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
  • A61J1/03—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
  • A61J7/04—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers
• • 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
  • A61J7/0418—Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers with timers with electronic history memory
• • 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
  • B65D2203/00—Decoration means, markings, information elements, contents indicators
  • B65D2203/10—Transponders
• • 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
  • B65D2401/00—Tamper-indicating means
• • H—ELECTRICITY
  • H05—ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
  • H05K—PRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS
  • H05K1/00—Printed circuits
  • H05K1/02—Details
  • H05K1/0286—Programmable, customizable or modifiable circuits
  • H05K1/0293—Individual printed conductors which are adapted for modification, e.g. fusable or breakable conductors, printed switches
• • H—ELECTRICITY
  • H05—ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
  • H05K—PRINTED CIRCUITS; CASINGS OR CONSTRUCTIONAL DETAILS OF ELECTRIC APPARATUS; MANUFACTURE OF ASSEMBLAGES OF ELECTRICAL COMPONENTS
  • H05K1/00—Printed circuits
  • H05K1/02—Details
  • H05K1/09—Use of materials for the conductive, e.g. metallic pattern
  • H05K1/092—Dispersed materials, e.g. conductive pastes or inks
  • H05K1/095—Dispersed materials, e.g. conductive pastes or inks for polymer thick films, i.e. having a permanent organic polymeric binder

Definitions

• This invention relates to an Objective therapy Compliance Measurement (OtCM) system that is incorporated in standard blister packs of, in particular, medication and is realised by means of electronic circuitry that is printed using polymer printing techniques.
• OtCM Objective therapy Compliance Measurement
• the solution to this problem may be found in the use of an electronic system that monitors the intake of medicine and crosschecks this with patient information that is stored in a database. Such a system needs to be able to read the information from the user's medication package and transmit this to a database no matter where the patient is located.
• the invention relates to a method and device for the objective measurement of the therapy compliance of patients who are undergoing prescribed medication therapy.
• the medication is provided in blister packages upon which a polymer- based electronic circuit is printed directly on the blister film or foil, using so- called intelligent system-in-foil or system-on-foil technology.
• the printed polymer circuit comprises a number of conductive tracks, which run under each blister so that when a pill is expelled from the blister breaking the foil seal, the corresponding track is broken. These tracks are connected to a silicon or printed polymer integrated circuit that records the event when a track is broken and stores this information, including the time of the event and the position of the blister and any other clinically relevant data.
• a polymer or electret microphone is used to detect the sound that is generated when a pill is expelled from a blister, breaking the foil seal in the process.
• the microphone is connected to a silicon or printed polymer integrated circuit that records the event when the seal is broken and stores this information, including the time of the event and the position of the blister and any other clinically relevant data.
• the electronic circuit also contains RFID (Radio Frequency IDentification) technology to enable the information stored in the integrated circuit to be accessed using an RFID reader.
• the integrated circuit of both embodiments can be programmed using the RFID interface during the blister filling phase with information about the filling medication, including unique codes to counteract counterfeiting, and logistical data.
• the circuit further comprises an antenna and a power source, both of which can be printed during the same, or a separate, system-in-foil and/or system-on-foil process or mounted as discrete components.
• the intelligent system-in-foil or system-on-foil in accordance with the invention replaces the standard film or foil currently used in the existing standard blister packaging manufacturing process.
• Figure 1 illustrates a normal medicine blister pack where (1) is the carrier in most cases aluminium foil, covering the film (2) material containing the compartments (4) and the openings (5) for the pills (7).
• Figure 2 shows the printed material on the carrier (1), including conductive polymer tracks (3), a printed or mounted power source (9), a printed or mounted antenna (10) and a dedicated polymer or silicon IC (6).
• Figures 3 and 4 illustrate the second embodiment of the invention where the conductive tracks are replaced by a microphone (11) embedded in the film (2) picking-up vibrations via the conduits (13) formed in the film (2) material and fed to the dedicated IC (12) supplied by the printed or mounted power source (9) on the same carrier as the antenna (10).
• Figure 5 illustrates the possible system-in-foil option where the printed and mounted material is covered by an additional foil (8), which can be realised for both embodiments of the invention.
• the invention relates to a method for monitoring at least one product, from a series of products for example, each of which is located at a predefined location, whereby when an article is removed from one of the pre-defined locations a signal is emitted, which signal is transmitted to a sensor, which contains or is connected to a signal processor such as an Integrated Circuit, in which the signal is measured and the measurement result is compared with the standard values for each of the circumstances that are stored in the IC such as the magnitude of the measurement result; period of time between successive measurements, and the like, whereby in the event that the standard value is exceeded by more than the permitted deviation a specific control code is generated which can be converted into an associated message for a display, radio transmitter or control memory, that can have contacts for making contact with a reader for reading and storing the
• control signal is linked with a display remotely via for example an antenna or by a "reader” that contains a remotely readable RFID (Radio Frequency IDentification) detector, that can display data from the control memory or transfer it to a databank, that is consulted by the observer for assessing the period of time between successive measurements respectively presence or absence and/or identity of each product.
• Integrated Circuit used in either or both embodiments of the invention is programmed using a unique algorithm, during or after the blister manufacturing process with unique identification codes, production parameters such as date and time, permitted storage temperature range, medication type, medication classification, expiration date and the like, for anti-counterfeiting and logistical purposes, as well as other clinically relevant data for the use of physicians and pharmacists.
• the invention also relates to a device for carrying out the method in accordance with the invention and a method for manufacturing the device.
• Similar methods and devices are known, such as for example from the international patent applications WO 03/090663, WO 03/055769, the American patent document 4,616,316 and the American patent document 6,628,199, along with which, the article "Electronic Compliance Packaging hits the market” from "Medical device link” of 9 November 2004, can also be mentioned.
• the objection is that numerous metal containing components with metal contacts are needed, that are connected to the frame by means of mainly metal contacts to the under layer of the usually sheet like carrier, which conductors usually are formed at least partially from metal, or conductive ink tracks or conductive organic materials printed on a support layer such as foil, which foil is glued to the under layer of the carrier.
• this device is expensive, and also the components, in particular the battery, are relatively heavy, so that the total package is large and cumbersome.
• carrying such a device is objectionable, and in addition the fact that such an expensive package is thrown away after use, in spite of the high price, makes the possible purchase and use of this device problematic for those with less financial means.
• the invention defines a method and a device that is manufactured in accordance with that method, that removes the aforementioned objections due to the fact in the embodiment of the invention illustrated in figure 4,
• the sensor contains at least one microphone (11) and that in the event of a deformation or breakage at a location of the compartment, cavity, shell, storage cell or the like, associated with product, a signal is emitted that is transmitted by the microphone (11) to a signal processor, such as an IC (12), which together with at least one microphone, is located on an under layer that is connected with the carrier, whereby the carrier preferably, at least partially, serves on the one hand to emit a signal upon deformation or breakage and on the other as a conductor.
• a signal processor such as an IC (12)
• the embodiment of the invention illustrated in figures 1 and 2 uses, in addition to, or instead of a microphone, an element that produces an electrical signal, such as a resistor, capacitor or the like, that connects to a conductive circuit (3) in the vicinity of each product, whereby the conductive circuit, that is mainly composed of organic materials such as polymers and preferably also the elements, IC (6) and antenna (10), are printed by means of a suitable printing technique such as a printing method (jet printing) or rotation offset method, in accordance with a prescribed route on a surface such as the fill of the carrier; In this way, a device can be produced simply and cheaply, that is suitable for mass production and general usage.
• a suitable printing technique such as a printing method (jet printing) or rotation offset method
• each package thereof is programmed for each type of medication, a number of blisters with individual characteristics, (colour, large print, audio signal or the like), obviates these human errors.
• the unique signals and/or a voltage will be emitted when at least one compartment wall is deformed or broken.
• a capacitor made of organic materials is as such already known from the aforementioned American patent application 82525 from 2005.
• the use of the method in accordance with the invention is particularly suitable for producing a device whereby the carrier consists of a multitude of compartments, whereby within each compartment some type of product can be stored and whereby, by placing a number of different products each in a predestined space or room and by comparing the unique signals, like special frequencies or sound tones or the like of deformation or of the break through of the specific elements, or of the specific walls of each predestined space or room as controlled by a specific hereto loaded program in the IC, which comparison results in operating signals for a sound or light alarm and/or messages or reports on a display and/or audible through radio or mobile telephone or the like and/or registered in the memory of a database;
• This further developed device is of great importance in particular for patients with conditions whereby the medication must be taken in a strict order and in a short fixed timeframe.
• a light or sound signal can be emitted if a product is erroneously taken out or when the space wall containing a product that not yet has to be taken out according to the prescription is being deformed or an alarm signal, such as a sound or light flash is generated and/or a message on a display warns the user that he is taking a wrong product and gives an advice to wait for the right time or choose an other product according to the prescription.
• a display that consists of electronic cells that are composed of organic materials, to make it clear to a patient that it is time to take a specific medication, whereby the packaging reacts if the wrong choice is about to be made by accident, so that the patient is prevented from making the mistake.
• Packaging for medication for example whereby a signal is given when it is time to take medication are already known as such from the International patent application WO 73977 from 2003 for example, while electronic monitoring of therapy compliance with the aid of separate signal processing devices and databanks is known from the American patent document 4.178.112 or the American patent document 4.616.316.
• none of these known proposals is the use of microphones and/or of electronic systems that are composed of the aforementioned printed polymers known.
• a temperature sensor is added to one or more of the signal sensors such as the microphones too, that monitor the quality of the product in the event that it is sensitive to temperatures that are too high or too low.
• the sensed under- and overload is detected by the sensor connected to the IC generates an error signal.
• the invention consists of a package whereby at least one element consists of a capacitor that can be charged that is composed of at least two layers of suitable polymers, that when deformed and/or torn generates a current peak with an associated certain magnitude, large enough to activate the elements connected to the chip, and a certain frequency, that indicates the position of the product and whether it is absent or present.
• the packaging in accordance with the invention is in the form of a so-called blister pack and the products are medication, whereby the pattern (3) is printed on the foil (1), which foil is used to seal the openings (5) in the compartments (4) that are formed in the film (2) and which contain the medication (7).
• This packaging is particularly suitable for measuring the therapy compliance of a patient, who is supposed to take medication that has been prescribed by the doctor and/or dispensed by a pharmacist in accordance with a prescribed order and at prescribed time intervals.
• Figure 1 illustrates the front side of a blister with compartments (4), which are filled with pills (7) which can be expelled from the blister via openings (5) in the film (2), which openings are sealed with foil (1);
• Figure 2 illustrates the rear side of such a blister pack whereby the foil (1) a pattern of conductive tracks (3) have been printed in such a way that when the pills (7) are expelled via the openings (5) the conductive track under the opening is broken and this break in the conductive track is detected by the integrated circuit (6);
• Figures 3 and 4 respectively illustrate the front and rear sides of a similar blister pack whereby conduits (13) have been formed in the film (2) during the manufacturing process.
• a microphone (11) is mounted in the film (2) or on the foil (1). When a pill (7) is expelled from the blister via the openings (5) the vibrations are guided by the conduits (13) to the microphone material (11).
• the microphone (11) is connected to a dedicated IC (12).
• Figures 2 and 4 illustrate the use of a printed or mounted power source (9) for supplying the IC and show a printed or mounted antenna (10) for RFID communications.
• Figure 5 illustrates the option for manufacturing either or both embodiments of the inventions in a system-in-foil process.

Priority Applications (1)

Applications Claiming Priority (2)

Publications (1)

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Family Applications After (1)

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• 2006
  • 2006-09-01 EP EP20060783902 patent/EP1933801A2/de not_active Withdrawn
  • 2006-09-01 EP EP20100185222 patent/EP2269561A1/de not_active Withdrawn
  • 2006-09-01 WO PCT/NL2006/000435 patent/WO2007043858A2/en active Application Filing

Non-Patent Citations (1)

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