Instrumented metered-dose inhaler and methods for predicting disease exacerbations

• US 8,342,172 B2
• Filed: 02/03/2008
• Issued: 01/01/2013
• 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: Levy, Bruce D., Singer, Michael S.
• Primary Examiner(s): RICHMAN, GLENN E
• Application Number:
  US12/525,540
• Publication Number:
  US 20100094099A1
• Time in Patent Office: 1,794 Days
• Field of Search: 12820011-20024, 128/202.13, 12820314-20315, 700/281, 700/275
• US Class Current: 128/200.23
• 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. 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.

2. The metered dose inhaler of claim 1, 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.

3. The metered dose inhaler of claim 2, 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.

4. The metered dose inhaler of claim 3, wherein a medication reservoir installed in the medication reservoir compartment serves as the movable part.

5. The metered dose inhaler of claim 4, wherein the dose-dispensing sensor comprises a mechanical pressure switch that is activated when depressed.

6. The metered dose inhaler of claim 5, 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.

7. The metered dose inhaler of claim 1, wherein the wireless transmitter is a cellular network wireless transmitter.

8. The metered dose inhaler of claim 1, further comprising a microprocessor connected between the dose-dispensing sensor and the wireless transmitter.

9. The metered dose inhaler of claim 8, 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.

10. The metered dose inhaler of claim 1, wherein the inhaler portion nests within the sensor/transmitter portion.

11. The metered dose inhaler of claim 1, wherein the sensor/transmitter portion is releasably secured to the inhaler portion.

12. The metered dose inhaler of claim 6, wherein the wireless transmitter is a cellular network wireless transmitter.

13. The metered dose inhaler of claim 6, further comprising a microprocessor connected between the dose-dispensing sensor and the wireless transmitter.

14. The metered dose inhaler of claim 13, 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.

15. The metered dose inhaler of claim 14, wherein the inhaler portion nests within the sensor/transmitter portion.

16. The metered dose inhaler of claim 14, wherein the sensor/transmitter portion is releasably secured to the inhaler portion.