Data-enabled pharmaceutical container and methods for using same

• US 9,514,282 B2
• Filed: 01/19/2016
• Issued: 12/06/2016
• Est. Priority Date: 10/01/2013
• Status: Active Grant

• Current Assignee: Dosecue, LLC
• Original Assignee: Dosecue, LLC
• Inventors: Burrows, Mark, Eckhaus, Neal, Grube, Donald, Christoffersen, George
• Primary Examiner(s): WAGGONER, TIMOTHY R
• Application Number:
  US15/000,409
• Publication Number:
  US 20160136055A1
• Time in Patent Office: 322 Days
• Field of Search: 221/15
• US Class Current: 1/1
• CPC Class Codes: A61J 1/16 Holders for containers
• CPC Class Codes: A61J 7/0418 with electronic history memory
• CPC Class Codes: A61J 7/0436 resulting from removing a drug from, or opening, a container
• CPC Class Codes: A61J 7/0454 for dispensing of multiple drugs
• CPC Class Codes: A61J 7/049 automatically changing in response to a schedule deviation by the patient
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/13 delivered from dispensers

Abstract

A data-enabled pharmaceutical container and methods for reminding at dose time, then tracking and communicating valid dose events and/or dose exception events are disclosed. Examples of dose exception events include, but are not limited to, missed doses, extra doses, early doses, and late doses. The data-enabled pharmaceutical container includes control electronics for processing and communicating information about valid dose events and/or dose exception events. For example, using a dose detection algorithm, a dose event is deemed valid based on (1) sensing the open state of the data-enabled pharmaceutical container (e.g., sensing that the closure is not present), (2) sensing a certain orientation or tilt of the data-enabled pharmaceutical container, and (3) sensing that the data-enabled pharmaceutical container is both opened and tilted simultaneously for a certain amount of time (e.g., a few seconds).

Claims

1. A method of determining a valid dose event using a data-enabled pharmaceutical container, the method comprising:

a) providing a data-enabled pharmaceutical container comprising;

i) a pharmaceutical container comprising

1.) a container body;

2.) a container neck; and

3.) a container closure, wherein the container body is configured as a reservoir for holding a quantity of medication, the container neck comprises an opening for dispensing the medication from the container body, and wherein the container closure is configured to secure the container neck opening; and

ii) an electronics module configured for sensing and tracking dose events coupled to the pharmaceutical container, wherein the electronics module comprises a housing, one or more indicators, one or more switches, and one or more sensors, and wherein one of the one or more sensors comprises a movable lever, and wherein the movable lever extends through an opening in the housing and toward the container neck, wherein the movable lever is part of a mechanism for sensing whether the container closure is present at or absent from the container neck, and wherein the movable lever is configured such that when the container closure is present on the container neck an edge of the container closure is in contact with a tip of the movable lever causing the movable lever to be in a first position, and when the container closure is not present on the container neck the edge of the container closure does not contact the tip of the movable lever causing the movable lever to be in a second position;

b) monitoring the data-enabled pharmaceutical container for pre-defined valid dose event criteria;

c) determining whether the data-enabled pharmaceutical container has met the pre-defined criteria for the valid dose event; and

d) recording the valid dose event upon determining the pre-defined criteria for the valid dose event is met.

2. The method of claim 1 wherein the electronics module comprises a printed circuit board (PCB) assembly housed within the housing, the PCB assembly comprising a PCB.

3. The method of claim 1 wherein determining whether the data-enabled pharmaceutical container has met the pre-defined criteria for the valid dose event comprises one or more of determining if the data-enabled pharmaceutical container is in an opened state, determining whether the data-enabled pharmaceutical container has met a defined tilt criteria, and determining whether the data-enabled pharmaceutical has met a defined time criteria.

4. The method of claim 3 wherein the pre-defined criterion for the valid dose event comprises the data-enabled pharmaceutical container being in an opened state and the data-enabled pharmaceutical container exceeding a defined tilt threshold criterion for a defined period of time.

5. The method of claim 1 further comprising detecting, tracking, and communicating data regarding valid dose events and/or dose exception events.

6. The method of claim 1 wherein monitoring the data-enabled pharmaceutical container for pre-defined valid dose event criteria comprises, the electronics module continuously monitoring the state of the one or more switches and sensors, and time of a real-time clock in relation to a patient'"'"'s defined dosing regimen.

7. The method of claim 1 further comprising detecting, tracking, and communicating data regarding a patient'"'"'s actual dose information.

8. A method of using a data-enabled pharmaceutical container for reminding at dose time, then tracking and communicating valid dose events and/or dose exception events, the method comprising:

a) preparing the data-enabled pharmaceutical container for use wherein the data-enabled pharmaceutical container comprises;

i) a pharmaceutical container comprising

1.) a container body;

2.) a container neck; and

3.) a container closure, wherein the container body is configured as a reservoir for holding a quantity of medication, the container neck comprises an opening for dispensing the medication from the container body, and wherein the container closure is configured to secure the container neck opening; and

ii) an electronics module configured for sensing and tracking dose events coupled to the pharmaceutical container, wherein the electronics module comprises a housing, one or more indicators, one or more switches, and one or more sensors, and wherein one of the one or more sensors comprises a movable lever, and wherein the movable lever extends through an opening in the housing and toward the container neck, wherein the movable lever is part of a mechanism for sensing whether the container closure is present at or absent from the container neck, and wherein the movable lever is configured such that when the container closure is present on the container neck an edge of the container closure is in contact with a tip of the movable lever causing the movable lever to be in a first position, and when the container closure is not present on the container neck the edge of the container closure does not contact the tip of the movable lever causing the movable lever to be in a second position;

b) monitoring valid dose event criteria and medication adherence;

c) determining whether a valid dose event has occurred; and

d) recording actual dose event data.

9. The method of claim 8 wherein preparing the data-enabled pharmaceutical container for use comprises one or more of programming a patient'"'"'s dosing regimen into a processor of the data-enabled pharmaceutical container;

loading updates into the processor of the data-enabled pharmaceutical container;

retrieving stored dose event data;

setting or resetting a real-time clock of the data-enabled pharmaceutical container;

checking diagnostics of the data-enabled pharmaceutical container;

filling the data-enabled pharmaceutical container with medication; and

labeling the data-enabled pharmaceutical container.

10. The method of claim 9 wherein monitoring valid dose event criteria and medication adherence comprises the processor receiving and interpreting data from one or more of the patient'"'"'s dosing regimen;

a dose detection algorithm;

the real-time clock;

whether and when valid dose events occur and whether they are in compliance with/adherent to dosing instructions stored in the patient'"'"'s dosing regimen.

11. The method of claim 10 wherein the one or more indicators are capable of being monitored by the patient.

12. The method of claim 11 wherein the one or more indicators are one or more of visual and audible.

13. The method of claim 11 wherein the one or more indicators are configured to indicate to the patient at least one of, time to take a dose, a dose has been missed, and time for a prescription refill.

14. The method of claim 8 further comprising transmitting data from the data-enabled pharmaceutical container to an external computing device using a communications interface.

15. The method of claim 11 further comprising following an actual dose event, deactivating any previously activated indicators and activating an applicable indicator according to the patient'"'"'s dosing regimen and recording the actual dose event data.

16. The method of claim 14 wherein data from the data-enabled pharmaceutical container is transmitted to one or more of the patient, caretaker, and an authorized party via the communications interface.

17. The method of claim 15 wherein if the recorded actual dose event is a missed dose event according to the patient'"'"'s dosing regimen the one or more indicators indicate a missed dose, and if the recorded actual dose event is a valid dose event according to the patient'"'"'s dosing regimen the one or more indicators indicate a taken dose, and the applicable actual dose event is recorded.

18. The method of claim 8 further comprising determining whether a prescription refill is needed based on a number of valid dose events as compared to the recorded actual dose data and the patient'"'"'s dosing regimen.

19. The method of claim 18 wherein if it is determined a prescription refill is needed the one or more indicators indicate a prescription refill is needed.

20. The method of claim 19 wherein a prescription refill notice is sent to one or more of the patient, a pharmacy, and any other caretaker or authorized party via a communications interface.