WO2019147855A1 - Tamper-proof pill dispensing system and methods of use - Google Patents

Tamper-proof pill dispensing system and methods of use Download PDF

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Publication number
WO2019147855A1
WO2019147855A1 PCT/US2019/015010 US2019015010W WO2019147855A1 WO 2019147855 A1 WO2019147855 A1 WO 2019147855A1 US 2019015010 W US2019015010 W US 2019015010W WO 2019147855 A1 WO2019147855 A1 WO 2019147855A1
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WO
WIPO (PCT)
Prior art keywords
patient
pills
pill
storage container
application
Prior art date
Application number
PCT/US2019/015010
Other languages
English (en)
French (fr)
Inventor
John Hsu
Original Assignee
John Hsu
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
Priority claimed from US15/882,803 external-priority patent/US20180215526A1/en
Priority claimed from US16/144,685 external-priority patent/US10426707B2/en
Application filed by John Hsu filed Critical John Hsu
Priority to EP19744482.1A priority Critical patent/EP3746031A4/de
Priority to CA3089073A priority patent/CA3089073A1/en
Priority to PCT/US2019/015010 priority patent/WO2019147855A1/en
Publication of WO2019147855A1 publication Critical patent/WO2019147855A1/en

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Classifications

    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/13ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered from dispensers
    • 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
    • A61J7/0427Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system
    • A61J7/0445Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system for preventing drug dispensing during a predetermined time period
    • 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
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
    • 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
    • A61J2205/60General identification or selection means using magnetic or electronic identifications, e.g. chips, RFID, electronic tags
    • 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

Definitions

  • U.S. non-provisional application serial number 16/144,685 is a continuation-in-part application and so claims the benefit pursuant to 35 U.S.C. ⁇ 120 of prior filed and co-pending U.S. non-provisional patent application serial number 15/882,803, filed on January 29, 2018, which itself claims priority pursuant to 35 U.S.C. ⁇ 1 19(e) to and is entitled to the filing date of U.S. provisional patent application serial number 62/451 ,634, filed on January 27, 2017. The contents of the aforementioned applications are incorporated herein by reference.
  • the subject of this patent application relates generally to medication dispensing devices, and more particularly to a tamper-proof pill dispensing system and associated methods of use.
  • opiods include prescription drugs such as oxycodone (OXYCONTIN®, OXECTA®, ROXICODONE®), oxycondone and acetaminophen (PERCOCET®, ENDOCET®, ROXICET®), hydrocodone (HYSINGLA ER®, ZOHYDRO ER®), hydrocodone and acetaminophen (LORCET®, LORTAB®, NORCO®, VICODIN®), hydromorphone (DILAUDID®), meperidine (DEMEROL®), methadone, codeine, morphine, and fentanyl as well as illegal drugs such as heroin.
  • prescription drugs such as oxycodone (OXYCONTIN®, OXECTA®, ROXICODONE®), oxycondone and acetaminophen (PERCOCET®, ENDOCET®, ROXICET®), hydrocodone (HYSINGLA ER®, ZOHYDRO ER®),
  • an at least one tamper-proof pill storage container provides an at least one pill magazine positioned within a housing of the pill storage container and configured for storing and selectively dispensing a plurality of pills through a pill outlet provided by the housing.
  • a patient application residing in memory on an at least one patient device under the control of the patient, is in selective communication with the at least one pill storage container.
  • An at least one monitoring device is in selective communication with the patient application, the at least one monitoring device configured for assisting the patient application with monitoring an at least one vital of the patient.
  • the system is configured for obtaining from the patient a security code and an at least one biometric marker associated with the patient.
  • a prescription associated with the pills including a dosage interval and a dosage quantity, is registered with the system.
  • the patient application Upon the patient application determining that a dosage of the pills is available for the patient, based on the associated dosage interval, the patient application notifies the patient via at least one of an audible alert, a visual alert and a vibrational alert via the at least one patient device.
  • the patient application then obtains from the patient the security code and the at least one biometric marker.
  • the patient application Upon the patient application authenticating the security code and the at least one biometric marker, the patient application transmits a signal to the at least one pill storage container, instructing said pill storage container to distribute a quantity of pills equal to the associated dosage quantity. Upon the pill storage container distributing the pills to the patient, it transmits a signal back to the patient application, and the patient application schedules a future dosage of the pills based on the associated dosage interval. In the event the patient application determines that the at least one monitored vital is abnormal, the patient application notifies the patient via at least one of an audible alert, a visual alert and a vibrational alert via the at least one patient device, and temporarily suspends future dosages of the pills until the patient application determines that said monitored vital has returned to normal
  • Figure 1 is a simplified schematic view of an exemplary tamper-proof pill dispensing system, in accordance with at least one embodiment
  • Figure 2 is a simplified schematic view of a further exemplary tamper-proof pill dispensing system, in accordance with at least one embodiment
  • Figure 3 is a flow diagram of an exemplary method for dispensing pills using the exemplary tamper-proof pill dispensing system, in accordance with at least one embodiment
  • Figure 4A is a cross-sectional view of a further exemplary pill storage container, in accordance with at least one embodiment
  • Figure 4B is a perspective view of the pill storage container of Fig. 4A;
  • Figure 4C is a cross-sectional view of a pill magazine of the pill storage container of Fig.
  • Fig. 4D is a side view of the pill storage container of Fig. 4A;
  • FIGs. 5A-50 are illustrations of exemplary user interfaces as displayed by an exemplary patient device, in accordance with at least one embodiment
  • FIGs. 6A-6D are images of a further exemplary pill storage container, illustrating the sequential process of replacing an exemplary pill magazine, in accordance with at least one embodiment
  • Figs. 7A-7C are images of a still further exemplary pill storage container, in accordance with at least one embodiment
  • FIGS. 8A-8C are further images of the exemplary pill storage container of Figs. 7A-7C;
  • FIG. 9 is a simplified schematic view of a further exemplary tamper-proof pill dispensing system, in accordance with at least one embodiment.
  • Figure 10 is a flow diagram of a further exemplary method for dispensing pills using the exemplary tamper-proof pill dispensing system, in accordance with at least one embodiment.
  • Fig. 1 there is shown a simplified schematic view of an exemplary tamper-proof pill dispensing system 20 configured for managing the distribution of pills 14 to an at least one patient.
  • the system 20 provides an at least one tamper-proof pill storage container 12, and an at least one patient device 1 in selective communication with the at least one pill storage container 12, with each of the pill storage container 12 and patient device 1 in the possession or control of the associated patient (or a designated, authorized surrogate such as a nurse, a family member, a law enforcement officer, a substance abuse counselor, an aide, etc.) - for simplicity purposes, the user will be referred to generally herein as“patient.”
  • the at least one pill storage container 12 is controlled remotely by the associated at least one patient device 1.
  • the patient device 1 is also in selective communication with an at least one clinician device 8 in the possession or control of a participating clinician tasked with monitoring the patient’s proper consumption of the pills 14.
  • the term“clinician” is intended to generally include any type of medical professional or medical entity which might be tasked with monitoring the patient’s proper consumption of the pills 14 - including but not limited to a physician, a nurse, a pharmacist, and an electronic medical record system.
  • each of the at least one tamper-proof pill storage container 12, at least one patient device 1 , and at least one clinician device 8 may be achieved using any wired- or wireless-based communication protocol (or combination of protocols) now known or later developed.
  • any wired- or wireless-based communication protocol or combination of protocols
  • the present invention should not be read as being limited to any one particular type of communication protocol, even though certain exemplary protocols may be mentioned herein for illustrative purposes.
  • patient device and“clinician device” are intended to include any type of computing or electronic device, now known or later developed, capable of communicating with one another as described herein - such as desktop computers, mobile phones, smartphones, laptop computers, tablet computers, personal data assistants, gaming devices, wearable devices, etc.
  • system 20 should not be read as being limited to use with any one particular type of computing or electronic device, even though certain exemplary devices may be mentioned or shown herein for illustrative purposes.
  • each of the at least one tamper-proof pill storage container 12, at least one patient device 1 , and at least one clinician device 8 contains the hardware and software necessary to carry out the exemplary methods for administering the pill dispensing system 20, as described herein.
  • the at least one patient device 1 provides a patient application 3 residing locally in memory 9 on the patient device 1 , the patient application 3 being configured for selectively communicating with at least one of the at least one pill storage container 12 and the at least one clinician device 8, as discussed further below.
  • each of the at least one patient device 1 and clinician device 8 may reside on a single computing and/or electronic device, or may separately reside on two or more computing and/or electronic devices in communication with one another.
  • the functionality provided by the patient application 3 resides remotely in memory on the at least one clinician device 8 (or a server in communication with the at least one clinician device 8 - hereinafter collectively referred to as the clinician device 8 for simplicity purposes), with the at least one patient device 1 capable of accessing said functionality via an online portal hosted by the clinician device 8 and/or server, either in addition to or in lieu of the patient application 3 residing locally in memory 9 on the at least one patient device 1.
  • the functionality provided by the patient application 3 will be described herein as such - even though certain embodiments may provide some or all of said functionality through an online portal.
  • the at least one patient device 1 provides an at least one display screen 10 for providing an at least one graphical user interface to allow the associated patient to access and utilize the various functions provided by the system 20.
  • the at least one patient device 1 provides an at least one biometric sensor 2, the purpose of which is discussed further below.
  • the at least one biometric sensor 2 is at least one of a fingerprint scanner, a facial recognition system (i.e., a camera with corresponding facial recognition software), an iris scanner, and a retinal scanner.
  • the at least one biometric sensor 2 may be any other type of biometric sensor now known or later developed.
  • the at least one pill storage container 12 provides the at least one biometric sensor 2.
  • the at least one pill storage container 12 further provides a combination lock 11.
  • the combination lock functionality is implemented electronically by the patient application 3 via the display screen 10 of the patient device 1.
  • Fig. 1 also illustrates the internal components contained within a housing 19 of the at least one pill storage container 12, in at least one embodiment.
  • the housing 19 may take on any other size, shape or dimensions now known or later conceived - for example, a square or rectangular box, an oval container, an oblong container, a cylindrical container, or a pen-shaped container.
  • the pill storage container 12 provides an at least one pill magazine 13 positioned within the housing 19 and configured for storing and selectively dispensing a plurality of pills 14 through a pill outlet 5 provided by the housing 19.
  • the pill magazine 13 is spring-loaded.
  • the pill magazine 13 is in mechanical communication with a drive shaft 16 positioned and configured for ejecting a pill 14 from the pill magazine 13 through the pill outlet 5.
  • an at least one battery 17 is in electrical communication with a solenoid 18, and a magazine drive shaft 15 is in operable connection with the drive shaft 16, which in turn is in operable connection with the solenoid 18.
  • the pill storage container 12 may provide any other mechanism or combination of mechanisms, now known or later developed, capable of ejecting a pill 14 from the pill magazine 13 through the pill outlet 5.
  • the housing 19 further provides a selectively lockable outlet cover 22 positioned and configured for selectively restricting access to the pill outlet 5, as discussed further below.
  • the housing 19 further provides an actuator 4 configured for causing a pill 14 to be ejected from the pill magazine 13 through the pill outlet 5.
  • the actuator 4 is a button.
  • the actuator 4 may be any other mechanism or combination of mechanisms, now known or later developed, capable of mechanically or electrically causing a pill 14 to be ejected from the pill magazine 13 through the pill outlet 5.
  • the housing 19 further provides a wireless microcontroller 6 and a power source 7.
  • the power source 7 is at least one of an internal battery, an external battery, and an AC/DC electrical plug.
  • the pill storage container 12 provides an at least one tamper-proof substance positioned and configured for selectively rendering the pills 14 inert, inactive or intolerable to the patient in the event the pill storage container 12 or the pill magazine 13 is tampered with.
  • the tamper-proof substance is cyanoacrylate configured for being released and coating the pills 14 in the event the housing 19 of the pill storage container 12 or the pill magazine 13 is physically compromised - i.e., if an attempt is made to access the pills 14 in any way, when access to the pills 14 is otherwise not permitted.
  • the cyanoacrylate is at least one of methyl cyanoacrylate, ethyl cyanoacrylate, N-butyl cyanoacrylate and 2-octyl cyanoacrylate.
  • the tamper-proof substance is methyl methacrylate configured for being released and coating the pills 14 in a gel in the event the housing 19 of the pill storage container 12 or the pill magazine 13 is physically compromised or exposed to water.
  • the patient application 3 residing either locally in memory 9 on the at least one patient device 1 or remotely on the clinician device 8, upon the associated patient utilizing the system 20 to manage the distribution of their prescribed pills 14, the patient application 3 first determines whether the associated patient is new to the system 20. If the associated patient is new, the patient is required to properly register a new user account with the system 20 via the patient application 3 - or, alternatively, via any other computing or electronic device capable of communicating with the system 20.
  • the patient is asked to provide select details related to at least one of the patient’s personal information, as well as a security code and an at least one biometric marker associated with the patient (such as a fingerprint, a facial image, a retinal image, or an iris image for example).
  • the patient is also provided with the at least one pill storage container 12, which is then associated with the patient device 1 for enabling selective communication therebetween, as discussed further below.
  • the pills 14 are loaded into the pill storage container 12 (via the pill magazine 13) by an authorized clinician, to better ensure that the patient will not attempt to misuse or share the pills 14.
  • the patient application 3 requires the patient (or the clinician) to register the prescription with the patient application 3.
  • the patient is able to register the prescription by scanning or inputting a unique prescription code into the patient application 3, with the prescription code containing the necessary information related to the prescription distribution, including a dosage interval (i.e., the amount of time between distributing the pills 14) and a dosage quantity (i.e., the quantity of pills 14 to be distributed at each dosage interval).
  • the patient is able to register the prescription by scanning a visual barcode (such as a QR code, for example) using a camera 24 of the patient device 1.
  • the patient application 3 encrypts each of the biometric marker, security code and prescription code with a unique hash value (such as a random number, in at least one embodiment) to be stored in each of the patient device 1 and the associated pill storage container 12, thereby creating a unique link therebetween.
  • a unique hash value such as a random number, in at least one embodiment
  • the patient application 3 after the prescription has been registered with the patient application 3, the patient application 3 provides a countdown timer or otherwise notes the date and time for the next dosage (based on the associated dosage interval) via the display screen 10 of the patient device 1. Upon determining that the next dosage is available for the patient, the patient application 3 notifies the patient using at least one of an audible, visual and/or vibrational alert via the patient device 1. In at least one embodiment, the patient is required to provide the appropriate biometric marker via the at least one biometric sensor 2 and also input their security code via either the patient application 3 or a combination lock 11 provided by the pill storage container 12.
  • the patient must provide the appropriate biometric marker within a finite, pre-defined period of time - such as within five minutes from the patient application 3 notifying the patient of the dosage availability, for example - else the pills 14 will not be distributed to the patient for that dosage interval. Additionally, in at least one such embodiment, the patient must input their security code within a finite, pre-defined period of time - such as within one minute from the patient providing the appropriate biometric marker, for example - else the pills 14 will not be distributed to the patient for that dosage interval. Additionally, in at least one such embodiment, the patient application 3 requires the patient to provide the appropriate biometric marker and the security code in sequence.
  • the patient application 3 Upon the patient application 3 authenticating the provided biometric marker and security code, the patient application 3 transmits a signal to the pill storage container 12, instructing the pill storage container 12 to distribute a quantity of pills 14 equal to the associated dosage quantity via the pill outlet 5.
  • the pill storage container 12 will only distribute the quantity of pills 14 after the patient activates the actuator 4 positioned on the housing 19 of the pill storage container 12.
  • the outlet cover 22 is temporarily unlocked to allow the patient access to the pill outlet 5.
  • the actuator 4 must be activated by the patient within a finite, pre-defined period of time - such as within five minutes from the patient application 3 notifying the patient of the dosage availability, for example - else the pills 14 will not be distributed to the patient forthat dosage interval.
  • the pill storage container 12 Upon the pill storage container 12 distributing the pills to the patient, the pill storage container 12 transmits a signal back to the patient application 3, and the patient application 3 schedules the next dosage based on the associated dosage interval.
  • the patient application 3 also records the date, time and dosage quantity, which can be subsequently reviewed by the patient or an authorized clinician.
  • the patient application 3 utilizes blockchain to securely store this data, so as to maintain a tamper-proof record that may be reviewed by the authorized clinician. In at least one embodiment, if the patient attempts to obtain pills 14 during any time other than the scheduled dosage times, the patient application 3 informs the patient that they must wait until the next scheduled dosage time.
  • the patient device 1 via the patient application 3, can also securely transmit the data to the at least one clinician device 8.
  • an authorized user of the clinician device 8 can change the patient’s prescription - including the associated dosage interval and dosage quantity - and communicate the changes to the patient application 3.
  • the clinician device 8 is capable of securely transmitting other messages to the patient application 3 as well.
  • the patient application 3 upon the patient application 3 determining that the at least one pill magazine 13 of the pill storage container 12 is empty or running low, the patient application 3 notifies the patient that a new prescription (or alternatively, a refill) is required. In at least one such embodiment, where the patient application 3 is in selective communication with the at least one clinician device 8, the patient application 3 also notifies the associated clinician that a new prescription (or alternatively, a refill) is required.
  • the process of removing the empty pill magazine 13 from the pill storage container 12 and inserting a full pill magazine 13, in accordance with at least one embodiment, is sequentially illustrated in Figs. 6A-6D. [0038] In at least one embodiment, as illustrated in the simplified schematic view of Fig.
  • the system 20 also provides an at least one monitoring device 26 in selective communication with the patient device 1 and configured for assisting the patient application 3 with monitoring one or more vitals associated with the patient, in order to better manage the distribution of pills 14 to the patient.
  • the at least one monitoring device 26 is a respiratory monitor positioned and configured for assisting the patient application 3 with monitoring a breathing rate of the patient, utilizing acoustic respiratory monitoring or impedance respiratory monitoring for example.
  • the at least one monitoring device 26 may include any other type of device, sensor, or combination thereof - now known or later developed
  • the patient device 1 and the at least one monitoring device 26 are one and the same
  • the patient application 3 attempts to notify the patient using at least one of an audible, visual and/or vibrational alert via the patient device 1 (1014). In at least one embodiment, the patient application 3 will also transmit a notification to the at least one associated clinician device 8 (1012). Additionally, in at least one embodiment, if the patient fails to timely respond to the notification via the patient application 3 (1016), depending on the degree of abnormality in the at least one monitored vital (1018) - for example, where the patient application 3 determines that the patient is not breathing - the patient application 3 automatically alerts local emergency personnel and provides the patient’s current location based on the GPS location of the patient device 1 (1020).
  • the patient application 3 may temporarily suspend future distributions of the pills 14 (1010) until the at least one monitored vital returns to normal. In this way, the patient application 3 is able to monitor the effects of the pills 14 and automatically respond accordingly.
  • the patient application 3 upon the patient application 3 determining that the patient is not properly using the at least one monitoring device 26 (1002) - for example, if the user is not wearing the at least one monitoring device 26 in the proper position, or not wearing the at least one monitoring device 26 at all - the patient application 3 attempts to notify the patient using at least one of an audible, visual and/or vibrational alert via the patient device 1 (1006) and may also temporarily suspend future distributions of the pills 14 (1004) until the patient begins using the at least one monitoring device 26 properly.
  • the system 20 further provides an at least one database 28 in selective communication with the patient device 1 and configured for storing data obtained by each of the patient application 3 and the at least one monitoring device 26, as discussed above.
  • the patient device 1 and database 28 are one and the same - as such, it is intended that those terms as used herein are to be interchangeable with one another as well.
  • a method for administering a pill dispensing system for managing the distribution of pills to a patient comprising the steps of: implementing an at least one tamper-proof pill storage container that provides an at least one pill magazine positioned within a housing of the pill storage container and configured for storing and selectively dispensing a plurality of pills through a pill outlet provided by the housing; implementing a patient application residing in memory on an at least one patient device under the control of the patient, the patient application in selective communication with the at least one pill storage container; implementing an at least one monitoring device in selective communication with the patient application, the at least one monitoring device configured for assisting the patient application with monitoring an at least one vital of the patient; obtaining from the patient, via the patient application, a security code; obtaining from the patient, via an at least one biometric sensor provided by at least one of the at least one patient device and the at least one pill storage container, an at least one biometric marker associated with the patient; registering, via the patient application, a prescription associated with the pills contained
  • step of obtaining an at least one biometric marker associated with the patient further comprises the step of obtaining at least one of a fingerprint of the patient, a facial image of the patient, a retinal image of the patient, and an iris image of the patient.
  • step of registering a prescription associated with the pills further comprises the step of processing, via the patient application, a unique prescription code associated with the pills, said prescription code containing the dosage interval and the dosage quantity.
  • step of processing a unique prescription code associated with the pills further comprises the step of scanning a visual barcode associated with the pills using a camera of the at least one patient device, said visual barcode containing the dosage interval and the dosage quantity.
  • step of instructing said pill storage container to distribute a quantity of pills equal to the associated dosage quantity further comprises the step of requiring the patient to activate an actuator positioned on the housing of said pill storage container in order for the pills to be distributed.
  • step of the patient application determining that the at least one monitored vital is abnormal further comprises the step of notifying the at least one clinician device, via the patient application, of the abnormal vital.
  • step of releasing an at least one tamper-proof substance further comprises the step of releasing cyanoacrylate.
  • step of releasing an at least one tamper-proof substance further comprises the step of releasing methyl methacrylate.
  • step of implementing an at least one monitoring device further comprises the step of implementing an at least one respiratory monitor positioned and configured for obtaining a breathing rate of the patient.
  • step of the patient application determining that the at least one monitored vital is abnormal further comprises the step of, upon the patient application failing to receive a response from the patient within a predefined period of time, automatically alerting, via the patient application, local emergency personnel.
  • a method for administering a pill dispensing system for managing the distribution of pills to a patient comprising the steps of: implementing an at least one tamperproof pill storage container that provides an at least one pill magazine positioned within a housing of the pill storage container and configured for storing and selectively dispensing a plurality of pills through a pill outlet provided by the housing; implementing a patient application residing in memory on an at least one patient device under the control of the patient, the patient application in selective communication with the at least one pill storage container; implementing an at least one respiratory monitor in selective communication with the patient application, the at least one respiratory monitor configured for assisting the patient application with monitoring a breathing rate of the patient; obtaining from the patient, via the patient application, a security code; obtaining from the patient, via an at least one biometric sensor provided by at least one of the at least one patient device and the at least one pill storage container, an at least one biometric marker associated with the patient; registering, via the patient application, a prescription associated with the pills contained within the
  • a pill dispensing system for managing the distribution of pills to a patient, the system comprising: an at least one tamper-proof pill storage container that provides an at least one pill magazine positioned within a housing of the pill storage container and configured for storing and selectively dispensing a plurality of pills through a pill outlet provided by the housing; a patient application residing in memory on an at least one patient device under the control of the patient, the patient application in selective communication with the at least one pill storage container; and an at least one monitoring device in selective communication with the patient application, the at least one monitoring device configured for assisting the patient application with monitoring an at least one vital of the patient; wherein, upon the patient desiring to utilize the system to manage the distribution of pills, the system is configured for: obtaining from the patient, via the patient application, a security code; obtaining from the patient, via an at least one biometric sensor provided by at least one of the at least one patient device and the at least one pill storage container, an at least one biometric marker associated with the patient; registering, via
  • the open-ended transitional term “comprising” encompasses all the expressly recited elements, limitations, steps and/or features alone or in combination with un-recited subject matter; the named elements, limitations and/or features are essential, but other unnamed elements, limitations and/or features may be added and still form a construct within the scope of the claim.
  • the meaning of the open-ended transitional phrase “comprising” is being defined as encompassing all the specifically recited elements, limitations, steps and/or features as well as any optional, additional unspecified ones.
  • the meaning of the closed-ended transitional phrase “consisting of” is being defined as only including those elements, limitations, steps and/or features specifically recited in the claim, whereas the meaning of the closed-ended transitional phrase “consisting essentially of is being defined as only including those elements, limitations, steps and/or features specifically recited in the claim and those elements, limitations, steps and/or features that do not materially affect the basic and novel characteristic(s) of the claimed subject matter.
  • the open-ended transitional phrase“comprising” (along with equivalent open- ended transitional phrases thereof) includes within its meaning, as a limiting case, claimed subject matter specified by the closed-ended transitional phrases“consisting of or“consisting essentially of.”
  • embodiments described herein or so claimed with the phrase“comprising” are expressly or inherently unambiguously described, enabled and supported herein for the phrases “consisting essentially of and“consisting of.”
  • logic code programs, modules, processes, methods, and the order in which the respective elements of each method are performed are purely exemplary. Depending on the implementation, they may be performed in any order or in parallel, unless indicated otherwise in the present disclosure. Further, the logic code is not related, or limited to any particular programming language, and may comprise one or more modules that execute on one or more processors in a distributed, non-distributed, or multiprocessing environment.
  • the methods as described above may be used in the fabrication of integrated circuit chips.
  • the resulting integrated circuit chips can be distributed by the fabricator in raw wafer form (that is, as a single wafer that has multiple unpackaged chips), as a bare die, or in a packaged form.
  • the chip is mounted in a single chip package (such as a plastic carrier, with leads that are affixed to a motherboard or other higher level carrier) or in a multi-chip package (such as a ceramic carrier that has either or both surface interconnections or buried interconnections).
  • the chip is then integrated with other chips, discrete circuit elements, and/or other signal processing devices as part of either (a) an intermediate product, such as a motherboard, or (b) an end product.
  • the end product can be any product that includes integrated circuit chips, ranging from toys and other low-end applications to advanced computer products having a display, a keyboard or other input device, and a central processor.

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PCT/US2019/015010 2018-01-29 2019-01-24 Tamper-proof pill dispensing system and methods of use WO2019147855A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP19744482.1A EP3746031A4 (de) 2018-01-29 2019-01-24 Manipulationssicheres pillenausgabesystem und verwendungsverfahren
CA3089073A CA3089073A1 (en) 2018-01-29 2019-01-24 Tamper-proof pill dispensing system and methods of use
PCT/US2019/015010 WO2019147855A1 (en) 2018-01-29 2019-01-24 Tamper-proof pill dispensing system and methods of use

Applications Claiming Priority (5)

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US15/882,803 2018-01-29
US15/882,803 US20180215526A1 (en) 2017-01-27 2018-01-29 Tamper Proof System For Dispensing Pills
US16/144,685 US10426707B2 (en) 2017-01-27 2018-09-27 Tamper-proof pill dispensing system and methods of use
US16/144,685 2018-09-27
PCT/US2019/015010 WO2019147855A1 (en) 2018-01-29 2019-01-24 Tamper-proof pill dispensing system and methods of use

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US6304797B1 (en) * 1997-07-31 2001-10-16 Rapid Patient Monitoring, L.L.C. Automated medication dispenser with remote patient monitoring system
US20030099158A1 (en) * 1996-12-20 2003-05-29 Carlos De La Huerga Interactive medication container
US7366675B1 (en) * 2000-03-10 2008-04-29 Walker Digital, Llc Methods and apparatus for increasing, monitoring and/or rewarding a party's compliance with a schedule for taking medicines
US20150359711A1 (en) * 2013-08-26 2015-12-17 James Dean Ducatt Prescription control system
US20160158107A1 (en) * 2013-12-05 2016-06-09 Sheri Dvorak Prescription medication security and dispensing systems

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GB201418350D0 (en) * 2014-10-16 2014-12-03 Elucid Mhealth Ltd Dispenser and methods of use thereof
US20170028178A1 (en) * 2015-05-01 2017-02-02 Ahkeo Ventures LLC Systems and methods for medical diagnostics and medication delivery
US10660824B2 (en) * 2015-08-11 2020-05-26 Edmund L. Valentine Devices, system and method to control the delivery of oral medications to ensure they are efficacious , taken as prescribed, and to avoid unwanted side effects

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US20030099158A1 (en) * 1996-12-20 2003-05-29 Carlos De La Huerga Interactive medication container
US6304797B1 (en) * 1997-07-31 2001-10-16 Rapid Patient Monitoring, L.L.C. Automated medication dispenser with remote patient monitoring system
US7366675B1 (en) * 2000-03-10 2008-04-29 Walker Digital, Llc Methods and apparatus for increasing, monitoring and/or rewarding a party's compliance with a schedule for taking medicines
US20150359711A1 (en) * 2013-08-26 2015-12-17 James Dean Ducatt Prescription control system
US20160158107A1 (en) * 2013-12-05 2016-06-09 Sheri Dvorak Prescription medication security and dispensing systems

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Title
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CA3089073A1 (en) 2019-08-01
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