WO2021140352A1 - Module complémentaire rotatif de surveillance d'injection - Google Patents

Module complémentaire rotatif de surveillance d'injection Download PDF

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Publication number
WO2021140352A1
WO2021140352A1 PCT/IB2020/000054 IB2020000054W WO2021140352A1 WO 2021140352 A1 WO2021140352 A1 WO 2021140352A1 IB 2020000054 W IB2020000054 W IB 2020000054W WO 2021140352 A1 WO2021140352 A1 WO 2021140352A1
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WO
WIPO (PCT)
Prior art keywords
injection
monitoring module
main body
pen
hollow main
Prior art date
Application number
PCT/IB2020/000054
Other languages
English (en)
Inventor
Alain MARCOZ
Lionel ALDON
Original Assignee
Biocorp Production S.A.
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 S.A. filed Critical Biocorp Production S.A.
Priority to PCT/IB2020/000054 priority Critical patent/WO2021140352A1/fr
Publication of WO2021140352A1 publication Critical patent/WO2021140352A1/fr

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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
    • A61M5/31—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
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31515—Connection of piston with piston rod
    • 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
    • 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
    • A61M5/31525—Dosing
    • 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
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose

Definitions

  • the present invention relates generally to monitoring systems for injectable drug delivery devices, and in particular to injection monitoring for injection pen systems.
  • 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 transferred more recently to 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 their own injection regimes, and in many cases, the doses actually administered, 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 electro-mechanically 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.
  • metallic components such as a helically wound drive spring located within a housing body of the injection pen system and physically coupled to the dose setting wheel.
  • metallic elements are relatively large objects in comparison to the electronic component systems that are included in many pen injection systems today, these large metallic objects can further perturb signals that the sensors in such electronic component systems are designed to capture or pick up, rendering the systems potentially less accurate, and/or requiring that complex correction mechanisms be put in place to avoid calculation errors.
  • published PCT patent application WO2014128156A1 relates to a sensor assembly having a first rotary sensor part with a plurality of individual electrically conducting sensor areas arranged in a pattern, a second rotary sensor part arranged rotationally relative to the first part, and comprising a plurality of contact structures adapted to be in contact with conducting sensor areas on the first sensor rotary part.
  • the contact structures are configured to engage and connect different sensor areas as the first and second part of the rotary sensor rotate relative to each, the created connections being indicative of a rotational position between the first and second portions.
  • One of the contact stmctures is an actuatable contact structure being axially moveable relative to the first portion and having a connected position in which the actuatable contact structure is in contact with a sensor area and a disconnected position in which the actuatable contact structure is not in contact with a sensor area.
  • This system is housed within the pen injector body, at least partly within the volume inside the dose setting wheel.
  • the system also comprises a visual display, such as an LCD display located on, or instead of, the injection activator button.
  • published PCT application W02018013419A1 relates to a dose detection system including a dosing component attached to an actuator and rotationally and axially moveable relative to a coupling component attached to a dose setting member, and comprising a module including an electronic sensor operative to detect a relative rotation of the coupling component and the dosing component to detect a dose delivered by the medication delivery device.
  • the dose detection module is removably coupled to a proximal end of a pen injection system, and is intended to function as a means to detect the amount of medication dispensed by the pen injection system while attached thereto, store the detected dose in memory, and transmit a signal representative of the detected dose to a remote communication device.
  • the system comprises a pair of rotatable and translatable cylinders that interact with each other via electrical contacts provided on the cylinder surfaces to denote various states or positions of the injection administration process including dose setting, the electrical contacts being connected to a collection of electronic components housed on a flexible printed circuit board, disposed in an accordion- style arrangement of superimposed folds within the removably couple body, and which is insulated between the overlapping layers of circuit board by an electrically non-conducting spacer layer to prevent potential electric, electronic and electromagnetic interference.
  • one object of the present invention is to provide an injection monitoring module adapted and configured to be removably attached to a proximal extremity of an injection pen system for delivery of a drug, the injection pen system having a dose setting wheel that can be rotated for setting a dose of drug to be injected, wherein said dose setting wheel optionally also rotates during injection, and wherein the injection monitoring module has a much simpler configuration, whilst at the same time obviating the need for complicated shielding or protecting solutions to counter any unwanted electrical, electronic, or electromagnetic effects caused by the relatively high density of the electronic components within the monitoring module.
  • Another object of the present invention is to provide an injection monitoring module as above, wherein said module is adapted and configured to detect an injection end point in a pen system having a rotating dose setting wheel that rotates during injection, or alternatively by design, does not rotate during injection.
  • injection end point signifies not only the completion of an injection of a dose of injectable substance such as a drug, where a user injects a required dose of injectable substance in a single operation, but also includes any amount of drug actually ejected by the pen injection system when the injection monitoring module is mounted thereon.
  • Yet another object of the invention is to provide an injection monitoring module as above, in which said module is adapted and configured to detect or calculate a dose or amount set by a user of injectable substance contained within the pen injection system, an injection beginning or start point and an injection end point in said pen injection system, and therefrom determine whether or not all of the dose or amount set by the user of the pen injection system has been ejected from said pen system.
  • an injection monitoring module adapted and configured to be removably mounted to a proximal extremity of an injection pen system for delivery of a drug
  • the injection pen system being 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 for dose setting and during injection
  • the injection monitoring module comprising: a hollow main body adapted and configured to be coaxially mounted on, and engage in co rotation with, the dose setting wheel at the proximal extremity of the pen injection system; the hollow main body comprising a central longitudinal bore having a proximal extremity and a distal extremity, and a central longitudinal axis; an injection monitoring system comprising at least one or a plurality of magnetic sensors, the injection monitoring system being located within the central longitudinal bore of the main body at the proximal extremity thereof, in fixed rotating engagement with the hollow main body about the central longitudinal axis; the injection monitoring module further comprising a magnetic
  • pen injection system and “injection pen system” 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 self -injection of a drug by the user in need of treatment for the given medical indication. This is for example the case with insulin, intended to treat the consequences of diabetes, one such example being the pen injector commercialized under the brand name Lantus® SoloSTAR® by Sanofi-Aventis.
  • drugs also fall into this category, required for example, to address potentially life-threatening situations, and enabling immediate emergency injection of a required drug, such as anaphylactic shock treatments, anti-coagulants, opioid receptor agonists and antagonists, and the hke, 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, anti-coagulants, opioid receptor agonists and antagonists, and the hke
  • the injection pen system to which the injection monitoring module according to the invention is adapted and configured for removable attachment, is equipped with a proximally located dose setting wheel and an injection activator.
  • 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 both a clockwise, and a counter-clockwise direction, these directions corresponding generally to an increase in the selected dose, and a decrease in the selected dose, to be administered, respectively.
  • the injection activator is often represented by a push-button.
  • the injection monitoring module is adapted and configured to be removably attached to a proximal extremity of such an injection pen system.
  • Such attachment and subsequent removability can be achieved by providing coupling means on the monitoring module which engage in a releasable manner with the proximal extremity of the pen injection system, for example via frictional or elastic engagement, or via other releasable fastening means, such as clips, straps, screw threads and corresponding tightening rings, and the like, which engage with either the dose setting wheel, or the injection activator, or both.
  • coupling means on the monitoring module which engage in a releasable manner with the proximal extremity of the pen injection system, for example via frictional or elastic engagement, or via other releasable fastening means, such as clips, straps, screw threads and corresponding tightening rings, and the like, which engage with either the dose setting wheel, or the injection activator, or both.
  • the removably attachable or mountable injection monitoring module comprises a hollow main body adapted and configured to be coaxially attached to, or mounted on, and engage in co-rotation with, the dose setting wheel at the proximal extremity of the pen injection system.
  • the hollow main body of the injection monitoring module comprises a central longitudinal bore with a proximal extremity and a distal extremity.
  • the distal extremity of the bore is preferably configured and dimensioned to elastically engage with, for example, via friction, and surround, an outer surface of the dose setting wheel of the pen injection system, such that if the hollow main body is rotated, then so does the dose setting wheel in the same direction, and to substantially the same or identical degree of rotation, and conversely, if the dose setting wheel is rotated, then so does the hollow main body.
  • the hollow main body can be said to co-rotate with the dose setting wheel.
  • the hollow main body is appropriately made of any suitable material, for example of a durable polymer or plastic material.
  • the hollow body is made of transparent, translucent, or opaque material, in order to enable a user to apprehend and recognise any visual cues, such as light emitting diodes, that might also be provided or integrated into the injection monitoring module, where such cues can be optionally used to indicate various states of operation of the injection monitoring system.
  • visual cues such as light emitting diodes
  • the injection monitoring module also comprises an injection monitoring system located within the central longitudinal bore of the main body at the proximal extremity thereof.
  • the injection monitoring system will be described in further detail below, but basically, the injection monitoring system comprises a number of different components and means that provide for monitoring of an injection state, for example, such as: initiation of an injection operation; termination of an injection operation, whereby termination of an injection operation is to be understood to cover both a complete administration of a selected dose of substance to be injected, or discrete injection operations in which a user only injects a part of a dose, or causes a part of the selected dose to be ejected from the pen injection system.
  • the injection monitoring system is movable within the central longitudinal bore of the main body along the central longitudinal axis from a first monitoring position in which the injection monitoring system is not in abutting contact with a proximal surface of the injection activator, to a second monitoring position in which the injection monitoring system is in abutting contact with a proximal surface of the injection activator.
  • the injection monitoring system can be moved from an initial position where there is no physical contact between the monitoring system and the activator button, to a different position where physical contact is established between the monitoring system and the proximal surface of the injection activator.
  • Such movement will generally be a translational movement of the monitoring system along the central longitudinal axis within the bore of the hollow main body from the first position to the second position.
  • the injection monitoring module is configured so that a translational movement along the central longitudinal axis of the hollow main body such as described above is responsible for enabling detection or determination of an injection begin and/or end point.
  • the monitoring system when the monitoring system translates in a distal direction, the monitoring module can be configured to detect a begin point of injection.
  • said monitoring system can be configured to detect an end point of injection or ejection of injectable substance.
  • the invention monitoring module comprises a magnetic field producing means.
  • Various means for producing a magnetic field are known, 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;
  • thermoplastic matrix and isotropic neodymium-iron-boron powder 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;
  • thermo-hardening plastic matrix 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;
  • Such composites are generally formed from a synthetic elastomer charged with strontium ferrite grains.
  • the resulting magnets can be anisotropic or isotropic, the sheet varieties generally having a magnetic particle alignment due to calendering;
  • - laminated composites generally comprising a flexible composite as above, co-laminated with a soft iron-pole plate;
  • magnetic field producing 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 preferred.
  • Such magnets are known for their ability to be dimensioned at relatively small sizes whilst maintaining relatively high magnetic field strength.
  • the magnetic field producing means can be of any suitable general shape, for example disk shaped, including circular, ellipsoid, or any other suitable polygonal shape, it preferably has only a single dipole, with a single pair of diametrically opposing north and south magnetic poles.
  • the magnetic field producing means can be substantially disk-shaped, such a disk-shape can also preferably include magnets which have an orifice substantially in the centre of the disk to form a ring or annular shaped magnet.
  • the magnetic field producing means are integrated, inserted, encapsulated, or otherwise introduced, into a separate magnetic field producing means holder body.
  • the holder body in this case is advantageously configured and dimensioned to form a disk, or an annular-shaped disk or ring, i.e. a disk with a hole substantially in its middle.
  • the magnetic field producing means is separate from the hollow main body, located on and around a peripheral surface of a body of the injection pen system, adjacent the proximal extremity, but distally of the dose setting wheel of the injection pen system and the hollow main body of the injection monitoring module.
  • the magnetic field producing means is preferably a ring-shaped or annular magnet, located or seated within a magnet holder body.
  • the magnet holder body is preferably made of moulded material, and encapsulates the annular magnet.
  • the magnet holder is also preferably substantially annular, and is shaped or formed in order to be slidingly engageable with a peripheral surface of the body of the injection pen system.
  • the substantially annular magnet holder body is suitably positioned and located in elastic frictional engagement with the peripheral surface of the pen injection system body by sliding the magnet holder body over the proximal extremity of the pen injection system body, and pushing the magnet holder body in a distal direction beyond the dose setting wheel of the pen injection system to locate the magnet holder body distally thereof.
  • the frictional elastic engagement of the magnet holder body can be readily obtained for example, by providing a suitable elastically frictional engaging surface on an inner circumferential surface of the substantially annular magnet body holder.
  • Such an elastically frictional engaging surface can readily be provided by applying or locating an appropriate elastomeric coating on the inner circumferential surface of the magnet holder body.
  • the magnet holder body can additionally be provided with an indexing position marker, for example, allowing the magnet holder body to be positioned correctly with regard to the pen injection system body. Additionally, or in lieu of the indexing position marker, the magnet holder body can also be provided with a recessed portion in the shape of a window, which window corresponds to the general shape of a dose display window provided on the body of the injection pen system in order to allow a user to continue to be able to visualize the dose that has been dialled by the dose setting wheel. Thus positioned, the magnet holder body is located distally of the dose setting wheel, but nonetheless adjacent the proximal extremity of the pen injection system body.
  • the injection monitoring module further comprises an injection detection switch.
  • the injection detection switch is configured to signal a beginning and/or an end of an injection.
  • the injection detection switch is configured to be activated and deactivated by a translational movement along the central longitudinal axis of the hollow main body.
  • a translational movement along the central longitudinal axis of the hollow main body is responsible for enabling detection or determination of an injection begin and/or end point.
  • the monitoring module can be configured to detect a begin point of injection.
  • said monitoring system can be configured to detect an end point of injection or ejection of injectable substance.
  • the switch is accordingly activated and deactivated via the translational movement along the longitudinal axis.
  • the switch when the translational movement takes place in a distal direction, the switch is configured to interact with that translational movement in such a way that the switch gets activated, or turned on.
  • the switch when the translational movement takes place in a proximal direction, the switch is configured to interact with that translational movement in such a way that the switch gets deactivated, or turned off.
  • the turning on, or respectively off, of the switch signals the beginning, and respectively the end, of an injection operation.
  • such a set up could be configured in an opposite manner of functioning, i.e. the switch could be configured to be activated by a translational movement in the proximal direction, and deactivated by a translational movement in the distal direction, should that be so desired.
  • the monitoring module can comprise one, several, or more, injection detection switches which are activated separately or in sequence, depending on the desired configuration and interaction that one might wish to have between the translational movement and the switch.
  • injection detection switch can be a purely mechanical switch, an electrical or electronic switch, an optical, or light activated, switch, an optoelectronic switch, an acoustic switch, or any suitable combination or adaptation of these various switches.
  • the translational movement along the central longitudinal axis of the hollow main body is provided by an axially located shaft connected to a proximally located injection activation button situated at a proximal extremity of the hollow main body.
  • the axially located shaft thus extends from a proximal extremity, at which it is connected to the proximally located injection activation button, to a distal extremity, along the central longitudinal axis within the bore of the hollow body of the monitoring module.
  • the activation button connected to the axially located shaft is separate, and distinct, from the pen injection system activator button.
  • the shaft is comprised of a suitably rigid material such that it does not substantially flex or deviate from the central longitudinal axis when pressure is brought to bear on the proximal injection activation button connected thereto. Such materials are known to the skilled person per se.
  • the axially located shaft comprises at least one switch interaction zone located along the length of the shaft.
  • At least a part of the at least one switch interaction zone of the axially located shaft receives and engages with at least a part of the injection detection switch.
  • the one, several, or more switch interaction zones is/are designed and configured to enable, and facilitate interaction between at least a part of the switch interaction zone and at least a corresponding part of the injection detection switch.
  • the interaction can be physical, for example, surface to surface contact, or any other suitable form of interaction, e.g. electrical, electronic, acoustic, optic, and the like.
  • the interaction between the at least part of the switch interaction zone and the at least part of the injection detection switch is a physical interaction based on surface-to-surface contact between a part of the shaft and a part of the injection detection switch.
  • the switch is configured to be activated by exerting pressure, for example, digital pressure, on the proximal injection activation button.
  • the switch is configured to be deactivated by removing pressure, for example, digital pressure, from the proximal injection activation button.
  • digital pressure used herein refers to pressure exerted generally by the digits of a hand, such as a finger or thumb, in line with the actual common and current use of such injection pen systems.
  • a press of the thumb on the injection activation button at the proximal extremity of the shaft causes the shaft to translate along the central longitudinal axis from a first position, for example a position in which the distal extremity of the shaft is in resting surface contact with the injection activator button of the injection pen system, to a second position in which the injection activator button of the pen injection system is depressed, thereby activating the injection of the injectable substance from the injection pen system.
  • a press of the thumb on the injection activation button at the proximal extremity of the shaft causes the shaft to translate along the central longitudinal axis from a first position, for example a position in which the distal extremity of the shaft is in resting surface contact with the injection activator button of the injection pen system, to a second position in which the injection activator button of the pen injection system is depressed, thereby activating the injection of the injectable substance from the injection pen system.
  • at least one of the switch interaction zones will interact with at least a part of the injection detection switch. This will cause
  • the shaft When digital pressure is removed from the shaft’s proximal activation button, the shaft will translate once again, for example, under the spring recoil energy imparted through the activation button of the injection pen system, along the central longitudinal axis in an opposite direction, causing another interaction to occur between at least one of the switch interaction zones on the shaft and at least a part of the injection detection switch. Such a further interaction will cause a further signal to be generated, signalling that an injection has ended, for example.
  • the total distance of translational movement of the shaft at any given position along its length at the end of a translational movement with respect to the corresponding initial position of said shaft before commencement of said translational movement is generally less than a millimetre.
  • the configuration of the signalling, and whether and in what manner a given signal is generated as a response to a given interaction between the injection detection switch and a corresponding interaction zone on the shaft, can be tailored to the particular use case of the pen injection system.
  • the monitoring module according to the invention is removably attached, attachable, mounted or mountable to the injection pen system.
  • the applicants have found however, and according to another object of the invention, that a particularly advantageous monitoring module can be obtained which has such a removable mounting of the hollow main body on the dose setting wheel of the injection pen system, by providing that at least in part the magnetic field produced by the magnetic field production means be used in combination with a magnetizable substrate located within the hollow main body.
  • Such a mounting system uses the magnetic field created by the magnet held within the magnet holder body, for example, and mounted distally to the dose setting wheel of the pen injection system, to induce a magnetic field in the magnetizable substrate located generally around the distal extremity of the hollow main body.
  • the induced magnetic field in such a magnetizable substrate is attracted to the magnet held within the magnet holder body due to the opposite poles of the magnet and respectively the area of magnetizable substrate nearest to the magnet.
  • This induced attractive magnetic force maintains the hollow main body of the monitoring module in relative close proximity on the dose setting wheel to, and in substantial axial alignment with, the magnet body holder.
  • the magnetizable substrate is located within the hollow main body and is also in elastically- engaging surface contact with an outer surface of the dose setting wheel.
  • the hollow main body can enter into elastically frictional engagement with the dose setting wheel in order to permit the transmission of any rotation applied via the hollow body to the dose setting wheel and enable a user to dial, or set a dose or amount of substance to be injected, with a high degree of accuracy.
  • the magnetizable substrate mentioned above can be any suitably magnetizable material, for example, an elastomer containing ferritic material, or a suitably commercially available plastomagnetic material, that can be embedded, dispersed or encapsulated within the elastically frictional engagement material.
  • suitable elastically deformable friction inducing magnetizable materials that can be applied to, or adhered to, an inside distal surface of the hollow main body, are envisaged and encompassed by the present specification.
  • the magnetic field produced by the magnetic field production means is configured to provide a sufficiently strong magnetic field to interact with the magnetizable substrate to maintain the hollow main body in longitudinal axial alignment in a distal direction with the injection pen system.
  • the strength of the induced magnetic field will depend on a number of factors, including initial magnetic field strength of the magnetic field production means, and the magnetizable characteristics of the magnetizable substrate. It should nonetheless be borne in mind that, according to another object of the invention, the magnetic field produced by the magnetic field production means is also advantageously configured to provide a sufficiently weak magnetic field to permit separation of the hollow main body from the magnetic field production means in a proximal direction.
  • the magnetic field production means is also provided so that the magnetic field sensor can detect any changes in magnetic field, for example, due to rotational movement of the hollow main body relative to the magnetic field producing means, to enable the dialled dose set via the dose setting wheel to be detected and determined.
  • the magnetic field sensor is thus used to measure the magnetic field produced by the magnetic field producing means. Movement of the magnetic field sensor around the central longitudinal axis relative to the fixed distal positioning of the magnetic field production means, as the dose wheel is rotated, via the hollow main body in contact therewith, is used to calculate or determine a dose of injectable substance in the injection pen system that has been dialled or set by the user. Once the dose has been set, the interaction between the shaft and the injection detection switch, caused by activation of the proximal activator button leading to translational movement of the shaft along the central longitudinal axis, is used to determine or calculate whether an injection has begun, or ended.
  • magneto-resistors are a well known means. Such magneto-resistors are often designated by their abbreviations, e.g. AMR, GMR, TMR sensors, which designate the physical mechanisms by which these sensor components function.
  • Giant magnetoresistance is a quantum mechanical magnetoresistance effect observed in thin-film structures composed of alternating ferromagnetic and non-magnetic conductive layers.
  • Anisotropic magnetoresistance, or AMR is said to exist in materials in which a dependence of electrical resistance on the angle between the direction of electric current and direction of magnetization is observed.
  • Tunnel magnetoresistance is a magnetoresistive effect that occurs in a magnetic tunnel junction (MTJ), which is a component consisting of two ferromagnets separated by a thin insulator. Resistors that use these various properties are known per se.
  • the injection monitoring module and/or system according to the invention preferably uses one, or more, or a plurality of magnetometers as the one, more or plurality of magnetic field sensors.
  • magnetometers differ from the GMR, AMR or TMR sensors in that it directly measures magnetic field strength.
  • Magnetometers measure magnetic fields in two main ways : vector magnetometers measure the vector components of a magnetic field, and total field magnetometers or scalar magnetometers measure the magnitude of the vector magnetic field.
  • Another type of magnetometer is the absolute magnetometer, which measures the absolute magnitude or vector magnetic field, using an internal calibration or known physical constants of the magnetic sensor.
  • Relative magnetometers measure magnitude or vector magnetic field relative to a fixed but uncalibrated baseline, and are also called variometers, used to measure variations in magnetic field.
  • a preferred type of magnetometer therefore for use in the injection monitoring module according to the present invention is an ultra low-power high performance three axis Hall-effect magnetometer. Whilst it is possible for the magnetometer to be configured to measure magnetic field over three mutually perpendicular or orthogonal axes, it is preferred in the present case that the magnetic field sensors be configured to measure magnetic fields over just two of the three orthogonal axes, for example the X and Z axes.
  • the injection monitoring system comprises an electronic component board.
  • the one or more or plurality of magnetic field sensors are electrically connected to the electronic component board.
  • the magnetic field sensors can helpfully be located on the electronic component board in diametrally opposed positions or otherwise radially distributed on the electronic component board, around the central longitudinal axis.
  • the electronic component board comprises an integrated control and data processing unit, such as at least one micro-controller, connected electrically to the one or more, or plurality, of magnetic field sensors, for processing information received from the magnetic field sensors.
  • the electronic component board can therefore suitably be, for example, a printed circuit board of correspondingly appropriate dimensions.
  • a printed circuit board is advantageously disk-shaped, and advantageously provided with a central orifice through which the central longitudinal axis passes.
  • the electronic component board is advantageously housed within the bore of the hollow main body, and preferably is held such that a horizontal plane of the component board is located in a plane substantially orthogonal to said central longitudinal axis.
  • the electronic component board is further located within the bore in a fixed rotational relationship with the hollow main body, so that rotation of the hollow main body causes the electronic component board to rotate in synchronised movement, matching that of the hollow main body. This means that when the hollow main body is rotated, the at least one or more or plurality of magnetometers located on the electronic component board also rotate around the central longitudinal axis.
  • the integrated control and data processing unit comprising at least one micro-controller, handles all electrical communication and signalhng between the different electronic components of the electronic component board and the magnetic field sensors.
  • integrated control and data processing units are known per se, and often integrate a central processing unit, a real time clock, one or more memory storage systems, and optionally communications systems or subsystems, along with other desired components.
  • the electronic component board comprises a communications unit in electrical connection with the at least one microcontroller.
  • a communications unit can be one or more of any number of communications units known per se, such as a wireless communications unit, for example, Bluetooth®, Bluetooth LE® or any other short or long range wireless communication technologies.
  • the electronic component board comprises an autonomous, and preferably rechargeable, power supply, for example a lithium ion battery, which can be easily exchanged when depleted, or alternatively, a rechargeable battery, such as a rechargeable lithium ion battery, which can be charged up when depleted for example via a corresponding charging port, such as a USB port, provided in the injection monitoring module and connected to the rechargeable battery, both types of battery being generally known per se to the skilled person.
  • a corresponding charging port such as a USB port
  • a process for detecting the beginning and/or end of an injection for an ejected or injected substance from a pen injection system comprising: mounting an injection monitoring module according to the invention to a proximal extremity of an injection pen system for delivery of a drug, the injection pen system being equipped with a proximally located dose setting wheel and an injection activator, the dose setting wheel being rotatable about a central longitudinal axis of the pen injection system for dose setting and optionally also during injection; setting a dose via rotation of the dose setting wheel; detecting activation and/or deactivation of an injection detection switch via a translational movement along a central longitudinal axis of a hollow main body of the injection monitoring module; determining a beginning and/or an end of an injection or ejection from said detected translational movement along the central longitudinal axis.
  • a process for detecting, in an injection pen system, whether a dose or amount of injectable substance selected by a user is equal to a dose or amount of injectable substance ejected from said injection pen system comprising: mounting an injection monitoring module according to the invention to a proximal extremity of an injection pen system for delivery of a drug, the injection pen system being equipped with a proximally located dose setting wheel and an injection activator, the dose setting wheel being rotatable about a central longitudinal axis of the pen injection system for dose setting and optionally also during injection; setting a dose via rotation of the dose setting wheel; determining the dose set; detecting activation and/or deactivation of an injection detection switch via a translational movement along a central longitudinal axis of a hollow main body of the injection monitoring module; determining a beginning and/or an end of an injection or ejection from said detected translational movement along the central longitudinal axis; determining, from said determined beginning and end of injection or
  • Figures 1A and IB are schematic side-view representations of an injection monitoring module mounted on a handheld pen injection, whereby Figure IB is rotated through 90° about a central longitudinal axis of rotation compared to Figure 1A;
  • Figure 2 is an exploded schematic perspective view of the injection monitoring module of Figure 1;
  • Figures 3Aand 3B are schematic, cross-sectional representations of the injection monitoring module of Figure 1, whereby Figure 3B is rotated through 90° about a central longitudinal axis of rotation compared to Figure 3A.
  • FIG. 1A and IB schematic sideview partially cross-sectional representations of an injection monitoring module (1) according to the invention are shown.
  • the injection monitoring module (1) is mounted on a handheld injection pen system (2), which comprises a pen injection system body (3) having an outer peripheral surface (4), a pen cap (5) covering the distal extremity of the pen injection system, a dose setting or dialling wheel (6), located at the proximal extremity of the pen injection system body (3), and a dialled dose visualisation window (7), located distally of the dose setting wheel (6), and displaying the dose which has been dialled by a user of the pen injection system.
  • a handheld injection pen system (2) which comprises a pen injection system body (3) having an outer peripheral surface (4), a pen cap (5) covering the distal extremity of the pen injection system, a dose setting or dialling wheel (6), located at the proximal extremity of the pen injection system body (3), and a dialled dose visualisation window (7), located distally of the dose setting wheel (6), and displaying
  • the injection monitoring module (1) is located on or adjacent to the proximal extremity (8) of the injection pen system (2), in particular at least partly around and in contact with the peripheral outer surface (4), surrounding and in contact with the dose setting wheel (6) and extending in a proximal direction beyond the proximal extremity (8) of the pen injection system body (3).
  • a central longitudinal axis (9) is also illustrated, which traverses the longitudinal axial centre of both the injection monitoring module (1) and the injection pen system body (3).
  • the injection pen system is provided with an activator button (10) proximally located from the dose setting or dialling wheel (6), as can be found in several commercially available injection pen systems.
  • the injection monitoring module (1) comprises (1) a hollow main body (11), adapted and configured to be coaxially mounted on, and engage in co- rotation with, the dose setting wheel (6) at the proximal extremity of the pen injection system (2).
  • the hollow main body (11) comprises a central longitudinal bore (12) having a proximal extremity (13) and a distal extremity (14), with the central longitudinal axis (9) passing through the lengthwise axial centre of the bore (12).
  • the hollow main body (11) has an outside surface shape similar to that of a dumbbell, with a cinched or narrower central area (15), which extends in a proximal direction towards the proximal extremity (13), forming a cone shape leading to an expanded proximal circumference (16) at the proximal extremity (13) in comparison to the cinched or narrowed central area (15).
  • the body (11) also extends outwardly from the cinched or narrowed central area in a distal direction forming a cone shape towards leading to an expanded distal circumference (17) at the distal extremity (14).
  • the central longitudinal bore (12) is similarly dimensioned to reflect the internal volume required to house the various other components of the monitoring module.
  • the expanded distal bell shaped part (17) of the body (11) generally has a larger circumference than the corresponding expanded proximal bell shaped part (16), due mainly to the necessity of it being able to fit onto, surround, and engage with an outer peripheral surface of the dose setting wheel (6) of the pen injection system (2).
  • an inner annular peripheral shoulder (18) is defined within the bore by a corresponding projecting area of the inside wall (19) of the body.
  • a projecting annular skirt (20) extends from the shoulder (18) in a distal direction towards to the distal extremity (14).
  • a ridged and correspondingly grooved area (21) located on the inside wall (19) of the body (11).
  • These ridges and grooves (21) are configured to mate respectively with corresponding ridges and grooves provided on the dose setting wheel (6), and are generally comprised of an elastomeric material that enables a push-fit or elastically frictional engagement of the inside wall (19) of the body (11) with the outside surface of the dose setting wheel (6).
  • the injection monitoring module further comprises a magnetic field production means (22) separate from the hollow main body (11), which is mounted and located on and around the peripheral outer surface (4) of the pen body (4) of the injection pen system (2).
  • the magnetic field production means (22) is located adjacent the proximal extremity (8) of the injection pen system (2), but distally of both the dose setting wheel (6) and the hollow main body (11) of the injection monitoring module (1).
  • the magnetic field production means (22) comprises a magnet holder body (23) having a longitudinal bore (24), the centre of which is axially aligned with the longitudinal central axis (9).
  • the magnet holder body (23) has a substantially frustoconical shape extending from a narrower, distal extremity (25) to a wider, proximal extremity (26).
  • the diameter and circumference of the proximal extremity (26) of the magnet holder body (23) substantially match that of the distal bell shaped part (17) of the hollow main body (11) at the distal extremity (14) thereof.
  • the magnet holder body (23) has a proximal peripheral annular shoulder (27) at its proximal extremity (26), from which a projecting annular peripheral wall (28) extends in the proximal direction.
  • the annular peripheral wall (28) of the magnet holder body (23) is configured to have a diameter that is smaller than the corresponding diameter of skirt (20) of the hollow main body (11).
  • a proximal facing edge (29) of the annular peripheral wall (28) comes into contact with a distal facing edge (30) of the shoulder (18).
  • the skirt (20) of the hollow main body (11) surrounds the projecting annular peripheral wall and a distal facing edge of the skirt comes to rest on a proximal facing edge of the peripheral annular shoulder (27) of the magnet holder body (23). In this way, the hollow main body and the magnet holder body are axially aligned along the central longitudinal axis (9).
  • the magnet holder body incorporates at least one magnet.
  • the magnet holder body (23) incorporates an annular magnet (31), for example, encapsulated, located or otherwise seated within the magnet holder body near the proximal extremity (26) of said magnet holder body (23) and spaced radially from the central longitudinal axis.
  • the distal bell shaped part (17) of the the hollow main body (11) is provided with a magnetizable substrate material which becomes magnetized with an induced opposite magnetic field pole to that of the proximal side of the magnetic field production means, when the monitoring module (1) is mounted on the pen injection system (2).
  • the attractive magnetic forces of are configured to be sufficiently strong to maintain the hollow main body and magnet holder body in alignment during positioning and mounting of the monitoring module, yet sufficiently weak to allow a user to move the hollow main body in a proximal direction, for example to remove it, or simply to move it slightly in such a proximal direction to begin a dose setting operation by dialling the dose setting wheel.
  • the magnetizable substrate material can be directly integrated into the body material of the hollow main body (11) at the distal bell shaped part (17), or alternatively, can be applied as a separate body to the inside wall (19) of the main hollow body (11), or for example, and preferably, be integrated into the elastomeric frictionally engaging material of the ridges and grooves area (21).
  • the holder body (23) of magnetic production means (22) is in a fixed position on the injection pen system body (3), and is generally indexed to a dialled dose visualisation window (7) on said pen body (3).
  • Such indexation can occur, for example, by providing a corresponding recess or windowed portion (32) in a distal part of the magnet holder body (23), which is aligned with the dialled dose visualisation window (7) of the pen injection system (2). Consequently, the magnet holder body (23) does not rotate around the pen body (3) of the injection pen system (2).
  • the hollow main body (11) can rotate about the central longitudinal axis and cause the dose setting or dialling wheel (6) of the injection pen system (2) to rotate to the same degree of precision as the hollow main body (11), via the frictionally engaging contact established by the material provided on the inside wall (19) of the distal bell shaped part (17) of the hollow main body (11).
  • This arrangement allows a dose to be dialled or set, by rotating the hollow main body (11) about the central longitudinal axis.
  • the hollow main body (11) further comprises, in the proximal bell shaped part (18) a port orifice
  • the monitoring module (1) further comprises an injection monitoring system
  • the injection monitoring system comprising at least one or a plurality of magnetic sensors (35a, 35b), for example as shown in the Figures, two magnetometers, the injection monitoring system being located within the central longitudinal bore (12) of the hollow main body (11) substantially at the proximal extremity thereof (13), in fixed rotating engagement with the hollow main body (11) about the central longitudinal axis (9).
  • the injection monitoring system would usually also comprise an integrated control and data processing unit (36) electrically connected to the magnetic field sensors for processing information received from the magnetic field sensors.
  • This integrated control and data processing unit (36) can be mounted, along with the magnetometers, for example, on an electronic component board (37), such as a printed circuit board of suitable dimensions to be located within the bore (12) of the hollow main body (11).
  • the integrated control and data processing unit (36) handles all electrical communication and signalling between the different electronic components of the dose control device. It is also responsible for execution of the dose management system and calculations enabling the precise positional location of the magnet to be calculated and determined, as well as handling signals from an autonomous power supply (38), such as a substantially flat and arc-shaped rechargeable lithium ion battery, which battery can for example be recharged via a suitably provided electrical connection port (39) such as a USB port.
  • the integrated control and data processing unit (36) usually also comprises communication means which communicate with a local or remote data processing system, e.g. on a smartphone, such as a wireless communications circuit, for example, a Bluetooth ® or BluetoothLE ® wireless communications system, to name but two of many types of suitable communications means.
  • the electrical connection port (39) used for charging the battery (38) is located at the level of the port orifice (33) so that it is accessible from outside the monitoring module.
  • the integrated control and data processing unit (36) can be programmed remotely, upon first use, or receive information and updates, in a similar way to other electronic devices today containing integrated control and data processing units, for example, wirelessly, or via any other suitable link.
  • integrated control and data processing units are known per se, and often integrate a central processing unit, a real time clock, one or more memory storage systems, and optionally communications systems or subsystems, along with other desired components.
  • the electronic component board (37) is seated or located within the bore (12) of the hollow main body (11) substantially along the horizontal plane of the circuit board, i.e.
  • the recesses (41) can be used to facilitate placement and seating of the electronic component board within the bore (12) to the extent that they are shaped to correspond to and interact with, corresponding projections provided on the inside wall of the hollow main body. Additionally, the locating and seating of the electronic component board can be further facilitated by providing one or more projecting shoulder portions (42), or an annular projecting shoulder portion, extending radially from the inside wall (19) of the hollow main body (11) towards the centre of the bore (12).
  • one or more wall portions (43) can be provided which extend from the projecting shoulder portions in a proximal direction.
  • the proximally extending walLportions (43) can be contiguous or semi-contiguous, for example forming an inner annular wall which extends in a proximal direction.
  • these proximally extending wall portions (43) traverse the central aperture (40) of the electronic component board (37), and frictionally engage with the peripheral facing edge (44) of the electronic component board 37) that defines the limits of the central aperture (40), thereby holding the board (37) in position.
  • the proximally extending walls (43) traversing the central aperture (40) of the electronic component board, the proximally extending walls (43) do not completely fill the aperture, with a suitable space remaining available for other elements of the monitoring module along the central longitudinal axis.
  • the injection monitoring module further comprises a covering cap (45) for covering the proximal face, and proximally located components of the electronic component board (37).
  • the covering cap (45) has a suitably recessed portion (46) in the proximal direction to take account of the height of the various components situated on the proximal face of the electronic component board (37).
  • the covering cap can also be provided with seating recesses (47) located around a peripheral edge (48) of the covering cap to facilitate seating with respect to the inside wall (19) of the hollow main body (11).
  • the covering cap (45) is furthermore provided with one or more central, and axially aligned with the central longitudinal axis, projecting wall portions (48) extending from a distal side of the cap (45) in the distal direction.
  • the one or more distally projecting wall portions (48) can form a substantially contiguous annular wall, the distal extremity face (49) of which comes into contact with, and rests upon, the proximal face (50) of corresponding proximally extending walls (43).
  • the electronic component board is substantially encased within the bore (12) of the hollow main body, and seated and located by these elements in such a way that the electronic component board can not be moved independently either laterally, axially, or substantially out of the orthogonal plane compared to the central longitudinal axis (9). Indeed, such undesired movement of the electronic component board might lead to false readings by the magnetometers with regard to any detected magnetic field.
  • the distally projecting wall portions (48) do not completely fill the aperture (40), with a suitable space remaining available for other elements of the monitoring module (1) along the central longitudinal axis (9).
  • the monitoring module also comprises an injection activator button (51).
  • the injection activator button is shaped and dimensioned to cover the recessed portion (46) of the covering cap (45).
  • the injection activator button is connected to a shaft (52), which extends from a distal surface of the activator button in a distal direction.
  • the shaft extends in a distal direction along the central longitudinal axis (9) through the aperture (40) of the electronic component board (37) and within the space created inwardly along the central longitudinal axis by the wall portions (43, 48).
  • the shaft (52) is configured to extend all the way to a distal tip (53) which is in contact with the activator button of the pen injection system (2).
  • the shaft comprises at least one switch interaction zone (54), for example, a groove located part way along the shaft (52) at a suitable point, that is substantially on a level with the aperture (40) of the electronic component board (37).
  • the at least one switch interaction zone (54) is configured and dimensioned to interact with at least part of a detection switch (55), which is located on the electronic component board (37).
  • Any suitable kind of switch can be provided, so long as it can interact with the switch interaction zone to move or be moved from a deactivated state to an activated state, or vice-versa.
  • the switch (55) represented is an angled actuated detect switch, for example a micro mini angled detect switch of the kind available commercially under the FDSE series from C&K (France).
  • This kind of switch has an angled lever arm (56) that moves through an arc to activate and deactivate the switch circuit.
  • the lever arm (56) is set at an angle with regard to the shaft (52) and is situated in the switch interaction zone (54), which is defined by a groove or recess, with the sidewalls (57, 58) of the groove or recess representing the translational limits of any interaction along the central longitudinal axis (9).
  • Switch detection functions as follows: a user of the pen injection device dials a dose of injectable substance to be administered, for example, insulin, by rotating the hollow main body (11) about the central longitudinal axis (9), which in turn causes the dose setting wheel in the pen injection system to rotate and dial a dose.
  • the visual display area (7) of the pen injection system changes to approximately match the dialled dose in a known manner.
  • the magnetometers (35a, 35b) located in a fixed position on the electronic component board (37), the latter also being correspondingly seated within the bore of the hollow main body and rotating therewith, detect changes in the magnetic field produced by the annular magnet in the magnet holder body (23), which does not rotate.
  • the detected magnetic fields are communicated to the integrated control and data processing unit (36), which then determines which dose of injectable substance has been dialled.
  • the monitoring module (1) does not however yet know nor been provided with any indication of whether an injection has taken place, and if so, how much product has been injected or ejected from the pen injection system.
  • the proximal activation button (51) of the monitoring module (1) is pressed by the user, the button moves in a distal direction.
  • the shaft translates along the central longitudinal axis (9) and pushes the activation button of the pen injection system.
  • the switch interaction zone also translates in a distal direction.
  • the lever arm (56) of the detect switch (55) is located in the recess of the switch interaction zone (54)
  • translational movement of the shaft brings the lever arm into interacting contact with at least one of the sidewalls (57, 58), for example, the proximal sidewall (57) and causes the lever arm (56) to move through an arc angle sufficient to cause activation of the switch (55), which then signals the integrated data processing and control unit (36) that injection has begun, for example via a generated timestamp value.
  • the shaft translates in a proximal direction under the recoil force of the pen injection system as the activator button of the pen injection system pushes back against the tip (53) of the shaft (52).
  • the reverse translational movement of the shaft along the central longitudinal axis (9) causes the lever arm (56) of the switch to interact once again with the switch interaction zone (54) and move the lever arm through an arc angle that leads to deactivation of the switch (55).
  • the deactivation signal is communicated to the integrated data processing and control unit, which then determines the point in time at which the injection step terminated, for example, once again, via a generated timestamp value.
  • the integrated data processing and control unit can then determine how much of the selected dose was actually injected or ejected according to its preprogrammed or otherwise acquired data corresponding to the type of pen and/or injectable substance to be administered.
  • the combination of calculated dose dialled and actual dose administered can be stored permanently or temporarily in the volatile or non-volatile memory of the monitoring module, and/or communicated to an external device over a wireless or other communications means, such as a smartphone or remotely located server or cloud computing system, and the results displayed to the user in a meaningful manner to facilitate management and compliance with the treatment regime requiring such injections to be carried out.
  • a wireless or other communications means such as a smartphone or remotely located server or cloud computing system

Abstract

L'invention concerne un module de surveillance d'injection pour un montage amovible sur un système de stylo d'injection, comprenant : un corps principal creux destiné à être monté de manière coaxiale sur la roue de réglage de dose du système de stylo d'injection et entrer en rotation conjointe avec celle-ci ; le corps principal creux comprend un alésage longitudinal central et un axe longitudinal central ; et un système de surveillance d'injection situé à l'intérieur de l'alésage longitudinal central comprenant au moins un ou plusieurs capteurs magnétiques, en prise rotative fixe avec le corps principal creux autour de l'axe longitudinal central ; le module de surveillance d'injection comprenant en outre un moyen de production de champ magnétique distinct du corps principal creux, situé sur et autour d'une surface périphérique et adjacent à l'extrémité proximale, d'un corps de système de stylo d'injection, mais de manière distale à la roue de réglage de dose du système de stylo d'injection et du corps principal creux du module de surveillance d'injection.
PCT/IB2020/000054 2020-01-10 2020-01-10 Module complémentaire rotatif de surveillance d'injection WO2021140352A1 (fr)

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Publication number Priority date Publication date Assignee Title
WO2023170437A1 (fr) * 2022-03-09 2023-09-14 Biocorp Production S.A. A Conseil D'administration Dispositif de mesure de dose électronique pouvant être fixé de manière amovible pour un système de stylo d'injection
WO2023187434A1 (fr) * 2022-03-31 2023-10-05 Biocorp Production S.A. A Conseil D'administration Module de surveillance d'injection avec système de verrouillage de position
WO2023209411A1 (fr) * 2022-04-28 2023-11-02 Biocorp Production S.A. A Conseil D'administration Système et procédé de surveillance de point d'extrémité d'injection

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WO2019129623A1 (fr) * 2017-12-28 2019-07-04 Sanofi Appareil de collecte de données destiné à être fixé sur un dispositif d'injection
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WO2014128156A1 (fr) 2013-02-19 2014-08-28 Novo Nordisk A/S Module capteur rotatif à commutateur axial
US20140276583A1 (en) * 2013-03-15 2014-09-18 Bayer Healthcare Llc Injection device with automatic data capture and transmission
WO2018013419A1 (fr) 2016-07-15 2018-01-18 Eli Lilly And Company Module de détection de dose pour dispositif d'administration de médicament
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WO2019129623A1 (fr) * 2017-12-28 2019-07-04 Sanofi Appareil de collecte de données destiné à être fixé sur un dispositif d'injection
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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023170437A1 (fr) * 2022-03-09 2023-09-14 Biocorp Production S.A. A Conseil D'administration Dispositif de mesure de dose électronique pouvant être fixé de manière amovible pour un système de stylo d'injection
WO2023187434A1 (fr) * 2022-03-31 2023-10-05 Biocorp Production S.A. A Conseil D'administration Module de surveillance d'injection avec système de verrouillage de position
WO2023209411A1 (fr) * 2022-04-28 2023-11-02 Biocorp Production S.A. A Conseil D'administration Système et procédé de surveillance de point d'extrémité d'injection

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