Apparatus, device and method for prescribing, administering and monitoring a treatment regimen for a patient

• US 7,395,214 B2
• Filed: 05/08/2002
• Issued: 07/01/2008
• Est. Priority Date: 05/11/2001
• Status: Expired due to Fees

• Current Assignee: Craig P. Shillingburg
• Original Assignee: Craig P. Shillingburg
• Inventors: Shillingburg, Craig P
• Primary Examiner(s): GILLIGAN, CHRISTOPHER L
• Assistant Examiner(s): Glass; Russell Shay
• Application Number:
  US10/142,310
• Publication Number:
  US 20020169635A1
• Time in Patent Office: 2,246 Days
• Field of Search: 705 2- 3, 128897-906
• US Class Current: 705/2
• CPC Class Codes: G16H 20/13 delivered from dispensers

Abstract

A treatment Device is provided which enables a Doctor/Pharmacist to provide patient specific instructions in a textual format to a patient. The instructions are converted by a speech synthesizer provided in the Device into an audibly perceptible format. When configured as a hand-held unit, the Device may store a plurality of medications. Upon activation or automatically, instructions saved in the device are communicated to a patient/user via various audible, visual and/or tactile indicators. The instructions are provided to the device via a Platform which enables Doctors and Pharmacists input instructions into the Platform, which, via a Platform interface, are saved into a storage device provided in the Device. In an additional embodiment, a removable medication dispensing cartridge is provided which facilitates the controlled and automatic dispensing of a medication to a patient based upon a treatment schedule. Patient compliance information with a treatment schedule may be provided by the Device.

Claims

1. An apparatus utilized to provide messages which include instructions related to a treatment regimen for a patient, wherein the treatment regimen is provided to the apparatus via a Platform accessed by at least one of a Doctor and a Pharmacist, comprising:

a microprocessor for controlling the operation of a treatment device and gathering compliance information on the patient'"'"'s compliance with the treatment regimen;

a storage device, connected to the microprocessor, providing a storage location for a message that includes at least one instruction for administering a treatment regimen to the patient, wherein the message is provided to the apparatus via a Platform accessed by at least one of a Doctor and a Pharmacist;

an internal clock, providing timing signals to the microprocessor;

a speech synthesizer, connected to the microprocessor, for converting a message retrieved from the storage device by the microprocessor from a first format into an audibly perceptible message format for subsequent presentation to the patient, wherein the processor is configured, upon determining based upon a reading from the internal clock that a predetermined time has arisen, to retrieve the message from the storage device and provide the message to the speech synthesizer;

a communications interface, connected to the microprocessor, for providing feedback to at least one of the Doctor and the Pharmacist, the feedback at least partially based on the compliance information; and

at least one internal chamber for storing a medication, wherein the medication is at least one element of the treatment regimen and the medication is a prescribed medication or an over-the-counter medication; and

a cap configured to restrict access to the internal chamber, wherein the cap is selected from the group consisting of;

sliding top opener, sliding side opener, tab opener, pop top, twist top, and a child Proof top, the cap further comprises;

a cap sensor which detects when the cap is open, and the microprocessor records in the storage device a record of each opening of the cap and a time indicator when the cap was opened;

wherein the record of each opening of the cap and the time indicator comprise compliance information stored in the storage device, the compliance information being accessible via the Platform for playback and analysis by a Doctor or a Pharmacist.

2. The apparatus of claim 1, wherein the apparatus further comprises:

an amplifier, connected to the speech synthesizer, which amplifies the audibly perceptible message; and

a speaker, connected to the amplifier, which presents the audibly perceptible message to a user.

3. The apparatus of claim 1, wherein the internal chamber is configured to hold a disposable sleeve, wherein the disposable sleeve is configured to store and dispense at least one medication.

4. The apparatus of claim 1, wherein access to the internal chamber is restricted by a locking mechanism.

5. The apparatus of claim 4, wherein the locking mechanism further comprises a solenoid locking mechanism controlled by the microprocessor, wherein access to the internal chamber via the cap is allowed at those times when a treatment regimen calls for the dispensing of a medication from the apparatus, and at all other times, access to the internal chamber is restricted.

6. The apparatus of claim 1, wherein the apparatus further comprises at least one visual indicator of an operating status of the apparatus, selected from the group consisting of:

light emitting diode, liquid crystal display, fluorescent, incandescent, and neon.

7. The apparatus of claim 1, wherein the apparatus further comprises a user input interface selected from the group consisting of:

Talk button, volume control, alphanumeric keypad, voice command system, and at least one button.

8. The apparatus of claim 7, whereupon inputting a first utilization sequence via the user input interface, the microprocessor retrieves from the storage device a schedule for a medication treatment regimen, compares the schedule to a current reading of the internal clock, and selects a message to be presented to the user based upon whether the current reading is before, during or after a scheduled time for providing a treatment regimen to the patient;

whereupon inputting a second utilization sequence via the user input interface, the microprocessor retrieves from the storage device and presents to the user a message providing contact information for at least one of a Doctor and a Pharmacist; and

whereupon inputting a third utilization sequence via the user input interface the microprocessor retrieves from the storage device and presents to the user at least one of conflicts, warnings, and treatment regimen information.

9. The apparatus of claim 8, wherein the first utilization sequence, second utilization sequence and third utilization sequence further comprise depressing a Talk button for a pre-determined period of time or a pre-determined number of repetitions.

10. The apparatus of claim 1, wherein the apparatus further comprises:

a holding chamber, connected to the at least one internal chamber, for storing a dosage of a medication to be dispensed to a patient, wherein the holding chamber is accessible to the user; and

a medication transferring device, which transfers medication from the at least one internal chamber to the holding chamber;

whereupon receiving a command from the microprocessor, the medication transferring device transfers a pre-determined dosage of at least one medication from the at least one internal chamber to the holding chamber.

11. The apparatus of claim 10, wherein at least one internal chamber is configured to accept a removable medication dispensing cartridge further comprising:

a spring loaded platform that applies an upward pressure upon a medication contained within the cartridge;

a top, situated above and at the farthest extension of the spring loaded platform;

a first opening, situated near the top, providing access to the medication by the medication transferring device; and

a second opening, situated opposite from and parallel to the first opening, through which a dosage of a medication may be dispensed by the medication transferring device into the holding chamber;

whereupon receiving a command from the microprocessor to extract a medication from the cartridge within the internal chamber, the medication transferring device utilizes the first opening to direct the transfer of a dosage of medication stored in the cartridge through the second opening and into the holding chamber.

12. The apparatus of claim 11, wherein the medication transferring device further comprises a probe driven by a motor and a gear;

wherein the operation of the motor is controlled by the microprocessor; and

whereupon activation of the motor by the microprocessor, the probe enters through the first opening, makes contact with a dosage of medication, and pushes the dosage of medication through the second opening and into the holding chamber;

whereupon the probe returns through the first opening, and the spring loaded platform positions a next dosage opposite the probe for future insertion into the holding chamber.

13. The apparatus of claim 12, wherein the medication transferring device provides a tactile indication signal that a medication is available for dispensing to the patient.

14. The apparatus of claim 11, wherein the cartridge further comprises a first electrical connector, which includes an associated storage device containing information identifying the medication contained within the cartridge;

and wherein the apparatus further comprises a second electrical connector, connected to the microprocessor and situated opposite the first electrical connector;

wherein information identifying the medication contained within the cartridge is communicated to the microprocessor via the first and second electrical connectors.

15. The apparatus of claim 1, wherein the apparatus further comprises a Platform interface which facilitates bi-directional communications between the apparatus and the Platform, and wherein the Platform interface receives from the Platform, information related to the treatment regimen and provides the information to the storage device for storage.

16. The apparatus of claim 15, wherein the Platform interface further comprises a data port selected from the group consisting of:

a serial, a parallel, universal serial bus, infrared, RF, IrDA, Blue Tooth, wireless, Ethernet, RS-232, and a telephone data port.

17. The apparatus of claim 15, wherein the Platform interface further comprises a smart card reader, wherein the smart card reader, under the control of the microprocessor, retrieves from a smart card information related to the treatment regimen, and provides the information to the storage device for storage, wherein the information related to the treatment regimen is stored on the smart card by a Platform accessed by a Doctor or a Pharmacist.

18. The apparatus of claim 1, wherein the first format of the message is a text based format.

19. The apparatus of claim 1, wherein the apparatus further comprises a means for storing a verbal message.

20. The apparatus of claim 19, whereupon the occurrence of the predetermined time, the microprocessor directs the playback of the stored verbal message.

21. A device for providing patient specific prescription medication related treatment information comprising:

at least one internal chamber for storing a prescription medication;

a microprocessor for controlling the operation of the device and gathering compliance information on the patient'"'"'s compliance with the treatment regimen;

a memory storage device, connected to the microprocessor, for storing at least one message containing patient specific prescription medication related treatment information, wherein the message is associated with a scheduled treatment;

an internal clock for providing timing signals to the microprocessor;

a speech synthesizer, connected to the microprocessor, for receiving and converting the message into an audibly perceptible message, wherein the microprocessor is configured to, upon the occurrence of a scheduled treatment time, as determined by a comparison of the treatment schedule and the timing signals provided by the internal clock, recall the message from the memory storage device and provide the message to the speech synthesizer;

a speaker for presenting the audibly perceptible message to a patient;

a cap providing access to the prescription medication stored in the at least one internal chamber;

a Platform interface, connected to the microprocessor, providing an interface between the device and a Platform configured to enable at least one of a Doctor and a Pharmacist to provide the patient specific prescription medication related treatment information to the device and to monitor compliance by the patient with a treatment schedule;

a communications interface, connected to the microprocessor, for providing feedback to at least one of the Doctor and the Pharmacist, the feedback at least partially based on the compliance information; and

a cap sensor, connected to the microprocessor, and situated to monitor the position of the cap, whereupon opening of the cap by a user, a cap sensor signal is transmitted to the microprocessor, whereupon the receipt of the cap sensor signal the microprocessor records in the memory storage device the occurrence of the opening of the cap and a time of the opening as compliance information, the compliance information being utilized by at least one of the Doctor and Pharmacist, via the Platform connected to the device via the Platform interface, to verify the patient'"'"'s compliance with the treatment schedule.

22. The device of claim 21, wherein the memory storage device stores at least one verbal message.

23. The device of claim 22, wherein a stored verbal message is played back to the patient via the speaker.

24. The apparatus of claim 21, wherein the apparatus further comprises:

a holding chamber, connected to the at least one internal chamber, for storing a dosage of a medication to be dispensed to a patient; and

a medication transferring device, which transfers medication from the at least one internal chamber to the holding chamber;

whereupon receiving a command from the microprocessor, the medication transferring device transfers a pre-determined dosage of at least one medication from the at least one internal chamber to the holding chamber.

25. The device of claim 24, wherein the at least one internal chamber is configured to hold a removable medication dispensing cartridge further comprising:

a spring loaded platform that applies an upward pressure upon a medication contained within the cartridge;

a top, situated above and at the farthest extension of the spring loaded platform;

a first opening, situated near the top, providing access to the medication by the medication transferring device; and

a second opening, situated opposite from and parallel to the first opening, through which a dosage of a medication may be dispensed by the medication transferring device into the holding chamber;

whereupon receiving a command from the microprocessor to extract a medication from the internal chamber, the medication transferring device utilizes the first opening to direct the transfer of a dosage of medication through the second opening and into the holding chamber.

26. A method for providing instructions to a patient for a treatment regimen provided by a patient accessible device, comprising:

receiving an indication from a patient regarding a treatment regimen;

wherein the indication is provided by depressing a button on the patient accessible device;

gathering compliance information on the patient'"'"'s compliance with the treatment regimen;

retrieving a message, responsive to the indication and containing at least one instruction related to a treatment regimen for a patient, from a memory storage device provided in a patient accessible device;

converting the message into an audible format;

presenting the audibly formatted message to the patient via the patient accessible device;

providing feedback to at least one of a Doctor and a Pharmacist, the feedback at least partially based on the compliance information;

wherein the message was previously provided, at least one of the Doctor and the Pharmacist, to the memory storage device via a Platform connected to the memory storage device

determining whether a pre-determined time for dispensing a medication to the patient via the patient accessible device has arisen;

presenting the audibly formatted message to the patient when the pre-determined time has arisen; and

activating a visual indicator;

wherein the audibly formatted message presented and the visual indicator activated varies depending upon whether a current time is the same as the pre-determined time for dispensing a medication, a first warning time, or a second warning time;

monitoring the utilization of the patient accessible device, wherein the utilization of the patient accessible device is monitored by providing a cap and a cap sensor, wherein the cap sensor determines when the cap has been accessed by a user in order to gain access to at least one medication provided by the patient accessible device; and

recording each utilization of the patient accessible device by a user;

wherein each recording of each utilization of the patient accessible device provides compliance information utilized by the Doctor and Pharmacist to determine a compliance history for the patient with the treatment regimen.

27. The method of claim 26, wherein the method further comprises unlocking a cap securing access to at least one internal chamber provided in the patient accessible device in which a prescription medication is stored.

28. The method of claim 27, wherein the method further comprises monitoring the cap and recording when the cap is opened and access to the internal chamber is obtained.

29. The method of claim 26, wherein the method further comprises dispensing a medication from an internal chamber into a holding chamber at a scheduled time for providing the medication to the patient, wherein the holding chamber is accessible to the user.

30. The method of claim 29, wherein the scheduled time is provided in a treatment regimen schedule communicated to the device by the Platform via the Platform interface, wherein the treatment regimen schedule is specified to the Platform by at least one of the Doctor and the Pharmacist.

31. The method of claim 26, wherein the method further comprises verifying, via a treatment clearance system connected to the Platform, the treatment regimen is safe for the patient prior to providing the message to the patient accessible device.

32. The method of claim 26, wherein the method further comprises activating a medication transferring device, wherein the medication transferring device dispenses a medication from a first chamber into a holding chamber, the holding chamber being accessible to the patient for removing the dispensed medication from the patient accessible device.

33. The method of claim 26, wherein the determinations of the cap sensor are utilized by the Platform to generate a report indicating the patient'"'"'s compliance with the treatment regimen.