WO2011054000A1 - Smart medicament management methods and devices - Google Patents

Smart medicament management methods and devices Download PDF

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Publication number
WO2011054000A1
WO2011054000A1 PCT/US2010/055163 US2010055163W WO2011054000A1 WO 2011054000 A1 WO2011054000 A1 WO 2011054000A1 US 2010055163 W US2010055163 W US 2010055163W WO 2011054000 A1 WO2011054000 A1 WO 2011054000A1
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WO
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Patent type
Prior art keywords
medicament
patient
device
management device
medicament management
Prior art date
Application number
PCT/US2010/055163
Other languages
French (fr)
Inventor
Markus Glimm
Mark Aiken
Echo Harger
Frankie Chi-Bun Wong
Original Assignee
Trxcare Holding S.A.R.L.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035Blister-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0418Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with electronic history memory
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0481Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers working on a schedule basis
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F19/00Digital computing or data processing equipment or methods, specially adapted for specific applications
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F19/00Digital computing or data processing equipment or methods, specially adapted for specific applications
    • G06F19/30Medical informatics, i.e. computer-based analysis or dissemination of patient or disease data
    • G06F19/34Computer-assisted medical diagnosis or treatment, e.g. computerised prescription or delivery of medication or diets, computerised local control of medical devices, medical expert systems or telemedicine
    • G06F19/3456Computer-assisted prescription or delivery of medication, e.g. prescription filling or compliance checking
    • G06F19/3462Computer-assisted distribution of medication from dispensers, i.e. making sure that medication is correctly delivered to patients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00General characteristics or adaptations
    • A61J2200/30Compliance analysis for taking medication
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2205/00General identification or selection means
    • A61J2205/70Audible labels, e.g. for pre-recorded info or messages
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0427Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system
    • A61J7/0436Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system resulting from removing a drug from, or opening, a container

Abstract

The invention relates to methods and devices for medicament management. More specifically, the present invention relates to an electronic medicament method and apparatus, capable of wireless communication with remote parties like health care professionals and pharmacies, for managing a patient's medicament regimen, including drug refilling, drug dosage, drug dispensing, drug intervention and prescription compliance. The invention further relates to a medicament dispenser and method for monitoring an individual's response to various dosages of drugs for more effective treatment of a condition.

Description

SMART MEDICAMENT MANAGEMENT METHODS AND DEVICES

FIELD OF THE INVENTION

The present invention relates to methods and devices for medicament management. More specifically, the present invention relates to an electronic medicament method and device, capable of wireless communication with remote parties like health care professionals and pharmacies, for managing a patient's medicament regimen, including drug refilling, drug dosage, drug dispensing, drug intervention and prescription compliance.

BACKGROUND OF THE INVENTION

All publications herein are incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. The following description includes

information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

Advancements in pharmacology and medicine have afforded numerous individuals the opportunity to prolong and improve their lives with the aid of drugs and therapies. Advancements in treating cancer, AIDS, diabetes and various other ailments have produced various drugs that substantially enhance physical or mental well-being. Although most ailments may be treated by one drug, various ailments require treatment with one or more combination of drugs. In addition, various dosage regimens require irregular intervals and asystematic increases and decreases in dosage. Combined with the fact that many individuals taking drugs are elderly, disabled, cognitively impaired, or patients with psychiatric disorders, it is not uncommon to have patients forget to take their medication, forget their recommended dosage, or forget that they have already taken a dose.

Unfortunately, the result of the medicament miscues may affect the course of the ailment, treatment of patients and/or reactions to misdosage. Despite great advances in medicine, there are numerous studies listing the mismanagement of drug dosage and treatment as the primary cause for unsatisfactory drug therapy. Some factors attributing to this mismanagement include poor compliance with medicament regimen as patients forget to take their medicaments; frequent need for refills and visits to the health care professional's office to monitor and amend medicament regimen; lack of adequate health education and inadequate reinforcement thereof; under or over dosing of medicament; altered dosing regimen; and incorrect administration of medicament.

Further frustrating the matter is the common practice of patients failing to inform their physicians of their non-compliance, leading to changes in medicament dose and/or the addition or substitution of other drugs.

Several strategies are currently used in the field to increase adherence and adequately report adherence. Patients use dosette boxes and other pill organizing devices to help them to decrease the risk of both under and over medication. In addition, patients have utilized alarm clocks and other reminder devices in order to prompt timely medication intakes and reduce unintended missed medication. While these techniques are proven to increase adherence, many patients still struggle to take their medication on time. Alarm clocks have proven to be a help and a hindrance, as the reminders often cause "reminder-fatigue," a state where the patient becomes over- sensitized to the reminder to the point of disabling the reminder or de-sensitized to the reminder to the point of not noticing the reminder.

In order to combat reminder-fatigue, current offerings on the market include smart-reminder devices or services that only issue reminder messages or alerts if the patient forgets to take the medication. These products, however, typically require the patients to only take the medications in a single physical location (such as a specific bedroom in the home) or, where portability is an issue, within a mobile wireless network. In these products, any attempt to take the devices beyond the operating constraints of the system (or a failure of the communications system) results in erroneous reminder messages, additional reminder fatigue, and incorrect adherence reporting.

Due to the disadvantages associated with the current methods and devices for drug monitoring and dispensing, as evidenced above, there exists a need in the industry for medicament dispensers and associated methods, capable of wirelessly communicating with remote parties like health care professionals and pharmacies in monitoring the use of a prescribed drug by a patient. These devices or systems should be portable, effective in outage conditions, capable of acting autonomously, yet still connected to the patient's health provider network. Additionally, there exists a need for medicament dispensers and associated methods capable of regimenting, refilling, and dispensing medicament, and for reminding a patient when and how much of a given drug to take. There is a further need to develop a medicament dispenser and method for monitoring an individual's response to various dosages of drugs for more effective treatment of a condition.

SUMMARY OF THE INVENTION

All references cited herein are incorporated by reference in their entirety as though fully set forth. One skilled in the art will recognize many methods, apparatus and materials similar or equivalent to those described herein, which could be used in the practice of the present invention. Indeed, the present invention is in no way limited to the methods, apparatus and materials described.

The present invention provides methods and devices for a portable, intelligent medicament dispenser, capable of monitoring and managing a patient's medicament regimen remotely. Embodiments of the invention provide a refillable container for storing the patient's medicament, and a processor for monitoring and managing the patient's medicament regimen. Embodiments of the invention also provides an audio, sensory and/or visual notice for alerting the patient when a medicament dose is scheduled for consumption, as well as providing information related to the medicament. The invention provides a wireless communication means for transmitting and receiving information from third parties. The wireless communication means may transmit information relating to patient compliance or non-compliance with the medicament regimen to a third party, as well as receive information from third parties regarding instructions and changes in medicament dosage and frequency. The medicament dispenser further provides a memory module for storing medicament information, patient and medicament compliance information, and intervention information. In some embodiments, the processor, audio/sensory/visual notice, wireless communication means and memory module are in communication with one another through a bus board affixed in the medicament dispenser.

In an embodiment of the invention, the wireless communication means may comprise Wi-Fi, a general packet radio service ("GPRS"), global system for mobile communications ("GSM") or other cellular network, short message service ("SMS"), or other communications systems known in the art. The wireless communication means may comprise additional components including an antenna for aiding such wireless communication. The processor may further comprise a subscriber identity module ("SIM") slot for a removable SIM card, used to assign the medicament dispenser an internet protocol ("IP") address for identifying the medicament dispenser. A SIM lock may be provided for restricting and monitoring use of the medicament dispenser to an individual patient and designated networks.

In another embodiment of the invention, the medicament container has an external port for providing communication between a computer and the medicament container. Various examples of external ports may include a Universal Serial Bus ("USB"), Firewire, MIDI, InfiniBand, Serial ATA, proprietary ports, and the like. The invention may also provide for a short-range wireless communication means, such as Bluetooth and Wi-Fi.

BRIEF DESCRIPTION OF THE FIGURES

Exemplary embodiments are illustrated in referenced figures. It is intended that the embodiments and figures disclosed herein are to be considered illustrative rather than restrictive.

Figure 1 depicts an exploded view of a medicament dispenser, in accordance with an embodiment of the present invention.

Figure 2 depicts a top perspective view of a medicament dispenser with a partially open lid, in accordance with an embodiment of the present invention.

Figure 3 depicts a top perspective view of a medicament dispenser in accordance with an embodiment of the present invention.

Figure 4 depicts a bottom perspective view of a medicament dispenser in accordance with an embodiment of the present invention. Figure 5A depicts a bottom view of a medicament dispenser in accordance with an embodiment of the present invention.

Figure 5B depicts a top view of a medicament dispenser in accordance with an embodiment of the present invention.

Figure 5C depicts a side view of a medicament dispenser in accordance with an embodiment of the present invention.

Figure 5D depicts a rear side view of a medicament dispenser in accordance with an embodiment of the present invention.

Figure 5E depicts a front side view of a medicament dispenser in accordance with an embodiment of the present invention.

Figures 6A and 6B depict a top perspective view of a medicament dispenser in accordance with an embodiment of the present invention.

Figures 7A and 7B depict block diagrams of electronic components of a medicament dispenser in accordance with an embodiment of the present invention.

Figure 8 depicts a cross-sectional view of a medicament dispenser in accordance with an embodiment of the present invention.

Figure 9 depicts an exploded view of a medicament dispenser, in accordance with an embodiment of the present invention.

Figure 10 depicts a top perspective view of a medicament dispenser in accordance with an embodiment of the present invention.

Figure 1 1 depicts a flow chart of a medicament dispenser method in accordance with an embodiment of the present invention.

Figure 12A depicts a top perspective view of a medicament dispenser in accordance with an embodiment of the present invention, with a lid of the medicament dispenser in a partially opened position.

Figure 12B depicts a top perspective view of a medicament dispenser in accordance with an embodiment of the present invention, with the lid of the medicament dispenser in a closed position.

Figure 12C depicts a top perspective view of a compartment of a medicament dispenser in accordance with an embodiment of the present invention. Figure 12D depicts an exploded view of a medicament dispenser in accordance with an embodiment of the present invention.

Figure 13A depicts a top perspective view of a medicament dispenser in accordance with an embodiment of the present invention, with a lid of the medicament dispenser in a partially opened position.

Figure 13B depicts a top perspective view of the medicament dispenser shown in Figure 13A with a blister pack stored therein.

Figure 13C depicts and exploded view of the medicament dispenser shown in Figure 13A in accordance with an embodiment of the present invention.

Figure 14A depicts a top perspective view of a medicament dispenser in accordance with an embodiment of the present invention, with the lid of the medicament dispenser in a closed position.

Figure 14B-C depict top perspective views of a medicament dispenser in accordance with an embodiment of the present invention, during operation of the medicament dispenser.

Figure 14D depicts a side cross-sectional view of a medicament dispenser in accordance with an embodiment of the present invention.

Figure 15A depicts a top perspective view of a medicament dispenser in accordance with an embodiment of the present invention, with a lid of the medicament dispenser in a partially opened position.

Figure 15B depicts and exploded view of a medicament dispenser in accordance with an embodiment of the present invention.

Figure 16A depicts a top perspective view of a desktop medicament dispenser in accordance with an embodiment of the present invention, with a lid of the desktop medicament dispenser in a partially opened position.

Figure 16B depicts a top perspective view of a desktop medicament dispenser in accordance with an embodiment of the present invention, with a lid of the desktop medicament dispenser in a closed position.

Figures 17A-B depict a flow chart of a medicament dispenser operations process in accordance with an embodiment of the present invention. Figure 18 depicts a flow chart of a non-conformance process for a medicament dispenser in accordance with an embodiment of the present invention.

Figure 19 depicts a flow chart of a failover process for a medicament dispenser in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Referring now to the drawings in which like parts are designated by like reference characters throughout the several views, Figure 1 depicts an exploded view of a medicament dispenser 10 in accordance with an embodiment of the invention. The exploded view shows various components of the medicament dispenser 10, including a base 12 and a removable lid 14. The base 12 houses a plurality of pill boxes 16, which are readily removable from the base 12 for easy refilling, and may be replaced with pill boxes of various sizes, shapes and materials for housing various medicaments. The base 12 further houses a battery 18 for powering the medicament dispenser 10, and an electronics housing 20 for operating various functions of the medicament dispenser 10.

The electronics housing 20 comprises an electronic bus port 22 for wired communication between the medicament dispenser 10 and a third party electronic device, such as a computer, phone, or the like. The electronics housing 20 further comprises at least one patient to dispenser interface (or "patient-processor interface") 24. The interface 24 provides a means for communicating information between the medicament dispenser 10 and the patient. The information means for communicating information may include, but is not limited to, a light emitting diode ("LED"), vibrating motor, graphic user interface or "GUI" (e.g., a text display, a video display, a touch screen display providing input as well as output, and the like), audio device, or other means known in the art.

Figure 2 depicts a top perspective view of the medicament dispenser 10. The medicament dispenser 10 comprises the lid 14, partially open in Figure 2, exposing the pill boxes 16 each containing a medicament 26. The pill boxes 16 are housed in the base 12 of the medicament dispenser 10. In this embodiment, the medicament 26 is in the form of pills, and the pill boxes 16 are each configured for dispensing such pills. In various other embodiments, the pill boxes 16 may be configured for dispensing medicament of one or more various forms, including, liquid, gel, powder, cream, spray, or other forms known in the art. In various embodiments, the pill boxes 16 may also be configured to house medicament in various forms, including, a blister pack, a syringe (with and without hypodermic needle), a bottle, gel-cap, accessories such as alcohol swabs, and/or other forms know in the art. The lid 14 depicted in Figure 2 slides open to reveal the pill boxes 16, and may use a stop mechanism to stop the lid from completely detaching from the base 12. In another embodiment (shown in Figure 6), the lid 14 may be pivotally attached to the base 12, such that access to the medicament 26 is provided when the lid 14 is pivoted open relative to the base. In various other embodiments, the lid 14 may be pivotally or slidably attached to the base 12 by other means known the art. As shown, the lid 14 and/or base 12 may also incorporate a latching mechanism 28 to close the lid 14, thereby securing the pill boxes 16 and medicament 26.

Figure 3 depicts a top perspective view of the medicament dispenser 10. In this view, the lid 14 is in the closed position with the latching mechanism 28 engaged, and the lid 14 abutted against the base 12.

Figure 4 depicts a bottom perspective view of the medicament dispenser. The medicament dispenser 10 comprises at least one patient to dispenser interface 24 and bus port 22. The interface 24 provides a means for communicating information between the medicament dispenser 10 and the patient, and may include a light emitting diode ("LED"), vibrating motor, graphic user interface ("GUI"), audio device, and/or other means known in the art. The electronic bus port 22 provides a wired means for exchanging information between the medicament dispenser 10 and a third party electronic device, such as a computer, phone, or the like. Figure 4 further depicts a compliance button 30 on the base 12 of the medicament dispenser 10. During use, the patient may press the compliance button 30 once the patient takes the prescribed dose of medicament to provide a notification that the dose has been taken. As can be appreciated, the compliance button 30 is in communication with an electronic bus board 50 (see Figures 7A and 7B).

Figures 5A-5E depict various views of the medicament dispenser 10. As discussed above, the medicament dispenser 10 in comprises the base 12 and the removable lid 14. The base 12 comprises at least one patient to dispenser interface 24 and bus port 22, best viewed in Figure 5D. Figure 5D further depicts the compliance button 30 on the base 12 of the medicament dispenser 10. Figures 5B and 5E also depict the latching mechanism 28 to close the lid 14, thereby securing the pill boxes 16 and medicament 26. In the present embodiment, the latching mechanism 28 is configured on the base 12. In another embodiment, the latching mechanism 28 may be configured on the lid 14, the base 12, or combinations thereof.

Figures 6A and 6B depict a top perspective view of a medicament dispenser 60 in accordance with an embodiment of the present invention. The medicament dispenser 60 is similar to the medicament dispenser 10 in most respects, except that the medicament dispenser includes a lid 64 that is pivotably attached to a base 62 (e.g., via a hinge). Figure 6A depicts the lid 64 in the partially open configuration exposing the pill boxes 66. The medicament dispenser 60 further incorporates a latching mechanism 78 found on the base 62 for closing the lid 74. The medicament dispenser 60 also comprises at least one patient to dispenser interface 74 and a bus port 72. The interface 74 provides a means for communicating information between the medicament dispenser 60 and the patient, and may include a light emitting diode ("LED"), vibrating motor, graphic user interface ("GUI"), audio device, and/or other means known in the art. The electronic bus port 72 provides a wired means for exchanging information between the medicament dispenser 60 and a third party electronic device, such as a computer, phone, or the like. Figure 6A further depicts a compliance button 80 on the base 62 of the medicament dispenser 60.

Figure 6B depicts the lid 64 in the closed configuration, with a latching

mechanism 78 enacted to close the lid 64. Figure 6B also depicts the at least one patient to dispenser interface 74 and the bus port 72. In various embodiments, the latching mechanism 78 may be configured on the lid 64 and/or the base 72, at various positions of the medicament dispenser 60.

Figures 7A and 7B depict block diagrams of electronic components of a medicament dispenser (e.g., the medicament dispenser 10) in accordance with an embodiment of the present invention. Figure 7A depicts a top view an embodiment of an electronics housing 20 comprising a GSM module 32 and Bluetooth device 34. The GSM module 32 enables wireless communication, such as GPSR, SMS, or other means known in the art, between the medicament dispenser 10 and a remote electronic device, such as a server or third party computer. The Bluetooth device 34 enables short-range wireless communication between the medicament dispenser 10 and a remote electronic device, such as a computer. Figure 7B depicts a bottom view of the electronics housing 20, which comprises a SIM lock 36 for accepting a SIM card 38, and establishing an IP address for the medicament dispenser 10. The electronics housing 20 further comprises a global positioning system ("GPS") module 40, a GPS antenna 42, and a processor 44. The GPS module 40 may identify the geographic location of the medicament dispenser 10 remotely, or may relay real-time geographic location information to the patient. The processor 44 functions to direct operations of the medicament dispenser 10, which are detailed below. The electronics housing 20 further comprises a memory module 46, in communication with the processor 44 for storing information, and an oscillator 48 that may be used to indicate, measure, keep and coordinate time. Additionally or alternatively, time information may be received from and sent to an external source, such as a server. As can be appreciated, the battery 18, bus port 22, compliance button 30, GSM module 32, Bluetooth 34, SIM lock 36, SIM card 38, processor 44, memory module 46, oscillator 48, and latching mechanism 28 may be in electronic communication with one another. In an embodiment of the invention, the battery 18, bus port 22, compliance button 30, GSM module 32, Bluetooth 34, SIM lock 36, SIM card 38, processor 44, memory module 46, oscillator 48 and latching mechanism 28 may be in electronic communication with one another through the bus board 50. It should be appreciated that the medicament dispensers described herein may include other components known in the art to provide the functionality described herein. Such components may include video displays, video controllers, speakers, vibration sources, user interfaces and controllers, antennas, and the like.

Figure 8 depicts a cross-sectional view of the medicament dispenser 10. This view depicts the placement of the pill boxes 16 within the outer confines of the medicament dispenser 10, comprising the base 12 and the lid 14. Figure 8 further depicts sensors 52 in communication with the pill boxes 16 and situated in the base 12 of the medicament dispenser 10, wherein the sensors 52 are capable of detecting a variety of information concerning the pill boxes 16 and medicament 26. The sensors 52 are in communication with the processor 44 (see Figure 7B). Information detected by the sensors 52 may include medicament presence, medicament dosage, medicament identity, medicament expiration, or other information. In various embodiments, the sensors 52 may be configured on the pill boxes 16, the lid 14, or combinations thereof. In a further embodiment, the medicament dispenser 10 may incorporate multiple sensors of varying types for detecting medicament information.

Figure 9 depicts an exploded view of the medicament dispenser 10. The exploded view shows various components of the medicament dispenser 10, including a bottom section 12a, a middle section 12b, and a top section 12c of the base 12. The base 12 houses the pill boxes 16, which are readily removable from the base 12 for easy refilling, and may be replaced with pill boxes of various sizes, shapes and materials for housing various medicaments. As shown in Figure 9, the base 12 further houses the battery 18 for powering the electronic components of medicament dispenser 10, and the electronics housing 20 for operating various functions of the medicament dispenser. The base 12 further houses the sensors 52 for detecting medicament information from the pill boxes 16. The present embodiment depicts multiple sensors 52, all in communication with the electronics housing 20, which houses the processor 44 (shown in Figure 7B). Figure 9 further depicts the lid 14 that is slidably attachable to the base 12 and operative to secure the pill boxes 16 and medicament 26. Figure 9 further illustrates the latching mechanism 28 for locking the lid 14 of the medicament dispenser 10 in a closed position (shown for example in Figure 3).

Figure 10 depicts a top perspective view of the medicament dispenser 10. As described above, the medicament dispenser 10 comprises the base 12 that includes a storage space. In this embodiment, the base 12 receives a pre-formed plastic packaging 17, commonly referred to as a blister pack, for storing a medicament 27.

Figure 1 1 depicts a flow chart of a method 100 of using a medicament dispenser (e.g., the medicament dispenser 10 or any other medicament dispenser described herein). In operation, the medicament dispenser 10 may be located and identified by its IP address (or by its phone number, etc.) by a third party server 102. The server 102 is operative to provide wireless medicament regimen information over a network 104 to the medicament dispenser 10, including medicament dosage, medicament name, medicament strength, medicament frequency, patient name, prescribing physician's name, and other pertinent information. The information is stored on the memory module 46 of the medicament dispenser 10. In another embodiment, the information stored in the memory module 46 may be provided and/or inputted by a pharmacist or pharmacy assistant on location at a pharmacy. In yet another embodiment, a medicament manufacturer or doctor may prerecord the information in the memory module 46.

Upon first operation of the medicament dispenser 10, the processor 44 may be activated and may direct the oscillator 48 to commence time management. At a predetermined time before the medicament 26 is to be taken, the processor 44 may trigger the interface 24 to initiate a first alert 106 to the patient. Alerts may be auditory, visual, sensory or combinations thereof. If the patient is receptive to the first alert 106 and consumes the prescribed medicament, the patient may reset the alert by activating the compliance button 30 found on the medicament dispenser 10. Alternatively, the alert may be automatically reset by triggering an electric mechanism in communication with the processor 44 when the lid 14 is unlatched from the base 12. Alternatively, the latching mechanism 28 described above may comprise an electric trigger, in

communication with the processor 44, for resetting the alert. Once the alert is reset and the patient has taken the medicament 26, the medicament consumption time may be recorded in the memory module 46, and wirelessly relayed over the network 104 by the GSM module 32 to a third party server or computer (e.g., the server 102), step 1 10. If the patient is non-responsive to the first alert 106 and does not consume the prescribed medicament in an allotted medicament consumption time, the processor 44 may initiate a secondary alert 1 12 prompting the patient to consume the prescribed medicament. If the patient is receptive to the second alert 1 12 and consumes the medicament, thereby resetting the alert 1 14, the medicament consumption time is recorded in the memory module 46, and wirelessly relayed over the network 104 by the GSM module 32 to a third party server or computer (e.g., the server 102), step 1 16. In an alternative embodiment, the delay time associated with consuming the medicament is also recorded in the memory module 46 and wirelessly relayed over the network 104 by the GSM module 32 to a third party server or computer. If the patient continues to be non- responsive to the second alert 1 12, the processor 44 may direct the GSM module 32 to alert a third party receiver 1 18, prompting an alert from the third party receiver to the patient. Alternatively, the GSM module 32 may contact a server, which in turn may alert a third party receiver prompting an alert from the third party receiver to the patient.

A third party receiver may include various electronic devices including a cell phone, electronic mail, text message, and other devices known in the art. In an alternative embodiment, the processor 44 may direct the GSM module 32 to contact a physician, pharmacist, a relative or other third party in communication with the patient. Information regarding a patient's medicament consumption, including dosage, time, and consistency may recorded in the memory module 46 and relayed to a server or third party computer in real-time to allow remote medicament monitoring, adherence, and data collection.

In various embodiments, the number and/or frequency of alerts, as well as the progression of alerts to a third party receiver or server, may be varied by patient, medicament, and/or physician/pharmacist. In addition, alerts may be dictated by a medical professional or at the direction of a medical professional.

Figures 12A-D depict various views of another embodiment of a medicament dispenser 140. The medicament dispenser 140 comprises a base 142 coupled to a lid 144. The lid 144 is partially open in Figures 12A, 12C, and 12D, exposing a removable insert 160 positioned within a compartment 143 of the base 142. The lid 144 is pivotally attached (e.g., via a hinge assembly) to the base 142, such that access to the compartment 143 is provided when the lid 144 is pivoted open relative to the base. As discussed above, in various other embodiments, the lid 144 may be pivotally or slidably attached to the base 142 by other means known the art. The lid 144 and/or base 142 may also incorporate a latching mechanism to close the lid, thereby securing the contents contained within the medicament dispenser 140.

In this embodiment, the medicament dispenser 140 includes a touch screen display 154 and a plurality of buttons 150 disposed on the lid 144. In this regard, a patient may interact with applications of the medicament dispenser 140 as described herein with reference to Figures 1 1 and 17-19. Similar to embodiments discussed above, the medicament dispenser 140 also includes a compliance button 151 positioned on an outer surface of the lid 144 that allows patients to confirm that an intake event occurred. It should be appreciated that medicament dispensers described herein may have a variety of buttons and button types (e.g., physical buttons, virtual or soft buttons, needle buttons, and the like). The medicament dispenser further includes an electronics assembly housed inside the lid 144 comprising similar electronic components the medicament dispenser 10 described above. As best shown in Figure 12B, the medicament dispenser 140 also comprises an electronic bus port 152 (e.g., a USB port, or the like) for wired communication between the medicament dispenser 140 and a third party electronic device, such as a computer, phone, or the like.

As shown in Figures 12A and 12D, the removable insert 160 is sized and shaped to fit within the compartment 143 of the base 142. The insert 160 comprises a compartment 162 sized to receive a removable blister pack 176. As may best be viewed in Figure 12A the insert 160 includes two spaced apart tabs 166 and 168 disposed on each longitudinal side of the insert 160 that extend over lateral portions of the compartment 162. The tabs 166 and 168 are configured for retaining the blister pack 176 within the compartment 162. In use, a patient may simply slide the blister pack 176 out of the compartment 162 of the insert 160 (i.e., from the top-left to the bottom-right in the view shown in Figure 12A), to access a medicament contained within the blister pack.

As may best be viewed in Figure 12C, the insert 160 also comprises a

compartment 164 positioned adjacent the compartment 162 and sized to receive medicament 174. The compartment 164 further comprises a lid 170 pivotably attached to the insert 160 which allows the medicament 174 housed in the compartment to be selectively secured and accessed by a user. The lid 170 comprises a tab 171 configured to be selectively attached to tab engagement portions 165A and 165B of the insert 160 such that the lid 170 may be secured over the compartment 164. For each of the medicaments 174, the compartment 164 includes a separate compartment 179 sized to receive a medicament. Each of the compartments 179 comprise a biasing portion 178 (or "spring holder") configured to secure an individual medicament positioned therein. As can be appreciated, the presence of the biasing portion 178 ensures the medicaments 174 do not move substantially within the compartment 164.

Figures 13A-C depict another embodiment of a removable insert 190 in accordance with the present invention. Similar to the insert 160 described above, the insert 190 may be sized and shaped to fit within the compartment 143 of the base 142 of the medicament dispenser 140. Alternatively, the insert 190 may be sized and shaped to fit within other medicament dispensers with which is intended to be used. The insert 190 comprises a single compartment 192 sized to receive the blister pack 176 (or other blister pack ). The insert 190 includes a tab 194 that extends over a portion of the compartment 192 and operates to retain the blister pack 176 housed therein. Further, the insert 190 comprises two indentions 196 and 198 which allow a user to more easily remove a blister pack disposed within the compartment 192 by inserting a finger between the blister pack and the wall of the insert at the location of the indentations.

Figures 14A-D depict another medicament dispenser 200 in accordance with an embodiment of the present invention. The medicament dispenser 200 may be similar to the medicament dispensers described above in several respects, so only distinguishing features of the medicament dispenser 200 are described herein.

The medicament dispenser 200 comprises a base 202 coupled to a lid 204. The lid 204 is partially open in Figures 14B and 14C, exposing a compartment 203 (see Figure 14C) of the base 202. The lid 204 is pivotally attached (e.g., via a hinge assembly) to the base 202, such that access to the compartment 203 is provided when the lid 204 is pivoted open relative to the base. As discussed above, in various other embodiments, the lid 204 may be pivotally or slidably attached to the base 202 by other means known the art. The lid 204 and/or base 202 may also incorporate a latching mechanism to close the lid, thereby securing the contents contained within the medicament dispenser 200.

In this embodiment, the medicament dispenser 200 includes a touch screen display 214 positioned on an outside surface the lid 204. In this regard, a patient may interact with applications of the medicament dispenser 200 without having to open the lid 204. As can be appreciated, the display 214 disposed on the outside surface of the lid 204 may be provided as an alternative to, or in addition to, a display disposed on an inside surface of the lid.

The medicament dispenser 200 also includes two laterally spaced apart tabs 206 and 208 that extend over a portion of the compartment 203. As shown in Figures 14B and 14C, a blister pack 220 may be slidably inserted into and removed from the compartment 203 by a patient.

The medicament dispenser 200 further comprises a second compartment 218 that includes a slidable cover 212. The cover 212 may be slid by a patient from a closed position (shown in Figure 14B) to an opened position (shown in Figure 14C) such that medicament 216 housed in the compartment 218 may be secured and accessed, respectively.

Figure 14D depicts a side cross-sectional view of the medicament dispenser 200. As can be seen, the medicament dispenser 200 comprises an electronics assembly 222 (e.g., a PCB, electronic components, and the like) disposed within the lid 204 behind the display 214. Further, the medicament dispenser 200 comprises a battery 224 disposed within the lid 204 adjacent the display 214 and the electronics assembly 222. The batter 224 is used to power the display 214 and the components of the electronics assembly 224.

Figures 15A-B depict another embodiment of inserts that may be used with a medicament dispenser, such as the medicament dispenser 140, for a patient that requires the use of an injectable pen 244. In this embodiment, two separate removable inserts 240 and 250 are provided. As shown in Figure 15A, the inserts 240 and 250 are sized and shaped such that they together fit within compartments 264 and 262, respectively, of a removable tray 260. In turn, the removable tray 260 is configured to fit within the compartment 143 of the base 142 of the dispenser 140. In other

embodiments, the inserts 240 and 250 may be configured to be positioned directly within the compartment 143 of the base 142 without the use of the removable tray 260.

The removable insert 240 comprises a compartment 242 that is sized to securely receive (e.g., by a press fit) the pen 244. The insert 250 comprises a plurality of compartments 256 that are selectively covered by a clear lid 252 pivotably attached to the insert. The lid 252 is shown closed in Figure 15A and opened in Figure 15B. The plurality of compartments 256 may be configured to retain various supplies 254 that a patient may need, such as insulin, alcohol swabs, needles, and the like.

Figures 16A-B illustrate another embodiment of a medicament dispenser 300 in accordance with the present invention. The medicament dispenser 300 is generally referred to as a "desktop medicament dispenser," and may be configured to hold substantially more medicaments than the dispensers described above. The

medicament dispenser 300 comprises a base 302 and a lid 304 that is pivotably attached to the base via a hinge 306. A latch 308 is positioned on the lid 302 and is configured to selectively secure the lid in a closed position. As discussed above with reference to other embodiments, the latch 308 (or another mechanism) may be configured to provide a hardware trigger to a device application to indicate when the lid 304 has been opened or closed by a patient.

The medicament dispenser 300 also includes a control panel 310 that may include a variety of input devices (e.g., buttons 315, touch screen display 313, and the like), and output devices (e.g., the touch screen display 313, LED's, a speaker 312, and the like). As shown in dashed lines, the control panel and other input and output devices may be positioned at various locations of the medicament dispenser 300.

The medicament dispenser 300 is configured to receive four weekly medicament trays 316A, 316B, 316C, and 316D, with each tray comprising medicaments for a patient for a full week. Alternatively, the medicament dispenser 300 may be configured to receive a single tray that provides medicaments for a patient for an extended period of time (e.g., two weeks, one month, or the like). In some embodiments the trays 316A- D are each sized and shaped to fit within a compartment of a mobile medicament dispenser (e.g., the medicament dispenser 140 shown in Figures 12A-D), such that a patient may use the desktop dispenser 300 when at home, and may switch to a mobile dispenser when traveling by simply removing one of the trays 316A-D from the desktop dispenser and placing it within a mobile medicament dispenser.

Device Applications

Figures 17A, 17B, and 18-19 depict flow diagrams of the various operations of a device application executable on a medicament dispenser, such as the medicament dispensers described hereinabove. The device application may begin to execute a device operations process 350 upon successful boot up and upon there being no error detected that prevents normal execution. This is the normal operational state where multiple threads or processes are initiated to perform various application functions. As shown in Figure 17, the application threads include a Scheduler 362, an SMS

Messenger 360, an Intake Event Monitor 358, a User Event Handler 355, a

Communicator 356, and a Device Configurator 354. Each of these threads of the device application is described below.

Scheduler

The device application implements the Scheduler 362 (a rule-based inference system) based on calendar and timer functions. In operation, specific intake time may be recorded once, and a timer of the device may then be set with reference to the calendar accordingly. The operation of the Scheduler is shown generally in Figures 17A-B at steps 370, 372, 374, 376 and 378, and is described below.

At initialization of the device application, the time of day (TOD) value may be subtracted from the last intake time recorded in a device log. If the resulting value is greater than the anticipated interval between intakes, the application determines that there was a missed intake and a "missed intake" message is displayed on a user interface (e.g., the user interface or display 154 shown in Figure 12A) of the device. If the resulting value is not greater than the anticipated interval between intakes, a reminder timer may be set to the next scheduled intake time minus the TOD. When the reminder timer expires, an "intake reminder" message may be displayed. Further, if a snooze event occurs, the reminder timer may be set to expire again in a predetermined number of minutes (e.g., 60 minutes, or the like). Following the snooze period, a second reminder message may indicate to the user that if an intake event does not occur in a specified number of minutes (e.g., 60 minutes, or the like), a missed intake log will be recorded in the device log. Alternatively, a short interval timer may be set (e.g., to a value equal to the reminder interval) that wakes up and checks TOD against the scheduled intake time. In this embodiment, the snooze action may simply put the timer thread back to sleep for the specified interval. Intake Event Monitor

Initially, the device application may listen for an intake event attempt to occur, step 386. As described above, hardware of the medicament dispenser devices may generate an intake event attempt when a patient performs certain physical actions to the device, step 388. For example, hardware may be configured to generate an intake event attempt when a dispenser compartment is opened. As an example, the TOD of the intake event attempt may be stored in the device's log according to the set of rules described below.

First, if the TOD is not within a predetermined number of minutes until the next scheduled intake time, a warning message (e.g., "too early") is displayed on the device to indicate that the patient should not take the medication at this time, steps 390 and 402. Further, if there is no patient confirmation of intake (e.g., the intake or compliance button is not activated), step 404, then no intake event is logged and the "intake event occurred" state is reset, step 408.

Second, if the TOD is within the predetermined number of minutes until the next scheduled intake time, step 392, the user interface may display and log a positive message (e.g., "on time"), and suggest that it is fine for the patient to take the medication now. Further, if the intake compliance button is touched, the intake event may be logged, step 394.

Third, if the TOD is within the predetermined number of minutes past scheduled intake time, the user interface of the device may display a message indicating that the medication was taken too late, steps 392 and 396. If the patient confirms that the intake occurred (e.g., by pressing the compliance button on the device), step 398, the device may write that the medication was taken "too late" to the device log, step 400. If there is no patient confirmation of intake (e.g., the compliance button is not activated), then the application may proceed to a non-conformance sub-process 450 described below with reference to Figure 18.

Fourth, if a patient is catching up with a missed intake (i.e., the TOD minus the last scheduled intake time is greater than the intake interval), and the TOD is within a predetermined number of minutes until the next scheduled intake time, a message may be displayed on the user interface instructing the user to skip that dose. An example of such a message is: "Although you missed the last scheduled intake, do not attempt to catch up. Just take the current scheduled medication." However, if the next scheduled intake time minus the TOD is greater than a minimum intake interval, a message may be displayed on the user interface of the device instructing the patient to take the medication without skipping that does. An example of such a message is: "You are a bit late, but please take your medication now."

Fifth, under conditions when a patient should not have taken a medication, but the intake confirmation button was activated by the patient, a message may be displayed to indicate to the patient that they may have taken an extra dosage. An example of such a message is: "You may have taken extra dosage. The last two intakes were... (display the date/time of the last two intakes).... Call your doctor." It is noted that the warning "do not attempt to catch up" may have also been displayed according to the fourth rule discussed above.

Non-conformance Process

Figure 18 depicts a flow chart for the non-conformance process 450 of the device application according to an embodiment of the invention. The application may first check to determine if the non-conformance process 450 was initiated by the device, step 452. If so, the device may write a "missed intake" indication to its log, step 454. Next, if the application determines that the non-conformance process 450 was initiated as a result of a timer event, step 456, the device application may display a reminder message and trigger a vibrational alert, steps 458, 460, and 462. On the other hand, if the non-conformance process 450 was not initiated as a result of a timer event, the application may sleep for a period of time (e.g., 50 minutes), step 464, before displaying a second reminder and triggering an audio alarm and vibrational alert, steps 466 and 468.

In the case where the non-conformance process 450 was not initiated by the device, the device may trigger escalating reminders (messages, alarms, and vibrational alerts), depending on the number of reminders that have been provided. For example, the application may first determine whether the event is a first reminder from the server, step 470. If so, the application may display a first reminder message and cause a vibrational alert, steps 472 and 476. If the event was not a first reminder from the server, the application may display a second reminder message, step 474, and cause a vibrational and audio alert, step 478. Next, the device application may wait for a period of time (e.g., 50 minutes) before checking again whether an intake event occurred, steps 480 and 482. The device may then write whether an intake event has occurred (step 484) or has not occurred (step 486), and then send the log file to the server, step 488.

SMS Messenger

The SMS Messenger 360 thread listens for SMS messages sent from the server (e.g., the server 102 shown in Figure 1 1 ). When the SMS Messenger determines that a new message has been received, step 382, the SMS messenger may initiate a Server Command Process 384, which is described below. Received SMS messages (or commands) may trigger one or more of the following actions on the device:

1 ) Connect to the server now to get device software updates.

2) Connect to the server now to get schedule, appointment, or application data updates.

3) Send the device log to the server now.

4) Connect to the server to confirm the device is still responsive. This can be confirmed by analyzing the last sent log. If the device has moved to a different time zone, the device may have to connect to a different server positioned in a different location to achieve a better response time. This SMS message may inform the device to which server it should be connected. As an example, this message may be triggered by the user setting the current time zone of a particular device.

5) Display a server generated message provided for display on the device. This message may be any suitable message, such as a motivational message, an instructional message, or the like. Further, this server-generated message may cause the device to generate an audio, visual and/or vibrational alert to indicate to the user that a message has been received. Generally, SMS messages may be modeled after Electronic Data Interchange (EDI) format and describe action to be taken by the device to which they are sent. The SMS messages may also contain the information described below.

The SMS messages may contain the date and time the message is sent from the server to the device. As can be appreciated, SMS message delivery is not guaranteed and delays must be tolerated. An SMS message therefore may or may not trigger a device action, depending on the current state of the device and whether the message has an expiration time. As an example, a device may not respond to a message when it is in an offline or "Airplane" mode, since the device will not receive the message until it exits this mode. A device may also not respond to a message when the device does not receive it when no network is available. Further, a device may not respond to a message when the message arrives too late and the corresponding action is no longer applicable or has been taken just prior to receiving the message. For example, if the server requests the device to send its device log, the device may not send the log if the device had sent the log just prior to receiving the message.

As yet another example, the device may not respond to a message when the command contained in the message has an expiration time. In this case, the server may determine that if the message is not handled within a certain time period, the device should ignore it. For example, if the server requests the device to download software updates, and the server has scheduled 10,000 devices to download the updates within a certain date and time window, it may instruct a device not to take action if the message arrives after the designated download window. In this event, the server may reschedule the software update for the device at a later time.

The SMS messages also contain a command code that is mapped to a command that drives corresponding actions on the device. The commands may be encrypted for higher security if desired, but encryption may not be necessary since there is generally no confidential or private information disclosed in the messages.

The SMS messages also contain various parameters associated with each command. Parameters may include, but are not limited to, date and time of the message (from the server's side); time zone (if multiple servers are located at different time zones); expiration time for the message; and text and/or graphics of messages to be displayed on device.

Server Command Process

The server command process 384 may initiate communication with any device directly via SMS messaging, or through other communication protocols. Direct SMS messaging may be used to avoid the relatively high cost of securing a fixed IP address for each device. The server database may store a mobile phone number for each device to be activated. The SMS message (and command) may be sent to the phone number of the specific device. Bulk SMS messaging may also be available by prior arrangement with the mobile service providers if desired. Typically, the server executes scheduled batch jobs and messages to a certain subset of the devices that are intended to receive the same message content. Even intake reminders may be sent in batches. For example, every 15 minutes there may be a controlled number of deployed devices targeted to receive an intake reminder message from the server.

Device Update Message

The server is also configured to send a Device Update Message, which is an SMS message that instructs a device to download a software update. Upon receiving this SMS message from the server, the device may perform the following tasks: 1 ) parse the command (identified to be software update); 2) record this command in the device log; 3) connect to the server and send the device log (since software update may render the device non-functional, all data of the device should normally be backed up to the server); 4) request download of the software update; 5) execute the software update file(s) to apply the software update to the device; 6) record in the device log the result of the software update (i.e., update succeeded or failed); 7) if the update is successful, and a reboot is required, disconnect from the server and initiate the reboot (since the server protocol is stateless, the device may not need to disconnect from the server); 8) record in the device log that the software update has completed successfully; 9) record in the log all errors that occurred during the update, and rollback the change if possible; 10) connect to the server and send the device log including the update status; and 1 1 ) resume normal operation of the device, or initiate a recovery process if errors occurred during the update.

Schedule Update Message

The server is also configured to send a Schedule Update Message, which is an SMS message that instructs a device to download updates to information relating to schedules, appointments, and application data. A patient may have access to the intake schedule, clinical appointments, and calendar information using a patient portal (e.g., a web portal) accessible using a computer, phone, medicament dispenser device, or the like. Other configuration parameters may also be changed through the patient portal interface. Other than the clinical appointments, both schedule and application data updates may not expire until they are modified. Therefore, in some cases the Schedule Update Message may not include an expiration time parameter. For example, even though clinical appointments may have passed when a message is received by the device, the appointment change may be recorded in the device and therefore would not require an expiration time parameter.

Upon receiving a Schedule Update Message, a device may perform the following actions: 1 ) parse the command (identified to be a schedule update); 2) record this command in the device log; 3) connect to the server to download the applicable updates; 4) apply the updates to the schedule, appointment/calendar and/or application data; 5) refresh the application with the updates, including a reboot of the device if necessary; 6) record in the device log that the data update has completed successfully; 7) if the application refresh fails, initiate a device recovery process; and 8) resume the normal operation of the device.

Send Log Message

A device may be scheduled to send its log to the server on a regular basis. For example, depending on the frequency of medicament intakes, the device log may be sent within an hour after a scheduled intake time. If the server has not received a log file from a device, it may send a Send Log Message commanding the device to send its log file immediately. Even though the server did not receive a log from a device, a reminder message may not be required at this time because an intake event may have already occurred, and a reminder message could cause confusion to the patient. If the device is capable of sending its log upon receiving the send log command, then the log may be analyzed by the server to determine if an intake has indeed occurred. If it is determined that the scheduled intake has not occurred, then the server may send out an intake reminder message to the device. A monitoring process on the server may begin upon sending the intake reminder to the device. If the device does not send the device log indicating that an intake event occurred within a certain time period (e.g., one hour), the server may escalate the notification to the patient's mobile phone, to designated caregiver(s), or the like.

Upon receiving a Send Log Message from the server, the device may perform the following actions: 1 ) parse the command (identified to be send log request); 2) record the command in the device log; 3) connect to the server and send the device log; 4) remove the device log records older than a certain number of days; 5) record the send log event in the device log; 6) if the send log process fails, attempt to resend the log a predetermined number of additional times; 7) if the send log process continues to fail, check for the next available communication protocol and attempt to send the log using that protocol until the log is successfully sent or all available communication methods have been exhausted; 8) whether the send log process is successful or not, resume normal operation of the device, or initiate a recovery process if the devices fails to resume its normal operation.

Device Probe Message

As discussed above, a device is scheduled to send its log to the server on a regular basis. If the server has not received a device update an hour past the scheduled time, it may send to the device a Device Probe Message. If the server does not receive the device update after an hour, it may escalate the messaging to the patient or caregiver's mobile phone. Further, if a device update is not received an hour after the escalation measure, the server may send out additional probe messages hourly to the device, prompting the device to report back to the server by sending its log file. A device may not send its log file if the Device Probe Message arrives just after the device has sent its log. The server may check for a device's latest log upload time to decide if another probe message should be sent. Expiration time for the command contained in the Device Probe Message may be one hour, since another probe message would have been sent by then.

Upon receiving the Device Probe Message from the server, the device may perform the following actions: 1 ) parse the command (identified to be device probe request); 2) record this command in the device log; 3) connect to the server and send the device log; 4) if the send log process should fail, attempt 2 more times; 5) if the send log process continues to fail, check for the next available communication protocol and attempt to send the device log again until the log is successfully sent or all available communication methods are exhausted; and 6) whether the send log process is successful or not, resume device normal operation or initiate a device recovery process if the device is not able to resume its normal operation.

Server Messages

During normal operation, a patient has set up a medication intake schedule that is registered with the server. The server may be expecting to receive the device log at the schedule intake time, with a one-hour tolerance before and after the scheduled intake time. As discussed above, the warning messages for "intake too early" or "intake too late" may be displayed on the device under the device application control. Further, the server may be notified of such events since they are included in the device log. If the device log indicates a consistent deviation from the intake schedules, the server may generate appropriate motivational messages to be sent to the device to help assist the patient to take the medicaments closer to the scheduled intake times.

Upon receiving a Server Message, a device may perform the following actions: 1 ) parse the command (identified to be server message); 2) record the message in the device log; 3) display the message on the device's display. The device may also trigger various audio, video, and/or vibrational alarms to indicate to the patient that a message has been received. Motivational messages may expire within 24 hours or longer as they are generated in response to certain behavioral patterns of the patient. These patterns are generally developed over several intake event cycles and may be unlikely to change without consistent coaching.

Server Communicator Process

The device application also includes a Server Communication Process 368 for controlling communication between devices and the server. A GSM module (e.g., the GSM module 32 shown in Figure 7A) in each device may be embedded with a TCP/IP protocol stack. The operating system of the device may also support TCP/IP socket interface. A device communication manager may be operative to manage multiple wireless networks, and to make use of these networks in the following order of preference: 1 ) Wi-Fi; 2) EDGE; 3) GPRS; 4) CDMA; and 5) other networks. As can be appreciated, the hierarchical order of networks may be varied depending on the type of networks available, costs, locations, etc.

Wireless communication may be used to send transactions between the device and the server choosing the least cost communication method. The device may initiate a connection to the server using the URL of the server that is pre-stored on the device, choosing the communication method in the order of availability. Because patients are mobile and thus the devices are mobile, not all wireless networks may be accessible at all particular geographic locations where the device is used.

The system may include multiple servers that may be deployed at disparate geographical locations (e.g., United Kingdom, Canada, Singapore/Hong Kong, and the like). In this embodiment, multiple server URLs may be pre-stored in each device. In this regard, devices may be operative to connect to the server nearest to its current location, thereby improving the response time for the device. This feature is further described below with reference to Figure 19.

The device application may also be configured to operate in an autonomous mode, also referred to herein as an offline mode or "Airplane" mode. This mode may be initiated by a user of the device, or may be initiated in the event that communication network services are not available or no server is connectable. When in the autonomous mode, the device may perform all the functions described herein with the exception of sending and receiving messages to and from the servers.

User Event Handler

When the lid of a device is opened, the patient may be prompted to login (if device security was activated). The User Event Handler 355 may control of all the input/outputs events of the user interface of the device. User events generally include all user interactions with the device. Examples of user events are shown in the display 154 shown in Figure 12A and may include, but are not limited to: 1 ) User Preferences including display settings, sounds, security, and date/time information; 2) Modes of Operation such as Normal and Airplane mode; 3) Pharmacy Information including prescriptions, pill counts, and side effects; 4) Calendar information including intake schedules, clinical appointments, and "My Info" (reports and history).

Many of the changes to user preferences (e.g., display wallpaper, sounds, other display settings, and the like) may not be required to be sent to the server for updating the server's database, except for changes made to date, time and locale. As can be appreciated, these parameters may directly affect the enforcement of intake time, server priority, and server-generated messages, so it is appropriate that changes made to these parameters are sent to the server.

Generally, the date, time and locale of a device are configured during a device registration process, which stores these values in both the device's memory and the server database. The device may use these values to calculate the time when various reminder messages and alerts should be displayed. The server may use the same set of values to calculate the time when it should generate reminder alerts, motivational messages, and SMS messages to a patient's and/or caregiver's mobile phones. Once the locale of a device is changed, calculations may have to be adjusted in the device override mode to account for changes in time zones, etc. Generally, both the device and the server database should not overwrite the values initially set during the Device Registration process. In this regard, all new values may be stored in an override stack, which is reset back to the original values when a user resets the overrides. Generally, the original values may only be reset by erasing the memory of the device, thus erasing all user specific data stored during Device Registration, Device Activation and Device Configuration processes, with the exception of the URLs of the server that may be required for the device to remain updatable.

Device Configurator

As shown in Figure 17, the device application also includes a Device

Configurator 354 that is operative to permit devices to be configured for use by a patient. Initially, certain information may be preset at a distribution center before a device is shipped to a clinic. Typical set up information may include a Device ID, Clinic ID, Drug (description, side effects, and help information), SIM ID (mobile network), locale, and the URL of the server. Device information may be recorded in the server database. For ease of provisioning, such information may be programmed on a workstation and bulk loaded onto a plurality of devices. Typically, only the SIM ID will be changed from device to device for the batch of devices to be shipped to a particular clinic. This step is generally referred to as Device Registration, and is part of a larger Device Provisioning Process.

Next, a clinician working at a clinic may set up the Clinic ID, Clinic Phone, Patient ID and Phone before handing the device over to a patient. Additional clinical, physician and pharmacy information (when later identified) may also be recorded on the device. The information may be sent as a single transaction to the server for updating the record of the device, identified by the Device ID, previously registered in the server database at the aforementioned distribution center. This process is generally referred to as Device Activation, and may require devices to be registered to the server as a prerequisite thereto.

Once a device has been registered and activated, the patient may enter additional information and preferences into the device by the device's user interface (e.g., a touch screen). This process is generally referred to as Device Configuration. As can be appreciated, updates to this information and preferences may be changed at any time by the patient via the user interface of the device. Device Failover Process

Figure 19 depicts a Device Failover Process 500 in accordance with an embodiment of the present invention. In this embodiment, multiple servers are deployed in various locations that are replicas of each other. In this regard, a device can potentially access anyone of the operational servers, following a server priority list organized by locale proximity and prepared by a master server. Further, this list may be dynamic to recognize new servers registered with the system.

As shown in Figure 19, a device may attempt to send its log file to a target server that is the device's default server, steps 502 and 504. If the device fails to communicate with its default server, it may periodically retry to connect with the default server a plurality of times (e.g., three times), steps 506, 508, 510, 512, and 504. If the device receives a response from the default server, it may then wait for a certain period to resend its log file to the default server as part of the device's normal operations process, step 514.

Once the device has tried and failed to communicate with the default server, the device may check to determine whether a Switch Server command has been received, step 516. If a Switch Server command has been received, the device will set a new server, Server X, as its target server, step 518. Next, the device will set its log file with the ID of the new target server and report in the log the ID of the server that failed to respond, step 520. If the device did not receive a Switch Server command, the device may determine whether there are other servers available, step 524. If no other servers are available, the device will retain the default server as its target server and retry communicating with the default server in 30 minutes, steps 528 and 530. However, if other servers are available, the device will set the next available server as its target server, step 526. Next, the device may set its log file with the ID of the new target server and report in the log the ID of the server that failed to respond, steps 520 and 522. As can be appreciated, the available server, being a replica with all information necessary to support the device, may not have the device log records to perform the appropriate tasks for the device. This server, therefore, may have to retrieve a number of device log records from a master server database as part of the takeover process.

Various embodiments of the invention are described above in the Detailed Description. While these descriptions directly describe the above embodiments, it is understood that those skilled in the art may conceive modifications and/or variations to the specific embodiments shown and described herein. Any such modifications or variations that fall within the purview of this description are intended to be included therein as well. Unless specifically noted, it is the intention of the inventors that the words and phrases in the specification and claims be given the ordinary and accustomed meanings to those of ordinary skill in the applicable art(s). It is, therefore, evident that the particular embodiments disclosed above may be altered or modified and all such variations are considered within the scope and spirit of the invention.

Claims

CLAIMS WHAT IS CLAIMED IS:
1. A medicament management device, comprising:
a compartment for housing medicaments;
a memory module for storing information related to a patient's medicament regimen;
a processor for managing the patient's medicament regimen;
at least one patient-processor interface for communicating with the patient; and a wireless communication module for communicating with a third party.
2. The medicament management device of claim 1 , wherein the patient- processor interface is configured for providing at least one of an audio, visual, and vibrational notification to the patient.
3. The medicament management device of claim 1 , wherein the wireless communication module is configured to transmit or receive information relating the patient's compliance or non-compliance with the medicament regimen.
4. The medicament management device of claim 1 , wherein the wireless communication module is configured to transmit and receive information to and from the third party regarding instructions and changes to the patient's medicament regimen.
5. The medicament management device of claim 1 , wherein the memory module stores medicament regimen information, patient compliance information, and intervention information.
6. The medicament management device of claim 1 , wherein the wireless communication module is configured for communicating over a Wi-Fi network.
7. The medicament management device of claim 1 , wherein the wireless communication module is configured for transmitting and receiving messages using short message service (SMS).
8. The medicament management device of claim 1 , wherein the wireless communication module is configured for transmitting and receiving messages over one or more cellular networks.
9. The medicament management device of claim 1 , wherein the
compartment is configured to receive a removable insert that comprises medicaments.
10. The medicament management device of claim 1 , wherein the patient- processor interface comprises a touch screen display.
11. The medicament management device of claim 1 , wherein the patient- processor interface comprises a text display.
12. The medicament management device of claim 1 , wherein the patient- processor interface comprises physical buttons or needle buttons.
13. The medicament management device of claim 1 , further comprising: a sensor coupled to the processor and configured to detect an action
corresponding to the patient accessing the medicaments.
14. The medicament management device of claim 1 , wherein the
compartment is shaped and sized to contain a blister pack of medicaments.
15. The medicament management device of claim 1 , wherein the
compartment is a first compartment, the medicament management device further comprising:
a second compartment configured to house medicament different than the medicament housed in the first compartment.
16. The medicament management device of claim 1 , wherein the compartment is configured for housing more than one type of medicaments.
17. The medicament management device of claim 1 , further comprising: a lid configured to selectively cover the compartment to alternately secure and provide access to the medicaments housed within the compartment.
18. The medicament management device of claim 17, wherein the lid is pivotably attached to the medicament management device.
19. The medicament management device of claim 17, wherein at least a portion of the patient-processor interface is positioned on the lid.
20. The medicament management device of claim 17, wherein the lid is slidably attachable to the medicament management device.
21. The medicament management device of claim 1 , wherein the wireless communication module is further configured for short-range wireless communication between the medicament management device and a remote electronic device.
22. The medicament management device of claim 1 , wherein the wireless communication module is configured for communicating with the third party using at least two communication services selected from the group consisting of: a cellular network, Wi-Fi, and short message service (SMS).
23. The medicament management device of claim 1 , wherein the memory module stores a device application, and the processor is operative to execute instructions of the device application to cause the medicament management device to: provide an alert to the patient indicating that the medicament is to be taken, wherein the alert is provided dependent on the patient's medicament regimen; monitor for receipt of an indication that the patient consumed the medicament; and
provide a communication to the patient via the patient-processor interface dependent on the monitoring.
24. The medicament management device of claim 23, wherein the process is further operative to execute instructions of the device application to cause the medicament management device to:
provide an alert to the patient through the patient-processor interface in the event an indication was not received within a specific time period.
25. The medicament management device of claim 1 , wherein the memory module stores a device application, and the processor is operative to execute instructions of the device application to cause the medicament management device to: provide an alert to the patient indicating that the medicament is to be consumed, wherein the alert is provided dependent on the patient's medicament regimen;
monitor for receipt of an indication that the patient consumed the medicament; and
communicate the results of the monitoring to the third party.
26. The medicament management device of claim 1 , wherein the wireless communication module is operative to receive update information from the third party related to at least one of device updates, patient information updates, and patient medicament regimen updates.
27. The medicament management device of claim 1 , wherein the wireless communication module is operative to communicate using a plurality of networks according to a predetermined order of preference.
28. The medicament management device of claim 1 , wherein the memory module stores the addresses for a plurality of third party servers, and wherein the medicament management device is operative to communicate with the plurality of third party servers according to a predetermined order of preference.
29. The medicament management device of claim 28, wherein the
predetermined order of preference is dependent of the physical location of the medicament management device.
30. A method for medicament management, comprising:
providing a medicament management device that comprises:
a compartment for housing medicaments;
a memory module for storing information related to a patient's medicament regimen;
a processor for managing the patient's medicament regimen; at least one patient-processor interface for communicating with the patient; and
a wireless communication module for communicating with a third party; providing a first alert to the patient via the patient-processor interface that notifies the patient to consume the medicament; and
monitoring for receipt of an indication that the patient consumed the medicament within a predetermined period of time.
31. The method for medicament management of claim 30, wherein the indication is received via the patient-processor interface.
32. The method for medicament management of claim 30, further comprising: in response to a failure to receive the indication within the predetermined period of time, providing a second alert.
33. The method for medicament management of claim 32, wherein the second alert is provided via the patient-processor interface.
34. The method for medicament management of claim 32, wherein the second alert is provided to a device other than the medicament management device.
35. The method for medicament management of claim 32, wherein the second alert is provided by voicemail, electronic mail, or text message.
36. The method for medicament management of claim 30, further comprising: providing a notification to the patient via the patient-processor interface dependent on the monitoring.
37. The method of medicament management of claim 30, wherein the monitoring comprises comparing a time at which the indication is received to an expected time interval.
38. The method of medicament management of claim 30, wherein the indication is provided by an electric trigger communicatively coupled to the processor of the medicament management device.
39. A medicament management device comprising:
a compartment for housing medicaments for a patient;
a user interface comprising an input device and an output device;
an electronics module communicatively coupled to the user interface and operative to cause the output device to provide a notification to the patient according to a medicament regimen for the patient, the electronics module being further operative to receive signals from the input device indicating that the patient may have consumed the medicament; and
a wireless communication module for communicating with a third party.
40. The medicament management device of claim 39, wherein the electronics module is further operative to cause the output device to provide a notification to the patient when signals received from the input device do not conform to a predetermined rule relating to the patient's medicament regimen.
41. The medicament management device of claim 39, wherein the
medicament management device is configured to operate in an autonomous mode when the wireless communication module is unable to communicate with the third party.
42. The medicament management device of claim 39, wherein the wireless communication module is configured to communicate with a designated server and at least one additional server different from the designated server, and the wireless communication module is further configured to automatically communicate with the at least one additional server when unable to communicate with the designated server.
43. The medicament management device of claim 42, wherein the wireless communication module is configured to resume communication with the designated server after determining that the designated server is once again available.
PCT/US2010/055163 2009-11-02 2010-11-02 Smart medicament management methods and devices WO2011054000A1 (en)

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