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WO2025021887A1 - Electronic module for a metered dose inhaler and metered dose inhaler assembly comprising the electronic module - Google Patents

Electronic module for a metered dose inhaler and metered dose inhaler assembly comprising the electronic module Download PDF

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Publication number
WO2025021887A1
WO2025021887A1 PCT/EP2024/071046 EP2024071046W WO2025021887A1 WO 2025021887 A1 WO2025021887 A1 WO 2025021887A1 EP 2024071046 W EP2024071046 W EP 2024071046W WO 2025021887 A1 WO2025021887 A1 WO 2025021887A1
Authority
WO
WIPO (PCT)
Prior art keywords
electronic module
metered dose
hooks
dose inhaler
housing
Prior art date
Application number
PCT/EP2024/071046
Other languages
French (fr)
Inventor
Marco DI CASTRI
Alan Tweedie
Daniel David Higgins
Jeremy Alan MOULTON
Original Assignee
Chiesi Farmaceutici S.P.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 Chiesi Farmaceutici S.P.A. filed Critical Chiesi Farmaceutici S.P.A.
Publication of WO2025021887A1 publication Critical patent/WO2025021887A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0065Inhalators with dosage or measuring devices
    • A61M15/0068Indicating or counting the number of dispensed doses or of remaining doses
    • A61M15/008Electronic counters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/009Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0015Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors
    • A61M2016/0018Accessories therefor, e.g. sensors, vibrators, negative pressure inhalation detectors electrical
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M16/00Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/0003Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/0027Accessories therefor, e.g. sensors, vibrators, negative pressure pressure meter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/14Detection of the presence or absence of a tube, a connector or a container in an apparatus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/332Force measuring means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/58Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583Means for facilitating use, e.g. by people with impaired vision by visual feedback

Definitions

  • the present invention relates to an electronic module for a metered dose inhaler (MDI) and to an assembly comprising a metered dose inhaler and the electronic module.
  • the metered dose inhaler is a device for dispensing a medicament preparation by inhalation.
  • the metered dose inhaler may be a pressurized metered dose inhaler (pMDI).
  • the electronic module is configured to detect inhalation by the user and possible other working parameters of the metered dose inhaler.
  • MDI or pMDI inhalers comprising sensors and electronics to check the correctness and regularity of medication intake by the user are also known.
  • the inhalers may include sensor/s and electronics or may be coupled to electronic modules comprising sensors and electronics configured to monitor the correct intake. Medication intake may be checked by detecting inhalation through measures of a flow rate through a body of the inhaler.
  • Document US2020155773 discloses an accessory for a pMDI inhaler.
  • the accessory comprises a fastening structure for fastening to the inhaler.
  • the fastening structure forms a ring that is sled onto the open upper end of a receiving portion of the inhaler housing.
  • the accessory has a pressure port. When the accessory is fastened to the inhaler, the pressure port is arranged upstream from a mixing zone of the inhaler with respect to an air flow caused by inhalation by a patient through the inhaler.
  • An electronic sensor is in communication with the pressure port and is sensitive to a pressure change at the pressure port caused by the air flow.
  • Document W02021/069940 discloses a bidirectional flow meter for an MDI device and an MDI device comprising the bidirectional flow meter.
  • the flow meter includes a collar that mounts to the inlet of the MDI device and fits around the circumference of the inlet of the MDI.
  • the flow meter has a flow channel and first and second pressure tap points arranged in the flow channel.
  • the collar is hollow to house manometers or other components belonging to the pressure tap points.
  • the flow channel comprises a first channel part and a second channel part. The channel parts are separated by a constriction. The first channel part widens in a direction leading away from the constriction.
  • US2017290527A1 discloses a compliance monitoring module for a pressurized Metered Dose Inhaler comprising a miniature pressure sensor.
  • the sensor port of the sensor is configured to be pneumatically coupled to a flow channel of the inhaler through which a user can inhale.
  • the compliance module is clipped on to the pressurized Metered Dose Inhaler.
  • both the fastening structure of US2020155773 and the collar of WO2021/069940 may affect the air flow rate caused by inhalation by the patient through the inhaler with respect to the inhaler without the additional electronic module, i.e. with respect to working design conditions of the inhaler.
  • both the fastening structure of US2020155773 and the collar of W02021/069940 fully surround the canister and the gap between the canister and an edge of the MDI and therefore affect the air flow through this gap. This may increase the device resistance, decrease the air flow rate inhaled by the user and may prevent a proper medicament inhalation.
  • W02021/069940 is quite complex and may also prevent a proper medicament inhalation by the user.
  • the position of the pressure port of US2020155773 requires pressure sensors provided with high sensitivity which are relatively expensive.
  • the pressure sensor of US2020155773 is placed inside the accessory, is spaced from the respective pressure port and is in fluid connection to said pressure port through a channel. In order to properly detect a pressure at the pressure port, a high sensitive and expensive pressure sensor is required.
  • At least one of the above objects is substantially achieved by an electronic module for metered dose inhalers and by a metered dose inhaler assembly according to one or more of the appended claims and/or of the following aspects.
  • an electronic module for metered dose inhalers comprises: a casing having an external surface provided with a pressure detection point; an electronic unit and a pressure sensor enclosed in the casing, the pressure sensor being operatively connected to the electronic unit and to the pressure detection point; the casing comprising two hooks configured to engage an edge of a housing of a metered dose inhaler accommodating or configured to accommodate a canister containing a drug formulation to be dispensed; wherein the pressure detection point is located between the two hooks.
  • the electronic module is attached or attachable to the metered dose inhaler.
  • a metered dose inhaler assembly comprises: a metered dose inhaler, comprising: a hollow body comprising: a housing accommodating or configured to accommodate a canister containing a drug formulation to be dispensed; a mouthpiece in fluid communication with the housing; a valve seat located in the hollow body, between the housing and the mouthpiece and accommodating or configured to accommodate a valve dispensing nozzle of the canister; the electronic module according to the preceding 1 st aspect or according to one or more of the following aspects.
  • the electronic module is attached or is configured to be attached in removable manner to the metered dose inhaler.
  • the metered dose inhaler may be a pressurized metered dose inhaler.
  • the metered dose inhaler may comprise the canister containing the drug formulation to be dispensed.
  • the Applicant verified that the electronic module according to the invention provides easy and safe coupling of the module to the inhaler and, at the same time, ensures a very low disturbance of the overall air flow flowing through the hollow body when the user inhales the medicament.
  • the Applicant verified that the electronic module according to the invention requires no changes of the commercial inhalers available on the market to allow coupling of the module to the inhaler and a correct air flow passage and air flow detection by said module when coupled to the inhaler.
  • the two hooks ensure docking of the electronic module to the metered dose inhaler while keeping free all the remaining gap between the module and the canister.
  • the two hooks in addition to their hooking function, integrate an additional function, that of delimiting the flow channel and conveying air on the pressure point.
  • the two hooks delimit therebetween a flow channel and the pressure detection point is configured to interact with an airflow crossing said flow channel.
  • mutually facing sides of the two hooks delimiting the flow channel have a planar or concave shape.
  • the two hooks delimit therebetween an inlet port of the flow channel and the flow channel diverges from the inlet port towards free ends of the two hooks.
  • the inlet port is positioned on an outer portion of the casing.
  • an inlet diverging angle of the flow channel at the inlet port is between 50° and 90°.
  • the free ends of the two hooks delimit therebetween an outlet opening of the flow channel.
  • the pressure detection point is positioned halfway between the inlet port and the outlet opening.
  • an outlet diverging angle of the flow channel at the outlet opening is between 0° and 20°.
  • an average diverging angle of the flow channel is between 20° and 70°.
  • each of the two hooks comprise an engaging surface configured to rest on the edge of the housing.
  • the pressure detection point is located between the inlet port and a lying plane of the engaging surface.
  • the pressure detection point is located on a center plane of the flow channel.
  • the flow channel is symmetrical with respect to a plane containing a respective axis of the casing.
  • the flow channel is symmetrical with respect to a plane containing a main axis of the housing.
  • the flow channel is asymmetrical with respect to a plane containing a respective axis of the casing.
  • the flow channel is asymmetrical with respect to a plane containing a main axis of the housing.
  • a gap for airflow is delimited between an edge of the housing and the canister and surrounds the canister.
  • the two hooks engaged on the edge of the housing close only a portion of the gap.
  • the two hooks span around the canister for an angle comprised between 50° and 90°, optionally of 60°. Therefore, only a small portion of the gap around the canister is closed.
  • the two hooks engage the edge of the housing and the electronic module is attached to the metered dose inhaler, said two hooks lie against the canister and the flow channel is delimited by: the two hooks, an outer surface of the canister and the external surface of the casing provided with the pressure detection point.
  • the pressure detection point is above the edge of the housing.
  • the flow channel produces a high flow speed of the flow of air over the pressure detection point and increases a pressure drop.
  • the Applicant verified that the electronic module according to the invention is able to promote acceleration of the air flow over the pressure detection point and to increase the sensitivity of pressure detection. Indeed, the flow channel increases the pressure drop at the pressure detection point and allows the electronic module to discern a much lower airflow rate than if the pressure sensor were to be in communication with the airflow without the flow channel.
  • the Applicant verified the electronic module according to the invention allows adopting low-cost pressure sensors, having a relatively low sensitivity, while ensuring a proper airflow detection, since the flow channel of the invention allows to boost sensitivity through amplifying the depression in the vicinity of the pressure port.
  • the pressure sensor has an absolute pressure range of 0 kPa to 8 kPa, optionally of 1 kPa to 7 kPa, optionally of 1 kPa to 6 kPa.
  • the pressure sensor has an analog output.
  • the pressure sensor has a sensitivity from 1 kPaA/ to 3 kPa/V, optionally from 1 .5 kPa/V to 2.5 kPa/V.
  • the pressure sensor has digital output (output in decimal counts).
  • the pressure sensor has a sensitivity from 0.0000002 kPa/count to 0.0000006 kPa/count, optionally of 0.000000447 kPa/count.
  • the pressure detection point is a pressure detection port in fluid communication with the pressure sensor.
  • the pressure detection port is connected to the pressure sensor through a manifold, optionally an elastomeric manifold.
  • the casing has a portion complementary to a part of the hollow body of the metered dose inhaler, i.e. the portion of the casing is shaped to match the part of the hollow body, and, when the two hooks engage the edge of the housing and the electronic module is attached to the metered dose inhaler, said portion of the casing abuts against said part of the hollow body.
  • the assembly is therefore compact and easy handle.
  • the casing protrudes beyond the housing and the hooks are protected from any impacts.
  • the external surface provided with a pressure detection point is flush with an internal surface of the housing. Air flow turbulence inside the hollow body is thus limited.
  • the casing comprises a projection, optionally an elastic projection, spaced from the two hooks, the projection being configured to clip on the hollow body at a zone spaced from the edge of the housing. Hooks and projection allow easy latch and unlatch.
  • the housing extends along a respective main axis and the mouthpiece has a respective central axis.
  • the main axis and the central axis being skew with respect to each other such that the hollow housing is L-shaped or substantially L-shaped.
  • the main axis and the central axis delimit an angle between 90° and 120°.
  • the casing is elongated along a respective axis, when the electronic module is attached to the metered dose inhaler said respective axis being parallel to the main axis of the housing.
  • the edge is located at a first extremity of the housing and the mouthpiece protrudes from a second extremity of the housing located in opposite position from the first extremity.
  • the edge bounds an opening of the housing for insertion of the canister.
  • said canister when the canister is accommodated in the housing, said canister protrudes partially from the opening.
  • the second extremity of the housing comprises an elbow fashioned on an opposite side from the mouthpiece.
  • the projection of the casing is clipped on or is configured to clip on said elbow.
  • said part of the hollow body is a side of the hollow body opposite the mouthpiece.
  • said part of the hollow body comprises the elbow.
  • the two hooks protrude from said portion of the casing.
  • the external surface of the casing provided with the pressure detection point is bounded by the mutually facing sides of the two hooks.
  • the external surface of the casing provided with the pressure detection point has a triangular outline or a roughly triangular outline. In an aspect, the external surface of the casing provided with the pressure detection point is in relief from the portion of the casing.
  • the engaging surface is transverse to the external surface of the casing provided with the pressure detection point and to said portion of the casing.
  • each of the two hooks comprises a protrusion overhanging from the engaging surface and delimiting, together with said engaging surface and with the portion of the casing, a respective seat for the edge of the housing.
  • the inlet port is bounded by the two hooks and by the outer surface of the canister.
  • the inlet port opens on the outer portion of the casing and said outer portion is transversal to the outer surface of the canister and lies side by side with said outer surface of the canister.
  • the outlet opening is bounded by the two hooks and the outer surface of the canister.
  • the electronic unit is configured to receive at least one pressure signal from the pressure sensor, to elaborate the at least one pressure signal and to output a signal indicative of a flow of gas (air), optionally of a flow rate of gas.
  • the electronic unit is configured to measure the flow rate of gas from the at least one pressure signal.
  • the electronic unit is configured to correlate the at least one pressure signal and/or the flow rate of gas to a correct inhalation by the user and to provide a feedback to the user through at least one signaling device.
  • the electronic module comprises one additional sensor or more additional sensors operatively connected to the electronic unit and configured to detect manipulation by the user and/or actuation of the metered dose inhaler and/or proper attachment of the electronic module to the metered dose inhaler.
  • the one additional sensor or more additional sensors are enclosed in the casing and/or operate on an outer surface of the casing.
  • the one additional sensor or more additional sensors comprise: accelerometers, proximity sensors, movement sensors, etc..
  • the electronic module comprises at least one signaling device, e.g. providing visual or sound signals, operatively connected to the electronic unit and configured to alert the user of the status and/or of the operation of the electronic module and/or of the metered dose inhaler.
  • signaling device e.g. providing visual or sound signals
  • the electronic module comprises a battery to power the electronic unit and the sensor or sensors and any signaling device or devices.
  • the metered dose inhaler is actuated by pushing the canister towards the housing in order to press the valve dispensing nozzle in the valve seat and ejecting the drug formulation.
  • Figures 1 A and 1 B show 3D views of a metered dose inhaler assembly comprising a metered dose inhaler and an electronic module according to the present invention
  • Figure 2 is a top view of the metered dose inhaler assembly of Figures 1 A and 1 B
  • Figure 3 is a 3D view of the electronic module of the metered dose inhaler assembly of Figures 1 A, 1 B and 2;
  • Figure 4 is an enlarged portion of Figure 3;
  • Figure 5 is a front view of the enlarged portion of Figure 4.
  • Figure 6 shows an element of Figure 5 and an airflow flowing through said element
  • Figure 7 shows a detail of the electronic module hooked to the metered dose inhaler
  • Figure 8 is a schematic view of electronic module components from the preceding Figures.
  • FIGS 1A, 1 B and 2 show a metered dose inhaler assembly 1 according to the present invention.
  • the metered dose inhaler assembly 1 comprises a metered dose inhaler 2 (MDI) and an electronic module 3.
  • MDI metered dose inhaler 2
  • the electronic module 3 is configured to be easily mounted on and dismounted from the metered dose inhaler 2 using no tools, so that the same electronic module 3 may be coupled to another inhaler when said inhaler is exhausted and should be replaced.
  • the metered dose inhaler 2 may be per se known and commercially available on the market.
  • the metered dose inhaler 2 shown as example in Figures 1 A, 1 B and 2 comprises a hollow body 4, or actuator, and a canister 5 containing a drug formulation to be dispensed.
  • the canister 5 is accommodated in the hollow body 4.
  • the hollow body 4 comprises a housing 6 accommodating or configured to accommodate the canister 5 and a mouthpiece 7 which is in fluid communication with the housing 6.
  • a valve seat not shown in the appended drawings, is located in the hollow body 4 between the housing 6 and the mouthpiece 7.
  • the housing 6, the mouthpiece 7 and the valve seat may be a single part of molded plastic.
  • the housing 6 is a sort of tubular element extending along a main axis “X-X”.
  • the mouthpiece 7 is a sort of tubular element extending along a central axis “Y-Y”.
  • the main axis “X-X” and the central axis “Y-Y” are skew with respect to each other, such that the hollow housing 4 is L-shaped or substantially L-shaped.
  • the main axis “X- X” and the central axis “Y-Y” of the embodiment of the appended Figures delimit an angle of about 100° - 110°.
  • a first extremity of the housing 6 has an opening delimited by an edge 9.
  • An opposite second extremity of the housing 6 is connected to the mouthpiece 7 and an elbow is fashioned on an opposite side from the mouthpiece 7.
  • the canister 5 may be produced in aluminum or stainless steel and comprises a valve dispensing nozzle or metering valve, which may be per se known and is not shown.
  • the drug formulation in the canister comprises a liquefied gas propellant (pressurized MDI) and, in many cases, stabilizing excipients.
  • valve dispensing nozzle of the canister 5 When the canister 5 is accommodated in the housing 6 of the hollow body 4, like in Figures 1 A, 1 B and 2, the valve dispensing nozzle of the canister 5 is placed in the valve seat of the hollow body 4 and a part of the canister 5, opposite the valve dispending nozzle, protrudes from the opening. A gap 8 is delimited between the canister 5 and the edge 9 and surrounds the canister 5.
  • the metered dose inhaler is actuated by pushing the canister 5 towards the housing 6, i.e. by pressing the part of the canister 5 protruding from the opening 8.
  • the valve dispensing nozzle is pressed in the valve seat and ejects the drug formulation.
  • the user draws from the mouthpiece 7, air enters the hollow body 4 through the gap 8 and flows in the mouthpiece 7 where air and drug medicament mix and are inhaled by the user through an opening in the mouthpiece 7.
  • the electronic module 3 is configured to be attached in removable manner to the metered dose inhaler 2, so that the same electronic module 3 may be used with another new metered dose inhaler once the medicament in the old metered dose inhaler is over.
  • the electronic module 3 comprises a casing 10, for instance a plastic casing, enclosing an electronic unit 11 and a battery 12, for instance a lithium battery, connected to the electronic unit 11 to power said electronic unit 11 .
  • the electronic module 3 further comprises sensors operatively connected to the electronic unit 11 and configured to detect, for instance, manipulation by the user and/or actuation of the metered dose inhaler and/or proper attachment of the electronic module 3 to the metered dose inhaler 2.
  • the sensors may operate on an outer surface of the casing 10 or may be placed inside the casing 10.
  • the electronic module 3 comprises a signaling device 15, e.g. a led or a speaker, operatively connected to the electronic unit 11 and configured to alert the user (e.g. through a visual or audio signal) of the status and/or of the operation of the electronic module 3 and/or of the metered dose inhaler 2.
  • the electronic module 3 here detailed comprises a pressure sensor 13 and an accelerometer 14. All these electronic components are schematically represented in Figure 8 and are all enclosed and protected in the casing 10.
  • the pressure sensor 13 is housed in the casing 10 and is in fluid communication with a pressure detection point 16, i.e. a pressure detection port, located on an external surface 17 of the casing 10 ( Figures 3, 4, 5, 7).
  • the hardware of the pressure sensor 13 is mounted on a printed circuit board (PCB) and connected to the pressure port through an elastomeric manifold, creating a seal between the pressure sensor 13 and the casing 10.
  • PCB printed circuit board
  • the airflow is not diverted into the manifold and onto the pressure sensor 13 and only the pressure due to the airflow over the pressure port 16 is monitored in use. Indeed, air is substantially stagnant in the pressure port and in the manifold.
  • the casing 10 has a portion 18 or face which is complementary to a side of the housing 6 of the hollow body 4 of the metered dose inhaler 2 opposite to the side from which the mouthpiece 7 protrudes. Said portion 18 is concave to match the convex rounded side of the housing 6.
  • the casing 10 is elongated along a respective axis “Z-Z” which, when the electronic module 3 is attached to the metered dose inhaler 2, is parallel to the main axis “X- X” of the housing 6.
  • a first end of the casing 10 comprises a hooking assembly which protrudes from the portion 18 and comprises two hooks 19.
  • a second end of the casing 10, opposite the first end along the axis “Z-Z”, comprises an elastic projection 20.
  • the external surface 17 of the casing 10 and the pressure point 16 are located between the two hooks 19 ( Figures 3 - 7).
  • the hooking assembly comprises the external surface 17 which protrudes from the portion 18 and the two hooks 19 protrude from the portion 18.
  • Each of the two hooks 19 comprises a protrusion 21 spaced from the portion 18 and extending towards the second end of the casing 10.
  • Each of the two hooks 19 comprises an engaging surface 22 connecting the protrusion 21 to the portion 18.
  • the engaging surface 22 is transverse to the portion 18 and to the external surface 17 of the casing 10.
  • the two engaging portions 22 of the hooks 19 are interconnected through a further transversal surface 23 extending between the external surface 17 and the portion 18.
  • the two engaging surfaces 22 together with the further transversal surface 23 form a continuous surface arranged on a lying plane and configured to rest against the edge 9 of the housing 6 when the electronic module 3 is installed on the metered dose inhaler 2.
  • Each protrusion 21 overhangs from the respective engaging surface 22 and delimits, together with said engaging surface 22 and with the portion 18, a respective seat 24 ( Figure 4) for receiving and hooking the edge 9 of the housing 6.
  • the two hooks 19 protrude also from the external surface 17 and delimit said external surface 17.
  • the external surface 17 is indeed bounded by mutually facing sides 25 of the two hooks 19.
  • Each of the facing sides 25 of the two hooks 19 have concave shape.
  • Said facing sides 25 are closer at an outer portion of the casing 10 located on the first end and diverges from each other as they move away from said first end ( Figure 5). Therefore, the external surface 17 has a roughly triangular outline.
  • the facing sides 25 may be planar, like in schematic Figure 6.
  • the flow channel diverges from the inlet port 26 towards the outlet opening 27.
  • the electronic module 3 is coupled to the metered dose inhaler 2 by hooking the two hooks 19 on the edge 9 and clipping the elastic projection 20 to the elbow of the hollow body 4.
  • the portion 18 abuts the convex rounded side of the housing 6.
  • the two hooks 19 engage the edge 9 of the housing 6, said two hooks 19 lie against the canister 5 and the flow channel is delimited also by an outer surface of the canister 5.
  • the inlet port 26 is bounded by the two hooks 19 and by the outer surface of the canister 5.
  • the inlet port 26 opens on the outer portion of the casing 10 and said outer portion is transversal to the outer surface of the canister 5 and lies side by side with said outer surface of the canister 5.
  • the outlet opening 27 is bounded by the two hooks 19 and by the outer surface of the canister 5.
  • Figure 7 shows the electronic module 3 coupled to the metered dose inhaler 2 with no canister 5 inside. Ribs 28 to hold the canister are also visible. As shown in Figure 7, when the electronic module 3 is coupled to the metered dose inhaler 2, the two engaging surfaces 22 and the further transversal surface 23 rest against the edge 9 of the housing 6, the external surface 17 is flush with an internal surface of the housing 6 and the pressure detection point 16 is positioned above the edge 9 of the housing 6. One of the ribs 28 may be positioned below the pressure detection point 16 (see also Figure 6). Furthermore, the casing 10 protrudes beyond the housing 6 and the hooks 19 are protected from any impacts.
  • the hooking assembly partly surrounds the canister 5 and closes only a small portion of the gap 8. For instance, the hooking assembly spans around the canister 5 for an angle A of about 60° (300° of gap 8 are free).
  • an inlet diverging angle a delimited between the facing sides 25 at the inlet port 26 is about 80° and an outlet diverging angle [3 of the flow channel at the outlet opening 27 is about 10°.
  • An average diverging angle y of the flow channel may be for instance about 30°, wherein said average diverging angle y is the angle between two straight lines: a first straight line connecting a rim of one of the facing sides 25 at the inlet port 26 to a rim of the same side at the outlet opening 27; a second straight line connecting a rim of the other facing side 25 at the inlet port 26 to a rim of the same side at the outlet opening 27.
  • the flow channel is symmetrical with respect to a plane containing the respective axis “Z-Z” of the casing 10.
  • the flow channel is symmetrical with respect to a plane containing the main axis “X-X” of the housing 6.
  • the pressure detection point 16 is located on a center plane (symmetry plane) of the flow channel, positioned halfway between the inlet port 26 and the outlet opening 27 and close to the further transversal surface 23, i.e. close to the base of the triangular external surface 17.
  • the flow channel may be asymmetrical with respect to a plane containing the respective axis “Z-Z” of the casing, such that, when the electronic module 3 is attached to the metered dose inhaler 2, the flow channel is asymmetrical with respect to the plane containing the main axis “X-X” of the housing 6.
  • the pressure sensor 13 may be a low sensitive pressure sensor.
  • the pressure sensor 13 is an analog sensor having an analog voltage output with a pressure range of 1 .03 kPa to 6.89 kPa and a sensitivity of 2.22 kPaA/.
  • the pressure sensor 13 is an analog sensor having an analog voltage output with a pressure range of 0 kPa to 6 kPa and a sensitivity of 1 .5 kPa/V.
  • the pressure sensor may also be a digital output pressure sensor having a digital output (decimal counts) with a pressure range of 0 kPa to 6 kPa and a sensitivity of 0.000000447 kPa/count.
  • digital pressure sensor are Honeywell MicroPressure Board Mount Pressure Sensors (MPR series).
  • the flow channel according to the invention maximizes the pressure sensor 13 response to a given flow rate through the metered dose inhaler 2.
  • the pressure detection point 16 experiences a relatively high depression for a given air flow rate and hence the pressure drop is boosted improving the pressure sensor 13 performance.
  • this flow path does not significantly affect the airflow resistance of the metered dose inhaler and is comparable in resistance to a metered dose inhaler 2 without the electronic module 3 fitted.
  • the electronic unit 11 is configured to receive pressure signals from the pressure sensor 13, to elaborate pressure signals and to output a signal indicative of a flow of air or to measure the air flow rate.
  • the electronic unit 11 is configured to correlate the pressure signals and/or the air flow rate to a correct inhalation by the user and to provide a feedback to the user through the signaling device or devices.

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Abstract

An electronic module for a metered dose inhaler comprises a casing (10) having an external surface (17) provided with a pressure detection point (16), an electronic unit (11) and a pressure sensor (13) enclosed in the casing (10). The pressure sensor (13) is operatively connected to the electronic unit (11) and to the pressure detection point (16). The casing (10) comprises two hooks (19) configured to engage an edge (9) of a housing (6) of a metered dose inhaler (2) accommodating a canister (5) containing a drug formulation to be dispensed. The pressure detection point (16) is located between the two hooks (19). The electronic module is attachable to the metered dose inhaler.

Description

“Electronic module for a metered dose inhaler and metered dose inhaler assembly comprising the electronic module”
DESCRIPTION
Technical field of the invention
The present invention relates to an electronic module for a metered dose inhaler (MDI) and to an assembly comprising a metered dose inhaler and the electronic module. The metered dose inhaler is a device for dispensing a medicament preparation by inhalation. The metered dose inhaler may be a pressurized metered dose inhaler (pMDI). The electronic module is configured to detect inhalation by the user and possible other working parameters of the metered dose inhaler.
Background art
The administering of a medicament preparation by inhalation from an MDI or a pMDI is commonly known. MDI or pMDI inhalers comprising sensors and electronics to check the correctness and regularity of medication intake by the user are also known. The inhalers may include sensor/s and electronics or may be coupled to electronic modules comprising sensors and electronics configured to monitor the correct intake. Medication intake may be checked by detecting inhalation through measures of a flow rate through a body of the inhaler.
Document US2020155773 discloses an accessory for a pMDI inhaler. The accessory comprises a fastening structure for fastening to the inhaler. The fastening structure forms a ring that is sled onto the open upper end of a receiving portion of the inhaler housing. The accessory has a pressure port. When the accessory is fastened to the inhaler, the pressure port is arranged upstream from a mixing zone of the inhaler with respect to an air flow caused by inhalation by a patient through the inhaler. An electronic sensor is in communication with the pressure port and is sensitive to a pressure change at the pressure port caused by the air flow.
Document W02021/069940 discloses a bidirectional flow meter for an MDI device and an MDI device comprising the bidirectional flow meter. The flow meter includes a collar that mounts to the inlet of the MDI device and fits around the circumference of the inlet of the MDI. The flow meter has a flow channel and first and second pressure tap points arranged in the flow channel. The collar is hollow to house manometers or other components belonging to the pressure tap points. The flow channel comprises a first channel part and a second channel part. The channel parts are separated by a constriction. The first channel part widens in a direction leading away from the constriction. The second pressure tap point is arranged in the second channel part and the first pressure tap point is arranged in the first channel part in the vicinity of the constriction. Measurement of expiratory and inspiratory volume flow is performed by measuring the difference in pressure before and after the constriction arranged in the flow path by using differential pressure measurement. US2017290527A1 discloses a compliance monitoring module for a pressurized Metered Dose Inhaler comprising a miniature pressure sensor. The sensor port of the sensor is configured to be pneumatically coupled to a flow channel of the inhaler through which a user can inhale. The compliance module is clipped on to the pressurized Metered Dose Inhaler.
Summary
The Applicant realized that the fastening structure of US2020155773 and the collar of WO2021/069940 may affect the air flow rate caused by inhalation by the patient through the inhaler with respect to the inhaler without the additional electronic module, i.e. with respect to working design conditions of the inhaler. Indeed, both the fastening structure of US2020155773 and the collar of W02021/069940 fully surround the canister and the gap between the canister and an edge of the MDI and therefore affect the air flow through this gap. This may increase the device resistance, decrease the air flow rate inhaled by the user and may prevent a proper medicament inhalation.
The Applicant also realized that the structure adopted by W02021/069940 is quite complex and may also prevent a proper medicament inhalation by the user.
The Applicant further realized that the position of the pressure port of US2020155773 requires pressure sensors provided with high sensitivity which are relatively expensive. Indeed, the pressure sensor of US2020155773 is placed inside the accessory, is spaced from the respective pressure port and is in fluid connection to said pressure port through a channel. In order to properly detect a pressure at the pressure port, a high sensitive and expensive pressure sensor is required.
It is an object of the present invention to eliminate the above drawbacks of hitherto known electronic modules for metered dose inhalers. In particular, it is an object of the present invention to provide an electronic module for metered dose inhalers affecting as little as possible the overall air flow rate resistance of the inhaler and the efficacy of medicament inhalation when the user inhales.
It is also object of the present invention to provide an electronic module for metered dose inhalers assuring safe and easy mounting and dismounting to/from the metered dose inhaler.
It is also object of the present invention to provide an electronic module for metered dose inhalers which requires no modification of the commercially available meter dose inhalers for properly coupling said electronic module to said inhaler.
At least one of the above objects is substantially achieved by an electronic module for metered dose inhalers and by a metered dose inhaler assembly according to one or more of the appended claims and/or of the following aspects.
In accordance with a 1st independent aspect, an electronic module for metered dose inhalers, comprises: a casing having an external surface provided with a pressure detection point; an electronic unit and a pressure sensor enclosed in the casing, the pressure sensor being operatively connected to the electronic unit and to the pressure detection point; the casing comprising two hooks configured to engage an edge of a housing of a metered dose inhaler accommodating or configured to accommodate a canister containing a drug formulation to be dispensed; wherein the pressure detection point is located between the two hooks.
The electronic module is attached or attachable to the metered dose inhaler.
In accordance with a 2nd independent aspect, a metered dose inhaler assembly comprises: a metered dose inhaler, comprising: a hollow body comprising: a housing accommodating or configured to accommodate a canister containing a drug formulation to be dispensed; a mouthpiece in fluid communication with the housing; a valve seat located in the hollow body, between the housing and the mouthpiece and accommodating or configured to accommodate a valve dispensing nozzle of the canister; the electronic module according to the preceding 1st aspect or according to one or more of the following aspects.
The electronic module is attached or is configured to be attached in removable manner to the metered dose inhaler.
The metered dose inhaler may be a pressurized metered dose inhaler.
The metered dose inhaler may comprise the canister containing the drug formulation to be dispensed.
The Applicant verified that the electronic module according to the invention provides easy and safe coupling of the module to the inhaler and, at the same time, ensures a very low disturbance of the overall air flow flowing through the hollow body when the user inhales the medicament.
The Applicant verified that the electronic module according to the invention requires no changes of the commercial inhalers available on the market to allow coupling of the module to the inhaler and a correct air flow passage and air flow detection by said module when coupled to the inhaler.
Indeed, the two hooks ensure docking of the electronic module to the metered dose inhaler while keeping free all the remaining gap between the module and the canister.
The two hooks, in addition to their hooking function, integrate an additional function, that of delimiting the flow channel and conveying air on the pressure point.
In an aspect, the two hooks delimit therebetween a flow channel and the pressure detection point is configured to interact with an airflow crossing said flow channel.
In an aspect, mutually facing sides of the two hooks delimiting the flow channel have a planar or concave shape.
In an aspect, the two hooks delimit therebetween an inlet port of the flow channel and the flow channel diverges from the inlet port towards free ends of the two hooks. In an aspect, the inlet port is positioned on an outer portion of the casing.
In an aspect, an inlet diverging angle of the flow channel at the inlet port is between 50° and 90°.
In an aspect, the free ends of the two hooks delimit therebetween an outlet opening of the flow channel.
In an aspect, the pressure detection point is positioned halfway between the inlet port and the outlet opening. In an aspect, an outlet diverging angle of the flow channel at the outlet opening is between 0° and 20°.
In an aspect, an average diverging angle of the flow channel is between 20° and 70°.
In an aspect, each of the two hooks comprise an engaging surface configured to rest on the edge of the housing.
In an aspect, the pressure detection point is located between the inlet port and a lying plane of the engaging surface.
In an aspect, the pressure detection point is located on a center plane of the flow channel.
In an aspect, the flow channel is symmetrical with respect to a plane containing a respective axis of the casing. When the electronic module is attached to the metered dose inhaler, the flow channel is symmetrical with respect to a plane containing a main axis of the housing. Alternatively, the flow channel is asymmetrical with respect to a plane containing a respective axis of the casing. When the electronic module is attached to the metered dose inhaler, the flow channel is asymmetrical with respect to a plane containing a main axis of the housing.
In an aspect, a gap for airflow is delimited between an edge of the housing and the canister and surrounds the canister.
In an aspect, the two hooks engaged on the edge of the housing close only a portion of the gap.
In an aspect, the two hooks span around the canister for an angle comprised between 50° and 90°, optionally of 60°. Therefore, only a small portion of the gap around the canister is closed.
In an aspect, when the two hooks engage the edge of the housing and the electronic module is attached to the metered dose inhaler, said two hooks lie against the canister and the flow channel is delimited by: the two hooks, an outer surface of the canister and the external surface of the casing provided with the pressure detection point.
In an aspect, when the two hooks engage the edge of the housing and the electronic module is attached to the metered dose inhaler, the pressure detection point is above the edge of the housing.
In an aspect, the flow channel produces a high flow speed of the flow of air over the pressure detection point and increases a pressure drop. The Applicant verified that the electronic module according to the invention is able to promote acceleration of the air flow over the pressure detection point and to increase the sensitivity of pressure detection. Indeed, the flow channel increases the pressure drop at the pressure detection point and allows the electronic module to discern a much lower airflow rate than if the pressure sensor were to be in communication with the airflow without the flow channel.
The Applicant verified the electronic module according to the invention allows adopting low-cost pressure sensors, having a relatively low sensitivity, while ensuring a proper airflow detection, since the flow channel of the invention allows to boost sensitivity through amplifying the depression in the vicinity of the pressure port.
In an aspect, the pressure sensor has an absolute pressure range of 0 kPa to 8 kPa, optionally of 1 kPa to 7 kPa, optionally of 1 kPa to 6 kPa.
In an aspect, the pressure sensor has an analog output.
In an aspect, the pressure sensor has a sensitivity from 1 kPaA/ to 3 kPa/V, optionally from 1 .5 kPa/V to 2.5 kPa/V.
In an aspect, the pressure sensor has digital output (output in decimal counts).
In an aspect, the pressure sensor has a sensitivity from 0.0000002 kPa/count to 0.0000006 kPa/count, optionally of 0.000000447 kPa/count.
In an aspect, the pressure detection point is a pressure detection port in fluid communication with the pressure sensor.
In an aspect, the pressure detection port is connected to the pressure sensor through a manifold, optionally an elastomeric manifold.
In an aspect, the casing has a portion complementary to a part of the hollow body of the metered dose inhaler, i.e. the portion of the casing is shaped to match the part of the hollow body, and, when the two hooks engage the edge of the housing and the electronic module is attached to the metered dose inhaler, said portion of the casing abuts against said part of the hollow body. The assembly is therefore compact and easy handle.
In an aspect, when the two hooks engage the edge of the housing and the electronic module is attached to the metered dose inhaler, the casing protrudes beyond the housing and the hooks are protected from any impacts.
In an aspect, when the two hooks engage the edge of the housing and the electronic module is attached to the metered dose inhaler, the external surface provided with a pressure detection point is flush with an internal surface of the housing. Air flow turbulence inside the hollow body is thus limited.
In an aspect, the casing comprises a projection, optionally an elastic projection, spaced from the two hooks, the projection being configured to clip on the hollow body at a zone spaced from the edge of the housing. Hooks and projection allow easy latch and unlatch.
In an aspect, the housing extends along a respective main axis and the mouthpiece has a respective central axis.
In an aspect, the main axis and the central axis being skew with respect to each other such that the hollow housing is L-shaped or substantially L-shaped.
In an aspect, the main axis and the central axis delimit an angle between 90° and 120°.
In an aspect, the casing is elongated along a respective axis, when the electronic module is attached to the metered dose inhaler said respective axis being parallel to the main axis of the housing.
In an aspect, the edge is located at a first extremity of the housing and the mouthpiece protrudes from a second extremity of the housing located in opposite position from the first extremity.
In an aspect, the edge bounds an opening of the housing for insertion of the canister.
In an aspect, when the canister is accommodated in the housing, said canister protrudes partially from the opening.
In an aspect, the second extremity of the housing comprises an elbow fashioned on an opposite side from the mouthpiece.
In an aspect, the projection of the casing is clipped on or is configured to clip on said elbow.
In an aspect, said part of the hollow body is a side of the hollow body opposite the mouthpiece.
In an aspect, said part of the hollow body comprises the elbow.
In an aspect, the two hooks protrude from said portion of the casing.
In an aspect, the external surface of the casing provided with the pressure detection point is bounded by the mutually facing sides of the two hooks.
In an aspect, the external surface of the casing provided with the pressure detection point has a triangular outline or a roughly triangular outline. In an aspect, the external surface of the casing provided with the pressure detection point is in relief from the portion of the casing.
In an aspect, the engaging surface is transverse to the external surface of the casing provided with the pressure detection point and to said portion of the casing.
In an aspect, each of the two hooks comprises a protrusion overhanging from the engaging surface and delimiting, together with said engaging surface and with the portion of the casing, a respective seat for the edge of the housing.
In an aspect, when the two hooks engage the edge of the housing and the electronic module is attached to the metered dose inhaler, the inlet port is bounded by the two hooks and by the outer surface of the canister.
In an aspect, the inlet port opens on the outer portion of the casing and said outer portion is transversal to the outer surface of the canister and lies side by side with said outer surface of the canister.
In an aspect, when the two hooks engage the edge of the housing and the electronic module is attached to the metered dose inhaler, the outlet opening is bounded by the two hooks and the outer surface of the canister.
In an aspect, the electronic unit is configured to receive at least one pressure signal from the pressure sensor, to elaborate the at least one pressure signal and to output a signal indicative of a flow of gas (air), optionally of a flow rate of gas.
In an aspect, the electronic unit is configured to measure the flow rate of gas from the at least one pressure signal.
In an aspect, the electronic unit is configured to correlate the at least one pressure signal and/or the flow rate of gas to a correct inhalation by the user and to provide a feedback to the user through at least one signaling device.
In an aspect, the electronic module comprises one additional sensor or more additional sensors operatively connected to the electronic unit and configured to detect manipulation by the user and/or actuation of the metered dose inhaler and/or proper attachment of the electronic module to the metered dose inhaler.
In an aspect, the one additional sensor or more additional sensors are enclosed in the casing and/or operate on an outer surface of the casing.
In an aspect, the one additional sensor or more additional sensors comprise: accelerometers, proximity sensors, movement sensors, etc..
In an aspect, the electronic module comprises at least one signaling device, e.g. providing visual or sound signals, operatively connected to the electronic unit and configured to alert the user of the status and/or of the operation of the electronic module and/or of the metered dose inhaler.
In an aspect, the electronic module comprises a battery to power the electronic unit and the sensor or sensors and any signaling device or devices.
In an aspect, the metered dose inhaler is actuated by pushing the canister towards the housing in order to press the valve dispensing nozzle in the valve seat and ejecting the drug formulation.
Further features and advantages will be clearer from the detailed description of preferred but not exclusive embodiments of an electronic module for a metered dose inhaler and a metered dose inhaler assembly according to the present invention.
Description of the drawings
Figures 1 A and 1 B show 3D views of a metered dose inhaler assembly comprising a metered dose inhaler and an electronic module according to the present invention; Figure 2 is a top view of the metered dose inhaler assembly of Figures 1 A and 1 B; Figure 3 is a 3D view of the electronic module of the metered dose inhaler assembly of Figures 1 A, 1 B and 2;
Figure 4 is an enlarged portion of Figure 3;
Figure 5 is a front view of the enlarged portion of Figure 4;
Figure 6 shows an element of Figure 5 and an airflow flowing through said element; Figure 7 shows a detail of the electronic module hooked to the metered dose inhaler; Figure 8 is a schematic view of electronic module components from the preceding Figures.
Detailed description
With reference to the appended drawings, Figures 1A, 1 B and 2 show a metered dose inhaler assembly 1 according to the present invention. The metered dose inhaler assembly 1 comprises a metered dose inhaler 2 (MDI) and an electronic module 3. The electronic module 3 is configured to be easily mounted on and dismounted from the metered dose inhaler 2 using no tools, so that the same electronic module 3 may be coupled to another inhaler when said inhaler is exhausted and should be replaced.
Metered dose inhaler The metered dose inhaler 2 may be per se known and commercially available on the market. The metered dose inhaler 2 shown as example in Figures 1 A, 1 B and 2 comprises a hollow body 4, or actuator, and a canister 5 containing a drug formulation to be dispensed. The canister 5 is accommodated in the hollow body 4. The hollow body 4 comprises a housing 6 accommodating or configured to accommodate the canister 5 and a mouthpiece 7 which is in fluid communication with the housing 6. A valve seat, not shown in the appended drawings, is located in the hollow body 4 between the housing 6 and the mouthpiece 7. The housing 6, the mouthpiece 7 and the valve seat may be a single part of molded plastic.
The housing 6 is a sort of tubular element extending along a main axis “X-X”. The mouthpiece 7 is a sort of tubular element extending along a central axis “Y-Y”. The main axis “X-X” and the central axis “Y-Y” are skew with respect to each other, such that the hollow housing 4 is L-shaped or substantially L-shaped. The main axis “X- X” and the central axis “Y-Y” of the embodiment of the appended Figures delimit an angle of about 100° - 110°.
A first extremity of the housing 6 has an opening delimited by an edge 9. An opposite second extremity of the housing 6 is connected to the mouthpiece 7 and an elbow is fashioned on an opposite side from the mouthpiece 7.
The canister 5 may be produced in aluminum or stainless steel and comprises a valve dispensing nozzle or metering valve, which may be per se known and is not shown. The drug formulation in the canister comprises a liquefied gas propellant (pressurized MDI) and, in many cases, stabilizing excipients.
When the canister 5 is accommodated in the housing 6 of the hollow body 4, like in Figures 1 A, 1 B and 2, the valve dispensing nozzle of the canister 5 is placed in the valve seat of the hollow body 4 and a part of the canister 5, opposite the valve dispending nozzle, protrudes from the opening. A gap 8 is delimited between the canister 5 and the edge 9 and surrounds the canister 5.
In order to intake the medicament, the metered dose inhaler is actuated by pushing the canister 5 towards the housing 6, i.e. by pressing the part of the canister 5 protruding from the opening 8. This way, the valve dispensing nozzle is pressed in the valve seat and ejects the drug formulation. Meanwhile or just after pressing, the user draws from the mouthpiece 7, air enters the hollow body 4 through the gap 8 and flows in the mouthpiece 7 where air and drug medicament mix and are inhaled by the user through an opening in the mouthpiece 7. Electronic module
The electronic module 3 is configured to be attached in removable manner to the metered dose inhaler 2, so that the same electronic module 3 may be used with another new metered dose inhaler once the medicament in the old metered dose inhaler is over.
The electronic module 3 comprises a casing 10, for instance a plastic casing, enclosing an electronic unit 11 and a battery 12, for instance a lithium battery, connected to the electronic unit 11 to power said electronic unit 11 .
The electronic module 3 further comprises sensors operatively connected to the electronic unit 11 and configured to detect, for instance, manipulation by the user and/or actuation of the metered dose inhaler and/or proper attachment of the electronic module 3 to the metered dose inhaler 2. The sensors may operate on an outer surface of the casing 10 or may be placed inside the casing 10. The electronic module 3 comprises a signaling device 15, e.g. a led or a speaker, operatively connected to the electronic unit 11 and configured to alert the user (e.g. through a visual or audio signal) of the status and/or of the operation of the electronic module 3 and/or of the metered dose inhaler 2. The electronic module 3 here detailed comprises a pressure sensor 13 and an accelerometer 14. All these electronic components are schematically represented in Figure 8 and are all enclosed and protected in the casing 10.
The pressure sensor 13 is housed in the casing 10 and is in fluid communication with a pressure detection point 16, i.e. a pressure detection port, located on an external surface 17 of the casing 10 (Figures 3, 4, 5, 7).
For instance, the hardware of the pressure sensor 13 is mounted on a printed circuit board (PCB) and connected to the pressure port through an elastomeric manifold, creating a seal between the pressure sensor 13 and the casing 10. The airflow is not diverted into the manifold and onto the pressure sensor 13 and only the pressure due to the airflow over the pressure port 16 is monitored in use. Indeed, air is substantially stagnant in the pressure port and in the manifold.
As shown in Figure 3, the casing 10 has a portion 18 or face which is complementary to a side of the housing 6 of the hollow body 4 of the metered dose inhaler 2 opposite to the side from which the mouthpiece 7 protrudes. Said portion 18 is concave to match the convex rounded side of the housing 6. The casing 10 is elongated along a respective axis “Z-Z” which, when the electronic module 3 is attached to the metered dose inhaler 2, is parallel to the main axis “X- X” of the housing 6. A first end of the casing 10 comprises a hooking assembly which protrudes from the portion 18 and comprises two hooks 19. A second end of the casing 10, opposite the first end along the axis “Z-Z”, comprises an elastic projection 20.
The external surface 17 of the casing 10 and the pressure point 16 are located between the two hooks 19 (Figures 3 - 7).
Referring to Figure 4 and 5, the hooking assembly comprises the external surface 17 which protrudes from the portion 18 and the two hooks 19 protrude from the portion 18.
Each of the two hooks 19 comprises a protrusion 21 spaced from the portion 18 and extending towards the second end of the casing 10. Each of the two hooks 19 comprises an engaging surface 22 connecting the protrusion 21 to the portion 18. The engaging surface 22 is transverse to the portion 18 and to the external surface 17 of the casing 10. The two engaging portions 22 of the hooks 19 are interconnected through a further transversal surface 23 extending between the external surface 17 and the portion 18. The two engaging surfaces 22 together with the further transversal surface 23 form a continuous surface arranged on a lying plane and configured to rest against the edge 9 of the housing 6 when the electronic module 3 is installed on the metered dose inhaler 2. Each protrusion 21 overhangs from the respective engaging surface 22 and delimits, together with said engaging surface 22 and with the portion 18, a respective seat 24 (Figure 4) for receiving and hooking the edge 9 of the housing 6.
The two hooks 19 protrude also from the external surface 17 and delimit said external surface 17. The external surface 17 is indeed bounded by mutually facing sides 25 of the two hooks 19. Each of the facing sides 25 of the two hooks 19 have concave shape. Said facing sides 25 are closer at an outer portion of the casing 10 located on the first end and diverges from each other as they move away from said first end (Figure 5). Therefore, the external surface 17 has a roughly triangular outline. In other embodiments, the facing sides 25 may be planar, like in schematic Figure 6.
Parts of the facing sides 25 of the two hooks 19 belonging to the protrusions 21 extend overhanging beyond the external surface 17 and towards the second end of the casing 10. In other words, the protrusions 21 extend overhanging beyond a base of the triangular external surface 17, wherein said base matches with the above cited further transversal surface 23 (Figure 5).
The facing sides 25 of the two hooks 19 together with the external surface 17 delimit a flow channel having an inlet port 26, located on the outer portion at the first end of the casing 10 (where the facing sides 25 are closer), and an outlet opening 27 between free ends of the protrusions 21 of the two hooks 19. The flow channel diverges from the inlet port 26 towards the outlet opening 27.
The electronic module 3 is coupled to the metered dose inhaler 2 by hooking the two hooks 19 on the edge 9 and clipping the elastic projection 20 to the elbow of the hollow body 4. The portion 18 abuts the convex rounded side of the housing 6.
When the electronic module 3 is coupled to the metered dose inhaler 2, the two hooks 19 engage the edge 9 of the housing 6, said two hooks 19 lie against the canister 5 and the flow channel is delimited also by an outer surface of the canister 5. As shown in Figure 2, the inlet port 26 is bounded by the two hooks 19 and by the outer surface of the canister 5. The inlet port 26 opens on the outer portion of the casing 10 and said outer portion is transversal to the outer surface of the canister 5 and lies side by side with said outer surface of the canister 5. Even if not shown in the drawings, when the electronic module 3 is attached to the metered dose inhaler 2, also the outlet opening 27 is bounded by the two hooks 19 and by the outer surface of the canister 5.
Figure 7 shows the electronic module 3 coupled to the metered dose inhaler 2 with no canister 5 inside. Ribs 28 to hold the canister are also visible. As shown in Figure 7, when the electronic module 3 is coupled to the metered dose inhaler 2, the two engaging surfaces 22 and the further transversal surface 23 rest against the edge 9 of the housing 6, the external surface 17 is flush with an internal surface of the housing 6 and the pressure detection point 16 is positioned above the edge 9 of the housing 6. One of the ribs 28 may be positioned below the pressure detection point 16 (see also Figure 6). Furthermore, the casing 10 protrudes beyond the housing 6 and the hooks 19 are protected from any impacts.
As visible in Figure 2, when the electronic module 3 is attached to the metered dose inhaler 2, the hooking assembly partly surrounds the canister 5 and closes only a small portion of the gap 8. For instance, the hooking assembly spans around the canister 5 for an angle A of about 60° (300° of gap 8 are free). In the embodiment shown in the appended Figures, an inlet diverging angle a delimited between the facing sides 25 at the inlet port 26 is about 80° and an outlet diverging angle [3 of the flow channel at the outlet opening 27 is about 10°. An average diverging angle y of the flow channel may be for instance about 30°, wherein said average diverging angle y is the angle between two straight lines: a first straight line connecting a rim of one of the facing sides 25 at the inlet port 26 to a rim of the same side at the outlet opening 27; a second straight line connecting a rim of the other facing side 25 at the inlet port 26 to a rim of the same side at the outlet opening 27.
The flow channel is symmetrical with respect to a plane containing the respective axis “Z-Z” of the casing 10. When the electronic module 3 is attached to the metered dose inhaler 2, the flow channel is symmetrical with respect to a plane containing the main axis “X-X” of the housing 6.
The pressure detection point 16 is located on a center plane (symmetry plane) of the flow channel, positioned halfway between the inlet port 26 and the outlet opening 27 and close to the further transversal surface 23, i.e. close to the base of the triangular external surface 17.
In other embodiments, not shown in the appended drawings, the flow channel may be asymmetrical with respect to a plane containing the respective axis “Z-Z” of the casing, such that, when the electronic module 3 is attached to the metered dose inhaler 2, the flow channel is asymmetrical with respect to the plane containing the main axis “X-X” of the housing 6.
When the user actuates the metered dose inhaler 2 by pushing the canister 5 towards the housing 6 and then inhales, air enters through the gap 8 and also through the inlet port 26 and flows towards the mouthpiece 7. The airflow entering the inlet port 26 crosses the flow channel. The shape of the flow channel is such to produce a high flow speed “V” of the flow of air over the pressure detection point 16 and thus to increase a pressure drop which can be easily detected by the pressure sensor 13. Figure 6 shows higher flow velocity at the selected location (darker zone) of the pressure point 16 leading to a bigger pressure drop for a given inhalation flow rate.
Therefore, the pressure sensor 13 may be a low sensitive pressure sensor.
For instance, the pressure sensor 13 is an analog sensor having an analog voltage output with a pressure range of 1 .03 kPa to 6.89 kPa and a sensitivity of 2.22 kPaA/. For instance, the pressure sensor 13 is an analog sensor having an analog voltage output with a pressure range of 0 kPa to 6 kPa and a sensitivity of 1 .5 kPa/V.
The pressure sensor may also be a digital output pressure sensor having a digital output (decimal counts) with a pressure range of 0 kPa to 6 kPa and a sensitivity of 0.000000447 kPa/count. Examples of digital pressure sensor are Honeywell MicroPressure Board Mount Pressure Sensors (MPR series).
Indeed, the flow channel according to the invention maximizes the pressure sensor 13 response to a given flow rate through the metered dose inhaler 2. The pressure detection point 16 experiences a relatively high depression for a given air flow rate and hence the pressure drop is boosted improving the pressure sensor 13 performance.
Furthermore, the addition of this flow path does not significantly affect the airflow resistance of the metered dose inhaler and is comparable in resistance to a metered dose inhaler 2 without the electronic module 3 fitted.
The electronic unit 11 is configured to receive pressure signals from the pressure sensor 13, to elaborate pressure signals and to output a signal indicative of a flow of air or to measure the air flow rate. The electronic unit 11 is configured to correlate the pressure signals and/or the air flow rate to a correct inhalation by the user and to provide a feedback to the user through the signaling device or devices.
List of parts
1 metered dose inhaler assembly
2 metered dose inhaler
3 electronic module
4 hollow body
5 canister
6 housing
7 mouthpiece
8 gap
9 edge
10 casing
11 electronic unit
12 battery
13 pressure sensor 14 accelerometer
15 signaling device
16 pressure detection point
17 external surface
18 portion
19 two hooks
20 elastic projection
21 protrusion
22 engaging surface
23 further transversal surface
24 seat
25 facing sides
26 inlet port
27 outlet opening
28 ribs
“X-X” main axis
“Y-Y” central axis
“Z-Z” respective axis a inlet diverging angle
[3 outlet diverging angle
Y average diverging angle
A angle

Claims

1. An electronic module for a metered dose inhaler, wherein the electronic module is attached or attachable to the metered dose inhaler, the electronic module comprising: a casing (10) having an external surface (17) provided with a pressure detection point (16); an electronic unit (11 ) and a pressure sensor (13) enclosed in the casing (10), the pressure sensor (13) being operatively connected to the electronic unit (11 ) and to the pressure detection point (16); the casing (10) comprising two hooks (19) configured to engage an edge (9) of a housing (6) of a metered dose inhaler (2) accommodating or configured to accommodate a canister (5) containing a drug formulation to be dispensed; wherein the pressure detection point (16) is located between the two hooks (19); wherein the two hooks (19) delimit therebetween a flow channel and the pressure detection point (16) is configured to interact with an airflow crossing said flow channel.
2. The electronic module according to claim 1 , wherein each of the two hooks (19) comprises an engaging surface (22) configured to rest on the edge (9) of the housing (6).
3. The electronic module according to claim 1 or 2, wherein mutually facing sides (25) of the two hooks (19) delimiting the flow channel have a planar or concave shape.
4. The electronic module according to claim 1 , 2 or 3, wherein the two hooks (19) delimit therebetween an inlet port (26) of the flow channel and the flow channel diverges from the inlet port (26) towards free ends of the two hooks (19).
5. The electronic module according to claim 4, wherein the inlet port (26) is positioned on an outer portion of the casing (10); wherein an inlet diverging angle (a) of the flow channel at the inlet port (26) is between 50° and 90°.
6. The electronic module according to claim 4 or 5, wherein the free ends of the two hooks (19) delimit therebetween an outlet opening (27) of the flow channel and the pressure detection point (16) is positioned halfway between the inlet port (26) and the outlet opening (27); wherein an outlet diverging angle ([3) of the flow channel at the outlet opening (27) is between 0° and 20°.
7. The electronic module according to any of claims 4 to 6, wherein an average diverging angle (y) of the flow channel is between 20° and 70°.
8. The electronic module according to any of claims 4 to 7, wherein the pressure detection point (16) is located between the inlet port (26) and a lying plane of the engaging surface (22).
9. The electronic module according to any of claims 1 to 8, wherein the pressure detection point (16) is located on a center plane of the flow channel.
10. The electronic module according to any of claims 1 to 9, wherein the flow channel is symmetrical with respect to a plane containing a respective axis of the casing (10).
11. A metered dose inhaler assembly comprising: a metered dose inhaler (2), optionally a pressurized metered dose inhaler, comprising: a hollow body (4) comprising: a housing (6) accommodating or configured to accommodate a canister (5) containing a drug formulation to be dispensed; a mouthpiece (7) in fluid communication with the housing (6); a valve seat located in the hollow body (4), between the housing (6) and the mouthpiece (7) and accommodating or configured to accommodate a valve dispensing nozzle of the canister (5); the electronic module (3) according to one of the preceding claims 1 to 10; wherein the electronic module (3) is attached or is configured to be attached in removable manner to the metered dose inhaler (2).
12. The inhaler assembly of claim 11 , wherein a gap (8) for airflow is delimited between an edge (9) of the housing (6) and the canister (5) and surrounds the canister (5); wherein the two hooks (19) engaged on the edge (9) of the housing (6) close only a portion of the gap (8).
13. The inhaler assembly of claim 12, wherein the two hooks (19) span around the canister (5) for an angle (A) comprised between 50° and 90°, optionally of 60°.
14. The electronic module according to claim 11 or 12 or 13, wherein, when the two hooks (19) engage the edge (9) of the housing (6) and the electronic module (3) is attached to the metered dose inhaler (2), said two hooks (19) lie against the canister (5) and the flow channel is delimited by: the two hooks (19), an outer surface of the canister (5) and the external surface (17) of the casing (10) provided with the pressure detection point (16).
15. The electronic module according to any of claims 11 to 14, wherein, when the two hooks (19) engage the edge (9) of the housing (6) and the electronic module (3) is attached to the metered dose inhaler (2), the pressure detection point (16) is above the edge (9) of the housing (6).
PCT/EP2024/071046 2023-07-27 2024-07-24 Electronic module for a metered dose inhaler and metered dose inhaler assembly comprising the electronic module WO2025021887A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP23188007 2023-07-27
EP23188007.1 2023-07-27

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8807131B1 (en) * 2013-06-18 2014-08-19 Isonea Limited Compliance monitoring for asthma inhalers
US20170290527A1 (en) 2014-08-28 2017-10-12 Microdose Therapeutx, Inc. Compliance monitoring module for an inhaler
US20200155773A1 (en) 2018-11-19 2020-05-21 Sensirion Ag Determination of air flow rate through an inhaler
WO2021069940A1 (en) 2019-10-11 2021-04-15 Spirocco Kft. Bidirectional flow meter for an mdi device and an mdi device containing such a bidirectional flow meter
WO2022171791A1 (en) * 2021-02-13 2022-08-18 Norton (Waterford) Limited Inhaler system
US20220273235A1 (en) * 2019-07-31 2022-09-01 Reciprocal Labs Corporation Modular inhaler adherence monitor
US20220273891A1 (en) * 2019-08-21 2022-09-01 Aptar Radolfzell Gmbh Inhaler and evaluation unit therefor

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8807131B1 (en) * 2013-06-18 2014-08-19 Isonea Limited Compliance monitoring for asthma inhalers
US20170290527A1 (en) 2014-08-28 2017-10-12 Microdose Therapeutx, Inc. Compliance monitoring module for an inhaler
US20200155773A1 (en) 2018-11-19 2020-05-21 Sensirion Ag Determination of air flow rate through an inhaler
US20220273235A1 (en) * 2019-07-31 2022-09-01 Reciprocal Labs Corporation Modular inhaler adherence monitor
US20220273891A1 (en) * 2019-08-21 2022-09-01 Aptar Radolfzell Gmbh Inhaler and evaluation unit therefor
WO2021069940A1 (en) 2019-10-11 2021-04-15 Spirocco Kft. Bidirectional flow meter for an mdi device and an mdi device containing such a bidirectional flow meter
WO2022171791A1 (en) * 2021-02-13 2022-08-18 Norton (Waterford) Limited Inhaler system

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