DATA-ENABLED PHARMACEUTICAL CONTAINER AND METHODS FOR USING SAME

• US 20150095047A1
• Filed: 10/01/2013
• Published: 04/02/2015
• Est. Priority Date: 10/01/2013
• Status: Active Grant

• Current Assignee: Dosecue, LLC
• Original Assignee: Dosecue, LLC
• Inventors: Burrows, Mark, Eckhaus, Neal, Christoffersen, George, Grubbe, Donald
• Granted Patent: US 9,460,265 B2
• Time in Patent Office: Days
• US Class Current: 705/2
• 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 data-enabled pharmaceutical container, comprising:

a) a pharmaceutical container; and

b) an electronics module configured for sensing and tracking dose events coupled to the pharmaceutical container.

2. The container of claim 1 wherein the pharmaceutical container comprises:

a container body;

a container neck; and

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 the container closure is configured to secure the container neck opening.

3. The container of claim 2 wherein medication comprises pills, capsules, or caplets.

4. The container of claim 2 wherein the electronics module comprises a housing and a printed circuit board (PCB) assembly housed therein, the PCB assembly comprising a PCB;

one or more indicators, one or more switches; and

one or more sensors.

5. The container of claim 4 wherein the one or more sensors comprise active and/or passive sensors.

6. The container of claim 4 wherein at least one of the sensors are configured to sense one or more of a presence or absence of the container closure and an orientation or tilt of the pharmaceutical container.

7. The container of claim 4 wherein the electronics module further comprises electrical components for processing data from the sensors with respect to a patient'"'"'s predefined dosing regimen, and for storing and communicating data about doses taken, doses missed, extra doses, early doses, and/or late doses.

8. The container of claim 4 wherein one of the one or more sensors comprises a movable lever.

9. The container of claim 8 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.

10. The container of claim 9 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.

11. The container of claim 10 wherein one of the one or more switches of the PCB assembly comprises a momentary contact switch and wherein the movable lever in one of the first and second positions engages an actuator of the momentary contact switch.

12. The container of claim 11 wherein the movable lever and the momentary contact switch provide the sensing mechanism for determining whether the container closure of pharmaceutical container is in an opened or closed state, wherein when the container closure is present and in contact with the tip of the movable lever, a portion of the movable lever is pushed against the actuator of the momentary contact switch, and the momentary contact switch is in one state, and when the container closure is not present and not in contact with the tip of the movable lever, the movable lever is not pushed against the actuator of the momentary contact switch, and the momentary contact switch is in another state.

13. The container of claim 2 wherein the electronics module is coupled to the pharmaceutical container, such that there is no contact between the electronics module and the medication therein.

14. The container of claim 13 wherein the electronics module is coupled to the container body using a sleeve, wherein the sleeve affixes the electronics module to the container body.

15. The container of claim 1 wherein the pharmaceutical container comprises an integrated pharmaceutical container, wherein the pharmaceutical container comprises a compartment for housing the electronics module.

16. The container of claim 15 wherein the pharmaceutical container further comprises a battery compartment.

17. The container of claim 4 wherein the electronics module comprises control electronics comprising a communications interface;

a processor;

a real-time clock;

a contact switch;

a tilt sensor; and

the one or more indicators.

18. The container of claim 17 wherein the processor comprises data storage for storing one or more of a patient'"'"'s dosing regimen;

a dose detection algorithm; and

actual dose data.

19. The container of claim 17 wherein the control electronics are configured for providing a reminder at dose time, detecting valid dose events, and processing and communicating data about dose events and/or dose exception events.

20. The container of claim 6 wherein the at least one of the sensors comprise a tilt sensor.

21. The container of claim 20 wherein the tilt sensor senses when the container body is in a tilted state exceeding a threshold angle from a first position.

22. The container of claim 21 wherein the threshold angle is in the range of about 45°

to about 90°

.

23. The container of claim 20 wherein the tilt sensor comprises any one of an on/off tilt sensor, an accelerometer, an inertial measurement unit (IMU), or an inclinometer.

24. The container of claim 4 wherein sensing a valid dose event requires data input from at least two of the one or more switches and/or sensors to coincide with one another.

25. The container of claim 24 wherein the coinciding at least two data inputs from the one or more switches and/or sensors comprises data input indicating the container closure is not present on the container neck and the container body is in a tilted state exceeding a threshold angle from a first position.

26. The container of claim 4 wherein the one or more indicators comprise light-emitting diodes (LED).

27. The container of claim 1 wherein the electronics module is further configured for providing a dose reminder and communicating valid dose events and/or dose exception events.

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

a) providing a data-enabled pharmaceutical container;

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.

29. The method of claim 28 wherein the data-enabled pharmaceutical container, comprises:

a) a pharmaceutical container; and

b) an electronics module configured for sensing and tracking dose events coupled to the pharmaceutical container, wherein the pharmaceutical container comprises;

a container body;

a container neck; and

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 the container closure is configured to secure the container neck opening, and wherein the electronics module comprises a housing and a printed circuit board (PCB) assembly housed therein, the PCB assembly comprising a PCB;

one or more indicators, one or more switches; and

one or more sensors.

30. The method of claim 28 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.

31. The method of claim 30 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.

32. The method of claim 28 further comprising detecting, tracking, and communicating data regarding valid dose events and/or dose exception events.

33. The method of claim 29 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.

34. The method of claim 28 further comprising detecting, tracking, and communicating data regarding a patient'"'"'s actual dose information.

35. 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;

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.

36. The method of claim 35 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.

37. The method of claim 36 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.

38. The method of claim 37 wherein the data-enabled pharmaceutical container comprises one or more indicators capable of being monitored by the patient.

39. The method of claim 38 wherein the one or more indicators are one or more of visual and audible.

40. The method of claim 38 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.

41. The method of claim 35 further comprising transmitting data from the data-enabled pharmaceutical container to an external computing device using a communications interface.

42. The method of claim 38 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.

43. The method of claim 41 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.

44. The method of claim 42 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.

45. The method of claim 35 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.

46. The method of claim 45 wherein if it is determined a prescription refill is needed the one or more indicators indicate a prescription refill is needed.

47. The method of claim 46 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.