Dose Counter and Recording Method

• US 20110041845A1
• Filed: 08/12/2010
• Published: 02/24/2011
• Est. Priority Date: 08/18/2009
• Status: Active Grant

• Current Assignee: Teva Pharmaceutical Industries Limited
• Original Assignee: Teva Pharmaceutical Industries Limited
• Inventors: Solomon, Ian, Goldhirsh, Moti
• Granted Patent: US 8,539,945 B2
• Time in Patent Office: Days
• US Class Current: 128/203.12
• 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 2205/332 Force measuring means
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

A dose counter for a metered dose inhaler includes a force sensor, an electronic controller, a memory for storing data indicative of a remaining number of doses and an electronic display device coupled to the controller for displaying the remaining number of doses. The dose counter is attached or integrated into a base of a canister containing medicament such that force applied to the base of the canister is registered by the force sensor, the controller being configured to measure force applied to the dose counter when depressing the canister and being responsive to measured force to decrement the remaining number of doses stored in the memory and shown on the display device.

Claims

1. A dose counter for a metered dose inhaler comprising a force sensor, an electronic controller, a memory for storing data indicative of a remaining number of doses and an electronic display device coupled to the controller for displaying the remaining number of doses, said dose counter being attached or otherwise integrated into a base of a canister containing medicament such that force applied to the base of the canister is registered by the force sensor, said controller being configured to measure force applied to said dose counter when depressing said canister and being responsive to measured force to decrement the remaining number of doses stored in the memory and shown on said display device.

2. The dose counter of claim 1 where said force sensor belongs to the group including force sensitive resistors, piezoelectric sensors, strain gauges, and MEMS-based sensing technologies for measuring strain and capacitance.

3. The dose counter of claim 1 where said dose counter is fabricated as a multi-layer “

sandwich”

type product.

4. The dose counter of claim 1 further comprising at least one icon showing the status of the metered dose inhaler in regard of the number of doses remaining.

5. The dose counter of claim 1 further comprising at least one icon showing the status of the metered dose inhaler in regard of the need to take the next dose.

6. The dose counter of claim 1 further comprising means to download data showing the dose history of the inhaler.

7. The dose counter according to claim 1, further comprising an internal clock which is set to an absolute time at time of manufacture, assembly or distribution.

8. The dose counter according to claim 1, comprising a controller and a power saving means including but not limited to a switch activated during the initial depression action of said canister, said switch activating the controller.

9. The dose counter of claim 1, further including an internal clock for associating with each dose a respective time-stamp indicating an absolute time adjusted to a local time reference when the dose was administered, the controller being adapted to record and upload to an external device coupled to the dose counter a time-stamped dose history for allowing the external device to determine the absolute time when each dose was administered.

10. The dose counter of claim 1, further including an internal clock for associating with each dose a respective time-stamp indicating a time interval between doses, the controller being adapted to record and upload to an external device coupled to the dose counter a time-stamped dose history for allowing the external device to determine relative times between doses within the memory of the dose counter and to map these relative time-stamps to local time, in order to time-stamp the dose history uploaded to the external device.

17. The dose counter of claim 1 wherein there is a specific recommendation in the prescribing information to the medical practitioner to verify the compliance of a patient to an existing MDI medication regimen prior to prescribing a different medication regimen.

11. A method for facilitating monitoring by a medical practitioner of adherence by a patient to a medication regimen requiring administering to the patient at least two drugs using more than a single metered dose inhaler, said method comprising:

recording in a memory of each inhaler dosage data indicative of actual dosage including for each dose administered to the patient a time-stamp permitting determination by the medical practitioner of an actual time;

coupling each of the metered dose inhalers to a computer of the medical practitioner for downloading said dosage data to said computer; and

presenting the respective dosage data from each of the inhalers in a form that allows a unified picture thereof.

12. The method according to claim 11, wherein presenting the respective dosage data includes displaying the data graphically on a common time axis.

13. The method of claim 11 wherein coupling the metered dose inhaler to a computer includes coupling via an IP network.

14. The method of claim 13, wherein the IP network is the Internet.

15. The method of claim 11, including associating with the metered dose inhaler a recommendation to the medical practitioner to verify compliance by the patient to an existing MDI medication regimen prior to prescribing a different medication regimen.

16. The method according to claim 15, wherein associating said recommendation with the metered dose inhaler includes adding to the metered dose inhaler package instructions bearing said recommendation.

18. A method for minimizing risk of a medical practitioner prescribing a change of drug treatment administered via a metered dose inhaler to a patient whose poor response to an existing medication regimen is due to his or her non-compliance with a current medication regimen, said method comprising:

coupling a memory of the metered dose inhaler to a computer for downloading dosage data stored in said memory to computer, said dosage data being indicative of actual dosage administered to the patient including for each dose administered to the patient a time-stamp permitting determination by the medical practitioner of an actual time adjusted to a local time reference;

determining from the dosage data whether the patient has complied with a current medication regimen; and

associating with the metered dose inhaler a recommendation to the medical practitioner to verify compliance by the patient to an existing MDI medication regimen prior to prescribing a different medication regimen.

19. A metered dose inhaler (MDI) comprising:

a canister and a memory for storing dosage data indicative of actual dosage administered to the patient including for each dose administered to the patient a time-stamp permitting determination by the medical practitioner of an actual time adjusted to a local time reference, and

prescribing information attached to or otherwise associated with the canister that includes a recommendation to the medical practitioner to verify the compliance of a patient to an existing MDI medication regimen prior to prescribing a different medication regimen.