Instrumented Metered-Dose Inhaler and Methods for Predicting Disease Exacerbations

• US 20100094099A1
• Filed: 02/03/2008
• Published: 04/15/2010
• Est. Priority Date: 02/05/2007
• Status: Active Grant

• Current Assignee: Brigham and Women's Hospital Incorporated
• Original Assignee: Brigham and Women's Hospital Incorporated
• Inventors: Singer, Michael S., Levy, Bruce D.
• Granted Patent: US 8,342,172 B2
• Time in Patent Office: Days
• US Class Current: 600/300
• CPC Class Codes: A61M 11/04 operated by the vapour pressure of the liquid to be sprayed or atomised air-humidification, e.g. "room humidifiers" F24F6/00
• CPC Class Codes: A61M 15/0028 using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
• CPC Class Codes: A61M 15/0065 Inhalators with dosage or measuring devices A61M15/0028 takes precedence; dosage devices incorporated in aerosol cans B65D83/52
• CPC Class Codes: A61M 15/008 Electronic counters
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

The present invention is directed to devices, systems, and methods for monitoring inhaled drug usage to predict when an acute attack or exacerbation of a disease, such as a respiratory disease, is imminent. Instrumented inhalers that use modular designs with standard components are disclosed, as are systems for monitoring the instrumented inhalers. Also disclosed are methods for determining whether or not a patient'"'"'s inhaled drug usage pattern indicates that an acute attack or disease exacerbation is imminent, and notifying appropriate medical personnel of any usage patterns indicative of an attack or disease exacerbation. If such an attack or exacerbation is imminent, additional therapeutic agents may be dispensed to the patient or other interventions made.

Claims

1-20. -20. (canceled)

21. A metered dose inhaler, comprising:

a) an inhaler portion including;

i) a medication reservoir compartment constructed and adapted to engage a medication reservoir or to contain medication;

ii) a mouthpiece; and

iii) a flow pathway opening into and connecting the medication reservoir compartment and the mouthpiece so as to deliver a metered dose of a medication from the medication reservoir compartment to the mouthpiece when the inhaler portion is actuated to dispense a metered dose of the medication; and

b) a sensor/transmitter portion including;

i) a dose-dispensing sensor positioned external to the inhaler portion, the dose-dispensing sensor being coupled to the inhaler portion such that when the inhaler portion is actuated to dispense the dose of the medication, the dose-dispensing sensor establishes a signal in response thereto; and

ii) a wireless transmitter connected to the dose-dispensing sensor, the wireless transmitter being constructed and arranged to accept the signal from the dose-dispensing sensor and transmit a signal indicating that a dose has been dispensed to a remote station.

22. The metered dose inhaler of claim 21, wherein the inhaler portion further comprises a movable part constructed and arranged to move between:

(1) a dispensing position in which the inhaler portion is actuated to dispense a dose of the medication; and

(2) a non-dispensing position in which medication does not flow from the medication reservoir compartment into the mouthpiece, the movable part being biased toward the non-dispensing position.

23. The metered dose inhaler of claim 21, further comprising a coupling element connected to the movable part, the coupling element being constructed and arranged to couple the dose-dispensing sensor to the movement of the movable part such that the dose-dispensing sensor is activated when the movable part moves into the dispensing position.

24. The metered dose inhaler of claim 23, wherein a medication reservoir installed in the medication reservoir compartment serves as the movable part.

25. The metered dose inhaler of claim 24, wherein the dose-dispensing sensor comprises a mechanical pressure switch that is activated when depressed.

26. The metered dose inhaler of claim 25, wherein the coupling element comprises a cap or lip secured to the medication reservoir such that the cap or lip will contact and depress the dose-dispensing sensor when the medication reservoir is in the depressed, dispensing position.

27. The metered dose inhaler of claim 21, wherein the wireless transmitter is a cellular network wireless transmitter.

28. The metered dose inhaler of claim 21, further comprising a microprocessor connected between the dose-dispensing sensor and the wireless transmitter.

29. The metered dose inhaler of claim 28, wherein:

a) the microprocessor controls the wireless transmitter to transmit the signal indicating that the dose has been dispensed at a predetermined interval of time after the dose has been dispensed; and

b) the signal indicating that the dose has been dispensed comprises the amount of the dose or number of times that the inhaler portion was actuated, and the time that the dose was dispensed.

30. The metered dose inhaler of claim 21, wherein the inhaler portion nests within the sensor/transmitter portion.

31. The metered dose inhaler of claim 21, wherein the sensor/transmitter portion is releasably secured to the inhaler portion.

32. A system for predicting disease exacerbations based on inhaled drug usage patterns, comprising:

a) one or more inhalers, each of the one or more inhalers being adapted to dispense a dose of a first therapeutic agent to a patient, and to transmit information regarding the dispensing of the dose wirelessly; and

b) a monitoring system in communication with the one or more inhalers, the monitoring system being operable to record and associate the information from the one or more inhalers with patient records;

wherein;

1) either or both of the one or more inhalers and the monitoring system are adapted to analyze the information to determine whether the inhaled drug usage patterns established by the information are exacerbation patterns indicative of an imminent disease exacerbation; and

2) the monitoring system is adapted to notify medical personnel of patient conditions, including any exacerbation patterns.

33. A method for predicting disease exacerbations based on inhaled drug usage patterns, comprising:

a) collecting data on usage of a first inhaled therapeutic agent by a patient essentially in real time as doses of the first inhaled therapeutic agent are dispensed;

b) analyzing the data to determine whether an exacerbation pattern indicative of an imminent disease exacerbation exists; and

c) notifying medical personnel of any exacerbation pattern.

34. The method of claim 33, wherein the first inhaled therapeutic agent is a short acting bronchodilator.

35. The method of claim 34, wherein the short acting bronchodilator is selected from the group consisting of albuterol;

bitolterol mesylate;

levalbuterol;

metaproterenol sulfate;

pirbuterol acetate; and

terbutaline sulfate.

36. The method of claim 33, further comprising causing or allowing a patient to receive a second therapeutic agent if the analysis indicates an exacerbation pattern.

37. The method of claim 36, wherein the second therapeutic agent is selected from the group consisting of:

salmeterol;

formoterol;

bambuterol;

beclomethasone;

budesonide;

flunisolide;

fluticasone;

triamcinolone;

cromolyn;

nedocromil;

montelukast;

zafirlukast;

zileuton;

prednisolone;

prednisone;

omalizumab;

methylprednisolone; and

theophyline.

38. The method of claim 33, wherein an exacerbation pattern comprises one or more conditions selected from the group consisting of:

a) increased usage of the first inhaled therapeutic agent;

b) nocturnal usage of the first inhaled therapeutic agent; and

c) increased frequency of use of the first therapeutic agent.

39. The method of claim 33, further comprising notifying the patient of any exacerbation patterns.

40. The method of claim 33, wherein said method is performed using machine-readable instructions on a machine-readable medium interoperable with one or more machines.