WO2022031698A1 - Inhalateur et interface associée - Google Patents

Inhalateur et interface associée Download PDF

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Publication number
WO2022031698A1
WO2022031698A1 PCT/US2021/044336 US2021044336W WO2022031698A1 WO 2022031698 A1 WO2022031698 A1 WO 2022031698A1 US 2021044336 W US2021044336 W US 2021044336W WO 2022031698 A1 WO2022031698 A1 WO 2022031698A1
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WO
WIPO (PCT)
Prior art keywords
data
processor
therapeutic composition
clause
user
Prior art date
Application number
PCT/US2021/044336
Other languages
English (en)
Inventor
Eric W. Starr
Jacob ZELTMAN
Original Assignee
Mylan Inc.
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 Mylan Inc. filed Critical Mylan Inc.
Publication of WO2022031698A1 publication Critical patent/WO2022031698A1/fr

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Classifications

    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/13—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered from dispensers
    • 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
    • A61M15/00—Inhalators
    • A61M15/06—Inhaling appliances shaped like cigars, cigarettes or pipes
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4833—Assessment of subject's compliance to treatment
    • 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
    • A61M15/00—Inhalators
    • A61M15/0028—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003—Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
    • A61M2016/003—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter
    • A61M2016/0033—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical
    • A61M2016/0042—Accessories therefor, e.g. sensors, vibrators, negative pressure with a flowmeter electrical in the expiratory circuit
    • 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
    • A61M2205/18—General characteristics of the apparatus with alarm
    • 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
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3553—Range remote, e.g. between patient's home and doctor's office
    • 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
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • A61M2205/505—Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
    • 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
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • 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
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback
    • 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
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/587—Lighting arrangements
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/04—Heartbeat characteristics, e.g. ECG, blood pressure modulation
    • A61M2230/06—Heartbeat rate only
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • A61M2230/205—Blood composition characteristics partial oxygen pressure (P-O2)
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/40—Respiratory characteristics
    • A61M2230/43—Composition of exhalation
    • A61M2230/432—Composition of exhalation partial CO2 pressure (P-CO2)

Definitions

  • Disclosed embodiments relate generally to devices, systems, and methods for delivery of inhaled therapeutic compositions, and, in embodiments, devices with pressure sensors for determining airflow during inhalation. Disclosed embodiments also relate generally to systems and methods for monitoring administration compliance for therapeutic compositions.
  • Cystic fibrosis is an inherited disorder that causes significant damage of organ systems, including, notably, the respiratory system and the lungs. CF causes the normally thin layer of mucus in the lungs to become more viscous, which can cause blockage in lung airways. Critically, this altered lung environment makes it difficult for the body's immune system to effectively clear pathogens, rendering the lungs hospitable for infections. In particular, individuals with CF become susceptible to chronic infections by Pseudomonas aeruginosa, which is the leading cause of morbidity and mortality in individuals with CF.
  • Aminoglycosides such as tobramycin
  • tobramycin are a class of potent bactericidal agents. Their main mechanism of action is on the bacterial ribosome, which in turn inhibits protein synthesis.
  • Inhaled (powder or nebulized solution) tobramycin is the treatment of choice for P. aeruginosa infections in individuals with CF.
  • delivery of sufficient levels e.g., at or above the minimum inhibitory concentration (MIC)
  • MIC minimum inhibitory concentration
  • a handheld aerosolization apparatus having a housing defining an interior and having at least two air inlets, the inlets configured and dimensioned to produce a swirling airflow within the interior; a mouthpiece comprising a perforated member and an aerosolized pharmaceutical formulation outlet, the mouthpiece being connectable to the housing to define a capsule chamber, the mouthpiece further comprising a shield which covers at least one of the air inlets, wherein the shield prevents blockage of at least one of the air inlets by a user grasping the apparatus; a puncturing mechanism disposed within the housing for creating one or more openings in the capsule; a plunger connected to the puncturing mechanism; and a communication device.
  • a handheld aerosolization apparatus having a housing defining an interior and having one or more air inlets; a pressure sensor arranged in the housing interior; a mouthpiece connectable to the housing to define a capsule chamber; a communication device; and at least one processor in communication with the pressure sensor.
  • a handheld aerosolization apparatus training device having a housing defining an interior and having at least two air inlets, the inlets configured and dimensioned to produce a swirling airflow within the interior; a pressure sensor arranged in the housing interior; a mouthpiece comprising a perforated member and an aerosolized pharmaceutical formulation outlet, the mouthpiece being connectable to the housing to define a capsule chamber, the mouthpiece further comprising a shield which covers at least one air inlet, wherein the shield prevents blockage of at least one air inlet by a user grasping the apparatus; a communication device; and at least one processor in communication with the pressure sensor and the communication device.
  • Also provided herein is a computer-implemented method for monitoring medication adherence, including steps of receiving, with at least one processor, tobramycin schedule data, the tobramycin schedule data comprising data relating to one or more times a dose of tobramycin is to be administered; generating, with at least one processor and based on the tobramycin schedule data, one or more alerts; and receiving, with at least one processor, tobramycin dosing data, the tobramycin dosing data comprising data relating to one or more times a dose of tobramycin was administered.
  • a system for monitoring medication adherence including a communication device; a display; a user input; and at least one processor in communication with the communication device, the display, and the user input, the at least one processor programmed or configured to: receive tobramycin schedule data, the tobramycin schedule data comprising data relating to one or more times a dose of tobramycin is to be administered; generate one or more alerts based on the tobramycin schedule data; and receive tobramycin dosing data, the tobramycin dosing data comprising data relating to one or more times a dose of tobramycin was administered.
  • a handheld aerosol ization device including: a handheld aerosol ization apparatus having: a housing defining an interior and having at least two air inlets, the inlets configured and dimensioned to produce a swirling airflow within the interior; a mouthpiece comprising a perforated member and an aerosolized pharmaceutical formulation outlet, the mouthpiece being connectable to the housing to define a capsule chamber, the mouthpiece further comprising a shield which covers at least one of the air inlets, wherein the shield prevents blockage of at least one of the air inlets by a user grasping the apparatus; a puncturing mechanism disposed within the housing for creating one or more openings in the capsule; and a plunger connected to the puncturing mechanism; and a storage case defining a storage interior and configured to hold the handheld aerosol ization apparatus in the storage interior, the storage case including: a communication device.
  • a handheld aerosol ization apparatus comprising: a housing defining an interior and having at least two air inlets, the inlets configured and dimensioned to produce a swirling airflow within the interior; a mouthpiece comprising a perforated member and an aerosolized pharmaceutical formulation outlet, the mouthpiece being connectable to the housing to define a capsule chamber, the mouthpiece further comprising a shield which covers at least one of the air inlets, wherein the shield prevents blockage of at least one of the air inlets by a user grasping the apparatus; a puncturing mechanism disposed within the housing for creating one or more openings in the capsule; a plunger connected to the puncturing mechanism; and a communication device.
  • Clause 4 The handheld aerosol ization apparatus according to clause 3, further comprising: at least one processor in communication with the Bluetooth transmitter; a user input in communication with the at least one processor; and memory storing tobramycin dosing data, the tobramycin dosing data comprising a use history of the apparatus, wherein the tobramycin dosing data is recorded in response to actuation of the user input.
  • Clause 5 The handheld aerosol ization apparatus according to clause 4, wherein the at least one processor is programmed or configured to transmit the tobramycin dosing data to a computing device with the Bluetooth transmitter.
  • Clause 8 The handheld aerosol ization apparatus according to any of clauses 4-7, wherein the at least one processor is further programmed or configured to receive schedule data from the computing device with the Bluetooth transmitter and store the schedule data in the memory.
  • Clause 11 The handheld aerosolization apparatus according to clause 9 or clause 10, wherein the at least one indicator comprises a haptic indicator.
  • Clause 12 The handheld aerosolization apparatus according to any of clauses 9-11 , wherein the at least one processor is further programmed or configured to trigger the at least one indicator to provide an alert based on the schedule data.
  • Clause 14 The handheld aerosolization apparatus according to clause 12 or clause 13, wherein the alert comprises a repeating visual alert.
  • Clause 15 The handheld aerosolization apparatus according to any of clauses 12-14, wherein the at least one processor is further programmed or configured to maintain the alert until the user input is actuated.
  • Clause 16 The handheld aerosol ization apparatus according to any of clauses 9-11 , wherein the at least one processor is further programmed or configured to trigger the at least one indicator to provide an alert based on successful transmission of the tobramycin dosing data to the computing device and/or successful receipt of the schedule data from the computing device.
  • Clause 17 The handheld aerosol ization apparatus according to any of clauses 9-11 , wherein the at least one processor is further programmed or configured to trigger the at least one indicator to provide an alert based on unsuccessful transmission of the tobramycin dosing data to the computing device and/or unsuccessful receipt of the schedule data from the computing device.
  • Clause 18 The handheld aerosol ization apparatus according to clause 17, wherein the at least one processor is further programmed or configured to maintain the alert until successful transmission of the tobramycin dosing data to the computing device and/or successful receipt of the schedule data from the computing device.
  • Clause 19 The handheld aerosol ization apparatus according to any of clauses 16-18, wherein the tobramycin dosing data is deleted from the memory upon successful transmission of the tobramycin dosing data to the computing device.
  • Clause 20 The handheld aerosol ization apparatus according to any of clauses 3-19, further comprising a battery.
  • Clause 21 The handheld aerosol ization apparatus according to clause 9- 19, wherein the at least one processor is further programmed or configured to trigger the at least one indicator to provide an alert based on a charge state of the battery.
  • Clause 22 The handheld aerosol ization apparatus according to any of clauses 3-21 , further comprising a pressure sensor arranged in the housing interior.
  • Clause 23 The handheld aerosol ization apparatus according to clause 22, wherein the pressure sensor is configured to detect airflow through the mouthpiece.
  • Clause 24 The handheld aerosol ization apparatus according to clause 22 or clause 23, wherein the at least one processor is further programmed or configured to: receive first pressure data from the pressure sensor; receive atmospheric pressure data from the pressure sensor; and compare the first pressure data to the atmospheric pressure data to generate airflow data.
  • Clause 25 The handheld aerosol ization apparatus according to any of clauses 22-24, wherein the at least one processor is further programmed or configured to: receive first pressure data from the pressure sensor at a first time prior to onset of inhalation; receive second pressure data from the pressure sensor at a second time during inhalation; and compare the second pressure data to the first pressure data to generate airflow data.
  • Clause 26 The handheld aerosol ization apparatus according to clause 24 or clause 25, wherein the at least one processor is further programmed or configured to: compare the airflow data to a target airflow; and trigger the at least one indicator to provide an alert based on whether the airflow data differs from the target airflow by more or less than a predetermined threshold.
  • Clause 27 The handheld aerosol ization apparatus according to clause 26, wherein the at least one indicator is a visual indicator.
  • Clause 28 The handheld aerosol ization apparatus according to clause 27, wherein the visual indicator comprises an LED arranged within the plunger, and wherein the at least one processor is further programmed or configured to: cause the LED to emit a green light when the airflow data differs from the target airflow by less than the predetermined threshold; and cause the LED to emit an orange light or a red light when the airflow data differs from the target airflow by more than the predetermined threshold.
  • Clause 29 The handheld aerosol ization apparatus according to any of clauses 24-28, wherein the at least one processor is further programmed or configured to transmit the airflow data to the computing device with the Bluetooth transmitter.
  • Clause 31 The handheld aerosol ization apparatus according to clause 30, wherein, upon activation of the pressure sensor and the at least one processor, the at least one processer triggers the at least one indicator to provide an alert that the apparatus is ready to be used.
  • Clause 32 The handheld aerosol ization apparatus according to clause 31 , wherein the alert comprises a visual indicator.
  • Clause 33 The handheld aerosol ization apparatus according to clause 32, wherein the visual indicator is an LED arranged within the plunger, and wherein the at least one processor is further programmed or configured to cause the LED to emit a blue light indicating that the apparatus is ready to be used.
  • the visual indicator is an LED arranged within the plunger
  • the at least one processor is further programmed or configured to cause the LED to emit a blue light indicating that the apparatus is ready to be used.
  • Clause 34 The handheld aerosol ization apparatus according to any of clauses 24-33, wherein the at least one processor is further programmed or configured to trigger the at least one indicator to provide an alert based on successful transmission of the airflow data to the computing device.
  • Clause 35 The handheld aerosol ization apparatus according to any of clauses 24-34, wherein the at least one processor is further programmed or configured to trigger the at least one indicator to provide an alert based on unsuccessful transmission of the airflow data to the computing device.
  • Clause 36 The handheld aerosol ization apparatus according to clause 35, wherein the at least one processor is further programmed or configured to maintain the alert until successful transmission of the airflow data to the computing device.
  • Clause 37 The handheld aerosol ization apparatus according to any of clauses 34-36, wherein the airflow data is deleted from the memory upon successful transmission of the tobramycin dosing data to the computing device.
  • a handheld aerosol ization apparatus comprising: a housing defining an interior and having one or more air inlets; a pressure sensor arranged in the housing interior; a mouthpiece connectable to the housing to define a capsule chamber; a communication device; and at least one processor in communication with the pressure sensor.
  • Clause 40 The handheld aerosol ization apparatus according to clause 38 or clause 39, wherein the at least one processor is programmed or configured to: receive first pressure data from the pressure sensor; receive atmospheric pressure data from the pressure sensor; and compare the first pressure data to the atmospheric pressure data to generate airflow data.
  • Clause 41 The handheld aerosol ization apparatus according to any of clauses 38-40, wherein the at least one processor is programmed or configured to: receive first pressure data from the pressure sensor at a first time prior to onset of inhalation; receive second pressure data from the pressure sensor at a second time during inhalation; and compare the second pressure data to the first pressure data to generate airflow data.
  • Clause 42 The handheld aerosol ization apparats according to any of clauses 38-41 , further comprising: a puncturing mechanism disposed within the housing for creating one or more openings in the capsule; and a plunger connected to the puncturing mechanism.
  • Clause 43.A kit comprising: the handheld aerosol ization apparatus according to any of clauses 1-42; at least one blister pack comprising: a plurality of capsules comprising a powdered composition comprising tobramycin; and instructions for a user to actuate the apparatus to release the powdered composition and to inhale the powdered composition at a rate of less than or equal to 80 liters per minute for at least three seconds.
  • a handheld aerosol ization apparatus training device comprising: a housing defining an interior and having at least two air inlets, the inlets configured and dimensioned to produce a swirling airflow within the interior; a pressure sensor arranged in the housing interior; a mouthpiece comprising a perforated member and an aerosolized pharmaceutical formulation outlet, the mouthpiece being connectable to the housing to define a capsule chamber, the mouthpiece further comprising a shield which covers at least one air inlet, wherein the shield prevents blockage of at least one air inlet by a user grasping the apparatus; a communication device; and at least one processor in communication with the pressure sensor and the communication device.
  • Clause 45 The handheld aerosol ization apparatus training device according to clause 44, wherein the device is configured so as to be unable to aerosolize a composition.
  • Clause 46 The handheld aerosol ization apparatus training device according to clause 44 or clause 45, wherein the communication device is a Bluetooth transmitter.
  • Clause 47 The handheld aerosol ization apparatus training device according to any of clauses 44-46, wherein the pressure sensor is configured to detect airflow through the mouthpiece.
  • Clause 48 The handheld aerosol ization apparatus training device according to clause 47, wherein the at least one processor is further programmed or configured to: receive first pressure data from the pressure sensor; receive atmospheric pressure data from the pressure sensor; and compare the first pressure data to the atmospheric pressure data to generate airflow data.
  • Clause 49 The handheld aerosol ization apparatus according to any of clauses 44-49, wherein the at least one processor is further programmed or configured to: receive first pressure data from the pressure sensor at a first time prior to onset of inhalation; receive second pressure data from the pressure sensor at a second time during inhalation; and compare the second pressure data to the first pressure data to generate airflow data.
  • Clause 50 The handheld aerosol ization apparatus training device according to clause 48 or clause 49, wherein the at least one processor is further programmed or configured to: compare the airflow data to a target airflow; and trigger the at least one indicator to provide an alert based on whether the airflow data differs from the target airflow by more or less than a predetermined threshold.
  • Clause 51 The handheld aerosol ization apparatus training device according to clause 50 wherein the at least one indicator is a visual indicator.
  • Clause 52 The handheld aerosol ization apparatus training device according to clause 51 , wherein the visual indicator comprises an LED, and wherein the at least one processor is further programmed or configured to: cause the LED to emit a green light when the airflow data differs from the target airflow by less than the predetermined threshold; and cause the LED to emit an orange light or a red light when the airflow data differs from the target airflow by more than the predetermined threshold.
  • the visual indicator comprises an LED
  • the at least one processor is further programmed or configured to: cause the LED to emit a green light when the airflow data differs from the target airflow by less than the predetermined threshold; and cause the LED to emit an orange light or a red light when the airflow data differs from the target airflow by more than the predetermined threshold.
  • Clause 53 The handheld aerosolization apparatus training device according to any of clauses 48-52, wherein the at least one processor is further programmed or configured to transmit the airflow data to a computing device with the Bluetooth transmitter.
  • Clause 54 The handheld aerosolization apparatus training device according to any of clauses 48-53, wherein the at least one processor is further programmed or configured to trigger the at least one indicator to provide an alert based on successful transmission of the airflow data to the computing device.
  • Clause 55 The handheld aerosolization apparatus training device according to any of clauses 48-54, wherein the at least one processor is further programmed or configured to trigger the at least one indicator to provide an alert based on unsuccessful transmission of the airflow data to the computing device.
  • Clause 56 The handheld aerosolization apparatus training device according to clause 55, wherein the at least one processor is further programmed or configured to maintain the alert until successful transmission of the airflow data to the computing device.
  • Clause 57 The handheld aerosolization apparatus training device according to any of clauses 44-56, further comprising a user input arranged on the housing.
  • Clause 58 The handheld aerosolization apparatus training device according to clause 57, wherein the pressure sensor and the at least one processor are activated when a user actuates the user input.
  • Clause 59 The handheld aerosolization apparatus training device according to clause 57 or clause 58, wherein, upon activation of the pressure sensor and processor, the processer triggers the at least one indicator to provide an alert that the apparatus is ready to be used.
  • Clause 60 The handheld aerosolization apparatus training device according to clause 59, wherein the alert comprises a visual indicator.
  • Clause 61 The handheld aerosolization apparatus training device according to clause 60, wherein the visual indicator is an LED arranged within the user input, and wherein the at least one processor is further programmed or configured to cause the LED to emit a blue light indicating that the apparatus is ready to be used.
  • the visual indicator is an LED arranged within the user input
  • the at least one processor is further programmed or configured to cause the LED to emit a blue light indicating that the apparatus is ready to be used.
  • Clause 62 The handheld aerosolization apparatus training device according to any of clauses 44-61 , further comprising an accelerometer in communication with the at least one processor, wherein the pressure sensor and the at least one processor are activated when the accelerometer detects acceleration above a predetermined threshold, optionally where the predetermined threshold is about 1 g.
  • Clause 63 The handheld aerosolization apparatus training device according to any of clauses 44-62, wherein the at least one processor is further programmed or configured to activate periodically.
  • Clause 64 The handheld aerosolization apparatus training device according to clause 62, wherein the at least one processor is programmed or configured to activate at least once every 24 hours.
  • a computer-implemented method for monitoring medication adherence comprising: receiving, with at least one processor, tobramycin schedule data, the tobramycin schedule data comprising data relating to one or more times a dose of tobramycin is to be administered; generating, with at least one processor and based on the tobramycin schedule data, one or more alerts; and receiving, with at least one processor, tobramycin dosing data, the tobramycin dosing data comprising data relating to one or more times a dose of tobramycin was administered.
  • Clause 66 The computer-implemented method according to clause 65, further comprising storing, with at least one processor, the tobramycin schedule data.
  • Clause 67 The method according to clause 65 or clause 66, further comprising storing, with at least one processor, the tobramycin dosing data.
  • Clause 68 The method according to any of clauses 65-67, further comprising transmitting to a remote database, with at least one processor, the tobramycin schedule data and/or the tobramycin dosing data.
  • Clause 69 The method according to any of clauses 65-68, wherein the one or more alerts comprise a haptic alert.
  • Clause 70 The method according to any of clauses 65-69, wherein the one or more alerts comprise a visual alert.
  • Clause 71 The method according to any of clauses 65-70, wherein the one or more alerts comprise an audible alert.
  • Clause 72 The method according to any of clauses 65-71 , wherein the one or more alerts are generated until user input is received or a predetermined period of time has elapsed.
  • Clause 73 The method according to any of clauses 65-72, further comprising receiving, with at least one processor, non-tobramycin activity schedule data.
  • Clause 74 The method according to clause 73, further comprising storing, with at least one processor, the non-tobramycin activity schedule data.
  • Clause 75 The method according to clause 73 or clause 74, further comprising generating, with at least one processor and based on the non-tobramycin activity schedule data, one or more second alerts.
  • Clause 76 The method according to clause 75, wherein the one or more second alerts comprise a haptic alert.
  • Clause 77 The method according to clause 75 or clause 76, wherein the one or more second alerts comprise a visual alert.
  • Clause 78 The method according to any of clauses 75-77, wherein the one or more second alerts comprise an audible alert.
  • Clause 79 The method according to any of clauses 75-78, wherein the one or more second alerts are generated until user input is received or a predetermined period of time has elapsed.
  • Clause 80 The method according to any of clauses 65-79, further comprising displaying, with at least one processor, instructions relating to proper administration of tobramycin with a handheld aerosolization apparatus.
  • Clause 81 The method according to clause 80, wherein the instructions comprise one or more video clips.
  • Clause 82 The method according to clause 80 or clause 81 , wherein the instructions comprise one or more images.
  • Clause 83 The method according to any of clauses 65-82, further comprising: transmitting, with at least one processor, location data to an air quality monitoring system, the location data comprising data relating to a geographic location of a user; receiving, with at least one processor, air quality data from the air quality monitoring system, the air quality data comprising one or more metrics related to air quality in the geographic location; and displaying, with at least one processor, the one or more metrics.
  • Clause 84 The method according to clause 83, further comprising generating, with at least one processor, one or more third alerts when the one or more metrics meet a predetermined threshold.
  • Clause 85 The method according to clause 84, wherein the one or more third alerts comprise a haptic alert.
  • Clause 86 The method according to clause 84 or clause 85, wherein the one or more third alerts comprise a visual alert.
  • Clause 87 The method according to any of clauses 84-86, wherein the one or more third alerts comprise an audible alert.
  • Clause 88 The method according to any of clauses 65-87, further comprising: displaying, with at least one processor, a prompt for a user to enter tobramycin cycle data; and receiving, with at least one processor, the tobramycin cycle data.
  • Clause 89 The method according to clause 88, further comprising generating, with at least one processor and based on the tobramycin cycle data, the tobramycin schedule data.
  • Clause 90 The method according to any of clauses 65-89, further comprising: displaying, with at least one processor, a prompt for a user to enter nontobramycin activity cycle data; and receiving, the non-tobramycin activity cycle data.
  • Clause 91 The method according to clause 90, further comprising generating, with at least one processor and based on the non-tobramycin activity cycle data, non-tobramycin activity schedule data.
  • Clause 92 The method according to any of clauses 65-91 , further comprising: displaying, with at least one processor, a prompt for a user to enter tobramycin dosing data; and receiving, with at least one processor, the tobramycin dosing data.
  • Clause 93 The method according to any of clauses 65-92, further comprising calculating, with at least one processor and based at least in part on the tobramycin dosing data, tobramycin adherence data.
  • Clause 94 The method according to clause 93, wherein calculating the tobramycin adherence data comprises: comparing, with at least one processor, the tobramycin dosing data to the tobramycin schedule data; and calculating, with at least one processor, a percentage of tobramycin doses administered by a user.
  • Clause 95 The method according to clause 94, further comprising displaying, with at least one processor, the tobramycin adherence data for one or more time periods.
  • Clause 96 The method according to any of clauses 93-95, further comprising transmitting, with at least one processor, the tobramycin adherence data to a mobile device, a remote database, and/or a healthcare provider system.
  • Clause 97 The method according to any of clauses 65-96, further comprising calculating, with at least one processor and based on the tobramycin dosing data, a number of consecutive scheduled doses that were administered.
  • Clause 98 The method according to any of clauses 65-97, further comprising: determining, with at least one processor, whether dosing data was received; and in response to determining that tobramycin dosing data was not received, transmitting to a mobile device associated with a user’s caregiver, with at least one processor, a fourth alert indicating that the scheduled dose of tobramycin was missed.
  • Clause 99 The method according to any of clauses 65-98, further comprising pairing, with at least one processor, a first communication device with a second communication device, the first communication device associated with a user’s mobile device and the second communication device associated with a handheld aerosol ization apparatus, for example a handheld aerosol ization apparatus or training device according to any of clauses 1 -42, clauses 44-64, and/or clauses 161-164.
  • Clause 101 The method according to clause 99 or clause 100, further comprising receiving, with at least one processor, the tobramycin dosing data from the handheld aerosol ization apparatus.
  • Clause 102 The method according to any of clauses 99-101 , further comprising: receiving, with at least one processor and from the handheld aerosol ization apparatus, flow data relating to inhalation of tobramycin by a user; comparing, with at least one processor, the flow data to a target flow data; and based on the comparison, providing, with at least one processor, instructions to the user to increase or decrease inhalation rate.
  • Clause 103 The method according to clause 102, wherein the flow data is generated by: receiving first pressure data from the handheld aerosol ization apparatus at a first time prior to onset of inhalation; receiving second pressure data from the handheld aerosol ization apparatus at a second time during inhalation; and comparing the second pressure data to the first pressure data.
  • Clause 104 The method according to clause 102, wherein the flow data is generated by: receiving first pressure data from the handheld aerosol ization apparatus at a first time during inhalation; receiving atmospheric pressure data from the handheld aerosol ization apparatus; and comparing the first pressure data to the atmospheric pressure data.
  • Clause 105 The method according to any of clauses 102-104, further comprising displaying, with at least one processor, the flow data.
  • Clause 106 The method according to any of clauses 102-105, further comprising: determining, with at least one processor and based on whether the flow data is within a predetermined range, whether the inhalation was acceptable or unacceptable; and based on the determination, providing, with at least one processor, an indication that the inhalation was acceptable or unacceptable.
  • Clause 107 The method according to any of clauses 65-106, further comprising receiving, with at least one processor, symptom data relating to one or more symptoms of cystic fibrosis.
  • Clause 108 The method according to any of clauses 65-107, further comprising receiving, with at least one processor and from a monitoring device, one or more health parameters.
  • Clause 109 The method according to clause 108, wherein the monitoring device is one or more of a smartwatch, a pulse oximeter, a spirometer, a capnometer, and a heart rate monitor.
  • the monitoring device is one or more of a smartwatch, a pulse oximeter, a spirometer, a capnometer, and a heart rate monitor.
  • a system for monitoring medication adherence comprising: a communication device; a display; a user input; and at least one processor in communication with the communication device, the display, and the user input, the at least one processor programmed or configured to: receive tobramycin schedule data, the tobramycin schedule data comprising data relating to one or more times a dose of tobramycin is to be administered; generate one or more alerts based on the tobramycin schedule data; and receive tobramycin dosing data, the tobramycin dosing data comprising data relating to one or more times a dose of tobramycin was administered.
  • Clause 111 The system according to clause 110, wherein the communication device is a Bluetooth transmitter.
  • Clause 112. The system according to clause 110 or clause 111 , wherein the at least one processor is programmed or configured to receive the tobramycin dosing data from the user input, optionally wherein the tobramycin dosing data comprises data relating to the number of tobramycin capsules that were administered.
  • Clause 113 The system according to any of clauses 110-112, wherein the at least one processor is programmed or configured to receive the tobramycin schedule data from the user input.
  • Clause 114 The system according to any of clauses 110-113, wherein the at least one processor is further programmed or configured to store the tobramycin schedule data.
  • Clause 115 The system according to any of clauses 110-114, wherein the at least one processor is further programmed or configured to store the tobramycin dosing data.
  • Clause 117 The system according to any of clauses 110-116, wherein the at least one processor is programmed or configured to receive, from a remote database, the tobramycin schedule data.
  • Clause 118 The system according to any of clauses 110-117, wherein the one or more alerts comprise a haptic alert.
  • Clause 119 The system according to any of clauses 110-118 wherein the one or more alerts comprise a visual alert.
  • Clause 120 The system according to any of clauses 110-119, wherein the one or more alerts comprise an audible alert.
  • Clause 121 The system according to any of clauses 110-120, wherein the at least one processor is further programmed or configured to generate the one or more alerts until the user input is actuated or a predetermined period of time has elapsed.
  • Clause 122 The system according to any of clauses 110-121 , wherein the at least one processor is programmed or configured to receive, from the user input, non-tobramycin activity schedule data.
  • Clause 124 The system according to any of clauses 110-123 wherein the at least one processor is programmed or configured to receive, from a remote database, non-tobramycin activity schedule data.
  • Clause 125 The system according to any of clauses 122-124, wherein the at least one processor is further programmed or configured to generate one or more second alerts based on the non-tobramycin activity schedule data.
  • Clause 126 The system according to clause 125, wherein the one or more second alerts comprise a haptic alert.
  • Clause 127 The system according to clause 125 or clause 126, wherein the one or more second alerts comprise a visual alert.
  • Clause 128 The system according to any of clauses 125-127, wherein the one or more second alerts comprise an audible alert.
  • Clause 129 The system according to any of clauses 125-128, wherein the at least one processor is further programmed or configured to generate the one or more second alerts until the user input is actuated or a predetermined period of time has elapsed.
  • Clause 130 The system according to any of clauses 110-129, wherein the at least one processor is further programmed or configured to cause the display to provide instructions relating to proper administration of tobramycin with a handheld aerosol ization apparatus.
  • Clause 131 The system according to clause 130, wherein the instructions comprise one or more video clips.
  • Clause 132 The system according to clause 130 or clause 131 , wherein the instructions comprise one or more images.
  • Clause 133 The system according to any of clauses 110-132, wherein the at least one processor is further programmed or configured to: transmit location data to an air quality monitoring system, the location data comprising data relating to a geographic location of the system; receive air quality data from the air quality monitoring system, the air quality data comprising one or more metrics related to air quality in the geographic location; and display the one or more metrics.
  • Clause 134 The system according to clause 133, wherein the at least one processor is further programmed or configured to provide one or more third alerts when the one or more metrics meets a predetermined threshold.
  • Clause 135. The system according to clause 134, wherein the one or more third alerts comprise a haptic alert.
  • Clause 136 The system according to clause 134 or clause 135, wherein the one or more third alerts comprise a visual alert.
  • Clause 137 The system according to any of clauses 134-136, wherein the one or more third alerts comprise an audible alert.
  • Clause 138 The system according to any of clauses 110-137, wherein the at least one processor is programmed or configured to: provide, on the display, a prompt for a user to enter tobramycin cycle data; and receive, from the user input, the tobramycin cycle data.
  • Clause 139 The system according to clause 138, wherein the at least one processor is further programmed or configured to generate, based on the tobramycin cycle data, the tobramycin schedule data.
  • Clause 140 The system according to any of clauses 110-139, wherein the at least one processor is programmed or configured to: provide, on the display, a prompt for a user to enter non-tobramycin activity cycle data; and receive, from the user input, the non-tobramycin activity cycle data.
  • Clause 141 The system according to clause 140, wherein the at least one processor is further programmed or configured to generate, based on the non- tobramycin activity cycle data, non-tobramycin activity schedule data.
  • Clause 142 The system according to any of clauses 110-141 , wherein the at least one processor is programmed or configured to: provide, on the display, a prompt for a user to enter tobramycin dosing data; and receive, from the user input, the tobramycin dosing data.
  • Clause 143 The system according to any of clauses 110-142, wherein the at least one processor is further programmed or configured to calculate, based on the tobramycin dosing data, tobramycin adherence data.
  • Clause 145 The system according to clause 144, wherein the at least one processor is further programmed or configured to display tobramycin adherence data for one or more time periods.
  • Clause 146 The system according to any of clauses 143-145, wherein the at least one processor is further configured or programmed to transmit the tobramycin adherence data to a mobile device associated with a user’s caregiver, a remote database, and/or a healthcare provider system.
  • Clause 147 The system according to any of clauses 110-146, wherein the at least one processor is further programmed or configured to calculate, based on the tobramycin dosing data, a number of consecutive scheduled doses that were administered.
  • Clause 148 The system according to any of clauses 110-147, wherein the at least one processor is programmed or configured to: determine whether tobramcyin dosing data was received; and in response to determining that tobramycin dosing data was not received, transmit, to a mobile device associated with a user’s caregiver, a fourth alert that the scheduled dose of tobramycin was missed.
  • Clause 149 The system according to any of clauses 110-148, wherein the at least one processor is further programmed or configured to cause the communication device to pair with a second communication device associated with a handheld aerosol ization apparatus, for example a handheld aerosol ization apparatus or training device according to any of clauses 1-42, clauses 44-64, and/or clauses 161- 164.
  • a handheld aerosol ization apparatus for example a handheld aerosol ization apparatus or training device according to any of clauses 1-42, clauses 44-64, and/or clauses 161- 164.
  • Clause 150 The system according to clause 149, wherein the at least one processor is further programmed or configured to transmit the tobramycin schedule data to the handheld aerosolization apparatus.
  • Clause 151 The system according to clause 149 or clause 150, wherein the at least one processor is further programmed or configured to receive the tobramycin dosing data from the handheld aerosolization apparatus.
  • Clause 152 The system according to any of clauses 149-151 , wherein the at least one processor is further programmed or configured to: receive, from the handheld aerosolization apparatus, flow data relating to inhalation of tobramycin by a user; compare the flow data to a target flow data; and based on the comparison, provide instructions to the user to increase or decrease inhalation rate.
  • Clause 153 The system according to any of clauses 149-151 , wherein the at least one processor is programmed or configured to: receive first pressure data from the handheld aerosolization apparatus at a first time prior to onset of inhalation; receive second pressure data from the handheld aerosolization apparatus at a second time during inhalation; and compare the second pressure data to the first pressure data to generate flow data relating to inhalation of tobramycin by a user.
  • Clause 154 The system according to any of clauses 149-151 , wherein the at least one processor is programmed or configured to: receive first pressure data from the handheld aerosolization apparatus at a first time during inhalation; receive atmospheric pressure data from the handheld aerosolization apparatus; and compare the first pressure data to the atmospheric pressure data to generate flow data relating to inhalation of tobramycin by a user.
  • Clause 155 The system according to clauses 152-154, wherein the at least one processor is further programmed or configured to display the flow data.
  • Clause 156 The system according to any of clauses 152-155 wherein the at least one processor is further programmed or configured to: determine, based on whether the flow data is within a predetermined range, whether the inhalation was acceptable or unacceptable; and based on the determination, provide an indication that the inhalation was acceptable or unacceptable.
  • Clause 157 The system according to any of clauses 110-156, wherein the at least one processor is further programmed or configured to receive, with the user input, symptom data relating to one or more symptoms of cystic fibrosis.
  • Clause 158 The system according to any of clauses 110-157, wherein the at least one processor is further programmed or configured to: transmit a message to a healthcare provider system; and receive a message from the healthcare provider system.
  • Clause 159 The system according to any of clauses 110-158, wherein the at least one processor is programmed or configured to receive one or more health parameters from a monitoring device.
  • Clause 160 The system according to clause 159, wherein the monitoring device is one or more of a smartwatch, a pulse oximeter, a spirometer, a capnometer, and a heart rate monitor.
  • the monitoring device is one or more of a smartwatch, a pulse oximeter, a spirometer, a capnometer, and a heart rate monitor.
  • a handheld aerosol ization device comprising: a handheld aerosol ization apparatus comprising: a housing defining an interior and having at least two air inlets, the inlets configured and dimensioned to produce a swirling airflow within the interior; a mouthpiece comprising a perforated member and an aerosolized pharmaceutical formulation outlet, the mouthpiece being connectable to the housing to define a capsule chamber, the mouthpiece further comprising a shield which covers at least one of the air inlets, wherein the shield prevents blockage of at least one of the air inlets by a user grasping the apparatus; a puncturing mechanism disposed within the housing for creating one or more openings in the capsule; and a plunger connected to the puncturing mechanism; and a storage case defining a storage interior and configured to hold the handheld aerosol ization apparatus in the storage interior, the storage case comprising: a communication device.
  • Clause 162 The handheld aerosol ization device according to clause 161 , wherein the communication device is a near-field communication device.
  • Clause 164 The handheld aerosol ization device according to clause 163, further comprising: at least one processor in communication with the Bluetooth transmitter; a user input, arranged on the storage case and in communication with the at least one processor; and memory storing tobramycin dosing data, the tobramycin dosing data comprising a use history of the apparatus, wherein the tobramycin dosing data is recorded in response to actuation of the user input.
  • a kit comprising: the handheld aerosol ization apparatus according to any of clauses 161-164; at least one blister pack comprising: a plurality of capsules comprising a powdered composition comprising tobramycin; and instructions for a user to actuate the apparatus to release the powdered composition and to inhale the powdered composition at a rate of less than or equal to 80 liters per minute for at least three seconds.
  • a computer-implemented method for monitoring medication adherence comprising: receiving, with at least one processor, therapeutic composition schedule data, the therapeutic composition schedule data comprising data relating to one or more times a dose of a therapeutic composition is to be administered; generating, with at least one processor and based on the therapeutic composition schedule data, one or more alerts; and receiving, with at least one processor, therapeutic composition dosing data, the therapeutic composition dosing data comprising data relating to one or more times a dose of the therapeutic composition was administered.
  • Clause 167 The computer-implemented method according to clause 166, further comprising: storing, with at least one processor, the therapeutic composition schedule data.
  • Clause 168 The method according to clause 166 or clause 167, further comprising: storing, with at least one processor, the therapeutic composition dosing data.
  • Clause 169 The method according to any of clauses 166-168, further comprising: transmitting to a remote database, with at least one processor, the therapeutic composition schedule data and/or the therapeutic composition dosing data.
  • Clause 171 The method according to any of clauses 166-170, wherein the one or more alerts comprise a visual alert.
  • Clause 172 The method according to any of clauses 166-171 , wherein the one or more alerts comprise an audible alert.
  • Clause 173 The method according to any of clauses 166-172, wherein the one or more alerts are generated until user input is received or a predetermined period of time has elapsed.
  • Clause 174 The method according to any of clauses 166-173, further comprising: displaying, with at least one processor, instructions relating to proper administration of therapeutic composition.
  • Clause 175. The method according to clause 174, wherein the instructions comprise one or more video clips.
  • Clause 176. The method according to clause 174 or 175, wherein the instructions comprise one or more images.
  • Clause 177 The method according to any of clauses 166-176, further comprising: transmitting, with at least one processor, location data to an air quality monitoring system, the location data comprising data relating to a geographic location of a user; receiving, with at least one processor, air quality data from the air quality monitoring system, the air quality data comprising one or more metrics related to air quality in the geographic location; and displaying, with at least one processor, the one or more metrics.
  • Clause 178 The method according to clause 177, further comprising: generating, with at least one processor, one or more second alerts when the one or more metrics meet a predetermined threshold.
  • Clause 180 The method according to clause 178 or clause 179, wherein the one or more second alerts comprise a visual alert.
  • Clause 181 The method according to any of clauses 178-180, wherein the one or more second alerts comprise an audible alert.
  • Clause 182 The method according to any of clauses 166-181 , further comprising: displaying, with at least one processor, a prompt for a user to enter therapeutic composition cycle data; and receiving, with at least one processor, the therapeutic composition cycle data.
  • Clause 183 The method according to clause 182, further comprising: generating, with at least one processor and based on the therapeutic composition cycle data, the therapeutic composition schedule data.
  • Clause 184 The method according to any of clauses 166-183, further comprising: displaying, with at least one processor, a prompt for a user to enter therapeutic composition dosing data; and receiving, with at least one processor, the therapeutic composition dosing data.
  • Clause 185 The method according to any of clauses 166-184, further comprising: calculating, with at least one processor and based at least in part on the therapeutic composition dosing data, therapeutic composition adherence data.
  • calculating the therapeutic composition adherence data comprises: comparing, with at least one processor, the therapeutic composition dosing data to the therapeutic composition schedule data; and calculating, with at least one processor, a percentage of therapeutic composition doses administered by a user.
  • Clause 187 The method according to clause 186, further comprising displaying, with at least one processor, the therapeutic composition adherence data for one or more time periods.
  • Clause 188 The method according to any of clauses 185-187, further comprising transmitting, with at least one processor, the therapeutic composition adherence data to a mobile device, a remote database, and/or a healthcare provider system.
  • Clause 189 The method according to any of clauses 166-188, further comprising calculating, with at least one processor and based on the therapeutic composition dosing data, a number of consecutive scheduled doses that were administered.
  • Clause 190 The method according to any of clauses 166-189, further comprising: determining, with at least one processor, whether dosing data was received; and in response to determining that therapeutic composition dosing data was not received, transmitting to a mobile device associated with a user’s caregiver, with at least one processor, a third alert indicating that the scheduled dose of therapeutic composition was missed.
  • Clause 191 The method according to any of clauses 166-190, further comprising: pairing, with at least one processor, a first communication device with a second communication device, the first communication device associated with a user’s mobile device and the second communication device associated with a handheld aerosol ization apparatus.
  • Clause 192 The method according to clause 191 , further comprising: transmitting, with at least one processor, the therapeutic composition schedule data to the handheld aerosolization apparatus.
  • Clause 193 The method according to clause 191 or clause 192, further comprising: receiving, with at least one processor, the therapeutic composition dosing data from the handheld aerosolization apparatus.
  • Clause 194 The method according to any of clauses 191-193, further comprising: receiving, with at least one processor and from the handheld aerosolization apparatus, flow data relating to inhalation of therapeutic composition by a user; comparing, with at least one processor, the flow data to a target flow data; and based on the comparison, providing, with at least one processor, instructions to the user to increase or decrease inhalation rate.
  • Clause 195 The method according to clause 194, wherein the flow data is generated by: receiving first pressure data from the handheld aerosol ization apparatus at a first time prior to onset of inhalation; receiving second pressure data from the handheld aerosol ization apparatus at a second time during inhalation; and comparing the second pressure data to the first pressure data.
  • Clause 196 The method according to clause 195, wherein the flow data is generated by: receiving first pressure data from the handheld aerosol ization apparatus at a first time during inhalation; receiving atmospheric pressure data from the handheld aerosol ization apparatus; and comparing the first pressure data to the atmospheric pressure data.
  • Clause 197 The method according to any of clauses 194-196, further comprising: displaying, with at least one processor, the flow data.
  • Clause 198 The method according to any of clauses 194-197, further comprising: determining, with at least one processor and based on whether the flow data is within a predetermined range, whether the inhalation was acceptable or unacceptable; and based on the determination, providing, with at least one processor, an indication that the inhalation was acceptable or unacceptable.
  • Clause 199 The method according to any of clauses 166-198, further comprising: receiving, with at least one processor, symptom data relating to one or more symptoms of one or more diseases or conditions for which the therapeutic composition is being administered.
  • Clause 200 The method according to any of clauses 166-199, further comprising: receiving, with at least one processor and from a monitoring device, one or more health parameters.
  • Clause 201 The method according to clause 200, wherein the monitoring device is one or more of a smartwatch, a pulse oximeter, a spirometer, a capnometer, and a heart rate monitor.
  • the monitoring device is one or more of a smartwatch, a pulse oximeter, a spirometer, a capnometer, and a heart rate monitor.
  • Clause 202 The method according to any of clauses 166-201 , further comprising: receiving, with at least one processor, activity schedule data.
  • Clause 203 The method according to clause 202, further comprising: storing, with at least one processor, the activity schedule data.
  • Clause 204 The method according to clause 202 or clause 203, further comprising: generating, with at least one processor and based on the activity schedule data, one or more fourth alerts.
  • Clause 205 The method according to clause 204, wherein the one or more fourth alerts comprise a haptic alert.
  • Clause 206 The method according to clause 204 or clause 205, wherein the one or more fourth alerts comprise a visual alert.
  • Clause 207 The method according to any of clauses 204-206, wherein the one or more fourth alerts comprise an audible alert.
  • Clause 208 The method according to any of clauses 204-207, wherein the one or more fourth alerts are generated until user input is received or a predetermined period of time has elapsed.
  • a system for monitoring medication adherence comprising: a communication device; a display; a user input; and at least one processor in communication with the communication device, the display, and the user input, the at least one processor programmed or configured to: receive therapeutic composition schedule data, the therapeutic composition schedule data comprising data relating to one or more times a dose of therapeutic composition is to be administered; generate one or more alerts based on the therapeutic composition schedule data; and receive therapeutic composition dosing data, the therapeutic composition dosing data comprising data relating to one or more times a dose of therapeutic composition was administered.
  • Clause 210 The system according to clause 209, wherein the communication device is a Bluetooth transmitter.
  • Clause 211 The system according to clause 209 or clause 210, wherein the at least one processor is programmed or configured to receive the therapeutic composition dosing data from the user input, and wherein the therapeutic composition dosing data comprises data relating to the amount of therapeutic composition that was administered.
  • Clause 212 The system according to any of clauses 209-211 , wherein the at least one processor is programmed or configured to receive the therapeutic composition schedule data from the user input.
  • Clause 213. The system according to any of clauses 209-212, wherein the at least one processor is further programmed or configured to store the therapeutic composition schedule data.
  • Clause 214 The system according to any of clauses 209-213, wherein the at least one processor is further programmed or configured to store the therapeutic composition dosing data.
  • Clause 215. The system according to any of clauses 209-214, wherein the at least one processor is further programmed or configured to transmit the therapeutic composition schedule data and/or the therapeutic composition dosing data to a remote database.
  • Clause 216 The system according to any of clauses 209-215, wherein the at least one processor is programmed or configured to receive, from a remote database, therapeutic composition schedule data.
  • Clause 217 The system according to any of clauses 209-216, wherein the one or more alerts comprise a haptic alert.
  • Clause 218 The system according to any of clauses 209-217, wherein the one or more alerts comprise a visual alert.
  • Clause 219. The system according to any of clauses 209-218, wherein the one or more alerts comprise an audible alert.
  • Clause 220 The system according to any of clauses 209-219, wherein the at least one processor is further programmed or configured to generate the one or more alerts until the user input is actuated or a predetermined period of time has elapsed.
  • Clause 221 The system according to any of clauses 209-220, wherein the at least one processor is further programmed or configured to cause the display to provide instructions relating to proper administration of the therapeutic composition.
  • Clause 224 The system according to any of clauses 209-223, wherein the at least one processor is further programmed or configured to: transmit location data to an air quality monitoring system, the location data comprising data relating to a geographic location of the system; receive air quality data from the air quality monitoring system, the air quality data comprising one or more metrics related to air quality in the geographic location; and display the one or more metrics.
  • Clause 225 The system according to clause 224, wherein the at least one processor is further programmed or configured to provide one or more second alerts when the one or more metrics meets a predetermined threshold.
  • Clause 226 The system according to clause 225, wherein the one or more second alerts comprise a haptic alert.
  • Clause 227 The system according to clause 225 or clause 226, wherein the one or more second alerts comprise a visual alert.
  • Clause 228 The system according to any of clauses 225-227, wherein the one or more second alerts comprise an audible alert.
  • Clause 229. The system according to any of clauses 209-228, wherein the at least one processor is programmed or configured to: provide, on the display, a prompt for a user to enter therapeutic composition cycle data; and receive, from the user input, the therapeutic composition cycle data.
  • Clause 230 The system according to clause 229, wherein the at least one processor is further programmed or configured to generate, based on the therapeutic composition cycle data, the therapeutic composition schedule data.
  • Clause 231 The system according to any of clauses 209-230, wherein the at least one processor is programmed or configured to: provide, on the display, a prompt for a user to enter activity cycle data; and receive, from the user input, the activity cycle data.
  • Clause 232 The system according to clause 231 , wherein the at least one processor is further programmed or configured to generate, based on the activity cycle data, activity schedule data.
  • Clause 233 The system according to any of clauses 209-232, wherein the at least one processor is programmed or configured to: provide, on the display, a prompt for a user to enter therapeutic composition dosing data; and receive, from the user input, the therapeutic composition dosing data.
  • Clause 234 The system according to any of clauses 209-233, wherein the at least one processor is further programmed or configured to calculate, based on the therapeutic composition dosing data, therapeutic composition adherence data.
  • Clause 235 The system according to clause 234, wherein calculating the therapeutic composition adherence data comprises comparing the therapeutic composition dosing data to the therapeutic composition schedule data, and calculating a percentage of therapeutic composition doses administered by a user.
  • Clause 236 The system according to clause 235, wherein the at least one processor is further programmed or configured to display therapeutic composition adherence data for one or more time periods.
  • Clause 237 The system according to any of clauses 234-236, wherein the at least one processor is further configured or programmed to transmit the therapeutic composition adherence data to a mobile device associated with a user’s caregiver, a remote database, and/or a healthcare provider system.
  • Clause 238 The system according to any of clauses 209-237, wherein the at least one processor is further programmed or configured to calculate, based on the therapeutic composition dosing data, a number of consecutive scheduled doses that were administered.
  • Clause 239. The system according to any of clauses 209-238, wherein the at least one processor is programmed or configured to: determine whether therapeutic dosing data was received; and in response to determining that therapeutic composition dosing data was not received, transmit, to a mobile device associated with a user’s caregiver, a third alert that the scheduled dose of therapeutic composition was missed.
  • Clause 240. The system according to any of clauses 209-239, wherein the at least one processor is further programmed or configured to cause the communication device to pair with a second communication device associated with a handheld aerosol ization apparatus.
  • Clause 241 The system according to clause 240, wherein the at least one processor is further programmed or configured to transmit the therapeutic composition schedule data to the handheld aerosol ization apparatus.
  • Clause 242 The system according to clause 240 or clause 241 , wherein the at least one processor is further programmed or configured to receive the therapeutic composition dosing data from the handheld aerosolization apparatus.
  • Clause 243 The system according to any of clauses 240-242, wherein the at least one processor is further programmed or configured to: receive, from the handheld aerosolization apparatus, flow data relating to inhalation of therapeutic composition by a user; compare the flow data to a target flow data; and based on the comparison, provide instructions to the user to increase or decrease inhalation rate.
  • Clause 244 The system according to any of clauses 240-243, wherein the at least one processor is programmed or configured to: receive first pressure data from the handheld aerosolization apparatus at a first time prior to onset of inhalation; receive second pressure data from the handheld aerosol ization apparatus at a second time during inhalation; and compare the second pressure data to the first pressure data to generate flow data relating to inhalation of therapeutic composition by a user.
  • Clause 245. The system according to any of clauses 240-244, wherein the at least one processor is programmed or configured to: receive first pressure data from the handheld aerosol ization apparatus at a first time during inhalation; receive atmospheric pressure data from the handheld aerosol ization apparatus; and compare the first pressure data to the atmospheric pressure data to generate flow data relating to inhalation of therapeutic composition by a user.
  • Clause 246 The system according to clauses 243-245, wherein the at least one processor is further programmed or configured to display the flow data.
  • Clause 247 The system according to any of clauses 243-246, wherein the at least one processor is further programmed or configured to: determine, based on whether the flow data is within a predetermined range, whether the inhalation was acceptable or unacceptable; and based on the determination, provide an indication that the inhalation was acceptable or unacceptable.
  • Clause 248 The system according to any of clauses 209-247, wherein the at least one processor is further programmed or configured to receive, with the user input, symptom data relating to one or more symptoms of one or more diseases or conditions for which the therapeutic composition is being administered.
  • Clause 249. The system according to any of clauses 209-248, wherein the at least one processor is further programmed or configured to: transmit a message to a healthcare provider system; and receive a message from the healthcare provider system.
  • Clause 250 The system according to any of clauses 209-249, wherein the at least one processor is programmed or configured to receive one or more health parameters from a monitoring device.
  • Clause 251 The system according to clause 250, wherein the monitoring device is one or more of a smartwatch, a pulse oximeter, a spirometer, a capnometer, and a heart rate monitor.
  • the monitoring device is one or more of a smartwatch, a pulse oximeter, a spirometer, a capnometer, and a heart rate monitor.
  • Clause 252 The system according to any of clauses 209-251 , wherein the at least one processor is programmed or configured to receive, from the user input, activity schedule data.
  • Clause 253 The system according to clause 252, wherein the at least one processor is further programmed or configured to store the activity schedule data.
  • Clause 254 The system according to any of clauses 209-253, wherein the at least one processor is programmed or configured to receive, from a remote database, activity schedule data.
  • Clause 255 The system according to any of clauses 252-254, wherein the at least one processor is further programmed or configured to generate one or more fourth alerts based on the activity schedule data.
  • Clause 256 The system according to clause 255, wherein the one or more fourth alerts comprise a haptic alert.
  • Clause 257 The system according to clause 255 or clause 256, wherein the one or more fourth alerts comprise a visual alert.
  • Clause 259. The system according to any of clauses 255-257, wherein the one or more fourth alerts comprise an audible alert.
  • Clause 260 The system according to any of clauses 255-259, wherein the at least one processor is further programmed or configured to generate the one or more fourth alerts until the user input is actuated or a predetermined period of time has elapsed.
  • FIGS. 1A-1D are cross-sectional (1A-1B), side (1C), and perspective (1D) views of a handheld aerosolization apparatus according to a non-limiting embodiment or aspect;
  • FIGS. 2A-2C are perspective views of the interior of a handheld aerosolization apparatus according to a non-limiting embodiment or aspect
  • FIG. 3 is a cross-sectional view of a handheld aerosolization apparatus according to a non-limiting embodiment or aspect
  • FIG. 4 is a cross-sectional view of a handheld aerosolization apparatus according to a non-limiting embodiment or aspect
  • FIGS. 5A-5B are side (5A) and perspective (5B) views of a handheld aerosolization apparatus according to a non-limiting embodiment or aspect;
  • FIG. 6 is a perspective view of the interior of a handheld aerosolization apparatus according to a non-limiting embodiment or aspect
  • FIG. 7 is a cross-sectional view of a handheld aerosolization apparatus according to a non-limiting embodiment or aspect
  • FIGS. 8A and 8B are side (8A) and perspective (8B) views of a handheld aerosol ization apparatus according to a non-limiting embodiment or aspect
  • FIGS. 9A-9C are perspective views of the interior of a handheld aerosol ization apparatus according to a non-limiting embodiment or aspect
  • FIG. 10 is a cross-sectional view of a handheld aerosol ization apparatus according to a non-limiting embodiment or aspect
  • FIG. 11 is a cross-sectional view of a handheld aerosol ization apparatus according to a non-limiting embodiment or aspect
  • FIGS. 12A and 12B are side views of a handheld aerosol ization device according to a non-limiting embodiment or aspect
  • FIGS. 13A and 13B are perspective views of a handheld aerosol ization device according to a non-limiting embodiment or aspect
  • FIG. 14 is a cross-sectional view of a handheld aerosol ization apparatus according to a non-limiting embodiment or aspect
  • FIG. 15 is a schematic view of a system for monitoring medication adherence according to a non-limiting embodiment or aspect
  • FIG. 16 is a process diagram of a computer-implemented method for monitoring medication adherence according to a non-limiting embodiment or aspect
  • FIGS. 17A-17E are graphs showing inhalation feedback in a computer- implemented method for monitoring medication adherence according to a non-limiting embodiment or aspect.
  • APPENDIX A describes handheld aerosol ization apparatuses and systems and methods for monitoring medication adherence according to non-limiting embodiments or aspects.
  • any numerical range recited herein is intended to include all sub-ranges subsumed therein.
  • a range of “1 to 10” is intended to include all subranges between (and including) the recited minimum value of 1 and the recited maximum value of 10, that is, having a minimum value equal to or greater than 1 and a maximum value of equal to or less than 10.
  • the term “patient” may refer to any mammal, including humans, and a “human patient” is any human.
  • the term “user” and “user device” may refer to a patient and a computing device associated with a patient.
  • the term “computing device” or “computer” may refer to one or more electronic devices configured to process data.
  • a computing device may, in some examples, include the necessary components to receive, process, and output data, such as a processor, a bus, a display, a memory, an input device, a network interface, and/or the like.
  • a computing device may be a mobile device.
  • a mobile device may include a cellular phone (e.g., a smartphone or standard cellular phone), a portable computer, a wearable device (e.g., watches, glasses, lenses, clothing, and/or the like), a personal digital assistant (PDA), and/or other like devices.
  • a computing device may also be a desktop computer or other form of non-mobile computer.
  • the terms “communication” and “communicate” refer to the receipt or transfer of one or more signals, messages, commands, or other type of data.
  • one unit e.g., any device, system, or component thereof
  • to be in communication with another unit means that the one unit is able to directly or indirectly receive data from and/or transmit data to the other unit. This may refer to a direct or indirect connection that is wired and/or wireless in nature.
  • two units may be in communication with each other even though the data transmitted may be modified, processed, relayed, and/or routed between the first and second unit.
  • a first unit may be in communication with a second unit even though the first unit passively receives data and does not actively transmit data to the second unit.
  • a first unit may be in communication with a second unit if an intermediary unit processes data from one unit and transmits processed data to the second unit.
  • an intermediary unit processes data from one unit and transmits processed data to the second unit.
  • Any known electronic communication protocols and/or algorithms can be used such as, for example, TCP/IP (including HTTP and other protocols), WLAN (including 802.11a/b/g/n and other radio frequency-based protocols and methods), analog transmissions, Global System for Mobile Communications (GSM), 3G/4G/LTE, BLUETOOTH, ZigBee, EnOcean, TransferJet, Wireless USB, and the like known to those of skill in the art.
  • the term “server” may refer to or include one or more computing devices that are operated by or facilitate communication and processing for multiple parties in a network environment, such as the Internet, although it will be appreciated that communication may be facilitated over one or more public or private network environments and that various other arrangements are possible. Further, multiple computing devices (e.g., servers, mobile devices, handheld aerosol ization apparatuses or training devices etc.) directly or indirectly communicating in the network environment may constitute a “system.”
  • Reference to “a server” or “a processor,” as used herein, may refer to a previously-recited server and/or processor that is recited as performing a previous step or function, a different server and/or processor, and/or a combination of servers and/or processors.
  • a first server and/or a first processor that is recited as performing a first step or function may refer to the same or different server and/or a processor recited as performing a second step or function.
  • a mobile device may refer to one or more portable electronic devices that are configured to communicate with one or more networks.
  • a mobile device may include a cellular phone (e.g., a smartphone or standard cellular phone), a portable computer, a wearable device (e.g., watches, glasses, lenses, clothing, and/or the like), a PDA, and/or other like devices.
  • the term “healthcare provider system” may refer to one or more server computers, processors, online interfaces, third-party hosted services, and/or the like that are used to receive, transmit, and/or store healthcare information.
  • the term “healthcare provider” may include doctors, hospitals, pharmacies, and/or the like.
  • the term “healthcare provider system” may also refer to one or more server computers, processors, online interfaces, third-party hosted services, and/or the like that are used to transmit and/or receive communications with the United States Department of Health and Human Services, the United States Food and Drug Administration, national health ceremonies/departments in countries outside of the United States, and/or state and/or local health departments/ministries.
  • air quality monitoring system may refer to one or more server computers, processors, online interfaces, third-party hosted services, and/or the like that are used to receive, transmit, and/or store data relating to air quality.
  • air quality monitoring system may also refer to one or more server computers, processors, online interfaces, third-party hosted services, and/or the like that are used to transmit and/or receive communications with the United States National Weather Service, the United States Environmental Protection Agency, environmental and/or weather departments/ministries in countries outside of the United States, and/or state and/or local weather services/agencies/ministries, state and/or local environmental agencies/departments/ministries, and/or the like.
  • Non-limiting embodiments or aspects of the devices, systems, and methods disclosed herein provide for improved delivery of aerosolized medication to the lungs of patients, improved adherence to medication regimens, and improved communication between patients, caregivers, and healthcare professionals, facilitating improved treatments and improved outcomes in the management of diseases and conditions where repeated administration of therapeutic compositions is required.
  • the improvements in handheld aerosolization apparatuses described herein increase the efficacy of aerosolized medications due to increased access of the medications to small airways of the lungs.
  • the improvements in the systems and methods for monitoring medication adherence described herein reduce the load on computer resources associated with healthcare providers and their patients, increasing efficiency and allowing for greater oversight of medication adherence, symptom management, and therapeutic outcomes.
  • Handheld aerosolization apparatus includes a housing (110) having a proximal end, a distal end, and a sidewall therebetween defining an interior.
  • Housing (110) includes one or more air inlets (120).
  • one or more air inlets are arranged at a distal end of housing (110) to allow flow of air from outside of the apparatus (100) to a capsule chamber (160) within interior (110).
  • one or more air inlets (120) and capsule chamber (160) can be configured and dimensioned to produce a swirling airflow within capsule chamber (160).
  • Handheld aerosolization apparatus (100) includes a mouthpiece (130) through which a user inhales an aerosolized therapeutic composition. Mouthpiece (130) can include a perforated member (140) that includes one or more openings therethrough, providing fluid connection between an aerosolized formulation outlet (150) and capsule chamber (160), and, thus, between mouthpiece (130) and capsule chamber (160).
  • handheld aerosolization apparatus (100) includes a shield (170), which can cover one or more of air inlets (120), thereby preventing a user from covering air inlet(s) (120) and allowing flow of air from outside of handheld aerosolization apparatus (100) to the interior (e.g., capsule chamber (160)).
  • Handheld aerosolization apparatus (100) can further include a puncturing mechanism (180), disposed within housing (110) and configured to puncture a capsule provided within capsule chamber (160). Puncturing mechanism (180) can include one or more puncture points for producing one or more openings in a capsule.
  • Handheld aerosolization apparatus (100) can further include plunger (190).
  • Plunger (190) can extend from a proximal end of housing (1 10), and can be attached or integral with puncturing mechanism (180), allowing a user to control puncturing of a capsule by depressing plunger (190).
  • plunger (190) and/or housing (110) includes at proximal end thereof, one or more seals, such that airflow into housing (110) from proximal end thereof is reduced and/or prevented.
  • One or more springs (200, 205) arranged within housing (1 10) can be provided to resiliently bias plunger (190) in a proximally-extended position. A user can then depress plunger (190) against the bias of one or more springs (200, 205) to cause puncturing mechanism (180) to puncture a capsule in capsule chamber (160).
  • one spring e.g., spring 200
  • another spring e.g., spring 205
  • depressing plunger (190) e.g., pressing plunger (190) in a distal direction relative to housing (110)
  • a first part of depressing plunger (190) can require less force (e.g., be easier), and a second part of depressing plunger (190) can require greater force (e.g., be more difficult).
  • components of handheld aerosol ization apparatus (100) can be formed of any useful material, such as plastic, metal, and the like.
  • spring(s) (200, 205) those of skill will appreciate that differing materials and differing spring arrangements (e.g., winding rise angle) can be used to provide desired resilience and/or resistance.
  • handheld aerosolization apparatus (100) can include a communication device (210).
  • communication device (210) is a near-field communication device (NFC).
  • NFC is configured to be scanned using a mobile device, for example, to indicate that a dose of a therapeutic composition has been administered with handheld aerosolization apparatus (100).
  • communication device (210) is a Bluetooth transmitter.
  • handheld aerosolization apparatus (100) can further include at least one processor (220), in communication with communication device (210). At least one processor (220) can be programmed or configured to perform any number of tasks, as will be described herein. As used herein, the term “programmed or configured” may refer to an arrangement of software, hardware circuitry, or any combination thereof on one or more devices. Handheld aerosolization apparatus (100) can further include memory (240) for storing, e.g., programming instructions to be executed by at least one processor (220), data relating to use of handheld aerosolization apparatus (100), data relating to when one or more doses of a therapeutic composition are to be administered, and other like information.
  • handheld aerosolization apparatus (100) can include one or more user inputs (230), e.g., a user-actuable button, in communication with at least one processor (220).
  • One or more user inputs (230) can be arranged at any useful location on housing (110) used, for example and without limitation, to indicate to processor (220) that a user has administered a dose of a therapeutic composition.
  • actuation of user input (230) can cause dosing data (e.g., data indicating that a dose of a therapeutic composition was administered) to be stored in memory (240) by at least one processor (220).
  • user input (230) is arranged on housing (110).
  • user input (230) is arranged on a storage case that holds handheld aerosol ization apparatus (100) (e.g., a storage case as shown in FIGS. 12A-13B).
  • memory (240) stores one or more of dosing data and scheduling data. While handheld aerosolization apparatus (100) can be used for any powdered therapeutic compositions designed to be delivered through aerosolization, administration of tobramycin (e.g., tobramycin schedule data and/or tobramycin dosing data), for example for treatment of CF, will be exemplified throughout this disclosure.
  • tobramycin e.g., tobramycin schedule data and/or tobramycin dosing data
  • Tobramycin dosing data can include a use history of the handheld aerosolization apparatus (100), including, for example, a number of times (optionally including date and/or time data) over a given period (e.g., day, week, month, year, and/or device lifetime) that handheld aerosolization apparatus (100) has been used to deliver a dose of powdered tobramycin for inhalation by a user.
  • a dose of tobramycin is four capsules.
  • tobramycin dosing data is generated based on user actuation of user input (230), and, optionally, stored in memory (240) simultaneously or thereafter.
  • At least one processor (220) is programmed or configured to transmit dosing data, such as tobramycin dosing data, to a computing device with communication device (210).
  • At least one processor is programmed or configured to receive, e.g., with communication device (210), tobramycin schedule data.
  • Tobramycin schedule data can include a schedule of doses of tobramycin that are to be administered over a given time period (e.g., day, week, month, and/or year).
  • tobramycin schedule data can be received from a computing device, e.g., a smartphone running an application, as described herein.
  • tobramycin schedule data is stored in memory (240).
  • handheld aerosolization apparatus (100) further includes at least one indicator (250).
  • At least one indicator (250) can be any type of indicator, e.g., an audible indicator (e.g., a speaker), a visual indicator (e.g., a light, such as an LED), and/or a haptic indicator. While the appended figures show indicator (250) provided at a proximal end of plunger (190), those of skill in the art will appreciate that an indicator can be provided anywhere on or in handheld aerosol ization apparatus (100), so long as the indication can be perceived by a user.
  • indicator (250) is in communication with at least one processor (220), and at least one processor (220) can be programmed or configured to trigger an alert by causing indicator (250) to provide an audible, visual, and/or haptic indication that it is time for a scheduled dose of tobramycin.
  • an audible, visual, and/or haptic indication is provided for a predetermined amount of time prior to a scheduled dose.
  • the audible, visual, and/or haptic indication is repeated until a dose is administered.
  • Confirmation that a dose has been administered can be from user actuation of plunger (190), user input (230), or from a pressure sensor (e.g., pressure sensor 270) indicating that a predetermined change in pressure within interior of handheld aerosol ization apparatus (100), indicative of administration of a dose, has occurred.
  • a pressure sensor e.g., pressure sensor 270
  • indicator (250) can be triggered by at least one processor (220) to alert a user that tobramycin dosing data has successfully been transmitted to a computing device, and/or receipt of tobramycin schedule data from a computing device. In non-limiting embodiments or aspects, indicator (250) can be triggered by at least one processor (220) to alert a user that tobramycin dosing data has not been successfully transmitted to a computing device, and/or tobramycin schedule data has not been successfully received from a computing device. In non-limiting embodiments or aspects, indicator (250) provides the indication until successful transmission and/or receipt of tobramycin dosing data and/or tobramycin schedule data.
  • handheld aerosol ization apparatus (100) further includes at least one battery (260).
  • indicator (250) can be triggered by at least one processor (220) to provide an indication of a charge state of battery (260), e.g., that battery (260) is fully charged, or that battery (260) has less than, e.g., 50%, 25%, 20%, 15%, 10%, 5%, and/or 1% charge remaining, all values and subranges therebetween inclusive.
  • handheld aerosol ization apparatus (100) can include in the interior thereof a pressure sensor (270).
  • Pressure sensor (270) can be arranged anywhere within housing (110) of handheld aerosol ization apparatus (100).
  • pressure sensor (270) is arranged on plunger (190).
  • pressure sensor (270) is arranged within housing (110) such that pressure sensor (270) can detect pressure within housing (110) and outside of housing (110) (e.g., atmospheric pressure).
  • pressure sensor (270) is arranged in the interior of housing (110), but is not arranged in capsule chamber (160).
  • At least one processor (220) can, via communication with pressure sensor (270), detect airflow through mouthpiece (130), through measurement of pressure within interior of handheld aerosolization apparatus (100).
  • at least one processor (220) can receive first pressure data (relating to pressure within housing (110) of handheld aerosolization apparatus (100) from pressure sensor (270) at one or more times during administration of a dose (through inhalation)), and can compare first pressure data to pressure outside of housing (110) (e.g., atmospheric pressure) to determine airflow through mouthpiece (130).
  • At least one processor (220) can receive first pressure data (relating to pressure within housing (110) of handheld aerosolization apparatus (100) from pressure sensor (270) at one or more times prior to administration of a dose, and second pressure data at one or more times during administration of a dose (e.g., during inhalation)), and can compare first pressure data to second pressure data to determine airflow through mouthpiece (130).
  • pressure sensor (270) samples pressure within housing (110) at 1 , 5, 10, 15, 20, 25, 30, 35, 40, 45, and/or 50 ms intervals, all values and subranges therebetween inclusive.
  • At least one processor (220) can compare the calculated airflow through mouthpiece (130) (as calculated by any method, including those described above) to a predetermined target airflow value, for example, a target airflow value that is specific for a given therapeutic composition (examples for tobramycin provided in International Patent Application Publication No. WO 2020/163416), and, cause indicator (250) to provide an audible, visual, and/or haptic indication that the calculated airflow is within and/or outside of a predetermined threshold difference from the target airflow.
  • a predetermined target airflow value for example, a target airflow value that is specific for a given therapeutic composition (examples for tobramycin provided in International Patent Application Publication No. WO 2020/163416), and, cause indicator (250) to provide an audible, visual, and/or haptic indication that the calculated airflow is within and/or outside of a predetermined threshold difference from the target airflow.
  • indication as to the difference between calculated airflow and predetermined target airflow is provided in real-time (e.g., during administration), and can provide an indication and/or instructions to increase or decrease inhalation (thus, increasing or decreasing airflow through mouthpiece (130)).
  • indication is a colored light, e.g., green light when calculated airflow through mouthpiece (130) is within an acceptable range compared to target airflow and a red or orange colored light when calculated airflow is outside of an acceptable range compared to target airflow.
  • indication is an audible indication, including verbal instructions to increase or decrease inhalation.
  • a determination that airflow through mouthpiece (130) is within or outside of an acceptable range is based on standards set by the International Society of Aerosol in Medicine/European Respiratory Society Task Force.
  • At least one processor (220) is programmed or configured to transmit first pressure data, second pressure data, and/or calculated airflow through mouthpiece (130) to a computing device, for example through communication device (210).
  • at least one processor (220) causes indicator (250) to provide an indication that first pressure data, second pressure data, and/or calculated airflow data has successfully been transmitted or has not been successfully transmitted.
  • indication is provided until successful transmission of first pressure data, second pressure data, and/or calculated airflow data.
  • first pressure data, second pressure data, and/or calculated airflow data are stored in memory (240) for a predetermined period of time.
  • first pressure data, second pressure data, and/or calculated airflow data are deleted from memory (240) upon successful transmission.
  • communication device (210), at least one processor (220), and/or pressure sensor (270) are configured to sleep or hibernate between doses, and can be activated, or awakened, by, for example and without limitation, actuation of plunger (190), actuation of user input (230), an accelerometer (not shown), and/or a predetermined time (e.g., a scheduled dose).
  • actuation of plunger (190) by a user awakens communication device (210), at least one processor (220), and/or pressure sensor (270).
  • Triggering events for awakening communication device (210), at least one processor (220), and/or pressure sensor (270) can also include a predetermined time for assessing whether communication device (210) is paired with a computing device, a predetermined time for dose administration, such as a time for a scheduled dose (e.g., based on tobramycin schedule data), a predetermined time for transmission of tobramycin dosing data to a computing device, and/or a predetermined time for receipt of tobramycin schedule data, for example, from a computing device.
  • awakening of communication device (210), at least one processor (220), and/or pressure sensor (270) triggers indicator (250) to provide an indication that handheld aerosolization apparatus (100) is ready for use.
  • indication is a colored light, e.g., blue light.
  • Handheld aerosolization apparatus (300) can include any feature described herein.
  • handheld aerosolization apparatus (300) includes housing (310) having a proximal end, a distal end, and a sidewall therebetween defining an interior.
  • Housing (310) can include one or more air inlets (320) at a distal end thereof to allow flow of air from outside of the apparatus to a capsule chamber (350).
  • Handheld aerosolization apparatus (300) includes a mouthpiece (340) through which a user inhales an aerosolized therapeutic composition.
  • Handheld aerosolization apparatus (300) further includes a pressure sensor (330) arranged in an interior of housing (310), a communication device (360), and at least one processor (370), which can be in communication with pressure sensor (330) and/or communication device (360).
  • Communication device (360) can be an NFC and/or a Bluetooth transmitter.
  • the NFC is configured to be scanned using a mobile device, for example, to indicate that a dose of a therapeutic composition has been administered with handheld aerosolization apparatus (300).
  • At least one processor (370) can, via communication with pressure sensor (330), detect airflow through mouthpiece (340), through measurement of pressure within interior of handheld aerosolization apparatus (300).
  • at least one processor (370) can receive first pressure data (relating to pressure within housing (310) of handheld aerosolization apparatus (300) from pressure sensor (330) at one or more times during administration of a dose (through inhalation), and can compare first pressure data to pressure outside of housing (310) (e.g., atmospheric pressure) to determine airflow through mouthpiece (340).
  • At least one processor (370) can receive first pressure data (relating to pressure within housing (310) of handheld aerosolization apparatus (300) from pressure sensor (330) at one or more times prior to administration of a dose (through inhalation), and second pressure data at one or more times during inhalation, and can compare first pressure data to second pressure data to determine airflow through mouthpiece (340).
  • first pressure data relating to pressure within housing (310) of handheld aerosolization apparatus (300)
  • second pressure data at one or more times during inhalation
  • handheld aerosol ization apparatus (300) can also include a puncturing mechanism (385) disposed within housing (310) and configured to puncture a capsule placed within interior of housing (310). Puncturing mechanism (385) can include one or more puncture points for producing one or more openings in a capsule.
  • Handheld aerosolization apparatus (300) can further include plunger (390).
  • Plunger (390) can extend from a proximal end of housing (310), and can be attached or integral with puncturing mechanism (385), allowing a user to control puncturing of a capsule by depressing plunger (390).
  • One or more springs (352, 354) arranged within housing (310) can be provided to resiliently bias plunger (390) in a proximally- extended position. A user can then depress plunger (390) against the bias of one or more springs (352, 354) to cause puncturing mechanism (385) to puncture a capsule placed within interior of housing (310).
  • one spring e.g., spring 352
  • another spring e.g., spring 354
  • depressing plunger (390) can have one or more steps in terms of force required to puncture a capsule.
  • a first part of depressing plunger (390) can require less force (e.g., be easier), and a second part of depressing plunger (390) can require greater force (e.g., be more difficult).
  • handheld aerosolization device 600
  • a handheld aerosolization apparatus 610
  • a storage case 800
  • Handheld aerosolization apparatus can include any feature described herein.
  • handheld aerosolization apparatus (610) includes a housing (620) having a proximal end, a distal end, and a sidewall therebetween defining an interior.
  • Housing (620) can include one or more air inlets (630) at a distal end thereof to allow flow of air from outside of the apparatus to a capsule chamber (635).
  • one or more air inlets (630) and capsule chamber (635) can be configured and dimensioned to produce a swirling airflow within capsule chamber (635).
  • Handheld aerosolization apparatus includes a mouthpiece (650) through which a user inhales an aerosolized therapeutic composition. Mouthpiece (650) can include a perforated member (660) that includes one or more openings therethrough, providing fluid connection between an aerosolized formulation outlet (670) and capsule chamber (635), and, thus, between mouthpiece (650) and capsule chamber (635).
  • handheld aerosol ization apparatus (610) includes a shield (680), which can cover one or more of air inlets (630) thereby preventing a user from covering air inlet(s) (630) and allowing flow of air from outside of handheld aerosol ization apparatus (610) and the interior (e.g., capsule chamber (635)).
  • Handheld aerosol ization apparatus further includes a puncturing mechanism (690), disposed within housing (610) and configured to puncture a capsule. Puncturing mechanism (690) can include one or more puncture points for producing one or more openings in a capsule.
  • Handheld aerosolization apparatus (610) can further include plunger (700).
  • Plunger (700) can extend from a proximal end of housing (620), and can be attached or integral with puncturing mechanism (690), allowing a user to control puncturing of a capsule by depressing plunger (700).
  • One or more springs (640, 645) arranged within housing (620) can be provided to resiliently bias plunger (700) in a proximally- extended position. A user can then depress plunger (700) against the bias of one or more springs (640, 645) to cause puncturing mechanism (690) to puncture a capsule in capsule chamber (635).
  • one spring e.g., spring 640
  • another spring e.g., spring 645
  • depressing plunger (700) can have one or more steps in terms of force required to puncture a capsule.
  • a first part of depressing plunger (700) can require less force (e.g., be easier), and a second part of depressing plunger (700) can require greater force (e.g., be more difficult).
  • handheld aerosolization apparatus (610) can also include an indicator (715), positioned, configured, and having functionality as described elsewhere herein.
  • components of handheld aerosolization apparatus can be formed of any useful material, such as plastic, metal, and the like.
  • spring(s) 640, 645
  • differing materials and differing spring arrangements e.g., winding rise angle
  • handheld aerosolization apparatus (610) can further include at least one processor (710). At least one processor (710) can be programmed or configured to perform any action described herein. Handheld aerosol ization apparatus (610) can further include memory (720) for storing, e.g., programming instructions to be executed by at least one processor (710), data relating to use of handheld aerosol ization apparatus (610), data relating to when one or more doses of a therapeutic composition are to be administered, and other like information, as described herein.
  • handheld aerosol ization device can include a storage case (800).
  • Storage case (800) can include a closed proximal end, an open distal end, and a sidewall therebetween defining an interior configured to hold handheld aerosol ization apparatus (610) therein.
  • Storage case (800) can be formed of any suitable material, and can include a cap (not shown) that can be detached and reattached to allow removal of handheld aerosolization apparatus (610) from storage case (800) by known mechanisms, such as threaded engagement, friction fit, and the like.
  • storage case (800) can include a communication device (810) arranged thereon. Communication device (810) can be arranged in any useful location on storage case (800).
  • communication device (810) is a nearfield communication device (NFC).
  • NFC is configured to be scanned using a mobile device, for example, to indicate that a dose of a therapeutic composition has been administered with handheld aerosolization apparatus (610).
  • communication device (810) is a Bluetooth transmitter.
  • At least one processor (710) of handheld aerosolization apparatus (610) can be in communication with communication device (810) arranged on storage case (800).
  • storage case (800) can include one or more user inputs (820, e.g., a user-actuable button).
  • One or more user inputs (820) can be in communication with communication device (810), and, in some embodiments, communication device (810) can be received within a user input (820), e.g., a housing associated with a button.
  • user input (820) and communication device (810) can be in communication with at least one processor (710) and/or with a computing device, to effect the functionality described herein.
  • one or more user inputs (820) can be used to indicate to processor (710) and/or a computing device that a user has administered a dose of a therapeutic composition, and such data (e.g., tobramycin dosing data) can be stored in memory (720).
  • data e.g., tobramycin dosing data
  • kits including a handheld aerosol ization apparatus as described herein.
  • kits can include an apparatus, one or more doses of a therapeutic composition (e.g., tobramycin), and instructions for operating the apparatus to administer the therapeutic composition.
  • a therapeutic composition e.g., tobramycin
  • the therapeutic composition is tobramycin
  • the instructions direct a user to inhale the therapeutic composition at a rate of less than or equal to 80 liters per minute for at least three seconds.
  • the one or more doses are provided in a blister pack.
  • Handheld aerosolization apparatus training device (400) can include any feature described herein, except that, in non-limiting embodiments or aspects, training device (400) does not include a puncturing mechanism and/or plunger (e.g., training device (400) is not capable of aerosolizing a therapeutic composition).
  • handheld aerosolization apparatus training device (400) includes a housing (410) having a proximal end, a distal end, and a sidewall therebetween defining an interior.
  • Housing (410) can include one or more air inlets (420) at a distal end thereof to allow flow of air from outside of the apparatus to a capsule chamber (480).
  • one or more air inlets (420) and capsule chamber (480) can be configured and dimensioned to produce a swirling airflow within capsule chamber (480) similar to airflow that would be present in a functioning device capable of aerosolizing a therapeutic composition, as described herein.
  • Handheld aerosolization apparatus training device (400) includes a mouthpiece (450) through which a user inhales. Mouthpiece (450) can include a perforated member (460) that includes one or more openings therethrough, providing fluid connection between an outlet (470) and capsule chamber (480), and, thus, between mouthpiece (450) and capsule chamber (480).
  • handheld aerosolization apparatus training device (400) includes a shield (490), which can cover one or more of air inlets (420), thereby preventing a user from covering air inlet(s) (420) and allowing flow of air from outside of handheld aerosol ization apparatus training device (400) and the interior (e.g., capsule chamber (480)).
  • Handheld aerosol ization apparatus training device (400) can further include plunger (495).
  • Plunger (495) can extend from a proximal end of housing (410).
  • One or more springs (430, 435) arranged within housing (410) can be provided to resiliently bias plunger (495) in a proximally-extended position. A user can then depress plunger (495) against the bias of one or more springs (430, 435) to simulate administration of a therapeutic composition.
  • One or more spring (430, 435) can be arranged and constituted as in handheld aerosol ization apparatuses described herein (e.g., different resilience).
  • Handheld aerosolization apparatus training device (400) can include a communication device (500).
  • communication device (500) is a near-field communication device (NFC).
  • communication device (500) is a Bluetooth transmitter.
  • handheld aerosolization apparatus training device (400) can further include at least one processor (510), in communication with communication device (500). At least one processor (510) can be programmed or configured to perform any tasks described herein. Handheld aerosolization apparatus training device (400) can further include memory (515) for storing, e.g., programming instructions to be executed by at least one processor (510) and/or data relating to use of handheld aerosolization apparatus training device (400). [00335] In non-limiting embodiments or aspects, handheld aerosolization apparatus training device (400) can include one or more user inputs (520), e.g., a user-actuable button, in communication with at least one processor (510).
  • user inputs 520
  • a user-actuable button in communication with at least one processor (510).
  • One or more user inputs (520) can be used, for example and without limitation, to indicate to processor (510) that a user is preparing to engage in a training session and/or has finished a training session.
  • user input (520) is arranged on housing (410).
  • user input (520) is arranged on a storage case that holds handheld aerosolization apparatus training device (400) (not shown).
  • handheld aerosolization apparatus training device (400) can include in the interior thereof a pressure sensor (440).
  • Pressure sensor (440) can be arranged anywhere within housing (410) of handheld aerosol ization apparatus (400).
  • pressure sensor (440) is arranged on plunger (495).
  • pressure sensor (440) is arranged within housing (410) such that pressure sensor (440) can detect pressure within housing (410) and outside of housing (410) (e.g., atmospheric pressure).
  • At least one processor (510) can, via communication with pressure sensor (440), detect airflow through mouthpiece (450), through measurement of pressure within interior of handheld aerosol ization apparatus training device (400).
  • at least one processor (510) can receive first pressure data (relating to pressure within housing (410) of handheld aerosolization apparatus training device (400) from pressure sensor (440) at one or more times during a training session (e.g., during inhalation)), and can compare first pressure data to pressure outside of housing (410) (e.g., atmospheric pressure) to determine airflow through mouthpiece (450).
  • At least one processor (510) can receive first pressure data (relating to pressure within housing (410) of handheld aerosolization apparatus training device (400) from pressure sensor (440) at one or more times prior to a training session begins), and second pressure data at one or more times during inhalation, and can compare first pressure data to second pressure data to determine airflow through mouthpiece (450).
  • first pressure data relating to pressure within housing (410) of handheld aerosolization apparatus training device (400) from pressure sensor (440) at one or more times prior to a training session begins
  • second pressure data at one or more times during inhalation
  • At least one processor (510) can compare the calculated airflow through mouthpiece (450) (as calculated by any method, including those described above) to a predetermined target airflow value, for example a target airflow value that is specific for a given therapeutic composition (examples for tobramycin provided in International Patent Application Publication No. WO 2020/163416), and, cause an indicator (540) to provide an audible, visual, and/or haptic indication that the calculated airflow is within and/or outside of a predetermined threshold difference from the target airflow.
  • a predetermined target airflow value for example a target airflow value that is specific for a given therapeutic composition (examples for tobramycin provided in International Patent Application Publication No. WO 2020/163416)
  • an indicator (540) to provide an audible, visual, and/or haptic indication that the calculated airflow is within and/or outside of a predetermined threshold difference from the target airflow.
  • indication as to the difference between calculated airflow and predetermined target airflow is provided in real-time (e.g., during a training session), and can provide an indication and/or instructions to increase or decrease inhalation (thus increasing or decreasing airflow through mouthpiece (450)).
  • indication is a colored light, e.g., green light when calculated airflow through mouthpiece (450) is within an acceptable range compared to target airflow and a red or orange colored light when calculated airflow is outside of an acceptable range compared to target airflow.
  • a determination that airflow through mouthpiece (450) is within or outside of an acceptable range is based on standards set by the International Society of Aerosol in Medicine/European Respiratory Society Task Force.
  • indication is an audible indication, including verbal instructions to increase or decrease inhalation.
  • at least one processor (510) is programmed or configured to transmit first pressure data, second pressure data, and/or calculated airflow through mouthpiece (450) to a computing device, for example through communication device (500).
  • At least one processor (510) causes indicator (540) to provide an indication that first pressure data, second pressure data, and/or calculated airflow data has successfully been transmitted or has not been successfully transmitted. In non-limiting embodiments or aspects, indication is provided until successful transmission of first pressure data, second pressure data, and/or calculated airflow data.
  • first pressure data, second pressure data, and/or calculated airflow data are stored in memory (515) for a predetermined period of time. In non-limiting embodiments or aspects, first pressure data, second pressure data, and/or calculated airflow data are deleted from memory (515) upon successful transmission.
  • communication device (500), at least one processor (510), and/or pressure sensor (440) are configured to sleep or hibernate between doses, and can be activated, or awakened, by, for example and without limitation, actuation of plunger (495), actuation of user input (520), an accelerometer (530), receipt of a communication from a computing device, and/or a predetermined time (e.g., a scheduled training session).
  • actuation of plunger (495) by a user awakens communication device (500), at least one processor (510), and/or pressure sensor (440).
  • a user awakens handheld aerosol ization apparatus training device (400) by picking up or moving the device with sufficient force to exceed a predetermined threshold detected by accelerometer (530) (e.g., 0.5 g, 1 g, 1.5 g, and/or 2 g, all values and subranges therebetween inclusive).
  • a predetermined threshold detected by accelerometer (530) (e.g., 0.5 g, 1 g, 1.5 g, and/or 2 g, all values and subranges therebetween inclusive).
  • Triggering events for awakening communication device (500), at least one processor (510), and/or pressure sensor (440) can also include a predetermined time, such as a predetermined interval or the time for a training session, a predetermined time for transmission of airflow data to a computing device, a predetermined time for assessing whether communication device (500) is paired to a computing device, and/or receipt of a query from a computing device, such as a request for airflow data.
  • awakening of communication device (500), at least one processor (510), and/or pressure sensor (440) triggers indicator (540) to provide an indication that handheld aerosol ization apparatus training device (400) is ready for use.
  • indication is a colored light, e.g., blue light.
  • training device (400) is configured to be usable fora limited period of time.
  • training device (400) can include a battery (not shown) with a charge configured to last for 1 week to 1 month, all values and subranges therebetween inclusive.
  • Battery (not shown) can be inaccessible and can be unable to be recharged by a user, thus, requiring the user to return the training device (400) to manufacturer or distributor, or disposing of training device (400).
  • FIG. 15 illustrates a non-limiting embodiment or aspect of a system (10000) that includes a user device (1000).
  • User device (1000) includes a processor (1020), and can include one or more of a communication device (1040), memory (1060), display (1080), and/or user input (1100).
  • user device (1000) is a computing device.
  • User device (1000) may communicate with other devices or systems through network (1010).
  • Processor (1020) can, in non-limiting embodiments or aspects, generate a graphical user interface (GUI) for display (1080).
  • GUI graphical user interface
  • GUI graphical user interface
  • GUI graphical user interface
  • GUI graphical user interface
  • user device (1000) may include a communication device (1040).
  • communication device (1040) is an NFC.
  • communication device (1040) is a Bluetooth transmitter. It is to be understood that user device (1000) may include, in addition to communication device (1040), one more additional communication devices for communicating with other devices or systems over network (1010), for example through cellular data, Ethernet, and/or Wi-Fi.
  • User device (1000) receives schedule data relating to administration of a therapeutic composition.
  • schedule data can be data relating to one or more times that a dose of the therapeutic composition is to be administered.
  • tobramycin e.g., tobramycin schedule data and/or tobramycin dosing data
  • aerosol ization apparatuses described herein can be useful for administering any aerosolized therapeutic composition, and systems and methods described herein can be useful for monitoring medication adherence for any therapeutic composition.
  • the schedule data is tobramycin schedule data.
  • Processor (1020) can also receive dosing data relating to one or more doses of a therapeutic composition administered to a patient.
  • the dosing data is tobramycin dosing data.
  • Tobramycin schedule data can be data relating to one or more times that a dose of tobramycin is to be administered.
  • Tobramycin dosing data can be data relating to one or more times that a dose of tobramycin was administered.
  • tobramycin schedule and dosing data can be received by the user device (1000) through user input (1100), for example by a user entering a schedule for taking one or more doses of tobramycin.
  • tobramycin schedule data can be received from a healthcare provider system (1180), for example based on a prescription written by a healthcare provider, from a remote database (1120), and/or from a pharmacy system (not shown), for example based on a prescription filled by that pharmacy.
  • therapeutic composition dosing data can be received from a device that delivers one or more therapeutic compositions to a user.
  • the therapeutic composition is tobramycin and the device is a handheld aerosol ization apparatus (1200), for example through communication device (1040) and a corresponding communication device provided on the handheld aerosol ization apparatus (1200).
  • the tobramycin schedule data and/or the tobramycin dosing data are stored in memory (1060) of user device (1000).
  • processor (1020) in response to receiving tobramycin schedule data, generates one or more alarms based on the tobramycin schedule data.
  • the tobramycin schedule data relates to a number of capsules to be administered
  • the tobramycin dosing data relates to a number of capsules administered using an aerosol ization apparatus, such as handheld aerosol ization apparatus (1200).
  • tobramycin schedule data is based on tobramycin cycle data.
  • a user may enter, with user input (1100), a first date, and, optionally, a first time at which a cycle of tobramycin administration is to begin, and user device (1000) can calculate a daily dosing schedule based thereon.
  • user device (1000) may prompt a user to enter tobramycin cycle data periodically, for example every 28 days.
  • user device (1000) may prompt a user to enter tobramycin dosing data periodically.
  • user device (1000) transmits tobramycin schedule data and/or tobramycin dosing data to one or more of a remote database (1120), healthcare provider system (1180), and/or a computing device associated with a caregiver (1160) for a user of user device (1000).
  • user device (1000) can generate one or more first alerts based on tobramycin schedule data.
  • the one or more first alerts can be configured to alert the user of user device (1000) that it is time to take a dose of tobramycin.
  • the alert can be a visual alert, displayed, for example, on display (1080), an audible alert, for example provided through a speaker (not shown) of user device (1000), and/or a haptic alert, generated by a haptic interface (not shown).
  • the one or more first alerts can be generated until a user actuates user input (1100), for example to enter tobramycin dosing data and/or indicating that a dose was administered, and/or until dosing data is received from handheld aerosol ization apparatus (1200).
  • the one or more first alerts can be generated until a predetermined amount of time has elapsed.
  • schedule data for medications that are not tobramycin, and/or activity data for treatment regimen(s) can be received by the user device (1000).
  • Non-tobramycin activity schedule data can be data relating to one or more times that a dose of medication is to be administered, data relating to one or more times a treatment is to be performed and/or administered, data relating to one or more times that a physiological parameter is to be measured, and/or data relating to one or more subjective assessments of a user’s condition.
  • non-tobramycin activity schedule data can be received by the user device (1000) through user input (1100), for example by a user entering a schedule for taking one or more doses of a non-tobramycin medication.
  • non-tobramycin activity schedule data can be received from a healthcare provider system (1180), for example, based on a prescription written by a healthcare provider or instructions for performing one or more exercises or therapies provided by a healthcare provider, from a remote database (1120), and/or from a pharmacy system (not shown), for example, based on a prescription filled by that pharmacy.
  • the non-tobramycin activity schedule data is stored in memory (1060) of user device (1000).
  • non-tobramycin activity schedule data is based on non-tobramycin activity cycle data.
  • user may enter, with user input (1100) a first date, and, optionally, a first time at which a cycle of administration of a non-tobramycin medication or therapy is to begin, and user device (1000) can calculate a daily dosing schedule based thereon.
  • User device (1000) may prompt a user to enter non-tobramycin activity cycle data periodically, for example every 28 days.
  • user device (1000) transmits non- tobramycin activity schedule data to one or more of a remote database (1120), healthcare provider system (1180), and/or a computing device associated with a caregiver (1160) for a user of user device (1000).
  • user device (1000) can generate one or more second alerts based on non-tobramycin activity schedule data.
  • the one or more second alerts can be configured to alert the user of user device (1000) that it is time to take a dose of a non-tobramycin medication, perform one or more therapies or exercises, and/or obtain and/or record one or more physiological or subjective assessments.
  • the alert can be a visual alert, displayed, for example, on display (1080), an audible alert, for example provided through a speaker (not shown) of user device (1000), and/or a haptic alert, generated by a haptic interface (not shown).
  • the one or more first alerts can be generated until a user actuates user input (1100), for example to enter tobramycin dosing data and/or indicating that a dose was administered and/or a therapy was performed, and/or until data is received from a monitoring device (1220).
  • Monitoring device (1220) can be one or more of a smart watch, activity tracker, other medical device (e.g., a pulse oximeter, spirometer, capnometer, heart rate monitor), and/or the like.
  • the one or more first alerts can be generated until a predetermined amount of time has elapsed.
  • user device (1000) can provide, for example through a speaker (not shown) or display (1080), instructions as to proper usage of a handheld aerosolization apparatus.
  • instructions are one or more images, one or more video clips, one or more sets of audio instructions, or the like.
  • user device (1000) can communicate with air quality monitoring system (1140), to receive air quality data for a geographic region in which the user resides and/or where the user device (1000) is located.
  • user device (1000) communicates location data to air quality monitoring system (1140), and receives air quality data based on the location data.
  • Location data may be based on data received by user device (1000) from a global positioning system (GPS) (not shown).
  • GPS global positioning system
  • user device (1000) displays, via display (1080), or provides an audible indication, of one or more metrics of air quality based on the air quality data.
  • user device (1000) can generate one or more third alerts based on the air quality date, for example, when the air quality data exceeds or falls below a predetermined threshold.
  • the alert can be a visual alert, displayed, for example, on display (1080), an audible alert, for example provided through a speaker (not shown) of user device (1000), and/or a haptic alert, generated by a haptic interface (not shown).
  • user device (1000) can, based on tobramycin schedule data and tobramycin dosing data, calculate tobramycin adherence data.
  • calculating adherence includes comparing tobramycin dosing data (e.g., a number of a doses of tobramycin administered for a given time period) to tobramycin schedule date (e.g., a number of doses of tobramycin that were scheduled to be administered during the given time period), and, based thereon, calculate a percentage of doses take and/or a percentage of doses missed.
  • user device (1000) can store the tobramycin adherence data for one or more time periods, display the tobramycin adherence data for one or more time periods, generate reports that can optionally be printed (such as reports in .PDF or .DOCX form), and/or transmit the tobramycin adherence data for one or more time periods to a remote database (1120), healthcare provider system (1180), a computing device associated with a caregiver (1160) for a user of user device (1000), and/or to a server associated with one or more online social networks.
  • user device (1000) can calculate, and optionally display, a number of consecutive doses administered (or missed).
  • the display includes, for each scheduled administration, indicia (e.g., a check mark or an ‘x’) denoting whether each capsule (or, more generically, a scheduled dose) was administered or missed.
  • indicia e.g., a check mark or an ‘x’
  • the display includes an indication that a nontobramycin medication or activity was completed or is incomplete.
  • user device (1000) determines that one or more doses of tobramycin were missed (e.g., if tobramycin dosing data is not received within a predetermined period of time from a scheduled dose)
  • user device (1000) can generate one or more fourth alerts and transmit, to a healthcare provider system (1180), and/or a computing device associated with a caregiver (1160) for a user of user device (1000), the one or more fourth alerts.
  • user device (1000) can, through communication device (1040), pair with a communication device associated with handheld aerosol ization apparatus and/or handheld aerosol ization training apparatus, as described herein.
  • user device (1000) can transmit tobramycin schedule data to handheld aerosol ization apparatus (1200) and/or receive tobramycin dosing data from handheld aerosol ization apparatus (1200).
  • user device (1000) can receive flow data relating to inhalation by a user of a handheld aerosol ization apparatus or training apparatus, for example aerosolization devices and training devices as described herein.
  • flow data can be pressure data, measured from within a cavity of handheld aerosolization apparatus by a pressure sensor arranged therein.
  • pressure data can include pressure from within a cavity of handheld aerosolization apparatus (1200) or training apparatus at a first time prior to initiation of inhalation, and at one or more second times during inhalation.
  • pressure data can include pressure from within a cavity of handheld aerosolization apparatus (1200) or training apparatus at one or more times during inhalation and atmospheric pressure.
  • user device (1000) can receive, from handheld aerosolization apparatus (1200) or training apparatus, flow data calculated from the pressure data.
  • user device (1000) calculates flow data based on the pressure data received from handheld aerosol ization apparatus (1200) or training apparatus.
  • user device (1000) can display the flow data and/or provide an indication of whether the flow data was acceptable or unacceptable.
  • a determination that airflow through mouthpiece (130) is within or outside of an acceptable range is based on standards set by the International Society of Aerosol in Medicine/European Respiratory Society Task Force.
  • user device (1000) can provide feedback based on the flow data.
  • feedback may be visual and/or audible (e.g., one or more indicia or audible cues instructing a user to inhale more quickly, more slowly, and/or more deeply).
  • Pressure data, flow data received from handheld aerosol ization apparatus (1200) or training apparatus and/or calculated by user device (1000), and feedback based on flow data can be stored in memory (1060), a report can be generated for optional printing (e.g., in .PDF or .DOCX form) and/or transmitted to a remote database (1120), healthcare provider system (1180), and/or a computing device associated with a caregiver (1160) for a user of user device (1000).
  • user device (1000) may receive, for example, through user input (1100), data relating to one or more symptoms of a disease or condition, such as CF.
  • Symptom data such as CF symptom data
  • CF symptom data can be stored in memory (1060) and/or transmitted to a remote database (1120), healthcare provider system (1180), and/or a computing device associated with a caregiver (1160) for a user of user device (1000).
  • user device (1000) can transmit one or more messages to and receive one or more messages from healthcare provider system (1180), for example, messages relating to medication adherence, air quality, symptom data, physiologic parameters (e.g., oxygen saturation level, pulse, blood pressure, etc.) and the like.
  • healthcare provider system (1180) for example, messages relating to medication adherence, air quality, symptom data, physiologic parameters (e.g., oxygen saturation level, pulse, blood pressure, etc.) and the like.
  • healthcare provider system (1180) can include a computing device having least one processor, memory, and a communication device enabling communication between healthcare provider system and a plurality of user devices, e.g. user device (1000) for various patients.
  • a computing device having least one processor, memory, and a communication device enabling communication between healthcare provider system and a plurality of user devices, e.g. user device (1000) for various patients.
  • Healthcare provider system can receive adherence data, airflow data, air quality data, symptom data, and/or data relating to one or more physiologic parameters from one or more user devices, and, with the at least one processor included in the healthcare provider system (1180), can be programmed or configured to generate one or more reports showing, e.g., current and/or historical (for one or more time periods) medication adherence, airflow data, physiologic parameters, environmental (e.g., air quality), and/or symptom data for one or more users.
  • Healthcare provider system (1180) can also be programmed to automatically follow up, for example, through an alert generated for a healthcare provider and/or an alert transmitted to a user device, with any user in response to receipt of data showing adherence below a certain threshold, airflow outside of an acceptable range, symptom data and/or physiological parameters indicative of a medical problem, and/or any user device for which no data has been received for a predetermined time period.
  • Alerts provided by healthcare provider system (1180) can take the form of text messages, automated voice calls, electronic mail, and/or a notification sent to a computing device associated with a healthcare professional, a computing device (e.g., user device, (1000)) associated with a patient, and/or a computing device associated with a patient’s caregiver (e.g., device (1160)).
  • Healthcare provider system (1180) can also provide an interface for a healthcare provider to review and assess a patient’s history (including data received from user device, e.g.
  • user device (1000) and/or the patient’s electronic medical record read and respond to messages (e.g., text messages, electronic mail messages) received from a user device (e.g., user device, (1000)), enter notes relating to the patient, and schedule reminders and follow ups.
  • messages e.g., text messages, electronic mail messages
  • FIG. 16 shown is a flowchart of a computer-implemented method for monitoring medication adherence (20000).
  • the method includes the steps of receiving tobramycin schedule data (2020).
  • at least one processor as described herein can generate one or more alarms to indicate to a user that a dose of tobramycin is to be administered.
  • at least one processor, as described herein can receive tobramycin dosing data. Further steps of a computer-implemented method are described above with reference to FIG. 15.
  • a user makes use of a handheld aerosol ization apparatus training device, with a mobile application running on a mobile device, to train for administration of an inhaled therapeutic composition.
  • the user opens a mobile application on their mobile device and depresses the plunger on the handheld aerosol ization apparatus training device to activate the processor, pressure sensor, and/or communication device.
  • the pressure sensor Upon being activated, the pressure sensor begins monitoring pressure in the housing of the handheld aerosol ization apparatus training device.
  • the user exhales, then, through mouthpiece, inhales and holds their breath.
  • pressure sensor provides pressure data to processor, or, with communication device, to mobile application on mobile device, and processor (in training device or mobile device) calculates airflow through mouthpiece based on that pressure data.
  • Airflow data calculated by processor can be stored in memory on the training device and/or transmitted to mobile device, where it can be viewed, transmitted to a healthcare professional, and/or stored in memory.
  • a user makes use of a handheld aerosol ization apparatus, optionally with a mobile application running on a mobile device, to administer four capsules of tobramycin.
  • the user receives a reminder from a mobile device running a mobile application, as described herein, or from handheld aerosol ization apparatus, as described herein.
  • the user retrieves their tobramycin, for example, from a blister pack, and places a capsule in the capsule chamber by removing the mouthpiece/shield, exposing the capsule chamber.
  • the mouthpiece/shield is then reattached and the user presses the plunger to pierce the capsule, thereby activating the processor, pressure sensor, and/or communication device.
  • the pressure sensor Upon being activated, the pressure sensor begins monitoring pressure in the housing of the handheld aerosol ization apparatus.
  • Airflow data calculated by processor can be stored in memory and/or transmitted to mobile device, where it can be viewed, transmitted to a healthcare professional, and/or stored in memory.
  • airflow through mouthpiece can be calculated as a difference in pressure in a cavity within the apparatus or training device, and pressure outside of the apparatus or training device.
  • airflow is determined empirically for each individual device. For example, at each airflow rate, the change in pressure within the device can be measured, and a table generated. Using this table of airflow versus pressure, a line of best fit (e.g., based on a second-order polynomial) can be determined that would provide an approximation for a processor to utilize in determining airflow during inhalation. Based on this equation, an airflow inhalation pattern is generated. This is shown in FIGS. 17A-17E as the variable trace.
  • FIGS. 17A-17E show various acceptable (FIG. 17A) and unacceptable (FIGS. 17B-17E) airflow inhalation patterns. Based on the comparison, feedback can be provided through the mobile application, and, optionally, instructions in the form of audible instructions, images, and/or videos can be provided to aid the user.

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  • Medicinal Chemistry (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un procédé mis en œuvre par ordinateur permettant de surveiller l'observance thérapeutique, comprenant des étapes consistant à recevoir, avec au moins un processeur, des données de planification de composition thérapeutique, les données de calendrier de composition thérapeutique comprenant des données relatives à une ou plusieurs fois qu'une dose d'une composition thérapeutique doit être administrée, générer, avec au moins un processeur et sur la base des données de planification de composition thérapeutique, une ou plusieurs alertes, et recevoir, avec au moins un processeur, des données de dosage de composition thérapeutique, les données de dosage de composition thérapeutique comprenant des données relatives à une ou plusieurs fois qu'une dose de la composition thérapeutique a été administrée.
PCT/US2021/044336 2020-08-05 2021-08-03 Inhalateur et interface associée WO2022031698A1 (fr)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004097617A (ja) * 2002-09-11 2004-04-02 Canon Inc 吸入装置および該吸入装置の制御方法
KR20110035424A (ko) * 2009-09-30 2011-04-06 노아테크놀로지(주) 주기적으로 복용하는 약 복용 보조장치
KR20150025353A (ko) * 2013-08-29 2015-03-10 삼성전자주식회사 약제 흡입기
US20150100335A1 (en) * 2012-06-25 2015-04-09 Gecko Health Innovations, Inc Devices, Systems, and Methods for Adherence Monitoring and Patient Interaction
US20150112707A1 (en) * 2013-10-19 2015-04-23 CoheroHealth, LLC Interactive respiratory device usage tracking system
US20160354562A1 (en) * 2015-06-03 2016-12-08 Microdose Therapeutx, Inc. Medical device notification system

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004097617A (ja) * 2002-09-11 2004-04-02 Canon Inc 吸入装置および該吸入装置の制御方法
KR20110035424A (ko) * 2009-09-30 2011-04-06 노아테크놀로지(주) 주기적으로 복용하는 약 복용 보조장치
US20150100335A1 (en) * 2012-06-25 2015-04-09 Gecko Health Innovations, Inc Devices, Systems, and Methods for Adherence Monitoring and Patient Interaction
KR20150025353A (ko) * 2013-08-29 2015-03-10 삼성전자주식회사 약제 흡입기
US20150112707A1 (en) * 2013-10-19 2015-04-23 CoheroHealth, LLC Interactive respiratory device usage tracking system
US20160354562A1 (en) * 2015-06-03 2016-12-08 Microdose Therapeutx, Inc. Medical device notification system

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