WO2020172484A1 - Distributeur de médicaments sous emballages coques commandé par une application de pharmacie au point d'intervention - Google Patents

Distributeur de médicaments sous emballages coques commandé par une application de pharmacie au point d'intervention Download PDF

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Publication number
WO2020172484A1
WO2020172484A1 PCT/US2020/019141 US2020019141W WO2020172484A1 WO 2020172484 A1 WO2020172484 A1 WO 2020172484A1 US 2020019141 W US2020019141 W US 2020019141W WO 2020172484 A1 WO2020172484 A1 WO 2020172484A1
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WIPO (PCT)
Prior art keywords
blister pack
dose
drug dispenser
dispenser
designed
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Ceased
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PCT/US2020/019141
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English (en)
Inventor
Edmund L. Valentine
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Accoy Pharmaceuticals Inc
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Accoy Pharmaceuticals Inc
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Publication of WO2020172484A1 publication Critical patent/WO2020172484A1/fr
Anticipated expiration legal-status Critical
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/18—Arrangements for indicating condition of container contents, e.g. sterile condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035—Blister-type containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0076—Medicament distribution means
    • A61J7/0084—Medicament distribution means for multiple medicaments
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/325—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil
    • B65D75/326—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil and forming one compartment
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/36—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed
    • B65D75/366—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages, the recess or recesses being preformed and forming one compartment
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/52—Details
    • B65D75/58—Opening or contents-removing devices added or incorporated during package manufacture
    • B65D75/5805—Opening or contents-removing devices added or incorporated during package manufacture for tearing a side strip parallel and next to the edge, e.g. by means of a line of weakness
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/52—Details
    • B65D75/58—Opening or contents-removing devices added or incorporated during package manufacture
    • B65D75/66—Inserted or applied tearing-strings or like flexible elements
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT 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
    • G16H20/13—ICT 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
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT 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
    • G16H40/20—ICT 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 management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT 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
    • G16H40/60—ICT 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
    • G16H40/67—ICT 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
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H70/00—ICT specially adapted for the handling or processing of medical references
    • G16H70/40—ICT specially adapted for the handling or processing of medical references relating to drugs, e.g. their side effects or intended usage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/30—Compliance analysis for taking medication
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/70—Device provided with specific sensor or indicating means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/70—Device provided with specific sensor or indicating means
    • A61J2200/72—Device provided with specific sensor or indicating means for temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS 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
    • A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
    • A61J7/0409—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers
    • A61J7/0427—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system
    • A61J7/0445—Arrangements 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02W—CLIMATE CHANGE MITIGATION TECHNOLOGIES RELATED TO WASTEWATER TREATMENT OR WASTE MANAGEMENT
    • Y02W30/00—Technologies for solid waste management
    • Y02W30/50—Reuse, recycling or recovery technologies
    • Y02W30/80—Packaging reuse or recycling, e.g. of multilayer packaging

Definitions

  • the present disclosure relates to a novel app-controlled Blister Pack pill dispenser that enables Point of Care Pharmacy through Dose-by-Dose Dispensing control.
  • the tamper-proof design deters Medication Diversion and accidental ingestion.
  • the integrated Intrusion Detection alerting system is an intrusion deterrent.
  • Biometric Authentication ensures only the Patient has access to the Medication, decreasing Medication Diversion.
  • the app interface precludes misuse and facilitates in identifying Patients who Abuse the Medication.
  • the unit dose Blister Pack design allows Medication tracking down to the Patient level and assists the Patient in opening the Blister Pack.
  • the Blister Pack protects the Medication from degradation, moisture, and outside contaminants. Sensors monitor storage temperature and humidity to ensure proper storage.
  • the dispenser housing is designed to be Moisture Resistant, accommodate a prescribed number of doses, fit in the Patient’s pocket or purse, facilitate Electronics Recycling and unused Drug disposal.
  • the design is scalable to accommodate different pill sizes, shapes and quantities in the smallest possible footprint.
  • the dose dispensing system can be configured to store and dispense more than one type of Medication.
  • ADEs Adverse Drug events
  • ED emergency department
  • Misuse of Prescription Drugs means taking a Medication in a manner or dose other than prescribed.
  • emergency department (ED) visits among children usually were due to ADEs caused by antibiotics and antipsychotics while three fourths of ADEs among older adults were caused by anticoagulants, antiplatelet agents, antidiabetic Drugs, and opioid analgesics.
  • the present invention describes a novel app-controlled Blister Pack Tamper Resistant Drug dispensing device and EasyOpenTM Blister Pack designed to enable app-controlled Point of Care PharmacyTM.
  • the app and dispenser are integrated to ensure: 1) the Medication is only dispensed to or (in the case of a minor) for the Patient for whom the Drug is prescribed (avoid divergence); 2) that the Prescription is only dispensed per the Prescription instructions (preclude misuse); and 3) that the dispensing of each dose is controlled by the app.
  • the present invention is able to use various Drug Dispenser configurations, designs, and sizes. They can be limited to a single Drug or configured to dispense multiple Drugs.
  • the Drug Dispenser can be a disposable unit or a reusable unit. It can be a standalone unit with a resident app or a Tethered Drug Dispenser controlled by an app resident on an Interface Device (e.g., smartphone, computer, tablet, or similar devices or a combination thereof).
  • an Interface Device e.g., smartphone, computer, tablet, or similar devices or a combination thereof.
  • the dispenser dispenses unit dose Blister Packs.
  • the dispenser can be filled at the factory or configured to be filled at the pharmacy or other authorized location.
  • Each Drug Dispenser is designed to: (i) fit in a pants pocket and/or purse, (ii) be water, and dust resistant, (iii) withstand being dropped and/or banged, (iv) operate and withstand hot and cold temperatures within defined temperature ranges, (v) be powered by a Battery with a life equal to or greater than the Medications’ expiration date, (vi) have a Drug Cassette containing a the desired quantity of the Medication that is integrated into the dispenser housing or that docks into the dispenser housing, (vii) have a Tamper Resistant dispenser housing that becomes an integral unit with no access to the Medication except for when the single dose is dispensed via a small dispenser port, (viii) remains Locked from dispensing unless the dispensing device receives an encrypted signal authorization from the App to dispense a dose, and (ix) one click dose dispensing.
  • the Drug Dispenser (i) effectuates a Handshake with the app and then transmits the following information since starting from the last time the information was uploaded to the app (ii) current and historic dispenser temperatures and humidity levels, (iii) unsuccessful dispensing attempts, (iv) dispenser intrusion attempts, (v) dispensing problem alerts, and (vi) date and time the previous dose or doses were dispensed.
  • the Drug Dispenser dose dispensing is effectuated by the“Dispense Button”.
  • the Dispense Button is shut off until it is turned on by the app for the specific dose or per the Prescription dosing schedule allowed between required app sign on.
  • FIG. la and lb is an exemplary embodiment of commonly available oral Medications, e.g., pills, Tablets, caplets, capsules, dissolving films.
  • FIG. 2 is an exemplary embodiment of an EasyOpen Blister Pack.
  • FIG. 3 is an exemplary embodiment of the outside of the dispenser housing.
  • FIG. 4 is an exemplary embodiment of the integrated tamper sensor.
  • FIG. 5 is an exemplary embodiment of the integrated dispense button and LED indicator lights.
  • FIG. 6 is an exemplary embodiment of the Blister Pack pills dividers and guides.
  • FIG. 7 is an exemplary embodiment of the interior and exterior of the integrated dispenser house and where the front and back housing sections are bonded together.
  • FIG. 8 is an exemplary embodiment of how the dispenser unit, PCB, Battery, and pills fit into the Drug Dispenser.
  • FIG. 9 is an exemplary embodiment of the components that make up the Blister Pack dispenser unit.
  • FIG. 10 is an exemplary embodiment of Drug Dispenser’s electronic components.
  • FIG. 11 is an exemplary embodiment of the Drug Dispenser sensor placements.
  • FIG. 12a and 12b is an exemplary embodiment of Drug Dispenser Firmware logic.
  • AKA denotes terms used interchangeably:
  • Abuse refers to the act or practice of improperly using Medications (examples include but are not limited to opioids, anxiolytics, antidepressants, stimulants). It also refers to the compulsive, excessive, and self-damaging use of habit-forming Drugs or of using opioids and other Medications in harmful amounts, leading to addiction or Dependence, serious physiological injury (such as damage to kidneys, liver, heart) and/or psychological harm (such as dysfunctional behavior patterns, hallucinations, memory loss), or death.
  • Medications include but are not limited to opioids, anxiolytics, antidepressants, stimulants. It also refers to the compulsive, excessive, and self-damaging use of habit-forming Drugs or of using opioids and other Medications in harmful amounts, leading to addiction or Dependence, serious physiological injury (such as damage to kidneys, liver, heart) and/or psychological harm (such as dysfunctional behavior patterns, hallucinations, memory loss), or death.
  • App Controlled refers to a Blister Pack Drug Dispenser whose dose dispensing is controlled by an App.
  • the App may reside on an Interface Device or be resident on a standalone Drug Dispenser.
  • Battery refers to rechargeable and disposable batteries commonly used for consumer medical products that have the long shelf life/lifespan, discharge profile, high beam light support, low probability of leakage, able to function for limited times in cold climates profiles. These may include but are not limited to Alkaline, High-Drain Alkaline, Lithium, Carbon Zinc, Zinc Chloride, Nikel-Metal Hydride (NiMH), LSD NIMH (low self-discharge), Nickel-Zinc (NiZn), Rechargeable Alkaline, or similar Battery technologies. The objective is to have the Battery life, under normal dispensing conditions, that is equal to or exceeds the Medication’s shelf life/dating.
  • Biometric Authentication (AKA Biometric Identification, Biometric Sign On, Voice Print, Face Recognition, Iris Scan, Retinal Scan, Eye Scan, Palm Scan, Motion Pattern Recognition, Heart Rhythm, Fingerprint Scan, Log On Name, PIN Number, Authentication PIN, Two-Factor Authentication, 2FA, Multi-Factor Authentication, MFA) encompasses but is not limited to biometric technologies that digitally capture fingerprint, palm, full-hand, voice, facial, iris, retina, eye, motion pattern, heart rhythm, and/or PIN numbers to limit access to the Patient.
  • Biometric Authentication also refers to the use of two or more of these biometric technologies in combination.
  • Blister Pack for this invention refers to unit dose Blister Packs used for Tablets, pills, caplets, capsules, and/or lozenges. It also refers to unit dose sublingual film packaging.
  • the blister is made up of a pocket made from a formable web, usually a thermoformed plastic joined to a paperboard backing and/or a lidding seal of aluminum foil or plastic or similar material.
  • the Blister Packs protect the Medication against external factors, such as humidity and contamination for extended periods of time.
  • Opaque blisters also protect light-sensitive products against UV rays.
  • the back of the lidding material allows printing to facilitate identification, dating and traceability.
  • 30 Day Drug Supply refers to the design requirement of being able to house 60 large
  • Blister Pack Tablets (e.g., .8 inches long by .36 inches wide by .16 inches high) in a Drug Dispenser that can fit in someone’s pocket.
  • Smaller Tablets means the dispenser can handle more pills or that the dispenser can be smaller in size.
  • Compliance (AKA Adherence, Prescription Compliance, Medication Compliance, Drug Compliance) describes the degree to which a Patient correctly follows the Prescription’s Drug dosing, dispensing and storage instructions.
  • Consolidation App is an App designed to recognize other Drug Specific Apps resident on a standalone dispenser or Interface Device and then to consolidate the requisite digitally captured information, Patient Self-Assessment screens and/or Patient Self-Test screens and/or Patient Self-Reported screens into a single interface for the control and dispensing of multiple Drugs from the same Drug Dispenser.
  • AKA Physical Dependence refers to the physiological adaptation of the body to the presence of a substance, examples include but are not limited to opioids, barbiturates, benzodiazepines, hypnotics, gamma-hydroxybutyric acid, carisoprodol, baclofen, chloral hydrate, glutethimide, clomethiazole, methaqualone, gabapentin, antiepileptics, antipsychotics, antidepressants, blood pressure Medications, androgenic-anabolic steroids, glucocorticoids.
  • Dispenser Button (AKA On/Off Button, Biometric Button, Finger Scan Button) is the switch and/or sensor on the Drug Dispenser that may be used to initially turn the dispenser on and dispense each Medication dose.
  • the App controls the power to the Dispenser Button.
  • Dispensing may constitute different configurations - some examples include but are not limited to: 1) a simple on/off switch that is depressed by the Patient to dispense a Blister Pack when the App has authorized the Drug Dispenser to dispense the dose and indicates to the Patient he/she can dispense the dose, 2) a Biometric on/off switch that dispenses a Blister Pack when the App authorized dose dispensing upon Patient authentication, 3) a Biometric Authentication device that authenticates the patient and then dispenses the authorized dose, 4) a button where the Firmware is programmed to allow the Patient to dispense a number of doses between Patient App interfaces, 5) a Dispenser Button where the Firmware is programmed to allow the Patient to dispense a number of doses, in keeping with Prescription intervals, between Patient App interfaces, 6 a Dispenser Button where the Firmware checks to see if an interface device is connected before dispensing a Blister Pack that is authorized to be dispensed by the
  • Dispenser Door is the slide that closes the dispenser housing opening required for Blister Pack dispensing.
  • Dispensing Mechanism refers to the electrical/mechanical unit designed to dispense a Blister Pack.
  • Diversion is a medical and legal concept involving the transfer of any legally prescribed controlled substance from the individual for whom it was prescribed to another person for any illicit use.
  • Dose-bv-Dose Dispensing refers to the Drug Dispenser’s ability to control dose dispensing as well as the ability of the tethered App to be able to exercise dose dispensing control on a dose-by-dose basis.
  • Drug Cassette is either a reusable or disposable unit that contains Blister Pack Medications to be dispensed over a defined period of time per the Prescription instructions that is designed as an integral part of a Drug Dispenser or as a cassette that docks into a Drug Dispenser.
  • the Drug Cassette may come either prefilled with the Medication from the Drug manufacturer or be filled by a medical professional at the pharmacy or at any location which is authorized to dispense the Medication.
  • Drug Dispenser (AKA Point of Care App Controlled Blister Pack Drug Dispenser, Blister Pack Drug Dispenser, Disposable Point of Care App Controlled Blister Pack Drug Dispenser, Disposable Blister Pack Drug Dispenser, Dispensing Device, Standalone Dispenser, Dispenser Unit, Dispensing Unit, Disposable Drug Dispenser, Disposable Dispenser, Reusable Drug Dispenser, Refillable Drug Dispenser, Drug Dispensing Unit, Tethered Drug Dispenser) refers to the disposable or reusable Drug Dispensing Unit with a Docked or Integrated Drug Cassette whose dispensing is controlled by a Medication Specific App or a Standalone Drug Dispenser with a resident Medication Specific App or a Drug dispensing program that controls dose Drug dispensing.
  • Dispensing Device Drug Delivery Device, Standalone Drug Delivery Device, Standalone Drug Dispenser, Disposable Drug Dispenser, Multiple Drug Dispenser
  • Drug Cassette is resident in the Dispensing Unit and whose dispensing mechanism (lock, unlock, and dispensing) are activated by Firmware controlled by a Medication and/or Patient Specific App and/or Drug and/or Patient Specific Apps resident in the Standalone Drug Dispenser.
  • Drug Dispensing Software refers to dispensing software resident on an Interface Device or Standalone Drug Dispenser that: 1) requires Biometric Authentication, and 2) controls dose dispensing by a Drug Dispenser’s Drug Dispensing Unit.
  • Electronics Recycling refers to the Drug Dispenser design which allows easy access to the electronic components for future recycling or disposal. This includes the recycling of the Dispenser Unit, the PCB, and wiring harness, and easy disposal of the Battery and any unused Medication.
  • Handshake AKA Digital Handshake refers to an exchange of signals between devices ensuring synchronization whenever a connection, as with another device, is initially established.
  • Interface Device refers to the smartphone, tablet, computer, or standalone Drug Dispenser, or similar device with Internet communications capabilities or like communications capabilities where the App resides.
  • Intrusion Detection refers to three Drug Dispenser design features: 1) the Intrusion Detection sensor integrated into the Drug Dispenser’s front and back shells, 2) the detection of a buildup in resistance/heat when the linear dispenser that controls the opening and closing of the dispensing door is precluded from closing by some kind of physical force, and 3) a pressure sensor if someone is trying to pry the dispensing door open.
  • Locked indicates the Drug cannot be dispensed by the Dispensing Device until the Medication Specific App or the standalone device’s dispensing software unlocks the Dispensing unit and allows it to dispense the Medication.
  • Long Acting Medications are slowly effective Medications after initial dosage, but maintaining its effects over a long period of time, being slowly absorbed and persisting in the tissues before being excreted.
  • AKA Sustained Release, SR, Controlled Release, CR, Extended Release, ER are slowly effective Medications after initial dosage, but maintaining its effects over a long period of time, being slowly absorbed and persisting in the tissues before being excreted.
  • These can come in various forms, but by reference in this patent, refer to oral or transdermal formulations.
  • Medication refers to a substance used for medical treatment, specifically a medicine, legal or illegal Drugs, OTC Medications, vitamins, dietary supplements, herbal medicines, and/or recreational Drugs.
  • Moisture Resistant refers to the Drug Dispenser standard of protecting the Drugs housed in the Drug Dispenser from contact with harmful dust and the ability of being able to immerse the Drug Dispenser more than one meter in water for a few minutes without having water intrusion into the Drug Dispenser.
  • Patient refers to the individual that is prescribed and is taking one or more Medications.
  • Patient Specific Medication Specific App (AKA Patient and Medication Specific App, Patient and Drug Specific App, Drug Specific App, Medication Specific App) refers to an App used to control Drug Dispenser dose dispensing.
  • PCB AKA Printed Circuit Board, Motherboard, Logic Board
  • PCB AKA Printed Circuit Board, Motherboard, Logic Board
  • Point of Care App Controlled Blister Pack Drug Dispenser (AKA Drug Dispenser, Drug Dispensing Unit) Refer to Drug Dispenser definition.
  • Point of Care PharmacyTM refers to a system comprised of an App (Patient and/or Drug specific), a Drug Dispenser, and 24 hours per day and 365 days per year App, Drug Dispenser, and Medication support. It is designed to ensure: 1) the dispensed Medication is effective for the Patient, 2) only dispensed per the Prescription, 3) uses a dispensing algorithm which utilizes the Patient’s digitally captured and/or Patient tested/reported/entered (Patient entered) physiological, psychological, lifestyle, environmental, and/or concomitant Medication information to control Drug dose dispensing, 4) captures key point-of-care information to enable Medication management and better disease/condition management.
  • Polypharmacy is the practice of administering or using multiple Medications especially concurrently (as in the treatment of a single disease or of several coexisting conditions).
  • Prescriber is defined as any healthcare professional authorized by an individual country or state to write a Prescription for a Drug. Examples include but are not limited to physicians, physician assistants, nurse practitioners, nurses, pharmacists.
  • Prescription (AKA ePrescription, Paper Prescription, Manually Entered Prescription, Digital Prescription, Drug Prescription, Medication Prescription) is an instruction electronically entered or manually written by an authorized medical practitioner that authorizes a Patient to be provided a medicine or treatment.
  • Routines (AKA Software Program, Software Routines, Subroutine, Procedure, Function, Method, Subprogram) is a portion of software code within a larger program that performs a specific task and is relatively independent of the remaining code.
  • Serial Number (AKA Unique Device Identifier, UDI, Serial No., SN, S/N, Identification Number, Tracking Number, Identifier) is a unique number used for identification, tracking, and/or inventory purposes.
  • Short Acting Medications are quickly effective Medications that require regular repeated doses for long-term treatment. They are rapidly absorbed, distributed in the body, and excreted.
  • Tablets as used in this invention refers to all types of solid oral dose Medications and all the various shapes and sizes. This includes but is not limited to Tablets, pills, caplets, lozenges, hard capsules, soft capsules, gel caps, and medication strips.
  • Tamper Proof is a combination of the Disposable Drug Dispenser design features integrated to preclude dose dispensing unless it is authorized by the Prescription and the App.
  • the Disposable Drug Dispenser has an Intrusion Detection sensor integrated into the Drug Dispenser container shell, as are the Dispense Button and the indicator lights. After component assembly and filling with the desired number of Blister Pack pills, the front and back halves are bonded together to create a single unit.
  • the only opening is the small Dispenser Door. This door is precluded from being able to be forced open by the linear actuator opening and closing design. Any excessive pressure that is applied to open or keep the Dispenser Door open is picked up by a pressure sensor and/or Dispenser Door motor control software.
  • the pressure sensor as well as the Intrusion Detection sensor are designed to create an alert if an intrusion attempt or intrusion is detected. Tamper Proof refers to the combination of the Drug Dispenser housing and the integrated Intrusion Detection sensors (housing and Dispenser Door) and the related software to record and report intrusion attempts and intrusions.
  • Tamper Resistant refers to a design: 1) that precludes the Drug Dispenser from being opened without destroying it, 2) that makes it difficult to change, open, or remove the Drug Cassette from the Drug Dispenser except for authorized users, or 3) that results in damaging the Drug Dispenser when an unauthorized person attempts to open the Drug Dispenser.
  • Tethered Drug Dispenser is a Drug Dispenser that utilizes the Interface Device’s capabilities to offer functionality and ease of use that would not otherwise be possible in a Standalone Drug Dispenser with the same outside dimensions, the same size, or a battery life equal to or greater than the medication’ s shelf life. It also refers to a Drug Dispenser that cannot function without being tethered to an App. II. List of Medications the Invention in its Various Embodiments is Applicable To
  • the invention and its various embodiments can enable better dose dispensing control, decreasing misuse, Diversion and accidental ingestion. This improves the Drug’s safety profile and should decrease Drug mediated healthcare professional interventions, emergency department (ED) visits, and hospitalizations.
  • the invention is applicable to all Tablets, as defined, that are marketed or in development.
  • Drug compounds of interest are listed in: Goodman & Gilman's, The Pharmacological Basis of Therapeutics (13th Ed) (Goodman et al. eds) (McGraw-Hill) (2016); and latest mohi/ePOR (formerly Physician's Desk Reference); Cortellis Clinical Trials Intelligence databases by Clarivate Analytics; Adis Insight databases by Springer; and/or Pharmaproj ects databases by Citeline, and databases by IQ VIA. These Drugs are encompassed in the embodiment of the invention by reference.
  • FIG. la and lb illustrate an exemplary embodiment of the invention and how the Blister Pack design has to be configurable to accommodate different Tablet shapes and sizes 2, 4, 6. These are exemplary Tablets.
  • Pharmaceuticals science is evolving, and different shapes and sizes are expected to be introduced as pharmaceutical and manufacturing technologies, such as 3D pill printing, will make new Tablet designs available.
  • FIG. 2 illustrates an exemplary embodiment of an EasyOpenTM individual Blister Pack.
  • the top row illustrates different views of the see-through or opaque plastic blister that is preformed to contain the Tablet 20, 22, 24.
  • the top view 12 shows the margins around the preformed container.
  • the side view 14 shows the relationship of the EasyOpen Tab 10 and the Reinforced Dispense Ridge 16.
  • the right end view 18 shows the width and height of the Reinforced Dispense Ridge.
  • the second row shows a large pill, (for example, .36 inches wide 20, by .8 inches long 22 by .16 inches high 24) that fits in the cavity 14 of the preformed blister used for this exemplary illustration.
  • a large pill for example, .36 inches wide 20, by .8 inches long 22 by .16 inches high 24
  • the back lid of the blister 26 illustrates the two imbedded reinforcing strings 28 which support the pill when it is laying on the dispenser glide and assist in opening the Blister Pack when the EasyOpen Tab 10 is pushed down or pulled and broken away from the blister by the Patient.
  • the lid’ s paper backing 30 is designed to incorporate: 1) the Drugs name (proprietary and generic), a QR code that shows, for example: i) the manufacturer, ii) manufacturing location, iii) batch number, vi) fill date, and vii) a unique pill identification number, and 2) Discard After date 32. This allows traceability of the individual pill from the time it is manufactured down to the Patient.
  • the pill in the EasyOpen Blister Pack is illustrated from the left side 34, top view 36, side view 38, and right end view 40.
  • the bottom view shows the dispenser guide indents 42 designed to ensure the Blister Pack is properly oriented for dispensing.
  • FIG. 3 is an exemplary embodiment depicting the left side of the dispenser housing 44, the front 46, the dispensing port 48, the windows 50 to view how many pills are remaining, the Dispense Button 52, and the Power, Dispense, and Battery LEDs 54, the back of the dispenser 56 and the right side 58.
  • FIG. 4 is an exemplary embodiment of the Intrusion Detection sensor 60 that is embedded into the dispenser housing during manufacturing.
  • the electrical connectors 62 complete the circuits between the front and back halves of the dispenser housing and provide a plug in for connecting the sensor to the wiring harness used to connect the sensor to the processor (PCB).
  • PCB processor
  • FIG. 5 is an exemplary embodiment depicting the Dispenser Button 52 and the LED lights 54 that are imbedded into the Dispenser Housing Fig. 3.
  • FIG. 6 is an exemplary embodiment of Blister Pack dividers 56 on the front and back halves of the Drug Dispenser housing. It also illustrates the Blister Pack guides 58 which line up with the Blister Pack indents 42 to ensure the Blister Packs are correctly oriented to facilitate dispensing.
  • the Blister Cap stops 62 are designed to stop the spring cap 82 from dropping too low and blocking the dispensing tunnel once the column of pills has been dispensed.
  • the support rail 64 acts as a top seat for the dispensing assembly 72 and as a floor for the dispensing tunnel used to dispense the Blister Packs.
  • FIG. 7 is an exemplary embodiment of Blister Pack dispenser housing inside front 66, inside back 68, left side 44, outside front 46, outside back 56, right side 58, and the dividing line 70 where the two sections come together.
  • FIG. 8 is an exemplary embodiment of how the Blister Pack Dispenser is assembled. First the Dispenser Unit 72 is clicked into place, then the PCB is connected to the wiring harness and clicked into pace 74, then the Battery 76 is connected and slid into place. The unit is then filled with Blister Packed pills by first putting the Springs 80 and their Spring Cap 82 into the unit between the respective guides and then inserting the pill columns 84 into place so they are aligned between the Blister Pack Dividers 56 and are aligned with the Blister Pack Guides 58.
  • FIG. 9 is an exemplary embodiment of the design and components of the Dispenser Unit.
  • the Dispensing Door 86 is controlled by a linear slide actuator that moves the door up and down.
  • the end view of the assembly without the respective dispensing door and the linear slide motor is shown 88, as are the top of the dispenser unit 90, the right end view 92, the side of the unit without the dispensing door 94, and the bottom of the unit 96.
  • the side view with the dispensing door closed 98 illustrates the assembled unit.
  • Each dispensing unit is comprised of the dispensing door 100, the linear slide unit that moves the dispensing door 102, the gear assembly 104 that transfers the power from the stepper motor 106 to the spindle 108, and the sensor plate 110 that is used to properly position the dispensing arm 112 for dispensing from each of the respective Blister Pack columns.
  • FIG. 10 is an exemplary embodiment of the components comprising the Blister Pack Drug Dispenser logic board.
  • the major components are the low energy high performance processor 114, the Bluetooth Low Energy module 116, the temperature sensor 118, the humidity sensor 120, the intrusion sensor 122, the pressure sensor 124, the Dispense Button 126, the pill counter switch 128, the dispense door open stop switch 130, the dispense door close stop switch 132, the dispensing arm return switch 134, the dispensing arm stop for Blister Pack column one switch 136, the dispensing arm stop for Blister Pack column two switch 138, the dispensing arm stop for Blister Pack column three switch 140, the Battery life gas gauge 142, the Battery 144, the Clock 146, the dispenser motor 148, the dispense door linear motor 150, and the status LEDs 152.
  • FIG. 11 is an exemplary embodiment illustrates where the respective sensors or switches that do not reside on the logic board are placed on the Drug Dispenser: the intrusion sensor 124, the pressure sensor (it is part of the intrusion sensor system) 124, the Dispense Button 126, the pill counter switch 128, the dispense door open stop switch 130, the dispense door close stop switch 132, the dispensing arm return switch 134, the dispensing arm stop for Blister Pack column one switch 136, the dispensing arm stop for Blister Pack column two switch 138, and the dispensing arm stop for Blister Pack column three switch 140.
  • the intrusion sensor 124 the pressure sensor (it is part of the intrusion sensor system) 124
  • the Dispense Button 126 the pill counter switch 128, the dispense door open stop switch 130, the dispense door close stop switch 132, the dispensing arm return switch 134, the dispensing arm stop for Blister Pack column one switch 136, the dispensing arm stop for Blister Pack column
  • FIG. 12a and 12b are exemplary embodiments of dispenser Firmware logic.
  • the embodiment of the invention when coupled with a Drug and/or Patient specific app, can be utilized, for among other uses, 1) to improve the Drug’s safety profile by ensuring proper Patient personalized prescribing and Prescription management (e.g., personalized dispensing), 2) to ensure the Medication is efficacious, 3) as a diagnostic aid/tool, 4) to titrate the Medication, 5) to preclude Drug mediated adverse events, 6) to preclude over dosing, 7) to preclude under dosing, 8) to decrease the chance of misuse, 9) to decrease the chance of Abuse, 10) to decrease the chance of overdosing, 11) to increase Prescription Compliance, 12) to prevent the Patient from inadvertently taking a duplicate dose, 13) to decrease the chance of addiction, 14) to decrease the chance of Dependence, 15) to better manage Medication tolerance, 16) to manage Medication withdrawal, 17) to enable PRN dosing, - manage “Patient Controlled Oral AnalgesiaTM” (PCOATM
  • the physician could change/refme the dosage for the Patient and/or preclude the Patient from taking the dose in the event the physician ascertained that the dose was not warranted and/or that the dose may lead to a serious Medication mediated event and/or undesirable side effect.
  • the embodiment of the invention incorporates an App Controlled Drug Dispenser that enables Dose-by-Dose Dispensing control and captures certain critical data to ensure Compliance with the Prescription, improve Medication management, and enable Point-of Care Pharmacy.
  • the App Controlled Drug Dispenser enables Dose-by-Dose Dispensing control, measures the blood oxygen saturation (Sp02) and monitors respiratory rate to ascertain if a drug is leading to a depressed respiratory rate and to maintain healthy Sp02 levels is through breathing.
  • Sp02 blood oxygen saturation
  • the App Controlled Drug Dispenser estimates the amount of oxygen in the blood as an indicator of potential hypoxia which may be caused by a drug induced respiratory depression.
  • Opioids serve as an excellent exemplary of how the embodiment of the invention can be utilized to improve opioids and other Medications’ management and Patient outcomes.
  • CO2 Carbon dioxide
  • Heart Rate - Heart rate may become either rapid or very slow. Some opioid users may also develop postural hypotension or a severe fall in blood pressure on standing up from a sitting or lying position.
  • Miosis - Opioid use results in the formation of small, constricted pupils, similar to how pupils respond to bright light.
  • Constipation - Opioids cause sluggish peristaltic movements in the digestive tract. This causes stasis or loss of movement of the intestinal contents and leads to severe constipation, especially in the case of long-term use.
  • Drowsiness or Sedation - Opioids, and in particular morphine, are known to cause severe sedation and drowsiness.
  • Hyperalgesia - Opioid-induced hyperalgesia is another side effect of the use of opioids.
  • Opioid hyperalgesia is a phenomenon where the body develops an increased sensitivity to pain secondary to opioid use (hyper - over or excess, algesia - sensitivity to pain).
  • Pain is an important part of our body’s defense system, warning us of current or impending damage or injury.
  • opioids decrease our brain’s sensitivity to pain signals coming from the rest of the body, our brain begins to compensate by increasing our recognition of and sensitivity to pain.
  • the pain neurons going to the brain actually change to make them more responsive to pain and increase our perception of pain. This change is called neuroplasticity of the nerve cell.
  • Many mechanisms are believed to be involved in these changes (M. Lee, Silverman, Hansen, Patel, & Manchikanti, 2011). The result of this change is that after opioid levels decrease, our pain fibers are more sensitive than before consuming the opioid which results in an increase in pain.
  • opioid hyperalgesia is the decrease or discontinuation of opioids.
  • Tolerance and withdrawal - Tolerance occurs when the body has developed physiologic (both neuroplastic and chemical) changes that result in decreased effectiveness of the medicine necessitating a higher dose to get the same effect. Withdrawal is the unpleasant symptoms that develop upon decrease or discontinuation of that medicine. Brain changes and measurable withdrawal symptoms can occur after one dose of opioid (Rothwell, Thomas, & Gewirtz, 2012).
  • withdrawal symptoms can occur after five to seven days of opioid Medication (Anand et al., 2010). Withdrawal symptoms may consist of myalgia (muscle pain), chills, sweats, anxiety, increased pain, rapid heartbeat, dilated pupils, yawning, diarrhea and nausea.
  • Addiction - Addiction is characterized by inability to consistently abstain, impairment in behavioral control, craving, diminished recognition of significant problems with one’s behaviors and interpersonal relationships, and a dysfunctional emotional response.
  • Benzodiazepines It is also important to realize that the risk of death is markedly increased when opioids are taken with benzodiazepine Medications. The combination of opioids and benzodiazepines are the leading cause of overdose deaths when multiple Medications are involved (Calcaterra, Glanz, & Binswanger, 2013). Despite this danger, benzodiazepines are prescribed to about 30% of people on chronic opioid therapy (Nowak, Abou-Nader, & Stettin, 2014).
  • the Patient and/or opioid specific App utilizes digitally captured and Patient entered point-of-care and trended data to screen for potential overdose or side effects, (see side effects above) to ascertain whether or not it is safe for the Patient to dispense a dose.
  • the integration of digital sensor information will be via specific Application Program Interfaces (APIs) to translate the value into dispensing algorithm usable data.
  • APIs Application Program Interfaces
  • the App utilizes the App Tethered Drug Dispenser sensor data/information to ensure: 1) the opioid has been properly stored, 2) to ascertain when the last dose was dispensed to ascertained if the dose is authorized, and then, if the Prescription authorizes, dispensing the dose. If the decision is that the dose should not be dispensed, the decision can be remotely overwritten by the 24 hours per day 365 days per year Support Center within established guidelines after the Support Center talks with and evaluates the Patient.
  • the Drug Dispenser is the physical device that enables App Dose-by-Dose Dispensing control - playing a gatekeeper role in preventing opioid misuse.
  • Drug Dispenser Sensors provide date and time stamped: 1) temperature and humidity readings to ensure the Medication is being/has been properly stored, ensuring its efficacy 2) intrusion and intrusion attempts alerts to decrease opioid divergence and as an indicator of potential tolerance, 3) dose dispensed to track the number of remaining pills, and 4) dose dispensing to enable correlation with other reported data to empower better Patient specific pain and opioid tolerance management.
  • the Drug Dispenser electronics 1) enables communications with the App (via Bluetooth, Low Energy Bluetooth, Wi-Fi, or similar low energy communications technologies), 2) tethers the Drug Dispenser to the App, 3) manages the Dispenser Button, which may be a simple on/off switch to dispense the dose and power down the Drug Dispenser to lower Battery drain or a Biometric logon (examples include fingerprint scan, voice scan, face scan, iris scan, retina scan, PIN, two-factor or multi-factor authentication or any combination thereof) to dispense the dose and then power down the drug dispenser to lower Battery drain, 4) manages Battery power to ensure the Patient is alerted before running out of power that will prevent dose dispensing, 5) tracks and reports unauthorized dose dispensing attempts, 6) stores sensor values, 7) communicates sensor values, and 8) controls Dose-by-Dose Dispensing.

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Abstract

La présente invention concerne un nouveau distributeur de médicaments sous emballages coques commandé par une application de pharmacie au point d'intervention (Point of Care Pharmacy™ App) jetable ou réutilisable anti-effraction et une conception d'emballage coque à usage unique (EasyOpen™) configurée pour commander la distribution dose par dose et capturer des données de capteur pour activer la pharmacie au point d'intervention.
PCT/US2020/019141 2019-02-21 2020-02-21 Distributeur de médicaments sous emballages coques commandé par une application de pharmacie au point d'intervention Ceased WO2020172484A1 (fr)

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Publication number Priority date Publication date Assignee Title
US5046618A (en) * 1990-11-19 1991-09-10 R. P. Scherer Corporation Child-resistant blister pack
US5348158A (en) * 1991-12-19 1994-09-20 G. D. Searle & Co. Dispenser pack for the successive dispensing of a drug
US5339960A (en) * 1992-08-24 1994-08-23 Eli Lilly And Company Child resistant package and method for making same
US20060027480A1 (en) * 2004-08-04 2006-02-09 Buss Michael A System and a method for a V-indent blister opening cavity
US7401702B2 (en) * 2005-06-27 2008-07-22 Meadwestvaco Corporation Child-resistant blister package
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US20160193152A1 (en) * 2006-11-09 2016-07-07 Orexigen Therapeutics, Inc. Methods for administering weight loss medications
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US20090139893A1 (en) * 2007-05-30 2009-06-04 Walgreen Co. Multi-Dose Blister Card Pillbook
US20090184023A1 (en) * 2008-01-18 2009-07-23 International Paper Company Child-Resistant Package With Latch And Retaining Feature
US20100102062A1 (en) * 2008-10-27 2010-04-29 Steve Jones Child resistant blister package housing with tooled access
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