or finger, thereby also moving the magnetic field sensor disposed within the injection monitoring system in the proximal direction. While moving in this manner, changes in the magnetic field signal detected by the magnetic field sensor are processed by the injection monitoring system to determine the corresponding end of the injection or ejection operation. Processing of the signals generated by the start and end of the injection enables determination of the dose actually injected between the injection start and injection end signals.

[0071] Devices for measuring magnetic fields to determine are well known in the art. For example, magnetoresistance is a well-known method. Such magnetoresistances are often referred to by their abbreviations, such as AMR, GMR, TMR sensors, which indicate the physical mechanism by which these sensor components operate. The giant magnetoresistance effect (GMR) is a quantum mechanical magnetoresistance effect observed in thin film structures composed of alternating ferromagnetic and non-magnetic conductive layers. Anisotropic magnetoresistance, or AMR, is believed to exist in materials where the resistance is observed to be dependent on the angle between the direction of current flow and the direction of magnetization. Tunnel magnetoresistance (TMR) is a magnetoresistance effect that occurs in a magnetic tunnel junction (MTJ), which is a component consisting of two ferromagnets separated by a thin insulator. Resistors that use these different properties are known per se.

[0072] In view of the above, the injection monitoring module and / or system according to the present invention preferably uses one or more (more / a plurality) magnetometers as one or more magnetic field sensors. Such a magnetometer differs from a GMR, AMR or TMR sensor in that it directly measures the magnetic field strength. There are two main ways in which a magnetometer measures a magnetic field: a vector magnetometer measures the vector component of the magnetic field, and a total field magnetometer or scalar magnetometer measures the magnitude of the vector magnetic field. Another type of magnetometer is an absolute magnetometer, which measures the absolute magnitude or vector magnetic field using the internal calibration or known physical constants of the magnetic sensor. A relative magnetometer measures the magnitude or vector magnetic field relative to a fixed but uncalibrated baseline, also known as a variometer, and is used to measure changes in the magnetic field.

[0073] Therefore, according to the present invention, the preferred type of magnetometer for the injection monitoring module is an ultra-low power, high performance, three-axis Hall effect magnetometer. Although the magnetometer can be configured to measure the magnetic field on three mutually perpendicular or orthogonal axes, in the present case, it is preferred that the magnetic field sensor is configured to measure the magnetic field on only two of the three orthogonal axes, such as the X-axis and the Z-axis.

[0074] According to another aspect of the present invention, an infusion monitoring system includes an electronics board.

[0075] Advantageously, and in accordance with another aspect of the present invention, one or more magnetic field sensors are electrically connected to the electronics board. The one or more magnetic field sensors can advantageously be located at diametrically opposed positions on the electronics board or otherwise distributed radially about the central longitudinal axis on the electronics board, and preferably, a single magnetic field sensor is located on the central longitudinal axis.

[0076] Advantageously, the electronics board includes an integrated control and data processing unit, such as at least one microcontroller, electrically connected to the one or more magnetic field sensors for processing information received from the magnetic field sensors. The electronics board can thus suitably be, for example, a printed circuit board of correspondingly suitable dimensions. In the configuration contemplated by the present invention, such a printed circuit board is advantageously disc-shaped, with its center corresponding to the intersection of the central longitudinal axis.

[0077] The electronics board is advantageously housed within a housing located proximal to the hollow body, and preferably within an injection monitoring system housing located beyond the proximal end of the central aperture. Furthermore, and advantageously, the electronics board is positioned such that a horizontal plane of the electronics board lies within a plane substantially orthogonal to the central longitudinal axis. The electronics board is further positioned in a first position, e.g., during dose setting, to maintain a fixed rotational relationship with the inner sleeve, such that rotation of the hollow body causes the electronics board to rotate in a synchronized motion, matching the rotation of the inner sleeve. This means that, as the inner sleeve rotates, the at least one or more magnetometers located on the electronics board also rotate about the central longitudinal axis. The fixed rotational relationship between the injection monitoring system and the inner sleeve in the first position can be ensured by establishing any suitable coupling between the inner sleeve and the injection monitoring system in the first position, such as, for example, the coupling formed by at least one injection monitoring system connection surface and at least one injection system housing connection surface, as described above.

[0078] An integrated control and data processing unit, comprising at least one microcontroller, handles all electronic communications and signals between the various electronic components of the electronics board and the magnetic field sensor. It is also responsible for performing calculations that enable the precise position of the magnetic field sensor to be calculated and determined, as well as processing signals from autonomous power supply and communication devices integrated into the injection monitoring system, and communicating with a local or remote data processing system (e.g., via a smartphone). Such integrated control and data processing units are known per se and typically integrate a central processing unit, a real-time clock, one or more memory storage systems, and optionally a communication system or subsystem, as well as other desired components.

[0079] According to another object of the present invention, the electronic component board comprises a communication unit, which is electrically connected to the at least one microcontroller. Such a communication unit can be one or more of any number of communication units known per se, such as wireless communication units, e.g. Low power consumption or any other short or long range wireless communication technology.

[0080] According to another object of the invention, the electronic component board comprises an autonomous, selectable, rechargeable power source, such as a lithium-ion battery, which can be easily replaced when exhausted, or alternatively, a rechargeable battery, such as a rechargeable lithium-ion battery. In the case where a rechargeable battery is provided, the rechargeable battery can be charged when exhausted via a corresponding charging port (such as a USB charging port), which is provided in the injection monitoring module and is connected to the rechargeable battery. Non-rechargeable batteries (i.e. disposable batteries) and rechargeable batteries themselves are known to those skilled in the art. Nowadays, advances in charging technology also make wireless charging a reality, and such wirelessly rechargeable batteries, for example using an inductive charging system, are also foreseen as a possibility within the objects of the present invention.

[0081] These and other objects of the present invention will become apparent and described in more detail in the following description of the accompanying drawings and examples of monitoring modules. BRIEF DESCRIPTION OF THE DRAWINGS

[0082] The present invention will now be described in more detail with reference to the accompanying drawings, which are provided for the purpose of illustration and example, and in which:

[0083] Figure 1 is a schematic perspective view of an injection monitoring module mounted on a handheld pen injection system;

[0084] Figure 2 yes Figure 1 A schematic cross-sectional view of an injection monitoring module mounted on a handheld pen injection system;

[0085] Figure 3 yes Figure 1 or Figure 2 A schematic perspective view of an injection monitoring module;

[0086] Figure 4 It is from Figure 1 or Figure 2 a schematic axial view of the distal end of the injection monitoring module as viewed along the central longitudinal axis of the module;

[0087] Figure 5 yes Figure 1 or Figure 2 A schematic exploded perspective view of an injection monitoring module;

[0088] Figure 6A and Figure 6B yes Figure 1 or Figure 2 a schematic cross-sectional view of an injection monitoring module in a first position and a second position about a central longitudinal axis, in a dose setting position;

[0089] Figure 7 yes Figure 1 or Figure 2 A schematic cross-sectional view of an injection monitoring module in a dose injection position or a dosing position;

[0090] Figure 8 It is composed Figure 1 or Figure 2 A schematic perspective view of an injection monitoring system housing as part of an injection monitoring module, Figure 5 It is also reflected in. DETAILED DESCRIPTION

[0091] Now turn Figure 1 and Figure 2 , shows a schematic perspective view of an injection monitoring module (1) according to the present invention. The injection monitoring module (1) is mounted on a handheld injection pen system (2), which comprises a pen injection system body (3) having an outer peripheral surface (4), a pen cap (5) covering the distal end of the pen injection system, a dose setting or dialing wheel (6) located at the proximal end of the pen injection system body (3), and a dialed dose visualization window (7) located at the distal end of the dose setting wheel (6) and displaying the dose that has been dialed by the user of the pen injection system. The injection monitoring module (1) according to the present invention is located and adjacent to the proximal end (8) of the injection pen system (2), in particular at least partially surrounding and contacting the outer peripheral surface (4), surrounding and contacting the pen body (3), and extending in the proximal direction beyond the proximal end (8) of the pen body (3), in particular beyond the dose setting wheel (6). A central longitudinal axis (9) is also shown, which passes through the longitudinal axial center of the injection monitoring module (1) and the injection pen system body (3). The injection pen system is provided with an activator button (10) which is located proximal to the dose setting or dial wheel (6) and which can be found in several commercially available injection pen systems. Figure 1 and Figure 2 In the pen injection system shown, the dose setting wheel rotates about the central longitudinal axis (9) during dose setting, but is fixed and does not rotate during injection. An example of such a pen is the one commercially available from Novo Nordisk Insulin injection pen series.

[0092] The injection monitoring module (1) comprises a hollow body (11) sized and configured to be coaxially mounted around a body (3) of a pen-type injection system (2). To this end, the hollow body (11) comprises a central longitudinal bore (12) having a proximal end (13) and a distal end (14), and a central longitudinal axis coinciding with the central longitudinal axis (9). The hollow body further comprises a distal body portion (15) extending around an outer surface (4) of the body (3) at a position on the pen body (3) distal from a dose setting wheel (6) and frictionally engaging the outer surface (4) of the body (3). The frictional engagement of the hollow body (11) with the outer surface (4) of the pen body (3) can be achieved by providing an elastic friction material (16) on an inner peripheral surface (17) of the hollow body to provide a push-fit or slide-fit engagement of the distal portion (15) with the outer surface (4) of the pen body (3), such frictional engagement materials being well known in the art. The hollow body extends in a proximal direction above and beyond the limit of an activator button (10) of the pen-type injection system (2), so that the hole (12) accommodates both the dose setting wheel (6) and the activator button (10), and the dose setting wheel is free to rotate in the hole (12). The proximal end (13) of the hole corresponds to the proximal end of the hollow body (11).

[0093] The hollow body (11) further comprises magnetic field generating means (18, 19) located on or within the hollow body (11) at the proximal end (13) of the central longitudinal bore (12). The magnetic field generating means (18, 19) is suitably provided by a pair of single dipole magnets (18, 19) positioned diametrically opposite each other, each magnet having a north (N) pole (18a, 19a) and a south (S) pole (18b, 19b), the poles of each pair preferably being arranged axially from NS along the central longitudinal axis, with the north pole located at the proximal end and the south pole located at the distal end, e.g. see Figure 5 . The dipole magnets (18a, 18b, 19a, 19b) can be suitably formed into a rod shape, or alternatively into a disc shape or annular shape, or any other suitable shape. The magnets are located in grooves (20, 21) of appropriate size provided on the hollow body (11), the grooves (20, 21) being located at the proximal end (13) of the body (11). Alternatively, the magnetic field generating means can be a single dipole annular magnet located on the outer proximal surface of the hollow body (11) or in a corresponding annular groove at the proximal end (13) of the hollow body. It can be understood from the above that the magnetic field generating means cannot rotate freely around the central longitudinal axis because the hollow body (11) is mounted on the pen body (3) in a fixed positional relationship around the central longitudinal axis (9), and the hollow body (11) is frictionally fixed to the outer surface (4) of the pen body (3) by the friction engagement means (16).

[0094] The hollow body (11) further comprises an inner sleeve (22) located within the central longitudinal bore (12) and configured to frictionally engage an outer surface of the dose setting wheel (6) so as to rotate together with the dose setting wheel (6) about the central longitudinal axis (9) during dose setting without axially translating along the central longitudinal axis. The inner sleeve (22) will be described in more detail below, in particular Figure 5 、 6A and 6B.

[0095] The injection monitoring module is shown in a schematic perspective view. Figure 3 In this view, the hollow body (11), the distal portion (15) and the respective proximal (13) and distal (14) ends are shown. Figure 3 Also shown is the shape of the hollow body (11) having a diameter that gradually widens from the proximal end toward a point (23) adjacent to or proximal to the distal end (14) of the distal portion (15). This widening diameter corresponds to the widening of the aperture (12) so that the hollow body can be inserted into and around the proximal end of the pen and fit over the dose setting wheel (6) of the pen while leaving sufficient space within the aperture to accommodate the inner sleeve (22) so that the inner sleeve can engage with the outer surface of the dose setting wheel. The distal portion (15) includes a correspondingly shaped narrowing diameter extending from the point (23) where the hollow body (11) is at its widest diameter toward the distal end (14). The point of widest diameter (23) is also the point at which the hollow body (11) and the distal portion (15) are suitably configured to prevent translation of the inner sleeve (22) along the central longitudinal axis, as will be referred to hereinafter. Figure 5 、 6A and 6B are described in more detail.

[0096] Figure 4 is a schematic diagram of an injection monitoring module according to the present invention, when viewed from the distal end (14) of the distal part (15) of the hollow body (11) along the hole (12) and the central longitudinal axis (9), the central longitudinal axis (9) being represented by the intersection of the crosshairs A'-A" and B'-B". In this view, the inner peripheral surface (17) of the distal part (15) of the hollow body and the inner sleeve (22) are shown. Contact or engagement surfaces (24) respectively arranged at the proximal end of the inner sleeve (22) and corresponding contact or engagement surfaces (25) arranged on the injection monitoring system housing (26) and extending from its distal end into the hole (12) are also shown, and the engagement surfaces (24) and the corresponding engagement surfaces (25) cooperate with each other, as will be described in more detail below.

[0097] Figure 5A schematic exploded perspective view of the components of an exemplary injection monitoring module according to the present invention is shown. The hollow body (11) and the distal portion (15) are shown in this illustration as separate components that can be assembled together when the distal portion (15) and the hollow body are mounted on the body (3) of the pen injection system (2). Although not mandatory, this two-part presentation is particularly advantageous because it further facilitates the insertion of the inner sleeve (22) into the hole (12) and its position relative to the outer surface of the body (3) of the pen injection system (2), and helps to facilitate its relative positioning relative to the distal portion (15) and the hollow body, preventing the inner sleeve from translating in the proximal or distal direction once the monitoring module is mounted on the body (3) of the pen injection system. To this end, the point (23) of widest diameter of the hollow body (11) and the distal portion (15) is suitably the point at which these components fit together when the injection monitoring module is mounted, for example by providing a distal annular skirt (27) and a proximal protruding distal annular wall (28) on the distal end (29) of the hollow body (11), the distal annular wall (28) having a reduced diameter compared to the skirt (27), and providing a corresponding distal protruding annular wall (30) at the proximal end (31) of the distal portion, the annular wall (30) engaging the distal protruding annular wall (28) and the corresponding distal annular skirt (27). The hollow body (11) and the distal portion (15) may be suitably clamped, adhered and / or bonded to each other at the widest point (23), for example using ultrasonic welding, or any other suitable form of bonding technique, or other bonding method, so that the hollow body (11) and the distal portion (15) can be securely held together. Alternatively, the hollow body (11) and the distal portion (15) may be provided as a single component, suitably sized and configured to fit around and engage with a corresponding injection pen body (3).

[0098] The inner sleeve (22) further comprises at least one or more elastically deformable surfaces (32) extending inwardly from the inner sleeve (22) towards the central longitudinal axis (9) to form at least one or more frictional engagement surfaces (32) for frictionally engaging with the outer surface of the dose setting wheel. The at least one or more elastically deformable surfaces (32) extending inwardly from the inner sleeve (22) towards the central longitudinal axis can suitably be provided as a ring (33) of elastically deformable material comprising a plurality of coaxially arranged, radially spaced teeth extending in the same direction from the ring (33), and the ring being operatively mounted at the proximal end (34) of the inner sleeve (22), the teeth being oriented to extend in a distal direction along the outer and / or inner surface of the sleeve (22). Advantageously, the elastically deformable material is a suitable elastomer, such as a SEBS elastomer, which is known per se in the art. The elastically deformable surface (32) or teeth extend through a plurality of corresponding coaxially arranged, radially spaced openings (35) which extend from the outer surface (36) of the inner sleeve (22) to the inner surface (37) thereof. As will be readily appreciated from the above, the elastically deformable surface advantageously extends from one side, e.g. forming the outer surface (36) of the inner sleeve (22), through the bulk material of the inner sleeve (22), and to the other side, e.g. the inner surface (37) of the inner sleeve, thereby providing one or more frictionally engaging contact surfaces with the outer surface of the dose setting wheel (6) of the pen injection system, ensuring that any rotation of the inner sleeve is transmitted to the dose setting wheel and vice versa.

[0099] As mentioned above, and Figure 6A and 6B In more detail, Figure 6A and 6B is a representative cross-sectional view of an injection monitoring device according to the present invention, with the inner sleeve (22) being prevented from translational movement along the central longitudinal axis (9) in either the proximal or distal direction. Figure 6A and 6B Indicates that the injection monitoring module is in the first or dose setting position, ie the position in which the monitoring module is installed on the pen-type injection body. Figure 6A and Figure 6BThe only difference between the two is the rotation of the cross section about the central longitudinal axis (9). Therefore, the hollow body (11) also includes a translation support device (38) adapted and configured to prevent the inner sleeve (22) from performing an axial translational movement along the central longitudinal axis when the injection monitoring module (1) is in the installed position on the injection pen system (2). The shape and size of the translation support device (38) are such as to prevent the inner sleeve from performing an axial translational movement along the central longitudinal axis (9) beyond a predetermined point (23) in or on the hollow body in at least the distal direction, but advantageously and preferably prevent the inner sleeve from performing an axial translational movement along the central longitudinal axis (9) in the proximal direction. To this end, the translation support device of the hollow body (11) is formed as an annular groove (38) or annular slot provided on the inner surface (17) of the hollow body (11). The annular groove (38) may be suitably formed by mating surfaces formed by a distally directed surface (39) provided on the hollow body (11) and a proximally directed surface (40) of the respectively corresponding distal body portion (15).

[0100] Furthermore, the inner sleeve further comprises surface engagement means (41) located near or substantially at the distal end of the inner sleeve, wherein the surface engagement means is configured to engage with at least one inner surface of the distal body portion (15) and the hollow body (11), e.g., an annular groove (38) formed by a distally directed surface (39) and a proximally directed surface (40), thereby preventing translational movement of the inner sleeve in the distal and / or proximal direction when the injection monitoring module (1) is in the installed position on the injection pen system (2). To this end, the surface engagement means (41) can suitably be formed by at least one continuous protrusion (41) or a plurality of individual protrusions (41a, 41b, 41c, etc.), which extend radially outwards from the outer surface (36) of the inner sleeve (22). The protrusion (41) includes at least one distally directed surface (42) that engages with a corresponding proximally directed surface (40) of an annular groove (38) provided on the inner surface (17) of the hollow body (11). When the injection monitoring module is mounted on the pen-type injection system, the interaction between the mating surface of the protrusion (41) and the annular groove (38) and the corresponding surfaces (39, 40) prevents any substantial translational movement of the inner sleeve along the central longitudinal axis. However, the dimensions of the groove (38) and the protrusion (41) are still appropriate and corresponding to allow the inner sleeve (22) to rotate about the central longitudinal axis (9), such that the protrusion (41) is free to move about the axis (9) within the groove (38) when a rotational force or force is applied to the inner sleeve (22), for example during dose setting.

[0101] As can be seen from the figure, especially Figure 5 、 6Aand 6B, the inner sleeve is also connected to an injection monitoring system (43), which is indicated by square brackets and includes several components, one of which is an injection monitoring system housing (26). The injection monitoring system housing (26) is shaped and constructed similarly to a cup with a stem, wherein a bottom wall (44) extends on a diameter substantially the same as or similar to that of the hollow body (11) and is substantially perpendicular to the central longitudinal axis, and a first annular wall (45) extends from the periphery of the bottom wall (44) in a proximal direction away from the bottom wall (44) to form a cup-shaped portion having an interior volume, the interior volume being closed by a proximal cover (46) forming a button, the proximal cover (46) being fixed to the proximally extending first annular wall (45) at the proximal end (47) of the first annular wall by snapping, press-fitting, adhering or other means. The bottom wall (44) further includes a second annular wall (48) extending from the bottom wall (44) in a distal direction from a position radially spaced from the central longitudinal axis (9) and having a diameter smaller than the diameter of the bore (12) of the hollow body. The second annular wall (48) is closed at its distal end (49) by a transverse wall (50) to form a stem of the cup. The stem of the cup is located within the bore (12) of the hollow body. The injection monitoring system housing (26) defined by the cup-shaped interior volume receives and houses the electronics board (51). The interior volume of the stem formed by the second annular wall (48) and the transverse wall (50) receives an autonomous power source (52), such as a disposable or rechargeable battery, such as a lithium-ion battery, electrically connected to the electronics board (51) to provide power to the electronics board (51). The electronic component board (51), suitably and typically a printed circuit board of suitable dimensions, is located within the interior volume of the cup formed by the bottom wall (44) and the proximally extending first annular wall (45). The injection monitoring system housing (26) optionally further comprises a light guide window (54) integrated into or as part of the first annular wall (45), for example, of a translucent, opaque or transparent material, the shape and crystalline properties of which are selected to guide light waves from the interior volume of the cup, for example, to transmit light generated by an optionally present light emitting diode or other light wave generating component to the exterior of the injection monitoring system housing (26).

[0102] The electronic component board (51) further comprises at least one magnetometer (53), which is advantageously located on the central longitudinal axis, and in the case of a substantially circular component board, the magnetometer (53) is substantially located at its center so as to be aligned with the central longitudinal axis. In addition to the magnetometer (53), the injection monitoring system (43) also comprises an integrated control and data processing unit (55), which is electrically connected to the magnetometer (53) and is used to process information received from the magnetometer. The integrated control and data processing unit (55) handles all electronic communications and signals between the different electronic components of the injection monitoring system. It is also responsible for executing the dose management system and calculations so that the precise position of the magnet can be calculated and determined, as well as processing signals from the autonomous power supply (52). The electronic component board can further be connected to a USB port (56), which can be configured as a power charging port for the rechargeable battery (52) and / or configured to enable basic settings of any programmable memory on the electronic component board or to configure the data processing unit (55). The integrated control and data processing unit (55) also typically includes communication means for communicating with a local or remote data processing system, such as on a smartphone, such as wireless communication circuitry, e.g. or low power consumption Wireless communication systems are just two of many types of suitable communication means. The integrated control and data processing unit (55) can suitably be remotely programmed upon first use or receive information and updates in a manner similar to other electronic devices today incorporating integrated control and data processing units, for example wirelessly or via any other suitable connection, such as a USB port (56). Such integrated control and data processing units are known per se and typically integrate a central processing unit, a real-time clock, one or more memory storage systems, and optionally a communication system or subsystems, and other desired elements. The electronics board (51) is mounted or located within the cup formed by the first annular wall (45) and the bottom wall (44) of the injection monitoring system housing (26), substantially along the horizontal plane of the circuit board, i.e., substantially orthogonal and perpendicular to the central longitudinal axis (9).

[0103] The injection monitoring housing further comprises a third annular wall (57) extending from the bottom wall (44) at the periphery of said bottom wall (44) in a distal direction of the hollow body (11). The third annular bottom wall (57) provides axial stability to the injection monitoring system housing (26) and is in particular sized to surround the outer circumference of the hollow body at its proximal end (13) both in the first, dose setting position and during activation of the activator button, in other words, during injection and / or ejection of a substance from the injection pen system. Figure 6A 、 6B and Figure 7 shown.

[0104] Figure 7 ,in particular Figure 8 , both show some details relating to the physical connection between the inner sleeve (22) and the injection monitoring system housing (26). In particular, such connection is adapted and configured to enable the inner sleeve (22) and the injection monitoring system housing (26) to rotate together about the central longitudinal axis (9) in a first position (i.e., during dose setting), and then allow the injection monitoring system housing (26) to translate along the central longitudinal axis (9), but not rotate, in a second position (i.e., during injection and / or ejection of medication from the pen injection system).

[0105] The connection between the inner sleeve (22) and the injection monitoring system housing is advantageously provided by a series of interacting and cooperating connection surfaces (24, 25). Thus, the inner sleeve (22) is provided with at least one injection monitoring system connection surface (24), i.e. a surface for connection, contact or engagement with the injection monitoring system, which connection surface extends from the inner surface of the sleeve (22) and projects inwardly towards the central longitudinal axis of the bore (12). Figure 7 As shown, wherein the injection monitoring module (1) has been moved to the ejection or injection position and the activator button of the pen-type injection system has been activated, the connecting surface (24) is an annular surface formed on the innermost peripheral edge (58) of the annular shoulder (59) extending radially inward from the proximal end of the inner sleeve (22) into the hole (12). Such connecting surface (24) also usefully includes at least one or more recesses (60) provided on the inwardly protruding connecting surface.

[0106] Correspondingly, the injection monitoring housing (26) includes at least one corresponding connection surface (25) extending distally from the housing (26). As shown, the connection surface (25) extending distally from the injection monitoring housing (26) is provided as a plurality of one or more protrusions (61), one or more of which are further provided with a distal contact surface (62). The protrusions (61) extend from the bottom wall (44) and / or from the distal end (49) of the second annular wall (48) and / or from the transverse wall (50) and are radially spaced apart from each other around the central longitudinal axis (9). Some nubs (61), for example three nubs, are shaped and sized to be inserted into corresponding recesses (60) provided in the annular inwardly projecting shoulder (59). The remaining nubs (61) provide a rotational lock between the inner sleeve (22) and the injection monitoring system housing (26) in the first, dose setting position. The remaining nub (61) projects further in the distal direction and is of sufficient length to engage and contact the activator button (10) of the pen injection system when an injection and / or ejection operation is performed using the pen injection system, such as when a dose of an injectable substance (e.g., a drug) is injected. This is the case when the injection monitoring module is moved from a first, dose setting position to a second, dose ejection and / or injection position.

[0107] Thus, the cooperating connecting or contact surfaces (24, 25) engage each other in a first position in which the user, in accordance with the usual mode of operation of an injection pen system of the type described, rotates the injection monitoring system housing (26) using a finger and / or thumb, allowing a dose to be set, resulting in a co-rotation of the inner sleeve (22) as the inner sleeve also engages the outer surface of the dose setting wheel (6). Once the dose has been set, pressing the cover in the distal direction with the thumb and / or finger causes the connecting surfaces (24, 25) to slide into engagement with each other in a translational movement along the central longitudinal axis (9) without any rotational movement. In doing so, the nub (61) moves within the hole (12) along the central longitudinal axis (9) until the distal contact surface (62) comes into contact with the activator button (10). This corresponds to the second position. Since the longitudinal distance between the distal surface (62) not in contact and the distal surface (62) in contact with the activator button is only a few millimeters and this axial translation distance is a known value, the data processing unit can be configured to calculate the time the distal contact surface remains in contact with the activator button. For example, in this case, an elapsed time method can be used, which calibrates the predetermined detectable magnetic field change along the longitudinal axis as the magnetic field sensor moves from a first, dose setting position to a second, dose ejection / injection position and then back again due to recoil energy transmitted by an internal retaining spring of such pen-type injection system to an activator button (10) of the pen-type injection system (2). The calculation of the elapsed time by the data processing unit can further be used to perform pre-programmed calculations to determine an injection start point and a corresponding injection end point, these calculations being temporarily stored in the data processing unit of the injection monitoring module for later transmission via the communication unit (e.g., via wireless communication) to a remote device, such as a smartphone, tablet computer or other remote computing device.

[0108] As an example of how to use the injection monitoring module, the following description is provided:

[0109] The monitoring module is mounted on a pen-type injection device, e.g. Insulin pens;

[0110] The user rotates the injection monitoring system housing using the fingers and / or thumb of one hand while holding the body of the pen with the other hand;

[0111] Rotation of the injection monitoring system housing (26), which is rotationally locked to the inner sleeve (22) via the connecting surfaces (24, 25), causes the dose setting wheel (6) of the injection pen to rotate due to frictional contact between the inner sleeve and the outer surface of the dose setting wheel (6);

[0112] During dose setting, rotation of the magnetometer (53) about the central longitudinal axis (9) causes the magnetometer (53) and the data processing unit to record changes in the magnetic field as a function of the angular position of the magnetometer relative to the magnet;

[0113] When the user depresses the proximal cover (46), the injection monitoring housing (26) translates in a distal direction along the central longitudinal axis (9);

[0114] As a result of this translational movement, the magnetometer also translates in the distal direction along said axis, and any changes in the detected magnetic field signal a data processing unit;

[0115] The distal contact surface (62) of the nub (61) contacts the activator button, thereby initiating the injection / ejection operation;

[0116] During the injection / ejection operation, no further translational movement in the proximal direction occurs because the activator button has a predetermined, constrained limit of longitudinal axial movement, typically less than 1 mm;

[0117] When the user releases thumb or finger pressure on the cover (46), the activator button rebounds under the force of recoil energy imparted thereto by the pen system, the recoil energy being just sufficient to transfer said recoil energy to the distal surface (62) of the nub (61), thereby causing the injection monitoring housing (26) to move proximally from the second position back to the first position;

[0118] The magnetometer moves the same translation distance away from the magnet along the central axis and sends a corresponding magnetic field change signal to the data processing unit;

[0119] The data processing unit then performs calculations, for example using an elapsed time correlation method based on the known travel distance and the signal magnetic field, to determine the injection start point, the injection end point and the actual ejected and / or injected dose.

Claims

1. An injection monitoring module adapted and configured to be removably mounted to a proximal end of an injection pen system for delivering a drug, the injection pen system having a pen body, a dose setting wheel connected to the pen body at the proximal end, and an injection activator, the dose setting wheel being rotatable about a central longitudinal axis of the pen injection system during dose setting and being fixed against rotation during injection, wherein: The injection monitoring module includes: a hollow body adapted and configured to be coaxially mounted about a body of the pen injection system, the hollow body including a central longitudinal bore having a proximal end and a distal end, and a central longitudinal axis; a magnetic field generating device located on or within the hollow body proximal to the central longitudinal bore; an injection monitoring system, the injection monitoring system including a magnetometer, the injection monitoring system being located proximal to the bore of the hollow body; The hollow body further comprises an inner sleeve positioned within the central longitudinal bore and configured to frictionally engage an outer surface of the dose setting wheel to co-rotate with the dose setting wheel about the central longitudinal axis during dose setting without axially translating along the central longitudinal axis; The inner sleeve is connected to the injection monitoring system; and the connection between the inner sleeve and the injection monitoring system being adapted and configured to cause the inner sleeve and the injection monitoring system to co-rotate about the central longitudinal axis during dose setting, and to cause the injection monitoring system to translate along the central longitudinal axis from a first monitoring position to a second monitoring position, but not to cause the injection monitoring system to rotate about the central longitudinal axis, during injection of a medicament from the pen injection system; Wherein, the magnetometer is configured to detect changes in a magnetic field when the injection monitoring system is axially translated between the first monitoring position and the second monitoring position.

2. The injection monitoring module according to claim 1, wherein: The hollow body further comprises a distal body portion extending around and frictionally engaging an outer surface of the body of the injection pen system at a position distal from the dose setting wheel.

3. The injection monitoring module according to claim 2, wherein: The hollow body further comprises a translation support device adapted and configured to prevent axial translational movement of the inner sleeve along the central longitudinal axis when the injection monitoring module is in an installed position on the injection pen system.

4. The injection monitoring module according to claim 3, wherein: The translation support means of the hollow body is formed as an annular groove provided on the inner surface of the hollow body.

5. The injection monitoring module according to claim 3 or 4, wherein: The translational bearing means are formed by a distally directed surface provided on the hollow body and a corresponding proximally directed surface of the distal body portion, which together form a cooperating translational bearing surface for the inner sleeve.

6. The injection monitoring module according to claim 1, wherein: The inner sleeve further comprises a surface engagement device located near the distal end of the inner sleeve, wherein the surface engagement device is configured to engage with at least an inner surface of the distal main body portion of the hollow body, thereby preventing translational movement of the inner sleeve in a distal and / or proximal direction when the injection monitoring module is in an installed position on the injection pen system.

7. The injection monitoring module according to claim 6, wherein: The surface engaging means comprises at least one continuous protrusion or a plurality of separate protrusions extending radially outwardly from the outer surface of the inner sleeve.

8. The injection monitoring module according to claim 6 or 7, wherein: The surface engagement means comprises at least one distally directed surface, and the distally directed surface of the surface engagement means engages with a corresponding proximally directed surface of a translation support means provided on an inner surface of the hollow body.

9. The injection monitoring module according to claim 6, wherein: The surface engagement device includes at least one continuous protrusion, or multiple separate protrusions, extending radially outward from the outer surface of the inner sleeve, and the translation support device of the hollow body is formed as an annular groove arranged on the inner surface of the hollow body, wherein the size of the annular groove is suitable for receiving the at least one continuous protrusion or multiple separate protrusions extending radially outward from the outer surface of the inner sleeve in the engagement of the proximal and distal surfaces of the mating protrusions.

10. The injection monitoring module according to claim 1, wherein: The inner sleeve further comprises at least one resiliently deformable surface extending inwardly from the inner sleeve towards the central longitudinal axis forming at least one frictional engagement surface for frictionally engaging an outer surface of the dose setting wheel.

11. The injection monitoring module according to claim 10, wherein: The at least one elastically deformable surface extending inwardly from the inner sleeve toward the central longitudinal axis is a ring of elastically deformable material, which includes a plurality of coaxially arranged, radially spaced teeth extending in the same direction from the ring, and the ring is mounted at the proximal end of the inner sleeve, and the teeth are oriented to extend in a distal direction along the outer surface and / or inner surface of the inner sleeve.

12. The injection monitoring module according to claim 11, wherein: The inner sleeve also includes a plurality of coaxially arranged, radially spaced openings that traverse the inner sleeve from the outer surface to the inner surface.

13. The injection monitoring module according to claim 12, wherein: The at least one elastically deformable surface extends through the radially spaced openings that traverse the inner sleeve.

14. The injection monitoring module according to claim 1, wherein: The inner sleeve further includes at least one injection monitoring system connection surface extending from an inner surface of the inner sleeve and projecting inwardly toward a central longitudinal axis of the bore.

15. The injection monitoring module according to claim 14, wherein: The at least one injection monitoring system connection surface extending from the inner surface of the inner sleeve and protruding inwardly toward the central longitudinal axis of the bore includes at least one recess disposed on the inwardly protruding injection monitoring system connection surface.

16. The injection monitoring module according to claim 15, wherein: The infusion monitoring system comprises a housing including at least one connection surface extending distally from the housing.

17. The injection monitoring module according to claim 16, wherein: The at least one injection monitoring system connection surface and the at least one connection surface of the injection monitoring system housing are adapted and configured to engage with each other in a first position, wherein rotation of the injection monitoring system housing causes a joint rotation of the inner sleeve, and to engage with each other in a second position, wherein the injection monitoring system only translates in a distal direction or a proximal direction along the central longitudinal axis, and the injection monitoring system housing does not rotate around the central longitudinal axis.

18. The injection monitoring module according to claim 16, wherein: The at least one connection surface extending from the injection monitoring system housing includes at least one distally extending protrusion extending from a distal end of the housing and coaxially aligned with the central longitudinal axis.

19. The injection monitoring module according to claim 17, wherein: In the first position, at least one distally extending protrusion of the injection monitoring system housing each includes an outwardly facing connection surface that frictionally engages a corresponding inwardly facing surface provided on the at least one recess of the inwardly protruding injection monitoring system connection surface.

20. The injection monitoring module according to claim 17, wherein: In the second position, the at least one distally extending protrusion extending from the injection monitoring system housing further comprises at least one distally directed contact surface that contacts the injection activator.

21. The injection monitoring module according to claim 1, wherein: The injection monitoring system is further configured to determine an elapsed time during which the injection monitoring system is in physical contact with a pen activator of the pen injection system.

22. The injection monitoring module according to claim 1, wherein: The infusion monitoring system also includes an electronics board.

23. The injection monitoring module according to claim 22, wherein: The electronic component board is electrically connected to the magnetometer.

24. The injection monitoring module according to claim 22, wherein: The electronics board includes at least one microcontroller electrically connected to the magnetometer.

25. The injection monitoring module according to claim 24, wherein: The electronic component board includes a communication unit electrically connected to the at least one microcontroller.

26. The injection monitoring module of claim 22, wherein: The electronics board includes a rechargeable power source.

27. The injection monitoring module of claim 1, wherein: The inner sleeve further comprises a surface engagement device located at the distal end of the inner sleeve, wherein the surface engagement device is configured to engage with at least an inner surface of the distal main body portion of the hollow body, thereby preventing translational movement of the inner sleeve in a distal and / or proximal direction when the injection monitoring module is in an installed position on the injection pen system.

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