EP3269345A1 - System zur kontrolle der einhaltung von arzneimitteldosen für patienten - Google Patents

System zur kontrolle der einhaltung von arzneimitteldosen für patienten Download PDF

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Publication number
EP3269345A1
EP3269345A1 EP16001569.9A EP16001569A EP3269345A1 EP 3269345 A1 EP3269345 A1 EP 3269345A1 EP 16001569 A EP16001569 A EP 16001569A EP 3269345 A1 EP3269345 A1 EP 3269345A1
Authority
EP
European Patent Office
Prior art keywords
patient
medication
pill organizer
blister pack
alveoli
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP16001569.9A
Other languages
English (en)
French (fr)
Inventor
Jose Luis Gomez Ruiz
Melvin Eduardo Sequera Iriarte
Jorge Calvo Orta
Juan GIL Navas
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Becton Dickinson SA
Original Assignee
Becton Dickinson SA
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
Application filed by Becton Dickinson SA filed Critical Becton Dickinson SA
Priority to EP16001569.9A priority Critical patent/EP3269345A1/de
Publication of EP3269345A1 publication Critical patent/EP3269345A1/de
Withdrawn legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035Blister-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J7/00Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
    • A61J7/0076Medicament distribution means
    • A61J7/0084Medicament distribution means for multiple medicaments
    • 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
    • A61J7/0436Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with direct interaction with a dispensing or delivery system resulting from removing a drug from, or opening, a container
    • 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
    • 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

Definitions

  • the object of the present invention is a medication adherence control system for patients; comprising: a weekly pill organizer, electronic, usable by the patient, provided with a plurality of compartments for lodging the alveoli of a blister pack containing the medication corresponding to different daily dosages; and a control unit with means to warn about the dosages to be taken, and means of communication with a web platform containing a control program of patient data, medication and dosages assigned to the said patient, and of tracking the dosages taken by the aforementioned patient.
  • This system additionally incorporates a pharmaceutical pill organizer to fill the blister packs with the prescribed medication for each patient; and a bracelet wearable by the patient to receive the notifications related to taking the medication.
  • a pill dispenser device comprising a lid and a bottom part is provided with means for adjusting dosage times, means for indicating dosage times, means for placing a blister pack containing pills; means for ejecting a pill from the blister pack and a printed circuit placed on the lid to confirm the removal of pills; the bottom part of the device incorporates a printed circuit board to program the pill dosage cycle.
  • the patent US 2007272583 consisting of a smart device (pillbox) that keeps track of the pills taken and a method and device to acquire data related to the health care of the individual and transmission of data to a remote location where they can be processed to facilitate the medication reminder, the data collection uses primary analogue and digital telephones.
  • the utility model ES 1052269 U describes a device provided with compartments for the classification of different pills and which has acoustic and luminous alarm means for the dosage notification.
  • the utility model ES 1064960 U consists in a warning pill organizer provided with recesses for the placement of pills, and reports the incorporation of programming means for the dosage schedule and a warning alarm.
  • the patent US 2015083742 describes a device to provide a pill comprising a body and a unit containing a pill pack and a drive assembly for its removal into a discharge box, this device also comprises a control unit that controls operations of the drive assembly, a camera located on one side of the body and a communication module for transferring the image taken by the camera to a server connected to the network or computer.
  • the medication adherence control system for patients of this invention comprising an electronic pill organizer, of weekly usage, of the previously described type and mentioned in the pre-characterizing portion of the first claim, presents a series of constructive particularities oriented towards making possible two modes of use for the patient: daily or weekly, for this purpose it is provided of a daily pill organizer, detachably connected to a weekly pill organizer, both weekly and daily pill organizer can be used together or independently.
  • Another purpose of the invention is to enable the error correction in medication dosage, in case the patient would remove the medication from a compartment corresponding to the incorrect dosage; for this purpose the weekly pill organizer is provided with a specific compartment to store, until consuming time, the dosage removed by mistake.
  • Another purpose of the invention is to allow the monitoring and export, via web, of the results of using the device for monitoring the treatment by the prescribing physician or health-care personnel in charge.
  • this system comprises a pharmaceutical pill organizer to fill the blister packs with the prescribed medication for each patient; and a bracelet wearable by the patient to receive the notifications related to the medication dosage; being both elements optional, although they significantly facilitate the pharmacy the refilling of the blister packs with the medication corresponding to each patient; and the patient receiving possible notifications regarding the medication dosage.
  • This system has two types of web development associated: a web platform and a mobile application.
  • the different devices generate information flows that will allow us to know the adherence of the patient to the treatment in real time.
  • the real-time information is made possible due to the communication of the pill organizer wearable by the patient with the platform via GPRS and Wi-Fi, this platform is designed to receive, process, treat and adapt the information in such a way that the medical or pharmaceutical personnel can assess easily and intuitively that information and act accordingly.
  • this pill organizer has a book-like configuration, provided with a base and a lid.
  • the base comprises:
  • the lid comprises:
  • the daily pill organizer As for the daily pill organizer, it is designed to give autonomy to patients who will spend the whole day out of home and do not want to carry their medication all week.
  • This device is provided with Bluetooth, GPRS and WI-FI connections to allow receiving/sending information.
  • this device is able to get illuminated, sound and vibrate when required.
  • the pharmaceutical pill organizer has a similar appearance to the weekly pill organizer, and shows a difference in the level of intelligence since it does not need to be as sophisticated as the patient's pill organizer.
  • the pharmaceutical pill organizer is aimed to improve the process of refilling the blister packs with the accurate medication for each patient.
  • the improvement is mainly based on two concepts:
  • This platform allows full monitoring of dosed medicines and also the ability to keep track of medication stock for each patient.
  • the bracelet wearable by the patient has a Bluetooth connection to both the weekly and individual pill organizer, with a memory enabling it to store the weekly treatment. It will also be able to receive signals in order to alert the patient when needed, thus the system makes sure that the patient will always receive the dosage alert.
  • This bracelet is provided with the necessary electronics to register and send another type of data, such as the heart rate.
  • the blister pack to be used consists of two parts: a plastic sheet in which the compartments to lodge the medication are defined, a complex sheet (with a sheet of foil) that adheres to the blister pack, so the access to medication is only allowed by breaking the foil
  • the names of the days of the week and of the dosages are marked on the front area of the blister pack. At the top of the front area there is a space reserved for the date and the name of the patient so that both the pharmacist and the patient can identify them.
  • the blister pack has the space to attach an RFID (Radio Frequency) tag that allows automatic recognition by the Pill-box due to a radio frequency that will have the weekly Pill-box incorporated.
  • RFID Radio Frequency
  • the sealing between the two sides of the blister must ensure the leak-tightness of each of the compartments. This sealing, along with the characteristics of foil, neutralizes the entry of dirt, dust or moisture into the compartments or the alveoli containing the medication.
  • the mobile application module included in the system consists of a mobile application (APP MOBILE) available for both patients and caregivers.
  • APP MOBILE mobile application
  • the system is provided with a platform web that allows sharing the information, generated by the aforementioned physical devices, to all the stakeholders accessing the system, such as: Health Council or its equivalent, health centres; doctors / nurses (HCPs); pharmacies, patients and caregivers
  • the accessibility will depend on the level of each user, allowing for example:
  • the proposed architecture is based on layers, where the foundations for the upper layers start laying on a nucleus.
  • Figure 1 schematically represent the different elements constituting the medication adherence control system for patients, according to the invention, interrelated with each other.
  • the medication adherence control system of this invention comprises a weekly pill organizer (1), a daily pill organizer (2) attachable to the weekly pill organizer and a bracelet (3) to receive notifications, being said elements associated with the patient.
  • the system comprises a pharmaceutical pill organizer (4) for the refilling of the blister pack (5) with the medication for each patient prescribed by the corresponding physician.
  • This system has associated a web platform (6) with a (WEB MODULE); a mobile application (MOBILE APP) and a (HARDWARE MODULE) that allow having real-time information thanks to the communication of the weekly pill organizer (1), via GPRSNVi-Fi, with the web platform (6) that is designed to receive, process, treat and adapt the information in such a way that the medical or pharmaceutical personnel can assess that information easily and intuitively, and act accordingly. If it detects that the patient is not following the treatment, this system sends messages to the different stakeholders, communicating this issue to the patient's mobile phone (M) and to relatives or individuals (P) in charge of him.
  • M mobile phone
  • P relatives or individuals
  • Figure 2 represents the embodiment of the weekly pill organizer (1), provided with a book-like configuration, provided with a base (11) and a lid (12).
  • Figure 2 the number 111 appears doubled and number 11does not appear.
  • the base (11) comprises: a space with a plurality of alveoli (111), intended for the placement of the pill blister pack (5) and a grid (112) to hold the blister pack (5). It is inwardly provided with electronics comprising lighting means (113) (RGB LEDs) placed inside the alveoli (112) to alert to correct or incorrect dosage and sensors (114), specifically photocells, responsible for detecting the access to the alveoli and whether the medication therein contained has been removed.
  • lighting means 113
  • sensors specifically photocells
  • the lid (12) comprises: a screen (121) to allow communication with the patient and the related personnel; an extra compartment (122) to mend the incorrect dosages and store, until consuming time, the dosage incorrectly removed from one of the alveoli (112); and the necessary electronics to detect the opening, or not, of the aforementioned compartment, and to notify the system; a cavity (123) to lodge the daily pill organizer (2) when not in use; electronic boards (not represented) placed in an interior cavity and responsible for generating actions, treating information and externally communicating via Bluetooth, Wi-Fi or GPRS; and a buzzer (124) to produce alert sounds.
  • this system comprises a pharmaceutical pill organizer ( figure 5 ) to fill the blister packs with the prescribed medication for each patient; and a bracelet (3) wearable by the patient to receive the notifications related to the medication dosage. Both elements significantly facilitate the pharmacy to refill the blister packs with the medication corresponding to each patient, and the patient to receive possible notifications regarding the medication dosage.
  • the daily pill organizer (2) shown in figures 1 and 3 , is designed so the patient can carry a daily dosage without having to transport the weekly pill organizer (1): in order to use it, the patient has to remove it from the cavity (123) of the main pill organizer, activate the option of "daily pill organizer" on the screen (121) and select the dosage that he will take with him (from 1 to 4), thus, depending on the dosages, the alveoli (111) from which the medication has to be removed will lit one by one, and, at the same time, the screen will display in which compartment of the daily pill organizer it has to be placed.
  • the daily pill organizer (2) has Bluetooth, GPRS and Wi-Fi connections to allow receiving/sending information and with the necessary electronics to manage the alerts, lighting, ringing and vibrating when required.
  • the bracelet (3) wearable by the patient and schematically represented in the figures 1 and 4 is provided with a Bluetooth connection (not represented) to establish communication with the weekly pill organizer (1) as well as the daily one (2), and receive signals in order to alert the patient when needed, the system will make sure the patient always will receive the dosage alert; and electronics suited to register and send another type of data, such as the heart rate.
  • the pharmaceutical pill organizer (4) shown in figures 1 and 5 has features and appearance similar to those of the weekly pill organizer (1), with a base (41) and a lid (42), and its purpose is to improve the process of refilling the blister packs (5) by the pharmacy.
  • the aforementioned pharmaceutical pill organizer (4) is provided with alveoli (411) for positioning the empty blister pack (5), a grid (412) and some lighting elements (413) to light those alveoli where each medicine should be placed, based on the treatment prescribed by the medical personnel, and a screen (414) to fill correctly all the data related to the blister pack refilling and to see a graphical simulation of how to refill the blister pack.
  • the data required when filling the blister pack such as data of the patient, contact data of relatives of the patient, prescribed medicines, physician, health centre etc., are accessible through the web platform (6), which allows the complete monitoring of the dosed medicines and also the possibility of keeping track of stock for each patient.
  • the blister pack (5) to be used comprises a plastic sheet in which the compartments (51) to lodge the medication are defined and a complex film (52) that adheres to the blister pack and only allows the access to medication by breaking the film.
  • the system has a platform that allows sharing information, generated by different devices of the system, to all stakeholders that have access to the system; depending on the accessibility of each of their user level.
  • Figure 6 shows a diagram of the different components of the architecture of the web platform (6) including a (WEB MODULE), a module of mobile application (MOBILE APP) and a (HARDWARE MODULE).
  • WEB MODULE WEB MODULE
  • MOBILE APP module of mobile application
  • HARDWARE MODULE HARDWARE MODULE
  • Said components comprise:
  • the platform comprises a module of mobile application (MOBILE APP) available both for patients and caregivers, and a (HARDWARE MODULE)
EP16001569.9A 2016-07-15 2016-07-15 System zur kontrolle der einhaltung von arzneimitteldosen für patienten Withdrawn EP3269345A1 (de)

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EP16001569.9A EP3269345A1 (de) 2016-07-15 2016-07-15 System zur kontrolle der einhaltung von arzneimitteldosen für patienten

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EP16001569.9A EP3269345A1 (de) 2016-07-15 2016-07-15 System zur kontrolle der einhaltung von arzneimitteldosen für patienten

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EP3269345A1 true EP3269345A1 (de) 2018-01-17

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020008385A1 (en) * 2018-07-03 2020-01-09 Alertapack Ltd Smart medication blister pack

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES1052269U (es) 2002-05-31 2002-12-01 Behmpat Producciones S L Pastillero con alarma acustica y/o luminosa.
EP1446085A2 (de) 2002-04-22 2004-08-18 Six P. AG Vorrichtung zur ausgabe von tabletten
ES1064960U (es) 2007-02-28 2007-05-16 Grafia, S.A Pastillero avisador.
US20070272563A1 (en) 2005-06-08 2007-11-29 Adrian Petyt Biosensors and Methods of Preparing Same
WO2011054000A1 (en) * 2009-11-02 2011-05-05 Trxcare Holding S.A.R.L. Smart medicament management methods and devices
US20130002795A1 (en) * 2008-10-31 2013-01-03 Medminder Systems, Inc. Interactive medication dispensing system
US8773261B2 (en) * 2009-06-10 2014-07-08 Betty L Bowers Medication management apparatus and system
WO2015021543A1 (en) 2013-08-13 2015-02-19 Next Paradigm Inc. Method of using a medication reminder and compliance system i ncluding an electronic pill box
US20150083742A1 (en) 2013-09-26 2015-03-26 Ohsung Electronics Co., Ltd. Apparatus for providing pill
US20160008229A1 (en) * 2013-08-13 2016-01-14 Next Paradigm Inc. Method of using an electronic pill box prefill system
US20160158109A1 (en) * 2013-08-13 2016-06-09 Next Paradigm Inc. Electronic pill box with detachable day module

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1446085A2 (de) 2002-04-22 2004-08-18 Six P. AG Vorrichtung zur ausgabe von tabletten
ES1052269U (es) 2002-05-31 2002-12-01 Behmpat Producciones S L Pastillero con alarma acustica y/o luminosa.
US20070272563A1 (en) 2005-06-08 2007-11-29 Adrian Petyt Biosensors and Methods of Preparing Same
ES1064960U (es) 2007-02-28 2007-05-16 Grafia, S.A Pastillero avisador.
US20130002795A1 (en) * 2008-10-31 2013-01-03 Medminder Systems, Inc. Interactive medication dispensing system
US8773261B2 (en) * 2009-06-10 2014-07-08 Betty L Bowers Medication management apparatus and system
WO2011054000A1 (en) * 2009-11-02 2011-05-05 Trxcare Holding S.A.R.L. Smart medicament management methods and devices
WO2015021543A1 (en) 2013-08-13 2015-02-19 Next Paradigm Inc. Method of using a medication reminder and compliance system i ncluding an electronic pill box
US20160008229A1 (en) * 2013-08-13 2016-01-14 Next Paradigm Inc. Method of using an electronic pill box prefill system
US20160158109A1 (en) * 2013-08-13 2016-06-09 Next Paradigm Inc. Electronic pill box with detachable day module
US20150083742A1 (en) 2013-09-26 2015-03-26 Ohsung Electronics Co., Ltd. Apparatus for providing pill

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020008385A1 (en) * 2018-07-03 2020-01-09 Alertapack Ltd Smart medication blister pack

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