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WO2025168961A1 - Injection monitoring module - Google Patents

Injection monitoring module

Info

Publication number
WO2025168961A1
WO2025168961A1 PCT/IB2024/000049 IB2024000049W WO2025168961A1 WO 2025168961 A1 WO2025168961 A1 WO 2025168961A1 IB 2024000049 W IB2024000049 W IB 2024000049W WO 2025168961 A1 WO2025168961 A1 WO 2025168961A1
Authority
WO
WIPO (PCT)
Prior art keywords
magnetic field
injection
monitoring module
injection monitoring
processor
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/IB2024/000049
Other languages
French (fr)
Inventor
Alain MARCOZ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biocorp Production Sas
Original Assignee
Biocorp Production Sas
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biocorp Production Sas filed Critical Biocorp Production Sas
Priority to PCT/IB2024/000049 priority Critical patent/WO2025168961A1/en
Publication of WO2025168961A1 publication Critical patent/WO2025168961A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566—Means improving security or handling thereof
    • A61M5/31568—Means keeping track of the total dose administered, e.g. since the cartridge was inserted
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient

Definitions

  • the present invention relates generally to monitoring systems for injectable drug delivery devices.
  • Injection monitoring is a well known field associated with injectable drug delivery devices, especially with regard to infusion systems, for example.
  • monitoring systems have been made available for injection pen systems for delivery of a drug, enabling users of such pen injection systems, and health care professionals involved in the treatment and follow-up of such patients, to monitor more closely the associated injection regimes, in an attempt to lead to better healthcare outcomes.
  • software and portable communications devices such as tablets or smartphones, which have been programmed to receive information from, and interact with, the monitoring systems in order to provide information to the user or healthcare professional on-the-fly, or at regular intervals via appropriate communications units included in the monitoring systems.
  • the injection pen systems in question are well known per se and are commonly equipped with a proximally located dose setting wheel and injection activator, the dose setting wheel being rotatable about a central longitudinal axis of the pen injection system.
  • the wheel is rotated by the user to select the dose of drug to be administered.
  • the pen is generally configured, either mechanically or electromechanically to effect an injection upon activation of an injection activator.
  • injection activators are quite commonly a simple press or push-button, in mechanical or electrical contact with the dispensing mechanism located within the pen injection system, the pressing of which causes the injection mechanism to fire and inject the drug contained within the pen injection system.
  • the dose setting wheel is configured to rotate not only during dose setting, but also during injection.
  • each type of injection pen has a set of dimensions that are specifically tailored for that pen, or the medicament, drug or substance intended to be administered via such an injection pen system.
  • each pen manufacturer for any given brand of pen, and/or associated injectable product, may have pen bodies which vary in dimensions, in particular, in outer diameter, i.e. the diameter of a virtual circle following the circumference of an outer peripheral surface of the pen body, due to manufacturing tolerances.
  • injection monitoring modules for various injection pen systems, for example, such as those published as WO2017013463A1, WO2019175615A1, WO2019175790A1 , W02020217076A1 , WO2021140352A1 , W02020217094A1 , W02021260404A1 , WO2022079462A1 , WO20231 70437, WO2023187434, and WO2023209411.
  • pen injection system injection pen system
  • injection pen system injection pen system
  • injection pen injection pen
  • drugs are also used with this category of medical devices, and may be required, for example, to address a number of potentially life-threatening situations, enabling immediate emergency injection of a required drug, such as anaphylactic shock treatments, anticoagulants, opioid receptor agonists and antagonists, and the like, to the extent that it has become a common occurrence for patients suffering from, or susceptible to, such ailments to carry these devices around with them.
  • a required drug such as anaphylactic shock treatments, anticoagulants, opioid receptor agonists and antagonists, and the like
  • proximal refers to relative positions with regard to any of an injection monitoring system, injection monitoring module, and pen injection system in general, wherein “proximal” relates to a point or position or direction that is generally oriented in the direction towards the holder of the injection monitoring system, injection monitoring module, or pen injection system, and “distal” relates to a point or position or direction that is generally oriented in the direction away from the holder of the injection monitoring system, injection monitoring module, or pen injection system, for example towards a target site for injection, whether that be another part of the user’s body, or a different person’s, or animal’s, body, or simply a target site for ejection of the substance contained within the pen injection system.
  • the injection pen system to which the injection monitoring module according to the invention is adapted and configured for removable attachment, is generally equipped with a proximally located dose setting wheel and an injection actuator.
  • the dose setting wheel rotates about a central longitudinal axis of the pen injection system to allow a user to set the dose of medicament for injection.
  • the dose setting wheel is generally rotatable in a clockwise, and generally also, a counter-clockwise direction, these directions corresponding respectively to either an increase in the selected dose, or a decrease in the selected dose to be administered, or vice-versa, depending on the manufacturer.
  • the injection actuator is often represented by a push-button, usually located proximally of the dose setting wheel, and in the majority of injection pens at the proximal extremity of the injection pen system.
  • the dose dialing wheel and injection button are integrated together as a single proximal end component.
  • the dose setting wheel is sometimes, but not necessarily, also coupled to the injection drive mechanism so that it can, depending on the manufacturer and model of injection pen, also rotate as injection of the drug proceeds.
  • the functioning of such injection systems is well known per se in the art.
  • the injection monitoring module as envisaged according to the present invention is intended for mounting onto a pen injection system in which the dose setting wheel can be configured to either rotate during the ejection/injection phase of operation, or, on the contrary, not rotate during the ejection/injection phase of operation of the pen injection system.
  • the Kwikpen® injection pen does not have a dose setting wheel that rotates during injection, whereas the dose setting wheel of the Lantus Solostar®, FlexPen® and Rekovelle® injection pens do rotate during injection.
  • This differentiation in the way the various injection pens function in use has required the development of injection monitoring modules having injection monitoring systems which are tailored to the specific functioning of those various individual pens.
  • one aspect of the present invention is the provision of an injection monitoring module which is adapted for functioning on a range of different injection pen systems from various manufacturers.
  • an injection monitoring module comprising:
  • an injection monitoring system comprising: a magnetic field sensor, and a processor connected to the magnetic field sensor, wherein the processor is configured to receive and process signals from the magnetic field sensor;
  • a magnetic field production means for providing a magnetic field to the magnetic field sensor; wherein the processor is equipped with a first set of instructions which, when executed by the processor, determines a magnetic field classification for the magnetic field production means which identifies the injection monitoring module.
  • the processor of the injection monitoring system is therefore capable of determining the type of injection monitoring module of which it forms a part, through the use of the magnetic field produced by the magnetic field production means.
  • the injection monitoring module and more particularly, the injection monitoring system, is capable of a form of self-identification related to, or derived from, the magnetic field produced by the magnetic field production means and as measured by the magnetic field sensor.
  • the processor is configured with a second set of instructions defining a set of operating parameters for the operation of the injection monitoring system when the injection monitoring module is attached to an injection pen.
  • the injection monitoring system of the injection monitoring module offers much greater flexibility than similar previously described injection monitoring modules of a similar kind, due to the automatic, or self-regulated, reconfiguration of the operating parameters of the injection monitoring system forming a part of the injection module, whereby the operating parameters are tailored to correspond to the functioning, for example, the relative movements of its component parts with respect to each other, and/or with the interactions of a user following a use protocol, of an injection pen system on which the injection monitoring module is to be mounted, or is mounted.
  • the injection monitoring system is accordingly correspondingly configured to store, and/or communicate, the identifier information of the injection monitoring module, for example, within the injection monitoring system, and/or relay the injection monitoring module identifier information to the user of the injection pen in an appropriate manner, for example, via a wireless communication protocol, using a wireless communication unit.
  • the determination of the magnetic field classification by the processor comprises a comparison of the magnetic field sensor signals with a plurality of predetermined values, wherein each value represents one or more of a magnetic field strength, a magnetic flux density, a derivative thereof, or an array of such values.
  • these values are commonly expressed mathematically as vectors, and can be optionally represented by the processor as a virtual, three- dimensional map, or cloud, of vector points and magnetic orientations. Analysis of one or more zones of this map, or cloud, of vector points, by the processor of the injection monitoring system is one way in which to determine the magnetic field classification of the injection monitoring module comprising the magnetic field production means.
  • Other generally known means of analysis of magnetic fields could also be implemented as alternative ways to provide data to the processor for analysis in order to classify the magnetic field produced by the magnetic field production means.
  • the plurality of predetermined values is a plurality of ranges of said values, comprising a lower limit, and an upper limit.
  • the processor is provided with multiple, or a plurality, of ranges of said predetermined values, for example, as arrays.
  • the corresponding data can be stored in an appropriately configured volatile or non-volatile memory storage, integrated into the processor, or alternatively often comprised in the injection monitoring system, and connected to, and readable and/or writable by, the processor.
  • a lower limit of a first range of the plurality of ranges does not overlap, or coincide with, the lower limit or the upper limit of another range of the plurality of ranges.
  • an upper limit of a first range of the plurality of ranges does not overlap, or coincide with, the upper limit or the lower limit of another range of the plurality of ranges.
  • the plurality of ranges are each distinct, one from the other, thereby facilitating the determination by the processor of the classification of the magnetic field classification for the magnetic field production means.
  • the magnetic field production means comprise at least one magnet, or a plurality, of magnets, and advantageously, the at least one magnet, or plurality of magnets, are single dipole magnets.
  • the expression “magnetic field production means” refers to materials which produce a magnetic field. Magnetic field production means are known per se, for example, classical magnets, electromagnets, and mixed material magnets. Such magnets are typically made from magnetizable materials, having magnetic or paramagnetic properties, whether naturally or when an electric or other energizing flow traverses or affects said material to produce or induce a magnetic field in said material.
  • Suitable materials can be appropriately selected from: ferrite magnets, especially sintered ferrite magnets, for example, comprising a crystalline compound of iron, oxygen and strontium; composite materials consisting of a thermoplastic matrix and isotropic neodymium- iron-boron powder; composite materials made up of a thermoplastic matrix and strontium-based hard ferrite powder, whereby the resulting magnets can contain isotropic, i.e. non-oriented, or anisotropic, i.e.
  • oriented ferrite particles composite materials made of a thermo-hardening plastic matrix and isotropic neodymium-iron- boron powder; magnetic elastomers produced with, for example, heavily charged strontium ferrite powders mixed with synthetic rubber or PVC, and subsequently either extruded into the desired shape or calendered into fine sheets; flexible calendered composites, generally having the appearance of a brown sheet, and more or less flexible depending on its thickness and its composition, whereby such composites are generally formed from a synthetic elastomer charged with strontium ferrite grains, and the resulting magnets can be anisotropic or isotropic, having a magnetic particle alignment due to calendering; laminated composites, generally comprising a flexible composite as described elsewhere in the present specification, co-laminated with a soft iron-pole plate; neodymium-iron-boron magnets; steels made of aluminum-nickel-cobalt alloy and magnetized; alloys of samarium and cobalt.
  • magnetic field production means suitable for use in the present invention
  • those selected from the group consisting of neodymium-iron-boron permanent magnets, magnetic elastomers, composite materials made up of a thermoplastic matrix and strontium-based hard ferrite powder, and composite materials made of a thermo-hardening plastic matrix and isotropic neodymium-iron- boron powder are considered advantageous, and preferred.
  • Such magnets are known for their ability to be dimensioned at relatively small sizes whilst maintaining a relatively high magnetic field strength.
  • the injection monitoring module comprises a plurality of magnets, wherein a first magnet of the plurality of magnets is configured to produce a first magnetic field, and another magnet of the plurality of magnets is configured to produce a magnetic field which is different to the first magnetic field produced by the first magnet.
  • the difference in magnetic field produced by the first magnet of the plurality of magnets, and another magnet of the plurality of magnets is one advantageous way of establishing an overall magnetic field environment which provides a range of signals to the processor from the magnetic field sensor, the signals being analyzed by the processor, for example, via a suitable algorithm stored in a volatile or non-volatile memory integrated into the processor, or connected to the processor, which algorithm is executed to determine the classification of the magnetic field production means, for example, by comparing the magnetic field sensor signals with the plurality of predetermined values, wherein each value represents one or more of a magnetic field strength, a magnetic flux density, a derivative thereof, or an array of such values as described elsewhere in the present specification.
  • an injection monitoring module as described in the present specification, comprising: an injection monitoring system housing; and a magnetic field production means housing; wherein: the magnetic field production means housing comprises a first, proximal end, and extends from the first, proximal end to a second, distal end, and further defines an inner bore extending from the first, proximal end of the housing to the second, distal end of the housing; and the injection monitoring system housing is configured to be at least partially movable within the bore of the magnetic field production means housing.
  • the bore of the magnetic field production means housing has a central longitudinal axis extending through the bore from the first, proximal end to the second, distal end, and the injection monitoring system housing containing the injection monitoring system is configured to be selectively rotatable and/or translatable along said central longitudinal axis, within at least a part of the bore.
  • the magnetic field production means housing comprises a distal coupling element configured and adapted for coupling the second, distal end of the magnetic field production means housing to a dose setting mechanism of an injection pen.
  • the distal coupling element is configured, dimensioned and adapted to fit, and couple, the second, distal end of the magnetic field production means housing to the dose setting mechanism of the injection pen, for example via a frictional surface engaging contact with a dose setting wheel of the injection pen, and/or an outer peripheral surface of the body of the injection pen.
  • the distal coupling element can accordingly be configured for example, as a ring having a bore, wherein the bore of the ring is coaxially aligned with the bore of the magnetic field production means housing.
  • the ring of the distal coupling element can also comprise an elastomeric membrane located on an inward facing surface of the ring, whereby the ring, and/or the elastomeric membrane, define a frictional engagement surface which is brought into contact with, and which frictionally engages with, an outer surface of a dose setting wheel located on the injection pen, when the injection monitoring module is mounted on the injection pen.
  • the distal coupling element at least at its distal end, is shaped, configured and dimensioned to fit a particular aspect, or conformation, of a specific pen. To that extent, the distal coupling element can be said to be one of the modular aspects of the injection monitoring module.
  • the distal coupling element may form an integral part of the magnetic field production means housing, or alternatively, the distal coupling element can be a separate component which is inserted into, or connected to, the magnetic field production means housing, via an appropriate connector means, for example, a bayonet mount.
  • the magnetic field production means housing comprises a proximal coupling element configured and adapted for coupling the first, proximal end of the magnetic field production means housing to a proximal positioning indicator element, and/or an injection monitoring system housing.
  • the proximal position indicator element comprises a visible marker configured to indicate to a user that a correct mounting of the injection monitoring module onto an injection pen has occurred, prior to use of the injection monitoring module for monitoring operation of the injection pen.
  • the visible marker can typically be a ring of colored material, such as a plastic material, which stands out from the rest of the components of the injection monitoring module, and which only becomes visible when the injection monitoring module is correctly mounted to the injection pen.
  • the visible marker ring can be hidden from view when the injection monitoring module is not mounted on an injection pen, e.g. hidden beneath one or more distally extending peripheral outer walls of an injection monitoring system housing.
  • This can be readily achieved by enabling one, or the respective other, of either the injection monitoring housing and the magnetic field production housing, to translate between a first position, in which the proximal positioning indicator element is hidden, and a second position, in which the proximal positioning indicator element is visible.
  • the proximal coupling element of the magnetic field production means housing will typically comprise one or more coupling members configured to provide coupling of the magnetic field production means housing with the proximal positioning indicator element, for example, one or more bayonet connector projections, located alternatively at a proximal end of the magnetic field production means housing or at a distal end of the proximal positioning indicator element, and one or more receiving orifices, configured to receive an each one of the one or more bayonet connector projections.
  • the receiving orifices can advantageously be further configured to allow each bayonet connector projection to be moved, for example, along a corresponding guide track configured and provided for such movement, from a first, unlocked position, to a second, locked position.
  • the proximal coupling element and the magnetic field production means housing can be separated one from the other, i.e. they are unlocked,
  • the proximal coupling element and the magnetic field production means housing are locked together after movement of the bayonet connector projection along the guide track into an abutting stop which locks the connector into the second, locked position.
  • the magnetic field production means housing comprises at least one receiving zone configured to receive the at least one magnet, or plurality of magnets.
  • the magnetic field production means housing comprises two receiving zones, at spaced apart locations one from the other, a first receiving zone receiving a first magnet producing a first magnetic field, and a second receiving zone receiving a second magnet producing a second magnetic field different to the magnetic field of the first magnet.
  • the receiving zone, or at least two receiving zones are appropriately configured or shaped, for example, to receive, and/or hold, one or more correspondingly shaped and configured dipole magnets, or alternatively, a ring-shaped dipole or multipolar magnet. If each of such magnet receiving zones is provided with a corresponding dipole magnet, each magnet can be located in its respective magnet receiving zone in a respective head-to-tail configuration, i.e.
  • a first dipole magnet would be located in a first receiving zone with the N-pole facing in a proximal direction and the S-pole facing in distal direction
  • a second dipole magnet would be located in a second receiving zone with the N-pole facing in distal direction and the S-pole facing in a proximal direction.
  • This configuration can be repeated to provide a plurality of magnet receiving zones, each receiving zone having, in such a configuration, a magnet oriented in a head-to-tail relationship with regard to a nearest neighboring receiving zone.
  • an injection monitoring module comprising: mounting an injection monitoring module at, and around, a proximal end of an injection pen, the injection monitoring module comprising: an injection monitoring system comprising: a magnetic field sensor, and a processor connected to the magnetic field sensor, wherein the processor is configured to receive and process signals from the magnetic field sensor; a magnetic field production means for providing a magnetic field to the magnetic field sensor; and causing the processor to execute a first set of instructions to determine a magnetic field classification which identifies the injection monitoring module.
  • the process for the identification of an injection monitoring module comprises causing the processor to execute a second set of instructions to define a set of operating parameters for the operation of the injection monitoring system when the injection monitoring module is mounted to an injection pen.
  • a process for the automatic reconfiguration of an injection monitoring module comprising: providing an injection monitoring module comprising: an injection monitoring system comprising: a magnetic field sensor, and a processor connected to the magnetic field sensor, wherein the processor is configured to receive and process signals from the magnetic field sensor; a magnetic field production means for providing a magnetic field to the magnetic field sensor; causing the processor to execute a first set of instructions to determine a magnetic field classification which identifies the injection monitoring module; and based on the identification by the processor of the injection monitoring module, causing the processor to execute a second set of instructions to define a set of operating parameters for the operation of the injection monitoring system when the injection monitoring module is mounted to an injection pen.
  • Figure 1 is a schematic representation of an injection monitoring module according to the invention intended to be mounted on, and use with, a first commercially available injection pen, for example, a Kwikpen®, manufactured by the company Eli Lilly;
  • a first commercially available injection pen for example, a Kwikpen®, manufactured by the company Eli Lilly;
  • Figure 2 is a schematic cross-sectional representation of a variant of a part of the injection monitoring module generally illustrated in Figure 1 , adapted for a second commercially available injection, for example, a Flexpen®, manufactured by the company Novo Nordisk.
  • a Flexpen® manufactured by the company Novo Nordisk.
  • an injection monitoring module (1) is schematically represented in a mix of cross-section and perspective views, which is particularly adapted to functioning with a Kwikpen injection pen, as commercialized by Eli Lilly. More particularly, the injection monitoring module (1) comprises an injection monitoring system (2) located within an injection monitoring housing (3).
  • the injection monitoring system (2) comprises at least one, and preferably, only one, magnetic field sensor (4), for example, a magnetometer, and a processor (5) such as microprocessor, or a microcontroller including a microprocessor.
  • the magnetometer (4) is electrically connected to the processor (5) via a circuit board (6), and the processor is configured to receive and process signals received from the magnetometer (4).
  • the injection monitoring housing (3) is provided with a peripheral wall (7) which extends in a distal direction, which distally extending peripheral wall defines an inner volume into which a proximal part of a magnetic field production means housing (8) can be received, when the injection monitoring system housing (2) and magnetic field production means housing (8) are assembled together.
  • the magnetic field production means housing (8) comprises a first, proximal end (9), and extends from the first, proximal end (9) to a second, distal end (10), the housing (8) further defining an inner bore (11) extending from the first, proximal end (9) of the housing to the second, distal end (10) of the housing.
  • the injection monitoring system housing (2) is configured to be at least partially movable within the bore (11) of the magnetic field production means housing (8).
  • the injection monitoring system housing also comprises an autonomous power supply (12) which is located in a distal part (13) of the injection monitoring system housing specifically dedicated to that purpose.
  • This distal part (13) of the injection monitoring system housing is dimensioned to fit, and translate and or rotate, within the bore of the magnetic field production means housing (8), for example during dose setting, injection activation, and/or ejection of a medicament contained within the injection pen, depending on the known operation of the injection pen, onto which the injection monitoring module (1) is mounted for use.
  • the injection monitoring system housing, and magnetic field production housing (8) are aligned along a central longitudinal axis (14) which coincides with the central axis of the bore (11 ).
  • a distal coupling element is provided at the distal end (10) of the magnetic field production means housing (8).
  • the distal coupling element is configured and adapted for coupling the second, distal end (10) of the magnetic field production means housing (8) to a dose setting mechanism of an injection pen, and/or to a peripheral cylindrical surface on injection pen body (not shown).
  • the distal coupling element (15) enables a user to mount the injection monitoring module to an injection pen, by initially sliding the injection monitoring module via the bore (11) and distal end of the magnetic field production means housing (8), onto and over an activation button of an injection pen, and preferably to bring it into snug, elastic fitting, frictional contact with a dose setting wheel of the injection pen.
  • the distal coupling element (15) is accordingly configured for example, as a ring having a bore, wherein the bore of the ring is coaxially aligned with the bore of the magnetic field production means housing (8).
  • the distal coupling element (15), at least at its distal end, is shaped, configured and dimensioned to fit a particular aspect, or conformation, of a specific pen.
  • the distal coupling element represents a modular feature of the injection monitoring module.
  • the distal coupling element may form an integral part of the magnetic field production means housing (8), or alternatively, the distal coupling element can be a separate component which is inserted into, or connected to, the magnetic field production means housing, via an appropriate connector means, e.g. an outward facing screw thread that engages with a corresponding inward facing screw thread provided on an inside surface of the magnetic field production means housing (8).
  • the magnetic production means housing (8) further comprises one or more, and as illustrated in Figure 1 , preferably two or more, magnetic field production means receiving zones (16, 17).
  • the receiving zones which are positioned diametrically opposite, one with respect to the other, are dimensioned to each receive a corresponding magnet, for example a single dipole magnet.
  • the receiving zones are advantageously provided with differently sized and dimensioned receiving zones (16, 17), such that a first receiving zone can receive a first magnet (18) having a first magnetic strength, and a second receiving zone can receive a second magnet (19) having a different magnetic strength to the first magnet.
  • the difference in magnetic strengths provides an overall magnetic field context, signature, or environment that is specific to both the injection monitoring module, and correspondingly, specific to a particular type of injection pen. It is this magnetic field environment that is analyzed and processed by the processor of the injection monitoring system to determine which set of operating parameters is chosen when reconfiguring the injection monitoring system (2).
  • By varying the strengths of the magnets introduced into the magnetic field production means housing it is possible to provide a range of different injection monitoring modules that will each have a distinctive magnetic signature, context, or environment. That distinctiveness is used to associate each distinctive magnetic field context with a particular injection monitoring module and, by extension, with a specific injection pen.
  • the magnetic field production means housing (8) can also be provided with, as illustrated in Figure 1, a proximal coupling element (20), which is configured and adapted for coupling the first, proximal end (9) of the magnetic field production means housing (8) to a proximal positioning indicator element (21).
  • a proximal coupling element (20) which is configured and adapted for coupling the first, proximal end (9) of the magnetic field production means housing (8) to a proximal positioning indicator element (21).
  • the proximal end (9) of the magnetic field production means housing (8) is provided with a pair of diametrically opposed hooked, or bayonet, connector projections (22, 23) which extend in a proximal direction.
  • the proximal coupling element (20) can typically be formed as an outer ring (26) of hard, or inflexible, plastic material, such as ABS plastic, the outer ring (26) defining a bore which corresponds substantially to the bore (11 ) of the magnetic field production means housing (8).
  • the proximal coupling element (20) is also provided with apertures and guide slots (24, 25) to receive the bayonet connector projections (22, 23), and which are defined by an inner ring (27) of a diameter capable of permitting the battery holder part (13) to translate, and/or rotate, within the inner ring (27), and a set of one or more spars (28), extending radially outwardly from the inner ring (27) to the outer ring (26).
  • the spars therefore define the apertures and guide slots (24, 25) for receiving the connector projections and are configured to provide a locked and unlocked position of the proximal coupling element (20) with respect to the magnetic field production means housing (8), for example, depending on a degree of rotation of the coupling element (20) relative to the magnetic field production means housing (8), or vice-versa, for example, by applying a rotation of one to the other through an angle of between 30 to 60°.
  • the connector projections (22, 23) are free to be inserted into, or removed from, the apertures and guide slots (24, 25).
  • the locked position however, the connector projections are locked against release.
  • the positioning indicator (21) serves to indicate to a user whether or not the injection monitoring module has been mounted correctly onto an injection pen. It is therefore only generally visible after mounting the injection monitoring module onto an injection pen. Whilst the injection monitoring module is in storage, or not otherwise in use, the positioning indicator element. This is achieved through the positioning of the indicator (21), during factory assembly of the injection monitoring module, within the inner volume defined by the peripheral wall (7) of the injection monitoring system housing (3).
  • the injection monitoring system housing is pushed in a proximal direction as the injection monitoring system housing comes into contact with the injection pen’s activation button, and this proximal movement gradually exposes the positioning indicator until the relative positions are such that the indicator is fully exposed. In the fully exposed position, the user can be certain that the injection monitoring module has been mounted correctly on the injection pen.
  • Figure 2 illustrates an alternatively shaped, and configured, magnetic field production means housing (8) adapted for functioning with a Flexpen, as commercialized by Novo Nordisk.
  • the main difference here between Figure 2 and Figure 1 is the overall shape and length of the housing (8), and a different magnetic field context provided by the magnets (18, 19), to enable the processor of an associated injection monitoring system (2) to assign a magnetic field classification to the injection monitoring module (1) containing such a housing (8).
  • the magnetic field production means housing (8) is provided with projecting connectors at the proximal end (9) of the housing (8).
  • a low power mode may be configured within the injection monitoring system to only provide power to the magnetometer and processor pending actual use of the injection monitoring module to monitor operation of an injection pen, at which point full power can be supplied to the circuits, in order to preserve battery life.
  • the processor carries out a comparison of the magnetic field signals received from the magnetometer, and determines from this comparison a magnetic field classification for the injection monitoring module.
  • the magnetic field classification is derived from, or represented by, a set of distinct ranges of values representing the magnetic field context, signature, or environment of the injection monitoring module. None of the ranges overlap, and each of the ranges are distinct.
  • the magnetic field classifications can be stored, for example, in a lookup table, which is accessible to the processor.
  • any new injection pens which are released to the market can be added to the list by appropriate corresponding programming of the processor.

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Abstract

An injection monitoring module comprises: an injection monitoring system with a magnetic field sensor and a processor connected to the magnetic field sensor; and a magnetic field production means which provides a magnetic field to the magnetic field sensor. The processor is configured to receive and process signals from the magnetic field sensor and is equipped with a first set of instructions which, when executed by the processor, determines a magnetic field classification for the magnetic field production means which identifies the injection monitoring module.

Description

Description
Title of Invention : Injection Monitoring Module
[0001] The present invention relates generally to monitoring systems for injectable drug delivery devices.
[0002] Injection monitoring is a well known field associated with injectable drug delivery devices, especially with regard to infusion systems, for example. Over time, such monitoring systems have been made available for injection pen systems for delivery of a drug, enabling users of such pen injection systems, and health care professionals involved in the treatment and follow-up of such patients, to monitor more closely the associated injection regimes, in an attempt to lead to better healthcare outcomes. These developments have been accompanied by the increased associated use of software and portable communications devices such as tablets or smartphones, which have been programmed to receive information from, and interact with, the monitoring systems in order to provide information to the user or healthcare professional on-the-fly, or at regular intervals via appropriate communications units included in the monitoring systems.
[0003] In regard to pen injection systems in particular, for example, one of the challenges has been to provide easy to use, reliable and fairly failsafe monitoring systems that can be adapted to the various different variants of such commercially available pen injection systems, of which there are many. Previous attempts at providing such monitoring systems have usually involved adapting the body of the pen injection system by including electronic components therein along with one or more sensors.
[0004] The injection pen systems in question are well known per se and are commonly equipped with a proximally located dose setting wheel and injection activator, the dose setting wheel being rotatable about a central longitudinal axis of the pen injection system. The wheel is rotated by the user to select the dose of drug to be administered. The pen is generally configured, either mechanically or electromechanically to effect an injection upon activation of an injection activator. Such injection activators are quite commonly a simple press or push-button, in mechanical or electrical contact with the dispensing mechanism located within the pen injection system, the pressing of which causes the injection mechanism to fire and inject the drug contained within the pen injection system. In some pen injector systems, the dose setting wheel is configured to rotate not only during dose setting, but also during injection.
[0005] Commonly commercialized injection pen systems have a variety of pen body shapes and diameters, and as a general rule, each type of injection pen has a set of dimensions that are specifically tailored for that pen, or the medicament, drug or substance intended to be administered via such an injection pen system. Additionally, each pen manufacturer, for any given brand of pen, and/or associated injectable product, may have pen bodies which vary in dimensions, in particular, in outer diameter, i.e. the diameter of a virtual circle following the circumference of an outer peripheral surface of the pen body, due to manufacturing tolerances.
[0006] The applicant has previously described a number of injection monitoring modules for various injection pen systems, for example, such as those published as WO2017013463A1, WO2019175615A1, WO2019175790A1 , W02020217076A1 , WO2021140352A1 , W02020217094A1 , W02021260404A1 , WO2022079462A1 , WO20231 70437, WO2023187434, and WO2023209411.
[0007] As may be used in the present specification, the terms “pen injection system”, “injection pen system” and “injection pen” are used interchangeably to designate a generally handheld pen-shaped injection system, such systems being readily well known per se and commercially available for use in the treatment of many various medical indications. These systems are also often generally designed for selfinjection of a drug by the user in need of treatment for the given medical indication. This is for example the case with insulin, supplied in various forms for use in the treatment of diabetes, for example the pen injection systems commercialized under the brand names FlexPen®, as commercialized by Novo Nordisk, Kwikpen®, as commercialized Eli Lilly, or Lantus Solostar®, as commercialized by Sanofi, being but three of the most well known, but also with other hormones, such as growth hormone, or follicular stimulating hormones such as follitropin delta, commercialized in a pen injection system called Rekovelle®. Other drugs are also used with this category of medical devices, and may be required, for example, to address a number of potentially life-threatening situations, enabling immediate emergency injection of a required drug, such as anaphylactic shock treatments, anticoagulants, opioid receptor agonists and antagonists, and the like, to the extent that it has become a common occurrence for patients suffering from, or susceptible to, such ailments to carry these devices around with them. [0008] Additionally, the terms “proximal”, “proximally”, “distal” and “distally”, where such terms may be used in the present specification, refer to relative positions with regard to any of an injection monitoring system, injection monitoring module, and pen injection system in general, wherein “proximal” relates to a point or position or direction that is generally oriented in the direction towards the holder of the injection monitoring system, injection monitoring module, or pen injection system, and “distal” relates to a point or position or direction that is generally oriented in the direction away from the holder of the injection monitoring system, injection monitoring module, or pen injection system, for example towards a target site for injection, whether that be another part of the user’s body, or a different person’s, or animal’s, body, or simply a target site for ejection of the substance contained within the pen injection system.
[0009] The injection pen system, to which the injection monitoring module according to the invention is adapted and configured for removable attachment, is generally equipped with a proximally located dose setting wheel and an injection actuator. The dose setting wheel rotates about a central longitudinal axis of the pen injection system to allow a user to set the dose of medicament for injection. During the dose setting, or dose “dialing” step, the dose setting wheel is generally rotatable in a clockwise, and generally also, a counter-clockwise direction, these directions corresponding respectively to either an increase in the selected dose, or a decrease in the selected dose to be administered, or vice-versa, depending on the manufacturer. The injection actuator is often represented by a push-button, usually located proximally of the dose setting wheel, and in the majority of injection pens at the proximal extremity of the injection pen system. In some injection pens, the dose dialing wheel and injection button are integrated together as a single proximal end component. After a dose has been set, or “dialed”, as the term is commonly known in the art, when a user of the injection system then presses the injection actuator in a distal direction, a piston is driven which is connected to a plunger in order to expel drug from a chamber within the injection pen body out through a needle that the user has inserted into an appropriate injection site, for example, the skin, fatty tissue, or muscle, depending on the type of drug to be administered. The dose setting wheel is sometimes, but not necessarily, also coupled to the injection drive mechanism so that it can, depending on the manufacturer and model of injection pen, also rotate as injection of the drug proceeds. The functioning of such injection systems is well known per se in the art. The injection monitoring module as envisaged according to the present invention is intended for mounting onto a pen injection system in which the dose setting wheel can be configured to either rotate during the ejection/injection phase of operation, or, on the contrary, not rotate during the ejection/injection phase of operation of the pen injection system. For example, the Kwikpen® injection pen, mentioned elsewhere in the present specification, does not have a dose setting wheel that rotates during injection, whereas the dose setting wheel of the Lantus Solostar®, FlexPen® and Rekovelle® injection pens do rotate during injection. This differentiation in the way the various injection pens function in use has required the development of injection monitoring modules having injection monitoring systems which are tailored to the specific functioning of those various individual pens.
[0010] One consequence of such individual tailoring has been an increased developmental and industrialisation cost for the injection monitoring modules. Accordingly, it would be desirable to reduce such development and industrialisation costs as much as possible, whilst still retaining the reliability and functionality of the injection monitoring module and injection monitoring system provided with the injection monitoring module.
[0011] Additionally, it is not uncommon for a user of such injection pen systems to have more than one type of injection pen, depending on the substance to be administered, and this then means that the user is likely to require several different injection monitoring modules, each with an associated injection monitoring system specifically engineered and tailored to the functioning of injection pen on which they are mounted.
[0012] Accordingly, one aspect of the present invention is the provision of an injection monitoring module which is adapted for functioning on a range of different injection pen systems from various manufacturers.
[0013] According to one aspect therefore, there is provided an injection monitoring module comprising:
(a) an injection monitoring system comprising: a magnetic field sensor, and a processor connected to the magnetic field sensor, wherein the processor is configured to receive and process signals from the magnetic field sensor; (b) a magnetic field production means for providing a magnetic field to the magnetic field sensor; wherein the processor is equipped with a first set of instructions which, when executed by the processor, determines a magnetic field classification for the magnetic field production means which identifies the injection monitoring module.
[0014] The processor of the injection monitoring system is therefore capable of determining the type of injection monitoring module of which it forms a part, through the use of the magnetic field produced by the magnetic field production means. According to this aspect, the injection monitoring module, and more particularly, the injection monitoring system, is capable of a form of self-identification related to, or derived from, the magnetic field produced by the magnetic field production means and as measured by the magnetic field sensor.
[0015] According to another aspect, based on the magnetic field classification determined by the processor, the processor is configured with a second set of instructions defining a set of operating parameters for the operation of the injection monitoring system when the injection monitoring module is attached to an injection pen. Under this aspect, the injection monitoring system of the injection monitoring module offers much greater flexibility than similar previously described injection monitoring modules of a similar kind, due to the automatic, or self-regulated, reconfiguration of the operating parameters of the injection monitoring system forming a part of the injection module, whereby the operating parameters are tailored to correspond to the functioning, for example, the relative movements of its component parts with respect to each other, and/or with the interactions of a user following a use protocol, of an injection pen system on which the injection monitoring module is to be mounted, or is mounted.
[0016] According to another aspect, the injection monitoring system is accordingly correspondingly configured to store, and/or communicate, the identifier information of the injection monitoring module, for example, within the injection monitoring system, and/or relay the injection monitoring module identifier information to the user of the injection pen in an appropriate manner, for example, via a wireless communication protocol, using a wireless communication unit.
[0017] According to another aspect, the determination of the magnetic field classification by the processor comprises a comparison of the magnetic field sensor signals with a plurality of predetermined values, wherein each value represents one or more of a magnetic field strength, a magnetic flux density, a derivative thereof, or an array of such values. For example, these values are commonly expressed mathematically as vectors, and can be optionally represented by the processor as a virtual, three- dimensional map, or cloud, of vector points and magnetic orientations. Analysis of one or more zones of this map, or cloud, of vector points, by the processor of the injection monitoring system is one way in which to determine the magnetic field classification of the injection monitoring module comprising the magnetic field production means. Other generally known means of analysis of magnetic fields could also be implemented as alternative ways to provide data to the processor for analysis in order to classify the magnetic field produced by the magnetic field production means.
[0018] According to another aspect, the plurality of predetermined values is a plurality of ranges of said values, comprising a lower limit, and an upper limit. The lower limit value and upper limit value, together with the values that lie between the lower limit and the upper limit, form one range of the plurality of ranges. Accordingly, the processor is provided with multiple, or a plurality, of ranges of said predetermined values, for example, as arrays. The corresponding data can be stored in an appropriately configured volatile or non-volatile memory storage, integrated into the processor, or alternatively often comprised in the injection monitoring system, and connected to, and readable and/or writable by, the processor.
[0019] According to another aspect, and advantageously, a lower limit of a first range of the plurality of ranges does not overlap, or coincide with, the lower limit or the upper limit of another range of the plurality of ranges.
[0020] According to another aspect, and advantageously, an upper limit of a first range of the plurality of ranges does not overlap, or coincide with, the upper limit or the lower limit of another range of the plurality of ranges.
[0021] In this manner, the plurality of ranges are each distinct, one from the other, thereby facilitating the determination by the processor of the classification of the magnetic field classification for the magnetic field production means.
[0022] According to another aspect, the magnetic field production means comprise at least one magnet, or a plurality, of magnets, and advantageously, the at least one magnet, or plurality of magnets, are single dipole magnets. As may be used in the present specification, the expression “magnetic field production means” refers to materials which produce a magnetic field. Magnetic field production means are known per se, for example, classical magnets, electromagnets, and mixed material magnets. Such magnets are typically made from magnetizable materials, having magnetic or paramagnetic properties, whether naturally or when an electric or other energizing flow traverses or affects said material to produce or induce a magnetic field in said material. Suitable materials can be appropriately selected from: ferrite magnets, especially sintered ferrite magnets, for example, comprising a crystalline compound of iron, oxygen and strontium; composite materials consisting of a thermoplastic matrix and isotropic neodymium- iron-boron powder; composite materials made up of a thermoplastic matrix and strontium-based hard ferrite powder, whereby the resulting magnets can contain isotropic, i.e. non-oriented, or anisotropic, i.e. oriented ferrite particles; composite materials made of a thermo-hardening plastic matrix and isotropic neodymium-iron- boron powder; magnetic elastomers produced with, for example, heavily charged strontium ferrite powders mixed with synthetic rubber or PVC, and subsequently either extruded into the desired shape or calendered into fine sheets; flexible calendered composites, generally having the appearance of a brown sheet, and more or less flexible depending on its thickness and its composition, whereby such composites are generally formed from a synthetic elastomer charged with strontium ferrite grains, and the resulting magnets can be anisotropic or isotropic, having a magnetic particle alignment due to calendering; laminated composites, generally comprising a flexible composite as described elsewhere in the present specification, co-laminated with a soft iron-pole plate; neodymium-iron-boron magnets; steels made of aluminum-nickel-cobalt alloy and magnetized; alloys of samarium and cobalt.
[0023] Of the above list of magnetic field production means suitable for use in the present invention, those selected from the group consisting of neodymium-iron-boron permanent magnets, magnetic elastomers, composite materials made up of a thermoplastic matrix and strontium-based hard ferrite powder, and composite materials made of a thermo-hardening plastic matrix and isotropic neodymium-iron- boron powder, are considered advantageous, and preferred. Such magnets are known for their ability to be dimensioned at relatively small sizes whilst maintaining a relatively high magnetic field strength.
[0024] According to another aspect, the injection monitoring module comprises a plurality of magnets, wherein a first magnet of the plurality of magnets is configured to produce a first magnetic field, and another magnet of the plurality of magnets is configured to produce a magnetic field which is different to the first magnetic field produced by the first magnet. The difference in magnetic field produced by the first magnet of the plurality of magnets, and another magnet of the plurality of magnets is one advantageous way of establishing an overall magnetic field environment which provides a range of signals to the processor from the magnetic field sensor, the signals being analyzed by the processor, for example, via a suitable algorithm stored in a volatile or non-volatile memory integrated into the processor, or connected to the processor, which algorithm is executed to determine the classification of the magnetic field production means, for example, by comparing the magnetic field sensor signals with the plurality of predetermined values, wherein each value represents one or more of a magnetic field strength, a magnetic flux density, a derivative thereof, or an array of such values as described elsewhere in the present specification.
[0025] According to another aspect, there is provided an injection monitoring module as described in the present specification, comprising: an injection monitoring system housing; and a magnetic field production means housing; wherein: the magnetic field production means housing comprises a first, proximal end, and extends from the first, proximal end to a second, distal end, and further defines an inner bore extending from the first, proximal end of the housing to the second, distal end of the housing; and the injection monitoring system housing is configured to be at least partially movable within the bore of the magnetic field production means housing.
[0026] The bore of the magnetic field production means housing has a central longitudinal axis extending through the bore from the first, proximal end to the second, distal end, and the injection monitoring system housing containing the injection monitoring system is configured to be selectively rotatable and/or translatable along said central longitudinal axis, within at least a part of the bore. [0027] According to another aspect, the magnetic field production means housing comprises a distal coupling element configured and adapted for coupling the second, distal end of the magnetic field production means housing to a dose setting mechanism of an injection pen. The distal coupling element is configured, dimensioned and adapted to fit, and couple, the second, distal end of the magnetic field production means housing to the dose setting mechanism of the injection pen, for example via a frictional surface engaging contact with a dose setting wheel of the injection pen, and/or an outer peripheral surface of the body of the injection pen. The distal coupling element can accordingly be configured for example, as a ring having a bore, wherein the bore of the ring is coaxially aligned with the bore of the magnetic field production means housing. The ring of the distal coupling element can also comprise an elastomeric membrane located on an inward facing surface of the ring, whereby the ring, and/or the elastomeric membrane, define a frictional engagement surface which is brought into contact with, and which frictionally engages with, an outer surface of a dose setting wheel located on the injection pen, when the injection monitoring module is mounted on the injection pen. It will be understood that the distal coupling element, at least at its distal end, is shaped, configured and dimensioned to fit a particular aspect, or conformation, of a specific pen. To that extent, the distal coupling element can be said to be one of the modular aspects of the injection monitoring module. The distal coupling element may form an integral part of the magnetic field production means housing, or alternatively, the distal coupling element can be a separate component which is inserted into, or connected to, the magnetic field production means housing, via an appropriate connector means, for example, a bayonet mount.
[0028] According to another aspect, the magnetic field production means housing comprises a proximal coupling element configured and adapted for coupling the first, proximal end of the magnetic field production means housing to a proximal positioning indicator element, and/or an injection monitoring system housing. The proximal position indicator element comprises a visible marker configured to indicate to a user that a correct mounting of the injection monitoring module onto an injection pen has occurred, prior to use of the injection monitoring module for monitoring operation of the injection pen. The visible marker can typically be a ring of colored material, such as a plastic material, which stands out from the rest of the components of the injection monitoring module, and which only becomes visible when the injection monitoring module is correctly mounted to the injection pen. For example, the visible marker ring can be hidden from view when the injection monitoring module is not mounted on an injection pen, e.g. hidden beneath one or more distally extending peripheral outer walls of an injection monitoring system housing. This can be readily achieved by enabling one, or the respective other, of either the injection monitoring housing and the magnetic field production housing, to translate between a first position, in which the proximal positioning indicator element is hidden, and a second position, in which the proximal positioning indicator element is visible. The proximal coupling element of the magnetic field production means housing will typically comprise one or more coupling members configured to provide coupling of the magnetic field production means housing with the proximal positioning indicator element, for example, one or more bayonet connector projections, located alternatively at a proximal end of the magnetic field production means housing or at a distal end of the proximal positioning indicator element, and one or more receiving orifices, configured to receive an each one of the one or more bayonet connector projections. The receiving orifices can advantageously be further configured to allow each bayonet connector projection to be moved, for example, along a corresponding guide track configured and provided for such movement, from a first, unlocked position, to a second, locked position. In the first, unlocked position, the proximal coupling element and the magnetic field production means housing can be separated one from the other, i.e. they are unlocked, In the second, locked position, the proximal coupling element and the magnetic field production means housing are locked together after movement of the bayonet connector projection along the guide track into an abutting stop which locks the connector into the second, locked position.
[0029] According to another aspect, the magnetic field production means housing comprises at least one receiving zone configured to receive the at least one magnet, or plurality of magnets.
[0030] According to another aspect, the magnetic field production means housing comprises two receiving zones, at spaced apart locations one from the other, a first receiving zone receiving a first magnet producing a first magnetic field, and a second receiving zone receiving a second magnet producing a second magnetic field different to the magnetic field of the first magnet. [0031] The receiving zone, or at least two receiving zones, are appropriately configured or shaped, for example, to receive, and/or hold, one or more correspondingly shaped and configured dipole magnets, or alternatively, a ring-shaped dipole or multipolar magnet. If each of such magnet receiving zones is provided with a corresponding dipole magnet, each magnet can be located in its respective magnet receiving zone in a respective head-to-tail configuration, i.e. a first dipole magnet would be located in a first receiving zone with the N-pole facing in a proximal direction and the S-pole facing in distal direction, and a second dipole magnet would be located in a second receiving zone with the N-pole facing in distal direction and the S-pole facing in a proximal direction. This configuration can be repeated to provide a plurality of magnet receiving zones, each receiving zone having, in such a configuration, a magnet oriented in a head-to-tail relationship with regard to a nearest neighboring receiving zone.
[0032] According to another aspect, there is also provided a process for the identification of an injection monitoring module, comprising: mounting an injection monitoring module at, and around, a proximal end of an injection pen, the injection monitoring module comprising: an injection monitoring system comprising: a magnetic field sensor, and a processor connected to the magnetic field sensor, wherein the processor is configured to receive and process signals from the magnetic field sensor; a magnetic field production means for providing a magnetic field to the magnetic field sensor; and causing the processor to execute a first set of instructions to determine a magnetic field classification which identifies the injection monitoring module.
[0033] According to another aspect, the process for the identification of an injection monitoring module comprises causing the processor to execute a second set of instructions to define a set of operating parameters for the operation of the injection monitoring system when the injection monitoring module is mounted to an injection pen.
[0034] According to another aspect, there is provided a process for the automatic reconfiguration of an injection monitoring module, comprising: providing an injection monitoring module comprising: an injection monitoring system comprising: a magnetic field sensor, and a processor connected to the magnetic field sensor, wherein the processor is configured to receive and process signals from the magnetic field sensor; a magnetic field production means for providing a magnetic field to the magnetic field sensor; causing the processor to execute a first set of instructions to determine a magnetic field classification which identifies the injection monitoring module; and based on the identification by the processor of the injection monitoring module, causing the processor to execute a second set of instructions to define a set of operating parameters for the operation of the injection monitoring system when the injection monitoring module is mounted to an injection pen.
[0035] These and other aspects of the invention will become apparent from the following detailed description, accompanied by the figures, in which:
[0036] Figure 1 is a schematic representation of an injection monitoring module according to the invention intended to be mounted on, and use with, a first commercially available injection pen, for example, a Kwikpen®, manufactured by the company Eli Lilly;
[0037] Figure 2 is a schematic cross-sectional representation of a variant of a part of the injection monitoring module generally illustrated in Figure 1 , adapted for a second commercially available injection, for example, a Flexpen®, manufactured by the company Novo Nordisk.
Detailed Description
[0038] Turning now to Figure 1 , an injection monitoring module (1) is schematically represented in a mix of cross-section and perspective views, which is particularly adapted to functioning with a Kwikpen injection pen, as commercialized by Eli Lilly. More particularly, the injection monitoring module (1) comprises an injection monitoring system (2) located within an injection monitoring housing (3). The injection monitoring system (2) comprises at least one, and preferably, only one, magnetic field sensor (4), for example, a magnetometer, and a processor (5) such as microprocessor, or a microcontroller including a microprocessor. The magnetometer (4) is electrically connected to the processor (5) via a circuit board (6), and the processor is configured to receive and process signals received from the magnetometer (4). In such an injection monitoring system (2), the injection monitoring housing (3) is provided with a peripheral wall (7) which extends in a distal direction, which distally extending peripheral wall defines an inner volume into which a proximal part of a magnetic field production means housing (8) can be received, when the injection monitoring system housing (2) and magnetic field production means housing (8) are assembled together. The magnetic field production means housing (8) comprises a first, proximal end (9), and extends from the first, proximal end (9) to a second, distal end (10), the housing (8) further defining an inner bore (11) extending from the first, proximal end (9) of the housing to the second, distal end (10) of the housing. The injection monitoring system housing (2) is configured to be at least partially movable within the bore (11) of the magnetic field production means housing (8). Such a configuration is known generally per se from the applicants’ previously published patent applications already identified herein. For example, and as represented in Figure 1 , the injection monitoring system housing also comprises an autonomous power supply (12) which is located in a distal part (13) of the injection monitoring system housing specifically dedicated to that purpose. This distal part (13) of the injection monitoring system housing is dimensioned to fit, and translate and or rotate, within the bore of the magnetic field production means housing (8), for example during dose setting, injection activation, and/or ejection of a medicament contained within the injection pen, depending on the known operation of the injection pen, onto which the injection monitoring module (1) is mounted for use. As can be seen from Figure 1 , the injection monitoring system housing, and magnetic field production housing (8) are aligned along a central longitudinal axis (14) which coincides with the central axis of the bore (11 ). At the distal end (10) of the magnetic field production means housing (8), a distal coupling element (15) is provided. The distal coupling element is configured and adapted for coupling the second, distal end (10) of the magnetic field production means housing (8) to a dose setting mechanism of an injection pen, and/or to a peripheral cylindrical surface on injection pen body (not shown). The distal coupling element (15) enables a user to mount the injection monitoring module to an injection pen, by initially sliding the injection monitoring module via the bore (11) and distal end of the magnetic field production means housing (8), onto and over an activation button of an injection pen, and preferably to bring it into snug, elastic fitting, frictional contact with a dose setting wheel of the injection pen. The distal coupling element (15) is accordingly configured for example, as a ring having a bore, wherein the bore of the ring is coaxially aligned with the bore of the magnetic field production means housing (8). The distal coupling element (15), at least at its distal end, is shaped, configured and dimensioned to fit a particular aspect, or conformation, of a specific pen. To that extent, the distal coupling element (15) represents a modular feature of the injection monitoring module. The distal coupling element may form an integral part of the magnetic field production means housing (8), or alternatively, the distal coupling element can be a separate component which is inserted into, or connected to, the magnetic field production means housing, via an appropriate connector means, e.g. an outward facing screw thread that engages with a corresponding inward facing screw thread provided on an inside surface of the magnetic field production means housing (8).
[0039] The magnetic production means housing (8) further comprises one or more, and as illustrated in Figure 1 , preferably two or more, magnetic field production means receiving zones (16, 17). The receiving zones, which are positioned diametrically opposite, one with respect to the other, are dimensioned to each receive a corresponding magnet, for example a single dipole magnet. The receiving zones are advantageously provided with differently sized and dimensioned receiving zones (16, 17), such that a first receiving zone can receive a first magnet (18) having a first magnetic strength, and a second receiving zone can receive a second magnet (19) having a different magnetic strength to the first magnet. The difference in magnetic strengths provides an overall magnetic field context, signature, or environment that is specific to both the injection monitoring module, and correspondingly, specific to a particular type of injection pen. It is this magnetic field environment that is analyzed and processed by the processor of the injection monitoring system to determine which set of operating parameters is chosen when reconfiguring the injection monitoring system (2). By varying the strengths of the magnets introduced into the magnetic field production means housing, it is possible to provide a range of different injection monitoring modules that will each have a distinctive magnetic signature, context, or environment. That distinctiveness is used to associate each distinctive magnetic field context with a particular injection monitoring module and, by extension, with a specific injection pen. [0040] The magnetic field production means housing (8) can also be provided with, as illustrated in Figure 1, a proximal coupling element (20), which is configured and adapted for coupling the first, proximal end (9) of the magnetic field production means housing (8) to a proximal positioning indicator element (21). As shown in Figure 1 , the proximal end (9) of the magnetic field production means housing (8) is provided with a pair of diametrically opposed hooked, or bayonet, connector projections (22, 23) which extend in a proximal direction.
[0041] The proximal coupling element (20) can typically be formed as an outer ring (26) of hard, or inflexible, plastic material, such as ABS plastic, the outer ring (26) defining a bore which corresponds substantially to the bore (11 ) of the magnetic field production means housing (8). The proximal coupling element (20) is also provided with apertures and guide slots (24, 25) to receive the bayonet connector projections (22, 23), and which are defined by an inner ring (27) of a diameter capable of permitting the battery holder part (13) to translate, and/or rotate, within the inner ring (27), and a set of one or more spars (28), extending radially outwardly from the inner ring (27) to the outer ring (26). The spars therefore define the apertures and guide slots (24, 25) for receiving the connector projections and are configured to provide a locked and unlocked position of the proximal coupling element (20) with respect to the magnetic field production means housing (8), for example, depending on a degree of rotation of the coupling element (20) relative to the magnetic field production means housing (8), or vice-versa, for example, by applying a rotation of one to the other through an angle of between 30 to 60°. In the unlocked position, the connector projections (22, 23) are free to be inserted into, or removed from, the apertures and guide slots (24, 25). In the locked position however, the connector projections are locked against release. The configuration of such locking and release mechanisms is well known per se to the person skilled in the art, but as an example, the hooked projections can, for example, be shaped to engage with a stopping abutment provided on one or more of the spars (28), on in one or more of the guide slots (24, 25), or with a locking recess similarly provided on one or more of the spars (28) and/or guide slots (24, 25). As mentioned elsewhere, the proximal coupling element (20) is also provided with a proximal positioning indicator element (21 ), for example a ring of coloured, highly visible and or contrasting material which forms an integral part of the proximal coupling element (20) and which is located at a proximal end of the proximal coupling element (20). The positioning indicator (21) serves to indicate to a user whether or not the injection monitoring module has been mounted correctly onto an injection pen. It is therefore only generally visible after mounting the injection monitoring module onto an injection pen. Whilst the injection monitoring module is in storage, or not otherwise in use, the positioning indicator element. This is achieved through the positioning of the indicator (21), during factory assembly of the injection monitoring module, within the inner volume defined by the peripheral wall (7) of the injection monitoring system housing (3). When mounting the injection monitoring module onto an injection pen, the injection monitoring system housing is pushed in a proximal direction as the injection monitoring system housing comes into contact with the injection pen’s activation button, and this proximal movement gradually exposes the positioning indicator until the relative positions are such that the indicator is fully exposed. In the fully exposed position, the user can be certain that the injection monitoring module has been mounted correctly on the injection pen.
[0042] Figure 2 illustrates an alternatively shaped, and configured, magnetic field production means housing (8) adapted for functioning with a Flexpen, as commercialized by Novo Nordisk. The main difference here between Figure 2 and Figure 1 is the overall shape and length of the housing (8), and a different magnetic field context provided by the magnets (18, 19), to enable the processor of an associated injection monitoring system (2) to assign a magnetic field classification to the injection monitoring module (1) containing such a housing (8). As can be seen from Figure 2, the magnetic field production means housing (8) is provided with projecting connectors at the proximal end (9) of the housing (8).
[0043] A brief explanation of the functioning of the injection monitoring module will now be provided. As mentioned elsewhere, the processor is configured, for example via previous programming with an executable code or set of instructions, which may be stored in a non-volatile memory accessible to the processor, to analyse the signals received from the magnetometer. As soon as power is provided to the circuit on the circuit board, the magnetometer measures the magnetic field produced by the magnets located in the magnetic field production means housing. The signals from the magnetometer received by the processor are constant for as long as power is being provided to the circuits. Optionally, a low power mode may be configured within the injection monitoring system to only provide power to the magnetometer and processor pending actual use of the injection monitoring module to monitor operation of an injection pen, at which point full power can be supplied to the circuits, in order to preserve battery life. Irrespective of the power mode, the processor carries out a comparison of the magnetic field signals received from the magnetometer, and determines from this comparison a magnetic field classification for the injection monitoring module. The magnetic field classification is derived from, or represented by, a set of distinct ranges of values representing the magnetic field context, signature, or environment of the injection monitoring module. None of the ranges overlap, and each of the ranges are distinct. The magnetic field classifications can be stored, for example, in a lookup table, which is accessible to the processor. Upon determination of a magnetic field classification, the processor then subsequently executes a self-reconfiguration, or autoconfiguration program, which configuration program defines a set of operating parameters that are deemed sufficient for correct functioning of the injection monitoring module with any particular injection pen. The information relating to the identification of the injection monitoring module can be made available to the user, for example, via a wireless communication unit provided within the injection monitoring system (2), which would send a corresponding data message to a suitably equipped receiver, such as a smartphone running a correspondingly configured software application. There can be as many sets of operating parameters as there are different injection pens, and due to the programmed aspect of the injection monitoring system, and in particular the functioning of the processor, any new injection pens which are released to the market can be added to the list by appropriate corresponding programming of the processor.

Claims

Claims
[Claim 1] Injection monitoring module comprising: an injection monitoring system comprising: a magnetic field sensor, and a processor connected to the magnetic field sensor, wherein the processor is configured to receive and process signals from the magnetic field sensor; a magnetic field production means for providing a magnetic field to the magnetic field sensor; wherein the processor is equipped with a first set of instructions which, when executed by the processor, determines a magnetic field classification for the magnetic field production means which identifies the injection monitoring module.
[Claim 2] Injection monitoring module according to claim 1 , wherein, based on the magnetic field classification determined by the processor, the processor is configured with a second set of instructions defining a set of operating parameters for the operation of the injection monitoring system when the injection monitoring module is attached to an injection pen.
[Claim 3] Injection monitoring module according to claim 1 or claim 2, wherein the determination of the magnetic field classification by the processor comprises a comparison of the magnetic field sensor signals with a plurality of predetermined values representing a magnetic field strength, a magnetic flux density, a derivative thereof, or an array of such values.
[Claim 4] Injection monitoring module according to any one of claims 1 to 3, wherein the plurality of predetermined values is a plurality of ranges of said values, comprising a lower limit, and an upper limit.
[Claim 5] Injection monitoring module according to claim 4, wherein a lower limit of a first range of the plurality of ranges does not overlap, or coincide with, the lower limit or the upper limit of another range of the plurality of ranges.
[Claim 6] Injection monitoring module according to claim 4 or claim 5, wherein an upper limit of a first range of the plurality of ranges does not overlap, or coincide with, the upper limit or the lower limit of another range of the plurality of ranges.
[Claim 7] Injection monitoring module according to any one of claims 1 to 6, wherein the magnetic field production means comprises at least one magnet, or a plurality, of magnets.
[Claim 8] Injection monitoring module according to any one of claims 1 to 7, wherein the at least one magnet, or plurality of magnets, are single dipole magnets.
[Claim 9] Injection monitoring module according to claim 7 or claim 8, comprising a plurality of magnets, wherein a first magnet of the plurality of magnets is configured to produce a first magnetic field, and another magnet of the plurality of magnets is configured to produce a magnetic field which is different to the first magnetic field produced by the first magnet.
[Claim 10] Injection monitoring module according to any one of claims 1 to 9, comprising: an injection monitoring system housing; and a magnetic field production means housing; wherein: the magnetic field production means housing comprises a first, proximal end, and extends from the first, proximal end to a second, distal end, and further defines an inner bore extending from the first, proximal end of the housing to the second, distal end of the housing; and the injection monitoring system housing is configured to be at least partially movable within the bore of the magnetic field production means housing.
[Claim 11] Injection monitoring module according to claim 10, wherein the magnetic field production means housing comprises a distal coupling element configured and adapted for coupling the second, distal end of the magnetic field production means housing to a dose setting mechanism of an injection pen.
[Claim 12] Injection monitoring module according to claim 11 , wherein the coupling element of the magnetic field production means housing is configured and adapted to be removably coupled to the dose setting mechanism of a predetermined injection pen.
[Claim 13] Injection monitoring module according to claim 12, wherein the magnetic field production means housing comprises a proximal coupling element configured and adapted for coupling the first, proximal end of the magnetic field production means housing to a proximal positioning indicator element.
[Claim 14] Injection monitoring module according to any one of claims 7 to 13, wherein the magnetic field production means housing comprises at least one receiving zone configured to receive the at least one magnet, or plurality of magnets.
[Claim 15] Injection monitoring module according to claim 14, wherein the magnetic field production means housing comprises two receiving zones, at spaced apart locations one from the other, a first receiving zone receiving a first magnet producing a first magnetic field, and a second receiving zone receiving a second magnet producing a second magnetic field different to the magnetic field of the first magnet.
[Claim 16] Process for the identification of an injection monitoring module, comprising: mounting an injection monitoring module at, and around, a proximal end of the injection pen, the injection monitoring module comprising: an injection monitoring system comprising: a magnetic field sensor, and a processor connected to the magnetic field sensor, wherein the processor is configured to receive and process signals from the magnetic field sensor; a magnetic field production means for providing a magnetic field to the magnetic field sensor; and causing the processor to execute a first set of instructions to determine a magnetic field classification which identifies the injection monitoring module.
[Claim 17] Process for the identification of an injection monitoring module according to claim 16, comprising causing the processor to execute a second set of instructions to define a set of operating parameters for the operation of the injection monitoring system when the injection monitoring module is mounted to an injection pen.
[Claim 18] Process for the automatic reconfiguration of an injection monitoring module, comprising: providing an injection monitoring module comprising: an injection monitoring system comprising: a magnetic field sensor, and a processor connected to the magnetic field sensor, wherein the processor is configured to receive and process signals from the magnetic field sensor; and a magnetic field production means for providing a magnetic field to the magnetic field sensor; causing the processor to execute a first set of instructions to determine a magnetic field classification which identifies the injection monitoring module; and based on the identification by the processor of the injection monitoring module, causing the processor to execute a second set of instructions to define a set of operating parameters for the operation of the injection monitoring system when the injection monitoring module is mounted to an injection pen.
PCT/IB2024/000049 2024-02-08 2024-02-08 Injection monitoring module Pending WO2025168961A1 (en)

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