Injection Monitoring Module

Abstract

An injection monitoring module mounted on the body of an injection pen system having a rotatable dose setting wheel and an injection actuation mechanism and having a central longitudinal axis comprises a hollow main body including a central longitudinal bore, magnetic field generating means located on the hollow main body at a proximal tip of the bore, an injection monitoring system having at least one magnetic sensor, and an inner sleeve located within the bore that engages with the outer surface of the dose wheel during dose setting and co-rotates therewith without axial translation, the inner sleeve being connected to the monitoring system in a manner that allows both the sleeve and the monitoring system to co-rotate about the axis during dose setting and allows the monitoring system to translate along the axis without rotation during injection of a drug from the pen.

Description

Technical Field

[0001] The present invention generally relates to a monitoring system for an injectable drug delivery device, and more particularly to injection monitoring for an injection pen system.

Background Art

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

[0003] For example, particularly with regard to pen injection systems, one of the longstanding problems has been to provide a system that is easy to use, reliable, and has appropriate fail-safes and that can be adapted to the various different configurations of the many commercially available pen injection systems that exist. Previous attempts to provide such monitoring systems typically involved adapting the body of the pen injection system to include electronic components along with one or more sensors therein. However, one of the main drawbacks of such systems is that when all of the electronic components are incorporated, the final product becomes a rather bulky and unwieldy object by those systems, and thus more difficult to use from the user's perspective. Further, such modified systems tend to be specific to a given brand or manufacturer and thus are of little or no use with respect to other manufacturers. Still further, in an attempt to overcome the bulk and unwieldiness problems of the modified pen injection system, there has been a tendency to try to make the overall volume of the injection pen body as small as possible through miniaturization of the complex electronic components, but this results in problems of its own, particularly with regard to electromagnetic interference between the various components, due to the multiple circuits that are in close proximity to provide the necessary or desired integrated functionality. Moving the sensors within such a monitoring system further away from the source of electromagnetic interference only complicates the situation and in some cases leads to reading errors or requires additional systems to compensate for the physical separation of the sensors from other electronic components, such as the microcontroller that is designed to control and instruct the various components and manage their interactions.

[0004] The problem injection pen system is well-known per se and generally comprises a dosage setting wheel arranged proximally and an injection actuation mechanism, the dosage setting wheel being rotatable about the longitudinal central axis of the pen injection system. The user rotates the wheel to select the dosage of the drug to be administered. The pen is generally configured to perform an injection either mechanically or electromechanically when the injection actuation mechanism is actuated. Such an injection actuation mechanism is very commonly a simple press or push button in mechanical or electrical contact with a dispensing mechanism arranged within the pen injection system, by pressing which the injection mechanism injects and dispenses the drug contained within the pen injection system. In some pen syringe systems, the dosage setting wheel is configured to rotate not only during dosage setting but also during injection. This is generally achieved by including one or more metal components, for example, a helical drive spring arranged within the housing body of the injection pen system and physically connected to the dosage setting wheel. Since such metal elements are relatively large objects compared to the electronic component systems included in many pen injection systems today, these large metal objects may further disrupt signals designed to be captured or picked up by sensors within such electronic component systems, and in some cases reduce the accuracy of the system and / or require complex correction mechanisms to be placed in place 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, Patent Document 1 relates to a sensor assembly having a first rotational sensor portion comprising a plurality of individual conductive sensor regions arranged in a pattern, and a second rotational sensor portion arranged to rotate relative to the first portion and comprising a plurality of contact structures adapted to contact the conductive sensor regions on the rotating portion of the first sensor. The contact structures are configured to engage and connect to different sensor regions when the first and second portions of the rotational sensor rotate relative to each other, and the connections formed indicate the rotational position relationship between the first and second portions. One of the contact structures is an operable contact structure axially movable relative to the first portion, having a connection position where the operable contact structure contacts the sensor region and a disconnection position where the operable contact structure is not in contact with the sensor region. This system is housed within the pen injector body, at least partially within the volume inside the dose setting wheel. The system also comprises a visual display, such as an LCD display, disposed on or instead of the injection actuation mechanism button.

[0007] In contrast, Patent Document 2 includes an administration component that is rotatable and axially movable with respect to a connection component that is attached to the actuator and attached to the dose setting member, and includes a module including an electronic sensor operable to detect relative rotation of the connection component and the administration component to detect the dose delivered by the pharmaceutical delivery device. The dose detection module is removably connected to the proximal end of the pen injection system and is intended to function as means for detecting the amount of pharmaceutical dispensed by the pen injection system while attached thereto, storing the detected dose in a 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 provided on the cylinder surface to indicate various states or positions of the injection administration operation including dose setting, and the electrical contacts are configured in an accordion manner with overlapping folded portions in a removably connected body and are housed on a flexible printed circuit board that is insulated by a non-conductive spacer layer between overlapping layers of the circuit board to prevent possible electrical, electronic, and electromagnetic interference, and is connected to a set of electronic components.

[0008] One thing that can be directly seen by observing the above-described configuration is that, despite using a folded flexible printed circuit board to provide a plurality of surfaces for positioning electronic components, in terms of their relative spatial density and positioning with respect to each other, it is necessary to provide non-conductive spacers between layers of the electronic components. A direct consequence of this is that the height of the module increases, and inevitably the complexity of the clip-on dose detection module described in the same specification increases.

Prior Art Documents

Patent Documents

[0009]

Patent Document 1

[0010] Accordingly, one object of the present invention is an injection monitoring module adapted and configured to be removably attached to the proximal tip of an injection pen system for delivering a drug, wherein the injection pen system is rotatable about the longitudinal central axis of the pen injection system to set the dosage of the drug to be injected and is fixed so as not to rotate during injection, and has a dosage setting wheel, and to provide an injection monitoring module, in which case the configuration of the injection monitoring module is much simpler and at the same time there is no need for a complex shielding or protection solution to address any unwanted electrical, electronic, or electromagnetic effects caused by the relatively high density of electronic components within the monitoring module.

[0011] Another object of the present invention is to provide an injection monitoring module as described above, where the monitoring module is adapted and configured to determine an injection end point in a pen injection system in which a dose setting wheel does not rotate during injection. For the purposes of the present invention, the expression "injection end point", as used herein, not only means the completion of the injection of the dose of an injectable substance, such as a drug, when the user injects the required dose of the injectable substance in a single operation, but also includes any amount of drug actually ejected by the pen injection system after the selection or dial operation of the dose via the dose setting wheel when the injection monitoring module is mounted on the injection pen system. This means that when the user performs a series of short repeated injection operations, for example, by repeated continuous actuation of the injection mechanism, the corresponding end points for each injection step are registered and the corresponding amounts of the injectable substance are calculated as having been injected or ejected from the pen injection system.

[0012] Yet another object of the present invention is to provide an injection monitoring module as described above, where the module is adapted and configured to detect or calculate the dose of the injectable substance contained within the pen injection system or the amount set by the user, the injection start or starting point in the pen injection system, and the injection end point, and therefrom determine whether all of the dose or the amount set by the user of the pen injection system has been ejected from the pen system.

[0013] These and other objects of the present invention will become readily apparent upon a complete reading of this specification.

Means for Solving the Problems

[0014] According to any of the above objects, an injection monitoring module adapted and configured to be removably attached to the proximal tip of an injection pen system for delivering a drug, the injection pen system having a pen body, a dose setting wheel disposed proximally and connected to the body, and an injection actuation mechanism, the dose setting wheel being rotatable about the longitudinal central axis of the pen injection system during dose setting and fixed so as not to rotate during injection. In the injection monitoring module, A hollow main body adapted and configured to be coaxially mounted around the body of the pen injection system, having a longitudinal central hole with a proximal tip and a distal tip and a longitudinal central axis. Magnetic field generating means disposed on or in the surface of the hollow main body at the proximal tip of the longitudinal central hole. An injection monitoring system comprising at least one or a plurality of magnetic sensors, disposed at the proximal tip of the hole of the hollow main body. The hollow main body further comprises an inner sleeve disposed within the longitudinal central hole and configured to engage frictionally with the outer surface of the dose setting wheel during dose setting and co-rotate about the longitudinal central axis together with the dose setting wheel without translating axially along the longitudinal central axis. The inner sleeve is connected to the injection monitoring system. The connection between the inner sleeve and the injection monitoring system is adapted and configured such that during dose setting, both the inner sleeve and the injection monitoring system co-rotate about the longitudinal central axis, and during injection and / or ejection of the drug from the pen injection system, the injection monitoring system translates along the longitudinal central axis but does not rotate about the longitudinal central axis. An injection monitoring module is provided.

[0015] As used herein, the terms "pen injection system" and "injector pen system" are used interchangeably to generally designate a pen-shaped injection system that is held in one hand, such systems being well known per se and commercially available for use in a variety of medical applications. These systems are also often designed generally for self-injection of drugs by a user when treatment for a given medical application is required. This is the case, for example, with respect to insulin intended for the treatment of symptoms of diabetes, one such example being the pen injector commercially available under the brand name FlexTouch® from Novo Nordisk. However, other drugs also fall within this category of medical devices, enabling immediate emergency injection of necessary drugs such as anaphylactic shock treatment agents, anticoagulants, opioid receptor agonists and antagonists, etc., that may be required to address, for example, life-threatening situations, and this has come to correspond to the extent that patients suffering from or prone to such illnesses generally carry these devices with them.

[0016] The injection pen system comprises a dosage setting wheel disposed proximally and an injection actuation mechanism, and the injection monitoring module according to the present invention is adapted and configured to be removably attached to this injection pen system. The dosage setting wheel rotates about the longitudinal central axis of the pen injection system, whereby the user can set the dosage of the drug for injection. The dosage setting wheel is generally rotatable in both clockwise and counterclockwise directions, and these directions generally correspond to an increase in the selected dosage to be administered and a decrease in the selected dosage to be administered, respectively. The injection actuation mechanism is often represented by a push button, usually disposed proximally of the dosage setting wheel and, in most injection pens, at the proximal tip of the injection pen system. After setting the dosage, when the user of the injection system then presses the injection actuation mechanism in the distal direction, the piston connected to the plunger is driven, and the drug is discharged out through a needle inserted into an appropriate injection site, such as the skin, adipose tissue, or muscle, according to the type of drug to be administered by the user, from the chamber within the injection pen body. The dosage setting wheel is often connected to the injection drive mechanism so that it rotates as the drug injection proceeds, although this is not essential. The functional mode of such an injection system is well known per se in the art. However, the monitoring module according to the present invention is mounted on a pen injection system in which the dosage setting wheel does not rotate during the discharge / injection operation phase.

[0017] The injection monitoring module according to the present invention is thus adapted and configured to be removably attached to the proximal tip of such an injection pen system. As used herein, the expressions "removably attached", "removably attachable", "removably mounted" or "removably mountable" mean, for example, when transferring the injection monitoring module to another pen injection system, or when the monitoring module is damaged during use and needs to be replaced, that the injection monitoring module can be attached or mounted and then removed. Such attachment and subsequent removal can be achieved by means of a connecting means on the monitoring module, which connecting means engages in a releasable manner with the proximal tip of the pen injection system, for example via frictional or elastic engagement or other releasable fastening means such as clips, straps, clamping rings corresponding to threads, etc., and engages with either or both of the dose setting wheel or the injection actuation mechanism.

[0018] The hollow main body of the injection monitoring module has a longitudinal central hole with a proximal tip and a distal tip, and this hole is dimensioned to allow coaxial mounting of the hollow main body so as to surround the body of the pen injection system.

[0019] The hollow main body further comprises an inner sleeve which is arranged within the longitudinal central hole and which frictionally engages with the outer surface of the dose setting wheel during dose setting and is configured not to translate axially along the longitudinal central axis but to co-rotate about the longitudinal central axis together with the dose setting wheel. When the inner sleeve rotates, the dose setting wheel rotates in the same direction to substantially the same or identical degree of rotation. In this way, it can be said that the inner sleeve co-rotates with the dose setting wheel.

[0020] The hollow main body is suitably fabricated from any suitable material, such as a highly durable polymer or plastic material, such as high density or high impact polypropylene. Advantageously, the hollow body is fabricated from a transparent, translucent, or opaque material to enable the user to grasp and recognize some visual cue, such as a light emitting diode, although such a cue may be provided or incorporated into the injection monitoring module and may optionally be used to indicate various states of operation of the injection monitoring system. Similarly, the inner sleeve is also suitably fabricated from a suitable material, such as a highly durable polymer or high impact plastic material, such as ABS.

[0021] The inner sleeve is also further connected or coupled to the injection monitoring system. The connection or coupling between the inner sleeve and the injection monitoring system is adapted and configured such that during dose setting both the inner sleeve and the injection monitoring system co-rotate about the longitudinal central axis, and such that during injection and / or ejection of the drug from the pen injection system the injection monitoring system translates along the longitudinal central axis but does not rotate about the longitudinal central axis. For this purpose, the connection between the inner sleeve and the injection monitoring system is configured to selectively rotate about the longitudinal central axis and then selectively translate along the longitudinal axis, the two movements being mutually exclusive of each other.

[0022] According to another object, the hollow main body further comprises a distal body portion that extends around and engages in frictional contact with the outer surface of the body of the injection pen system at a location distal to the dosage setting wheel. In this way, the hollow main body is maintained in a predetermined position on and around the surface of the pen injection system distally from the dosage setting wheel, and the dosage setting wheel can consequently rotate freely within the bore of the hollow main body. Such a frictional elastic configuration can be provided, for example, by a suitable elastomeric coating or deposit disposed on the inner circumferential surface of the hollow main body, such as on one or more regions, or alternatively, as a continuous, or partially continuous / continuous coating deposited on the inner circumferential surface of the hollow main body. The purpose of such a frictional elastic coating or deposit is to provide a frictional gripping force between the distal body portion and the pen injection body in order to maintain proper positioning of the hollow distal body portion relative to the pen injection body. Suitable types of elastomeric materials that can provide the corresponding frictional engagement are known per se in the art.

[0023] The injection monitoring module is also an injection monitoring system comprising at least one or a plurality of magnetic sensors and is also provided with an injection monitoring system disposed at the proximal tip of the bore of the hollow main body. Although the injection monitoring system will be described in more detail below, basically, the injection monitoring system comprises several different components and means for providing monitoring of injection states such as, for example: - the start of the injection operation, the end of the injection operation, where the end of the injection operation is to be understood as including both the complete administration of the selected dosage of the substance to be injected, or separate injection operations where the user injects only a part of the dosage or discharges a part of the selected dosage from the pen injection system.

[0024] Furthermore, according to another object of the present invention, the injection monitoring system is movable along the longitudinal central axis from a first monitoring position where the injection monitoring system is not in abutting contact with the proximal surface of the injection actuating mechanism to a second monitoring position where the injection monitoring system is in abutting contact with the proximal surface of the injection actuating mechanism. The injection monitoring system is preferably mounted to the proximal tip of the bore and completely covers or at least substantially covers the proximal tip of the bore.

[0025] From the above, it will be understood that the injection monitoring system can be moved from an initial position without physical contact between the monitoring system and the actuating mechanism button to a different position where physical contact is established between the monitoring system and the proximal surface of the injection actuating mechanism. Such movement generally results in a translational movement of the monitoring system along the longitudinal central axis from a first position to a second position. After setting the dosage by rotation of the inner sleeve and corresponding connection of the dosage setting wheel, the injection monitoring module is further configured such that translational movement along the longitudinal central axis of the injection monitoring system as described above is responsible for detecting or determining the injection start and / or end points. For example, the monitoring module can be configured to detect the injection start point when the monitoring system translates in the distal direction. In the opposite manner, the monitoring system can be configured to detect the end point of injection or discharge of the injectable substance when the monitoring system translates in the proximal direction and thereby breaks the physical contact between the actuating mechanism button of the pen injection system and the monitoring system. One way to achieve this is, for example, by determining the time elapsed while the injection monitoring system is in physical contact with the pen actuating mechanism of the pen injection system. The translational movement in the direction opposite to the injection direction, i.e., the translational movement of the monitoring system in the proximal direction back towards the user's hand or thumb, in such a pen injection system can be suitably realized by directly or indirectly utilizing the repulsive energy of the detent spring disposed inside the injection pen, after the user releases the actuating mechanism button, for example by removing the pressure of the thumb or other finger on the button. This repulsive energy acts by repelling against anything in contact with the proximal surface of the actuating mechanism button of the pen injection system, thus moving the injection monitoring system away from the pen actuating mechanism button, and as a result the injection monitoring system no longer remains in contact with the pen actuating mechanism button.

[0026] According to another object of the present invention, the monitoring module of the present invention comprises magnetic field generating means disposed on or in the surface of the hollow main body at the proximal tip of the longitudinal central hole. It will be understood by the expression "disposed on or in the surface of the hollow main body" that the magnetic field generating means can be installed, for example, on the proximal facing surfaces at the proximal tip of the central hole of the hollow main body. Alternatively, the magnetic field generating means can be installed in a cavity or recess provided at the proximal tip of the central hole of the hollow main body.

[0027] Various means for generating a magnetic field are known, such as conventional magnets, electromagnets, and magnets of composite materials. Such magnets can typically be made from magnetizable materials having magnetic or paramagnetic properties, whether natural or such that a magnetic field is generated or induced in the material when a current or other energy-providing flow passes through the material. Suitable materials can be appropriately selected from the following: - Ferrite magnets, especially sintered ferrite magnets, such as crystalline compounds of iron, oxygen, and strontium, - Composite materials composed of a thermoplastic base material and isotropic neodymium-iron-boron powder, - Composite materials composed of a thermoplastic base material and strontium-based hard ferrite powder, in which case the resulting magnet can contain isotropic i.e. non-oriented or anisotropic i.e. oriented ferrite particles, - Composite materials composed of a thermosetting plastic base material and isotropic neodymium-iron-boron powder, - Magnetic elastomers, produced, for example, from heavily charged strontium ferrite powder mixed with synthetic rubber or PVC and then extruded or calendered into the desired shape to form a fine sheet, -A calendered flexible composite material generally having a brownish sheet appearance and having more or less flexibility depending on its thickness and composition. These composite materials never have rubber-like elasticity and tend to have a Shore hardness in the range of about 40 to 70 Shore D ANSI. Such composite materials are generally formed from a synthetic elastomer filled with strontium ferrite particles. The resulting magnets can be anisotropic or isotropic, and the various sheets generally have an alignment of magnetic particles due to the calendering process. -A laminated composite material laminated with soft iron pole pieces generally containing a flexible composite material as described above. -Neodymium-iron-boron magnets. -Steel made of an aluminum-nickel-cobalt alloy and magnetized. -An alloy of samarium and cobalt.

[0028] Among the above list of magnetic field generating means suitable for use in the present invention, those selected from the group consisting of neodymium-iron-boron permanent magnets, magnetic elastomers, composite materials composed of a thermoplastic base material and strontium-based hard ferrite powder, and composite materials made of a thermosetting plastic base material and isotropic neodymium-iron-boron powder are preferred. Such magnets are known for being able to be dimensioned to a relatively small size while maintaining a relatively high magnetic field strength.

[0029] The magnetic field generating means can be of any suitable overall shape, for example, a disc shape including circular, elliptical, or any other suitable polygonal shape, but preferably has only a single pair of north and south magnetic poles opposed in the diameter direction, i.e., a single dipole. The magnetic field generating means can also optionally be substantially disc-shaped, but such a disc shape preferably also includes magnets having an opening substantially at the center of the disc to form a ring or annular magnet. Such a ring or annular magnet can be usefully installed on the annular outer peripheral surface facing proximal at the proximal tip of the hollow main body.

[0030] According to yet another object, the hollow main body further comprises translational abutment means adapted and configured to prevent axial translational movement of the inner sleeve along the longitudinal central axis when the injection monitoring module is in the mounted position on the injection pen system. The translational abutment means are shaped and dimensioned to prevent axial translational movement of the inner sleeve beyond a predetermined point inside the hollow main body, at least in the distal direction along the longitudinal central axis, but advantageously and preferably also in the proximal direction along the longitudinal central axis.

[0031] According to yet another object, the translational abutment means of the hollow main body are formed as an annular groove or an annular slot provided on the inner surface of the hollow main body.

[0032] According to another further object, the translational abutment means are formed from a distal-facing surface provided on the hollow main body and a corresponding proximal-facing surface of the distal body portion, and the distal-facing surface and the proximal-facing surface together form cooperating translational abutment surfaces for the inner sleeve.

[0033] According to another object, the inner sleeve further comprises surface engagement means disposed adjacent to or substantially at the distal tip of the inner sleeve, and the surface engagement means are configured to engage at least the inner surface of the distal body portion of the hollow main body when the injection monitoring module is in the mounted position on the injection pen system, thereby preventing translational movement of the inner sleeve in the distal and / or proximal directions.

[0034] According to yet another further object, the surface engagement means comprise at least one continuous protrusion or a plurality of individual protrusions extending radially outward from the outer surface of the inner sleeve.

[0035] Advantageously, and for yet another purpose, the surface engaging means comprises at least one distally facing surface, and the distally facing surface of the surface engaging means engages with a corresponding proximally facing surface of the translational abutment means provided on the inner surface of the hollow main body.

[0036] For yet another purpose, the surface engaging means comprises at least one continuous protrusion or a plurality of discrete protrusions extending radially outwardly from the outer surface of the inner sleeve, and the translational abutment means of the hollow main body is formed as an annular groove or an annular slot provided on the inner surface of the hollow main body, and the annular groove or the annular slot is adapted and dimensioned to receive at least one continuous protrusion or a plurality of discrete protrusions extending radially outwardly from the outer surface of the inner sleeve in a form of cooperating proximal and distal surface engagement.

[0037] In summary, the translational abutment means of the hollow main body and the surface engaging means of the inner sleeve are provided with appropriately shaped surfaces and regions that cooperate with each other to prevent any translational movement in either the proximal or distal direction when the hollow main body is mounted on the body of the pen injection system.

[0038] For yet another purpose, the inner sleeve further comprises at least one or a plurality of elastically deformable surfaces extending inwardly from the inner sleeve towards the longitudinal central axis for frictional engagement with the outer surface of the dose setting wheel.

[0039] For yet another purpose, at least one or a plurality of elastically deformable surfaces extending inwardly from the inner sleeve towards the longitudinal central axis are rings of elastically deformable material, the rings comprising a plurality of coaxially aligned and radially spaced teeth extending in the same direction from the ring, the rings being provided at the proximal tip of the inner sleeve, and the teeth being oriented to extend distally along the outer and / or inner surface of the sleeve. Advantageously, the elastically deformable material is a suitable elastomer, such as SEBS elastomer.

[0040] According to yet another object, the inner sleeve further comprises a plurality of coaxially aligned and radially spaced openings that penetrate the inner sleeve from its outer surface to its inner surface.

[0041] Advantageously, according to another object, at least one or a plurality of elastically deformable surfaces extend through radially spaced openings that penetrate the inner sleeve.

[0042] As can be readily understood from the preceding paragraphs, the elastically deformable surface advantageously extends from one side of the inner sleeve, e.g., the outer surface, through the body material of the inner sleeve and penetrates to the other side, e.g., the inner surface of the inner sleeve.

[0043] According to yet another object, the inner sleeve further comprises a connection surface for at least one injection monitoring system that extends from the inner surface of the sleeve and projects inwardly toward the longitudinal central axis of the hole.

[0044] Advantageously, and according to yet another object, the connection surface for at least one injection monitoring system that extends from the inner surface of the sleeve and projects inwardly toward the longitudinal central axis of the hole comprises at least one or a plurality of recesses provided in the inwardly projecting connection surface.

[0045] According to yet another object, the injection monitoring system comprises a housing, and the housing of the injection monitoring system comprises at least one connection surface that extends distally from the housing.

[0046] According to yet another further object, the connection surface of at least one injection monitoring system and the connection surface of the housing of at least one injection system are adapted and configured such that they engage with each other in a first position where rotation of the housing of the injection monitoring system co-rotates the inner sleeve, and in a second position where the injection monitoring system translates only distally or proximally along the longitudinal central axis without rotation about the longitudinal central axis of the housing of the injection monitoring system and engages with each other.

[0047] As will be readily understood from the above, the connection surface of at least one injection monitoring system and the connection surface of the housing of at least one injection system engage with each other, one with the other. In the first position, for example during dose setting, the respective surfaces engage with each other and rotate together about the longitudinal central axis, and in the second position, the connection surface of the housing of at least one injection system abuts against the connection surface of at least one injection monitoring system and translates distally or proximally depending on whether the activation button is pressed or correspondingly released.

[0048] According to a further object, at least one connection surface extending from the housing of the injection monitoring system comprises at least one or a plurality of distally extending protrusions extending from the distal tip of the housing and aligned coaxially with the longitudinal central axis.

[0049] According to yet another further object, in the first position, each of the at least one or a plurality of distally extending protrusions of the injection monitoring housing comprises an outwardly facing connection surface that frictionally engages with a corresponding inwardly facing surface of at least one or a plurality of recesses provided in the inwardly protruding connection surface.

[0050] According to another further object, in the second position, at least one or a plurality of distally extending protrusions extending from the housing of the injection monitoring system further comprise at least one distally facing contact surface that contacts the injection actuating mechanism.

[0051] According to another further object, the injection monitoring system is further configured to determine the time elapsed while the injection monitoring system is in physical contact with the pen actuating mechanism of a pen injection system, such as a pen actuating mechanism push button.

[0052] Magnetic field generating means are provided, whereby during dose setting, the magnetic field sensor detects some change in the magnetic field due to, for example, rotational movement of the inner sleeve relative to the magnetic field generating means, so as to be able to determine the dialed dose set via the dose setting wheel. Still further, during injection, when a finger pressure is applied in the distal direction along the longitudinal central axis to the housing of the injection monitoring system, in the distal direction towards the magnetic field generating means and then in the opposite proximal direction when the finger pressure is released from the injection monitoring system, due to the sensor translating along the longitudinal axis, the magnetic field sensor will detect a change in the magnetic field.

[0053] The magnetic field sensor is thus used to measure the magnetic field generated by the magnetic field generating means. Using the movement of the magnetic field sensor about the longitudinal central axis when the dosing wheel rotates via the inner sleeve in contact therewith with respect to the proximal tip portion arrangement of the fixed hollow body of the magnetic field generating means, the dose of the injectable substance in the injection pen or dosing system set by the user is calculated or determined. When the dose is set, the actuation of the proximal actuation mechanism button, which results in a translational movement along the longitudinal central axis of the housing of the injection monitoring system and the correspondingly housed magnetic field sensor provided therewith, is used to determine or calculate whether the injection has been initiated. Conversely, correspondingly, when the pressure of the finger other than the thumb or the thumb on the proximal actuation mechanism button is released, the pen injection actuation mechanism button reacts due to the reaction energy provided by the injection pen, inducing a translational movement in the proximal direction towards the thumb or other finger of the user along the longitudinal central axis of the housing of the injection monitoring system, thereby also moving the magnetic field sensor housed within the injection monitoring system in the proximal direction. The change in the magnetic field signal detected by the magnetic field sensor when moving in this manner is processed by the injection monitoring system to determine the end of the corresponding injection or ejection operation. By processing the generated signals regarding the start and end of the injection, it becomes possible to determine the actually injected dose between the injection start signal and the injection end signal.

[0054] Means for measuring the magnetic field to be determined are known in the art. For example, magnetoresistors are well-known means. Such magnetoresistors are often represented by their abbreviations, such as AMR, GMR, TMR sensors, which represent the physical mechanism by which their sensor components function. The giant magnetoresistance effect (GMR) is a quantum mechanical magnetic resistance effect observed in a thin film structure composed of alternating ferromagnetic conductive layers and non-magnetic conductive layers. Anisotropic magnetoresistance, or AMR, is said to exist in materials where the dependence of electrical resistance on the angle between the direction of current and the direction of magnetization is observed. Tunnel magnetoresistance (TMR) is a magnetic resistance effect that occurs in a magnetic tunnel junction (MTJ), which is a component composed of two ferromagnetic bodies separated by a thin insulator. Resistors using these various characteristics are known per se.

[0055] In light of the above, the injection monitoring module and / or system according to the present invention preferably uses one, or more than one, or a plurality of magnetometers as one, more than one, or a plurality of magnetic field sensors. Such magnetometers differ from GMR, AMR, or TMR sensors in that they directly measure the magnetic field strength. Magnetometers mainly measure the magnetic field in two ways, namely, a vector magnetometer measures the vector components of the magnetic field, and a total magnetic 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 internal calibration of the magnetic sensor or known physical constants. A relative magnetometer measures the magnitude or vector magnetic field relative to a fixed but uncalibrated baseline, and is also called a geomagnetic variometer and is used to measure fluctuations in the magnetic field.

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

[0057] According to yet another object of the present invention, the injection monitoring system comprises an electronic component substrate.

[0058] Advantageously, and according to a further object of the present invention, one or more or a plurality of magnetic field sensors are electrically connected to the electronic component substrate. It is useful that one or more magnetic field sensors can be arranged on the electronic component substrate centered on the longitudinal central axis, at positions diametrically opposed to the electronic component substrate or otherwise radially dispersed, and it is preferable that a single magnetic field sensor is arranged on the longitudinal central axis.

[0059] Even more advantageously, the electronic component substrate comprises an integrated control and data processing unit, for example at least one microcontroller, electrically connected to one or more or a plurality of magnetic field sensors for processing information received from the magnetic field sensors. The electronic component substrate is thus preferably, for example, a printed circuit board of a corresponding suitable size. In the configuration contemplated by the present invention, such a printed circuit board advantageously has a disk shape whose center coincides with the intersection with the longitudinal central axis.

[0060] The electronic component substrate is advantageously housed within a housing disposed proximal to the proximal side of the hollow main body and preferably within a housing of an injection monitoring system disposed beyond the proximal tip of the central bore. Further, the electronic component substrate is advantageously held such that the horizontal plane of the component substrate is disposed within a plane substantially orthogonal to the longitudinal central axis. The electronic component substrate is further arranged, for example during dosage setting, in a rotationally fixed relationship with the inner sleeve at a first position, such that upon rotation of the hollow main body, the electronic component substrate rotates in a movement synchronized with and in alignment with the movement of the inner sleeve. This means that when the inner sleeve is rotated, at least one or more magnetometers arranged on the electronic component substrate also rotate about the longitudinal central axis. The rotationally fixed relationship of the injection monitoring system with respect to the inner sleeve at the first position can be ensured via any suitable connection established between the inner sleeve and the injection monitoring system at the first position, such as that described above with respect to the connection formed by, for example, the connection surface of at least one injection monitoring system and the connection surface of the housing of at least one injection system.

[0061] An integrated control and data processing unit comprising at least one microcontroller addresses any electrical communication and signal transmission between the various electronic components of the electronic component substrate and the magnetic field sensors. This unit also performs calculations that enable the precise position of the magnetic field sensors to be calculated and determined, and also addresses signals from a self - contained power supply and communication means incorporated in the injection monitoring system that communicate, for example, with a local or remote data processing system on a smartphone. Such integrated control and data processing units are known per se and often comprise a central processing unit, a real - time clock, one or more memory storage systems, and optionally a communication system or subsystem, incorporated together with other desired components.

[0062] According to yet another object, the electronic component substrate comprises a communication unit that is electrically connected to at least one microcontroller. Such a communication unit can be one or more of any number of communication units known per se, such as a wireless communication unit, for example Bluetooth®, Bluetooth LE®, or any other short-range or long-range wireless communication technology.

[0063] According to another further object of the present invention, the electronic component substrate comprises, optionally, a rechargeable self-power source, for example a lithium-ion battery that can be easily replaced when depleted, or alternatively, a rechargeable battery such as a rechargeable lithium-ion battery. When a rechargeable battery is provided, the rechargeable battery can be charged via a corresponding charging port provided in the injection monitoring module and connected to the rechargeable battery when depleted, for example a USB charging port. Non-rechargeable, i.e. single-use, batteries, as well as rechargeable batteries, are generally known per se to those skilled in the art. With the progress of charging technology, wireless charging has also been realized today, and such wirelessly rechargeable batteries using, for example, an inductive charging system are also foreseen as a possibility within the scope of the present invention.

[0064] In the following description related to each figure and the exemplary monitoring module, these and other objects of the present invention will become apparent and will be described in more detail.

[0065] The present invention will now be described in more detail with reference to the accompanying drawings provided for purposes of illustration and description.

Brief Description of the Drawings

[0066]

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6A

Figure 6B

Figure 7

Figure 8

DETAILED DESCRIPTION OF THE INVENTION

[0067] Referring to FIGS. 1 and 2, a schematic perspective representation of the injection monitoring module (1) according to the present invention is shown. The injection monitoring module (1) is mounted on a single-handed injection pen system (2), and the single-handed injection pen system (2) includes a pen injection system body (3) having an outer peripheral surface (4), a pen cap (5) covering the distal tip of the pen injection system, a dose setting or dialing wheel (6) disposed at the proximal tip of the body (3) of the pen injection system, and a dialed dose visualization window (7) disposed distally of the dose setting wheel (6) for displaying the dose dialed by the user of the pen injection system. The injection monitoring module (1) according to the present invention surrounds and contacts the pen body (3) adjacent to the proximal tip (8) of the injection pen system (2), particularly at least partially surrounding and contacting the outer peripheral surface (4) thereof, and extends proximally beyond the proximal tip (8) of the pen body (3), particularly beyond the dose setting wheel (6). A longitudinal central axis (9) passing through the longitudinal axis centers of both the injection monitoring module (1) and the pen injection system body (3) is also shown. The injection pen system includes an actuating mechanism button (10) disposed proximally of the dose setting or dialing wheel (6), as can be seen in some commercially available injection pen systems. In the pen injection system of the type shown in FIGS. 1 and 2, the dose setting wheel is rotated about the longitudinal central axis (9) during dose setting, but is fixed so as not to rotate during injection. Examples of such pens are available as part of the FlexTouch® insulin injection pen product line commercially available from Novo Nordisk.

[0068] The injection monitoring module (1) is dimensioned and sized to be coaxially mounted around the body (3) of the pen injection system (2), and comprises a hollow main body (11). For this purpose, the hollow main body (11) comprises a longitudinal central bore (12) having a proximal tip (13) and a distal tip (14), and a longitudinal central axis that coincides with the longitudinal central axis (9). The hollow main body further comprises a distal body portion (15) that extends around and frictionally engages the outer surface (4) of the body (3) of the pen injection system (2) at a location on the pen body (3) distal to the dose setting wheel (6). The frictional engagement between the hollow main body (11) and the outer surface (4) of the pen body (3) can be achieved by attaching an elastomeric friction material (16) on the inner circumferential surface (17) of the hollow main body to effect an interference or slip fit engagement between the distal portion (15) and the outer surface (4) of the pen body (3), such frictional engagement materials being readily known per se in the art. The hollow main body extends proximally beyond the boundary of the actuation mechanism button (10) of the pen injection system (2), at which time the dose setting wheel (6) and the actuation mechanism button (10) are received in the bore (12), and the dose setting wheel is free to rotate within the bore (12). The proximal tip (13) of the bore corresponds to the proximal tip of the hollow main body (11).

[0069] The hollow main body (11) further comprises magnetic field generating means (18, 19) disposed on or within the surface of the hollow main body (11) at the proximal tip (13) of the longitudinal central hole (12). The magnetic field generating means (18, 19) is preferably provided by a pair of single dipole magnets (18, 19) disposed with one and the other diametrically opposed, each magnet having a north (N:north) pole (18a, 19a) and a south (S:south) pole (18b, 19b), the pairs of poles being preferably axially aligned and oriented from N to S along the longitudinal central axis, the north pole being disposed proximally and the south pole being disposed distally. See, for example, FIG. 5. The dipole magnets (18a, 18b, 19a, 19b) may be preferably formed in the shape of a rod or alternatively as a disc or ring or any other suitable shape. The magnets are disposed within suitably dimensioned recesses (20, 21) provided in the hollow main body (11), the recesses (20, 21) being disposed at the proximal tip (13) of the main body (11). Alternatively, the magnetic field generating means may be a single ring-shaped dipole magnet which is installed on the proximal circumferential surface of the hollow main body (11) or within a corresponding annular recess at the proximal tip (13) of the hollow main body. From the above, the magnetic field generating means does not rotate freely about the longitudinal central axis, the reason being that the hollow main body (11) is mounted on the pen body (3) in a fixed positional relationship about the longitudinal central axis (9) and is frictionally held at a predetermined position of the distal portion so as to cover the outer surface (4) of the pen body (3) via the friction engaging means (16).

[0070] The hollow main body (11) further comprises an inner sleeve (22) disposed within the longitudinal central hole (12) and configured to co-rotate about the longitudinal central axis (9) together with the dose setting wheel (6) while not translating axially along the longitudinal central axis by frictionally engaging with the outer surface of the dose setting wheel (6) during dose setting. The inner sleeve (22) will be described in more detail below, particularly in relation to FIGS. 5, 6A, and 6B.

[0071] Figure 3 shows the injection monitoring module in a schematic perspective representation. In this figure, a hollow main body (11), a distal portion (15), and corresponding proximal and distal tips (13) and (14) are shown. Figure 3 also shows that the main hollow body (11) has a shape with a diameter that gradually expands towards a point (23) adjacent to or close to the distal tip (14) of the distal portion (15) from the proximal tip. This expanding diameter corresponds to the expansion of a hole (12) that allows the hollow main body to be inserted so as to cover the periphery of the proximal tip of the pen and fit over the dose setting wheel (6) of the pen. At this time, sufficient space is left in the hole to receive the inner sleeve (22), and the inner sleeve (22) can engage with the outer surface of the dose setting wheel. The distal portion (15) has a corresponding narrowing diameter of a corresponding shape that extends from the point (23) where the diameter of the hollow main body (11) is widest towards the distal tip (14). As will be described in more detail below with reference to Figures 5, 6A, and 6B, the point (23) with the widest diameter is also a point where the hollow main body (11) and the distal portion (15) are preferably configured to prevent translational movement along the longitudinal central axis of the inner sleeve (22).

[0072] Figure 4 is a schematic representation of the injection monitoring module according to the present invention when viewed along the hole (12) and the longitudinal central axis (9) from the distal tip (14) of the distal portion (15) of the hollow main body (11). The longitudinal central axis (9) is represented by the intersection of the crosshairs A'-A'' and B'-B'. In this figure, the inner peripheral surface (17) of the distal portion (15) of the hollow main body is shown, and the inner sleeve (22) is also shown. Further shown are contact or engagement surfaces (24) respectively provided at the proximal tips of the inner sleeve (22) and corresponding contact or engagement surfaces (25) provided on the housing (26) of the injection monitoring system and extending distally therefrom into the hole (12). The engagement surface (24) and the corresponding engagement surface (25) cooperate with each other as will be described in more detail below.

[0073] FIG. 5 presents a schematic exploded perspective view of the components of an exemplary injection monitoring module according to the present invention. The hollow main body (11) and the distal portion (15) are shown in this representation as separate components that can be assembled together when the distal portion (15) and the hollow main body are mounted on the body (3) of the pen injection system (2). Although not essential, such a presentation of the two components not only makes it easier to insert the inner sleeve (22) into the hole (12) and its placement relative to the outer surface of the body (3) of the pen injection system (2), but also facilitates their relative positioning with respect to the distal portion (15) and the hollow main body, and is particularly advantageous in that the translation of the inner sleeve in the proximal or distal direction is blocked when the monitoring module is mounted on the body (3) of the pen injection system. For this purpose, the widest points (23) of both the hollow main body (11) and the distal portion (15) are preferably the points where these components are joined together when the injection monitoring module is mounted, for example, this is achieved by providing on the distal tip (29) of the hollow main body (11), a distal annular skirt (27) and a distal annular wall (28) protruding proximally with a smaller diameter compared to the skirt (27), and on the proximal tip (31) of the distal portion, a corresponding annular wall (30) protruding distally that engages with the annular wall (28) and the corresponding distal annular skirt (27) protruding distally. The hollow main body (11) and the distal portion (15) can preferably be snap-fastened, adhered, and / or joined to each other at the widest point (23), which is done, for example, using ultrasonic welding or any other suitable form of joining technology, or other engaging means that enable the hollow main body (11) and the distal portion (15) to be firmly maintained as a single unit. Alternatively, both the hollow main body (11) and the distal portion (15) can be provided as a single unit that is appropriately dimensioned and configured to fit around and engage with the corresponding pen injection body (3).

[0074] The inner sleeve (22) further comprises at least one or a plurality of elastically deformable surfaces (32) that extend inwardly from the inner sleeve (22) towards the longitudinal central axis (9) to form at least one or a plurality of friction engagement surfaces (32) for frictionally engaging with the outer surface of the dosage setting wheel. The at least one or a plurality of elastically deformable surfaces (32) that extend inwardly from the inner sleeve (22) towards the longitudinal central axis can be preferably provided as a ring (33) of elastically deformable material. The ring (33) comprises a plurality of teeth that are coaxially aligned and radially spaced and extend in the same direction from the ring (33). The ring is usefully installed at the proximal tip (34) of the inner sleeve (22), and the teeth are directed to extend distally along the outer and / or inner surfaces of the sleeve (22). Advantageously, the elastically deformable material is a suitable elastomer, for example, the generally known SEBS elastomer itself. The elastically deformable surface (32) or teeth extend through a corresponding plurality of coaxially aligned and radially spaced openings (35) that penetrate the inner sleeve (22) from its outer surface (36) to its inner surface (37). As can be easily understood from the above, the elastically deformable surface advantageously extends from one side, for example, from the outer surface (36) of the inner sleeve (22), through the body material of the inner sleeve (22), and penetrates to the other side, for example, to the inner surface (37) of the inner sleeve, thereby providing one or more friction engagement contact surfaces that contact the outer surface of the dosage setting wheel (6) of the pen injection system, ensuring that any rotation of the inner sleeve is transmitted to the dosage setting wheel and vice versa.

[0075] As described so far, and as shown in more detail by FIGS. 6A and 6B, which are representative cross-sectional views of the injection monitoring device according to the present invention, the inner sleeve (22) is blocked from translating proximally or distally along the longitudinal central axis (9). FIGS. 6A and 6B represent the injection monitoring module in the first position or dose setting position, i.e., the position where the monitoring module would be after attachment onto the pen injection body. The difference between FIGS. 6A and 6B is simply the difference in the rotation of the cross-section about the longitudinal central axis (9). The hollow main body (11) thus further comprises translation abutting means (38) adapted and configured to prevent axial translation of the inner sleeve (22) along its longitudinal central axis when the injection monitoring module (1) is in the position mounted on the injection pen system (2). The translation abutting means (38) are shaped and dimensioned to prevent axial translation of the inner sleeve beyond a pre-determined point (23) in or on the surface of the hollow main body, at least in the distal direction along the longitudinal central axis (9), but advantageously and preferably also in the proximal direction along the longitudinal central axis (9). For this purpose, the translation abutting means of the hollow main body (11) are formed as an annular groove (38) or annular slot provided on the inner surface (17) of the hollow main body (11). The annular groove (38) may preferably be formed by cooperating surfaces formed from a distally facing surface (39) provided on the hollow main body (11) and a proximally facing surface (40) of the distal body portion (15) corresponding thereto, respectively.

[0076] Furthermore, the inner sleeve further comprises surface engaging means (41) disposed adjacent to or substantially at the distal tip of the inner sleeve, the surface engaging means being configured to engage with an annular groove (38) formed by at least the inner surfaces of the distal body portion (15) and the hollow main body (11), e.g., the surface (39) facing distally and the surface (40) facing proximally, when the injection monitoring module (1) is in the mounted position on the injection pen system (2), thereby preventing translational movement of the inner sleeve in the distal and / or proximal directions. For this purpose, the surface engaging means (41) may be suitably formed by at least one continuous protrusion (41) or a plurality of discrete protrusions (41a, 41b, 41c, etc.) extending radially outwardly from the outer surface (36) of the inner sleeve (22). The protrusion (41) comprises at least one distally facing surface (42), which engages with the corresponding proximally facing surface (40) of the annular groove (38) provided on the inner surface (17) of the hollow main body (11). When the injection monitoring module is mounted on the pen injection system, the interaction between the cooperating surfaces 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 longitudinal central axis, but the groove (38) and the protrusion (41) are suitably and correspondingly dimensioned to allow rotation of the inner sleeve (22) about the longitudinal central axis (9), e.g., when a rotational or advancing force is applied to the inner sleeve (22) during dose setting, the protrusion (41) can freely move within the groove (38) about the axis (9).

[0077] As can be seen from the figures, particularly FIGS. 5, 6A, and 6B, the inner sleeve is also further connected to an injection monitoring system (43) shown within angular brackets that includes several components, among which is the housing (26) of the injection monitoring system. The housing (26) of the injection monitoring system is shaped and configured to resemble a cup with legs, with a base wall (44) extending substantially perpendicular to the longitudinal central axis over a diameter that is substantially the same as or similar to that of the hollow main body (11), a first annular wall (45) extending proximally away from the base wall (44) from the outer periphery of the base wall (44) to form a cup-shaped portion having an internal volume closed by a proximal cap (46) that forms a push button, and the proximal cap (46) is snap-fitted or press-fitted or adhered or otherwise fixed to the proximal end portion (47) of the first annular wall (45) that extends in the proximal direction. The base wall (44) further includes a second annular wall (48) having a diameter smaller than the diameter of the hole (12) of the hollow main body and extending distally from a location radially spaced from the longitudinal central axis (9) starting from the base wall (44). The second annular wall (48) is closed at its distal end portion (49) by a transverse wall (50) to form the legs of the cup. The legs of the cup fit into the hole (12) of the hollow main body. The housing (26) of the injection monitoring system defined by the cup-shaped internal volume receives and secures an electronic component substrate (51). The internal volume of the legs formed by the second annular wall (48) and the transverse wall (50) receives a self-powered source (52), such as a single-use or rechargeable battery, for example, a lithium-ion battery that is electrically connected to and supplies power to the electronic component substrate (51). The electronic component substrate (51) is generally, suitably, a printed circuit board sized to be disposed within the internal volume of the cup formed by the base wall (44) and the first annular wall (45) that extends in the proximal direction.The injection monitoring housing (26) optionally further comprises a light guiding window (54) incorporated in or part of the first annular wall (45), for example, a molded translucent, opaque, or transparent material having crystal properties selected to direct light waves from the inner volume of the cup, such as generated by an optionally present light emitting diode or other light wave generating component, to the outside of the housing (26) of the injection monitoring system.

[0078] The electronic component substrate (51) further comprises at least one magnetometer (53) which is advantageously arranged on the longitudinal central axis and, in the case of a substantially circular component substrate, substantially at its center so as to be aligned on the longitudinal central axis. In addition to the magnetometer (53), the injection monitoring system (43) also comprises an integrated control and data processing unit (55) for processing information received from the magnetometer, which is electrically connected to the magnetometer (53). The integrated control and data processing unit (55) handles any electrical communication and signal transmission between the various electronic components of the injection monitoring system. This unit is also responsible for the execution of calculations enabling the dosage management system and the precise positioning and determination of the magnet, as well as for handling signals from the self - contained power supply (52). The electronic component substrate is further connectable to a USB port (56), which can be configured as a power recharge port for the rechargeable battery (52) and / or can be configured to enable the basic setup of any programmable memory on the electronic component substrate or to configure the data processing unit (55). The integrated control and data processing unit (55) also comprises communication means, such as a wireless communication circuit, which typically communicates with a local or remote data processing system on a smartphone. To mention just two of the many types of suitable communication means, for example, it is a Bluetooth (registered trademark) or BluetoothLE (registered trademark) wireless communication system. The integrated control and data processing unit (55) can be preferably programmed remotely at the time of first use or can receive and update information in a manner similar to other current electronic devices comprising the integrated control and data processing unit, for example, wirelessly or via any other suitable link such as the USB port (56). Such integrated control and data processing units are known per se and often comprise a central processing unit, a real - time clock, one or more memory storage systems, and optionally a communication system or subsystem, incorporated together with other desired components.The electronic component board (51) is installed or arranged in a cup formed by a base wall (44) and a first annular wall (45) of a housing (26) of an injection monitoring system, substantially along the horizontal plane of the circuit board, that is, perpendicularly and substantially orthogonal to the longitudinal central axis (9).

[0079] The injection monitoring housing further includes a third annular wall (57) that extends in a distal direction from the base wall (44) toward the hollow main body (11) at the peripheral edge of the base wall (44). As can be seen in FIGS. 6A, 6B, and 7, this third annular base wall (57) provides axial stability to the housing (26) of the injection monitoring system both when in the first dose setting position and when the actuating mechanism button (10) is actuated, that is, when injecting and / or discharging a substance from the injection pen system, particularly in the range dimensioned to surround the outer periphery at the proximal tip (13) of the hollow main body.

[0080] FIG. 7 and particularly FIG. 8 both show a part of the details related to the physical connection between the inner sleeve (22) and the housing (26) of the injection monitoring system. In particular, this connection allows co-rotation about the longitudinal central axis (9) of both the inner sleeve (22) and the housing (26) of the injection monitoring system in the first position, that is, during dose setting, and then allows translation along the longitudinal central axis (9) of the housing (26) of the injection monitoring system but does not allow rotation in the second position, that is, during injection and / or discharge of the drug from the pen injection system, and is adapted and configured accordingly.

[0081] The connection between the inner sleeve (22) and the housing of the injection monitoring system is advantageously provided through a series of interacting and cooperating connection surfaces (24, 25). Accordingly, the inner sleeve (22) comprises at least one connection surface (24) of the injection monitoring system, i.e., a surface that connects, contacts, or engages with the injection monitoring system, and this connection surface extends from the inner surface (22) of the sleeve and projects inwardly towards the longitudinal central axis (12) of the bore. As shown in FIG. 7 where the injection monitoring module (1) has been moved to the ejection or injection position and actuates the operating mechanism button of the pen injection system, the connection surface (24) is an annular surface formed on the innermost peripheral edge (58) of an annular shoulder (59) that extends radially inwardly from the proximal tip of the inner sleeve (22) into the bore (12). Such a connection surface (24) is usefully further provided with at least one or a plurality of recesses (60) provided in the inwardly projecting connection surface.

[0082] As the counterpart, the injection monitoring housing (26) comprises at least one corresponding connection surface (25) extending in the distal direction from the housing (26). As shown in the figure, the connection surface (25) extending in the distal direction from the injection monitoring housing (26) is provided as a plurality of one or more small protrusions (61), and one or more of them are further provided with a distal tip contact surface (62). The small protrusions (61) extend from either the base wall (44) and / or the distal tip (49) of the second annular wall (48) and / or the transverse wall (50), and are radially spaced from each other about the longitudinal central axis (9). Some of the small protrusions (61), for example three small protrusions, are shaped and dimensioned to be inserted into corresponding recesses (60) provided in an inwardly protruding annular shoulder (59). The remaining small protrusions (61) in this case provide a rotational lock between the inner sleeve (22) and the housing (26) of the injection monitoring system at the first dose setting position. The remaining small protrusions (61) protrude further distally and have a length sufficient to engage and contact the actuating mechanism button (10) of the pen injection system when an injection and / or ejection operation is performed using the pen injection system, for example when administering a dose of an injectable substance such as a drug. This is the case when the injection monitoring module is moved from the first dose setting position to the second dose ejection and / or injection position.

[0083] The mutually cooperating connecting or contacting surfaces (24, 25) engage with each other in this case in a first position and, in accordance with the normal operating mode of the injection pen system of the type described, the co-rotation of the inner sleeve (22) is caused by the rotation of the housing (26) of the injection monitoring system by the user using fingers other than the thumb and / or the thumb, and since the inner sleeve also engages with the outer surface of the dose setting wheel (6), the dose can be set. When the dose is set, by pressing the cap distally with the thumb and / or other fingers, the connecting surfaces (24, 25) translate along the longitudinal central axis (9) without any rotational movement and slide into engagement with each other. In doing so, the small protrusion (61) is moved along the longitudinal central axis (9) within the hole (12) until the distal tip contact surface (62) contacts the actuating mechanism button (10). This corresponds to a second position. The longitudinal distance between the non-contact of the distal surface (62) by the actuating mechanism button and the contact of the distal surface (62) is only a few millimeters, and since this axial translation distance is a known value, the data processing unit can be configured to calculate how long the distal tip contact surface remains in contact with the actuating mechanism button. For example, the elapsed time method can be used in such a situation, but this method is calibrated for changes in the magnetic field along a pre-determined detectable longitudinal axis when the magnetic field sensor is moved from the first dose setting position to the second dose ejection / injection position and then back again due to the repulsive energy imparted by the internal return spring of such a pen injection system to the actuating mechanism button (10) of the injection system (2). The calculation of the elapsed time by the data processing unit also enables further pre-programmed calculations for determining the injection start point and the corresponding injection end point, which are temporarily stored in the data processing unit of the injection monitoring module for later transmission via the communication unit, for example via wireless communication, to a remote device, such as a smartphone, tablet, or other remote computing device.

[0084] As an example of how the injection monitoring module can be used, the following description is provided: The monitoring module is mounted on a pen injection device, such as a Flextouch® insulin pen, while the user holds the pen body in one hand and rotates the housing of the injection monitoring system using the fingers other than the thumb and / or the thumb of the other hand, rotation of the dosing setting wheel (6) of the injection pen is caused due to frictional contact between the inner sleeve and the outer surface of the dosing setting wheel, by rotation of the housing (26) of the injection monitoring system which is rotationally locked to the inner sleeve (22) via the connection surfaces (24, 25), rotation of the magnetometer (53) about the longitudinal central axis (9) during dosing setting causes the magnetometer (53) to record fluctuations in the magnetic field as a function of the angular position of the magnetometer relative to the magnet using the data processing unit, when the user presses the proximal cap (46), the injection monitoring housing (26) translates distally along the longitudinal central axis (9), as a result of this translational movement, the magnetometer also translates distally along the axis and any change in the detected magnetic field is sent as a signal to the data processing unit, the distal contact surface (62) of the small protrusion (61) contacts the actuator button, thereby initiating the injection / dispensing operation, During the injection / ejection operation, no further translational movement in the proximal direction occurs because the actuating mechanism button has a pre-determined constraint limit, usually less than 1 mm, with respect to movement in the longitudinal axis direction. When the user releases the pressure of the thumb or other finger on the cap (46), the actuating mechanism button reacts just enough to receive the momentum of the reaction energy imparted to it by the pen system and transmit this reaction energy to the distal surface (62) of the small protrusion (61), thereby moving the injection monitoring housing (26) proximally from the second position back to the first position again. The magnetometer moves away from the magnet by the same translational distance along the central axis and sends the corresponding magnetic field change as a signal to the data processing unit. The data processing unit then performs calculations to determine, for example, the injection start point, the injection end point, and the actual dose administered by ejection and / or injection, using, for example, the elapsed time correlation method based on the known movement distance and the signalized magnetic field.

Claims

**Claim 1** An injection monitoring module adapted and configured to be removably attached to a proximal tip of an injection pen system for delivering a drug, said injection pen system having a pen body, a proximally located dose setting wheel connected to said body, and an injection actuation mechanism, said dose setting wheel being rotatable about the longitudinal central axis of said pen injection system during dose setting and being fixed so as not to rotate during injection, said injection monitoring module comprising A hollow main body adapted and configured to be coaxially mounted around said body of said pen injection system, said hollow main body having a longitudinal central hole with a proximal tip and a distal tip and a longitudinal central axis Magnetic field generating means located on or in said hollow main body at said proximal tip of said longitudinal central hole An injection monitoring system comprising at least one or a plurality of magnetic sensors, said injection monitoring system being located at said proximal tip of said hole of said hollow main body And comprising Said hollow main body further comprises an inner sleeve located within said longitudinal central hole and configured to frictionally engage an outer surface of said dose setting wheel during dose setting and to co-rotate about said longitudinal central axis together with said dose setting wheel without axially translating along said longitudinal central axis Said inner sleeve is connected to said injection monitoring system Said connection between said inner sleeve and said injection monitoring system is adapted and configured to co-rotate both said inner sleeve and said injection monitoring system about said longitudinal central axis during dose setting and to translate said injection monitoring system along said longitudinal central axis during injection and / or ejection of a drug from said pen injection system, but not to rotate said injection monitoring system about said longitudinal central axis, an injection monitoring module **Claim 2** The injection monitoring module according to claim 1, wherein said hollow main body further comprises a distal body portion extending around and frictionally engaging an outer surface of said body of said pen injection system at a location distal to said dose setting wheel **Claim 3** The injection monitoring module according to claim 1, wherein the hollow main body further comprises translation abutting means adapted and configured to prevent axial translational movement of the inner sleeve along the longitudinal central axis when the injection monitoring module is in the mounted position on the injection pen system.

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

5. The translation abutting means is formed from a surface facing the distal side provided on the hollow main body and a corresponding surface facing the proximal side of the distal body portion, and the surface facing the distal side and the surface facing the proximal side together form cooperating translation abutting surfaces for the inner sleeve. The injection monitoring module according to claim 3 or 4.

6. The inner sleeve further comprises surface engaging means adjacent to or substantially located at the distal tip of the inner sleeve, and the surface engaging means engages at least the inner surface of the distal body portion of the hollow main body when the injection monitoring module is in the mounted position on the injection pen system, thereby preventing translational movement of the inner sleeve in the distal and / or proximal directions. The injection monitoring module according to claim 1.

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

8. The injection monitoring module according to claim 6 or 7, wherein the surface engaging means comprises at least one surface facing the distal side, and the surface facing the distal side of the surface engaging means engages with a corresponding surface facing the proximal side of the translation abutting means provided on the inner surface of the hollow main body.

9. The surface engagement means comprises at least one continuous protrusion or a plurality of discrete protrusions extending radially outwardly from the outer surface of the inner sleeve, and the translation abutment means of the hollow main body is formed as an annular groove or an annular slot provided on the inner surface of the hollow main body, the annular groove or the annular slot being adapted and dimensioned to receive the at least one continuous protrusion or the plurality of discrete protrusions extending radially outwardly from the outer surface of the inner sleeve in a cooperating proximal and distal surface engagement, the injection monitoring module according to claims 3 to 5 or claim 8.

10. The inner sleeve further comprises at least one or a plurality of elastically deformable surfaces extending inwardly from the inner sleeve towards the longitudinal central axis, forming at least one or a plurality of friction engagement surfaces for frictionally engaging with the outer surface of the dosage setting wheel, the injection monitoring module according to claim 1.

11. The at least one or a plurality of elastically deformable surfaces extending inwardly from the inner sleeve towards the longitudinal central axis are a ring of elastically deformable material, the ring comprising a plurality of coaxially aligned and radially spaced teeth extending in the same direction from the ring, the ring being installed at the proximal tip of the inner sleeve, the teeth being directed to extend in the distal direction along the outer and / or inner surface of the sleeve, the injection monitoring module according to claim 10.

12. The inner sleeve further comprises a plurality of coaxially aligned and radially spaced openings penetrating the inner sleeve from the outer surface to the inner surface, the injection monitoring module according to claim 1.

13. The at least one or a plurality of elastically deformable surfaces extend through the plurality of radially spaced openings penetrating the inner sleeve, the injection monitoring module according to claims 10 or 11, and 12.

14. The inner sleeve further comprises at least one connection surface of the injection monitoring system extending from the inner surface of the sleeve and protruding inwardly towards the longitudinal central axis of the hole, the injection monitoring module according to claim 1.

15. The connection surface of the at least one injection monitoring system, which extends from the inner surface of the sleeve and projects inwardly towards the longitudinal central axis of the hole, comprises at least one or a plurality of recesses provided in the inwardly projecting connection surface, the injection monitoring module according to claim 14.

16. The injection monitoring system comprises a housing, and the housing of the injection monitoring system comprises at least one connection surface extending in a distal direction from the housing, the injection monitoring module according to claim 1.

17. The connection surface of the at least one injection monitoring system and the connection surface of the housing of the at least one injection system are adapted and configured to engage with each other in a first position where rotation of the housing of the injection monitoring system co-rotates the inner sleeve, and to engage with each other in a second position where the injection monitoring system translates only distally or proximally along the longitudinal central axis without rotating the housing of the injection monitoring system about the longitudinal central axis, the injection monitoring module according to claims 15 and 16.

18. The at least one connection surface extending from the housing of the injection monitoring system comprises at least one or a plurality of distally extending protrusions extending from the distal tip of the housing and aligned coaxially with the longitudinal central axis, the injection monitoring module according to claim 16.

19. In the first position, each of the at least one or a plurality of distally extending protrusions of the housing of the injection monitoring system has an outwardly facing connection surface that frictionally engages with a corresponding inwardly facing surface of the at least one or a plurality of recesses provided in the inwardly projecting connection surface, the injection monitoring module according to any one of claims 14 to 18.

20. At the second position, the at least one or more distally extending protrusions extending from the housing of the injection monitoring system further comprise at least one distally facing contact surface that contacts the injection actuation mechanism, the injection monitoring module according to any one of claims 14 to 19.

21. The injection monitoring system is further configured to determine the time elapsed while the injection monitoring system is in physical contact with the pen actuation mechanism of the pen injection system, the injection monitoring module according to claim 1.

22. The injection monitoring system further comprises an electronic component substrate, the injection monitoring module according to claim 1.

23. The one or more magnetic field sensors are electrically connected to the electronic component substrate, the injection monitoring module according to claims 1 and 22.

24. The electronic component substrate comprises at least one microcontroller that electrically connects to the one or more magnetic field sensors, the injection monitoring module according to claim 21 or 22.

25. The electronic component substrate comprises a communication unit that electrically connects to the at least one microcontroller, the injection monitoring module according to claims 22 and 24.

26. The electronic component substrate comprises a rechargeable power source, the injection monitoring module according to claim 22.

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