WO2025202308A1 - Module complémentaire électronique et ensemble de module complémentaire électronique et d'un dispositif d'administration de médicament - Google Patents

Module complémentaire électronique et ensemble de module complémentaire électronique et d'un dispositif d'administration de médicament

Info

Publication number
WO2025202308A1
WO2025202308A1 PCT/EP2025/058304 EP2025058304W WO2025202308A1 WO 2025202308 A1 WO2025202308 A1 WO 2025202308A1 EP 2025058304 W EP2025058304 W EP 2025058304W WO 2025202308 A1 WO2025202308 A1 WO 2025202308A1
Authority
WO
WIPO (PCT)
Prior art keywords
module
dose
sensor arrangement
output signal
acoustic sensor
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/EP2025/058304
Other languages
English (en)
Inventor
Paul Richard Draper
Aidan Michael O'hare
Robert Frederick Veasey
Andrew Wallace
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.)
Sanofi SA
Original Assignee
Sanofi SA
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
Priority claimed from EP24315109.9A external-priority patent/EP4623963B1/fr
Priority claimed from US18/620,385 external-priority patent/US20250303070A1/en
Application filed by Sanofi SA filed Critical Sanofi SA
Publication of WO2025202308A1 publication Critical patent/WO2025202308A1/fr
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
    • A61M5/31—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
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • 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
    • 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
    • A61M2205/3327—Measuring
    • 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
    • A61M2205/3375—Acoustical, e.g. ultrasonic, measuring means

Definitions

  • the present disclosure is generally directed to an electronic add-on module and to an assembly of an electronic system, e.g. an electronic add-on module, which is configured to be releasably attached to a drug delivery device.
  • Electronic add-on modules for releasable attachment to drug delivery devices are generally known and often used to provide further functionalities to drug delivery devices.
  • electronic add-on modules are known which measure relevant data with respect to dose setting and/or dose dispensing.
  • An exemplary data collection device for attachment to an injection device is for example shown in WO 2016/198516 A1.
  • modules for attachment to an injection device are known from EP 3 430 981 A1 , US 2016/235925 A1 , US 2023/135526 A1 and US 10 258 745 B2.
  • a drug delivery device with a clicker arrangement providing a click sound at the end of dose dispensing is known, for example, from EP 3 164 173 A1 .
  • the use of sounds that indicate a dose event, e.g. the start of a dose delivery can be an important indication, particularly for visually handicapped users. However, sound feedback can also be helpful for unexperienced users to recognize correct operation of the drug delivery device.
  • an electronic add-on module is used with a drug delivery device, e.g. for monitoring or measuring dose events, it is desirable if the electronic add-on module acts independently and safe and, for example, reliably records the amount of dose dispensed or the time at which a dose is dispensed.
  • sensors are used for monitoring and measuring, for example, sensors for optical detection of relative movements.
  • these sensors are typically complicated to implement.
  • relative movements are not always decisive and indicative of an actual drug delivery device event. For example, a brief interruption of a dose delivery does not necessarily mean that dose dispensing has ended, however, may as such be recognized by an electronic add-on module which relies only on, for example, optical sensing, i.e. optical detection of relative movements.
  • Background noises may also be called non-relevant noises or sounds which may be responsible for non-relevant first output signals of the sensor arrangement. These non-relevant first output signals or background noises may not be generated by dose events but still be detected by the acoustic sensor arrangement. Noises or sounds other than background noises may be called relevant noises. These noises or sounds are indicative for dose events.
  • the terms “noise” and “sound” are interchangeably used herein.
  • the acoustic sensor arrangement may be configured to detect click sounds from the drug delivery device or may be configured to detect beeps (beep sounds) emitted by the drug delivery device or a supplementary device such as a mobile phone, for example.
  • the sounds may be generated mechanically, electromechanically or electronically, e.g.
  • the electronic add-on module may have a coupling portion for releasable attachment to a drug delivery device, and wherein the port hole is directed towards the coupling portion.
  • the port hole may be arranged to face the drug delivery device.
  • the coupling portion is releasably attached to a dose dial grip of the drug delivery device, wherein the drug delivery device comprises a needle at its distal end
  • the port hole may (substantially) face in a distal direction, i.e. towards the distal end of the drug delivery device. This arrangement may be particularly helpful, if the relevant sound, i.e.
  • the circuit board assembly when the electronic add-on module is releasably attached to the drug delivery device, may be arranged between the drug delivery device and the acoustic sensor arrangement.
  • the acoustic sensor arrangement may thus be shielded from the coupling portion by the circuit board assembly, which may provide additional protection for the acoustic sensor arrangement, for example additional protection against ingress of dirt or liquid.
  • the acoustic sensor arrangement may be directly coupled to a side of the circuit board assembly facing away from the coupling portion.
  • “Comparison” may mean that the processing circuit may identify a transition of a voltage of the first output signal from below to above the threshold value. Alternatively, the processing circuit may identify a transition of a voltage of the first output signal from above to below the threshold value. In other words, the processing circuit may identify if an amplitude of the first output signal is higher (greater) or smaller (lower) than a threshold value. However, the processing circuit may also identify a number of transitions between an area below the threshold value and an area above the threshold value, i.e. a number of changes at which the first output signal exceeds the threshold value and falls below the threshold value. Alternatively, the processing circuit may also identify a number of transitions between an area above the threshold value and an area below the threshold value.
  • the threshold value may be chosen to be between 10% and 50%, e.g. 20%, above or below the zero crossing in relation to a maximum expected amplitude of a first output signal of a relevant sound, so that pulses that do not cross the threshold value are not used for detection.
  • a maximum expected amplitude of a relevant sound is +400 mV
  • the threshold value for a case where it is chosen to be 10% above the zero crossing is +40 mV. Consequently, only pulses that do cross the threshold value or that do change between an area below the zero crossing and above the zero crossing a predetermined number of times are used for detection.
  • the processing circuit may comprise an analog-to-digital converter configured to convert the first output signal to a numerical value.
  • the analog-to- digital converter may convert a voltage output signal of the acoustic sensor arrangement into a numerical value.
  • the processing circuit may be configured to compare the numerical value to a numerical threshold value.
  • the electronic add-on module may comprise, in addition to the processing circuit, a conditioning circuit configured to condition the first output signal of the acoustic sensor arrangement.
  • the conditioning circuit may modulate the first output signal received from the acoustic sensor arrangement.
  • the first output signal when received by the conditioning circuit may thus be untreated, unconditioned or unprocessed and may be described as a "raw signal”. After conditioning, the signal may then be referred to as a "conditioned signal".
  • the conditioning of the first output signal may be performed prior to being processed in the processing circuit, i.e. before the processing, for example, detection takes place. In other words, detection by the processing circuit may be performed based on a conditioned signal, i.e. a conditioned first output signal.
  • the process circuit may thus be downstream compared to the conditioning circuit.
  • Downstream may mean that something, i.e. a circuit or an electronic component, is located further away from the acoustic sensor arrangement in the signal path, wherein “upstream” may mean that something, i.e. a circuit or an electronic component, is located closer to the acoustic sensor arrangement in the signal path.
  • upstream may mean that something, i.e. a circuit or an electronic component, is located closer to the acoustic sensor arrangement in the signal path.
  • Upstream and downstream do not refer to items being necessarily physically closer or further away in proximity to the acoustic sensor, but to them being schematically closer or further away in the signal path.
  • the conditioning circuit and/or the processing circuit are predominantly provided by analog electronic components.
  • the conditioning of the first output signal may comprise at least one of, several of or all of the following conditioning operations:
  • acoustic sensor arrangements i.e. also microphones
  • a state in which no sound is detected by the acoustic sensor arrangement may be a "quiescent state". The sound subsequently detected by the acoustic sensor arrangement may lead to the pulse described above, i.e.
  • removing or filtering out the DC bias voltage may allow to use processing regardless of the specific implemented acoustic sensor arrangement. Further, a non-zero quiescent state may reduce the dynamic range of the processing circuit and may thus reduce the efficacy of the threshold value detection. Removing or filtering therefore means that the DC bias voltage does not affect the processing circuit, i.e. the DC bias voltage may enter the conditioning circuit but does not form part of the conditioned signal.
  • “Amplifying the first output signal by increasing an amplitude of the first output signal” may allow to use the first output signal in a (digital) logic circuit.
  • the first output signal of the acoustic sensor arrangement corresponding, for example to a dose click may have a smaller amplitude than an amplitude that may be detectable by typical digital logic circuits. If the first output signal is processed by an analog-to-digital converter, the first output signal would require a lower reference voltage for analog to digital conversion than is typical required for an embedded microcontroller. Increasing the signal amplitude may also increase the signal to noise ratio. Amplification may thus increase the magnitude of the signal, for example a time-varying voltage or current.
  • Modulating the first output signal by elongating a duration the first output signal, rectifying the first output signal and/or smoothing the first output signal may allow for better processing of the first output signal.
  • a duration of a first output signal corresponding to a click sound for example a dose click sound provided during dose dialing, is relatively short in time. Typically, less than 3 milliseconds (ms). Therefore, fast operation of the processing circuit may be required to detect the signal. Elongating the first output signal may thus allow for the processing circuit to operate slower.
  • a sound, for example a click sound, detected by the acoustic sensor arrangement may be a damped sine wave which may cross the threshold value, i.e.
  • rectifying the first output signal may allow to limit a number of times a first output signal of a single click sound may cross or transit a threshold value.
  • differentiating between a first output signal received from a single sound, for example a single dose click, compared to a first output signal received from multiple sounds, for example multiple dose clicks may be easier.
  • the conditioning circuit may thus comprise at least one of, several of or all of the following components and functionalities:
  • a DC-filter unit configured to remove a DC bias voltage of the acoustic sensor arrangement
  • the electrical impedance unit may be provided by a resistor. By setting the resistance value of the resistor, the current flow into the amplifier unit may be limited, i.e. the maximum current flowing into the amplifier unit. The amplifier unit may thus be protected from potential damage.
  • the amplifier unit may be provided by an amplifier used for increasing a magnitude of the signal, for example by setting a gain and increasing an amplitude of the first output signal.
  • the envelope conditioning circuit Without conditioning the first output signal, for example by the envelope conditioning circuit, it may be difficult to precisely process sound signals of drug delivery devices comprising for example two clicker arms as two click sounds may be very close, for example separated by only approximately 1 ms.
  • the envelope detection circuit may comprise an RC element with a resistor and a grounded capacitor, and a diode connected in parallel with the resistor.
  • the envelope detector may either have a resistor, it may have a grounded capacitor and it may have a diode in parallel with a resistor, or it may have a RC element with a resistor, a grounded capacitor and a diode in parallel with the resistor.
  • a voltage may thus directly pass through the diode in order to charge the capacitor.
  • the capacitor is thus charged quickly which leads to the aforementioned fast response to rising voltages.
  • the discharge of the capacitor is performed via the resistor. Consequently, the envelope detection circuit allows for a slow response to falling voltages.
  • the envelope detection circuit allows for a slower response speed of the processing circuit since a first output of a sound, for example a click sound, may be longer in time, i.e. elongated.
  • the envelope detection circuit may also allow for partial deletion or removal of several discrete amplitudes of a single sound, for example a single click sound.
  • the electronic add-on module may comprise a first portion defining an auxiliary dose dial grip. Rotation of the auxiliary dose dial grip may thus rotate the dose dial grip of the drug delivery device and may thereby be used for dose setting.
  • the first portion may be configured to be releasably attached to a dose dial grip of the drug delivery device. The first portion may thus for example allow for mechanical coupling by interacting mechanical coupling elements or by frictional or elastic engagement.
  • the first portion may comprise a longitudinal axis. The first portion may extend along the longitudinal axis. When the electronic add-on module is releasably attached to a drug delivery device, the longitudinal axis may be in line with a longitudinal axis of the drug delivery device.
  • the electronic add-on module may comprise a second portion coupled to the first portion.
  • the coupling between the first portion and the second portion may allow the second portion to be relatively moved rotationally about the longitudinal axis and axial parallel to the longitudinal axis with respect to the first portion.
  • the coupling may allow relative rotational movement about the longitudinal axis and relative axial movement parallel to the longitudinal axis with respect to the first portion.
  • the second portion may define an auxiliary dose button configured to apply pressure onto the dose button of the drug delivery device when the electronic addon module is releasably attached to the drug delivery device.
  • the electronic add-on module may additionally comprise a switch, for example a microswitch, wherein the switch may be configured to be actuated to activate electronic functionalities of the electronic add-on module.
  • the switch may be used to activate the acoustic sensor arrangement. Consequently, sound detection by the acoustic sensor arrangement may only be conducted, when the acoustic sensor arrangement is activated. Therefore, the switch may allow to reduce power consumption of electronics. In addition, the switch may prevent that sounds are detected accidentally as relevant noises although the electronic add-on module is not used.
  • the electronic add-on module may additionally comprise a clutch mechanism, wherein, when the clutch is engaged, relative rotational movement about the longitudinal axis between the first portion and the second portion may be prevented. Further, when the clutch is disengaged, relative rotational movement about the longitudinal axis between the first portion and the second portion may be allowed. Furthermore, when the electronic add-on module is releasably attached to a drug delivery device, the switch may be configured to be actuated prior to disengagement of the clutch. Consequently, the clutch mechanism may keep the first portion and the second portion rotationally fixed, i.e. no or at least no substantial relative rotational movement between the first portion and the second portion is possible, until sufficient load is applied.
  • the clutch mechanism may prevent dose dispensing before disengagement of the clutch mechanism. Therefore, the switch may be activated before the clutch disengages, which may allow to actuate the switch before a dose dispensing starts. Thus, this may ensure that the acoustic sensor arrangement is activated during dose dispensing, which may allow to ensure detection of a start of a dose dispensing event or an end of a dose dispensing event.
  • the electronic add-on module may comprise at least one non-acoustic sensor arrangement.
  • the electronic add-on module may comprise at least one further sensor arrangement which is not an acoustic sensor arrangement.
  • the nonacoustic sensor arrangement may be an optical, a magnetic, a mechanical or a capacitive sensor arrangement.
  • a second output signal of the at least one non-acoustic sensor arrangement may be used to classify a detected dose event into a relevant or a non-rele- vant dose event.
  • the processing circuit may detect, based on a first output signal from the acoustic sensor arrangement, that a dose dispensing event may have occurred, however, an optical sensor arrangement may detect no relative movement, for example no relative rotational movement between the dose dial grip with respect to the dose button, and may therefore classify the detected dose event, which was detected based on the first output signal, as a non-relevant dose event. Consequently, no dose dispensing event may be registered in a memory or sent to a further device, such as a mobile phone or the like.
  • Using multiple sensor arrangements may thus increase accuracy of the electronic add-on module. For example, using multiple sensor arrangements may thus prevent a user to dispense a dose, which would otherwise not be required.
  • the acoustic sensor arrangement may be a MEMS (micro-electromechanical systems) acoustic sensor arrangement, for example a capacitive or piezoelectric MEMS acoustic sensor arrangement.
  • the acoustic sensor arrangement may thus comprise a microphone which is MEMS.
  • a suitable MEMS sensor arrangement may for example be AMM-3742-T-EB-R MEMS microphone provided by Pill Audio or a Ole Wolff OWMMOA-271809A-S381 FANC-BP.
  • MEMS acoustic sensor arrangements for example MEMS microphones are highly sensitive.
  • the object may be solved by an assembly comprising a drug delivery device and an electronic add-on module according to the aforementioned aspects.
  • the electronic add-on module may be releasably attached to the drug delivery device.
  • the drug delivery device may for example be the drug delivery device known from EP 3 164 173 A1 .
  • EP 1 570 876 B1 EP 2 814 547B1 , EP 2 890 434 B1 , WO 2005/018721 A1 , WO 2009/132777 A1 , WO 2014/033195 A1 , US 5,693,027 A, US 6,663,602 B2, US 7,241 ,278 B2 or US 9,937,294 B2.
  • a housing may be stationary and may be used as a reference system for the further movements of other components.
  • a plunger may be stationary and may be guided in a housing thread.
  • a drive sleeve may perform a helical movement, i.e. a combined axial and rotational movement, and may be in threaded engagement with the plunger.
  • a dial grip may perform a helical movement.
  • a dose button may be free to rotate but axially constrained to the drive sleeve. For example, the dose button may be axially retained to the drive sleeve by a clutch.
  • An optional clutch may perform a helical movement and may couple a number sleeve to the drive sleeve.
  • An optional clutch spring may perform an axial movement and may be guided in housing splines and may click over clutch teeth.
  • An optional number sleeve may be permanently fixed on the dial grip and may perform a helical movement and may be guided in a housing thread.
  • An optional last dose nut may perform a helical movement on a drive sleeve track of the drive sleeve and may be rotationally constrained to the housing. Hence, the last dose nut may perform axial movement relative to the housing and a helical movement with respect to the drive sleeve.
  • the housing may remain stationary as a reference system for the further movements of other components.
  • the plunger may perform a helical movement and may be guided in the housing thread.
  • the drive sleeve may perform a pure axial movement and may be in threaded engagement with the plunger.
  • the dose dial grip may perform a helical movement and may be permanently fixed on the number sleeve.
  • the dose button may perform an axial movement if coupled to the drive sleeve and/or the clutch.
  • the optional clutch may perform pure axial movement and may de-couple the number sleeve from the drive sleeve.
  • the optional clutch spring may perform pure axial movement and may be rotationally constrained to the clutch due to a pressure applied to the dose button.
  • the optional number sleeve may perform a helical movement and may be guided in the housing thread.
  • the optional last dose nut may maintain its axial position on the drive sleeve track and may be rotationally constrained to the housing.
  • the components responsible for dose setting i.e. for increasing a dose to be dispensed, may thus be considered a dose dialing mechanism, wherein the components responsible for dose dispensing, i.e. for dispensing the dose, for example from the device into a user's body, may be considered a dose dispensing mechanism.
  • the electronic add-on module may comprise an interface for a dose dialing mechanism and/or a dose dispensing mechanism. Actuation of the corresponding mechanism, i.e. the dose dialing mechanism and/or the dose dispensing mechanism, may cause a clicking sound, for example, by a deflected clicker arm which may be deflected, by ratchets or the like, due to relative movements of the respective mechanism.
  • the electronic add-on module may be configured to detect a dose dialing event, a dose dispensing event and/or a dose amount, dialed and/or dispensed, based on a first output signal of the acoustic sensor arrangement resulting from the clicking sound, preferably provided by a clicker arm.
  • the beneficial technical effects described with respect to the electronic add-on module may thus also account for the assembly. Consequently, the assembly may allow for improved dose event detection.
  • the drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device.
  • the drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., short- or long-term storage) of one or more drugs.
  • the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days).
  • the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C).
  • An immunoglobulin single variable domain can be a heavy chain ISV, such as a VH (derived from a conventional four-chain antibody), or VHH (derived from a heavychain antibody), including a camelized VH or humanized VHH.
  • the immunoglobulin single variable domain may be a (single) domain antibody, a "dAb” or dAb or a Nanobody® ISV (such as a VHH, including a humanized VHH or camelized VH) or a suitable fragment thereof.
  • Nanobody® is a registered trademark of Ablynx N.V.]; other single variable domains, or any suitable fragment of any one thereof.
  • VHH domains also known as VHHs, VHH antibody fragments, and VHH antibodies, have originally been described as the antigen binding immunoglobulin variable domain of “heavy chain antibodies” (i.e., of “antibodies devoid of light chains”; Hamers-Caster- man et al. 1993 (Nature 363: 446-448).
  • VHH domain has been chosen in order to distinguish these variable domains from the heavy chain variable domains that are present in conventional 4-chain antibodies (which are referred to herein as “VH domains”) and from the light chain variable domains that are present in conventional 4- chain antibodies (which are referred to herein as “VL domains”).
  • VHH domains For a further description of VHH’s, reference is made to the review article by Muyldermans 2001 (Reviews in Molecular Biotechnology 74: 277-302).
  • CDR complementarity-determining region
  • framework region refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding.
  • framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.
  • antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).
  • Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.
  • An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608- 1 :2014(E), needle-based injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems.
  • the container may be a replaceable container or an integrated non-replaceable container.
  • a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).
  • Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).
  • a single-dose container system may involve a needle-based injection device with a replaceable container.
  • each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation).
  • each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).
  • a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container.
  • each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation).
  • each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).
  • axial axial
  • radial radial
  • circumferential may be used with respect to a longitudinal axis of the electronic add-on module, the first portion, the second portion, the drug delivery device, the cartridge, the housing, the cartridge holder or the assembly of the drug delivery device and the electronic add-on module, e.g. the axis which extends through the proximal and distal ends of the cartridge.
  • distal is used herein to specify directions, ends or surfaces which are arranged or are to be arranged to face or point towards dispensing end of the electronic add-on module or the drug delivery device or components thereof and/or point away from, are to be arranged to face away from or face away from the proximal end.
  • proximal is used to specify directions, ends or surfaces which are arranged or are to be arranged to face away from or point away from the dispensing end and/or from the distal end of the electronic add-on module or the drug delivery device or components thereof.
  • the distal end may be the end closest to the dispensing and/or furthest away from the proximal end and the proximal end may be the end furthest away from the dispensing end.
  • a proximal surface may face away from the distal end and/or towards the proximal end.
  • a distal surface may face towards the distal end and/or away from the proximal end.
  • the dispensing end may be the needle end where a needle unit is or is to be mounted to the device, for example.
  • a distal element compared to a proximal element is located closer to the dispensing end than to the proximal end.
  • distal may be used with regard to the more distal end of the electronic add-on module, which is located closer to the dispensing end of the drug delivery device when attached to the drug delivery device
  • proximal may be used with regard to the proximal end of the electronic add-on module, which is located further away from the dispensing end of the drug delivery device when attached to the drug delivery device.
  • Figure 1 shows a drug delivery device
  • Figure 2 shows a drug delivery device with an exploded view of an electronic add-on module arranged above the drug delivery device
  • Figure 3 shows an exemplary second portion of an electronic add-on module
  • Figure 4 shows a first state, prior to any movement, of a sequence of movement of an assembly
  • Figure 5 shows an intermediate state of a sequence of movement of the assembly
  • Figure 6 shows a final state of movement of a sequence of movement of the assembly
  • Figure 7 shows a circuit board assembly with a "top-ported” acoustic sensor arrangement
  • Figure 8 shows a circuit board assembly with a "bottom-ported” acoustic sensor arrangement
  • Figure 9 shows a conditioning circuit
  • Figure 11 shows a first output signal and a conditioned first output signal.
  • identical elements and components as well as identical elements and components in different examples or embodiments, i.e. elements and components acting identical or provided for the same purposes but belong to different examples, are provided with the same reference signs.
  • FIG. 1 shows an exploded view of an exemplary medicament or drug delivery device 1.
  • the drug delivery device 1 is a pen-type injector comprising a housing 10, i.e. a housing 10 of a drug delivery device 1 or a drug delivery device housing 10, in which a drive mechanism for dose setting and dose dispensing is arranged.
  • the drug delivery device 1 extends from a distal point to a proximal direction P or from a proximal point to a distal direction D along a drug delivery device axis Y of the drug delivery device 1 , i.e. a longitudinal axis of the drug delivery device 1.
  • a user may rotate or dial a dose dial grip 12 with respect to the housing 10, wherein the dose dial grip 12 is arranged at a proximal end of the housing 10.
  • the dose dial grip 12 may perform a helical movement, i.e. a combined axial and rotational movement, or may perform pure rotational movement.
  • the drive mechanism of the drug delivery device 1 may comprise a plunger, a drive sleeve (partially visible through window 13 in Figure 1), a clutch, a clutch spring, a number sleeve, a last dose nut and so on, which may move during dose setting and/or dose dispensing.
  • a plunger a drive sleeve (partially visible through window 13 in Figure 1)
  • a clutch a clutch spring
  • a number sleeve a last dose nut and so on
  • the user may press a dose button 11 arranged at the proximal end of the drug delivery device 1 in the distal direction D in order to dispense the dose.
  • a dose button 11 arranged at the proximal end of the drug delivery device 1 in the distal direction D in order to dispense the dose.
  • the user applies a force, for example on a proximal end surface 19 of the dose button, directed towards the proximal end of the drug delivery device 1 , wherein the force moves the dose button 11 in the distal direction of the pen and parallel to the second longitudinal axis Y.
  • This axial movement of the dose button 11 releases the drive mechanism for example by de-coupling a number sleeve from the drive sleeve, wherein irrespective of which component of the drug delivery device 1 performs a rotational movement during dose delivery, the dose dial grip 12 is coupled to a respective component in order to perform a rotational movement during dose delivery.
  • the exemplary drug delivery device 1 shown in Figure 1 comprises in addition to the dose dial grip 12 and the dose button 11 a display window 13, a needle hub 15 to which a container 14 may be attached and a needle.
  • the set dose may be displayed via the dosage window 13.
  • the container may be filled directly with a drug, for example, insulin or may be configured to receive a cartridge and thus act as a cartridge holder.
  • the needle may be affixed to the container 14 or the receptacle. During dose dispensing the drug is dispensed through the needle.
  • the needle may be protected by an inner needle cap 16 and/or an outer needle cap 17.
  • the needle or the inner needle cap 16 may be protected by an outer cap 18.
  • an electronic add-on module 100 may be functionally attached to a drug delivery device 1 , i.e. attached and usable, either the drug delivery device 1 can be adapted to the electronic add-on module 100 or, conversely, the electronic add-on module 100 can be adapted to the drug delivery device 1.
  • the electronic add-on module 100 may comprise a coupling portion. The coupling portion may thus be distally arranged and directed towards the drug delivery device, at least when attached.
  • Figure 2 shows a further schematic example of a drug delivery device 1 , wherein an exploded view of an electronic add-on module 100 is arranged above the dose button 11 of the drug delivery device 1. More precisely, above the proximal end surface 19 of the dose button 11 , which may be pressed in order to dispense a dose.
  • the schematic example of the drug delivery device 1 only shows the housing 10 together with the proximally arranged dose button 11 and dose dial grip 12. Further, a drive sleeve, which may also be a number sleeve instead, are shown together with the dosage window 13
  • the electronic add-on module 100 comprises a first portion 101 and a second portion 102. Together, the first portion 101 and the second portion 102 and as such outer walls of the first portion 101 and the second portion 102 together form a housing of the electronic add-on module 100.
  • the electronic add-on module 100 may also have a one-piece external design, i.e. have only one portion, or have more than two portions, for example three portions.
  • both portions 101 and 102 together provide for a clutch mechanism, which is formed by corresponding clutch teeth 103 on the second portion 102, which may engage in corresponding clutch slots 104 on the first portion 101 . When the clutch mechanism is engaged, the first portion 101 and the second portion 102 cannot rotate relative to each other.
  • rotation about the longitudinal axis X may also mean rotation about the longitudinal axis Y, for example when the electronic add-on module 100 is attached to the drug delivery device 1 in order to provide an assembly.
  • An assembly of a drug delivery device 1 and an electronic add-on module 100 is for example shown in Figures 4 to 6.
  • a pressure may be applied to a proximal end surface 105 of the electronic add-on module 100 in order to apply pressure to the proximal end surface 19 of the drug delivery device 1 , which may cause dose dispensing.
  • a corresponding arrangement of flexible arms 106 may be used to set whether, when a load is applied to the proximal end surface 105 of the electronic add-on module 100 and when the disc 107 comes into contact with the proximal end surface 19 of the drug delivery device 1 , the flexible arms 106 deflect first or the dose button 11 moves first distally and the flexible arms 106 deflect later on, for example, when the dose button 11 cannot be moved further distally because, for example, an end of dose dispensing is reached, i.e. dose delivery has been completed.
  • deflection of the flexible arms 106 may provide for a noise or sound, for example a click sound.
  • the membrane 109 may be a thin flexible adhesive component, such as a structural label or a thin sheet of polymer affixed with adhesive or adhesive tape, affixed to the second portion 102, for example the flexible arms 106.
  • FIG. 4 A corresponding sequence of movement is depicted in Figures 4 to 6, wherein the flexible arms 106 deflect before the dose button 11 is pressed.
  • a state is shown prior to any movement.
  • disc 107 abuts on the proximal end surface 19 of the dose button 11 no pressure is actively applied, for example by a user, to the proximal end surface 105 and thereby transferred onto the dose button 11.
  • a switch 110 configured to be actuated in order to activate electronic components of the electronic add-on module 100 is switched off, open or not actuated.
  • Corresponding electronic components may be arranged on a circuit board assembly 111 inside the electronic add-on module 100.
  • the circuit board assembly 111 is arranged inside the second portion 102.
  • Electronic components may for example be chips, switches, wires, sensors, light emitting diodes, displays or the like.
  • an acoustic sensor arrangement 112 may be arranged on the circuit board assembly 111 as shown in Figure 4.
  • Figure 5 shows an intermediate state, wherein a load on the proximal end face 105 of the electronic add-on module 100 has caused the second portion 102 to move axially along the longitudinal axis X distally relative to the first portion 101 , whereby the flexible arms 106 are deflected due to abutment of the disc 107 against the proximal end surface 19 of the dose button 11. Still, the dose button 11 has not been moved distally, however, the movement of the disc 107 has actuated the switch 110 and thus the electronic components may be powered (activated).
  • a flexible distal surface, provided by the disc 107 and the flexible arms 106 is less stiff and more flexible than drive mechanism so that a force required to move the dose button 11 distally is larger than a force required to deform or deflect the flexible distal surface, i.e. the flexible arms 106. Therefore, the dose button 11 has not been moved, wherein the flexible arms 106 have been deformed with the result of activating, actuating or closing the switch 110.
  • the electronic components may thus be activated.
  • Figure 6 shows a state in which the dose button 11 has been moved distally and a dose has been dispensed.
  • the depicted state may show the state at first point of dose dispensing starting, but it could equally be at the end of dispense. The full travel to this position is required to start dispensing, with both the clutch in the module and the clutch in the pen disengaged.
  • the dose button 11 may be fully depressed and end of dose dispensing may have been reached.
  • the switch 110 may thus still be actuated and the electronic components may still be activated.
  • the clutch mechanism is now disengaged. Consequently, the electronic components may still be activated at the end of dose dispensing.
  • the sequence of movement may also be reversed.
  • the dose button 11 may first be distally moved and then, for example, close to the end of dose dispensing, the flexible arms 106 are deflected, which may actuate the switch 110 and thus the electronic components.
  • the switch 110 is actuated prior to disengagement of the clutch mechanism and, thus, prior to a start of dose dispensing.
  • an acoustic sensor arrangement 113 may be used as shown in Figure 7.
  • the acoustic sensor arrangement 113 may be directly arranged on the circuit board assembly 111 as shown in Figure 7.
  • the acoustic sensor arrangement 113 may be a MEMS (micro-electromechanical systems) acoustic sensor arrangement, for example a capacitive or piezoelectric MEMS acoustic sensor arrangement.
  • the acoustic sensor arrangement 113 may thus comprise a microphone which is MEMS. Considering the assembly shown in Figures 4 to 7, the acoustic sensor arrangement 113 in Figure 7 is arranged on a distal facing surface of the circuit board assembly 111.
  • the acoustic sensor arrangement 113 may comprise a port hole 115, which allows sound waves to enter the acoustic sensor arrangement 113.
  • the sound waves for example the sound waves of a click sound, may be detected by a sensor, for example a microphone.
  • the port hole 115 is arranged “top-ported", i.e. facing away from the circuit board assembly.
  • the port hole 115 may also be arranged "bottom-ported” as will be explained with respect to Figure 8 later on.
  • the switch 110 is provided by a switch casing 116 into which a switch lever 117 may move, when load is applied.
  • the switch 110 may thus be mechanically moved in order to be operated.
  • the acoustic sensor arrangement 113 may be powered or activated.
  • the acoustic sensor arrangement 113 may then be in a state in which sounds (sound waves) may be detected.
  • a bias voltage may then be present, which allows a microphone inside the acoustic sensor arrangement 113 to be operated.
  • further sensor arrangements (not shown) may be present for dose recording, for classifying dose events etc.
  • the conditioning circuit 120 shown here comprises a DC-filter unit 123 configured to remove a DC bias voltage of the acoustic sensor arrangement 113.
  • the DC-filter 123 unit is provided by a capacitor C1.
  • a resistor R1 is provided, which biases the voltage at GND, so that the signal at a third node 124 will be at GND potential when quiescent and have positive or negative voltage components corresponding to a noise or sound, for example a dose click.
  • the conditioning circuit 120 comprises an electrical impedance unit 125 to limit a current into an amplifier unit 126.
  • the low-pass filter unit 125 is provided by resistor R2.
  • a gain of the amplifier unit 126 which amplifies the first output signal 119 by increasing an amplitude of the first output signal 119, may be set by resistors R3 and R4.
  • an amplifier-decoupling unit 127 may be provided in order to decouple a power supply to the amplifier unit 126, thereby, for example, reducing transmission of noise (signal noise) present on the electric power source 112 to the conditioning circuit output 120.
  • the amplifier-decoupling unit 127 is provided by decoupling capacitor C2.
  • an envelope detection circuit 128 configured to modulate the first output signal is provided at the "end" of the conditioning circuit 120, i.e. before the second node 122.
  • the envelope detection circuit 128 may elongate the duration of the first output signal 119 as can be seen in Figure 11 , wherein an unconditioned first output signal 119 is depicted above a conditioned first output signal 129, which may be amplified, rectified, smoothed and elongated.
  • the unconditioned first output signal 119 may not have passed a conditioning circuit 120, wherein the conditioning circuit 120 may have passed or may have been modulated or conditioned by the conditioning circuit 120.
  • the DC-filter unit 123 is located upstream with respect to the electrical impedance unit 125, the amplifier unit 126 and the envelope detection circuit 128.
  • the envelope detection circuit 128 is located downstream with respect to the amplifier unit 126.
  • the amplifier unit 126 is located downstream with respect to the DC-filter unit 123 and the electrical impedance unit 125.
  • the envelope detection circuit 120 comprises a diode D1 connected in parallel with a resistor R5.
  • a voltage may thus directly pass through the diode D1 in order to charge a grounded capacitor C3.
  • the capacitor C3 is thus charged quickly which leads a fast response to rising voltages. Still, discharging of the capacitor C3 is performed via the resistor R5. Consequently, the envelope detection circuit 120 allows for a slow response to falling voltages. Therefore, when a high voltage is received, the capacitor C3 may be charged quickly. A lower voltage afterwards may not pass the diode D1 resulting in a delay, stretching or elongating of the signal 119 as can be seen in Figure 11.
  • the conditioned (and elongated) first output signal may then be used in the processing circuit in order to detect dose events.
  • a background noise portion 119A of the unconditioned first output signal 119 may show signal of a background noise.
  • Noise portion 119B of the unconditioned first output signal 119 may refer to a relevant noise.
  • the noise portion 119B refers to a click sound, wherein the signal is used in a processing circuit for detection of dose events.
  • the portion of the conditioned first output signal 119 referring to the background noise portion 119B does not exceed a threshold value 130. This portion may be disregarded for this reason.
  • an unconditioned duration t1 of noise portion 119B of the unconditioned first output signal 119B may thus be elongated to a conditioned duration t2 of the conditioned first output signal 129.
  • both noises, the non- relevant background noise and the relevant noise show a signal deflection or voltage pulse, which is elongated when conditioned.
  • the elongated conditioned duration t2 may not only allow for the processing circuit to be slower but may also be used as a criterion for deciding whether the noise is relevant or non-relevant.
  • the portion of the voltage pulse may only be regarded to refer to a relevant noise when it exceeds a predetermined duration of time.
  • the duration t3 is shorter than the duration t2. Consequently, the voltage pulse of the conditioned background noise portion 119A may not only be below an amplitude threshold value but may also be shorter in time than a time threshold value, wherein the time threshold value may define a value which is greater than t3 and smaller than t2.
  • the number of times a signal is above the threshold value 130 may be counted to determine the number of set or delivered dose units. Still, confirmation of a dose event, i.e. that a dose dispensing, has actually occurred may be more reliable than counting the number of units dialed or dispensed.
  • the conditioned first output signal 129 would be even larger compared to the unconditioned first output signal 119, namely the conditioned first output signal 129 would be twice as large as shown here, wherein the unconditioned first output signal 119 would still comprise the same size.
  • Conditioning of the unconditioned first output signal 119 may improve detection in the processing circuit.
  • the detection may allow to identify certain dose events, for example a dose dialing event, a dose dispensing event and/or a dose amount, dialed and/or dispensed, based on the first output signal 119, 129 received from the acoustic sensor arrangement 113. Consequently, detection of dose events may be improved or supplemented by using acoustic sounds for dose event detection.
  • Y drug delivery device axis (longitudinal axis of the drug delivery device

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Life Sciences & Earth Sciences (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne un module complémentaire électronique (100) conçu pour être fixé de manière amovible à un dispositif d'administration de médicament (1). Le module complémentaire électronique comprend au moins un boîtier, une source d'alimentation électrique (112) disposée à l'intérieur du boîtier, un ensemble carte de circuit imprimé (111) connecté électriquement à la source d'alimentation électrique, un agencement de capteur acoustique (113) connecté électriquement à l'ensemble carte de circuit imprimé, et un circuit de traitement configuré pour traiter un premier signal de sortie (119, 129) provenant de l'agencement de capteur acoustique. Afin de fournir un module complémentaire électronique amélioré qui est configuré pour détecter des événements de dose d'un dispositif d'administration de médicament fiable et sûr, le circuit de traitement est configuré pour détecter un événement de réglage de dose, un événement de distribution de dose et/ou une quantité de dose, réglée et/ou distribuée, sur la base du premier signal de sortie reçu en provenance de l'agencement de capteur acoustique.
PCT/EP2025/058304 2024-03-28 2025-03-26 Module complémentaire électronique et ensemble de module complémentaire électronique et d'un dispositif d'administration de médicament Pending WO2025202308A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP24315109.9A EP4623963B1 (fr) 2024-03-28 2024-03-28 Module supplémentaire électronique et ensemble d'un module supplémentaire électronique et dispositif d'administration de médicament
EP24315109.9 2024-03-28
US18/620,385 US20250303070A1 (en) 2024-03-28 2024-03-28 Electronic add-on module and assembly of an electronic add-on module and a drug delivery device
US18/620,385 2024-03-28

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