EP1656923A1 - Apliccator device for medicament (Device for registering the individual adherence) - Google Patents

Apliccator device for medicament (Device for registering the individual adherence) Download PDF

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Publication number
EP1656923A1
EP1656923A1 EP20050022183 EP05022183A EP1656923A1 EP 1656923 A1 EP1656923 A1 EP 1656923A1 EP 20050022183 EP20050022183 EP 20050022183 EP 05022183 A EP05022183 A EP 05022183A EP 1656923 A1 EP1656923 A1 EP 1656923A1
Authority
EP
European Patent Office
Prior art keywords
application device
characterized
container
according
sensor unit
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Withdrawn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
EP20050022183
Other languages
German (de)
French (fr)
Inventor
Manuel Dr. Hermann
Michael Prof. Dr. Diestelhorst
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.)
Diestelhorst Michael
Original Assignee
Diestelhorst, Michael
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to DE200420017459 priority Critical patent/DE202004017459U1/en
Application filed by Diestelhorst, Michael filed Critical Diestelhorst, Michael
Publication of EP1656923A1 publication Critical patent/EP1656923A1/en
Application status is Withdrawn legal-status Critical

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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
    • 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
    • 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

Abstract

The invention relates to an application device for liquid medicaments with a container for receiving the medicament and with a miniaturized sensor unit for detecting individual parameters of an application of the liquid medicament from the container.
The object underlying the invention is achieved by further development of the generic application device in that the sensor unit has at least one microprocessor, has a flexible film pressure sensor, and thereby can be variably adapted to a wide variety of drug containers (e.g., eye dropper bottles) without having to modify the container. Advantageous developments of the invention can be found in the characterizing features of the subclaims.
According to the invention, the detection system is microprocessor-controlled, d. H. freely programmable. According to one embodiment of the invention, the sensor unit by means of the microprocessor is freely programmable with respect to the recording of parameters that characterize the circumstances and type of application, such as temperature, applied pressure, number of drip tests, dose, time data.
The device is needed to record the frequency and regularity of drug administration because it is the sole responsibility of the patient. Thus, on the one hand, the application device makes it possible to detect or determine the so-called adherence, ie to follow the therapy recommendation by the patient and, if necessary, to be able to influence the patient to apply the medication regularly. On the other hand, the application device can be used within the framework of pharmacological approval and / or comparative studies, since its significance is significantly improved by knowledge of the individual adherence.

Description

  • The invention relates to an application device for liquid medicaments with a container for receiving the medicament and with a miniaturized sensor unit for detecting parameters of an application of the liquid medicament from the container.
  • The device is needed to record the frequency and regularity of drug administration because it is the sole responsibility of the patient. Thus, on the one hand, the application device makes it possible to detect or determine the so-called adherence, ie to follow the therapy recommendation by the patient and, if necessary, to be able to influence the patient to apply the medication regularly. On the other hand, the application device can be used within the framework of pharmacological approval and / or comparative studies, since its significance is significantly improved by knowledge of the individual adherence.
    From "Arch Ophthalmol" - Vol. 102, Oct. 1984, pages 1550-1554, "A Miniature Compliance Monitor for Eyedrop Medication" is known an application device for eye drops which detects the date and time of administration of the eye drops over a several week period allowed. The data thus acquired were stored and could be subjected to evaluation.
  • In this application device known from the prior art, the sensor unit is arranged inside the medicament container (eye drop bottle). However, the installation of the sensor unit in the container is connected with the greatest effort and leads to high costs of the application device. A new bottle must be developed and approved for each drug, as the sensor unit can not be separated from the medication container. The continuous sterility of the drug is also not guaranteed by the sensor. The known prior art version is immovably connected to the drug container and thus can not be used for other containers (disposable).
  • In the "American Journal of Ophthalmology", Vol. 5, Nov. 1974, pages 774-778 "Medication Monitor for Ophthalmology" by Robert D. Yee, Pierre M. Hahn and Robert E. Christensen known application device, the sensor unit is housed in a housing having a closable with a lid chamber for receiving of the container, and the housing for the monitor is arranged laterally next to the bottle. However, these application devices are bulky and large. This is incompatible with a practical and simple application by the patients (jacket pocket). These devices have in common that not the application itself is recorded, but only the removal of the drug container from a housing, so the date and time of removal, not the application as such.
  • The present invention is therefore based on the object to provide an application device of the type mentioned above, which makes it possible to detect the application itself, their circumstances and nature as well as their time and period. This is simple and inexpensive to manufacture and therefore practical. It can be combined separately with a variety of conventional drug containers without having to modify their shape and drug approval. In addition, due to its small volume and weight, it can be transported on the move without affecting the patient.
  • The object underlying the invention is achieved by further development of the generic application device in that the sensor unit has at least one microprocessor, having a flexible film pressure sensor, and thereby variably to a variety of drug containers (eg eye dropper bottles) can be adapted without having to modify the container. Advantageous developments of the invention can be found in the characterizing features of the subclaims.
  • According to the invention, the detection system is microprocessor-controlled, d. H. freely programmable. According to one embodiment of the invention, the sensor unit by means of the microprocessor is freely programmable with respect to the recording of parameters that characterize the circumstances and type of application, such as temperature, applied pressure, number of drip tests, dose, time data.
  • According to the invention, it is possible to adapt the detection system of parameters of the application of a drug to the needs of the patient or a medical study, without having to carry out structural changes.
  • The inventive integration of new sensors or signal generator is made possible in a cost effective manner. It is not detected as before the removal of the drug container from a housing or the opening of a screw cap, but the actual application itself and additional parameters that characterize the circumstances and nature of the application comprehensively.
  • According to the invention, a novel housing design for the microprocessor-controlled sensor unit is proposed, in which a housing receiving the sensor unit is attached to the outside of a wall of the container. In this way, commercial containers can be used without damage or modification and equipped with the sensor unit.
    In particular, contact with the drug is excluded at any time.
  • First, a bottom-side, arranged outside the container sensor unit allows the use of conventional drug containers, such as small plastic bottles, which are known for example for eye drops, nasal sprays, etc. and can be produced inexpensively due to their large quantities.
  • A costly insertion of the sensor unit in the bottle is not necessary. Existing production facilities for the production of these containers or bottles can without any modifications to the appropriate forms, eg. As molds, continue to be used. Also, the filling of the bottles with a drug can be performed on existing machines without modification and the drugs remain sterile. According to the invention can container with content and sensor unit initially completely separate from each other and are joined together only after the application device. As a result, the sensor unit is separately reusable.
  • Furthermore, appears through the bottom-side arrangement of the housing, the cross section merges in a preferred embodiment, continuously in the cross section of the container or the bottle, the application device as a conventional drug bag, which only has a slightly greater height.
  • Often the containers for liquid drugs are small bottles with a round cross section, but may also have other cross sections (for example, oval or angular). With a round cross-section, the housing for the sensor unit could also be cylindrical and have the same diameter as the corresponding bottle. As a result, in each case the same cross-sections, the housing for the sensor unit would connect to the bottle steplessly.
  • The application device according to the invention is therefore a bottle-like container with a closable opening, a bottleneck, and a bottle body having an upper and a lower chamber. The upper chamber is for receiving the drug, while in the lower chamber, the sensor unit is housed. The upper chamber, the bottleneck and the closable opening can, as already mentioned above, be formed by a conventional medicine bottle. The application device thus corresponds, apart from the slightly larger height, of conventional medicine bottles and therefore, like these, can be used without restriction.
  • Preferably, a fastening means is provided which holds the housing and the container together. The fastening means may be, for example, an adhesive, by which the housing is glued to the container with the sensor unit therein. The fastener is designed so that the housing and the container are not damaged when connecting. Thus, the drug contained in the container remains unaffected and can then be readily used. Also, the fastener is suitably such that the housing and at least significant parts of the sensor unit remain undamaged when the housing and container are separated from each other, for example, the sensor unit for a new To be able to use the bottle again.
  • A preferred possibility is that the fastener comprises a foil that spans containers and housings. The film engages under tension the container and the housing disposed thereon such that a release of the housing from the container without cutting or destroying the film is not possible. For example, a shrink wrap placed around containers and casings at room temperature and permanently contracting upon heating could be used or an elastic adhesive sheet.
  • In a preferred embodiment, the sensor unit comprises an internal power source, which may be formed for example by a battery or a rechargeable battery. The internal power source does not need to supply power to the sensor unit from the outside by cables or the like, whereby the application device can be used like a conventional drug container without any handling problems with a cable connected thereto. In order to easily exchange the internal power source, the housing expediently has a detachable lid.
  • Preferably, the sensor unit comprises at least one microprocessor, which unites a plurality of components of the sensor unit. The microprocessor may combine a flash program memory, an oscillator, a voltage stabilizer, an A / D converter, a data memory (eg, data EEPROM), a timer, and optionally other components.
  • In order to trigger the data stored on the microprocessor and to be able to configure the microprocessor, a data interface is preferably provided, by means of which the sensor unit can be connected, for example, to a PC in a simple manner. This connection can also be wireless.
  • When connected to a cable, the housing can have an opening for a plug, so that a simple, fast connection of the sensor unit to the PC is possible. In addition, the data interface can have a connection for energy transmission, by means of which the internal energy source constructed as a rechargeable battery can be charged.
  • In a preferred embodiment, the sensor unit comprises at least one force / pressure sensor, by which a deformation of a side wall and / or the bottom of the container can be detected. Typically, a liquid drug is applied by the bottle receiving the drug on the sidewall or ampoule Ground is compressed. By squeezing the bottle, the liquid drug is forced out of the bottle and usually comes dropwise from an opening which can be closed by a lid or closure.
  • Additionally or alternatively, other contacts or switches may be used as the application signal generator.
  • The force / pressure sensor may have at least one preferably elastic film sensor for force / pressure measurement (film pressure gauge), which is preferably attached to a wall of the container. Upon deformation of the wall, the foil pressure gauge is also deformed, resulting in a signal that is captured and stored by the microprocessor.
  • Furthermore, the sensor unit may comprise a position sensor, by means of which it is possible to determine whether the bottle or the container is standing upright or occupying a position deviating from the upright position. The position sensor can be designed as a tilt switch or as an acceleration sensor (gravitational sensor). When the patient tilts the bottle and presses it to allow the drug therein to drop from the opening for application, the position sensor detects the tilted position and the force / pressure sensor simultaneously detects the pressure applied to the bottle. The characteristic chronological sequence of the signals of the position sensor and the force / pressure sensor is registered by the microprocessor and is stored as a running application.
  • Furthermore, the sensor unit may comprise a temperature sensor. This temperature sensor makes it possible to detect the course of the temperature to which the drug is exposed over a long period of time. Different drugs are e.g. allowed for storage only under defined temperature conditions. Exposure to heat (for example, in a car) can overheat a drug to the point where it loses all or part of its pharmacological properties and may no longer be functional.
  • At least one of the above-mentioned sensors (force / pressure sensor, position sensor, temperature sensor) or other sensors for detecting further parameters may be formed as a digital sensor that generates a digital signal that can be read in directly by the microprocessor as such.
  • In a preferred embodiment, the sensor unit comprises a signal generator, the z. B. may be formed as an acoustic and / or optical signal generator. In the case of an acoustic signal transmitter, a piezo beeper can be used. The signaler can be used to remind the patient to use the medicine. The signal generator is preferably activated by the microprocessor via the individual program. For example, if no deformation of the wall has been detected for a long time, the microprocessor issues an activation command to the signal generator. Also, the signal transmitter may transmit signals or data to a reporting device, such as a mobile phone, which then prompts the patient via a standard message to apply the medication.
  • Thus, the application device can not only be used to detect the time of application of the drug, but also actively influence the adherence of the patient.
  • Reference to the embodiments illustrated in the figures, the invention is explained in detail.
  • Show it:
  • FIG. 1
    a first embodiment in an exploded view;
    FIG. 2
    a second embodiment in the assembled state.
  • Figure 1 shows an application device, which is designated in its entirety by 1. The application device 1 comprises a container 2, which is designed here as a plastic bottle, and a housing 3 for a sensor unit 4. The bottle 2 and the housing 3 have a round cross section, each having the same diameter. The diameter of the cylindrical housing is about 20 mm and depends on the diameter of the bottle 2. The height of the housing is about 18 mm and can be chosen smaller / larger, if the space required by the sensor unit permits / requires. The total weight of the application device, including 3-10 ml for the drug, is preferably below 25 (twenty-five) grams.
  • The sensor unit 4 comprises a printed circuit board 5 on which a microprocessor or microcontroller 6, a position sensor 7 and a temperature sensor 8 are arranged.
  • Adjacent to the circuit board 5 is a battery 9, a lithium battery with a voltage of 3 volts, which is held by brackets 10 to the circuit board 5. By using SMD components, the height and the required cross-sectional area of the sensor unit 4 can be reduced / modified.
  • The sensor unit 4 further has a force or pressure sensor 11 which comprises a flat, flexible film pressure gauge 12. The foil pressure gauge 12 is connected via cable 13 to the circuit board 5. A detachable closure lid 14 allows a quick replacement of the battery 9. Through a data interface 15 in the form of a plug, the sensor unit 4 can be quickly connected to a PC (not shown).
  • FIG. 2 shows an application device 1 in the assembled state. The film pressure sensor 12 is fixedly connected to a side wall 16 of the container 2. The cable 14 is flat against the housing 3 or on the side wall 16. An opening 17 allows a connection between PC and data interface 15 without opening the housing.
    About a film 18, which is shown in dashed lines in Figure 2, housing 3 and container 2 are held together. The film is placed under tension on the housing 3 and the container 2 and gives the application device 1 the appearance of a conventional medicine bottle. A label not shown here can be stuck to the film in order to identify the contents of the container and, as far as the film is transparent, to cover the force / pressure sensor and the housing.
  • The application device 1 according to the invention can be used like a well-known medicine bottle for eye drops, for example. By turning off a closure 19, the container 2 can be opened. By turning the bottle over and pressing it lightly on a wall 16, the drug in the container drips out of it. Date, time, pressure on the side wall and the position of the container are recorded and stored.
  • This data can be used to individually document whether and when the drug has been used. The data from the temperature sensor can also be used to understand what temperatures the drug was exposed to.

Claims (18)

  1. Application device (1) for medicaments, with a container (2) for receiving the medicament and with a sensor unit (4) for detecting parameters of an application of the medicament from the container, characterized in that the sensor unit (4) has at least one external force / Pressure sensor (11), by which a deformation, preferably a wall (16) of the container (2) is detectable.
  2. Application device (1) according to claim 1, characterized in that the force / pressure sensor (11) comprises at least one preferably flexible foil pressure gauge (12) which is externally attached to a wall of the drug container (16).
  3. Application device (1) according to one of claims 1 to 2, characterized in that the sensor unit (4) comprises a position sensor (7).
  4. Application device (1) according to one of claims 1 to 3, characterized in that the sensor unit (4) comprises a temperature sensor (8).
  5. Application device (1) according to one of claims 1 to 4, characterized in that at least one of the sensors (7, 8, 11) is designed as a digital sensor.
  6. Application device (1) according to one of claims 1 to 5, characterized in that the sensor unit (4) is housed in a separate housing (3) which is arranged on the outside of a wall of the container, without coming into contact with the drug and without injuring the outer wall of the medicine container.
  7. Application device (1) according to one of claims 1 to 6, characterized in that the sensor unit (4) is housed in a separate housing (3) which can be manufactured separately from the medicament container and reused.
  8. Application device (1) according to one of claims 1 to 7, characterized in that the medicament container is designed as a conventional dropper bottle suitable for liquid medicaments.
  9. Application device (1) according to one of der'Ansprüche 1 to 8, characterized in that the sensor unit (4) comprises a signal generator, preferably an acoustic and / or optical signal generator.
  10. Application device (1) according to one of claims 1 to 9, characterized in that the sensor unit (4) has at least one microprocessor (6).
  11. Application device (1) according to one of claims 1 to 10, characterized in that the sensor unit (4) by means of the microprocessor (6) is freely programmable with respect to the recording of parameters that characterize the circumstances and type of application, such as temperature, applied pressure, number of drip tests, dose, time data.
  12. Application device (1) according to one of claims 1 to 11, characterized in that the sensor unit (4) has a data interface (15) for reading out data stored on the microprocessor (6) and for configuring the microprocessor (6) and for wireless transmission an external signaling device and / or PC has.
  13. Application device (1) according to one of claims 1 to 12, characterized in that a fastening means (18) is provided which holds the housing (3) and the container (2) together.
  14. Application device (1) according to claim 13, characterized in that the fastening means comprises a film (18) spanning the container (2) and the housing (3).
  15. Application device (1) according to claim 1 to 14, characterized in that in cross-section, the housing (3) steplessly connected to the container (2).
  16. Application device (1) according to one of claims 1 to 15, characterized in that the housing (3) has a detachable lid (14).
  17. Application device (1) according to one of claims 1 to 16, characterized in that the housing (3) has an opening (17) for an electrical connection.
  18. Application device (1) according to one of claims 1 to 17, characterized in that the sensor unit (4) comprises an internal energy source (9).
EP20050022183 2004-11-10 2005-10-12 Apliccator device for medicament (Device for registering the individual adherence) Withdrawn EP1656923A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
DE200420017459 DE202004017459U1 (en) 2004-11-10 2004-11-10 Application device for pharmaceuticals

Publications (1)

Publication Number Publication Date
EP1656923A1 true EP1656923A1 (en) 2006-05-17

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EP20050022183 Withdrawn EP1656923A1 (en) 2004-11-10 2005-10-12 Apliccator device for medicament (Device for registering the individual adherence)

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DE (1) DE202004017459U1 (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104884956A (en) * 2012-10-23 2015-09-02 卡利凯尔公司 Portable management and monitoring system for eye drop medication regiment
US10366207B2 (en) 2015-02-12 2019-07-30 Kali Care, Inc. Monitoring adherence to a medication regimen using a sensor
US10441214B2 (en) 2015-01-29 2019-10-15 Kali Care, Inc. Monitoring adherence to a medication regimen using a sensor

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KR20070041077A (en) * 2005-10-14 2007-04-18 한미약품 주식회사 Eye-drop case with temperature sign

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104884956A (en) * 2012-10-23 2015-09-02 卡利凯尔公司 Portable management and monitoring system for eye drop medication regiment
CN104884956B (en) * 2012-10-23 2018-07-06 卡利凯尔公司 For the portable management of eye drops medicine group and monitoring system
US10152867B2 (en) 2012-10-23 2018-12-11 Kali Care, Inc. Portable management and monitoring system for eye drop medication regiment
US10441214B2 (en) 2015-01-29 2019-10-15 Kali Care, Inc. Monitoring adherence to a medication regimen using a sensor
US10366207B2 (en) 2015-02-12 2019-07-30 Kali Care, Inc. Monitoring adherence to a medication regimen using a sensor

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